Tag Archives: Avandia

Justice to Pharma: “Do the Perp Walk!”

Former GSK counsel is the first target in government’s executive-liability crackdown. Could J&J be next? The US Department of Justice filed criminal charges last week against Lauren Stevens, a former VP and assistant general counsel at GlaxoSmithKline. Going after pharma execs marks a seismic shift in the government’s efforts to stem the tide of fraud and other illegal pharma marketing practices, which a raft of billion-dollar settlements have so far failed to end. Stevens is charged with obstruction of an investigation, concealment and falsification of documents, and making false statements to the FDA in its 2002 investigation of off-label promotion of the antidepressant Wellbutrin for weight loss, an indication for which it has never been approved but has shown some clinical benefit. The DoJ says that it has evidence, in the vast paper and electronic documentation turned over by GSK, showing that Stevens hid and otherwise misled the agency about some 1,000 instances of GSK-paid doctors promoting Wellbutrin for weight loss to other doctors.

When Big Pharma Breaks the Law—Prosecute the CEO

Since 2004, pharma has paid over $7 billion in fines and penalties, but even these figures barely dent profits. The $2.3 billion fine Pfizer paid in September 2009 for the way one of its subsidiaries marketed Bextra, the non-steroidal anti-inflammatory drug, and three other drugs, was the biggest ever paid by a corporation in the US. Yet the fine was just 14 per cent of $16.8 billion revenue from the drugs from 2001 to 2008, little more than the price of doing business.

Public ‘misled’ by drug trial claims

Doctors and patients are being misled about the effectiveness of some drugs because negative trial results are not published, experts have warned. Writing in the British Medical Journal, they say that pharmaceutical companies should be forced to publish all data, not just positive findings. The German team give the example of the antidepressant reboxetine, saying publications have failed to show the drug in a true light. Pfizer maintains its drug is effective. Reboxetine (Edronax), made by Pfizer, is used in many European countries, including the UK. But its rejection by US drug regulators raised doubts about its effectiveness, and led some to hunt for missing data. This is not the first time a large drug company has come under fire about its published drug trial data.