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Healthy Skepticism Library item: 18850

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

 

Publication type: news

Teichert E
Big Pharma behaving badly: A timeline of settlements
Fierce Pharma 2010 Oct 5
http://www.fiercepharma.com/special-reports/big-pharma-behaving-badly-timeline-settlements


Full text:

Sometimes pharma companies bend the rules. And increasingly, they’re getting caught. After Novartis’ recent $422.5 million settlement with the U.S. Attorney’s office and reader requests, we looked back at other Department of Justice and government fines levied against Big Pharma for improper marketing and other infractions. Those fines range from a relatively light slap on the wrists to multi-billion dollar charges in addition to criminal penalties.
Eleven companies have paid a total of over $6 billion to the government in 22 months. The biggest offender? Eli Lilly, with three appearances and over $1.4 billion in fines, all for Zyprexa. But those three settlements pale in comparison to Pfizer’s massive $2.3 billion charge for mis-marketing a host of drugs, including Bextra, Geodon, Lyrica and Zyvox.
Novartis
With: U.S. Attorney’s office for the Eastern District of Pennsylvania
When: Sept. 30, 2010
Scoop: Novartis agreed to a $422.5 million settlement with the Eastern District of Pennsylvania for its off-label promotion of Trileptal and other allegations against Diovan, Exforge, Sandostatin, Tekturna and Zelnorm.
Forest Labs
With: Dept. of Justice
When: Sept. 15, 2010
Scoop: After marketing Levothroid, an unapproved thyroid drug, Forest Labs received its penalty, to the tune of $313 million. The settlement also covered Forest’s off-label use of Celexa for children’s use.
Allergan
With: Dept. of Justice
When: Sept. 1, 2010
Scoop: Allergan’s $600 million DoJ settlement was broken into two parts: $375 million in fines and $225 milion in civil penalties, all of which stemmed from its off-label use of Botox for headaches, pain management and cerebral palsy.
Elan
With: U.S. Attorney’s Office in Massachusetts
When: July 15, 2010
Scoop: The Irish drugmaker received its $203.5 million fine for its marketing tactics of Zonegran, an epilepsy drug. Also, the company’s U.S. branch pled guilty to a misdemeanor and the company will enter into a corporate integrity agreement with the HHS Inspector General.
Johnson & Johnson
With: Department of Justice
When: April 29, 2010
Scoop: Though J&J’s more infamous woes stem from its phantom recalls, two of the troubled drugmaker’s subsidiaries received a $81 million penalty for off-label promotions of Topamax, an epilepsy drug.
AstraZeneca
With: U.S. Attorney’s office in Philadelphia
When: April 27, 2010
Scoop: In the same week as the J&J settlement, AstraZeneca was hit with a $520 million penalty for its antipsychotic, Seroquel. The company misled doctors and patients about the drug’s safety.

 

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Cases of wilful misrepresentation are a rarity in medical advertising. For every advertisement in which nonexistent doctors are called on to testify or deliberately irrelevant references are bunched up in [fine print], you will find a hundred or more whose greatest offenses are unquestioning enthusiasm and the skill to communicate it.

The best defence the physician can muster against this kind of advertising is a healthy skepticism and a willingness, not always apparent in the past, to do his homework. He must cultivate a flair for spotting the logical loophole, the invalid clinical trial, the unreliable or meaningless testimonial, the unneeded improvement and the unlikely claim. Above all, he must develop greater resistance to the lure of the fashionable and the new.
- Pierre R. Garai (advertising executive) 1963