Healthy Skepticism Library item: 3888

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: news

Curran J.
Scientist: Merck Didn't Try to Hide Data
Associated Press 2006 Mar 22
http://biz.yahoo.com/ap/060322/vioxx_trial.html?.v=4

Notes:

Ralph Faggotter’s Comments:

“ …said Merck’s new-drug application consisted of enough documents to fill more than 120 boxes, suggesting that Merck purposely buried the data because it showed Vioxx made users more susceptible to heart attacks.”

Robert Heinlein said that there are two ways to lie. One involves telling the truth, but so unconvincingly that no-one believes you. He might have added a third method— tell the truth but bury it in a huge pile of documents so that no-one actually gets around to reading it!

Full text:

Scientist: Merck Didn’t Try to Hide Data
Wednesday March 22, 5:56 pm ET
By John Curran, Associated Press Writer
Scientist Who Helped Develop Vioxx Rejects Claims That Merck Tried to Hide Data From Regulators

ATLANTIC CITY, N.J. (AP) — A scientist who helped develop the painkiller Vioxx rejected assertions by a plaintiff’s lawyer Wednesday that Merck & Co. actively tried to conceal from regulators unfavorable data about the popular arthritis drug’s potential heart safety problems.

In a court session delayed briefly by a bomb scare, Dr. Briggs Morrison defended the company’s handling of a 1995 clinical study of the effect of so-called Cox-2 inhibitors such as Vioxx on the body, saying the data was included in Merck’s 1998 application to the U.S. Food and Drug Administration to sell Vioxx. Cox-2 inhibitors were touted for causing less stomach upset than older painkillers.

But plaintiffs attorney Mark Lanier, in a pointed cross-examination of Morrison, said Merck’s new-drug application consisted of enough documents to fill more than 120 boxes, suggesting that Merck purposely buried the data because it showed Vioxx made users more susceptible to heart attacks.

“Do you think the FDA really zoned in on that one paper in those 127 boxes?” Lanier said.

Morrison, vice president of Merck Research Laboratories, is Merck’s first witness in the case, which centers on two New Jersey men who suffered heart attacks while taking the drug.

Thomas Cona, 59, of Cherry Hill, and John McDarby, 77, are suing Merck because they say that the drug triggered their heart attacks and that they never would have taken it had they known about clinical studies linking it to cardiovascular problems.

Merck, which faces about 9,650 such suits over Vioxx, contends the men were destined to have heart attacks because of their own health problems and that Vioxx can’t be blamed.

To date, the company has won two Vioxx verdicts and lost one. This is the first trial involving plaintiffs who took the drug for more than 18 months, the point at which Merck says Vioxx increases risk of heart attack and stroke.

Lanier showed jurors a copy of an internal review Morrison did in response to a 2001 paper summarizing clinical study data on cardiovascular risk. The paper stated there was no evidence Vioxx was causing heart attacks.

In his comments about the paper, Morrison said that was “wishful thinking” and that he felt the paper interpreted the data to support a preconceived notion.

“You never gave that to the FDA, did you?” Lanier said.

Morrison said no, that it was an internal review never shared with FDA. He also acknowledged — in response to a question from the jury — that during the time he worked on the Vioxx development team at Merck, the company did not do a clinical study specifically aimed at determining whether Vioxx caused heart attacks.

Merck never did such a study, an omission that plaintiffs’ attorneys say shows that the company willfully ignored unfavorable data about Vioxx.

The company contends that it carefully monitored cardiovascular events in all of its Merck trials and that it pulled Vioxx from the market as soon as the link to heart attacks and strokes was proven.

In New Jersey, juries in civil trials are allowed to ask questions of witnesses once lawyers in the case finish their interrogations.

Authorities evacuated the Atlantic County Civil Courthouse just after 8 a.m. after a sheriff’s deputy discovered what looked like an explosive device in the drawer of a first-floor office, said Atlantic County Undersheriff John Tuohy.

The device looked like a pipe bomb, with nails, wires, a battery and electrical tape wrapped around it, according to a courthouse employee who saw it but declined to give his name.

Police department spokesman Lt. Michael Tullio said the device was apparently left behind after a training exercise, although neither Tuohy nor Tullio knew how long ago that may have been.

“They believe it was a training aid that was secured and forgotten about and then found, and because nobody knew when and there’s this national trial going on, they decided to err on the side of caution,” Tullio said.