“We're almost like a covert group. We sometimes joke that you know when a medical science liaison has [visited a doctor], but you don't really know what he or she has done, whereas with a sales rep, you see samples everywhere — pens, paper, pads,” says Jane Chin, PhD, managing partner, MSL International Enterprises, a consulting organization based in Redondo Beach, Calif. “If MSLs are secretive and remain silent, it is because they are afraid of retaliation, of being punished for not being team players, afraid that their career advancement will be curtailed.”

So what are MSLs and why are they so afraid? The main role of medical science liaisons is thought leader development — admittedly a fuzzy concept, says Chin. (See box, page 78.) MSLs develop relationships with prominent physicians and act as scientific resources for them, responding to their research and educational needs. Thus MSLs have a critical role to play in improving patient care, Chin believes. But pharma companies sometimes misuse MSLs, deploying them as glorified salespeople, and punishing them if they object, says Chin. With marketing practices under intensifying government scrutiny, and with pharmaceutical companies expanding or developing MSL teams, she says, it is more important than ever for MSLs to proactively shape the way their roles are perceived. Toward that goal, she started a quarterly e-newsletter and Web site (www.mslquarterly.com), despite the objections of her then-employer, to provide a forum for MSLs to develop best practices.

Blowing the Whistle

The secrecy and silence surrounding medical science liaisons has now been lifted, thanks in part to the Parke Davis (now Pfizer) case. A medical science liaison was the whistleblower in that suit, accusing Parke-Davis of implementing a systematic, illegal campaign to promote the off-label uses of Neurontin. He charged that Parke-Davis trained MSLs to aggressively foster high prescribing, and even promoted MSLs based on their ability to sell. The case received widespread press coverage, focusing public attention on the role of MSLs. In addition, the OIG guidance identifies the activities of “whitecoat” marketers — which is how some companies see MSLs — as a potential risk area.

While many people in the pharmaceutical industry dread media attention, MSLs welcome that publicity, says Chin, even though it has been negative. The scrutiny forces companies to examine whether they are establishing MSL teams to “disseminate scientific information — or are they creating a scheme for off-label promotion?”

Separate Sales Reps and MSLs

In response to the scrutiny, many drug firms are moving their MSL teams from sales and marketing to medical affairs departments — a restructuring similar to what companies are doing with CME. But that's not necessarily enough, says Chin.

For instance, it's not appropriate for MSLs to participate in sales training, she says, which focuses on sales goals, promotional messages, and overcoming sales objections. When sales and MSL training is combined, horror stories can result, says Chin. In one instance, when a MSL voiced concerns about how the data was interpreted, “the sales trainer ripped into her, accusing her of not being a team player. The trainer even complained to her manager that she was not going along with the message.”

Instead of training with sales, Chin says, MSLs should have their own training programs, focusing on the science of the disease states and products.

Make Presentations Credible

MSLs may also be responsible for conducting educational programs for clinicians. This role can have regulatory sensitivity, she cautions. The presentations should not be used as a vehicle for off-label promotion; rather they should be fair, balanced scientific discussions. If MSLs are told, for example, “to go out and do 50 programs this year — what does that mean?” asks Chin. “Are they a true educational necessity — or are you building a campaign for inappropriate prescribing?”

There is also the question of whether the audience will view the MSL as credible. “Just because you are an MSL, it does not mean that you can't be fair and state the data exactly as it is. But MSLs must earn this credibility.”

No Joint Calls with Sales

Another area of contention has been joint sales calls, a practice Chin opposes. There have been instances when sales reps bring along MSLs specifically to solicit discussions of off-label uses to physicians, she says. Not kosher. The practice is also risky, she says, “even if the motivation is pure — if the rep brings the MSL in to address a question in response to a physician request.” However, MSLs can communicate with their sales colleagues before or after a physician visit to sustain teamwork.

The OIG guidance backs up her concerns. Right before she left her most recent position with a pharma firm, she said, the company reversed its policy, no longer allowing MSLs to do joint calls with reps, due to advice from an external regulatory consultant. When she had raised concerns about joint calls, she had gotten a lot of flak. “People were extremely upset with me. Now, I feel vindicated,” she says.

Integrity Compass

Judging from the anonymous comments on Chin's Web site, MSLs are still facing pressure to do the wrong thing, despite the new regulatory environment. Though she understands from her own experience how difficult and painful these situations can be, she says that MSLs have to take a stand.

“When I'm in the field speaking with a physician, my credibility and reputation are at stake. This customer trusts me because he sees me as a peer. Even in the context of the company's marketing objectives, I always make sure that the information that I present can stand up to scrutiny. We've all been ill; I remember what it was like as a patient. I [ask myself], if I were the patient, how would I want to have my physician exchange information with pharma company personnel? That is my internal compass.”

So, What Is an MSL?

  • Science Background

    Medical science liaisons have extensive clinical or research backgrounds in the therapeutic areas they work in. Increasingly, in today's regulatory environment, companies are hiring only MSLs who have degrees, such as MDs, PhDs, or PharmDs.

  • What They Do

    The MSL role is ambiguous and differs from company to company. Typically, they establish relationships with key opinion leaders, recruit clinical trial investigators, choose speakers for programs, and facilitate CME proposals.

  • Why They're Valuable

    “I've heard that the average sales call is about 45 seconds. Some thought leaders will not even see sales reps,” says Jane Chin, PhD, managing partner, MSL International Enterprises, a consulting organization based in Redondo Beach, Calif. “On the other hand, it is not unusual for an MSL to spend anywhere from 30 minutes to more than an hour with a prominent national or international thought leader discussing the scientific aspects of products and research.”