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#7 & #8, Counting the Bodies
Merck: 55,000 Dead McWane: Death on the Job
Source: Alternet, 2005-01-26
Candidate: Big Government
Merck: 55,000 Dead
It's not as if people in power didn't know about the impending disaster – what David Graham, a Food and Drug Administration (FDA) drug safety official, calls "maybe the single greatest drug-safety catastrophe in the history of this country.''
Testifying before a Senate committee in November, Dr. Graham put the number in United States who had suffered heart attacks or stroke as result of taking the arthritis drug Vioxx in the range of 88,000 to 139,000. As many as 40 percent of these people, or about 35,000-55,000, died as a result, Graham said.
The unacceptable cardiovascular risks of Vioxx were evident as early as 2000 – a full four years before the drug was finally withdrawn from the market by its manufacturer, Merck, according to a study released by the Lancet, the British medical journal.
"This discovery points to astonishing failures in Merck's internal systems of post-marketing surveillance, as well as to lethal weaknesses in the U.S. Food and Drug Administration's regulatory oversight," Lancet editors wrote.
Authors of the Lancet study pooled data from 25,273 patients who participated in 18 clinical trials conducted before 2001. They found that patients given Vioxx had 2.3 times the risk of heart attacks as those given placebos or other pain medications.
Merck withdrew Vioxx on Sept. 30 of this year after a company-sponsored trial found a doubling of the risks for heart attack or stroke among those who took the medicine for 18 months or more.
Merck says it disclosed all relevant evidence on Vioxx safety as soon as it acquired it, and pulled the drug as soon as it saw conclusive evidence of the drug's dangers.
"Over the past six years," Merck CEO Raymond Gilmartin told the Senate Finance Committee at the November hearing where Graham made his big splash, "since the time Merck submitted a New Drug Application for Vioxx to the FDA, we have promptly disclosed the results of numerous Merck-sponsored studies to the FDA, physicians, the scientific community and the media and participated in a balanced, scientific discussion of its risks and benefits."
Until the September clinical trial results came in, Gilmartin said, "the combined data from randomized controlled clinical trials showed no difference in confirmed cardiovascular event rates between Vioxx and placebo and Vioxx and NSAIDs other than naproxen. When data from the APPROVe study [the September results] became available, Merck acted quickly to withdraw the medicine from the market."
But there is evidence that strongly suggests a different version of the story.
The Lancet findings came in the wake of new disclosures that suggest Merck was fully aware of Vioxx's potential risks by 2000.
The Wall Street Journal revealed emails that confirm Merck executives' knowledge of their drug's adverse cardiovascular profile – the risk was "clearly there," according to one senior researcher.
"Given this disturbing contradiction – Merck's own understanding of Vioxx's true risk profile and its attempt to gloss over these risks in their public statements at the time – it is hard to see how Merck's chief executive officer, Raymond Gilmartin, can retain the confidence of the public, his company's most important constituency," the Lancet editors wrote.
Dr. Graham, the federal drug-safety reviewer, continues to seek to publish his study demonstrating the dangers of Vioxx, but he has been delayed and demeaned by top officials at the Food and Drug Administration.
At the Senate hearing, Dr. Graham said that the FDA "as currently configured is incapable of protecting America against another Vioxx," because of ties between agency reviewers and the pharmaceutical industry. Graham says that as a result of his testimony, his bosses have threatened to toss him out of the FDA's drug safety unit.
At the Senate hearing, Graham said that at least five medications currently on the market pose such risks that their sale ought to be limited or stopped. Graham named the five as Meridia, Crestor, Accutane, Bextra and Serevent.
In November 2004, Forbes.com named David Graham "face of the year."
We join with Forbes in saluting Graham "for his steadfast advocacy of drug safety and his willingness to blow the whistle on his bosses."
McWane: Death on the Job
The New York Times ran a three-part series by David Barstow and Lowell Bergman that exposed the egregious safety record of McWane Inc., a large, privately held Alabama-based sewer and water pipe manufacturer.
Nine McWane employees have lost their lives in workplace accidents since 1995. More than 4,600 injuries were recorded among the company's 5,000 employees.
According to the series, one man died when an industrial oven exploded after he was directed to use it to incinerate highly combustible paint. Another was crushed by a conveyor belt that lacked a required protective guard.
Three of McWane's nine deaths were the result of deliberate violations of safety standards. In five others, safety lapses were a contributing factor.
According to the Times, McWane pulled the wool over the eyes of investigators by stalling them at the factory gates, and then hiding defective equipment. Accident sites were altered before investigators could inspect them, in violation of federal rules.
When government enforcement officials did find serious violations, "the punishment meted out by the federal government was so minimal that McWane could treat it as simply a cost of doing business."
"After a worker was crushed to death by a forklift that apparently had faulty brakes, an Occupational Safety and Health Administration investigation found defects in all 14 of the plant's forklifts, including the one involved in the death," the Times reported. The fine was just $10,500. Employers are further protected by the workers' compensation system, which can make it hard for victims to sue."
According to the Times, in one McWane oven explosion that killed an employee, Frank Wagner, McWane "hired a well-connected lobbyist to lean on Dennis Vacco, then New York State's attorney general, and ended up with a settlement in which it did not admit responsibility for the death."
The experts who looked at the case determined that the explosion that killed him was the result of reckless criminal actions by McWane, which was operating a cast-iron foundry in Elmira, N.Y., where Wagner worked.
"The evidence compels us to act," the prosecution team wrote in a confidential memorandum to Vacco in 1996. The team urged him to ask a grand jury to indict McWane and its managers on manslaughter and other charges. A grand jury inquiry, senior investigators believed, could have taken them up the corporate ladder, the Times reported.
But Vacco never sought an indictment against McWane for any crime.
Only after an unusual intervention by the United States attorney in Buffalo, who threatened federal charges, did McWane agree to plead guilty to a state felony and pay $500,000.
"But as the company and Mr. Wagner's widow are quick to note, that charge, a hazardous-waste violation, specifically did not hold McWane accountable for Mr. Wagner's death," the Times reported.
"It was a reckless act on the part of certain individuals in that company that caused the death of that person. I'll believe that till the day I die," says Donald Snell, who supervised the state environmental agency's investigation. "The ends of justice were not met."
As the Times series showed, in plant after plant, year after year, "McWane workers have been maimed, burned, sickened and killed by the same safety and health failures."
McWane says it is changing – and it's certainly paying more attention to PR after the Times series.
"Over the last several years, our Company has embarked on significant changes that are focused on setting the industry standard in employee safety, health and environmental programs," asserts a May 2004 report from the company on health and safety.
That doesn't exactly jibe with what company managers call "the McWane way" – what federal and state regulators characterized to the Times as a "lawless" and "rogue" operation that ruthlessly sought profits with disregard for worker safety and well-being.
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