US Representative Henry Waxman has sent letters to three pharmaceutical companies and two medical device manufacturers requesting information about the way they test and market their products.
The drugmakers involved in the inquiry at this stage are Eli Lilly and AstraZeneca regarding the antipsychotics Zyprexa (olanzapine) and Seroquel (quetiapine) respectively, and Cephalon over its fentanyl painkillers Actiq and Fentora. Boston Scientific Corp and Cordis, a Johnson & Johnson unit, have also received letters relating to their drug-eluting stents.
Rep Waxman, in his role as chairman of the House Committee on Oversight and Government Reform, issued the letters as part of the Committee's ongoing inquiry into the research and marketing practices of the pharmaceutical industry and has asked for detailed information on allegations of “inappropriate” marketing of drugs, unapproved uses of stents and unwanted side effects that may not have been reported to the US Food and Drug Administration.
The choice of drugs that are being looked at comes as little surprise, not least Zyprexa. Lilly has been rarely out of the news in the last few months, amid claims that the firm kept quiet about side effects and promoted Zyprexa to doctors for unapproved uses, such as dementia, all of which have been vehemently denied.
Rep Waxman is asking AstraZeneca to provide information to deal with claims that it inappropriately marketed its schizophrenia drug Seroquel, while Cephalon has been told to explain its marketing practices for Fentora and Actiq. This comes days after the FDA warned the company about the marketing of its sleep drug Provigil (modafinil).
– Meantime, the US state of Pennsylvania is seeking compensation from Lilly, AstraZeneca and J&J over Zyprexa, Seroquel and Risperdal (risperidone). In each case, the state claims that the manufacturer persuaded doctors to prescribe the antipsychotics for unapproved uses, while hiding its risks and exaggerating its benefits.
Pennsylvania is the first state to make a claim over Seroquel, the second to sue over Risperdal and the fifth in the case of Zyprexa, The suit, which has been brought by the state Governor’s Office of General Counsel, seeks to recover both costs to the state’s Medicaid and seniors assistance programmes of reimbursing for “non-medically-accepted indications and non-medically necessary uses” of the three medicines, plus “significant sums of money” for the care and treatment of patients who, the state alleges, have been harmed by them.