The medical journal
has stepped into the debate over the heart risks of the diabetes drug Avandia, advocating "a balanced perspective" and warning against creating "unnecessary panic among patients."
The prestigious British publication issued an editorial Wednesday about the furor that followed Monday's study in the
New England Journal of Medicine
. The U.S. journal said patients receiving
Avandia have a statistically significant higher risk of
heart attack than patients taking other pills to control blood sugar or a placebo.
article, written by researchers at the Cleveland Clinic, and an accompanying editorial prompted a 7.8% plunge in GlaxoSmithKline's stock on Monday. In reaction, some analysts cut their ratings while others reduced price targets.
rebounded slightly Tuesday; but by early afternoon Wednesday, it was off 59 cents, or 1.1%, at $53.34.
Glaxo criticized the
article's methods and conclusions. The Food and Drug Administration, while urging caution, didn't change its opinion about Avandia or the warnings about cardiovascular risks on its label. The agency continues to analyze clinical-trial data, which it says are contradictory.
"To avoid unnecessary panic among patients, a calmer and more considered approach to the safety of
Avandia is needed,"
said Wednesday. "Alarmist headlines and confident declarations help nobody."
The British journal said the tone of the
article was "urgent." Based on a review of 42 clinical trials, researchers used a statistical technique called meta-analysis, which combines information from similar trials. An effective meta-analysis can enable researchers to detect issues that might not appear in smaller, individual trials.
The authors and the
editorial-writers said the study had drawbacks. "It would be premature to overinterpret a meta-analysis that the authors and
editorialists all acknowledge contains important weaknesses,"
The British journal cited what it called the two "most reliable" Avandia studies so far. Those studies are known by the acronyms DREAM and ADOPT. The former, published in
, showed no statistically significant increase in heart attacks or strokes among Avandia patients vs. those taking placebo.
The latter, published in the
, showed a significantly higher rate of congestive heart failure in Avandia patients vs. those taking glyburide, a generic drug that belongs to a different class of diabetes medications.
"Taken together, these results, although based on very small numbers of events, certainly raise a signal of concern and indicate the need for more reliable information,"
Better information will come from the ongoing Glaxo-sponsored clinical trial, called RECORD, which is designed to study heart risks, the journal said. Glaxo said an independent safety-monitoring board hasn't found anything that would cause it to recommend halting the study.
Results of the clinical trial, started in 2001, are due to be published in 2009. More than 4,400 people in 25 countries are being tested. The FDA says it has seen the results of an interim safety analysis and is using this information as it evaluates all Avandia test data. The FDA won't comment on these interim results.