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Archive for Politics and Regulation

The Golden State of Pseudo-Science

The state of California (CA) which is home to the most advanced education and research in biomedical sciences, computational biology, genomics and proteomics, etc, is also home to 19 institutions that have state-approved training programs in Traditional Chinese Medicine (TCM), a pseudo-medicine that is based on ideas and practices sourced by ancient cosmology, mythology, astrology, and a range of other pre-scientific beliefs that have been partially “sanitized” during the Maoist era.

Emerging out of the recent hype about complementary and alternative medicine (CAM), the educational curricula of these institutions include the study of acupuncture’s point-and-meridian system, the health and safety beliefs of ancient and medieval China, humoral pathology, herbalism, Asian massage, and a limited amount of modern biomedical sciences at a level below what is required from vocational nurses. These curricula are supposed to provide the necessary knowledge and skills for the graduates to pass a comprehensive state licensing exam and provide “primary” healthcare in CA. However, pursuant to CA Code of Regulations, Title 16, Section 1399.451(b) it is improper for these “primary” healthcare providers, “to disseminate any advertising which represents in any manner that they can cure any type of disease, condition or symptom!” Nonetheless, both the internet and the local press abound with ads by CA licensed practitioners who claim that acupuncture can cure or mitigate many diseases, ranging from allergies and infertility to stroke and paralysis.

Under the banner of CAM, a handful of these practitioners also advertise that they can communicate with spirits and heal with crystals, colors or sounds; they practice healing touch (reiki) and distance healing (via PayPal!); provide spiritual counseling and ministerial services, and make implausible medical claims such as healing a chronic condition with just one needle!

All 19 programs are approved by the CA Department Affairs’ (DCA) Board of Acupuncture, since CA law requires that the content of an acupuncture training program be assessed and approved by the State.

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Posted in: Acupuncture, Politics and Regulation, Public Health

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Sectarian Insertions

I will write occasional posts instead of being on a regular schedule.  The reasons: There are more contributors than positions. Newer people to the field have more ambition and belly fire.  I have a number of projects and papers to finish in increasingly limited time and decreasing efficiency.  So have at it. Meanwhile, some non-random thoughts.

I am as concerned with social and political expression of pseudoscience as with its errors.  Health care reformers can be just as pseudoscientific as sectarians who want to restructure the scientific edifice.  Political ideologues want to centralize the medical system without solid evidence that their substitute would work, let alone work better.  Sectarians already see a national government system as an opportunity for expansionism. Mark Hyman, the Functional Medicine promoter, met with the White House staff, displaying his vision of medicine under a federal plan. Word is out that other sects have also had input. Many hold  suspicions that the proposals front for more ambitious formulations. I am suspicious of their confidence – that they can fix a complex, fluxing system using epidemiology, mathematical models, treatment paradigms, and top-down control.  I might accept some proposals if it were not that all constructed systems are intrinsically inefficient, political, and corruptible. The closer the agents of control are to the controlled, the more control the controlled have over the controllers – if you can follow that.
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Posted in: Health Fraud, History, Medical Ethics, Politics and Regulation, Science and Medicine

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“There must be a reason,” or how we support our own false beliefs

ResearchBlogging.orgFor a change of pace, I want to step back from medicine for this post, although, as you will see (I hope), the study I’m going to discuss has a great deal of relevance to the topics covered regularly on this blog. One of the most frustrating aspects of being a skeptic and championing science-based medicine is just how unyielding belief in pseudscience is. Whatever realm of science in which there is pseudoscience I wander into, I find beliefs that simply will not yield to science or reason. Whether it be creationism, quackery such as homeopathy, the anti-vaccine movement, the “9/11 Truth” movement, moon hoaxers, or any of a number of pseudoscientific movements and conspiracy theories, any skeptic who ventures into discussions of such a topic with believers will become very frustrated very fast. It takes a lot of tenacity to keep going back to the well to argue the same points over and over again and refute the same nonsense you’ve refuted over and over again. Many do not have sufficient stick-to-it-iveness, leading them to throw up their hands and withdraw from the fight.

