That penalty seems small, however, compared to the $44.2 billion in pharmaceutical sales that the world’s largest drugmaker rang up last year.
Dr. Adriane Fugh-Berman of Georgetown University acknowledges that, while $2.3 billion is a lot of money,
“…but these are highly profitable drugs. It will not take them very long to make up that deficit. Drug companies will continue this unless the financial downside makes it unprofitable.”
Pfizer has agreed to pay this penalty to settle charges that it illegally marketed the pain drug Bextra and three other medicines for so-called ‘off label’ uses that were not approved by the Food & Drug Administration. It’s the largest health care fraud settlement in the U.S. Justice Department’s history. The previous champion in the Big Pharma Cost-Of-Doing-Business Olympics was Eli Lilly, who paid $1.4 billion in January 2009 for illegally promoting ‘off label’ use of their anti-psychotic drug Zyprexa by pushing doctors to prescribe it as a sleeping pill.
Lilly drug reps were apparently trained to push a “Five at Five” campaign, in which docs working in nursing homes were urged to prescribe a 5 milligram dose of the drug at 5 pm to assure a good night’s sleep for patients – and an uneventful night shift for the staff, I would guess. This campaign ran long after Lilly knew of the drug’s serious side effects such as increased incidence of Type II diabetes.
Pfizer, of course, now expressly denies all allegations involving their four drugs, except for one tiny acknowledgement about “certain improper actions related to the promotion of Zyvox.”
Here’s their official news release response (and the world’s longest sentence) with my translation following:
“We regret certain actions taken in the past, but are proud of the action we’ve taken to strengthen our internal controls and pioneer new procedures so that we not only comply with state and federal laws, but also meet the high standards that patients, physicians and the public expect from a leading worldwide company dedicated to healing and better health”
Allow me to translate this into plain English for you, as somebody with decades spent in the wonderful world of corporate PR – and who, I’m embarrassed to admit now, has written this kind of gobbledygook for countless news releases myself:
“There’s so much money in selling pills, that there’s a tremendous temptation to cheat,” explains Bill Vaughan, an analyst at Consumers Union, the nonprofit publisher of Consumer Reports.
“There’s a kind of mentality in this sector that (settlements) are just the cost of doing business, so we can cheat. But this penalty is so huge, I think consumers can have some hope that maybe these guys will tighten up and run a better ship.”
Is $2.3 billion a meaningful penalty?
It hits Pfizer at a time when they’ve just spent $68 billion to buy Wyeth Pharmaceuticals, and already worried about soon falling off the ‘patent cliff’. Lipitor, the world’s best-selling drug, for example, will lose Pfizer’s patent protection in 2011, and the drug’s already been fading a bit because of growing sales of its cholesterol-lowering competition out there.
But Big Pharma also hires another type of pharmaceutical rep whose actions remain completely unregulated. As New Hampshire physician Dr. Kevin Pho writes in his always-enlightening blog KevinMD:
“These reps have unfettered access to the top academics of all fields of medicine, are invited by medical societies to give keynote addresses, routinely publish articles in the best journals, and offer advice about medications that is accepted as gospel by doctors everywhere.
“These reps have medical degrees, and some have become millionaires by taking fat payments from drug companies.
“They are “the hired guns of medicine”.
Learn more about the Pfizer case, or visit PharmedOut, Dr. Fugh-Berman’s watchdog website.
See also: A Mere $2.3 Billion Later . . .
What do you think?