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The Dow of Accutane

At home the kids current TV show of choice is How I Met Your Mother, supplanting Scrubs as the veg out show in the evening. Both shows are always on a cable channel somewhere and are often broadcast late at night. Late night commercials can be curious, and as I work on projects, I watch the shows and commercials out of the corner of my eye.

Law firms trolling for business seem common. If you or a family member has had a serious stroke, heart attack or death from Avandia, call now. The non-serious deaths? I suppose do not bother. One ad in particular caught my eye: anyone who developed ulcerative colitis or Crohn’s disease (collectively referred to inflammatory bowel disease, or IBD) after using Accutane, call now. Millions have been awarded.

My eye may have been caught because of my new progressive lenses, but I will admit to an interest in inflammatory bowel disease, having had ulcerative colitis for years until I took the steel cure. It also piqued my interest as these were three conditions among which I could not seen any connections. Accutane, ulcerative colitis, and Crohn’s. One of these is not like the other.

Accutane (its generic name is isotretinoin) is an anti-acne medication, released long after my puberty. The drug is chemically related to retinoic acid, a natural vitamin A derivative, and works in part by decreasing the production of sebum, not an issue with IBD.

Ulcerative colitis (UC) and Crohn’s have the same clinical presentation: lots of bloody diarrhea. Any resemblance stops there. Pathologically they are completely different diseases. Crohn’s can affect the entire GI tract, from the mouth to the rectum, and its hallmark is noncaseating granulomas. While considered an autoimmune disease, I have, for uncertain reasons, been drawn to the data that suggests the disease may be due to atypical mycobacteria. Wherever there are granulomas, some sort of infectious disease is often not far behind.

UC is limited to the colon, has a high risk of leading to colonic cancer, and its etiology is even more uncertain, perhaps also an autoimmune disease. The two illnesses have different rates of extraintestinal manifestations as well.  Besides the bloody diarrhea and abdominal pain, the two diseases have little in common except they can wax and wane for no damn good reason and when active are a compelling reason to know where every public toilet in the city is.

The Wikipedia pages for both diseases have nice ‘compare and contrast’ tables, and it is obvious the illnesses have little in common. UC and Crohn’s are as different as pulmonary tuberculosis and bronchiolitis obliterans with organizing pneumonia, so it would be most curious if an anti-acne medication could be cause either one, much less both.

Ulcerative colitis occurs in 35–100 people for every 100,000 in the United States, and Crohn’s in 6 to 7.1 per 100,000, and there have been over 13 million prescriptions given for Accutane, more if you add in the other brands of isotretinoin. So there are bound to be, by coincidence, some people who will get IBD around the time they get their Accutane. Like Guillain Barré and flu vaccine, the question is whether or not the risk is increased.

As one review pointed out:

Assuming 1) a background incidence of IBD in the US of approximately 45,000 cases per year, 2) the number of persons taking isotretinoin is approximately 400,000 per year, and 3) the total US population is approximately 306 million, the expected number of cases of IBD among isotretinoin users would be 59 cases per year (if there were no association between isotretinoin and IBD), or 0.01% of Accutane users. If more than 59 cases per year were observed in isotretinoin users, this would suggest a positive relationship between isotretinoin use and IBD. However FDA MedWatch reports include an average of only 14 cases per year.

There are a smattering of case reports on the pubmeds of people developing IBD around the time they started isotretinoin. A few cases of IBD waxed on the medication and waned when isotretinoin was stopped. Interesting, but given the variability of the disease, causality is suspect.

Is there a basic mechanism whereby isotretinoin would lead to IBD?

The mechanism by which (endogenous and exogenous) retinoids cause or exacerbate intestinal inflammation is not understood. Retinoic acid affects intestinal epithelial growth and is involved in cell repair and apoptosis. Retinoids also impair neutrophil chemotaxis, a mechanism involved in Crohn’s disease. The production of induced regulatory T cells (iTreg) and T helper 17 (Th17) cells is also controlled by retinoic acid — these also being involved in gut epithelial homeostasis.

But there is also basic science to suggest that retinoic acid has the potential to be protective for IBD.

Retinoic acid, a form of vitamin A, has been shown to enhance barrier function by increasing expression of numerous tight junction proteins such as occludin, claudin-1, claudin-4, and zonula occludens-1. Furthermore, from the standpoint of immune function, retinoic acid has been shown to be capable of inhibiting pro-inflammatory interleukin-17-producing T helper cell (Th17) responses, while augmenting anti-inflammatory regulatory T cell induction. Such responses would be more likely to prevent the development of IBD, as opposed to trigger it.

