HealthLawProf Blog

More Bad News for Pscyhotropic Medications

It's been a bad several days for psychotropic medication.  Here's the latest -- the FDA has just required a boxed warning for atomoxetine (brand name Strattera), a medication indicated for treating ADHD.  Today's public health advisory states:    

"The increased risk of suicidal thinking for this drug was identified in a combined analysis of 12 short-term (6-18 weeks) placebo-controlled trials ... [that] involved a total of over 2200 patients... The analysis showed a greater risk of suicidal thinking during the first few months of treatment in those receiving Strattera.  The average risk of suicidal thinking was about 4 per thousand patients treated with Strattera compared to no events in placebo-treated patients.  There was 1 suicide attempt among these approximately 2200 patients, occurring in a patient treated with Strattera.  Based on these data, FDA has determined that the following points are appropriate for inclusion in the boxed warning:     * Strattera increases the risk of suicidal thinking in children and adolescents with ADHD.     * Anyone considering the use of Strattera in a child or adolescent for ADHD must balance the increased risk of suicidal thinking with the clinical need for the drug.     * Patients who are started on therapy should be observed closely for clinical worsening, suicidal thinking or behaviors, or unusual changes in behavior.     * Families and caregivers should be advised to closely observe the patient and to communicate changes or concerning behaviors with the prescriber.

The full public advisory statement can be found here:
http://www.fda.gov/cder/drug/advisory/atomoxetine.htm

Thanks to Dr. Doug Mossman for this post. 
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Bird Flu Hits the Mainstream

This week's National Geographic has a cover story on the potential of a killer flu outbreak.  It is graphic and frightening to read. 

In addition, Senate Minority Leader Harry Reid issued a statement concerning the need to prepare for the upcoming potential of the bird flu pandemic.  After noting how unprepared America is for this potential diaster, he states,

“Experts have warned us that an avian flu pandemic is inevitable. But the devastating consequences that could ensue from an outbreak are not – provided this nation and the world heed the science community’s warnings and take action immediately

 

“I propose we start by committing the resources necessary to protect Americans. We need not wait for a perfect plan on paper to start dedicating more resources to address this issue. We know today that funding certain programs can make dramatically reduce the consequences of a future avian flu outbreak. We also know that many of these programs are either unfunded or massively underfunded.

 

“Tomorrow, when we take up the Defense Appropriations Bill, Senators Harkin, Kennedy, Obama, and I, along with a number of my colleagues plan to offer an amendment that will ensure that we begin making the investments necessary to make sure this nation and the world do everything possible to ensure that history does not repeat itself and we do not have to relive 1918.”

For all the information you need about the bird flu and the slow political response, see Effect Measure.
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Judge Roberts Confirmed

Judge Roberts has been confirmed by the Senate as the new Chief Justice.  You can read about the vote here.  Some commentaryas well as the chatter about who might replace Justice O'Connor is available from TalkLeft and SCOTUSblog.   [bm]

Turkish Mental Hospitals: Problematic Treatments

Dr. Doug Mossman points to this New York Times article discussing the sad goings on among some mental health professionals in Turkey.  The Times reports,

Turkey's psychiatric hospitals are riddled with horrific abuses, including the use of raw electroshock as a form of punishment, according to a human rights report issued in Istanbul on Wednesday, just days before Turkey begins formal talks to join the European Union.

The report, by Mental Disability Rights International, a Washington-based group, came after several visits in the past year by the group's investigators to psychiatric hospitals and other facilities for people with developmental or mental disabilities.

While the report details many types of abuses, it said the most disturbing involved the use of electroconvulsive therapy without anesthesia to treat a wide range of illnesses in adults and children. The World Health Organization has called for a ban on "unmodified" or "direct" use of the treatment and states that children should never be subjected to it in any form.

The therapy, in which an electrical current is passed through the brain, was developed in the 1930's and continues to be used in mainstream psychiatry to treat a limited number of ailments. But it is normally administered with anesthesia and muscle relaxants.

Without them it can be painful, terrifying and dangerous. Patients can break jaws or crack vertebrae during the induced seizures. The report quotes a 28-year-old patient at Bakirkoy Psychiatric Hospital in Istanbul as saying, "I felt like dying."

The Health Ministry, which is responsible for psychiatric hospitals, said it had not yet read the report and declined to comment, other than to say that the director of the electroconvulsive therapy center at Bakirkoy denied administering unmodified electroshocks there.

