Big Pharma death count for VIOXX

Q: Who killed more Americans —al Qaeda with hijacked airplanes on 911, or Merck with Vioxx?

Answer: Merck, by a factor of 18.

“Merck has agreed to pay $950 million and has pleaded guilty to a criminal charge over the marketing and sales of the painkiller Vioxx,” the New York Times reported Nov. 23 (in the business section, where important medical news is usually found). The pharmaceutical giant copped to a misdemeanor: urging MDs to prescribe Vioxx for Rheumatoid Arthritis prior to 2002, when the Food & Drug Administration approved its use for that disorder.

The FDA had initially approved Vioxx (after a hasty “priority review”) in May, 1999 to treat osteoarthritis, acute pain, and menstrual cramps. By September 30, 2004, when Merck announced its “voluntary recall,” some 25 million Americans had been prescribed the widely hyped drug. Evidence that using Vioxx doubled a patient’s risk of suffering a heart attack or stroke —based on a review of 1.4 million patients’ records— was about to be published in Lancet by David Graham, MD, an FDA investigator. The FDA’s Office of New Drugs, devoted valet of Big PhRMA, had contacted the Lancet in a futile effort to stop publication of their own scientist’s findings.

In November 2004, according to the Union of Concerned Scientists, “Dr. Graham testified that the FDA’s failure to recall the arthritis drug Vioxx earlier resulted in as many as 55,000 premature deaths from heart attacks and stroke.” The Merck executives’ real crime was conspiracy to commit murder.

Once Vioxx was approved, Merck spent more than $100 million a year advertising it. (You may still remember the tune to “It’s a beautiful morning…”) Merck execs continued to ignore and suppress indications that their new blockbuster was causing strokes and heart attacks. Sales hit $2.5 billion in 2003. And when brave Dr. Graham first presented his irrefragable evidence to an FDA advisory committee in February 2004, Merck argued that the “unique benefits” of Vioxx warranted its remaining on the market. The FDA committee voted 17-15 to keep it available with a black box warning. Ten of the 32 committee members had taken money from Merck, Pfizer or Novartis (which were pushing drugs similar to Vioxx) as consultants. If these MDs had declared their conflicts of interest, Vioxx would have been pulled from the market by a vote of 14-8. By buying an extra seven and a half months, Merck made an extra billion or two, and killed 6,000 more Americans.

WORLDWIDE, VIOXX WAS USED BY 80 MILLION PEOPLE. ASSUMING THEIR DOSAGES WERE SIMILAR TO THE 1.4 MILLION KAISER PERMANENTE PATIENTS WHOSE RECORDS DR. GRAHAM ANALYZED, THE DEATH TOLL EXCEEDS 165,000.

Let the punishment fit the crime
In 2007 Merck paid out $4.85 billion to settle claims by 27,000 Vioxx victims and their survivors. “The reason ‘so few’ people filed lawsuits,” a physician explains, “is that there is a significant background rate of heart attack. People may not have recognized their event as being related to Vioxx.”

“No person was held liable for Merck’s conduct,”

[SO MUCH FOR PERSONHOOD CLAIMS, W.

Marketing dangerous drugs would still be “just a cost of doing business” to profit-driven corporations if a few individual execs were made to do time at Camp Fed. Why shouldn’t they be charged with conspiracy to commit murder, along with every accessory to the crime that a thorough investigation could identify? (This could provide meaningful work for the currently useless Drug Enforcement Administration.) The Vioxx conspiracy involved researchers who skewed data and sales execs who framed false pitches and government officials who tried to silence whistleblowers and God knows who else… If somebody is killed in a botched robbery at a Seven Eleven, the kid driving the getaway car is charged with homicide. But Merck’s CEO throughout the Vioxx era, Ray Gilmartin, left the company in 2006 with a golden parachute and joined the Harvard Business School faculty. The class he teaches is called “Building and Sustaining Successful Enterprises.”O.]

And there’s More:

A more effective way to counter deadly corporate fraud would be for the government to simply stop doing business with entities convicted of major crimes. If MediCare and state Medicaid programs stopped buying Merck or Pfizer drugs for, say, five years, it just might produce the result that we, the people, require.

The day before the Vioxx settlement was reported, the Wall St. Journal ran a story (in the Marketplace section) under the headline “Pfizer Near Settlement on Bribery.” The corporate boo-boo in this instance involved pay-offs to doctors who purchase drugs for state-owned institutions overseas. Johnson & Johnson recently settled a similar bribery case. Merck, AstraZeneca, Bristol-Myers Squibb, and GlaxoSmithKline are all in settlement negotiations with the government.

On the home front, Pfizer has paid $2.3 billion for violating the federal False Claims Act and bribing institutional purchasers in connection with Bextra, Lipitor, Viagra, Zithromax, Norvasc, Lyrica, Relpax, Celebrex, and Depo-provera.

The systemic corruption is getting worse. In the 15 years between 1991 and 2005, according to Public Citizen, drug companies paid the government $5 billion in penalties and settlements in connection with kickbacks and false claims. In the five years between 2006 and 2010 the pay out was $14.8 billion. Four companies accounted for more than half the blood money ($10.3 billion): Glaxo, Pfizer, Eli Lilly, and Schering-Plough.

In recent years the drug industry has surpassed the “defense” industry as the top defrauder of the federal government under the False Claims Act.

Where is zero tolerance when we need it? end

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