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Kangaroo Mother Care, Skin-To-Skin Contact, and the Risk of Sudden Unexpected Postnatal Collapse

Science Based Medicine - Fri, 02/12/2016 - 09:00


In January, a study published in Pediatrics, the American Academy of Pediatrics’ flagship peer-reviewed journal, presented evidence in support of Kangaroo Mother Care (KMC) and its primary intervention: prolonged skin-to-skin contact (SSC) between a mother and her newborn child. I was originally asked to discuss this report at the time by the editors of The Scientific Parent, which is a great resource by the way, but I wanted to expand on my initial thoughts after letting them simmer for a bit over the past few weeks. Please check out the great work done by Leslie and Julia over at TSP after you finish this post.

Another media fail

As is often the case, the mainstream media picked up the story, as presented in a press release from Harvard’s School of Public Health, and blindly ran with it. Without exception the reports tout the benefits found in a specific subset of newborns, exaggerate and extrapolate those benefits inappropriately to all newborns, and make no mention whatsoever of potential risk (see these reports by Livescience, Reuters, and The New York Times). The Daily Mail decided to educate readers on “How ‘kangaroo’ care could SAVE your baby” and even the AAP’s own healthychildren.org posted a glowing report on the study’s findings.

None of this is at all surprising given the study authors’ conclusions (and the media’s track record in handling complex medical topics):

KMC is protective against a wide variety of adverse neonatal outcomes and has not shown evidence of harm. This safe, low-cost intervention has the potential to prevent many complications associated with preterm birth and may also provide benefits to full-term newborns. The consistency of these findings across study settings and infant populations provides support for widespread implementation of KMC as standard of care for newborns. Additional research is needed to determine the ideal duration and components of KMC. Successful strategies for KMC implementation in various contexts should be disseminated among clinicians and policymakers.

As I will explain in today’s post, while there are absolutely some benefits in specific newborn populations, in most infants they do not appear to be clinically meaningful and there are undeniable risks associated with SSC. This risk includes severe injury to an infant’s brain and, as has been demonstrated around the world in numerous reports, even the possibility of death. That this risk has been ignored while endorsing an intervention for groups of newborns unlikely to reap objective benefit is upsetting to say the least. That this risk has not been addressed appropriately by medical professionals, organizations claiming to support the health of newborn infants, and government agencies tasked with protecting us from unnecessary harm is even more concerning.

What is Kangaroo Mother Care?

Kangaroo care, or more commonly just called skin-to-skin, is nothing new in the United States, although its implementation is quite variable from institution to institution. As a pediatric resident training at Vanderbilt Children’s Hospital over a decade ago, I remember encouraging monitored skin-to-skin contact in medically stable premature infants in the neonatal intensive care unit. We referred to it as kangaroo care as I recall. We also supported the practice in the NICU at Texas Children’s Hospital, also in medically stable kids being watched carefully. The current trend is to promote SSC in all newborns, even healthy term infants who will be staying in the room with their parent(s) and largely unmonitored. True KMC as practiced globally can be a bit different, yet it still varies depending on the available resources and the unique culture within and surrounding each individual facility.

As defined by the WHO, KMC involves “early, continuous, and prolonged skin-to-skin contact between the newborn and mother, exclusive breastfeeding, early discharge from the health facility, and close follow-up at home.” Infants are generally expected to be medically stable, so in the case of extremely premature or ill newborns this may mean that time lying against a caregiver’s bare chest is delayed for days to weeks. Some proponents consider this a problem because they feel that the stress caused by separation from the mother plays a significant role in why the baby is unstable in the first place, and they place great emphasis on SSC being initiated immediately after birth and uninterrupted. If “technology” must be added, they argue, it should be “with the baby in her SAFE place, on mother’s chest.”

The two mechanisms believed to be the driving force behind any potential benefits of KMC are SSC and breastfeeding, which proponents believe is more likely to be successfully initiated and maintained as the exclusive source of nutrition when KMC is prioritized. My goal with this post is to focus on the SSC component, which is the aspect of kangaroo care that contrary to the conclusions of the study in question, and pretty much all information available for parents online, does pose a significant risk to newborns as commonly practiced.

What did the new study actually show?

The study in question is a systematic review and meta-analysis of available published and unpublished data from 2000 to 2014 that involved some amount of SSC, even if the full WHO KMC criteria were not met. They excluded small studies of less than ten babies as well as studies that looked at subjective outcomes or that didn’t include a control group. Any quantitative endpoint was accepted, and when all was said and done 124 studies from countries around the world were found to be acceptable.

Among the outcomes included in the analysis were mortality, breastfeeding initiation and exclusivity, infection, heart rate, respiration, oxygenation, temperature, blood glucose and cortisol levels, length of initial hospitalization and readmission rate, growth, and pain response. The individual studies in the meta-analysis also contained numerous additional outcome measures that the authors were unable to finagle into a summary measure because of their one-off nature or the excessive heterogeneity in trial methodology. So what did they find?

The study’s big finding, and the one which the media jumped on, was that when a baby lives long enough after birth to undergo some amount of SSC there was a statistically significant decrease in mortality out to 3, 6, and 12 months compared to babies that did not. But this effect was only found to be truly significant in the subgroup of low birth weight (LBW) babies that were born weighing less than two kilograms. It did not appear to matter in which country the child was born or what the available resources were. It also did not seem to matter when SSC was initiated or how much the child received, which is curious.

In addition to the benefit of increased survival in that specific population, the study revealed a relationship between SSC and a moderate, across-the-board increase in exclusive breastfeeding up to 4 months of age, but did not show an effect of SSC on how quickly breastfeeding was initiated, which is one of the major benefits touted by proponents. SSC also appeared to lower the overall risk of newborn sepsis, but not any other type of infection, to improve regulation of blood sugar in LBW newborns only, and to lower the chance of hospital readmission slightly. Findings of differences between groups receiving SSC in vital signs, growth, and every other outcome were negligible and unlikely to be clinically relevant in most babies, such as a reduction in respiratory rate by three fewer breaths per minute. They were unable to demonstrate a dose response curve for any outcome, which also raises some interesting questions.

And now that risk nobody is talking about

I agree that a low-tech intervention like SSC is potentially beneficial in many babies, particularly in regards to premature and low birth weight infants, and it is certainly inexpensive. While the effects may not be substantial in healthy babies born at term and at an appropriate weight for their gestational age, reducing metabolic distress and stabilizing blood glucose levels in more medically fragile newborns is probably a good thing. And it appears that the most meaningful potential benefit, reduced mortality in low birth weight newborns, is realized even in resource rich regions like the United States.

Based on prior research, particularly in premature infants and in breastfeeding outcomes, there has already been a significant trend for this kind of intervention to be promoted by pediatric-focused organizations like the AAP, by private organizations like “Baby-Friendly USA “, as well as the CDC (which emphatically recommends that all hospitals be “Baby-Friendly”), and the WHO. Their intention for the most part is to have policies in place that support early and successful breastfeeding. These organizations also stress the importance of so-called “rooming in,” and increasing numbers of hospital in the U.S. are doing away with the option for a child to leave the mother’s room for any reason, even maternal pain or exhaustion.

When a mother spends time holding her newborn baby against her skin soon after delivery, there is good reason to believe that this may help improve breastfeeding success when exclusivity is the desired result. And it is a great way to help cement the connection between a mother (dad too) and her child. But it must be pointed out that both of these outcomes can and generally do occur even if no SSC takes place at all. I really have to stress that you are still a good mother even if you aren’t attached to your baby 24 hours a day, as recommended by some KMC proponents.

So KMC and SSC are promoted as a panacea for many newborn issues despite the lack of solid evidence for most objective outcomes in the average baby. When something is too good to be true, of course, it usually is. This is especially true in medicine where there have historically been a grand total of zero truly risk-free interventions. The media reports and the study conclusions that they are based on are flawed in at least one very important way, and this is likely putting babies at risk of injury to their brain and even death. There is in fact very good reason to suspect that SSC as commonly recommended, and in the current “baby-friendly” climate experienced in many hospitals, is a risk factor for something known as sudden unexpected postnatal collapse (SUPC).

What is sudden unexpected postnatal collapse?

SUPC occurs when a low-risk newborn without signs or symptoms of illness or injury has a sudden and unexpected episode of cardiorespiratory insufficiency within the first week of life, often occurring in the mother’s hospital room within the first few postnatal hours. The terminology used in reports around the world varies, with early SIDS, severe apparent life threatening event (ALTE), and sudden unexpected early neonatal death (SUEND) being common. But what doesn’t vary is that the outcome is frequently tragic. Roughly half of the children in these events die and many of the remaining newborns become disabled because of a period of low oxygen supply to the brain.

How common is SUPC? Thankfully, the overall incidence in low-risk (healthy term and near-term) babies is very low, but exact incidence figures are challenging because of different definitions and inclusion criteria used is the literature. This extensive 2013 review of the literature, which found highly variable rates ranging from 3/100,000 to more than 100/100,000, concluded that many studies have likely underestimated the true risk. To put this in perspective, the CDC and AAP have recommended the universal intramuscular injection of vitamin K into newborns within the first hour of life since the 1960s in order to prevent serious bleeding events that occur with a frequency of less than 10/100,000.

Although impossible to peg down exact numbers, the authors estimate that even with the lowest reported figures there could be 500 SUPC cases and around 150 newborn deaths out of 5 million births each year in the European Union alone. In reality, it is likely to be much worse than that. In comparison, there are roughly 4 million babies born in the United States annually which means that if investigated, SUPC would likely represent one of the most common causes of death in healthy term newborns.

Their literature review found 400 cases of SUPC documented within the first week of life. These were cases where they had enough information to rule out complications (premature birth, illness, injury, etc.) that increased the likelihood of collapse. They discuss 3 published cases that exemplify the range of SUPC presentations in detail, all of which occurred during SSC with a baby in the prone position (face down), something that pediatricians have universally recommended against since 1994.

During their review of the 400 well-documented SUPC cases, the authors found that three out of every four were associated with prone positioning of the infant, typically during SSC and initial attempts at breastfeeding. Their findings fall in line with other reports that have listed “prone positioning, first breastfeeding attempts, cobedding, mother in episiotomy position, a primiparous mother, and parents left alone with baby during first hours after birth” as risk factors. I hope this makes it clear how absurd and potentially dangerous the claim that SSC “has not shown evidence of harm” is.

SSC is a set up for the biggest risk factor for SUPC and potential death of an otherwise healthy newborn baby: prone positioning during sleep. And it isn’t just infant sleep I am worried about. Prolonged SSC in the early days of a baby’s life is very likely to result in infant prone positioning, often with their face pressed against the mother’s chest and breast, while the exhausted mother is also asleep. This is known as bed sharing, and it is a well-documented risk factor all on its own.

The scenario that increasingly is becoming the norm in many countries, and which is most likely to result in SUPC, not to mention an increased risk of a baby falling out of the bed and suffering a head injury, is a tired mom lying in bed in a quiet, dimly lit room that promotes “rest”, a lack of nursing presence in the room or monitoring of the baby for long stretches of time, and SSC. In many cases this scenario is encouraged without discussion of the potential risk. It should now be clear how CDC and WHO endorsed programs like “Baby-Friendly” might increase the likelihood of an overtired mother falling asleep during SSC.

What causes SUPC?

Why are newborn infants at increased risk of SUPC during SSC? If you think about it, it makes perfect sense. First and foremost, and especially during the first few hours of life when most of these incidences occur, this is a time of transitioning. The first 24 hours of life is typically a very sleepy period where newborns have diminished responsiveness to the outside world. They often barely arouse even with feeding attempts.

As in SIDS, there is likely some vulnerability in the brain during this pivotal period of development. When a baby is stressed by an environmental insult, such as being deeply asleep and lying prone against the body of an exhausted mother, this might result in failure to arouse, cessation of breathing, decreased oxygenation, and ultimately SUPC. And some babies are simply suffocated by their sleeping mother. Even more terrifying is the fact that this can occur while dad and other family members are admiring the beautiful, but dead, new arrival and the peacefully sleeping mother, the unfortunate outcome discovered only when a nurse comes by to grab a set of vitals.

Conclusion

Don’t get me wrong. I don’t mean to throw the baby out with the bathwater. Although perhaps exaggerated, there are some potential benefits to SSC. It isn’t anything earth shattering in healthy term infants of appropriate size, but I’m not going to tell a mother that her subjective experience while holding her newborn child against her bare skin is wrong or a waste of time. And even in appropriate weight term infants SSC may help establish breastfeeding or reduce the likelihood of sepsis. My desire is for hospitals and healthcare providers that take care of mothers and babies to be honest about the risks and provide a safe environment for the intervention, and I’m hardly alone in this observation.

In order to reduce the risk of SUPC during SSC, hospital staff and pediatricians must first recognize which newborns may be at particular risk and provide appropriate monitoring. A term and well-grown newborn whose mother was on a medication that may result in a sedated baby would be just one of many examples. If a nurse isn’t available to monitor the child continuously (family members don’t count), then perhaps unobtrusive monitoring of the child with continuous pulse oximetry, as is standard in Japan for SSC in all newborns, would be appropriate. In fact, I wouldn’t have a problem with following their lead on this.

Education for the family is just as important. They should be given appropriate information regarding SSC that includes the risk of SUPC in order to decrease the likelihood of a collapse taking place after leaving the hospital. Supine positioning and maintenance of an open airway should be encouraged, as should all SIDS risk reduction strategies for that matter, and the mother should be advised to place the baby in the bassinet or hand them off to another caregiver if she is feeling sleepy.
 
 

Categories: Medicine, Skepticism

Concern Trolls and Free Speech Nazis

Neurologica Blog - Fri, 02/12/2016 - 07:25

Note: This post was originally published on June 28, 2010 on SkepticBlog. Although it is not about the same issues as the current NECSS controversy, I found the underlying principles relevant, and I still stand by the position outlined here. 

One of the things that I love about the skeptical community is that it is a vibrant intellectual community that is not afraid to turn its critical eye inward. There is also sufficient diversity of background and perspective, superimposed upon a generally skeptical outlook, to provide some genuine conflict. While you won’t find many bigfoot believers in our ranks, we do run the spectrum from liberal to libertarian, militant atheist to Christian, scientist to artist, and politically correct to Penn Jillette.

The wringing of hands may at times seem tedious – but it’s all good. As long as we remember that at the end of the day we are all skeptics, a cultural minority looking to change the world.

Occasionally our diversity of approach does erupt into outright conflict, with the preferred medium usually being blogs. This happened recently in response to the appearance of Pamela Gay, an astronomer and co-host of the Astronomy Cast podcast with Fraser Cain, on my own podcast, the Skeptics’ Guide to the Universe. Pamela is a Christian, and on the SGU we have a tendency to be less than respectful of unscientific beliefs, including religious beliefs that wander into the arena of science.

This post is not going to be about the epistemological conflict over the limits of empiricism – whether or not science can address issue of pure faith, and how faith is distinct from “religion” – the latter being a cultural construct that involves many things, including using faith to invade science. If you are interested in that discussion, you can read here.

Rather, I am going to talk about the conflict between courtesy and free speech (which does often involve the religion issue as well). The start of this latest exchange was the blog response of Seth to an exchange we had on a recent episode of the SGU where Pamela was a guest. First, as an aside, Seth starts with the following premise:

This is an area of some controversy in the skeptical movement. Many skeptics believe that religion and personal belief are separate from skepticism, and that by conflating skepticism with atheism people with my viewpoint are hurting skepticism.

He then attributes this attitude to the SGU and many others. I would just say, this is not quite right, and you can read my earlier post for more detail. First, he conflates religion and faith (that is very problematic), and also he conflates science and skepticism – also a bit sloppy. I think that science and methodological naturalism are distinct and separate from faith. But skepticism includes not just empirical science, but also logic and philosophy, and you can take a philosophical approach to faith-based beliefs. You just cannot say that science proves faith is wrong.

Seth also makes another false assumption – that the distinction being made is largely tactical – it is about not “hurting skepticism.” While this is a legitimate concern, it is distinct from the epistemological issues.

But on to the meat of this post – Seth was concerned about the following exchange on the SGU, about which he writes:

So imagine my surprise when I was listening to The Skeptics Guide to the Universe episode 255 on my iPod today and heard the following exchange: (around 21:50)

Fraser Cain: That’s where the soul is. (General Laughter)
Steven Novella: Yeah, right!
Fraser Cain: So you remove all that, and the bacteria has no soul.
Steven Novella: A souless bacteria.

Bear in mind, Pamela Gay is on the phone at this moment. She is in the room. And her cohost from Astronomy Cast and the Host of the show she is a guest on are mocking the idea of the soul.

First, it must be noted that we and Pamela are friends. Pamela never voiced any concern over this exchange, and in a private e-mail to me following Seth’s post she expressed that while anti-religious talk may make her feel uncomfortable, we have never crossed the line with her and she likes coming on the SGU. Essentially – yeah, she is religious, but she is cool with it.

