Ethics Newsline®

NEW YORK
Citing a federal review of disclosure data, the New England Journal of Medicine (NEJM) last week accused three of the country’s leading drug companies of not providing enough information about their clinical trials.

NEJM editor Dr. Jeffrey Drazen took aim at GlaxoSmithKline, Merck, and Pfizer, saying the three firms were not disclosing enough data in a federal database designed to improve transparency.

That database, administered by the National Institutes of Health (NIH), was set up last year to track data on drug tests after manufacturers were accused of suppressing troubling data on marketed drugs.

Dr. Deborah Zarin of the NIH recently reviewed the database on behalf of the International Committee of Medical Journal Editors, which has warned drug makers that its members — including the NEJM — will refuse to publish studies on drugs not transparently tracked in the database. They want more data on such details as who is funding the research, what the specific study is meant to investigate, and the size of the sample population.

Drazen last week said three firms were lagging on supplying data as basic as the tested drugs’ actual names — a problem 90 percent of the time with Merck, 53 percent with Glaxo, and 36 percent with Pfizer.

Two other firms — Eli Lilly and Bristol-Myers Squibb — fared much better, providing the drug’s distinctive — and therefore trackable — names 95 percent of the time, reported the Associated Press.

Merck spokeswoman Janet Skidmore last week denied falling short, saying her firm has “done everything we can to expedite medical information and enhance transparency.”

The International Committee of Medical Journal Editors is demanding 20 items of information for each clinical trial. Companies that fail to meet the demand for trials starting after July 1 will have their studies refused for publication.