We recently hosted NYU’s Richard Epstein to discuss First Amendment issues related to regulating pharmaceutical marketing. Here’s the video from that talk:
Last week, a group of scientists reported (Science: subscription required) that they were able to identify “anonymous” donors in genetic information studies using little more than Internet sleuthing. The study was widely reported in the popular press, including a short piece in Wired where CLB’s own Hank Greely was quoted. I’m interested, and often disappointed, at how both law and genetics are covered in the popular press, and unfortunately, nothing in this press cycle disabused me of those feelings. The headlines ranged from the baldly wrong (“Anonymous Genealogy? Think Again, Everyone Can Be Traced“) to the fear-mongering (“Patients can be ID’d in ‘anonymous’ public genetics databases“); reporting elided over critical facts; and some articles relied on interested or one-sided interview subjects. But worse, perhaps, is that none of the reporting captured, or even discussed, what I think are the two most critical strands of concern for the public: (1) what genetic privacy means in the age of Facebook, and (2) how that analysis affects the Fourth Amendment. Read the rest of this entry »
Tuesday, January 15
2:00 – 3:00 PM
Stanford Law School Room 280A
Before a drug can be sold legally in the United States, the FDA must approve it as safe and effective for a particular indication — the indication that then appears on the drug’s label. Federal law, however, allows doctors to prescribe drugs that the FDA has approved for one indication for any otherwise legal purpose, even though the FDA never passed on the safety or efficacy of the drug for that use. This kind of “off-label use” is very common and completely legal, but federal law forbids drug companies from promoting their products for such off-label uses, apart from some limited safe harbors. Civil and criminal actions against drug companies for illegal promotion for off-label use have proliferated in recent years, leading to many large settlements. In United States v. Caronia, however, a divided Second Circuit panel recently ruled that the conviction of a drug marketing rep for off-label promotion violated the rep’s First Amendment free speech rights.
Richard Epstein, the Laurence A. Tisch Professor of Law at NYU and the Kirsten Bedford Senior Fellow at the Hoover Institution, has suggested courts should strike down not only the ban on off-label promotion, but (absent false or misleading information) all laws barring the sale of prescription drugs. See http://www.hoover.org/publications/defining-ideas/article/136416.
The Stanford Center for Law and the Biosciences is happy to sponsor a discussion with Professor Epstein about the Caronia decision and, more generally, the future of drug regulation.
This event is free and open to the public.
Part way through the holiday season either definitely is, or definitely is not, a good time to think about obesity. Between family feasts, work-related parties, New Year’s Eve, and cold (well, cold for California) weather, calories always seem to pack in more tightly this time year – leading to the clothes fitting more tightly. Read the rest of this entry »
Prashant Reddy Thikkavarapu
The field of medical diagnostics has travelled a long distance over the last century. Starting with Roentgen’s discovery of clinical X-rays in the November of 1885 to the revolutionary Human Genome project which was completed in 2003, healthcare has witnessed nothing short of a revolution in the manner in which medical illnesses have been diagnosed and treated. A key beneficiary of these advances has been pregnant mothers, who now have a range of inventive diagnostics tools designed to test their foetuses with minimal risk to either the mother or the unborn child. Read the rest of this entry »
A three-judge panel of the Ninth Circuit Court of Appeals just granted a temporary injunction pending appeal in the case of Pickup v. Brown,* a challenge to the constitutionality of a new California statute barring licensed health practitioners from providing the treatments defined as “sexual orientation change efforts” to minors. This is a quite interesting case, for lots of reasons – First Amendment speech rights of health care providers, the varying roles of parents, states, and minors over how children are raised, statutory regulation of medical practices, sexual orientation and the Constitution, and others. But one of the others that may get overlooked is that the case may be a bit of an imperfect test drive for arguments about “cognitive liberty.” Read the rest of this entry »
The lines we’ve drawn to distinguish the sick from the well, and legitimate treatment from drug “abuse,” are blurring beyond discernment. Earlier this month members of the American Psychiatric Association approved a new manual that re-defines many mental illnesses, prompting howls that the group has alchemized ordinary unpleasant behaviors and emotions into diseases. Critics claim the newly-minted “disruptive mood dysregulation disorder” turns kids who throw tantrums into mental patients, while changes to the definition of depression transform sadness due to the death of a loved one into a symptom of a disordered mind.
While this angst is understandable, it’s surprising we continue to take these disease definitions so seriously. Read the rest of this entry »
Friday, July 20, 2012, Aurora, Colorado
Sunday, August 5, 2012, Oak Creek, Wisconsin
Tuesday, December 11, 2012, Clackamas Mall, Clackamas, Oregon
Friday, December 14, 2012, Sandy Hook Elementary School, Newtown, Connecticut.
Tomorrow, two weeks from now, two months from now . . . your home town or mine? Probably not, but almost certainly some Americans’ home towns – we’ve seen at least four of these mass shootings in just the last 5 months.
Trying to stop or even reducing the number of mass shootings in a country that already has hundreds of millions of guns and billions of rounds of ammunition in private hands would not be easy. But if, for political reasons (bolstered by some newly successful constitutional arguments), we rule out the regulation of guns and ammunition, it seems likely to go from very difficult to beyond impossible.
Gun lovers will continue to deny that too many guns and too much ammo is a problem. Some will continue to mouth that the problem is too few. If only those second graders had been carrying – or, at least, their teachers. They will cry that this tragedy is being inappropriately politicized. Maybe a few of them will have qualms, maybe not.
But the rest of us – those not infatuated with automatic weapons and daydreams of using them to repel invasions from Russia, China, or Washington, D.C. – must not let gun politics continue as usual. We must say “enough” and start working, thoughtfully and carefully, to come up with effective ways to prevent, or at least limit, these shootings. If we never start, we can never have any success – that’s not bioscience, or rocket science.
Our lack of any policy response to these killings, though understandable in terms of short term politics, is, in a broader sense, just plain crazy. So maybe there is some kind of “biosciences” in it after all.
At Scientific American, Dr. Judy Stone is using a notorious case of research misconduct at the University of Minnesota (where I studied bioethics) to walk through the requirements of ethical research on human subjects and the many ways they can be violated. It can be difficult to keep up with the research scandals at Minnesota’s Psychiatry Department over the years, so for the sake of clarity: this is the one involving Dan Markingson, a young man who killed himself while participating in an industry-funded clinical trial of Seroquel (the “CAFE” study). Read the rest of this entry »