Is the Food and Drug Administration violating its own mandate to approve safe drugs? That was the question that Donald Light, co-author of The Risk for Prescription Drugs and a long-time medical sociologist, posed at a talk yesterday at Brandeis University. The answer, he concluded, is an unequivocal yes. By allowing drug companies to retain control over clinical trials and test new drugs against a placebo (a sugar pill) rather than an existing (and usually cheaper) drug in too-short studies that are designed to overlook or hide adverse side effects, the FDA is in essence approving drugs without really knowing whether they are safe or effective.

“We’re producing biased medical information in a system that makes it impossible to know what the real story is,” Light said. As a result, “most drugs are approved without clear evidence of clinical safety or effectiveness.”

As an example, Light pointed to the story of the SSRI antidepressants (which I chronicled in Side Effects). A number of recent studies, which combined unpublished data with the published data, show that these second-generation antidepressants are not very effective in treating most depression — see more here. “After 25 years, we get a fairly clear picture of efficacy of SSRIs,” he said. “But why do we have to wait 25 years?”

Not only are many patients harmed by this system — in the case of SSRIs like Prozac, Zoloft, Paxil and Celexa, many children and adults killed themselves because the drug companies hid a dangerous side effect of these drugs: they caused an increased risk of suicidal thoughts and behaviors in some people.  In addition, most of the drugs that are approved by the FDA and other regulatory agencies are minor variations on existing drugs and not the kind of breakthroughs that the public expects from an industry that is routinely given tax breaks, years of patent exclusivity and other privileges.

Light cited a study by French researchers, who analyzed new drug products from 2002 to 2011 and found that only 7.6 percent of the new drugs approved in the last decade were either significant clinical advances or had some therapeutic benefits. The vast majority of new drugs in the past decade had either minimum value, no added value or were actually worse — in terms of efficacy — than existing drugs.

“This isn’t really what the public wants,” Light said. This research shows that “most drug company R&D is devoted to filling the pipeline with minor variations because they’re easier to develop, cheaper and they can command high prices.”

These minor variations (what I and others call me-too drugs) are then marketed heavily to doctors, who, as Light says, seem “surprisingly willing to prescribe them.”  Indeed, Light has found that 80 percent of drug companies’ marketing budget goes to promote the me-too drugs and only 20 percent is spent to promote therapeutically superior drugs.

“I call it the inverse benefit law,” Light said. “The more widely the drugs are marketed, the more diluted their benefits are, but the more widespread the risk of harm.”

Light urged a number of reforms to address this systematic problem:

  • Have Congress pass a law requiring public funding of clinical trials so they are not controlled by drug companies that have a vested interest in ensuring positive outcomes — I’ve blogged about this here. According to Light, there is increasing talk in Europe of publicly funding clinical trials. The Netherlands has already announced plans of having independent researchers test every drug against an existing drug (instead of placebo) to ensure that regulators approve drugs that are truly effective, not just better than a sugar pill.
  • Delink drug prices from the current system of R&D. A recently introduced bill by Sen. Bernard Sanders (D-Vermont) would reward innovators who come up with a superior drug with a large cash prize — say, $2 to 3 billion paid out over a decade. With such rewards, the drug companies wouldn’t get years of patent exclusivity and generic price competition could kick in almost immediately. That would eliminate what Light calls “extortionist prices” for most new drugs.
  • Make it illegal to prescribe drugs for unapproved or off-label uses. Physicians have long been allowed to prescribe any drug for any use, but Light questions why this is permitted, since so many patients are harmed by drugs that have not been tested for their particular condition or demographic.

Light acknowledged that such reforms are a tall order because the Republican-controlled Congress doesn’t seem to be particularly interested in biting the hand that feeds it (the pharmaceutical industry is one of top special interests when it comes to Congressional campaign contributions and lobbying — see here). And it’s not just Republicans. The Democratic-controlled legislature in Massachusetts is also busy sucking up to the deep-pocketed drug and medical device industry. As Pharmalot reported today, the Massachusetts House is trying yet again to overturn the state’s landmark ban on gifts to doctors.

All of this is one more reason why this election year is so important. Consumers who are concerned about the way unsafe and inadequately tested drugs routinely get approved by the FDA should vote out any politician who is taking loads of money from the drug and medical device industry and rally for campaign reform so we can actually start improving the system. A tall order, yes. Impossible, no.








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