The NYTimes is doing a series of articles on one of my favorite rants: the pharmaceuticals and medical device companies. This article discusses how they are subverting the rules and regulations of the FDA through the recruitment of doctors.
At hundreds of speeches and seminars where he was rewarded with generous fees, Dr. Gleason advised other physicians that a powerful drug for narcolepsy could be prescribed for depression and pain relief. In doing so, he conspired with the drug’s manufacturer to recommend it for potentially dangerous uses, the prosecutors claim.
The case has put the spotlight on the murky financial relationships between drug companies and the physicians they use to promote their medicines. Companies cannot directly advertise drugs for purposes not approved by the Food and Drug Administration. But getting drugs prescribed for unapproved uses can increase a drug’s sales, so companies often skirt the rules by sponsoring seminars where doctors are paid to make presentations promoting their drugs, including the “off label” uses.
I actually first learned of this practice when I read Marcia Angell's book, The Truth About the Drug Companies, and I was absolutely appalled. Chapter 8 of her book, Marketing Masquerading as Education, goes in-depth into the pharmaceutical companies practice of marketing to doctors through the use of continuing education, the essence of the NYTimes article.
Dr. Gleason, 53, was taken aback because he was arrested, and later charged, for doing something that has become common among doctors: promoting a drug for purposes other than those approved by the federal government.
But prosecutors say that Dr. Gleason went too far. At hundreds of speeches and seminars where he was rewarded with generous fees, Dr. Gleason advised other physicians that a powerful drug for narcolepsy could be prescribed for depression and pain relief. In doing so, he conspired with the drug’s manufacturer to recommend it for potentially dangerous uses, the prosecutors claim.
This is called marketing drugs for "off-label" uses that are not (yet) approved by the FDA. While pharmaceuticals cannot market drugs for off-label uses, doctors can. Doctors are not held to the rules and regulations of using drugs for off-label uses as the pharmaceuticals are. The basis of this law is to stop pharmaceuticals from "broadening their claims without evidence," as Angell writes on page 137. This is not to take away from any successes stemming from off-label uses. This is about the way off-label uses are promoted, only.
But, it is also illegal for doctors to receive kickbacks or bribes to prescribe drugs. Enter "education" or continuing education. Pharmaceuticals recruit doctors to educate other doctors to promote drugs for off-label uses. Now, continuing education should continue to be a requirement for doctors. I am not, nor would I ever dispute the need for continuing education. What I would dispute is education disguised as marketing.
Despite the F.D.A.’s constraints on drug makers, though, the companies are allowed to hire independent doctors to talk to other physicians about their medicines. Companies can also sponsor “continuing medical education” sessions, ranging from lunches to weeklong conferences, where specialist doctors tell other physicians about the latest developments in their fields — including off-label uses for drugs already on the market. For such speaking engagements, doctors can receive $3,000 or more a day from the companies.
In other words, the F.D.A. rules allow drug makers to pay independent doctors to discuss medicines in ways that might be illegal for the companies themselves. Beyond the federal rules, guidelines by doctors’ groups give physicians wide latitude to talk about off-label use.
What this amounts to is doctors being paid to be company shills. Basically, pharmaceuticals are hiring "independent doctors" to discuss off-label uses of any particular drug, paying the doctor-presenter a speaking fee, and ALSO paying some 60+% of the costs of continuing education (ie. doctors aren't paying for all of their CME credits), as well as paying for the programs they present.
How can that be? As Angell asserts (with references), pharmaceutical representatives make up half of the task force that created and formulated policies of the accrediting agency (ACCME). She points to the fact that Eli Lilly has been accredited by the ACCME. Here we have a drug company wooing doctors into believing they are presenting impartial evidence on off-label uses of their drugs. [sarcasm] Righty-o! [/sarcasm]
The NYTimes article notes how the ACCME has relaxed their rules on the distinction between on-label and off-label uses in 2004. I wonder why that was?
The Accreditation Council for Continuing Medical Education, which oversees the groups that create medical education sessions, loosened its rules in 2004 so that speakers would not have to disclose whether a recommended use is on-label or off-label, said Dr. Murray Kopelow, the council’s chief executive.
“The A.C.C.M.E. abandoned the distinction between off-label and on-label,’’ Dr. Kopelow said. Instead speakers should make recommendations based on accepted medical and scientific evidence, he added.
Conflict of interest, considering who and what dictates the ACCME policies?
What is quite notable about the Gleason case, highlighted in the NYTimes article, is that the pharmaceutical company has left the doctor/sales rep in the dust to fend for himself.
As for his former benefactor, Jazz, Dr. Gleason says the company told him it was now cooperating with the investigation and that he would have to face the indictment on his own.
Subvert the laws and, well, I'm sure you know what I am about to say. Unfortunately, I have a funny feeling that the doctor will face more serious charges than the pharmaceutical company, and personally, I feel it should be the other way around.
The actions between the pharmaceuticals and doctors, the subverting of the laws, the shady continuing education business, is no different than the Abramoff case and the extravagant gift-giving to congresspersons. Both have had negative impacts on the average person.