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Paxil Information for Pregnant Women

Dr. Doug Mossman points to some big news on the pharmaceutical front for healthcare professionals,

Paxil (paroxetine HCL)
Paxil CR Controlled-Release Tablets

Audience: Neuropsychiatric and other healthcare professionals
[Posted 09/27/2005] GlaxoSmithKline (GSK) and FDA notified healthcare professionals of changes to the Pregnancy/PRECAUTIONS section of the Prescribing Information for Paxil and Paxil CR Controlled-Release Tablets to describe the results of a GSK retrospective epidemiologic study of major congenital malformations in infants born to women taking antidepressants during the first trimester of pregnancy. This study suggested an increase in the risk of overall major congenital malformations for paroxetine as compared to other antidepressants [OR 2.2; 95% confidence interval, 1.34-3.63]. Healthcare professionals are advised to carefully weigh the potential risks and benefits of using paroxetine therapy in women during pregnancy and to discuss these findings as well as treatment alternatives with their patients.

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Washington Post Takes Medicare Part D for a Spin

"Giving Part D A Spin" - that was the title of Tuesday's exploration of the in's and out's of the looming pharmaceutical benefit about to be rolled out by CMS in 2006. The complexity of Part D is no small matter.  A quick search on CMS' FAQ page unearths 528 Qs & As concerning the Medicare Drug Benefit.  528!

The authors mention a couple of useful resources to help seniors (and health law teachers) understand Part D:

• One of [the Healthcare Leadership Council's] educational tools is the "MedicareRx Made Simple" wheel, which considers an individual's marital status, income and approximate drug costs to estimate how much a person would pay annually for drugs under Part D.
• The Medicare Rights Center's webpage has a 101-question FAQ page.

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Law School Outdated?

Law.com has published an article by DeanStephen J. Friedman of the Pace Law School.  He provides some insight and criticism on the education provided by law schools.  He states,

A year ago, I became dean of Pace Law School after a career in law practice, government and corporate life. What I found throughout legal education surprised me. From the point of view of a practicing lawyer, legal education has not evolved to meet the demands of a rapidly changing profession.

It has, in fact, changed surprisingly little in the 40-odd years since I graduated -- certainly not enough to meet the needs of law firms under increasing pressure to transform students into productive lawyers as quickly as possible.

While we don't need radical changes in a law curriculum that has worked for a long time, legal education must be brought into closer alignment with the need of law students to hit the ground running when they begin to practice law. . . .

Law practice has become much more specialized in the last 20 years. Legal education needs to give students meaningful experience in some area of the law. The need for focus raises the dreaded debate about the dangers of specialization in law school.

I do not think that greater focus is a cause for concern. Most lawyers can remember when they first felt comfortable functioning as a lawyer. Something intrinsic kicks in, their knowledge and skills coalesce, and they reach a point where what they already know more than makes up for what they do not yet know. When a lawyer has a broad understanding of how the corporate tax system works, or of real estate practice, or of the legal complexities of international trade, then he or she can begin to think like a lawyer.

Navigating a legal regime is an intellectual skill that is transferable to mastering other legal regimes. Lawyers routinely shift their practice from one area to another as a former specialty becomes less important because of regulatory or market changes. Or their clients' needs change. When I began to practice law, there was an extensive market for financings in the form of extensively negotiated private placements by insurance companies. The market for private placements was displaced by quasi-public Rule 144A financings and then by other forms of widely distributed institutional debt. Lawyers made that shift with relative ease, even though the market and terms were entirely different.

Similarly, a student is far better off with a law school experience that comes as close as possible to an integrated combination of skills, knowledge and substantive law in one broad area -- such as litigation or corporate transactions -- than with a smorgasbord of unrelated courses, even if that student ends up practicing in an entirely different area. Law schools have the opportunity to create an integrated group of courses covering broad practice areas that would give students a meaningful introduction to the major tasks they will face as new lawyers.

This role for law schools has important implications for the design of the curriculum. It requires a more focused legal education. This approach starts out by asking, "What courses and skills does a student need in order to be an effective new corporate lawyer?" -- or litigator, or family lawyer, or nonprofit lawyer, or whatever.

The skills needed by each of these practice areas do not correspond easily to current curriculum design, and examining legal education through the prism of practice areas provides a useful perspective for organizing the curriculum. We can then ask whether the curriculum has the right mix of courses, both doctrinal and skill sets, and whether they are offered as a coherent series designed to achieve a meaningful objective.

Litigation offerings highlight the differences in approach. Most law schools offer many relevant courses and experiences in this area, including civil procedure, evidence, trial practice and other simulations, negotiation, arbitration, mediation and externships and clinical experience.

A practice-oriented approach might begin by asking what substantive and procedural law and skills a new litigator should know to be able to work effectively in dispute resolution. It would consider how existing courses dovetail with one another and what new courses are needed, which part of evidence is best taught in a doctrinal setting and which is best learned through simulations, where moot courts fit in, and which nonlegal skills are essential (such as presentation training and psychology).

