Doctors are busy. It seems as if they can barely sprint through their whirlwind succession of patient interviews, let alone devote real study to the medicines they prescribe. Quite naturally we fear that most of our physician’s pharmaceutical education comes from the drug company sales people, who are undeniably biased. And that may once have been so.
But the drug manufacturers are working on boosting their creditability, and the federal government has stepped in, demanding a clear firewall between pharmaceutical education and promotion. Toward this end, major pharmaceutical firms are establishing highly qualified ranks of trained medical science liaisons (MSLs) to work with local physicians.
To help explain the medical liaison’s role and training, Bernardsville-based Scientific Advantage (www.scientificadvantage.com) is sponsoring workshops on Tuesday, July 11, and Wednesday, July 12, at 7 a.m. each day at the Bridgewater Marriott. Call 908-204-0995 or E-mail to info@ScientificAdvantage to register. Cost: $710 for the July 11 workshop and $795 for the July 12 workshop.
The July 11 workshop provides detailed information on all legal, government, and institutional documents that influence how pharmaceutical, biotech, and medical device companies communicate with physicians and other healthcare providers. It also examines industry best practices in compliance and risk management. The July 13 workshop, MSL CORE Competency, teaches the fundamentals required to be a successful MSL, including effective approaches thought leader networking, external and internal networking, external and internal communications, and the integration of science and business.
The new profession is drawing medical doctors, molecular biologists, chemists, and pharmaceutical researchers, as well as directors and sales executives of related businesses.
If any person’s career has been pointed toward the scientific understanding of pharmaceuticals, it is Scientific Advantage’s vice-president Kathryn L. Gann. Born in Lockhaven, Pennsylvania, she began her education with a general arts and sciences B.A. from Pennsylvania State University in l973. She then obtained an M.S. in microbiology/immunology from the Catholic University of America and Ph.D. degrees in molecular biology and biochemistry from Wesleyan University. She performed her postdoctoral fellowship at the John Hopkins School of Medicine in the biological chemistry department.
Gann served as an assistant professor of laboratory medicine at Brown University and taught everything from cancer genetics to public health immunology. She supervised a molecular biology laboratory and researched autoimmune diseases. She has served as director of the Rhode Island Association of Facilities and Services for the Aging. She is an active member in the Drug Information Association and American Society of Consultant Pharmacists. Prior to training MSLs for Scientific Advantage, she directed medical therapeutic liaison programs for the major drug firms Sanofi-Synthelabo and Aventis.
Gann insists that the employment of more medical liaison teams is a great leap forward in patient healthcare and in pharmaceutical-physician communication. “An MSL is the a conduit of information, working both ways,” says Gann. “He brings explanations of products and solutions out into the healthcare community, and carries back from the physicians new trends, methods of treatment, and changes in practice.”
It sounds ideal, but doesn’t always work exactly that way. Dr. Jane Chin, president of the MSL Institute (www.mslinstitute.com) says that too often MSLs can be pushed into “touring the dinner circuit, acting mostly or only as technical sales support.” So the question becomes: what are medical liaisons doing out there in healthcare land?
Tellers versus sellers. In l967 Upton John developed the first medical liaison team to help physicians find the best treatment for a given disease. Physicians were fed up with an onslaught of drug salesmen who visited one at a time, each one selling his pharmaceutical solution, each with only a limited knowledge of his product. In the medical liaison physicians found a peer — an expert who could discuss the full range of pharmaceuticals available, and could describe the molecular difference of each.
This MSL tradition of sharing scientific knowledge has continued. Today the medical liaison works as the field-based face of the drug company’s medical affairs and research divisions. He does not make double-team visits with a sales person to the doctor’s office. Unlike the rep, he typically comes to the job with an M.D., or a Ph.D. in chemistry, biology, or pharmacology.
Government firewall. In 2002 the federal government gave MSLs a huge and unintentional boost. Tired of the pharmaceutical companies’ infomercial style of trade presentation, the Office of the Inspector General in Health Services published the O.I.G. Guidelines, which demanded a strict separation of promotional and informational material in physician continuing education courses taken for credit. This promo/educational firewall stated that educational materials should be presented to doctors by an outside third party, such as a medical association.
The institution of the MSL, already burgeoning since the l990s, took off as drug firms sought to make honest and balanced presentations. Companies like Scientific Advantage came into being to help pharmaceutical and medical device providers establish the MSL teams, which helped not only with O.I.G. compliance, but also with getting their message across.
Schooling an MSL. If you are going to chat with physicians and researchers about molecular differentials in various drugs’ makeups, you will probably want to bring a substantial background to the table. Typically, medical liaisons are drawn from the ranks of physicians, PhDs in biology, chemistry, or pharmacology. “But many less formally educated people have gained equivalent expertise through their work,” says Gann. Among these she includes physicians assistants, nurse practitioners, those with advanced clinical training experience, medical technicians who run trials, and therapeutic aids, such as those who run hospital diabetes clinics.
Scientific Advantage offers training for those with the right background. Those seeking an MSL certificate from Scientific Advantage take a one-day course. They take a pre-qualifying test, and a final, day’s end exam. In between, the students learn what Gann calls the soft skills of the job: what MSLs do, how to communicate, and the rules of legal compliance.
Upon completion these new MSLs are quickly hired by pharmaceutical companies, says Gann. Their new employer puts them in its own medical therapeutic liaison training program. Exactly how long this training lasts depends on the individual’s experience and the company’s product. But Gann says that it generally takes a year before MSLs feel comfortable.
Off-label, on-label. Depakote stops epileptic seizures. It has also proved successful in handling migraine headaches and attention deficit disorder. But the label only says that it is good for seizures. These other treatment potentials are termed off-label uses and for any salesperson to suggest — or even discuss — such off label uses is illegal.
Actually, no drug company employee, be he in sales, an MSL, or the CEO, can legally promote such off-label uses. The FDA wisely wants to halt a return to the old medicine show days. They will not allow promotions wildly claiming that “this drug is great for neuritis, neuralgia, and whatever else ails you.”
“But at the same time,” says Gann, “the FDA very sensibly does not want to restrict the flow of scientific information.” Thus if a physician initiates a question to an MSL about alternative uses, the discussion may legitimately begin. This way the doctor gets a source of expertise, and the claims are reined to match actual clinical test results. “It becomes a tricky part of the compliance,” says Gann “but it is one each MSL must have stamped deep into his brain.”
Doctors love MSLs. It’s like having expert, personal tech support to help them work out their problems — a medical geek squad that makes house calls. For the pharmaceutical companies that are paying the MSL salaries, the benefits are not quite so easily determined. MSLs are paid about $125,000 a year. They do not operate on commission, and talk science, not products.
It is difficult to actually determine their benefit to a pharma’s bottom line, but there is evidence to suggest that they build relationships. A physician, on average, will spend two hours with an MSL, versus just a few minutes with a drug rep.