So maybe there is a supporting mechanism, and maybe there isn’t. The putative mechanisms can go either way, although since there is perhaps less IBD than expected in patients on isotretinoin, the sparse data suggests a protective effect. Whether any of the basic science is clinically applicable is unknown and doesn’t really explain why it could be associated with two such widely divergent illnesses. Still, there may be unknown mechanisms that would be hinted at by epidemiology.

There really is a paucity of data with a grand total of about 49 references on Pubmed. One study found a relationship with UC, but not Crohn’s (which, given the etiology and pathology, perhaps makes more sense):

Isotretinoin use and the risk of inflammatory bowel disease: a case-control study.
OBJECTIVES:
Isotretinoin is commonly prescribed for the treatment of severe acne. Although cases of inflammatory bowel disease (IBD) have been reported in isotretinoin users, a causal association remains unproven.
METHODS:
We performed a case-control study using a large insurance claims database. Incident cases of IBD were identified and matched to three controls on the basis of age, gender, geographical region, health plan, and length of enrollment. Isotretinoin exposure was assessed in a 12-month period before case ascertainment. Conditional logistic regression was used to adjust for matching variables.
RESULTS:
The study population comprised 8,189 cases (3,664 Crohn’s disease (CD), 4,428 ulcerative colitis (UC), and 97 IBD unspecified) and 21,832 controls. A total of 60 subjects (24 cases and 36 controls) were exposed to isotretinoin. UC was strongly associated with previous isotretinoin exposure (odds ratio (OR) 4.36, 95% confidence interval (CI): 1.97, 9.66). However, there was no apparent association between isotretinoin and CD (OR 0.68, 95% CI: 0.28, 1.68). Increasing dose of isotretinoin was associated with elevated risk of UC (OR per 20 mg increase in dose: 1.50, 95% CI: 1.08, 2.09). Compared with non-users, the risk of UC was highest in those exposed to isotretinoin for more than 2 months (OR 5.63, 95% CI: 2.10, 15.03).
CONCLUSIONS:
UC but not CD is associated with previous isotretinoin exposure. Higher dose of isotretinoin seems to augment this risk. Although the absolute risk of developing UC after taking isotretinoin is likely quite small, clinicians prescribing isotretinoin as well as prospective patients should be aware of this possible association.

and another study found no relationship:

Isotretinoin is not associated with inflammatory bowel disease: a population-based case-control study.
OBJECTIVES:
There is anecdotal evidence that isotretinoin use is associated with development of colitis. We aimed at determining whether there is an association between isotretinoin use and development of inflammatory bowel disease (IBD).
METHODS:
The population-based University of Manitoba IBD Epidemiology Database and a control group matched by age, sex, and geographical residence were linked to the provincial prescription drug registry, a registry that was initiated in 1995. The number of users and duration of isotretinoin use were identified in both IBD cases and controls.
RESULTS:
We found that 1.2% of IBD cases used isotretinoin before IBD diagnosis, which was statistically similar to controls (1.1% users). This was also similar to the number of IBD patients who used isotretinoin after a diagnosis of IBD (1.1%). There was no difference between isotretinoin use before Crohn’s disease compared with its use before ulcerative colitis.
CONCLUSIONS:
Patients with IBD were no more likely to have used isotretinoin before diagnosis than were sex-, age-, and geography-matched controls. Although there may be anecdotes of isotretinoin causing acute colitis, our data suggest that isotretinoin is not likely to cause chronic IBD.

One for, one against. Crockett et. al. reviewed all the data, such as it is, and applied the nine Bradford Hill criteria to the data. The conclusions were underwhelming for causality

In conclusion, the only evidence to support a causal association between Accutane and IBD consists of isolated case reports. These reports support a possible temporal association between isotretinoin and the development of IBD, though such observations may have resulted from chance, confounding, bias, and misrepresentation of the natural history of IBD. A causal relationship remains biologically plausible, but beneficial effects of vitamin A derivatives on intestinal injury have been reported as well. None of the other commonly accepted causal criteria are met. The lack of evidence does not necessarily indicate lack of a causal connection.

Doesn’t seem to be the kind of data that warrants millions to plaintiffs. To double check, I asked some drug company shills, er, I mean gastroenterologists, what they thought of the data. They were equally underwhelmed.

Dow Corning was in bankruptcy protection for years stemming from multibillion dollar lawsuits in the 1980’s and 90’s over the assertion that silicone breast implants lead to breast cancer and autoimmune diseases. Subsequently, after billions were spent and the company was bankrupt, it was then determined that silicone breast implants are associated with neither cancer nor autoimmune diseases. Oh. That’s different. Never mind.