Seth’s post was followed by a thoughtful post from PZ Myers at Pharyngula. PZ makes some good points. I think he hits the nail most on the head with this statement:

The skeptic movement will be inclusive and allow anyone to participate, and participation means your ideas will be scrutinized and criticized and sometimes mocked and sometimes praised.

This is how I feel – our own beliefs are all fair game, whether religious, political, or social. We should not demand any litmus test for skeptical purity – that is not practical, reasonable, or healthy for any movement, let alone a minority movement like skepticism. Anyone who wants to participate should be welcome, in my opinion – even pseudoskeptics who don’t get it (but that doesn’t mean they get to speak at our meetings). However – everyone also has to recognize that your own beliefs are fair game for the criticism that is at the core of skeptical philosophy. That means that global warming dissidents, feminists, alternative medicine proponents, deists, free market zealots, anti-government conspiracy theorists, and communists all get to have their beliefs challenged, and have no reasonable expectations that their beliefs or their feelings will be spared.

Where I find the conflict within the skeptical movement to be most persistent and unresolvable is in the personal choices that people make with respect to balances between the dictates of free speech and intellectual integrity (a consistent application of skepticism with no sacred cows) and the desire for courtesy, creating a friendly and collegiate environment, and presenting skepticism in a positive light. Here we run the spectrum – at one end there are “concern trolls” who seem to advocate for an extreme of political correctness, and go out of their way to find offense. At the other end are “free speech nazis” (these are not my terms, BTW) who seem to go out of their way to be offensive, as if they are daring someone to ask for a modicum of courtesy so that they can cry “censorship” and get self-righteous about their freedom of speech.

While we have all likely encountered these extremes, most of us appear to be somewhere in the middle. It is also not easy to balance these concerns, as they are often at cross-purposes – so there is no perfect solution, you have to make a trade off and that will be driven for each individual by which concern resonates with them the most.

That is why I am not advocating for any particular balance. I don’t pretend to have the one true balance or compromise. I am advocating for tolerance and open discussion, and also just recognition that there are legitimate concerns on both sides and perhaps we can discuss it with each other without puffing our chests quite so much.

There are those, for example, who champion blasphemy as a form of social protest. PZ, Penn and Teller, Christopher Hitchens and others argue that nothing should be sacred. While individuals have the right to treat anything they want as sacred, they do not have the right to request that anyone else does so (a principle with which I agree). Some choose to make this point by going out of their way to blaspheme what others consider sacred – especially when they are being requested to respect the sacred. They have a right to this form of protest and free speech and I think it is important.

But also, not everyone should be expected to engage in this form of free speech. This has a lot to do with personality and style. It also has to do with (as PZ acknowledges) division of labor and specialization within the skeptical movement. I would add that context is also important – some venues and topics require more professionalism and courtesy than others. I would not go to a medical conference and decide that I needed to offend everyone’s religion just to make a point.

The SGU is one particular context. On our podcast we are open about our opinions. We champion the use of skepticism and reason in all areas. We feel free to use satire, sarcasm, and even occasional mockery to put absurd beliefs into perspective. But we also choose not to gratuitously attack individuals – we focus mainly on beliefs. We reserve our personal attacks not for the average believer, but for the promoters – those who are engaging in the public conversation and have made themselves fair game. They have no expectation of courtesy, and there the demands of public debate and exchange of ideas outweigh those of courtesy. With an individual “rank-and-file” believer, the balance is different.

Conclusion

I don’t expect this discussion to ever end – perhaps it shouldn’t. The complex balance of multiple social, ethical, and intellectual principles requires constant thought, discussion, and introspection. So let’s keep the conversation going. But I also advocate recognition that no one has the final “correct” answer – when value judgments and trade-offs are involved, there is no such thing.

Categories: Medicine

The Purpose of “Academic Freedom” Laws is to Promote Creationism

Neurologica Blog - Thu, 02/11/2016 - 07:49

Ever since the theory of evolution won over the scientific community and became the established consensus scientific opinion, creationists have fought a cultural and legal war against it. They failed to win the scientific war, and they continue to do so.

This is not an uncommon tactic – if you lose in the arena of science, evidence, or facts, then fight in the arena of public opinion or regulation. Pseudoscientists are unfortunately savvy to this tactic.

In the case of evolution, creationists tried banning it’s teaching outright, which was eventually struck down as unconstitutional. So they demanded equal time, which was eventually struck down as unconstitutional (teaching religion as science in public schools). So they tried to disguise creationism as intelligent design, which didn’t fool anyone.

Now, in an attempt to further secularise their position in order to get around the first Amendment, they argue that schools should “teach the controversy” and that teachers should have the “academic freedom” to introduces the “strengths and weaknesses” of a scientific theory.

Several states have successfully passed such laws, most notably Louisiana. These laws aren’t fooling anyone either – everyone knows their purpose is to open a back door to allow creationism to be taught as science in public schools. The real purpose of these laws is to create deniability in order to survive legal challenge.

Out of context, the notion that teachers should be allowed to teach controversies and weaknesses of scientific theories sounds reasonable. However, these laws often target evolution specifically, in addition to the Big Bang, and now even climate change. The problem is that there is no scientific controversy over the basic fact of evolution. The “controversies” and “weaknesses” of evolution they want to be introduced in the science classroom are just the same tired old creationist arguments they have been pushing into the classroom for decades.

It is also completely unnecessary to have a law that says that science teachers can teach about genuine scientific controversies or discuss genuine weakness of scientific theories. They already can. What they cannot do is introduce religiously motivated science denial and pretend it is legitimate science. These laws are meant, however, to shield teachers who do just that.

Lawmakers who introduce and support these latest crop of anti-evolution bills are often coy about their true motivation. Again – the whole point is deniability as a shield against legal challenge.

Apparently Mississippi Representative Mark Formby did not get the memo. Regarding an anti-evolution bill in Mississippi he introduced, he told a local paper:

“I just don’t want my teachers punished in any form or fashion for bringing creationism into the debate. Lots of us believe in creationism.”

Here is the most relevant section of the bill:

(d)  Neither the State Board of Education, nor any local school board, public school superintendent, public school administrator or principal shall prohibit any teacher of a public school system from helping students understand, analyze, critique and review in an objective manner the scientific strengths and scientific weaknesses of all existing scientific theories covered in the course being taught within the curriculum framework developed by the State Board of Education.

(e)  This section only protects the teaching of scientific information, and shall not be construed to promote any religious or nonreligious doctrine, promote discrimination for or against a particular set of religious beliefs or promote discrimination for or against religion.

It uses the “strength and weaknesses” format, and then further tries to shield itself by specifically stating this is not about any religious belief. It seems that Formby has now stated this section is a lie – a calculated deception as part of a deliberate legal strategy.

Earlier in the bill it states:

The teaching of some scientific subjects required to be taught under the curriculum framework developed by the State Board of Education may cause debate and disputation, including, but not limited to:

(i)  Biological evolution;

(ii)  The chemical origins of life;

(iii)  Global warming; and

(iv)  Human cloning.

So again, evolution is specifically mentioned, along with other topics of particular interest to creationists.

The notion that “strengths and weaknesses” laws are being crafted specifically to subvert the First Amendment and decisions made by the Supreme Court, and teach religion in public schools has never been in any serious doubt. It is interesting still to have such a brazen admission in the public record.

I honestly don’t know what it taking so long for legal challenges to these laws to emerge and filter up to the Supreme Court. They need to be struck down.

The predictable response to this position is that if you oppose such laws then you are treating evolution as a dogma that cannot be questioned. This is nonsense, however. That is just another rhetorical point that is one of the purposes of such laws.

Evolution has already been questioned in the scientific community. It is now overwhelmingly accepted as true (the basic fact that life on Earth is the result of organic evolution and demonstrates common descent) by the scientific community. It has already survived vigorous scientific challenge.

I also think it is perfectly acceptable to teach students how we know what we know – to teach them historical challenges to evolution and how they were resolved.

That is not what is happening in states with these anti-evolution laws, however. What is happening is that teachers are using creationist texts to teach creationist arguments that are simply wrong. They are teaching misinformation and science denial. They are teaching the fake controversy.

 

 

Categories: Medicine

Is it ethical to sell complementary and alternative medicine?

Science Based Medicine - Thu, 02/11/2016 - 07:00

Legal to sell, yes. But ethical to sell?

Complementary and alternative medicine (CAM) is no longer fringe, and anything but the mom-and-pop image manufacturers carefully craft. CAM is big business, and most Americans today take some sort of supplement. The impetus for my blogging (and tilting at CAM windmills) emerged from years spent working in a pharmacy with a heavy reliance on CAM sales. If it was unorthodox, this store probably sold it. Conventional drug products (the ones I was familiar with) were hidden off in a corner, and the store was otherwise crowded with herbal remedies, homeopathy, and different forms of detox kits and candida cleanses. All of this was unlike anything I’d ever seen or heard about in pharmacy school – so I started researching.

I looked at CAM from an scientific evidence perspective, the one I was taught in pharmacy school, using the same approach I’d take when assessing a new drug. Did the evidence support the claims made about these products, or not? The answers, as you might expect, were often the same. There was little or no credible evidence to demonstrate CAM had any meaningful benefits. I started blogging my own reviews – as a way of documenting my own research, while offering some information to anyone on the Interwebs who might be searching for evidence.

Over time, my blogging focus expanded, as I asked myself the inevitable questions: How could implausible products with no scientific backing even be approved for sale at all? I discovered the regulatory double-standard allowed for anything considered a dietary supplement (or in Canada, a “natural health product”) and the history and politics that have made CAM the “Wild West” of health care, with a marketplace that prioritizes a manufacturer’s right to sell over a consumer’s right to purchase a product that is safe and effective. Given the retail marketplace that’s been established by regulators like the FDA and Health Canada, I’ve turned my focus on health professionals, who have an ethical responsibility to put patient interests above that of commercial interests. From a professional practice and medical ethic perspective, I have argued that health professionals that sell or promote CAM are on ethically shaky ground, and compromise the credibility of the profession.

Despite the lack of evidence that CAM (in general) offers any health benefits at all, it’s been remarkable to watch its popularity grow, to the point where even large pharmacy chains now sell aisles of products that are implausible and often highly questionable. The pharmacy profession’s response, on balance, has been  a collective shrug, and it has even tried to lower its own ethical standards. While I do get the occasional encouragement from some of my peers, most just say “it’s business” or “the customer wants it, and these are legal products.” My argument today is CAM fails even this lower ethical bar.


Last fall I joined Professor Chris MacDonald of Ryerson University to give a talk as part of Ryerson’s business ethics speaker series. The topic was complementary and alternative medicine (CAM), and the ethics of selling these products. (You can watch that presentation here.) I’m pleased to announce that we have now published a paper on the same topic in the journal Bioethics, titled Alternative Medicine and the Ethics of Commerce. Here’s the abstract:

Is it ethical to market complementary and alternative medicines? Complementary and alternative medicines (CAM) are medical products and services outside the mainstream of medical practice. But they are not just medicines (or supposed medicines) offered and provided for the prevention and treatment of illness. They are also products and services – things offered for sale in the marketplace. Most discussion of the ethics of CAM has focused on bioethical issues – issues having to do with therapeutic value, and the relationship between patients and those purveyors of CAM. This article aims instead to consider CAM from the perspective of commercial ethics. That is, we consider the ethics not of prescribing or administering CAM (activities most closely associated with health professionals) but the ethics of selling CAM.

The paper is currently open access – so go grab a copy, read it, and come back to discuss.

An ethical framework for CAM

In our new paper, MacDonald and I pose (and answer) three primary questions:

  1. What is the case for selling CAM? We consider the value of a diversity of choice and the benefits of a free marketplace.
  2. What are the general ethics of commercial transactions? We outline an ethical framework that can guide an evaluation of CAM.
  3. What does this ethical framework say about the commercial sale of CAM?
    • Is CAM merchantable – does it fail to function?
    • Does the sale of CAM involve deception?
    • Does the sale of CAM harm third parties?
What exactly is CAM?

The question of what exactly is CAM is one that’s been discussed again and again at this blog.  This is a fair question and one which we considered carefully in drafting our paper. The boundaries of CAM are always in flux as science progresses. Rather than get bogged down with a specific definition, we used a general approach:

Further, it should be acknowledged that the borders of the entire category, CAM, are fuzzy. While it includes treatments that have not yet been tested, or lack sufficient evidence to be accepted as medicine, CAM also includes treatments that have been extensively tested, demonstrated to be ineffective from a scientific perspective, and consequently rejected from conventional medicine. Consequently what’s considered CAM may shift over time.

and

Our solution is to offer a broad framework that can be applied to any healthcare product or service – indeed, to any product or service at all. While our topic is CAM, when it comes to evaluating a particular product or service, very little hangs on whether that product or service is ‘really and truly’ an example of CAM, or on whether it is an example of complementary, as opposed to alternative, medicine. Second, the examples used below generally involve treatment modalities – such as homeopathy and acupuncture – that are typically and uncontroversially considered central examples of CAM.

The argument for CAM

The argument for CAM is one which I hear regularly from the pharmacy profession.  There are two important principles that provide legitimate support for the commercial sale of CAM:

Respect for individual (consumer) autonomy: It is morally good to respect the choices that people make in marketplaces, and it is generally better to avoid paternalism. More choices in the “marketplace” for health means more unique needs can be met. If consumers prefer CAM, then it is good that these products be available to purchase.

The respect for a competitive marketplace: Markets tend to work effectively when there are lots of choices from many vendors. Competition keeps prices low and keeps firms competitive. Restricting CAM restricts markets. By definition these products are alternatives to medicine and in particular, often considered to be legitimate substitutes for products and services considered “conventional” medicine.

An ethical framework for considering CAM

In developing an ethical framework, we strived to make the model as simple as possible. Our approach was to outline a small set of norms that we feel are assumed and effectively endorsed by those that participate in commercial transactions. We note the assumption that market transactions are assumed to be ethically legitimate. We agree with this presumption, but also highlight that their ethical legitimacy is conditional, as it’s based on assumptions that participants are well informed and that beneficial outcomes are expected by the participants. We propose the following:

Participants in commerce should endeavor to:

  1. Offer a product that works – a product that is, in the language of commercial law, ‘merchantable.’

  2. Only sell products to people who understand their fundamental characteristics, and who are reasonably capable of understanding (either on their own or with suitable professional help) whether that product will meet their needs. This implies a general demand for honesty on the part of sellers, and a refusal to profit from the ignorance of consumers.

  3. Take reasonable steps to ensure that third parties (those who do not consent to participate in a particular market exchange) are not harmed.

It should be fairly clear to anyone that looks at the actions of the FTC in the area of CAM that when this framework grossly violated, regulators can and will act, prosecuting CAM vendors when products do not work or when sellers are not honest about the characteristics of their product. Green coffee bean, which I’ve blogged about extensively, is an example of rank fraud in CAM sales and marketing.

Considering the ethics of selling CAM Does CAM work?

Any regular reader to this blog will know that there is little evidence to demonstrate that CAM offers any meaningful, beneficial medicinal effects. In fact, some CAM, such as homeopathy, is an elaborate placebo system, where most remedies contain no medicine at all – they are completely inert.

Some of the arguments for CAM efficacy are actually arguments against conventional medicine, such as the lack of efficacy for some products. However, while some “conventional” medicine products may lack robust evidence of efficacy, explanations for how they might work do not rely on magical (or wishful) thinking. And while conventional medicine is far from perfect, its scientific foundation means that products can be be testing for efficacy in ways that help us understand if effects are real, and if they cause harm. And we agree that this framework can also be applied to “conventional” medicinal products that may lack efficacy.

Another argument for CAM borders on post-modernism, where conventional medicine is felt to take a far too narrow view of what constitutes “evidence” of efficacy. We reject this argument:

We acknowledge that it is at least possible that some CAM modalities are not well suited to such study. However, we resist the implication that such difficulties do much to cast doubt upon the strong scientific consensus that says that most CAM treatments simply do not work. First, note that while treatment of particular patients may be highly individualized, this is true for patients of mainstream or conventional medicine too. And while treatment – whether alternative or conventional – may be highly individualized, it is inevitably based on broad clinical generalizations which ought to be susceptible to rigorous testing. Second, note that at least some clinicians who favour at least some forms of CAM believe that those forms are indeed capable of being fairly tested by means of randomized controlled trials. It should be noted noted that if CAM treatments are not rigorously tested, then ineffective CAM treatments will never be identified. But many such trials have been conducted, and on the whole the results have been dismal. Third, where there are legitimate reasons for thinking that the kind of rigour represented by the classical randomized controlled trial is out of place for testing a particular form of CAM, there remains a need for promoters of CAM to find some rigorous method – for example, something beyond intuition, tradition, and anecdote, something that goes some distance to overcoming the well-documented flaws to which personal observation is subject – for establishing efficacy. Where such non-RCT evidence is available, it is worthy of some measure of respect. But to the best of our knowledge, such credible, non-RCT evidence of effectiveness is not available for most forms of CAM.

