Editorial: Clinical research profitable

Monday, May 24, 1999 | 11:13 a.m.

Clinical research once was confined mainly to academics toiling away at universities. While the universities profited, there certainly wasn't much money in it for the researchers themselves. But a 10-month investigation by the New York Times has found that clinical research has changed dramatically. Increasing competition among drugs companies, prompted by HMOs' reduced payments for drugs, has driven companies to find cheaper and faster ways to get their drugs onto the market. Coupled with managed care's impact on reducing the income that doctors receive, it probably isn't too surprising that the path of drug companies and doctors would somehow intersect to improve the bottom line of all concerned -- except for patients.

Instead of relying on university research that typically takes longer -- and costs more money -- drug companies now are turning to doctors to perform their research since, unlike the universities, they have a ready supply of patients for the companies' studies. But the Times found that this trend to enlist private doctors has inherent conflicts of interest, especially when doctors are being paid bonuses to enlist patients quickly into these studies. In addition, the patients often aren't even told that their physicians are reaping financial windfalls by getting them to enroll.

In one instance documented by the Times, Thomas Parham of California was encouraged by his doctor to join a study to see whether a new drug could shrink an enlarged prostate. Parham thought it was odd his doctor would enroll him in the study, especially since there was nothing wrong with his prostate. What the doctor never disclosed to Parham was the financial incentive physicians were receiving -- doctors were getting $1,610 for each patient he signed up for the study.

The Times also found that drug companies are recruiting doctors to conduct research who have no expertise in the studies they're overseeing. For instance, one psychiatrist said she was asked to treat patients with diabetes and perform pap smears as part of a hormone replacement study. Even when the psychiatrist told the company she didn't feel she was qualified to do these studies, an executive dismissed her concerns.

Federal regulators say there isn't any reason to oversee the contracts between drug companies and the doctors performing research on their behalf. But the Times' series on clinical research convincingly demonstrates that doctors may be induced by financial gains to ignore quality research and that their loyalties to their patients might be eroded by these monetary incentives. Congress should investigate this issue and determine whether this burgeoning industry should be more tightly regulated.