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FDA Zicam Warning

On June 16th the FDA issued a warning advising consumers not to use Zicam Nasal Gel or Nasal Swabs because of reports that it can damage the sense of smell, a condition called anosmia. This event highlights some problems with current regulations of health products.

There have been 130 cases reported to the FDA of decreased sense of smell following the use of one of these Zicam products – sometimes after a single use, sometimes after repeated use.  All of these cases were reported by patients or their doctors; none were reported by the company, Matrixx Initiatives. According to reports, the FDA has asked Matrixx to turn over 800 consumer complaints regarding to Zicam. There is a 2007 law that requires company to report such complaints to the FDA, although the FDA has not said whether Matrixx violated this law.

Anosmia is a serious medical condition. The senses of smell is one of those things we take for granted until it is gone. People who lack a sense of smell cannot tell if milk has gone sour or if their food is bad. They cannot smell smoke to warn of a fire, nor can they smell a gas leak. The FDA fears that some of the cases of anosmia associated with Zicam use may be permanent.

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

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Politics as Ususal

POLITICS. We have a tacit understanding to exclude politics from the blog, but current events are pushing the borders.  It’s not our fault, other forces are on the move. At the border last year was the Iraqi civilian body count issue precipitated by articles in The Lancet. That’s when politics intrudes into medical research and literature.

Other borders are matters of licensure, and of permitted and rejected methods and materials, encoded into licensure, food and drug laws, and a myriad of administrative edicts and court decisions.  One can’t escape the politics of those, especially when Congress and states start to control as commercial entities, areas that historically belong in culture: professional behavior codes, codes of traditional relationships between physicians and patients, for instance. These are under further pressures of conformity and legal sanctions enforced by the power of central government.

Steve  Salerno (web site: www.journalismpro.com, blog: www.shamblog.com), author of the WSJ article on “CAM” and the NCCAM last December that precipitated the Chopra, and Co. responses, brought to attention a recent House hearing at which Congr. Riley (D, Ohio) queried Sec. Sibelius whether she was aware of “mindful meditation” as a cost-saving method that should be included in any federal health plan.

Here we go again. Ten to 15 years ago it was Sen. Harkin legislating research and practice from halls of Congress resulting in the Office of Alternative Medicine and NCCAM. That legislation resulted in financed medical school courses, multiple more lectures and demonstrations, and now med school divisions with endowed chairs, scores to hundreds of employed associates, and with little to no scientific feedback or oversight.
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Posted in: Health Fraud, Politics and Regulation, Science and the Media

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Counterfeit Drugs: A Growing Global Health Crisis

A resistant strain of bacteria –created by partially effective counterfeit antibiotics – doesn’t need a VISA and passport to get to the U.S.

-    Paul Orhii, National Agency for Food and Drug Administration and Control, Nigeria

I attended a conference in DC yesterday called, “The Global Impact of Fake Medicine.” Although I had initially wondered if homeopathy and the supplement industry would be the subjects of discussion, I quickly realized that there was another world of medical fraud that I hadn’t previously considered: counterfeit pharmaceuticals.

Just as designer goods have low-cost knock-offs, so too do pharmaceuticals and medical devices. Unfortunately, counterfeit medical products are a higher risk proposition – perhaps causing the death of hundreds of thousands of people worldwide each year.

It is difficult to quantify the international morbidity and mortality toll of counterfeit drugs – there have been no comprehensive global studies to determine the prevalence and collateral damage of the problem.  But I found these data points of interest (they were in the slide decks presented at the conference):
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Posted in: Pharmaceuticals, Politics and Regulation, Public Health

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Connecticut Legislature Intrudes on Debate Over Chronic Lyme Disease

The tick borne spirochete infection known as Lyme disease was named after Lyme, CT – a part of the country where the disease remains endemic. It is therefore especially poignant that the Connecticut state senate unanimously passed Public Act No. 09-128: AN ACT CONCERNING THE USE OF LONG-TERM ANTIBIOTICS FOR THE TREATMENT OF LYME DISEASE.The bill had previously passed the state House, also unanimously.

This is a terrible bill that is both anti-science and anti-consumer protection. How it passed both houses without dissent reflects exactly why such micro-management decisions should not be made by politicians.  It is the result of lobbying by a narrow interest group and does not reflect either the state of the science on Lyme disease nor the proper role of regulation to ensure standards of care within medicine.

This is also not an isolated case. There is already a similar law in Rhode Island, and there have been similar bills proposed in Pennsylvania, Massachusetts, and New York, and a bill in Maryland that would compel insurance companies to pay for antibiotic treatment for chronic Lyme disease CLD.   This is part of a coordinated effort by individuals and organizations who hold an ideological opinion regarding the cause and treatment of CLD. They wish to use the political process to win a victory for their view that they have been unable to win in the arena of science (sound familiar).