Of course, some might object that we have too narrow a notion of what it means for a health product to ‘work.’ A particular treatment, even if it has no demonstrable physiological effect, may for example have religious, spiritual, or cultural significance. If a product satisfies the needs of some religious rite, for example, then it should count as a product that ‘works’ in the relevant sense. In some cases, such significance might constitute ethical justification for selling a product even in the absence of proof of biological efficacy. But there are strict limits to such justification. In particular, if that is the sense in which the product is expected to ‘work,’ then that must be an understanding that is shared between buyer and seller and acknowledged in communications between them. Note also that in some cases, people may perceive in CAM cultural (or other) values that simply are not there. As MacDonald, (2002) argues with regard to women’s health, for example, the popularity of CAM may be the result, in part, of a values-based rejection of modern society’s intense ‘medicalization’ of nearly everything related to women’s health. But as MacDonald argues, in some cases the use of CAM products may in fact constitute ‘the substitution of one commercialized expert understanding of women’s health and bodies for another.’12 A complex homeopathic regime offered by an ‘expert’ naturopath, perhaps at some considerable cost, may not in fact prove any less alienating than more mainstream options. Another example: homeopathy is often touted as an alternative to ‘Western’ medicine despite the fact it was invented in a western nation, namely Germany. Anyone who thinks of homeopathy as somehow part of an exotic Eastern tradition, and who values it for that reason, is not getting what they’re paying for.

But what about the vendor who truly does believe that their particular CAM does work?  We do not doubt the sincerity of many providers of CAM. However, we argue that this is not an acceptable excuse:

However, it is not plausible to excuse vendors for selling a product that does not work simply because they have either not taken the time and effort to investigate whether their product works, or turned a blind eye to the evidence that is available to them. There is, after all, such a thing as willful ignorance. While the credulous seller of (for example) homeopathy may not be guilty of knowingly selling something that does not work, he or she is guilty of having culpably low epistemic standards. Such a person does not sell knowingly, but he or she does arguably sell recklessly.

We argue that vendors should be taking reasonable steps to determine if their product “works” based on the claims the are making  about their product. Given the specific (and often measurable) claims made about CAM effectiveness for different conditions and circumstances, we believe it is the responsibility of the vendor to evaluate the best evidence available, taking care to ensure the statements that are making are backed by supporting evidence. If a product or service cannot be reasonably expected to deliver as promised, then ethically, a vendor should stop selling that product in the marketplace.

Does the sale of CAM involve deception, or does it profit based on the ignorance of consumers?

Many consumers lack access to good information on the effectiveness of CAM remedies. Look at the marketing of Airborne above. Airborne has no demonstrable efficacy, and even after the manufacturer settled false advertising charges, it is still sold openly (albeit without explicit claims of efficacy).  Homeopathy is another excellent example. Homeopathic “remedies” are so dilute that most products don’t contain a single molecule of any medicinal ingredient – or even the ingredient that is listed on the label. Moreover, if homeopathy was to actually work, it would overturn much of what we know about biology, chemistry and physics. A similar argument can be made for acupuncture. Meridians and acupuncture points have never been shown to actually exist. There is no chi, and acupuncture is a theatrical placebo. Yest few consumers know these facts, and regulators do not require manufacturers to provide them.

Does CAM harm third parties?

One need only look to the use of endangered species in CAM remedies to illustrate the point that CAM can definitely harm those outside commercial transactions – it is driving some species extinct. Homeopathy provides another illustrative example. Homeopaths and naturopaths sell “nosodes” which are marketed as alternative to real vaccines. These “nosodes” are inert sugar pills. Those that use “nosodes” in place of vaccines compromise public health by reducing population vaccination levels, putting some members of the population (e.g., the immunocompromised) at risk of infection.  Finally there are multiple examples of children harmed by parental use of CAM in place of actual medicine.

Is selling CAM ethical?

Even setting aside medical ethics, we argue that the sale of CAM is unethical. CAM can violate all three ethical principles of commercial transactions. In order for commercial transactions to be ethical, must involve products that work. They must be advertised and promoted fairly and honestly. Finally, these transactions must not harm innocent third parties. Much of CAM fails on one or more of these measures.

 

Photo via flickr user Mike Mozart under a CC licence.

 

 

Categories: Medicine, Skepticism

Update on the Zika Virus

Science Based Medicine - Wed, 02/10/2016 - 07:56

A new word has been added to the public’s vocabulary – the Zika virus. It seems we have one more infectious agent to worry about. Here are the facts as we currently understand them regarding the recent Zika epidemic, and also some rumors and conspiracy theories that need debunking.

Zika Virus

The Zika virus (Flaviviridae, an arbovirus) is spread through Aedes mosquito bites, the same mosquitoes that also spread dengue fever, West Nile, and yellow fever. The infections themselves are usually mild, causing fever, rash, joint pain, and conjunctivitis. Many of those infected (about 80%) may even have a subclinical infection, meaning they do not notice any symptoms.

According to the World Health Organization:

Zika virus is diagnosed through PCR (polymerase chain reaction) and virus isolation from blood samples. Diagnosis by serology can be difficult as the virus can cross-react with other flaviviruses such as dengue, West Nile and yellow fever.

Although the primary infection is mild, the infection can have complications. There is one case report of Guillain-Barre Syndrome (GBS) following a Zika infection. GBS causes inflammation of the lining of nerves resulting primarily in weakness with variable recovery. This does not appear to be a huge risk, but something to monitor.

The bigger concern is about pregnant women being infected. There are numerous reports of poor pregnancy outcomes, mostly microcephaly, in women who have been infected with Zika while pregnant. Microcephaly means small head, and results from poor brain development. (More on this below.)

There is currently no treatment for a Zika infection (other than usual supportive care if necessary). There is also no vaccine, although efforts are already underway to develop one.

Zika was first identified in Uganda in 1947. It spread throughout Africa, and then spread to Southeast Asia in the late 20th century. Recently it has also spread to South America and Mexico, with Brazil being a particular hot spot.

There are as yet no cases of locally acquired Zika in the US. There have been a few cases of people returning from travel to South America with a Zika infection. It is possible for Zika to become endemic in the US.

The virus can spread wherever there are Aedes mosquitoes, which exist throughout the Americas except for Peru and Canada. Interestingly, these mosquitoes were previously localized to the tropics and subtropics, but have been spread as invasive species by human activity – paving the way for later viral infections.

Zika is in the news now because the pace of spread has dramatically increased. It is no longer a “slow” pandemic, but rather is spreading rapidly.

Microcephaly

The Zika infection itself is mild, in fact it is less of a problem than the flu. However, what has caused such great concern is the apparent association between Zika outbreaks and a condition known as microcephaly.

At this point the connection is still a correlation without proven causation, but the Zika virus being the cause is likely and it is reasonable to assume this is the case unless evidence proves otherwise.

Brazil is the center of the microcephaly concerns. According to reports: (source published study)

Public health officials in Brazil are investigating more than 4,000 cases of suspected microcephaly, and have confirmed more than 400. Prior to the Zika outbreak, Brazil saw on average 163 cases annually of microcephaly over the past five years, according to WHO. In 17 of the new cases, the presence of Zika was identified in the mother or the baby.

A study of 35 Brazilian babies born with microcephaly during the Zika outbreak reported by the CDC Jan. 29 added strength to the suspected connection.

The mothers of all 35 infants had lived in or visited Zika virus-affected areas during pregnancy, the report said. Twenty-five infants had severe microcephaly, and 17 had at least one neurologic abnormality.

In addition to the spike in cases of microcephaly in areas of Zika infection, the cases themselves are unusually severe. Microcephaly experts have examined the brain scans of some of the cases, and found:

    “These children have a very severe form of microcephaly,” Dobyns said. “The brain is not just small, it’s small with malformations of the cerebral cortex and calcifications. It has the appearance of a very severe, destructive injury to the brain.”

There is also evidence that the brains in severe cases have actually shrunk. These findings all point to severe brain injury as a result of the infection. These children are going to have severe lifelong neurological impairment.

While the connection between Zika and the spike in microcephaly needs to be absolutely confirmed, the evidence so far is very compelling, and other likely causes so far have been ruled out.

What to Do?

As there is no treatment or vaccine for Zika, basic precautions are necessary. This mostly involves limiting mosquito populations and avoiding exposure. Mosquitoes breed in standing water, even small puddles or containers with water. Eliminating any standing water is therefore an important measure.

Ponds and lakes can also be sprayed. In the US, the CDC embarked on a campaign to eliminate malaria in the South through control of mosquito populations, and they were successful. So it is possible to reduce mosquito populations to such a degree that infections cannot spread – although malaria is not a virus, which may be more difficult to control.

Meanwhile, those living in areas with the mosquitoes can use repellent, keep their windows closed, use mosquito nets and take other measures to avoid being bitten.

The WHO and CDC are advising pregnant women not to travel to areas where there is currently an outbreak of the Zika virus. They are also suggesting that women who live in an area of an active outbreak might want to delay pregnancy, although they acknowledge this is a very personal decision.

Conspiracies

Of course, no news story is wasted by the conspiracy theorists. There are already a number of rumors and conspiracies about the Zika virus, all apparently made up out of whole cloth.

Some anti-vaccine and medical conspiracy sites are blaming vaccines for the cases of microcephaly, specifically the Tdap vaccine given to pregnant women. There is no evidence for these claims.

In fact, there have been a number of safety studies showing no increased risk of adverse events in children of women receiving the Tdap vaccine during pregnancy.

Another popular conspiracy theory is that the virus is being spread by genetically modified mosquitoes. This theory fails on multiple levels, but perhaps the single biggest failure is that the genetically modified mosquitoes are all male, and male mosquitoes do not bite. The males are nectar feeders, and only the females feed on blood.

There are also a number of conspiracy theories that the outbreak of Zika is a hoax, or was created on purpose for some nefarious reason. These are Illuminati-level grand conspiracies and are not even coherent enough to directly address.

The Big Picture

The public has had to deal with a series of new serious infections emerging in the world. Prior to 1980 no one ever heard of HIV. This infection emerged as a world-wide pandemic fairly quickly, and literally changed the practice of medicine. Now we take for granted that we live in a world with HIV.

More recently the H1N1 flu emerged as a new strain, although fortunately did not turn out to be as virulent as feared. Still, we had to adapt, and now the annual flu vaccine targets the H1N1 strain routinely, in addition to the predicted circulating strains.

We have been hearing about the avian influenza (bird flu) for a number of years. This is an extremely virulent form of the flu that primarily affects birds and is a threat to the poultry industry. There are individual cases of humans being infected, but currently this virus is not spread from person to person. The fear is, however, that one or more strains will make the full transition to the human population and we could see a serious pandemic.

There have been serious pandemics in the past. Perhaps the most famous was the flu pandemic of 1918, which killed between 20-40 million people (more than World War I).

Fortunately the WHO and CDC are doing their job. They are on top of such outbreaks – that’s why we hear about them. The CDC is confident that if Zika reaches the US directly (so far it is just isolated cases of people coming from Zika areas), that they can contain the spread.

Outbreaks, epidemics, and pandemics are just part of the reality of having a large world-wide population. The Zika virus is just the latest example, and there are certain to be others. It is not fearmongering (as some conspiracy theorists suggest) to warn about emerging infections and to encourage people to take basic precautions.

Because the Zika virus is spread by mosquito, we can significantly reduce its spread by reducing mosquito populations and protecting against being bitten by mosquitoes. Meanwhile scientists are working on a vaccine.

Our greatest defense against the persistent reality of infectious diseases is science and information. Our greatest threat, more than the virus itself, is ignorance and misinformation.

Categories: Medicine, Skepticism

The Journal of Failure to Replicate

Neurologica Blog - Tue, 02/09/2016 - 13:05

(Note: We have been having some website issues over the weekend, which is why there has not been a post in a couple of days. All seems to be working now, but we are monitoring closely.)

Science may have a replication problem.

One of the goals of scientific skepticism is to examine the process of science itself, often through the lens of pseudoscience. I find this remarkably helpful, and something that many mainstream scientists often do not understand.

By closely examining pseudoscience as a phenomenon, we can see clear examples of how science goes wrong, how the process of science is subverted, and all the different ways scientists can make mistakes or bias their results. We can then apply this knowledge to legitimate science, flushing out more subtle manifestations of the same problems.

Said another way – if we explore all the reasons that a scientist can come to the conclusion that homeopathy works (when it clearly doesn’t) we will learn much about all the possible ways to fail when people do science (or think they are doing science).

For example, examining pseudoscience has really brought home for me the critical importance of independent replication. We often hear impressive-sounding results from single studies that appear to support one pseudoscience or another. It may not be possible from the published report where the researchers went wrong. The only way to really know is to independently replicate the results. If the researchers were genuine visionaries ready to change science, their results should replicate reliably.

Perhaps the best example of this is the psi research of Daryl Bem. He published a series of studies which he claims provide evidence for precognition, or future events affecting current cognitive processes. This is one of those claims in which it is fair to say, if we know anything in science, we know that this is impossible. This is reversing the arrow of causation. To say that such results are a paradox is an understatement.

Of course, I would be willing to accept such results if they were iron-clad. The results would have to be so robust as to make their falsity more of a paradox than their accuracy. What we got, however, were razor-thin effect sizes with a terrible signal-to-noise ratio, from a researcher who has endorsed questionable research practices. Just a tiny bit of “researcher degrees of freedom” is all that is necessary to explain the results.

The real test of these results, however, came in the replication. Several researchers tried to replicate one or more of Bem’s protocols, with mostly negative results. Not surprising. Far more important than Bem’s unlikely claims and unimpressive research was the reaction of journal editors to these replications.

Richard Wiseman and his colleagues submitting one such replication to the psychology journal that published Bem’s original studies, the Journal of Personality and Social Psychology. Their response was that they do not publish exact replications.

Richard’s response was to create a website where researchers can publish their replications of Bem’s studies.

The response by the journal is the real story here. Journal editors put a low priority on publishing replications of previous studies. They are not exciting. They don’t grab headlines or improve impact factor. That, in turn, decreases the incentive for researchers to carry out replications.

This is a systemic problem. Doing good replications is the only real way to know if a finding is reliable. In addition, with online publishing, journals no longer have the excuse of limited space in a print journal.

To me this is a problem of stoichiometry in science, to use a nerdy metaphor. In order for scientific progress to be optimal we need to have the perfect mix of researchers doing new and speculative research vs doing confirmatory research or applied research. This is like having the right mix of gas and oxygen to produce the hottest flame.

Right now I think the incentives are biased toward new and speculative research and away from confirmatory research. This may mean that we are wasting our time on lots of new ideas that will ultimately lead nowhere, and those ideas hang around longer than they should because we are not confirming them with replications.

This is not just my opinion but an increasingly recognized problem within science. One solution is to dedicate space in existing journals, or even make entirely new journals, for publishing replications. This critical component of science needs to be given a higher priority.

One journal editor is doing just that.

The contradictory results—along with successful confirmations—will be published by F1000Research, an open-access, online-only publisher. Its new“Preclinical Reproducibility and Robustness channel,” launched today, will allow both companies and academic scientists to share their replications so that others will be less likely to waste time following up on flawed findings, says Sasha Kamb, senior vice president for research at Amgen in Thousand Oaks, California.

The journal is the project of biotech company Amgen Inc. and biochemist Bruce Alberts. The journal is a response to evidence that many scientific findings that are still relied upon cannot be replicated.

One recent commentary published in Nature noted that of preclinical cancer research studies they attempted to replicate, only 11% replicated the results.

Another study of psychology studies found that only 39 out of 100 studies were successfully replicated.

Conclusion

I don’t want to overstate the problem. There is a lot of replication going on in science, this is still standard procedure. Typically when I research any medical issue there are multiple studies and we can look to see what the consensus of results show. Eventually replications are done.

But I don’t think are are at an optimal mix, because of perverse publishing incentives. Doing exact replications of studies should be looked upon not as boring but the gold standard of science. I hope we need more journals dedicated to publishing these studies, and a higher priority placed on exact replications by all the major science journals.

Categories: Medicine

Puritan’s Pride Vitamin Advisor Gives Questionable Advice

Science Based Medicine - Tue, 02/09/2016 - 03:00

 

The Puritan’s Pride website has a Vitamin Advisor that claims to provide a personalized supplement plan, with expert recommendations chosen just for you. In my opinion it is deceptive, designed not to provide evidence-based personalized health advice, but to sell their products; and one can only wonder what kind of “experts” would support such ill-advised recommendations. Stephen Barrett and I have just co-authored an article on the Quackwatch site analyzing the Vitamin Advisor advice. I wanted to share what we found with our SBM readers, with some further comments.

Their recommendations are based on a series of questions like age, sex, health concerns, whether you are exposed to cigarette smoke, etc. The full list can be found in our Quackwatch article. The one-size-fits-all questions are useless because “eye concerns” might mean anything from needing glasses to glaucoma.

