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The Trial to Assess Chelation Therapy: Equivocal as Predicted

The ill-advised, NIH-sponsored Trial to Assess Chelation Therapy (TACT) is finally over. 839 human subjects were randomized to receive Na2EDTA infusions; 869 were randomized to receive placebo infusions. The results were announced at this weekend’s American Heart Association meeting in Los Angeles. In summary, the TACT authors report a slight advantage for chelation over placebo in the “primary composite endpoint,” a combination of five separate outcomes: death, myocardial infarction, stroke, coronary revascularization, and hospitalization for angina:

 

Although that result may seem intriguing, it becomes less so when the data are examined more carefully. First, it barely achieved the pre-ordained level of statistical significance, which was P=.036. Second, none of the individual components of the composite endpoint achieved statistical significance, and most of the absolute difference was in coronary revascularization–which is puzzling:

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

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The Marino Center for Integrative Health: Hooey Galore

Two weeks ago I promised that I would discuss the Marino Center for Integrative Health, identified in the recent Bravewell report as having a “hospital affiliation” with the Newton-Wellesley Hospital (NWH) in Newton, Massachusetts, which is where I work. I also promised in that post that I’d provide examples of ‘integrative medicine’ practitioners offering false information about the methods that they endorse. I’d previously made that assertion here, and Jann Bellamy subsequently discussed its legal and ethical implications here. The Marino Center is a wellspring of such examples.

A Misleading ‘Affiliation’

Let’s quickly dispel the “hospital affiliation” claim. According to the Marino Center website:

Hospital Affiliations

In support of our services and to ensure that our patients have access to exceptional tertiary care, the Marino Center maintains deeply established relationships and affiliations for referrals and admitting privileges with major medical facilities in the Boston area.

The Marino Center:

  • Is a proud member of the Partners Healthcare family
  • Is affiliated with Newton Wellesley Hospital
  • Makes referrals to Mass General Hospital, Dana Farber, Children’s Hospital and more

Well, it wouldn’t surprise me if the Marino Center is a ‘member’ of the Partners Healthcare family, which includes not only the Newton-Wellesley Hospital, but lesser known entities such as the Massachusetts General Hospital and the Brigham and Women’s Hospital. After all, there are already unfortunate pseudomedical schemes involving Partners entities, such as the Osher Center for Complementary and Integrative Medical Therapies and, even under my own roof (I shudder as I write this), a Reiki Workshop. Nevertheless, it’s telling, I hope, that not only does the Marino Center fail to appear under any list of Partners affiliates, Community Health Partnerships, Wellness, Prevention, or any other conceivable category, but it fails to yield a single ‘hit’ when entered as a search term on the Partners website (the term ‘integrative’ yields seven hits, but none appears to be about ‘CAM,’ except possibly for an RSS feed that I’ve no patience to peruse. Is it possible that Partners is embarrassed by the Osher Center? I hope that, too).

I’ve previously asserted that the NWH is not affiliated with the Marino Center, other than that some Marino Center physicians have been—against my judgment, not that I was consulted—granted hospital staff privileges. I made this assertion in my original Bravewell post a couple of weeks ago, after having questioned the NWH Chief Medical Officer, Dr. Les Selbovitz, who verified it; nothing on the NWH website suggests otherwise.

I’ve no reason to doubt the Marino Center’s third bullet above, “makes referrals to Mass General Hospital,” etc., but this is something that any physician can do, regardless of affiliation. I suspect that if there were an ‘integrative hospital‘ in Boston, reason forbid, the Marino Center would make referrals to it.

False and Misleading Information about ‘Services’

Let’s get to the meat of the problem.

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Posted in: Acupuncture, Homeopathy, Medical Ethics, Science and Medicine, Science and the Media

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Dummy Medicine, Dummy Doctors, and a Dummy Degree, Part 2.2: Harvard Medical School and the Curious Case of Ted Kaptchuk, OMD (cont. again)

“Strong Medicine”: Ted Kaptchuk and the Powerful Placebo

At the beginning of the first edition of The Web that has no Weaver, published in 1983, author Ted Kaptchuk portended his eventual academic interest in the placebo:

A story is told in China about a peasant who had worked as a maintenance man in a newly established Western missionary hospital. When he retired to his remote home village, he took with him some hypodermic needles and lots of antibiotics. He put up a shingle, and whenever someone came to him with a fever, he injected the patient with the wonder drugs. A remarkable percentage of these people got well, despite the fact that this practitioner of Western medicine knew next to nothing about what he was doing. In the West today, much of what passes for Chinese medicine is not very different from the so-called Western medicine practiced by this Chinese peasant. Out of a complex medical system, only the bare essentials of acupuncture technique have reached the West. Patients often get well from such treatment because acupuncture, like Western antibiotics, is strong medicine.

