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Separating Fact from Fiction in the Not-So-Normal Newborn Nursery: Chiropractic and Craniosynostosis

Science Based Medicine - Fri, 03/27/2015 - 09:11

Pediatricians, particularly those who spend a significant amount of time caring for newborns, see a lot of babies with unusually-shaped heads. Although to be fair, the fact that the overwhelming majority of vaginally-delivered babies, and quite a few born via Caesarean section, will have a transient and abnormal shape to their heads makes it, well, not unusual. In fact, I rarely make it out of the room without some discussion and reassurance regarding the lumps and bumps of a new arrival’s head.

The potentially lumpy and misshapen head of the newborn occurs for a variety of reasons, some common and some extremely rare. It often is related to the development of the bones of the skull but can also involve the surrounding tissues of the scalp. A vaginal delivery, and some difficult Caesarean births, subject a baby’s head to a lot of pressure. This pressure frequently results in swelling of the scalp that can be quite impressive, but tends to resolve in a day or two.

This same pressure can also cause bleeding, perhaps because of an insufficient amount of vitamin K available to optimally activate clotting, that collects under the top layer of one or more of the bones of the skull. These cephalohematomas can also be impressive and may take weeks to completely resolve. Rarely the trapped blood becomes calcified and requires surgical correction to remove the otherwise-permanent lump and restore a normal contour to the head.

Newborns very frequently have a molded skull. Depending on the timing and severity of the pressure experienced during delivery, the shape and size of the uterus and positioning of the baby in the womb, the newborn can emerge with a variety of head shapes. The most common one that I see is a cone. If you’re thinking of a classic Saturday Night Live sketch right now, you’ve got the correct mental image.

Babies who are breech also have a distinct pattern of molding which involves a flattened and elongated top of the head because of pressure against the uterine wall. Abnormal positioning in the womb can also result in asymmetric molding of the head and facial structures like the jaw, nose and ear. Fortunately these pressure-induced and positional deformities usually resolve without intervention, often within a few days, but some are serious enough to require intervention and even surgical correction.

Why are the cranial bones of newborns so easily molded by the pressure of birth? This is a question I answer frequently for new parents and inexperienced medical students. The answer will segue us into the primary topic of this post, but before I discuss craniosynostosis, and the sadly unsurprising claims of some in the chiropractic community, a review of normal cranial anatomy is in order.

Why are newborn skulls so easily molded?

The skull of a typical healthy newborn is not just one large bone but is actually comprised of several bony plates, each joined by fibrous joints called sutures. These sutures, the major ones running mid-line down the top (sagittal) and diagonally and bilateral at the front (coronal) and back (lambdoid) of the skull, are made of strong connective tissue similar to the attachments of the teeth to the bony sockets. When fused, they allow minimal but usually clinically-insignificant movement.

But sutures in the newborn, the most well-known being the “soft spots” at the front and back of the skull, are not normally fused. The ability to shift freely with significant pressure allows for molding, so the skull doesn’t fracture or become stuck as it makes its way through the pelvis, and for the safe growth of the brain over the first two decades of life. The most rapid period of brain growth, the first two years of life, results in a brain that is four times larger than at birth. Without the ability to accommodate the expansion of the brain, a variety of problems can arise.

What is the normal pattern of cranial growth and fusion?

As the brain grows, it exerts outward pressure which pushes the bones of the skull apart. In response, new bone is formed along the edges of the cranial bones at the sutures. So appropriate growth, and this is important for later discussion of abnormal early fusion, occurs perpendicular to the suture line.

Normal fusion of the bones of the skull occurs in a reproducible pattern. At roughly two months of age, the posterior fontanel should be closed. At around two years, the anterior fontanel should no longer be palpable. The linear sutures fuse more slowly, with completion not occurring until well after full growth is achieved, but the ability of the bones to move relative to themselves to any meaningful degree is gone by two to three years of age. And prior to that it would still require significant amounts of pressure that would risk pain and injury to the skull and underlying brain.

What happens when fusion of cranial bones occurs too early?

Abnormal early fusion of one or more of the cranial sutures, known as craniosynostosis, is diagnosed in roughly 1 out of every 2000 to 2500 babies around the world. In a bit over half of cases, early fusion affects the sagittal suture that runs down the top of the head and separates the parietal bones of the skull. The second most common location is the coronal suture which runs from ear to ear separating the frontal and parietal bones.

Most of the time, craniosynostosis is an isolated abnormality with only partial fusion of one suture. But multiple sutures are prematurely fused in about 10% of cases, and this generally occurs due to a genetic syndrome with other dysmorphic features, such as cleft palate and fusion of the finger bones. Several specific gene defects resulting in craniosynostosis syndromes have been identified, typically in the fibroblast growth factor receptor family, the most well-known examples being Apert, Crouzon and Pfeiffer syndrome.

When a suture is fused too early, it restricts the growth of the skull in a predictable way. Remember earlier when I pointed out that normal growth occurs perpendicular to the suture line? If a suture is fused, normal perpendicular growth can’t occur, which accentuates growth at the sutures that aren’t fused because of increased pressure. So growth of the head will only occur parallel to the fused sutures.

For example, in the case of sagittal suture fusion the head tends to become strikingly long and narrow, a shape known as scaphocephaly. This translates to “boat skull.” When the coronal suture is fused prematurely on both sides of the forehead, the resulting shape is known as brachycephaly or “short skull.” The skull will be shortened from front to back but abnormally wide, and if untreated will begin to preferentially grow upward as well. So depending on which sutures are fused before their time, and if the fusion occurs on one or both sides of the head, there are a variety of recognized pathognomonic shapes ranging from mild to extreme.

How is craniosynostosis diagnosed and treated?

The diagnosis of abnormal early fusion of one or more sutures should be suspected when the shape of the head is abnormal. In the case of genetic syndromes, when multiple sutures are involved and associated dysmorphic features are present, it can be fairly easy to recognize. When the sagittal suture is involved, as it is in about half of cases, the classic head shape is an extremely helpful clue. But in the case of isolated non-syndromic premature fusion of other sutures, it isn’t always clear because abnormal head shape related to positioning of the infant’s head during sleep can mimic craniosynostosis.

Pediatricians see a lot of what is known as positional plagiocephaly (“twisted skull”), a phenomenon which increased significantly after universal recommendations that young infants sleep only on their backs in order to reduce the risk of SIDS. When children sleep on their backs, and especially when they have a persistent side preference, there can be significant flattening to one side of the skull. This is also more common in babies with difficulty turning the head from side to side, as occurs in a condition known as torticollis, or when they have neurological injury or disease resulting in difficulty moving at all.

It is important to consider conditions that mimic craniosynostosis because they can often be managed successfully without surgery. Positional plagiocephaly often responds to lifestyle changes, such as increased time off the back and repositioning of the head during sleep, and to physical therapy in the case of torticollis. Often suspected mild craniosynostosis resolves spontaneously before any significant diagnostic work-up is initiated. When it is severe, or doesn’t improve after a few weeks of conservative measures, the appropriate means of confirming the diagnosis is CT imaging of the skull.

Timely diagnosis and treatment of craniosynostosis is very important in order to prevent the development of complications. The most concerning potential complication is increased intracranial pressure and impaired growth of the brain. Untreated craniosynostosis can result in cognitive deficits and neurodevelopmental delays in feeding, vision, hearing and speech. It can also be a cosmetic concern that shouldn’t be taken lightly as it is linked with difficulty in social development that can have lifelong repercussions.

Except in very mild cases that are not associated with risk of increased intracranial pressure or problems with socialization, surgery is required. The complexity of management is naturally determined by the severity of the presentation and the presence of other dysmorphic features such as a cleft palate. Optimal outcomes depend on a multi-disciplinary approach that involves surgeons, pediatricians, dentists, a variety of other medical subspecialists, and various therapists. Many pediatric facilities have craniofacial teams set up for just such situations.

What does chiropractic have to do with craniosynostosis?

Unfortunately, there are practitioners of so-called complementary and alternative (or integrative) medicine out there claiming to be able to correct abnormally-shaped infant skulls. Long time readers of SBM are probably familiar with the pseudoscience known as craniosacral therapy. Drs. Hall, Crislip, and Ritchey have discussed this topic in detail in the past, although not in the setting of treating craniosynostosis. Of note, Dr. Hall links to the report of a 2-day-old child who died from injury to the brain caused by craniosacral therapy at the hands of a rogue dentist.

As I have discussed in prior posts, there are few things that chiropractors love more than a good anecdote trumped up as a case report and published in one of their low-quality journals. In fact, my first post for SBM looked at one such example of chiropractic “research” as it applies to the treatment of Tourette syndrome. Case reports when properly utilized, and their inherent weaknesses taken into account, can be a meaningful component of science-based medicine. But in the world of chiropractic they are frequently used to make inappropriate claims of treatment efficacy and as part of practice-building efforts.

One such case report exists for the use of chiropractic to correct potential craniosynostosis, the low plausibility of which rivals even homeopathy. Authored by chiropractor Joel Alcantara, the Director of Research for the International Chiropractic Pediatric Association, and published in their Journal of Pediatric, Maternal & Family Health – Chiropractic, the report discusses a 3-week-old infant supposedly diagnosed with craniosynostosis by her obstetrician and pediatrician.

The mother of the infant is described as having sought out chiropractic care during a period of recommended observation. If at that point the problem had not resolved, imaging and surgery would be arranged. The report describes the child as having a fused posterior fontanel, something that can’t be diagnosed by simple palpation, and an open but small anterior fontanel. It then describes the discovery of subluxations at multiple locations along the spine as well as the right temporomandibular joint. There were apparently also “cranial distortions of the right frontal/parietal and left parietal/occipital bones.”

The patient underwent “specific, gentle high velocity, low-amplitude type thrust” to the subluxations, as well as craniosacral therapy. After six visits, her “skull diameter” increased by roughly 5 cm from 34.5 to 39.2 cm. This is odd considering that skull diameter is not a routine measurement. I assume that they mean head circumference, which is on average 34.5 cm at birth in a term infant. If accurate, this demonstrates normal growth of the child’s head.

After her series of 13 chiropractic adjustments and “craniosacral therapy”, she was evaluated by appropriate medical professionals at almost 4 months of age who determined that surgery was not indicated. This is wonderful news of course, but it had absolutely nothing to do with subluxations or cranial distortions. From what I can piece together using the abstract, accompanying press release and some online discussion of the case by a chiropractor on her practice website, the child likely never had craniosynostosis.

Craniosynostosis is often only suspected by pediatricians. In the case of a nonsyndromic child with potential isolated early fusion, a period of observation prior to exposing them to the ionizing radiation of a CT scan can be very appropriate. These children are seen regularly to monitor for worsening of the shape of the head despite conservative measures, and signs or symptoms of increased intracranial pressure, and in many cases imaging and surgery are not needed. A false alarm is orders of magnitude more likely than chiropractic intervention reversing a fused suture, something which would require more force than pulling out a healthy tooth.

Alcantra, the author of the case report, was considerably more optimistic about the findings:

In this case we have a defect in the infant’s skull that did not require a planned surgery following a trial of chiropractic care of the spine and skull.

And:

While this is only a single case study, it shows what can happen when chiropractic to correct spinal and cranial distortions is included as a health care option for children.

In the press release, the journal’s editor Mathew McCoy also seems to conclude that the case proves efficacy:

Chiropractors work with the alignment and movement of the bones that make up the spine and many chiropractors also work on the bones of the skull, especially in children where its normal development is so crucial. So it is not so surprising that you’d see this type of outcome.

I agree that it isn’t surprising, but not that chiropractic had anything to do with it.

Unfortunately, it isn’t just that chiropractors are touting their ability to manipulate the positioning of the bones of the skull and unlock fused sutures. I easily found the blogs of clearly well-meaning but misinformed parents discussing their use of chiropractic for craniosynostosis. This post, which is found very high on Google when searching “chiropractic AND craniosynostosis” implies that it has benefit. If curious families don’t read the future posts, they won’t see that when imaging was eventually performed there was no improvement and successful surgery took place.

Conclusion

Abnormal head shape in the newborn period is extremely common and has varied causes. Premature fusion of the cranial bones, while less common, is a very serious condition that generally requires surgical correction because fused sutures are extremely strong. Improperly managed, craniosynostosis can lead to lifelong developmental delays, cognitive impairment and psychosocial difficulties.

Chiropractors who claim to be able to shift the bones of the skull, especially in children with craniosynostosis, are deluded. There is no evidence that chiropractic subluxations exist let alone play a role in the shape of the head. And it would take extreme pressure to move unfused skull bones, which would risk harming or even killing a young infant. Luckily, craniosacral therapy typically involves nothing more than a head massage and most chiropractors use gentle adjusting techniques.

Taking money from families without providing any actual benefit is wrong, but it isn’t my main concern. Abnormal head shapes do often correct on their own if related to birth pressure, which can give the appearance of chiropractic success, but many babies require true intervention. Education on proper positioning, physical therapy and even fitted helmets are common non-surgical treatments. If parents are delaying science-based medical care, it risks poor cosmetic and psychosocial outcomes. And if a child has actual craniosynostosis, improper management can also be dangerous.

 

 

Categories: Medicine, Skepticism

Separating Fact from Fiction in the Not-So-Normal Newborn Nursery: Chiropractic and Craniosynostosis

Science Based Medicine - Fri, 03/27/2015 - 09:11

Pediatricians, particularly those who spend a significant amount of time caring for newborns, see a lot of babies with unusually-shaped heads. Although to be fair, the fact that the overwhelming majority of vaginally-delivered babies, and quite a few born via Caesarean section, will have a transient and abnormal shape to their heads makes it, well, not unusual. In fact, I rarely make it out of the room without some discussion and reassurance regarding the lumps and bumps of a new arrival’s head.

The potentially lumpy and misshapen head of the newborn occurs for a variety of reasons, some common and some extremely rare. It often is related to the development of the bones of the skull but can also involve the surrounding tissues of the scalp. A vaginal delivery, and some difficult Caesarean births, subject a baby’s head to a lot of pressure. This pressure frequently results in swelling of the scalp that can be quite impressive, but tends to resolve in a day or two.

This same pressure can also cause bleeding, perhaps because of an insufficient amount of vitamin K available to optimally activate clotting, that collects under the top layer of one or more of the bones of the skull. These cephalohematomas can also be impressive and may take weeks to completely resolve. Rarely the trapped blood becomes calcified and requires surgical correction to remove the otherwise-permanent lump and restore a normal contour to the head.

Newborns very frequently have a molded skull. Depending on the timing and severity of the pressure experienced during delivery, the shape and size of the uterus and positioning of the baby in the womb, the newborn can emerge with a variety of head shapes. The most common one that I see is a cone. If you’re thinking of a classic Saturday Night Live sketch right now, you’ve got the correct mental image.

Babies who are breech also have a distinct pattern of molding which involves a flattened and elongated top of the head because of pressure against the uterine wall. Abnormal positioning in the womb can also result in asymmetric molding of the head and facial structures like the jaw, nose and ear. Fortunately these pressure-induced and positional deformities usually resolve without intervention, often within a few days, but some are serious enough to require intervention and even surgical correction.

Why are the cranial bones of newborns so easily molded by the pressure of birth? This is a question I answer frequently for new parents and inexperienced medical students. The answer will segue us into the primary topic of this post, but before I discuss craniosynostosis, and the sadly unsurprising claims of some in the chiropractic community, a review of normal cranial anatomy is in order.

Why are newborn skulls so easily molded?

The skull of a typical healthy newborn is not just one large bone but is actually comprised of several bony plates, each joined by fibrous joints called sutures. These sutures, the major ones running mid-line down the top (sagittal) and diagonally and bilateral at the front (coronal) and back (lambdoid) of the skull, are made of strong connective tissue similar to the attachments of the teeth to the bony sockets. When fused, they allow minimal but usually clinically-insignificant movement.

But sutures in the newborn, the most well-known being the “soft spots” at the front and back of the skull, are not normally fused. The ability to shift freely with significant pressure allows for molding, so the skull doesn’t fracture or become stuck as it makes its way through the pelvis, and for the safe growth of the brain over the first two decades of life. The most rapid period of brain growth, the first two years of life, results in a brain that is four times larger than at birth. Without the ability to accommodate the expansion of the brain, a variety of problems can arise.

What is the normal pattern of cranial growth and fusion?

As the brain grows, it exerts outward pressure which pushes the bones of the skull apart. In response, new bone is formed along the edges of the cranial bones at the sutures. So appropriate growth, and this is important for later discussion of abnormal early fusion, occurs perpendicular to the suture line.

Normal fusion of the bones of the skull occurs in a reproducible pattern. At roughly two months of age, the posterior fontanel should be closed. At around two years, the anterior fontanel should no longer be palpable. The linear sutures fuse more slowly, with completion not occurring until well after full growth is achieved, but the ability of the bones to move relative to themselves to any meaningful degree is gone by two to three years of age. And prior to that it would still require significant amounts of pressure that would risk pain and injury to the skull and underlying brain.

What happens when fusion of cranial bones occurs too early?

Abnormal early fusion of one or more of the cranial sutures, known as craniosynostosis, is diagnosed in roughly 1 out of every 2000 to 2500 babies around the world. In a bit over half of cases, early fusion affects the sagittal suture that runs down the top of the head and separates the parietal bones of the skull. The second most common location is the coronal suture which runs from ear to ear separating the frontal and parietal bones.

Most of the time, craniosynostosis is an isolated abnormality with only partial fusion of one suture. But multiple sutures are prematurely fused in about 10% of cases, and this generally occurs due to a genetic syndrome with other dysmorphic features, such as cleft palate and fusion of the finger bones. Several specific gene defects resulting in craniosynostosis syndromes have been identified, typically in the fibroblast growth factor receptor family, the most well-known examples being Apert, Crouzon and Pfeiffer syndrome.

When a suture is fused too early, it restricts the growth of the skull in a predictable way. Remember earlier when I pointed out that normal growth occurs perpendicular to the suture line? If a suture is fused, normal perpendicular growth can’t occur, which accentuates growth at the sutures that aren’t fused because of increased pressure. So growth of the head will only occur parallel to the fused sutures.

For example, in the case of sagittal suture fusion the head tends to become strikingly long and narrow, a shape known as scaphocephaly. This translates to “boat skull.” When the coronal suture is fused prematurely on both sides of the forehead, the resulting shape is known as brachycephaly or “short skull.” The skull will be shortened from front to back but abnormally wide, and if untreated will begin to preferentially grow upward as well. So depending on which sutures are fused before their time, and if the fusion occurs on one or both sides of the head, there are a variety of recognized pathognomonic shapes ranging from mild to extreme.

How is craniosynostosis diagnosed and treated?

