Whiff of bias in research grows harder to avoid

URL: http://www.globeandmail.com/gam/Health/20000613/HE13SECO.html

Date accessed: 24 June 2000

                      DR. MIRIAM SHUCHMAN

                     Tuesday, June 13, 2000

                     The editor of the New England Journal of Medicine recently accused

                     medical professors of being open to the charge that their words are for

                     sale-- to the pharmaceutical industry.

                     "What is at issue is not whether researchers can be 'bought' in the sense

                     of a quid pro quo," writes Dr. Marcia Angell. "It is that close and

                     remunerative collaboration with a company naturally creates goodwill on

                     the part of researchers and the hope that the largesse will continue. This

                     attitude can subtly influence scientific judgment?"

                     Dr. Angell thinks many of the speaking and writing arrangements

                     between medical school faculty members and drug companies should be

                     banned. And she's not alone. In a few weeks, the U.S. Congress will

                     hold hearings on the ties between medical researchers and drug

                     companies. Members of Congress are worried because there's mounting

                     evidence that in medicine, corporate connections can translate into

                     biased science.

                     And it's turned out that in some cases, the doctors making decisions for

                     the U.S. government about whether to approve a certain drug or

                     vaccine, have financial links to the makers of the same drug or vaccine.

                     That means that the decisions could be biased, or could appear to be

                     biased, in favour of the manufacturers.

                     Health Canada has similar concerns that doctor who serve as advisors to

                     the Health Protection Branch not have links to the makers of the very

                     drugs they were advising the government on. Health Canada's current

                     conflict of interest policy tries to protect against that possibility.

                     In a sample memo to would-be members of its advisory committees, it

                     states: "When acting for the government, it is not sufficient to avoid actual

                     conflicts of interest. One must also avoid any situation which might cause

                     the public to doubt the objectivity of government action. In other words,

                     the test in any given case is not simply whether there is an actual conflict

                     of interest but rather whether a well-informed member of the public might

                     have reasonable grounds for concern that the conduct of government is

                     influenced by illegitimate considerations."

                     And the memo goes further: "This is especially so in a sensitive area such

                     as health protection where the actions of government are subject to

                     intense scrutiny and where experience has shown that minor incidents

                     may occasionally be blown out of proportion and affect negatively the

                     reputation of the persons concerned."

                     The memo reads like an attempt to ensure that decisions about drugs at

                     the federal level are not biased in favour of the companies making the

                     drugs. It's a warning to medical experts with links to drug manufacturers

                     to please stay away, lest they and the government wind up regretting it

                     later.

                     But the government may have trouble putting the policy into practice.

                     Consider the difficulties John Hoey faced at the Canadian Medical

                     Association Journal, when he tried to make sure that editorials in the

                     journal were not biased in favour of drug manufacturers.

                     Dr. Hoey is the journal's editor. A few years back, he made a rule that

                     authors of editorials could not have financial connections to

                     manufacturers of the products they discuss. In other words, doctors

                     wouldn't be asked to advise their fellow physicians to prescribe a given

                     drug, if the doctors giving out the advice could be linked to the drug's

                     manufacturer.

                     The New England Journal of Medicine has had a similar policy in place

                     for the past decade. But at the Canadian Medical Association Journal,

                     Dr. Hoey had to abandon the policy early on. He says there simply

                     weren't enough doctors who had the requisite expertise to offer opinions

                     on a given drug, but didn't have ties to the makers of those drugs.

                     Canada doesn't lack for expert doctors. But, says Dr. Hoey, they almost

                     all have ties to the drug companies.

                     Even the austere New England Journal may no longer be perceived as

                     attempting to protect readers from biased viewpoints. Dr. Angell is soon

                     to be replaced, and the new editor, Dr. Jeffrey Drazen, has long-standing

                     ties to nine major drug companies. He's promised to stay out of

                     decisions around papers that concern products made by these firms.

                     But Dr. Drazen's appointment shows just how difficult it has become to

                     avoid the perception of bias in medical research today.

                     Dr. Shuchman is on assignment for the summer. Second Opinion

                     will return in the fall.

Category: 39. General Issue About Research