Does isotretinoin lead to inflammatory bowel disease? Maybe. Maybe not. The facts to prove or disprove the association lean against, the odds are “Five to one against and rising…Anything you still can’t cope with is therefore your own problem.” It is hard to prove a negative, and money is being spent and awarded, independent of a reasonable set of confirming facts. Hopefully this will not be like the Dow cases, where “a tort system that allowed a few lawyers to extort billions of dollars using a dollop of junk science.” Although as is often the case with corporations, Dow Corning apparently did not act as the model of integrity. No one acts their best when there is money to be made.

As one reference on the topic noted

In most policy matters, scientific evidence is only one among a complex assortment of factors that interact to produce particular decisions.” A careful reading of the events, stakeholders, and outcomes in the silicone breast implant controversy reveals the social, economic, legal, political, and scientific factors involved “the practice of Federal regulation, the relationship between science and courts, the lack of consistently enforced professional standards in law, medicine and journalism.” A major lesson from this case also involves the role of the plaintiffs. The Houston lawyers’ relentless pressure with inconclusive medical facts on Dow Corning, along with their courtroom successes, demonstrates that “facts” alone are insufficient factors in determining truth.

He could have been writing about SCAMs in general: the facts, in quotes, are insufficient factors in determining truth indeed.

Posted in: Legal, Politics and Regulation, Science and Medicine

Leave a Comment (41) ↓

41 thoughts on “The Dow of Accutane

  1. windriven says:

    “The Houston lawyers’ relentless pressure with inconclusive medical facts on Dow Corning, along with their courtroom successes, demonstrates that “facts” alone are insufficient factors in determining truth.”

    Where’s Joe Friday when you need him? His whole career kind of collapsed after Gannon went off to fight in Korea.

  2. I seem to recall that Rosecea can be mistaken for acne. I have heard that Rosecea has higher prevalence in people with auto-immune disorders.

    So, is it possible that people with both IBD and Crohn’s could have a higher rate of Accutane use, due to being prescribed it for rosecea (mistakenly, perhaps)?

    Also, is it possible that a rosecea flare could predict a bowel flare? It seems I’ve heard of this happening in lupus flares.

    If that was the case, you could see an increased association between Accutane and Crohn’s or IBD without causation.

    Just speculation* from laymen’s knowledge.

    * actually, “speculation” might be a generous characterization.

  3. Gastroenterologist says:

    I get the question from my UC/Crohn patients about Accutane sometimes (in Sweden Roaccutan), wheter they can use it or not.

    There has been insufficient data how Accutane affects colitis, and sometimes dermatologist suggests less effective treatment. Young people really suffers from bad acne.

    My opinion has been: chose the effective treatment, and I checkup the colitis more often. If it flares, we deal with it.

    This is anecdotal, but the two patients of mine that had moderate colitis and Accutane treatment the last year had absolutely no worsening of the colitis. Probably more patients had had Accutane without asking me for advice.

    I see about 100 new patients with colitis every year. I have never seen anyone where Accutane was the suspected reason of colitis. I am consultant since about 5 years.

  4. CarolM says:

    That is why plaintiff lawyers love jury trials. The jury is the arbiter of truth. These issues really need to be argued to a more discerning body than that, and I’m sure Congress has tried to set up something like that and ran smack into the trial lawyers’ lobby.

  5. Geoff says:

    One similarity between UC and Crohns’ is that they are both caused by cereal grain consumption. Additionally, they are both reversible by eliminating cereal grains from the diet, albeit anecdotally. Crohns’ may very well be a result of gut flora problems, while UC may be more about inflammation as a result of anti-predation proteins in grains.

    The only plausible way that I could MAYBE see accutane having an impact is if it throws off the vitamin a/vitamin k2 byproduct balance. Both vitamin a and vitamin k2 can both be toxic in high levels without the other. Most people don’t really get much of either these days since no one eats liver and we’re all afraid of butter, so it’s semi-possible that this vitamin a byproduct could be causing some problems this way. I’d also be interested to see if vitamin d status has been checked, because vitamin d also has a major role in vit a/k2 metabolism.

    Acne is a symptom of systemic inflammation, so we can say with a high level of confidence that the people taking this medication are already experiencing some metabolic damage and likely some gut inflammation, so there’s a slight chance that the above imbalance could throw people over the edge. I can’t really come up with any other plausible mechanism though.

  6. Harriet Hall says:

    @Geoff

    “One similarity between UC and Crohns’ is that they are both caused by cereal grain consumption.”

    “Acne is a symptom of systemic inflammation.”

    Says who? References, please.

  7. Scott says:

    @ Carol:

    Congress IS the trial lawyer’s lobby, for all intents and purposes. That’s mostly what they did “in real life.” No need for external lobbying to shut such things down at all.

