Search Results for ‘"off-label"’

Medical roundup

Medical roundup

  • Study of Type I, Type II error finds FDA much too conservative in drug approval [Vahid Montazerhodjat and Andrew Lo via Tabarrok]
  • Behind push to license/regulate personal trainers in Washington, DC and elsewhere: ACA opened spigot of publicly channeled wellness money [Aaron Davis/Washington Post via Tyler Cowen, Peter Suderman]
  • “Medical lending”: financiers “invest in operations to remove pelvic implants, [reap] payouts when cases settle” [Alison Frankel and Jessica Dye, Reuters]
  • War on Some Drugs again collides with cancer therapy: “Psilocybin, it appears, targets this existential and spiritual distress.” [Ann Althouse]
  • Citing First Amendment, federal court enjoins FDA from prohibiting truthful speech by drugmakers about off-label uses [WSJ, Alex Tabarrok (in recent years, federal government “has extracted billions of dollars in settlements from pharmaceutical firms for engaging in what appears to be constitutionally protected speech”), Beck and Sullivan, Drug & Device Law on Amarin v. FDA]
  • SEIU 1199: “The union that rules New York” [Daniel DiSalvo/Stephen Eide, Daily Beast and City Journal]
  • Controversial therapist who is also anti-vaccine expert witness loses court challenge to Maryland medical license revocation [Beck, Drug and Device Law]

Pharmaceutical roundup

  • “Report: Government warnings about antidepressants may have led to more suicide attempts” [Washington Post]
  • Celebrity doc known for touting diet-health snake oil told off by Senators known for touting socio-economic snake oil [NBC, Business Week]
  • Physicians’ prescription of drugs off-label may “seem odd to the uninitiated, but it is called the practice of medicine, and there is absolutely nothing wrong with [it].” [Steven Boranian/D&DLaw, Sidley, Steve McConnell/D&DLaw (False Claims Act angle, with much background on that law generally)]
  • “23andMe Closer to FDA Approval” [Matthew Feeney/Cato, earlier]
  • FDA guidance could foreclose most use of tweets, Google ads and other character-limited vehicles in pharmaceutical promotion [Jeffrey Wasserstein/FDA Law Blog, Elizabeth N. Brown/Reason]
  • Average wholesale price (AWP) litigation: “Pennsylvania High Court Joins Judicial Stampede That’s Trampling State Attorneys-General/Plaintiffs’ Bar Alliances” [WLF, Beck, earlier]
  • California infant’s death opens window on lucrative (for some prescribers) intersection of workers’ comp and compounded pharmaceuticals [Southern California Public Radio]

Medical roundup

  • Latest don’t-blame-the-regulators shortage of a generic medical supply is nitroglycerin for acute cardiac care [New York Times, ACSH]
  • “Does Medical Malpractice Law Improve Health Care Quality?” Maybe not so much [Michael Frakes and Anupam Jena, SSRN via Tyler Cowen]
  • “Affordable Care Act opening doors to IT security attacks” [Ponemon via Fierce CIO] “States Barred from Requiring Obamacare Navigators Carry Error and Omission Insurance” [Craig Gottwals, Benefit Revolution] On suspension of statutory dates, Rule of Law has scanty constituency [Ramesh Ponnuru]
  • “Video Debate: Richard Epstein and Ryan Abbott on FDA, Off-Label Drug Use” [Bill of Health]
  • “Trial lawyers helped FDA with rule opening generic drug firms to lawsuits” [Paul Bedard, Washington Examiner]
  • Everyone including the agency itself discontented with FDA’s handling of new sunscreen ingredients [WaPo via Alex Tabarrok]
  • Does writing up a more careful patient chart help keep a doctor from getting sued? [White Coat]

The Washington Post on Medicare eye drugs

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?

