Vioxx

By KEVIN FREKING, Associated Press Writer.  
Thu May 5, 6:25 PM ET
WASHINGTON - Merck & Co. sales personnel, using projects code-named "Offense" and "XXceleration," took extensive measures to deflect doctors' questions about the safety of the painkiller Vioxx before it was taken off the market. 

Documents released Thursday at a congressional hearing detail how a sales army of 3,000 turned the drug into a multibillion-dollar blockbuster before it was pulled last fall because of an increased risk of heart attack and stroke.
A Merck official told the House Government Reform Committee that the company was talking to federal health officials about what it could do to return the drug to pharmacy shelves.
But the hearing's focus was on the extraordinary glimpse into the marketing of drugs to doctors.
Instructions were as detailed as how long to shake a physician's hand — three seconds — and how to eat bread when dining with doctors — "one small bitesize piece at a time."
One memo, on Feb. 9, 2001, told sales reps, "Do not initiate discussions" on a study that raised heart concerns. Salesman training materials classify addressing physician concerns as "obstacle handling."
"When it comes to the one thing doctors most needed to know about Vioxx — its health risks — Merck's answer seems to be disinformation and censorship," said Rep. Henry Waxman (news, bio, voting record), D-Calif.
Merck Vice President Dennis Erb defended the company's handling of Vioxx, noting that it promptly released details of studies that first raised the specter of heart damage — and followed up by performing the study that ultimately doomed the drug.
"We believed wholeheartedly in the safety of Vioxx and that Vioxx was an important treatment option," he said. "My own father was a regular user of Vioxx until we voluntarily withdrew it from the market."
Erb also indicated the company is interested in making Vioxx available to consumers again.
"We're now in preliminary discussions (with the Food and Drug Administration) to see what information they would need to review for putting Vioxx back on the market," Erb said.
Merck pulled Vioxx after a study showed it doubled the risk of heart attacks and strokes in patients using the drug for more than 18 months. Merck is facing more than 2,300 lawsuits from customers, and on Thursday its chief executive, Raymond V. Gilmartin, stepped down. Merck named Richard T. Clark to replace him.
But because many people say Vioxx offered relief that other drugs haven't, FDA's scientific advisers in February narrowly voted that Vioxx might be able to come back onto the market under certain conditions, such as restricting its use to patients with severe pain or loading it with strong warnings about the heart risk.
That risk first appeared in 2001, when the so-called VIGOR study found that certain Vioxx users suffered twice as many heart attacks and other cardiovascular problems as users of the older painkiller naproxen. The following year, the FDA added warnings to Vioxx's label.
At first, scientists thought it may be because Vioxx users weren't getting a blood-thinning benefit that comes with many older painkillers. But by 2002, top specialists were worried that Vioxx might be the direct culprit — and Merck's own follow-up research prompted it to pull the drug.
FDA drug chief Dr. Steven Galson told lawmakers Thursday that the agency is taking steps to improve awareness by the public and doctors of potential drug risks as soon as they arise.
He said that what was happening with Vioxx wasn't clear-cut until the research completed last summer. He acknowledged, however, that it may have taken too long to put a new warning label on the drug.

"We think we've addressed the sort of problems that happened here, and to make sure it won't happen again," Galson said. 
Waxman tried to focus attention on the sales representatives, arguing that "the goal was sales, not education." 
Rep. Tom Davis, R-Va., the committee chairman, said the new documents raise questions about Merck's handling of Vioxx. But he said he was not prepared to criticize the company without more information, noting that Merck made public results of its own studies that raised the concerns — data subsequently widely published, in medical journals and newspapers. 
"A wide-awake physician would have obviously known about this?" Davis asked. 
"That is correct," Erb responded. 
But another witness, Dr. Michael Wilkes, vice dean for medical education at the University of California-Davis, said physicians are busy and look for shortcuts to get information. "Doctors don't read the medical literature," he said, and often rely on the salesman they meet in their office. 
When doctors asked about heart risks, the Merck sales reps were to provide a "cardiovascular card" with data suggesting that Vioxx could be eight to 11 times safer than other anti-inflammatory drugs. Waxman said FDA officials told him that comparison was inappropriate. A copy of the card was released with other documents. 
There's no indication the sales tactics were illegal, lawmakers said. 
"It strikes me there is a disconnect here. Isn't there a role for ethics to play here?" asked Rep. Gil Gutknecht (news, bio, voting record), R-Minn. ___ 

AP Medical Writer Lauran Neergaard contributed to this report. On the Net: 
Vioxx documents: http://www.democrats.reform.house.gov/features/vioxx/documents.asp