The diagnosis of abnormal early fusion of one or more sutures should be suspected when the shape of the head is abnormal. In the case of genetic syndromes, when multiple sutures are involved and associated dysmorphic features are present, it can be fairly easy to recognize. When the sagittal suture is involved, as it is in about half of cases, the classic head shape is an extremely helpful clue. But in the case of isolated non-syndromic premature fusion of other sutures, it isn’t always clear because abnormal head shape related to positioning of the infant’s head during sleep can mimic craniosynostosis.

Pediatricians see a lot of what is known as positional plagiocephaly (“twisted skull”), a phenomenon which increased significantly after universal recommendations that young infants sleep only on their backs in order to reduce the risk of SIDS. When children sleep on their backs, and especially when they have a persistent side preference, there can be significant flattening to one side of the skull. This is also more common in babies with difficulty turning the head from side to side, as occurs in a condition known as torticollis, or when they have neurological injury or disease resulting in difficulty moving at all.

It is important to consider conditions that mimic craniosynostosis because they can often be managed successfully without surgery. Positional plagiocephaly often responds to lifestyle changes, such as increased time off the back and repositioning of the head during sleep, and to physical therapy in the case of torticollis. Often suspected mild craniosynostosis resolves spontaneously before any significant diagnostic work-up is initiated. When it is severe, or doesn’t improve after a few weeks of conservative measures, the appropriate means of confirming the diagnosis is CT imaging of the skull.

Timely diagnosis and treatment of craniosynostosis is very important in order to prevent the development of complications. The most concerning potential complication is increased intracranial pressure and impaired growth of the brain. Untreated craniosynostosis can result in cognitive deficits and neurodevelopmental delays in feeding, vision, hearing and speech. It can also be a cosmetic concern that shouldn’t be taken lightly as it is linked with difficulty in social development that can have lifelong repercussions.

Except in very mild cases that are not associated with risk of increased intracranial pressure or problems with socialization, surgery is required. The complexity of management is naturally determined by the severity of the presentation and the presence of other dysmorphic features such as a cleft palate. Optimal outcomes depend on a multi-disciplinary approach that involves surgeons, pediatricians, dentists, a variety of other medical subspecialists, and various therapists. Many pediatric facilities have craniofacial teams set up for just such situations.

What does chiropractic have to do with craniosynostosis?

Unfortunately, there are practitioners of so-called complementary and alternative (or integrative) medicine out there claiming to be able to correct abnormally-shaped infant skulls. Long time readers of SBM are probably familiar with the pseudoscience known as craniosacral therapy. Drs. Hall, Crislip, and Ritchey have discussed this topic in detail in the past, although not in the setting of treating craniosynostosis. Of note, Dr. Hall links to the report of a 2-day-old child who died from injury to the brain caused by craniosacral therapy at the hands of a rogue dentist.

As I have discussed in prior posts, there are few things that chiropractors love more than a good anecdote trumped up as a case report and published in one of their low-quality journals. In fact, my first post for SBM looked at one such example of chiropractic “research” as it applies to the treatment of Tourette syndrome. Case reports when properly utilized, and their inherent weaknesses taken into account, can be a meaningful component of science-based medicine. But in the world of chiropractic they are frequently used to make inappropriate claims of treatment efficacy and as part of practice-building efforts.

One such case report exists for the use of chiropractic to correct potential craniosynostosis, the low plausibility of which rivals even homeopathy. Authored by chiropractor Joel Alcantara, the Director of Research for the International Chiropractic Pediatric Association, and published in their Journal of Pediatric, Maternal & Family Health – Chiropractic, the report discusses a 3-week-old infant supposedly diagnosed with craniosynostosis by her obstetrician and pediatrician.

The mother of the infant is described as having sought out chiropractic care during a period of recommended observation. If at that point the problem had not resolved, imaging and surgery would be arranged. The report describes the child as having a fused posterior fontanel, something that can’t be diagnosed by simple palpation, and an open but small anterior fontanel. It then describes the discovery of subluxations at multiple locations along the spine as well as the right temporomandibular joint. There were apparently also “cranial distortions of the right frontal/parietal and left parietal/occipital bones.”

The patient underwent “specific, gentle high velocity, low-amplitude type thrust” to the subluxations, as well as craniosacral therapy. After six visits, her “skull diameter” increased by roughly 5 cm from 34.5 to 39.2 cm. This is odd considering that skull diameter is not a routine measurement. I assume that they mean head circumference, which is on average 34.5 cm at birth in a term infant. If accurate, this demonstrates normal growth of the child’s head.

After her series of 13 chiropractic adjustments and “craniosacral therapy”, she was evaluated by appropriate medical professionals at almost 4 months of age who determined that surgery was not indicated. This is wonderful news of course, but it had absolutely nothing to do with subluxations or cranial distortions. From what I can piece together using the abstract, accompanying press release and some online discussion of the case by a chiropractor on her practice website, the child likely never had craniosynostosis.

Craniosynostosis is often only suspected by pediatricians. In the case of a nonsyndromic child with potential isolated early fusion, a period of observation prior to exposing them to the ionizing radiation of a CT scan can be very appropriate. These children are seen regularly to monitor for worsening of the shape of the head despite conservative measures, and signs or symptoms of increased intracranial pressure, and in many cases imaging and surgery are not needed. A false alarm is orders of magnitude more likely than chiropractic intervention reversing a fused suture, something which would require more force than pulling out a healthy tooth.

Alcantra, the author of the case report, was considerably more optimistic about the findings:

In this case we have a defect in the infant’s skull that did not require a planned surgery following a trial of chiropractic care of the spine and skull.

And:

While this is only a single case study, it shows what can happen when chiropractic to correct spinal and cranial distortions is included as a health care option for children.

In the press release, the journal’s editor Mathew McCoy also seems to conclude that the case proves efficacy:

Chiropractors work with the alignment and movement of the bones that make up the spine and many chiropractors also work on the bones of the skull, especially in children where its normal development is so crucial. So it is not so surprising that you’d see this type of outcome.

I agree that it isn’t surprising, but not that chiropractic had anything to do with it.

Unfortunately, it isn’t just that chiropractors are touting their ability to manipulate the positioning of the bones of the skull and unlock fused sutures. I easily found the blogs of clearly well-meaning but misinformed parents discussing their use of chiropractic for craniosynostosis. This post, which is found very high on Google when searching “chiropractic AND craniosynostosis” implies that it has benefit. If curious families don’t read the future posts, they won’t see that when imaging was eventually performed there was no improvement and successful surgery took place.

Conclusion

Abnormal head shape in the newborn period is extremely common and has varied causes. Premature fusion of the cranial bones, while less common, is a very serious condition that generally requires surgical correction because fused sutures are extremely strong. Improperly managed, craniosynostosis can lead to lifelong developmental delays, cognitive impairment and psychosocial difficulties.

Chiropractors who claim to be able to shift the bones of the skull, especially in children with craniosynostosis, are deluded. There is no evidence that chiropractic subluxations exist let alone play a role in the shape of the head. And it would take extreme pressure to move unfused skull bones, which would risk harming or even killing a young infant. Luckily, craniosacral therapy typically involves nothing more than a head massage and most chiropractors use gentle adjusting techniques.

Taking money from families without providing any actual benefit is wrong, but it isn’t my main concern. Abnormal head shapes do often correct on their own if related to birth pressure, which can give the appearance of chiropractic success, but many babies require true intervention. Education on proper positioning, physical therapy and even fitted helmets are common non-surgical treatments. If parents are delaying science-based medical care, it risks poor cosmetic and psychosocial outcomes. And if a child has actual craniosynostosis, improper management can also be dangerous.

 

 

Categories: Medicine, Skepticism

Dark Matter Collisions

Neurologica Blog - Fri, 03/27/2015 - 08:05

The existence of dark matter is one of the coolest science stories of my lifetime. When I was growing up I was in love with pretty much every field of science, but particularly with astronomy, and at that time we had no idea that 85% of the matter in the universe even existed. We now know that the astronomy I was so fascinated with was actually the study of 15% of the matter in the universe. If you count dark energy, which makes up 68% of the universe, then dark matter makes up 27%, and everything that we thought was the entire universe is actually only 5% of the universe.

This story dramatically contradicts every crank and pseudoscientist who tries to tell you that scientists only support the status quo. In my lifetime we discovered 95% of the universe, without any prior theory telling us to expect this result. (Dark matter was hinted at in observations of galaxy rotation, but not generally accepted.) The discoveries were based on unexpected observations, that broke our models of how we thought the universe worked. Scientists met these new ideas with skepticism, but explored them further, and were slowly convinced by mounting evidence. Now dark matter and dark energy are generally accepted – because the evidence convinced the scientists. That is how science works, kids, so don’t believe the cranks.

Dark matter is a powerful idea, even though we currently don’t know what it is, because it not only explains observations that otherwise don’t make sense, it makes predictions. Predictions are the key to scientific progress. They provide the opportunity to test ideas against reality. If an idea does not make any testable predictions, right or wrong it’s just worthless. (Not even wrong.)

The first hint of dark matters existence was in the observation of galaxy rotations. In short, the stars in the outer parts of galaxies are moving faster than can be explained by Newtonian gravity and the mass of observable stars. There were some preliminary observations to this effect, but it did not come to serious scientific light until Vera Rubin published her influential paper in 1980, based on her work over the previous decade plus. She showed, using the most accurate observations to date, that stars in spiral galaxies all orbited at roughly the same speed. This means that the mass of spiral galaxies increased linearly as you go out from the core, but this could not be explained by observable matter. Galaxies must be comprised of at least 50% invisible, or dark, matter.

An alternate theory, that of modified Newtonian dynamics (MOND), states that the gravitation constant is different at really large (galactic) scales and this explains the observations. This remains a minority opinion, and more recent observations seem to have killed MOND in favor of dark matter.

Those more recent observations indicate that dark matter is not just regular matter that is obscured by dust clouds or hidden from view for some other reason. Dark matter is actually a new and unknown type of matter, because it behaves unlike other known matter. The clincher comes from the observation of collisions between galaxy clusters. The first such observation was of the bullet cluster in 2006. 

Using the Chandra X-ray telescope, astronomers observed this collision of galaxy clusters. What they found was the the visible matter in the cluster slowed as they crashed into each other, as would be expected. This is because the matter in the two clusters interact with each other, causing the slow down. The astronomers also observed the gravitational lensing effect of the cluster. In essence, they could see the shape of the gravity of the colliding clusters. What they found was that the center of gravity of the two clusters had continued to move past each other, hardly interacting at all, even while the visible matter had crashed into each other and slowed down.

What this means is that dark matter, which contains most of the gravity, interacts very weakly with regular matter and with itself. It’s non-gravitational interaction is very minimal. In fact, astronomers could use the observation of the bullet cluster to set limits on this non-gravitational interaction of dark matter.

One data point is never satisfying to scientists, however. This brings us to a new study and the inspiration for today’s post. Astronomers have just published observations of 72 similar collisions of galaxy clusters. They write:

Using the Chandra and Hubble Space Telescopes, we have now observed 72 collisions, including both major and minor mergers. Combining these measurements statistically, we detect the existence of dark mass at 7.6σ significance.

The 7.6σ significance (or sigma) is a huge degree of confidence. Five sigma is generally considered to be the level of certainty in a data set where the results can be taken as true. This corresponds to a one chance in 3.5 million that the results were due to random chance. A result of 7.6 sigma is well beyond significant.

In other words – dark matter exists. It is a real thing. It is an unknown type of matter that has a strong gravitational field, but otherwise only very weakly interacts with other matter, including other dark matter.

We don’t know what dark matter is, but this new result gives us one more piece to the puzzle. The authors note that the results are, “disfavoring some proposed extensions to the standard model.”

I do hope I live to see this decades long science news story progress to the point where we know what dark matter actually is. But even if that discovery is still decades away, it has been an amazing ride. When I was born we thought we knew what the universe was made of, but our knowledge only encompassed 5% of the actual universe. Now, at least, we have a better idea of the extent of our ignorance, which is the beginning of discovery.

We now have very good evidence that 27% of the universe is made of an unknown type of matter that has gravity but otherwise only weakly interacts. We are gathering clues as to what this dark matter is and what it isn’t. Eventually we’ll figure out what it is. That knowledge will likely just create further mysteries for scientists to explore.

 

 

Categories: Medicine

Fox News, the NFL, and Concussion Denial

Neurologica Blog - Thu, 03/26/2015 - 08:08

I have been a fan of professional football since my college days (go Pats) but I also recognize that it is a brutal sport prone to injuries. In recent years awareness of the true neurological risk of concussions, especially repeated concussions, has been increasingly coming to light. This may cause some cognitive dissonance among fans, players, and anyone involved with the NFL, including broadcasters.

Recently Fox News published and article in which Dylan Gwinn writes:

Don’t look now, but concussions have become the new global warming: a debate where “consensus” trumps evidence, and heroes and villains are determined by their stances on an issue where the science is bogus at worst and murky at best.

This is classic FUD – fear, uncertainty, and doubt, the primary tactic of those who find reality not to their liking in some particular aspect.

Gwinn creates the classic false dichotomy between consensus and evidence. What if the consensus is based upon scientific evidence, and in fact the consensus of experts is the best way for non-experts to understand what the evidence actually says.

Further, all science is murky, at least to some degree. The clarity of a scientific conclusion exists along a spectrum from genuinely controversial to rock solid, but scientific evidence is always complex, subject to multiple interpretations, and incomplete. It doesn’t take much creativity to portray any scientific conclusion (even those at the rock solid end of the spectrum) as murky. Creationists are evidence of that.

Gwinn also does not address another issue at the core of this debate – the precautionary principle. This is the notion that it is best to err on the side of caution regarding a potential harm when the science is still preliminary. Application of the precautionary principle is admittedly complex and is easily abused. I write often about abuse of the precautionary principle when it comes to vaccines, GMO, and unnamed “toxins.” I also write about ignoring the precautionary principle when it comes to things like global warming, and now concussions from playing contact sports. These represent opposite extremes, when the reasonable position is somewhere in the middle, with Aristotle’s golden mean.

Abuse of the precautionary principle generally takes the form of overhyping possible risks, cherry picking evidence suggesting risk, ignoring, dismissing, or downplaying evidence of safety, and demanding unreasonable assurances of “zero risk.”

Ignoring the precautionary principle usually takes the form of FUD – we don’t know everything, so let’s act as if we know nothing and ignore potential risks. Until you can prove beyond doubt that the risk is real, we should not take any steps to mitigate it, even if by the time the risk is certain it will be too late.

There is no simple algorithm to calibrate where an issue lies along this spectrum. It takes a working knowledge of the science along with a fair and nuanced evaluation of all the relevant issues. Personally I have absolutely no idea if the planet is warming due to human activity. By this I mean that I am not competent to look at the raw data and meaningfully evaluate it while putting it into the context of a thorough understanding of climatology. That is because I am not a climatologist, and the kinds of data they deal with are not really accessible to a non-expert. I am dependent on the consensus of expert opinion. I can decide if their arguments make general scientific sense, and which side seems to have the last word when specific points are thoroughly debated.

With concussions I have a much better personal handle on the science. I am a neurologist. I treat patients with concussions, some from sports injuries. I can read the primary literature and understand it. With regard to concussions and sports the consensus has shifted over recent years to be far more cautious in returning players to the field. This is based upon studies showing that the risk of a second concussion is greater in those who have suffered a first concussion, and the damage is also more severe and longer lasting. The current recommendations are for a player to be symptom free before returning to play following a concussion.

We are also gathering more evidence about the long term neurological effects of repeated concussions over a career. A recent examination of retired NFL players found:

The retired players’ ages averaged 45.6 ± 8.9 years (range, 30-60 years), and they had 6.8 ± 3.2 years (maximum, 14 years) of NFL play. They reported 6.9 ± 6.2 concussions (maximum, 25) in the NFL. The majority of retired players had normal clinical mental status and central nervous system (CNS) neurological examinations. Four players (9%) had microbleeds in brain parenchyma identified in SWI, and 3 (7%) had a large cavum septum pellucidum with brain atrophy. The number of concussions/dings was associated with abnormal results in SWI and DTI. Neuropsychological testing revealed isolated impairments in 11 players (24%), but none had dementia. Nine players (20%) endorsed symptoms of moderate or severe depression on the BDI and/or met criteria for depression on PHQ; however, none had dementia, dysarthria, parkinsonism, or cerebellar dysfunction. The number of football-related concussions was associated with isolated abnormalities on the clinical neurological examination, suggesting CNS dysfunction. The APOE4 allele was present in 38% of the players, a larger number than would be expected in the general male population (23%-26%).

The concern is that repeated brain trauma causes chronic neurodegenerative disease over time. The above study finds evidence of chronic damage in a substantial minority of retired players. A 2015 review of the literature on chronic traumatic encephalopathy found:

We found that a history of mTBI was the only risk factor consistently associated with CTE.

But also:

Our review reveals significant limitations of the current CTE case reporting and questions the widespread existence of CTE in contact sports.

What both these recent reviews find, essentially, is that there is evidence of chronic neurological damage in professional athletes correlating with concussions, but that chronic injury is not widespread and exists in a minority of players. You can focus on either the positive or negative aspects of this data – on the fact that there is evidence of neurological injury in some players, or on the fact that injury is only present in a minority of players. Everyone agrees we need further research.

How do we apply the precautionary principle to this incomplete scientific data? As with global warming, those who wish to deny that there is any problem are likely to argue against the strawman of the most extreme solution, such as banning all contact sports. Often reasonable measures that are proportional to the evidence and the potential risk are ignored.

With global warming, for example deniers warn of a government take over of entire industries, and degrading civilization to a hippie paradise without electricity and automobiles. How about just investing in greater energy efficiency and renewable sources. Those are win-wins, whatever you think about global climate change.

With regard to contact sports and concussions there are also reasonable measures that can be and are being taken short of a total ban on high-risk sports. Recommendations are already moving in this direction – players should not return to play the day of a concussion, and they need a longer period of recovery before returning to play. Certain styles of play are more dangerous than others, and so rules can be tweaked to minimize risk (as they always have been). Incremental improvements in equipment can also reduce player injury.

Making contact sports safer for players is a no-brainer. We now have more information about concussions to inform efforts to make contact sport safer.

Gwinn is right about one thing – concussions in sports is the new global warming, just not in the way he intended. There is emerging science indicating a risk. The science has not all been worked out yet, but the signal of a risk of neurological injury is there, and is also quite plausible. At the very least we should be taking reasonable measures to minimize injury. This situation is fairly analogous to global warming in the context of risk management.

In both cases the evidence supports taking reasonable measures to mitigate risk. In both cases deniers are engaging in FUD to argue that we should do nothing.

Categories: Medicine

Should the FDA crack down on homeopathic “remedies”?

