HealthLawProf Blog

Editor: Katharine Van Tassel
Akron Univ. School of Law

A Member of the Law Professor Blogs Network

Saturday, March 11, 2006

Wine Lovers Rejoice!

Ok, red wine lovers may get excited -- red wine has been hsown to help prevent gum disease. The Times UK reports on a recent study that shows the benefits of red wine on dental health.   The article states,

Periodontitis is a common cause of tooth loss because it affects the bones as well as the gums, loosening teeth. About14 per cent of people between the ages of 21 and 50, and 65 per cent of those over 50 suffer from the disease.

The disease is caused by bacteria that stimulate the immune cells and release highly active oxygen free radicals. The Quebec team, led by Daniel Grenier, say that the antioxidants in many fruits and vegetables — and in red wine — can counter the free radicals.

The antioxidants involved are called polyphenols. The research, reported in the March issue of the Journal of Dental Research, shows that polyphenols are effective in scavenging the free radicals and reducing the inflammatory responses provoked by the bacteria.

The antioxidant properties of red wine polyphenols could be useful in the prevention and treatment of inflammatory periodontal diseases as well as other disorders involving free radicals, the researchers conclude. . . .

The team does not have any data showing that those who drink wine are less prone to periodontitis that those who do not, and earlier hopes that antioxidants could prevent disease have not been confirmed by properly organised trials. So some scepticism may be justified. . . .

Based on that last sentence I suppose that I cannot throw out the dreaded floss just yet. 
For those non-drinkers, never fear, the study showed that,

The components found in red wine are also in cranberry juice, as a team from the Université Laval, in Quebec, reported yesterday at a meeting of the American Association for Dental Research in Orlando, Florida.

Perhaps with St. Patrick's Day approaching, one might want to re-think the green beer choice in favor of a "healthier" drink such as red wine or cranberry juice.  [bm]
                  

March 11, 2006 | Permalink | Comments (0) | TrackBack (0)

Friday, March 10, 2006

Great Blog

Managed Care Matters edited by Joe Paduda is an informative and interesting blog.  I highly recommend it.  Thanks to Kate Steadman of Healthy Policy for the link.[bm]

March 10, 2006 | Permalink | Comments (0) | TrackBack (0)

Bush Administration and Science

This week's New Yorker has an article by Michael Specter that provides insight into some of the behind the scenes politics in the Bush Administration's science agenda, particularly with regard to stem cell research and FDA approval of certain drugs.  It is rather frustrating to readhow some individuals and their moral values trump science, science that provides vaccines that could prevent many deaths.   Although the article is not available on-line, an interview with the author is.  From the interview,

 

THE NEW YORKER: In your article this week, you write about the Bush Administration’s hostility to science. Broadly speaking, what does that mean?

 

      

MICHAEL SPECTER: I’m not sure I would use the word “hostility.” The Administration simply doesn’t seem to rely on the advice of scientists on a wide range of issues: climate change, pollution, and biomedical research, for example. Previous Administrations have taken science as an area that is above the political fray—this one does not seem to operate that way.

      

 

NY:  The opposition to science seems to have a number of strains, many religious. You write about how the Administration is vehemently opposed to “any drug, vaccine, or initiative that could be interpreted as lessening the risks associated with premarital sex.” Do policymakers have some other rationale, or is this more of a straightforward agenda?

 

      

MS:  Well, the Bush Administration is squarely on the record in favor of abstinence as the main approach to issues such as H.I.V. and abortion. Few groups, by the way, oppose abstinence as an approach, and many see it as an excellent first line of defense. Unfortunately, however, it doesn’t always work, and, when it does, it rarely works for long. Nonetheless, the Administration—and many of its allies among conservatives and the religious right—places far more emphasis on abstinence than on teaching children other methods of birth control and protection against sexually transmitted diseases.

      

 

NY:  What are some of the other branches of science that are suffering? For instance, you write about stem-cell research in your article.

 

      

MS:  Stem-cell research is considered by many to be the most exciting area of biomedical research. But, because it relies on human embryos, President Bush decided in 2001 that public funding for the work would be limited to those lines of cells that already existed. There are other difficult issues in the current Administration, though. The scientific recommendations of the Environmental Protection Agency have often been ignored by this Administration, and sometimes decisions on environmental policy have been heavily influenced by former, or even current, allies of industry. Climate change is another area, and so, in many ways, is nasa. President Bush has said he wants to send people to Mars. But critics say that such a program would simply take money away from more useful research.

I highly recommend the entire article.  [bm]

March 10, 2006 | Permalink | Comments (0) | TrackBack (0)

Hospital Excluded From Federal Programs Because of CIA Violations

From the HHS OIG:

Inspector General Daniel R. Levinson today announced an exclusion for a hospital's beach of its obligations under a Corporate Integrity Agreement. A portion of the press release:

OIG Excludes Miami Hospital from Participation in Federal Health Care Programs

Inspector General Daniel R. Levinson announced today that the Office of Inspector General (OIG) of the Department of Health and Human Services (HHS) is excluding Miami's South Beach Community Hospital (South Beach), formerly known as South Shore Hospital and Medical Center, from participation in Medicare, Medicaid, and all other Federal health care programs. Today's action resulted from South Beach's material breach of the terms of a corporate integrity agreement (CIA) it negotiated with OIG in 2002, as part of the resolution of a False Claims Act case against the hospital."

