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Archive for Politics and Regulation

Cancer research: Going for the bunt versus swinging for the fences

A couple of weeks ago, our resident skeptical medical student Tim Kreider wrote an excellent article about an op-ed in NEWSWEEK by science correspondent Sharon Begley, in which he pointed out many misconceptions she had regarding basic science versus translational research, journal impact factors, and how journals actually determine what they will publish. Basically, her thesis rested on little more than a few anecdotes by scientists who didn’t get funded or published in journals with as high an impact factor as they thought they deserved, with no data, science, or statistics to tell us whether the scientists featured in her article were in fact representative of the general situation. Begley’s article caught flak from others, including Mike the Mad Biologist and our very own Steve Novella. Naturally, as the resident cancer surgeon and researcher, I had thought of weighing in, but other issues interested me more at the time.

In retrospect, I rather regret it, given that this issue crops up time and time again. In essence, it’s a variant of the lament that pops up in the press periodically, when science journalists look at survival rates for various cancers and ask why, after nearly 40 years, we haven’t yet won the war on cancer. Because of his youth, Tim probably hasn’t seen this issue crop up before, but, trust me, every couple of years or so it does. Begley’s article and the NYT article strike me as simply “Why are we losing the war on cancer?” 2009 edition.

Now the New York Times has given me an excuse both to revisit Begley’s article and discuss yesterday’s front page article in the NYT Grant System Leads Cancer Researchers to Play It Safe. Basically, they are variants of the same complaints I’ve heard time and time again. Now, don’t get me wrong. By no means am I saying that the current system that the NIH uses to determine which scientists get funded. Those who complain that the system is often too conservative have a point. The problem, all too often, however, is that the proposals for how to fix the problem are usually either never spelled out or rest on dubious assumptions about the nature of cancer research themselves.
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Posted in: Basic Science, Cancer, Medical Academia, Politics and Regulation

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Tactless About TACT: Critiques Without Substance Should Be Abandoned

In May 2008, the article “Why the NIH Trial to Assess Chelation Therapy (TACT) Should Be Abandoned” was published online in the Medscape Journal of Medicine. The authors included two of our own SBM bloggers, Kimball Atwood and Wallace Sampson, along with Elizabeth Woeckner and Robert Baratz. It showed that the existing evidence on treating heart disease with IV chelation did not justify further study, and that the TACT trial was questionable on several ethical points. Their ethical concerns were taken seriously enough that enrollment in the trial was put on hold pending an investigation. It has now been re-opened after a few band-aids were applied to the ethical concerns. The scientific concerns were never addressed.

I have seen many critiques of the Atwood study, and not a single one has offered any cogent criticism of its factual content or reasoning. Most of them could have been written by someone who had not bothered to read beyond the title. Their arguments can be boiled down to a few puerile points that can be further simplified to:

(1) I believe the testimonial evidence that chelation works.
(2) Atwood and his co-authors are bad guys.

Now Beth Clay has chimed in with an article entitled “Study of Chelation Therapy Should Not Be Abandoned.” I found it truly painful to read, but even the worst has some value as a bad example. Clay’s article could be used for a game of “Count the Errors.” I will point out some of them below. (more…)

Posted in: Clinical Trials, Politics and Regulation, Science and Medicine

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Cranks, quacks, and peer review

Last week, I wrote one of my characteristically logorrheic meandering posts about what turns a scientist into a crank or a doctor into a quack. In a sort of continuation of this line of thinking, this week I’ll turn my attention to one of the other most common characteristics of a crank, be he scientific crank (i.e., a creationist), a quack, or historical crank (i.e., Holocaust deniers), specifically how he views the peer review system.