  8. icewings27 says:

    @ Geoff:

    Yes, references please. I’m very interested in this idea of yours.

    I’ve had UC for almost 10 years and I’ve seen five different gastroenterologists in that time. None of them have mentioned any correlation between eating grains and UC.

    Also, none of them have asked me if I ever took Accutane (which I did, briefly, many years prior to my UC diagnosis), so I don’t think they are convinced of a link between the two either.

  9. Angora Rabbit says:

    @Geoff:
    “Both vitamin a and vitamin k2 can both be toxic in high levels without the other.”

    No. They are completely distinct mechanistically (one is a transcriptional activator and the other a redox agent in carboxylation reactions) and only have in common their fat-soluble status. You may be confusing this with A and D – those two are both trans-activators and their receptors can compete at the nuclear level. And very few Americans are deficient in either A or K – in fact we are probably overfortified in A (eggs, dairy products, vitamin pills) and most of our K comes from gut microbes rather than the diet. A person has to work at it to become A or K deficient.

    My lab research has studied retinoids 30 yrs and Mark’s right. That dog don’t bark. The claim that Accutane and UC/CD are linked has as much merit as the (equally unsubstantiated) claim that Accutane causes teen suicide. But why let facts confuse a jury when there’s good trial lawyer money to be made?

  10. Mark Crislip says:

    “albeit anecdotally” = “talking out my ass”, for once an appropriate use of the idiom.

    A quick google and pubmed finds nothing of interest

  11. Geoff says:

    @Mark

    I have heard a couple of different stories of people reversing the disease process of UC and Crohn’s (as well as RI, MS, type 1 diabetes and many other autoimmune diseases) by eliminating grains, legumes and dairy from their diet. Most famously, Robb Wolf, who was told he needed to have a few feet of his colon removed.

    @Harriet

    I don’t have any good references for that one, probably should have used slightly softer language in stating that, but there is pretty good reason to believe that grain and legume consumption is a major player in these diseases, particularly since removing them reverses the disease process. For your reading pleasure:
    http://perfecthealthdiet.com/?p=873
    http://perfecthealthdiet.com/?p=235

    @Angora Rabbit

    Love the name, I was in New Zealand in the summer of 2001 and saw an angora rabbit getting sheared, they’re adorable.

    I wasn’t confusing vitamin k2 and vitamin d, although vitamin d does play a major role in vitamin a metabolism as well, which is why I asked about the vitamin d status. The three of them all seem to be tightly metabolically linked http://blog.cholesterol-and-health.com/2009/04/tufts-university-confirms-that-vitamin.html.

    @Icewings

    Have you ever been tested for celiac? There’s a very good chance that you have it, UC and celiac seem to go hand in hand.

    I highly recommend Robb Wolf’s book “The Paleo Solution,” in it Robb talks about his experience with bowel disease progression and how fixing his diet cured his UC. Alternatively, you can just try a 30 day self experiment for free using the resources on his site http://robbwolf.com/wp/wp-content/uploads/2010/09/thePaleoSolution_QuickStart.pdf

  12. windriven says:

    @Geoff

    The best I can find on Pubmed is the suggestion that gluten sensitivity may play a role in some fraction of IBS cases. Your statements however are sweeping yet lack even a single citation to back them.

    I could just as easily argue that the actual cause of IBS (and most other disease) is the MPR vaccination. After all, how many IBS sufferers in the US also have been immunized?

    I’ve offered as much proof as you have.

  13. Geoff says:

    @Windriven

    Gluten is one of 20+ anti-predation proteins in wheat, and it’s probably not even the most harmful, unless you have celiac. WGA and its ability to travel across an intact intestinal barrier by mimicking enzymes in our saliva, and then the subsequent ability to bind to sugar molecules causing a molecular mimicry effect, is likely much more nefarious.

    Everything I’m saying would be far less compelling if 1) removing grains and legumes from the diet did not reverse autoimmunity, which it does, 2) there weren’t strong proposed mechanisms that are holding up to experimental scrutiny.

  14. aeauooo says:

    @Harriet Hall

    “Says who? References, please.”

    I suspect that Geoff’s response, if he choses to do so, would be something along the lines of:

    1. “Google it!” and
    2. “Your question proves that doctors receive NO training in nutrition”

    Déjà vu

  15. Geoff says:

    @aeauooo

    I responded already, comment is awaiting moderation because of links.

  16. Harriet Hall says:

    @Geoff,
    “removing grains and legumes from the diet reverses autoimmunity”

    Another ridiculous unsupported (and unsupportable) claim. I’m getting tired of these fairy tales. This is a science-based medicine blog, not an imagination-based one.

