Prescription Shakedown Litigation Projection

  • by: |
  • 10/20/2008
Fred Baron, the tort lawyer who helped write the book on how to attack Merck and Pfizer on COX-2 liability, rolled out heavy hitters in the Democratic party to lobby Biogen to grant him a compassionate use of Tysabri to treat his late stage multiple myeloma.

I hope and pray it works for his sake and everyone else's suffering with the disease including my boyhood friend's mom who has gone through every other drug for the disease but who has now relapsed.

"Biogen Idec is running an early-stage trial of the drug in multiple myeloma, but Baron doesn’t meet the criteria to participate.

Baron’s a prominent donor to the Democratic party, and many of his powerful friends, including Lance Armstrong and Bill Clinton, made appeals on his behalf. And the family agreed not to sue if anything goes wrong."

Gee, why didn't he think of that when it came to Celebrex which generated billions for Pfizer and also had anti-cancer properties that were being studied until Baron's tactics were deployed in lawsuits against the the product: Ironically, Tysabri was yanked from the market in the wake of the Vioxx withdrawal...

Pfizer, the world's biggest drugmaker, has reached a settlement in thousands of cases involving two prescription painkillers." The company announced Friday that "it had agreed to set aside $894 million to settle virtually all the lawsuits related to its withdrawn painkiller Bextra (valdecoxib) as well as a similar drug that remains on the market, Celebrex (celecoxib)," the New York Times (10/18, B2, Saul) added. The agreement "comes approximately one year after Merck announced a $4.85 billion reserve to settle litigation involving the similar painkiller Vioxx (rofecoxib)."

In 2004, Celebrex and Vioxx, "part of a class of drugs called Cox-2 inhibitors," were found "to increase the risk of heart attacks and strokes, especially in patients who took them steadily over long periods of time," the Los Angeles Times (10/20, Healy) notes. And, despite several trials that have shown that Celebrex may "offer a real prospect of preventing cancer," Pfizer "called off a number of clinical trials...and abandoned efforts to have the drug's cancer-prevention qualities recognized by the Food and Drug Administration" after "Vioxx was withdrawn from the market."

 

Note the amount of cash Pfizer had to fork over to various special interests in a decision that had nothing to do with with real risks of the drug, including the Prescription Access Litigation Project which is a limited liability corporation that funds and reports directly to Community Catalyst which also runs The Prescription Project.

"The Pfizer agreements...came after several pre-trial court rulings in the company's favor," according to Amy Schulman, Pfizer's general counsel. In one case, a district judge "who oversaw the federal cases in San Francisco" ruled that "there was insufficient scientific evidence that Celebrex caused heart attacks or strokes at the 200-milligram dose."

There is a certain degree of chutzpah requried to push for the off-label use of a drug to save your life when you have made millions perfecting a strategy employed by an organization that launches lawsuits based on the principle that off-label prescribing is inherently deceptive. I have to say I admire it and would do anything to keep living as well. As I said at the outset, I hope Baron responds and lives a long and healthy life. As for the Prescription Shakedown Project...that's another matter entirely...
CMPI

Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.

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