Science Based Medicine - Thu, 03/26/2015 - 07:00

In the category of potentially dangerous complementary or alternative medicine, I can think of few products worse than ones claimed to relieve asthma, yet don’t actually contain any medicine. Yet these products exist and are widely sold. Just over a year ago I described what might be the most irresponsible homeopathic treatment ever: A homeopathic asthma spray. If there was ever a complementary or alternative product that could cause serious harm, this is it:

Photo Credit Ryan Meylon

 

Among the different treatments and remedies that are considered “alternative” medicine, homeopathy is the most implausible of all. Homeopathy is an elaborate placebo system, where the “remedies” lack any actual medicine. Based on the idea that “like cures like” (which is sympathetic magic, not science), proponents of homeopathy believe that any substance can be an effective remedy if it’s diluted enough: cancer, boar testicles, crude oil, oxygen, and skim milk are all homeopathic “remedies”. (I think Berlin Wall may be my favorite, though vacuum cleaner dust is a runner-up). The dilution in the case of homeopathy is so significant that there’s mathematically no possibility of even a trace of the original ingredient in the typical remedy – they are chemically indistinguishable from a placebo. To homeopaths, this is a good thing, as dilution is claimed to make the medicine-free “remedy” more potent, not less. As would be expected with inert products, rigorous clinical trials confirm what basic science (and math) predicts: homeopathy’s effects are placebo effects. Recently Steven Novella blogged about the Australian Government’s National Health and Medical Research Council’s (NHMRC) comprehensive report on homeopathy which concluded the following:

  • Based on the assessment of the evidence of effectiveness of homeopathy, NHMRC concludes that there are no health conditions for which there is reliable evidence that homeopathy is effective.
  • Homeopathy should not be used to treat health conditions that are chronic, serious, or could become serious. People who choose homeopathy may put their health at risk if they reject or delay treatments for which there is good evidence for safety and effectiveness. People who are considering whether to use homeopathy should first get advice from a registered health practitioner. Those who use homeopathy should tell their health practitioner and should keep taking any prescribed treatments.
  • The National Health and Medical Research Council expects that the Australian public will be offered treatments and therapies based on the best available evidence.

Despite the implausibility of homeopathy and the lack of any convincing evidence it is effective, homeopathy continues to enjoy modest popularity as an “alternative” medicine system, and some national health care systems have even funded treatments. In the United States, the Food and Drug Administration is responsible for regulating homeopathy – and it does so, with a very loose hand. If you want to sell a homeopathic remedy in the United States, you are not required to show that your product actually works. Unlike prescription drugs, there are no requirements for clinical trials at all. Yet these products can be legally sold. Thanks to a former US Senator who was a homeopathy fan, any product listed in the US Homeopathic Pharmacopoeia (HPUS) is by definition a drug to the FDA, and therefore falls under its purview. Alec Gaffney, in a nice summary of the regulatory framework, notes that the FDA relies on a Compliance Policy Guide (CPG), Conditions Under Which Homeopathic Drugs May be Marketed, which defines labelling and manufacturing standards for homeopathic products. Those regulatory standards, are in a word, homeopathic themselves. The framework puts the FDA in a difficult situation, such as licensing these products as “drugs” while simultaneously acknowledging that there’s no evidence to show homeopathy works:

FDA is not aware of scientific evidence to support homeopathy as effective.

Do the current FDA standards provide adequate consumer protection, given the marketing of homeopathy for the treatment of very real conditions, like asthma? These products may be labelled “not a rescue inhaler”, but it’s fair to ask why they are sold at all, when they offer no plausible benefit. Last week the FDA issued a warning about homeopathic asthma inhalers:

The U.S. Food and Drug Administration is warning consumers not to rely on asthma products labeled as homeopathic that are sold over-the-counter (OTC). These products have not been evaluated by the FDA for safety and effectiveness.

and

OTC asthma products labeled as homeopathic are widely distributed through retail stores and via the internet. Many of these products are promoted as “natural,” “safe and effective,” and include indications that range from treatment for acute asthma symptoms, to temporary relief of minor asthma symptoms. In general, consumers can identify such products by looking for the word “HOMEOPATHIC” or “HOMŒOPATHIC” on a product’s label and looking for whether the product’s active ingredient(s) are listed in terms of dilution (e.g., “LM1″ “6X” or “30C”).

Homeopathic asthma sprays are indeed widely sold, not just by Target, but by other pharmacies and online.

Now the FDA has announced plans to re-evaluate the homeopathy regulation framework, something I’m sure my American co-bloggers will applaud:

The Food and Drug Administration (FDA) is announcing a public hearing to obtain information and comments from stakeholders about the current use of human drug and biological products labeled as homeopathic, as well as the Agency’s regulatory framework for such products. These products include prescription drugs and biological products labeled as homeopathic and over-the-counter (OTC) drugs labeled as homeopathic. FDA is seeking participants for the public hearing and written comments from all interested parties, including, but not limited to, consumers, patients, caregivers, health care professionals, patient groups, and industry. FDA is seeking input on a number of specific questions, but is interested in any other pertinent information participants would like to share.

The event will be held April 20-21 in Silver Spring, Maryland. Registration is free (there will be a webcast) and you can even make an oral presentation. I strongly encourage anyone able to participate and give a science-based perspective to register and do so. It’s clear that the FDA recognizes that homeopathy is ineffective. So what does adequate and appropriate regulation, from an FDA perspective look like? Let’s hope it ensures that products like “homeopathic asthma sprays” will become a thing of the past.

More Reading

Homeopathic regulation diluted until no substance left

CAM and the Law Part 4: Regulation of Supplements and Homeopathic Remedies

An Alternative Perspective: Homeopathic Drugs, Royal Copeland, and Federal Drug Regulation

 

 

 

Categories: Medicine, Skepticism

Should the FDA crack down on homeopathic “remedies”?

Science Based Medicine - Thu, 03/26/2015 - 07:00

In the category of potentially dangerous complementary or alternative medicine, I can think of few products worse than asthma inhalers that don’t actually contain any medicine. Yet these inhalers exist and are sold. Just over a year ago I described what might be the most irresponsible homeopathic treatment ever: A homeopathic asthma inhaler. If there was ever a complementary or alternative product that could cause serious harm, this is it:

Photo Credit Ryan Meylon

 

Among the different treatments and remedies that are considered “alternative” medicine, homeopathy is the most implausible of all. Homeopathy is an elaborate placebo system, where the “remedies” lack any actual medicine. Based on the idea that “like cures like” (which is sympathetic magic, not science), proponents of homeopathy believe that any substance can be an effective remedy if it’s diluted enough: cancer, boar testicles, crude oil, oxygen, and skim milk are all homeopathic “remedies”. (I think Berlin Wall may be my favorite, though vacuum cleaner dust is a runner-up). The dilution in the case of homeopathy is so significant that there’s mathematically no possibility of even a trace of the original ingredient in the typical remedy – they are chemically indistinguishable from a placebo. To homeopaths, this is a good thing, as dilution is claimed to make the medicine-free “remedy” more potent, not less. As would be expected with inert products, rigorous clinical trials confirm what basic science (and math) predicts: homeopathy’s effects are placebo effects. Recently Steven Novella blogged about the Australian Government’s National Health and Medical Research Council’s (NHMRC) comprehensive report on homeopathy which concluded the following:

  • Based on the assessment of the evidence of effectiveness of homeopathy, NHMRC concludes that there are no health conditions for which there is reliable evidence that homeopathy is effective.
  • Homeopathy should not be used to treat health conditions that are chronic, serious, or could become serious. People who choose homeopathy may put their health at risk if they reject or delay treatments for which there is good evidence for safety and effectiveness. People who are considering whether to use homeopathy should first get advice from a registered health practitioner. Those who use homeopathy should tell their health practitioner and should keep taking any prescribed treatments.
  • The National Health and Medical Research Council expects that the Australian public will be offered treatments and therapies based on the best available evidence.

Despite the implausibility of homeopathy and the lack of any convincing evidence it is effective, homeopathy continues to enjoy modest popularity as an “alternative” medicine system, and some national health care systems have even funded treatments. In the United States, the Food and Drug Administration is responsible for regulating homeopathy – and it does so, with a very loose hand. If you want to sell a homeopathic remedy in the United States, you are not required to show that your product actually works. Unlike prescription drugs, there are no requirements for clinical trials at all. Yet these products can be legally sold. Thanks to a former US Senator who was a homeopathy fan, any product listed in the US Homeopathic Pharmacopoeia (HPUS) is by definition a drug to the FDA, and therefore falls under its purview. Alec Gaffney, in a nice summary of the regulatory framework, notes that the FDA relies on a Compliance Policy Guide (CPG), Conditions Under Which Homeopathic Drugs May be Marketed, which defines labelling and manufacturing standards for homeopathic products. Those regulatory standards, are in a word, homeopathic themselves. The framework puts the FDA in a difficult situation, such as licensing these products as “drugs” while simultaneously acknowledging that there’s no evidence to show homeopathy works:

FDA is not aware of scientific evidence to support homeopathy as effective.

Do the current FDA standards provide adequate consumer protection, given the marketing of homeopathy for the treatment of very real conditions, like asthma? These products may be labelled “not a rescue inhaler”, but it’s fair to ask why they are sold at all, when they offer no plausible benefit. Last week the FDA issued a warning about homeopathic asthma inhalers:

The U.S. Food and Drug Administration is warning consumers not to rely on asthma products labeled as homeopathic that are sold over-the-counter (OTC). These products have not been evaluated by the FDA for safety and effectiveness.

and

OTC asthma products labeled as homeopathic are widely distributed through retail stores and via the internet. Many of these products are promoted as “natural,” “safe and effective,” and include indications that range from treatment for acute asthma symptoms, to temporary relief of minor asthma symptoms. In general, consumers can identify such products by looking for the word “HOMEOPATHIC” or “HOMŒOPATHIC” on a product’s label and looking for whether the product’s active ingredient(s) are listed in terms of dilution (e.g., “LM1″ “6X” or “30C”).

Homeopathic asthma inhalers are indeed widely sold, not just by Target, but by other pharmacies and online.

Now the FDA has announced plans to re-evaluate the homeopathy regulation framework, something I’m sure my American co-bloggers will applaud:

The Food and Drug Administration (FDA) is announcing a public hearing to obtain information and comments from stakeholders about the current use of human drug and biological products labeled as homeopathic, as well as the Agency’s regulatory framework for such products. These products include prescription drugs and biological products labeled as homeopathic and over-the-counter (OTC) drugs labeled as homeopathic. FDA is seeking participants for the public hearing and written comments from all interested parties, including, but not limited to, consumers, patients, caregivers, health care professionals, patient groups, and industry. FDA is seeking input on a number of specific questions, but is interested in any other pertinent information participants would like to share.

The event will be held April 20-21 in Silver Spring, Maryland. Registration is free (there will be a webcast) and you can even make an oral presentation. I strongly encourage anyone able to participate and give a science-based perspective to register and do so. It’s clear that the FDA recognizes that homeopathy is ineffective. So what does adequate and appropriate regulation, from an FDA perspective look like? Let’s hope it ensures that products like “homeopathic asthma sprays” will become a thing of the past.

More Reading

Homeopathic regulation diluted until no substance left

CAM and the Law Part 4: Regulation of Supplements and Homeopathic Remedies

An Alternative Perspective: Homeopathic Drugs, Royal Copeland, and Federal Drug Regulation

 

 

 

Categories: Medicine, Skepticism

What Is Brain Death?

Science Based Medicine - Wed, 03/25/2015 - 08:21

Of course, any story illustrating the issues surrounding brain death is going to be a sad and tragic tale. In December of 2013, Jahi McMath suffered bleeding complications following a tonsillectomy and tissue removal for sleep apnea. This resulted in a cardiac arrest with an apparent prolonged period of lack of blood flow to the brain. While her heart function was brought back, Jahi suffered severe brain anoxia (damage due to lack of oxygen) and was declared brain dead on December 12, 2013.

Jahi’s tragic story is not over, however, because her family refused to accept the diagnosis of brain death. They took legal action to keep the hospital from pulling life support, and eventually worked out a compromise where the family was able to remove Jahi to their own care. At present Jahi is apparently being cared for in an apartment in New Jersey, on a ventilator and fed through a feeding tube.

There is often some confusion as to what brain death actually is. The term is unfortunately often used to refer to a persistent vegetative state or other severe impairment of consciousness, but this is not accurate. Brain death refers to a complete lack of function of the brain, including basic reflexes in the brain stem. There is a specific protocol for declaring a person brain dead, requiring detailed examination by at least two attending physicians to document the complete absence of any brain function. If the slightest pupillary reflex is present, then the patient cannot be declared brain dead. The criteria also include provisions that there are no medications in the person’s system that can suppress neurological function and their core body temperature is sufficiently high (being too cold can also suppress neurological function).

There are also several types of supporting evidence that can be used when appropriate. These include electroencephalogram, which reads the electrical activity of the brain. A complete absence of electrical activity supports the diagnosis of brain death. Tests looking at blood flow to the brain can also be performed. A complete absence of blood flow to the brain also supports the diagnosis of brain death. These laboratory criteria are not necessary if the patient meets the clinical criteria for brain death, but they can be used if some parts of the exam cannot be done for practical reasons.

Overall the criteria are very conservative. They are designed to minimize the chance of declaring someone brain dead when they aren’t. These are universally-accepted criteria, established in 1995 by the American Academy of Neurology. Since then there hasn’t been a single case of a patient who was declared brain dead by the standard criteria who later recovered.

Legally a patient who is brain dead can be declared dead. They are then legally no longer a living person.

In the case of Jahi the hospital doctors declared her dead based upon brain death criteria, even though her heart was still beating. At that point no further medical intervention is warranted. In fact many consider it unethical and abusive to perform any medical interventions on a dead body. Because of the family’s protests, however, the judge in the case assigned an independent doctor, Graham Fisher, M.D., the chief of Child Neurology at Stanford University School of Medicine, to examine Jahi and make his own determination. He agreed with the diagnosis of brain death.

The family requested that their own doctor also independently examine Jahi, but the judge refused. They wanted Paul Byrne to examine Jahi. Byrne, however, is hardly an objective physician. He is a crusader against the very notion of brain death. He is a neonatologist, past president of the Catholic Medical Association, and an outspoken critic of organ donation based upon the concept of brain death.

As is often the case when declarations of either persistent vegetative state or brain death are controversial, the family or those opposing the diagnosis often claim that there are signs of brain activity the doctors say are not present. In this case the family, sometimes through their lawyer, claim that Jahi has moved her limbs in response to commands. They are also now claiming that independent examination has revealed electrical activity and blood flow to the brain, however this information is not available for independent review.

It is common for there to be spinal reflexes that can cause even dramatic movements in someone who is brain dead. These types of reflexes have been termed the “Lazarus effect” because they may create the impression of someone rising from the dead. Activity in the spinal cord, however, is compatible with brain death, and may be triggered either spontaneously or through mechanical stimulation (such as when a patient is turned or moved during care).

Jahi was moved from California to New Jersey for a specific reason. New Jersey allows for religious exemptions to the legal declaration of brain death. Jahi’s family claims that according to their religious beliefs, as long as her heart is beating she is still alive.

Similar issues arose in the Terri Schiavo case, which came to national attention in 2005. In that case Schiavo was in a persistent vegetative state (not brain dead) and her husband wanted to withdraw life support, while her family refused, resulting in a prolonged court battle. The husband eventually prevailed. At autopsy it was found that Schiavo’s brain weighed about half of what a healthy brain for someone her size should have weighed, evidence of the diffuse and catastrophic brain damage she had suffered.

In that case, as with this one, the family tried to appeal to a cherry-picked expert to give them the answer they sought, and they also claimed that Schiavo was exhibiting signs of brain activity that multiple independent experts concluded was not present.

Reporting on the Schiavo case was also particularly bad. A review found that only 1% of mass media reporting defined a persistent vegetative state, while 21% of articles falsely claimed that Schiavo had the potential to recover.

Conclusion

It is understandable that there would be ethical discussions and disagreements over how best to balance the rights of patients, the demands of dignity, the responsibilities of health care professionals and the state, and the religious freedoms of patients and their families. At the very least, however, such discussions, and their application to individual cases, should be informed by reliable scientific and medical information. Media reporting should also strive to be as scientifically accurate as possible.

Distorting the science and cherry picking evidence are unfortunately common when strongly-held ideological beliefs are at stake.

In the case of Jahi there is also a legal matter at stake. The family is suing the hospital for malpractice. In California there is a legal cap of $250,000 for the wrongful death of a child. There is no cap if the child is injured but still alive, which the suit is claiming. It is therefore likely that a California court will have to officially rule on whether or not Jahi is alive or dead.
 
 

Categories: Medicine, Skepticism

What Is Brain Death?

Science Based Medicine - Wed, 03/25/2015 - 08:21

Of course, any story illustrating the issues surrounding brain death is going to be a sad and tragic tale. In December of 2013, Jahi McMath suffered bleeding complications following a tonsillectomy and tissue removal for sleep apnea. This resulted in a cardiac arrest with an apparent prolonged period of lack of blood flow to the brain. While her heart function was brought back, Jahi suffered severe brain anoxia (damage due to lack of oxygen) and was declared brain dead on December 12, 2013.

Jahi’s tragic story is not over, however, because her family refused to accept the diagnosis of brain death. They took legal action to keep the hospital from pulling life support, and eventually worked out a compromise where the family was able to remove Jahi to their own care. At present Jahi is apparently being cared for in an apartment in New Jersey, on a ventilator and fed through a feeding tube.

There is often some confusion as to what brain death actually is. The term is unfortunately often used to refer to a persistent vegetative state or other severe impairment of consciousness, but this is not accurate. Brain death refers to a complete lack of function of the brain, including basic reflexes in the brain stem. There is a specific protocol for declaring a person brain dead, requiring detailed examination by at least two attending physicians to document the complete absence of any brain function. If the slightest pupillary reflex is present, then the patient cannot be declared brain dead. The criteria also include provisions that there are no medications in the person’s system that can suppress neurological function and their core body temperature is sufficiently high (being too cold can also suppress neurological function).

There are also several types of supporting evidence that can be used when appropriate. These include electroencephalogram, which reads the electrical activity of the brain. A complete absence of electrical activity supports the diagnosis of brain death. Tests looking at blood flow to the brain can also be performed. A complete absence of blood flow to the brain also supports the diagnosis of brain death. These laboratory criteria are not necessary if the patient meets the clinical criteria for brain death, but they can be used if some parts of the exam cannot be done for practical reasons.

Overall the criteria are very conservative. They are designed to minimize the chance of declaring someone brain dead when they aren’t. These are universally-accepted criteria, established in 1995 by the American Academy of Neurology. Since then there hasn’t been a single case of a patient who was declared brain dead by the standard criteria who later recovered.