  17. Navinabob says:

    I can’t believe I’m coming out of lurking status for this, but Geoff appears to be a follower of Loren Cordain, Ph.D.

    He’s a big guru of the Paleolithic Diet and got his doctorate in Exercise Physiology from the University of Utah. Google that guy and that diet to see just how “scientific” this break-through in nutrition is. I’m waiting for the Infomercial I’m sure is being made up as I write this.

    Get used to hearing about this as I understand that this fad-diet is growing unfortunetly.

  18. aeauooo says:

    @Geoff

    Thanks, I look forward to reading them.

    After Googling “gluten anti-predation,” I think I see where this is going.

  19. Geoff says:

    @Harriet

    These aren’t fairy tales. Real people are really reversing autoimmune disease, and gut health has been linked to every autoimmune disease that it has been examined in. It makes sense that proteins that are making their way into the bloodstream undigested, and have very similar amino acid structures to proteins in our body, could be causing the production of antibodies that attack our cells. WGA is probably the worst offender since it can cross the intestinal barrier without any leakiness in the gut, but that doesn’t mean that similar proteins either in wheat or in other grains don’t have similar effects.

    There are a lot of anecdotes of people reversing autoimmune disease, and I am confident that if a real study was done on this, the results would be extremely compelling.
    http://robbwolf.com/2009/02/03/ulcerative-colitis/
    http://robbwolf.com/2008/09/17/paleo-vs-type-1-diabetes/
    http://robbwolf.com/2011/06/06/real-life-testimonial-rheumatoid-arthritis-gone/
    http://robbwolf.com/2011/05/09/real-life-testimonials-my-moms-best-75th-birthday-present/
    http://paleodiet.com/ra/
    http://video.google.com/videoplay?docid=-8901290975296745403#

  20. SloFox says:

    I didn’t find any studies on PubMed to support the claim for grain/legume-free or gluten-free diets and reversal of autoimmune diseases. Other than celiac disease and dermatitis herpetiformis I didn’t find much relating gluten to autoimmunity. There are a lot of studies that found autoantibodies for diseases of which there are no symptoms (e.g. Anti-gliadin in MS) but I don’t find this surprising considering the limited understanding we have of many autoimmune processes. Certainly no smoking guns.

    This blog is based on using science and evidence as the guiding principles behind medical practice and making medical claims. @Geoff I think you’ll find a lot of hostility if you continue to make controversial claims without backing them up. Even well-established claims are addressed here provided there is evidence to the contrary.

    Could the lack of evidence stem from a conspiracy, perhaps.

  21. Musculoskeletal pain is another reported/alleged side effect of Accutane. I had foolishly assumed that claim was uncontroversial, but after reading this I rather doubt that it has been confirmed. Does anyone know anything about Accutane and pain?

  22. BillyJoe says:

    aeauooo: “After Googling “gluten anti-predation,” I think I see where this is going.”

    Yes, nowhere.
    Good one, aeauooo!:D

  23. KB says:

    I had really, really bad acne back when I took Accutane. I used to tell people I’d brushed up against poison ivy when they asked about my “rash” (because the acne looked like a rash all the way down my arms). I once came across a medical textbook picture of acne that was rash-like across someone’s entire trunk, and the person with me exclaimed, “Oh my God!” and I was unimpressed because I had looked like that for years, and I knew my parents and siblings had too, well into adulthood. All this to say, if someone had told me Accutane increased the chance of UC or CD, I would have taken it anyway. It sucks that all the lawsuits could (theoretically, depending on how much money is lost) make the drug unavailable for such an unsubstantiated reason. Did I mention how bad my acne was?

  24. icewings27 says:

    @ Geoff:

    I tested negative for celiac.

    Every gastroenterologist I’ve seen has said there is no correlation between diet and IBD.

    The expression “reverse autoimmunity” makes about as much sense as “reverse aging” or “reverse hair loss”.

    I smell a product plug coming soon…How much does the amazing just-quit-eating-tasty-and-nutritious-food diet cost and where do I buy the books and supplements I need to complete it?

    Actually no, wait. I think I’ll continue seeing my gastroenterologist, taking my UC medication, and getting frequent colonoscopies. And I’m sure my doctor will let me know when a real cure for UC is available.

  25. pmoran says:

    Medical issues often get left in the hands of those having least grasp of the relevant subject matter.

    I recently listened to all three hours of Cassidy’s testimony to the Connecticut board examining the risk of stroke from neck manipulation, hoping to have certain questions about his study answered (they weren’t).

