Ontario naturopathic prescribing proposal is bad medicine

Posted on by

Two weeks ago, Canadian Skeptics United published on their Skeptic North site a piece by an Ontario pharmacist criticizing a proposal by the province to grant limited prescribing rights to naturopaths. The essay, which was reprinted in the National Post on Tuesday, outlines the intellectual and practical conundrum presented by allowing those with education that diverges from science-based practices to prescribe drugs.

The naturopath lobby came out in force and was relatively unopposed in the 54 comments that followed, primarily because the NP closes comments 24 hours after online posting. Therefore, those with a more rational and considered viewpoint based in facts were locked out from commenting. This is quite disappointing to me personally and professionally because of the wildly emotional appeals, strawman arguments, and smears and attacks on the author himself without, of course, addressing his well-founded criticism of the prescribing proposal before the provincial government.

At the Skeptic North post, the piece even drew a naturopath who equated the criticism of his/her field with the Nazis and Mussolini. However, you can’t write critiques of these practices without attracting attacks ad hominem, especially Godwin’s Law, that are the resort of those whose arguments are logically flawed.

Naturopathy, sometimes called naturopathic medicine, is an unusual and inconsistently regulated alternative medical practice that co-opts some evidence-based medicine, often in nutrition and natural product medicines, but also subscribes to “vitalism” (vis medicatrix naturae) and makes use of homeopathic remedies that defy the rules of physics and dose-response pharmacology.

Naturopathy is, however, a warm and fuzzy term, especially when equated with “natural medicine” and the fact that people with naturopathy degrees advertise themselves with the honorific of “Dr.” The increasing popularity of naturopathy is also supported by cultural influences. I’ve written elsewhere that many, uh, natural product enthusiasts have become interested in naturopathy following the relocation of musician Dave Matthews from Charlottesville, VA, to Seattle, WA, where his wife, Ashley Harper, earned a naturopathy degree at Bastyr University.

In addition to the description of the practice in the NP op-ed, an excellent review and critical analysis of naturopathy by SBM’s Kimball C Atwood IV, MD, can be found at Medscape General Medicine. The abstract is as follows:

“Naturopathic medicine” is a recent manifestation of the field of naturopathy, a 19th-century health movement espousing “the healing power of nature.” “Naturopathic physicians” now claim to be primary care physicians proficient in the practice of both “conventional” and “natural” medicine. Their training, however, amounts to a small fraction of that of medical doctors who practice primary care. An examination of their literature, moreover, reveals that it is replete with pseudoscientific, ineffective, unethical, and potentially dangerous practices. Despite this, naturopaths have achieved legal and political recognition, including licensure in 13 states and appointments to the US Medicare Coverage Advisory Committee. This dichotomy can be explained in part by erroneous representations of naturopathy offered by academic medical centers and popular medical Web sites.

Like many alternative practices, naturopathy claims to harness the body’s own healing power as if differentiating that fact-based medicine does not also employ the body’s capacity to heal. The very same drugs that naturopaths wish to prescribe are those which can only work because they interact with targets in the body for which our endogenous compounds already act.

It seems to me that naturopathy adopts either science-based medicine or pseudoscience depending on the venue in which it serves the organization.

Because of my oft-expressed love of Canada, I had always thought that our neighbors to the north were more rational and had more finely-tuned critical thinking skills than we in the United States. However, I learned from the op-ed that British Columbia has already given prescribing rights to naturopaths.

I’m really surprised about this because of the furor that erupts whenever a proposal comes up to confer limited prescribing rights to pharmacists. Having taught in US colleges of medicine and pharmacy, I can state confidently that pharmacists have roughly four times the pharmacology and therapeutics coursework of physicians (albeit with not nearly as intensive postgraduate training). With the Doctor of Pharmacy degree firmly established as the entry-level pharmacy degree, pharmacists are now participating with physicians to gain practical clinical training in specialty areas.

But even with this extensive training in the same environment, legislated pharmacist prescribing is extremely limited worldwide. I remember it being a monumental achievement when my former PharmD student became the first pharmacist in the state of Arizona to have earned limited prescribing rights.

Therefore, I am amazed that Canadian politicians and health authorities are lending support to naturopath drug prescribing.

Another major challenge of this proposal relates to medical liability, an issue that seems to have been ignored previously but is articulated nicely in the NP op-ed:

A key role of the pharmacist is to double-check the safety and appropriateness of a prescribed drug. When required, the pharmacist resolves drug related problems with the prescriber. This is only possible because pharmacists, physicians, and nurse practitioners work from a common, science-based understanding of drugs and disease. In contrast, naturopaths may not share this science-based approach to illness, and may rely on references that are unknown to, inconsistent with, or directly contradict the medically accepted standard of care. If naturopaths prescribe a drug based on a naturopathic belief system, and a pharmacist determines that the prescription is not appropriate from a scientific and evidence-based perspective, what will the pharmacist’s responsibility be? Will pharmacists be held liable for prescriptions written by naturopaths who do not share a science-based view of illness?

Here’s a question, though: if the legislation moves forward, could pharmacists refuse to fill a prescription from a naturopath the same way that some states allow for “conscientious objection” by pharmacists for filling emergency contraceptive prescriptions?

I also wonder why pharmaceutical companies have not gotten involved in this debate. Corporate liability is also likely to be influenced as improper prescription of drugs is bound to increase the number of reported adverse reactions.

