Last week the Washington Post flayed doctors who participate in the Medicare program, along with the pharmaceutical company Genentech, because they often prescribe the $2,000-a-dose (and fully FDA-approved) eye drug Lucentis in preference to Avastin, a biologically related compound also made by Genentech that seems to work equally well against “wet” age-related macular degeneration and can be obtained off-label from compounders for only $50 an injection (albeit with some additional risks and hassles). Taxpayers have shelled out billions of dollars, the Post complains with some justice, because many docs (currently close to half) choose FDA-approved in preference to off-label treatments.
Great investigation, guys. Now that you’ve accused doctors of being socially irresponsible and greedy for not going off-label to prescribe, could you investigate who exactly has been demonizing off-label prescribing as a dangerous, unregulated practice that the FDA needs to crack down on? What would happen if you found that that it was some of the Post’s own favorite sources and advocacy groups?
A chance for left-right policy alliance might have been missed here ["David Hume," Secular Right; Coyote]
I’ve got a new post up at Cato at Liberty on three important decisions for the business community decided today at the Supreme Court, two on employment law and one on pharmaceutical pre-emption: Vance v. Ball State on liability for supervisorial harassment, University of Texas Southwestern v. Nassar on mixed-motive retaliation, and Mutual v. Bartlett (more) on design default preemption for a generic drug. (& welcome Coyote, Point of Law, SCOTUSBlog, Taegan Goddard/WonkWire readers)
Trying to order medications for a heart attack victim using electronic medical records, White Coat is frustrated to run into screen after screen preventing him from completing the order without addressing unlikely allergy issues (and thus protecting the hospital from liability):
For those of you who don’t know what alarm fatigue is, think of a car alarm. The first time you hear it going off, you run to your window to see who’s breaking into a car. Maybe you run to the window the second time and the third time, too. By the tenth time the alarm goes off, you’re thinking that the alarm is broken and someone needs to get that fixed. After about thirty false alarms, you’re feeling like going out there and busting up the car yourself – especially if the car alarm wakes you when you’re asleep.
It’s a concept with many applications beyond the emergency room setting, too, product warnings being just the start.
P.S. Dr. Westby Fisher has some related thoughts about the limits of trying to engineer physician responsibility through electronic records design.
A WSJ editorial and news coverage have called attention to a case from the Alabama high court holding Pfizer liable for a drug it didn’t produce, namely a generic knockoff of its acid reflux drug Reglan. Michael Greve agrees that it’s daffy to allow such suits, but traces the problem to the U.S. Supreme Court’s popular (at least with the media) 2009 decision in Wyeth v. Levine, okaying state tort actions over federally approved labels — and cautions that any victories for regulated business on the issue of federal-state preemption tend to be temporary at best. More: Coyote, FedSocBlog.
“A bill that would allow patients addicted to prescription drugs to sue the doctors who prescribed the medication — and the drug’s makers — was met with stiff opposition Wednesday in a Nevada legislative hearing.” Sen. Tick Segerblom (D-Las Vegas), who introduced SB 75, defended the measure: “They know the person can get addicted to the drug so they should pay for the process of them getting off it.” [AP; related effort to use drug-dealer-liability laws] (& White Coat)
Compounding pharmacies, which mix medications to order, are a corner of the drug business that has been much less heavily regulated than mass-manufacturing drug companies. As a result, the compounders began expanding their market presence as against the mass manufacturers, and even get into mass manufacturing methods themselves. The process accelerated in the past few years after tightened FDA control of conventional makers’ production practices (under GMP, or Good Manufacturing Practice, regulation) began to result in widespread production-line suspensions; for hospitals and other users, the availability of compounded alternatives is often the only fallback in the face of shortages.
Unfortunately, poor quality control at some compounders resulted in a series of fiascos culminating in a meningitis outbreak. Now the Washington Post reports that major drug companies are seizing the chance to hobble their competition by pressing for maximally burdensome regulation of compounders, including the addition of regulations unrelated to safety, such as rules aimed at restricting the compounding of formulas that imitate the action of patented products. Hospitals, which sometimes engage in compounding themselves to obtain medication for their patients, say overregulation could worsen the problem of drug shortages. [Kimberly Kindy and Lena Sun, Washington Post] Earlier on drug shortages here, here, etc.