Florida sues Merck to recover money spent on Vioxx

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Posted on 2nd October 2008 by Gordon Johnson in Uncategorized

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Date: 10/1/2008 4:46 PM

By LINDA A. JOHNSON
AP Business Writer

TRENTON, N.J. (AP) _ Florida has joined eight other states in suing drugmaker Merck & Co. over what the state alleges was deceptive marketing of its former prescription painkiller Vioxx.

In a lawsuit brought by Florida Attorney General Bill McCollum, the state is seeking restitution for all money spent by state health programs on Vioxx, plus interest.

Florida’s Medicaid program alone spent more than $80 million on Vioxx, once a blockbuster arthritis treatment, between 1999 and 2004. Merck pulled Vioxx from the market four years ago after its own research showed the pill doubled risk of heart attack and stroke.

The lawsuit alleges that “Merck’s costly promotional campaign was intended to convince purchasers that the drug was not only safe, but that they should demand it from their healthcare professionals for pain treatment,” according to a statement from the attorney general.

The suit also seeks civil penalties of up to $10,000 for each time that Merck’s advertising caused a Vioxx purchase to be made, an amount that a court would have to determine, according to a spokeswoman for McCollum.

“The company also allegedly tried to intimidate physicians and researchers who questioned the safety of Vioxx,” the statement adds.

Merck spokesman Ron Rogers said Tuesday that Merck acted responsibly.

The Whitehouse Station, N.J.-based company said in a statement that Vioxx was an effective pain reliever and that the company carefully studied the drug and consistently made results of its studies available to U.S. regulators and the medical community.

“We intend to defend ourselves against the complaint,” Rogers said.

Alaska, Louisiana, Michigan, Mississippi, Montana, New York, Texas and Utah have previously brought similar suits, as has New York City.

Except for the Texas case, all those suits currently are pending in New Orleans under U.S. District Judge Eldon Fallon, who is overseeing the bulk of the massive Vioxx litigation, according to Rogers.

The litigation includes a $4.85 billion settlement that will end about 50,000 lawsuits by people alleging Vioxx caused heart attacks or strokes. Several thousand other lawsuits filed by people claiming other types of injuries from Vioxx also are pending, and Merck faces two personal injury class-action suits in Canada and a class action suit by shareholders seeking to recover losses on Merck stock.

Merck has already paid out $58 million under a settlement reached in May to end allegations its ads for Vioxx deceptively downplayed health risks. That settlement ended investigations by 29 states and the District of Columbia and also required Merck to submit all new TV commercials for its drugs to the Food and Drug Administration for review.

Merck shares rose 53 cents, or 1.7 percent, at $32.09.

Copyright 2008 The Associated Press.

Drug maker plans to disclose payments to doctors

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Posted on 26th September 2008 by Gordon Johnson in Uncategorized

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Date: 9/24/2008 12:01 AM

By KEVIN FREKING
Associated Press Writer

WASHINGTON (AP) _ In an industry first, Eli Lilly and Co. says it will begin disclosing how much money it paid to individual doctors for advice, speeches and other services.

The drug company’s move comes as members of Congress push a disclosure bill in an effort to prevent such payments from improperly influencing medical decisions.

Beginning next year, Eli Lilly will disclose payments of more than $500 to doctors for their roles as advisers and for speaking at educational seminars. In later years, the company will expand the types of payments disclosed to include such things as travel, entertainment and gifts.

Some have voiced concerns that doctors are influenced by these payments in their treatment decisions and that this in turn can drive up medical bills. Although most physicians believe that free lunches or trips have no effect on their medical judgment, research has shown that these type of payments can affect how people act.

“The ethical handwriting is on the wall. Disclosure is coming. States are pushing for it, and once a few states do, it’s hard to imagine the federal government won’t line up behind,” said Dr. Arthur Caplan, director of the Center for Bioethics at the University of Pennsylvania in Philadelphia. “I think that’s a good thing because we have a great deal of empirical evidence that gift giving can influence behavior in terms of prescriptions, publishing positive findings but suppressing negative findings, and generating enthusiasm for new drugs.”

Eli Lilly was also the first drug company to publicly report its educational grants for medical conferences. Dr. John Lechleiter, president and CEO of the company, said that made good business sense for the drug industry.

“We’ve learned that letting people see for themselves what we’re doing is a good way to restore trust,” Lechleiter said.

In the past two years, lawmakers from both chambers of Congress introduced bills that would require drug and medical device manufacturers to disclose any payments to doctors exceeding $25, but the industry chafed at the strict reporting threshold. Eli Lilly had announced earlier that it intended to comply with key aspects of the legislation once some lawmakers agreed to a higher reporting threshold of $500.

Eli Lilly’s disclosure of payments to doctors will begin in the second half of 2009, and will cover payments made in the first half of the year. The company doesn’t plan to report payments from 2008 or earlier, noting that the legislation before Congress also did not contemplate such a look back. Gradually, the company plans to expand its registry to incorporate all payments that the Physician Payment Sunshine Act would require to be made public.

Lechleiter said that physicians who advise the company or speak at conferences about their experiences in treating patients take time away from their medical practice. That’s why they need to be compensated at fair, market rates.

“We’re oftentimes taking them away from their practice for a day or more,” Lechleiter said. “It’s a service that they’re providing and they deserve compensation for that.”

A handful of states and the District of Columbia already have disclosure laws for payments from drug companies to doctors. Those states are Minnesota, Vermont, West Virginia and Maine. None of those states require disclosure of payments from medical device makers.

Dr. Peter Lurie, deputy director of the health research group at Public Citizen, said the state laws can let patients know when their doctors have a connection to a drug firm, but the state laws are not working very well. The laws have various exemptions and sometimes don’t even disclose the information to the public, he said.

Lurie was skeptical that Eli Lilly’s announcement represented a step forward on the issue of more transparency in health care.

“There are dozens of pharmaceutical companies. This is just one of them. Most won’t follow this guideline at all, and there will be no enforcement,” Lurie said. “This is Ely Lilly’s attempt to forestall the federal legislation by saying we’re in effect complying anyway.”

Public Citizen, a consumer advocacy group, also objects to the $500 threshold for reporting. Lurie said it should be much lower — $25 per gift.

“Most of what will wind up being disclosed is speaker’s fees, consulting and research grants,” Lurie said. “But most people want to know more than that. They want to know about meals, travel and that sort of thing. A lot of people will be cut out by the $500 annual limit.”

Sen. Charles Grassley, R-Iowa, applauded Eli Lilly’s announcement, but he said he would continue to push for legislation that requires disclosure of physician payments by drug and medical device manufacturers.

“Consumers and taxpayers deserve a federal requirement that applies to all kinds of payments to physicians in every state in the nation,” Grassley said.

Grassley’s bill calls for penalties of $1,000 to $5,000 for failure to report a payment, with an annual cap of $250,000 for knowingly failing to report. The legislation would pre-empt state reporting requirements.

Aides to the senator said health groups such as the American Medical Association as well as trade groups such as the Pharmaceutical Research and Manufacturers of America support his legislation. The trade group PHRMA has expressed support for Grassley’s bill in the past.

Ken Johnson, senior vice president for the drug makers’ trade group, said payments to physicians are an important part of the effort to inform health care providers about such things as new treatment options, appropriate dosing and potential interactions with other drugs.

“We believe that improving transparency in such interactions is a laudable, but complex, goal,” Johnson said. “Any steps toward transparency should be structured in a way that would not chill these important exchanges.”

Copyright 2008 The Associated Press.