Nevertheless, the bill is moving forward:

The Bill passed second reading and was referred to the Standing Committee on Social Policy. Several naturopath organizations were on the agenda, and argued for “unambiguous authority for prescribing, compounding, dispensing or selling a drug as designated in the regulations” – essentially a clause that will allow naturopaths gain access to prescription drugs, developing a list out of the public eye. The standing committee accepted this request (the revisions may be viewed here [PDF]), and put naturopath prescribing into Bill 179. Third reading is expected sometime this fall. If it passes, the right for naturopaths to prescribe drugs will become entrenched in Ontario law.

The legislation of quackery presents a major threat to public health, pure and simple.

A rebuttal from two naturopaths has now appeared at the National Post. Therein, the typical distancing from science-based medicine is claimed while concomitantly arguing that naturopathy is based in science, followed then by excoriation of the randomized, controlled clinical trial. The typical chesnuts of distinction are invoked such as recognizing the healing power of the body, individualized patient care, and focus on disease prevention – all of which science-based medicine employs no matter how it is spun. One cannot simultaneously claim to embrace and reject science, yet this is done in the NP rebuttal. The responses are much more reasoned including an especially superb point-by-point comment by “steveisgood” (the page doesn’t provide unique URLs for each comment so you’ll have to scroll down by hand).


[Slashdot]
[Digg]
[Reddit]
[del.icio.us]
[Facebook]
[Technorati]
[Google]
[StumbleUpon]

Why Universal Hepatitis B Vaccination Isn’t Quite Universal

Posted on by

I am just a parent with some questions about vaccine safety and was happy to find your website.  I have noticed that the Scandinavian countries do not routinely recommend HepB vaccination unless the mother is a known carrier.  I did not see this addressed anywhere on your website and I hope you or one of your colleagues might consider discussing the reasons that some advanced countries are not routinely giving this particular vaccine. Thank you.”

Vaccination is a complicated and at times confusing topic that generates a large number of quite reasonable questions by parents like the one above.  At the same time, the ever-wandering aim of the anti-vaccinationist movement appears once again to be falling on the vaccine against Hepatitis B, and I’ve heard them pose this very question with the intent of sowing doubt in the current vaccination schedule.  Regardless of the source, this question is clearly on the mind of some parents, and I am happy to answer it.

As usual, this question has quite a bit to parse out.  I think it may be most helpful to examine why we vaccinate against Hepatitis B the way we do in the US, how most countries in the world approach the problem, and finally examine the reason why eight European countries do not universally vaccinate against HBV.  First things first though: what is Hepatitis B?

HEPATITIS B

Hepatitis B (HBV) is a double stranded DNA virus found in the bodily fluids of infected people including their blood, semen, and saliva, and can be transmitted through sexual contact, exposure of infected fluid to mucous membranes, or through injection.

As the name suggests, infection causes damage primarily to the liver, though the spectrum of disease experienced by any one person can be quite broad.  In adults, 50-70% of infections are asymptomatic or mild enough to not come to medical attention.  The remaining adults experience a range of hepatitis lasting weeks to months, with ~1% of these being a fulminant, life-threatening infection.  Adults are relatively efficient in their ability to clear the virus after the initial infection, and only ~10% become chronicly infected carriers.

Children, on the other hand, present a very different pattern of disease.  Though ~90% of infected children are initially asymptomatic, they are rarely able to clear the virus.  90% of infants and 25-50% of those 1-5 years old will become lifelong carriers.

Chronic Hepatitis B infection is a serious problem.  Beyond the ability of most chronic carriers to spread the virus throughout their lives, ~ 20% of people with chronic Hepatitis B develop cirrhosis, a condition where the liver cells are lost and the liver becomes progressively more fibrotic and dysfunctional.

Cirrhosis isn’t the only life-limiting problem to result directly from chronic Hepatitis B infection.  Hepatocellular carcinoma, a primary cancer of the liver, is in the top 10 cancers in both sexes in the US, and 60-80% of all cases are cause by Hepatitis B.  All told, around 25 % of people who become chronically infected with Hepatitis B will die from its complications.

Hepatitis B is a major cause of worldwide morbidity and mortality. More than 1/3 of the world’s population has been infected with Hepatitis B and 5% are chronic carriers.  That totals up to around 350,000,000 people chronically infected, and around 620,000 deaths from HBV yearly.

As in many health care related issues, the worldwide epidemiology of HBV infection does not necessarily reflect that of the United States.  Even so, the picture isn’t particularly pretty.  Around 5% of the US population has been infected with Hepatitis B, and 0.3 are chronic carriers.  Most HBV infections occur in those aged 25-44 (4/100,000), with the lowest rates of infection in those under 15 (0.1/100,000).   In 2007 4,519 new cases in the US were reported to the CDC, though this represents a fraction of the total number of infections.

These numbers are significant.  To put this in perspective, the mortality from HBV in the US was 5 times higher than Haemophilus influenza type B and 10 times greater than measles before vaccination was introduced.

The Hepatitis B Vaccine

HBV is a relatively stable virus posing a serious public health threat with humans as the only known reservoir, and as such is a prime target for prevention, and theoretically eradication, through vaccination. The first vaccine against HBV became available in 1981, and the current recombinant vaccine has been in use since 1986.  As a recombinant vaccine it contains proteins normally made by HBV, but does not have the virus itself, and therefore carries no risk of HBV infection.