Legally a patient who is brain dead can be declared dead. They are then legally no longer a living person.

In the case of Jahi the hospital doctors declared her dead based upon brain death criteria, even though her heart was still beating. At that point no further medical intervention is warranted. In fact many consider it unethical and abusive to perform any medical interventions on a dead body. Because of the family’s protests, however, the judge in the case assigned an independent doctor, Graham Fisher, M.D., the chief of Child Neurology at Stanford University School of Medicine, to examine Jahi and make his own determination. He agreed with the diagnosis of brain death.

The family requested that their own doctor also independently examine Jahi, but the judge refused. They wanted Paul Byrne to examine Jahi. Byrne, however, is hardly an objective physician. He is a crusader against the very notion of brain death. He is a neonatologist, past president of the Catholic Medical Association, and an outspoken critic of organ donation based upon the concept of brain death.

As is often the case when declarations of either persistent vegetative state or brain death are controversial, the family or those opposing the diagnosis often claim that there are signs of brain activity the doctors say are not present. In this case the family, sometimes through their lawyer, claim that Jahi has moved her limbs in response to commands. They are also now claiming that independent examination has revealed electrical activity and blood flow to the brain, however this information is not available for independent review.

It is common for there to be spinal reflexes that can cause even dramatic movements in someone who is brain dead. These types of reflexes have been termed the “Lazarus effect” because they may create the impression of someone rising from the dead. Activity in the spinal cord, however, is compatible with brain death, and may be triggered either spontaneously or through mechanical stimulation (such as when a patient is turned or moved during care).

Jahi was moved from California to New Jersey for a specific reason. New Jersey allows for religious exemptions to the legal declaration of brain death. Jahi’s family claims that according to their religious beliefs, as long as her heart is beating she is still alive.

Similar issues arose in the Terri Schiavo case, which came to national attention in 2005. In that case Schiavo was in a persistent vegetative state (not brain dead) and her husband wanted to withdraw life support, while her family refused, resulting in a prolonged court battle. The husband eventually prevailed. At autopsy it was found that Schiavo’s brain weighed about half of what a healthy brain for someone her size should have weighed, evidence of the diffuse and catastrophic brain damage she had suffered.

In that case, as with this one, the family tried to appeal to a cherry-picked expert to give them the answer they sought, and they also claimed that Schiavo was exhibiting signs of brain activity that multiple independent experts concluded was not present.

Reporting on the Schiavo case was also particularly bad. A review found that only 1% of mass media reporting defined a persistent vegetative state, while 21% of articles falsely claimed that Schiavo had the potential to recover.

Conclusion

It is understandable that there would be ethical discussions and disagreements over how best to balance the rights of patients, the demands of dignity, the responsibilities of health care professionals and the state, and the religious freedoms of patients and their families. At the very least, however, such discussions, and their application to individual cases, should be informed by reliable scientific and medical information. Media reporting should also strive to be as scientifically accurate as possible.

Distorting the science and cherry picking evidence are unfortunately common when strongly-held ideological beliefs are at stake.

In the case of Jahi there is also a legal matter at stake. The family is suing the hospital for malpractice. In California there is a legal cap of $250,000 for the wrongful death of a child. There is no cap if the child is injured but still alive, which the suit is claiming. It is therefore likely that a California court will have to officially rule on whether or not Jahi is alive or dead.
 
 

Categories: Medicine, Skepticism

Ultrasound for Alzheimer’s Disease

Neurologica Blog - Tue, 03/24/2015 - 07:56

A new study published in Science Translational Medicine concerning a possible new treatment for Alzheimer’s disease is getting quite a bit of play on social media. While it is an interesting study, and excitement over any scientific study is great to see, I also think it’s important to always put such studies into a reasonable context (which is rarely done well).

Alzheimer’s disease (AD) is a devastating chronic degenerative brain disease in which neurons slowly die over years, causing memory loss of eventually overall cognitive impairment. Nancy Reagan described her husband Ronald’s AD as a “very long goodbye.” My grandmother died of AD, and it’s likely many of her relatives did as well, but in her it was confirmed at autopsy. About 75% of all dementia cases are due to AD:

The pooled data of population-based studies in Europe suggests that the age-standardized prevalence in people 65+ years old is 6.4 % for dementia and 4.4 % for AD.3 In the US, the study of a national representative sample of people aged >70 years yielded a prevalence for AD of 9.7 %.

In short, this is a common and serious disease. Most people will have a family member or know someone with AD. Further, as our population ages the incidence of AD will increase as a matter of course.

At present there is no cure for AD or treatment that significantly alters the course of the disease. Current medications are symptomatic, moderately increasing function but not altering the slope of cognitive decline. Research is making steady progress, but the disease has proven to be very complex. Researchers now recognize that AD is a result of a complex combination of genetics, environmental, and lifestyle factors. It has also been well established that a prominent feature of AD is the collection of Amyloid Beta protein, which is normally soluble. The protein then undergoes misfolding, and the misfolded protein clumps together, resulting in toxicity that eventually kills the neuron. That is not the whole story, however, and researchers are still trying to tease out further details.

Because there is so much active research into AD I frequently see press releases promising some sort of AD breakthrough – a new piece to the puzzle falling into place, a new way to diagnose AD early, or a potential new treatment approach. These are often genuine scientific advances, but they are incremental, and rarely directly lead to a new therapeutic intervention, or still require years of research to see how they will pan out. It’s easy, however, to get caught up in the headlines promoting every new tiny advance.

The latest research from Science is a good example. The study is, Scanning ultrasound removes amyloid-β and restores memory in an Alzheimer’s disease mouse model, by Gerhard Leinenga and Jürgen Götz. They used ultrasound to reduce the blood brain barrier and stimulate microglia, cells which would normally clean up Amyloid Beta. They found that in 75% of the mice studied there was a significant decrease in Amyloid plaques, and some of those mice had improved function on memory testing in a maze.

This is a genuinely exciting result, as ultrasound is a novel and rather non-invasive treatment option. The results are also very promising. But here now are the caveats that any responsible science journalist should note.

The mouse models of AD are not perfect models of the human disease. Specifically, in some mouse models of AD it seems that the clumped Amyloid Beta causes cognitive impairment, but it is unclear if this is also the case in human AD. While clearing plaque may slow decline, and can conceivably improve function of still living neurons, it will not restore dead neurons, so any loss of memory or cognitive function due to dead neurons is permanently gone.

In fact some researchers believe that in humans the Amyloid plaques are more of a downstream effect of AD and not the underlying cause. It is not clear how important they are in causing AD itself.

The current study should be considered preliminary and exploratory. This is the kind of research that is very interesting and useful to other researchers, but should be of very limited interest to the general public. Most research at this stage does not translate to a specific treatment in humans.

I certainly hope that this research does bear fruit. I would love nothing more than for there to be an effective treatment for AD. This approach may also apply to other neurodegenerative diseases. It is just way too early to tell.

This is also a general pattern in the way scientific research progresses vs how it is reported. Battery and solar technology are very similar – you can read just about every week about some new breakthrough in battery or solar technology, but the reporting rarely puts the preliminary research into proper context, and then you never hear about these amazing breakthroughs again. Meanwhile, the science continues to progress incrementally. Incremental advances (the reality), however, do not make good headlines. Breakthroughs (rarely the reality) do.

Categories: Medicine

Ken Burns Presents Cancer

Science Based Medicine - Tue, 03/24/2015 - 03:01

Note: I wrote two posts today to alert readers to two upcoming television events in time for them to plan their viewing. See the second post for an announcement about a film on scientology, along with an article about Scientology’s War on Medicine that I wrote for Skeptic magazine.

Filmmaker Ken Burns

Ken Burns has made a lot of outstanding films. His The Civil War has been listed as second only to Nanook of the North as the most influential documentary of all time. I was delighted to learn that he had applied his exceptional skills to a topic that is very important to us on the Science-Based medicine blog, cancer. His film is based on the Pulitzer Prize-winning book by Siddhartha Mukherjee, The Emperor of all Maladies: A Biography of Cancer.

I reviewed Mukherjee’s book in 2010. He is an oncologist and cancer researcher and also a superb writer. I characterized his book as:

a unique combination of insightful history, cutting edge science reporting, and vivid stories about the individuals involved: the scientists, the activists, the doctors, and the patients. It is also the story of science itself: how the scientific method works and how it developed, how we learned to randomize, do controlled trials, get informed consent, use statistics appropriately, and how science can go wrong.

I continue to think it is the best book ever written on cancer.

The film interviews Mukherjee and many of the researchers and patients whose stories appear in the book. If you haven’t read the book, it will give you an idea what it’s about. If you have read the book, you will enjoy it even more as you meet the people you have read about. It covers the history of cancer as well as the most recent scientific developments and is very optimistic about the future.

The movie is scheduled to premiere March 30 – April 1 at 9 PM EST on PBS, in 3 parts with a total duration of 6 hours. You can watch the trailer online. The producers sent me a press preview 1-hour highlight reel and I was very impressed. I can’t wait to watch the whole thing. I hope you will be able to watch it too.

Categories: Medicine, Skepticism

Ken Burns Presents Cancer

Science Based Medicine - Tue, 03/24/2015 - 03:01

Note: I wrote two posts today to alert readers to two upcoming television events in time for them to plan their viewing. See the second post for an announcement about a film on scientology, along with an article about Scientology’s War on Medicine that I wrote for Skeptic magazine.

 

Ken Burns has made a lot of outstanding films. His The Civil War has been listed as second only to Nanook of the North as the most influential documentary of all time. I was delighted to learn that he had applied his exceptional skills to a topic that is very important to us on the Science-Based medicine blog, cancer. His film is based on the Pulitzer Prize-winning book by Siddhartha Mukherjee, The Emperor of all Maladies: A Biography of Cancer.

I reviewed Mukherjee’s book in 2010. He is an oncologist and cancer researcher and also a superb writer. I characterized his book as:

a unique combination of insightful history, cutting edge science reporting, and vivid stories about the individuals involved: the scientists, the activists, the doctors, and the patients. It is also the story of science itself: how the scientific method works and how it developed, how we learned to randomize, do controlled trials, get informed consent, use statistics appropriately, and how science can go wrong.

I continue to think it is the best book ever written on cancer.

The film interviews Mukherjee and many of the researchers and patients whose stories appear in the book. If you haven’t read the book, it will give you an idea what it’s about. If you have read the book, you will enjoy it even more as you meet the people you have read about. It covers the history of cancer as well as the most recent scientific developments and is very optimistic about the future.

The movie is scheduled to premiere March 30 – April 1 at 9 PM EST on PBS, in 3 parts with a total duration of 6 hours. You can watch the trailer online.  The producers sent me a press preview 1-hour highlight reel and I was very impressed. I can’t wait to watch the whole thing. I hope you will be able to watch it too.

Categories: Medicine, Skepticism

Scientology’s War on Medicine

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

Note: The film Going Clear: Scientology and the Prison of Belief will be available on HBO starting March 29th. I haven’t seen it yet, but apparently it profiles former members who reveal details that have elicited a very angry response from the Church of Scientology. I thought I would use the occasion to reprint a SkepDoc column that originally appeared in Skeptic magazine (Volume 18: Number 3) titled “Scientology’s War on Medicine.”

Scientology has openly declared war on psychiatry and is ambivalent if not openly hostile towards the rest of medicine. Its “mind over matter” philosophy promises that attaining the “Clear” state will eliminate illness.

Recently there has been a spate of exposés of Scientology, ably reviewed by Jim Lippard on eSkeptic. They offer some shocking revelations. Defectors from Scientology have described kidnappings, deliberate lying, unnecessary deaths, human trafficking, thought control (“brainwashing”), coercion, violations of labor standards, violations of human and civil rights, and other crimes. Scientology has been protected from prosecution by its designation as a religion and its vast wealth and influence; but if even a fraction of these accusations are true, Scientology has much to answer for.

Initially people are attracted to Scientology because it provides answers. Your problems are due to past experiences holding you back. Scientology can help you deal with those problems and the upper levels will reveal the secret of life itself.

Mark VIII E-Meter, from the Wikimedia Commons by Colliric

Members are audited with an E-Meter (similar to a lie detector) and one-on-one attention. The auditing process is similar to psychotherapy in that it encourages people to think about their problems and work to overcome them. In Scientology, ideas are not immaterial: they have weight and solidity. The E-Meter locates and discharges mental masses that are blocking the free flow of energy. Memories are blamed and traced back in time even into past lives. Patients keep repeating the details of the experience until they are drained of any emotional charge. Once the painful experiences and associations are drained off, there are astonishing results: asthma, headaches, arthritis, menstrual cramps, astigmatism, and ulcers simply disappear. The reactive mind is replaced by the rational mind. In one case a boy’s IQ supposedly rose from 83 to 212.

Scientology believes no memory is ever erased: every sound and smell can be completely recaptured. Even prenatal memories and past life memories remain. The fetus remembers if the mother attempted to abort it and develops psychological problems because it knows it is living with murderers. Cells are sentient and remember painful emotions. “Engrams” become a physical part of cellular structure, controlling behavior like a post-hypnotic suggestion. This understanding of memory is incompatible with current scientific knowledge.

Then there is a second stage of Scientology where people pay for ever more expensive classes, are indoctrinated into the mythology, progress up the church’s ladder of OT (Operating Thetan) levels, and may even join the elite Sea Org, signing a billion year contract.

The Scientology myth was originally a secret revealed only to those who reached the OT III level, but it is now public knowledge. The universe began 4 quadrillion years ago. Evil lord Xenu and his psychiatrist co-conspirators froze individuals (thetans), sent them to the planet Earth, dropped them into volcanoes and blew them up with hydrogen bombs. Freed from their bodies, the thetans were trapped in an electronic ribbon and subjected to brainwashing with a colossal motion picture device which implanted them with all the world religions. Free-floating thetans attach themselves to living people, as many as millions of them in a single body. These “body thetans” have to be eliminated to achieve spiritual progress. If not cleared by Scientology, these thetans will blow themselves up and destroy civilization as they have done many times before. Only Scientology can save humanity from the cycle of self-destruction.

We are all thetans (Scientology’s term for the soul), immortal spiritual beings that are incarnated in innumerable lifetimes. Auditing is not just to resolve psychological problems but to “recall to the thetan his immortality and help him relinquish his self-imposed limitations” – to emancipate a person from the laws of matter, energy, space and time (MEST). Bored thetans had created MEST universes and then forgot they weren’t real.

When you become “clear” of body thetans, you have a flawless memory able to recall anything you have ever studied; are less susceptible to diseases; rarely have accidents; and are free of neuroses, compulsions, and psychosomatic illnesses. As you progress to the higher OT levels you will be able to levitate, travel through time, control the thoughts of others by telepathy, and have total command over the material universe. With these superhuman powers you can make a traffic light turn green or emit an electric shock that can put out someone’s eyes or cut him in half.

Only one problem: there never were any “clears.” Attempted demonstrations of these powers consistently failed. When auditing was independently tested, it failed (Hubbard claimed they didn’t do it right). Auditing may indeed help people, but its results have never been validated.

As in other cults, confession and re-education are used to control thought. Past lives provide misdeeds to confess. Instead of providing consolation, confession exploits vulnerabilities and steers people into thinking about their faults. The cult keeps its victims in a suggestible state and vigorously suppresses questions and doubts. Exit costs make the prospect of leaving more painful than staying.

Scientology was invented by a science fiction writer, L. Ron Hubbard. He was a liar, fantasist, bigamist, and adulterer; charismatic, vindictive, with sexual and psychological problems that he revealed in the Affirmations, a secret memoir which the church now claims is a forgery. One ex-lover described him as manic-depressive with paranoid tendencies and delusions of grandeur. At one point, concerned that divorce would hurt his reputation, he proposed that if his wife really loved him, she should kill herself.

Hubbard began to develop his ideas in Dianetics, a book that Nobel physicist Isidor Isaac Rabi said “probably contains more promises and less evidence per page than has any publication since the invention of printing.” The book empowered people to become practitioners themselves. Hubbard said, “I’d like to start a religion. That’s where the money is.” A religion could maintain control of devotees permanently with a series of veiled revelations and levels.

Scientology discourages any use of medication. Pain and other symptoms are treated by “Assists.” For the Contact Assist you repeatedly press the injured part of the body against the object that hurt it until the pain goes away. There is also the Touch Assist; one person who was treated as a child said her mother wouldn’t stop prodding her with a finger until she said she felt better. So of course she said she did. John Travolta once did an Assist on Marlon Brando at a party; he touched Brando’s leg, both closed their eyes, and Brando said it helped.

Assists can supposedly awaken unconscious persons, eliminate boils, reduce earaches and back pain, and make a drunk sober.

At age 7, Jenna Miscavige was assigned the post of Medical Liaison Officer, responsible for treating sick children and providing vitamins to the healthy. Scientology allowed vaccinations but didn’t permit the use of medicine for the treatment of pain or fever. The church doesn’t believe in comforting children, believing they are adults in young bodies and can handle pain like an adult.

Hubbard chastised subordinates for wearing eyeglasses, tried to convince them they could see without them, and said needing them was a transgression against Scientology.

OTs should not have accidents and illnesses; when one woman developed a cold sore, she was consigned to a condition of Treason.

Hubbard had his own (untrained) medical officer. He was afraid of doctors. When a motorcycle accident left him in severe pain from broken ribs and other injuries, he refused to go to the hospital and even refused pain pills, complaining that they slowed down his heart.

Operating Thetans supposedly didn’t get sick, but L. Ron Hubbard had poor hearing, poor vision, was obese, and had numerous physical and psychological problems. His lame excuse was that he was at such a high level he couldn’t get down to the power level of a body. When he died following a stroke, they said that he didn’t die, but intentionally dropped his body to move on to a higher level of existence. He is expected to return some day. Every Scientology facility maintains an office furnished exactly as he liked, even down to a pair of slippers.

Hubbard theorized that one wealthy Scientologist was not making progress because he had taken LSD and it must still be in his system. He put him to work swabbing the decks on the Sea Org ship to sweat it out of his system. That was the beginning of the Scientology drug treatment program, Narconon.

A fundamental feature of Narconon is the Purification Rundown, a 3 week program to eliminate toxins. Patients spend up to 8 hours a day in a sauna; they exercise and take massive doses of vitamins, especially niacin. Niacin causes skin flushing and tingling sensations which they interpret as evidence of toxins being purged. One woman said Novocaine from previous dental work began to surface and her mouth went numb for 90 minutes.

