Crime and Punishment: Big Pharma Biz as Usual?

July 2012—British drug giant GlaxoSmithKline has agreed to pay a multibillion-dollar fine for civil andcriminal fraud, making it the largest and costliest health care lawsuit in U.S. history. Now the company is ducking and weaving but promising better transparency and harsher punishment for any shenanigans going forward. The question is whether penalties or criminal implications will deter further industry misconduct— resulting in growing stats for ‘morbid and mortal’ drug injury from hype and concealed side effects.

GSK’s CEO Sir Andrew Witty cited illicit behavior as occurring ‘in the past’: [But] ‘We have fundamentally changed with regard to U.S. compliance, marketing, and selling procedures.’ This means no more rewards for sales forces based on number of pills sold per year; also— should anyone be caught acting in non-compliance— executives may lose their bonuses. Originally two employees,whistleblowers, came forward with allegations that started the fray. GSK has also agreed to be monitored by U.S. regulators.

Will we get caught or not? This is business as usual in an industry where bad actors abound though plenty invite no scandal. Observers say Witty’s remarks seem silly in light of the fact that $3 billion amounts to less than a single year’s sales of Avandia alone. Over several years GlaxoSmithKline has grossed tens of billions. It is reported the company anticipated and prepared in advance for this particular hit, factoring into their budget a $3.2 billion loss some months ago. When that happened the stock only rose.

No amount of monetary or criminal punishment is likely to affect lasting deterrence, observers say— not as long as only money is involved. So far, no executives have been charged in the case. Doctors and patients are commonly imprisoned for illegal drug sales, but not pharma execs who sell drugs with illegal marketing ploys.

Glaxo had already lost $4.5 billion settling 35,000 previous injury cases. Criminal charges in this case resulted from PSRs (pharmaceutical sales reps) persuading physicians to recommend the antidepressant Paxil for patients under age 18— bribing docs with lavish trips, spa treatments, and tickets to Madonna concerts. The FDA never approved Paxil for younger teens; research had clearly warned it increases their risk for suicidal behavior. Sales reps also called on pediatricians to encourage Paxil for children.

Re: Wellbutrin, another popular antidepressant. GSK hyped it with the phrase ‘happy, horny, and skinny’ when none of these benefits is factual. Avandia, prescribed for diabetes 2: Glaxo refused to publish research warning that Avandia increases risk of heart attack and stroke: To date 50,000-100,000 people have suffered heart attacks or strokes after using Avandia; its labels now carry a black-box warning. Glaxo even failed to provide the government with volatile new research.

New regulations may make some headway but ultimately physicians and other health experts encourage ‘continued vigilance and surveillance’ as the means to greatest fundamental change: If the public continues relying on big pharma’s ethics, it may never know the pills it pops.

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