    I was appalled at the lack of preparation of the lawyers interrogating Cassidy. Their questions were mostly aimless, meandering, as though they were seeing this complex piece of work for the first time in the courtroom.

  26. Jann Bellamy says:

    But what the jury awardeth, the court can taketh away.
    There are two reported groups of cases involving Accutane and IBD according to my Lexis search. (Jury verdicts are not part of the typical system of reporting, but appellate decisions are generally reported, i.e., published) One group of cases is in the New Jersey state court system. The lower appellate court decisions to reverse jury verdicts in favor of plaintiffs, based in part on plaintiffs’ experts causation testimony, is now before the NJ Supreme Court on the issue of whether the trial courts improperly excluded certain aspects of Hoffman-LaRoche’s (Accutane’s manufacturer) scientific evidence.
    Another group of cases, consolidated by the federal district courts in Florida, resulted in the district court excluding plaintiffs’ expert’s testimony, which meant that the plaintiffs were left without causation testimony and summary judgment was entered in favor of Hoffman-LaRoche. That decision was affirmed by the 11th Circuit Court of Appeals. In other words, those plaintiffs never even got to trial.
    I agree that juries in complex civil cases (scientific, economic, and otherwise) are a problem. I think that at least the federal courts are addressing this, and, as with the breast implant cases, are realizing that a multi-district consolidation of cases to rule on common questions, including expert testimony, is best.
    The plaintiffs’ expert regarding causation in the NJ cases is David Sachar, M.D. He is, according to the court, a board-certified internal medicine specialist and a Professor of Medicine at Mount Sinai School of Medicine, past chairman of the FDA advisory committee on gastroenterology, and has authored or co-authored over two hundred articles on IBD, ulcerative colitis, and Crohn’s disease. According to the court, “Dr. Sachar opined that, as a general matter, Accutane in regularly-prescribed doses is a cause of IBD in humans.” [I’m not defending his testimony, but it was there for the jury to consider.]
    In the consolidated federal district court cases, the plaintiffs’ expert was Ronald Fogel, M.D., “head of the Division of Gastroenterology at Henry Ford Hospital in Detroit, Michigan, a member of the Gastrointestinal Drug Advisory Committee for the [FDA] [etc.] and a practicing board certified gastroenterologist for over twenty five years,” who opined that Accutane causes IBD. The court found, however, that “a conclusion that there is a ‘potential association’ or that something is ‘perhaps acting as a trigger’ is not an opinion of causation, but rather an hypothesis. A scientist tests an hypothesis to determine its validity and reliability, and then, depending on the results, may form an opinion.” Well said.

  27. Jann Bellamy says:

    Just as I was posting above, I saw pmoran’s comments about the testimony of David Cassidy and feel some explanation of the circumstances is in order. As I explained in the post, “Not to worry! Chiropractic Board says stroke not a risk of cervical manipulation,” http://www.sciencebasedmedicine.org/index.php/not-to-worry-chiropractic-board-says-stroke-not-a-risk-of-cervical-manipulation/,
    “Dr. Cassidy was plopped down into the middle of the hearing as a witness for the chiropractors, even though no one had listed him as a witness, as was required, prior to the hearing. This is why he had to pretend to be speaking for the ICA, as they were allowed to substitute him for the previously listed ICA witness.”
    In other words, the attorneys had no opportunity to prepare to question Cassidy. Even had he not been an unscheduled witness, normally one would have the opportunity to take Cassidy’s deposition prior to a “real” trial and to present one’s own expert witnesses in opposition to Cassidy’s testimony. However, this was a Connecticut admininstrative hearing and none of these procedures were available in that forum. Despite what you might see on TV, no attorney can reasonably be expected to effectively examine a witness on a subject such as appropriate study methodology and conclusions without any preparation. In fact, the rule is that if you don’t already know the witness’s answer to the question you are going to ask, you should refrain from asking it. The attorneys had to tread very, very carefully here with the limited information about Cassidy they had.

  28. pmoran says:

    Jann, that would explain much, and I apologise to those attorneys if I have misunderstood the setting.

    Then again, can you explain to me how anyone would expect Cassidy’s study NOT to surface at some point in such a hearing, and require detailed assessment?

  29. lilady says:

    I do recall reading an excellent synopsis of the Corning Dow breast implant litigation fiasco…in one of my husband’s law journals. I failed to locate it, but found a better analysis on the AMA Journal of Ethics website:

    Virtual Mentor Silicone Breast Implant Litigation

    It is a scathing indictment of certain lawyers known for Class Action Lawsuits, complicit plaintiff doctors and of course the plaintiffs themselves…who sought and got huge settlements… for nebulous complaints such as “auto-immune reactions” and the onset of Chronic Fatigue Syndrome, following breast implant surgeries.