The bill now awaits Governor Rell’s signature, which given the heavy political support for this bill seems almost certain.

This bill represents much which is wrong with the state of science and medicine in the US.

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Posted in: Politics and Regulation, Science and Medicine

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“Acupuncture Anesthesia”: A Proclamation from Chairman Mao (Part II)

An Anesthesiologist’s Perspective

The late John Bonica (1917-1994), one of the great anesthesiologists of the 20th century, has been called “The Founding Father of the Pain Field.” He developed this interest while treating wounded soldiers at Fort Lewis, Washington, during WW II. Shortly thereafter he became a pioneer of epidural analgesia and other forms of safe pain relief for labor and delivery. In 1947 he created the first multidisciplinary pain clinic, at Tacoma General Hospital, and in 1960 brought it to the University of Washington School of Medicine when he became the founder and first chairman of its Department of Anesthesiology. In 1953 he published the first comprehensive textbook on the subject of pain, the 1500 page Management of Pain. In 1973 he founded what is now the largest professional organization devoted to pain relief, the International Association for the Study of Pain (IASP).

Dr. Bonica was born in Italy. He came to New York City with his family when he was 11. His father died four years later and he became the major breadwinner for the family. He competed in wrestling while in high school and won both the New York City and state championships. Later he worked his way through college and medical school by wrestling professionally under the pseudonym ‘Johnny (Bull) Walker’, and according to several sources he was the “Light Heavyweight Wrestling Champion of the World.” He continued to wrestle while in the army but concealed his military identity by becoming, in the ring, the “Masked Marvel.”

At the time of the burgeoning Western interest in acupuncture in the early 1970s, Dr. Bonica became the Chairman of the Ad Hoc Committee on Acupuncture of the National Institutes of Health (NIH). In 1973 he was “selected by the Committee on Scholarly Communication with the People’s Republic of China of the National Academy of Sciences to be a member of the first official American medical delegation to visit the People’s Republic of China, and was given the responsibility of evaluating acupuncture and anesthesia as practiced in that country.”

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Posted in: Acupuncture, Medical Academia, Politics and Regulation, Science and the Media

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Chemical castration for autism: After three years, the mainstream media finally notices

We’ve written a lot about anti-vaccine zealotry on this blog, as Steve and I take a particular interest in this particular form of dangerous pseudoscience for a number of reasons. One reason, of course, is that the activities of antivaccine groups like Generation Rescue and its spokesmodel since 2007 (Jenny McCarthy, a frequent topic on this blog) have started to frighten parents about vaccines enough that vaccination rates are falling well below that required for herd immunity in some parts of the country. Indeed, McCarthy, at the behest of her handlers in Generation Rescue, serves up a regular “toxic” brew of misinformation and nonsense about vaccines, most recently in a video that was the subject of a post by Val Jones about her unbelievably pseudoscience-laden blather. Truly, it has to be seen to be believed. Meanwhile, Generation Rescue has sent McCarthy on a media propaganda tour for her latest antivaccine pro-quackery book and set up a misinformation-laden propaganda site called Fourteen Studies (blogged about by Steve Novella, Mark Crislip, and, of course, yours truly) in which they attack well-designed studies that have failed to confirm their pet idea that somehow, some way, vaccines must be the cause of autism. And, when their pseudoscience is criticized, the antivaccine movement has a tendency to launch vicious ad hominem attacks, as they recently did against Steve Novella and have done multiple times in the past against me.

However, there is one other consequence of the antivaccine movement, however, and it is at least as important as the public health implications of the potential dimunition of herd immunity caused by the fear mongering of groups like Generation Rescue. That consequence is the cottage industry of “biomedical” treatments to which desperate parents subject their children. Gluten-free diets, chelation therapy (which has caused deaths), hyperbaric oxygen chambers (a recent story described a child getting severely burned when one of these caught fire), autistic children have been subjected to it all. But of all the biomedical woo to which autistic children have been subjected, one form of woo stands out as being particularly heinous. Indeed, I agree with our fearless leader Steve in characterizing it as an “atrocity.”

