The news last week was filled with various reports concerning the manner in which pharmaceutical manufacturers market their products, such as OxyContin, anemia medicines, and atypical psychotics, including ways in which doctors are encouraged to prescribe their products, even to children. The U.S. Senate passed, by a vote of 93-1, a bill that gives the Food and Drug Administration additional authority to regulate drug advertising, among other powers such as the ability to order changes in drug labels.
The bill was passed in large part as a reaction to the experience with Vioxx, where it took 14 months to change the drug’s label to warn doctors and patients of known dangers. A bill in the House of Representatives is expected to be passed by July.
Perhaps coincidentally, also last week the maker of the powerful painkiller OxyContin, Purdue Pharma LP, and three current and former executives pleaded guilty and agreed to pay $634.5 million to settle criminal and civil claims they misled doctors and the public about the drug’s risk of addiction. The plea came two days after the company agreed to pay $19.5 million to 26 states and the District of Columbia to settle complaints that it encouraged physicians to overprescribe OxyContin.
Anemia medicines are used to treat anemia caused by kidney disease or cancer chemotherapy, and a recent FDA report suggests that their use might need to be curtailed in cancer patients. These medicines clearly help correct severe anemia. The concern is that they are being prescribed in super high doses to patients who have moderate anemia, which can shorten rather than lengthen patients’ lives. It has been revealed that Johnson & Johnson and Amgen are paying hundreds of millions of dollars to doctors a year in return for giving anemia medicines to their patients. These medicines are Aranesp, Epogen and Procrit, generically known as epoetin and darbepoetin, or EPO. The payments are legal, because there is no violation of the federal prohibition against drug companies from paying doctors to prescribe specific medicines. But drug companies are allowed to rebate to doctors part of the price the doctor pays for drugs that the doctor dispenses in the office as part of treatment. The rebates are related to the amount of drugs that physicians buy; higher rebates are given where a doctor agrees to use one company’s drugs exclusively.
In psychiatry, increasing payments to doctors have coincided with the growing use in children of atypical antipsychotics, a relatively new class of drugs. These include Risperdal, Seroquel, Zyprexa, Abilify and Geodon, manufactured by Johnson & Johnson, Eli Lilly and AstraZeneca.
Controversy surrounds the increasingly common diagnosis of pediatric bipolar disorder. An FDA report found that in 2006 at least 29 children died and at least 165 suffered serious side effects in which an antipsychotic was listed as the primary suspect. In 2000, there were at least 10 deaths and 85 serious side effects among children linked to the drugs. Payments to doctors often take the form of payments to deliver drug marketing lectures discussing the medicines.
In Minnesota, the only state that requires public reports of drug company marketing payments to physicians, drug maker payments to psychiatrists rose more than sixfold, to $1.6 million, from 2000 to 2005. During those years, prescriptions of antipsychotics for children in Minnesotas Medicaid program rose more than ninefold.
If you believe that you have been harmed by a dangerous drug, please contact our office to speak with a personal injury attorney who will try to help. The personal injury lawyers at Levine & Slavit have decades of experience in handling personal injury claims involving dangerous and defective products . If you or someone close to you has been injured by a drug that was not properly labeled, contact the offices of Levine & Slavit in for their help. Levine & Slavit has offices in Manhattan and Long Island, handling cases in New York City, the Bronx, Brooklyn, Queens and surrounding areas including Westchester County.