More allegations of off-label marketing. Two former salesmen have filed a lawsuit that details how the drugmaker tried to boost sales of its big-selling anemia drug by offering contracts that fattened doctors’ profits and urging its salespeople to push higher-than-approved doses.

One is Dean McClellan, who worked for 12 years at J&J’s Ortho Biotech unit selling Procrit. He was obviously concerned enough about sales practices that he saved 15,000 pages of company memos, contracts and other work-related documents in a storage unit and shed he built off his garage (like the one to the right, we imagine). He tells The Wall Street Journal that he was forced to retire in 2004 because J&J told him his sales increases weren’t high enough. He believes the company wanted him out because of his age, which was 55 at the time.

So he agreed to join a whistleblower lawsuit by another former Procrit salesman, Mark Duxbury. A brief filed by J&J says Duxbury was fired in 1998 for racial and sexual harassment. Through his attorney, Jan Schlichtmann, Duxbury says he was a star salesman for Ortho whom the company turned on after he told the truth about their business practices at a court-ordered deposition.

And what were those practices?

The paper reports that J&J made offers to allow Procrit buyers to receive discounts off an already-reduced price as well as rebates. For example, an internal company memo calculates that a physician who bought nearly $1 million of Procrit over 15 months would get a check for $237,885 back, or 24 percent.

Another J&J program offered hospitals an incentive to buy Procrit and shun Amgen’s Aranesp: discounts on purchases from across J&J’s product line of drugs and devices sold by different subsidiaries - if the hospital used Procrit at least 75 percent of the time when prescribing anemia drugs. In addition, J&J created a “Right of First Refusal” contract for doctors, requiring them to allow Ortho Biotech to make a counteroffer if the Aranesp price undercut Procrit.

McClellan also alleges the company pushed docs to prescribe a higher dose before it was approved by the FDA. In the mid-1990s at a national sales force meeting, an Ortho executive announced that the division was moving to promote what it called “QW dosing,” switching patients from three, 10,000-unit doses a week to a single, 40,000-unit dose in cancer patients, McClellan says. At that time, that dose wasn’t approved for cancer patients.

Doctors also got other financial support, McClellan says. The Arizona Cancer Center, one of the larger clinics in his sales territory, in 2003 received $10,000 to train 12 to 20 J&J employees, with a series of lectures given by the center’s doctors. In 2004, the Center announced in its newsletter that J&J’s Ortho Biotech unit had donated $40,000 to the center to “provide salary support” for a Hematology/Oncology fellow.

Yesterday, we posted an item that featured a different newspaper report about Amgen offering docs incentives to use its anemia meds. The rivalry in this particular market is clearly cause for concern, and J&J and Amgen have both disclosed probes by Congress and various government agencies into their practices.

But the broader issue of off-label marketing and the alleged willingness of some docs to accept incentives remains troubling. Big pharma lawyers argue the entire notion is poorly defined, but there’s a double standard at play. Industry is happy to cite an FDA rule about pre-emption to deflect product liability lawsuits in state courts, but argues FDA dictates about marketing for unapproved uses is either vague or may violate certain rights.

Drugmakers are free to quarrel with the agency as much as they want, but if they truly care about patients - as their slogans and ads always suggest - they shouldn’t bribe docs or instruct sales reps to flout rules.

You can read the full story here (subscription required).
[tags]Johnson & Johnson, Off-Label Marketing, Procrit[/tags]