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NECSS and SfSBM: A weekend of science and skepticism

Science Based Medicine - Sat, 02/28/2015 - 10:37

A day of Science-Based Medicine, a weekend of science and skepticism

Registration for NECSS, the North-East Conference on Science and Skepticism, is open. Included in the program will be a day of Science-Based Medicine.

Full Conference schedule here with Bill Nye as the Keynote speaker.

SfSBM speakers will be Harriet Hall, Jann Bellamy, David Gorski, Steve Novella and Mark Crislip.

SfSBM speakers will also participate in panels on the 11th and 12th.

NECSS will be held April 9th–12th, 2015, in New York City at the Fashion Institute of Technology.

Description: NECSS welcomes over 400 attendees to New York City for a celebration of science and critical thinking. Through individual presentations, panel discussions, and performances, attendees are informed and inspired by leading scientists, educators, activists, and performers – each bringing their own perspective and passion to the goal of fostering a more rational world.

The SfSBM program will be Friday, April 10 and you can attend one or more of the days. $95 for one day or $195 for the entire conference.  The target audience of the SfSBM presentations will be the general population.

Preliminary SfSBM Program  (Updated 2.15.15, subject to change)

09:00 – 10:00 60 minutes Registration/Will Call
10:00 – 10:10 10 minutes OPENING: Steve Novella and David Gorski
10:10 – 10:45 35 minutes: Steve Novella. SBM – Going Beyond Evidence-Based Medicine.
10:45 – 11:20 35 minutes: Harriet Hall. Chiropractic.
11:20 – 11:55 35 minutes: David Gorski. Integrative Medicine
11:55 – 12:30 35 minutes: Mark Crislip. How Acupuncture ‘Works’
12:30 – 02:00 90 minutes LUNCH
02:00 – 02:35 35 minutes Speaker 4: Jann Bellamy. Political Pseudoscience
02:35 – 03:35 60 minutes Panel 1 Discussion
03:35 – 03:50 15 minutes BREAK
03:50 – 04:35 45 minutes Q&A from Twitter & Audience
04:35 – 05:20 45 minutes SBM Jeopardy
05:20 – 05:30 10 minutes CLOSING
05:30 – 06:00 30 minutes SBM Business Meeting

For more information and to register, go to NECSS or this registration page.

The Society for Science-Based Medicine is a co-sponsor of NECSS and paid SfSBM members can get a 15% discount using the code SFSBM2015.

Also at NECSS

 SGU Skeptical Extravaganza with guest star Bill Nye

 April 10, 2015 @ 7:30PM

Haft Auditorium, 227 W. 27th St., NY, NY 10001

Cost: $25 general public / $15 NECSS attendees

Website: www.necss.org/extravaganza

Special guest Bill Nye joins multi-talented musician George Hrab and the award-winning Skeptics’ Guide to the Universe podcast for a two-hour stage show celebrating science, skepticism, and everything geeky (including the ever-popular quiz show). Best of all, tickets are open to the general public; conference registration is not required to attend!

Categories: Medicine, Skepticism

SSPE: A Deadly and Not-That-Rare Complication of Measles

Science Based Medicine - Fri, 02/27/2015 - 09:00

From the CDC Public Health Image Library #132 via the Wikimedia commons. Child with classic measles day-four rash.

As a pediatrician, even one who has spent the majority of his career caring only for hospitalized children, the death of a patient has been a rare occurrence. There are certainly some pediatric specialties, such as intensive care and oncology, that because of the nature of their patient population must develop a more intimate relationship with the end of life. But compared to the adult world, even their exposure pales in comparison. The most common form of pediatric cancer, acute lymphoblastic leukemia, has a cure rate that is over 90% for example – making the unnecessary death of Makayla Sault after some worthless “treatment” at the Hippocrates Health Institute all the more tragic.

A bit more common in pediatrics are the patients that require significant intervention, and who may come close to death, but recover thanks to advances in modern medicine. These patients, however, are dwarfed by the number of children who receive routine hospital care and recover fairly uneventfully. And most children emerge into adulthood having never had more than a few self-limited viral illnesses and maybe a cavity or two. This wasn’t always the case. In 1900, 10% of 1-year-old children would not make it to adulthood.

I remember every patient that has died while I took part in their care, the bulk of which occurred during my residency training over a decade ago. Their names are lost to time but not their faces, and certainly not the lasting emotional impression they made on me. My experiences with patients who did not survive have changed the way I think about and practice medicine, and significantly influenced the way I approach life in general.

During my first rotation as a resident in the pediatric intensive care unit, seven children died. This was a bad month even for a large academic facility. One young girl suffered a catastrophic injury to her brain because of a rare complication of infection caused by eating improperly cooked hamburger at a church picnic. And a newborn infant just a few days home from the hospital was accidentally smothered by her parents while sleeping between them in bed. I won’t list them all, but I would hope that it is clear why this month stands out in my mind as the worst of my career so far, and why to this day I have a deep and unwavering hatred for all-terrain vehicles.

Lately I have been thinking a lot about one of the children that died that month. I only knew him and his family for a short time but the course of his illness had been long and exceptionally tragic, and he had been brought to the hospital to die. Over the roughly two years prior to his death, this previously healthy and thriving teenager had slowly but steadily deteriorated, beginning with his parents noticing that his temperament had changed and that his grades were dropping. They thought that maybe he had started experimenting with drugs.

As the months passed, his condition worsened. His ability to think became more and more impaired and he began to have odd muscle spasms, eventually losing the ability to even walk or care for himself. He lost the ability to speak and then to swallow, becoming dependent on nutrition administered through a tube surgically inserted directly into his stomach. By the time of his last admission to a hospital, he was in a persistent vegetative state. His brain began to shut down, his drive to breathe became erratic.

The cause of his deterioration had been diagnosed by the time I knew him. It wasn’t related to a traumatic injury or stroke, and it wasn’t because of an infection in his brain, at least not a new one. It was actually the result of what some would consider a mild illness of childhood – no big deal even.

In reality this infection is one of the most common causes of death in children around the world and has only recently re-entered general public awareness in the United States thanks to widespread media coverage of a large cluster of cases centered at Disneyland. I’m of course talking about measles. The complication that ended my patient’s life in such a tortuous way is called subacute sclerosing panencephalitis or SSPE.

What is SSPE?

Measles can make children very sick, primarily when one or both of two organs are involved: the lungs and the brain. Pneumonia associated with measles, which can occur in as many as 1 out of every 20 young children who acquire the infection, is the most common culprit in fatal cases. But inflammation of the brain, called encephalitis, can kill during the initial illness or leave a child with permanent cognitive impairment or hearing loss. SSPE occurs when infection of the brain becomes clinically apparent years later, often after an otherwise mild and uncomplicated case.

Acute encephalitis occurs when the immune system reacts to measles virus that has found its way into the central nervous system. But the immune system doesn’t always respond aggressively. In some cases, a mutation occurs in the virus which renders it unable to produce certain proteins that would have served as a signal flare. In addition, particularly in children less than 2 years of age, an immature immune system simply fails to respond.

Regardless of the specific reason, measles virus is allowed to remain in neural tissue relatively unchecked and it slowly proliferates under the radar as the years go by. Eventually, usually in the ballpark of 6 to 8 years later, the progressive inflammatory process becomes clinically apparent. Death is almost certain and occurs within 1 to 3 years of diagnosis in most cases, although there are case reports of more rapid progression as well as the occasional patient who survives.

How does SSPE present?

The early stages of SSPE are subtle and often confused with other issues. As with my patient, it often begins with behavioral changes, such as irritability, and mild memory problems that mimic psychiatric conditions or drug use. As the condition progresses, central nervous system control of the muscles is affected. This leads to involuntary muscular activity in the form of spasms or rapid jerking movements. Seizures and impairment of vision are also common.

Eventually in most cases the ability to walk becomes impaired. Loss of motor control also tends to affect the ability to speak and swallow, which increases the risk of aspirating. Continued decline in cognitive capabilities occurs. Dementia, coma and a persistent vegetative state represent the final stages of the illness, with death resulting when the brain loses control of vital functions like breathing and cardiovascular regulation.

How is SSPE diagnosed and treated?

The diagnosis of SSPE requires clinical suspicion, especially in an area where measles rates are low. This currently still includes the United States but that may change if the ongoing increase in cases we are seeing continues. When a patient has signs and symptoms consistent with SSPE, the next step is usually imaging of the brain and obtaining an EEG. Results of these studies are often non-specific, although there are some EEG findings considered to be fairly consistent with the diagnosis. Testing the patient’s blood and spinal fluid for evidence of an immune response in the form of anti-measles antibodies (IgG) plays a role, as does PCR testing, which can reveal the presence of actual virus.

A variety of antiviral drugs have been tried over the years, as well as potent immune-suppressing medications, without significant success. If started very early in the course, preferably before there is significant cognitive impairment, there is a chance that treatment might slow the progression of symptoms. These therapies, when helpful, must be taken for the duration of the patient’s life. Unfortunately, there is no cure for SSPE.

Who gets SSPE and how common is it?

From the PMC 2640885, “Subacute sclerosing panencephalitis, a measles complication, in an internationally adopted child”, via the Wikimedia commons. Initial (A & B) and three-month (C & D) presentation of a thirteen-year-old adopted child with SSPE.  C & D show widespread shrinking of the brain tissue.

Where there is more measles, there is more SSPE. In regions where vaccine uptake is high, such as the United States, the incidence is extremely low with roughly ten cases diagnosed per year total. In developing regions where measles remains endemic and common, SSPE is diagnosed at a rate of 20 per million people. But this data likely doesn’t reflect the true risk considering that many cases will go undiagnosed.

The last large outbreak of measles in the United States occurred from 1989 to 1991 with over 55,000 cases reported. Most of the cases involved unimmunized preschool children. 11,000 patients were hospitalized and 123 died, which was consistent with the expected 1-2 deaths per 1,000 cases. Worse actually.

In 2005, CDC researchers combed through medical records and tested available brain tissue samples from patients diagnosed with SSPE. They wanted, using modern PCR technology, to determine the rate of SSPE specifically in patients who were infected with measles during the outbreak from 1989 to 1991. Their results revealed a risk of 1-2 per 10,000 cases, which was 10-fold higher than prior estimates.

Conclusion

Even considering the recent increase in measles cases in the United States, it is still a very rare condition. And SSPE is an uncommon sequelae, although perhaps not as uncommon as historical estimates would have us believe. But measles is not rare in many regions of the world, and our attempts at eliminating it have stalled. Worldwide measles deaths actually increased from 2012 to 2013 and the number of cases in some developed nations is increasing.

SSPE is a horrific potential complication of infection with measles that can arise years after even an uneventful case. No child should have to suffer through it and no parent should have to worry about their child developing it. And although there is no effective cure for the condition, there is a highly safe and effective vaccine which can prevent it.

 

 

Categories: Medicine, Skepticism

What Color Is This Dress? It’s An Optical Illusion

Neurologica Blog - Fri, 02/27/2015 - 07:57

This is pretty amazing – almost as much for how quickly this has gone viral as for the effect itself. There is now an intense debate going on in the intertubes over whether this dress is black and blue or white and gold. Take a look and decide for yourself. Buzzfeed has a poll which currently puts it at 72% white and gold, and 28% black and blue. Right now there are about 2 million votes, so that is probably statistically significant.

I see black and blue, no matter what screen or version of that picture I look at. It does not seem to be an issue with the monitor or viewing conditions.

The reason, in my opinion, this has gone so viral so quickly is that people are legitimately freaked out by the realization that how they see the world is ultimately a subjective construction of our brains. Taylor Swift tweeted about the debate:

“I don’t understand this odd dress debate and feel like it’s a trick somehow. I’m confused and scared. PS It’s OBVIOUSLY BLUE AND BLACK.”

That about sums it up. She thinks it must be a trick (it is – a trick of the brain), and is scared and confused. At the same time she is caps-lock-certain that her perception of the dress’s color is the objective truth.

This is clearly an optical illusion. The type of illusion is called color constancy. Our brains evolved to favor consistency over accuracy, in both memory and perception. If we see a tiger running through a sun-dappled forest, it’s important that we perceive a constant entity, not a morphing and changing image.

The actual color that falls upon our retina will change dramatically in different lighting conditions. This might trick a perceptive system into thinking that one item is actual multiple items, divided along lines of shade and light. In order to perceive the item as the single continuous thing that it is, our brains evolved color and shading correction algorithms White, for example, will appear blue in dark light, but our brains still see white – it corrects the blue perception into white.

Here is a black and white version of this illusion – the checkerboard illusion. The shade of squares A and B are identical, but our brains see them as light and dark. It makes assumptions about shading, and then corrects for the shadow effect, so that we correctly perceive the light squares as light, even when they are in shadow.

Below is a really intense color illusion. The blue and green stripes are actually the exact same color. Our brains perceive them differently because of the surrounding colors, which force our brains to make different assumptions about shading, and therefore they correct the color in opposite directions.

The dress is a similar color constancy illusion, but is also an ambiguous stimuli illusion. Ambiguous optical illusions are ones in which our brains are given conflicting information, or there are different ways to resolve the image that are equally valid. Remember the spinning girl illusion? This remains one of my most popular posts, for the same reason this dress controversy has gone viral. Our brains can make different assumptions to “see” the girl spinning clockwise or counterclockwise. There are lots of this type of illusion – is it a young girl or old woman, which way are the cubes facing, do you see a wine glass or two faces, etc.

The photo of the dress just happens to hit the sweet spot of ambiguity in terms of lighting and shading. Different people’s brains will therefore make different assumptions and correct for either apparent overexposure or underexposure. Do you have to correct for the glare of bright lights, or the dulling of colors because of shade? Remember, white appear blue when it is shadowed, and our brains correct the blue to white.  Our brains can correct the reflective part of the dress darker to be black, or the dark parts of the dress lighter to appear gold.

Conclusion

This is a fun viral phenomenon, and one that is a useful teaching moment. The dress color debate is the result of an optical illusion. Don’t be “scared and confused,” this is just how our brains work.

I want to emphasize that this is not just a isolated weird case. This is how our brains work all the time. What we perceive is a constructed illusion, based upon algorithms that make reasonable assumptions about distance, shading, size, movement, and color – but they are assumptions, none-the-less, and sometimes they can be wrong or misleading.

By the way, it appears that the dress is objectively black and blue (see the photos here), which means that 72% of people are correcting in the wrong direction.

Categories: Medicine

The Straw Protocol: A Chiropractor’s Aggressively Promoted Neuropathy Treatment

Science Based Medicine - Fri, 02/27/2015 - 00:01

Full-page ads promoting free dinner seminars addressing the topic of “Non-surgical, drug-free approach to relief from Peripheral [sic] Neuropathy [sic]” appeared last year on at least nine Sundays in the main news section of the print edition of The Los Angeles Times. The seminars were scheduled at various restaurants in Orange County, Los Angeles County, and Inland Empire.

The Los Angeles Times claims a Sunday circulation of 962,192 and a readership of two million for the Sunday main news section. The cost of full-page ads in the main section of Sundays varies, but I was given a quote of $32,500 by an advertising consultant for the paper.

The ads included on their upper left, in small print, the words “HEALTH TODAY” and on the same line—though perhaps less noticeably—at the far right of the page the word “ADVERTISEMENT.” In a much larger font was the headline:

Do You Suffer from One Of These Seven Symptoms Of This Often Misdiagnosed Problem?

It was followed by this subtitle:

Tens of Millions Suffer And Often Don’t Know Where to Turn

The ads indicated that discussion at the seminars would include:

  • What REALLY causes Peripheral [sic] Neuropathy [sic]
  • Three crippling effects of Neuropathy [sic]
  • Dangers associated with medications
  • The Straw Protocol, which utilizes proprietary treatment methods and provides outstanding results for people who suffer from Neuropathy

The ads warned that seating at the dinner seminars would be limited and instructed readers to call for a reservation and to provide the RSVP code in the ad (apparently to enable the marketer to keep track of where each caller found out about the seminars). Next to the toll-free number provided in each ad was the name of the advertiser: OPTIMAL HEALTH, and then below it in much smaller, easily overlooked print: Straw Chiropractic. Keeping the print small for the word chiropractic is a clever promotional tactic; many prudent consumers would not be inclined to seek chiropractors for peripheral neuropathy treatment.

I called the advertised phone number, but since I said (honestly) that I didn’t have any of the seven symptoms of neuropathy listed in the ad, I would not be permitted to attend any of the free dinner seminars. (I was disappointed to not qualify for a free dinner since I’m on a tight budget just like many other critics of health pseudoscience who get falsely accused of being paid off by Big Pharma.)

However, the ad offered a second phone number to call in order to obtain more detailed information and answers to common questions about the Straw Protocol without a having to indicate one’s symptoms and attend a seminar. I called the number, 888-858-9291, and left a message with my name and address along with a request that the advertised “Free special report and DVD” be mailed to me. The materials arrived a few days later.

click to enlarge

The promotional DVD

The title on the label of the DVD is “Our Patients Speak” followed by “The Neuropathy Treatment Center by Optimal Health Straw Chiropractic.” On the left side of the label is the instruction: “Call Today for a FREE Consultation and Evaluation!” (The exclamation mark here is a strong signal of hype.) On the right side of the label, it exclaims “$249 Value!” I guess that’s supposed to be the value of the consultation and evaluation rather than the value of the DVD.

On the bottom of the label is a number to call to find the location to find the nearest location of the Neuropathy Treatment Center. I called and was told there are five locations. Three are in Los Angeles County: Glendale, Placentia, and Gardena. The other locations are in Corona (Inland Empire) and Lake Forest (Orange County). I learned from the website of the practice, optimalhealthsc.com, that there is also an “affiliated practice,” Restore Medical Group Greathouse Chiropractic Inc., with locations in San Diego and Sunnyvale.

The DVD plays for just a few minutes and consists of five neuropathy patients expressing satisfaction with treatment from the Neuropathy Treatment Center and dissatisfaction with medications previously prescribed for them from other doctors. Many people can be persuaded to try treatments based on such testimonials, but testimonials regarding clinical benefits are not trustworthy. Consumers often fail to consider that the experiences described in testimonials may poorly represent the experiences of most people who try a new advertised treatment. If the patients actually experienced relief from their neuropathy while they were receiving Straw Protocol treatment, it doesn’t necessarily mean that the relief is attributable to the treatment. And it’s important to recognize that some chiropractors who have solicited testimonials from patients have been found to provide incentives and/or discounts to patients who offer testimonials.

The cover letter for the mailing comes with instructions to watch the enclosed DVD before reading the enclosed special report. Advertisers recognize that this sequence tends to make their messages more persuasive. It’s likely that people tend to be less suspicious of information provided in literature after they have been exposed to relatable role models who appear sincere while offering encouraging stories.

The special report

The tabloid layout of the report reminds me of the many advertising mailers made to look like health newsletters that are sent to people who get on mailing lists of quacks. I wrote about such “Advertising Mailers in Disguise” in 2001 when I served as president of the National Council Against Health Fraud, Inc.

The front cover of the report is made to look official with the words “Optimal Health’s” in the upper left-hand corner, “Summer 2014” in the upper right hand corner, “Natural Health Journal” as a heading, and “Practical Solutions for Optimum Health & Healing” as a sub-heading. The rest of the cover shouts out its hype with lots of bold lettering, enlarged lettering, varied font styles, varied colored lettering, all-caps, italicized lettering, exclamation points, a photo of an older woman along with a quotation that supposedly comes from her, and a concluding sentence in title case. Here’s the text:

A REVOLUTIONARY new way of treating peripheral neuropathy can help you throw away your pills and…

“KISS YOUR PAIN & NUMBNESS GOODBYE”

  • BANISH THE NUMBNESS!
  • Sleep restfully without tossing & turning or stabbing and shooting pain waking you!
  • End those weird ‘skin-crawling’ feelings!
  • No more limitations on your activities!
  • Regain your good balance!
  • Live the life you deserve!

“I now have feeling in my feet that I have not felt in over twenty years!!”

Thousands Have Already Experienced This Advanced Method of Treatment and Found Freedom From The Vise-Like Hold Neuropathy Had Over Their Lives!

See Inside [along with a curved arrow as a guide to turn the page]


I suggest that health consumers should be wary of tabloid-style messages telling patients they can have their greatest hopes realized from a supposedly REVOLUTIONARY treatment.

The inside of the report consists of eight pages (page 2 through 9) along with a back cover offering tabloid-style hype similar to what appears on the front cover. Page 2 consists of a letter to the reader that indicates the treatment protocol “has already helped more than 3000 people over the last three years!” In an attempt to overcome any reasonable skepticism, the letter includes this paragraph:

This is neither far-fetched [sic] hope nor over-the-top hype like you’ve seen thrown around by ‘Miracle Pill” hucksters.

Well, I’ll be the judge of that. And so will you if you read on.

Page 3 consists of three testimonials and an introduction to “Dr. Phil Straw, D.C.” (I previously pointed out in my discussion of the supposed experts interviewed in the execrable first part of the video “The Quest for the Cures…Continues” that it’s a bad sign when practitioners are introduced redundantly with “Dr.” before their names and a degree after their names.)

I learned that Dr. Straw is the author of the 2014 book Neuropathy: How to Relieve Foot Numbness, Tingling, Burning, and Cramping Without Drugs or Surgery, he earned his “under-graduate [sic] degree from the University of California Santa Barbara in 1988 and doctor [sic] of Chiropractic in 1995” (from an unidentified institution, but clearly not UCSB), that he’s a “[s]ought-after speaker on peripheral neuropathy and the importance of maintaining optimum health through natural medicine and proper nutrition” (and I would be similarly sought-after if I also offered free dinners with my free seminars), and that he’s the “Creator of THE STRAW PROTOCOL.”

By the way, I am following THE LONDON PROTOCOL in writing about THE STRAW PROTOCOL (and you are supposed to be very impressed indeed by the capital letters in the name of my protocol).

Part of THE LONDON PROTOCOL is to check for disciplinary actions against practitioners who advertise aggressively. I found that, in November 2012, California’s Board of Chiropractic Examiners issued a citation to Philip Arthur Straw for his advertisements and Straw paid his fine in full.

I contacted a staff member serving California’s Board of Chiropractic Examiners and obtained a copy of the citation sent to Dr. Straw, which remains a public record. The section of the letter with the heading “Cause of Citation” reads:

On July 27, 2012 the Board received a complaint from N. F. alleging that the claims made in your advertisements, “Which of These Warning Signs Could Lead to Foot Amputation?” and “Don’t Let Your Neuropathy Put You in a Wheel Chair” are misleading to the public. The advertisements and your response to the Board’s Inquiry were forwarded to a chiropractic expert consultant for review. The Board expert opined that you have used worst-case clinical scenarios as headlines in your advertisements, and in doing so you have engaged in the use of misrepresentations, distortions, sensational or fabulous statements, or which have a tendency to deceive the public. In doing so, you are in violation of CCR section 311 advertisements.

