Pubdate: Tue, 25 Apr 2006
Source: Los Angeles Times (CA)
Copyright: 2006 Los Angeles Times
Contact:  http://www.latimes.com/
Details: http://www.mapinc.org/media/248
Author: Shannon Brownlee
Note: SHANNON BROWNLEE is a Bernard L. Schwartz senior fellow at the 
New America Foundation.
Note: Posted to archives because of attention to FDA during the last 
week regarding marijuana.

A HEALTHY DOSE OF REALITY ON DRUG SAFETY

Publicly Funded Studies Must Replace Industry Research If Consumers 
Want Honesty.

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.
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MAP posted-by: Beth Wehrman