Healthy Skepticism Library item: 160

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: news

Goozner M.
Op-Ed Contributor: Overdosed and Oversold
New York Times 2004 Dec 21

Full text:

IN the early 1960’s, Congressional hearings on skyrocketing drug prices went nowhere. But the political logjam was broken when a eagle-eyed doctor at the Food and Drug Administration averted a potential disaster by advising the agency not to let thalidomide into the United States market.

While the final legislation back then had little to do with prices or safety, the new law ushered in efficacy testing and led to the withdrawal of hundreds of drugs of no medical benefit from the market.

Once again, an agency badly in need of reform faces growing popular outrage over drug safety. The F.D.A.‘s failure to spot the warning signs that popular painkillers like Pfizer’s Celebrex or Merck’s Vioxx increased the risk of heart attacks, or its failure to warn doctors and parents about the risk of suicide among children taking antidepressants, has resulted in bipartisan anger on Capitol Hill. Prominent voices have joined the call for an independent drug safety board.

But reform at the F.D.A. needs to go much further if it is to once again become the gold standard of medical oversight not just for consumers but for providers and insurers. Only an updated regulatory system can provide them with the information they need to come up with the right answers.

People confront dizzying choices in health care every day: are brand-name drugs better than generic versions? What are the real costs and benefits of a medical intervention? How serious are the side effects of a drug and how do its benefits compare to, say, losing 30 pounds or going for 10 sessions of therapy? Does an expensive new imaging system or test really provide doctors with critical information?

To make rational choices, doctors and consumers need the F.D.A. and other agencies to be independent arbiters of not just the safety and efficacy of new drugs and devices, but of their relative medical usefulness and economic viability. Moreover, the medical oversight system needs a new ethic – one that scrupulously adheres to a standard that says its studies and decisions have been made entirely free of commercial bias and conflicts of interest.

Sadly, that is very far from the situation today. Drug and device companies sponsor most clinical trials; F.D.A. advisory panels are larded with scientists tied to private companies; corporate user fees help finance the F.D.A. that is conducting reviews; doctors get most of their medical information either from sales representatives of drug companies or corporate-sponsored continuing medical education; and the companies are given primary responsibility for post-marketing safety surveillance of their own products.

To break these ties, there needs to be an independent arm of F.D.A. that contracts with independent clinicians and scientists for the final testing of all new drugs and medical devices. After a company submits its drug application based on safety and early efficacy trials, this arm would design the protocols to learn not just if the new drug is effective versus a placebo, but how it compares to other therapies and how it can be most effectively used. At the same time, the F.D.A. agency would need an adequately financed post-marketing system that would follow through on a drug’s safety, using information and financing independent of the drug manufacturers. It should also reimpose the pre-1997 restrictions on direct advertising to consumers, one of the elements that led to vast popularity of Celebrex and Vioxx among arthritis patients.

Congress should also set up an independent agency for conducting comparative trials for thousands of existing therapies. This new center, perhaps housed at the National Institutes of Health, would also evaluate the cost-effectiveness of new technologies and finance the work of scientists who want to test older, off-patent medicines for new uses. And it could oversee the creation and updating of clinical practice guidelines free from commercial sponsorship so that hospitals and doctors can base their decisions on objective evidence.

This new center could also be the data bank for registration of all clinical trials, whether conducted by the public or private sector. This should include the trials’ initial goals, the final results and reasons for stopping the trial if that occurred.

The medical profession also has to play a role. It should adopt strict ethics rules that limit the access of drug representatives to doctors’ offices, and ban the growing practice by medical institutions of accepting donations from drug makers for continuing-education courses.

Unless the entire oversight system is overhauled, there will be many more fiascos in which risks or long-term side effects are played down or ignored, as they were with Celebrex and Vioxx. Not until the system of medical approval and information is returned to objective hands will doctors and consumers be able to make the wisest and most cost-effective medical choices.

Merrill Goozner, director of the Integrity in Science project at the Center for Science in the Public Interest, is the author of “The $800 Million Pill: The Truth Behind the Cost of New Drugs.”