Articles

Archive for Politics and Regulation

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.

(more…)

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

Leave a Comment (41) →

Exorcism and Sorcery as Health Benefits?!

Luis Fernando Verissimo, a Brazilian writer, once proposed “voodoopuncture”. Instead of going to the acupuncturist, you would be treated without leaving home. The voodoopuncturist would stick acupuncture needles in the voodoo dolls of you! I add that voodoopuncture could be outsourced to Haiti and/or China. It is a win-win-win situation!

– Leonardo Monasteri, Brazilian economist

As unbelievable as this might sound, “voodoopuncture” is no fiction at all.

The practice is called “Tong Ren healing,” and involves needling or hammering an acupuncture mannequin, as if it were a voodoo doll. The main Tong Ren “Master” in the US is an acupuncturist in the Boston area by the name of Tom Tam. He treats groups of terminally ill and debilitated patients in a deliverance ceremony that is noting but a revamped Taoist exorcism — only the clay or straw doll is replaced by a plastic mannequin:

Unfortunately, Tom Tam is not the only licensed healthcare provider who is treating patients with hocus pocus and crackpottery. There are over 30,000 other adepts of Traditional Chinese Medicine (TCM) in the US who practice medicine based on notions of health and disease that are rooted in paranormal and magical beliefs. Some of these practitioners take their delusions to the outer limits of absurdity: consider, for instance, “acutonics” and “colorpuncture” as described in these videos:

In anthropology of religion, the principles that underline the above practices are called “imitation” (e.g. using a doll to affect a person), and “correspondence” (e.g. using a sound to affect an object). They are the hallmarks of what is called “sympathetic magic,” meaning the belief that a person, or a thing, can be affected through something that represents it, or that has similar attributes.1 The principle of magical correspondence in TCM is called wu xing (五行) in Chinese, and is known as the Five Phases/Elements Theory in English. It can be summarized as follows:
(more…)

Posted in: Acupuncture, Politics and Regulation, Public Health

Leave a Comment (33) →

When you can’t win on science, invoke the law…

Late last week, the anti-vaccine underground was all atwitter. The reason was the announcement of an impending press conference, scheduled for yesterday at noon in Washington, DC that proclaimed:

Investigators and Families of Vaccine-Injured Children to Unveil Report Detailing Clear Vaccine-Autism Link Based on Government’s Own Data

Report Demands Immediate Congressional Action

Directors of the Elizabeth Birt Center for Autism Law and Advocacy (EBCALA), parents and vaccine-injured children will hold a press conference on the steps of the U.S. Court of Federal Claims (717 Madison Place, NW in Washington, DC) on Tuesday, May 10 at 12:00 PM to unveil an investigation linking vaccine injury to autism. For over 20 years, the federal government has publicly denied a vaccine-autism link, while at the same time its Vaccine Injury Compensation Program (VICP) has been awarding damages for vaccine injury to children with brain damage, seizures and autism. This investigation, based on public, verifiable government data, breaks new ground in the controversial vaccine-autism debate.

The investigation found that a substantial number of children compensated for vaccine injury also have autism. The government has asserted that it “does not track” autism among the vaccine-injured. Based on this preliminary investigation, the evidence suggests that autism is at least three times more prevalent among vaccine-injured children than among children in the general population.

I could hardly wait.
(more…)

Posted in: Neuroscience/Mental Health, Politics and Regulation, Public Health, Science and the Media, Vaccines

Leave a Comment (19) →

Marketing Pharmaceuticals in today’s Regulatory Environment

In the comments to my previous article I had said I would tackle the topic of how Pharmaceutical Products are marketed and how the FDA is involved in that process. Then I managed to get a new job with a different company, and have been busy getting up to speed. I still do the same thing, but with a different company and more responsibility. All of that aside, I am now up to speed, and had the good fortune to be browsing the FDA’s website when I came across, the following article: “FDA issues warnings to marketers of unapproved ‘chelation’ products”. This seemed to me a good lead in to discuss the situation down at the FDA and why it is beneficial to have an outside party look at your marketing materials before you present them to the public.

