July 3rd, 2009 by Dr. Val Jones in Quackery Exposed
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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.
February 10th, 2009 by Dr. Val Jones in Health Policy, Medblogger Shout Outs, Opinion
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Dr. Rob Lamberts does an admirable job explaining why physicians are worried about the Recovery Audit Contractor (RAC) approach to identifying Medicare fraud. Complying with Medicare coding and billing rules is so difficult that physicians regularly resort to undercharging for their services, just to avoid the perception of fraudulent practices. Any medical practice that bills more than average is potentially subject to RAC audit, and the auditors themselves are paid a commission for finding “fraud.” In many cases, the “fraud” amounts to insufficient documentation of appropriate and necessary work performed by the physician.
Dr. Rob writes:
The complexity of E/M coding makes it almost 100% likely that any given physician will have billing not consistent with documentation. Those who chronically undercoded (if they are still in business) are at less risk than those who coded properly. Every patient encounter requires that physicians go through an incredibly complex set of requirements to be paid, and physicians like myself have improved our coding level through the use of an EMR. This doesn’t necessarily imply we are over-documenting, it simply allows us to do the incredibly arduous task of complying with the rules necessary to be paid appropriately.
Have I ever willingly committed fraud? No.
Am I confident that I have complied with the nightmarish paperwork necessary to appropriately bill all of my visits? No way.
Am I scared? You bet. The RAC will find anything wrong with my coding that they can – they are paid more if they do.
Dr. James Hubbard writes:
It would be fine if they were truly looking for fraud and abuse, but they look for some technicality or just a different interpretation. Forget about any recourse. A few years ago, I was asked to pay Medicaid back $5000. I protested they were completely wrong with their interpretation of their findings. The auditors said I had to pay it, but could argue for a refund by sending forms and proof to the “review committee”. I did that and received a reply that the $5000 was too small for the review committee to take up. I stopped taking Medicaid.
Sounds like the Spanish Inquisition, doesn’t it?
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For more excellent analysis of the subject, I strongly recommend Dr. Rich Fogoros’ recent book: Fixing American Healthcare.
November 1st, 2008 by Dr. Val Jones in Announcements, Medblogger Shout Outs
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Regular readers of my blog will know that health fraud, misleading product and treatment claims, and deception of vulnerable populations (snake oil for cancer patients, for example) really get under my skin. For this reason, I’ve teamed up with a group of scientists and physicians to create a blog devoted to medical accuracy, transparency, and integrity in health reporting. It’s called Science Based Medicine, and we offer daily exposés of misleading health claims and practices. It’s a great way to learn about how to think critically – and to apply a scientific approach (rather than subjective and anecdotal) to discerning truth from error.
My contribution to the blogging team is to highlight online health fraud, scams, deception and misguided attempts to help consumers “live healthier lives.” I post once a week, every Thursday morning. Please head on over and check it out. It’s a great team of bloggers – and they’re looking out for you!
Here is a list of my recent posts:
A Shruggie Awakening: One Physician’s Journey Toward Scientific Enlightenment
Disintegrating Integrative Medicine: Lessons From Baking
When Further Research Is Not Warranted: The Wisdom of Crowds Fallacy
Knowledge Vs. Expertise: The View From Consumer Land
February 7th, 2008 by Dr. Val Jones in True Stories
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This (hat tip to KevinMD) is one of the worst cases of attempted personal injury fraud that I’ve heard of:
It was a very busy weekend afternoon in the ED when a city bus accident occurred. What a disaster. Rarely is anyone really injured but everyone on board almost always winds up coming into the ED. The city encourages it so things can be documented and people are like “Cha-Ching!”, lawsuit! So, this particular time, about 5 people were brought in on back boards (we were lucky to get so few!) As the 3rd year resident started interviewing them one at a time (since all were stable and ambulatory (walking) at the scene), one of the patients said, “Hey Doc, that guy over there was not even on the bus at the time of the accident! He jumped on board afterwards and started complaining of back and neck pain!” The resident could have gone over and confronted him angrily (who would blame him) but instead chose a different approach. He calmly went through all the other backboarded patients, clearing them all clinically out of their cervical collars. He simply ignored the man suffering from “Allstate-itis”. The funny thing is that 2 hours went by and everyone just ignored him (although I think he was triaged at some point – damn EMTALA). All manner of stuff was going on around him. His stretcher was parked right next to the nursing station yet it was like he did not exist! Finally, the guy called the resident over and said, “Hey Doc, isn’t someone going to check me out and do x-rays?” He replied, “Well, you weren’t even on the bus so in my mind, you are already checked out!” Knowing the jig was up, the man sat up, took his C-collar off, and left the ER. I guess he was thinking, “Oh well, maybe next time I’ll hit the jackpot!”
This post originally appeared on Dr. Val’s blog at RevolutionHealth.com.
February 5th, 2008 by Dr. Val Jones in Quackery Exposed
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So my last post stimulated some interesting discussion amongst friends and colleagues. Some applauded the late night supplement “smack down,” and others felt it was too harsh. Still others who don’t read my blog regularly complained that it was unfair to pick on the supplement industry without also pointing out the flaws of Big Pharma. Well, here’s to equal opportunity smack downs – where things “applied directly to the forehead” are as fair game as anti-psychotics, IT mishaps, healthcare professional SNAFUs, and misguided policies resulting in unanticipated harm to patients.
But let’s not forget the happy stories, the unlikely triumphs, and the snatching of victory from the jaws of defeat. We can laugh at ourselves, cry with our friends, and mourn the loss of the lonely. Medicine is full of a broad array of emotions and perspectives, captured here for you in this blog.
And now, back to bunnies and puppies…This post originally appeared on Dr. Val’s blog at RevolutionHealth.com.
