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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Easy Health Tip: Wash Hands

Today's New York Times Science section has an article discussing a recent study on handwashing habits.  The study reveals that women are more likely to wash their hands than men - no reason for the difference was discovered.  According to the Times,

Most people say they wash their hands after using the bathroom. But a new study suggests that many of them are not telling the truth.

The researchers demonstrated that people were not as conscientious as they say they were by comparing answers given in a telephone poll to observed behavior.

In the nationwide poll, conducted from Aug. 19 to Aug. 22 by Harris Interactive, 1,013 adults were interviewed about their hand washing habits. Then observers were sent into public restrooms to see what actually happened.

Ninety-one percent of adults claimed in the poll that they washed their hands after using a public restroom. But of the 6,336 adults whose behavior was observed, only 82 percent actually did so.

Women, the study found, were more diligent than men: 90 percent washed their hands, compared with only 75 percent of the men.

Michael T. Osterholm, chairman of the public health committee of the American Society of Microbiologists, which commissioned the survey, said he could not explain what accounted for the difference.

"I don't think anyone knows why men are so much less likely to wash than women," he said. "People who use urinals probably think they don't need to wash their hands. But the overall message is that most Americans do wash their hands after using the bathroom, even though we have a long way to go."

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Patient Backlash Against Defensive Medicine?

According to a Wall Street Journal Online/Harris Interactive Health-Care poll, patients are questioning aggressive treatment decisions by their physicians more than ever.  (This is what most of the health care reforms of the past decade were intended to do, right?  Make patients more informed and skeptical consumers, through a variety of mechanisms that put more of the first-dollar payment obligation on them and reduced the impact of third-party payer mechanisms?  Maybe it's starting to work!) Here is the straight dope:

Considerable Concern Exists Amoung U.S. Adults About the Frequency of Unnecessary or Overly Aggressive Medical Treatment

There is considerable concern among U.S. adults about the frequency with which patients are medically over treated by their doctors, according to a new Wall Street Journal Online/Harris Interactive Health-Care Poll. Nearly three-quarters (72%) of U.S. adults think that patients who have medical conditions experience problems because of being over treated (i.e., getting too many treatments or getting more aggressive treatment than is appropriate). In light of these concerns by the public, it's not surprising to learn that half (50%) of all adults are somewhat or very concerned, personally, about being over treated when they are sick or in need of medical care. More than half (52%) of all adults have chosen to question or forego recommended care because they felt it was unnecessary or too aggressive. Specifically:

• Nearly a third (32%) did not fill a prescription that their doctor gave them because they felt it was unnecessary.
• About one-fifth (21%) got a second opinion from another doctor because they thought their doctor's recommendations were too aggressive.
• Sixteen percent (16%) did not get a diagnostic test that their doctor recommended because they felt it was unnecessary.
• One in 10 (10%) did not get a surgical procedure that their doctor recommended because they felt it was unnecessary.
• Nine percent (9%) changed doctors because they felt their doctor's approach was too aggressive.

Source:Wall Street Journal Online/Harris Interactive Health-Care Poll Date: September 16, 2005 http://www.harrisinteractive.com/news/allnewsbydate.asp?NewsID=970

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New FDA Acting Commissioner

As you are probably well aware, Dr. Andrew C. von Eschenbach, head of the National Cancer Institute, has become the new acting FDA commissioner.  The Associated Press provides a brief glimpse on how he plans to govern the agency.  It reports,

The new acting chief of the Food and Drug Administration, Dr. Andrew C. von Eschenbach, said yesterday that he will be presiding over a transformation in medicine, as scientists understand diseases in a way that could improve doctors' ability to treat patients.

Von Eschenbach, tapped by President Bush as the temporary chief of the regulatory agency, said yesterday that discoveries about diseases at ''a molecular level" will lead to a new kind of healthcare.

Now, doctors treat illnesses based on how well other people have responded to a given treatment. Soon, they will develop a tailored response, built around specific understandings of the patient, the treatment and the disease, he said.

''We are discovering so much about diseases like cancer at the molecular level," said von Eschenbach, who is a urologic surgeon by training. ''Much of what we have done . . . has been based on a model of empiricism." Soon, doctors will be able to intervene with medical treatments more effectively matched to a specific patient's illness.

Preparing the FDA for such a transformation is among his goals, von Eschenbach said.