In addition, the Board’s expert opined that your self-appointed designation as a “leading regional authority” and “expert” in such matters is a sensational, distorted statement that has a tendency to deceive the public. The Board expert added that the Board of Chiropractic Examiners does not recognize such expertise, and you have not demonstrated that you possess any diplomate status that might lend truthfulness to such a claim. In doing so, you are in violation of CCR section 311 advertisements.

As mentioned by Los Angeles Times business and consumer columnist David Lazarus in a column published August 25th 2014, the fine was only $500. That slap on the wrist tells you how seriously the Board of Chiropractic Examiners takes CCR section 311. Although the ads from Straw in 2014 didn’t have the same fear-mongering headlines and claims of expertise as the ads mentioned in the 2012 complaint, the claim that the Straw Protocol provides outstanding results should be viewed as a CCR section 311 violation.

Another part of THE LONDON PROTOCOL is to check for publication of clinical research findings in the scholarly literature. A Google Scholar search on “Philip Straw” revealed no such publications. No surprise! I see little reason to consider the Straw Protocol as an “Advanced Method of Treatment” as the ads in 2014 characterized it.

Page 4 of the special report consists of a brief description of peripheral neuropathy in simple language followed by criticisms of the drugs prescribed the medical community to treat peripheral neuropathy. The discussion includes the misleading suggestion that medical doctors treat peripheral neuropathy only to manage symptoms, with drugs and sometimes surgery. It disregards how standard treatment begins with addressing conditions underlying peripheral neuropathies and includes mechanical aids for symptom management. It includes a common medical establishment-bashing trope:

Perhaps the reason you may not have heard of the treatment options available for your peripheral neuropathy (like the method described on the next couple of pages of this report) is because of the stubbornly-held notion that, when it comes to medical treatments that don’t involve a needle or a pharmaceutical company’s pill, the establishment community can be ‘a bit set in their ways.’

Then again, perhaps this is a straw person (or straw establishment community) attack and the popular press has ignored THE STRAW PROTOCOL because it’s just one of the hundreds of non-evidence-based gimmicks for healing promoted by chiropractors. If there was compelling clinical research evidence indicating that the Straw Protocol is safe and the advertising claims made for it are valid, I think we would have heard about it (especially from the Straw-supported Los Angeles Times).

(A fact sheet from the National Institute of Neurological Disorders and Stroke provides a much more informative description of peripheral neuropathy than does Straw’s report. The fact sheet describes the classification, symptoms, causes, diagnostic tests, and treatment, for peripheral neuropathy.)

Pages 5 through 8 include eleven more testimonials, more hype from Dr. Straw, and a description of the four steps of the Straw Protocol (also described on Straw Chiropractic’s website).

  • Step 1 (Stimulate) of his protocol uses an electronic device that, we are told, has approval for a number of pain indications, but is not a transcutaneous electrical nerve stimulation device. It’s good to be wary of devices that promoters fail to identify by name. When practitioners are secretive about their treatments, they sidestep scrutiny. I’m reminded of a catchphrase of Dana Carvey’s Church Lady character: “How convenient!”
  • Step 2 (Rejuvenate) is to increase overall circulation by utilizing light emitting diode (LED) therapy. The description of Step 2 also includes a reference to investigations by NASA. Such references are common in the promotion of non-validated health gimmicks.

According to the BlueCross BlueShield of Tennessee Medical Policy Manual’s statement on LED therapy (reviewed most recently on 9/11/14):

Light emitting diode therapy for the treatment of conditions / diseases, including but not limited to diabetic peripheral neuropathy, lymphedema, non-healing wounds, tendonitis, capsulitis, and pain is considered investigational. (Emphasis in original.]

Investigational means not appropriately promoted in free dinner seminars to recruit paying patients. Another key point in the statement:

Scientific evidence in peer review literature is lacking regarding the use, safety, improvement or effectiveness on health outcomes for light emitting diode therapy.

  • Step 3 (Activate) “uses different frequencies of vibration on different areas of your body which further stimulates new capillary and nerve regeneration.” It would appear that Straw’s patients are shaken (if not stirred), but it isn’t clear that they’re pickin’ up good vibrations, excitations, or healing.

Exposure to some sources of vibration is one of many recognized causes of peripheral neuropathy. That doesn’t mean other sources of vibration provide relief. A review article published in 2015 on whole body vibration (WBV) for rehabilitation of peripheral neuropathies concluded:

The results of this literature search suggest insufficient evidence to assess the effectiveness for the effects of WBV on neuropathic pain, muscle strength and balance in patients with peripheral neuropathies, as there is a clear lack of methodologically high quality research on the subject.

In other words, WBV is a non-validated treatment.

  • Step 4 (Empower) is described as “truly THE KEY to not only reaching your desired level of pain-free health, but staying there for as long as you like.” It amounts to “nutritional education and proper supplementation” against chronic inflammation.

Inflammation is a complex bodily response to infection and injury that can be either beneficial or harmful. While chronic inflammation appears to play a role in the development of some chronic diseases, it is unclear that any special supposedly anti-inflammatory regimen of foods and dietary supplements can provide clinically-significant relief to peripheral neuropathy patients.

Dietary supplements are frequently tainted with drugs and often do not contain ingredients in doses listed on their labels. Paying more for practitioner-recommended (or -dispensed) supplement formulations provides illusory assurance.

On page 9 of the report is this pitch (bolding in original):

If you call and schedule your appointment for your own exam within 7 days of receiving this package, I will waive the entire $249 fee for you.

It’s followed by an offer of a free copy of Straw’s book at the exam.

I didn’t call within seven days. Soon after I received a letter from Straw Chiropractic renewing the offer for the free exam if I called within two to three days and the book would still be available for me.

click to enlarge

After failing to make the second deadline, I received a second notice which began “Hello…?” followed by a letter beginning with the words: “You’re smart. I can tell.” The letter went on to express surprise that I hadn’t called. The free diagnostic exam offer was still available along with the free book, but “is just not going to be an option for very much longer.” The letter came with a flyer featuring eleven more testimonials.

click to enlarge

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I waited for months to call to find out about costs of the Straw Protocol. The initial free exam and consultation offer was still available.

Costs to patients

Consumers should be wary of high-pressure sales pitches for limited time offers. Practitioners who place full-page newspapers ads need to work hard to get patients into their clinics. They need to recoup their investments in advertising (e.g., newspaper ads) and direct selling (e.g., dinner seminars) and then earn enough from fees charged to patients to make good money.

I reached a sales representative over the phone for Straw Chiropractic and was told that if I were a candidate for the treatment (that I really had peripheral neuropathy and it wasn’t too advanced), it would cost me $500 to $10,000 for five to fifteen weeks of treatment. Insurance doesn’t pay for any of the treatment. The representative wasn’t sure whether the quoted figures include the cost of purchasing dietary supplements.

Advertising in 2015

Thus far in 2015, in some, but not all Sundays, ads of varying sizes for the Straw Protocol have appeared in the main section of The Los Angeles Times. The most recent advertisements (as of this writing), on February 15th and 22nd were smaller than a quarter of a page and included an invitation to call for the free DVD and report. None of the newer ads included invitations to free dinner seminars.

However, I noticed on another page in the main section of the paper a half-page ad for free dinner seminars from the NEUROPATHY RELIEF CENTER of Long Beach Presented by Ballerini Chiropractic. The pitch is very similar to the pitch used by Straw Chiropractic. I will need to investigate further to find out the source of marketing campaigns used by chiropractors to promote peripheral neuropathy treatments services.

Other chiropractors who promoted free dinner seminars

Dr. Straw’s marketing campaign featuring free dinner seminars reminds me of similar recent campaigns by other chiropractors. For example, as I described previously:

[Brandon Lee Babcock, D.C.] pitched a bogus nutritional cure for diabetes. But, as reported December 9th, 2013 by The Salt Lake Tribune, his scheme bilked older adults in Utah of thousands of dollars. To recruit patients, he offered free gourmet dinners where attendees were shown video testimonials and given information about Babcock’s supposed “diabetes breakthrough.” He tricked patients into signing papers that established lines of credit with Chase Health Advance and he maxed out the $6,000 limit when patients tried to withdraw from his services. Some patients testified that Dr. Babcock and his staff misled them into signing up for credit without their knowledge or consent. Others said Babcock refused to provide refunds despite a 30-day opt-out guarantee and a promise of 100% satisfaction.

In 2008, the Utah Department of Occupational and Professional Licensing (DOPL) issued a “non-disciplinary cease-and-desist order” after finding that he advertised treatments for conditions he wasn’t qualified to treat: depression, multiple sclerosis, fibromyalgia, learning problems, attention deficit disorder, allergies, hormone replacement relief, sleep problems and memory loss.

In April 2012, the DOPL suspended Babcock’s chiropractic license by emergency order. In August 2012, West Jordan City revoked Babcock’s business license. The Salt Lake Tribune noted, however, that he continued to lead seminars promoting his program to reverse Type II diabetes.

In October 2013, a jury convicted him of six third-degree felony counts of exploiting a vulnerable adult. In December 2013, he was sentenced to six months in jail.

Colorado-based chiropractors Brandon Credeur, D.C. (a classmate of Brandon Babcock at Parker College of Chiropractic) and his wife Heather Credeur, D.C. also used newspaper advertising to attract diabetics to seminars following free gourmet dinners to promote their “functional endocrinology” treatments to diabetics and people with symptoms of low thyroid function. Jann Bellamy has discussed both Babcock and the Credeurs previously on ScienceBasedMedicine.

A September 2011 complaint from Colorado’s Board of Chiropractic Examiners against Brandon Credeur charged him with violations of the Board’s rules regarding scope of practice; misleading, deceptive, false, or unethical advertising; untrue, deceptive or misleading practices regarding unproven and/or unnecessary services; and record keeping requirements. But instead of losing his chiropractic license, as many of his former patients had hoped, following a hearing in an administrative court room, Credeur’s case ended in a settlement in which he admitted to nothing and agreed to keep better records.

On June 19th, 2013, the Colorado Medical Board sent an order to Brandon and Heather Credeur to cease and desist practicing medicine without a license. That same day, they declared bankruptcy to the dismay of former patients who have sued them to get their money back. A ruling from an administrative law judge is anticipated in response to the Credeur’s challenge to the Medical Board’s order.

The Credeurs remain licensed to practice chiropractic in Colorado.

Candice McCowin, an Irvine, California chiropractor ran newspaper ads claiming breakthrough treatments for diabetes and other chronic illnesses to be discussed at free dinner events. In March 2014, the California Board of Chiropractic Examiners cited the “free diabetic guides” she distributed as misleading ads. As noted in a column by David Lazarus, “McCowin paid a $500 fine and agreed to ensure that future ads ‘not be construed as misleading or deceiving to the public.” Dr. McCowin, I will be looking for your ads.

A few final thoughts

Advertisements that appear in The Los Angeles Times (or any other newspaper) should never be presumed to be trustworthy. The screening processes used by advertising departments of news organizations are typically inadequate to assure that ads are not false or misleading.

The $500 fine for “advertising in a potentially deceptive manner and for portraying himself as a neuropathy expert” that Dr. Straw paid in 2012 was no serious deterrent. I consider recent advertisements by Straw Chiropractic in newspapers and in mailers to patients to be misleading.

The direct selling approach of free dinner seminars and free initial consultations can be seductive. People often respond to acts of apparent kindness and generosity with a sense of obligation to reciprocate. But reciprocation to a sales pitch for a non-validated treatment protocol is unlikely to lead to relief and is likely to be costly.

I don’t expect that licensing boards in California are inclined to take appropriate action to protect consumers from inappropriate advertising of health services. But consumers need to file complaints and they need to let legislators know that they object to practitioners who deceptively advertise health services for financial gain and to licensing boards that fail to adequately protect the public.

William M. London is a professor of public health at California State University, Los Angeles and a co-author of the sixth, seventh, eighth, and ninth (2013) editions of the college textbook Consumer Health: A Guide to Intelligent Decisions. He is one of two North American editors of the journal Focus on Alternative and Complementary Therapies, associate editor of the free weekly e-newsletter Consumer Health Digest, and co-host of the Credential Watch site. Most of his recent writings about extraordinary claims for health products and services can be found at Swift, published by the James Randi Educational Foundation, and the Skeptic Ink Network.

 

 

Categories: Medicine, Skepticism

Liberals and Conservatives Both Resist Science, But Differently

Neurologica Blog - Thu, 02/26/2015 - 08:00

There have been a number of studies looking at how ideological belief influence attitudes toward science. It is no surprise that in general people, of whatever ideological bent, engage in motivated reasoning to deny science that appears to contradict their religious or political beliefs. There are different views, however, regarding whether or not the two main political ideologies in the US, liberal and conservative, are equal or substantially different in their resistance to science.

A series of articles in a special section of The Annals of the American Academy of Political and Social Science explore this question.  In a commentary summarizing the findings, Kraft et al write:

The studies presented in the preceding section of the volume consistently find evidence for hyperskepticism toward scientific evidence among ideologues, no matter the domain or context—and this skepticism seems to be stronger among conservatives than liberals. Here, we show that these patterns can be understood as part of a general tendency among individuals to defend their prior attitudes and actively challenge attitudinally incongruent arguments, a tendency that appears to be evident among liberals and conservatives alike.

As is often the case when there are two schools of thought, both are partly right. In this case it appears that the tendency to defend one’s position, resist incongruent evidence, and engage in motivated reasoning is a universal trait among humans.  However, the research does consistently show that the magnitude of this effect is greater for conservatives than liberals. No one doubts that this asymmetry is consistently seen in research, but there remains a difference in interpretation.

In one survey analysis by Blank and Shaw they found that liberals were more receptive to information from experts than conservatives or independents. They interpret these results to mean that conservatives are not particularly skeptical of experts, but liberals are particularly receptive.

In a separate study by Nisbet et al they presented subjects with science videos on either evolution, global warming, fracking, nuclear power, astronomy, or geology. They found that conservatives were resistant to scientific information that contradicted their views on evolution and global warming, while liberals resisted information on nuclear power and fracking. No one seems to have a problem with astronomy or geology. (I assume that astronomy did not get into cosmology, and geology did not get into the age of the Earth.)

While liberals and conservatives both resisted information that contradicted their existing political views, the negative reaction of conservatives was four times greater than that of liberals. So again we see the asymmetry.

How do we interpret these results? Those such as Chris Mooney, author of The Republican War on Science, believe the evidence shows the difference is inherent to the ideology. Liberals tend to be more open, by definition, while conservatives tend to be more authoritarian and dogmatic.

In an interview study author Nisbet offered another possible interpretation:

“Climate change and evolution are much bigger issues in the media and political discourse than are fracking and nuclear power,” Nisbet said.

“The fact that the issues that challenge conservatives are currently more polarizing in society today may intensify feelings.”

For me this remains an open question. In these studies it is typical for the issues used to test Republican resistance to science to be evolution and global warming. The former involves religious beliefs, while the latter is a hot button political issue. Nuclear power just doesn’t have the same cultural power these days of these other topics. Perhaps, therefore, the asymmetry is in the topics used, not the subjects. Of course, both answers could be correct – there may be asymmetries in both the ideological resistance to science and in the topics used to study the phenomenon.

One way to resolve this debate is to conduct similar studies but with a larger variety of issues, with particular attention to balancing the intensity of the issues themselves. There are many other issues to choose from where strongly held ideological beliefs might clash with scientific facts – gun control, abortion, risk of rape, effectiveness of the death penalty, etc.

There is a potential inherent problem, however, in that conservative and liberal is a bit of a false dichotomy when it comes to American politics. Where do libertarians fit it? Fiscal conservatives are different than the religious right. Social progressives may be different than populists. Anti-government and anti-corporate sentiments can cross the simple divide between liberal and conservative.

Opposition to GMOs is an excellent example. This might be a good topic to study, in that the intensity is likely on a par with issues such as evolution and global warming. The problem, however, is that anti-GMO sentiments are bipartisan. Some liberals oppose GMOs because of anti-corporate ideology, adherence to the naturalistic fallacy, and extreme application of the precautionary principle. Some conservatives oppose GMOs because they don’t trust the government. Meanwhile conspiracy theorists don’t trust anyone.

Still, to answer to core question here, it might be useful to study liberals who oppose GMOs based on liberal ideology to see if their reaction is similar to conservatives who oppose global warming.

Conclusion

Until further studies are done, over a greater range of issues to better control for any asymmetry in issue intensity, I am reserving judgment about whether or not liberals or conservatives are more resistant to or accepting of science.

Meanwhile, what is clear is that people in general will tend to engage in motivated reasoning to defend existing beliefs from contradictory evidence – even scientific evidence from experts.

Categories: Medicine

Pseudoscience North: What’s happening to the University of Toronto?

Science Based Medicine - Thu, 02/26/2015 - 08:00

 

Today’s post is a reluctant challenge. I’m nominating my own alma mater, the University of Toronto, as the new pseudoscience leader among large universities – not just in Canada, but all of North America. If you can identify a large university promoting or embracing more scientifically questionable activities, I’ll happily buy you a coffee. Yes, it’s personal to me, as I have two degrees from U of T. But I’m more concerned about the precedent. If Canada’s largest university is making decisions that appear to lack a careful consideration of the scientific evidence, then what does that suggest about the scientific standards for universities in Canada?

Documenting the spread of pseudoscience within academic institutions, particularly in health and medicine, is a recurring topic at this blog. In recent years, these tactics have usually been branded as a move towards what has been called “integrative” medicine, where the apparent objective is to “integrate” unproven or disproven treatments into health programs and disciplines. It has been pointed out many times that there simply no basis or need to redefine medicine, “alternative”, “integrative” or otherwise. Integrative medicine is simply a marketing term, nothing more. This statement on alternative medicine, from Fontanarosa & Lundberg, back in 1998, still rings true:

There is no alternative medicine. There is only scientifically proven, evidence-based medicine supported by solid data or unproven medicine, for which scientific evidence is lacking. Whether a therapeutic practice is “Eastern” or “Western,” is unconventional or mainstream, or involves mind-body techniques or molecular genetics is largely irrelevant except for historical purposes and cultural interest. We recognize that there are vastly different types of practitioners and proponents of the various forms of alternative medicine and conventional medicine, and that there are vast differences in the skills, capabilities, and beliefs of individuals within them and the nature of their actual practices. Moreover, the economic and political forces in these fields are large and increasingly complex and have the capability for being highly contentious. Nonetheless, as believers in science and evidence, we must focus on fundamental issues—namely, the patient, the target disease or condition, the proposed or practiced treatment, and the need for convincing data on safety and therapeutic efficacy.
Phil B. Fontanarosa & George D. Lundberd

Academic institutions that grant legitimacy to pseudoscience create problems beyond their own walls. They do so by either lending their good name to questionable practices, or they facilitate education on pseudoscience under the rubric of “alternative” or “integrative” practices. Not only do educational standards suffer, but the affiliation gives alternative medicine practices the imprimatur of scientific legitimacy in the wider community.

What’s painful about documenting the problems with the University of Toronto is that it ought to know better. It’s the biggest university in Canada and one of the largest universities in the world, and U of T is consistently ranked among the best schools in the world. Its medical faculty and research output are highly regarded worldwide. Insulin and stem cells was discovered at U of T. Despite this stellar reputation, a recent series of decisions and announcements has made me question where U of T is headed. Is this a series of missteps, or a deliberate trend? Here are the four reasons for my nomination:

1. The University has endorsed the study of homeopathy for treating ADHD

Last week Joe Schwarcz documented that the Dean of the Leslie Dan Faculty of Pharmacy is the principal investigator in a clinical trial examining the use of homeopathy for ADHD. In an open letter to the Dean, Heather Boon, Schwarcz and 90 other individuals (including several SBM editors and contributors) asked Boon to explain the rationale for this research. In a related column, Schwarcz noted that there has been no response yet, which is disappointing given the circumstances of this clinical trial, as Schwarcz notes:

ADHD is a serious condition that merits serious research. Apparently, the University of Toronto researchers carried out a pilot study involving homoeopathy that seemed to indicate benefit. That study, however, was unblinded, devoid of randomization, had no control group and relied on a subjective outcome, making any data derived from it essentially meaningless. Even if we were to attach some importance to the claimed reduction of symptoms, the effect was about half of that seen with conventional medication, making the homeopathic treatment clearly inferior. Furthermore the proposed study would use individualized treatments for each subject as determined by a homeopathic consultation, so at best the results would be ambiguous in terms of making any recommendation.

The study is actually to be carried out at the Riverdale Homeopathic Clinic, a private institution that also offers ear candling, cranial sacral therapy and “nosodes,” which are homeopathic versions of vaccines. No public funding is involved; support comes from a foundation dedicated to alternative medicine. Nevertheless, one wonders why with various nutritional and biofeedback treatments with significant potential for helping with ADHD needing exploration, a scientifically insolvent notion is being pursued.

Why the Faculty of Pharmacy is sponsoring a trial of homeopathy raises a number of troubling questions. And when that trial is being conducted by the head of the school, it’s even more important for Boon to explain her research. What is also troubling, and remains unexplained, is how this trial came to be approved by the University of Toronto’s Research Ethics Board (REB) (what Canadians call an IRB). Presumably the REB felt this is ethically acceptable research. This is puzzling, because homeopathy is rank quackery. If homeopathy actually works, then almost everything the Faculty of Pharmacy currently teaches its pharmacy students is wrong, as are the foundational facts of biology and chemistry. Yet despite the overwhelming implausibility of sugar pills having any medicinal effect on children with ADHD, the REB gave this trial a green light. Why?

How this trial was approved is problematic for the University and it needs to be addressed. To be clear, Boon’s research hasn’t always been favourable to CAM, and she has gone on record criticizing a popular herbal remedy. She has also given statements that are not supportive of homeopathy (see video around 2:07), making it all the more important for there to be a clear explanation for this homeopathy trial, and an detailed disclosure on how this trial was considered by the university to be ethically acceptable for children.

2. The University has established a new Centre for Integrative Medicine

In a past post I noted that the University of Toronto was establishing a new “Centre for Integrative Medicine”, which I described as the perfect Trojan rabbit to embed pseudoscience in both the pharmacy and medicine schools. Here’s how it was described:

The mission of this new Centre is to facilitate, conduct, and obtain support for collaborative basic, clinical, and health services research in complementary and alternative medicine; to serve as an educational and to develop integrative curricula and educational programs on complementary and alternative medicine; to work collaboratively with other departments within both Faculties and their hospital partners to support the integration of evidence-based complementary and integrative medicine into existing clinical settings and clinical research programs.

As this is a partnership between the Faculties of Medicine and Pharmacy, I noted this was a clever strategy to truly embed alternative medicine into practice. To change the standard of medical practice, you have to target both pharmacists and physicians – otherwise one group will call out the other for quackery. Normalize CAM as part of the curriculum, and students might not even notice. The program even has an explicit intent to embed practices into teaching centres – where it’s more likely to be accepted as standard medical practice.