In general, the promotional review process at the FDA works as follows. A Pharmaceutical, or CAM Company decides upon an advertisement they wish to have for their product. They review it internally to ensure compliance with the regulations as they understand them, then they send it to the FDA either as an informational piece or requesting a formal review. Which one they choose is dependent on how much of a risk they feel they are willing to take, which can also come down to the risk/benefit profile of the product in question. There is a group in each Center for the FDA which handles this. For the two Centers I have primarily dealt with on these issues, it is DDMAC (Division of Drug Marketing, Advertising and Communications) in CDER (Center for Drug Evaluation and Research) and APLB (Advertising and Promotional Labeling Branch, also pronounced “Apple-Bee”) in CBER (Center for Biologics Evaluation and Research). Now this is where the path between legitimate Pharmaceuticals and CAM takes a massive divergent twist.
(more…)

Posted in: Pharmaceuticals, Politics and Regulation

Leave a Comment (10) →

European Union “Ban” On Herbal Products

Regulations have just gone into effect in the EU regarding the sale of herbal products. The regulations seem reasonable, but they have sparked near hysteria on the part of herbal sellers and advocates of “natural” medicine. They are calling the regulation a “ban” on herbal products, which much of the media has parroted, but it is not a true ban, just a requirement for registration.

The law was sparked by cases of toxicity from over-the-counter herbal products. For example, aristolochia is a toxic plant species that is either used deliberately or can be accidentally or carelessly substituted for other plant species. It is known to cause kidney damage – even leading to kidney failure is some cases. Another herb, kava, has been linked to liver damage.

The new EU law, which went into effect May 1, 2011, will require herbal products to be licensed, or prescribed by a licensed herbal practitioner. In order to be licensed evidence for safety of the product must be presented. It is estimated that it will cost between 80,000 and 120,000 British pounds to get an individual herbal product licensed.

(more…)

Posted in: Herbs & Supplements, Politics and Regulation

Leave a Comment (105) →

“Motivated reasoning,” alternative medicine, and the anti-vaccine movement

One theme that we at Science-Based Medicine keep revisiting again and again is not so much a question of the science behind medical therapies (although we do discuss that issue arguably more than any other) but rather a question of why. Why is it that so many people cling so tenaciously to pseudoscience, quackery, and, frequently, conspiracy theories used by believers to justify why various pseudoscience and quackery are rejected by mainstream science and medicine? Certainly, I’ve touched on this issue before on several occasions, for example, with respect to the anti-vaccine movement, the claim that abortion causes breast cancer, and how we as humans crave certainty.

It turns out that science and science-based medicine are hard for humans to accept because they often conflict with what our senses perceive and brains interpret as irrefutable evidence. The pattern-seeking function of our brain, when evaluating questions of causation in medicine, frequently betrays us. For instance, when a parent sees her child regress into autism sometime not long after being vaccinated, the easiest, most instinctive, and most emotionally compelling conclusion is that the vaccine must have had something to do with it. When scientists tell her that, no, in large studies looking at hundreds of thousands of children, there is no good evidence that vaccination confers an increased risk of autism and a lot of evidence that it does not, it’s a very hard message to believe, because it goes against how the parent interprets what she’s seen with her own eyes. Indeed, how often have we seen believers in the vaccine-autism link pour derision on the concept that when something like autistic regression happens in close temporal proximity to vaccination that the correlation does not necessarily equal causation? Similarly, believers in “alternative medicine” who experience improvement in their symptoms also pour derision on the observation, explained so well by R. Barker Bausell in Snake Oil Science, that people frequently take remedies when their symptoms are at their worst, leading them to attribute natural regression to the mean to whatever nostrum they started taking at the time.