As far as efficacy is concerned, the HBV vaccine has a very high response rate, inducing an appropriate antibody response in more than 95% of people from birth to 30 years of age, and decreasing but still significant response rates in older age groups.  Immunity from the vaccine lasts at least 20 years in healthy individuals.

The HBV vaccine has an excellent safety record.  The most common side effects are pain and swelling at the injection site in ~3% of people, and fever in ~1%.  The only serious confirmed reaction is anaphylaxis that occurs in 1/600,000 injections with no deaths reported in over 20 years of use.  Concerns regarding the HBV vaccine’s association with demyelinating diseases, the use of thimerosal in its formulation in the past or aluminum at the present have all been investigated and found to be without support; I will give such allegations no further time in this post.

Strategies of Hepatitis B Vaccine Use

There are a number of viable strategies available to countries seeking to address the spread of HBV in their populations, and variants on each.  When deciding which strategy is best for any given country, there are multiple factors to consider, including disease severity, the availability and efficacy of treatments, the risk and cost of infection, the risk, efficacy and cost of vaccination, etc.

The first option is to vaccinate people at high risk of infection.  In situations where the risk of infection is very low this makes good sense.  For instance, in the US the risk of contracting Yellow Fever is essentially zero at baseline without vaccination.  No risk or cost of vaccination, no matter how small, is small enough to offset zero risk of disease, therefore we do not routinely vaccinate against it.  However, if you were to travel to an area where Yellow Fever is endemic, your personal risk can suddenly become significant, and easily justify the minimal cost and risk of vaccinating you as a person at high risk.

Since the majority of people infected with HBV have identifiable risk factors, this approach makes some sense.  However, it has several major drawbacks.  It requires all individuals in a high-risk group to have health care, be identified, and to acquire the vaccine before they are infected.  This is labor and cost intensive, and extremely unlikely to capture the entire target population. Well executed, this approach can protect a majority of people at high risk, but in the case of HBV it will not immunize a large enough population to generate a herd immunity effect. The greatest flaw of this approach lies in the 1/3 of HBV infections that occur in people with zero known risk factors who, by definition, are unable to further reduce their risk, and are left unprotected by a vaccine. These shortcomings guarantee this strategy will fail to fully control the spread of HBV in the community.

The second approach is to vaccinate the entire population as they enter into the age of greatest incidence of infection, adolescence and early adulthood.  This addresses one of the shortcomings of the first strategy, namely the need to identify people at high risk.  It also takes advantage of the fact that children more reliably have health-maintenance office visits than do adults, and are more likely to be given vaccinations as part of a universal schedule.

Though this captures a large majority of the total number of infections, it too has a flaw; it fails to address the people infected in early childhood.  Though this is a relatively small number of people (4% of HBV infections), remember that children are far more likely to become lifelong carriers, and thus make up a disproportionate number of the infected at any one point in time (24% of chronic carriers).  While more effective at reducing the prevalence of HBV in the population than only vaccinating high-risk groups, this strategy too has little hope of eliminating HBV.

The third possible strategy is to vaccinate people at the time of birth.  This strategy addresses the problem of perinatal infection, prevents the acquisition of HBV by people during early childhood when the risk of chronic infection is highest, and since the immunity it induces lasts for decades it covers the entire population during the highest risk times of their lives.  Universal vaccination with HepB vaccine at birth, even in regions with a low prevalence of chronic carriers like the US, could reduce mortality by an additional 10-20% compared to early childhood vaccination.

Even this strategy has a drawback, however, and that is time.  Beginning an immunization program with only infants would take a few decades to generate a maximum reduction in HBV in the population.

The US Vaccination Strategy

Though the burden of disease from HBV in the US is relatively low compared to say, heart disease, it remains a significant public health threat only partially addressed through screening, education, and preventative measures, and with limited treatment options.  This makes it an ideal target for vaccination.

From 1981 through 1991 the US vaccinated only people with identified risk factors. Predictably, this campaign had an underwhelming effect on HBV infections seen during this time period.

In 1991, the strategy was reworked to better address the various methods of HBV transmission in an attempt to eliminate HBV spread in the US.  The new strategy is an amalgam of all three strategies described earlier. In addition to vaccination of high risk groups, we began universal vaccination of all infants at birth, vaccination of adolescents, and prenatal screening of pregnant women to identify children who would require not only vaccination at birth but also Hep B immunoglobulin (HBIG).

Since its launch in 1991, we have seen a steady decrease in Hepatitis B infections. Hep B incidence in the US fell from 10.7/100,000 in 1983 to 2.1 per 100,000 in 2004. (25,916 total cases down to 6212 cases).  Though it’s true other factors have been contributing to HBV’s decline, most notably the public education campaign aimed at curbing the spread of HIV, this doesn’t account for the pattern of HBV decline across age groups.  There has been a 95% drop in HBV in people under 15 years of age, 87% in ages 15-24, 71% from 25-44, and 51% decrease in people over 45 years old.  This is precisely what you would expect from a pediatric vaccination campaign.

Using a cost effective and exceptionally low-risk intervention of universal Hep B vaccination the US is well on its way to control, if not elimination, of HBV.

