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When doctors betray their patients and science-based medicine for money

We spend a lot of time on this blog discussing failures of the medical system. Usually, we such discussions occur in the context of how unscientific practices and even outright quackery have managed to infiltrate what should be science-based medicine (SBM) in the form of so-called “complementary and alternative medicine” (CAM) or “integrative medicine,” in which the quackery of alternative medicine is “integrated” with SBM. Our attitude towards this practice is, of course, completely in tune with that of fellow SBM blogger Mark Crislip when he so famously wrote, “If you integrate fantasy with reality, you do not instantiate reality. If you mix cow pie with apple pie, it does not make the cow pie taste better; it makes the apple pie worse.” However, as grave a threat to SBM as CAM and integrative medicine are, there is a threat at least as grave here in the U.S. (and, I presume, in many places in the world). It has little or nothing to do directly with CAM, but often CAM practitioners benefit from it. What I am referring to is the utter ineffectiveness of most state medical boards in reining in quackery and bad physician behavior that endangers patients. A recent story about a prominent Detroit area oncologist named Farid Fata, MD, who has been arrested and charged with administering unnecessary chemotherapy and of diagnosing patients with cancer who turned out not to have cancer in order to defraud Medicare, has led me to think that now might be a good time to revisit this issue. Then I heard about an Ohio spine surgeon indicted for performing unnecessary surgeries to defraud insurance companies, and I knew that now is a good time to revisit the issue.

I’ve discussed this issue before with respect to various practitioners over the years. One that comes to mind immediately is Dr. Rolando Arafiles at the Winkler County Memorial Hospital in Kermit, TX. Basically, a CAM-friendly physician was practicing substandard medicine, and two nurses reported him anonymously to the Texas Medical Board. Dr. Arafiles was a business partner with Winkler County Sheriff Robert Roberts, who left no stone unturned to discover who had complained about his good buddy, leading to the prosecution of the two whistleblowing nurses for violation of patient privacy, even though Texas law explicitly said that using patient information to report substandard care is not a violation of patient privacy. The entire medical establishment seemed to be trying to come down on the two brave nurses like the proverbial ton of bricks. Ultimately, the Texas Medical Board did the right thing, but it took a long time, and two responsible nurses who couldn’t bear seeing Dr. Arafiles continue to betray patient trust. There are many other examples, such as that of Dr. Rashid Buttar, a North Carolina doctor known for using “alternative” treatments for autism and cancer who got off with a slap on the wrist for some truly horrendous violations of the standard of care.

And don’t even get me started on the utter failure of the Texas Medical Board to put a stop to Dr. Stanislaw Burzynski’s unethical abuse of clinical trials and use of an unproven cancer drug for over 36 years or on how it took decades to finally put a stop to Dr. Mark Geier’s autism quackery in the United States. So what about these recent cases have in common? It’s that they were both busted by the feds. The relevant state medical boards in Michigan and Ohio (both states in which I hold a medical license) did not detect the medical misadventures and did, as far as I can tell, basically nothing to stop it.
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Posted in: Health Fraud, Politics and Regulation

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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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Antivaccine hero Andrew Wakefield: Scientific fraud?

Pity poor Andrew Wakefield.

Actually, on second thought, Wakefield deserves no pity at all. After all, he is the man who almost single-handedly launched the scare over the MMR vaccine in Britain when he published his infamous Lancet paper in 1998 in which he claimed to have linked the MMR vaccine to regressive autism and inflammation of the colon, a study that was followed up four years later with a paper that claimed to have found the strain of attenuated measles virus in the MMR in the colons of autistic children by polymerase chain reaction (PCR). It would be one thing if these studies were sound science. If that were the case, then Wakefield’s work would have been very important and would have correctly cast doubt on the safety of the MMR. Unfortunately, they were not, and, indeed, most of the authors of the 1998 Lancet paper later withdrew their names from it.

Over the next decade, aided and abetted by useful idiots in the media, by British newspapers and other media that sensationalized the story, and the antivaccine movement, which hailed Wakefield as a hero, Wakefield managed to drive MMR vaccination rates in the U.K. below the level of herd immunity, from 93% to 75% (and as low as 50% in some parts of London). As a result Wakefield has been frequently sarcastically “thanked” for his leadership role in bringing the measles back to the U.K. to the point where, fourteen years after measles had been declared under control in the U.K., it was in 2008 declared endemic again.

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Posted in: Science and the Media, Vaccines

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