Since my last post there has been an update: a new head of the Centre and an explicit objective to integrate CAM and Traditional Chinese Medicine into medical practice:

Today, the University of Toronto (U of T) and The Scarborough Hospital (TSH) announced a partnership that will provide new answers for the 74% of Canadians who are using some form of complementary and alternative medicine, including traditional Chinese medicine. Called the Centre for Integrative Medicine (CIM), it will bring together researchers from U of T’s Leslie Dan Faculty of Pharmacy and Faculty of Medicine alongside health care professionals at TSH to provide evidence-driven practices. Together, U of T and TSH will create a living laboratory that will allow us to study ways to safely and effectively integrate evidence-informed complementary therapies and traditional Chinese medicine with conventional medical care.

With an appeal to popularity seemingly the rationale for this work, the University of Toronto is well on its way to starting the integration of CAM into medicine. Let’s be clear. Studying if “alternative” medicine practices actually work is important. What’s not necessary is a different evidentiary framework for evaluating them. For example, pharmacognosy is the study of natural products. It’s an appropriate (and productive) research stream, given so many therapeutic drugs have their origins in natural substances. There’s no need to study natural remedies in an “alternative” or “integrative” manner. The same scientific standards should be applied. And as has been pointed out before, the history of Traditional Chinese Medicine is an invented history – not a factual one. Studying TCM needs to start with evaluating the underlying science – which has already been found to be pseudoscience.

3. The University has announced a collaboration with the Canadian Memorial Chiropractic College

The University of Toronto has announced it will collaborate with a chiropractic school to do the following:

The Canadian Memorial Chiropractic College (CMCC) has signed an official Memorandum of Understanding to explore education and research collaborations with the University of Toronto, through the Faculty of Medicine, Leslie Dan Faculty of Pharmacy and the Faculty of Kinesiology and Physical Education.

“This collaboration shows our commitment to expanding research and educational opportunities across the health care spectrum,” said Professor Catharine Whiteside, U of T’s dean of medicine and vice-provost, relations with healthcare institutions. “We’re delighted to partner with an organization committed to improving health with an evidence-based approach.”

This is quite the coup for CMCC, which reportedly has been seeking a collaboration or affiliation with a university for decades. What’s concerning is that chiropractic lacks a sound scientific basis. Chiropractic research has produced no evidence to support the underlying chiropractic theory. While there is evidence that spinal manipulation therapy can be effective for low back pain, that treatment is not exclusive to chiropractors. Beyond low back pain, there’s no evidence that chiropractic treatments offer any meaningful benefit for other conditions. It’s possible to be an evidence-based chiropractor, as SBM contributor and chiropractor Sam Homola has taught us. Unfortunately the profession of chiropractic is not made up of Sam Homolas. This collaboration between U of T and CMCC is reminiscent of an attempt by CMCC to affiliate with York University almost 15 years ago. At that time it was noted that there were serious scientific concerns about chiropractic that made the incorporation of the school into York University inappropriate. It’s not clear what’s changed with chiropractic since that time.

4. The University gives a platform for the promotion of pseudoscientific ideas about health and medicine

It’s been noted by many, but there is no such thing as “alternative” medicine, as medicine doesn’t fail to work in a conventional sense yet work in an “alternative” manner. Medicine either works or it doesn’t. What works we call medicine. The rest is either proven not to work, or is not proven to work. Despite this the University of Toronto Scarborough (a satellite campus) is hosting a conference that’s filled with pseudoscience. Coming this Saturday is Alternative Cares of Medicine, a Population Health and Policy Conference:

Among the speakers is Beth Landau-Halpern, a Toronto homeopath recently caught on camera by the CBC television show Marketplace selling homepathic “nosodes” to a mother as a substitute for a real vaccine. Homeopathic “nosodes” are a dangerous consequence of the pseudoscience of homeopathy. “Nosodes” are just sugar pills, like all homeopathy, but may be sold by homeopaths as substitutes for vaccination. They are not. After the Marketplace episode aired, Landau-Halpern went on record noting that while Health Canada requires nosodes to be labelled “not a vaccine”, that she is not required to do so. She knows they are not to be sold as a substitute for a vaccine, yet she did so anyway. This conference is labelled as being about population health, and given the resurgence of measles in Ontario and across North America, there is no better case study for the threat that homeopaths make to public health than examining homeopathic “nosodes” and the behaviour of homeopaths. What’s even more concerning is that Landau-Halpern actually seems to have a teaching appointment at the university. How a homeopath has obtained a teaching appointment in the Department of Anthropology at the University of Toronto is another question that the university should answer. Given the recent public outcry over a professor at Queen’s University teaching anti-vaccine pseudoscience, why the University of Toronto is sponsoring a talk by an anti-vaccine homeopath deserves an explanation.

Another speaker is Bryce Wylde, another homeopath and self-described “alternative medicine expert, philanthropist, television host” who certainly gets significant television exposure, whether it’s his own show or guest appearances on The Dr. Oz Show. He’s been criticized for repeatedly promoting ideas and treatments that lack good evidence. There’s also Jennifer Yun, a naturopath who is the co-founder and “clinical director” of Adara Integrative Clinic which offers quackery like intravenous vitamin infusions and a pseudoscience I’d never heard of, esoteric acupuncture, described by her clinic as:

Drawing upon the disciplines of Traditional Chinese acupuncture, sacred geometry, the qabbalastic tree of life, the ayurvedic nadi system, and high Qi nutrition, esoteric acupuncture brings the subtle and finer aspects of Qi (vital energy) into balance.

The entire program is a cornucopia of pseudoscience, and I see little on the agenda that is going to contribute meaningfully to supporting population health. It’s not surprising to see this program is also sponsored by the Toronto School of Chinese Medicine and the Canadian College of Naturopathic Medicine. It’s a clever way to leverage the credibility of the university while promoting your particular form of pseudoscience.

Conclusion

Like many universities, the University of Toronto appears to be taking a new and discouraging turn towards supporting pseudoscientific ideas about health and medicine. The line between science and pseudoscience is increasingly becoming difficult to see, especially when alternative medicine and quackery is rebranded as “integrative” medicine. Yet as can be seen with the resurgence of infectious disease driven by dropping vaccination rates, there are very real consequences to promoting incorrect ideas about health and wellness. We need academic centres like the U of T to be strong societal proponents of the scientific method and the best scientific evidence, rather than using appeals to popularity to determine academic programs and collaborations. Moreover, when the university or its staff make decisions that raise questions about their judgement, the university owes the community an explanation.

 

 

Categories: Medicine, Skepticism

Psychology Journal Bans Significance Testing

Science Based Medicine - Wed, 02/25/2015 - 08:09

This is perhaps the first real crack in the wall for the almost-universal use of the null hypothesis significance testing procedure (NHSTP). The journal, Basic and Applied Social Psychology (BASP), has banned the use of NHSTP and related statistical procedures from their journal. They previously had stated that use of these statistical methods was no longer required but can be optional included. Now they have proceeded to a full ban.

The type of analysis being banned is often called a frequentist analysis, and we have been highly critical in the pages of SBM of overreliance on such methods. This is the iconic p-value where <0.05 is generally considered to be statistically significant.

The process of hypothesis testing and rigorous statistical methods for doing so were worked out in the 1920s. Ronald Fisher developed the statistical methods, while Jerzy Neyman and Egon Pearson developed the process of hypothesis testing. They certainly deserve a great deal of credit for their role in crafting modern scientific procedures and making them far more quantitative and rigorous.

However, the p-value was never meant to be the sole measure of whether or not a particular hypothesis is true. Rather it was meant only as a measure of whether or not the data should be taken seriously. Further, the p-value is widely misunderstood. The precise definition is:

The p value is the probability to obtain an effect equal to or more extreme than the one observed presuming the null hypothesis of no effect is true.

In other words, it is the probability of the data given the null hypothesis. However, it is often misunderstood to be the probability of the hypothesis given the data. The editors understand that the journey from data to hypothesis is a statistical inference, and one that in practice has turned out to be more misleading than informative. It encourages lazy thinking – if you reach the magical p-value then your hypothesis is true. They write:

In the NHSTP, the problem is in traversing the distance from the probability of the finding, given the null hypothesis, to the probability of the null hypothesis, given the finding. Regarding confidence intervals, the problem is that, for example, a 95% confidence interval does not indicate that the parameter of interest has a 95% probability of being within the interval. Rather, it means merely that if an infinite number of samples were taken and confidence intervals computed, 95% of the confidence intervals would capture the population parameter. Analogous to how the NHSTP fails to provide the probability of the null hypothesis, which is needed to provide a strong case for rejecting it, confidence intervals do not provide a strong case for concluding that the population parameter of interest is likely to be within the stated interval.

Another problem with the p-value is that it is not highly replicable. This is demonstrated nicely by Geoff Cumming as illustrated with a video. He shows, using computer simulation, that if one study achieves a p-value of 0.05, this does not predict that an exact replication will also yield the same p-value. Using the p-value as the final arbiter of whether or not to accept or reject the null hypothesis is therefore highly unreliable.

Cumming calls this the “dance of the p-value,” because, as you can see in his video, when you repeat a virtual experiment with a phenomenon of known size, the p-values that result from the data collection dance all over the place.

Regina Nuzzo, writing in Nature in 2014, echoes these concerns. She points out that if an experiment results in a p-value of 0.01, the probability of an exact replication also achieving a p-value of 0.01 (this all assumes perfect methodology and no cheating) is 50%, not 99% as many might falsely assume.

The real world problem is worse than these pure statistics would suggest, because of a phenomenon known as p-hacking. In 2011 Simmons et al. published a paper in Psychological Science in which they demonstrate that exploiting common researcher degrees of freedom could easily manipulate the data (even innocently) to achieve the threshold p-value of 0.05. They point out that published p-values cluster suspiciously around this 0.05 level, suggesting that some degree of p-hacking is going on.

This is also often described as torturing the data until it confesses. In a 2009 systematic review, 33.7% of scientists surveyed admitted to engaging in questionable research practices – such as those that result in p-hacking. The temptation is simply too great, and the rationalizations too easy – I’ll just keep collecting data until it wanders randomly over the 0.05 p-value level, and then stop. One might argue that overreliance on the p-value as a gold standard of what is publishable encourages p-hacking.

So what’s the alternative? Many authors here have suggested either doing away with the p-value, or (a less radical solution) simply bring it back down to its proper role – it provides one measure of the robustness of the data, but is not the final arbiter of whether or not the null hypothesis should be rejected. We have also supported those researchers who have called for increased use of Bayesian analysis as a more appropriate alternative. The Bayesian approach is to ask the right question, what is the probability of the hypothesis given both the prior probability and the new data?

The BASP give a lukewarm acceptance of the Bayesian approach:

Bayesian procedures are more interesting. The usual problem with Bayesian procedures is that they depend on some sort of Laplacian assumption to generate numbers where none exist. The Laplacian assumption is that when in a state of ignorance, the researcher should assign an equal probability to each possibility. The problems are well documented. However, there have been Bayesian proposals that at least somewhat circumvent the Laplacian assumption, and there might even be cases where there are strong grounds for assuming that the numbers really are there (see Fisher, 1973, for an example). Consequently, with respect to Bayesian procedures, we reserve the right to make case-by-case judgments, and thus Bayesian procedures are neither required nor banned from BASP.

OK – case-by-case analysis. That seems reasonable.

The journal editors are clear that their new policy does not mean they will accept less-than-rigorous research. They believe it will lead to more rigorous research:

However, BASP will require strong descriptive statistics, including effect sizes. We also encourage the presentation of frequency or distributional data when this is feasible. Finally, we encourage the use of larger sample sizes than is typical in much psychology research, because as the sample size increases, descriptive statistics become increasingly stable and sampling error is less of a problem.

Conclusion

I don’t know if the BASP solution to the problem of p-values is the best, ultimate, or only solution. Other solutions might include supplementing p-values with a discussion of the statistics that place them in their proper context, supplementing with Bayesian analysis, and having other requirements for scientific rigor. This would be a more difficult approach, and may not be able to dislodge the p-value from its lofty perch the way an outright ban might.

Requiring larger sample sizes is a good thing overall, but can create problems for young researchers just looking for a preliminary test of their new ideas. This then dovetails with another problem I and others have pointed out – presenting preliminary findings in the mainstream media as if they are definitive. Preliminary research is important, and if properly used can inform later research, but should not be used as a basis for clinical practice or hyperbolic headlines that ultimately misinform the public.

One solution is for journals to obviously separate preliminary research from confirmatory research. Preliminary research should be labeled as such with all the proper disclaimers and should not be the basis of hyped press releases. This may also provide the opportunity for having separate publishing rules for preliminary and confirmatory research – for example, for preliminary research journals can allow the use of p-values and techniques specifically designed to allow for smaller sample sizes.

The new BASP policy is a step in the right direction. At the very least I hope it raises awareness of the problems with relying on p-values and encourages a more nuanced understanding among researchers of statistics and methodological rigor.

 

 

Categories: Medicine, Skepticism

Anti-GMO Propaganda

Neurologica Blog - Tue, 02/24/2015 - 08:11

There is so much anti-science propaganda out there I often feel like I am emptying the ocean with a spoon. Just today I was faced with an array of choices for my post – should I take on anti-vaccine, anti-GMO, or anti-AGW propaganda? For today, anyway, anti-GMO won. I’ll get to the others eventually.

This was sent to me by a reader – 5 reasons to avoid GMOs.  The content is mostly tired anti-GMO tropes (lies, really) that have been thoroughly debunked, but it is good to address such propaganda in a concise way. Also, it is a useful demonstration of the intellectual dishonesty of the anti-GMO movement. I may not get through all of them today – each one is so densely packed with wrong, and it takes longer to correct a misconception than to create one. Here is point #1 – GMOs are not healthy:

GMOs are unhealthy: Since the introduction of GMOs in the mid-1990s, the number of food allergies has sky-rocketed, and health issues such as autism, digestive problems and reproductive disorders are on the rise. Animal testing with GMOs has resulted in cases of organ failure, digestive disorders, infertility and accelerated aging. Despite an announcement in 2012 by the American Medical Association stating they saw no reason for labeling genetically modified foods, the American Academy of Environmental Medicine has urged doctors to prescribe non-GMO diets for their patients.

The author begins with an assumption of causation from correlation. The increase in food allergies actually does not correlate well with the introduction of GMOs. The correlation between organic food and autism is much more impressive. In fact, the organic food industry has been rising steadily over this same time period, and so one could make the even stronger point that organic food causes all the listed ills.

Food allergies is a particularly bad target for fear mongering, however. There has yet to be a single case of food allergy linked to a GMO. Not one. Further, GMOs are tested for the allergic potential. Allergenic foods have features in common. For example, the proteins that provoke and allergic response are able to survive stomach acids sufficiently intact that they can still produce a reaction. Scientists can therefore test any new proteins against known allergens and look for homology. (The same is true for known toxins.) This, of course, is not an absolute guarantee, but it is a very good safety net, and it has worked so far.

What about the animal studies? Well, 19 years of animal feeding with GMO has not resulted in any detectable increase in negative health outcomes of livestock. Further, systematic reviews of animal feeding studies have shown no harm. The author here is cherry picking a couple of poor quality outliers. They don’t give specific references, but the same few studies (such as the retracted Seralini study) always crop up on such lists.

They finish with an odd argument from authority. They mention that the AMA says GMOs are safe, but fail to mention the dozens of other medical and scientific organizations that have also reviewed the evidence and found current GMO crops to be safe. Instead they cherry pick another outlier, an anti-GMO environmental group.

They increase herbicide use: When Monsanto came up with the idea for Round-up Ready crops, the theory was to make the crops resistant to the pesticide that would normally kill them. This meant the farmers could spray the crops, killing the surrounding weeds and pests without doing any harm to the crops themselves. However, after a number of years have passed, many weeds and pests have themselves become resistant to the spray, and herbicide-use increased (both in amount and strength) by 11% between 1996 and 2011. Which translates to – lots more pesticide residue in our foods – yum!

The story is more complex than this cartoon. First, the introduction of Bt GMO varieties has clearly reduced the use of insecticide (pesticides include insecticides and herbicides). The introduction of glyphosate resistant crops has increased the use of glyphosate (an herbicide), but decreased the use of other herbicides. Total herbicide use has actually decreased. Further, glyphosate is among the least toxic herbicides, and so the trend has been to replace more toxic herbicides with a less toxic herbicide.

Therefore, the bottom line conclusion of the author – more pesticides in our food – is the opposite of the truth.

Herbicide resistant crops has also allowed the reduction in tilling, which harms the soil and releases CO2 into the atmosphere.

It is true that overreliance on any single strategy for weed control will lead to resistance. This is a generic problem with any strategy that we use. This is a problem of the massive farming needed to feed the world, and is not unique to GMO. Therefore, of course we need to use technology carefully and thoughtfully to optimize sustainability. Some form of integrated pest management is therefore probably a good idea, but this is not incompatible with GMO technology.

They are everywhere! GMOs make up about 70-80% of our foods in the United States. Most foods that contain GMOs are processed foods. But they also exist in the form of fresh vegetables such as corn on the cob, papaya and squash. The prize for the top two most genetically modified crops in the United States goes to corn and soy. Think about how many foods in your pantry or refrigerator contain corn or its byproducts (high fructose corn syrup) or soy and its byproducts (partially hydrogenated soybean oil).

So what? GMO are safe to eat. They are good for the environment. I would be happy if 100% of our crops were genetically modified in order to optimize their traits. In fact, 100% of our crops have been extensively genetically modified through breeding over centuries and even millennia. You would hardly recognize the pre-modified versions of the food you eat every day.

GM technology is faster and more precise. It can also introduce genes from distant branches of life, but again – so what? All life on earth shares a common genetic code and basic biochemistry. We share genes with peas. There is no such thing as a “fish gene” really. There are just genes that are found in fish, most of which are also found in vegetables but some that aren’t. As long as we know what the genes are doing, and test their net effects on the crop, who cares where they came from?

GM crops don’t ensure larger harvests. As it turns out, GMO crop yields are not as promising as some projections implied. In fact, in some instances, they have been out-yielded by their non-GMO counterparts. This conclusion was reached in a 20 year study carried out by the University of Wisconsin and funded by the U.S. Department of Agriculture. Thus negating one of the main arguments in favor of GMOs.

This is one of those – sort of true, but very misleading – factoids that are common in propaganda. The currently available GM crop traits are not specifically designed to increase yield. They are designed to make yield more predictable, by reducing loss through pests, drought, or disease. Higher yielding traits are in the pipeline, however.

What about that University of Wisconsin study the author specifically cites (it’s nice when they give a specific reference to check their sources)?  It concludes:

Their analysis, published online in a Nature Biotechnology correspondence article on Feb. 7, confirms the general understanding that the major benefit of genetically modified (GM) corn doesn’t come from increasing yields in average or good years, but from reducing losses during bad ones.

That’s a little different than what the author implied. It reduces losses in bad years – which mean overall yields are increased. This also only referred to corn. Bt cotton has increased yields by an average of 24%, increasing profit and quality of life for cotton farmers in India.

A 2014 meta-analysis concluded:

On average, GM technology adoption has reduced chemical pesticide use by 37%, increased crop yields by 22%, and increased farmer profits by 68%. Yield gains and pesticide reductions are larger for insect-resistant crops than for herbicide-tolerant crops. Yield and profit gains are higher in developing countries than in developed countries.

Still, anti-GMO activists continue to lie about the data, claiming the exact opposite of what the scientific evidence shows.

And finally:

U.S. Labeling suppression: Many of the companies who have an interest in keeping GMOs on the market don’t want you to know which foods contain them. For this reason, they have suppressed recent attempts by states such as California and Washington to require labeling of GMO products. And since they have deep pockets, they were successful – for now. The companies who spent the most on these campaigns are Monsanto (who produces the GMO seeds), and Pepsi, Coca Cola, Nestle and General Mills, who produce some of the most processed foods in existence. Incidentally, most other developed countries such as the nations of the European Union, Japan, Australia, Brazil, and China have mandatory labeling of genetically modified foods. Food for thought!

They somehow fail to mention that the multi-billion dollar organic food industry lobbies for labeling. But again I say, so what? The fact that there is a political argument about labeling does not directly imply anything about the safety of GMO or whether or not it is a good thing for people and the planet. In fact – that is the very reason that many people (the corporations aside) oppose labeling.

Mandatory labels imply that there is something for the consumer to worry about. It is a transparent attempt to demonize a safe and effective technology, so that anti-GMO propaganda will have a target. This is also an attempt by a competitor – the organic food industry – to create a negative marketing halo around its competition.

Conclusion

This is only a small sampling of the anti-GMO propaganda that is out there. I am all for a vigorous evidence-based discussion about the true risks and benefits of a new technology. This includes how to optimally regulate such technologies. I believe in the need for thoughtful and effective regulations of any technology that has health or environmental impacts. We have seen what happens when an industry, like the supplement industry, is not effectively regulated.

GMOs are highly regulated. They are the most tested food that we eat. Cultivars that resulting from hybridizing plants and mutation farming, using chemicals or radiation to speed up the process of DNA mutation, are not tested and are even considered organic. This is a double standard, but fine. Let’s test the hell out of GMOs to make sure there are no surprises. This is already happening – and GMOs currently on the market are safe.

The anti-GMO campaign is largely an anti-science campaign. This one article is not an outlier – it is squarely in the mainstream of anti-GMO rhetoric.

Categories: Medicine

Placebo, Are You There?

Science Based Medicine - Tue, 02/24/2015 - 03:00

By Jean Brissonnet, translation by Harriet Hall

Note: This was originally published as “Placebo, es-tu là?” in Science et pseudo-sciences 294, p. 38-48. January 2011. It came to my attention in the course of an e-mail correspondence with the editors of that magazine, where one of my own articles was published in French translation in January 2015. I thought this was the best explanation of placebo that I had ever read. It covers the same points my colleagues and I have addressed and more. It describes the pertinent research and uses particularly effective graphs to illustrate the principles (a picture is worth a thousand words). The author, Jean Brissonnet, kindly gave his permission for me to translate it and share it with our readers.

In fact, you don’t need to give a placebo to get a placebo effect and therefore we can now think about how we can maximize the pladefincebo component of routine care.

~ Damien Finniss, 2010

The scene takes place in a surgical suite where they are preparing to do a cataract operation. The patient is lying on the operating table. A few minutes earlier the anesthetic gel was applied to the cornea to permit an operation under simple local anesthesia. The surgeon arrives in the company of the anesthetist. They are engaged in a spirited discussion and don’t seem to be agreeing.

“It has been proven,” says the surgeon, “that 30% of the action of a medical treatment is due to the placebo effect.”

“I doubt that,” retorts his interlocutor, “I think that placebo story is one of those medical myths on a par with the idea that we only use 10% of our brain, that nails and hair grow after death, or that cellphones create interference in hospitals.”[1]

“No,” insists the surgeon with a superior tone, “the fact is established and has been proven by numerous studies.”

The anesthetist shakes his head with a slight smile, but he doesn’t reply. As for the patient, who might have much to say on the subject, he keeps quiet, because it would not be prudent to argue with someone who is about to suck the lens out of your eye.

This true anecdote would not be of interest if it didn’t concern two members of the medical profession. Why such uncertainty? Why such lack of knowledge about such a fundamental subject? This faith in an all-powerful, magical, and mysterious placebo is common among the general public and it serves as justification for resorting to unconventional medicines that have never been able to show solid proof of efficacy; but we see that it still persists among the medical profession.