Psychotic episodes were treated with the Introspection Rundown: solitary confinement, vitamins, calcium and magnesium. 1995 Lisa McPherson suffered a mental breakdown and died following 17 days of this treatment under guard in a Florida hotel. She lapsed into a coma and died en route to a hospital where there was a doctor affiliated with the church (the ambulance bypassed several closer hospitals). Church officials lied in sworn statements to police, claiming that she hadn’t been subject to an Introspection Rundown. A defector later confessed that he had destroyed incriminating documents. The medical examiner determined that the cause of death was a pulmonary embolus: a clot had formed due to the worst case of dehydration she had ever seen, following 5 days without any liquids. Church lawyers pressured her attorney, threatening a legal battle, and she changed her ruling to say the death was “accidental.” Shortly thereafter she retired and became a recluse.

One former Sea Org member said he went psychotic on OT III. He said he lost his sense of identity when he found out that thousands of individual alien beings were struggling for control of his body, trying to give him cancer or drive him insane.

One auditor was declared a “Suppressive Person” and had a nervous breakdown. Instead of treatment he was punished and made to do manual labor. He escaped, killed his wife, and committed suicide.

Anyone who questions Scientology doctrine is sent to RPF (Rehabilitation Project Force). There they are subjected to terrible living conditions and an inadequate diet, and are made to do manual labor; it has been compared to the prison camps of the Soviet Gulag. One Sea Org man was forced to shovel up asbestos in a renovation project with no protective gear, not even a mask. A woman was made to weld without protective glasses; she burned her eyes and got no medical attention at all. A severely handicapped MS patient who was unable to talk was sent to RPF.

Medical treatment is often cruel and inadequate. A woman who had incapacitating migraines kept auditing herself on the E-Meter in lieu of treatment, because she felt responsible for her pain. A little deaf mute girl was isolated in the Sea Org ship’s chain locker for a week because Hubbard thought it might cure her deafness. Yvonne Gillham, a Sea Org member, died of a brain tumor that would have been operable with earlier diagnosis. She blamed herself for her symptoms and refused to take pain meds because it might interfere with her auditing.

Scientologists are persuaded to wean themselves off any medications. John Travolta’s son was taken off his seizure meds, which may have contributed to his death. A young man taking Lexapro was labeled as a drug addict and his father was ordered to lock his son’s Lexapro in the trunk of his car. The patient killed himself with his father’s pistol. The case was dismissed for lack of evidence.

Brooke Shields got through post-partum depression with the help of antidepressants. Tom Cruise erupted with fury on a talk show, dissing psychiatry and saying she should have treated her depression with diet and exercise.

Despite their aversion to prescription drugs, Scientologists are curiously gullible about alternative medicine. John Travolta is enthusiastic about bee pollen. David Miscavige, the current president, follows the Blood Type Diet and takes his personal chiropractor along when he travels. Hubbard invented Dianazene, a mixture of nicotinic acid and vitamins taken daily with milk and chocolate to cure cancer and sunburns. He recommended a baby formula of boiled barley and corn syrup that he picked up in Roman days in a former lifetime. He was fanatical about taking vitamins.

Hubbard blamed psychiatrists for helping Xenu commit genocide 5 billion years ago. Scientologists hold psychiatrists responsible for modern wars, racism, ethnic cleansing, and terrorism, including the Holocaust, apartheid, and 9/11. Hubbard called psychiatry the sole cause of decline in the universe. He said if psychiatrists “had the power to torture and kill everyone, they would do so…they are psychotic criminals…” He accused them of trying to institute world government by manipulating human behavior. Scientologists accused Osama bin Laden’s deputy, a “psychiatrist,” (actually a general surgeon) of controlling his thoughts. Another “psychiatrist” who allegedly masterminded the Madrid train bombings was actually a used-car salesman who had nothing to do with the incident. Scientology maintains the exhibit “Psychiatry: An Industry of Death” in Hollywood, featuring errors of psychiatry like madhouses, lobotomies, electric shock, and drugs for spurious diagnoses. Scientology aims to eliminate psychiatry in all its forms, claiming that no mental diseases have ever been proven to exist.

When TIME magazine criticized Scientology, they claimed Eli Lilly had ordered the article in retribution for the damage Scientology had caused to their “killer drug Prozac,” which supposedly causes people to commit mass murder and suicide.

Scientology lobbyists even got legislation passed in Florida that would hold schoolteachers criminally liable for just suggesting to parents that kids might have a mental health condition such as ADD. Fortunately the governor vetoed it.

Hubbard claimed to have obtained a perfect understanding of human nature by self-examination and to have an exact science. Nonsense! There is no science in Scientology. Crispian Jago has created The Venn Diagram of Irrational Nonsense: overlapping circles for quackery bollocks, religious bollocks, pseudoscientific bollocks, and paranormal bollocks; he put Scientology at the center where all these overlap. I agree: that’s exactly where it belongs.

Note: My source for much of this information is Going Clear: Scientology, Hollywood, and the Prison of Belief by Lawrence Wright. Further details and full references can be found in the book.

 

 

Categories: Medicine, Skepticism

Scientology’s War on Medicine

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

Note: The film Going Clear: Scientology and the Prison of Belief will be available on HBO starting March 29.  I haven’t seen it yet, but apparently it profiles former members who reveal details that have elicited a very angry response from the Church of Scientology. I thought I would use the occasion to reprint a SkepDoc column that originally appeared in Skeptic magazine (Volume 18: Number 3) titled “Scientology’s War on Medicine.”

Scientology has openly declared war on psychiatry and is ambivalent if not openly hostile towards the rest of medicine. Its “mind over matter” philosophy promises that attaining the “Clear” state will eliminate illness.

Recently there has been a spate of exposés of Scientology, ably reviewed by Jim Lippard on eSkeptic. They offer some shocking revelations. Defectors from Scientology have described kidnappings, deliberate lying, unnecessary deaths, human trafficking, thought control (“brainwashing”), coercion, violations of labor standards, violations of human and civil rights, and other crimes. Scientology has been protected from prosecution by its designation as a religion and its vast wealth and influence; but if even a fraction of these accusations are true, Scientology has much to answer for.

Initially people are attracted to Scientology because it provides answers. Your problems are due to past experiences holding you back. Scientology can help you deal with those problems and the upper levels will reveal the secret of life itself.

Members are audited with an E-Meter (similar to a lie detector) and one-on-one attention. The auditing process is similar to psychotherapy in that it encourages people to think about their problems and work to overcome them. In Scientology, ideas are not immaterial: they have weight and solidity. The E-Meter locates and discharges mental masses that are blocking the free flow of energy. Memories are blamed and traced back in time even into past lives. Patients keep repeating the details of the experience until they are drained of any emotional charge. Once the painful experiences and associations are drained off, there are astonishing results: asthma, headaches, arthritis, menstrual cramps, astigmatism, and ulcers simply disappear.  The reactive mind is replaced by the rational mind. In one case a boy’s IQ supposedly rose from 83 to 212.

Scientology believes no memory is ever erased: every sound and smell can be completely recaptured. Even prenatal memories and past life memories remain. The fetus remembers if the mother attempted to abort it and develops psychological problems because it knows it is living with murderers. Cells are sentient and remember painful emotions. “Engrams” become a physical part of cellular structure, controlling behavior like a post-hypnotic suggestion. This understanding of memory is incompatible with current scientific knowledge.

Then there is a second stage of Scientology where people pay for ever more expensive classes, are indoctrinated into the mythology, progress up the church’s ladder of OT (Operating Thetan) levels, and may even join the elite Sea Org, signing a billion year contract.

The Scientology myth was originally a secret revealed only to those who reached the OT III level, but it is now public knowledge. The universe began 4 quadrillion years ago. Evil lord Xenu and his psychiatrist co-conspirators froze individuals (thetans), sent them to the planet Earth, dropped them into volcanoes and blew them up with hydrogen bombs. Freed from their bodies, the thetans were trapped in an electronic ribbon and subjected to brainwashing with a colossal motion picture device which implanted them with all the world religions. Free-floating thetans attach themselves to living people, as many as millions of them in a single body. These “body thetans” have to be eliminated to achieve spiritual progress. If not cleared by Scientology, these thetans will blow themselves up and destroy civilization as they have done many times before. Only Scientology can save humanity from the cycle of self-destruction.

We are all thetans (Scientology’s term for the soul), immortal spiritual beings that are incarnated in innumerable lifetimes.  Auditing is not just to resolve psychological problems but to “recall to the thetan his immortality and help him relinquish his self-imposed limitations” – to emancipate a person from the laws of matter, energy, space and time (MEST). Bored thetans had created MEST universes and then forgot they weren’t real.

When you become “clear” of body thetans, you have a flawless memory able to recall anything you have ever studied; are less susceptible to diseases; rarely have accidents; and are free of neuroses, compulsions, and psychosomatic illnesses. As you progress to the higher OT levels you will be able to levitate, travel through time, control the thoughts of others by telepathy, and have total command over the material universe. With these superhuman powers you can make a traffic light turn green or emit an electric shock that can put out someone’s eyes or cut him in half.

Only one problem: there never were any “clears.” Attempted demonstrations of these powers consistently failed. When auditing was independently tested, it failed (Hubbard claimed they didn’t do it right). Auditing may indeed help people, but its results have never been validated.

As in other cults, confession and re-education are used to control thought. Past lives provide misdeeds to confess. Instead of providing consolation, confession exploits vulnerabilities and steers people into thinking about their faults. The cult keeps its victims in a suggestible state and vigorously suppresses questions and doubts. Exit costs make the prospect of leaving more painful than staying.

Scientology was invented by a science fiction writer, L. Ron Hubbard. He was a liar, fantasist, bigamist, and adulterer; charismatic, vindictive, with sexual and psychological problems that he revealed in the Affirmations, a secret memoir which the church now claims is a forgery. One ex-lover described him as manic-depressive with paranoid tendencies and delusions of grandeur. At one point, concerned that divorce would hurt his reputation, he proposed that if his wife really loved him, she should kill herself.

Hubbard began to develop his ideas in Dianetics, a book that Nobel physicist Isidor Isaac Rabi said “probably contains more promises and less evidence per page than has any publication since the invention of printing.”  The book empowered people to become practitioners themselves. Hubbard said, “I’d like to start a religion. That’s where the money is.” A religion could maintain control of devotees permanently with a series of veiled revelations and levels.

Scientology discourages any use of medication. Pain and other symptoms are treated by “Assists.” For the Contact Assist you repeatedly press the injured part of the body against the object that hurt it until the pain goes away. There is also the Touch Assist; one person who was treated as a child said her mother wouldn’t stop prodding her with a finger until she said she felt better. So of course she said she did. John Travolta once did an Assist on Marlon Brando at a party; he touched Brando’s leg, both closed their eyes, and Brando said it helped.

Assists can supposedly awaken unconscious persons, eliminate boils, reduce earaches and back pain, and make a drunk sober.

At age 7, Jenna Miscavige was assigned the post of Medical Liaison Officer, responsible for treating sick children and providing vitamins to the healthy. Scientology allowed vaccinations but didn’t permit the use of medicine for the treatment of pain or fever. The church doesn’t believe in comforting children, believing they are adults in young bodies and can handle pain like an adult.

Hubbard chastised subordinates for wearing eyeglasses, tried to convince them they could see without them, and said needing them was a transgression against Scientology.

OTs should not have accidents and illnesses; when one woman developed a cold sore, she was consigned to a condition of Treason.

Hubbard had his own (untrained) medical officer. He was afraid of doctors. When a motorcycle accident left him in severe pain from broken ribs and other injuries, he refused to go to the hospital and even refused pain pills, complaining that they slowed down his heart.

Operating Thetans supposedly didn’t get sick, but L. Ron Hubbard had poor hearing, poor vision, was obese, and had numerous physical and psychological problems.  His lame excuse was that he was at such a high level he couldn’t get down to the power level of a body. When he died following a stroke, they said that he didn’t die, but intentionally dropped his body to move on to a higher level of existence. He is expected to return some day. Every Scientology facility maintains an office furnished exactly as he liked, even down to a pair of slippers.

Hubbard theorized that one wealthy Scientologist was not making progress because he had taken LSD and it must still be in his system. He put him to work swabbing the decks on the Sea Org ship to sweat it out of his system. That was the beginning of the Scientology drug treatment program, Narconon.

A fundamental feature of Narconon is the Purification Rundown, a 3 week program to eliminate toxins. Patients spend up to 8 hours a day in a sauna; they exercise and take massive doses of vitamins, especially niacin. Niacin causes skin flushing and tingling sensations which they interpret as evidence of toxins being purged. One woman said Novocaine from previous dental work began to surface and her mouth went numb for 90 minutes.

Psychotic episodes were treated with the Introspection Rundown: solitary confinement, vitamins, calcium and magnesium. 1995 Lisa McPherson suffered a mental breakdown and died following 17 days of this treatment under guard in a Florida hotel. She lapsed into a coma and died en route to a hospital where there was a doctor affiliated with the church (the ambulance bypassed several closer hospitals). Church officials lied in sworn statements to police, claiming that she hadn’t been subject to an Introspection Rundown. A defector later confessed that he had destroyed incriminating documents. The medical examiner determined that the cause of death was a pulmonary embolus: a clot had formed due to the worst case of dehydration she had ever seen, following 5 days without any liquids. Church lawyers pressured her attorney, threatening a legal battle, and she changed her ruling to say the death was “accidental.” Shortly thereafter she retired and became a recluse.

One former Sea Org member said he went psychotic on OT III. He said he lost his sense of identity when he found out that thousands of individual alien beings were struggling for control of his body, trying to give him cancer or drive him insane.

One auditor was declared a “Suppressive Person” and had a nervous breakdown. Instead of treatment he was punished and made to do manual labor. He escaped, killed his wife, and committed suicide.

Anyone who questions Scientology doctrine is sent to RPF (Rehabilitation Project Force). There they are subjected to terrible living conditions and an inadequate diet, and are made to do manual labor; it has been compared to the prison camps of the Soviet Gulag. One Sea Org man was forced to shovel up asbestos in a renovation project with no protective gear, not even a mask. A woman was made to weld without protective glasses; she burned her eyes and got no medical attention at all. A severely handicapped MS patient who was unable to talk was sent to RPF.

Medical treatment is often cruel and inadequate. A woman who had incapacitating migraines kept auditing herself on the E-Meter in lieu of treatment, because she felt responsible for her pain. A little deaf mute girl was isolated in the Sea Org ship’s chain locker for a week because Hubbard thought it might cure her deafness. Yvonne Gillham, a Sea Org member, died of a brain tumor that would have been operable with earlier diagnosis. She blamed herself for her symptoms and refused to take pain meds because it might interfere with her auditing.

Scientologists are persuaded to wean themselves off any medications. John Travolta’s son was taken off his seizure meds, which may have contributed to his death. A young man taking Lexapro was labeled as a drug addict and his father was ordered to lock his son’s Lexapro in the trunk of his car. The patient killed himself with his father’s pistol. The case was dismissed for lack of evidence.

Brooke Shields got through post-partum depression with the help of antidepressants. Tom Cruise erupted with fury on a talk show, dissing psychiatry and saying she should have treated her depression with diet and exercise.

Despite their aversion to prescription drugs, Scientologists are curiously gullible about alternative medicine. John Travolta is enthusiastic about bee pollen. David Miscavige, the current president, follows the Blood Type Diet and takes his personal chiropractor along when he travels. Hubbard invented Dianazene, a mixture of nicotinic acid and vitamins taken daily with milk and chocolate to cure cancer and sunburns. He recommended a baby formula of boiled barley and corn syrup that he picked up in Roman days in a former lifetime. He was fanatical about taking vitamins.

Hubbard blamed psychiatrists for helping Xenu commit genocide 5 billion years ago. He held them responsible for modern wars, racism, ethnic cleansing, and terrorism, including the Holocaust, apartheid, and 9/11. He called psychiatry the sole cause of decline in the universe. He said if psychiatrists “had the power to torture and kill everyone, they would do so…. they are psychotic criminals…” He accused them of trying to institute world government by manipulating human behavior. Scientologists accused Osama bin Laden’s deputy, a “psychiatrist,” (actually a general surgeon) of controlling his thoughts. Another “psychiatrist” who allegedly masterminded the Madrid train bombings was actually a used-car salesman who had nothing to do with the incident. Scientology maintains the exhibit “Psychiatry: An Industry of Death” in Hollywood, featuring errors of psychiatry like madhouses, lobotomies, electric shock, and drugs for spurious diagnoses.  Scientology aims to eliminate psychiatry in all its forms, claiming that no mental diseases have ever been proven to exist.

When TIME magazine criticized Scientology, they claimed Eli Lilly had ordered the article in retribution for the damage Scientology had caused to their “killer drug Prozac,” which supposedly causes people to commit mass murder and suicide.

Scientology lobbyists even got legislation passed in Florida that would hold schoolteachers criminally liable for just suggesting to parents that kids might have a mental health condition such as ADD. Fortunately the governor vetoed it.

Hubbard claimed to have obtained a perfect understanding of human nature by self-examination and to have an exact science. Nonsense! There is no science in Scientology. Crispian Jago has created The Venn Diagram of Irrational Nonsense: overlapping circles for quackery bollocks, religious bollocks, pseudoscientific bollocks, and paranormal bollocks; he put Scientology at the center where all these overlap.   I agree: that’s exactly where it belongs.

Note: My source for much of this information is Going Clear: Scientology, Hollywood, and the Prison of Belief by Lawrence Wright. Further details and full references can be found in the book.

Categories: Medicine, Skepticism

Sting Shows Supplement Regulation Worthless

Neurologica Blog - Mon, 03/23/2015 - 07:47

It seems that the regulation of supplements, homeopathy, and “natural” products in Canada is as bad as the US. The Canadian Broadcasting Corporation (CBC, the equivalent of NPR and PBS in the US) recently conducted a demonstration of just how worthless and deceptive the regulations are.

They created a fake treatment called “Nighton” which they claimed treated fever, pain, and inflammation in children and infants. They then applied to the government for a Natural Product License. On the application they checked all the appropriate boxes amd submitted as evidence copied pages from a 1902 homeopathic reference book. That was it. Five months later their fictitious product was approved as “safe and effective.”

What this means is that when the Canadian government approves a natural product as safe and effective, it is completely meaningless. It is essentially a license to lie to the public about a health product.

It is reasonable to assume that many if not most of the public, if they see a product on the pharmacy shelf with the label, “licensed as safe and effective for fever, pain, and inflammation,” with an official government issued product number, that some sort of testing and quality assurance was involved.

The situation is identical in the US. Companies can market homeopathy products or supplements without providing any evidence that the product is safe, and can even make health claims (as long as they don’t mention a specific disease by name) again without the need to provide any evidence. In essence, in the US or Canada a company can put anything in a pill or bottle (as long as it doesn’t contain an actual drug), then without any testing market their random assortment of vitamins, herbs, or just water (in the case of homeopathy) with specific health claims. Pharmacies are happy to sell these fake products side-by-side with real medicines.

