Pharma 101 - Pharmaceutical Fraud

Archive for April, 2006

ARE CLINICAL DRUG STUDIES BEING MANIPULATED?

 A pharmaceutical company can violate the false claims act by submitting false statements in connection with drug applications and other records to the United States Food and Drug Administration (”FDA”).  For example, clinical trial results can involve false statements; and subsequent false statements and claims in marketing materials promoted to the medical community and other health care providers, can cause the submission of hundreds of millions of dollars worth of claims to Government Healthcare Programs in violation of the False Claims Act. This can occur by the misrepresentation of data i.e. overstating a drug’s efficacy or safety in order to generate sales for uses that are marginally effective or even unsafe. These fraudulent acts deceive the FDA and physicians as well as jeopardizing the lives of seriously ill patients.

In the Op-Ed section of the April 25, 2006, Los Angeles Times, Shannon Brownlee suggests that if consumers want honesty, clinical research for drug studies need to be publicly funded. She cites that, “…two-thirds of clinical trials and three-quarters of the papers published in the top medical journals commercially funded, the drug industry has gained unprecedented leverage over what doctors and patients know — and don’t know — about drugs.” While researchers may dispute the implication that their results are manipulated, Ms. Brownlee cites the following: “The recent case of drugs known as atypical antipsychotics is instructive. These new and expensive drugs, with sales of about $10 billion annually, are used to treat serious mental illnesses such as schizophrenia. Earlier this year, the American Journal of Psychiatry published an analysis of 30 separate trials involving head-to-head comparisons of five drugs. Nine out of 10 times, the drug made by the company that funded the study came out on top. When Eli Lilly, the maker of Zyprexa, funded five studies of its drug, Zyprexa was found superior in all five. But when Janssen, the maker of Risperdal, ran its studies, Risperdal came out ahead.”
She suggests that,”.. If we want high-quality medical care, dozens of other drugs — as well as medical devices and non-drug treatments should be subjected to… noncommercial scrutiny.”

Industry Drug Studies Can Mislead

Article Says Industry Drug Studies Can Mislead, With Results Often Favoring Test Company’s Product

An article in The Wall Street Journal Europe discusses how trials conducted by drug companies and those conducted by the government and other public entities may produce varied results, prompting some to ask whether the research establishment needs to be reoriented toward publicly funded studies.

For example, an analysis published in the American Journal of Psychiatry found that in every publicly available trial funded by the pharmaceutical industry pitting five new antipsychotic drugs against one another, nine in 10 showed that the best drug was the one made by the company funding the study. The authors point out that the discrepancies may result from biases in design and interpretation.

Experts say the problem is exacerbated in areas of medicine where the goal of trials is not to demonstrate cures but to measure symptomatic relief, which allows more latitude in how the results are interpreted and marketed. (The Wall Street Journal Europe)