The Northern European Vaccination Strategy

The strategy taken by the US is typical of most developed nations, even those with a relatively low incidence of HBV.  In 1992 the WHO recommended the inclusion of HBV vaccination in nearly all national vaccination programs.  Since that time, the vast majority of countries (177/193 countries) have adopted infant HBV vaccination into their childhood schedules as can be seen here.  This graphic also illustrates the few countries that have instead opted to vaccinate only high-risk individuals, primarily those in Northern Europe, including Scandinavia.

The reason these countries have not adopted universal vaccination against HBV is the exceptionally low level of HBV in their population and the associated costs of prevention.  Sweden, for instance, has one of the lowest prevalences of HBV in the world at 0.05%.  This is 6 times lower than what we have in the US, with the majority of cases occurring in those engaged in high-risk activities or in immigrant populations that tend to have minimal contact with the indigenous population.  The public health organizations of these Northern European countries consider HBV to be a minor public health problem best addressed by targeted vaccination.  The cost of instituting universal vaccination would not offset the benefit of further reduction in HBV prevalence in their countries.

It is interesting to note that though these countries have low baseline rates of HBV infection, they have not generated the same relative decrease in rates that countries, like the US, have been able to produce with universal HBV vaccination.  This fact, in combination with high immigration rates to these countries from areas of heavy HBV, makes it likely that the cost/benefit ratios of the Northern European countries will sway even more strongly in favor of universal HBV vaccination over the next several years.

It is also worth noting that of the many factors being weighed by the medical community and public health officials of these Northern European nations, serious concerns of the Hepatitis B vaccine’s efficacy or safety are not among them.

Conclusion

We will continue to make progress in medicine by never being satisfied the care we provide is good enough; the ongoing debate about how best to apply the Hepatitis B vaccine is an excellent example of this concept.  The inconsistency between these nations’ vaccination policies is little more than physicians and health care officials seeking the most efficient and effective use of the vaccine within the unique conditions inside their borders.


[Slashdot]
[Digg]
[Reddit]
[del.icio.us]
[Facebook]
[Technorati]
[Google]
[StumbleUpon]

Man in Coma 23 Years – Is He Really Conscious?

Posted on by

I don’t know. The mainstream media is doing a wonderful job sensationalizing this case, presenting it without skepticism. Some outlets are doing a good job of discussing the relevant issues – but they don’t have the information to have a meaningful discussion of this particular case. Details are tantalizing but thin.

The case is that of Rom Houben. The story was broke, as far as I can tell, by the Mail Online – yes, that is a huge red flag. It does not make the story wrong, it just doesn’t instill in me confidence in the reporting.

Mr. Houben was in a terrible motor vehicle accident 23 years ago and has been paralyzed ever since. His diagnosis has been PVS – persistent vegetative state. However, recently, we are told, his mother insisted on a neurological re-evaluation. This is actually quite reasonable, generally speaking (again, without knowing specific details of this case).

As a result Dr. Steven Laureys did some advanced neuro-imaging on Mr. Houben. Laureys is a neurologist with not only legitimate but impressive expertise in coma and disorders of consciousness. Often the press throws around the term “top expert” without any meaning, but in this case the term seems appropriate.

I do not know what imaging was done, but Dr. Laureys’ team is doing research using functional MRI scanning and MRI spectroscopy – techniques which infer brain function from blood flow or metabolism. They are using these scanning techniques, during resting and activated states, to see how much cortical brain function there is in patients in apparent coma.

According to the press reports, Dr. Laureys found that Houben’s brain function was intact, or almost intact. This led to further evaluation of Mr. Houben’s clinical state, and it was discovered that he was able to communicate by typing out messaging on a board. Mr. Houben soon began recounting how he was awake the whole time, screaming inside his head, and eventually retreated into his dreams. He now feels like he has been reborn and looks forward to interacting with his family.

This is a wonderful story for the media. But to this neurologist, and I would think to any critically-thinking journalist, some questions come to mind. The biggest problem with this case as presented is that the finger-typing of Mr. Houben looks suspiciously like facilitated communication.

But first, a little background.

Coma, PVS, Minimally Conscious State, and Locked In Syndrome.

I have written previously about the various types of coma or disorders of consciousness. There are three states that are worth defining to understand this and similar cases. The first is persistent vegetative state (PVS) in which there is insufficient brain activity to general consious awareness. People in a PVS may display signs of wakefullness, like moving their eye and opening their mouths, but do not interact with their environment.

It is important to note that many people in PVS have documented brain damage of such an extent that there really is no question about the diagnosis, or their prognosis.

But, of course, there is also a gray zone, or transition from PVS to minimally conscious state (MCS). In an MCS a person cannot communicate but they do display signs that they can respond to their environment. Prognosis is very poor, like in PVS, but one notch above hopeless, with rare cases of meaningful recovery.

I must point out at this point also that I am talking about chronic states – not people who are days or weeks after an injury or event. People can recover after a significant injury, but they typically show potential for recovery early on. After months or years in a coma, the prognosis is grim.

In terms of diagnosis, it can be challenging to distinguish between PVS and MCS – it’s the different between no signs of consciousness and minimal signs of consciousness. Of course, there may be very subtle signs that are missed. And as our technology improves, we are sure to have greater sensitivity and pick up more cases of MCS misdiagnosed as PVS.

It remains to be seen, however, if the subtle distinction is clinically meaningful.