$100 worth of stuff I don’t need

I filled out the questionnaire honestly, and it advised I take these 6 products:

  1. UltraWoman 50 Plus Multivitamins
  2. CoQ10 100 mg
  3. Omega Fish Oil 1000 mg
  4. Absorb Calcium 1200 mg with Vitamin D 1000 IU
  5. Triple strength Glucosamine, Chondroitin, MSM Joint Soother
  6. Vitamin D 2000 IU

The total price of these six products is $99.90. In my informed opinion, this advice is wrong. There is no credible scientific evidence that I would benefit from any of these. Dr. Barrett was also advised to take six products, none of which he needed. I stopped taking multivitamins many years ago; I explained my reasoning here.

My Puritan’s Pride Vitamin Advisor recommendations add up to a total of 8000 IU vitamin D and 2044 mg of calcium. The tolerable upper intake level of vitamin D is 4000 IU; of calcium, 2000 mg. For women my age, the recommended amount (from all sources) is 800 IU of vitamin D and 1200 mg of calcium. The benefits of calcium and vitamin D supplementation remain uncertain, and calcium supplementation has been associated with increased cardiovascular risks.

Deciphering the algorithm

Dr. Barrett and I were curious, so we had fun doing a little detective work. We tried putting different answers into the questionnaire, posing as a man or woman of various ages. The algorithm it uses was easy to figure out:

  • If you are a teenager, it asks no further questions and recommends Mega Vita Min Multivitamins for Teenagers.
  • EVERYONE gets a multivitamin: If you are a woman under 50, you get UltraWoman; if you are over 50 you get Ultrawoman 50 Plus; if you are trying to get pregnant, you get Pre-Natal Complex.
  • If a woman checks poor emotional wellbeing, she gets UltraWoman, B-50, Omega, vitamin D.
  • If you are tired, you get Vitamin B12 1000 mg
  • If you are a woman with PMS: B-50 complex, magnesium, calcium/D
  • If you are a woman with menopausal symptoms: B-50 vitamin complex, Estrobalance, and magnesium   (Estrobalance contains phytonutrients found in soy and black cohosh, vitamins and minerals including E, folic acid and calcium)
  • Eye concerns: lutein/zeaxanthin
  • Joint concerns: Glucosamine/Chondroitin/MSM
  • Air pollution: Vitamin C, Selenium 200 mcg, Vitamin E 400 IU
  • Cigarette smoke exposure: Vitamin C with bioflavonoids and rose hips
  • Urinary tract concerns: cranberry fruit concentrate with C and E
  • Cigarette exposure: Vitamin C with bioflavonoids and rose hips
  • Stress, tired, poor emotional well-being: vitamin B complex, vitamin C/bioflavonoids/rose hips, vitamin B12 1000 mcg, omega, vitamin D
  • Digestive concerns: Probiotic 10
  • Blood sugar concerns: cinnamon/chromium, magnesium
  • No sun exposure: vitamin D 2000 IU
  • If you’re a vegetarian: B12, fish oil, calcium/D
  • If you’re concerned about heart health and BP: CoQ10, Omega fish oil 1000 mg, Magnesium 250 mg.
  • If you have concerns about bone density: Calcium/D, magnesium 250 mg, and an additional vitamin D pill with 2000 IU.
  • If you are a man who wakes up to urinate during the night, you get a saw palmetto product.

In our judgment, none of these recommendations is based on good scientific evidence. You can read our critique of each recommendation, explaining why we thought it was wrong.

Who needs supplements?

Obviously, customers would not consult a Vitamin Advisor unless they were already convinced they needed supplements. But most people don’t need supplements; their nutritional needs are met by their diet. If it can be determined that their diet is inadequate, the obvious remedy is to improve the diet. Taking pills is a poor second best, and money spent on supplements could be better spent on healthy foods. Many people take a multivitamin out of insecurity, as “insurance” to allay their fears that they may not be eating right. Others take them in the false belief that they will improve their energy or for other reasons that are not supported by evidence.

In most cases a multivitamin is harmless, even though it may accomplish nothing more than creating expensive urine. But every vitamin and mineral can be harmful in high doses. There is growing concern that taking high doses of antioxidant supplements such as beta-carotene might do more harm than good.  You may remember how Gary Null almost killed himself with his own brand of supplement that happened to be inadvertently overloaded with vitamin D.  And there is even some evidence that a daily multivitamin is associated with an increased rate of death in older people.  (Admittedly, this is correlation, not causation; a causal link has not been established.)

 According to The Medical Letter, Vol 47 No 1213:

Supplements are necessary to assure adequate intake of folic acid in young women and possibly of vitamins D and B12 in the elderly. There is no convincing evidence that taking supplements of vitamin C prevents any disease except scurvy. Women should not take vitamin A supplements during pregnancy or after menopause. No one should take high dose beta carotene supplements. A balanced diet rich in fruits and vegetables may be safer than taking vitamin supplements. No biologically active substance taken for a long term can be assumed to be free of risk.

According to the American Academy of Family Physicians at the time I wrote my SBM article about multivitamins:

 The decision to provide special dietary intervention or nutrient supplementation must be on an individual basis using the family physician’s best judgment based on evidence of benefit as well as lack of harmful effects. Megadoses of certain vitamins and minerals have been proven to be harmful.

Their current advice about vitamin and mineral supplementation for various specific indications either recommends against supplementation or states there is insufficient evidence to assess the balance of benefits and harms.

The disclaimers

And while poor diet might be a rationale for vitamin and mineral supplements, most of the diet supplements on the market are not intended to supply dietary deficiencies but to provide some kind of alleged preventive or therapeutic effects. Under the DSHEA,  sellers are not allowed to make claims about such effects. Puritan’s Pride includes the usual disclaimer, and they comply with FDA regulations by only mentioning vague function/support claims. For example, for the lutein/zexanthin supplement that they recommend for everyone with “eye concerns,” they say:

 Lutein helps to improve vision in low contrast situations, which is essential for night driving. Lutein Lutigold™ plays a role in the maintenance of eye health and is the principal Carotenoid found in the central area of the retina called the macula. Carotenoids are fat-soluble antioxidants found in fruits, vegetables, marigolds and other plants.…Nutrients such as lutein, zeaxanthan, and EPA may support eye health.

For eye health, in addition to the Lutein/Zeaxanthin supplement recommended by the Vitamin Advisor, the company sells 35 other products to support healthy eyes, including various combinations of antioxidants, some of which contain up to 25,000 IU of beta carotene. The Medical Letter has said no one should take high doses of beta carotene.

The only evidence-based use of supplements for eye health is that a specific mixture (different from any of the ones sold by Puritan’s Pride) has been shown to slow the progression of moderate-to-advanced macular degeneration. I reviewed that evidence here. There is no evidence that supplements offer any benefit for prevention of macular degeneration or for treatment of early disease, and there is no evidence that they benefit any other eye conditions.

Stephen Barrett “translated” Puritan’s Pride’s disclaimer thusly:

We’d like to sell you products, so here is a questionnaire that will recommend something no matter how you answer it. Our information is not necessarily derived from sources that are trustworthy or even relevant to humans. When ingredients are included in more than one product, the combined amounts can exceed safe levels, but our recommendations won’t take this into account. We would like you to believe that our products are useful. However, our words are not intended to suggest that they can help treat, cure, or prevent any disease. They are merely “informational.” We say that you should not consume any product we recommend without discussing it with your doctor. However, we really don’t mean this, because most doctors will advise you not to take the products. We just say it as part of our effort to avoid legal responsibility for any harm caused by our advice or products.

Conclusion

 Most people don’t need vitamin supplements. There are specific indications for supplementation in specific circumstances. All women who might become pregnant should take a folic acid supplement. Otherwise, it is best to consult a doctor who can provide truly individualized advice based on detailed knowledge about the patient. Relying on an online questionnaire for medical advice is foolhardy. Your physician wants to do what’s best for your health; the Puritan’s Pride company wants to sell you stuff. Buyer beware!

Categories: Medicine, Skepticism

Did chiropractic neck manipulation kill Katie May?

Science Based Medicine - Mon, 02/08/2016 - 19:30

Well, we’re back.

Yes, after having our WordPress database somehow borked to the point where no new posts could be added and no existing posts could be edited since Friday, Science-Based Medicine is back in business—finally! As a result, some of you might have seen this post elsewhere, as it was considered to be somewhat time-sensitive, and I didn’t want to delay, particularly given that I didn’t know how long SBM would be down. Fortunately, we’re back a bit sooner than I thought; so let’s look at something that was in the news over the weekend.

Katie May was a model, and by all accounts a very successful one, having appeared in Playboy, Sports Illustrated, and other magazines and websites. Self-proclaimed the “Queen of Snapchat,” she also had nearly two million Instagram followers and was a major social media force, having recently parlayed her modeling and social media career into becoming an entrepreneur. She also died unexpectedly on Thursday night at the too-young age of 34, leaving behind a seven-year-old daughter. What makes May’s tragic death an appropriate topic for SBM is not so much her young age but rather the circumstances surrounding her death, particularly the cause. Basically, May died of complications of a stroke, as her family confirmed in a statement issued on Friday:

“It is with heavy hearts that we confirm the passing today of Katie May – mother, daughter, sister, friend, businesswoman, model and social media star – after suffering a catastrophic stroke caused by a blocked carotid artery on Monday,” the statement reads.

“Known as MsKatieMay on the Internet and the “Queen of Snapchat,” she leaves behind millions of fans and followers, and a heartbroken family. We respectfully ask for privacy in this this difficult time. Those wishing to contribute to the living trust being set up for the care of her young daughter may do so at her GoFundMe page.”


Given her young age, that alone makes her death curious, but what makes it discussion-worthy to me is that, having injured her neck in a fall at a photo shoot, she apparently had had two chiropractic neck adjustments before her collapse one week ago that lead to her hospitalization, deterioration, and, ultimately, the decision to take her off of life support. Indeed, starting early Friday morning, people were e-mailing me and Tweeting at me, some already having concluded that chiropractic killed Katie May. But did it?

Maybe. Or: It’s complicated. At least, answering that question is more complicated than just concluding that May’s adjustment caused the stroke.

Because I had decided to do something highly unusual for me and take the day off Friday in order to recover from my grant writing frenzy over the two weeks prior that had sapped my energy, I was hanging out at home when the e-mails and news reports started appearing. I almost whipped out a quick, ranty post for my not-so-secret other blog right then and there, but decided to wait for more news over the weekend and do a post, if appropriate. Doing that allowed me to construct a timeline, which leaves open the biggest question: Was it May’s neck injury or the chiropractic adjustments that caused the stroke that killed her?

Let’s dig in.

A timeline, or: Just the facts, Ma’am

In late January, Katie May was doing a photo shoot. Although the details are not clear, we do know from various sources that during that shoot she fell—hard—and apparently hit her neck on something. After the fall she complained of severe neck pain, severe enough to go to the hospital to be checked out:

Sources with direct knowledge of Katie’s situation tell us the accident happened late last week when she was shooting in Los Angeles. We’re told Katie’s neck pain after the fall was so bad, she went to a hospital to get checked out, and was released later that day.

But on Friday the pain remained — she tweeted, “Pinched a nerve in my neck on a photoshoot and got adjusted this morning. It really hurts!”

So apparently she did go back to her chiropractor on Monday, the same day she suffered her fatal stroke.

One notes that this report, as well as this report and others, conflict with what the family said about May’s death, as reported in People:

“To the best of my family’s knowledge, and we are fairly but not totally certain of this, Katie did not seek medical care prior to Monday evening; if she had, it seems reasonable to conclude, the subsequent days would have unfolded very differently,” her brother, Stephen May, says.

It is, of course, possible that Stephen May didn’t know that his sister was checked out in the emergency room, or it is possible that she never was, although, given multiple news reports indicating that she did seek medical attention, I suspect that she probably did. I haven’t been able to find out for sure. Whatever the case with respect to seeking out standard science-based medical care, we do know that May sought out a chiropractor for neck adjustment First, here’s her Tweet from January 29:

Pinched a nerve in my neck on a Photoshoot and got adjusted this morning. It really hurts! Any home remedy suggestions loves? XOXO

— Katie May (@Ms_katiemay) January 29, 2016

Then, on January 31 in response to a Tweet by one of her fans asking how her neck was:

Thanks love! It still hurts, going back to chiropractor tomorrow xoxoxo https://t.co/xTw080sjrK

— Katie May (@Ms_katiemay) February 1, 2016

Other than these Tweets, between the time of May’s initial injury on (probably) January 28 and the evening of her stroke (February 1), there was nothing on May’s Twitter or Instagram feeds to indicate that anything was wrong. Her last Instagram post was dated February 1 and included a photo of her in a swimsuit with a message, “️Hope everyone is having a great Monday! It’s very windy here today in LA ☀️.” Her Twitter feed abruptly went silent after 5:19 PM PT on February 1, her last Tweet being a photo with her asking her fans to help her “win most Arsenic Girl.” Remember, it was that Monday night when she apparently collapsed and was rushed to the hospital, where she was in critical condition until she was removed from life support on Thursday and died a few hours later that evening.

Given that timeline, which is as accurate as I can currently deduce based on the news reports, the next question is: What killed Katie May? Obviously, it was a stroke. But what caused the stroke that killed her? Was it chiropractic? Was it her original trauma to the neck suffered when she fell? Was it a combination? Contrary to a lot of the speculation out there, this is not nearly as straightforward a question as it sounds at first. Let’s take a look at the two main possibilities.

Chiropractic neck adjustments and stroke

Regular readers of this blog know that chiropractic is a pseudoscientific system of “healing” founded in 1895 by Daniel David Palmer, who claimed to have restored the hearing to a deaf janitor by “adjusting” a bump on his spine. It’s based on the vitalistic concept of “innate intelligence,” whose proper flow through the nervous system is interfered with by “subluxations” in the spine. To chiropractors, the way to remove this interference is to “adjust” the spine. To Palmer, the “innate” intelligence was very much similar to the vitalistic concept of the “spark of life,” the “life force,” or, as it is frequently called in Asian cultures, qi. Of course, there are some spinal conditions for which manipulation is an effective treatment, but many chiropractors go beyond that to claim that chiropractic adjustments can treat allergies, asthma, and a wide variety of other illnesses that have nothing to do with the spine. Many chiropractors are antivaccine, as well. It’s not for nothing that I have frequently referred to chiropractors as inferior physical therapists with delusions of grandeur. If you don’t believe me, consider that there is a movement among chiropractors to win the status of primary care provider, a role they are completely unqualified for.

The issue of whether chiropractic neck adjustments can cause strokes is a question I haven’t really discussed on this blog, mainly because others here at SBM have examined several times in the past, so many times that I never really felt the need to address the question myself. This case, however, is different because it poses the question of whether what killed Katie May was a stroke due to her original trauma or a complication of chiropractic adjustments. Also, it must be pointed out that her stroke would be considered atypical for a chiropractic-induced stroke, for reasons that I will discuss shortly.

What is the relationship between chiropractic neck adjustments and stroke? Given how extensively the issue has been discussed elsewhere, I don’t feel the need to go into my usual level of extreme detail, but a brief (for me) recap is certainly appropriate. First, check out this video of a chiropractor doing neck adjustments:

If you cringe when you hear the pop during the violent twist given to the neck, you’re not alone. So do I. So how could such a motion cause a stroke? To understand that, you need to know a bit more about the anatomy of the neck. I thus refer you to this figure that I stole from one of Mark Crislip’s posts on chiropractic and stroke:

Extreme rotation of the atlas on the axis (at the atlantoaxial joint) stretches the vertebral artery. In layman’s terms, 40% of a hanging.

Basically, two very important arteries that supply blood to the brain pass through the two highest vertebrae, the atlas (C1, so named because it was thought to support the head the way the mythical Atlas held up the earth) and the axis (C2). Another illustration shows how the vertebral arteries are tethered to the spine and make a big loop around the atlas before entering the skull and joining together to form the basilar artery (click to embiggen):

Vertebral artery anatomy. The arrows point to the vertebral artery. Note how it bends around bony protrusions.

It’s thus not difficult to see how a rapid rotation of the head could potentially stretch the basilar arteries. Generally, chiropractors describe this as “high velocity, low amplitude” (HVLA), which it is, but, given the constraints of vertebral artery anatomy, high amplitude is not required to cause injury. With HVLA, it is quite possible to tear the intima (the lining of the artery consisting of vascular endothelial cells). Intimal tears become “sticky” for platelets, leading them to lodge there and start to form a clot. This is the same reason atherosclerotic plaques can lead to strokes; the “rough” area of the plaque is thrombogenic; i.e., has a tendency to attract platelets and cause clots. When a clot forms in such an injured area of intima, regardless of where the artery is, one of three things can happen. It can resolve completely; it can leave a narrowed segment of the artery as it resolves; or it can break off and flow further downstream, there to lodge where the artery narrows and block blood flow. When that happens in the brain, it’s called a stroke.

