Pfizer Moves To Block Memo On Controversial Drug Sale

- Jim Edwards

As new Pfizer CEO Jeffrey Kindler settles into Hank McKinnell's old office on 42nd Street in New York he will have several things on his mind: getting Pfizer out of its new-product drought; fending off competitors to Lipitor; and repairing the company's relationship with Wall Street.

But lurking in Kindler's litigation files is another issue that may yet frustrate the company: a memo, dated Feb. 7, 2000, which advised a Pfizer acquisition that it was OK to sell its human growth hormone brand, Genotropin, to an "anti-aging" clinic in Miami.

The memo is controversial because a 1996 federal law states that whoever "distributes" human growth hormone "for any use" other than those approved by the government may be subject to five years in federal prison.

Growth hormone is not approved for anti-aging; in fact it can cause cancer in healthy humans, according to the Journal of the American Medical Association.

Pfizer is now under investigation by the U.S. Department of Justice for those sales, according to Pfizer's March annual financial report.

Two former employees have testified to a grand jury in Boston in the probe, the employees told Brandweek earlier this year.

On July 11, a lawyer retained by Kindler's office successfully persuaded a U.S. District Court judge in New York to rule that documents in the case "should be kept confidential and not shared with the public."

Brandweek obtained a copy of the memo during the preparation of a story describing the Genotropin investigation ("Bad Medicine," March 20), but the article did not mention the memo.

The memo's existence was mentioned by Pfizer in May, when the company asked for the court ruling. In its request, the company specifically complained that the 2000 memo had been shared with the media.

The memo was written by the Washington office of law firm Morgan, Lewis & Bockius to Pharmacia, a New Jersey company acquired by Pfizer in 2003.

Morgan Lewis gave Pharmacia advice on "Possible Arrangements With Renaissance Longevity Center," the Miami-based clinic, according to the memo.

The memo began by noting that there were risks in selling growth hormone: "In April 1999, Genentech [a competing company] settled an investigation with the Department of Justice ('DOJ') for $50 million which involved the off-label promotion of its human growth hormone drug," the memo said.

After discussing other legal risks, the six-page memo concluded: "Off-label prescribing of drugs is a legal and common practice for physicians, and it is lawful for P&U [Pharmacia's former corporate name] to supply the Center."

The memo added that Pharmacia "can reduce the risks of off-label promotion by selling the drug directly to the Longevity Center."

The memo does not mention the 1996 regulation.

Neither Pfizer nor former executives of Pharmacia returned calls for comment. One of the two Morgan Lewis lawyers who authored the memo declined comment; the other did not respond to calls.

Pharmacia signed a contract with the Longevity Center in April 2000 and sold Genotropin to the Center, according to a copy of the contract and copies of Pharmacia's billing records.

The secrecy order applies to Pfizer and Peter Rost, the former vp-marketing at Genotropin, who is suing his ex-employer for wrongful dismissal. Rost alleges that Pfizer fired him in revenge for disclosing the allegedly illegal growth hormone sales.

Kindler should be familiar with the litigation and the federal investigation because prior to taking the top job at Pfizer he was the company's general counsel. The new secrecy order restricts anyone from seeing the memos except "named parties" (who can only view the memos in the office of their lawyers) and "in-house counsel" to Pfizer.