Monday, May 11, 2009

Gardasil and Conflicts of Interest in Cancer Studies

It’s just been one thing after another for drug companies lately. Hot on the heels of revelations that Gardasil maker Merck had published several issues of an entire fake medical journal—as well as maintaining a list of nay-saying researchers and doctors to be ‘discredited’ or ‘neutralized’—comes a new study regarding potential conflicts of interest in cancer study reporting.

A team from the University of Michigan looked at more than 1,500 cancer studies published in well-regarded journals like Cancer, The New England Journal of Medicine and The Lancet.

Although researchers are supposed to disclose any conflict of interest the boundaries are often unclear, and the study found that there are many such potential conflicts that could influence more favorable reporting of results when financial backers are involved.

The study found that where a potential conflict existed, randomized trials were more likely to link patient survival to a particular treatment.

Furthermore, although conflicts such as industry funding, co-authorship with industry employees or consulting fees were declared in only 17 percent of studies published in the eight major journals, a review of authorship credits found conflicts in a whopping 29 percent.

Also, 62 percent of industry studies focused on treatment while only 36 percent of non-industry studies did so. Conversely, 47 percent of non-industry studies looked at epidemiology, prevention, risk factors, screenings or diagnostic methods, while only 20 percent of industry studies did so—a compelling argument for moving away from purely market-driven research.

The study’s authors concluded that "attempts to disentangle the cancer research effort from industry merit further attention, and journals should embrace both rigorous standards of disclosure and heightened scrutiny when conflicts exist."

The study is to be published in the June 15 issue of Cancer.

Skewed drug trial reporting

The UM study is just the latest in a long line of studies critical of drug company ploys and drug trial reporting.

Earlier this year a UCSF study found that ‘skewed’ reports of drug trial in medical journals are often written either by physicians involved in the development of the drug, or by specialized companies that attribute authorship to doctors who have participated in the trials. Such articles typically emphasize the positive reports of the trials.

Bias was shown, according to the study, both by lack of publication of trials with unfavorable outcomes and by selective reporting of data. Trials with favorable outcomes were about five times more likely than those with unfavorable outcomes to be published; there were often many discrepancies between the results the FDA received and the published data; and one-fourth of the results of trials testing the effectiveness of new drugs were not published at all within five years after the FDA approved them.

Studies on bias in medical journals shouldn’t be taken lightly by either publishers or doctors. Many doctors decide which therapies to use based largely on what they read in medical journals, and evidence of potentially biased and incomplete reporting ought to be seriously worrisome—particularly for patients who rely on their doctors to have good information.

For example, our pediatrician and my daughter’s gynecologist are both really pushing for our girls to get the series of Gardasil shots. Gardasil, by protecting against four strains of HPV (human papillomavirus) is intended to stop cervical cancer before it starts. But how accurate and complete is the information our doctors have been getting about Gardasil?

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