To add to the complexity, however, there is a condition call locked in syndrome. In this (thankfully rare) syndrome patients are conscious but paralyzed. For example, a brainstem stroke might cause a person to be paralyzed below the eyes – all they can do is blink and move their eyes. But they are fully conscious if the thinking part of the brain is intact.

Facilitated Communication

Facilitated communication, or FC, has nothing to do with coma but is relevant to this case because of some of the media reports. FC is the technique of holding a patient’s hand to “help” them communicate by pointing to letters on a board.

When FC was first proposed to the therapy community, it seemed like a powerful new technique – countless children who were thought to be too brain damaged to communicate were believed, due to FC, to actually have almost intact intellects trapped inside a non-communicating body.

Unfortunately, FC was promoted prior to proper scientific validation. When it was studied in properlyh controlled blinded trials it turned out the the facilitator, and not the client, was doing all the communicating. FC is nothing but a well-meaning delusion. But it is also a dangerous one – FC testimony has led to the false conviction of adults accused of abuse.

While we do not want to miss any cases of a person’s hidden ability to communicate, the FC experience teaches us to be cautious. We must always ask – is communication (or any sign of consciousness) real? Has it been validated in an objective and controlled way?

The Houben Case

I am always a bit uneasy analyzing these media cases, because I often do not have direct access to the patient or the medical records. So I have to add the standard disclaimer – my analysis is based upon the information that has been made public, not a thorough medical evaluation of the patient. I can often only analyze the pieces of evidence I am given, and speculate as to probabilities.

In this case there are several interesting aspects that do not all fit together. The first question is whether or not it is plausible that a patient would be diagnosed as being PVS when in fact they were locked in (that is the claim in this case). That would be unusual, but not impossible.

Typically when patients are locked in there is identifiable damage that can produce widespread paralysis, but the cortex should be relatively spared. In addition, there are typically some residual functions remaining, like eye movements. But it is possible for even that to be lacking.

More likely is the possibility that Mr. Houben was initially comatose but then over the years his brain function improved until he was able to be conscious. But by that time he was paralyzed and debilitated, and so not able to move to demonstrate his consciousness – locked in. Also by that time he would likely be in a chronic care facility and may not have had close neurological exams.

So while this would be an usual case, I can buy it. Further, this is consistent with the finding of preserved cortical activity on functional scanning.

The implications of this case, and similar cases, is that we need to use careful and standardized neurological exams to assess comatose patients, and they should be periodically reevaluated. But at the same time – not all cases have the potential to improve. Some patients are injured beyond the plausibility of making meaningful recover, and families should be given a realistic assessment of their loved-one’s condition. Also  – cases like this are the rare exception, not the rule.

Now comes the tricky part – the clinical correlation. Looking at brain anatomy and activity is important, but must be placed into a proper clinical context. At present, the clinical exam is still critical.

I don’t know what Mr. Houben’s exam is. But I do have a video of him communicating. What I can say with high confidence is that this is a video of bogus facilitated communication. The “facilitator” appears to not just be supporting Houben’s hand, but moving it around the keyboard.

Houben is looking in the general direction of the keyboard, but at times not directly at it (which is necessary for single finger typing). It is not clear if he can even see, and since his eyes are not in line it is not clear which eye he would be using.

His hand is also in a brace; his finger is not touching the board – the plastic of the brace is – so he would have little sensory feedback.

And yet his hand flies dextrously across the board typing very quickly. It seems impossible that someone with his level of paralysis, and years of inactivity, would be able to type so quickly with just a little “support”. There is little doubt, in other words, that his typing is the product of bogus FC – the facilitator is doing the communicating, not Houben.

Reporting of his typing is without skepticism, and so basic questions are not addressed. It would also be almost trivial to test whether or not the communication were legitimate – the report says he responds in Flemish – so have a non-Flemish speaking facilitator hold his hand. Apparently, he also understands English so you could have a non-English speaking facilitator answer questions posed in English. Or blind the facilitator to the keyboard or visual information that Houben has access to.

What would not be sufficient, however, is a knowledge test – asking Houben about events in the past or about his life, for example. This is too difficult to tightly control – a facilitator may have been contaminated, or may just make obvious or lucky guesses.

In an interview for NPR, Laureys reports that the family came up with the method of communication, and it was validated by having Houben identify objects that were show to him – that’s it. Laureys also reports that the medical doctors were skeptical of this communication, and it seems right that they were.

Until a tightly controlled test is done, the FC evidence is worthless.

But I do not know if this is the only clinical evidence of consciousness in Houben. Perhaps he can do what other locked in patients can do – tap once for “yes” and twice for” no,” for example. Maybe the FC is a later addition – a misguided attempt to communicate with Houben, who really is locked in. (In which case I wonder what he thinks about his facilitator – perhaps he is still screaming in his head, “get rid of this nut and let’s go back to the finger tapping.”)

The only thing I am certain about in this case is that the typing out of messages through FC is bogus. Otherwise, I do not have access to sufficiently detailed information to make any specific conclusions.

Hopefully, more information will come to light as further journalists are attracted to this case. Also, I have e-mailed Dr. Laureys hoping to get some more information directly from him. He responded with a link to his paper on this topic, but there is no identifiable information in the paper about Houben. He simply says that Houben illustrates the problem discussed in his paper – the misdiagnosis of MCS as PVS. He did not comment on the FC used in this case. If I get any further information I will write a follow up.