These issues have come to the fore again, thanks to an article by an acquaintance of mine, Chris Mooney, author of The Republican War on Science, Storm World: Hurricanes, Politics, and the Battle Over Global Warming, and Unscientific America: How Scientific Illiteracy Threatens our Future (co-authored with Sheril Kirshenbaum). The article appeared in a recent issue of Mother Jones and was entitled, rather ironically, The Science of Why We Don’t Believe Science. Chris made his name as an author primarily in writing about the science of anthropogenic global warming and the political battles over policies intended to mitigate it and, to a lesser extent, over creationism and evolution denial. Of late he has written about the anti-vaccine movement as an anti-science movement, leading predictably to his being attacked by the likes of J.B. Handley as viciously as I and others have. Also of note, although he was widely praised for The Republican War on Science and Storm World, Mooney has been widely criticized in some circles for being too critical of “new atheists” and for lack of substance. In his current article, he discusses some of the science thus far about why people can cling to beliefs that science doesn’t just cast doubt upon but shows convincingly are totally wrong.
(more…)

Posted in: Evolution, Neuroscience/Mental Health, Pharmaceuticals, Politics and Regulation, Science and the Media, Vaccines

Leave a Comment (33) →

The Free Speech About Science Act (H.R. 1364), “health freedom,” and misinformed consent

“Health freedom.” It’s a battle cry frequently used by supporters of “alternative” medicine against what they perceive to be persecution by the medical and scientific establishment that uses the Food and Drug Administration, the Federal Trade Commission, and other federal agencies charged with regulating pharmaceuticals, food, cosmetics, and medical devices in order to protect the public against fraud, adulterated food, and quackery. It’s a potent argument to those not versed in skepticism and science-based medicine, and even to many who are. After all, Who could argue with “health freedom”? How dare the government tell me what I can and can’t use to treat my own body? Of couse, as I (and others) have said many times before, in reality “health freedom” is a sham. In reality, “health freedom” is not an argument made for the benefit of the consumer; it’s an argument made for the benefit of the sellers of supplements. In practice “health freedom” really means freedom for quacks from any pesky laws and regulations that would prevent them from exercising their quackery.

So it was last week when I saw two websites known for anything but science-based medicine (SBM), namely the quackery-promoting website NaturalNews.com and the quackery apologist blog Vitamin Lawyer Health Freedom Blog promoting a bill that I hadn’t heard of before, namely H.R. 1364, entitled the “Free Speech About Science” (FSAS) Act of 2011. This bill is being touted in all the usual “health freedom” venues as an antidote to what supplement manufacturers apparently see as the “overreach” of the FDA. For example, Ethan A. Huff of NaturalNews.com (where’s Mike Adams, one wonders?) urges his readers to tell Congress to support the Free Speech about Science Act of 2011., while “vitamin lawyer” Ralph Fucetola subtitles his post HR 1364, S.216 and the Struggle for Health and Food Freedom Action Item. So what do these advocates for dubious supplements say?
(more…)

Posted in: Herbs & Supplements, Pharmaceuticals, Politics and Regulation

Leave a Comment (38) →

Hope and hype in genomics and “personalized medicine”

“Personalized medicine.” You’ve probably heard the term. It’s a bit of a buzzword these days and refers to a vision of future medicine in which therapies are much more tightly tailored to individual patients than they currently are. That’s not to say that as physicians we haven’t practiced personalized medicine before; certainly we have. However it has only been in the last decade or so that our understanding of genomics, systems biology, and cell signaling have evolved to the point where the vision of personalized medicine based on each patient’s genome and biology might be achievable within my lifetime.