Other than to wonder if Kaptchuk had watched too many cowboy ‘n’ Native American movies as a kid, when I first read that passage I barely blinked. Although the Chinese peasant may have occasionally treated someone infected with a bacterium susceptible to his antibiotic, most people will get well no matter what you do, because most illnesses are self-limited. Most people feel better even sooner if they think that someone with special expertise is taking care of them. If you want to call those phenomena the “placebo effect,” in the colloquial sense of the term, fine. That, I supposed, was what Kaptchuk meant by “strong medicine.”

Turns out I was mistaken. Let’s briefly follow Kaptchuk’s career path after 1983. In the 2000 edition of The Web, he wrote:

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Posted in: Acupuncture, Basic Science, Book & movie reviews, Chiropractic, Clinical Trials, Homeopathy, Medical Academia, Science and Medicine

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Update on Josephine Briggs and the NCCAM

Dr. Gorski is in the throes of grant-writing, so I’m filling in for him today by following up on a topic introduced a few months ago. It involves a key medical player in the U.S. government: Dr. Josephine Briggs, Director of the National Center for Complementary and Alternative Medicine (NCCAM).

Background

Steve Novella and I first encountered Dr. Briggs at the 2nd Yale Research Symposium on Complementary and Integrative Medicine in March, 2010. I reported here that she seemed well-meaning and pro-science but that she also seemed naive to the political realities of her office and to much of the content of “CAM” (as illustrated by her recommending the NCCAM website, which is full of misinformation; previously I’d noticed her unfortunate innocence of “acupuncture anesthesia,” which is to be expected of most academics but not of the CAM Explicator-in-Chief).

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Posted in: Clinical Trials, Health Fraud, Herbs & Supplements, Homeopathy, Naturopathy, Politics and Regulation, Science and Medicine, Vaccines

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Of SBM and EBM Redux. Part II: Is it a Good Idea to test Highly Implausible Health Claims?

Review

This is the second post in a series* prompted by an essay by statistician Stephen Simon, who argued that Evidence-Based Medicine (EBM) is not lacking in the ways that we at Science-Based Medicine have argued. David Gorski responded here, and Prof. Simon responded to Dr. Gorski here. Between that response and the comments following Dr. Gorski’s post it became clear to me that a new round of discussion would be worth the effort.

Part I of this series provided ample evidence for EBM’s “scientific blind spot”: the EBM Levels of Evidence scheme and EBM’s most conspicuous exponents consistently fail to consider all of the evidence relevant to efficacy claims, choosing instead to rely almost exclusively on randomized, controlled trials (RCTs). The several quoted Cochrane abstracts, regarding homeopathy and Laetrile, suggest that in the EBM lexicon, “evidence” and “RCTs” are almost synonymous. Yet basic science or preliminary clinical studies provide evidence sufficient to refute some health claims (e.g., homeopathy and Laetrile), particularly those emanating from the social movement known by the euphemism “CAM.”

It’s remarkable to consider just how unremarkable that last sentence ought to be. EBM’s founders understood the proper role of the rigorous clinical trial: to be the final arbiter of any claim that had already demonstrated promise by all other criteria—basic science, animal studies, legitimate case series, small controlled trials, “expert opinion,” whatever (but not inexpert opinion). EBM’s founders knew that such pieces of evidence, promising though they may be, are insufficient because they “routinely lead to false positive conclusions about efficacy.” They must have assumed, even if they felt no need to articulate it, that claims lacking such promise were not part of the discussion. Nevertheless, the obvious point was somehow lost in the subsequent formalization of EBM methods, and seems to have been entirely forgotten just when it ought to have resurfaced: during the conception of the Center for Evidence-Based Medicine’s Introduction to Evidence-Based Complementary Medicine.

Thus, in 2000, the American Heart Journal (AHJ) could publish an unchallenged editorial arguing that Na2EDTA chelation “therapy” could not be ruled out as efficacious for atherosclerotic cardiovascular disease because it hadn’t yet been subjected to any large RCTs—never mind that there had been several small ones, and abundant additional evidence from basic science, case studies, and legal documents, all demonstrating that the treatment is both useless and dangerous. The well-powered RCT had somehow been transformed, for practical purposes, from the final arbiter of efficacy to the only arbiter. If preliminary evidence was no longer to have practical consequences, why bother with it at all? This was surely an example of what Prof. Simon calls “Poorly Implemented Evidence Based Medicine,” but one that was also implemented by the very EBM experts who ought to have recognized the fallacy.

