Tag Archives: Justice Department

American Psychiatric Association’s Interests in Conflict

At the annual American Psychiatric Association meeting in New Orleans this summer, 200 protestors chanted “no conflicts of interest” and held up photos of individual doctors outside the convention center. Inside the hall, their charges were verified. The meeting’s Daily Bulletin disclosed that the APA president himself, Alan Schatzberg, has 15 links to drug companies including stock ownership and serving on a speakers bureau. Doctors on other speaker bureaus like Shire’s Ann Childress and Wyeth’s Claudio Soares gave presentations and workshops that — surprise! — extolled company drugs. And signing books, side by side, was the duo now accused of penning an entire book for the drug industry: Alan Schatzberg and Charles Nemeroff.

This month ProPublica and the New York Times report that Schatzberg and Nemeroff’s book, Recognition and Treatment of Psychiatric Disorders: A Pharmacology Handbook for Primary Care, may be the first entirely drug industry-approved textbook ever. Published in 1999, the book’s preface says it was funded by an unrestricted education grant to Scientific Therapeutics Information through London-based GlaxoSmithKline (GSK). Scientific Therapeutics Information of Springfield, NJ is the same medical publishing company that spun Vioxx.

Drug Industry Fraud—The Whistle Has Been Blown, But Where’s the Enforcement?

by Ralph Nadar
One of the worst violations involves companies promoting unproven, often dangerous uses for their medicines. Last year, Pfizer paid $1.2 billion for illegal off-label promotion -the largest criminal fine in U.S.history. Other major corporate violators were GlaxoSmithKline, Eli Lilly, Schering-Plough, Bristol-Myers Squibb, AstraZeneca, TAP Pharmaceutical, Merck, Serono, Purdue, Allergan, Novartis, Cephalon, Johnson & Johnson, Forest Laboratories, Sanofi-aventis, Bayer, Mylan, Teva and King Pharmaceuticals.

The violations by these and other drug companies point to the wide range of impacts, including taking many lives of patients, which stems from these recurrent activities. These criminal or civil illegalities cover (1) overcharging government health programs, (2) unlawful promotion, (3) monopoly practices, (4) kickbacks, (5) concealing study findings, (6) poor manufacturing practices, (7) environmental violations, (8) financial violations and (9) illegal distribution.

Drug Industry Settlements In 2010 Largest Ever—$2.5 Billion

The Justice Department has collected a whopping $3 billion in settlements this year with help from whistleblowers and a powerful law known as the False Claims Act, Assistant Attorney General Tony West announced this morning. And guess where $2.5 billion of that $3 billion came from? Big Pharma. This year’s biggest hauls under the False Claims Act include $669 million of the record-shattering $2.3 billion total the government took from Pfizer over its improper promotion of the painkiller Bextra, $302 million from Astra Zeneca over the anti-psychotic drug Seroquel, and $192 million from Novartis.

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.

Mental health clinics targeted in Medicare fraud crackdown

Even by Miami-Dade’s reputation for Medicare fraud, the indictment was a shocker: American Therapeutic’s patients could not feed themselves or control their own bodily waste. Many lacked the mental capacity to respond to counseling; instead they simply stared at walls or watched TV. An employee complained that those patients should be ineligible for Medicare since they could not benefit from treatment.She got fired. That launched whistle-blower and criminal investigations that led to the Justice Department’s takedown Thursday of Miami-based American Therapeutic Corp., the nation’s largest chain of mental health clinics.