As much as chiropractors try (unsuccessfully) to deny it, there is a convincing correlation between chiropractic neck manipulation and vertebral artery stroke in multiple studies. The evidence has been summarized in Quackwatch. It’s been summarized by others here, such as Mark Crislip, Harriet Hall, Steve Novella, and Sam Homola. Clay Jones even described a case of a six year old child who suffered a stroke after chiropractic manipulation, while Harriet Hall described the case of a 40 year old woman named Sandra Nette, who suffered a stroke after a neck adjustment, leaving her in a state very closed to locked in syndrome, leading to a landmark lawsuit.

How strong is the correlation, though? Harriet points out that estimates of neck manipulation-induced strokes range from one in ten million manipulations to one in 40,000. Not surprisingly, it’s chiropractic literature that tends to downplay the risk and come up with the lower estimates of post-manipulation strokes. It’s a difficult question to study, because the incidence of vertebral artery strokes is very low to begin with; so detecting increased risk is difficult. For instance, one study of patients under 45 found that those who had this kind of stroke were more than five times more likely to have visited a chiropractor during the preceding week than control patients. Meanwhile, studies that purport to show that neck manipulation is not associated with stroke tend to have serious flaws, as Mark Crislip likes to point out.

The link between neck manipulation and basilar artery stroke is definitely plausible on anatomic considerations. There is enough evidence that it is real as to be concerned. However, it must be conceded that such chiropractic-induced strokes are admittedly very uncommon. As has been pointed out, given how rare basilar artery strokes are in young people, even a high relative risk of such a stroke after a chiropractic intervention would still be a low risk. The problem, of course, is that the consequences of such strokes, even if they are rare, are catastrophic. Balancing the lack of evidence that chiropractic neck manipulation is more effective for neck pain than, for example, mobilization with its small risk of a catastrophic complication and the fact that most chiropractors don’t provide truly informed consent about the risks of stroke after cervical manipulation, I tend to agree with Harriet Hall that “existing evidence is inadequate to conclusively determine causality, but I think it supports a high probability of causality, and the alternate explanations he [a chiropractor] offers to exonerate chiropractors are questionable.” Given that assessment, I find it hard to justify cervical manipulation as a treatment for, well, anything.

But what about Katie May?

So how does this evidence apply to the case of Katie May? Here’s the problem. By all news reports, Katie May didn’t suffer a vertebral artery stroke. She suffered a carotid artery stroke. While it is true that cervical manipulation very likely can cause vertebral artery strokes, it is not at all clear whether such manipulation can cause carotid artery strokes. From a simple anatomic standpoint, there is less plausibility, as well, but not zero. Let’s take a look at carotid artery anatomy (click to embiggen):

Carotid artery anatomy

In the neck, you have two carotid arteries. More specifically, these are the common carotid arteries. Around the level of the thyroid cartilage, the common carotid artery branches into external and internal branches. The external branch supplies blood to the face and neck. The internal branch proceeds up the neck to the temporal bone, where, to put it simply, it enters a canal in the petrous portion of the temporal bone and emerges within the skull to supply the brain and other structures (such as the eye) by branching into several arteries, the end branches of which are the anterior and middle cerebral arteries. When atherosclerotic plaque builds up in this system, it most commonly builds up in the internal carotid artery just past the bifurcation of the common carotid, and that’s where vascular surgeons perform carotid endarterectomies to remove such plaques and prevent strokes.

Evidence implicating chiropractic manipulation as a cause of strokes arising from the carotid system is much thinner than the evidence for chiropractic-induced vertebral artery strokes. There have been case reports, such as one that Harriet Hall discussed in which a man who had known carotid disease, with calcified plaque, noticed left arm weakness and numbness 30 minutes after a chiropractic neck manipuliation. Imaging showed a calcified embolus in the right middle cerebral artery, which was strongly suggestive that neck manipulation had loosened part of the plaque an allowed this embolus to flow into the middle cerebral artery. Other sources of embolus were systematically ruled out. Another case report described a 34 year old otherwise healthy man who suffered acute left-sided numbness and loss of coordination after neck manipulation. He was found to have bilateral carotid artery dissections and a right vertebral artery dissection. (An arterial dissection occurs when there is a tear in the innermost intimal layer, allowing the shear force of flowing blood to start to pull that layer away from the muscular layer of the artery.) Other case reports exist as well, some linking dissection to collagen-vascular disease. However, larger studies have failed to find a compelling link between carotid artery strokes and chiropractic neck manipulation.

In other words, there is more uncertainty about a link between chiropractic manipulation and stroke from carotid arteries, which makes the case for link between Katie May’s two neck manipulations and her stroke harder to argue.

Post-traumatic stroke

Another possibility is that Katie May died as initial reports suggested before people noticed that she had Tweeted about undergoing neck adjustment and reports came out that she had undergone two such adjustments between injuring her neck and suffering her massive stroke; that is, of a post-traumatic stroke. The annual incidence of spontaneous internal carotid artery dissection is around 2.5-3 per 100,000, making it pretty rare, although the true incidence of dissection is probably higher because this number doesn’t take into account injuries without neurologic symptoms. The most common initial symptoms of a dissection include neck pain and headache, the former of which May definitely had. Crissey et al described four main mechanisms leading to carotid injury:

  • Neck hyperextension associated with rotation (which May might have had from her manipulation).
  • Direct blow to the neck (which May almost certainly appears to have had from her fall).
  • Blunt intra-oral trauma (which May didn’t have).
  • Basilar skull fracture involving the carotid canal (which May also didn’t have, at least not as far as we know).

Carotid artery dissection has also been reported after sports injuries, the sports including judo, skiing, yoga, ice hockey, rowing, wrestling, horse riding, soccer, jogging, and others—even after treadmill running. In other words, although they are rare, trivial trauma can cause carotid dissections in young, healthy people.

Once such an injury occurs, the latency period for an ischemic event (i.e., stroke) is such that 80% of strokes arise within the first seven days (which May’s did), but post-dissection strokes can still occur as long as five months later.

What killed Katie May

So what killed Katie May? The bottom line is that we don’t know for sure. We can’t know for sure. If you leave out the chiropractic manipulations of her neck, her clinical history—at least as far as I can ascertain it from existing news reports—is classic for a dissection due to neck trauma. She was, after all, a young person who suffered a seemingly relatively minor neck injury that, unbeknownst to her, could have caused a carotid artery dissection, leading to a stroke 4 or 5 days later. Even if May were examined in the emergency room shortly after her injury, in the absence of neurological symptoms it would have been very easy to miss the possibility of an intimal tear that ultimately could lead to a dissection. Absent focal neurological findings, there’s really nothing on physical exam that can raise the index of suspicion for a dissection, and given how rare dissections are after trauma doing an ultrasound or angiography would have been hard to justify absent more worrisome symptoms.

Thus, it seems jumping to conclusions for May’s friend Christina Passanisi to say that May “really didn’t need to have her neck adjusted, and it killed her.” Don’t get me wrong. I completely agree that May didn’t need to have her neck adjusted, particularly after having suffered trauma to it. I just can’t be so sure that it was the manipulation that killed May, given that May’s history also fits with that of a traumatic carotid dissection. Even if there were an autopsy that found an internal carotid artery dissection, there would be no good way to tell whether the trauma from May’s fall or trauma from her two neck adjustments caused it.

That being said, don’t mistake my concluding that we can’t be sure that the chiropractic neck manipulation didn’t cause May’s stroke with my concluding that it didn’t cause her stroke. Her two sessions of chiropractic manipulation might well have either worsened an existing intimal tear or caused a new one that lead to her demise. Or they might have had nothing to do with her stroke, her fate having been sealed days before, when she fell during that photoshoot. There is just no way of knowing for sure. It is certainly not wrong to suspect that chiropractic neck manipulation might have contributed to Katie May’s demise, but it is incorrect to state with any degree of certainty that her manipulation did kill her.

Categories: Medicine, Skepticism

Curse Removal from the Annals

Science Based Medicine - Fri, 02/05/2016 - 03:30

A short post this week. Last weekend was a busy call weekend and as I type this I am heading for Palm Springs for a long weekend of hiking in the desert. If there is no entry in 14 days, look for my bleached bones somewhere in Joshua Tree.

Some observations about a recent article in the once respected Annals of Internal Medicine, whose recent articles  on acupuncture suggest their motto should be “The Annals. We have one too many n’s.”

First there was, Alexander Technique Lessons or Acupuncture Sessions for Persons With Chronic Neck Pain: A Randomized Trial (discussed here) and now Acupuncture for Menopausal Hot Flashes: A Randomized Trial.

Why do the study? Why do any acupuncture study? Negative studies will not change practice.  There are no reality based reasons to think that acupuncture would be effective for any process. All the high quality studies show no efficacy.

As of the last Cochrane review, the data suggested for hot flashes that

When acupuncture was compared with sham acupuncture, there was no evidence of any difference in their effect on hot flushes. When acupuncture was compared with no treatment, there appeared to be a benefit from acupuncture, but acupuncture appeared to be less effective than HT.

Treatment is no different than placebo, so for any real therapy it would be concluded that the intervention is not effective.

And the results continue in  this study?

Chinese medicine acupuncture was not superior to noninsertive sham acupuncture for women with moderately severe menopausal HFs.

Nicely said.  Avoided the proper and rigorous interpretation of the study, acupuncture is not effective.  For once the take on the web was correct:  acupuncture doesn’t work for hot flashes.  This probably suggests the authors of the study never learned to spin their results.  So often when acupuncture is equal to placebo, acupuncture is declared effective since it has the “power of the placebo”. You probably do not remember, but two years ago there was a similar study where acupuncture and sham acupuncture were equal for reducing hot flashes.  Then the spin was Acupuncture may reduce severity and frequency of menopausal hot flashes.  

The lead author needs to get her SCAM speak down better, instead saying

“Acupuncture has been shown to be more effective than placebo for a number of conditions, specifically chronic pain,” said the lead author, Dr. Carolyn Ee, a family physician trained in both Western and Chinese medicine. “To say that it doesn’t work for hot flashes is not the same as saying it doesn’t work.”

Chronic pain is singular, so I guess the number of conditions specifically is one.  The loneliest number as I remember.  And while I agree it isn’t the same, acupuncture still doesn’t work.

It would be an interesting sociological study. Do a test of acupuncture vrs sham acupuncture vrs wait list. Doesn’t matter the symptom as long as there is a subjective endpoint. Real and sham will be equal in symptom relief and superior to doing nothing. Then send out two identical press releases except one that concludes acupuncture does nothing and one concludes it is effective.

It would be interesting to see if anyone actually cognates on the releases.

And why would the Annals publish an article that says the study was using

Chinese medicine needle acupuncture designed to treat kidney yin deficiency

My first google hit using “kidney yin deficiency” as a search term suggests kidney yin deficiency

usually presents as lumbar soreness

and

follows the rules of yang vacuity internal cold; therefore it usually presents cold symptoms, e.g. cold and pain in the lumbar area and cold limbs. Kidney qi deficiency is a common clinical diagnosis and does not usually present with cold symptoms. When the kidney’s astringent or storage functions are poor with a kidney qi deficiency, associated symptoms appear, e.g. frequent urination, copious amounts of clear urine, incontinence, enuresis, seminal emission, abortion, or miscarriage

Nowhere on the search result do they mention hot flashes.

Next hit. Menopause hot flashes? Nope

The next? Nope.

So I searched for menopause and kidney yin deficiency and found it.

When hot flashes or sweating are the major complaints, TCM regards these as internal damage problems due to such things as blood and qi deficiency, kidney yin deficiency, spleen and heart deficiency, phlegm stagnation, heat or phlegm irritating heart.

It goes to the heart of Traditional Chinese Pseudo-Medicine. They have zero standards and  basically make stuff up as they go along.

When I see kidney yin deficiency as a rationale for a clinical intervention, I wonder if the Annals would have published a similar trial using the Traditional European Pseudo Medicine of 4 humors as the basis of a study and bleeding as the treatment. It would have the same result. It is a hoax that needs to be played.

One last thought about acupuncture. I like the concept of acupuncture as a complex therapeutic ritual. But the longer I am in the SCAM world, the more I think this gives acupuncture, and other pseudo-medicines, too much benefit of the doubt.

Occasionally there is an article about the arrest of a fortune teller. The fortune teller has convinced someone that they or their material goods are cursed and the curse is the source of problems or discontent in the household. In modern times the curse is sometimes referred to as negative energy.

The fortune teller then helps lift the curse. It may be money to help perform a ritual to lift the curse or remove the negative energy. Sometimes the valuables are cleansed and then disappear.  Magic? In the legal system this behavior is considered fraud and theft and the fortune teller, if caught, often goes to jail.

I cannot find if the victims of the curse scam feel better after their curse has been lifted or the negative energy banished. There are no studies I could locate on the topic. At least I could find no studies outside of the literature for pseudo-medicines.

Is the practice of acupuncture, reiki, homeopathy, chiropractic and the other pseudo-medicines any different from the practice of curse removal? Not that I can see.  They have the same basic principles, just different language. Barely. ‘

Acupuncture is a ritual, it is a curse removal ritual.  At it’s center, so is most of CAM.

Does the ends justify the means? It depends on the ends and the means. But in medicine there are those who consider it OK to do the equivalent of the curse removal, fraud and theft,  as long as the patient reports benefit.

There is little information on curses as a cause of illness outside of the bible references, so it would appear to an area with the potential for growth.

It would be simple enough to do. Get an online pseudo-medical degree like ND, DC or Lac.  Then you can do virtually anything and call it  therapy. Then set up a clinic to remove the negative energies and curses for medical purposes. The authorities will never look twice. And in a year or two you will probably be hired by the local University Medical Center’s Integrative Medical Clinic.  I bet the Cleveland Clinic will be the first.

Now my seat back needs to be in the upright and locked position and my computer stowed under the seat in front of me.  Later.

Categories: Medicine, Skepticism

Pseudoscience sneaks into Ohio guidelines for non-drug pain treatment

Science Based Medicine - Thu, 02/04/2016 - 01:00

Legitimately prescribed drugs can be stolen from a medicine cabinet a few at a time usually without notice. http://www.iowa.gov/odcp/images/pdf/Parentskids.pdf

Ohio recently issued Acute Pain Prescribing Guidelines as part of an effort to reduce the epidemic of opioid abuse and death from overdose. They were drafted under the auspices of the Governors Cabinet Opiate Action Team (GCOAT), assisted by medical organizations and other groups.

The guidelines include recommendations for non-pharmacologic treatment, a typical feature of pain treatment guidelines and a worthy effort to avoid prescribing opioids for pain. Unfortunately, the guidelines include treatments that are not evidence based and potentially harmful. We’ll return to that issue shortly.

But first, a brief look at the extent of the opioid problem. According to the CDC, opioids are used to treat moderate-to-severe pain and are often prescribed following surgery, injury, or for health conditions, like cancer. In the past few years, there has been a dramatic increase in the acceptance and use of prescription opioids for the treatment of chronic, non-cancer pain, such as back pain or osteoarthritis. From 1999 to 2013, opioid prescription and sales in the U.S. have nearly quadrupled, and overdose deaths have quadrupled right along with it.

The most common drugs involved in prescription overdose deaths include:

  • Hydrocodone (e.g., Vicodin)
  • Oxycodone (e.g., OxyContin)
  • Oxymorphone (e.g., Opana)
  • Methadone (especially when prescribed for pain)

44 people in the U.S. die from overdose of prescription painkillers every day, and a big part of the overdose problem results from prescription opioid painkillers. These drugs can be highly addictive – in some cases, all it takes is one prescription. Once addicted, it can be hard to stop. In 2013, nearly two million Americans abused prescription painkillers. Almost 7,000 people are treated in emergency departments each day for using these drugs in a manner other than as directed.

There is wide variation in opioid prescribing between states that can’t be explained by state differences in health issues that cause people pain.  Because the states have the authority to regulate health care practices, they are at the front lines of strategies to reduce improper prescribing and overdose.

State prescription drug monitoring programs (PDMPs) and regulation of pain clinics have shown promising results. My state, Florida, became well known for its “pill mills” and Broward County (Ft. Lauderdale) was ground zero for the industry. In 2010, there were more pill mills than McDonalds restaurants in the county, and people were driving in from states like Tennessee and Kentucky for their meds. (The local sheriff speculated that Broward’s popularity as a drug destination was due to “better beaches.”) That year, the state enacted more stringent pain clinic regulations and stopped practitioners from dispensing prescription painkillers from their offices. By 2012, there was a 50% decrease in oxycodone overdose deaths.

Where one-stop shopping isn’t available, one strategy used by addicts is to see multiple providers for painkillers. In 2012, both New York and Tennessee began requiring prescribers to check the state’s PDMP before prescribing painkillers. By 2013, these states had a 75% and a 36% drop, respectively, in patients seeing multiple providers for the same drugs.

Like Ohio, several states and medical organizations have issued prescribing guidelines for practitioners, as has the CDC (now in draft), although not without criticism. (These guidelines are for chronic pain, while Ohio’s are for acute pain, but they share recommendations that are addressed in this post.)

