Helping Doctors Cheat

From an August 19 AP story: Drugmaker GlaxoSmithKline used a sophisticated ghostwriting program to promote its antidepressant Paxil, allowing doctors to take credit for medical journal articles mainly written by company consultants, according to court documents obtained by the Associated Press.

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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Comments

[VP]

Seems a bit of a stretch? I'm not sure how many of the foreign drs. would qualify as "officials".

If the ghostwriter signed his/her name, it wouldn't be unfair--so it's just the additional prestige of a US dr.'s name that makes it unfair?

[The FCPA Blog]

All doctors employed overseas by government-owned or controlled hospitals are "foreign officials" for the FCPA.