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Senator Frist and HCA Stock Sale

Although this is not strictly a health law topic, it is interesting that HCA is once again under scrutiny as well as Senator/Dr. Frist.  According to USA Today,

Senate Majority Leader Bill Frist, R-Tenn., was updated several times about his investments in blind trusts during 2002, the last time two weeks before he publicly denied any knowledge of what was in the accounts, documents show.

The updates included stock transactions involving HCA Inc., the hospital operating company founded by Frist's family.

Frist's sale of HCA stock is under scrutiny by the federal government. Nashville-based HCA said Friday it had received a subpoena from prosecutors for the Southern District of New York, asking for documents the company believes are related to Frist's sale of company stock this past summer.

Prosecutors also have contacted the senator's office, Frist spokesman Bob Stevenson said Friday. He said neither the senator nor his office had received a subpoena.

Frist's office confirmed the Securities and Exchange Commission was looking into the sale. . . . .

HCA, the nation's largest for-profit hospital company, was founded by Frist's father, the late Thomas Frist Sr. His brother, Thomas Jr., was formerly its CEO and chairman and remains on the board of directors. Frist is a heart surgeon by training.

Frist asked a trustee to sell all his HCA stock in June, near a 52-week price peak of $58.40 a share. Reports to the SEC showed HCA insiders sold about 2.3 million shares.

Frist's sale came about two weeks before the company issued a disappointing earnings forecast that drove its stock price down almost 16% by mid-July and still have not recovered. HCA rose $1.70 Friday, closing at $47.60.

The value of Frist's stock at the time of the sale was not disclosed. Earlier this year, he reported blind trusts with all holdings valued at $7 million to $35 million.

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Medical Decision Making By Parents

Saturday's Los Angeles Times had an interesting (heart-wrenching) story of an woman who disbelieves the link between HIV and AIDS.  As a result, her three-year old daughter is dead.  This seems to be the year for these kinds of stories . . . maybe every year is, but we're seeing more coverage than ever.  If anyone is aware of such stories (involving parents who reject traditional medical treatments and then been accused of endangering their child), please contact me.  This is the topic of my next law review article. [tm]

Kristof to Feds: Rebuild Health Care System While You're At It

The Times' Nicholas Kristof writes in Sunday's paper that, just as surely as the infrastructure of New Orleans and other Gulf sites devastated by Hurricane Katrine need to be rebuilt, so too does the country's health care system. 

We've all read comparative life-expectancy statistics, but Kristof offers some that are truly staggering:

In both Mississippi and Louisiana, infant mortality is worse (for every 1,000 babies born, 10 die in their first year of life) than in Costa Rica (8 die per 1,000). For black babies in either state, the picture is still more horrifying: 15 die per 1,000. In poor, war-torn Sri Lanka, where per capita medical spending is only $131, babies have better odds, with 13 dying per 1,000.

By the way: If there's anyone reading this who isn't a "Times Select" subscriber, please click on the link above and see if it will open Kristof's column.  With the paper's new server for certain features, my reliable old RSS feed generator can't convert to a permanent XML or RSS address.  I fear the "select" server, which is the only address I have for columnists like Kristof, may only open up for Times Select subscribers. Please let me know your results.  [tm]

Health Affairs: New Issue Looks at Health IT

Announcement from Health Affairs:

The September/October issue of Health Affairs is devoted to the topic of health information technology. Upon reviewing the issue's table of contents, national coordinator of HIT, David Brailer called the volume a "tour de force." In the issue:

• Barriers to Adoption: David Gans writes that physicians are experiencing barriers to adoption of electronic health records, but the adoption rate continues to rise.
• Electronic Medical Records: Catharine Burt documents how many physicians are using electronic medical records and the characteristics of their practices.
• Cost Savings: Richard Hillestad estimates annual savings of $81 billion for the health care system with fully implemented, interoperable electronic medical records.

There's plenty else in this issue that isn't listed in the blurb above, e.g.:

From the Editor    Pursuing Health IT: The Delicate Dance Of Government And The Market
John K. Iglehart

Economics Of Health Information Technology   
PROLOGUE: The Economics Of Health Information Technology 

PERSPECTIVE: Electronic Medical Records And Health Care Transformation
James M. Walker

PERSPECTIVE: Hope And Hype: Predicting The Impact Of Electronic Medical Records
David U. Himmelstein and Steffie Woolhandler

PERSPECTIVE: Savings In Electronic Medical Record Systems? Do It For The Quality
Clifford Goodman

