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Archive for Politics and Regulation

Senator Tom Harkin and Representative Darrell Issa declare war on science-based medicine

In discussions of that bastion of what Harriet Hall likes to call “tooth fairy science,” where sometimes rigorous science, sometimes not, is applied to the study of hypotheses that are utterly implausible and incredible from a basic science standpoint (such as homeopathy or reiki), the National Center of Complementary and Alternative Medicine (NCCAM), I’ve often taken Senator Tom Harkin (D-IA) to task, as have Drs. Novella, Lipson, and Atwood. That’s because Senator Harkin is undeniably the father of that misbegotten beast that has sucked down over $2.5 billion of taxpayer money with nothing to show for it. NCCAM is the brainchild of Senator Harkin, who foisted it upon the National Institutes of Health not because there was a scientific need for it or because scientists and physicians cried out for it but rather because Senator Harkin, who believed that alternative medicine had healed a friend of his, wanted it, and he used his powerful position to make it happen, first as the Office of Unconventional Therapies, then as the Office of Alternative Medicine, and finally as the behemoth of woo that we know today as NCCAM. The result has included a $30 million trial of chelation therapy in which convicted felons were listed among the investigators and a totally unethical trial of the Gonzalez therapy for pancreatic cancer. It’s not for naught that Wally Sampson called for the defunding of NCCAM, as have I and others. Not surprisingly, alternative medicine practitioners are appalled at this idea.

Most recently, Harkin has been most disturbed by the observation that NCCAM’s trials have all been negative, going so far as to complain that NCCAM hasn’t produced any positive results showing that various alternative therapies actually work. This is, of course, not a surprise, given that vast majority of the grab bag of unrelated (and sometimes theoretically mutually exclusive) therapies are based on pseudoscience. One of the only exceptions is the study of herbal remedies, which is a perfectly respectable branch of pharmacology known as pharmacognosy. Unfortunately, as David Kroll showed, in NCCAM the legitimate science of pharmacognosy has been hijacked for purposes of woo. Meanwhile, earlier this year, Senator Harkin hosted a hearing in which Drs. Dean Ornish, Andrew Weil, Mehment Oz, and Mark Hyman (he of “functional medicine“) were invited to testify in front of the Senate. Add to that other powerful legislators, such as Representative Dan Burton (R-IN), trying to craft legislation in line with his anti-vaccine views and pressure the NIH to study various discredited hypotheses about vaccines and autism. Clearly, when it comes to quackery, there are powerful legislative forces promoting pseudoscience and studies driven by ideology rather than science.
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Posted in: Acupuncture, Chiropractic, Homeopathy, Politics and Regulation, Science and Medicine

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Is Tylenol Safe?

Tylenol (acetaminophen, also known as paracetamol outside the US) has been in the news recently. Most of the stories I’ve seen have been accurate, but I’ve run across a couple of people who misunderstood what they read. I thought I’d try to put the record straight.

An FDA advisory panel has recommended reducing the maximum allowed single dose from 1000 mg to 650 mg in over-the-counter acetaminophen products. The 1000 mg dose would be available by prescription only. They also recommended eliminating painkillers like Percocet and Vicodin that contain a combination of a narcotic and acetaminophen. They did not recommend removing acetaminophen from over-the-counter cold remedies, cough medicines and similar products that combine acetaminophen with other drugs. Advisory panel recommendations are not binding, but the FDA usually follows them.

Some people got the impression that the FDA had just discovered that acetaminophen can be dangerous. No, we always knew that. The danger is when you take too much: it can damage the liver. The “new” information is just that acetaminophen overdose is now the leading cause of liver damage, causing an estimated 1600 cases of liver failure each year. (more…)

Posted in: Pharmaceuticals, Politics and Regulation

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DSHEA: a travesty of a mockery of a sham

In 1994, Congress enacted the Dietary Supplement Health and Education Act (DSHEA). This act allows for the marketing and sales of “dietary supplements” with little or no regulation. This act is the work of folks like Tom Harkin (who took large contributions from Herbalife) and Orrin Hatch, whose state of Utah is home to many supplement companies.

DSHEA has a couple of very important consequences (aside from filling the pockets of supplement makers). (more…)

Posted in: Health Fraud, Herbs & Supplements, Politics and Regulation, Science and Medicine

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NIH Awards $30 Million Research Dollars To Convicted Felons: Cliff’s Notes Version

In case you’re coming late to this discussion (or have ADD), I’ve summarized Dr. Kimball Atwood’s terrific analysis of the ongoing clinical trial (TACT trial) in which convicted felons were awarded $30 million by the NIH.

