WSJ.com - Doctor Criticizes Merck's Handling of Vioxx

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Doctor Criticizes Merck's Handling of Vioxx

By HEATHER WON TESORIERO

Staff Reporter of THE WALL STREET JOURNAL

December 4, 2005 1:27 a.m.

HOUSTON -- One of the nation's leading physicians told a government

official that Merck & Co. had engaged in " scientific misconduct " in its

handling of its Vioxx painkiller, according to evidence presented in a

federal trial here.

Topol, the provost of the Cleveland Clinic College of Medicine and the

eighth most-cited medical researcher in the world, said in videotaped

testimony shown to jurors in the first federal Vioxx trial that Merck had

data years prior to its September 2004 withdrawal of its painkiller that

suggested Vioxx posed cardiovascular dangers.

Dr. Topol, who was also one of the first people to raise questions about

Vioxx's safety, did not appear as an expert witness and had sought to avoid

the trial but was subpoenaed by plaintiff's attorneys. His stature in the

medical community and his sharply critical views of how Merck handled

questions about the safety of Vioxx may prove damaging to the company in

this third trial. His testimony did not appear in the first two trials, of

which Merck lost one and won one.

Last year, Merck voluntarily withdrew Vioxx from the market after a study

linked the drug to an increased risk of heart attacks and strokes in

patients who took the drug for 18 months or longer.

In this case, Irvin Plunkett is suing Merck over the 2001 fatal

heart attack of her then-husband, " Dicky " Irvin, who took Vioxx for

less than a month before he died.

Under questioning by R. Kline, of Kline & Specter, Philadelphia, Dr.

Topol described his attempts to point out Vioxx's potential cardiovascular

dangers. Central to these efforts was an August 2001 study he published in

the widely read Journal of the American Medical Association, in which he

called for Merck to conduct a study to test Vioxx on patients with heart

disease. His paper followed the results of a 2000 study known as Vigor

which compared Vioxx to naproxen, an older painkiller, and found four to

five times more heart attacks in the patients taking Vioxx.

At the time, Merck explained the results by saying that naproxen worked to

protect the heart. In his testimony, Dr. Topol flatly rejected this

explanation, saying " the only appropriate conclusion was that there would

have been a problem " with Vioxx. He also said that there were discrepancies

between the Vioxx data used for the Vigor study and Vioxx data from a Food

and Drug Administration database.

Prior to publishing his 2001 JAMA article, Dr. Topol sent a draft of his

paper to Merck. He testified that scientists from the company visited him

in Cleveland to tell him that he " got it wrong " and would be " embarrassed "

if his paper were to appear. As part of the testimony, Mr. Kline showed Dr.

Topol a Merck document that took aim at the doctor's paper, and included a

note that said, " We prefer to flip the data and say [cardiovascular risks]

were reduced " because of naproxen.

" I'm actually appalled by this, " Dr. Topol said during his testimony.

He also said that Merck neglected to publish data from a study known as 090

that compared Vioxx to an older painkiller and showed that patients taking

Vioxx had a 760% increase risk of heart attacks. Dr. Topol also dismissed

the notion that Vioxx only causes problems when taken in the long-term,

saying that four studies showed that the drug can cause heart attacks as

soon as four to six weeks after being taken.

Under cross-examination by a Merck defense attorney, Dr. Topol said he

himself had taken Vioxx starting in 1999 for arthritis in his knees, and

that it offered him more relief than older painkillers. He said he didn't

believe he personally was at greater risk of a heart attack while on the

drug. The Vigor trial tested Vioxx in patients with rheumatoid arthritis

and when questioned, he said that those patients are at a higher risk for

heart attacks.

The defense questioned Dr. Topol about an email he sent to one of the Merck

scientists following their meeting about his JAMA study in which he wrote

that he enjoyed meeting with them. " I was trying to be politically correct

and smooth over difficulties, " he said in his testimony. The defense also

questioned Dr. Topol on the merits of his JAMA piece, and pointed out an

excerpt of the study that says naproxen's cardioprotective properties might

explain the results. Dr. Topol said that that was included, but that it was

Merck's explanation.

Dr. Topol said that in 2004, following an opinion piece he wrote about

Vioxx, he was told that former Merck chief executive and chairman called

Cleveland Clinic executive Malachi Mixon and said, " What has Merck ever

done to the Cleveland Clinic to warrant this? " During his testimony, he

said he found the phone call to be " entirely repulsive. "

Write to Won Tesoriero at heather.tesoriero@...

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