The Value Of Electronic Health Records In Solo Or Small Group Practices
Robert H. Miller, Christopher West, Tiffany Martin Brown, Ida Sim, and Chris Ganchoff

Medicare’s Next Voyage: Encouraging Physicians To Adopt Health Information Technology
Sheera Rosenfeld, Cathy Bernasek, and Dan Mendelson

PERSPECTIVE: Using Quality Incentives To Drive Physician Adoption Of Health Information Technology
Glenn Hackbarth and Karen Milgate

Interview   Action Through Collaboration: A Conversation With David Brailer
Robert Cunningham

Implementation   
PROLOGUE: Implementing Health Information Technology

E-Prescribing And The Medicare Modernization Act Of 2003
Douglas S. Bell and Maria A. Friedman

Exchanging Health Information: Local Distribution, National Coordination
John Halamka, J. Marc Overhage, Lygeia Ricciardi, Wes Rishel, Clay Shirky, and Carol Diamond

Physicians And Ambulatory Electronic Health Records
David W. Bates

PERSPECTIVE: State And Community-Based Efforts To Foster Interoperability
Mark E. Frisse

PERSPECTIVE: Regulatory And Policy Barriers To Effective Clinical Data Exchange: Lessons Learned From MedsInfo-ED
Lawrence K. Gottlieb, Elliot M. Stone, Diane Stone, Lynne A. Dunbrack, and John Calladine

PERSPECTIVE: The Making And Adoption Of Health Data Standards
W. Ed Hammond

PERSPECTIVE: The Indiana Network For Patient Care: A Working Local Health Information Infrastructure
Clement J. McDonald, J. Marc Overhage, Michael Barnes, Gunther Schadow, Lonnie Blevins, Paul R. Dexter, Burke Mamlin, and the INPC Management Committee

Health Information Technology Policy   
PROLOGUE: Policy Issues Surrounding Health Information Technology

Strategic Action In Health Information Technology: Why The Obvious Has Taken So Long
Edward H. Shortliffe

Promoting Health Information Technology: Is There A Case For More-Aggressive Government Action?
Roger Taylor, Anthony Bower, Federico Girosi, James Bigelow, Kateryna Fonkych, and Richard Hillestad

Dot-Gov: Market Failure And The Creation Of A National Health Information Technology System
J.D. Kleinke

PERSPECTIVE: Federal Investment In Health Information Technology: How To Motivate It?
Anthony G. Bower

PERSPECTIVE: Wiring Health Care
George C. Halvorson

PERSPECTIVE: Achieving U.S. Health Information Technology Adoption: The Need For A Third Hand
Blackford Middleton

Health Tracking   
TRENDS: Functional Gaps In Attaining A National Health Information Network
Rainu Kaushal, David W. Bates, Eric G. Poon, Ashish K. Jha, David Blumenthal, and the Harvard Interfaculty Program for Health Systems Improvement NHIN Working Group

FROM THE FIELD: The Missing Link: Bridging The Patient–Provider Health Information Gap
Paul C. Tang and David Lansky

FROM THE FIELD: Transforming Care: Medical Practice Design And Information Technology
Charles M. Kilo

DataWatch   Medical Groups’ Adoption Of Electronic Health Records And Information Systems
David Gans, John Kralewski, Terry Hammons, and Bryan Dowd

GrantWatch   
REPORT: Toward A High Performance Health System: The Commonwealth Fund’s New Commission
Karen Davis

UpDate   
CONFERENCE REPORT: The Adoption Gap: Health Information Technology In Small Physician Practices
Jason Lee, Carol Cain, Scott Young, Nancy Chockley, and Helen Burstin

If you don't subscribe, all you're probably going to be able to see is an abstract.  I finally bit the bullet about 10 years ago and am glad I did.  If your library subscribes, you might look into the possibility of an institutional password that will give you access to the electronic version.  [tm]

Lester Crawford Resigns

Lester Crawford, the FDA's Commission, has resigned.  I am not sure what is behind the resignation  but this seems very mysterious to me.  Reuters reports,

U.S. Food and Drug Administration Commissioner Lester Crawford abruptly resigned on Friday after a bruising fight over whether the agency would approve over-the-counter sales of a morning-after pill and a string of drug-safety controversies.

    Crawford's resignation takes effect immediately, health officials said. They offered no reason for his sudden departure less than three months after he was confirmed for the job.

    President George W. Bush asked National Cancer Institute Director Andrew Von Eschenbach to serve as acting FDA commissioner, the White House said.

