Clinical Trials Control
This is my site Written by Alex on March 25, 2009 – 11:26 am   

Clinical trials are out of control. Years of unprecedented growth and regulatory neglect have left whatever piecemeal system that was in place to safely conduct, report, regulate, litigate, and manage clinical trials fractured, out dated, and broken. It’s gotten so bad that clinical trials may actually pose health risks to people in the United States and around the world. If this sounds alarmist, consider some events involving clinical trials that have taken place in only the past two months:

Drug maker AstraZeneca is accused of knowingly withholding negative findings from clinical trials for the anti-anxiety drug Seroquel showing it caused weight gain and diabetes in some patients.

Pfizer, meanwhile, announced that it is close to settling a lawsuit from 1996 when it was sued for $2.75 billion after a clinical trial in Nigeria for the meningitis drug Trovan allegedly left 11 children dead and 189 others deformed or handicapped.

The American Medical Association and the American College of Physicians says it is unethical for sponsors of clinical trials to pay doctors “finder’s fees” ranging from $2,000 to $10,000 per subject for recruiting patients as clinical research subjects. The AMA report faults internal oversight committees for typically not having written rules to address such a clear conflict of interest, especially when physicians are paid to recruit their own patients into trials. The AMA meanwhile, does not have a policy that forbids doctors from receiving compensation – what some call a “bounty” – for delivering clinical trials subjects to researchers.

Also last month, the United States Attorney’s office in Boston charged pharmaceutical company Forest Laboratories with defrauding the government of millions of dollars by promoting the antidepressants Celexa and Lexapro for unapproved use in children and teenagers even after clinical trials showed the drugs were not effective in those populations. The Justice Department alleges that from 2001 to 2004 the company touted the results of one clinical trial showing the drugs were effective while withholding the results of another study showing the drugs didn’t work.

For sponsors of clinical trials, publishing the results of a clinical trial that is favorable to their new drug, device, or treatment while not releasing the results of a study that is negative to their interests is not an uncommon practice. That’s because there is no law stipulating that the results of clinical trials must be published. That means sponsors can cherry pick results from studies that they want released and shove the rest in a drawer. And the drawer is getting pretty full. A recent article in the journal The Oncologist, says results of up to 90% of cancer clinical trials published in peer-reviewed medical journals are positive to the goals of the sponsor. Compare that to the fact that only 20% of all trials’ results are ever published and it means there is a huge store of negative results not becoming public.

Many criticize the Food and Drug Administration for letting such practices flourish, saying that the agency is lax in overseeing clinical trials. The FDA inspected just one percent of the 350,000 trials conducted over a recent five-year period. But that’s only a small part of the story. The FDA is at pains to even keep pace with the astonishing growth of clinical trials. The number of clinical trials has tripled in the last decade. There are 20 million people in the United States enrolled in clinical trials. They are a $24 billion-a-year industry. The majority of trials are now carried out by private companies and not by public research institutions. The boom, coupled with increased privatization of research, has effectively outstripped the physical capability of FDA inspectors to closely monitor studies.

Meanwhile, medical associations, industry groups, institutional review boards, and others charged with safeguarding the integrity of research and protecting subject safety are proving to be inconsistently effective in fulfilling their missions. Even the last bastion of redress, the legal system falters in holding sponsors accountable. Cases involving clinical trials fall through the cracks because they are tried under medical malpractice standards. And clinical trials, despite what a doctor might tell a patient, are not medical treatment. They are research.

Are clinical trials safe? How safe are they? Are they more or less safe than they were a decade ago? Twenty years ago? Has increased privatization of medical research improved clinical trials procedures and results? If so, to what degree has it? The truth is, no one knows for certain. It is long overdue that the answers to these and many other basic questions about testing drugs, devices, and treatments on human beings became common knowledge.

Getting some measure of control over clinical trials should be included in the discussions about overhauling health care. Among the many options for achieving this is to establish a special and temporary office of federal clinical trials oversight, independent of the FDA and industry, to shed light on current and past clinical trials practices. If, after a careful examination, a “clinical trials czar” recommends reforms then the most important ones should be instituted not as guidelines but as laws. Laws will finally provide subjects with a tool (beside long, drawn out civil actions) to hold researchers and sponsors of clinical trials accountable for their actions and their inaction.

Another option, of course, is to let clinical trials continue to grow and operate without comprehensive and close examination until the number of people killed or harmed gets too large to ignore. By that time things will really be out of control. 

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