    The Virtual Mentor website also has an (older) article about Accutane lawsuits back when the only major problem with the drug was getting pregnant because of the known teratogenic effects of Accutane.

    I swear these lawyers cruise the FDA Medical Devices website and even before local media publicizes a recall, they are preparing the TV ads trolling for class action clients.

    Frivolous individual lawsuits and many of the class action lawsuits against defendants with deep pockets, have a profound effect on the practice of medicine in the United States. Many physicians have closed their private practice and are now affiliated with HMOs due to huge costs of medical malpractice insurance. In rural areas, many OB/GYNs have closed their obstetrics practice, due to the prohibitive cost of malpractice insurance. And, of course the costs for implantable medical devices such as cardiac pacemakers and stents add to the burgeoning costs of medical insurance coverage.

    Our budget busting costs of public health insurance and the ever escalating premiums for private medical insurance make it imperative that we ask our federal and state governments to implement meaningful tort reform.

  30. BillyJoe says:

    The danger of acronyms:

    IBD = Inflammatory Bowel disease
    IBD = Irritable Bowel Syndrome

  31. BillyJoe says:

    ..oops, just realised my mistake.

    It is, in fact, Irritable Bowel Syndrome, not Irritable Bowel Disease. Yet I read that every time I came across the acronym IBD.

    Carry on…

  32. Jann Bellamy says:

    @pmoran:

    “Then again, can you explain to me how anyone would expect Cassidy’s study NOT to surface at some point in such a hearing, and require detailed assessment?”

    The article was in evidence and it was attacked (and defended) by the parties on various grounds. Cassidy’s presence gave him the opportunity to “explain away” the attacks in a manner that could not have been anticipated if one didn’t know he would appear as a witness. Had the attorneys been able to question him in a real trial (even without preparation) they would likely have come out better because the rules of evidence would have been more strictly applied and the forum would have been better controlled. However, the case was before the Connecticut Board of Chiropractic Examiners — in other words, the Board was the “judge.”

    BTW, Marcia Angell, M.D., wrote an interesting and informative book on the breast implant litigation: “Science on Trial: The Clash of Medical Evidence and the Law in the Breast Implant Case.”

  33. Kultakutri says:

    @Geoff
    I’m on gluten-free diet and I still have asthma and my allergies are gradually worsening. Now what?

    In fact, I’ve read about GF diet recommended for just about every other ailment but I fail to notice that I’m any healthier but for the mess it caused to my digestive tract. I haven’t lost any weight, I have as much acne and inflamed hair follicles as before, I get cracked heels, I don’t feel any less tired, my temporo-mandibular joint is acting up just these days that I’m not only gluten-free but on semisolid food to add to the general fun. You’re allowed to add my rant to your testimonials.

  34. Anthro says:

    Arghhhhh!

    Not the “Paleo-diet” again!

    For the umteenth-thousandth time:

    Paleolithic people did not get most of their calories from meat. Their diet was plant based–plants that were gathered mostly by women. The proper term is gatherer-hunters, but it’s never caught on with the public. Nuts and berries, people, nuts and berries–and tubers, grasses, fish for some cultures and then, yes–meat from hunting and scavenging (mostly scavenging early on).

    Hunting was only sporadically successful and while is was important evolutionarily in supplying protein for brain development, it was not the mainstay of the diet. I’m actually talking pre paleolithic on some of this, but it’s not as if paleolithic people existed in a vacuum, or even all had the same diet physically or temporally.

    This horrible book by Rob Wolfe gets thrown at me every time I comment on any food-related blog. He knows nothing..NOTHING about the evolution of home sapiens. He has nothing but anecdotes and the wildest speculations based on nothing but a gross and tortured distortion of well-established anthropological findings.

  35. Chris says:

    Geoff:

    I have heard a couple of different stories of people reversing the disease process of UC and Crohn’s (as well as RI, MS, type 1 diabetes and many other autoimmune diseases) by eliminating grains, legumes and dairy from their diet.

    We will assume everything you write was pulled out of thin air unless properly documented with valid scientific studies. I looked at Mr. Robb Wolf’s wiki page, and I am not impressed. So please stick to references that can be found in a medical school library. Thank you.

  36. Chris “We will assume everything you write was pulled out of thin air.”

    But didn’t you read the other comments in the skepticism comments? Geoff doesn’t need evidence, because he “knows” if he tested his ideas, he would get evidence (Kind of like some police investigations I’ve heard of).

    As a person with (luckily mild) auto-immune disease, I find his testimonials about as convincing as the plethora of other “treatments” for auto-immune disease found through google that post amazing results.