    Crawford won a contentious confirmation battle in the Senate after Health and Human Services Secretary Mike Leavitt assured Senate Democrats the FDA would act on over-the-counter sales of the morning after pill Plan B by Sept. 1.

    But he came under fresh attack in late August when the FDA indefinitely postponed a ruling on whether Barr Pharmaceuticals Inc. (BRL.N: Quote, Profile, Research) could sell the Plan B contraceptive without a prescription. The agency's top women's health official resigned in protest.

    The FDA also faced a string of drug safety controversies during Crawford's tenure. Some critics charged the agency with being too slow to react to signs of serious side effects from Merck & Co. Inc.'s (MRK.N: Quote, Profile, Research) recalled painkiller Vioxx and other medicines.

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IRS Proposes Intermediate-Sanctions/Corporate-Governance Rule

Thanks to Barbara Kincaid for sending along a link to Jones Day's announcement about the IRS's new proposed intermediate-sanction regulation. According to the firm:

On September 8, 2005, the IRS released a set of Proposed Regulations that set forth the standards the IRS proposes to use to determine whether to revoke the § 501(c)(3) status of an organization that has engaged in a transaction that constitutes both traditional private inurement and an excess benefit transaction. Under these Proposed Regulations, organizations that attempt in good faith to follow good corporate governance and compliance practices both before and after a private inurement problem occurs will survive with their tax-exempt status intact. Those organizations that do not follow good corporate governance and compliance practices will lose their tax-exempt status.

Want to know more?  Here's what one of my favorite sites (www.Regulations.gov) has on it:

TITLE:	Standards for Recognition of Tax-Exempt Status if Private Benefit Exists or If an Applicable Tax-Exempt Organization Has Engaged in Excess Benefit Transaction(s)
SUBJECT CATEGORY:	Income and excise taxes: Excess benefit transactions
	View this Regulation in HTML Format
	View this Regulation in PDF Format
PROPOSED RULE
Docket ID:	[REG-111257-05]
CFR Citation:	26 CFR 1, 53
Published:	September 09, 2005 [FR Doc. 05-17858]
Comments Due:	December 08, 2005
How to Comment:	Submit a Comment on this Regulation Send submissions to: CC:PA:LPD:PR (REG-111257-05), room 5203, Internal Revenue Service, POB 7604, Ben Franklin Station, Washington, DC 20044. Submissions may be hand delivered Monday through Friday between the hours of 8 a.m. and 4 p.m. to: CC:PA:LPD:PR (REG-111257-05), Courier"s Desk, Internal Revenue Service, 1111 Constitution Avenue, NW., Washington, DC. Alternatively, taxpayers may submit comments electronically via the IRS Internet site at http://www.irs.gov/regs or the FederaleRulemaking Portal at http://www.regulations.gov (IRS-REG-111257-05). A public hearing may be scheduled if requested.

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Flu Vaccine: Not So Helpful

So, here I am worrying about whether there will be a sufficient supply of flu vaccine this year and along comes this article in the New York Times examining two recent studies concerning the efficacy of the vaccine.  I guess I can start worrying about this now.  According to the Times,

Just as governments around the world are stockpiling millions of doses of flu vaccine and antiviral drugs in anticipation of a potential influenza pandemic, two new surprising research papers to be published Thursday have found that such treatments are far less effective than previously thought.

"The studies published today reinforce the shortcomings of our efforts to control influenza," wrote Dr. Guan Yi, a virologist at the University of Hong Kong, in an editorial that accompanied the papers. The two studies were published early online by The Lancet, the London-based medical publication, because of their important implications for the coming flu season.

In one paper, international researchers analyzed all the data from patient studies on the flu vaccine performed worldwide in the last 37 years and discovered that vaccines showed at best a "modest" ability to prevent influenza or its complications in elderly people.

"The runaway 100 percent effectiveness that's touted by proponents was nowhere to be seen," said Tom Jefferson, a researcher in Rome with the Cochrane Vaccine Fields project, an international consortium of scientists who perform systematic reviews of research data.

"There is a wild overestimation of the impact of these vaccines in the community," he said. "In the case of a pandemic, we are unsure from the data whether these vaccines would work on the elderly."

In the second paper, researchers from the Centers for Disease Control and Prevention in Atlanta found that influenza viruses, particularly those from the dreaded bird flu strain, had developed high rates of resistance to the only class of cheap antiviral drugs available - drugs mainly used to treat flu once patients have caught it. These resistance rates have increased rapidly since 2003, particularly in Asia.

