As if things weren't bad enough for pharmaceutical giant Merck and Co., the picture just got a little grimmer. Already facing tremendous heat and a long line of lawsuits over Vioxx -- its arthritis medication that was pulled off the market in September 2004 after it was determined to increase heart attack and stroke risk -- the editors of a prominent medical journal are now accusing Merck of withholding crucial study data that showed the drug's heart risk.
Dr. Gregory D. Curfman, executive editor of the New England Journal of Medicine and editor-in-chief, Dr. Jeffrey M. Drazen, write in their "Expression of Concern" editorial in the Dec. 29 issue of the Journal that a Merck editor knowingly deleted Vioxx study results about three heart attacks among study participants before submitting the study to the Journal for publication.
"We have very solid evidence that important data on cardiac events was deleted or withheld, which rendered the study of suboptimal quality," Curfman told HealthDay.
According to Curfman, the three deleted heart attacks occurred in people who were otherwise at low risk for heart problems, which would ultimately discredit the study's primary conclusion that Vioxx only increases heart attack risk in those already at high risk.
Ironically, Merck has frequently cited the study, called VIGOR (Vioxx Gastrointestinal Research) in defense of Vioxx. Therefore, if the results of this Merck-funded study were indeed falsified, it could leave the drug company virtually defenseless.
The VIGOR study was originally published in The New England Journal of Medicine in November 2000 before the deception was discovered, according to the Journal's editors.
Although the editors first became aware of the missing data in 2001, they did not suspect any wrongdoing at the time.
"Until the end of November 2005, we believed these were late events that were not known to the authors in time to be included in the article published in the Journal on Nov. 23, 2000," they write in "Expression of Concern".
The editors say they did not learn until after Vioxx was pulled off the market that study authors had apparently deleted heart attack data from the study prior to sending it to the journal. The discovery was apparently made when the Journal's editors uncovered an electronic version of the study that contained data that was missing from the paper version submitted to them.
The accusations against Merck came at a particularly significant time, as deliberations in the first federal trial against Merck over Vioxx got underway in Houston. Of course, Merck disputes the Journal's claims, arguing that the heart attacks omitted from the study results occurred after the prescribed analysis cutoff date.
A statement from Merck, quoted in Forbes Magazine, reads in part, "Nevertheless, the additional events were disclosed to the FDA's Advisory Committee in February 2001 and included in numerous press releases subsequently issued by Merck. We also note that these additional events did not materially change any of the conclusions in the article."
However, The New England Journal of Medicine isn't buying it. After all, the heart attacks that happened to be omitted occurred in patients at low risk for heart problems, while the study concluded Vioxx only posed potential dangers to people who already had high risk for heart trouble.
The accusations levied here loom large for Merck, as it is highly unusual for a high-profile medical journal to accuse a company of withholding information about a potentially fatal risk. The New England Journal of Medicine has asked Merck to submit a written correction to the Journal, but, whether they comply or not, it is impossible to correct the damage that may have been done to patients who suffered fatal heart attacks after taking Vioxx.