Merck accused of scientific fraud

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NewsTarget: Merck accused of scientific fraud

Wed, 15 Feb 2006 15:17:32 -0700

 

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Recently, the New England Journal of Medicine accused Merck of

scientific fraud in its clinical trials. Today, our reporter Alexis

Black brings you the details on this groundbreaking accusation from

one of the industry's most powerful medical journals:

 

http://www.newstarget.com/017875.html

 

 

 

 

NewsTarget.com

 

Originally published February 15 2006

 

New England Journal of Medicine accuses Merck of deleting important

Vioxx information from study

 

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.