January 27, 2012
Worth Reading This Week
Amy Monahan, Fairness Versus Welfare in Health Insurance Content Regulation, SSRN/Ill. L.Rev.
Alex Stein, Toward a Theory of Medical Malpractice, SSRN/Iowa L.Rev.
Pieter Cohen, Assessing Supplement Safety — The FDA's Controversial Proposal, NJEM
Sharon Long et al, Massachusetts Health Reforms: Uninsurance Remains Low, Self-Reported Health Status Improves As State Prepares To Tackle Costs, Health Affairs
January 22, 2012
Health Law Headlines of the Week (1/15-1/21)
Sam Baker, Court Angst for Left Over Healthcare, The Hill, Jan. 18, 2012 (here).
Supporters of President Obama’s healthcare reform have lost the high level of confidence they once displayed that the Supreme Court would throw out constitutional challenges to the law’s individual mandate.
Many liberals and some Democratic leaders initially waved off lawsuits challenging the law’s individual mandate, saying the suits were “frivolous” political stunts.
But that tone has shifted significantly since the Supreme Court devoted nearly six hours to arguments in the case—a modern record. That the high court would set aside so much time for the landmark case suggests that the justices certainly don’t see the challenges as a waste of time.
The law’s critics were also encouraged that the justices agreed to hear arguments against its Medicaid expansion. That part of the suit does not meet the criteria the court usually uses when deciding which cases to consider.
David Sherfinski, Bill Would Add Virginia to Health Care Opponents, Wash. Times, Jan. 17, 2012 (here).
A Virginia lawmaker is pushing legislation to add the state to an interstate compact that would exempt members from President Obama’s health care overhaul—a budding movement that’s providing states across the country with another constitutional weapon to combat the landmark law.
. . . [U]nder [the bill] Virginia would join other states collectively seeking to create their own health care policies through federal block grants and shield themselves from any conflicting federal law or regulation. . . .
Four other states — Georgia, Texas, Oklahoma and Missouri — already have approved measures that put the compact into law, and legislation is pending in at least 12 others . . . . For a compact to take effect, it needs at least two member states and congressional approval.
Enabled by the “Compact Clause” in Article 1 of the Constitution, interstate compacts generally are used to solve cross-border problems such as transportation. About 200 compacts are currently in effect. In the Washington area, the Metrorail system is one example. But the health care compact would be the first to explicitly protect states from federal law.
Jonathan D. Rockoff & Mia Lamar, Medivation, Pfizer End Work on Alzheimer’s Drug, Wall St. J., Jan. 18, 2012 (here).
Pfizer Inc. and partner Medivation Inc. are abandoning development of an experimental Alzheimer's drug, a decision that underscores the risks that Big Pharma faces in trying to bolster drug pipelines with expensive deals.
The companies decided to end the program for developing the compound, called Dimebon, after it failed to meet two primary endpoints in a phase 3 trial studying its use with the existing treatment Aricept in patients with mild-to-moderate Alzheimer's. The failure was Dimebon's second in a phase 3 trial.
Finding a treatment for Alzheimer's, a brain disease that progressively robs sufferers of their memory, is a priority of many drug makers. Some 5.4 million people in the U.S. and 18 million world-wide are estimated to have Alzheimer's. Analysts say sales of effective treatments could reach $25 billion a year.
Seeking an edge in that market, in 2008 Pfizer agreed to pay Medivation $225 million upfront—and up to $500 million more if milestones were met—for development rights to Dimebon. . . .
Skeptics on Wall Street, however, questioned the drug's prospects and size of the deal. The drug was originally a common-cold remedy in Russia. No one could fully explain how an antihistamine might slow the progression of Alzheimer's, although clinical trials conducted in Russia suggested it could. . . .
Announcing the failure of the latest trial Tuesday, the two companies said they would halt development of Dimebon for all indications and cease an ongoing open-label extension study in Alzheimer's disease. The companies also said they would terminate an agreement to codevelop and market the drug.
Robert Pear, U.S. to Force Drug Firms to Report Money Paid to Doctors, N.Y. Times, Jan. 17, 2012, at A1 (here).
To head off medical conflicts of interest, the Obama administration is poised to require drug companies to disclose the payments they make to doctors for research, consulting, speaking, travel and entertainment.
Many researchers have found evidence (here) that such payments can influence doctors’ treatment decisions and contribute to higher costs by encouraging the use of more expensive drugs and medical devices. . . .
Large numbers of doctors receive payments from drug and device companies every year—sometimes into the hundreds of thousands or millions of dollars—in exchange for providing advice and giving lectures. Analyses by The New York Times and others have found that about a quarter of doctors take cash payments from drug or device makers and that nearly two-thirds accept routine gifts of food, including lunch for staff members and dinner for themselves.
The Times has found that doctors who take money from drug makers often practice medicine differently from those who do not and that they are more willing to prescribe drugs in risky and unapproved ways, such as prescribing powerful antipsychotic medicines for children.
Under the new standards, if a company has just one product covered by Medicare or Medicaid, it will have to disclose all its payments to doctors other than its own employees. The federal government will post the payment data on a Web site where it will be available to the public. . . .
Companies will be subject to a penalty up to $10,000 for each payment they fail to report. A company that knowingly fails to report payments will be subject to a penalty up to $100,000 for each violation, up to a total of $1 million a year. . . .
Manuel Roig-Franzia, After the Death of Jack Kevorkian, Lawrence Egbert Is the New Public Face of American Assisted Suicide, Wash. Post, Jan. 19, 2012 (here).
[Lawrence] Egbert[, a retired anesthesiologist,] estimates he has been present for 100 suicides in the past 15 years, a figure that puts him in the same league with the famed assisted-suicide maverick Jack Kevorkian, who claimed to have helped more than 130 people die. Egbert calls Kevorkian a “radical” because the latter took an active role in some suicides, building a machine to administer lethal doses and sometimes injecting patients himself. Egbert sees his work as a calling, a vocation aimed at ending suffering. But he says he provides only guidance and support.
Egbert says he approved applications for about 300 suicides, most as medical director of the Final Exit Network, a loosely knit group that claims 3,000 dues-paying members. Even within his own organization, Egbert is controversial. The vast majority of the network’s members suffer from painful physical ailments such as late-stage cancer, he says. But unlike the group’s current leadership, Egbert is also willing, in extreme cases, he says, to serve as an “exit guide” for patients who have suffered from depression for extended periods of time.
. . . [W]ith Kevorkian gone—he died in June—two indictments of Egbert, one in Arizona and another in Georgia, have transformed [Egbert] into the public face of American assisted suicide . . . .
Egbert has been acquitted in Arizona, but the Georgia case looms, trudging slowly through the court system toward a possible trial that could further shape national opinion about assisted suicide.
Denise Grady, Scientists to Pause Research on Deadly Strain of Bird Flu, N.Y. Times, Jan. 21, 2012, at A3 (here).
The scientists who altered a deadly flu virus to make it more contagious have agreed to suspend their research for 60 days to give other international experts time to discuss the work and determine how it can proceed without putting the world at risk of a potentially catastrophic pandemic.
Suspensions of biomedical research are almost unheard of; the only other one in the United States was a moratorium from 1974 to 1976 on some types of recombinant DNA research, because of safety concerns.
A letter explaining the flu decision (here) is being published in two scientific journals, Science and Nature, which also plan to publish reports on the research, but in a redacted form, omitting details that would let other researchers copy the experiments. The letter is signed by the scientists who produced the new, more contagious form of the flu virus, as well as by more than 30 other leading flu researchers.