Meanwhile, this case stands as a cautionary tale – mostly about the dangers of the media discussing the implications of a story before the facts have been verified. It may also be a rare case of misdiagnosed locked in syndrome. My best guess is that Dr. Laureys is correct about the preserved cortical activity, but he is simply not familiar with the phenomenon of FC (he did not sound familiar on the interview) and has been deceived by it.  If this is so, then the FC is an unfortunate distraction from this case (and getting disproportionate attention from the media). I am already reading science bloggers comment on the fact that the video of Houben typing calls the whole case into question.

It is also, in my opinion, a further abuse of this patient. Mr. Houben, if he is truly conscious, has now been deprived once again of his ability to communicate – usurped by a facilitator, who will be communicating in his name (and even writing a book, we are told). Never underestimate the ability for pseudoscience to make a bad situation worse.

Addendum: Here is a new video in which Houben clearly has his eyes closed while the “facilitator” is typing furiously. This is completely impossible. (Hat tip to Orac for the link – he has also discussed the case.)


[Slashdot]
[Digg]
[Reddit]
[del.icio.us]
[Facebook]
[Technorati]
[Google]
[StumbleUpon]

Does C-section increase the rate of neonatal death?

Posted on by

It is a potentially devastating indictment of the rising C-section rate. Most midwifery and “natural” childbirth websites claim that elective C-section triples the rate of neonatal mortality. Mainstream web sites like Feministing.com, and newspapers like The New York Times have repeated the claim. There’s just one problem. It’s not true.

The claim originated with the paper Infant and Neonatal Mortality for Primary Cesarean and Vaginal Births to Women with “No Indicated Risk,” United States, 1998–2001 Birth Cohorts, MacDorman et al, Birth Volume 33 Page 175, September 2006. According to the authors:

Neonatal mortality rates were higher among infants delivered by cesarean section (1.77 per 1,000 live births) than for those delivered vaginally (0.62). The magnitude of this difference was reduced only moderately on statistical adjustment for demographic and medical factors, and when deaths due to congenital malformations and events with Apgar scores less than 4 were excluded. The cesarean/vaginal mortality differential was widespread, and not confined to a few causes of death. Conclusions: Understanding the causes of these differentials is important, given the rapid growth in the number of primary cesareans without a reported medical indication.

The implication, of course, is C-sections done without a medical indication raises the risk of neonatal death by a factor of three. The entire study hinges on a critical detail. Are women with “no indicated risk” really women who have no risk factors? The answer is a resounding no.

Since birth certificates are such an important source for research information, they have been repeatedly studied for accuracy. Birth certificates are highly accurate for administrative data like parents’ names or numerical data like weight or Apgar scores. It is well known, however, that they are highly inaccurate when it comes to listing complications.

How Well Do Birth Certificates Describe the Pregnancies They Report? The Washington State Experience with Low-Risk Pregnancies, Dobie et al report:

Conclusions: Because birth certificates significantly underestimated the complications of pregnancies, number of interventions, number of procedures, and prenatal visits, use of these data for health policy development or resource allocation should be tempered with caution.

The reporting of pre-existing maternal medical conditions and complications of pregnancy on birth certificates and in hospital discharge data,  M. Lydon-Rochelle,  et al. found:

Results Birth certificate and hospital discharge data combined had substantially higher true-positive fractions than did birth certificate data alone for cardiac disease (54% vs 29%), acute or chronic lung disease (24% vs 10%), gestational diabetes mellitus (93% vs 64%), established diabetes mellitus (97% vs 52%), active genital herpes (77% vs 38%), chronic hypertension (70% vs 47%), pregnancy-induced hypertension (74% vs 49%), renal disease (13% vs 2%), and placenta previa (70% vs 33%)… Conclusion In Washington, most medical conditions and complications of pregnancy that affect mothers are substantially underreported on birth certificates,…

In other words, for virtually every serious pregnancy complication, that information was missing from the birth certificate in more than half the cases.

Even a cursory look at the data showed that the authors assumptions were entirely unfounded. Women in the group characterized as planned C-sections for “no medical indication” had birth certificates that indicated that they had been in labor for hours before the C-section. Although the indications had been absent, it was clear that there must have been indications for the C-section.

In response to pointed criticism in the Letters to the Editor, the authors who had originally looked at births from the 1998-2001 cohort, now looked at births from the 1999-2002 cohort, performing the same analysis but applying an intention to treat methodology. The paper entitled Neonatal Mortality for Primary Cesarean and Vaginal Births to Low-Risk Women: Application of an “Intention-to-Treat” Model was published in February 2008. As the authors explained:

… an “intention-to-treat” methodology, a methodology commonly used in medical research… [E]mergency cesarean sections performed after a woman was in labor would be combined with vaginal births to create a “planned vaginal delivery” category since the original intention of the physician and the mother in both cases was presumably to deliver the infant vaginally. The “planned cesarean delivery” group would include only those deliveries where a cesarean section was performed without labor.

This analysis led to very different results:

… In the most conservative model, the adjusted odds ratio for neonatal mortality was 1.6 (95% CI 1.35–2.11) for cesareans with no labor complications or procedures, compared with planned vaginal deliveries. Conclusions: The finding that cesarean deliveries with no labor complications or procedures remained at a 69 percent higher risk of neonatal mortality than planned vaginal deliveries is important, given the rapid increase in the number of primary cesarean deliveries without a reported medical indication.