    I could spend my whole life and a good sized bundle of cash trying special diets, supplements, herbs, breathing methods, etc with the same claims. The fact is, I would end up with very little information about what helps. Since most of these conditions have their own ebb and flow, it’s very difficult to tell what works unless you have scientific studies, and reliable tests to get a big picture.

    If someone wants me to bet on their horse with my money and my health, they have to show more me evidence than testimonials, technical gobbly gook and vague references to evolution.

  37. Anthro – I was hoping you’d chime in.

    Lovely!

  38. Angora Rabbit says:

    Geoff: Thanks for the links. Alas they go to some guy’s blog and not to the peer-reviewed literature. When I looked at the actual paper, it wasn’t telling us anything different from what those of us in the ADK field already knew (which is why the paper was in J Nutr – and apologies to the editor who is a good friend). Check out Neil Binkley’s work, for example, for another variation on this theme. In fact, I can spin that sort of interaction story for pretty much any micronutrient combination. But I would never go as far to extrapolate from a single interaction to a conclusion that “the interaction plays a major role in regulating the other micronutrient’s action.” Such a statement betrays a lack of comprehension about micronutrient homeostasis and the broader physiological and biochemical mechanisms that regulate function and activity.

  39. Kumputer says:

    Note my suggestions below are based more on what I believe to be common sense than on science, so readers feel free to pick them apart if you’re so inclined:

    @icewings27
    I’m relatively confident as you are about the unlikelihood of any kind of diet reversing UC in any way. However, I do believe that certain foods may minimize the symptoms, while others may exacerbate them. So, I think it’s logical that there’s at least a weak link between diet and UC in that different foods simply cause different kinds of bowel movements. But I think there’s excessive folly in touting a one-size-fits-all diet plan to make it all better. I think it may indeed be reasonable that some people can all but eliminate their symptoms with a certain diet plan, but make any other patient follow the same diet, and it simply won’t work.

    Anecdotally, I’ve had UC for about 7 years. The bulk of my effective treatment comes from medication (mesalamine), but indeed some foods in excess can cause me sometimes extreme discomfort, like too much gluten, or even the slightest amount of dairy on accident. I wasn’t lactose intolerant before adopting a vegan diet (well before I got the disease). Who knows, maybe even my vegan diet was a partial cause of an internal imbalance in my colon that led to me getting UC. But, for personal reasons, I won’t stop being vegan.

    As far as accutane being linked to IBD, I’d imagine that link is much weaker than the link between emotional stress and the onset of the disease. In my personal case, my GI even asked me if I’d been under stress before or around the time I first became symptomatic, which I definitely was. It might be reasonable to link UC, accutane, and stress together in that bad acne in adolescents can be a cause for emotional stress due to social pressure and a negative personal body image. Of course, if that’s true, it wouldn’t necessarily matter whether the patient used accutane or not. For reference, google UC and stress, and you’ll find a few hits for sure.

  40. cinnamongirl says:

    As a fourth-year pharmacy student who tends to avoid medications whenever possible, I have taken Accutane twice in the past eight years and am certainly grateful that it was an option to help get me past the hormonal imbalances of adolescence that seemed to manifest themselves in their most vulgar form on my face. I feel strongly that as every medication has potential toxicity, Accutane should be a last resort for patients who have exhausted all other options. It is important for patients and prescribers to exercise responsibility and to consider safer alternatives before jumping to a big gun. The risk-to-benefit consideration must be carefully weighed. If a patient decides that the risks of Accutane therapy are worth clearer skin, he or she must be willing to deal with potential side effects. In my experience, the worst side effects were decreased night vision and chapped lips. I always try to use natural products before prescription drugs–I was hesitant to use even antibiotics! However, due to the severity of my acne, there were not many effective alternatives available.
    Natural Standard, the most comprehensive database for natural products, lists a multitude of therapeutic options for treating acne. Vitamin A was the only one with a level of evidence grade A. Vitamin A, which is structurally very similar to Accutane, is unfortunately also toxic in high doses. At the time that I sought treatment, I read that it was associated with a higher risk than isotretinoin in doses proven efficacious in treating acne. However, zinc has a grade B for the indication of acne and may indeed hold some promise. I wish that I had known about it sooner!
    I did not see ulcerative colitis, irritable bowel disease, or Crohn’s disease on the list of side effects and warnings on the vitamin A monograph on naturalstandard.com. If these conditions lack association with vitamin A, I am skeptical to think that they have causal association with Accutane.

    1. Harriet Hall says:

      @cinnamongirl,

      I’m curious. Why do you use Natural Standard rather than the Natural Medicines Comprehensive Database?

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