"We were alarmed to find such a dramatic increase in drug resistance in circulating human influenza viruses in recent years," said Dr. Rick Bright of the disease control centers. "Our report has broad implications for agencies and governments planning to stockpile these drugs for epidemic and pandemic strains of influenza."

To top it all off, not only do I need to worry about my parents, grandparents and young son, but also my dogs.  The Times has an additional report on a dog flu sweeping the country.  [bm]

New Play Explores Cloning and Family Relationships

For those of you in the Washington, DC area with an interest in bioethics, this looks like a terrific event -- 

THE STUDIO THEATRE’S DYNAMIC 2005-2006 SEASON BEGINS!
TED VAN GRIETHUYSEN AND TOM STORY STAR IN CARYL CHURCHILL’S ELECTRIFYING A NUMBER

Deeply intriguing and rich in mystery, A Number is the latest masterwork by the endlessly imaginative Caryl Churchill. The Studio Theatre’s production reunites Ted van Griethuysen and Tom Story, who last appeared together in The Invention of Love, in which they both played poet A.E. Houseman¾at two different periods in his life. In A Number, the two actors explore the complex relationship between father and son. Churchill’s play sets their emotionally gripping power struggle against the backdrop of a world profoundly altered by powerful new technology. Founding Artistic Director Joy Zinoman, who also directed The Studio Theatre’s critically acclaimed production of Caryl Churchill’s Far Away, here reunites with members of her Far Away creative team, including Set Designer Debra Booth, Lighting Designer Michael Lincoln, and Sound Designer Gil Thompson. A Number runs September 7 – October 16, 2005. Tickets are on sale now at The Studio Theatre, 14^th and P Streets NW, 202-332-3300 or www.studiotheatre.org.  . . . .

The Evening Standard of

London

called A Number “the first true play of the 21^st century.” Daunting and important questions haunt the play: Does cloning technology weaken individual identity? Are we the product of our genes or our experiences? The true heart of A Number is the pain, rage, and hope that accompany the bond of family. The father in Churchill’s play is a man of secrets, a man who has lost one son and is desperate for a second chance. Full of half-told stories and tantalizing clues, A Number ushers audiences into a hall of mirrors, where they are invited to follow Churchill’s carefully laid path through the minefield of family relationships.

A NUMBER INFORMATION

Director and Designers: Joy Zinoman (Director), Debra Booth (Set Designer), Michael Lincoln
(Lighting Designer), Brandee Mathies (Costume Designer), Gil Thompson (Sound Designer),
Erik Trester (Projections).

Where: The Mead Theatre

Dates: September 7 – October 16, 2005

Performances: Wednesday – Saturday: 8:00pm, Sundays: 7:00pm, Matinees: Saturday

and Sunday 2:00pm, Select Tuesdays: 8:00pm (September 20 and 27, October 11)

Ticket Prices:  $32.00 - $52.00

Pay-What-You-Can: Saturday, September 10, 2:00pm. Tickets go on sale two hours before the performance on a first-come, first-served basis.

Sign Interpreted Performance: Saturday, October 15 2:00pm.

THE STUDIO THEATRE INFORMATION

Discounts:  Student, senior citizen (62+), and military discounts $5.00, (except Saturday evenings). 

Student Rush: half-price tickets for full-time students are available one-half hour before curtain on a seating available basis (except Saturday evenings).

Groups:  Discount rates available for parties of 10 or more.  Call the Group Sales Manager at 202-232-7267.

Accessibility:  All performances are fully accessible to accommodate patrons with special needs. FM listening assistive system available, call for schedule for sign-interpreted performances. Accessible seats available by reservation. Call the Box Office at 202-332-3300 or V/TTY 202-667-8436.

Location: 

1501 14^th Street, NW

(Northeast corner of 14th and P Streets). 

Parking:  Please call the Box Office for parking information.

Metro Stops: Red Line:

Dupont Circle

,

Orange

/Blue Lines:

McPherson Square

, and

Green Line U Street

/Cardozo.

