MERCK STOCK OFF ON ASTOUNDING NEWS FROM THE NEW ENGLAND JOURNAL OF MEDICINE . . . Merck stock suffered a precipitous late-afternoon drop today when the New England Journal of Medicine posted an editorial accusing authors of the VIGOR study of withholding key data about the cardiovascular risks of Vioxx.
Here's the Associated Press on the news: "New England Journal Alleges Merck Hid Heart Attacks Suffered by Three Patients During Study," by Linda A. Johnson.
Vioxx maker Merck & Co. concealed heart attacks suffered by three patients during a clinical study of the now-withdrawn painkiller in a report on the study published in the New England Journal of Medicine in 2000, the journal wrote in an editorial released Thursday.
The editorial, written by the journal's editor in chief, Dr. Jeffrey M. Drazen, executive editor Dr. Gregory D. Curfman and a third doctor, also alleges the study's authors deleted other relevant data before submitting their article for publication.
"Taken together, these inaccuracies and deletions call into question the integrity of the data on adverse cardiovascular events in this article," the doctors wrote.
The NEJM editorial is here (pdf). According to its authors, "[w]e determined from a computer diskette that some of these data were deleted from the VIGOR manuscript two days before it was initially submitted to the Journal on May 18, 2000."
UPDATE . . . Ted Frank suggests in the comments here, as well as in a post at Point of Law, that the three chief editors of the New England Journal of Medicine are working in concert with plaintiffs' lawyers to affect the outcome of the ongoing federal trial. It's a "garbage tactic," Frank says below. Anyone buy it?
Frank also claims the attention being paid to the NEJM editorial amounts to "mountains out of molehills." I'm not so sure. Among other things, the NEJM editors are alleging that the manuscript of the key VIGOR study was altered--that material data other than the three additional heart attacks was in a draft of the study but then was removed by one of the authors just before being submitted to the NEJM. Since one of the authors of the VIGOR study was Dr. Alise Reicin, Merck's vice president for clinical research, I'd say Frank's downplaying of the story is premature. Reicin is a key Merck witness--arguably its most key witness--who has presented the company's case in all three trials. Reicin and the other authors will have to address the implication I think was raised by the NEJM editorial that there was an attempt to hide information about the cardiovascular risks of Vioxx. The answer to this question is important whether or not the information was later publicly known.
UPDATE II . . . For all of my collected Vioxx posts, look here. If you are (a) someone who was harmed by Vioxx or (b) a lawyer who wants to refer your Vioxx cases to a highly-competent team of mass-tort lawyers, look here.