To know whether the placebo effect is real or should be relegated to the same category as poltergeists, it will help to go back in history.

The history of the placebo effect

Although the placebo effect had long been recognized, official attention to it really followed the generalization of controlled clinical trials by the Cornell Conferences on Therapy in 1946. The popularization of this effect wouldn’t really occur until the publications by Beecher in 1955 and Haas in 1959.

Beecher reviewed 15 articles describing the treatment of 1052 patients and estimated that across all the conditions studied, the average placebo effect was 32%. These results were confirmed by Haas a few years later based on 1400 cases from 96 articles. He also found an average of around 30%, but he found a lot of variation depending on what was being studied. The improvement in the symptom of pain varied from 15% to 60%.

The consequence of these articles was the introduction of a simple additive model that considered the placebo effect as the difference between the global effect observed and the pharmacological effect. It was then defined as “the clinical effect produced by the administration of a placebo.”

This definition is important, because it attributes causality (“produced by”) to something that was really no more than a correlation. We had to wait a long time for that conception to be called into question. The reason for that was that the placebo effect was a little-known mechanism, because it had been little studied.

This lack of interest undoubtedly comes from the fact that the placebo effect competes with the actions of the doctor and takes away some of his credit for healing. In addition, the placebo is not interesting to the pharmaceutical industry that finances the majority of research. They are content to research the pharmaceutical effects of their products and don’t much care about other mechanisms of action.

Over half a century, there were around 20 studies on the placebo per se, and only a few hundred on the placebo in the context of pharmacologic studies. Consider this in comparison with the very many studies carried out on drugs.

The consequences of that state of affairs are numerous. They range from the highlighting, even in relatively recent articles, of old studies of questionable methodology, to the persistence of certain accepted ideas – including the famous 30% – and the unwillingness to question the models being used.

The authors of an article (Kienle and Keine,1997) that was one of the first to desanctify the placebo effect wrote, “False impressions of the placebo effect can be produced in various ways.” They cite numerous examples such as spontaneous improvement, fluctuation of symptoms, regression to the mean, additional treatment, scaling bias, answers of politeness, and many others. They find that “These factors are still frequent in modern literature on the placebo.”

Knowing that these authors analyzed over 800 articles, one can note that all references prior to this publication should be regarded with the greatest caution.

Questioning the placebo

This questioning comes from the fact that many researchers have not taken natural healing into account, which is curious considering how many pathological conditions heal spontaneously. For example, the journal Prescrire, in its February 2007 issue, wrote on this subject, “it can be estimated that without treatment, 50-70% of cases of simple acute cystitis resolve spontaneously, usually after having been asymptomatic for several months.”

In fact, what is called the placebo effect is the result obtained in a placebo control group (Figure 1).

Figure 1

 

Therefore, it is necessary to conceptualize a new model in which the effect observed is equal to the specific effect of the medicine being studied plus a complex nonspecific effect in which the natural healing process plays a large part.

One will then have the scheme seen in Figure 2. The equation becomes:

Observed effect = specific effect + natural course of healing + a residual effect that we will provisionally call the placebo effect.

Figure 2

 

But isn’t this new “placebo effect” in turn composed of different elements? First among these are measurement errors made during the course of the trial. There are many such potential errors depending on the type of study. The best known are the phenomenon of regression to the mean, the Hawthorne effect, the Simpson paradox, the Will Rogers phenomenon, etc. (see box). Others come to mind: for example, an inaccuracy in the inclusion of subjects in the trial or the fact that patients tend to seek help when their symptoms are at their peak.

If all these measuring errors are subtracted, what remains can be called the “true placebo effect,” a term proposed by Ernst (1995), to distinguish it from the “false” placebo effect as traditionally conceived (figure 3).

Figure 3

 

The polemics

The resulting placebo effect is so reduced compared to the initial concept that some have gone so far as to question whether it exists at all. The first serious blow against the traditional understanding of the placebo effect was struck by Kienle and Kiene (1996).

The authors had the idea of repeating Beecher’s study to verify its validity. In their conclusion, they wrote:

 

Since 1955, when HK Beecher published his classic “The Powerful Placebo,” it generally has been accepted that 35% of patients with any of a wide variety of disorders can be treated with placebos alone. In recent years, average cure rates of 70%, and up to 100%, also have been quoted. It has been postulated that placebos can prolong life, that their effects occur in surgery as well as in medicine…In this article source material that forms the scientific basis for such claims is examined. Analysis shows that the studies on which such ideas are based, except perhaps in bronchial asthma, do not in any way justify the conclusions drawn from them. The truth is that the placebo effect is counterfeited by a variety of factors including the natural history of the disease, regression to the mean, concomitant treatments, obliging reports, experimental subordination, severe methodological defects in the studies, misquotations, etc; even, on occasion, by the fact that the supposed placebo is actually not a placebo, but has to be acknowledged as having a specific action on the condition for which it is being given.

Errors and Bias in Measurement

The Hawthorne effect: subjects may change their usual behavior just because they are participating in a study, and this can lead to overestimating the effects of treatment, particularly in the control group.

Regression to the mean: Including patients with very high or very low values at the beginning of a study gives the illusion that the statistical variation of subsequent measurements is improvement caused by the treatment.

Simpson’s paradox: When unrecognized determining factors (“confounders”) influence the data, the overall results of a study can be completely changed by analysis of sub-groups. [Translator’s note: another way of saying this is that a trend that appears in different groups of data can disappear or reverse when the groups are combined.]

The Will Rogers phenomenon: Improved diagnostic methods that artificially increase the prevalence of a disease can improve the apparent prognosis of a patient without the measurement parameters having been changed. [Translator’s note: If cancers are diagnosed earlier but there is no change the time of death, the survival time will appear to have increased. The name comes from a Will Rogers quotation: “When the Okies left Oklahoma and moved to California, they raised the average intelligence level in both states.]

Taken from « Quatre effets, phénomènes et paradoxes de la médecine. Leur signification et leurs racines historiques », Peter Kleist. Forum Med Suisse 2006 ;6 :1023–1027

And the authors are the first to say that “another error of judgment is the lack of clarity of the concept of placebo itself.” They conclude bluntly “that the literature relative to the magnitude and frequency of the placebo effect is unfounded and grossly overestimated, if not entirely false.” Finally, they raise the question of whether the very existence of the so-called placebo effect “is not in fact largely or totally illusory.”

This was like throwing a stone into the pond.

Nevertheless, neither this study nor the following article published a year later by the same authors on the same subject (Kienle and Kiene,1997) provoked reactions, even though they had all the requisite qualities and were published in peer-reviewed journal.

And yet, it is not for nothing that today “Beecher’s error” is commonly talked about! It was necessary to wait six years for another study, arriving at the same conclusions, to awaken the torpor of the medical community.

In 2001, Hrobjartsson and Gotzsche published an article based on 214 studies with a total of 8525 patients. Their conclusions were as follows: “We found little evidence in general that placebos had powerful clinical effects…they had possible small benefits in studies with continuous subjective outcomes and for the treatment of pain.” And they concluded that “outside the setting of clinical trials, there is no justification for the use of placebos.”

This study, which goes against conventional wisdom, would be widely disputed, but the ensuing controversies would be very fertile.

To better understand this paradox, another team, Vase et al. (2002) repeated Hrobjartsson’s study separating it into two meta-analyses depending on whether the purpose of a study was to use placebo as a control for an active treatment or to investigate the mechanisms of placebo analgesia. They show that the two groups Hrobjartsson studied were in fact two placebo groups, because the patients in a no-treatment group know they are part of a clinical study and they are regularly evaluated by doctors. So therefore, the use or non-use of a placebo “object” changes nothing. That’s why the authors propose a new definition: “The placebo response is the reduction in a symptom as a result of factors related to a subject’s/patient’s perception of the therapeutic intervention.”

It is therefore found that the terminology surrounding the famous placebo is extremely ambiguous, because it appears that the placebo effect is no longer linked to the placebo object and that this new definition requires that we distinguish “the placebo effect” from “the effect measured in the placebo group” and from “the effect of a placebo.”

We can’t hope to get the public to understand (or even the medical profession, which necessarily lacks the time to delve into these syntactical-semantic subtleties) unless we resort to a clarification and stop using the same word in several unrelated senses.

An attempt at clarification

It seems natural, in the current state of things, to distinguish two situations. In the context of a controlled clinical study, what matters is to determine the specific effect of the treatment. Everything else, which can be called “non-specific effects,” consists of complex elements and is of no interest to the sponsor of the study who is seeking to evaluate the specific efficacy of a given molecule (figure 4).

Figure 4

 

In the clinical context of treating a patient, on the other hand, the observed effect is equal to the pharmacological effect to which is added natural healing and an effect that we have called “true placebo,” but which, for the reasons indicated above, would now be preferable to call “contextual effect,” [2] as various researchers have proposed. (Di Blasi et al. 2003, Miller and Kaptchuk 2008).

Measurement errors have obviously disappeared from this context, which explains that the overall effect can be slightly inferior to that observed in the case of a clinical study.

Implementation of the contextual effect

It remains to know what are the elements that can enter into play in the implementation and in the optimization of this contextual effect.

The first element is the therapeutic ritual: the results are different according to the route of administration, the taste, the name, the price, the color, etc. Several studies have confirmed the action of some of these parameters.

The second has to do with environmental conditions: the personality and beliefs of the patient, the attitude of his companions, the place where care is being administered, the attitudes of the treatment team, etc.

Finally, it seems that the most important element is the doctor/patient relationship.

In order to determine the influence of these three factors, to evaluate their relative importance and to see how they can be combined to provide clinical improvement, Kaptchuk (2008) studied three groups of patients suffering from irritable bowel syndrome. The first group was placed on a waiting list, the second received simple placebo acupuncture treatments, and the third received placebo acupuncture accompanied by special attention from the provider (a warm relationship, building trust, sustained attention). At the end of six weeks, they observed an improvement of 28%, 44%, and 62% respectively. The author concluded that “Non-specific effects can produce statistically and clinically significant outcomes and the patient-practitioner relationship is the most robust component.”

Psychological mechanisms

The psychological mechanisms involve two elements that can act simultaneously or separately: conditioning and suggestion.

Conditioning

Conditioning has been known since the work of Pavlov. He showed that if a dog becomes accustomed to the arrival of his food being accompanied by a sound stimulus, after a while the salivation reflex can be triggered by the sound alone in the absence of food. The same mechanism occurs when taking a placebo. As Gotzsche (1994) wrote in The Lancet, “A lactose capsule has a greater effect in people who have previously reacted favorably to taking a benzodiazepine than in those who have never taken it.”

Suggestion

The power of suggestion has been known for a long time. One can cite its utilization by Mesmer under the fallacious pretext of an alleged animal magnetism or, closer to our day, by the famous Coué method.

More recent studies provide evidence of its role in the implementation of the contextual effect. Thomas (1997) followed 200 patients with functional illnesses. He divided them into four groups receiving either a placebo or nothing and either a positive or negative consultation. The first group received a placebo and a positive consultation (assurance of correct diagnosis, certainty of healing), the second, a placebo and a negative consultation (hesitation about the diagnosis, lack of confidence about the course of the disease), and the other two groups got a positive or negative consultation without a placebo. After two weeks, 64% of the patients who got a positive consultation had improved compared to 39% of those who got a negative consultation. But there was no significant difference between those who got or didn’t get a placebo. The improvement they found was therefore due to the suggestion created by the doctor and had nothing to do with taking or not taking a placebo object.

This clearly confirms that, as Bourreau and Coichard (2003) wrote, “It is useless to resort to a placebo to induce a placebo effect.” Which could be written more clearly today by saying that the placebo object is not necessary for the contextual effect.

Neurobiologic mechanisms

It is not enough to understand the psychological mechanisms that mediate between between the context of care and the development of a therapeutic effect. We should also investigate how these psychological mechanisms are capable, in turn, of causing biochemical and neurobiological changes that can themselves produce measurable results.

Endogenous opioids

It is no coincidence that the vast majority of studies on placebo are performed in the area of pain, either artificially provoked or not. It is indeed in this area that one gets the most important nonsignificant effects. We can’t help but note the extreme importance of the contextual effect in relieving pain. This is why it was hypothesized that the observed effect was due to the secretion of opioids by the patient’s body. The results of studies on this subject are quite numerous and consistent. They confirm this hypothesis (see box).

The power of context in the treatment of pain

A study by Levine et al. (1981) perfectly illustrates the power of context in the treatment of pain. The authors studied the effect of intravenous morphine and intravenous placebo in 74 post-operative patients after extraction of impacted third molars. Two hours after the start of anesthesia, all patients openly received an intravenous saline placebo.* An hour later, each patient got either a second open placebo or a hidden dose of 4, 6, 8, or 12 mg of morphine administered automatically by a pump under double blind conditions. The level of pain was evaluated 50 minutes later using a visual analog scale. The average relief of pain after the second dose of placebo was found to be equivalent to that of a hidden dose of 4-6 mg. of morphine and no patient got complete relief, even from that maximum dose of morphine (12 mg).

One can also cite, among the most significant studies, that of Petrovic et al. (2002), in which a light skin burn was induced in volunteers. They were divided into three groups who got either an opioid analgesic, a placebo, or nothing. In the patients who got relief from either the drug or the placebo, positron emission tomography (PET) showed an increase in activity in the rostral anterior cingulate cortex and in the brainstem, areas of the brain that are involved in the relief of pain. To confirm these findings, the patients were given naloxone (an opioid antagonist) and the pain returned.

*In an “open” intervention, the patient receives all the usual care from caregivers (putting medication in the intravenous line, verbal exchanges … ). In a “hidden” intervention, the staff is not involved and the injection is given by an automatic pump, unbeknownst to the patient.

Neurotransmitters

Dopamine

It has been noticed that the contextual effect appears to be active in Parkinson’s disease. Parkinson’s disease is a condition that causes the degeneration of dopaminergic neurons, resulting in a deficit of dopamine in the nigrostriatal pathway that manifests clinically as a movement disorder.

De la Fuente-Fernandez et al. (2001) used labeled raclopride, a molecule binding to dopamine receptors, to detect dopamine receptors in the brain with PET scan (positron emission tomography). The patients received either an injection of levodopa[3] or placebo. They found that the placebo produced the same effect on dopamine receptors, triggering substantial release of endogenous dopamine in the brain. They concluded: “Our findings indicate that the placebo effect in Parkinson’s Disease is powerful and is mediated through activation of the damaged nigrostriatal dopamine system.”

It still remains to be seen whether these imaging findings translate into clinical results. A more recent study (Fregni et al., 2006) has modified the findings of the preceding study. It studied not just the patient’s subjective response, but also objective tests. The authors sought to investigate the immediate effects of two different kinds of placebo (a pill and sham transcranial magnetic stimulation) and compared them to the effects of standard treatment with levodopa. Subjective motor function was measured with a visual analog scale, and objective motor function was measured with a unified Parkinson’s disease rating scale (UPDRS). They concluded: “…placebo interventions in Parkinson’s Disease may have an immediate subjective sensation of improvement but result in no significant objective motor changes compared with levodopa treatment.”

Serotonin

Mayberg et al. (2002) carried out a randomized double blind study on 17 patients who were hospitalized for six weeks to test fluoxetine (an anti-depressant) against placebo. They did PET scans before treatment, a week later, and at the end of the sixth week. In each group, they found four patients who improved and who demonstrated increased activity in the part of the brain associated with emotions. However, the relief was less durable with the placebo.

Can placebos be used to treat patients? 

We have just seen that the contextual effect is an essential element in terms of pain and probably also the various functional diseases. It affects subjective perception, but no evidence of action has ever been found in the areas of infectious diseases or tumors. As for the reality and the importance of its effects in Parkinson’s disease or depression, that remains unclear. It is obvious that the placebo, as an object, is useful in controlled clinical studies. In that setting, ethics committees require that the patient be informed and give informed consent. The problem that has been debated for a long time is the issue of its use in the clinic. There are many arguments against its use in healthcare practice. Do we have the right to fool the patient? Do we have the right to act without his consent? Can we risk permanently damaging the doctor/patient relationship if the patient finds out that he has been deceived?  A better understanding of the phenomenon makes such questions obsolete. To the extent that the “placebo effect” is only a contextual effect that doesn’t depend on the use of an inactive object, it can and should be used in healthcare practice. It can probably be used instead of a prescription in certain functional diseases, and it certainly can potentiate the effect of prescribed drugs in many cases (analgesics, antidepressants…)

The authors of a recent study (Finiss et al., 2010) clarify this issue perfectly when they write, “For many years, placebos have been defined by their inert content and their use as controls in clinical trials and treatments in clinical practice. Recent research shows that placebo effects are genuine psychobiological events attributable to the overall therapeutic context, and that these effects can be robust in both laboratory and clinical settings. There is also evidence that placebo effects can exist in clinical practice, even if no placebo is given. Further promotion and integration of laboratory and clinical research will allow advances in the ethical use of placebo mechanisms that are inherent in routine clinical care, and encourage the use of treatments that stimulate placebo effects.”

So, then! Placebo, are you there? The placebo object is certainly there! It will be irreplaceable for the foreseeable future in carrying out the controlled clinical studies that are essential to medical research. As for the effect of the placebo, that doesn’t exist. As for the effect “called” placebo, if its existence is undeniable albeit limited, it would be better to simply name it “contextual effect” in order to better understand its true nature and to make its magical connotations disappear.

Notes
  1. These myths and many others are refuted in the article “Medical myths” BMJ 2007:335, 1288-1289 (22 December). return
  2. In the rest of this article, the term “placebo effect” will be designated “true placebo effect” or “contextual effect. return
  3. The international pharmacological name for L-DOPA, a substance used in the treatment of Parkinson’s disease that increases dopamine. return
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  • Petrovic et al. (2002) Placebo and opioid analgesia– imaging a shared neuronal network. Science 295(5560):1737-40.
  • Thomas KB (1987) General practice consultations : is there any point in being positive? BMJ 294:1200-1202
  • Vase L et al. (2002) “A comparison of placebo effects in clinical analgesic trials versus studies of placebo analgesia.” Pain 99: 443-452.

 

 

Categories: Medicine, Skepticism

Special thanks to Dr Andrey Pavlov

Science Based Medicine - Mon, 02/23/2015 - 21:16

I don’t write posts very often. In fact, I’ve only ever written one before, and I didn’t even post it under my account. That’s because I’m not a doctor or a scientist, I just babysit the server on a volunteer basis.

Trying to keep a site as popular as SBM running on a non-profit budget is no easy feat. Especially when everyone involved has their own day jobs. I’m constantly amazed at the dedication of the SBM staff. The hours everyone puts in writing these posts is nothing short of monumental.

Well, something happened today, and SBM reader and contributor Dr Andrey Pavlov deserves recognition and gratitude.

The technical details are pretty boring, but the main thrust is that an unknown number of readers were unable to access SBM. Everything was working fine on our end. This was a problem somewhere in the Byzantine mess of a certain national-level ISP who shall remain nameless. Before we even knew what was happening, Dr Pavlov took it upon himself to deal with the ISP and get the whole mess sorted out. He even managed to pull off a really impressive magic trick and got the ISP to admit that it was a technical fault on their end.

Again, we don’t know how many people this affected. But thanks to Dr Pavlov’s efforts, the issue has been resolved without me developing a single tech-support-hotline-induced headache.

Dr Pavlov, on behalf of myself and the entire ScienceBasedMedicine crew, you have our sincerest gratitude.

And now, here’s a picture of a hamster wearing a sweater.

Admit it, that’s just adorable.

Categories: Medicine, Skepticism

ADHD Is Real

Neurologica Blog - Mon, 02/23/2015 - 08:13

Attention Deficit Hyperactivity Disorder (ADHD) has long been a target of those who dislike the very concept of mental disorders. This is partly because the emotional stakes are high – the diagnosis often results in children being treated with stimulants. Opposition to the concept of ADHD also reflects fundamental misunderstandings about medicine.

A recent opinion piece in The Blaze by Matt Walsh reflects this deep misunderstanding and unease with the concept of mental illness.

Throughout the piece he uses the terms “disease” and “disorder” interchangeably, without defining either. The distinction is important, because it relates to how medicine defines diagnostic entities. Not all diagnoses are created equal. I spend a great deal of time teaching medical students to have a sophisticated and nuanced understanding of the labels they will be attaching to their patients.

As with every branch of science, labels are used as placeholders of our understanding of phenomena, and also as a necessary contrivance to allow technical communication among experts, in the scientific literature, and also to the public. In medicine we need labels for certain practical applications, such as documentation, epidemiology, drug indications, reimbursement, and research. Labels are a scientific tool, and they need to be understood to be used properly.

ADHD is certainly not a “disease.” The term disease should be reserved for entities that involve a discrete pathophysiological condition. Type II diabetes is a disease – it is defined by specific physiological conditions.

In medicine, however, there are also clinical syndromes, disorders, and categories of disorders. This is because we don’t understand everything about every medical condition. Further, we are trying to describe 7 billion people, who display tremendous variability – it’s a variable and chaotic system.

What typically happens, therefore, is that new entities are first described clinically. They are recognized and defined as a cluster of signs and symptoms and perhaps a natural history that tend to occur together, meaning that more than one patient will display the same constellation of findings, suggesting a common underlying process. This does not necessarily mean that the underlying pathology or ultimate cause is the same, however. The clinical syndrome may just represent the final common pathway of multiple processes.

We talk, for example, about heart failure as a clinical syndrome, even though many underlying pathologies may cause the heart failure.

Over time, as our understanding improves, there is a tendency to shift from clinical syndromes to more pathophysiological diagnoses. Sometimes this requires a change in the labels and categories, sometimes it doesn’t. The muscular dystrophies started out their medical life as clinical syndromes. It was decades later that the underlying genetic mutations that cause these disorders were identified and understood. Some muscular dystrophy diagnoses survived this change, others did not.

In the area of mental conditions, we are largely still in the era of clinically defined syndromes. We are starting to understand the underlying neurological causes of some of the more discrete disorders, such as schizophrenia, and this is also started to change our classification system.

However, brain disorders are different than other organ systems in that function relies upon more than just the biological health of the cells and tissue. Liver disease is largely caused by pathological processes affecting liver cells. There is also brain disease caused by pathological processes affecting brain cells. However, brain cells also have other layers of complexity to their function, the pattern of connections and the biochemical processes that underlie brain processing. Therefore there can potentially be a brain disorder without underlying classical pathology – with healthy brain cells but that happen to be connected in a dysfunctional pattern.

To add another layer of complexity, part of the function of the brain is to interact with the environment, including other people and society.

Because of this, medicine uses the concept of mental disorder to define a clinical entity in which a cluster of signs and symptoms relating to thought, mood, and/or behavior causes demonstrable harm. This is a reasonable and practical definition. But it is a clinical placeholder, and should not be confused with a discrete pathophysiological entity. That does not mean it’s not a real disorder, or that any specific intervention to mitigate the harm is not useful or appropriate.

