Day on Torts

A new article from Bloomberg reports that changes may have to be made to an Annals of Internal Medicine article linking Vioxx to heart problems.

Here is the complete article.

Tuesday, May 3, 2005

By JULIANN WALSH
BLOOMBERG NEWS

The Annals of Internal Medicine may publish a correction to a Merck & Co.-sponsored study of the pain pill Vioxx to show the drug had a higher risk of heart attacks than originally stated, journal editor Harold Sox said.
The study, published in 2003, listed five heart attacks among arthritis patients taking Vioxx compared with one in those taking naproxen. Three additional cardiac deaths in the Vioxx group went unmentioned, including one in which company officials may have pressured a researcher to change his opinion about the likely cause of death, the New York Times reported on April 24.

"Corrections happen all the time, but corrections that materially change the message of the article are pretty uncommon," Sox said in a telephone interview April 27. "If they had told us it was 8-to-1, it would have been much different than 5-to-1."

Merck, the third-largest U.S. drugmaker, says it had no definitive evidence of Vioxx's heart risks until right before it pulled the $2.5 billion-a-year drug in September 2004 in the largest drug recall ever. Some doctors, lawmakers and plaintiffs have said the Whitehouse Station-based company should have known before then that Vioxx might be dangerous.
Sox said he learned that the trial results he published might have been manipulated when he opened his New York Times on April 24. He met with his editorial staff the following day and posted a notice on the magazine's Web site notifying readers the staff was considering a correction.

"Basically, we want to find out, did those patients really have a heart attack or not," Sox, who is also a physician, said in the interview last week. He hopes to have an answer within the month.

Merck spokeswoman Jeanine Clemente said in an e-mailed statement Monday that the study doesn't need to be corrected and the company would be happy to discuss any concerns the journal editors may have. On April 24, Merck spokeswoman Cynthia Smith told Bloomberg News that Merck submitted the results of the research, including data on adverse effects regardless of whether they were classified as cardiovascular, promptly to the U.S. Food and Drug Administration.

The Annals editors plan to contact Jeffrey Lisse, the study's author, before determining whether to run a correction, said Sox. Lisse, a rheumatologist at |the University of Arizona, was quoted in the Times story as saying that while he is listed as the study's author, Merck actually wrote the report.
Lisse did not return a call to his office seeking comment.
Merck shares rose 10 cents to $34 at 4:01 p.m. in New York Stock Exchange composite trading. They have fallen 25 percent since the Vioxx recall was announced. As of March 31, Merck was the subject of about 2,300 lawsuits from 4,600 plaintiffs' groups alleging personal injury from Vioxx.

The study in question, called Advantage, sought to show that Vioxx was easier on the stomach than the older painkiller naproxen, sold in pharmacies under the brand name Aleve. The 12- week trial involved about 5,500 arthritis patients taking either 25 mg of Vioxx or 100 mg of naproxen. The study was completed in 2000.
Merck overruled a suggestion by one of its researchers that a 73-year-old woman participating in the study probably died of a heart attack, the New York Times reported, citing documents provided by a person working with plaintiffs.
The cause of death was eventually listed as "unknown," the newspaper said, adding that FDA reviewer Maria Lourdes Villalba concluded in a November 2001 report that Merck had misclassified the woman's death.

Merck would rather let a patient die than lose any profit. They're new campaign with "innocent children" is appalling.

A Drug Maker's Ads, Hold the Disclaimer
By STUART ELLIOTT

THE troubled drug maker Merck is introducing this week what it describes as the first campaign in its 114-year history to help burnish the reputation of its corporate brand rather than sell its products.

The campaign, with a budget estimated at more than $20 million, is elaborate, running on television and radio as well as in print and online. The ads seek to counter perceptions among skeptical consumers that Merck in particular - and giant drug makers in general - are more interested in profits than in people.

The intent of the campaign, which is to continue through the end of the year, can be divined from its slogan: "Merck. Where patients come first."

Executives of Merck and Ogilvy & Mather Worldwide in New York, the agency that created the campaign, said in separate interviews that it had been in the works for more than two years - well before Merck began to confront challenges last fall related to the voluntary recall of the pain medication Vioxx, one of its most lucrative drugs.

