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Thursday, February 04, 2010

Did Cephalon Pay James Mcmillen $101,650 to Help Promote Actiq for Off-Label Use?

In a recent post, I wondered why a doctor from Dillsberg, PA, a town with a total area of 0.8 square miles and only 2,063 people, would be the 5th highest paid physician on Cephalon's list of payments to physicians. That doctor -- James Mcmillen -- received $101,650 in 2009 (see "Transparency Vs. Translucency in Reporting Physician Payments").

Since I first posted this bit of information, I learned that:
(1) Cephalon agreed to plead guilty to promoting painkiller Actiq, narcolepsy pill Provigil and the epilepsy treatment Gabitril for uses that weren’t approved by FDA. As a result of the plea agreement, Cephalon was REQUIRED to post all payments it made to physicians in 2009 and quarterly thereafter.

(2) Dr. James Mcmillen is a member of the National Fibromylgia Association (he's listed on the Association's Web site here).
Could it be that Doctor Mcmillen was paid to promote Actiq for the treatment of fibromyalgia, which is a use not approved by the FDA?

BTW, Actiq gets high ratings from patients for the treatment of "Fibromyalgia syndrome (FMS)" on RevolutionHealth (see here) -- the Wisdom of the Crowd health web site founded by Steve Case (listen to this podcast interview of Jay Silverstein, COO of Revolution Health).

FURTHER THOUGHTS: I have learned a few more interesting tidbits about Dr. Mcmillen's relationships with the drug industry. In 1999, for example, Merck tried to "neutralize" Dr. Mcmillen because his message about the drug Vioxx was "consistently negative" (see this series of Merck emails). "We need to neutralize this physician as soon as possible," said Merck's Arthritis & Analgesia Specialist, Thomas McCready.

It appears that Dr. Mcmillen was, at the time, working for Searle, a company that co-marketed (with Pfizer) Celebrex, a product that competed with Vioxx before the latter drug was pulled from the market for safety reasons.

In his email, Merck's McCready listed all the work that Mcmillen was doing on behalf of Searle:
  • Speaking engagements 200 days per year (approx. 400-500 programs)
  • Conducts Speaker Training teleconferences
  • Conducts Sales Rep Training teleconferences
  • Primary Care Investigator
First, I am amazed at Merck's intelligence regarding Mcmillen's activities with Searle. They must have good informants! Second, Mcmillen appears to have been working FULL TIME for Searle! How else can you do 200 speaking engagements per year!

Now I know why a physician from "podunk" (ie, Dillsberg, PA) can earn over $100K from Cephalon -- Mcmillen, according to the Merck memos, is affiliated with the prestigious Hershey Medical Center, which is located nearby.

Mcmillen was also working for Merck at the time as an investigator. He was set to participate in Merck's clinical trials for its second generation COX-2, but was informed that his participation in that study was no longer needed.

Merck met with Dr. Mcmillen and reviewed his slides relating to COX-2's and Vioxx. McCready said he was "open to coaching" and to making the "necessary changes" Merck recommended. McCready, however, questioned whether Mcmillen would make the changes. McCready said the ball was in Mcmillen's court.

That's where the story from these memos/emails ends. I do not know if Mcmillen "won" the Mexican standoff with Merck and got back on its payroll or not. According to the person who alerted me to the Merck memos, "McMillen ran drug trials at his site including for merck. His experience led him to believe that Vioxx was bad -- lots of hypertension & CHF & renal problems. He spoke out about this while on the merck study. They came after him hard. He did not back off. He was a hero in this area."

I'll leave it at that.

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