Walsh describes his own symptoms this way:

Even now, I daydream all the time. I can’t sit still. I can’t concentrate on mundane tasks. I get lost in my own head. I forget things. I can’t stay on one train of thought for very long. At this very moment, I have four different word documents open on my computer and I am working on four different posts at the same time. Three of them will never be published or completed. Ask my wife, she’ll tell you all about it.

Walsh prefers to think that this is part of the normal variation of human behavior, and the only reason it is defined as a disorder is because it causes inconvenience to others. The latter part of the claim is not fair. Many people who are diagnosed with ADHD find it an inconvenience to themselves and want help.

ADHD is understood as a disorder of executive function, which is a definable neurological function that localizes to the frontal lobes. Executive function is what enables us to pay attention, to plan our behaviors for strategic benefit, and to inhibit behaviors that are not socially appropriate or in our own best interests. Like every human trait, executive function varies from person to person. Even in the “normal” population (meaning without specific injury or disease) there will be those at the low end of the Bell curve. The same is true for music ability, math ability, reading ability – pretty much any neurological function. Decreased executive function can also be acquired by injury or a pathological process.

Low executive function is considered a disorder, while low musical aptitude is not, because the former is associated with demonstrable harm while the latter is not. Those with low executive function tend to have difficulty in school or any structured and restrictive setting, they have higher divorce rates, higher incarceration rates, lower lifetime income potential, and are at higher risk of depression. Often they are frustrated by their inability to adapt to the demands of school or work.

Further, evidence clearly shows that medication for ADHD improves function and outcomes and is cost effective. Behavior interventions also have an effect, but it is smaller and less certain.

In short, the scientific evidence clearly points to the conclusion that ADHD is a real neurological disorder characterized by hypofunctioning of executive function with demonstrable negative outcomes. Further, these outcomes can be improved with treatment. Walsh and others, however, try to deny this basic scientific reality with logical fallacies and misdirection.

One strategy Walsh employs, which is typical of denialism, is to cherry pick outlying experts, rather than reflect the consensus of expert opinion. He also misrepresents some of those experts. For example, he links to this article by Dr. Richard Saul.  Sure, the headline says: Doctor: ADHD Does Not Exist. This might lead someone who did not read and understand the article to the wrong conclusion. Saul writes:

However, there are some instances in which attention symptoms are severe enough that patients truly need help. Over the course of my career, I have found more than 20 conditions that can lead to symptoms of ADHD, each of which requires its own approach to treatment.

He is not saying that the syndrome of ADHD does not exist, or does not need to be treated. What he is saying is that ADHD is not a primary disorder, but rather a secondary symptom of a number of different underlying disorders. Those underlying disorders need to be indentified and treated specifically. While I agree with him that ADHD is sometime a secondary symptom, I don’t think you can scientifically justify the conclusion that there is no primary ADHD disorder. He is correct, however, in that lazy or insufficiently trained clinicians might use ADHD as a catchall diagnosis and fail to look for underlying problems. This is a generic problem of quality control in clinical medicine, and we see this in every field.

Walsh then plays the, “behaviors cannot be a disease,” card:

There are many reasons to view ADHD as a fraud, but let’s start with the fact that at the very beginning, before you take one step into the issue, it already makes no sense. Impulsive? Impatient? These are personality traits, not medical conditions.

Daydream? Talk a lot? Interrupt? These are behaviors, not symptoms of a disease.

Since behaviors emerge from the functioning of the brain, and the brain can be disordered, then behaviors can be symptoms of a brain disorder. This is where he uses definitions, like “disease”, in a slippery way to cause confusion.

He goes on to argue that these behaviors are normal in children. The obvious response is that the disorder, as with most mental disorders, is a matter of degree, to which he responds:

Now you might say, well yes, they’re normal, but some kids, like, talk A LOT, and daydream A LOT, and interrupt A LOT.

To that I’d respond: yeah, still pretty normal.

The question is – is there any degree of behavior that can meaningfully be described as a disorder? Walsh is implying that no matter how impulsive, distracted, and disruptive a child is, it must be consider part of the normal spectrum. Part of the problem is that “normal” is not a useful technical term, because it doesn’t have a good operational definition. Walsh can call anything normal – it all occurs as part of the human condition. Any gene variant is just as valid as any other gene variant. Whose to say which is “normal.”

“Disorder,” however, does have an operational definition – it must be the lack of a trait or ability that most people possess that is linked to demonstrable harm. This is independent of any judgement about whether or not the condition is “normal.”

Even Walsh has to admit that some children are really far off the mean of the Bell curve, so he employs a little distraction:

But maybe you have kids who do these things A LOT A LOT. Beyond the normal a lot, and into the realm of REALLY A LOT. Alright, fine. So where’s the cut off?

This is a non sequitur. Sure, it’s a continuum, just like height. There is no dividing line between short and tall, but Kareem Abdul Jabbar is freaking tall. Further, we draw dividing lines to separate continuums of biological functioning in order to define diseases and disorders all the time. High blood pressure is defined as 160/90. Does that mean that 159/89 is perfectly healthy? Of course not, but we need to draw a line somewhere. This is the “false continuum” logical fallacy -denying the existence of the extreme ends of a continuum because there is no sharp dividing line.

This raises another one of my criticisms of mental illness denial – it uses features that are generic to all of medicine and pretends that they are unique to psychiatry. He is doing this when he writes:

Let’s look at an Actual Sickness for comparison. Let’s look at dementia. There’s an honest-to-God mental disease. It’s also a disease that can be physically observed in the human body. You can see it quite unmistakably in a brain scan. And there are clear symptoms, like hallucinations. Notice, there isn’t a spectrum where acceptable hallucinations graduate into unacceptable hallucinations. Hallucinations are always bad, to any degree whatsoever.

Walsh here is completely wrong on every point. First, you cannot always see dementia on a brain scan. Dementia is a category of diseases, it is not one disease. Some do not have specific brain scan findings. The early stages of most will not be evident on brain scan. Dementia is defined clinically, by a cluster of signs and symptoms. We then have to look for underlying causes, and may or may not find one. Further, there is no clear demarcation between normal aging and early dementia. There is a diagnosis called minimal cognitive impairment, which defines those who have symptoms of mild dementia but may not have dementia.

His example of hallucinations is also highly problematic. First, that is not a classic symptom of dementia. It’s a symptom of psychosis. Also, it is not always pathological as he says.  Hallucinations sometimes are “acceptable.” For example, a percentage of the healthy population have hypnagogic hallucinations – associated with transition from sleep to wakefullness. These are hallucinations, but they are benign, not part of any disease or disorder. They can also be a symptom of a sleep disorder. And hallucinations generally can be a symptoms of many things, from drug side effects to schizophrenia. Symptoms often have to be put into context.

This really was a terrible example for Walsh to use to make his point, but makes my point perfectly. Walsh simply does not understand the nature of diseases and disorders and how they are defined.

The rest of his article essentially repeats the same fallacies – false continuum, appeal to cherry picked outliers, misunderstanding the nature of medical diagnoses, and flat out denial and mischaracterization of the science. He also adds the argument that it’s all good:

I told you about my “ADHD.” Well, a funny thing happened. The precise disposition that made it very difficult for me to excel in chemistry class or while working as a cashier is now the precise disposition that makes it possible for me to excel in my current career. Writing, debating, creating new ideas, trying to earn a living in the ever changing world of new media — I couldn’t do any of that if I wasn’t like this. What made me a failure in school makes me extremely successful in this realm. How do you explain that?

He has a kernel of a point here – human behavior is complex and we always need to strive for a sophisticated and nuanced understanding of the interaction of brain function with society and culture. Overly simplistic approaches can be counterproductive, and with behavior there are often trade offs. If your ADHD is working for you, then don’t treat it. No one is going to strap you down and give you stimulants.

The situation is more complex for children, and we do need to be their advocates. Some children are truly struggling, are frustrated and unhappy because of the challenges presented by their ADHD (even if it might have advantages in other contexts). Researchers are looking for ways to mitigate the negative effects of ADHD with behavioral methods, parenting methods, and individualized approaches as school.  These have some benefit, but often not enough. Walsh has not presented a coherent argument for why medication should not be used in such cases, even though the evidence shows it is safe and effective.

Conclusion

There is a clear consensus based upon robust scientific evidence accumulated over decades that ADHD is a real disorder. Denying the reality of ADHD, in my opinion, is just like any other science denial, and employs the same suite of methods and fallacies in order to do so.

At the core of mental illness denial is a fundamental misunderstanding of medicine in general. False dichotomies are drawn between mental health and the rest of medicine, and the examples used to make those dichotomies are always fatally flawed.

I also find that mental illness denial has many potential negative consequences. It further stigmatizes mental illness, which should be viewed as just another biological function without any social stigma. Walsh, in his denial, is also quick to blame ADHD on parents for not properly raising their children. This is both untrue and counterproductive.

Ironically it is the stigma that often motivates the denial of mental illness. The solution is not to deny mental illness, but to recognize that the brain is just another organ and should provoke no more of a social stigma than liver disease.

Categories: Medicine

The Hippocrates Health Institute: Cancer quackery finally under the spotlight, but will it matter?

Science Based Medicine - Mon, 02/23/2015 - 03:20

This is a screenshot from the website of the Hippocrates Health Institute, showing how high end its grounds and facilities are.

I first came across Brian Clement, the proprietor of the Hippocrates Health Institute in West Palm Beach, Florida, a little more than a year ago based on the story of Stephanie O’Halloran. Ms. O’Halloran was—word choice unfortunately intentional—a 23-year-old mother of an 18 month old child from Ireland who was diagnosed with stage IV breast cancer in 2013, with metastases to her lymph nodes, liver, lung, and leg. Unfortunately for her, she found Brian Clement at the Hippocrates Health Institute, who gave her false hope with his claims that a raw vegan diet and wheatgrass can treat just about everything. Unfortunately, but not unexpectedly, Ms. O’Halloran died in June 2014, Less than nine months after having been diagnosed with metastatic breast cancer.

I didn’t write about Stephanie O’Halloran at the time (at least not here), but I did write about Brian Clement and the Hippocrates Health Institute (HHI) twice over the last several months in the context of the case of two 11-year-old aboriginal girls in Canada with cancer, specifically lymphoblastic leukemia, one named Makayla Sault the other referred to as “JJ” to protect her privacy in her parents’ legal proceedings to assert their right to use traditional medicine to treat their daughter’s cancer rather than curative chemotherapy, which was estimated to have a 75% chance of curing Makayla Sault and an 85% to 90% chance of curing JJ. Unfortunately, both girls and their parents fell under the spell of Brian Clement and his cancer quackery. The result was one unnecessarily dead girl (Makayla Sault, who died last month) and one likely to be dead by the end of this year or not much longer (JJ). Such is the price of cancer quackery. In this case, even more puzzlingly, these girls’ parents seemed quite content to conflate the quackery of Brian Clement, a white man practicing in Florida, with “traditional aboriginal medicine,” the sort of practices they were claiming to have a right to.

Brian Clement: Preying on desperate cancer patients for nearly three decades

Because I’ve adequately discussed the issues involving JJ and Makayla for now (that is, unless something new happens with respect to these girls’ stories), what I want to do now is to focus my attention more on Brian Clement himself and his practices. Over the last three years, I’ve spent considerable time and effort trying to pull the cover off of the machinations and abuse of clinical trial ethics by Stanislaw Burzynski. There’s been a growing thought in my mind that a similar effort should be directed at Brian Clement, because, although he doesn’t even make a pretense of doing clinical trials, he sells his cancer quackery the same way that Burzynski does: Through testimonials. Indeed, if there is one “good” thing that’s come out of the stories of Makayla Sault and JJ, it’s been increased scrutiny of Brian Clement and the HHI.

Most recently, this increased scrutiny has come in the form of news stories that have been appearing in the Canadian Press, two just over this weekend:

After having spent so much verbiage last week criticizing the Star for its execrable “expose” on Gardasil (an expose that the editors of the Star finally saw fit to withdraw under a barrage of well-justified criticism, although they clearly still don’t get it), I feel that in fairness I have to note that Alamenciak goes part of the way towards redeeming the Star after that journalistic debacle by actually traveling down to West Palm Beach and interviewing Clement, although Clement wouldn’t say anything on camera for this report:

What Alamenciak was allowed to see included several classrooms, the wheatgrass juicing room, and a greenhouse. Pointedly, they weren’t allowed into the Vida Building, where many of the alternative treatments are administered. (I wonder why.) Even more pointedly, Alamenciak was accompanied everywhere by HHI’s lawyer and PR person, as well as Clement himself. As you’ll note, Alamenciak and crew do a good job of putting the lie to Clement’s claims that he doesn’t promise he can cure cancer, using, conveniently enough, clips from Clement’s own talks in which he—you guessed it—tells his audience his raw vegan diet and wheatgrass can cure cancer.

Similarly, Tom Blackwell’s story quotes Clement as saying in one of his videos:

The appeal is powerful. Though he often insists he does not “cure” or heal anyone, Mr. Clement has repeatedly claimed impressive results.

“We have … the longest history on the planet earth, the highest success rate on the planet earth of people healing cancer,” he said in a Hamilton, Ont., talk, recorded and uploaded to YouTube in 2010. “We have dealt with mostly stage-three, stage-four catastrophic cancers — a big percentage of them, probably 25%, have been told they’re going to die. We have seen thousands and thousands of those people recover.”

Of course, Clement never manages to present anything resembling credible evidence to back up this claim.

There’s another segment as well with Steven Pugh, former Director of Nursing, HHI, who relates stories of Clement ordering blood work without a doctor and telling Pugh that he would review the results himself. This is what led Pugh to quit and sue. Because he is a registered nurse, he can’t take orders for lab tests or other medical interventions from non-physicians. If Pugh’s allegations are true (and I personally have little doubt myself that they likely are), that is most definitely practicing medicine without a license:

“Almost every single patient there, the majority of patients, got an appointment with Anna Maria and/or Brian to go over their medical history, their labs, blood work, their disease process or just their wellness process and they would recommend treatment,” alleges Steven Pugh, Hippocrates’ former director of nursing and one of the ex-employees suing the facility.

Johnson offered a written response on Thursday to Pugh’s statement: “All blood tests are administered by a medical professional and reviewed by the medical director. As nutritionists, the Clements review the guests’ entire health history, which includes the blood tests, with a view toward nutritional recommendations. . . . The medical director is responsible for all medical decisions of any kind.”

Hippocrates, which houses as many as 100 people at a time, has one licensed medical doctor working for the facility — Dr. Paul Kotturan.

I had never heard of Dr. Paul Kotturan before; not surprisingly, I wondered what kind of physician would associate himself with an institute like the HHI. So I did some Googling. Dr. Kotturan appears to run an urgent care center, Hillsboro Urgent Care in Deerfield Beach, Florida. His role at HHI is described on its website thusly:

Under the supervision of Dr. Paul Kotturan, Hippocrates’ specialized therapies include hyperbaric oxygen therapy, cranial electrotherapy stimulation, IV nutrition and antioxidants, Aqua Chi detoxification therapy, advanced diagnostics, bio-frequency research, targeted supplementation, thermography and more.

What does that “more” include? According to Alamenciak’s report, it includes quackery such as:

One of the treatments often mentioned by Clement in videos is Cyber Scan — a machine that claims to read your “bio-frequency” and tells which diseases you have or are at risk for. The machine then spits out a magnetized card — similar to a debit card — that contains the “morphogenetic footprint” of whoever put their hand on the device.

For Pugh, the most surreal treatment moment came when he saw a man blowing a long alpenhorn on the feet of a guest at the centre. The man claimed to be removing “toxins,” Pugh said.

And, of course, supplements:

The institute also sells its own line of supplements, called LifeGive, as well as a store stocked with everything from $400 amulets that claim to block electromagnetic waves to a stool designed to angle one’s feet while on the toilet that is said to promote “more complete bowel evacuation.”

And, of course, there are stem cell treatments. Given that on the surface, the South Florida Bone Marrow/Stem Cell Transplant Institute looks relatively straightforward, treating hematologic malignancies with what sound like fairly standard-of-care treatments. Why Dr. Dipnarine Maharaj would affiliate himself with an entity like the HHI is the first question I asked. Surely it does not speak well of him to be featured on the HHI website.

But back to Dr. Kotturan. I was actually rather amazed that it was difficult to find out much about him. He seems to have kept a relatively low profile compared to other doctors administering dubious therapies, at least with respect to the ability of Google searches to reveal much other than his clinic. (And, make no mistake, the medical therapies administered at HHI are highly dubious, ranging from wheatgrass enemas, to the “Cyber Scan” test, to the most unbelievably quacky treatments like Aqua Chidetox footbaths.”) One thing I was able to find out is that he was a site principle investigator of TACT.

For those who don’t remember, TACT stands for Trial to Assess Chelation Therapy; it was a $30 million unethical boondoggle of a multiinstitutional study designed to assess whether chelation therapy has any value for treating cardiovascular disease. It was basically a negative study, but its principal investigator, Gervasio Lamas, has been spinning it furiously as showing that chelation very well might for cardiovascular disease and that, of course, “more study is needed” (preferably in the form of another large NIH grant to do a followup multiinstitutional study. In this publication, Kotturan is listed as one of the investigators, which means he must have been administering chelation therapy during the timeframe of the study, which was several years. Certainly, Kotturan’s name comes up as offering chelation therapy and IV vitamin therapy for at least one “holistic retreat.” His name also pops up in this TACT Talk newsletter as one of the site investigators as one of the winners the Persistence Award in the 2005 TACT Derby for enrolling five patients over three months. He’s also a member of the American College for Advancement in Medicine (ACAM), a leading proponent of chelation therapy and what Dr. Kimball Atwood likes to refer to as a pseudomedical pseudoprofessional organization. His ACAM entry lists him as providing “Allergy, Chelation Therapy, Cosmetic Laser Surgery, Family Practice, Gynecology, Holistic Medicine, IV Therapies.” One wonders what else is covered in the “holistic medicine” part. Does he offer the same sorts of quackery at his own practice as he does at HHI? Inquiring minds want to know!

Alamenciak’s story adds more detail to a story carried by the local NBC affiliate WPTV affiliate a couple of weeks ago. Here is the story:

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Overall, it’s not a bad start to uncovering HHI’s cancer quackery. Note how posh the HHI campus is, as well. I’ve described the “treatments” offered by Brian Clement as part of HHI’s “Life Transformation Program” before. They include almost every imaginable form of cancer quackery, including “detoxification,” colonics, wheatgrass, ozone pools, “bio-energy treatments,” the aforementioned “Cyber Scan,” and, of course, the Aqua Chi “detox footbaths.” One particularly silly treatment offered by HHI is called a “wheatgrass implant.” For those of you who don’t remember what “implants” are. It turns out that wheatgrass “implants” are, in actuality, wheatgrass juice enemas. Indeed, if you believe the hype on the HHI website, there’s nothing that wheatgrass can’t do. If the HHI is to be believed, wheatgrass can increase red blood cell count, decrease blood pressure, cleanse the blood, organs and GI tract of “debris,” stimulate the thyroid gland, “restore alkalinity” to the blood, “detoxify” the blood, fight tumors and neutralize toxins, and many other fantastically beneficial alleged effects. Basically, combine a raw vegan diet with a veritable cornucopia of other kinds of quackery, and you have the HHI.

Elsewhere, a little Googling reveals this woman’s account of what HHI offers:

The list of therapy options was impressive: hyperbaric therapy, cranial stimulation, hydrocolon therapy, IV Vitamin C and other IV therapies, complete blood analysis upon arrival, hormone therapy, and thermography.

There were several other therapies that I was not familiar with that are also included in your stay with HHI such as Ceregam-RH, H-Wave Therapy, Lymphatic Drainage Bed, Migun, MRS 2000, Ondamed Biofeedback Treatment, Q1000 Laser, Soft Laser, Theragem, Turbosonic Therapy, and Viofor.

Amazingly, I haven’t heard of some of these things, which led me to add them to my “to-do” list for SBM posts. I can’t help but note that it was touted that Coretta Scott King had visited HHI. She died of her cancer in a Tijuana clinic.

Lately, it seems, Clement is getting into “vibration” and “quantum.” For instance, get a load of this video on Quantum Biology:

I admit that I didn’t watch the whole thing. Not even close. It was just too darned painful, given how much pseudoscience is packed into nearly two hours. Nor do I expect you to watch the whole thing; that is, unless you’re a total glutton for punishment. (Seriously, physicists and chemists viewing this video will feel a near-irresistible urge to claw their eyes out.) One brief example occurs at 1:11:30 or so, when he shows a highly simplified version of the cell followed by pure vitalism, where he talks about the “life force” gathered through nutrients. The cell is surrounded by words representing vitamins, protein, water, minerals, essential fatty acids, and oxygen (to which he verbally adds “electromagnetic frequencies”). After this, there is this text:

These elements with their varied frequencies are attracted to the magnetic energy of the cell. This allows building and life maintaining processes. It also expels exhausted and used matter from the cell.

Clement “translates” this to mean that if you have the life force in the cell and the life force in the nutrients, they’re attracted to each other.

Elsewhere, he describes quantum biology thusly:

Painting a picture to describe this fruitful exploration begins with yourself. Beyond the protein that holds your body together, the vitamin and mineral sheathing that covers it, the essential fats that fuel it and the water and oxygen that shape it, the underlying purpose for your body’s existence is the electricity that it takes in and creates. There is a continual and perfect communication from cell to cell and from gathering of cells (organs and / or skeletal) to gathering of cells. This communication also reaches beyond your body to all other life outside.

This rhythmic and energetic process is strong, yet fragile. It can be thrown off by a weakening of the anatomical integrity of the cells or their central electrical frequencies. This weakening can occur via poor nutrition, dehydration and / or polluted hydration, lack of oxygen, intake of heavy metals or chemicals or renegade electromagnetic fields such as cell phones, Wi-Fi, etc.

All abnormalities that have been labeled as diseases stem from the negative energies that are endured from the poor lifestyle choices and unsustainable environment that we have created on planet earth today.

Our core vulnerability stems from the reduction of bio-frequency that occurs in the cell, which heightens its fragility to make it ineffective in communication and contribution. When these disturbances are critical, they can even cause a cell to mutate.

When you ingest ionized, rich, raw plant-based foods, it provides foundational energy. You then have to consider avoiding negative energy fields or at least protecting yourself from them with electromagnetic field interrupting devices or tools.

What is more difficult to avoid and personally restrain from is the negative energy that we absorb or spew from discontented emotional states. Most of you have seen this and experienced it. Certain people, places or environments can make you feel uncomfortable, on edge and literally drained.

I couldn’t take any more! Not only is Clement spewing total and utter BS about quantum theory and science a la Deepak Chopra, but he explicitly embraces a “Secret”-like concept that “negative energy” from people’s “discontented emotional states” causes disease. Oh, and let’s not forget “toxins” needing “detoxification.” You get the idea. Clement understands neither physics, chemistry, nor biology. He thinks wheatgrass, either eaten or administered as enemas, is a cure-all. He treats cancer with a raw vegan diet plus a wide variety of quackery, even detox foot baths. He blathers spiritual nonsense about god, “energy” and consciousness.

