(Martha Rosenberg)
Toxic assets. Unsafe drugs. Ponzi schemes. Safety studies that were never conducted. Indecent profits footed by taxpayers. Medicaid fraud about patent drugs. Mayday mergers? Pfizer/Wyeth, Merck/Schering-Plough. New business models after investment-banking crashed? Hello biologics and vaccines.
While the nation gasps at AIG and Fannie Mae losses, pharma is running a strong second with Merck paying out $4.85 billion for Vioxx, Pfizer paying $2.3 billion for Bextra (and $430 million for Neurontin), and Lilly paying $1.4 billion for Zyprexa.
Nor will settlements cease after March’s Wyeth vs. Levine Supreme Court ruling, which found that regulator approval doesn’t trump personal injury lawsuits. Expect cases over fen-phen, Baycol, Vytorin, Ketek, Avandia, Bextra, Celebrex, Prempro, Premarin, Zyprexa, Risperdal, Seroquel, Lexapro, Celexa, Cymbalta, Fosamax, Boniva, Effexor, Lyrica, Geodon, (pant, pant), Ablify, Zoloft, Paxil, Prozac, Chantix, Singulair, Ambien, and Trovan to reach the courts.
Of course you can blame the Bush Administration’s FDA packed with industry vets who waved their buddies’ new drugs through after six-week trials for the iffy drugs. You can blame ghostwriters, “bought” doctors, and direct-to-consumer disease advertising for getting them in medicine cabinets and on formularies.
But it’s the public that asks itself, “Do I have restless legs syndrome, social phobia, fibromyalgia, and non-restful sleep?”
Still, the days when pharma reps would drive up to the state mental hospital and just ask for the order are clearly over. (In four years, Pfizer reps made over 200 visits to Western State Hospital in Tacoma, Wash., where 118 prescriptions of controversial Geodon are written a day.)
So are the days when reps could just slide by the nursing home to see how their Seroquel, Risperdal, and Zyprexa scripts were doing—elderly warning label notwithstanding—or collect their post-traumatic-stress-disorder veteran “dividend” from psychoactive drugs for combat and post-combat.
Gone, too are the automatic antipsychotic and antidepressant prescriptions for the poor, mentally challenged, and children on Medicaid, now that the drugs are causing diabetes, and the states are suing. Antipsychotic drugs for children under 6 have dropped by 75 percent since the state of Florida began requiring physicians to receive prior approval, according to the St. Petersburg Times.
Few third-party payers and benefits managers are cooperating with the “patent drug two-step,” in which once-a-week or time-release formulations are billed as breakthroughs. And even pharma’s continuing medical education courses at universities—which “teach” doctors a sales pitch—are under the ethical microscope.
Part of the problem is pharma can’t stop shooting itself in the foot.
Just as the public forgets that Merck/Schering-Plough’s miracle cholesterol drug Vytorin was worthless and even harmful, that Merck’s bone drug Fosamax sometimes fractured the bones it was supposed to strengthen and causes esophageal cancer and osteonecrosis, and just as people were forgetting that Wyeth’s hormone drug Prempro causes breast cancer, new subterfuge surfaces.
In February, New York-based Forest Laboratories was charged in U.S. District Court in Boston with illegally marketing antidepressants Celexa and Lexapro, for burying a damning FDA study, and paying Dr. Jeffrey Bostic, director of school psychiatry at Massachusetts General Hospital, $750,000 a year to promote illegal pediatric drug uses. (FDA approved Lexapro for adolescents in March—oblivious to the Justice Department complaint. Is the FDA bipolar?)
In March, London-based AstraZeneca was charged in U.S. District Court for the Middle District of Florida, in Orlando, with covering up the diabetic side effects of its atypical antipsychotic Seroquel. Its U.S. Medical Director for Seroquel, Dr. Wayne MacFadden, is accused of having affairs with two women responsible for Seroquel’s “safety” studies.
Bet they’re looking for jobs too.
Martha Rosenberg is a freelance writer.