Vioxx, Merck and the NEJM

Watergate for Merck? The NEJM has uncovered some data in Vioxx’s VIGOR trial – suggesting a cover-up:

A top editor of the New England Journal of Medicine says that he was stunned to find out that data linking Vioxx to cardiovascular risk was deleted from a major study his journal published five years ago–and that it appears that Merck researchers may have deleted that data.

“I was somewhere between surprised and stunned,” Dr. Gregory Curfman, executive editor of The Journal, says. “They allowed us to publish an article that was just incomplete and inaccurate in some respects and was misleading and may have contributed to the detriment to the public health.” . . .

. . . Just days after Merck recalled Vioxx from the market, editors at the Journal discovered a diskette containing earlier versions of a manuscript for a crucial Vioxx clinical trial called VIGOR that they had published in November 2000.

The early versions of the manuscript contained a blank table entitled “CV events”–which is standard jargon for cardiovascular events. Time stamps in the software indicated that the table was deleted two days before the manuscript was submitted to the New England Journal on May 18, 2000. “When you hover the cursor over the editing changes, the identity of the editor pops up, and it just says ‘Merck,’” Curfman says.

It also appears that VIGOR’s lead author may be in trouble:

Curfman says he called lead author Claire Bombardier of the University of Toronto, on Monday, indicating that the statement would be published. She told him that she would begin working on a correction. However, in an e-mail to Forbes.com, Bombardier said that the VIGOR paper appropriately disclosed the data and that the authors were working on finalizing a response to the editorial.

Catharine Whiteside, dean of medicine at the University of Toronto, said today that she has yet to talk to Dr. Bombardier. “In the event that information is brought to light in which we would need to investigate Dr. Bombardier, we would initiate due process,” Whiteside says.

Evan Schaeffer takes a look at the hit Merck’s stock took this afternoon.

PointofLaw.com thinks the NEJM is in bed with the plaintiff bar:

Why make a press release at 5 pm on the day of the closing argument? This looks like an attempt to affect the federal trial””and the NEJM editorial writers say they got their information from a deposition.

Even assuming improper data mining (i.e., would Merck have disregarded the scope of the study to provide positive data?) where is the proximate causal harm from the chronological difference between the NEJM Bombardier publication and the release of the full study?

In after-market trading, Merck stock dropped 6%. One day I’m going to open a hedge fund and make a mint just on plaintiff-planted press releases.

Update:
Derek Lowe with his take.

email

Comments are moderated before they are published. Please read the comment policy.

  • Anonymous

    Trial lawyers have now infiltrated the NEJM!! It’s true physicians – you can only trust what your liability carriers and the drug companies tell you. They are the only people looking out for your wallet – I mean best interests!

    I know, you thought you could also swallow the claims of the most respected medical journal in the country the same way you swallow the claims of the other two – but no!! If the NEJM is not shut down, liability rates will skyrocket!! Good drugs will not get to the people who need them!! They will be laying off good looking pharmaceutical reps like auto workers!!

    The horde must be stopped. Immunity for all is the only answer!

    That is my call to arms.

    CJD

  • Anonymous

    CJD, You haven’t reviewed the evidence or records. You are rushing to judgment without full scrutiny of the issue, as usual. You’re full of sound and fury, signifying nothing.

  • Anonymous

    Kevin,

    Kick CJD off of here like GruntDoc did. We have heard his tired old message enough.

  • Anonymous

    Laying off Pharm reps? Darn!! And I just read they’re hiring former college cheerleaders for the job! I always miss out!

  • Anonymous

    Good call second anonymous. You should always move to silence anyone who disagrees with you. That way you can remain in blissful ignorance!

  • Anonymous

    I take it none of you have a factual defense of Merck here? Surely the same great minds that can diagnose malpractice from a newspaper article can defend this poor helpless multinational drug company against the voracious trial lawyers and their money grubbing clients!

    CJD

  • Anonymous

    CJD, have you reviewed all the facts? Apparently not. Is that the kind of service you provide your clients – mediocre type of service. Apparently, yes. Now, we know why you don’t work for a big firm. Not only will they not hire you, they’ll lay you off as soon as their Wall Street investments go south.

  • Anonymous

    “Surely the same great minds that can diagnose malpractice from a newspaper article can defend this poor helpless multinational drug company against the voracious trial lawyers and their money grubbing clients!”

    CJD, the only “great minds” that diagnose malpractice from a newspaper article are trial lawyers, not physicians. Of course, that doesn’t include the whoring physicians who provide “expert” testimony.

  • Anonymous

    How betrayed you must all feel by your good friends at Merck.

    As for the great minds that do the newspaper diagnosis, if it’s only everyone else, how is it that you guys know all of John Edwards’ verdicts were not legit? Oops, your sillyness bites you in the ass again!

    As for working for a big firm, I don’t work there so I can help people like you. What, you didn’t know those guys won’t help you when your wife gets in a wreck and it’s the other guy’s fault?

    I do love you guys!

  • Anonymous

    “Kick CJD off of here like GruntDoc did. “

    LOL!!! I didn’t know about this. No doubt he deserved it, being the classic internet troll that he is, but I hope doesn’t get banned here. It’s too much fun seeing a lawyer make an idiot out of himself in a public forum on a daily basis. :)

  • Anonymous

    A troll is someone who makes inflammatory statements which aren’t true.

    I like to think of myself as a special education teacher dealing with children whose disabilities are overinflated egos which inhibit their learning abilities.

    And Grunt Doc didn’t ban me. He is just as frustrated by the facts as you guys, though.

  • Anonymous

    CJD is having delusions. He needs help, guys. On the other hand, it’s too late. He’s brain dead. He’s writing and talking but his brain ain’t working.

  • Anonymous

    CJD speaks the truth for a change:

    “A troll is someone who makes inflammatory statements which aren’t true.”

    I rest my case. :)

  • Anonymous

    Keep CJD on here. The more time lawyers waste on the internet, the less they spend sodomizing our profession. Next week, i’m thinking of sending Doc Elliot a hooker.

  • Anonymous