Contact Information:    Tickets:  202-332-3300     V/TTY:  202-667-8436     Fax:  202-332-1187

  Administration:  202-232-7267         Admin. Fax:  202-588-5262

  Web site:  www.studiotheatre.org      E-mail: studio@studiotheatre.org

Collaborations of Doctors, Hopsitals, Insurers, and Employers Are Bringing Electronic Record Keeping to Small Doctors' Offices

A large collaboration of doctors, hospitals, insurers and employers are making modern information technology accessible to hundreds of thousands of small doctors' office around the nation.  According to the N.Y. Times, the Hudson Valley effort consisting of around 500 doctors, hospitals, insurers and employers is being watched as a potential model to bring this technology to small doctors' offices.  These groups pool their resources and knowledge to create a web-based central database in which a doctor only needs a few PCs, a high speed internet connection, and to pay a monthly subscription fee of $500 to $600. 

Electronic records, particularly one shared online by different doctors and hospitals, can improve the quality and safety of patient care by reducing errors that kill tens of thousands of patients each year.  Dr. Heslin, a family physician in Saugerties says that "the large groups can afford the software.. for the onesies and twosies, small groups like ours, there is no profit margin." 

With very little financial help from Congress and the Bush Administration, big organizations such as Kaiser Permanente, the Mayo Clinic and many medical centers are spending billions to convert to electronic records.  Health and Human Services Secretary Mike Leavitt says that Katrina disaster "powerfully demonstrated the need for electronic health records."  Government and health officials had to rush to build an electronic database of prescription drug records for hundreds of thousands of people who lost their records in the storm. 

Medicare and some employers, are paying incentives to medical providers that achieve better efficiency and patient care through improved information management. However, smaller medical practices lack the computerized records that help them qualify, primarily due to the huge up-front costs as as high as $30,000 for each doctor, as well as support and training.  Thus, these type of collaborations can make the technology and use more accessible to small doctor practices.  The Taconic group received a $100,000 grant from the eHealth Initiative, a national nonprofit organization which strives to bring the medical profession into the modern digital era.  The Taconic network has also received $1.5 million from the federal Agency for Healthcare Research and Quality, to pay for an evaluation of the system by an independent researcher. 

Thanks to Lindley Bain, SMU 3L, for her assistance with this post.  [tm]

Ethical Considerations for Research Involving Children

New report released from The National Academies:

Ethical Considerations for Research on Housing-Related Health Hazards Involving Children: Public Briefing

In April the U.S. Environmental Protection Agency cancelled a study of how young children are exposed to indoor pesticides and other household chemicals after critics argued that child participants were intentionally placed at risk and parents were not fully informed of the study's potential dangers. A recent study of lead-based paint abatement by the Kennedy Krieger Institute in Baltimore also drew sharp criticism for its work with child participants [see Grimes v. Kennedy Krieger Institute, Inc., 366 Md. 29 (2001) (PDF)]. Ethical Considerations for Research on Housing-Related Health Hazards Involving Children, a new report from the National Research Council and the Institute of Medicine of the National Academies, outlines how to conduct such research in a way that ultimately improves child health, ensures that child participants do not face inappropriate risks, and fully informs their parents. The report will be released at a public briefing.

You can link to the webcast of the public briefing (Sept. 19, 2005, 2:00 p.m to 3:30 p.m. EST) here.

FDA Approves Internet Based Monitoring System of Implanted Heart Devices For In-Home Use

The Wall Street Journal reports that the FDA has approved the final components of Guidant Corp.'s Latitude Internet-based system of monitoring implanted heart devices for use in the home. The Latitude Communicator and secure data storage system is an in-home monitoring device that wirelessly reads patient information provided by devices such as pacemakers and defibrillators and transmits the data to a secure Internet server where physicians can access it.  The in-clinic use of this system has been available since November. 

This past summer, Guidant recalled tens of thousands of its defibrillators and pacemakers due to malfunctions.  In June, the FDA issued a safety alert about problems with Guidant heart devices due to some units short-circuiting.   Johnson & Johnson is to buy Guidant for about $25.4 billion, pending approval by the FTC in October. 

Thanks to Lindley Bain, SMU 3L, for her help with this post.  [tm]

Upcoming Supreme Court Assisted Suicide Case

The Cornell Legal Information Institute is a terrific source for a wide variety of legal issues including background information on upcoming Supreme Court cases.  Two weeks from today, on October 5th, the Court (presumably with the new Chief Justice Roberts presiding) will be addressing the issue of Oregon's Death with Dignity Act in the Gonzales v. Oregon.  The Cornell LII has a brief and extremely helpful overview of the case and the many complex issues that is raises.  It concludes that Oregon will probably be seeing a change in its law (and this without the C.J. Roberts factor considered explicity):