Although some of us here have blamed this phenomenon on “cultishness” and, make no mistake, I do think that there is an element of that in many of these movement, particularly the anti-vaccine movements, cultishness alone can’t explain why people hold on so hard to beliefs that are clearly not supported by science or evidence, such as the belief that vaccines are responsible for an “autism epidemic.” Then last week, what should pop up in the newsfeeds that I regularly monitor but a rather interesting article in Science Daily entitled How We Support Our False Beliefs. It was a press release about a study1 that appeared a few months ago in Sociological Inquiry, and the the study was described thusly:
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Posted in: Clinical Trials, Politics and Regulation, Science and Medicine, Vaccines

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The Rise of Placebo Medicine

It is my contention that terms such as “complementary and alternative medicine” and “integrative medicine” exist for two primary purposes. The first is marketing – they are an attempt at rebranding methods that do not meet the usual standards of unqualified “medicine”. The second is a very deliberate and often calculating attempt at creating a double standard.

We already have a standard of care within medicine, and although its application is imperfect its principles are clear – the best available scientific evidence should be used to determine that medical interventions meet a minimum standard of safety and effectiveness. Regulations have largely (although also imperfectly) reflected that principle, as have academia, publishing standards, professional organizations, licensing boards, and product regulation.

With the creation of the new brand of medicine (CAM and integrative) came the opportunity to change the rules of science and medicine to create an alternative standard, one tailor made for those modalities that do not meet existing scientific and even ethical standards for medicine. This manifests in many ways – the NCCAM was created so that these modalities would have an alternate standard for garnering federal dollars for research. Many states now have “health care freedom laws” which create a separate standard of care (actually an elimination of the standard of care) for self-proclaimed “alternative” practices.

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Posted in: Politics and Regulation, Science and Medicine

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Health care reform and primary sources

One thing I always encourage my residents and students to do is to go to primary sources.  If someone tells you that thiazide diruetics should be the first line treatment for hypertension, get on MedLine and see if that assertion is congruent with the evidence.  It’s important to see how we arrive at broad treatment recommendations, how strong and consistent the evidence is, and the best way to do this is go back to the beginning.

This is not an explicitly political blog, and for that reason, I don’t feel it’s appropriate for me to advocate for one or another proposed health care reform plan.  But I do want to encourage everyone to follow health care reform closely, and to go to the primary sources. Certain aspects of the proposed bill will be hard for any of us to understand, especially cost.  There are all sorts of wild claims about how much reform will save us or cost us, and I’m betting that none of these claims is completely congruent with the truth.  But some of  what we’re hearing on the news is so far from the truth that to call them lies would be generous. (more…)

Posted in: Politics and Regulation, Science and Medicine

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Quack Clinics

Reuters recently reported on the raid of a stem-cell clinic in Hungary. This is welcome news, if the allegations are correct, but really is only scratching the surface of this problem – clinics offering dubious stem cell therapies to desperate patients. And in fact this is only one manifestation of a far greater problem – the quack clinic. They represent a serious problem for patients, doctors, and health care regulation.

Stem Cell Clinics

There is a very disturbing trend in the last few years – the proliferation of clinics offering stem cell therapy for a variety of serious, often incurable, diseases such as spinal cord injury, ALS, Parkinson’s disease, and other neurological disorders. These clinics claim to improve and even cure these diseases by injecting stem cells into the spinal cord or other parts of the body. Treatments typically cost 20-25,000 dollars, plus travel expenses, for a single treatment.

The problem is that these clinics do not have any published evidence that their treatments are valid. There is good reason to think that they are not – stem cell technology is simply not at the point yet where we can use them to cure such diseases. There are many technical hurdles to be overcome first – knowing how to control the stem cells, to get them to survive and become the types of cells necessary to have the desired therapeutic effect, and also figuring out how to keep them from growing into tumors. Basic issues of safety have not yet been sorted out.

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Posted in: Politics and Regulation, Science and Medicine

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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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