According to the Institute of Medicine,

trustworthy clinical practice guidelines appropriately manage conflict of interest, use systematic reviews of the evidence to inform recommendations, and rate the strength of the evidence and recommendations.

A common element of opioid prescribing guidelines is the recommendation that practitioners try non-opioid pharmacologic treatment (e.g., NSIADS) and non-pharmacologic treatment for pain. That is certainly reasonable in appropriate situations – no opioids, no addiction and no overdoses. Ohio’s new Guidelines for non-pharmacologic treatment of acute pain include (emphasis mine):

  • Ice, heat, positioning, bracing, wrapping, splints, stretching
  • Massage therapy, tactile stimulation, acupuncture/acupressure, chiropractic adjustment, osteopathic neuromusculoskeletal medicine
  • Biofeedback
  • Directed exercise such as physical therapy

The guidelines received a fair amount of attention in the Ohio media. Unfortunately, in one media report, Dr. Mary DiOrio, medical director for the state Department of Health, stretched the guidelines even further by saying “seeing a chiropractor” was an appropriate alternative to drug therapy.

I could find no report or discussion of the research backing up these recommendations. Even without that information, one can confidently conclude that acupuncture, acupressure and chiropractic adjustments are not evidence-based recommendations.

Acupuncture can be readily dispensed with, as the lack of convincing research supporting its effectiveness for pain (or anything else) has been widely discussed on SBM. Acupuncture is nothing more than a theatrical placebo.  SBM has an excellent short description of acupuncture, plus many additional posts. To summarize:

  • There is no plausible basis in science for the notion that a mysterious force called “qi” runs through the body along “meridians” or that sticking needles in certain points along those meridians can affect any bodily function.
  • Attempts to provide a scientific rationale for acupuncture’s putative effects have failed to come up with a plausible explanation.
  • It doesn’t matter where you stick the needles, or if you use needles at all.
  • All the evidence, taken together, leads to the inevitable conclusion that acupuncture doesn’t work. For anything.

Acupressure is based on the same pre-scientific idea as acupuncture, except that it uses pressure instead of needle insertion. There is no more reason to think it would work, and no more reason to believe any study that “shows it works,” than there is for acupuncture. There is another form of acupressure, auricular acupressure, which suffers from, again, the same fantastical explanation of its supposed mechanism of action as well as lack of evidence of effectiveness. Here, a picture is worth a thousand words:

How auricular acupressure “works.”

 

 

Ohio should “adjust” the Guidelines

Whatever the mistakes made in recommending acupuncture/acupressure, I have to believe that GCOAT and its collaborators knew what acupuncture is, at least in its needle acupuncture form. But I also have to believe this group (with one exception) had no idea what they were doing when they recommended “chiropractic adjustments.” I imagine they thought that “chiropractic adjustment” is simply another name for spinal manipulation.

Here’s what the GCOAT needs to know: Spinal manipulation and the “chiropractic adjustment” are two entirely different concepts, although easily confused by those who aren’t familiar with chiropractic lingo.

Chiropractors, and only chiropractors, believe in the existence of the “subluxation” and the ability of “chiropractic adjustments” to “correct” them.  They use the term “subluxation” differently than the medical profession and physical therapists, to whom it means a partial dislocation of a joint, such as a dislocated shoulder. Chiropractors define subluxation (or one of its many synonyms, like “joint dysfunction” or “neurobiomechanical lesion” or “vertebral subluxation complex”) as

a health concern that manifests in the skeletal joints, and, through complex anatomical and physiologic relationships, affects the nervous system and may lead to reduced function, disability, or illness.

They’ve never been able to explain what these “anatomical and physiologic relationships” are and how they “affect the nervous system” or “lead to reduced function, disability, or illness” in any way that accords with basic anatomy or physiology. Nevertheless, chiropractors purport to be able to detect these mythical subluxations (sometimes with x-rays, thereby exposing the patient to totally unnecessary radiation) and “correct” them with “adjustments,” all to the purported, but never proven, benefit to the patient’s health.

What does this have to do with spinal manipulation? Spinal manipulation is a legitimate manual therapy used by physical therapists, osteopathic physicians, medical physicians and some evidence-based chiropractors. According to SBM’s own Sam Homola:

Recent reviews of the literature indicate that manipulation may not be any more effective than other treatment methods in affecting the ultimate outcome in recovery from back pain. For symptomatic relief of uncomplicated mechanical-type back pain, however, use of hands-on manipulation may provide more immediate and dramatic relief by stretching tight muscles and mobilizing the spine.

But only chiropractors who believe in the non-existent subluxation (and these are in the majority) use “spinal manipulation” as a synonym for the “chiropractic adjustment,” the purpose of which is to “realign” the spine and get rid of the subluxation. Again, according to Dr. Homola:

Endorsement of the use of manipulation in the treatment of mechanical-type back pain is not an endorsement of chiropractic adjustments used to correct subluxations or some other “joint disturbance” alleged to cause illness or poor health.

Nor is it appropriate to use the term “chiropractic adjustment” when describing spinal manipulation as an appropriate manual therapy for pain.

GCOAT might have legitimately recommended spinal manipulation as a non-pharmacologic treatment (putting aside the issue of its questionable effectiveness). But, in using the term “chiropractic adjustment,” it adopted a pseudoscientific treatment, the “adjustment,” for a pseudoscientific condition, the “subluxation.” If GCOAT would like to see examples of Ohio chiropractors who subscribe to these beliefs, here are a few: from Chiropractic Care for Women (Columbus), Upper Arlington Family Chiropractic (Upper Arlington) and Chagrin Natural Health Clinic (Chagrin Falls).

Patient belief in the efficacy of chiropractic adjustments is not without consequences. A chiropractor adjusts the spine at the location of the “subluxation,” which may not be where the patient is actually experiencing his pain, as in this notorious example. Some chiropractors adjust the cervical spine exclusively, which can cause a dissection leading to a stroke. (Despite chiropractors’ unconvincing protestations to the contrary.)

In addition to these risks, patients being subjected to worthless treatments due to chiropractic belief in the “subluxation” and “adjustments” to correct it have been documented numerous times on SBM, such as Clay Jones series of posts on chiropractic treatment (via “adjustments”) of newborn supraventricular tachycardia,  for SIDS prevention,  nocturnal enuresis, colic, ear infections as well as chiropractors use of general fear-mongering about the health effects of normal childhood activity (such as play) if one’s child is not regularly “adjusted.”

How did this happen?

Last fall the Ohio State Chiropractic Association was appointed to the Opiates and Other Controlled Substances Committee to offer their professional insight as to how to tackle the addiction problem in Ohio.  Currently, the OSCA’s President, Dr. Kreg Huffer and the association’s executive director, Bharon Hoag, are the OSCA’s representatives to the committee.

Given this input, I have to assume that the other members of the Committee did not come up with the term “chiropractic adjustments” on their own. And I have to assume that none of the other members had any idea what they were endorsing when “chiropractic adjustments” was added as a treatment option. But the Ohio State Chiropractic Association representatives damn sure knew what they were doing.

This is the danger of an “integrative” approach to patient care. You can’t combine science-based health care professions with those steeped in an unscientific culture. The two don’t mix. Other members of the committee saw the guidelines as an opportunity to stem the tide of opiate abuse in Ohio. Chiropractors saw it as a marketing opportunity, and it worked.

Note: Thanks to the pre-med student who alerted SBM to the Ohio Guidelines and their inclusion of acupuncture and chiropractic. It is gratifying to know that we have science-based physicians in the pipeline. 

Categories: Medicine, Skepticism

Laws Limiting Vaccine Exemptions Work

Science Based Medicine - Wed, 02/03/2016 - 08:12

It’s nice when a question can be resolved with objective numbers of unequivocal outcomes. Subjective outcomes give scientists a headache.

In this case we are talking about the effect of vaccine exemption laws on vaccine compliance rates. The question here is not the ethical one, the rights of parents to determine the fate of their children vs the right of the state to protect the health of children and the public health. I think the latter trumps the former, but some disagree.

Regardless of what you feel about the ethical question, we need to know if the laws we pass to achieve our goals actually work, or if they don’t work, or even have unintended consequences. Having an admirable goal is not enough; when you make actual decisions (practice decisions, policy decisions, healthcare decisions for you and for family) you want to know that those decisions are having the desired effect.

We recently had another opportunity to test the effect of vaccine exemption laws, with California law SB 277 making it more difficult for parents to obtain vaccine exemptions. We’ll get to that below.

Vaccine exemption laws

One of the advantages of the US health care system is that in many ways it is 50 statewide systems. This provides the opportunity to experiment – each state is a type of experiment and we can compare the various statewide health care policies on outcomes.

There are a range of policies among the states. All 50 states require some vaccinations for entry into public school. Most offer religious exemptions to vaccines, all but Mississippi and West Virginia. As of 2016, 18 states allow for personal belief or philosophical exemptions (California and Vermont passed laws that remove philosophical exemptions this year). In addition, some states make it more difficult to obtain exemptions – you may have to just check a box on a form, or you may need a notarized note from a doctor, or you may need to be counseled by a doctor about the dangers of vaccine-preventable diseases.

How do these ranges of policies affect vaccine exemptions and therefore the incidence of vaccine-preventable diseases? The answer has consistently been that the more permissive the state regulations, the higher the rate of vaccine exemptions, and the higher the rate of vaccine-preventable illness. The correlation is strong.

For example, a 2006 study looking at state laws and statistics governing vaccine exemptions from 2001-2004 found:

Permitting personal belief exemptions and easily granting exemptions are associated with higher and increasing nonmedical US exemption rates. State policies granting personal belief exemptions and states that easily grant exemptions are associated with increased pertussis incidence.

A 2014 systematic review of state vaccine exemptions concluded:

Findings from 42 studies suggest that exemption rates are increasing and occur in clusters; most exemptors questioned vaccine safety, although some exempted out of convenience. Easier state-level exemption procedures increase exemption rates and both individual and community disease risk.

The easier it is to obtain an exemption the higher the exemption rate, and the higher the incidence of vaccine-preventable diseases like pertussis and measles. Further, private schools have a higher incidence of vaccine refusal than public schools. The exemptions also geographically cluster.

The clustering is important because of herd immunity. If we look only at overall vaccine rates, they usually remain high, enough for herd immunity to prevent outbreaks. But vaccine exemptions cluster, both geographically and in schools, which means there are pockets in which herd immunity is lost. Unsurprisingly, pertussis outbreaks tend to cluster in the same places that vaccine refusal clusters.

It should also be emphasized that the primary reason for vaccine refusal is concerns about vaccine safety. There is no scientific basis for this concern – it is entirely due to a campaign of fearmongering and misinformation on the part of those ideologically opposed to vaccines.

California Law SB277

Comparing different states is useful, and provides a powerful correlation with an obvious causation. However, when one state changes its laws that provides and even stronger source of evidence for the effects of vaccine exemptions laws – because everything is the same except for the law itself.

Largely in response to the Disneyland measles outbreak, California passed a law eliminating personal belief exemptions from the vaccine requirements for public school. The full effects of this law do not kick in until July 1 of this year, but parents were already informed of the upcoming change.

Here come the objective numbers I so love:

Of 551,123 kindergarten children whose schools reported their status, 511,708 (92.9%) had received all required immunizations, an increase from the previous school year of 2.5 percentage points overall, 2.5 percentage points in public schools, and 1.6 percentage points in private schools (Table 1).

Already there has been a 2.5 percent absolute increase in kindergarten children receiving their full vaccination schedule. This is huge from a public health perspective, and will likely have a measurable effect on disease outbreaks in the state.

This also sends a clear message to other states with philosophical exemptions, especially easily-obtained exemptions – this policy does have an effect on public health, which is a direct responsibility of the state.

The net effect of eliminating vaccine exemptions

Requiring vaccines for entry into public schools is a sensible public health policy that is incredible effective in terms of protecting the public and cost. The cost effectiveness should not be overlooked or minimized at a time when rising healthcare costs literally threaten the quality of our healthcare.

All exemptions increase vaccine noncompliance and increase the risk of outbreaks of vaccine-preventable diseases. The data are clear. This cannot be a point of disagreement when crafting public policy.

There is a reasonable case to be made for not allowing any vaccine exemptions. However, for those states who feel that some exemptions, such as religious exemptions, are appropriate, the data also show they should make those exemptions as limited and difficult to obtain as possible.

I don’t see any justification for philosophical exemptions. They essentially represent allowing a parent to substitute their own ill-informed opinion about the scientific facts for the carefully vetted consensus of scientific opinion. Most parents object because they fear vaccines are not safe, and they are simply and objectively wrong. The benefits of vaccines vastly outweigh the tiny risks. Their children should not suffer, and the public health should not suffer, because of their incorrect beliefs regarding the scientific facts.

 

 

Categories: Medicine, Skepticism

NASA – Defending Earth

Neurologica Blog - Tue, 02/02/2016 - 08:05

NASA recently announced that it has created a Planetary Defense Coordination Office (PDCO). The purpose of this new office is to defend the Earth from alien invasion.

OK, no, but the name does sound like that, doesn’t it?

The purpose of the office is to coordinate efforts to defend the Earth from Near Earth Objects (NEOs) – essentially comets and asteroids on a collision course with the Earth. The director is Lindley Johnson, who is currently the NEO program executive, which is an obvious fit with the new office.

NEOs do pose a threat to our civilization. You don’t have to be Bruce Willis to imagine how devastating it could be for a large rock traveling faster than a bullet to hit the Earth. Of course, the answer is that it could fall anywhere along a spectrum from nothing to wiping out our entire species. Obviously NASA is more concerned with the latter.

There are many NEOs, mostly asteroids whose orbits cross the orbit of Earth or bring it close. Objects pass close to the Earth all the time, in fact.

Perhaps more worrisome are objects that are visitors to the inner solar system. These are mostly comets, either periodic or one time comets, barrelling in from the outer solar system. These are more worrisome because they can be more difficult to predict and they are traveling, relative to the Earth, much faster than asteroids moseying across our orbit.

The probability of getting hit by a large asteroid or comet is very low over the short term. According to NASA:

A working group chaired by Dr. David Morrison, NASA Ames Research Center, estimates that there are some 2,100 such asteroids larger than 1 kilometer and perhaps 320,000 larger than 100 meters, the size that caused the Tunguska event and the Arizona Meteor Crater. An impact by one of these larger meteors in the wrong place would be a catastrophe, but it would not threaten civilization. However, the working group concluded that an impact by an asteroid larger than 1-2 kilometers could degrade the global climate, leading to widespread crop failure and loss of life. Such global environmental catastrophes, which place the entire population of the Earth at risk, are estimated to take place several times per million years on average.

So it may be 100,000 years before the new PDCO is called into action. Or it could be in 10 years. We can’t predict.

Well actually, we can, to some extent. We can look for NEOs, catalogue them, map their orbits, and predict which ones will come dangerously close to the Earth and when. In fact, that is one of the projects that will keep PDCO busy. They will also be working in coordination with the UN and European Space Agency (ESA):

That UN subcommittee has formalized the International Asteroid Warning Network (IAWN) and a Space Mission Planning Advisory Group (SMPAG) of U.N. member states that have space agencies.

In addition to finding all the potential threats, PDCO and its international partners will be developing the technology to deflect asteroids (otherwise, what’s the point). It certainly makes sense to have this technology ready to go. It is quite possible we will find out the Earth is going to get hit will little warning. Even a 10 year warning is possibly not enough, if we are starting from scratch.

Even if the technology is fully developed, a few years lead time would be nice.

The ESA is planning a possible Asteroid Impact & Deflection Assessment mission (AIDA), which will send up two spacecraft. The first will ram into an asteroid, and the second will monitor the effects. NASA is still deciding if PDCO will be part of this mission.

Crashing a fast-moving rocket into an asteroid is a crude, but effective, method for deflecting an asteroid. It’s all about momentum – a heavy rocket at high speed would impart a lot of momentum to even an asteroid. The more lead time we have (and this is why surveillance is critical) the greater change we can make in the orbit of the asteroid. Even a slight change over four years can be enough to turn a hit into a miss.

While this seems like a simple method, it’s still rocket science. We need to have the ability to quickly launch one or more rockets with accuracy and predict the result. We could just as easily to a near hit into a guaranteed hit, or have the asteroid miss on this pass then come around and hit us in 20 years.

We also need to develop methods for fine-tuning. Smashing stuff into an asteroid makes a big change, but then we may want to give the asteroid a nudge. There are a variety of possible mechanisms for this. We could use a gravity tractor, a ship that stays close to the asteroid and uses its engines to slowly pull it by gravity in one direction.

A nuclear explosion could also be used, not to blow up the asteroid but change its course. Blowing it up would likely not be a good idea – then we would have a swarm of smaller asteroids still on a collision course, perhaps causing even more damage.

There are more exotic ideas, such as painting one side of the asteroid white so that solar pressure will push it. This is very tricky, however, as most asteroids are tumbling with respect to the sun.

Conclusion

I, for one, feel a tiny bit safer knowing that the space agencies of the world are working together to identify and develop the technology to deflect large asteroids. While the short term probability is low, I think of it like insurance for our civilization.