Particularly galling was his response to a breast cancer surgeon who, even though she appeared to buy into some of what Clement was selling, did challenge him about surgery for cancer. One thing I learned in his response is that Clement clearly does not understand cancer stem cell theory, stating categorically that no cancer comes from anything other than stem cells. That is not true; some cancers have been strongly linked to cancer stem cells. Others have not. It’s not as though cancer stem cell theory is settled science. It’s an area of active investigation and, yes, controversy. Based on his misunderstanding and his claim that he might not be able to “activate” the immune system fast enough with the raw vegan diet and wheatgrass, he then launches into a spiel about how he brings in “advanced therapies” such as cold laser, electromagnetic therapies, that, he claims, fire up the stem cells with a “higher frequency.”

He then denigrates the claim that cancer surgeons can produce 90% survival with stage I breast cancer. I must admit that I chuckled when Clement states, “The only disease in history that they put a five year survival criteria on is cancer.” No, it’s not. We do it for heart disease. We do it for stroke. We do it for renal failure. What’s the difference? In many cancers, if you survive five years, for all intents and purposes you can be considered “cured,” because the disease is very unlikely to recur after five years. Breast cancer, unfortunately, is one cancer that is an exception to that rule, with recurrences at ten years and beyond being not as uncommon as we would like, particularly for estrogen-sensitive breast cancer. Be that as it may, contrary to what Clement claims, we didn’t choose five year survivals as a surrogate for cancer cure arbitrarily. Indeed, the difference between diseases like diabetes compared to cancer is that if you survive five years after cancer, depending on the cancer, you probably are “cured.” If you survive five years after being diagnosed with diabetes or heart failure, you still have diabetes or heart failure.

Marketing HHI: Testimonials a-go-go

If there’s one thing all three stories show, it’s that Clement makes a lot of money running HHI. Blackwell’s story, for instance, reports that filings to the IRS indicate that Brian Clement and his wife Anna Maria Gahns-Clement, the latter of whom serves as HHI vice-president, earned almost $1 million between them in 2013, even though the HHI is classified as a non-profit institute and therefore tax-exempt. Almenciak reports that Clement and his wife were paid $529,363 and $432,291 in income and benefits that same year and that the HHI reported receiving $15.1 million in fees for its “services.” Given that HHI has been operating in West Palm Beach since 1987, one can imagine how much wealth the Clements have amassed from its operations and their evangelizing speeches all over the world. It’s also not hard to see where he might “earn” such money, given that he charged JJ and Makayla $18,000 each for their “treatment.” All three stories feature photos and video showing just how large and fancy the grounds and facilities of HHI are.

Like Stanislaw Burzynski, a key element of the Clements’ marketing campaign includes patient testimonials. They can be found on the HHI website and YouTube channel. I very well might analyze several of these testimonials, either here or at my not-so-super-secret other blog, but for now, given the length of this post, I’ll just look at two.

First, there is this testimonial from Dr. Jackie Campisi:

Jacki Campisi’s story is horrifying. Basically, she started out by denying herself her one best shot at survival after her diagnosis. My observations on the brief video include:

  • It is not clear in the video whether Dr. Campisi ever had surgery for her primary tumor or not. She says that the was told that she would require “chemo, radiation, and drugs.” Besides the chemo, which drugs? Tamoxifen? Arimidex? Herceptin? It turns out that she did have a mastectomy, but I had to do some Googling to discover this (and also to discover that she’s an optometrist, not a physician). In any case, that same link revealed that she embraced quite a bit of cancer quackery six and a half years ago, before she ever encountered Brian Clement.
  • Dr. Campisi recurred six years later with spine metastases. Doesn’t that tell you that what she did wasn’t really working? Unfortunately, her spine metastases resulted in fractures, as spine metastases all too frequently do.
  • It’s quite possible that Campisi had a fair amount of healing from her fractures while at HHI, but it’s obvious that she still couldn’t walk until after she had surgery. Also, her weight loss probably made a big difference.
  • It’s good that her spine surgery helped her quite a bit. Surgery for malignant fractures usually does help. It’s unclear to me what operation she had, though.
  • A four day hospitalization sounds about right for the surgery Dr. Campisi had, neither too long, but certainly not significantly shorter than the usual range.
  • It’s very telling that Dr. Campisi doesn’t explicitly say whether she still has spine metastases or if her tumor is gone. She does, however, go on and on about the oxygen in her blood, her blood glucose levels, etc. I presume the cancer is still there.
  • Overall (and fortunately for her) Dr. Campisi seems to have a variety of breast cancer that is slow-growing and indolent. That it took six years to recur suggests it’s probably estrogen receptor-positive, and that it doesn’t seem to have progressed much since also argues that it’s probably fairly indolent. If this is true, she could still live quite a long time with such a tumor, as it appears to have favorable biology. However, it would be interesting to know some things: Stage at diagnosis; status of estrogen and progesterone receptors; HER2 status; the specific operation she had.

Basically, here we have a woman who underwent surgery alone for a stage III cancer, apparently refused radiation and chemotherapy in favor of a raw vegan diet and other “alternative” treatments, recurred in the spine, found Brian Clement, and is continuing to make the same mistakes. I’m glad she seems to be doing better, but, sadly, Clement is not going to save her. Nothing can. Fortunately, she might still live several more years because of the seemingly favorable biology of her tumor. Unfortunately, she might have done even better if she had accepted standard-of-care palliative therapy. Also, she will likely credit Clement for how well she does.

Another testimonial, mentioned in Blackwell’s article, is Samantha Young:

One Canadian woman, Samantha Young, says she was given just months to live after being diagnosed with pancreatic cancer, and maintains she was rid of the frightening disease after visits to Hippocrates.

Young’s testimonial can be found on the HHI website as well, oddly enough, filed under “Depression,” rather than cancer:

Back in the late nineties I found myself suffering unimaginable fatigue, nausea and constant interrupted sleep brought on by the excruciating pain in my stomach. My physician conducted some investigative blood work which appeared completely normal. Finally, upon my insistence, she suggested an ultrasound. That revealed a ten centimeter mass in the tail of my pancreas.

The doctor explained that if I were older, she would believe that the tumor was benign. However, because I was young she suspected it might be cancer. Just that word instilled so much fear in my heart. My mind started to race, ruminating on all the medical statistics about the increase of cancer and how treatments most often are more harmful than helpful. Of course the doctor advised that my options were surgery, chemotherapy, and radiation.

What could that benign diagnosis have been? If there are any general surgeons or gastroenterologists reading, I bet they know. I’ll get to it momentarily. In the meantime:

Finally, my physician suggested that I see a specialist, Dr. Taylor, who supported the pancreatic cancer diagnosis with finality. Thank God my five daughters came and nurtured me. They adjusted their schedules and stayed with me at the onset of this sad period of my life. They described my color as gray green. Every day seemed insurmountable. On top of all of this the doctors finally admitted that although chemotherapy and radiation treatment were suggested, they ultimately would not make any difference in my case, nor would they prolong my life. They told me, “I am sorry, Samantha, get your house in order.”

We’ve heard this story before. Of course, a 10 cm mass in the tail of the pancreas would make me consider something other than pancreatic cancer in the diagnosis. Run-of-the-mill pancreatic cancer, the kind that kills most patients within a couple of years of diagnosis even if operable and successfully resected (expected five year survival after a Whipple operation, for instance, for pancreatic cancer is only on the order of 25%, generally doesn’t grow to 10 cm without metastasizing. That this one did implies that it’s either a less aggressive form of pancreatic cancer or not pancreatic cancer at all. Notice, in any case, that nowhere is there a report of a biopsy confirming the diagnosis. (Actually, rereading the testimonial, I don’t see any evidence that Young ever had even a CT scan, which is considered mandatory for determining whether a pancreatic cancer might be resectable.) Of course, if pancreatic cancer has already metastasized, then expected survival is measured in months. So what happened? Young found Dr. Clement, of course, and this happened:

I slowly adopted the program and was so impressed when I microscopically viewed cancer cells thriving on cooked food. This wrenched me into the full adoption of the living food diet. Slowly but surely, my color returned to a more acceptable yellow pallor, and as time passed my normal complexion prevailed.

In addition to the diet I also used far infrared therapy to gently heat my body up to 40 degrees Celsius. I also made sure to include lots of massage and reflexology, as well as continuing my medication and creative visualization, along with copious amounts of wheatgrass.

After two years the tumors had shrunk from 10 centimeters to 4.5 centimeters.

Before I knew it, I was in remission. Now I understood fully that cancer can be beaten.

In other words, she did nothing to treat her presumed cancer. Of course, I doubt that she ever had cancer in the first place. Given her clinical history, what I rather suspect (and, I bet, any general surgeons out there suspected) is that she really had was a pancreatic pseudocyst. Pseudocysts often arise after a bout of pancreatitis. Early in her testimonial, Young describes herself “suffering unimaginable fatigue, nausea and constant interrupted sleep brought on by the excruciating pain in my stomach,” all of which can be symptoms of pancreatitis. Not knowing more of her clinical course, I find it not hard to envision that Young suffered pancreatitis and developed a large pancreatic pseudocyst, which slowly resolved spontaneously, as many pancreatic pseudocysts, even ones larger than 5 cm, do. Moreover, pancreatic pseudocysts are sometimes misdiagnosed as cancer and vice-versa, but less commonly these days given that virtually any large pancreatic mass can be biopsied pre-operatively, something that wasn’t necessarily true 20 years ago when I trained. Again, we have no evidence of a tissue diagnosis anywhere to help guide us, and, given that, I rather suspect that this was indeed a pancreatic pseudocyst that resolved.

In Blackwell’s story, we learn:

Mr. Pugh said it is quite possible that some of the cancer patients at Hippocrates are cured, but in the little over a year that he worked there, he was not personally aware of any such successes.

“I would get emails occasionally from a family member saying a patient had succumbed to cancer,” he said.

I’d be willing to bet that no one at HHI survives cancer due to anything done for them at HHI. Indeed, as Alamenciak reports, there are testimonials on the HHI website whose stories have not been updated to report that the patient died, patients like Annalisa Cummings, who died in 2009.

Cancer quackery unfettered

The more I learn about Brian Clement, the more I wonder: How on earth has this guy been operating for three decades in Florida? Clearly, the State of Florida has utterly failed to protect its citizens from quackery. In fact, given how many people, such as Makayla Sault, come from all over the world, Florida has failed to protect everyone. Clement and his wife are both registered as nutrition counselors. Clement’s PhD in nutrition comes from the University of Sciences, Arts and Technology, a school licensed by the government of Montserrat, an island in the Caribbean with a population of about 5,000. It’s widely viewed as a diploma mill. Yet, thanks to a loophole in Florida law (see below), the Clements continue to get away with making promises they can’t fulfill, all the while with a “wink-wink, nudge-nudge” disclaimer that they “don’t promise cures,” even though everything they say in their promotional literature and talks would lead one to think that they can cure stage III and IV cancers where scientific medicine can’t.

The scam is so obvious, too. The Hippocrates Health Clinic has a Massage Establishment license, issued by the Florida Board of Massage Therapy. Also, the Florida Agency for Health Care Administration (AHCA) licenses health care facilities, such as health care clinics and hospitals, and processes complaints about the quality of care in these facilities. Further, it is known that a complaint was filed with ACHA against the HHI for operating a health clinic without the proper state license. However, as our resident Florida lawyer and SBM regular contributor Jann Bellamy informed me when I asked her about it, under state law, only clinics receiving reimbursement from third-parties, such as public or private insurers, are required to have an AHCA-issued license. Because Hippocrates is a cash-only business, AHCA was apparently without jurisdiction to take action. The result of this gap in state law is that clinics offering only unproven treatments, which aren’t reimbursed by insurance, are the very ones who are outside the reach of state supervision. Meanwhile the FTC won’t say whether it’s investigating or not.

In both the WPTV report and Tim Alamenciak’s report, Clement is asked about accusations that he gives cancer patients false hope. He immediately replies, “There is no such thing as false hope.”

Wrong, wrong, wrong, wrong. Hope is important, but cancer patients need that hope to be tempered with a realistic assessment of their prognosis. Clement takes that away from them, and he’s damned callous about it too, as his answer to Alamenciak’s same question reveals:

When confronted with the testimonials people wrote — testimonials full of hope, that have not been updated to indicate those who later died — Clement says:

“That’s not false hope. I’m going to die. Do you realize that? You’re going to die,” he says. “I have hope that I’ll become a multi-billionaire some day and be able to change the world. Is it going to happen?

“I would never tell somebody don’t do chemotherapy. I’m not a medical doctor, nor do I believe I should tell them to do that … I’m going to die; they’re going to die. Does it mean that I did something wrong because they came here? Maybe they were very, very sick at some point and they went home and eventually died? What do I have to do with that? Explain, what does Hippocrates have to do with that?” said Clement.

In response to questions about Stephanie O’Halloran, Clement is quoted thusly:

“ … From a one-hour lecture in Dublin, this woman decided that I could heal her? That’s not even realistic when you think about that,” said Clement said in an interview in his Florida office.

These are, of course, the sorts of questions that a con man asks when confronted to deflect responsibility from himself to his marks. It’s not his fault they believed him! Unfortunately, Florida law lets the Clements continue to offer false hope at a high price with impunity. Until the HHI is shut down, there will be more patients like Makayla Sault, Stephanie O’Halloran, and Annalisa Cummings spending tens of thousands of dollars to chase the false hope that Brian Clement offers.

Categories: Medicine, Skepticism

A Day of Science and Skepticism with NECSS SfSBM

Science Based Medicine - Sat, 02/21/2015 - 17:18

A day of Science-Based Medicine, a weekend of science and skepticism

Registration for NECSS, the North-East Conference on Science and Skepticism, is now open. Included in the program will be a day of Science-Based Medicine.

Full Conference schedule here with Bill Nye as the KeyNote.

Speakers will be Harriet Hall, Jann Bellamy, David Gorski, Steve Novella and Mark Crislip.

NECSS will be held April 9th–12th, 2015, in New York City at the Fashion Institute of Technology. The SfSBM program will be Friday, April 10 and you can attend one or more of the days. $95 for one day or $195 for the entire conference.

Preliminary SfSBM Program  (Updated 2.15.15.  Subject to change)

09:00 – 10:00 60 minutes Registration/Will Call
10:00 – 10:10 10 minutes OPENING: Steve Novella and David Gorski
10:10 – 10:45 35 minutes: Steve Novella. SBM – Going Beyond Evidence-Based Medicine.
10:45 – 11:20 35 minutes: Harriet Hall. Chiropractic.
11:20 – 11:55 35 minutes: David Gorski. Integrative Medicine
11:55 – 12:30 35 minutes: Mark Crislip. How Acupuncture ‘Works’
12:30 – 02:00 90 minutes LUNCH
02:00 – 02:35 35 minutes Speaker 4: Jann Bellamy. Political Pseudoscience
02:35 – 03:35 60 minutes Panel 1 Discussion
03:35 – 03:50 15 minutes BREAK
03:50 – 04:35 45 minutes Q&A from Twitter & Audience
04:35 – 05:20 45 minutes SBM Jeopardy
05:20 – 05:30 10 minutes CLOSING
05:30 – 06:00 30 minutes SBM Business Meeting

For more information and to register, go to NECSS or this registration page.

The Society for Science-Based Medicine is a co-sponsor of NECSS and paid SfSBM members can get a 15% discount using the code SFSBM2015.

Categories: Medicine, Skepticism

Traditional Chinese Pseudo-Medicine Hodgepodge

Science Based Medicine - Fri, 02/20/2015 - 03:27

As I have noted before, more is published on acupuncture and traditional Chinese pseudo-medicine than the other SCAM. Here are some of the articles that drew my attention.

Captain Hook and Acupuncture

Here is one of the more curious articles on acupuncture I have yet to find, Psychophysical and neurophysiological responses to acupuncture stimulation to incorporated rubber hand.

I did not know this, but you can fool a person into thinking that a rubber hand is their own.

The synchronous tactile stimulation of the real hand of an individual and rubber hand leads to the feeling that the rubber hand is incorporated with the body of that individual. This is referred to as 36 the rubber hand illusion (RHI), and it occurs because the brain is 37 attempting to interpret the interaction of the visual, tactile, and 38 proprioceptive systems of the body, which in turn, leads to a re- 39 calibration of the touch and the felt position of the hand . The 40 multimodal visuotactile stimulation inherent in the RHI induces the brain to temporarily incorporate external objects into its body image. In addition, when the experimenter threatens the rubber hand with a needle during this illusion, it generally elicits an enhanced sympathetic response and a measurable cortical anxiety response, which indicates that the bodily ownership of the rubber hand causes changes in the interoceptive system of the brain.

Cool. Check out this video to see how it is done.  So what happens when you do acupuncture on a rubber hand that the brain thinks is its own?

The findings of the present study clearly demonstrate that acupuncture stimulation to a rubber hand resulted in the experience of the DeQi sensation when the rubber hand was fully incorporated into the body.

as judged by fMRI findings (always taken with a grain of salt substitute) and patient reports.  DeQi is what dey feel when de needle is twirled in de skin.

So acupuncture of a rubber hand causes the same response as acupuncture in a real hand. What does that say about acupuncture? That meridians and qi are  spontaneously generated in the rubber hand? Or that the response to acupuncture is all psychological with no effect on an underlying physiology, real or imagined?

And now that there are socks with built in acupuncture I wonder if the socks would  have the same effect on an artificial leg.

Acupuncture: Beer Goggles or Over Priced Wine?

Painting with a broad brush, I would say that acupuncture doesn’t work. By ‘work’ I would say that it has no effect to change the underlying physiology or anatomy of the person receiving the acupuncture.

‘Works” is different from having an effect, even a beneficial effect. Positive interactions between a patient and a health care provider, even when offering a pseudo-medicine, will make some patients feel better about their disease. I compare these pseudo-medicines, like acupuncture, as beer goggles. They change perception but not reality.

While changing the perception of disease for the better is of benefit, it is just not ethical to base treatment on a lie.

What happens with a process like acupuncture to alter patients perception? It doesn’t matter where the needles are placed or even if needles are used; twirled tooth picks are just as effective. What matters most for efficacy is if the patient thinks they are getting acupuncture and if they believe acupuncture is effective. Then acupuncture will have an effect. That’s it. So what is going on?

Another hint on the mechanism of acupuncture is in When pain is not only pain: Inserting needles into the body evokes distinct reward-related brain responses in the context of a treatment.

In this study 24 people received three identical stimuli: tactile, acupuncture, and pain stimuli. There were two groups to receive the three stimuli, an acupuncture treatment (AT) group and an acupuncture stimulation (AS) group. What differed is what they were told before the stimuli

participants in the AS group were primed to consider the acupuncture as a painful stimulus, whereas the participants in the AT group were told that the acupuncture was part of therapeutic treatment.

They had fMRI (who doesn’t) and a questionnaire about their subjective experience.

Behavioral results generally revealed no differences between the AT and AS groups. The questionnaire results confirmed that there were no significant differences in expectancies, fear, or anticipation and subjective pain ratings related to needles being inserted into the body between patients in the AT and AS groups.

They found no analgesic effect in the acupuncture group. But there was a difference in the fMRI (for what that is worth):

We found that reward-related regions (specifically, the ventral striatum) of the brain were activated by acupuncture stimulation and that in response to painful simulation, activity in pain-processing regions(the SII and DLPFC) was decreased only when participants were told that acupuncture needles were a therapeutic tool.

and

As greater activation of the ventral striatum is generally correlated with more expectations of pleasure and rewards, our results could be interpreted to suggest that acupuncture stimulation was associated with the expectation of a reward – possibly an analgesic effect – for patients experiencing acupuncture in the context of a treatment (AT group).

So depending on the context,  people process the same stimulus differently. A needle for therapeutic acupuncture is different than the exact same needle used for stimulation.

Maybe. It is a small study and fMRI’s have issues as we know from dead salmon. But taken in the context of the literature pointing to the predominantly positive subjective effects of pseudo-medicines it is curious finding.  Maybe not beer goggles; probably more like making wine taste better by giving it a higher price.

Acupuncture works. If you believe it will

I like antibiotics. They kill of the bacteria infecting my patients.  It doesn’t matter what the patient thinks about the effectiveness of the antibiotics.  They just work.  Having a practice based almost entirely in acute care medicine, most of the interventions have effect (or not) independently of patient belief concerning the interventions.

Not so with acupunctures. As I have said many times, acupuncture doesn’t work i.e. alter any underlying physiologic process. But that doesn’t mean that the innumerable forms of acupuncture don’t have an effect. They do.

I have mentioned in other entries the importance of expectation in acupunctures effect. Believing does make it so is an example. The more patients thought acupunctures would have an effect, the greater the response. If the patients were unenthusiastic about acupunctures efficacy, nothing happened.

There is a paper in the Clinical Journal of Pain, Psychological Covariates of Longitudinal Changes in Back-related Disability in Patients Undergoing Acupuncture that carries on that theme.

They note

Indeed, acupuncture can be conceptualized as a complex intervention in which changes in patients’ health are produced not only by needling but also by more psychosocial factors such as empathic therapeutic relationships and holistic consultations in which discussions of lifestyle and self-care can trigger changes in how patients think and feel about their symptoms and their ability to manage them.

But ask what are the psycho-social factors that lead to success or failure of acupuncture for low back pain?

They had 485 patients from 83 acupuncturists before starting acupuncture for back pain who took several questionnaires over the 6 months of their acupuncture

Interstingly, among other findings,

“People who started out with very low expectations of acupuncture – who thought it probably would not help them – were more likely to report less benefit as treatment went on.

As is often the case with the response to pseudo-medicines, rather than concluding that since the effects of acupuncture are an elaborate ritual with no intrinsic value beyond placebo, perhaps it should be abandoned as useless at best and unethical at worst, they suggest teaching acupuncturists to be better at their elaborate ritual.  You know, be a better liar and manipulator:

Dr Bishop added that to improve the effectiveness of treatment, acupuncturists should consider helping patients to think more positively about their back pain as part of their consultations…his understanding could lead in the future to better targeting of acupuncture and related therapies in order to maximise patient benefit.”

Why not keep the power of positive thinking but attach it to reality-based interventions instead of selling patients the TCM equivalent of supplements?

But researchers in pseudo-medicines are never looking to apply negative results to patient care.

Massive Head Scourge and Acupuncture

I am old school. A germ theory kind of guy. Mumps, as an example, is due to the Mumps virus, a Paramyxovirus that likes to infect the parotid glands and occasionally other organs. There is no treatment but tincture of time.

There are other, more curious, supposed etiologies for mumps:

Mumps is caused by invasion of the body by exopathogenic wind-heat toxin from the mouth and nose. This pathogen mixing with phlegm turns into fire to obstruct the Shaoyang and Yangming Channels, leading to lump due to accumulation of heat in the parotid region. Therefore, the principle of treatment should be to eliminate stagnated heat from the Shaoyang and Yangming Channels.

And how would one eliminate stagnated heat from the Shaoyang and Yangming Channels? According to Dr. Long Wenjun needles in the ear points of Antitragic Apex and Pancreas-Gallbladder are the first choice in treatment.