This is nothing short of a scandal. It amazes me that consumer advocates are nowhere to be seen on this issue. Where is Ralph Nader when you need him? Companies are allowed to sell products (health products, no less) with made-up claims, all government approved and sealed. This is a legislative gift to a specific industry at the expense of the consumer, a government-sanctioned scam.

The CBC asked Health Canada to comment on their sting operation, and they responded:

“Canadians want a range of treatment choices available to them for conditions they can manage themselves,” wrote Health Canada spokesperson Eric Morrissette.

People want choices, sure, but they don’t want to be scammed by their own government working with snake oil salesmen. If this is all about choice then give consumers total transparency. Don’t pretend these products are regulated when they aren’t. Prominently display on the package – “Not regulated by the government. There is no assurance of safety or effectiveness with this product. The manufacturer did not provide any evidence of safety or efficacy. Hey, we don’t even know what’s in this crap.” Pharmacies should not sell them, or if they do they should sell them is their own section, clearly labeled as “Potions and Snake Oil. Use at your own risk.”

What Health Canada is missing is that real choice requires true information and transparency. The problem with the system is the inherent deception. Regulations as they currently stand in the US and Canada are inherently deceptive. They are pro-industry and anti-consumer. Consumers should be pissed and demanding change, but it seems like the public has been so thoroughly sold on the supplement industry propaganda they don’t even realize how they are being scammed.

There are some easy fixes to this regulatory scandal (conceptually easy, politically very difficult). First, ban homeopathy. Homeopathy is 100% a complete pseudoscientific scam. It is the poster child for snake oil. Just ban it already.

Next, put in place some actual regulation for any other product that makes health claims. There is debate among my colleagues and I about where, exactly, the threshold of evidence should be placed for non-pharmaceutical products. I don’t think we necessarily need to have the same threshold of evidence as for drugs. That’s never going to happen anyway, I would argue. But, health claims need to be specific, and should be backed by a reasonable degree of scientific evidence. This can include a systematic review of studies in the peer-reviewed literature, even if they were not performed specifically by the company for the purpose of approval.

Companies should provide evidence and monitoring of their products for purity and accuracy of the ingredients on the label. Safety data should also be required, including drug-drug interactions. I also think bioavailability evidence should be provided – how much of the product actually get absorbed into the system?

These are the regulations that the public already assumes are in place. People assume that when the government sanctions a product and a pharmacy sells the product with health claims that those claims have been vetted. Just give the public what they think they already have, and end the deception.

These regulations should dramatically reverse the explosion of supplements and natural products over the last two decades, and that’a a good thing. I suspect that almost every such product is utterly worthless for health. The net effect of the natural health product industry is to suck billions of dollars out of the public without benefiting their health one bit. In fact the net effect on health is probably negative, as consumers spend their finite healthcare resources on worthless products and may replace or delay effective treatment.

I applaud the CBC for doing this expose. I hope they see the opportunity to keep the momentum going, and not treat this as a one-off news item. The public needs to understand what is going on so that we can build the political will to make real change.

Categories: Medicine

On the “right” to challenge a medical or scientific consensus

Science Based Medicine - Mon, 03/23/2015 - 06:00

Jenny McCarthy flaunting her “expertise” at the antivaccine “Green Our Vaccines” rally in Washington, DC in 2008

The major theme of the Science-Based Medicine blog is that the application of good science to medicine is the best way to maintain and improve the quality of patient care. Consequently, we spend considerable time dissecting medical treatments based on pseudoscience, bad science, and no science, and trying to prevent their contaminating existing medicine with unscientific claims and treatments. Often these claims and treatments are represented as “challenging” the scientific consensus and end up being presented in the media—or, sadly, sometimes even in the scientific literature—as valid alternatives to existing medicine. Think homeopathy. Think antivaccine views. Think various alternative cancer treatments. When such pseudoscientific medicine is criticized, frequently the reaction from its proponents is to attack “consensus science.” Indeed, I’ve argued that one red flag identifying a crank or a quack is a hostility towards the very concept of a scientific consensus.

Indeed, I even cited as an example of this attitude a Tweet by Jane Orient, MD, executive director of the American Association of Physicians and Surgeons (AAPS). This is an organization of physicians that values “mavericky-ness” above all else, in the process rejecting the scientific consensus that vaccines are safe and effective and do not cause autism or sudden infant death syndrome (SIDS), that HIV causes AIDS, and that abortion doesn’t cause breast cancer, to name a few. Along the way the AAPS embraces some seriously wacky far right wing viewpoints such as that Medicare is unconstitutional and that doctors should not be bound by evidence-based practice guidelines because they are an affront to the primacy of the doctor-patient relationship and—or so it seems to me—the “freedom” of a doctor to do pretty much damned well anything he pleases to treat a patient.

I’ll repost Dr. Orient’s Tweet:

@secularbloke @gorskon @AAPSonline Skepticism is the essence of science; consensus is its death

— Jane Orient, MD (@jorient) December 1, 2014

As I said at the time (a great example can be found here), on the surface this seems quite reasonable, but, as I’ve discussed on many occasions, science is all about coming to provisional consensuses about how the universe works. Such consensuses are challenged all the time by scientists. Sometimes they are shown to be incorrect and require revision; sometimes they are reinforced. That’s how science works.

The reason I brought up this issue again is because I came across a couple of articles relevant to this topic. The first is one by John Horgan, who blogs over at Scientific American, entitled ‘Everyone, Even Jenny McCarthy, Has the Right to Challenge “Scientific Experts”.’ Having a tendency towards snarkiness, my first thought was to simply dismiss this as a straw man argument (at least the title), because I know of no strong defender of science (least of all I) saying that non-experts—yes, even Jenny McCarthy—don’t have the right to challenge experts. When we complain about “false balance,” it’s not because we think that, for example, antivaccine activists don’t have the “right” to challenge the experts supporting the scientific consensus. Rather, it’s because we argue—correctly, I believe—that media outlets all too often present such challenges as falsely equivalent to the actual consensus science being challenged, in essence, putting someone like Jenny McCarthy on or near the same plane as actual scientists. Examples abound and have been discussed on this very blog, embracing many relevant topics, such as influenza, dubious cancer cures, homeopathy, vaccine safety and efficacy, fear mongering about food by Vani Hari (a.k.a. The Food Babe) and many other topics.

So let’s see what Horgan objects to:

Years ago I was blathering to a science-writing class at Columbia Journalism School about the complexities of covering psychiatric drugs when a student, who as I recall had a medical degree, raised his hand. He said he didn’t understand what the big deal was; I should just report “the facts” that drug researchers reported in peer-reviewed journals.

I was so flabbergasted by his naivete that I just stared at him, trying to figure out how to respond politely. I had a similar reaction when I spotted the headline of a recent essay by journalist Chris Mooney: “This Is Why You Have No Business Challenging Scientific Experts.”

Mooney is distressed, rightly so, that many people reject the scientific consensus on human-induced global-warming, the safety of vaccines, the viral cause of AIDS, the evolution of species. But Mooney’s proposed solution, which calls for non-scientists to yield to the opinion of “experts,” is far too drastic.

Oddly enough, the article by Chris Mooney cited by Horgan isn’t particularly recent. It’s close to 10 months old. Be that as it may, Yes, that hapless student did have a rather naïve attitude, but what he said is not quite the same as what Mooney argued, Horgan’s conflation of the two notwithstanding. Let’s put it this way. There’s a not-insignificant difference between saying “you have no business challenging scientific experts” and “you have no right to challenge scientific experts.” The first is a warning to lay people and people without the appropriate expertise about why they should be very careful challenging a scientific consensus without saying that they have no right to make such challenges. What Mooney calls for is the recognition that there is such a thing as expertise and challenging it requires more than just a Google education.

Mooney’s article relied heavily on the viewpoint of Professor Harry Collins of Cardiff University, who runs the Centre For The Study Of Knowledge Expertise Science at the Cardiff School of Social Sciences. Specifically, Mooney was discussing a book by Collins entitled Are We All Scientific Experts Now? In the book, Collins lays out a robust defense of scientific expertise. According to Mooney, Collins is known for his investigation in which he was embedded for over a decade within the community of gravitational wave physicists to the point where he became so familiar with their culture that he was actually able to trick physicists into thinking he was one of them. During his time he refuted several myths about science, such as the “eureka moment” and the idea that scientists always follow the data where they lead when in fact sometimes they cling to established paradigms in the face of new evidence. As Mooney put it, the upshot was that “while the scientific process works in the long run, in the shorter term it is very messy—full of foibles, errors, confusions, and personalities.”

I’ve said almost exactly the same thing myself on more occasions than I can remember. In the short term, science can be incredibly messy. Early results that seemed promising often undergo a “decline effect” and appear less solid. In medicine, in particular, physicians and scientists sometimes cling to old paradigms longer than they should in the face of new evidence. On the other hand, because human lives are at stake, this is somewhat understandable. Because being wrong about new findings in medicine can cause actual harm to human beings, physicians tend to be conservative and need a lot of convincing. Sometimes this tendency goes too far. Indeed, we have a bit of a joke in medicine that no medical treatment is ever entirely abandoned until the last group of physicians who trained when it was the standard of care has retired or died off. It’s actually not quite that bad, and doctors do pay attention to negative studies. There are lots of things we as surgeons did in the 1990s as part of breast cancer treatment, for instance, that we no longer do and things that we didn’t do then (and hadn’t even thought of yet) that we do now. There’s also a countervailing tendency among physicians to “jump on the bandwagon” of new treatments before they’re properly validated, sometimes for marketing advantage, sometimes just to be a trailblazer. Laparoscopic cholecystectomy in the early 1990s comes immediately to mind as an example of this tendency.

Still, as messy as science is, I agree with Mooney that in the long term the scientific process works. I also like the Collins’ concept of the Periodic Table of Expertises, described by Mooney:

Read all the online stuff you want, Collins argues—or even read the professional scientific literature from the perspective of an outsider or amateur. You’ll absorb a lot of information, but you’ll still never have what he terms “interactional expertise,” which is the sort of expertise developed by getting to know a community of scientists intimately, and getting a feeling for what they think.

“If you get your information only from the journals, you can’t tell whether a paper is being taken seriously by the scientific community or not,” says Collins. “You cannot get a good picture of what is going on in science from the literature,” he continues. And of course, biased and ideological internet commentaries on that literature are more dangerous still.

Interactional expertise requires deep experience with a specialty of the kind that can’t be simply learned by reading the literature; in essence, it involves, to some extent or other, actual experience studying and doing research in the relevant specialty. Our professors in medical school often pointed out that at least half of what we were being taught will be incorrect in a decade. Whether that exact estimate is true or not is not critical to the main point, which is that medicine and medical knowledge changes fairly rapidly as new scientific findings are reported and that we, as physicians, have to learn to adapt and integrate these new findings into our practices. Because it’s not uncommon for keeping up with the latest literature to be too much for one person to do without help, we rely on the society of physicians and medical scientists. One way we do this is to attend medical and scientific conferences relevant to our specialty. (For example, I will be going to Houston later this week to attend the Society for Surgical Oncology meeting, and in April I will be attending the American Association for Cancer Research annual meeting in Philadelphia.) We form professional societies who gather groups of experts together to produce and periodically update guidelines based on the best existing evidence.

To show the difference between literature knowledge and interactional knowledge, Collins uses this analogy:

The next step after popular understanding is the kind of knowledge that comes with reading primary or quasiprimary literature. We will call it ‘primary source knowledge.’ Nowadays the internet is a powerful resource for this kind of material. But even the primary sources provide only a shallow or misleading appreciation of science in deeply disputed areas though this is far from obvious: reading the primary literature is so hard, and the material can be so technical, that it gives the impression that real technical mastery is being achieved.

It may that the feelings of confidence that come with a mastery of the primary literature is a factor feeding into the ‘folk-wisdom view’ [the view that ordinary people are wise in the ways of science and technology]. But any amateur trying to apply the knowledge gained from car-repair manuals will soon learn the bitter lesson that much less can be done as result of reading information than appears to be the case. The same applies to doctoral students in the sciences; their first experience of real research is usually a shock, however well accomplished they have become in reading the published literature and doing well-rehearsed experiments as undergraduates. But even experienced scientists tend not to understand the amount of tacit knowledge on which their abilities depend. Thus, studies of tacit knowledge transmission show, inter alia, that scientists will embark confidently on an experimental project having done nothing more than read the literature and only later discover the degree of joint practice and/or linguistic socialisation that is needed to make a success of it (to generate the capacity to do the thing rather than talk about it).13 Given trainee scientists’ experiences, and professional scientists’ lack of reflective appreciation of their own tacit knowledge, it is no surprise that a member of the public encountering the professional journals or the internet might easily come to think that they have found a direct line to understanding.14

Footnote 14 brings this concept home to medicine:

14. A familiar image is today’s informed patient visiting their doctor armed with a swathe of material printed from the internet. While this kind of information gathering, especially in the context of a support or discussion group, can be valuable, it is important not to lose sight of what sociologists have shown: a great deal of training and experience is needed to evaluate such information. Sociologists of science seem to forget the lessons of their own subject rather easily.

Exactly.

None of this is to say that those who haven’t reached the level of interactional knowledge about a subject don’t have the right to criticize scientific consensuses within that subject. It does, however, warn those who would be critical to avoid the hubris of thinking that their popular science or even primary literature knowledge is sufficient.

It’s also important to remember that there are scientific consensuses and then there are scientific consensuses. What I mean is that some consensuses are stronger than others, something Horgan seems to ignore or downplay. For example, he seems quite pleased with himself when seemingly he got something right that Stephen Hawking got wrong. Last year, cosmologists overseeing a project called Background Imaging of Cosmic Extragalactic Polarization 2 (BICEP2) reported the “first direct evidence” of inflation, a theory which says that the universe went through a period of extremely rapid expansion right after the Big Bang. Hawking had made a bet with another scientist, cosmologist Neil Turok, director of the Perimeter Institute in Canada, that gravitational waves from the first fleeting moments after the Big Bang would be detected by BICEP2. He had even declared victory on the BBC, leading Horgon to nearly strain his shoulder and elbow patting himself on the back when Hawking turned out to be wrong:

No less an authority than Stephen Hawking declared that the BICEP2 results represented a “confirmation of inflation.” I nonetheless second-guessed Hawking and the BICEP2 experts, reiterating my long-standing doubts about inflation. Guess what? Hawking and the BICEP2 team turned out to be wrong.

I’m not bragging. Okay, maybe I am, a little. But my point is that I was doing what journalists are supposed to do: question claims even if–especially if—they come from authoritative sources. A journalist who doesn’t do that isn’t a journalist. He’s a public-relations flak, helping scientists peddle their products.

Here’s the thing. There’s a huge difference between a well-settled scientific consensus and cutting edge cosmology. Yes, Stephen Hawking is undeniably an expert, but he was expressing a scientific opinion on a matter that was (and is) not at all close to settled science. That he turned out to be wrong is not shameful. It turns out that the BICEP2 investigators teamed up with another group of scientists from the European Space Agency to analyze the data from BICEP2 and ESA’s Planck satellite and found that the previous analysis had overlooked factors that could produce a false positive. Again, this is the sort of reversal that is not uncommon when scientists are doing research at the bleeding edge of scientific discovery.

It is a very different thing than the science that tells us homeopathy can’t work, that vaccines are safe and effective, and that energy healing is more magic than science. Moreover, as one commenter pointed out to Horgan, the “first meaningful (i.e. based on actual scientific arguments) doubts about the BICEP2 results I saw were on the blogs of professional cosmologists, and not issues raised by journalists themselves (although yes, they were later reported by journalists).” Also, as another commenter pointed out, just because the BICEP2 team was wrong about the interpretation of their experiment doesn’t necessarily mean they were wrong about inflation. That commenter also pointed out (as I just did) that inflation is not yet consensus theory.

Horgan goes on to argue that “it’s precisely because we journalists are ‘outsiders’ that we can sometimes judge a field more objectively than insiders.” Well, yes and no. It might well be possible for an outsider like Horgan to judge conflicts of interest, disclosed or undisclosed, better than “insiders” can, as in the case of pharmaceutical funding and influence on drug development. Indeed, just check out Brian Deer’s excellent work outside his other excellent work exposing Andrew Wakefield’s scientific fraud (e.g. his work on the TGN 1412 clinical trial and ). Just look at what Ben Goldacre has accomplished. That being said, unless Horgan has reached the level of interactional knowledge, his “insights” about a scientific field, in particular the scientific consensuses within that field, should not be treated the same as those of real experts.

Unfortunately, Horgan rather misses the point in his conclusion:

Google is reportedly working on algorithms for evaluating the credibility of websites based on their factual content. But there will never be a foolproof way to determine a priori whether a given scientific consensus is correct or not. You have to do the hard work of digging into it and weighing its pros and cons. And anybody can do that, including me, Mooney and even Jenny McCarthy.

By the way, I think McCarthy grossly overstates the dangers of vaccines–I’m glad my kids got vaccinated–but I, too, have concerns about some vaccines.

Reading Horgan’s article referenced in the last sentence, “Michele Bachmann Wasn’t Totally Wrong about HPV Vaccines“, made me cringe. Although Horgan does point out that he didn’t believe Bachmann’s ignorant blather about Gardasil causing mental retardation, he does seem to conflate questions of Merck’s marketing strategy for Gardasil with whether a mass vaccination campaign to prevent HPV is worth the expense and bother, seeking to poison the well about Gardasil based on distrust of pharmaceutical marketing instead of concentrating on the scientific and medical merits and disadvantages of the vaccine.

A number of commenters had excellent retorts to Horgan’s argument that anyone, including Jenny McCarthy, Chris Mooney, and yes, John Horgan, can do the “hard work of digging into” a scientific consensus and “weighing its pros and cons”: And anybody can play basketball, including me, Michael Jordan, and Stephen Hawking.

Or, with the country being in the thick of March Madness and all:

People can pretend to be scientists. That doesn’t make them scientists. They can forget that they failed high school math, majored in art history in college, and became an actor. I can also forget that I did not play for the Tar Heels and the Bulls, but basketball sure is fun. Expertise takes a lot of hard work. Someone claiming they have expertise when they don’t is arrogant. James Inhofe melting a snowball is not expertise in climatology. Call it a gimmick, but it was a gimmick that showed he did not know the difference between global climate and local weather. Yes, he does have the right to his beliefs, but others have the right to laugh at his beliefs as being profoundly ignorant.

Precisely. This is where Horgan again misses the point. It’s not about people without expertise not having the “right” to question a scientific consensus. Clearly, a fair reading of his article indicates that not even Mooney meant that when he said you have “no business” questioning scientific consensus. (Besides, as I recently learned when I was published in Slate.com, it’s usually the editor who comes up with the headline, not the writer.) Rather, it’s about how that consensus is questioned. When it’s questioned, as Jenny McCarthy and antivaccinationists question scientific consensus, using misinformation, pseudoscience, cherry picked studies, and misinterpretation of other scientific studies, such “questioning” devolves into denialism and should be called out. In other words, how one questions a scientific finding matters. A lot.

