September 28, 2007

FDA Doesn't Police Clinical Trials, Many Shady -- NYTimes

Today's New York Times reports on the study of regulation of clinical trials by the F.D. A. conducted by the inspector general of the Department of Health and Human Services, Daniel R. Levinson. His report said that federal health officials did not know how many clinical trials were being conducted, audited fewer than 1 percent of the testing sites and, on the rare occasions when inspectors did appear, generally showed up long after the tests had been completed.

Report Assails F.D.A. Oversight of Clinical Trials

The article goes on to cite examples of clinical trails being run by marginal criminal characters, like a psychiatrist about whom they write,"Last November, the Oklahoma Board of Medical Licensure and Supervision suspended Dr. Linden’s license for three months because he had sex with two patients and gave them genital herpes infections." [This is NOT the first New York Times report of drug companies doing business with doctors who have been disciplined for serious ethical violations .]

The most telling statement in the report is this one:

" 'In many ways, rats and mice get greater protection as research subjects in the United States than do humans,” said Arthur L. Caplan, chairman of the department of medical ethics at the University of Pennsylvania.

"Animal research centers have to register with the federal government, keep track of subject numbers, have unannounced spot inspections and address problems speedily or risk closing, none of which is true in human research, Mr. Caplan said.

Many so-called "clinical trials" are run by questionable clinical trial mills, after the drug has been approved for use. They have with one goal, and one goal only: to make it possible for the sponsoring drug company to expand the uses for its drug.

These trials are likely to be poorly supervised and often throw out any data that doesn't prove the result they set out to get. When doctors participate in these trials--which many do--they are paid hundreds of dollars--sometimes thousands--per participant. This is NEVER disclosed to the patients they enroll who may be given the impression that the doctor is prescribing the drug or device under study because it will improve their health--though often there is no evidence for this at all.

Trials run as part of drug company marketing efforts and conducted by by for profit clinical trial mills earn huge amounts of money for these clinical trail mills. Since it is very difficult to recover damages no matter how badly the participant is hurt, thanks to the legal disclaimers participants sign, there is no motivation to protect the people taking the drugs.

Why does this matter to you, a person with diabetes? Because people with diabetes are a huge market for expensive, dangerous new drugs, so you are very likely to run into a doctor who wants you to sign up for such a trial.

You'll also notice a lot of Google Ads displayed on Diabetes-related sites are trying to recruit you to participate in clinical studies. There is rarely any identifying information when you click through as to WHO is conducting the study. Unless the trial clearly identifies who is running the trial, and it is a major, well respected, well known medical organization like Joslin Medical Center or Rockefellar University, with a track record in diabetes or obesity research, you'd be well advised to ignore it.

Finally, be aware that drug companies often sponsor "clinical trials" of drugs already on the market where the purpose of the "study" is only to sign up hundreds of thousands of new patients to take their expensive new drug, with the idea being that once they are on it for a couple months, they will stay on it forever. Often these kinds of trials never result in any publication of any result, because no true study is being done. This kind of study is also common with medical devices. It's a technique companies use to lure you away from their competitors.

Before you participate in any clinical trial, get answers to the following questions in writing.

1. What are the known dangers of the drug, including all side effects? All drugs have serious side effects and if you are told, NONE it either means you are being lied to or the drug is so little understood that the purpose of the trial is to find out what dangerous side effects it causes.

2. What restitution will the testing company make if you suffer a serious side effect or see your health deteriorate as a result of taking the drug under study? Prepare to hear some major weasel wording here.

3. If your doctor "invites" you into a study for a new drug or device, ask the doctor how much they are being paid, per patient, to recruit people into the study? This is not an insult to your doctor. Doctors ARE paid for recruiting subjects. They should disclose this to the people they are profiting on. Ask the doctor what hard evidence he or she has seen that this drug will be good for you. Don't trust your doctor to know about side effects. Recent research shows that most doctors are unfamiliar with even the most dangerous side effects of commonly prescribed drugs. Google the drug using its generic name until you find out what is known about it. Then bring what you find to your doctor's attention.

4. Google the testing company on Google Scholar to see whether studies done by this clinical trial company ever turn into research papers and if they do, what the quality of the publications is that publishes them. Some supposed medical journals are marginal publications that verge on being Vanity Press offerings where anyone can publish if they pay enough. If you don't see the studies performed by the testing organization reported in top medical journals like New England Journal of Medicine, and Journal of the American Medical Association, be wary. The "clinical trial" may have one purpose only--drug marketing, and these are the kinds of trials where you are the most likely to be hurt.

5.If the drug or device involved is already on the market, research it carefully and be aware that the study may well be only an attempt to convert you from using a cheaper alternative. If the trial involves a psychiatric drug, like an antidepressant, be twice as careful. Many of these drugs are claimed to be non-addictive, but people who have tried to stop taking them report this is far from the case. Once you have been "habituated" to a powerful psychiatric drug [the euphemism now used in place of "addicted" though it means the same thing in practice], you may experience severe withdrawal symptoms if you go off it.


Scott S said...

Pseudo science is widespread in the U.S., and there is not sufficient oversight. Unfortunately, Congress just passed, and President Bush just signed a bill that will continue the practice of having the drug companies fund a majority of the FDA's budget, then we wonder why the oversight isn't as good as it used to be. When this was implemented in 1993 or so, it was supposed to be a temporary way to cover the agency's budget without increasing taxes that the GOP had just worked to cut. But today, the FDA is no longer funded by taxpayers, its funded by fees collected from drug companies. This is really a dysfunctional system!

Anna said...

This is where a glucose meter can be invaluable. If we just rely on counting carbs from labels, then we have no way of seeing what really is happening after consumption. But a meter could potentially alert an suspecting label reader to a discrepancy in the listed carb count if an unusual glucose result shows up.