A healthy dose of reality on drug safety

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SHANNON BROWNLEE is a Bernard L. Schwartz senior fellow at the New America Foundation.

ONLY 9% OF American adults think the pharmaceutical industry is trustworthy, according to a recent Harris poll. That means that the makers of lifesaving and life-enhancing drugs rank just above tobacco companies in the public’s esteem.

How could this happen? Easily. Despite efforts to reform the Food and Drug Administration after its scandalous failures to police drug-safety standards in the cases of Vioxx and other dangerous drugs, the FDA still does not have clear safety policies and can be too slow in responding to danger signals, according to a report released Monday by the Government Accountability Office.

The GAO report comes on the heels of other indications that medical knowledge itself is being corrupted by self-interested or faulty research conducted by or for industry. Although the headlines target drug companies, a larger danger is hidden from view: American taxpayers no longer are funding the majority of clinical research. With two-thirds of clinical trials and three-quarters of the papers published in the top medical journals commercially funded, the drug industry has gained unprecedented leverage over what doctors and patients know -- and don’t know -- about drugs.


The recent case of drugs known as atypical antipsychotics is instructive. These new and expensive drugs, with sales of about $10 billion annually, are used to treat serious mental illnesses such as schizophrenia. Earlier this year, the American Journal of Psychiatry published an analysis of 30 separate trials involving head-to-head comparisons of five drugs. Nine out of 10 times, the drug made by the company that funded the study came out on top. When Eli Lilly, the maker of Zyprexa, funded five studies of its drug, Zyprexa was found superior in all five. But when Janssen, the maker of Risperdal, ran its studies, Risperdal came out ahead.

Researchers scoff at the notion that that their scientific integrity is for sale. Certainly most researchers aren’t corrupt, but their institutions are guilty of allowing the drug industry to manipulate medical science.

Meanwhile, industry-funded research is failing to provide the clinically useful answers physicians and patients need in order to pick the best treatment. Which drug is right for which patient? What are the risks? Are the added benefits of a new, expensive drug worth the cost? If not, should insurance companies and Medicare be paying for them?

If we want answers to such questions, the public is going to have to start paying for them. Earlier this year, a $44-million National Institutes of Health study found that drug makers’ claims notwithstanding, not one of the five newer antipsychotic drugs offered any meaningful improvement over an older drug that cost up to 10 times less.

But the study looked at only one category of drug. If we want high-quality medical care, dozens of other drugs -- as well as medical devices and non-drug treatments -- should be subjected to the same noncommercial scrutiny.

Because the FDA has been flunking, the NIH might seem like the most obvious agency to fund such studies, but it isn’t set up to do the job. The institutes spend only a tiny fraction of their $30-billion annual budget on clinical research, and they have historically focused on basic science, not on studying the safety and effectiveness of drugs.


What’s needed is a new Institute for Effective Medicine, which would need to be modeled on the Federal Reserve Board or the Securities and Exchange Commission to protect it from political pressure. Its mission would be threefold. It would serve as a new, independent source of research dollars for medicine. It would provide independent evaluation of data generated by industry. And it would oversee the creation of clinical practice guidelines, a manual of proven “best practices” for physicians devised entirely without industry influence.

If insurance companies and the federal government set aside just one-half of 1% of their current annual spending on prescription drugs, they could endow a new institute with roughly half-a-billion dollars. Doctors, employers and insurers all have a stake in this -- but not as much as patients do. Americans spend a staggering $200 billion a year on prescription drugs, and that figure is going up about 12% annually, faster than any other healthcare cost. With studies like the NIH’s, physicians could prescribe on the basis of solid science, while private insurers and Medicare would have the data they need to rein in costs without sacrificing healthcare quality.

Congress may be reluctant to fund a new agency -- particularly one the drug industry may hate-- but an Institute for Effective Medicine would be worth its freight in better healthcare and lower costs.