Finally, it’s also about how much the questioning of a scientific consensus by a non-expert should be valued. Someone like Horgan might have a modicum of credibility questioning a scientific consensus based on his experience as a science journalist, particularly when we’re talking about something that isn’t a particularly strong consensus (inflation), if it’s even consensus at all. Someone like Jenny McCarthy, with no relevant expertise even reaching the level of “literature knowledge,” has no credibility at all. Having people like me say so and people like Mooney saying that she has “no business” making such pronouncements is simply the price she pays for parading her ignorance to the world, particularly when her ignorance contributes to real degradations in public health through increasing numbers of parents not vaccinating their children. In the end, what Horgan seems to be arguing is that we should take pseudoexpertise seriously. I disagree.

Related posts:

  1. Hostility towards scientific consensus: A red flag identifying a crank or quack
  2. Science-based medicine, skepticism, and the scientific consensus
  3. Pseudo-expertise versus science-based medicine
  4. The “decline effect”: Is it a real decline or just science correcting itself?

 

 

Categories: Medicine, Skepticism

On the “right” to challenge a medical or scientific consensus

Science Based Medicine - Mon, 03/23/2015 - 06:00

Jenny McCarthy flaunting her “expertise” at the antivaccine “Green Our Vaccines” rally in Washington, DC in 2008

The major theme of the Science-Based Medicine blog is that the application of good science to medicine is the best way to maintain and improve the quality of patient care. Consequently, we spend considerable time dissecting medical treatments based on pseudoscience, bad science, and no science and trying to prevent their contaminating existing medicine with unscientific claims and treatments. Often these claims and treatments are represented as “challenging” the scientific consensus and end up being presented in the media—or, sadly, sometimes even in the scientific literature—as valid alternatives to existing medicine. Think homeopathy. Think antivaccine views. Think various alternative cancer treatments. When such pseudoscientific medicine is criticized, frequently the reaction from its proponents is to attack “consensus science.” Indeed, I’ve argued that one red flag identifying of a crank or a quack is a hostility towards the very concept of a scientific consensus.

Indeed, I even cited as an example of this attitude a Tweet by Jane Orient, MD, executive director of the American Association of Physicians and Surgeons (AAPS). This is an organization of physicians that values “mavericky-ness” above all else, in the process rejecting the scientific consensus that vaccines are safe and effective and do not cause autism or sudden infant death syndrome (SIDS), that HIV causes AIDS, and that abortion doesn’t doesn’t cause breast cancer, to name a few. Along the way the AAPS embraces some seriously wacky far right wing viewpoints such as that Medicare is unconstitutional and that doctors should not be bound by evidence-based practice guidelines because they are an affront to the primacy of the doctor-patient relationship and—or so it seems to me—the “freedom” of a doctor to do pretty much damned well anything he pleases to treat a patient.

I’ll repost Dr. Orient’s Tweet:

@secularbloke @gorskon @AAPSonline Skepticism is the essence of science; consensus is its death

— Jane Orient, MD (@jorient) December 1, 2014

As I said at the time (a great example can be found here), on the surface this seems quite reasonable, but, as I’ve discussed on many occasions, science is all about coming to provisional consensuses about how the universe works. Such consensuses are challenged all the time by scientists. Sometimes they are shown to be incorrect and require revision; sometimes they are reinforced. That’s how science works.

The reason I brought up this issue again is because I came across a couple of articles relevant to this topic. The first is one by John Horgan, who blogs over at Scientific American, entitled, Everyone, Even Jenny McCarthy, Has the Right to Challenge “Scientific Experts”. Having a tendency towards snarkiness, my first thought was to simply dismiss this as a straw man argument (at least the title), because I know of no strong defender of science (least of all I) saying that non-experts—yes, even Jenny McCarthy—don’t have the right to challenge experts. When we complain about “false balance,” it’s not because we think that, for example, antivaccine activists don’t have the “right” to challenge the experts supporting the scientific consensus. Rather, it’s because we argue—correctly, I believe—that media outlets all too often present such challenges as falsely equivalent to the actual consensus science being challenged, in essence, putting someone like Jenny McCarthy on or near the same plane as actual scientists. Examples abound and have been discussed on this very blog, embracing many relevant topics, such as influenza, dubious cancer cures, homeopathy, vaccine safety and efficacy, fear mongering about food by Vani Hari (a.k.a. The Food Babe) and many other topics.

So let’s see what Horgan objects to:

Years ago I was blathering to a science-writing class at Columbia Journalism School about the complexities of covering psychiatric drugs when a student, who as I recall had a medical degree, raised his hand. He said he didn’t understand what the big deal was; I should just report “the facts” that drug researchers reported in peer-reviewed journals.

I was so flabbergasted by his naivete that I just stared at him, trying to figure out how to respond politely. I had a similar reaction when I spotted the headline of a recent essay by journalist Chris Mooney: “This Is Why You Have No Business Challenging Scientific Experts.”

Mooney is distressed, rightly so, that many people reject the scientific consensus on human-induced global-warming, the safety of vaccines, the viral cause of AIDS, the evolution of species. But Mooney’s proposed solution, which calls for non-scientists to yield to the opinion of “experts,” is far too drastic.

Oddly enough, the article by Chris Mooney cited by Horgan isn’t particularly recent. It’s close to 10 months old. Be that as it may, Yes, that hapless student did have a rather naive attitude, but what he said is not quite the same as what Mooney argued, Horgan’s conflation of the two notwithstanding. Let’s put it this way. There’s a not insignificant difference between saying “you have no business challenging scientific experts” and “you have no right to challenge scientific experts.” The first is a warning to lay people and people without the appropriate expertise about why they should be very careful challenging a scientific consensus without saying that they have no right to make such challenges. What Mooney calls for is the recognition that there is such a thing as expertise and challenging it requires more than just a Google educations.

Mooney’s article relied heavily on the viewpoint of Professor Harry Collins of Cardiff University, who runs the Centre For The Study Of Knowledge Expertise Science at the Cardiff School of Social Sciences. Specifically, Mooney was discussing a book by Collins entitled Are We All Scientific Experts Now? In the book, Collins lays out a robust defense of scientific expertise. According to Mooney, Collins is known for his investigation in which he was embedded for over a decade within the community of gravitational wave physicists to the point where he became so familiar with their culture that he was actually able to trick physicists into thinking he was one of them. During his time he refuted several myths about science, such as the “eureka moment” and the idea that scientists always follow the data where they lead when in fact sometimes they cling to established paradigms in the face of new evidence. As Mooney put it, the upshot was that “while the scientific process works in the long run, in the shorter term it is very messy—full of foibles, errors, confusions, and personalities.”

I’ve said almost exactly the same thing myself on more occasions than I can remember. In the short term, science can be incredibly messy. Early results that seemed promising often undergo a “decline effect” and appear less solid. In medicine, in particular, physicians and scientists sometimes cling to old paradigms longer than they should in the face of new evidence. On the other hand, because human lives are at stake, this is somewhat understandable. Because being wrong about new findings in medicine can cause actual harm to human beings, physicians tend to be conservative and need a lot of convincing. Sometimes this tendency goes to far. Indeed, we have a bit of a joke in medicine that no medical treatment is ever entirely abandoned until the last group of physicians who trained when it was the standard of care has retired or died off. It’s actually not quite that bad. There are lots of things we as surgeons did in the 1990s as part of breast cancer treatment, for instance, that we no longer do and things that we didn’t do then (and hadn’t even thought of yet) that we do now. There’s also a countervailing tendency among physicians to “jump on the bandwagon” of new treatments before they’re properly validated, sometimes for marketing advantage, sometimes just to be a trailblazer. Laparoscopic cholecystectomy in the early 1990s comes immediately to mind as an example of this tendency.

Still, as messy as science is, I agree with Mooney that in the long term the scientific process works. I also like the Collins’ concept of the Periodic Table of Expertises, described by Mooney:

Read all the online stuff you want, Collins argues—or even read the professional scientific literature from the perspective of an outsider or amateur. You’ll absorb a lot of information, but you’ll still never have what he terms “interactional expertise,” which is the sort of expertise developed by getting to know a community of scientists intimately, and getting a feeling for what they think.

“If you get your information only from the journals, you can’t tell whether a paper is being taken seriously by the scientific community or not,” says Collins. “You cannot get a good picture of what is going on in science from the literature,” he continues. And of course, biased and ideological internet commentaries on that literature are more dangerous still.

Interactional expertise requires deep experience with a specialty of the kind that can’t be simply learned by reading the literature; in essence, it involves, to some extent or other, actual experience studying and doing research in the relevant specialty. Our professors in medical school often pointed out that at least half of what we were being taught will be incorrect in a decade. Whether that exact estimate is true or not is not critical to the main point, which is that medicine and medical knowledge changes fairly rapidly as new scientific findings are reported and that we, as physicians, have to learn to adapt and integrate these new findings into our practices. Because it’s not uncommon for keeping up with the latest literature to be too much for one person to do without help, we rely on the society of physicians and medical scientists. One way we do this is to attend medical and scientific conferences relevant to our specialty. (For example, I will be going to Houston later this week to attend the Society for Surgical Oncology meeting, and in April I will be attending the American Association for Cancer Research annual meeting in Philadelphia.) We form professional societies who gather groups of experts together to produce and periodically update guidelines based on the best existing evidence.

To show the difference between literature knowledge and intersectional knowledge, Collins uses this analogy:

The next step after popular understanding is the kind of knowledge that comes with reading primary or quasiprimary literature. We will call it `primary source knowledge.’ Nowadays the internet is a powerful resource for this kind of material. But even the primary sources provide only a shallow or misleading appreciation of science in deeply disputed areas though this is far from obvious: reading the primary literature is so hard, and the material can be so technical, that it gives the impression that real technical mastery is being achieved.

It may that the feelings of confidence that come with a mastery of the primary literature is a factor feeding into the `folk-wisdom view’ [the view that ordinary people are wise in the ways of science and technology]. But any amateur trying to apply the knowledge gained from car-repair manuals will soon learn the bitter lesson that much less can be done as result of reading information than appears to be the case. The same applies to doctoral students in the sciences; their first experience of real research is usually a shock, however well accomplished they have become in reading the published literature and doing well-rehearsed experiments as undergraduates. But even experienced scientists tend not to understand the amount of tacit knowledge on which their abilities depend. Thus, studies of tacit knowledge transmission show, inter alia, that scientists will embark confidently on an experimental project having done nothing more than read the literature and only later discover the degree of joint practice and/or linguistic socialisation that is needed to make a success of it (to generate the capacity to do the thing rather than talk about it).13 Given trainee scientists’ experiences, and professional scientists’ lack of reflective appreciation of their own tacit knowledge, it is no surprise that a member of the public encountering the professional journals or the internet might easily come to think that they have found a direct line to understanding.14

Footnote 14 brings this concept home to medicine:

14. A familiar image is today’s informed patient visiting their doctor armed with a swathe of material printed from the internet. While this kind of information gathering, especially in the context of a support or discussion group, can be valuable, it is important not to lose sight of what sociologists have shown: a great deal of training and experience is needed to evaluate such information. Sociologists of science seem to forget the lessons of their own subject rather easily.

Exactly.

None of this is to say that those who haven’t reached the level of intersectional knowledge about a subject don’t have the right to criticize scientific consensuses within that subject. It does, however, warn those who would be critical to avoid the hubris of thinking that their popular science or even primary literature knowledge is sufficient.

It’s also important to remember that there are scientific consensuses and then there are scientific consensuses. What I mean is that some consensuses are stronger than others, something Horgan seems to ignore or downplay. For example, he seems quite pleased with himself when seemingly he got something right that Stephen Hawking got wrong. Last year, cosmologists overseeing a project called Background Imaging of Cosmic Extragalactic Polarization 2 (BICEP2) reported the “first direct evidence” of inflation, a theory which says that the universe went through a period of extremely rapid expansion right after the big bang. Hawking had made a bet with another scientist, cosmologist Neil Turok, director of the Perimeter Institute in Canada, that gravitational waves from the first fleeting moments after the big bang would be detected by BICEP2. He had even declared victory on the BBC, leading Horgon to nearly strain his shoulder and elbow patting himself on the back when Hawking turned out to be wrong:

No less an authority than Stephen Hawking declared that the BICEP2 results represented a “confirmation of inflation.” I nonetheless second-guessed Hawking and the BICEP2 experts, reiterating my long-standing doubts about inflation. Guess what? Hawking and the BICEP2 team turned out to be wrong.

I’m not bragging. Okay, maybe I am, a little. But my point is that I was doing what journalists are supposed to do: question claims even if–especially if—they come from authoritative sources. A journalist who doesn’t do that isn’t a journalist. He’s a public-relations flak, helping scientists peddle their products.

Here’s the thing. There’s a huge difference between a well-settled scientific consensus and cutting edge cosmology. Yes, Stephen Hawking is undeniably an expert, but he was expressing a scientific opinion on a matter that was (and is) not at all close to settled science. That he turned out to be wrong is not shameful. It turns out that the BICEP2 investigators teamed up with another group of scientists from the European Space Agency to analyze the data from BICEP2 and ESA’s Planck satellite and found that the previous analysis had overlooked factors that could produce a false positive. Again, this is the sort of reversal that is not uncommon when scientists are doing research at the bleeding edge of scientific discovery.

It is a very different thing than the science that tells us homeopathy can’t work, that vaccines are safe and effective, and that energy healing is more magic than science. Moreover, as one commenter pointed out to Horgan, the “first meaningful (i.e. based on actual scientific arguments) doubts about the BICEP2 results I saw were on the blogs of professional cosmologists, and not issues raised by journalists themselves (although yes, they were later reported by journalists).” Also, as another commenter pointed out, just because the BICEP2 team was wrong about the interpretation of their experiment doesn’t necessarily mean they were wrong about inflation. That commenter also pointed out (as I just did) that inflation is not yet consensus theory.

Horgan goes on to argue that “it’s precisely because we journalists are ‘outsiders’ that we can sometimes judge a field more objectively than insiders.” Well, yes and no. It might well be possible for an outsider like Horgan to judge conflicts of interest, disclosed or undisclosed, than “insiders” can, as in the case of pharmaceutical funding and influence of drug development. Indeed, just check out Brian Deer’s excellent work outside his other excellent work exposing Andrew Wakefield’s scientific fraud (e.g. his work on the TGN 1412 clinical trial and ). Just look at what Ben Goldacre has accomplished. That being said, unless Horgan has reached the level of intersectional knowledge, his “insights” about a scientific field, in particular the scientific consensuses within that field, should not be treated the same as those of real experts.

Unfortunately, Horgan rather misses the point in his conclusion:

Google is reportedly working on algorithms for evaluating the credibility of websites based on their factual content. But there will never be a foolproof way to determine a priori whether a given scientific consensus is correct or not. You have to do the hard work of digging into it and weighing its pros and cons. And anybody can do that, including me, Mooney and even Jenny McCarthy.

By the way, I think McCarthy grossly overstates the dangers of vaccines–I’m glad my kids got vaccinated–but I, too, have concerns about some vaccines.

Reading Horgan’s article referenced in the last sentence, Michele Bachmann Wasn’t Totally Wrong about HPV Vaccines, made me cringe. Although Horgan does point out that he didn’t believe Bachmann’s ignorant blather about Gardasil causing mental retardation, he does seem to conflate questions of Merck’s marketing strategy for Gardasil with whether a mass vaccination campaign to prevent HPV is worth the expense and bother, seeking to poison the well about Gardasil based on distrust of pharmaceutical marketing instead of concentrating on the scientific and medical merits and disadvantages of the vaccine.

A number of commenters had excellent retorts to Horgan’s argument that anyone, including Jenny McCarthy, Chris Mooney, and yes, John Horgan, can do the “hard work of digging into” a scientific consensus and “weighing its pros and cons”: And anybody can play basketball, including me, Michael Jordan, and Stephen Hawking.

Or, with the country being in the thick of March Madness and all:

People can pretend to be scientists. That doesn’t make them scientists. They can forget that they failed high school math, majored in art history in college, and became an actor. I can also forget that I did not play for the Tar Heels and the Bulls, but basketball sure is fun. Expertise takes a lot of hard work. Someone claiming they have expertise when they don’t is arrogant. James Inhofe melting a snowball is not expertise in climatology. Call it a gimmick, but it was a gimmick that showed he did not know the difference between global climate and local weather. Yes, he does have the right to his beliefs, but others have the right to laugh at his beliefs as being profoundly ignorant.

Precisely. This is where Horgan again misses the point. It’s not about people without expertise not having the “right” to question a scientific consensus. Clearly, a fair reading of his article indicates that not not even Mooney meant that when he said you have “no business” questioning scientific consensus. (Besides, as I recently learned when I was published in Slate.com, it’s usually the editor who comes up with the headline, not the writer.) Rather, it’s about how that consensus is questioned. When it’s questioned, as Jenny McCarthy and antivaccinationists question scientific consensus, using misinformation, pseudoscience, cherry picked studies, and misinterpretation of other scientific studies, such “questioning” devolves into denialism and should be called out. In other words, how one questions a scientific finding matters. A lot.

Finally, it’s also about how much the questioning of a scientific consensus by a non-expert should be valued. Someone like Horgan might have a modicum of credibility questioning a scientific consensus based on his experience as a science journalist, particularly when we’re talking about something that isn’t a particularly strong consensus (inflation), if it’s even consensus at all. Someone like Jenny McCarthy, with no relevant expertise even reaching the level of “literature knowledge,” has no credibility at all. Having people like me say so and people like Mooney saying that she has “no business” making such pronouncements is simply the price she pays for parading her ignorance to the world, particularly when her ignorance contributes to real degradations in public health through increasing numbers of parents not vaccinating their children. In the end, what Horgan seems to be arguing is that we should take pseudoexpertise seriously. I disagree.

