Seven years after Merck withdrew Vioxx amid controversy and outrage, the drugmaker has agreed to pay $950 million to settle criminal and civil charges into the promotion and marketing of the painkiller, which was linked to heart attacks and strokes.
The settlement caps a tumultuous period for Merck, the pharmaceutical industry and the FDA. Although there were earlier episodes in which scandal erupted over promotional efforts and the extent to which safety risks were adequately disclosed - such as the fen-phen diet pills sold by Wyeth and the Rezulin diabetes pill sold by Warner-Lambert - the Vioxx debacle ushered in a new era.
During the intervening years, Vioxx has become synonomous with a growing skepticism that drugmakers can be trusted to put patients ahead of profits. Several other large drugmakers, in fact, have similarly paid large fines - in some cases, much larger - to settle charges that they illegally promoted or hid the risks associated with their drugs. Among them were Pfizer and Eli Lilly.
For Merck, the Vioxx episode unraveled what once was a venerable reputation that was built on emphasizing innovation, seemingly high standards and a devotion to patients. Now, the drugmaker, which subsequently reached a $4.85 billion settlement with patients in the US, has come to be seen as just another marketing machine that vies for shareholder attention.
Like the settlements involving its rivals, there is no indication that any current of former Merck exec will be held accountable, even though the feds have often signaled a desire to single out execs who can be seen as responsible for such illegal activities. In its own statement, the drugmaker says that, as part of its plea agreement, the US "acknowledged that there was no basis for a finding of high-level management participation in the violation" (see here). The Office of Inspector General at the US Department of Health & Human Services has wanted to exclude, or ban, execs from doing business with federal health care programs, such as Medicaid.
An attempt to do so last year involving Forest Laboratories ended in embarrassment when the HHS OIG quietly concluded its effort without any explanation (see here and here). Four former Purdue Pharma execs, who pleaded guilty to a criminal misdemeanor in connection with the misbranding of the OxyContin painkiller, are currently fighting an OIG ban (read here).
The settlement calls for a subsidiary known as Merck, Sharp and Dohme to plead guilty to a misdemeanor for its illegal promotional activity and pay a $321.6 million criminal fine for a single violation of the Food Drug and Cosmetic Act for introducing a misbranded drug into interstate commerce (here is the information sheet and the settlement agreement).
The drugmaker is also entering into a civil settlement agreement under which it will pay $628.4 million to resolve additional allegations of off-label marketing and false statements about Vioxx cardiovascular safety. Of the total civil settlement, $426.4 million will be recovered by the federal government, and the rest will be shared by participating states whose Medicaid programs suffered losses as a result.
Merck’s criminal plea relates to misbranding Vioxx by promoting the drug for treating rheumatoid arthritis before this indication was approved by the FDA. The agency had approved the painkiller in May 1999 for three other indications and issued a September 2001 warning letter for marketing the drug for rheumatoid arthritis. The civil settlement covers a host of other illegal activities, such as allegations that sales reps made inaccurate, unsupported or misleading statements about cardiovascular safety in order to increase sales, which prompted overpayment by Medicaid. Merck also signed a Corporate Integrity Agreement, which requires execs to file annual compliance certifications and post info about payments to docs on its website (you can read the CIA here).
“Today’s resolution appropriately reflects the severity of Merck’s conduct," US Attorney Carmen Ortiz in Boston says in a statement. “Any marketing activity that ignores the importance of FDA approval, or that makes unsupported safety claims about a drug is unacceptable, and will be pursued vigorously in both the criminal and civil arena.”
benjamins pic thx to amagill on flickr
3 Comments
"Just business as usual" no real consequences, built into the price of the drugs, no criminal penalties...still made a hefty profit....haven't we seen this all played out before...sign a CIA and go back to work making money first & foremost by any and all means possible... who's going to report on the victims...you know; those poor suckers that had their lives ruined or ended...I'm not seeing or hearing any headlines talking about them and their fate....just another big dollar fine news headline and done...and that reported $4.85 billion settlement to patients... http://www.bloomberg.com/news/2010-07-27/merck-paid-3-468-death-claims-to-resolve-vioxx-suits.html
....most goes to the lawyers...here are some numbers reported in 2010.
Now remember to deduct half or more from the following figures for lawyers fees, distribution firms, and hold backs such as medicare, medicaid, and any other holds/liens..
The average payment for all heart attack cases was $186,825. The payments for fatal heart attacks ranged from $18,743 to $1.79 million, with the average at $374,112.
The law firm concluded that 12,447 stroke claims merited payment, including the 590 death cases. Average payments for all stroke cases was $61,165. Payments for fatal strokes ranged from $5,015 to $818,119, with the average at $119,618.
Then factor in the years of suffering, the waiting, the forever health damage, loss of productivity, diminished quality of life and the deaths... this is what a human life is worth to the pharmaceutical industry; even when they get caught criminally red handed...shameful ----------------------------------------- http://www.thetowntalk.com/article/20111122/BUSINESS/111122012/Merck-plead-guilty-pay-950-million-over-Vioxx-marketing?
In its statement, Merck emphasized the civil settlement first, noting that it "does not constitute any admission by Merck of any liability or wrongdoing."
"We believe that Merck acted responsibly and in good faith in connection with the conduct at issue in these civil settlement agreements, including activities concerning the safety profile of Vioxx," said Bruce N. Kuhlik, the company's executive vice president and general counsel. He did not comment on the criminal charge.
Merck's release also notes that "the United States acknowledged that there was no basis for a finding of high-level management participation in the violation." ------------------------------------------
Vioxx, Avandia, Zyprexa, Seroquel, Risperdal, Paxil, Phen Fen...and the list just goes on and on...lives ruined or ended and then just forgotten...that's what News has become...forget about the humanity...just play the headline numbers game...
Be aware of drugs that potentiate diabetes. Eli Lilly Zyprexa Olanzapine issues linger.
The use of powerful antipsychotic drugs has increased in children as young as three years old. Weight gain, increases in triglyceride levels and associated risks for diabetes and cardiovascular disease. The average weight gain (adults) over the 12 week study period was the highest for Zyprexa—17 pounds. You’d be hard pressed to gain that kind of weight sport-eating your way through the holidays.One in 145 adults died in clinical trials of those taking the antipsychotic drug Zyprexa. This was Lilly's #1 product $5 billion per year sales,moreover Lilly also make billions more on drugs that treat diabetes.
--- Daniel Haszard Zyprexa victim activist and patient. FMI zyprexa-victims(dot)com
No question led to the FDAAA, with all its compromises, and a range of damning studies of FDA post-marketing surveillance, REMS, etc.
But do people think we are in a "new era" since 2004--in public attitudes, awareness, trust, FDA effectiveness, industry self-reg, "transparency," etc.?