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In one of the most unethical clinical trial debacles of our time, the NIH approved a research study (called the TACT Trial – Trial to Assess Chelation Therapy – a supposed treatment for arteriosclerosis) in which the treatment had no evidence for potential benefit, and clear evidence of potential harm – and even the risk of death. Amazingly, the researchers neglected to mention this risk in their informed consent document. The NIH awarded $30 million of our tax dollars to ~100 researchers to enroll 2000 patients in this risky study (ongoing from 2003-present). Even more astounding is the fact that several of the researchers have been disciplined for substandard practices by state medical boards; several have been involved in insurance fraud; at least 3 are convicted felons.

But wait, there’s more.

The treatment under investigation, IV injection of Na2EDTA, is specifically contraindicated for “generalized arteriosclerosis” by the FDA. There have been over 30 reported cases of accidental death caused by the administration of this drug – and prior to the TACT, 4 RCTs and several substudies of chelation for either CAD or PVD, involving 285 subjects, had been reported. None found chelation superior to placebo.

So, Why Was This Study Approved?

The NIH and the TACT principal investigator (PI) argued that there was a substantial demand for chelation, creating a “public health imperative” to perform a large trial as soon as possible. In reality, the number of people using the therapy was only a small fraction of what the PI reported.

It’s hard to know exactly what happened “behind the scenes” to pressure NIH to go forward with the study – however a few things are clear: 1) the National Heart, Lung, and Blood Institute (NHLBI) initially declined to approve the study based on lack of scientific merit 2) congressman Dan Burton and at least one of his staffers (Beth Clay) and a lobbyist (Bill Chatfield) worked tirelessly to get the study approved through a different institute – NCCAM 3) some of the evidence used to support the trial was falsified (The RFA cited several articles by Edward McDonagh, the chelationist who had previously admitted in a court of law to having falsified his data.) 4) The NIH Special Emphasis Panel that approved the TACT protocol included L. Terry Chappell, whom the protocol had named as a participant in the TACT.

All evidence seems to suggest that political meddling managed to trump science in this case – putting the lives of 2000 study subjects at risk, without any likely benefit to them or medicine.

A formal analysis of the sordid history and ethical violations of the TACT trial was published by the Medscape Journal of Medicine on May 13, 2008. Atwood et al. provide a rigorous, 9-part commentary with 326 references in review of the case. Congressman Burton’s staffer, Beth Clay, published what is essentially a character assassination of Dr. Atwood in response.

The NIH Writes TACT Investigators a Strongly Worded Letter

On May 27, 2009 the Office for Human Research Protections Committee sent a letter to the investigators of TACT, stating that they found, “multiple instances of substandard practices, insurance fraud, and felony activity on the part of the investigators.” The letter describes a list of irregularities and recommends various changes to the research protocol.

It is almost unheard of for a letter from the NIH to state that research study investigators are guilty of fraud and felony activity – but what I don’t understand is why they haven’t shut down the study. Perhaps this is their first step towards that goal? Let’s hope so.

Conclusion

The TACT trial has subjected 2000 unwary subjects and $30 million of public money to an unethical trial of a dubious treatment that, had it been accurately represented and judged by the usual criteria, would certainly have been disqualified. Political meddling in health and medical affairs is dangerous business, and must be opposed as strongly as possible. Congressmen like Tom Harkin and Dan Burton should not be allowed to push their political agendas and requests for publicly funded pseudoscience on the NIH. I can only hope that the new NIH director will have the courage to fend off demands for unethical trials from political appointees.

Posted in: Clinical Trials, Health Fraud, Medical Ethics, Politics and Regulation, Science and Medicine

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Human Subjects as Political Pawns

When it comes to “alternative medicine” trials, it seems that the NIH is willing to experiment on people in ways that would be unthinkable for real biomedical research. The federal Office for Human Research Protections (OHRP) has posted a preliminary determination letter, dated May 27, 2009, addressing some of the charges we had made against the politics-driven NIH Trial to Assess Chelation Therapy (TACT).

It is a remarkably damning statement, particularly regarding an NIH study. That is, it found—or the recipients admitted—that each of several charges was valid. Among these are misleading statements and unstated risks in the consent form, and the embarrassing backgrounds of TACT investigators. According to the determination letter,

…investigations revealed multiple instances of substandard practices, insurance fraud, and felony activity on the part of investigators.”

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Posted in: Politics and Regulation, Science and Medicine

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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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