Although Song treated 1000 cases with a single needle at the Pingjian point (MA-T2). As with all self-limited diseases, the effect is satisfactory. And don’t forget,

The needle should be sterilized carefully to prevent infection.

If the Pingjian point is the same as either the Antitragic Apex and Pancreas-Gallbladder I can’t say for sure.  The interwebs are not clear.

Both are incorrect, as the Fire-needle with sulfur is obviously better, although I can’t discover exactly what it is. It does sound better.  Fire-needle.  With sulfur. Kids will love that.

That is what I could find on Pubmed concerning mumps and acupuncture. Others  on the web suggest different places on the skin to needle and perhaps a different etiology.  I do like the terms ‘massive head scourge’ and ‘frog scourge’  for mumps and that website offers yet another acupuncture intervention point.

Give the known viral pathophysiology of mumps, there is zero reason to suspect that the fanciful and inconsistent interventions mentioned above would have any effect on the mumps. It doesn’t stop the Cochrane reviews from looking for something to meta-analyze. Like the prior review from 2012, they

aimed to determine the effectiveness and safety of using acupuncture to treat mumps in children.

but

identified no trials for inclusion in this updated review.

Oddly, the background does not mention that Mumps is a virus but rather

 …caused by ‘wind warmth evil’ (epidemic heat) and ‘pyretictoxicity‘ accumulated in the Shaoyang and Yangming meridians, thus the flow of Qi, sputum and ‘heat evil’ stagnate in and around the ears and the cheeks. Acupuncture can help expel ‘wind warmth evil’, clear pathogenic heat, remove toxic substances, act as an anti-inflammatory, alleviate pain and re-establish the normal flow of Qi, thus restoring internal balance.

That is a reasonable background?  Makes their motto, “Trusted evidence. Informed decisions. Better health.” suspect. Then  they suggested that

More high-quality research is needed.

More suggests there has been some quality research. There hasn’t. And is any research needed? I think not. I would hope that IRB’s would recognize useless pseudo-medicine when they see it and protect children from needless needles. Yeah. Right. Like that will happen.

Otzi the Iceman and Acupuncture. Redux

I try to be circumspect. I really do. Respectful of the person, if not the idea.  Hate the sin, not the sinner.  But some things are Just. So. Stupid.

Last year the stupidest comment by a reputable source I found was in the Cochrane review of vitamin C for the cold:

it may be worthwhile for common cold patients to test on an individual basis whether therapeutic vitamin C is beneficial for them.

Seriously. As I said at the time

The uselessness of personal experience in determining efficacy of medical interventions is why we do clinical trials. For crying out loud, I though it the raison d’être of the whole Cochrane Collaborative: relying on evidence instead of anecdotes. Wrong.

Here it is, less than two months into the new year and I doubt you will find a more stupid interpretation of information for the rest of 2015 than New tattoos found on Otzi the Iceman support prehistoric acupuncture theory.

Otzi, the 5300 year old corpse found in the Italian ice, has 61 tattoos in 19 groups across his body. More were recently found using special photographic techniques

Lars Krutak, an anthropologist who has published a book about the medicinal applications of tattoos, has said they may be on or near other acupuncture points.

Commenting on the findings, Krutak said: “I was intrigued by the possibility that the new set of tattoos were located on or near classical acupuncture points or meridians. If they were, perhaps these could be traced to Otzi’s known pathological conditions, such as gallbladder stones, whipworms in his colon and atherosclerosis.”

He consulted Gillian Powers, an acupuncturist, who said the location of the new tattoos corresponds with treatments associated with whipworms and gallstones.

I wonder if archeologists are ingesting some of the hallucinogenic indigenous plants to come up with ideas like that.

It seems that every time someone comes across a tattoo on a mummy, goodness gracious, it is near an acupuncture point. Find tats on the neck of a Peruvian mummy? It’s

A possible therapeutic origin may lie in the fact that the circles on the neck lie close to acupuncture points, having a relaxing and pain-relieving effect in the neck and head region.

There are perhaps 350 common acupoints,  with some estimates putting the number at over 2000. The average male is about 2900 square inches, so there is an acupuncture point every .68 square inches. Except, curiously, and understandably, the eyes, under the nails, and the genitals.

With that many points, it is not hard to find associations because every point on the skin is on or near an acupuncture point. He doesn’t seem to consider the notion that acupoints and meridians are nonsense that have no therapeutic effect for any process. One gets the feeling this is the worst example (or best example?) of confirmation bias ever.

“It cannot be ruled out that the Iceman’s tattoos were indeed applied as a therapeutic treatment. In future studies, the location of the new tattoos and its relation to acupuncture points and/or meridians should be further explored and discussed.”

I think the tats were put there to ward off Big Foot and Nessie.  Cannot rule that out either and it should be further explored and discussed.

Body art is currently popular. 5000 years from now they will pull the body of an Oregonian out of an ice crevice on Mt. Hood or from a bog along the coast. Looking at the barbed wire on the arm, the Chinese character on the calf or the abstract tramp stamp in the small of the back, they will find the tats near acupoints and conclude they were medical tats.

So stupid. But the year is young. I still am betting the Cochrane will surpass this bit of idiocy. They have yet to fail me.

It’s a Bad Flu Season. Use Acupuncture!?!

It was a bad flu season. We have had one death in my hospital system from influenza this year. So what is to be done for the prevention and treatment of influenza? University Hospitals in Cleveland suggests a worthless pseudo-medicine: Acupuncture for Cold and Flu Season.

As an Infectious Disease doctor when I think of treating or preventing potentially fatal illnesses, somehow magic doesn’t jump to the top of the list.

They suggest that acupuncture

could also help you avoid colds and flu this winter – or at least send them packing sooner.

Weasel word, could. A search of PubMed for ‘influenza’ and ‘acupuncture’ yields nothing of note; less searching for ‘cold’ and ‘acupuncture.’ As far as the Pubmeds goes, there are no clinical trials to suggest that acupuncture helps influenza or cold prevention or treatment.

Well not clinical trials but philosophy is the basis of treatment. Yes. Philosophy.

Eastern medical philosophy, acupuncture works by balancing and harmonizing qi (pronounced “chee”), or vital, life-force energy.

At one time Western philosophy thought illness was due to an imbalance of humors. That was superseded by treating illness not based on philosophy but rather on the reality of the sciences.  Eastern medical philosophy evidently prefers the philosophical fantasy of unblocking and revitalizing a mythical qi. Why a University is treating diseases based on philosophy instead of reality eludes me. I mean, besides the whole getting money for nothing thing.

Western medicine views acupuncture as a form of therapy that releases hormones into the bloodstream, sending signals to the nervous system.

No. Western medicine (and I hate the terms Western and Eastern, that seem slightly racist and suggests there are two versions of reality when there is one) sees acupuncture as an elaborate placebo that has never been shown to have efficacy in well controlled clinical trials for any objective endpoint. They continue

Q: How can acupuncture help during the cold and flu system?

A: Studies have shown that patients receiving acupuncture have elevated immune-enhancing hormones and blood counts for up to three days after treatment. If you begin to feel the symptoms of the cold or flu coming on, it is important to visit your acupuncturist right away to get the most benefit from your treatment. Acupuncture can:

• Prevent colds and flu by boosting the immune system

• Help you get over the cold or flu faster if you already have it

• Reduce chills, fever and body aches

• Relieve sore throat and congestion

Absolute nonsense unsupported by known biology or clinical trials. As I have said before, you cannot boost the immune system, much less with fantastical acupuncture, against influenza.  Having your immune system boosted may be part of the reason for worse outcomes in the obese and pregnant.

Still, this advice is a offered by a University Integrative Medicine program that offers multiple therapies divorced from known reality: Acupuncture, Ayurveda, Reflexology and Reiki.  It would probably be unreasonable to expect them to offer actual useful therapies.

That a University hospital’s website suggests nonsense for a serious illness confirms the choice of Sisyphus for the logo of the Society.

Seriously. It’s a Bruise

Sometimes I see an article and I have to double check that it is not from the Onion. The Epoch Times is not a satire publication (although their ad for seeing how acidic your body is gives me pause ) but they did publish Ancient Technique Scrapes Away Pain.

The article concerns Gua sha, yet another ancient Chinese healing pseudo-medicine where the skin is scrapped with a tool such as

something with a rounded edge that can be comfortably stroked across the body. Tools range from stones and bones shaped specifically for the job to large coins.

Gua sha is used to release congestion and stagnation of some sort or other to help the body heal itself from the usual hodgepodge of illnesses. There are few studies on the Pubmed on the technique and none of quality.

Look at the pictures with article.

It is a bruise from trauma.

Read the caption:

Gua sha raises dark marks that can be mistaken for tissue damage.

What? Are you nuts? It’s a BRUISE. It IS tissue damage.  Are you blind?

The Gua sha instructor says

“It looks like we are creating a bruise, or like we are breaking capillaries and causing some damage. What we’re actually doing is extravasating blood from the capillary bed,”

“extravasating blood from the capillary bed?!?!” That’s what a BRUISE is.

Look at the results of an internet search for Gua sha. It’s bruising from trauma.

At least the medical literature recognizes a “contusion injury to underlying soft tissue” and an “intentionally create(d) therapeutic petechiae and ecchymosis representing extravasation of blood in the subcutis.”

Or

Gua Sha is a traditional Chinese folk therapy that employs skin scraping to cause subcutaneous microvascular blood extravasation and bruises”

It’s a bruise.

The most impressive denial of reality I have ever seen in years.

And Finally

I received a tweet that said if acupuncture needs belief to work, why does it work on animals. Well, it doesn’t. The SkepVet is a nice source for more erudite discussions of the topic. With veterinary pseudo-medicine you are relying on the reports of the owner, or perhaps the zookeeper.

Acupuncture provides relief for Palm Beach Zoo Komodo dragon’s pain is a perfect example of reporting bias and silly reporting. Bob and Ray would be proud.

Hannah, a Komodo dragon, has neck pain. So they corner the poor beast, hold her against her will and stick the poor animal with needles using horrible infection control technique. I see septicemia in her feature. When she finally escapes, jacked up on fear and adrenaline, she goes to a place of prior safety and comfort to escape what to her must be a close call with death. However, the zoo says

”After receiving the acupuncture treatment, Hannah seemed to experience almost immediate relief, zoo officials said.

“She seemed to get very active and very interested in heading back to her sunny spot after the acupuncture…”

Of course she did.   Stress and fear will can make even severe injuries temporarily seem insignificant as many a war story will confirm, a serious wound ignored until the firefight is over.  An injured animal will get more animated when stressed to avoid being, I don’t know, killed and eaten? Lizards try and get warm when stressed by infection. It is part of their survival technique since they cannot mount a fever on their own.

That is animal acupuncture: a terrified animal trying to escape its tormenters, transiently appearing better after an intervention.

Sad.

Categories: Medicine, Skepticism

Phantom Acupuncture

Neurologica Blog - Thu, 02/19/2015 - 08:15

There are two basic schools of thought when it comes to acupuncture, which is the practice of placing thin needles into alleged acupuncture points in order to have a therapeutic or symptomatic effect. The “traditional” interpretation is that the needles are stimulating a physiological response of some kind at the acupuncture points. Within this school there is a range of opinions as to whether this response is due to a biochemical, neurological, or another known biological response or whether it is due to the still more traditional (but actually less than a century old) belief that the needles are manipulating the life force or Qi.

The other school holds that acupuncture is essentially an elaborate placebo. (Note – this article contains all the references necessary to support my statements below, so I will not repeat them.) Any apparent response is a non-specific response to the attention of the practitioner, expectation, distraction from pain, simple regression to the mean, and other illusory effects.

Each school makes different predictions about the various lines of evidence that can be brought to bear to resolve this question. There have been in total several thousand clinical studies looking at the apparent effects of acupuncture. These have failed to convincingly reject the null hypothesis, meaning that they have not demonstrated a clear biological response to acupuncture for any indication. The better controlled studies consistently show that needle location does not matter (sham acupuncture), and that needle insertion does not matter (placebo acupuncture). You can literally have a non-acupuncturist randomly poke someone with toothpicks and get the same response as the full acupuncture treatment.

The other line of evidence regarding acupuncture are studies that look at physiological responses to having needles poked through the skin. These studies, completely unsurprisingly, show that “stuff happens” when you stick a needle through the skin. There is a local reaction to the trauma, and the brain reacts in a predictable way. I do not think these studies in any way distinguish between the two interpretations of acupuncture. Even if acupuncture is nothing but a placebo, we would still expect these types of responses to sticking needles into tissue.

One way in which these studies might differentiate the two interpretations is if it could be convincingly shown that acupuncture points are real – the body responds in a consistently and functionally different way when acupuncture points are jabbed then when non-acupuncture points are jabbed. However, the evidence does not support this conclusion. In fact the totality of the evidence strongly supports the conclusion that acupuncture points have no basis in reality – they don’t exist.

There is now a new line of evidence that is very interesting, and one that I had not previously considered – phantom acupuncture. A recent study looked at performing acupuncture on a phantom limb. They used a now well-established technique of tricking the brain into incorporating a dummy body part as if it were real. They placed subjects in front of a table so that one of their arms was below the table, with a rubber arm above the table placed in such a way that visually the rubber arm looked like their own arm. They then stroke the rubber arm and the subjects real arm simultaneously. The brain sees and feels the rubber arm being stroked, and this sensory feedback is often enough for the brain to create the sensation of ownership over the rubber arm.

The researchers then placed acupuncture needles into the rubber arm that subjects had incorporated as their own. Obviously there is no possibility of any physiological response from the needle penetrating the rubber arm. I further think it is reasonable to conclude that placing a needle into a rubber arm cannot activate acupuncture points (if they existed) or alter Qi (if it existed). This experiment nicely eliminates local physiological responses and any Qi responses to the needles.

The researchers performed functional MRI scanning (fMRI) on subjects while needles were placed in their phantom rubber limbs. Keep in mind that fMRI research involves collecting lots of data and aggregating it. So the researchers are not looking at brain reactions in real time, just the aggregate brain activity of many subjects over many trials. They then look for statistical associations in the activity.

What they found was the same brain activation that previous studies have found with acupuncture of real limbs.

When the rubber hand was fully incorporated with the real body, acupuncture stimulation to the rubber hand resulted in the experience of the DeQi sensation as well as brain activations in the dorsolateral prefrontal cortex (DLPFC), insula, secondary somatosensory cortex (SII), and medial temporal (MT) visual area. The insular activation was associated with the DeQi sensation from the rubber hand.

If these results hold up, this implies that the brain is simply responding to the expectation and visualization of the needle penetration. Actual needle penetration is unnecessary. The most parsimonious interpretation of this data is that acupuncture is all in the mind. There is no need to hypothesize the existence of Qi, acupuncture points, or a specific physiological mechanism for acupuncture.

There are plenty of studies that show that the perception of pain is easily manipulated by simple things such as distraction. Swearing, distorting body image, and crossing your arms while one of them is pricked will all reduce pain perception. Pain perception is closely tied to attention, and so simple distraction is effective. It’s no surprise, therefore, that the brain responds to phantom stimulation.

At the very least this study demonstrates that all prior studies looking at fMRI responses to acupuncture needle insertion were likely simply showing a non-specific brain response to the expectation and/or visualization of needle insertion, without the need to invoke any specific physiological responses.

Conclusion

The totality of evidence strongly indicates that there is nothing specific to acupuncture. Acupuncture points don’t exist, Qi does not exist, and the elaborate details of acupuncture treatment do not matter. In other words – acupuncture is an elaborate (and unnecessarily so) placebo.

We can now add phantom acupuncture to sham and placebo acupuncture as lines of evidence demonstrating that acupuncture is no more than a placebo. The researchers indicate their desire to take the next step – to see if there is a clinical response to phantom acupuncture. The placebo hypothesis predicts that there should be, at least to some extent, depending on proper blinding (if possible).

What all of this means is that the very concept of acupuncture adds nothing to our understanding of the universe, and biology and medicine specifically. It is a failed concept. We lose nothing by discarding it. Any part of acupuncture that “works” is mere placebo and therefore not specific to acupuncture. Anything specific to acupuncture does not work.

Any non-specific symptomatic benefits to acupuncture (which do not appear to be clinically significant, by the way) can be achieved without sticking needles through the skin (which entails some risk), does not require special training, and does not require an expensive elaborate procedure. Further, persisting in the myth of acupuncture fosters misunderstanding of science, biology, and medicine which has insidiously negative effects.

Acupuncture itself is a phantom phenomenon and should go the way of the ether and N-rays.

Categories: Medicine

2015 NHIS Report on Complementary Health Approaches (whatever that means)

Science Based Medicine - Thu, 02/19/2015 - 01:00

Formerly known as “relaxing,” now known as a “complementary health approach.” Gustav Courbet, “Young ladies on the banks of the Seine,” 1857. Public domain, via Wikimedia Commons.

Back in 2004, data from the 2002 National Health Interview Survey (NHIS) appeared in a report titled “Complementary and Alternative Medicine Use Among Adults: United States, 2002.” It showed a whopping 62% of adults had used CAM in the past 12 months, but only if prayer for health reasons was included. With prayer excluded, the percentage was substantially lower, at 35%.

“CAM” was defined as

a group of diverse medical and health care systems, therapies, and products that are not presently considered to be part of conventional medicine.

The authors noted that, in earlier surveys of CAM use, “CAM has been operationally defined in a variety of ways” and the lists of CAM interventions/therapies included “varied considerably among the surveys.”

The most commonly used CAM therapies (excluding prayer) were non-vitamin, non-mineral natural products (18.9%), deep breathing exercises (11.6%), chiropractic care (7.5%), yoga (5.1%), massage (5.0%) and diet-based therapies (3.5%). CAM was most often used to treat back pain or problems, head or chest colds, neck pain or problems, joint pain or stiffness, and anxiety or depression. Most CAM use was self-prescribed.  Rebranding things like exercise (yoga) as “CAM” was in the mix from the get-go.

Non-vitamin, non-mineral natural products used most frequently were Echinacea, ginseng, ginkgo biloba, and garlic supplements. (I am leaving out percentages because the period covered, as well the way of calculating percentages, changed from year to year, and I gave up.)

Use of acupuncture (1.1%), homeopathic treatment (1.7%) naturopathy (0.2%), and energy healing (0.5%) was miniscule.

All in all, the authors found the results “surprising given the lack of definitive evidence supporting the safety and efficacy of most CAM interventions.”

In 2008, analysis of more recent data from the NHIS was published: “Complementary and Alternative Medicine Use Among Adults and Children: United States, 2007.” This time, CAM was defined as

a heterogeneous spectrum of ancient to new-age approaches that purport to prevent or treat disease. By definition, CAM practices are not part of conventional medicine because there is insufficient proof that they are safe and effective.

Or, in more condensed language, CAM was defined as practices that have insufficient proof of safety and effectiveness.

Several changes were made in both the definition and reference period for some CAM treatments. More “natural” products were included and their reference period was reduced from 12 months to 30 days. “Chiropractic care” became “chiropractic or osteopathic manipulation.” Children were included for the first time.

Overall use by adults jumped to 38%. Yet, the therapies most commonly used by adults and their percentages didn’t change all that much: non-vitamin, non-mineral, natural products (17.7%), deep breathing exercises (12.7%), meditation (9.4%), chiropractic or osteopathic manipulation (8.6%), massage (8.3%), and yoga (6.1%) were at the top of the list.

Adults most often used CAM for the pretty much the same things as the 2004 article reported: back pain or problems, neck pain or problems, joint pain or stiffness or other joint conditions, arthritis, anxiety and depression, and other musculoskeletal conditions. However, use for head and chest colds decreased markedly.

Of the top 4 natural products, only Echinacea remained. Fish oil, omega 3 or DHA were at the top of the list. Glucosamine and flaxseed oil or pills made the top 4 as well.

Homeopathic treatment (1.8%), naturopathy (0.3%), energy healing (0.5%) and acupuncture (1.4%) still showed very little use among adults.

The most interesting insight of the 2004 Report was not so much CAM use as it was CAM use v. CAM research:

The attention given by the scientific community does not correlate with the prevalence of use by the public as measured by the 2007 NHIS. For example, the Institute of Medicine identified 79 systematic reviews of acupuncture and 38 studies of homeopathy, placing them 3rd and 4th among all CAM therapies. Yet NHIS found that less than 1.5% of the adult U.S. public used each of these therapies in a given year.   In fact, there is no meaningful correlation between the number of published studies of a CAM therapy and its use by the U.S. public. CAM therapies with relatively infrequent use by the public (e.g., biofeedback, hypnotherapy, acupuncture) are those with the highest level of acceptance and referral by physician groups, including pediatricians.

On February 10, 2015, a new Report was unveiled: “Trends in the Use of Complementary Health Approaches Among Adults: United States, 2002-2012.” A separate Report covered children.

Once again, complementary medicine was redefined. In fact, it’s not even “medicine” anymore. With no explanation for the change that I could find, complementary and alternative medicine is no more; we are now looking at “complementary health approaches,” which are

an array of modalities and products with a history of use or origins outside of conventional Western medicine.

The Report includes “revised prevalence estimates for 2002 and 2007 [which] were lower than those published previously: 32.8% compared to 35% for 2002 and 35.5% compared with 38% for 2007.” This is explained by a “narrower definition,” but of what and how it is “narrower” I am at a loss to find. In any event, the figure for 2012 is 34%.

The authors do note that a “confusion with definitions” about “which complementary health approaches are included in the definition of any complementary health approach” [got that?] has led to “an effort to establish an internationally accepted standard for what approaches should be included in prevalence surveys of complementary health approaches.” I take it this goal remains unrealized.

“Alternative” and “medicine” were not the only things dropped. For reasons that are not explained, statistics regarding, or discussion of, the diseases or conditions for which consumers are using these “health approaches” is missing from the article. That is not to say it might not be somewhere in the information gathered in the survey, but it is a mystery why the authors wouldn’t mention it. After all, as the authors state, these surveys were designed to help guide the NCCIH (f/k/a NCCAM) research agenda, which, according to the authors, has now shifted from disease treatment to symptom management and “the promotion of optimal health,” whatever “optimal health” might be.

So what health approaches are American adults using most often?   Surprise! It’s non-vitamin, non-mineral dietary supplements (17.7%), deep-breathing exercises (10.9%), yoga (9.5%), chiropractic or osteopathic manipulation (8.4%), meditation (8.0%), and massage therapy (8.0%).   After that, special diets come in at 3.0%, with all others at 2.2%, for homeopathic treatment, or below. The “below” includes acupuncture (1.5%), energy healing (0.5%) and naturopathy (0.4%).

The top 4 supplements were fish oil, glucosamine or chondroitin, probiotics or prebiotics, and melatonin.

I find these Reports both interesting and disturbing. Obviously, it is interesting to read what healthcare practices people are using. But the disturbing elements predominate.

