Trusting PhRMA?
posted by David Orentlicher
I might have been persuaded by Justice Stephen Breyer’s dissent on behalf of drug company sales representatives in Christopher v. SmithKline until I got to his reliance on the ethics code of the Pharmaceutical Research and Manufacturers of America (PhRMA). [The majority rejected a claim by sales representatives (detailers) that they were entitled to overtime pay under the Fair Labor Standards Act because they were not really engaged in sales.]
As Breyer observed, the PhRMA ethics code “refers to detailers as ‘delivering accurate, up-to-date information to healthcare professionals.’” The code also “explains why a detailer should not (hence likely does not) see himself as seeking primarily to obtain a promise to prescribe a particular drug, as opposed to providing information so that the doctor will keep the drug in mind with an eye toward using it when appropriate” (emphasis added).
Perhaps Breyer is correct that drug company detailers see themselves as educators, rather than salespersons, in accordance with the PhRMA ethics code. But it’s difficult to square that view with the reality of the detailers’ compensation. As the majority pointed out, detailers receive substantial incentive pay (more than 30 percent of gross pay for one of the plaintiffs) that is based on sales volume of the detailers’ assigned drugs in their sales territory. They are not given bonus pay based on the extent to which doctors in their sales territory are knowledgeable about their assigned drugs.
Breyer’s dissent is also difficult to square with his dissent in Sorrell v. IMS Health last year. In supporting restrictions on the use of patient prescription data by detailers, Breyer characterized the activities of detailers as “sales discussions.” He also defended the restrictions on the ground that they would counter the tendency of the data to “help sell more of a particular manufacturer’s particular drugs . . . by diverting attention from scientific research about a drug’s safety and effectiveness.”
When I worked at the American Medical Association and helped develop its ethics guidelines on the relationship between physicians and drug companies, I remember meeting a detailer who was responsible for promoting just one drug. You can bet he was consumed with generating high sales of the drug.
[cross-posted at HealthLawProf]
June 20, 2012 at 8:35 am
Posted in: Health Law, Supreme Court
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Responses (3)
Frank - June 20, 2012 at 10:07 am
Given the industry practices below (as summarized and quoted from Efthimi Parasidis’s Patients over Politics, p. 976), the Breyer of Sorrell may have been a bit closer to the mark:
1. Excluding patients with profiles that are judged to be more likely to suffer adverse health events;
2. clinical trials with short durations so latent effects are less likely to be uncovered;
3. Limiting the number of participants in clinical trials so as to reduce the likelihood of uncovering all adverse health effects;
4. Recording only selective side effects;
5. Excluding patients who removed themselves from clinical trials because they could not tolerate the side effects;
6. Selectively publishing study results to disproportionally favor positive research findings;
7. Removing patients who have strong placebo responses;
8. Testing some patients before the trial officially begins and selecting only those patients who have an initially positive response to the product under evaluation;
9. Secretly un-blinding interim results midway through a clinical trial and altering the trial design prior to reblinding the study;
10. Conducting trials in countries where quality and ethical oversight is lacking;
11. Utilization of ingredients from sources where FDA oversight is minimal or precluded;
12. Ghost writing scientific articles;
13. Ghost managing academic research; and
14. Off-label promotion absent evidence of safety and efficacy
Based on: Donald W. Light, Bearing the Risks of Prescription Drugs, in THE RISKS OF PRESCRIPTION DRUGS 15-17 (Donald W. Light ed., 2010). See also Ernest R. House, Blowback: Consequences of Evaluation for Evaluation, AMERICAN JOURNAL OF EVALUATION 2008. (“In a study of 370 ‘randomized’ drug trials, studies recommended the experimental drug as the “treatment of choice” in 51% of trials sponsored by for-profit organizations compared to 16% sponsored by nonprofits.”).
Frank - June 20, 2012 at 10:09 am
By the way, industry fans (and devotees of empirical legal studies) may want to take a look at these documents, and the podcast:
“Yong on Science, Replication, and Journalism”
http://www.econtalk.org/archives/2012/06/yong_on_science.html
Ken Rhodes - June 20, 2012 at 10:49 am
I am puzzled by this case in its entirety. It appears to me that SmithKline has allowed Christopher et al to frame the issue based on one part of the FLSA (outside sales persons) and ignored another (exempt professionals).
Look at this sentence from page 7:
The overtime compensation requirement, however, does not apply withrespect to all employees. See §213. As relevant here, the statute exempts workers “employed . . . in the capacity ofoutside salesman.” §213(a)(1).1
Footnote 1 at the bottom of that page says: 1This provision also exempts workers “employed in a bona fide executive, administrative, or professional capacity.” 29 U. S. C. §213(a)(1).
Why all the discussion of whether the “detailer” are, in fact, sales people. Why not simply stipulate that they are not sales people, as they claim? Then, given that they are highly compensated, and given the function they perform, which is educating and assisting doctors, they are clearly “professional” within the FLSA and DOL meanings of that word. So they are exempt, and thus not entitled to overtime pay.
What am I missing here?
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