I’m referring to Mark and David Geier’s favored “treatment” for autistic children, namely a drug called Lupron.
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Posted in: Clinical Trials, Health Fraud, Medical Ethics, Neuroscience/Mental Health, Politics and Regulation, Public Health, Science and the Media, Vaccines

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The British Chiropractic Association versus Simon Singh

Simon SinghIf there’s one thing I’ve learned in my years promoting skepticism and science in medicine and writing critically about various forms of unscientific medical practices and outright quackery, it’s that there will always be pushback. Much, if not most, of the time, it’s just insults online. However, occasionally, the pushback enters into the realm of real life. I can remember the very first time this happened to me. It was in 2005, and a man by the name of William P. O’Neill of the Canadian Cancer Research Group sent legal threats to my Department Chairman, my Division Chief, and my Cancer Center Director. The legal threat was clearly vacuous, as Mr. O’Neill seemed upset mainly that I had praised his arch-nemesis, Australian skeptic Peter Bowditch (who even keeps a running tally of threats he receives from Mr. O’Neill under the heading The GAL Chronicles, where GAL stands for “gutless anonymous liar”). I must admit, at the time it scared the crap out of me, but the reaction of my Chairman at the time, Dr. Stephen Lowry, was classic in that he said he did not care what I did in my spare time and referred to Mr. O’Neill as a “cowardly bully.” From then on, every time Mr. O’Neill tried something similar, I simply replied that I was forwarding his e-mail to Dr. Lowry (who was amused by all this) and thanked him for his concern.

More recently, J.B. Handley wrote a rather ugly screed (one of two, actually) about me. Somehow, this screed was e-mailed to my cancer center director. Whether Mr. Handley, one of the crew at Age of Autism, or an AoA reader did it, I don’t know. However, it is typical behavior of the anti-vaccine movement. Based on this history, I’ve concluded that, if you’re going to be a skeptic you’d better be prepared for this sort of thing, and if you’re going to blog under a pseudonym you’d better expect that sooner or later someone will try very, very hard indeed to “out” you and use that against you–which is of course blogging at SBM is in a way liberating in that it removes that threat.

However, whatever obnoxiousness or attempts to harass me at my job I may on occasion have to worry about, one thing I don’t have to worry about (much) is legal threats, at least as long as I keep all my ducks in a row, so to speak. In the U.S., libel is a very difficult charge to prove. The First Amendment gives wide latitude to free speech, and that places the burden of proof on the plaintiff to show that a statement is defamatory, with libel being in essence written defamation. In general, this is what constitutes defamation in the U.S.:

In order for the person about whom a statement is made to recover for libel, the false statement must be defamatory, meaning that it actually harms the reputation of the other person, as opposed to being merely insulting or offensive.

The statement(s) alleged to be defamatory must also have been published to at least one other person (other than the subject of the statement) and must be “of and concerning” the plaintiff. That is, those hearing or reading the statement must identify it specifically with the plaintiff.

The statement(s) alleged to be defamatory must also be a false statement of fact. That which is name-calling, hyperbole, or, however characterized, cannot be proven true or false, cannot be the subject of a libel or slander claim.

The defamatory statement must also have been made with fault. The extent of the fault depends primarily on the status of the plaintiff. Public figures, such as government officials, celebrities, well-known individuals, and people involved in specific public controversies, are required to prove actual malice, a legal term which means the defendant knew his statement was false or recklessly disregarded the truth or falsity of his statement. In most jurisdictions, private individuals must show only that the defendant was negligent: that he failed to act with due care in the situation.

A defamation claim — at least one based upon statements about issues that are matters of public interest — will likely fail if any of these elements are not met.

As you can see, it is a high bar of evidence to overcome to prove libel. Of course, that is a two-edged sword in that it allows J.B. Handley to slime me whenever he wishes, with little I can do about it, but I am also allowed, as I see fit, to respond or not to such attacks. I can also continue to criticize anti-vaccine propagandists like Mr. Handley as I see fit. Unfortunately, for my U.K. colleagues, the same is most assuredly not true in British courts, where the rules are very much weighted against the defendant. Witness this travesty of a ruling on the libel case against Simon Singh, coauthor with Edzard Ernst of Trick or Treatment: The Undeniable Facts about Alternative Medicine (which Harriet Hall reviewed last year) by the British Chiropractic Association, as related by Jack of Kent. This ruling came about because the BCA did not like an article that Singh wrote for The Guardian entitled Beware the spinal trap.
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Posted in: Chiropractic, Medical Ethics, Politics and Regulation, Science and the Media

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Georgia on my mind

Scales

My inaugural post was about vaccines, and I promised that I wouldn’t write exclusively on this topic. But something rotten is brewing in the state of Georgia and this story is just too important to ignore.