Related posts:

  1. Hostility towards scientific consensus: A red flag identifying a crank or quack
  2. Science-based medicine, skepticism, and the scientific consensus
  3. Pseudo-expertise versus science-based medicine
  4. The “decline effect”: Is it a real decline or just science correcting itself?
Categories: Medicine, Skepticism

NECSS and SfSBM: A weekend of science and skepticism

Science Based Medicine - Sat, 03/21/2015 - 01:37

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

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

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

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

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

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

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

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

Preliminary SfSBM Program  (Updated 2.15.15, subject to change)

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

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

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

Also at NECSS

 SGU Skeptical Extravaganza with guest star Bill Nye

 April 10, 2015 @ 7:30PM

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

Cost: $25 general public / $15 NECSS attendees

Website: www.necss.org/extravaganza

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

Categories: Medicine, Skepticism

NECSS and SfSBM: A weekend of science and skepticism

Science Based Medicine - Sat, 03/21/2015 - 01:37

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

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

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

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

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

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

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

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

Preliminary SfSBM Program  (Updated 2.15.15, subject to change)

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

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

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

Also at NECSS

 SGU Skeptical Extravaganza with guest star Bill Nye

 April 10, 2015 @ 7:30PM

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

Cost: $25 general public / $15 NECSS attendees

Website: www.necss.org/extravaganza

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

Categories: Medicine, Skepticism

Titius-Bode Law and Exoplanets

Neurologica Blog - Fri, 03/20/2015 - 08:01

A recent Washington Post headline reads: Most stars in the galaxy have planets in the habitable zone, according to new research. Some version of this headline was attached to every mainstream media reporting on this story. Not just the headlines were this hyped – most of the time the reporting presented this new research as if this is an accepted conclusion.

I have been following our exoplanet explorations since they began. Like many astronomy enthusiasts, I am particular interested in a few questions – how many planets do stars have on average, what are the typical arrangements of those planets, how typical or atypical is our own system, and how many earth-like planets are out there? We are starting to get a good idea of how many exoplanets are out there – most stars likely have multiple planets.

The other questions are still open at this time. While we are gathering more and more data points, with hundreds of systems now known to have planets, and currently 1,821 confirmed exoplanets. There are a couple thousand more possible exoplanets awaiting confirmation.

This may sound like a lot, but it really isn’t nearly enough data points to answer the remaining questions above. One problem is that we don’t have a thorough survey of each system. We are finding planets that are the easiest to find – those close to their parent stars, and larger planets. Small planets far from their stars would be almost impossible to find given current methods. They would not have a significant gravitational effect on their parent star, and even if they happened to transit their star they would probably have an undetectable effect on the light from that star. Also, with periods of hundreds of years, it would take hundreds of years to confirm them by the transit method.

Therefore our data on the planetary composition of other solar systems is incomplete and biased. We just don’t have enough data to draw many conclusions about the composition of planetary systems. We can answer some questions, like how many systems have hot Jupiters, jovian planets close to their stars?

Fortunately, we can detect earth-sized planets in the habitable zone of their stars because for many stars that puts them close enough to detect and confirm using the transit method.

The researchers in the current paper, the one grabbing exciting headlines, used a theoretical method to predict the composition of planetary systems in which we have detected between three and six planets. They then applied the Titius-Bode law to predict where other planets likely reside. One problem with this approach is that the T-B law is not really a law. It is not generally accepted as having genuine predictive value. At the very least it should be considered controversial.

Titius first noticed that the planets in our system are spaced out in a regular pattern, and Bode worked out the math in 1778. If you take the series 0, 3, 6, 12, 24, 48, 96, 192. 384 (after the three you simply double the preceding number), then add four to each number and divide by ten, you get a very good approximation of the distance in astronomical units of the planets in our solar system from the sun. According to this sequence, there should be a planet at 2.8 AU, which corresponds to the asteroid belt and the dwarf planet, Ceres.

Does this mathematical relationship reflect underlying physics, perhaps something to do with probability of stable orbits, or gravitational fields, or is it just numerology? Perhaps it’s a bit of both – orbits might have a tendency to be spaced out in a certain way because if they were too close together they might gravitationally disrupt each other’s orbits, but the precise mathematical relationship is just a coincidence and not a “law” of any kind.

The hallmark of science is not the ability to explain existing observations, but the ability to predict future observations. How well does the T-B law predict, for example, the orbits of moons that were not discovered until later? For those large planets that have moons which likely formed with the planets (as opposed to captured later) they do appear to have a regular spacing, but in a non-Bode pattern. So the regular spacing part seems to hold up so far as a reasonable rule of thumb, but there does not appear to be a precise mathematical relationship. This, of course, has lead many to try to work out variations on Bode’s math to derive a more general rule. One example being Dermott’s law. Again, none of these are generally accepted, they are mostly dismissed as numerology and popular fascination with working out the math seems to be an annoyance to journal editors and serious astronomers.

Now that we are in the age of exoplanet discovery, the T-B law has a new life and researchers who are so inclined have new sets of data to apply their favorite version of Bode’s math. This is what the current researchers are doing. They claim that of the 151 systems they looked at a “generalized version” of Bode’s law holds up in 124 of them. They then calculate where additional planets should be in those systems. That is how they predict that most systems will have 1-3 planets in the habitable zone.

From reading the headlines one might assume that scientists were counting confirmed exoplanets, but no, they were counting theoretical exoplanets. Further, the application of the “generalized version” of Bode’s law makes me wonder how much wiggle room this allowed. That is a common criticism of the T-B concept – that in any system where planets are simply spaced out so as not to bump into each other, you can force fit some mathematical series if you give yourself some wiggle room.

The best thing about this study, however, is that it makes specific predictions about where new exoplanets may be discovered. If their generalized version of T-B is found to have genuine predictive value, that would make it more than wild speculation. However, the devil will be in the details – how close will future exoplanets have to be to their predicted location, and how many of them are needed before the idea is considered confirmed? Again there is the potential for wiggle room, allowing the actual data, almost no matter what it is, to fit the theory.

What is most disappointing, as usual, is that the mainstream media generally failed to properly report this story. This is a speculative paper, and honestly is not even worth reporting to the public as a news item. The bottom line, expressed in the headline, is highly misleading, and is not a finding of this paper. This type of speculative research should be relegated to the technical literature, or at best popular science magazines where the nerdy details can be explained thoroughly and the paper put in its proper context.

Categories: Medicine

Lyme: Two Worlds Compared and Contrasted

Science Based Medicine - Fri, 03/20/2015 - 03:57

The western black-legged tick, carrier of the Borrelia burgdorferi bacteria which causes Lyme disease.

The practice of infectious disease (ID) is both easy and difficult. If you read my ID blog on Medscape you are aware of my trials and tribulations in diagnosing and treating infections.

ID is easy since, at least in theory, diseases have patterns and an infecting organism has a predictable epidemiology and life cycle. So if you can recognize the pattern and relate it to the life cycle and exposure history, you can often make a diagnosis before the cultures come back.

My favorite story is the time I was asked to see a young girl with endocarditis. The history was she had a week of fevers, headache and myalgia that went away for five days, returned for a week, went away for five days and returned yet again.

So I asked her “How was your vacation at Black Butte?”

The look of astonishment on her face as she asked how I knew she had been to Black Butte was so satisfying.

But the pattern was relapsing fever and Black Butte is where all the relapsing fever in Oregon is located. And sure enough, her smear had Borrelia. A course of antibiotics and the spirochete was dead and gone.

However, my son says all I ever do is say “Get cultures and start vancomycin.” How hard is that?

ID is hard because in practice patients do not read the textbooks and do not always present with the correct signs and symptoms. If you have an uncommon infection with an uncommon presentation it can be difficult to diagnose. I get a fair number of these in consultation and syphilis has been the tricky one the last few years. While there is the classic progression from primary to secondary to latent to tertiary, patients often have peculiar manifestations that bypass the classic findings and are sometimes hesitant to mention risk factors.

Once you make the diagnosis of syphilis, you give a course of antibiotics and the spirochete is dead and gone.

Relapsing fever and syphilis are two spirochetal illnesses that can be both straightforward and difficult. Both have well-understood pathophysiology but that doesn’t mean that they are easy to diagnose.

Lyme is also a simple and complex diseases. Caused by the spirochete Borrelia burgdorferi (as least in the US; there are other Borrelia in Europe that cause Lyme and worldwide there at least 36 Borrelia species) its epidemiology, pathophysiology, and treatment are well understood. Like all infections, it can be tricky and present atypically, but the science is clear: there is no chronic Lyme disease that is amenable to long term antibiotics.

Let me mention here, not that it will make any difference, that I do not deny the symptoms and suffering of patients with the “diagnosis” of chronic Lyme. They are often quite ill with something that is not, however, from Lyme.

Unfortunately, in public discourse science and reality do not necessarily triumph over pseudo-science. Last year, New York passed a bill to allow:

rogue doctors [to] be able to shill their non-evidence-based treatments without worrying about intervention.

the bill:

prohibits the state Office of Professional Medical Conduct from investigating a licensed physician based solely upon the recommendation or provision of a treatment that is not universally accepted by the medical profession.

Those protections include, but are not limited to, treatments for Lyme disease and other tick-borne illnesses.

A similar bill is now before the Oregon Legislature, House Bill 916. A public hearing on the bill will be held on Monday, March 30th. I have no doubt that similar bills will be appearing in legislatures throughout the US. They may be there now, unbeknownst to you. I only discovered the Oregon bill by serendipity.

The bill, sponsored by the Oregon Lyme Disease Network, says:

SECTION 1. (1) The Oregon Medical Board and the Oregon State Board of Nursing shall each adopt rules regarding the diagnosis and treatment of Lyme disease.

(2) The rules adopted under this section must:

(a) Permit professionals regulated by the boards to diagnose and treat, in manners consistent with the standards of care guidelines developed by the International Lyme and Associated Diseases Society, Lyme disease and associated viral, bacterial and parasitic diseases;

and

(b) Establish disciplinary procedures that consider as a mitigating factor whether, in diagnosing or treating Lyme disease or associated diseases, a professional who is facing discipline followed evidence-based diagnosis and treatment guidelines not recognized by the boards.

There are two sets of Lyme Treatment Guidelines. One is from the Infectious Disease Society of America and is about to undergo an update from the 2006 guidelines. The guidelines suggest (note the not):

Selected antimicrobials, drug regimens, or other modalities not recommended for the treatment of Lyme disease.

  • Doses of antimicrobials far in excess of those provided in tables 2 and 3
  • Multiple, repeated courses of antimicrobials for the same episode of Lyme disease or a duration of antimicrobial therapy prolonged far in excess of that shown in table 3
  • Combination antimicrobial therapy
  • Pulsed-dosing (i.e., antibiotic therapy on some days but not on other days)
  • First-generation cephalosporins, benzathine penicillin G, fluoroquinolones, carbapenems, vancomycin, metronidazole, tinidazole, trimethoprim-sulfamethoxazole, amantadine, ketolides, isoniazid, or fluconazole
  • Empirical antibabesiosis therapy in the absence of documentation of active babesiosis
  • Anti-Bartonella therapies
  • Hyperbaric oxygen therapy
  • Fever therapy (with or without malaria induction)
  • Intravenous immunoglobulin
  • Ozone
  • Cholestyramine
  • Intravenous hydrogen peroxide
  • Vitamins or nutritional managements
  • Magnesium or bismuth injections

I suspect, given the creativity of those who treat chronic Lyme, that this list will grow in the next version of the guidelines. These are the kinds of pseudo-therapies, and there are many more, that the people with the pseudo-diagnosis of chronic Lyme undergo. All useless, all costly, and, occasionally, fatal. Key in the IDSA guidelines is the avoidance of long term and repeat courses of intravenous antibiotics.

Long term antibiotics are not benign. Besides allergic and other side effects, secondary infections of the intravenous catheters can and has killed people.

A 30-year-old woman died as a result of a large Candida parapsilosis septic thrombus located on the tip of a Groshong catheter. The catheter had been in place for 28 months for administration of a 27 month course of intravenous cefotaxime for an unsubstantiated diagnosis of chronic Lyme disease.

I keep thinking the 27 months is a typo, but it is neither a typo nor atypical in the chronic Lyme world. Twenty five years of infection control has only served to emphasize that unnecessary intravenous catheters can only cause harm and one of the keystones of non-standard chronic Lyme therapy is prolonged intravenous antibiotics.

The other Lyme treatment guideline is from ILADS, The International Lyme and Associated Disease Society. They differ from the IDSA, as noted by ILADS:

The ILADS panel recommendations differ from those of the IDSA. Different guideline panels reviewing the same evidence can develop disparate recommendations that reflect the underlying values of the panel members, which may result in conflicting guidelines. The IOM explains that conflicting guidelines most often result ‘when evidence is weak; developers differ in their approach to evidence reviews (systematic vs non-systematic), evidence synthesis or interpretation and/or developers have varying assumptions about intervention benefits and harms. Conflicting guidelines exist for over 25 conditions and there is no current system for reconciling conflicting guidelines.

It may be more than a simple difference of opinion. But I would note that every recommendation in the ILADS guidelines is based on:

very low-quality evidence.

There are multiple differences in the two approaches to Lyme. First is the belief (belief is what you have when you lack data), unsupported by the preponderance of the scientific medical literature, that Lyme persists despite adequate treatment.

The other major issues concern treatment. ILADS supports prolonged intravenous therapy for Lyme, re-treatment for patients with persisting symptoms after treatment and the use of adjunctive therapies including treatments of co-infections. All are not supported by Lyme literature.

ILADS suggests repeat courses of intravenous antibiotics for patients who remain symptomatic; IDSA does not and the best studies to date supports the IDSA approach:

There is considerable impairment of health-related quality of life among patients with persistent symptoms despite previous antibiotic treatment for acute Lyme disease. However, in these two trials, treatment with intravenous and oral antibiotics for 90 days did not improve symptoms more than placebo.

This is because antibiotics are effective in killing off Lyme:

There continues to be no evidence that viable B. burgdorferi persist in humans after conventional treatment with antimicrobials.

Most studies looking for living B.burgdorferi after treatment have failed and those that do have severe flaws. Antibiotics eradicate the organism and in animal models, where they can culture the entire mouse, 5 days of antibiotics is enough to kill off all the Lyme:

Our findings further document the effectiveness of antibiotic therapy in eradicating cultivable cells of B. burgdorferi, irrespective of tissue or organ site.

The organism does not hide out, protected in some organs, as some believe. As the 2014 NEJM review succinctly puts it:

Several carefully conducted, placebo-controlled, randomized trials of prolonged antimicrobial treatment in patients with persistent subjective symptoms after treatment for Lyme disease have shown a minimal benefit or none and a substantial risk of adverse effects. Consequently, prolonged antimicrobial treatment for subjective symptoms is not recommended in patients whose objective signs of Lyme disease have resolved in response to conventional therapy. Consideration of other causes of persistent symptoms is warranted. In most of these patients, nonspecific symptoms resolve over time without additional antimicrobial treatment.

When it comes to adjunctive therapies, ILADS is less proscriptive than the IDSA:

ILADS agrees that first-generation cephalosporins, intravenous hydrogen peroxide and bismuth injections are not recommended. However, ILADS has concluded that it is premature to exclude other potentially beneficial therapies based on the evidence to date. Therefore, ILADS contends that the use of such agents should not be precluded until studies have demonstrated their ineffectiveness in the treatment of Lyme disease.

A real difference in approach to treatment. Given the potential dangers in all medical interventions, therapies should be precluded until studies have demonstrated their effectiveness in the treatment of Lyme disease.

Lyme diagnosis is also mentioned in the Oregon bill, although the ILADS guidelines do not address issues related to the diagnosis of Lyme. Lyme is classically diagnosed by a two-step procedure: a screening ELISA followed by a confirmatory Western Blot, although the ELISA for antibodies against the C6 peptide may be helpful.

There are laboratories, in my experience evidently beloved by naturopaths, that use unvalidated and unreliable non-standard tests, of which there are many. This is because:

in the mid–1970s, the FDA began exempting certain diagnostic tests from its approval process. Many of these tests — developed, manufactured, and offered by a single lab, such as in a hospital — were variations on common tests, low-risk, or devised for rare diseases and could not be adequately validated.

And Lyme testing has proliferated with all the subsequent false positives in patients and resultant un-needed therapies. Patients often do not realize that when a lab is CLIA certified it means little as to the validity of the testing offered, just as a restaurant being certified as sanitary says nothing about the quality of the cooking.

The FDA recognizes this is a problem with many kinds of tests:

The US Food and Drug Administration, responding to growing concerns that a host of diagnostic tests for illnesses from cancer to Lyme disease may be inaccurately identifying conditions, announced Thursday that it intends to regulate many of the tests.

and there are new guidelines for these tests that may result in less unreliable testing.

I heard a story at a meeting that a company developed a Lyme test and everyone tested positive. Rather than recognize a flawed test, they concluded everyone had Lyme. Probably apocryphal, but the mindset of the Lyme world is often:

No Lyme test has no false negatives, but it is important to understand that there is no such thing as a false positive.

Also popular in the nonstandard Lyme world is treating co-infections. I once had a patient tell me she also had a Babesia infection as well as Lyme, diagnosed at one of the creative Lyme labs by a naturopath. The accompanying photomicrograph had an arrow pointing to…a platelet clump misidentified as Babesia. While there is occasionally more than one infection spread with a tick bite, it is not common:

Often, the controversial diagnosis of chronic Lyme disease is given to patients with prolonged, medically unexplained physical symptoms. Many such patients also are treated for chronic coinfections with Babesia, Anaplasma, or Bartonella in the absence of typical presentations, objective clinical findings, or laboratory confirmation of active infection…The medical literature does not support the diagnosis of chronic, atypical tick-borne coinfections in patients with chronic, nonspecific illnesses.

The ILADS guidelines mention:

A survey of 3090 patients diagnosed with Lyme disease found that laboratory confirmed cases of babesiosis and anaplasmosis were reported by 32.3 and 4.8% of respondents, respectively

Although given that this is a survey, we have no idea as to the rigor with which these diagnoses were made; they may have had misidentified platelet clumps.

This bill is especially worrisome when combined with HB 3301 that designates naturopaths as “primary care” providers. Not only will this bill remove consumer protections from providers of questionable therapies, it has the potential to expand the ability for pseudo-doctors with no standards to provide pseudo-therapies for pseudo-diseases.

The reason that the ILADS approach is not embraced by other organizations such as the IDSA is that their recommendations are not based on the best understanding of the treatment and diagnosis of Lyme and they ignore or rationalize away high quality evidence.

The IDSA is often vilified for supporting the best data and science. When not supported by the science, organizations often resort to the law, a poor way to adjudicate medicine and science; House Bill 916 is no different in that respect to attempts to legislate the value of pi.

Removing consumer protections and institutionalizing substandard medical care will not benefit the health of Oregonians, will lead to the protection of those practicing substandard medicine, and will protect those practicing substandard medicine from being held accountable for their practice.

As an aside, I will mention that I have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed above. The odd thing about the world of pseudo-medicine is that most of the time we are accused of being big pharma shills, prescribing vaccines willy-nilly to line the pockets of our masters. Except for Lyme where we are accused of being insurance company shills, not willy-nilly prescribing antibiotics to line the pockets of our masters. Can’t win for trying.

More information on the status House Bill 916 as well as Oregonians for Science-Based Medicine, part of the Society for Science-Based Medicine.

Other Lyme posts

 

Categories: Medicine, Skepticism
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