The Vioxx fiasco contributed to the last month's departure of Merck's chief executive, Raymond V. Gilmartin, and the promotion of Richard T. Clark to succeed him. Merck has had other problems, too, like a paucity of blockbuster new prescription drugs.

When Mr. Clark was president of the Merck manufacturing division, he "was supportive of the campaign," said Len Tacconi, executive director for corporate communications at Merck in Whitehouse Station, N.J., "and he remains that way as the new C.E.O."

"It's an important time for people to know who Merck is and what we stand for as a company," Mr. Tacconi said.

No kidding, say consultants in marketing and corporate identity.

"It is high time Merck did something substantive on the marketing front for its brand name," said Gary M. Stibel, principal at the New England Consulting Group in Westport, Conn. "Merck is a wonderful company with a great reputation, but it needs to get the word out."

Robert Passikoff, president of Brand Keys in New York, a brand and customer-loyalty consultant, called the campaign "a great idea" because "the castle has been under siege for a long, long time."

"Merck would be wise to make sure it has more friends than disgruntled patients," Mr. Passikoff said. "Ultimately, you're better off having a tighter emotional bond to your customer base."

The campaign will try in several ways to build emotional ties between Merck and consumers. For instance, one television commercial shows cute children reacting in charming confusion to requests to define "measles," "mumps" and "chicken pox."

"Most kids today don't have a clue about diseases adults remember, thanks to Merck's scientists," a female announcer says, adding: "We've invested billions to research heart disease and asthma. Now we're trying to make Alzheimer's, diabetes and cancer history too."

In another commercial, the announcer asks, "If you ran a drug company, what would you change?" Among the responses presented in people-on-the-street vignettes: "I would try to prevent disease, not just treat it," and "I'd make it so folks wouldn't have to choose between their groceries and their medicine." The announcer says, "At Merck, we believe in the same things you do."

The down-home feel of the spot is underscored by scenes set in a diner, which has come to symbolize Merck's home state, New Jersey.

Also, more than 40 percent of the ads in the campaign are being devoted to information about what Merck calls its access programs, which are efforts to provide some consumers with prescription drugs either free or at reduced prices.

"At Merck, we believe our medicines should be available to the people who need them," the announcer declares in another commercial, which runs 60 seconds. She recites a toll-free telephone number that can be called for enrollment information (1-800-727-5400) and reads the Merck Web address (merck.com). The information is also superimposed on the screen several times, as if viewers are being encouraged to order gadgets or greatest-hits CD's.

"We want the public to understand a little more who Merck is and raise the awareness of Merck, but we also want to communicate useful information," said Michael Guarini, managing director for the health care practice at Ogilvy, owned by the WPP Group. "We'd be silly not to consider that it's a very charged environment out there and drug companies, once revered, are not held in as high esteem as 10, 25 years ago."

Mr. Guarini acknowledged that "there will be some people cynical about this campaign, who see this as reactive" to Merck's problems with Vioxx. But "that is simply not the case," he said. "It's always good to engage in dialogue, to make sure the public has true, balanced, accurate information."

Ogilvy is one of several agencies that work for Merck, creating ads aimed at consumers for prescription products. Ogilvy has been on the Merck roster for almost a decade, working on drugs like Zocor.

Ogilvy was selected to produce the campaign in spring 2004, more than a year after Merck began its initial research among consumers, health care professionals and so-called opinion leaders to determine their attitudes toward the company, Mr. Tacconi said.

"It became frustrating to us - we did all these things and nobody knew about them," he added.

From November through April, the elements of the campaign that centered on the access programs were tested in five small markets, including Scranton, Pa., and Wausau, Wis., Mr. Tacconi said. The results led Merck to decide to proceed with the national introduction, he said.

"We're hoping for the campaign to be seen as benefit-driven to patients and not a chest-thump to the company," Mr. Tacconi said.

The TV commercials are scheduled to run on broadcast and cable networks. The print ads are planned to appear in 40 magazines as well as national newspapers. The Internet ad purchase includes Web sites like webmd.com. In all, Mr. Tacconi said, the campaign should reach "more than 90 percent of the U.S. population" by the time it concludes.