Medical roundup

  • Pressure from HHS leads day cares to ban practice of baby-swaddling, and not everyone’s pleased about that [Abby Schachter, Reason]
  • “If Big Pharma likes your healthcare plan, you can keep it” [Tim Carney]
  • For “those of us with polycystic kidney disease… stringent FDA regulation seems to be taking away hope” [Bill Brazell, Atlantic] And: speaking of the FDA, “Dallas Buyers Club Is a Terrific Libertarian Movie” [David Boaz, Cato] Also: New Peter Huber book, “The Cure in the Code: How 20th Century Law Is Undermining 21st Century Medicine” [Basic/Manhattan Institute, Wired]
  • $7,440 annual expected loss per hospital bed in Florida vs. $810 in Minnesota, and other med-mal loss statistics [Becker’s Hospital Review via TortsProf]
  • Charge: black lung defense firm finds ways to conceal medical expert reports from adversaries [Center for Public Integrity via Joe Patrice, Above the Law]
  • Prescribing drugs for off-label uses is perfectly legal, but Johnson & Johnson will pay $2.2 billion for promoting the practice [Ann Althouse]
  • Jury awards $4 million legal malpractice verdict against prominent D.C.-based plaintiff’s firm [Richmond Times-Dispatch via White Coat]
  • “Can You Secretly Record the Medical-Legal Exam?” [Eric Turkewitz]

Colleges and universities roundup

  • New Obama “pay-for-performance” scheme for higher ed would drastically increase federal power over university sector [D.C. Examiner editorial] Don’t expect new moves to curb the escalating cost of college [Neal McCluskey, Cato]
  • Funniest IRB (institutional review board) anecdote in a while [via Tyler Cowen, earlier]
  • Will colleges start awarding admissions preferences to applicants who say they’re gay? [John Rosenberg, Discriminations]
  • “8 Cringeworthy Allegations From The New Lawsuit Against Donald Trump” [Business Insider]
  • Judge rules student can proceed with suit against Morgan State over attack by brain-eating cannibal, because what could be more reasonably foreseeable than that? [Baltimore Sun, Daily Caller]
  • Dartmouth, USC: Office of Civil Rights, following “blueprint,” suggests colleges’ procedures not extreme enough in campus sex cases [KC Johnson/Minding the Campus, earlier]
  • NCAA concussion suit seeks class action status [ESPN]

Medical roundup

  • “Blaming doctors for prescription drug abuse” [White Coat] Judge rules victim of pharmacy robbery can proceed with suit against doctor who prescribed painkillers [NYLJ]
  • Louisiana Gov. Jindal’s proposal for letting contraceptives be sold over counter has good libertarian pedigree [David Henderson, Jonathan Adler] More: Ramesh Ponnuru.
  • FDA vs. antiemetics: “How Long Before Zofran Gets Black Boxed?” [White Coat]
  • ObamaCare vulnerable to an Origination Clause challenge? [Sandefur vs. Taranto, via Randy Barnett]
  • “When a child drinks cologne, by all means, sue the doctor… ” [NJLRA]
  • U.S. v. Caronia: does First Amendment protect promotion of off-label drug use? [Richard Epstein/Hoover, PoL, WSJ Law Blog, D&DL, Shackford]
  • Ideas from John Goodman on med-mal reform [Psychology Today]

Medical and pharmaceutical roundup

Medical roundup

  • How’d we get shortages of hospital and community sterile injectables? Check out the role of FDA Good Manufacturing Practice (GMP) regs, warning letters, and resulting plant closures [Tabarrok, with comments controversy; earlier here, here, here, etc.]
  • California orthopedist sues, wins damages against medical society that took action against him based on his testimony for plaintiff in liability case [American Medical News; earlier here, etc.]
  • Can’t have that: medical apology should be opposed because it “can create an emotional connection with an injured patient that makes the patient less likely to ask for compensation.” [Gabriel Teninbaum (Suffolk Law), Boston Globe]
  • Feds’ war on painkillers is bad news for legit patients and docs [Reuters, Mike Riggs/Reason]
  • New federal pilot project in Buffalo will provide concierge-style home care to emergency-department frequent fliers. Spot the unintended consequence [White Coat]
  • Dastardly drug companies? Deconstructing Glaxo SmithKline’s $3 billion settlement [Greg Conko, MPT] More: Beck, Drug and Device Law, on suits over “what are mostly medically valid and beneficial off-label uses”. Paging Ted Frank: “HIPAA’s Vioxx toll” thesis may depend on whether one accepts that the premised Vioxx toll has been established [Stewart Baker, Ted’s recent post]
  • U.K.: “Lawyers seizing lion’s share of payouts in NHS negligence cases” [Telegraph]
  • Silver linings in SCOTUS ObamaCare ruling? [Jonathan Adler and Nathaniel Stewart] “DNC Scientists Disprove Existence of Roberts’ Taxon” [Iowahawk humor] Did Ginsburg hint at the court’s direction on the HHS contraception mandate? [Ed Morrissey, Hot Air]

[cross-posted at Cato at Liberty]