International Law

Helping Doctors Cheat

The AP story here said drug companies often hire outside firms to "draft a manuscript touting a company's drug, retain a physician to sign off as the author and then find a publisher to unwittingly publish the work." It added that doctors eagerly participate because publication credit increases their prestige and professional standing. For their part, the drug-company salespeople "often present medical journal articles to physicians as independent proof that their drugs are safe and effective."

This is the FCPA Blog so let's ask the question: Could a drug-company's ghostwriting program violate the Foreign Corrupt Practices Act?

We think so.

The FCPA's antibribery provisions prohibit among other things (1) giving anything of value (2) to a foreign official (3) to secure any improper advantage. See, e.g., 15 U.S.C. §78dd-1(a) [Section 30A of the Securities & Exchange Act of 1934].

So. . . . .

(1) Anything of value? Producing high-level research and publishing the results in a reputable professional journal is hard work and a rare event for most people. As the AP story says, publishing papers always enhances the author's professional reputation. So an unsigned research-based manuscript of publication quality that a doctor can call his or her own is as good as gold. Strike one.

(2) Doctors working in government-owned or managed hospitals overseas are "foreign officials" under the FCPA. Strike two.

(3) Medical-journal articles that tout a drug and falsely appear to be written by independent doctors can easily secure an unfair advantage for the company and its product. In fact, that's the whole idea. The AP story says Glaxo's ghostwriting program, according to an internal memo, was designed to "strengthen the product positioning and overcome competitive issues." An unfair advantage it is. Strike Three.

And that's how a drug company's ghost-writing program could violate the Foreign Corrupt Practices Act. Will there ever be an enforcement action based on one? Who knows.

Final notes: GlaxoSmithKline has never been accused of violating the FCPA (or apparently any other law) because of its ghostwriting program. A spokesperson for the company said the program mentioned in the AP article "was discontinued a number of years ago." Paxil, the drug promoted by the program, is the subject of wrongful-death lawsuits that allege the company downplayed risks associated with the drug, including increased suicidal behavior and birth defects.
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Full post as published by The FCPA Blog on August 24, 2009 (boomark / email).