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Lester Crawford Resigns Update

Today's New York Times has an interesting story about the possible reason for former FDA commissioner Lester Crawford's sudden resignation.  According to the Times, his resignation was perhaps due to a failure to disclose financial information,

Lester M. Crawford's wife has told family members that an unintentional failure to disclose financial holdings prompted his sudden resignation as commissioner of food and drugs last week, her brother said yesterday. . . . .

Dr. Crawford, reached by phone yesterday, said that he would not comment on whether his resignation had anything to do with his financial holdings.

"I appreciate the opportunity," he said, "but I don't have any comment on that."

The abruptness and mystery surrounding Dr. Crawford's departure, only two months after his Senate confirmation, have fueled speculation that he had investments in companies regulated by the F.D.A., which oversees the food, drug and cosmetics industries.

The Times further reports that the new interim FDA commissioner will continue in his job as the National Cancer Institute as well.  The Times states,

As for the F.D.A.'s new leadership, President Bush named Dr. Andrew C. von Eschenbach, the director of the National Cancer Institute, as acting commissioner on Friday, and Dr. von Eschenbach has said he will keep his position at the cancer institute while running the F.D.A.

But yesterday Senator Edward M. Kennedy of Massachusetts, the senior Democrat on the Senate health committee, said Dr. von Eschenbach should not try to juggle the two jobs.

"There are intrinsic conflicts of interest between the role of N.C.I. director, who manages a research program that includes drug development, and the role of F.D.A. commissioner, whose responsibility is to review the safety and effectiveness of those drugs," Mr. Kennedy said in a letter to the secretary of health and human services.

Moreover, Mr. Kennedy, like Senator Charles E. Grassley, Republican of Iowa, said that each job had immense responsibilities and that it was therefore not feasible for one person to run the two agencies.

Christina Pearson, a spokeswoman for the secretary, Michael O. Leavitt, said yesterday that the administration was not changing its plan for Dr. von Eschenbach to keep his job at the cancer institute while serving as interim chief of the F.D.A.

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L.A. Hospital's Liver Transplant Program Suspended

Reuters (among others) is reporting that L.A.'s St. Vincent Medical Center has suspended its liver transplant program and fired two top liver transplant surgeons.  The actions were taken after a routine UNOS audit revealed that a Saudi national who 52nd on the local OPO's waiting list was jumped to the top and transplanted in return for a $339,000 payment by the Saudi embassy that was 25-30% higher than what most U.S. insurers pay for a liver transplant. To make matters worse, the probe that followed uncovered falsified documents to cover up the breach of UNOS policies involved.  And don't forget the impact of all this on the 75 patients who were on the liver transplant waiting list.  With the St. Vincent program suspended, they are being contacted to see what the next step will be for them.  Click the links for the UNOS and St. Vincent statements. [tm]

Patient Response to HSAs

Ezra Klein's blog has a great discussion of how HSAs might impact patient spending on health care.   He examines a recent article by Joe Paduda of the Managed Care Matters blog which states,

Catastrophic patients – about 5% of the population...are also not affected – they’ll blow through their MSA account balance in a month or two, after which the insurance company or Medicare or Medicaid pays the rest. So, no funds out of their pockets, and realistically, no way for them to pay the huge costs of their health care. By the way, the top one percent of the population that falls into this category spends 40% of all health care dollars, the top five percent that falls into this category spends over 50% of all health care dollars.

OK, that leaves the medium users. The remaining part of the population consumes more than $1000 in health care (a typical MSA plan deductible), and therefore might be more influenced by finances than the other two groups. But there’s a problem here. Studies indicate that a significant percentage of people with high deductible plans tend to not fill prescriptions, not seek care, and otherwise “under-utilize” health care due to financial reasons.

Well, their costs are constrained, at least for today. But what if they are not taking their hypertension medications and suffer a stroke? What if they don’t get a mammogram and their breast cancer is not diagnosed until it is marginally “curable”? They’ll become part of the top 5%, where costs are really uncontrollable.

Ezra's take:  The point?  HSA's aren't going to change a thing.  But you have to realize, reigning in costs and creating a more sensible system really isn't their aim.  A few libertarians have messianic hopes for the structure, but HSA's, on sum, are meant to do two things:

• Offer Republicans a policy on health care.  So long as Democrats kept pushing for universal care and manage care was collapsing, the right was left holding the bag marked status quo while voters were searching for anything but.  HSA's gave Republicans a little-understood policy to tout as the answer to all our health care problems, and thus as the way to fix the system without increasing government involvement.  Since no one really understood them they just muddled, and ended, the debate.

• Shift costs from businesses.  Those companies that do pay health costs -- mainly dinosauric entities from the days when unions walked the earth -- were crying for government help, making them potent allies in the fight for single-payer.  If they could somehow push their people onto HSA's, there's a chance they'd stop advocating for major change.  This isn't actually working, but it seems to have been part of the initial plan.

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