Recently a couple of posters took issue with some things that I said about the FDA in the comments section of a Booman post titled Perry’s Gaffe Was Minor. One of them posted “Arthur, you are a moron. The FDA is one of the most important agencies we have.” Another said “Shorter Arthur: sometimes, the FDA allows things to happen that I would allow to happen all the time, so therefore it’s bad. “
Read the article below the fold and weep.
The VIOXX Settlement-Merck Pays a Pittance for Mass Deaths
A little teaser for the undecided:
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?
Read on.
Q: Who killed more Americans –al Qaeda crashing airplanes into the World Trade Center, or Merck pushing Vioxx?
A: Merck, by a factor of 18.
One of the most downplayed stories of our time ended with a whimper this week. “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 director’s office, devoted valet of Big PhRMA, had contacted the Lancet in a futile effort to stop publication of their own scientist’s findings.
Graham’s data indicate that 140,000 Americans suffered Vioxx-induced heart attacks and strokes; 55,000 died, and many more were permanently disabled. The Merck executives’ real crime was conspiracy to commit murder.
Some 3,000 Americans died in the attack on the World Trade Center. The murders perpetrated by Merck executives were not as dramatic, obviously, but were every bit as intentional. An early clinical trial had alerted them to the fact that Vioxx caused coronary damage. Their response was to exclude from future trials anyone with a history of heart trouble!
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 420,000.
—snip—
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.” The survivors of people who smoked cigarettes, were overweight or had other risk factors would have been discouraged by lawyers from filing claims, he added, because they’d have a hard time convincing jurors that their loved ones’ heart attacks were brought on by Vioxx use.
“No person was held liable for Merck’s conduct,” Duff Wilson of the Times reported Nov. 23. To be fair-and-balanced in an otherwise Merck-friendly story, he quoted Erik Gordon of the University of Michigan’s Ross School of Business, commenting “It’s just a cost of doing business until a pharmaceutical executive does a perp walk.”
That sounds tough but it isn’t. 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.”
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?
Read it and weep.
The entire system is rotted through, folks. It’s just a matter of time before it all comes tumbling down unless something truly radical is done to cleanse this kind of money-driven rot out of the system. Ron Paul is only national candidate who is presenting a viable solution or even acknowledging the scope of the problem…decentralize things so that massive lobbying systems like this Big Pharma scam can no longer buy nationwide get-out-of-jail-free cards under the cover of a huge (and almost impenetrably secretive because of its immense size) federal apparatus.
Wake the fuck up.
Every other candidate is in the pocket of this system. Every one. They are all bought and sold, right on up the line from that asshole Santorum to our OH so glib good cop Preznit Obama.
Wake the fuck up.
They’re killin’ us.
AG