The definitional calisthenics on display over a decade of NHIS surveys of alternative/complementary medicine/healthcare apporoaches is simply a symptom of the real problem underlying the whole enterprise, one that has vexed us here at SBM since the beginning. Kimball Atwood tackled it early on in two posts documenting the slide from “quackery” to “CAM.” More recently, David Gorski blogged about yet another definitional reboot when the National Center for Complementary and Alternative Medicine changed its name to the National Center for Research on Complementary and Integrative Health, not long after Mark Crislip weighed in on the “loose” terms of SCAM.

I’ll add my observations, if not a better understanding or a solution.

The root cause, if I may use that term, lies in the uselessness of a “Western conventional medicine”/”not Western conventional medicine” dichotomy. The real distinction to be made, and the only one that is useful, is one of science and evidence.

“Western conventional medicine” is characterized by the rational application of science to healthcare practices, one feature of which is determining efficacy and safety, as best we can, in advance of using any particular treatment. But “Western conventional medicine” doesn’t have to be the exclusive repository of those characteristics. Any healthcare discipline or practice can take up science and evidence as its standard.   Acupuncture, chiropractic and naturopathy are, in varying degrees, Western, conventional and medicine, but none is all of those. Yet any of these disciplines is more than welcome to employ science and evidence. As are the dietary supplement or homeopathic industries.   But they don’t, or at least not consistently or reliably.

That is the key difference and that is the distinction that must be made when discussing these practices, instead of using some fabricated terms that paper over what is really going on. NCCIH and the NHIS Reports admit that evidence is an issue, but NCCIH doesn’t want to make it clear that it is also the difference that really matters. And by the way, it’s unfortunate to see the NHIS dragged into this by NCCIM’s apparently false assurance that the results would “guide” their research agenda. If that is truly the case, why so much acupuncture research? According to the NCCIM website, they are still into acupuncture, now in cahoots with the military:

the report  proposes expanded collaboration between NCCIH and the U.S. Department of Defense (DoD) and the Department of Veterans Affairs (VA) to test approaches to pain management that integrate complementary treatments such as acupuncture, massage, and meditation with conventional models of care.

Because of my interest in CAM practitioner licensing and other legislation affecting CAM practices, such as DSHEA, I was also struck by the tremendous gap between what these laws permit and what people are actually doing. Why are legislatures defining chiropractic scope of practice to include the diagnosis and treatment of almost any disease or condition when, by far, the only thing people use them for is a limited range of musculoskeletal problems? Why do so many states license acupuncturists and give them leeway to use all sorts of nonsense on patients when hardly anyone uses them for anything? And why do states continue to fall for pleas for naturopathic licensing when there is no demand? Why the hassle of a regulatory board and the other accouterments of bureaucracy to accommodate a handful of people?

Finally, consumer demand as an excuse for “integrative medicine” is a bunch of hooey.  The idea that patients are “demanding” acupuncture is just nonsense. Looks like some physicians are the ones demanding acupuncture and acupuncture research, in spite of, not because of, patient demand.   Other popular integrative medicine center practices, such as cranial sacral therapy, reiki and energy healing are registering at below 3%.

I’ve come to believe that CAM and “integrative medicine” is mostly about money and ideology, not patients.   Money from research, money from academic and government jobs beholden to perpetuating CAM, money from selling CAM products and services, money from education and training in CAM. Fortunately, despite the efforts of the many people whose livelihood depends on CAM, the public seems remarkably resistant to their efforts. They tend to cluster around treatments that, if not supported by sufficient evidence of safety and effectiveness, at least have some plausible potential for helping them, even it it turns out to be an unrealized potential: spinal manipulation for musculoskeletal issues, supplements like fish oil, relaxation techniques like deep breathing and exercise practices like yoga. It is amazing that so few have been fooled by so many who are trying so hard. It’s not ideal, it’s not an excuse to tolerate CAM, and its not a reason to become complacent, but it does look like consumers are smarter than the ideologues and money makers give them credit for.

Categories: Medicine, Skepticism

Reporting Research Misconduct

Science Based Medicine - Wed, 02/18/2015 - 08:17

Perhaps one of the greatest threats to the enterprise of Science-Based Medicine is research fraud and misconduct. Rigorous research methods can be used to minimize the effects of bias, but when those methods themselves are the problem there is no easy fix. Related to this is the need for transparency. When fraud or misconduct is uncovered it erodes confidence in the system because it provokes speculation about how much fraud and misconduct has not been uncovered.

A recent study published in JAMA looks at one aspect of this issue – reporting of misconduct uncovered by the FDA. The good news here is that FDA trials, those that will be used to apply to the FDA for approval of a drug, are carefully monitored and inspected by the FDA. This is an important quality control measure. When the FDA uncovers misconduct it takes steps to correct it. If the misconduct is severe enough then any data that is associated with the poor research practices will be excluded from the trial so as not to taint the results. Even an entire study can be disqualified if necessary.

The problem highlighted by the study is that there is no systematic way for the FDA to communicate its findings through the peer-reviewed literature. Tainted studies, or ones that require a correction or retraction (because the violations were discovered after publication) may therefore persist in the peer-reviewed literature without any indication of the uncovered misconduct.

The sole author, Charles Seife, found:

Fifty-seven published clinical trials were identified for which an FDA inspection of a trial site had found significant evidence of 1 or more of the following problems: falsification or submission of false information, 22 trials (39%); problems with adverse events reporting, 14 trials (25%); protocol violations, 42 trials (74%); inadequate or inaccurate recordkeeping, 35 trials (61%); failure to protect the safety of patients and/or issues with oversight or informed consent, 30 trials (53%); and violations not otherwise categorized, 20 trials (35%). Only 3 of the 78 publications (4%) that resulted from trials in which the FDA found significant violations mentioned the objectionable conditions or practices found during the inspection. No corrections, retractions, expressions of concern, or other comments acknowledging the key issues identified by the inspection were subsequently published.

Seife gives some specific examples, includes an entire trial that was deemed unreliable by the FDA (the RECORD4 trial looking at an anticoagulant for deep vein thrombosis), but the FDA’s findings are not mentioned in any of the publications describing the trial’s results.

In a separate case Seife reports:

A clinical site in China taking part in a large trial of apixaban, a novel anticoagulant, had apparently altered patient records. If one were to exclude the data from the patients at that site, the claim of a statistically significant mortality benefit disappears.179 For this reason, among others, the FDA wrestled with whether it was appropriate to allow the manufacturer to claim a mortality benefit. None of this discussion appears in the literature.

Reporting of these findings expose a serious concern, but one that has some obvious solutions. As Seife himself suggests, when the FDA finds violations it can be required to report their findings on clinicaltrials.gov. Seife also proposes that a separate database be created just to report FDA inspections that find misconduct. Further, peer-reviewed journals can require that submitting authors disclose any FDA violations, similar to the required reporting of potential conflicts of interest.

The FDA has responded to the study by saying they are:

“…committed to increasing the transparency of compliance and enforcement activities with the goal of enhancing the public’s understanding of the FDA’s decisions, promoting the accountability of the FDA, and fostering an understanding among regulated industry about the need for consistently safe and high-quality products.

“Regarding redaction of warning letters, the majority of information that is redacted from warning letters about clinical trials pertains to either the protocol or patient identifiers. The FDA redacts protocol information from warning letters because the information pertains to a pending application, not because it may reveal investigator misconduct. Information on pending applications is exempt from public disclosure based on several federal statutes and regulations, such as the Freedom of Information Act.”

Mainstream reporting of these results have been, in my opinion, a bit hyped. This stems partly from the fact that Seife, who is an investigative journalist interested in exposing research fraud, wrote an editorial in Slate to accompany the publication of his study. Seife claims that the FDA is “burying” and has “hidden” evidence of misconduct. This is why the FDA addressed the issue of redacted warning letters in the quote above – redaction was interpreted as an effort to hide details of misconduct.

To put the problem into perspective, in 2013 FDA inspections uncovered misconduct in 2% of their investigations. Further, the FDA takes steps to correct the problems they uncover, such as excluding tainted data or even entire studies. The problem here is one of transparency, especially in the peer-reviewed literature. I don’t know if it is fair to say that the FDA buries its findings of misconduct, rather than they simply have no systematic method of reporting their findings.

As can be expected, the results of this study and the perhaps overly hyped reporting have fueled conspiracy theories and science denial. Taken out of context, the study can be used to dismiss any scientific findings that one finds inconvenient to their ideology.

This is part of a broader problem, and one that we confront frequently at SBM. The institutions of science are certainly flawed, as is every human endeavor. Those flaws, however, are not fatal. The culture of science is also one that is self-reflective and contains a sincere motive for self improvement and quality control.

We frequently point out flaws in the practice of science as a way to inform interpretation of the scientific literature, and to suggest specific improvements to make the practice of science more reliable and transparent. Others, however, point to the same flaws as a way of dismissing the findings of science in general, or at least anything with which they disagree.

Findings such as these can be used as a way of improving the institutions of science, or as a way of tearing it down. I prefer the former.

Categories: Medicine, Skepticism

Anderson Cooper Takes Down Dan Burton

Neurologica Blog - Tue, 02/17/2015 - 10:42

I criticize bad, biased, and or just lazy science journalism frequently, and so it’s a pleasure to occasionally have the opportunity to praise good journalism. This recent interview of Dan Burton by Anderson Cooper could be a template for how to conduct an interview over a scientific issue.

Dan Burton is a former Republican Congressman who has a long history of being anti-vaccine. He likes to repeat anti-vaccine tropes, and does so with the clueless persistence of a seasoned politician with an agenda.

Anderson Cooper is one of the few American journalists who has demonstrated his ability to do a tough and probing interview – you know, actual journalism. He demonstrated his chops again here. Specifically:

He was clearly prepped for the interview. He did his research, understood the issues, and was able to challenge Burton on specific points. You can’t go into an interview like this cold, or with only a superficial understanding of the issue. You have to know what the other person is going to say and how to respond.

Proper research will set you up for the next critical aspect of a proper interview, challenging your subject when they make statements that are wrong or misleading. Cooper did this well, and pressed Burton when he tried to wiggle out of his blatant errors.

Cooper pressed Burton enough that he exposed Burton’s position for the house of cards that it is, and that’s the point. Until you get to the point where the interviewee’s position is exposed as the sham that it is, you haven’t done your job.

To give what is perhaps the most dramatic example from the interview, Burton claims that mercury in vaccines is linked to autism, citing his three years of research on a House committee as authority for this statement. Cooper pointed out that in 2001 mercury was removed from all vaccines, except for some flu vaccines.

Burton simply kept responding with his talking points: autism rates have risen from 1/10,000 to 1/80. (As an aside, Cooper could have challenged him on this point also, those numbers clearly being an artifact of diagnosis and definition.) Burton also kept saying that mercury is a proven toxin and should not be in any vaccines.

This is a great example of how politicians and those with an agenda deceive. You make  statements that in isolation may be superficially correct, and weave them together to suggest a desired narrative. Cooper’s job was to deconstruct that narrative by exploring those fact further.

When you do we find that autism rates were increasing throughout the 1990s. In 2001 mercury containing thimerosal was removed from the routine childhood vaccine schedule, dramatically decreasing childhood exposure to mercury through vaccines. In the 14 years since this was done autism rates have continued to rise without any change. This is a powerful argument against an association between mercury in vaccines and autism. Burton, however, does not appear to be interested in the scientific truth, only his narrative.

Cooper pushed him on this point. Burton restated his talking points. Cooper pushed again. Burton appealed to anecdote, “say that to the parents of children who became autistic after being vaccinated.” Cooper pushed again. Burton claimed that mercury was still in three vaccines. Cooper corrected this misinformation, challenged Burton to name the vaccines (he couldn’t, beyond the subset of flu vaccines that Cooper already acknowledged). Burton appealed to scientific studies showing an association. Cooper corrected him, pointing out that the consensus of scientific evidence and opinion shows no association. He challenged Burton to cite his sources; he couldn’t.

That is how you interview a crank, pseudoscientist, or anti-science activist. You arm yourself with the facts, and keep challenging until you expose the crank’s deceptions and poor reasoning.

This is difficult, make no mistake. It is likely that the person you are interviewing has one issue about which they are passionate. They may have spent years promoting their agenda, and are likely full of misinformation, facts out of context, and subtly wrong talking points. They can easily Gish Gallop you into a corner, or play “gotcha” with claims you never heard before.

This is why debates are so problematic. But this was not a debate, it was an interview. Cooper controlled the discussion. He kept it focused on a few points and dug down to the bottom of each point. That is critical. It means you have to be disciplined. You may need to let some comments go by so as not to get distracted.

It is common in such a discussion for the person being challenged to raise an entirely new point when you finally have their back against the wall on one point. You may feel tempted to take the bait and challenge them on their new point, but this just lets them wiggle out of the previous one. I always find it best to pick one claim and push it as far as you can. Force them to defend their position or acknowledge their error.

In truth this rarely works that way, because they will almost always just make up new crap, make vague references to evidence, or try to get to an “agree to disagree” position. This is what Burton did – he did not acknowledge anything, but hid behind vague references to his own research.

But the interview still worked because Cooper pushed enough to force Burton to make ridiculous statements, such as his appeal to anecdote. Burton became flustered, and could not answer to some obvious contradictions in his position, for example the continued rise in autism following the removal of thimerosal from most vaccines.

Other journalists take note – this is how you interview an ideologue. It takes work and good journalism, but anything less is a disservice to the public.

 

Categories: Medicine

Glucosamine Update

Science Based Medicine - Tue, 02/17/2015 - 03:00

Osteoarthritis, the “wear-and-tear” type of arthritis, affects a great many of us as we grow older. Knee pain is a common symptom. The diet supplements glucosamine and chondroitin have been proposed as a more “natural” treatment than pharmaceuticals, and they are components of a number of proprietary “joint health” formulations like Osteo Bi-Flex.

The GAIT study (Glucosamine/Chondroitin Arthritis Intervention Trial), compared glucosamine, chondroitin, a combination of the two, and a pharmaceutical (celecoxib) to a placebo in patients with knee pain from osteoarthritis. The only one that worked better than placebo was celecoxib. I wrote about the GAIT trial in 2008.   The study was reported in the media as both negative and positive. The positive reports emphasized the subgroup analysis: in one of ten subgroups, patients with moderate to severe pain, the combination of glucosamine and chondroitin outperformed placebo. But in the subgroup of patients with mild to moderate pain, it did not. The authors themselves commented that their study was not powered to draw any conclusions from subgroups and that further studies would be required. (The “power” of a study is a measure of its ability to show an association or relationship between two variables if such a relationship exists.) Now a further study with sufficient power claims to have confirmed the subgroup findings. This may encourage some people to try glucosamine/chondroitin, but I remain skeptical.

Contradictory evidence

Following the GAIT trial, there were several other studies showing that glucosamine was ineffective for osteoarthritis. There are other studies showing it is effective. There are a lot of studies out there, with varying quality. I think it’s fair to say the evidence is mixed and still questionable even when the new study is added into the mix. I was particularly impressed by a 2004 study of patients who had had a positive response to glucosamine. It compared continuance of glucosamine to substitution with a placebo; it found no difference in disease flares or any of the secondary outcomes they looked at. Pain is particularly susceptible to placebo responses, and studies of pain must be interpreted with more caution than studies with more objective outcomes.

The American Academy of Orthopaedic Surgeons reviewed the evidence and recommended against the use of glucosamine, chondroitin, and the combination. They said

Glucosamine and chondroitin sulfate have been extensively studied. Despite the availability of the literature, there is essentially no evidence that minimum clinically important outcomes have been achieved compared to placebo, whether evaluated alone or in combination.

The new study

The new study, “Combined chondroitin sulfate and glucosamine for painful knee osteoarthritis,” was published in the Annals of the Rheumatic Diseases on Jan 14, 2015. The full text is available online. It was a randomized double-blind study of patients with moderate to severe knee pain from osteoarthritis. 264 patients were given a prescription drug sold in Europe that contains 400 mg chondroitin sulfate plus 500 mg glucosamine (taken 3 times daily) and 258 were given celecoxib, a non-steroidal anti-inflammatory drug (NSAID), in a dose of 200mg once daily, plus placebo capsules to provide the same number of pills. Celecoxib outperformed glucosamine/chondroitin for the first four months of treatment, but by 6 months there was no difference. They concluded that glucosamine/chondroitin was equivalent to celecoxib. The authors recognize that current evidence-based guidelines advise against glucosamine/chondroitin, but think their study supports its use in patients with cardiovascular or gastrointestinal conditions where NSAIDs are inadvisable.

Why I remain skeptical

A Medscape reporter contacted me about the new study because I had written a letter to the editor that was published in American Family Physician where I identified misconceptions about the GAIT trial.  She asked me several questions, and in the resulting article she devoted two paragraphs to my answers. I expressed my reservations and said I would withhold judgment until the weight of evidence falls more clearly on one side or the other.

In the comments to the Medscape article, a pathologist said:

I doubt that dietary glucosamine or chondroitin sulfate are absorbed from the gut as such.  Further, human cartilage contains N-acetyl galactosamine, not glucosamine.  Depending on source, the dietary CS may have a different structure than human CS. Finally, the cartilaginous glycosaminoglycan matrix is synthesized by the chondrocytes, and it is naive to assume that dietary supplements will “home” to that avascular tissue.  It is all placebo effect, making lots of money for manufacturers.

I don’t know enough about that to comment on it, but I remain skeptical for several reasons of my own:

  • Neither drug alone has been shown effective, only the combination. A synergistic effect can’t be ruled out, but such an effect would be unusual.
  • Glucosamine and chondroitin are produced in the body in far greater amounts than the pills contain. Wallace Sampson, one of the founders of SBM, wrote: “Glucosamine is not an essential nutrient like a vitamin or an essential amino acid, for which small amounts make a large difference. How much difference could that small additional amount make? If glucosamine or chondroitin worked, this would be a medical first and worthy of a Nobel. It probably cannot work.”
  • Patients who responded continued to respond when their glucosamine was replaced by placebo
  • I don’t know of any other medication for pain that is effective only for more severe pain and ineffective for less severe pain.
  • The study was done with a prescription formulation that is not available in the US; patients who buy it over the counter may not be getting the equivalent of the study drug.
  • Celecoxib was more effective in the first 4 months and was equally safe; I’d think most patients would want the faster-acting option.

Conclusion

Glucosamine/chondroitin might work for osteoarthritis, and might be worth trying in patients who can’t take NSAIDs, but the evidence is still far from clear. Based on the currently available evidence, I wouldn’t feel comfortable prescribing it or telling patients “it works;” but if a patient wanted to try it, I wouldn’t have any objections to a therapeutic trial. There don’t appear to be any worrisome side effects, and even if patients only had a placebo response, they might feel better.

 

Categories: Medicine, Skepticism

New Caveatus Emptora Superfood Medicinal Supplement

Neurologica Blog - Mon, 02/16/2015 - 08:14

About once a week I get a question about a specific supplement, often new but sometimes a supplement that has been around for a while. The questioner wants to know if there is any value to the product. I suspect they often already know the answer, but it’s hard to resist the promises being made. I can give a generic answer, an emphatic, “No,” because the marketing of such products is just as generic. You literally can substitute the name of any new supplement you wish to market into the copy.

Snake oil purveyors are looking for the next exotic plant from a tropical location that they can sell as a supplement. It doesn’t matter what it is. Science and evidence do not even enter the equation. They want to know – can they get a supply of it, or even corner the market. If they cannot get enough of the plant it doesn’t matter. They will fill their bottles with wheat, alfalfa, or other fillers. Then they put it in a bottle, plug in the standard claims, do a little marketing, and rake in the millions. That’s it. Sometimes they deliberately adulterate their supplement with actual drugs, especially if they are for weight loss or erectile dysfunction.

Does the new exotic supplement from Gondwanaland, Caveatus Emptora, really work? No! It’s a scam. Save your money.

There are a few standard types of these scams. Here is the most recent miracle supplement about which I was asked, but I will swap out the name so as not to give it the slightest additional exposure.

The Superfood

Some supplements are sold as superfoods. The very idea is nonsensical – the notion that your health will be improved by eating one special food that is just packed with nutrients. Sure, some foods are more nutritious than others, and it’s a good idea to eat a variety, with lots of fruits and vegetables, to get enough micronutrients. But there are not “superfoods” that have such overwhelming nutrition that they will supercharge your health.

Here is an example of such marketing:

This product is great for people who need a boost in their nutrition. As an example, carrots only have 25% of the vitamin A that you can get in the same amount of Caveatus Emptora. Shocked? It also has four times as much calcium as you get from milk, three times the amount of potassium as you get from bananas.

Luckily, more and more distributors are creating supplements in pill and powder form so that the average American can have access to Caveatus’s valuable effects.

If you live in Africa (I mean, Gondwanaland) and have poor nutrition, then incorporating leaves, seeds, or roots from Caveatus is a good idea. It’s the equivalent of “eat your vegetables.” If you are an “average American” you don’t need to buy an exotic tropical plant to get your vitamins. The grocery store has all you need – much cheaper.

What always amazes me, however, is that the superfoods are often sold in pill form. So essentially they are a multivitamin. The source doesn’t matter. Everything else they have said up to that point is now irrelevant – it’s a multivitamin. So far the evidence indicates that routinely taking a multivitamin for most people living in industrialized nations is unnecessary and may even be harmful.

Medicinal 

Exotic plants are also sold for their medicinal purposes. The claims are often vague, or cover the most common conditions – whatever maximizes the potential market:

Caveatus is an energizing product that helps with healing and medical prevention as well. It is used for many reasons, skin disorder treatment, diabetes, sleep improvement, relief for anxiety and depression. It can give you a huge boost in energy, it has the ability to even out your blood sugar levels, and it can even help you recover more quickly after a workout.

Of course, plants contain hundreds of chemicals. There will always be basic science studies showing that there are bioactive chemicals in the plants that do stuff to cells in petri dishes or sometimes to mice or rats. This level of evidence, however, should not be used to make clinical claims. There are just too many variables involved – bioavailability, proper dosing, active ingredients, etc. What we need are clinical studies in people, but you rarely see those beyond almost worthless pilot studies, or worse in-house studies paid for by the supplement seller.

The claims are always too good to be true. Every product has to be a panacea, and miracle cure for everything. There are also some common themes:

- All natural
- Ancient wisdom
- Exotic
- Doctors are not telling you about it
- Celebrity endorsement

These days the hottest celebrity to endorse your miracle supplement is Dr. Oz.

Luckily, the word is out! Partly due to Dr. Oz featuring Caveatus on his successful afternoon talk show. He referred to it as an energy blaster, and he’s right! People who have taken Caveatus report that they’ve seen a boost in their energy levels and feel better than ever!

I’m sure they do. The same can be said about every supplement ever marketed.

Conclusion

Marketing an exotic plant for supernutrition or as a medicinal is a huge industry, and its a complete scam. There will always be a new miracle supplement on the market. This pattern has been repeating itself literally for over a century, probably longer.

If you think to yourself – how did this product come to market?, it will make sense. It was brought to market as I outlined above. Plants that have truly unique medical properties are studied to identify their active ingredient(s) and used as a source of pharmaceuticals.

The “miracle superfood medicinal supplement” is a scam. It might as well be Caveatus Emptora from Gondwanaland.

Categories: Medicine
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