Killing People for Profits....and Other Drug Company News (Joe Rothstein's Commentary)

August 20, 2008

By Joe Rothstein, Editor
USPoliticstoday.com

Buried in a brief filed at the U.S. Supreme Court the other day by ten current and former editors of the prestigious New England Journal of Medicine is this heart of darkness claim that's received all too little public attention:

“Pharmaceutical companies at times learn about dangers caused by their drugs long before the FDA does, but have failed to disclose this information to the FDA. Thus, as exemplified by the cases of Pondimin/Redux, Vioxx, and Trasylol, the drug companies have withheld key information from the FDA and ardently negotiated against stricter label warnings ---- all the while continuing to market their unsafe drugs to an unsuspecting public.

“In the case of these three drugs alone, literally tens of thousands of American lives have been lost or ruined long after the manufacturers realized that the drugs were not safe.”

That's quite an accusation. Tens of thousands of American lives....lost from deliberate withholding of information about their dangers....while profits poured in from unsuspecting users….

And the charge is leveled not against no-name fly-by-nighters. The companies that developed the three drugs in question are Merck, Wyeth and Bayer---industry giants.

The FDA estimates that nearly one hundred million Vioxx prescriptions were sold between 1999 and 2003. Vioxx sales generated approximately $2.5 billion dollars in sales revenue each year that this popular painkiller was available on the market. In November 2004 the FDA estimated that the number of U.S. Vioxx deaths totaled approximately 28,000 as a result of Vioxx-induced heart attacks and other fatal cardiovascular events.

These three drugs are noteworthy for the revenue they produced before being yanked from the market, but they don't stand alone. In fact, according to the GAO more than half of all drugs approved by the FDA turn up with at least one serious health risk not recognized before approval.

The FDA's approval of a new drug usually comes after a series of clinical trials. Who conducts those trials? The drug company that developed the drug. The FDA does no independent testing. It relies on information provided by the party most interested in bringing the drug to market----the drug manufacturer. Numerous recent studies of the FDA have underscored how overmatched it is against the $700 billion pharmaceutical industry.

As dangerous as this system is for the consumer, it could get much worse very quickly. In November the U.S. Supreme Court will hear a case that could decide whether FDA decisions on drug safety and adequacy will override regulations by individual states.

The case involves a Vermont musician by the name of Donna Levine who went to a hospital emergency room to get relief from severe migraine and wound up having her arm amputated because a nausea medicine, Phenergan, was wrongly administered. Levine successfully argued in Vermont courts that even though Phenergan labeling complied with FDA requirements, the adequacy of the warning still wasn't established.

Wyeth, the maker of the drug, has appealed the $6 million verdict to the U.S. Supreme Court on the grounds that FDA approval gives it blanket immunity from state laws challenging safety, efficacy or labeling. The doctrine at stake is known as federal preemption of state laws. The Supreme Court will hear the Levine case November 3.

The Levine case has evolved into a major test of state rights versus federal rights, and ultimately it's about the rights of citizens versus the rights of corporations.

It should come as no surprise that the Bush administration has jumped into the case on the side of the drug company, along with the U.S. Chamber of Commerce and other business groups.

Arguing against the drug company are 47 state attorneys general, former FDA commissioners, the AARP, a number of medical groups, Senate Judiciary Chairman Patrick Leahy and other members of Congress and a long list of constitutional experts. The New England Journal of Medicine also weighed in on the side of the states. That's the brief that charges the drug companies with knowingly withholding information from the public that led to so many deaths.

Could there be a more damning statement against a company than that it let people die to enhance its profits?

You might think that given recent corporate history of gross irresponsibility and all the product liability cases it spawned against the pharmaceutical companies, the Supreme Court would not sanctify a system in which the public's interest is left to their tender mercies through the vehicle of the FDA. But earlier this year the corporate-friendly Supreme Court immunized medical device makers from state lawsuits.

The next administration and the next Congress will have a long to-do list to unwind much of the damage of the Bush years. Strengthening the FDA, reining in the pharmaceutical companies, and quite possibly the passage of major legislation reversing court decisions adverse to the public interest---are important additions to that list.

Joe Rothstein is a veteran national political strategist and media producer and editor of USPoliticstoday.com. He can be contacted at joe@ipdgroup.com.