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It’s a part of my paleo fantasy, it’s a part of my paleo dream

There are many fallacies that undergird alternative medicine, which evolved into “complementary and alternative medicine” (CAM), and for which the preferred term among its advocates is now “integrative medicine,” meant to imply the “best of both worlds.” If I had to pick one fallacy that rules above all among proponents of CAM/IM, it would have to be either the naturalistic fallacy (i.e., that if it’s natural—whatever that means—it must be better) or the fallacy of antiquity (i.e., that if it’s really old, it must be better). Of course, the two fallacies are not unrelated. In the minds of CAM proponents, old is more likely to have been based on nature, and the naturalistic fallacy often correlates with the fallacy of antiquity. Basically, it’s a rejection of modernity, and from it flow the interest in herbalism, various religious practices rebranded as treatments (thousands of years ago, medicine was religion and religion was medicine—the two were more or less one and physicians were often priests as well), and the all-consuming fear of “toxins,” in which it is thought that the products of modernity are poisoning us.

Yes, there is a definite belief underlying much of CAM that technology and pharmaceuticals are automatically bad and that “natural” must be better. Flowing from that belief is the belief that people were happier and much healthier in the preindustrial, preagricultural past, that cardiovascular disease was rare or nonexistent, and that cancer was seldom heard of. Of course, it’s hard not to note that cancer and heart disease are primarily diseases of aging, and life expectancy was so much lower back in the day that a much smaller percentage of the population lived to advanced ages than is the case today. Even so, an implicit assumption among many CAM advocates is that cardiovascular disease is largely a disease of modern lifestyle and diet and that, if modern humans could somehow mimic preindustrial or, according to some, even preagricultural, lifestyles, that cardiovascular disease could be avoided. Not infrequently, evolutionary and genomic arguments are invoked, claiming that the estimated 10,000 years since the dawn of human agriculture is not a sufficiently long period of time for us to have evolved to handle diets rich in grains and meats and that we are “genetically wired” to exist on a diet like those of our paleolithic hunter-gatherer ancestors. For instance, in 2004, James H. O’Keefe Jr, MD and Loren Cordain, PhD wrote an article in the Mayo Proceedings entitled Cardiovascular Disease Resulting From a Diet and Lifestyle at Odds With Our Paleolithic Genome: How to Become a 21st-Century Hunter-Gatherer that asserted in essence, just that. Over the last decade, Cordain has become the most prominent promoter of the so-called “Paleo diet,” having written The Paleo Diet: Lose Weight and Get Healthy by Eating the Foods You Were Designed to Eat and multiple other books advocating a paleolithic-mimetic diet as the cure for what ails modern humans. Meanwhile, diets thought to reflect what our hunter-gatherer ancestors ate, such as the Paleo Diet consisting largely of animal and fish that can be hunted and fruits and vegetables that can be foraged for in the wild, have been promoted as a near-panacea for the chronic diseases of aging, such as cardiovascular disease and cancer.

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Posted in: Evolution, History, Nutrition

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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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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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