There will be more evidence for these assertions as we proceed, but the main thrust of Part II is to begin to respond to this statement from Prof. Simon: “There is some societal value in testing therapies that are in wide use, even though there is no scientifically valid reason to believe that those therapies work.”

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Posted in: Chiropractic, Clinical Trials, Energy Medicine, Health Fraud, History, Homeopathy, Medical Academia, Medical Ethics, Naturopathy, Politics and Regulation, Science and Medicine

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My NCCAM Wish List

For a number of reasons, well-argued many times here on SBM, it would be beneficial to American citizens if the National Center for Complementary and Alternative Medicine (NCCAM) were abolished. This does not seem to be in the cards anytime soon. Here, then, are my suggestions for making the Center less dangerous and less of a marketing tool for pseudomedicine than it has been since its inception. Some suggestions might even make the Center somewhat useful. They are listed in order of priority. The Center should:

1. Abandon all unethical trials, beginning with the Trial to Assess Chelation Therapy (TACT, which is under the joint auspices of the NHLBI). This should be done in a very public manner. The reasons for abandoning the TACT, in summary, are as follows.

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Posted in: Medical Ethics, 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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Update on the NIH “Trial to Assess Chelation Therapy”

A few days ago, while gathering information for last week’s post about intravenous hydrogen peroxide, I noticed this:

ACAM Supports NIH Decision to Suspend TACT Trial

September 3, 2008, Laguna Hills, Calif. — The American College for Advancement in Medicine, ACAM today announced its support for the National Institute for Health’s (NIH) decision to suspend patient accrual of the Trial to Assess Chelation Therapy (TACT) Trial until allegations of impropriety can be proven false.  ACAM believes that the TACT trial represents a important milestone in assessing the role of chelation therapy in modern healthcare and respects the decision of the NIH.

ACAM continue to work with Dr Tony Lamas to answer the unfounded allegations of impropriety.

“We believe that the Office of Human Research Protection (OHRP) will find that the allegations are of a political nature. To serve the best interests of participants enrolled in the TACT trial and all patients and their physicians who seek answers about chelation therapy, we call for a swift end to the moratorium and resumption of the trial,” said Jeanne Drisko, MD, President of ACAM.

I alerted a few others, including Stephen Barrett of Quackwatch, who queried the news room of the National Heart, Lung and Blood Institute (NHLBI: the joint sponsor, along with the NCCAM, of the trial) and got this reply:

The investigators and institutions performing the Trial to Assess Chelation Therapy (TACT), in conjunction with their Institutional Review Boards, have temporarily and voluntarily suspended enrollment of new participants in the study. NIH has not issued any announcement or press release about this action. To contact the Office for Human Research Protections’ (OHRP) press office, call Pat El-Hinnawy, (202) 253-0458.

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Posted in: Clinical Trials, Medical Ethics

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The TACT is at least as Bad as We Predicted

I had wanted to follow Dr. Sampson’s discussion of “Healing Touch” with one of my own, because I had an interesting experience with one of its proponents years ago, and I’ll do that soon. I had also wanted to begin a series of posts about acupuncture, which I’ll also do eventually. Just yesterday, however, Liz Woeckner, co-author of our recently published critique of the NIH Trial to Assess Chelation Therapy (TACT), made a startling discovery: the TACT “Portal” website, intended for investigators and others associated with the trial and previously password protected, is now available to anyone: http://www.chelationwatch.org/s/tact/index.html It is a goldmine of information and I’ve barely begun to look at it, but so far it verifies much of what we’ve written and more. For example, the latest version of the Consent Form is dated 2006 and includes this statement under “risks”:

EDTA, or ethylenediamine tetraacetate is in the chelation solution. It is approved for use by the FDA as a treatment for lead poisoning but not for coronary artery disease.

Yet three Investigator Brochures, dating back to 2003, contain this language:

Edetate disodium USP should not be confused with its calcium salt (calcium edetate), which is used to treat lead toxicity.

We had called attention, in our article, to TACT literature repeatedly conflating Na2EDTA and the safer CaNaEDTA. Now we have reason to believe that this has been done cynically, with eyes wide open.

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