The first successful challenge to the National Childhood Vaccine Injury Compensation Act (NCVICA) has taken place in Georgia, and we all should be just a little bit worried. In Ferrari v. American Home Products Corp., the plaintiffs, Marcello and Carolyn Ferrari of Atlanta, have sued American Home Products Corp. (otherwise known as Wyeth) and the co-defendant GlaxoSmithKline, claiming that the vaccine preservative thimerosal led to their son’s autism. The consequences of this ruling could effect the health of the entire nation. To understand why, we need to delve a bit into what the NCVICA is exactly, and why it was created in the first place.
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Posted in: Politics and Regulation, Public Health, Science and Medicine, Vaccines

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The Huffington Post‘s War on Medical Science: A Brief History

I realize that our fearless leader Steve Novella has already written about this topic twice. He has, as usual, done a bang-up job of describing how Arianna Huffington’s political news blog has become a haven for quackery, even going so far as to entitle his followup post The Huffington Post’s War on Science. And he’s absolutely right. The Huffington Post has waged a war on science, at least a war on science-based medicine, ever since its inception, a mere two weeks after which it was first noticed that anti-vaccine lunacy ruled the roost there. Because I’ve had experience with this topic since 2005, I thought I’d try to put some perspective on the issue, in order to show you just how pervasive pseudoscience has been (and for how long) at the blog whose name is often abbreviated as “HuffPo.”
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Posted in: Cancer, Health Fraud, Herbs & Supplements, Homeopathy, Politics and Regulation, Science and the Media, Vaccines

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Harvard Medical School: Veritas for Sale (Part VI)

Loose Ends: Dr. Koh and More

After Dr. Federman’s letter and my reply, posted in Part V of this series,† there seemed little point in pursuing the matter further. Although Dr. Federman never answered my reply, he did send, at my request, a copy of Commissioner of Public Health Howard Koh‘s written “construction of the events in the Massachusetts Special Commission.” As you may recall, those events had occurred at meetings that Dr. Koh never attended:

July 29, 2002

Dear Dr. Federman:

I have had an opportunity to review Dr. Kimball Atwood’s characterizations of the role Dr. David Eisenberg played as an advisor and designee of the Department of Public Health (DPH) and I am writing to clarify several misrepresentations of that role. As you may know, I personally selected Dr. Eisenberg as my designee for the Massachusetts Special Commission on Complementary and Alternative Medical Practitioners based on his high level of scientific and clinical expertise in the field, as well as his international reputation for evidence-based research. I felt at that time, as I do now, that he was the appropriate choice to represent the Department and I am extremely grateful for his advice and his integrity during this most contentious process.

During the course of the Commission, Dr. Eisenberg brought to my attention some of the conflicts that had arisen among the members, despite his attempts to diffuse the hostility and to engage the members in collegial debate. In an effort to overcome these difficulties and deflect unwarranted criticism, Nancy Ridley, Assistant Commissioner for Health Quality Management, attended the meetings over the last six months as the DPH voting designee, with Dr. Eisenberg as an advisor. She also organized a DPH workgroup of the Commission in an attempt to bring consensus and closure to what had become a very polarized and highly personalized process.

I need to state emphatically that the approval of the final Commission report is my responsibility, and is largely a product of the DPH workgroup that Assistant Commissioner Ridley chaired. Dr. Eisenberg had actually not been supportive of either the “majority” or “minority” reports that were originally presented, and neither was Ms. Ridley. She attempted to address as many of Dr. Eisenberg’s concerns as possible but knew he still had issues with the final document. She feels very strongly that there needs to be regulatory oversight of non-physician practitioners of complementary and alternative naturopathic practice. Assistant Commissioner Ridley, on behalf of the Department and with my consent, signed the report that included a significant number of revisions which narrowed the scope of practice, ensured collaborative relationships between physician and non-physician practitioners, and broadened the scope of any proposed regulatory oversight required. Dr. Eisenberg’s advice to DPH was delivered in a fair and balanced manner based his outstanding experience as a clinician and scientist.

I believe that one of the contributing factors for the polarization within the Commission had little to do with Dr. Eisenberg’s participation rather than that of his staffperson, Michael Cohen, who attended Commission meetings in his absence. Mr. Cohen was repeatedly characterized as the alternate DPH designee, which he was not.

In summary, Dr. Eisenberg’s expertise and professionalism throughout this difficult process have been greatly appreciated by the Department. DPH was truly fortunate to be represented and advised by a person of Dr. Eisenberg’s stature and character. I would be more that pleased to speak to you or Dean Martin on his behalf. Please feel free to contact me at xxx.xxx.xxxx if you need any additional information.

Sincerely,

Howard K. Koh, MD, MPH

The range of self-serving misrepresentations in that letter is wide, and is worrisome in someone who will be “responsible for the major health agencies, including the CDC, FDA and NIH, and [will be] the leading health advisor to the Secretary of HHS.” I have already discussed some of the facts here and here, and will add more now.

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

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