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.