So now instead of claiming that C-sections increase the risk by a factor of 3, they are claiming that C-sections increase the risk of neonatal death by only half that amount. But the authors still do not address the primary flaw of the study. They really have no idea which C-sections were indicated and which were not. The difference is critical. If only 0.002% of the remaining birth certificates were missing risk data, there would be no difference in mortality in the two groups at all. Based on what we know about the reliability of birth certificate data, there is reason to believe that far more than 0.002% of birth certificates lack the relevant data.

The bottom line is that MacDorman and colleagues never showed that C-section increased the risk of neonatal death by any amount.. They demonstrated an entirely different principle: garbage in, garbage out. When you apply statistical analysis to erroneous data, you reach unsubstantiated, erroneous conclusions.


[Slashdot]
[Digg]
[Reddit]
[del.icio.us]
[Facebook]
[Technorati]
[Google]
[StumbleUpon]

Recombinant Human Antithrombin – Milking Nanny Goats for Big Bucks

Posted on by

Antithrombin deficiency is a hereditary disease causing low levels or defects of antithrombin, a blood protein required for controlling clot formation. Patients are at risk of blood clots, organ damage, and death. They usually have to take oral anticoagulant drugs like warfarin for life.

During high-risk procedures like surgery or childbirth, oral anticoagulants must be discontinued to minimize the chance of bleeding complications. While patients are off oral anticoagulants, they are given preventive treatment with antithrombin derived from pooled human blood. With any human blood product there is a small risk of infection with diseases like hepatitis C. And human antithrombin supplies are not plentiful.

Clever researchers found an ingenious solution. Put a human antithrombin gene in goats, milk them, isolate the human antithrombin protein from the milk, and voila! An udderly safe and plentiful source. A Brit might call it bleatin’ brilliant.

Yes, transgenic goats. No, they are not human/goat hybrids, despite a recent report that a goat had given birth to a human faun in Zimbabwe.

Sex between humans and animals does happen, but it can’t result in pregnancy because of the chromosome differences and other factors. 28% of men with bestial desires are attracted to goats. Goats come fourth after canines, equines and bovines.

You probably don’t know anyone who practices bestiality, but that doesn’t mean it doesn’t happen. I was e-mailed a video clip filmed by a Marine unit in Iraq, a light magnified night image (Improved Thermal Sight System). The marines were monitoring a known Taliban safe house. When they saw a suspect acting strangely, they thought he might be emplacing an IED. As they filmed him, they realized he was copulating with a donkey. They caught the whole thing on video. The best part is their comments as they watch the blurry images and gradually realize what they are seeing. It was apparently on YouTube briefly before it got banned. There is a similar clip with two Iraqis, one holding the donkey, that hasn’t been banned yet.  Of course, I can’t guarantee this isn’t video trickery. But in 2005 there was a well-documented case of a man who died after having sex with a horse just a few miles from where I live. Washington State is one of 17 states where sex with animals is not against the law. Instead of choosing a receptive female equine, this unfortunate man chose a stallion. The man died of a perforated colon; the horse suffered no physical damage, although I suppose we could speculate about possible psychological damage…  The whole thing was caught on videotape. Now there is even a movie. I report the facts without judgment: humani nihil a me alienum puto.

Pardon the prurient diversion. Back to the subject. Transgenic goats can’t be created by such “natural” methods: they require complicated tricky maneuvers in the lab. They are just like normal goats in every respect except that they produce one human protein, antithrombin. Still, it’s a wonder the religious fundamentalists haven’t been denouncing the evil scientists and bombing goat labs. Do they even know about this?

The recombinant human antithrombin is marketed under the brand name ATryn. It has been approved by the FDA for patients with antithrombin deficiency who are undergoing surgery or childbirth. Two clinical studies were done with 5 and 14 patients, respectively. Small studies, but it didn’t seem to call for a lot of investigation since it only amounted to replacing one of the patients’ own deficient proteins. No serious adverse events were reported.

The Medical Letter has evaluated ATryn (Volume 51, issue 1323, October 19, 2009. pages 83-63) and concluded it is a safe and effective source of replacement that may well turn out to have additional therapeutic applications.

Only one problem. It costs $2.34 per international unit, and patients in one study received anywhere from 39,200 IU to 294,000 IU. That adds up to $91,728 to $687,960 for one course of treatment for one patient. The manufacturer has a patient assistance program, but WOW! That’s a lot of money to protect one patient during childbirth! We don’t yet know how many patients will need to be treated to prevent one blood clot or save one life.

I can’t stop thinking about this. I am constantly amazed at the cost of some of the new drugs with limited applications, especially chemotherapy. And it’s not just the new, limited-use drugs. I recently got a prescription for what I thought was a cheap old antibiotic long available as a generic, and I was appalled at the price. It was more than ten times what I would have guessed.

It’s wonderful that science can accomplish such feats, and I have no ethical qualms about using goats as factories to help humans, but I wonder about the ethics of saddling society with unaffordable bills for treatments that provide only a small advantage. As we develop more of these expensive drugs, we could go bankrupt trying to provide them for every patient. It’s a dilemma that bears thinking about before it happens. One of the 4 basic principles of medical ethics is justice, or fair distribution of medical services to society.