It always a judgement call – when you advocate for taking action to prevent a low probability but very damaging event. How low a probability, and how devastating an event?

I think that the investment of resources we would need to make to protect ourselves is relatively tiny, and it buys us a measure of insurance (of course, no guarantee) against a world-wide catastrophic event. Even if we prevent only a small meteor from hitting a city and killing thousands or tens of thousands of people, and causing trillions of dollars of damage, that is worth it and probably cost-effective.

Categories: Medicine

Prenatal Multivitamins and Iron: Not Evidence-Based

Science Based Medicine - Tue, 02/02/2016 - 03:00

 

When I was pregnant, I obediently took the iron pills and prenatal vitamins prescribed by my obstetrician. And I prescribed them for every pregnant patient I took care of as a family physician. I never questioned the practice. It seemed intuitively obvious that it was a good thing; we know pregnancy makes extra nutritional demands and depletes iron stores. It never occurred to me to question what I had been taught, because it seemed perfectly logical. I did question other things I was taught that didn’t seem so logical. In my internship, we were ordered to do episiotomies on every patient (the rationale was that it made birth less traumatic for the baby and prevented uncontrolled perineal tearing in the mother). I was severely chastised for omitting an episiotomy on a patient who begged me not to do one. She had had several babies and was stretchy enough to deliver easily without an episiotomy. In this case, my common-sense clinical judgment was vindicated by further research in the years after my internship; new evidence showed that routine episiotomies were of no benefit, practice changed in response to the new evidence, and episiotomies are no longer done routinely.

That was a long time ago. I have long since learned that even the most reasonable assumptions can be wrong. I happened to be right about episiotomies, but I might just as well have been wrong; and the only way to know whether a belief is true is to test it in controlled scientific trials. As Will Rogers said, “It isn’t what we don’t know that gives us trouble, it’s what we know that ain’t so.” It turns out that routine multivitamin and iron supplementation is not supported by any convincing evidence from scientific studies. And practice is changing. Recently, when one woman asked her OB what she should do about prenatal vitamins he pulled his wastebasket out from under his desk and said “put them there.”

The evidence for folic acid

Folic acid prevents serious congenital abnormalities, neural tube defects like spina bifida and anencephaly. It is recommended for any woman who might become pregnant, because the damage occurs early, sometimes before she knows she is pregnant. The United States Preventive Services Task Force (USPSTF) found high quality (Grade A) evidence to support their recommendation that “All women planning or capable of pregnancy take a daily supplement containing 0.4 to 0.8 mg of folic acid.”

The American Academy of Family Physicians seconds that recommendation and recommends folic acid supplementation be continued for the first 6-12 weeks of pregnancy. But it points out that many other elements of routine prenatal care are based on tradition and lack a firm evidence base. It makes recommendations about healthy diet, but it doesn’t make specific recommendations about prenatal multivitamins. It doesn’t recommend iron supplements for all pregnant women, only for those with iron deficiency anemia.

The evidence for iron

The USPSTF found insufficient evidence to recommend for or against routine iron supplementation in pregnancy. In summary, it said:

routine iron supplementation during pregnancy may improve maternal hematologic indices and reduce the incidence of iron deficiency and iron deficiency anemia (IDA) in the short term. However, there is no clear or consistent evidence that prenatal iron supplementation has a beneficial clinical impact on maternal or infant health. In addition, no trials are available on the effect of prenatal screening for IDA on clinical outcomes despite routine screening practices in many high-income countries. Rigorous studies are needed to fully understand the short- and long-term effect of routine iron supplementation and screening during pregnancy on women and infants, including the effects on rates of cesarean delivery, small size for gestational age, and low birthweight. Until then, the evidence on routine iron supplementation and screening in prenatal care will remain unclear at best.

The evidence for multivitamins

The American Congress of Obstetricians and Gynecologists (ACOG) recommends a multivitamin with folic acid.

A review of the literature found evidence to support routine folic acid supplementation but not supplementation of omega-3 fatty acids, vitamin D, or iron. It found evidence of harm from supplementation with large doses of vitamins A, C, and E. As for multivitamins, it concluded:

Vitamin and mineral supplements cannot replace a healthy diet, and there are not enough high-quality data to recommend multivitamin supplements for all American women.

The Skeptical OB, Amy Tuteur, says

Folic acid does prevent neural tube defects like spina bifida. The rest of the vitamins in prenatal vitamin preparations probably don’t provide any benefit for women who are well nourished.

Evidence of harm?

There is little evidence of harm from routine supplementation with multivitamins and iron. Some women have trouble swallowing pills, especially when they suffer from morning sickness. Allergic reactions to components in the pill can occur, but they are rare. Some patients report constipation, diarrhea, and nausea, which can often be relieved by switching to a different formulation.

Diet instead of pills?

There’s no reason to think that the nutritional needs of pregnancy can’t be adequately met through diet alone. There are published dietary guidelines for pregnant women. In addition to the general nutritional advice that is applicable to everyone, specific advice for pregnant women includes:

  • Minimize intake of food and drinks containing saccharin (other artificial sweeteners are probably OK).
  • Limit consumption of caffeine (possible association of high caffeine intake with spontaneous abortion and low birth weight; moderate amounts are probably safe).
  • Most pregnant women require an additional 300-400 calories a day beyond what would normally be required to maintain their weight when not pregnant.
  • Avoid unpasteurized dairy products, delicatessen foods, pâtés, and meat spreads (risk of Toxoplasma and Listeria contamination, based on case reports).
  • Avoid raw eggs (risk of Salmonella contamination, based on case reports).
  • Fruits and vegetables: wash before eating.
  • Avoid certain herbal teas that have been associated with adverse outcomes, like chamomile, licorice, peppermint, or raspberry leaf; teas containing ginger, citrus peel, lemon balm, and rose hips are probably safe in moderation.
  • Reheat leftover foods thoroughly before eating.
  • Avoid undercooked meat; cutting boards, utensils, and hands should be washed with hot, soapy water after contact with uncooked meat.
  • Liver and liver products should be eaten in moderation (risk of vitamin A toxicity).
  • Avoid shark, swordfish, mackerel, tilefish, and tuna steaks and limit intake of other fish (to minimize mercury intake).
  • Avoid refrigerated smoked seafood, raw fish, and shellfish; eat farmed salmon in moderation.

Dietary sources of iron include fruits, vegetables, meat, and poultry. The non-heme iron in vegetarian diets is not as well absorbed as the heme iron from meat, so vegetarians have almost double the requirement for iron compared to women who eat meat.

“It seemed like a good idea at the time”

One of my husband’s friends was shocked to hear that he had finally married at age 41; everyone thought of him as a confirmed bachelor. My husband explained, “ Yes, I got married. It seemed like a good idea at the time.” Thirty-four years later, after raising two daughters, he still thinks it was a good idea. Routine prescription of prenatal vitamins and iron seemed like a good idea at the time, and it might still be a good idea, at least for women who are at risk of anemia or inadequate diet. The lack of evidence of benefit doesn’t necessarily mean the practice should be abandoned. The chance of harm is minimal.

 Conclusion

 There is compelling evidence to support the use of folic acid supplements before pregnancy and during the first trimester. There is no good evidence to support the routine use of multivitamins or iron, but there is no good reason not to use them. If doctors recommend them, they should be honest about the uncertainty of the evidence and let their patients participate in the decision. As for which prenatal multivitamin to choose, Scott Gavura has provided some guidance here.  Whether or not patients choose to take multivitamins and iron, they should be given guidance about a healthy diet that meets the nutritional needs of mother and child.

Incidentally, this is a good example of how mainstream medicine is willing to re-examine its own practices and change course. Something alternative medicine never seems to do.

 

Categories: Medicine, Skepticism

Spa Death and the Dangers of Pseudoscience

Neurologica Blog - Mon, 02/01/2016 - 08:08

Three Quebec spa workers were just sentenced to prison for their role in the death of Chantal Lavigne. During their “spiritual” treatment, Lavigne was wrapped in mud, then is cellophane, covered in multiple layers, and her head put in a cardboard box, on a hot summer day, for nine hours. It will probably not shock you to learn that this treatment resulted in dehydration.

The dehydration was so severe that she had to be rushed to a hospital, where she suffered multiple organ failure and eventually died. The three spa workers were given 2-3 year sentences, which seem fairly light.

This is not the first time that this has happened. In 2011 James Ray, a self-proclaimed guru, was sentenced to two years in prison after the sweat lodge death of three people. That’s less than one year per person.

Cases such as these get filed under “What’s the Harm.” It is important to frequently remind people that pseudoscience is often dangerous. Sometimes these cases are dismissed as extreme examples, but that misses the point. What leads someone to think it is a good idea to be wrapped in multiple insulating layers for hours on a hot day? It is a thought process that is divorced from reality, that is not overtly based in logic and evidence.

These extreme examples illustrate the phenomenon that exists across the entire spectrum, from blatant to subtle. These examples are useful because they represent direct obvious physical harm, but there is also indirect harm, and psychological and financial harm, or perhaps direct but not-so-obvious physical harm.

For example, Hot Yoga is all the rage. This essentially consists of exercising in a hot environment – you know, to maximize the risk of heat stroke and dehydration. Hot Yoga is a fad, it is not based on any reasonable medical reasoning, it is not based on any evidence. It represents a basic failure of reasoning and judgement. It also likely causes some harm. Becoming dehydrated, for example, puts a strain on the kidneys.

Unless someone drops dead in the middle of a hot yoga session, however, the potential harm will likely be overlooked.

There is one form of indirect harm, however, that is often overlooked by those not steeped in the skeptical narrative, and that is belief in nonsense itself. The psychological evidence we have suggests that belief in nonsense begets belief in more nonsense. Of course it is difficult to tease apart cause and effect.

Fostering a society in which magical claims are taken for granted, and where pseudo-authorities (like sweat lodge gurus) are given respect, creates an environment in which people are more likely to believe in magic. It creates an environment in which someone would subject themselves to a slow death by dehydration because (insert spiritual nonsense) and because they trust someone who calls themselves a spiritual guide or a guru.

Instead we should be fostering a society in which people think critically, challenge claims, demand evidence, and question authority.

Categories: Medicine

When antivaccine pseudoscience isn’t enough, Bill Maher fawns over Charlie Sheen’s HIV quack

Science Based Medicine - Mon, 02/01/2016 - 03:00

Bill Maher (right) expresses admiration for HIV quack Samir Chachoua (right), who claims to be able to cure people of HIV and cancer using milk from arthritic goats.

 

I know I must be getting older because of Friday nights. After a long, hard week (and, during grant season, in anticipation of a long, hard weekend of grant writing), it’s not infrequent that my wife and I order pizza, plant ourselves in front of the TV, and end up asleep before 10 or 11 PM. Usually, a few hours later, between midnight and 3 AM one or both of us will wake up and head upstairs to bed, but not always. Sometimes it’s all Friday night on the couch.

Last Friday was a bit different. It wasn’t different in that I did fall asleep on the couch sometime around 10 PM. However, unlike the usual case, when I woke up around 1:30 or 2 AM to head upstairs I was stone cold wide awake, feeling like Alex in A Clockwork Orange, eyes held wide open. So I did what I do when insomnia strikes. I popped up the computer and checked my e-mail and Facebook. Immediately, I saw messages asking me if I had seen Real Time With Bill Maher that night and, oh boy, I really should watch Maher. Apprehensive but curious, I fired up the DVR and watched.

And, shortly after the monologue, was totally appalled by this;

Funny, how the segment hasn’t yet been posted to Bill Maher’s YouTube page, as many of his interviews are. If he ever does post it, I’ll switch out the video above for the “official” source. Somehow, though, I doubt that the video will ever be posted, the reason being that it contains an embarrassingly fawning 10 minute interview with “Dr.” Samir Chachoua, better known (at least to skeptics) as Charlie Sheen’s HIV quack. Somehow, when Charlie Sheen was on The Dr. Oz Show a couple of weeks ago, other things were going on and I didn’t blog about it. Fortunately, Steve Novella did. Now, with Sheen’s very own quack who failed him being fawned over by Bill Maher, it gives me a chance to take down three birds with one stone: Bill Maher, Dr. Oz, and, of course, Sam Chachoua. Sadly for Bill Maher, America’s Quack Dr. Mehmet Oz comes off looking a lot better than he does, and that’s saying something.

Prelude: Charlie Sheen does The Dr. Oz Show

When Charlie Sheen first announced that he was HIV-positive on the Today Show in November, it appeared to be an announcement that surprised exactly no one. Nor was it particularly surprising that he only went public because he had been discovered. As has been the case with any celebrity diagnosed with HIV, Sheen’s revelation was an excellent opportunity to point out how HIV is no longer a death sentence and can be managed with a very effective cocktail of anti-retroviral drugs, such that the life expectancy of HIV-positive people is approaching normal. It was also a great opportunity to point out yet again that, if there is any one disease in our lifetime that demonstrates the power of science-based medicine, it is AIDS. Back when I was in medical school and early into my residency HIV was basically a death sentence. Patients, once diagnosed with full blown AIDS, did not survive long. Once diagnosed as HIV-positive, most progressed within several years to full blown AIDS (although some patients progressed very slowly or not at all, which helped to fuel the rise of the HIV/AIDS denial, an pseudoscientific belief system that claims that HIV does not cause AIDS). By the mid-1990s, a mere 15 years or so since the syndrome was first defined and only a decade or so after the identification of HIV as the cause of AIDS, there was effective antiretroviral therapy. Now, 32 years after the identification of HIV, HIV-positive people can expect to live a relatively long time, as long as they manage their disease and take their medications.

It sounds easy, but I realize that for patients it’s not. The drugs must be taken according to schedule, and some of them have nasty side effects. It’s not surprising that some people, when their viral titers fall to undetectable, might think they can get away without taking their medications. It’s similar to patients stopping their antibiotics when they start to feel better, letting their infections come roaring back, or parents of children facing two years of chemotherapy thinking that if the first course drives the tumor into remission the child doesn’t need the remaining courses. It’s human nature, and apparently it’s just what Charlie Sheen fell prey to. With HIV, the drugs can cause spectacular falls in viral titers to the undetectable range, but that doesn’t mean that the virus is gone. HIV can “hide” within certain cells in the body, where the drugs don’t eradicate it. Stop the drugs, and it will reemerge. That’s what Charlie Sheen did.

Enter Dr. Oz.

About three weeks ago, Dr Oz and Charlie Sheen’s doctor, Robert Huizenga, staged an on-air “intervention” because apparently Sheen had gone off his HIV medications and sought out a doctor in Mexico who claims to be able to cure cancer, HIV, and all manner of diseases. (Don’t they all?) This doctor was—you guessed it—”Dr.” Samir Chachoua.

Initially in the segment, Dr. Oz, with Sheen’s permission, shows a graph of Sheen’s viral load, which was 4.4 million/mL. Treatment was begun on July 19, 2011, and by December 7, 2011 Sheen’s viral load was zero, undetectable. There it stayed for three and a half years. Here’s one video of it:

The official videos are here and here.

One thing that came out in this segment is the sort of thinking that leads to a decision as bad as Sheen’s. He defends his action by saying that he didn’t view it as “Russian roulette” (actually, his odds with Russian roulette would have been better) and says he’s presenting himself as a “guinea pig” and that he doesn’t recommend that anyone else do what he did.

Dr. Oz tracked down this Dr. Chachoua and found pretty much what I found (more on that later), namely that there isn’t much to find out about him online. He managed to get Chachoua on the phone, where Chachoua claimed that Charlie Sheen is the first adult in history to go HIV negative and that conventional medicine has never done that. He even went further and said that Sheen’s count went to zero after taking just his treatments. It’s a rather remarkable claim, given that to prove it you’d need a lot of long term followup to show that Sheen’s HIV didn’t for a long period of time after stopping his antiretrovirals and that antiretrovirals are very good at driving viral load to zero. We just know that the virus, although eradicated from the bloodstream, is “hiding” elsewhere, ready to emerge.

To get an idea of the magical thinking going on here, Sheen describes an “experiment” in which he mixed his blood with blood drawn from two friends, incubated it, and noted that all three samples had undetectable levels of HIV, an experiment that tells us exactly nothing. Perhaps the most shocking revelation from the Oz segment was that Chachoua drew some of Charlie Sheen’s blood and injected himself with it, an act so reckless and stupid that it’s hard to believe any physician would do it. Sheen also pointed out that this was not blood from a venipuncture, but rather drawn from a “lump” on his elbow (which sounded like a hematoma from an injury), which means it was old blood.

Through this segment, I kept asking two questions, which were never answered. First, when did Sheen stop taking his meds? Chachoua claimed that Sheen was HIV-positive again, but the graph shown in the segment showed sheen HIV-negative as recently as December 3, 2015. So when was he suddenly “HIV-positive” again? December 3, 2015 to January 12, 2016 (when the show aired) is only six weeks. In any case, at the end of the segment, Dr. Huizenga (who looks just like the way I pictured him, all spray-tanned and with perfect hair) implores Charlie Sheen to start taking his medications again and makes a very moving speech about how HIV used to be a death sentence but isn’t any more. In response, Sheen promised to start taking his meds on the flight home, asking, “What am I, an idiot?”

