Pills' profits cloud safety

By A TIMES EDITORIAL
Published July 9, 2007

A medical research company named PPD Inc. is running a clinical trial on a new drug for chronic sinusitis. If the study shows the drug to be safe and effective, its maker, Accentia BioPharmaceuticals of Tampa, will make lots of money. So will a major investor in Accentia - none other than PPD Inc.

Yes, after getting the financial backing of PPD to help bring the drug, called SinuNase, to market, Accentia then hired PPD to do the required testing. If the drug wins approval, PPD stands to get at least 7 percent of the royalties - possibly in the tens of millions of dollars.

If that sounds like a conflict of interest to you, then you probably don't work for the Food and Drug Administration, which has the final word on new drugs. Both the pharmaceutical industry and the FDA rely on "contract research organizations" (or CROs) such as PPD to do the necessary research. As for the fact that PPD has a hefty financial stake in the outcome, the FDA doesn't care. Quite the contrary.

"We assume CROs have a financial interest in the compounds they're testing, " Dr. David LePay, FDA senior adviser for clinical science, told St. Petersburg Times staff writer Kris Hundley.

Indeed, this is far from the only instance in which a CRO has a significant investment in the outcome of a clinical trial it's running, Hundley reported. PPD has four such arrangements with drug companies, and its chief rival, Quintiles Transnational Corp., has several deals in which it exchanges its services for royalties.

Dr. Francis O'Donnell, Accentia's chief executive, dismisses any concerns about the practice. "There are enough checks and balances built into the system, " he said.

Others aren't so sure. "The problem is that drug companies have inordinate influence over the evaluation of their own products, " said Dr. Marcia Angell, an author and senior lecturer at Harvard Medical School. "That, on the face of it, doesn't make sense."

All of which brings us back to the key player in this apparent conflict of interest: the FDA. In a recent article in FDA Consumer magazine, the agency noted that "even with a rigorous evaluation process, some safety problems surface only after a drug is used in the wider population."

It's ludicrous to call a clinical trial run by a self-interested party "rigorous." And maybe fewer safety problems would arise after a drug is approved if the FDA took a more active role in the process.

Drug companies used to oversee clinical trials themselves, a dubious enough practice, but increasingly have turned to CROs to speed things up. Even with no financial stake in the outcome, a CRO that too often finds risks in a new drug it is testing isn't likely to get repeat business.

There has to be a better way when lives are at stake. While CROs have developed the expertise to run clinical trials, they should be kept at a distance from the drug companies. The FDA itself should take a more active role in choosing the CRO and overseeing its work, even if that requires a law change. Under no circumstance should the FDA allow a financial relationship between the company making a drug and the one testing it.

[Last modified July 8, 2007, 20:02:42]