Pharmaceutical companies are barred by the Food and Drug Administration from promoting unapproved drug uses, called off-label use, but they are using employees called "medical science liaisons," who are often physicians and pharmacists, as a legal way to discuss those uses.
Medical science liaisons (MSLs), who are considered medical rather than sales staff, have greater freedom than salespeople as they visit doctors offices to discuss the science behind a medicine, including unapproved uses.
The FDA permits drug companies to respond to unsolicited requests for information from doctors, including off-label data, if they provide truthful, nonpromotional material, says Rita Chappelle, an agency spokeswoman.
And while the FDA requires traditional sales reps to refer information requests to their employers' medical or scientific staff, MSLs are usually on those staffs.
"I see them as primarily being in a position to give us information and educational support," says Robert Sundel, a physician at Children's Hospital Boston and an associate professor at Harvard Medical School. "While they're generally objective, as with everyone, I try to keep track of the ways in which their own interests might affect the information they provide."
Though still small, the number of MSLs has increased steadily, totaling 1,970 in 2008, up 48% from 1,335 in 2003, according to data for 12 major pharmaceutical and biotech companies compiled by PharmaForce International, a market-research firm.
Partial numbers for 2009 indicate a decline to 1,640, but Sean McCrae, an executive at PharmaForce, says that number is "an aberration," reflecting across-the-board cuts in the industry.
And companies appear to still be hiring MSLs: The online job-search site Monster.com lists many MSL job postings.
At the same time, drug makers have been cutting their conventional sales forces. By the end of 2008, the number of U.S. sales reps had dropped to 90,000 from a peak of about 106,000 in 2006, according to ZS Associates, a consulting firm.
Last month Amylin Pharmaceuticals Inc. said it plans to cut 35% of its sales force, or 200 sales reps, but none of its MSLs.
MSLs generally make at least 50% more than primary-care sales reps, who are paid an average of $86,000, including bonus, according to ZS.
MSLs bring additional value to a company because of their ability to help the company seek new uses for a drug, says Jane Chin, president of the MSL Institute, a company dedicated to the ethical training of MSLs.
Dr. Chin, a former drug-sales rep for Bristol-Myers Squibb and a former MSL for Aventis Pharmaceuticals and Takeda Pharmaceuticals, says she quit being an MSL because she was asked to work more closely with the sales team than made her comfortable. She adds that she worries about the training of MSLs and how they deal with off-label information.
In some situations, MSLs are "pressured to do more for the sales team," says Dr. Chin, adding that in her experience, "some pharma companies have the impression if you just hire somebody [with a professional degree] and you call them an MSL, it doesn't matter what they say."
A Sanofi-Aventis spokeswoman said, "We provide extensive training, policies and procedures, and other tools to assist all employees in identifying and complying with all applicable requirements." Takeda declined to comment.
The drug companies themselves argue that their medical-science and sales forces have different functions. Novartis, which has one of the largest MSL staffs in the industry, also says that unlike sales reps, its MSLs don't receive incentives for sales in their territories and get continuing training on industry advances.
Jeff Patrick joined biopharmaceutical company Dyax Corp. as head of MSLs in March. Before that, he had 10 years of experience as an MSL at companies ranging from small biotech companies to global drug makers.
The "common thread" in his MSL roles was his goal to "educate and increase awareness" about diseases and treatments, says Dr. Patrick, who has a doctorate in pharmacy.
He says he often took "deep dives" with doctors into clinical-trial results as doctors asked such questions as "Were there pediatrics in your trial?" or "What were the success rates in patients who had multiple treatments?"
Sales reps couldn't talk about pediatric use in a clinical trial if the drug wasn't approved for use in kids, and sales reps might not have enough scientific knowledge to answer complex or technical questions, Dr. Patrick says.
Write to Shirley S. Wang at email@example.comPrinted in The Wall Street Journal, page B3