Remembering the Flexner Report as a drug firm pays $520 million for misleading marketing

The one-hundredth anniversary of a prescient warning about the "education" of physicians should not pass unmarked.

"[T]he practitioner is subjected, year in and year out, to the steady bombardment of the unscrupulous manufacturer, persuasive to the uncritical, on the principle that 'what I tell you three times is true'," wrote Abraham Flexner, whose Flexner Report for the Carnegie Endowment for the Advancement of Teaching reformed medical education in the United States. "The laity has in this matter more to fear from credulous doctors than from advertisements themselves: for a nostrum containing dangerous drugs is doubly dangerous if introduced into the household by the prescription of a physician who knows nothing of its composition and is misled as to its effect."

 

A recent example is AstraZenca's agreement "to pay $520 million to settle federal investigations into marketing practices for its blockbuster schizophrenia drug, Seroquel," the New York Times reported in April. Seroquel sales were put at $4.9 billion just in 2009.       

 

"The company, based in London, has been accused of misleading doctors and patients by playing up favorable research and not adequately disclosing studies that show Seroquel increases the risk of diabetes," Duff Wilson wrote in the Times. "According to company e-mail unsealed in civil lawsuits, AstraZeneca 'buried' - a manager's term - a 1997 study that showed Seroquel users gained 11 pounds a year, while publicizing a study that claimed users lost weight. Company e-mail messages also refer to doing a 'great smoke-and-mirrors job' on unfavorable studies."

 

 

There's nothing extraordinary about the AstraZenca case, as Wilson pointed out:

The company will join a series of American pharmaceutical companies that have admitted to illegal marketing after federal investigations and whistle-blower filings and have signed agreements with the government to monitor and avoid such activity in the future.

In the largest such case, Pfizer paid $2.3 billion last September, including $1.3 billion in the biggest criminal fine of any type in United States history, for off-label marketing of the painkiller Bextra and other drugs. Bextra was withdrawn from the market in 2005. The Pfizer fine included $301 million for off-label marketing of its antipsychotic drug Geodon.

Eli Lilly paid $1.4 billion in January 2009 to settle investigations into illegal marketing of its antipsychotic drug Zyprexa. Lilly's settlement included a $515 million criminal fine, which until the Pfizer case was the largest such fine ever imposed on a corporation.

In 2007, Bristol-Myers Squibb and a subsidiary paid $515 million to settle federal and state investigations into marketing of its antipsychotic drug Abilify.

   The more things change,...