I was thinking about personalized medicine recently because of the confluence of several events. First, I remembered a post I wrote late last year about integrating patient values and experience into the decision process regarding treatment plans. Second, a couple of months ago, Skeptical Inquirer published an execrably nihilistic article by Dr. Reynold Spector in Skeptical Inquirer in which he declared personalized medicine to be one of his “seven deadly medical hypotheses,” even though he never actually demonstrated why it is deadly or that it’s even really a hypothesis. Come to think of it, with maybe–and I’m being very generous here–one exception, that pretty much describes all of Dr. Spector’s “seven deadly medical hypotheses”: Each is either not a hypothesis, not deadly, or is neither of the two. Third, this time last week I was attending the American Association for Cancer Research (AACR) meeting in Orlando. I don’t really like Orlando much (if you’re not into Disney and tourist traps, it’s not the greatest town to hang out in for four days), but I do love me some good cancer science. One thing that was immediately apparent to me from the first sessions on Sunday and perusing the educational sessions on Saturday was that currently the primary wave in cancer research is all about harnessing the advances in genomics, proteomics, metabolomics, and systems and computational biology, as well as the technologies such as next generation sequencing (NGS) techniques to understand the biology of each cancer and thereby target therapies more closely to what biological abnormalities drive each cancer. You can get an idea of this from the promotional video the AACR played between its plenary sessions:

Which is actually a fairly good short, optimistic version of my post Why haven’t we cured cancer yet? As I mentioned before, with this year being the 40th anniversary of the National Cancer Act, as December approaches expect a lot of articles and press stories asking that very question, and I’m sure this won’t be the last time I write about this this year.
(more…)

Posted in: Basic Science, Cancer, Clinical Trials, Diagnostic tests & procedures, Politics and Regulation

Leave a Comment (18) →

Asian Bear Bile Remedies: Traditional Medicine or Barbarism?

Imagine living 20 years spending 24 hours a day in a cage that tightly fits your body, not giving you room to stand up, stretch out, turn around, or move at all.

Imagine that twice a day during these years you would have a metal catheter inserted into a hole which has been cut into your abdomen, allowing the catheter to easily puncture your gall bladder, or maybe a long syringe inserted into your gall bladder, piercing through your skin again and again, by people who are not doctors.

Imagine becoming infected and cancerous because of this twice-daily physical invasion, and becoming neurotic due to your claustrophobic imprisonment.

Imagine having one or both of your hands cut off so someone can sell them for a lot of money.

Imagine you begin to chew at your hands, if you are lucky enough to have one or both left, due to your developing neuroticism, and to distract yourself from the pain you experience twice a day, every day, for your entire life.

This is reality for an estimated minimum of 12,000 bears across Asia.

– Sara Pegarella, JD

Currently, animal activists across China are up in arms because Gui Zhen Tang Pharmaceutical Corporation, a Fujian-based company that sells bear bile for use in Traditional Chinese Medicine (TCM), has tried to increase production through an initial public offering (IPO). The company is being accused of cruelty towards animals in the process of extracting their bile at an industrial scale. Bear bile, or Xiong Dan (熊胆), is an important ingredient in TCM.

(more…)

Posted in: Medical Ethics, Politics and Regulation, Science and Medicine

Leave a Comment (46) →

Diet Supplements or Nutritional Supplements: A Ruse by Any Other Name is Still a Ruse

I was surprised to get this e-mail from a reader:

Surely, Dr. Hall, the public mania for nutritional supplements is baseless. All the alleged nutrients in supplements are contained in the food we eat. And what governmental agency has oversight responsibility regarding the production of these so-call nutritional supplements? Even if one believes that such pills have value, how can the consumer be assured that the product actually contains what the label signifies? I have yet to find a comment on this subject on your otherwise informative website.

My co-bloggers and I have addressed these issues repeatedly. Peter Lipson covered DSHEA (The Diet Supplement Health and Education Act) nicely. It’s all been said before, but perhaps it needs to be said again; and maybe by writing this post I can make it easier for new readers to find the information.
(more…)

Posted in: Herbs & Supplements, Politics and Regulation

Leave a Comment (47) →
Page 20 of 39 «...101819202122...»