Wednesday, November 10, 2004

HEALTH CARE: The Merck-y Case for Tort Reform
The Merck-y Case for Tort Reform

Mounting evidence suggests that, for at least five years, pharmaceutical company Merck aggressively concealed evidence that its painkiller Vioxx was associated with an increased risk of heart attack and stroke – recklessly endangering tens of millions of people. Meanwhile, the Bush administration is working actively to ensure that drug companies like Merck don't have to pay one red cent to the patients they harm. In December 2003, FDA Chief Counsel Daniel Troy promised a group of drug industry lobbyists that "the FDA would exercise its intervention powers to protect [drug industry] defendants" from lawsuits. The FDA's actions back up Troy's words. Since Bush took office, the FDA or Department of Justice has intervened repeatedly in cases on behalf of pharmaceutical company defendants, each time claiming the FDA's own judgment to approve the drug means that drug companies can't be held responsible. The administration's broader tort reform agenda – including caps on how much a patient can recover – would provide further protection for companies like Merck. If the Bush administration gets its way, drug companies like Merck will be able to push products they know are dangerous to the public with impunity.

MERCK KNEW ABOUT THE DANGERS OF VIOXX FOR YEARS: An e-mail written on 3/9/00 by Merck's research chief, Edward Scolnick, acknowledges that results of a study conducted by a company showed cardiovascular events "are clearly there" among those who take the drug. The data showed "a fivefold increase in heart attacks in patients taking Vioxx compared with those taking an older painkiller, naproxen." Scolinick's e-mail, obtained by the Wall Street Journal, called the results "a shame," especially since the risk of heart attack or stroke was "mechanism based," meaning it was a risk inherent in Vioxx.

MERCK WILLFULLY COVERED UP THE DATA: The following month, Merck released a press statement saying the data from the trial showed "NO DIFFERENCE in the incidence of cardiovascular events" between Vioxx and older painkillers like aspirin. The WSJ also obtained a 16-page internal training document entitled "Dodge Ball Vioxx." Each of the first 12 pages lists one question that may be raised by doctors, including, "I am concerned about the cardiovascular effects of Vioxx" and "The competition has been in my office telling me that the incidence of heart attacks is greater with Vioxx than Celebrex." The last four pages contain a single word written in capital letters: "DODGE!"

MERCK THREATENED ACADEMICS WHO RAISED QUESTIONS: Merck attacked medical researchers who raised questions about Vioxx's safety. A Merck official called the Stanford Medical School to complain that a professor there, Gurkipal Singh, was giving lectures that were "irresponsibly anti-Merck and specifically anti-Vioxx." On the call, the Merck official, Louis Sherwood, said if Singh's conduct continued "Dr. Singh would 'flame out' and there would be consequences...for Stanford." Other academics (and their superiors) received similar calls.

MERCK UNDER CRIMINAL INVESTIGATION: The Justice Department and the Securities and Exchange Commission have launched criminal investigations into Merck's conduct. The Justice Department probe is investigating allegations that "Merck misled regulators or perhaps caused federal health programs to pay for the prescription drug when its use was not warranted."

VIOXX SHOULD HAVE BEEN PULLED BY THE FDA MORE THAN THREE YEARS AGO: There is another reason why FDA approval should not insulate pharmaceutical companies like Merck for liability: the FDA hasn't been doing its job. Jerry Avorn, a Harvard University drug safety expert, described the probes by the Justice Department and the SEC as "doing the FDA's work at a time when the FDA has been asleep at the switch in its regulatory function." Avorn's view is bolstered by a recent study in the prestigious medical journal Lancet that found Vioxx's "heart risk was evident in studies four years before the drug was recalled." By the end of 2000, "the evidence was strong enough to initiate discussion of whether the drug should be recalled." The Lancet study concluded that "too often the FDA saw and continues to see the pharmaceutical industry as its customer – a vital source of funding for its activities – and not as a sector of society in need of strong regulation." Sen. Charles Grassley (R-IA) said, "It looks like the FDA saw a lot of red flags from the beginning. The agency must address what looks like systemic problems when it comes to putting safety first and public relations second."

MERCK'S IRRESPONSIBLE ADVERTISING BLITZ: Why did 20 million people take Vioxx when, for most, it was no more effective at pain relief than aspirin? Marketing. In 2003, Merck spent half a billion dollars marketing Vioxx to health care professionals. In 2000, Merck spent more money advertising Vioxx to the public ($160 billion) than was spent marketing Budweiser ($146 billion) or Pepsi ($125 billion).