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Lesson From Gilead: Don't Describe Your Drugs as "Dope"

By Jim Edwards

Updated on: January 4, 2011 / 6:43 PM EST / MoneyWatch

Gilead (GILD) learned recently it's not just PowerPoints and emails that can come back to haunt you: tactless comments in meetings can too. The pharmaceutical company dodged a bullet last month when a lawsuit alleging the company's CV Therapeutics unit illegally pushed the angina drug Ranexa for unapproved "off-label" purposes was voluntarily dismissed after the Department of Justice declined to intervene.

It's not clear why the suit was ended, although the plaintiff, a former CVT employee, withdrew it in such a way that he retains the right to update it and file it again.

The case was interesting because it relied heavily on the spoken words of executives in meetings rather than documents, as is usually the case in pharmaceutical litigation. The takeaway for managers is that just because it's not in an email doesn't mean it didn't happen -- and can't come back to haunt you. In one meeting, sales rep Ricardo Forges of Orange Park, Fla., claimed his boss told him that CVT's goal was to sell "gobs of dope," and to "get those pills in people's mouths any way you can":

The drug is only approved for chronic angina in patients where other treatments have failed, and Gilead earns about $240 million a year in revenues from the product. The drug's use is restricted by the FDA because it carries a risk of heart problems. Forges, however, claims that the company didn't care whether the drug was promoted on- or off-label, and pushed the product for unapproved uses such as coronary artery disease and heart failure. At one point his boss threatened to fire him if he was caught promoting Ranexa only for the FDA-approved purpose, he alleged. At another meeting, a CVT manager allegedly told Forges "I do not care what you do to sell the drug":

CVT even allegedly had an internal jargon for unofficial, unapproved sales materials created off the record: "homemade bread."

Like many companies, CVT employed doctors to give dinner lectures to other physicians about Ranexa, but drama allegedly ensued if those lecturers only talked about the drug's approved uses:

The company allegedly knew what it was doing was wrong because it coached doctors to write that their prescriptions were for angina even if they were not in order to get government reimbursement, and even provided them with partially filled-out forms to speed the process.

Gilead did not respond to the suit, which was under seal until it was dismissed. The company had been under investigation by the DOJ since August 2009.

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Image by Flickr user Hamed Saber, CC.