Safeguarding Patient Welfare: Who’s In Charge?
I recommend to you the editorial by Jane Henney (former FDA Commissioner) and the article which prompted it. As you’ll read, the original article is an exposition of marketing practices used in the promotion of Gabapentin (Neurontin) by Pfizer. The authors used publicly available documents obtained from Pfizer during a federal lawsuit that was settled in 2004, with Pfizer admitting that it violated federal law by promoting the drug for unapproved uses. I especially appreciate the editorial, because Dr. Henney understands that industry is always going to be under pressure from its investors to seek maximum profits from each drug it sells and that maximum profits come only with effective promotion. Thus, there will always be pressure on sales and marketing personnel to push the envelope of allowable promotional practices. This means that the targets of these promotional efforts–primarily physicians–must actively guard against illegal or unethical promotional activities. In particular, so-called key opinion leaders must be very careful to monitor their own behavior during sanctioned and informal educational activities. The guidelines for such activities are already written, but they must be followed consistently. As Henney clearly understands, the prescribing physician is ultimately responsible for shielding patients from harm. As such, physicians must not allow themselves to become compromised by financial or ego-boosting inducements from industry.
