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You can’t beat the common cold, and that’s a fact

>> Disclaimer: nothing in this post is meant to be taken as medical advice. Always consult your own provider.

For those of us dedicated to supporting science-based medicine and fighting the ever-widening reach of sCAM, pseudoscience, and health fraud, finding a new woo-filled claim or a dangerous, evidence-lacking trend to write about is relatively easy. Many of us may not realize, however, that some of the most commonly used and recommended treatments, one of which at least is probably sitting in your medicine cabinet as you read this, is equally devoid of evidence to support its use.

Every drug store has row upon row of medicines designed to treat or prevent an acute upper respiratory tract infection, otherwise known as the common cold. Despite this, very few are able to live up to their promise. In most cases, particularly where children are concerned, the side effects of these medicines can be worse than the symptoms they are intended to treat. Because I am a pediatrician, and because the evidence for cough and cold medicines (I will refer to them here as CCMs) for children is particularly absent and because adverse events due to CCMs are most frequently seen in children, I will focus mainly on this population. (more…)

Posted in: Pharmaceuticals, 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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Bad Books

In the interests of fairness and intellectual honesty, I’ve forced myself to read a lot of really bad books. The True Believer tells me his guru’s book is the Real Stuff. He tells me I have a closed mind and won’t look at anything outside establishment dogma, and if I only read the book and understood Dr. Quack’s evidence and arguments, I would be a True Believer too. I have tried, really I have. I’ve given the Dr. Quacks every chance to convert me, and I’ve hoped to learn something new, but I’m always disappointed. I’ve come to the point that I feel like I’m reading the same book over and over: it is always a mixture of real science, pseudoscience, and speculation, based on cherry-picked evidence and argued with the same logical fallacies.

I recently got hooked into reading another one by a correspondent who had called me an “ignorant relic” for writing a “grossly ignorant article” about alternative medicine. I suggested he read R. Barker Bausell’s book Snake Oil Science and a couple of others, which he promised to do. Then he said, “If I am willing to buy three books that you have suggested and read them and you are not willing to read what I have suggested, then that pretty much says all that needs to be said.”

I was willing, even though the very title of the book suggested that its message was incompatible with the scientific evidence as I know it: How to Prevent and Treat Cancer with Natural Medicine. The authors are big names in naturopathic and herbal medicine: Michael Murray, Tim Birdsall, Joseph Pizzorno, and Paul Riley. It’s nowhere near as bad as some of the bad books I’ve read, but it is a good example of the genre and I’ll use it to illustrate why I call them bad.

It offers “an arsenal of disease-fighting tools for prevention, treatment, and coping with side effects” (Yes, it offers tools; but do those tools work?) And it promises to “change your internal environment so cancer can’t survive.” (Wow! If it could really do that, every oncologist in the world would enthusiastically adopt these methods and the authors would be eligible for a Nobel prize.)
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Posted in: Book & movie reviews, Herbs & Supplements, Science and Medicine

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Not Treating – A Neglected Option

One of the criticisms of modern medicine is that doctors prescribe too many pills. That’s true. Patients and doctors sometimes get caught up in a mutual misunderstanding. The patient assumes that he needs a prescription, and the doctor assumes that the patient wants a prescription. But sometimes patients don’t either need or want a prescription.

I’ll use myself as an illustration. I get occasional episodes of funny, blurry spots in my visual field that gradually expand to a sparkling zigzag pattern and go away after 20 minutes. They are typical scintillating scotomas, the aura that precedes some migraines. I am lucky because I never get the headache. My doctor said we could try to prevent my symptoms with the same medications we use to prevent migraine, but there was no need to treat them from a medical standpoint. Nothing bad would happen if we didn’t treat. I told her I didn’t want them treated. They are a minor annoyance; I can carry on with my normal activities, even reading, throughout the episodes, and I have no desire to take pills with potential side effects and with the cost and the hassle of remembering when to take them.

If it had been a typical patient and a typical doctor, the sequence of events might have been very different. The patient might have been more frightened by the strange phenomenon than I was. (I thought the weird tricks my brain could play on me were fascinating and fun to watch, not scary.) The patient might have desperately wanted those threatening symptoms to go away without understanding how insignificant and non-threatening they really were. The doctor might have assumed the patient wanted them to go away. The pills might have been offered and accepted with little thought. (more…)

Posted in: Science and Medicine

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