Not suprisingly, one of the favorite targets of pseudoscientists is, in fact, the peer review system. Indeed, it’s a very safe thing to say that, almost without exception, cranks really, really, really don’t like the peer review system for scientific journals and grant review. After all, it’s the system through which scientists submit their manuscripts describing their scientific findings or their grant proposals to their peers, and their peers make a judgment whether manuscripts are scientifically meritorious enough to be published and grant applications scientifically compelling enough to be funded. Creationists hate peer review. HIV/AIDS denialists hate it. Anti-vaccine cranks like those at Age of Autism hate it. Indeed, as a friend of mine, Mark Hoofnagle pointed out a couple of years ago, pseudoscientists and cranks of all stripes hate it. There’s a reason for that, of course, namely that vigorous peer review is a major part of science that keeps pseudoscientists from attaining the respectability that science possesses and that they crave so.
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Posted in: Medical Academia, Politics and Regulation, Science and Medicine

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Naturopathic Prescribing: The Dark Side Beckons

I am a terrible Oregon chauvinist.  I think there is no better place to live on the planet. Period.  Great natural beauty, not a lot of people, best beer ever and no pro football team. Oregon is both casual and tolerant.  It is safe to say that dressing up in the Pacific NW means tucking your t shirt into your jeans.  And the citizens of the NW, especially in the Portland metro area, are tolerant of  a diverse number of alternative life styles. What more could you want?

No good deed goes unpunished. The downside of toleration is the proliferation of alternative medicine.  Portland has  a school of chiropractic, a college of oriental medicine and  the country’s oldest school of naturopathy, established in 1956.  It is a year older than me. There are about 850 ND’s in Oregon.  To judge from the number of alternative practitioner offices around my hospital,  most of the graduates stay in Portland.

There are five health care systems in Portland.   Three of the five have hired naturopaths as part of their complementary medicine programs.   My system, as of yet, does not have a scam practitioner on staff, a fact of which I am most proud.  Yet,  I suppose it will come some day. However, if you wonder if a hospital practices evidence and science based medicine, see if they have a naturopath, a chiropractor or an acupuncturist on staff.  If they do, they may be interested in issues other than providing quality health care.

Oregon has had a Board of Naturopathic physicians since 1929 to oversee naturopathic practice.  There has been a long tradition of legislative oversight of naturopathy in Oregon, but they have been able, until recently, to only prescribe medications that are naturally derived.  None of that synthetic nonsense for naturopaths. Natural products only.  Until this month.

In Oregon, naturopaths are no longer limited to natural, herbal and homeopathic concoctions, they can also prescribe substances that actually work.  Recently House Bill 327  was passed by the Oregon legislature to expand the prescriptive privileges of naturopaths.  Drugs can now be added to the naturopathic  formulary just by asking.  The bill was passed by the Senate 22-7 and the House unanimously.  Bummer. If you live in Oregon and want to pester your representative on their profound stupidity, a list is at  http://gov.oregonlive.com/bill/SB327/. Send them a link to this post.

As a shill for big pharma and a tool of the medical-industrial complex, I suggest this may not be such a  good idea.  Naturopaths do not have the training, experience  or understanding of medicine to safely prescribe medications. Their understanding of disease and the various therapies taught at naturopathic schools are antithetical to what is required to safely and knowledgeably  prescribe modern medications.
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Posted in: Legal, Naturopathy, Pharmaceuticals, Politics and Regulation, Science and Medicine

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Barriers To Adoption of Science-Based Medicine

I have a confession to make – it’s not easy keeping up with the other “Joneses” on this blog. My colleagues do a terrific job with thoroughly referenced analyses of key issues in medicine – and I sometimes struggle to think of topics that they haven’t already covered in more depth than I can. So today I asked my friends on Twitter if they had any suggestions for this week’s post.

One Twitter respondent asked me for my “perspective on the biggest barriers to better funding and adoption of science- based medicine.” As I contemplated that question, an experience leapt immediately to mind…

I attended a recent press conference held at a major Washington, DC think tank. An all-star cast was assembled, including Senator Baucus and Peter Orszag, to discuss the subject of comparative effectiveness research (CER). The most memorable part of the conference, however, was when one of the CER policy “experts” took the podium and actually said this (I’m going to paraphrase slightly):

The problem with science is that it’s too narrow. We’d have a lot more information to go on if we got rid of the narrow inclusion criteria in clinical trials. The exclusivity is not an irreversible flaw in the method – we just need to open up trials to larger groups of people of all kinds of different backgrounds so we can get better information.

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Posted in: Politics and Regulation

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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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