Saturday, February 16, 2008

Pharma cries wolf (again)

You have to feel bad for the poor, oppressed pharmaceutical industry. I mean, even politicians are starting to pick on them (mind you, it's an election year, the politicians will probably stop) and support consumer advocacy group requests that safeguards be put in place against the use of journal reprints to promote off-label use. Basically, the way the provision of journal reprints supposedly works is that a pharma Sales Rep or Medical Science Liaison (MSL)* meets with a physician who (of his or her own volition, of course) requests detailed information and specific journal articles about a certain off-label use of a product. Ostensibly, the physician who initiated the request, fills out a form to indicate his or her desire to have these reprints sent and then reads those articles to fulfill his/her intellectual curiosity; sometimes, the physician even considers using the product on his/her own patients based on the information contained in the articles. The way it really works, most likely the pharma company employee meets with the doctor, the subject of off label use comes up and the games begin. Sales Reps are not allowed to discuss off label use at all, compliant reps at complaint companies will address the issue by having a physician information request form filled out (the rep may actually fill out the form and get the doc to sign it to "ensure" compliance and verify that it was the doctor's idea) and then put the doctor in contact with the MSL who can talk about off label use to the company's delight.

Companies state they need to be able to supply these articles to provide a physician with information that will ensure that any use of their product in a non-approved indication will be done safely. To a certain extent that is true. These articles not only provide information about dosing of the medication in the off label use, but may also provide detailed instructions how to administer the medication (this is especially important for injectable drugs such as botulinum toxin, which may be injected into large muscles for an approved indication but require a different technique to inject into smaller muscles, glands, joints, etc. to treat off label).

Randy Lutter, deputy Commissioner of the FDA, inadvertently gives a clear reason of why pharma companies want to provide the reprints and how they increase sales in his description of the current draft FDA guidance about distribution of literature [emphasis added]:
"articles that discuss unapproved uses of FDA-approved drugs and devices can contribute to the practice of medicine and may even constitute a medically recognized standard of care.” [Pharmalot]
So, you tell me. If these reprints can lead to a new standard of care that includes use of a marketed product to treat an indication for which it has not been adequately tested, let alone undergone a rigorous review of raw datasets (FDA inadequacy aside) and approval, who benefits the most? While Pharma will state the patients and medical community get the benefit, it is actually the manufacturer that gets the great reward at the end of the day. They get increased sales without having to burden the financial cost and safeguards of conducting and monitoring controlled trials or submitting a New Drug Application, and they get it in much less time than it would take to obtain an approval of the drug. They may even end up with limitation in liability since they supposedly do not promote off label and the label doesn't include the indication, the primary liability is the physician's.

If a physician is really curious enough to want information on use of a product for a non approved indication, he or she does have the ability to conduct a literature search and obtain their own copies of a journal article. Removing free, easy, quick access via Pharmaceutical companies does not prevent anyone from obtaining these publications. Whenever I've brought this up to sales reps, MSLs and even on Pharmalot, I've received the same response of "the docs are too busy to do a lit search or get reprints on their own" and/or "not all journal articles are available free of charge". While there is some validity to the charge related to the costs of articles through a publishing company (at least for those not affiliated with academic centers), more articles are available for free these days and one can usually obtain a copy of a reprint from the author free of charge; the cost of articles and subscriptions to medical journals can also be charged to a practice as a legitimate business expense. It is the complaint that the docs don't have the time that concerns me more. If these docs don't have the time to obtain the literature, do they have the time to delve into the articles to critical evaluate what's presented in them? My guess is that, in many cases, pharma companies rely on limited time to spoon feed the information in the articles they want to convey to get the doc prescribing.

To make matters worse, many of these articles are from research paid for by the manufacturer (but called "independent" since it's not sponsored by the company or submitted to a regulatory authority) and the primary purpose is to get a quick and dirty study completed and published in much less time and for much less money than it would take to conduct a truly adequate and well controlled study.

Let's be honest, Pharma is calling this a free-speech issue because they don't like anything that curtails their ability to promote off-label. They'll bite the bullet and pretend they don't directly promote off label but they will not stand for any limitations to indirect routes of off label promotion. It's past time to ensure that real safeguards are put in place, we need actual enforcement and accountability for regulations that are already on the books.

*MSLs are, technically, part of Medical Affairs and are permitted to discuss off label , but are widely seen and used as an arm of sales/marketing

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