As Steve noted, the whole segment was ethically dubious, but probably good television, as was the segment where Oz took Sheen to a morgue to show him what drugs and alcohol can do to one’s organs. Part of the answer as to when Sheen stopped his meds appears in a segment following him around as he visits Dr. Huizenga and to the the Scripps Research Institute to interview a researcher about vaccines, who explained how HIV “hides” in the genome of certain cells in the body, to reemerge if HIV medications are stopped. Not surprisingly, there’s a trip to Dr Miles Farr, described as a “renowned integrative HIV specialist” (in other words, someone who combines quackery with science based medicine) and who has his acupuncturist give Sheen a session of what looks like auricular acupressure. It’s after this that he admits that he has been off his medications for about a week and “feels great.” It’s not clear when this segment was taped, but, given that he tells Oz that he’s still off his meds, it’s unlikely that it was taped much more than a month or so before the show aired. So, whatever Chachoua says, Sheen was not off of his medications very long, fortunately. Unfortunately, just before going on the show, Sheen discovered that his viral load had started to rise again, which is likely what led to his agreeing to go back on his meds.

Overall, I’m glad that Sheen is (apparently) back on his antiretroviral medications, but there are so many unanswered questions that would better allow me to put things into proper perspective. Obviously, Chachoua’s claims that Sheen was rendered “HIV-negative” with his treatment is worthless without independent verification and long-term followup. After all, I could give Charlie Sheen the proper cocktail of antiretroviral drugs and then, after his viral load drops to zero, tell him he’s HIV negative. It’d be meaningless without long term followup, because the virus eventually starts replicating again.

So before I get to Bill Maher, who is this Samir Chachoua, anyway, and what is his treatment?

Samir Chachoua and the goat milk cure

Oddly enough, before Sheen was on Dr. Oz’s show, I had never heard of him before. I thought I knew all the major quacks out there, but obviously that’s a conceit. I keep encountering new ones every month. Naturally, I went straight to Chachoua’s website, which had many of the red flags of quackery right there on the first page, starting with this a statement that “There is no disease you cannot access. No disease you cannot improve. Nothing is incurable. No situation is ever so hopeless that you stop trying.” Apparently his “cure” for cancer and HIV is based on something he calls “nemesis theory”:

The nemesis theory first postulated by me in 1980 was that – “for every disease there is an anti-disease organism capable of destroying it and restoring health.” It is not surprising therefore that every case of spontaneous remission investigated shows that cancer or AIDS or other disease may disappear miraculously even for a short period of time after infection with its nemesis.

Of course, this is far more a statement of philosophy than science. There is no a priori scientific reason why for every disease there is an anti-disease organism that can destroy it. This sounds far more like yin and yang in Asian philosophy and religion than it does science. Indeed, nemesis theory rather reminds me of homeopathy, which postulates “like cures like” in that there’s no scientific reason to believe that this is true. Be that as it may, this idea lead Chachoua to develop “induced remission therapy” (IRT).

In the case of HIV, this “theory” led Chachoua to “discover” that a goat virus, Caprine Arthritis Encephalitis Virus (CAEV) is the virus that is the “anti-disease” organism, and that it is this virus that allowed him to make a “vaccine” that eliminates HIV and, as Chachoua puts it, produce an “effective therapy against cancer and other diseases with no side effects.” Yes, this is another red flag of quackery, the claim that one’s treatment cures many diseases with no side effects, and Chachoua’s website has it in spades. In the case of HIV, CAEV is indeed a goat retrovirus, and some researchers have even speculated that it might be used as a model for HIV in in animal research. Based on this and little else, Chachoua claims:

In the greatest experiment done by nature, millions of Mexicans have drunk goat milk infected with CAEV (Caprine Arthritis Encephalitis Virus). I followed people from a small village in Mexico who were infected with CAEV, and thousands more were studied by USC, not one developed AIDS over decades of follow-up.

Just like a cold will affect the nose and the flu the lungs, there are infections that will only infect cancer cells or other disease tissue. There are organisms that neutralize each other in nature, such as seen above in CAEV and HIV.

Even measles and mumps can interfere with AIDS and leukemia and other types of cancer. These common infections have been reported to give long lasting remissions from these ailments, but there are strains and infection types that are far more efficient than others. I had developed, isolated and enhanced a library of organisms that could be used to create vaccines and therapies to eradicate cancer and AIDS. The therapies achieved phenomenal success and when American celebrities were cured, Cedar Sinai Medical Center and UCLA sought me out to work with them with promises of FDA registration and the healing of mankind.

Yes, Chachoua’s “preliminary evidence” is the claim that people from a small village in Mexico drink milk from arthritic goats (I kid you not) and as a result none of them ever developed AIDS, coupled with the existence of a goat retrovirus that can cause this arthritis.

I perused the science sections of Chachoua’s website, and found them…wanting. OK, it’s a lot of horrifying pseudoscience based on a germ of real science. Sadly, that’s the case with so many quacks’ nostrums. See if you can see the problems in Chachoua’s treatment:

  1. Biological lytic and apoptosis agents are used to destroy disease cells and organisms.
  2. Vaccines made from Nemesis Organisms TM are used to optimize the above process and protect cells and tissues that have not been corrupted by disease (this essentially stops metastasis in cancer and prevents HIV from being able to progress). These vaccines also contain DNA correction enzymes that enables disease removal from our genetic blueprint. This process is both enzymatic and immunologic.
  3. In most disease cases the immune system is exhausted and a fresh younger version is supplied from a bank or from children of the ill person. This can be more than just a younger fresher system. For example, if the measles or mumps are used to tag and attack cancer, and blood from children recently vaccinated against measles and mumps is used, then the immune response from the children will directly attack any cancer cells carrying the measles or the mumps virus.

This system, described as profound and exciting by Cedar Sinai Medical Center and UCLA, showed that the blood transfusions from children were an effective treatment for cancer and without side effects.

While Chachoua is correct that cancer is a genetic disease, he seems to vastly underestimate the complexity of the genetic derangements and mutations and how difficult it would be to correct them. As for blood transfusions curing cancer without side effects, first of all it’s not at all true that tranfusions are without side effects. They carry the risk of hypersensitivity reactions, disease, and the like. Second, using the MMR against cancer is highly experimental and uses an experimental genetically modified MMR vaccine instead of the standard MMR vaccine. Using the blood of one’s children recently vaccinated with MMR will not result in the child’s white cells attacking the cancer, and certainly Chachoua provides no evidence or publications to indicate otherwise. Indeed, his entire website suffers from what I like to call cite-openia in that he cites no scientific literature directly and just makes a lot of claims that have nothing to back them up.

I then perused some of his case studies, particularly the breast cancer case studies. To call them unconvincing is to be flattering. For instance, the first breast cancer case study shows two mammograms, one in which it’s claimed that the breast cancer is adherent to the chest wall (it doesn’t look like it to me) and then one after treatment in which it is claimed that the film “Clearly shows that the oval Cancer structure has shrunk and receded away from the muscle wall. This mass is now easier to resect and remove. Response was after four weeks of Dr. Chachoua’s therapy.” To me the cancer looks roughly the same size and any differences in appearance look like differences in mammographic technique.

Indeed, if there’s one thing that these “case histories” have in common it’s that the images of scans are such poor quality that it’s hard to say much about them one way or the other. Another thing is that frequently we’re not looking at the same thing. For instance, Chachoua shows a “before and after” image of a liver tumor and claims that the “image below it clearly shows the disappearance of one of the metastases (black hole) with shrinkage of the other after four weeks of therapy.” No, it doesn’t. Bad film quality aside, it looks as though these films were taken at two different levels, and the contrast is so different that it’s hard to say much of anything. Ditto the case with lung CTs. Another set of breast cancer “before and after” images shows no clear effect due to differences in technique of the mammograms. “Before and after” films of breast cancer metastases to the liver were taken at different levels.

At the bottom of the page, it states, “The slides and exhibit references all refer to evidence presented to the judge during Dr. Chachoua vs. Cedars Sinai. This is why they may seem non sequential.” No kidding.

Then, in the testimonials section, there are a bunch of testimonials of the type that regular readers have no doubt become familiar with, such as a thyroid tumor disappearing after a biopsy (small ones sometimes do; sometimes the biopsy is enough to remove them); a melanoma not completely excised by shave technique that hasn’t come back (this happens sometimes; incomplete excision increases the risk of recurrence greatly but the tumor doesn’t always come back); and the like. As is the case with such testimonials, it’s difficult or impossible to tell if Chachoua’s treatment had any effect.

Chachoua has, however, added a section on Charlie Sheen to his website. In it, he seems to mistake regular statistical “noise” you’ll see in any test of a very low to undetectable viral titer for actual effects, for instance mistaking a decline from 34 to undetectable as significant (anything under 50 is considered undetectable). There are some real howlers in it too:

It doesn’t matter if Cedars played with the numbers or not when they found out what Charlie was going to say on air. And nothing in Charlie’s history or life style would have taught him how viruses grow and spread. But if 700 is a true representation of what his counts were like after stopping Dr. Chachoua’s treatment for a week, then the virus was still being controlled otherwise, it would have been in the hundreds of thousands or millions. When Charlie stopped conventional therapy for a day, his count went up to 34.

In other words, if it weren’t for my woo, the viral load would have been hundreds of times higher! Of course, there’s no way to know that. Also:

1.) Again, when he stopped Dr. Chachoua’s medicines for two or three days, the virus remained non detectable and only went up after he abstained for a week. This makes it better than the conventional therapy.

Um, no. Just no.

2.) During the two months or so he was on this treatment, there was no detectable virus even though he was not taking any conventional medicine and was only taking Dr. Chachoua’s treatment. The virus was at lower counts i.e. non detectable to the more sensitive tests. He had not been able to achieve this in 5 years of normal treatment. This makes it better than conventional treatment.

Except that during much of that time period Sheen appears to have been still taking his antiretrovirals, and it’s not clear at all that Chachoua’s treatment had anything to do with this. Admittedly, it’s unclear exactly when Sheen stopped his HIV medications, but it doesn’t appear to have been for more than a month or so.

To me, the bottom line is that Chachoua is a quack, and Bill Maher sure does love him some quackery, so much so that he irresponsibly promoted Chachoua, lips planted firmly on Chachoua’s posterior, on Real Time With Bill Maher on Friday.

Bill Maher: Credulously promoting alternative medicine quackery

If there’s one person who is living proof that being an atheist has nothing to do with being a skeptic, it’s Bill Maher. Touting himself as being supremely rational in comparison to those “God botherers” and Republicans, Maher has himself embraced antivaccine pseudoscience, other cancer quackery, and general pseudoskepticism about “Western medicine.” Nor is this the first time he’s embraced HIV quackery, either. Indeed, I’ve been pointing out for more than a decade now just how much pseudoscience Maher embraces. Unfortunately, in some circles, that doesn’t seem to matter. For example, in 2009 Atheist Alliance International awarded Maher the Richard Dawkins Award, which was likened to Jenny McCarthy receiving a public health award.

So I suppose it’s not that surprising that Maher went full quack. I just never expected him to embrace so quacky a quack so credulously. My bad.

The first thing that bothered me about the interview was just how unethical it all was. Sure, I was a bit skeeved out by the things Dr. Huizenga revealed, but Sheen was right there and the doctor clearly had Sheen’s permission to discuss his case. There was no such deal in the case of Chachoua, who gleefully started disclosing private medical information about Sheen (and did so on his website as well, as discussed above), in clear violation of HIPAA law and medical ethics in general. For instance, he claims that Sheen had severe encephalitis, which, if true, would indicate that he needed to be hospitalized, not treated by a quack. After Chachoua’s description of Sheen keeping his house all dark, Maher quipped, that that was because of the hookers. (Stay classy. That’s all I can say.) Chachoua also claimed that Sheen had liver failure, which is certainly possible given his history of alcohol abuse.

Maher, for his part, does inject a little “skepticism” when he asks, in essence, how come anyone else doesn’t know about this if it’s so great. Interestingly, as is so often the case (I’m talking to you, Stanislaw Burzynski), Chachoua has a lovely conspiracy theory in which he claims UCLA and Cedar-Sinai Medical Center “came courting” him to test out his work in the mid 1990s, which might actually be true given that the NIH was at the time being politically pressured to examine alternative cancer cures. As is the usual case, this collaboration, if it ever happened, didn’t turn out well. If you believe Chachoua, “they published it on their own and buried it.” Well, certainly there are no publications by Chachoua about it. Searching PubMed didn’t turn up anything. There is another Chachoua who has published about AIDs, but it obviously isn’t Samir Chachoua.

So what is Chachoua’s claim? Maher played an excerpt from this old news clip (the video quality stinks, unfortunately):

It’s a story about a $10 million judgment against Cedar-Sinai for Samir Chachoua for allegedly taking or losing cultures of many of the microorganisms that Chachoua claimed to be able to use to treat and cure cancer and AIDS. (It was at this point that I asked: What kind of idiot gives anyone all of his cultures and doesn’t save aliquots for himself?) It’s a very credulous report. Of course, Maher neglects to mention a very important bit of followup information about that lawsuit, namely that it was dismissed (more on that in a moment), instead choosing to let Chachoua blather on about how he studied spontaneous remission and that led him to his ideas. Meanwhile, Maher waxes poetic about “groupthink” in Western medicine (irony meter destroyed—again) and how it’s usually individuals not working for institutions who discover things (maybe 150 years ago, but not any more, and of course, many of the examples cited did work for hospitals or universities).

He also let Chachoua outright lie. I’m sorry, but it’s hard to see how I can characterize what Chachoua said when he claimed that all of Sheen’s great tests were during his treatment, not his conventional doctors, any other way. Of course, the plummeting of Sheen’s viral load happened in 2011, four years before he ever met Chachoua. Yet Maher never challenged even that blatant of a lie. Instead, he climbed up on his own cross, prefacing his question with an observation about how he would be attacked for featuring Chachoua (consider it done) and Chachoua had been called a quack (which he is). His question was: Does it last? In response, Chachoua claimed that his vaccine had eradicated HIV in a small country (Comoros). It was the sort of obscure claim that most wouldn’t be able to check, but someone on Twitter did:

@MarkHoofnagle @gorskon @DrJenGunter @billmaher Claims to have eliminated HIV in Comoros. https://t.co/CrO0nvx6rE pic.twitter.com/2RMw5TUFjR

— tangentgirl (@derivative_of_f) January 31, 2016

What’s wrong, Bill? Couldn’t your fact checkers have bothered to Google?

Finally, what really happened with the Cedar-Sinai lawsuit? The judge tossed it out on appeal, stating that the award was based on speculative testimony. Chachoua only received $11,250. HIV activist Peter Staley points out:

The $10 million case that “Doctor” Sam Chachoua claims he won from L.A.’s Cedars-Sinai Medical Center was another lie he told to Bill Maher. The court immediately reduced the “breach of contract” damages to $11,250 (in 2001). Cedars then successfully sued for recovery of their own court costs, in excess of that amount, and Chachoua started missing court dates after that. His own lawyer quit the case at that point. Cedars never paid him a dime.

I paid small amounts to look at the case reports, which are endless, starting in 1997, and ending in 2004. One of the court’s orders called it “the longest case in this court’s history.” If any of my legal friends want to provide a fuller account of these record, which are accessible with a PACER account, you can find them all here:

https://ecf.cacd.uscourts.gov/cgi-bin/HistDocQry.pl?891618340300786-L_1_0-1

The central reason listed for dismissing the case was:

[Chachoua’s] consistent refusal to comply with court orders regarding representation; his pattern of using medical excuses as a device to prolong the action unnecessarily, avoid appearances for deposition or other court proceedings, and obtain continuances at the last minute; and his pattern of substituting counsel in order to secure deadline extensions or continuances of potentially dispositive proceedings.

Staley and Gay City News reporter Duncan Osbourne have also pointed out that Chachoua charges big bucks for his “cures,” with one patient paying him $603,000 and then another $21 million over time for treatments that didn’t work. Even Stanislaw Burzynski isn’t that greedy.

In the past, I’ve said that nothing Maher could say or do would surprise me any more. I was mistaken. As highly critical as I’ve been of his promotion of antivaccine pseudoscience and outright quackery, even I never thought he’d fall for such an obvious cancer quack hook, line, and sinker like this or that he’d let this quack repeat such obvious misinformation, all while admiringly lapping it up. I mention destruction of irony meters, but at the end of his show, the rest of which was fairly standard issue Maher-led political commentary and snark, Maher declared that “Lies are the new truth” thanks to the Internet:

Now there’s an irony meter so well and truly fried that it’s been vaporized. Bill Maher just doesn’t realize it, so far down the rabbit hole of antivaccine pseudoscience and cancer quackery he’s fallen.

Categories: Medicine, Skepticism
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