On its face, Gonzales v. Oregon (formerly Oregon v. Ashcroft), 368 F.3d 1118 (9th Cir. 2004), cert. granted, 125 S. Ct. 1299 (2005), is an intriguing case because it presents a clash of federal and state spheres of influence. On the one hand, the Attorney General has taken the position that Oregon's decision to permit physicians to distribute controlled substances for physician-assisted suicide is contrary to federal law. On the other hand, Oregon argues that the Attorney General has misinterpreted the CSA to invalidate state law that represents the democratic choice of the people of Oregon in the medical arena. These views present two different perspectives of the concept of federalism, while also implicating serious moral and policy concerns. Given framing of the central issues, the Court will not likely address this question on policy or moral grounds. The plain language of the CSA, Congressional intent and administrative law will all inform the Court's decision. The Court will likely avoid such slippery slope issues if favor of uniformity in the implementation of the CSA, perhaps a more preferable outcome to variable multi-state regulation. The safe route to resolving this case with the minimal amount of controversy suggests that change may be on the horizon for the Oregon Act.

Thanks to TalkLeft for this website and update.  [bm]

New Group Blog

This is a terrific new blog founded by a number of African-American law professors:http://blackprof.com/

It has some extremely interesting posts on a wide variety of topics.  Enjoy!

[bm]

Openings at Georgia State University's College of Law

FYI: For those of you on the teaching market -- two wonderful opportunities at Georgia State University's College of Law in Health Law.

Georgia State University’s College of Law seeks highly qualified applicants for two full-time faculty positions in health-related legal disciplines beginning with the 2006-2007 academic year. These faculty positions will support the development of the College’s health-related law program and its Center for Law, Health & Society (http://law.gsu.edu/clhs/ ).

One faculty position is in the focus area of public health law; the second faculty position is in the focus area of law related to the health sciences, health technology, and research ethics. Applicants should have an excellent academic background, strong experience in the focus area applied for, and a proven record of (or clear demonstrated potential for) successful teaching, scholarship, and service. Rank is open and commensurate with experience.

The ideal candidate for the first faculty position in public health law will have strong interdisciplinary research and teaching interests and be able to collaborate actively with research faculty in Georgia State University’s Partnership for Urban Health Research under the direction of the Institute of Public Health (see http://urbanhealth.gsu.edu/home.html).

The ideal candidate for the second faculty position in law related to health sciences, technology, and research ethics (including, e.g., biotechnology, genetics, scientific evidence, development of scientific advances, intellectual property) will have strong interdisciplinary research and teaching interests and be able to collaborate with faculty and administrators in other related University units and with other academic, business, government, or community partners in Atlanta or elsewhere.

Part of a comprehensive research university, the College of Law is a dynamic urban-centered law school located in the heart of Atlanta with approximately 650 full- and part-time law students. We encourage applications from candidates who would diversify our faculty. Georgia State University, a unit of the University System of Georgia, is an equal opportunity educational institution and an equal opportunity/affirmative action employer.

Applications and nominations should be submitted to: Professor Charity Scott Chair, Faculty Recruitment Committee Director, Center for Law, Health & Society College of Law Georgia State University P.O. Box 4037 Atlanta, GA 30302-4037 Telephone: 404-651-2083 E-mail: cscott@gsu.edu

Scott H. Bice Chair in Healthcare Law, Policy and Ethics

The University of Southern California Gould School of Law announced that QueensCare, a leading provider of healthcare to uninsured and low-income families in Los Angeles County, has given the school $1.5 million to establish the Scott H. Bice Chair in Healthcare Law, Policy and Ethics.  According to USC's press release,

The endowed chair is named in honor of the law school’s former dean, Scott Bice, who is currently a professor at USC Law. 

The chair will significantly enhance USC Law’s leadership in producing high-quality education and research on the policy, legal and ethical issues surrounding healthcare, said Matthew Spitzer, USC Law dean.  After a rigorous national search, the position is expected to be filled by a scholar with a strong record of national leadership in health care law and ethics research and teaching.

Once installed, the Scott H. Bice Chair in Healthcare Law, Policy and Ethics will convene scholarly explorations of needs, resources and determinants for improving healthcare for the underserved populations QueensCare serves. Such research would also impact national healthcare and policy analysis and could strengthen advocacy efforts on behalf of underserved communities.

