Of course I find pressure, to varying degrees, from my commercial organization to expand the options for our MSL’s to speak to physicians quesitons to off-label use but to date that has always been in the contest of how we can provide more DOF information in our medical information letters. I have met directors in the commercial organization who made me uncomfortable with their requests but happily they have been the minority as there is currently great concern in my organizations senior management to not attract attention that would be the source for a negative front page NY Times article.

I think that for the sake of balance we all have to consider whether the business influence that our commercial stakeholders have in our communications with physicians are materially different from those that influence decisions in hospital and outpatient practice. Most of academic collegues are now division chiefs, department chairs or senior partners in clinical practices. When my friends and I talk about the hard nosed decisions they are now making regarding nursing staffing, the amount of referral pay to provide to community feeder physicians, formulary decisions, whether or not to include given procedures in their ambulatory care centers… I find that I’m often shocked and saddened by decisions that are fare more cynical and profit-centered than anything that we would ever accept in Pharma. I’ve seen decisions on awarding NIH grants belie a “scratch my back and I’ll scratch yours” reciprocity in the academic world that cause most of my marketing VP’s to recoil from the downside risk of public relations in our industry.

My personal perspective is that many of those who think that Pharma should apply a perfect model of separation between clinical and commercial motivations have not lived much in the messy world of clinical practice. It doesn’t mean that we don’t have to work harder but we shouldn’t undervalue what we have achieved.

Hmmm. I don’t know if it a major rung on the career ladder or not–our MSL is the mother of nine (count ‘em!) girls under the age of 20, including triplets that are about 4 years old, so I think she is happy where she is (also, I suspect chronically hypo-manic). The MSL we had prior to that was a dingbat; don’t know where she went. I think it could be career-enhancing, depending on where you want yours to go. Certainly an MSL with other business experience would be primed to move up the corporate ladder. Might be kind of nice to have someone up there with medical, field AND business experience. (I say “field” experience not in the sense of their having acted promotionally, but in the sense of having been in much contact with the field and so to be in the position of knowing the ins and outs of sales.)

I regret that my use of quotation marks implied that they are not much punishment. That wasn’t my intent.

And your comment on prosecuting fraud as having a high ROI is right on target.

While some pharma CIAs are due to pricing and reimbursement violations they can result from any kind of illegal activity - False Claims and Anti-Kickback violations will also result in a CIA, usually in conjunction with a DPA (deferred prosecution agreement). The OIG guidance is really quite vague when you get down to the nuts and bolts and smart companies glean additional guidance by studying these documents. For instance - last year five orthopedic companies were nailed for Anti-Kickback violations and in their CIAs was a restriction that HCPs not receive more than $500/hour for their work. In essence this sets the upper limit for fair market value unless you have a damn good reason for paying more. Read some - they’re really interesting.

And, Bob, you put bad in quotes as if to say they are not much punishment, but having an outside agency come in and tell you how you’re going to run your business for five years, and then paying them extravagantly for doing so, can be quite galling. But - companies keep violating the statutes which is why I keep hearing the prosecutor’s say they’re going to go after the C-suite. I, for one, believe them. TAF says for every $1 the gov. invests in prosecuting medical fraud they get $15. They have the resources and they want the results.

In days gone by, being a MSL was a major rung on the career ladder. HC, is that still the case?

I have been to many meetings between our MSLs and physicians. 1) Our MSL doesn’t just interact with thought leaders; she interacts with anyone I take her to see.
2) Our MSL answers a lot of questions about where research is going, investigator-initiated trials, the grant process (how to apply only, she has no connection at all to the process itself), etc. One example of a recent interaction was that she talked to a physician about his desire to form a consortium of like-minded researchers and clinicians; she was able to give him the name and contact information of the director of such a consortium in another state. 3) She can answer off-label questions, but again, the company restricts her from doing so in certain cases, even though she would legally be able to answer.

HC

MSLs are field-based people who call on Key Opinion Leaders, generally academic physicians, and provide information oftentimes not product-specific information. Their purpose is to build long-term relationships for clinical research, CME, etc. MSLs are not considered sales reps and their academic backgrounds include PharmDs, MD, or PH.D.s in a basic science area. They are usually tied to a therapeutic team and report in to a regional business center and a HQ-based MSL executive. (Some pharma companies have PSLs or Pharmacy Science Liasons, but most are now called MSLs.) It is a peer calling on a peer, but, a noted, the pressure to sell (allbeit a soft sell) is always there.

A CIA is a binding agreement between the company and the HHS OIG and is the result of a the company’s violation of Medicare’s, Medicaid’s or other federal program’s pricing/reimbursement regulations. Usually a safe harbor trade practice has been violated or alledged to have been violated, and a CIA is put into effect, often for up to 5 years. It is a “bad” thing.