However you look at it, our technical ability will eventually outrun our ability to pay.


[Slashdot]
[Digg]
[Reddit]
[del.icio.us]
[Facebook]
[Technorati]
[Google]
[StumbleUpon]

Support Passports with Purpose 2009

Posted on by
Kids playing in Cambodia
Kids playing in Cambodia. Photo by Dave Rubin.

Passports with Purpose is back for another year, this time with the goal of raising $13,000 to build a school in rural Cambodia, through American Assistance for Cambodia.

Passports with Purpose, for those of you who haven’t heard of it, is an annual fundraiser organized by four travel bloggers: Debbie Dubrow of DeliciousBaby, Pam Mandel of Nerd’s Eye View, Michelle Duffy of WanderMom and Beth Whitman of Wanderlust and Lipstick. It works as a raffle, with travel bloggers sponsoring a prize which donors can nominate as their preferred prize.

Last year, the Passports with Purpose fundraiser raised $7,420 for Heifer International. With this year’s goal set at $13,000, the stakes have been raised.

Our Prize: $250 Accommodation Voucher

Last year, TravelBlogs missed the boat on sponsoring a prize for the fundraiser, but we’re doing our bit this year. We’re contributing a $250 accommodation voucher for use on Travellerspoint’s budget accommodation area.

Here’s what you need to know:

  • The Travellerspoint accommodation voucher will be delivered digitally to the lucky winner and is valid for use any time before January 1, 2011.
  • All donations go directly to American Assistance for Cambodia, which will be using the funds to build a school in Cambodia. They are a 501 (c)(3) charity.
  • Each raffle ticket costs $10. You can buy multiple tickets and nominate different prizes, or nominate the same prize more than once to increase your chances.
  • See all the Passports with Purpose rules here.

For more information, check out the Passports with Purpose website.

A story by Kudra Ricketts

Posted on by

I flew the short distance from Vila to Malekula by plane. We arrived at the tiny brick building with no furniture which was the airport. The runway was a grass paddock. I drove by truck with my dad and the two midwives Kelly and Carrie until we reached Banam Bay. There we were met by the friendly crew of the Alvei. The ship we were staying on. Once we were settled in I went with the Project MAR

Auckland City

Posted on by

El Centro de Auckland Es Hermoso super ordenado muy prolijo. Los buses pasan a la hora exacta en cada una de las paradas la gente muy amable.Esta lleno de Asiaticos son la graaan mayoria y hay maoris tammbien son otra cultura de una contextura enorme y de piel mas morena. Pongo algunas fotos para que vean

A Sparkling Xmas Surprise Penny

Posted on by

I stumbled home last night through the minus 13 degree night air after a long double shift at the pub. Dave aka the world's greatest boyfriend had promised a surprise. I discovered him barricading the front door and blindfolding me before my finelytuned sense of Christmassmell gave everything away. A REAL LIVE CHRISTMAS TREEHe'd lugged the monstrosity up the icy street and negotiated our w

Sandboarding

Posted on by

Bonjour a tousNous avons passe 6 jours dans le desert afin d'experimenter un nouveau sport le sandboarding. Nous avons commence a Huacachina un oasis au milieu des dunes. Le premier jour nous avons devie de notre but car nous avons entendu parle du vin Peruvien. Donc nous avons visite 3 vignobles qui faisaient aussi du Pisco qui est pas mal la boisson nationale. La premiere ferme que nous

The Way Of Make Money In Runescape

Posted on by

The Way Of Make Money In Runescape Hello guys here are the way of make runescape money that came from other website. Let's go see it These are combos that should be used just about every single fight. In Runescape money is one of the main things you need you need it for armor food quests and much more. There are sertain ways to make money in runescape and im going to show you some of the best

Highway 1 California

Posted on by

Despite the freezing weather and the possibility that we would look slightly crazy we set off with the top down in Clyde the convertable Chrysler and headed for the highway.Our first stop was Santa Cruz which was much nicer then I expected. I was finally seeing the attraction of America. We did a bit of shopping and I didn't once feel pressured into emptying my purse into a homeless mans hat. Our

cancun on thanksgiven

Posted on by

We started the day on 112409 by going to work just like any other person in Los Angeles it was a cold day and a long day at work since the exciment of going away finally kicked in.Took the bus to LAX Los Angeles International Airport got to lax about an hour later walked into the Delta Air Lines terminal and checked in within 5 minutes I guess it pays to be a silver medallion with Delta

On tour with Louise and Zane 46 students

Posted on by

Action Tours annual trip to the South Island with 46 international students of all ages on board. Zane driving the bus and me trailing behind in the van. 6 days until take off. Its preparation time now 2 Christmas cakes made and decorated. One with a bucket load of brandy poured over and the other without.All well organised and confirmed now but with 462 personalities on board we are going

Hvad vi har lavet siden Gili

Posted on by

Efter vi forlod Indonesien havde vi et kort men fantastisk gensyn med Bangkok hvor vi fik shoppet var paa dansk resturant hvor Steffen fik hakkeboef og Tanya leverpostej og frikadeller behoever vi at sige at der ikke blev sagt mange andre ord end mmmmmmmmm shoppet lidt mere havde Steffen paa privathospital hvor han blev tjekket for det ene og det andet og et lille smut i biografen. I Ban