Congratulations to USC Gould School of Law - what a wonderful chair! [bm]

Antipsychotic Medications: New Study

The online version of the New England Journal of Medicine (NEJM) contains results of an important study of five antipsychotic medications, which are drugs used to treat schizophrenia and other major mental illnesses. The study, conducted by psychiatrist Jeffrey Lieberman and colleagues across the U.S., looked at the 18-month treatment outcomes for patients randomly assigned to one of four newer (and comparatively expensive) “second-generation” antipsychotic medications and one older (and inexpensive) “conventional” drug. The print version of the study will appear in the September 22 edition of NEJM.
 
The key finding of the study: most patients in each group stopped their assigned medication because of ineffectiveness, side effects, or other problems. The older drug (perphenazine) appeared similar in effectiveness to three of the newer drugs. The groups of patients assigned to the fourth second-generation drug (olanzapine) stayed with treatment more consistently, but they also experienced greater weight gain, increases in blood sugar levels, and increases in blood lipid levels. 

This study may have important implications for patients who received treatment through programs (e.g., Medicaid) where concern about funding is necessarily an issue. You can locate the online version of the NEJM study here: 

http://content.nejm.org/cgi/content/abstract/NEJMoa051688 

An editorial discussing the significance of the study appears here: 

http://content.nejm.org/cgi/content/abstract/NEJMe058200
 

A useful summary of the article (“Little Difference Found in Schizophrenia Drugs,” by Benedict Carey), appears in the September 20 edition of the New York Times. This article includes comments from Dr. Lieberman and pharmaceutical company spokesmen.

Thanks to my fine colleague Douglas Mossman for this excellent post.  [bm]

Moody's Analyzes Not-for-Profit Governance Issues

From the Sarbanes-Oxley Act Task Force over at the American Health Lawyers Association comes this link to Moody's Investor Service report, "Governance of Not-for-Profit Healthcare Organizations" (PDF).  As described by the Task Force in their e-mail alert:

When the AHLA published Tax-Exempt Bonds: Is Sarbanes-Oxley Relevant? earlier in 2005, the authors, Paul Gilbert and Mark Pickrell, argued that corporate-governance issues should be relevant, and would become increasingly relevant, for not-for-profit bond issuers and other bond-market participants. Moody's Special Comment bolsters their argument that corporate-governance issues are being examined by ratings agencies and will, therefore, remain of significance to bond issuers for the foreseeable future. The Moody's report also shows that, although this ratings agency is explicitly examining corporate-governance issues in its bond-issuer research, the quantifiable effect of specific corporate-governance practices on issuer ratings, and on the interest rates of specific bond issuances, is yet to be determined.

[tm]

New Book on Terri Schiavo Case

Jon Eisenberg, one of the attorneys who respresented Michael Schiavo in the some of the federal court litigation, has written a new book.  Entitled, "Using Terri: The Religious Right's Conspiracy to Take Away Our Rights," the book provides insight into the ongoing battles concerning the right to die/refuse medical treatment.  Professor Samuel R. Bagenstos of the excellent Disability Law Blog provides a brief critique: 

The book isn't without its flaws: Eisenberg puts himself into the story too much, and some of the writing is tendentious. Disability rights opponents of the right to die come across as deluded tools of the Religious Right, rather than as people with well-grounded concerns (but perhaps a wrongheaded policy prescription). But if you want a forceful lawyer's brief for the right-to-die side of the Schiavo case (in language the lay reader can easily understand), you could do a lot worse than this book.

Amazon.com provides brief reviews by Publishers Weekly and Arthur Caplan. [bm]

Sexism Shortens Life

A new study appearing in Journal of Epidemiology and Community Health may help explain why men have a lower life expectancy world-wide.  No it isn't related to their engagement in more physically demanding jobs or risk-taking.  Apparently patriarchy is to blame.  According to Health News Daily, 

British researchers analyzed rates of female murders and male death rates from all causes in 51 countries in Europe, Asia, Australasia, and North and South America. The prevalence of violence against women was used to indicate the extent of patriarchal control in each of the countries. Socioeconomic factors were also taken into consideration.

The study found that women lived longer than men in all 51 countries. The study also found that those countries with higher rates of female murders (indicating higher levels of patriarchy) also had higher rates for male death and shorter male life expectancies, compared to countries with lower female murder rates, the researchers said.

In fact, statistical analysis showed that variations between countries in rates of violence against women accounted for close to half (49 percent) of the variation in male death rates, the researchers noted.

"Our data suggest that oppression and exploitation harm the oppressors as well as those they oppress," researchers at the University of Liverpool concluded.

  [bm].