South Beach has committed repeated and flagrant violations of its obligations under the CIA," said Inspector General Levinson. "This exclusion sends a clear message to the provider community that the OIG will not hesitate to pursue an action against those providers that fail to abide by their integrity agreement obligations."

The full release is here.

I was blocked from South Beach's web site, allegedly because of an excessive number of hits on its home page this morning.  There's an article about the purchase of South Beach by a local physician in a May 2005 issue of South Florida Business Journal.  The May 2002 CIA with South Shore Hospital is here[tm]

March 10, 2006 | Permalink | Comments (0) | TrackBack (0)

Abortion Rates Mostly Unaffected By Notification Laws

The New York Times and the New England Journal of Medicine both published on this topic this week:

  • "For all the passions they generate, laws that require minors to notify their parents or get permission to have an abortion do not appear to have produced the sharp drop in teenage abortion rates that some advocates hoped for, an analysis by The New York Times shows. The analysis, which looked at six states that introduced parental involvement laws in the last decade and is believed to be the first study to include data from years after 1999, found instead a scattering of divergent trends. For instance, in Tennessee, the abortion rate went down when a federal court suspended a parental consent requirement, then rose when the law went back into effect. In Texas, the rate fell after a notification law went into effect, but not as fast as it did in the years before the law. In Virginia, the rate barely moved when the state introduced a notification law in 1998, but fell after the requirement was changed to parental consent in 2003."  "Scant Drop Seen in Abortion Rate if Parents Are Told," NY Times, March 6, 2006.   
  • From the New England Journal article, a little more on the effect of the Texas notification law:

ABSTRACT

Background On January 1, 2000, Texas began enforcement of a law that requires physicians to notify a parent of a minor child seeking an abortion at least 48 hours before the procedure.

Methods We assessed changes in the rates in Texas of abortions and births (events per 1000 age-specific population) before enforcement of the parental notification law (1998 to 1999) and after enforcement (2000 to 2002). We did this by comparing the rate changes among minors 15 to 17 years of age at the time of conception (i.e., those who were subject to the law) with those of teens 18 years of age at the time of conception (i.e., those who were not subject to the law).

Results After enforcement of the law, abortion rates fell by 11 percent among 15-year-olds (rate ratio, 0.89; 95 percent confidence interval, 0.83 to 0.94), 20 percent among 16-year-olds (rate ratio, 0.80; 95 percent confidence interval, 0.76 to 0.85), and 16 percent among 17-year-olds (rate ratio 0.84; 95 percent confidence interval, 0.80 to 0.87), relative to the rates among 18-year-olds. Among the subgroup of minors 17.50 to 17.74 years of age at the time of conception (who would have been subject to the parental notification law in early pregnancy), birth rates rose by 4 percent relative to those of teens 18.00 to 18.24 years of age (rate ratio, 1.04; 95 percent confidence interval, 1.00 to 1.08). The adjusted odds ratio for having an abortion after 12 weeks' gestation among minors 17.50 to 17.74 years of age as compared with 18-year-olds was 1.34 (95 percent confidence interval, 1.10 to 1.62).

Conclusions The Texas parental notification law was associated with a decline in abortion rates among minors from 15 to 17 years of age. It was also associated with increased birth rates and rates of abortion during the second trimester among a subgroup of minors who were 17.50 to 17.74 years of age at the time of conception.

Joyce T et al., Changes in Abortions and Births and the Texas Parental Notification Law. NEJM 2006;354:1031-1038.

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March 10, 2006 | Permalink | Comments (0) | TrackBack (0)

Thursday, March 9, 2006

New Bill of Rights

Slate posts a "funny" redacted version of the Bill of Rights.  My new favorites are articles III and X.

Thanks for discourse.net for the cite.  [bm]

March 9, 2006 | Permalink | Comments (0) | TrackBack (0)

Universal Health Care Article

Lief Wellington Haase has a post entitled, "Universal Coverage:  Many Roads to Rome," on ways to achieve universal health care coverage at the Talking Points Memo Cafe website.  His article discusses the single payer option and concludes that better (perhaps more realistic) methods for reaching universal health care coverage may exist.  He states,

Many think that straying from the single-payer camp means compromising the goal of  seeking universal coverage. I disagree. The means of getting to universal coverage might be single-payer. But there are other possible ways to do so—which are radical, clear in their demands for universal coverage, and attentive to the actual medical power structure.  Since the U.S. is highly unlikely to adopt a pure single-payer system—where all health funds pass through a government payer and the benefit package is largely uniform—it makes sense to take these hybrid approaches seriously. Compromise on design and implementation are acceptable, but not on the principles. . . .

Single payer shouldn’t be dismissed as a viable strategy, perhaps the viable strategy, for achieving universal coverage, but it’s hardly airtight. John Rodat summarizes a lot of the concerns about single-payer quite well. I broached some others in an earlier exchange with Yglesias. Here are some of the more serious:

           --The private sector does more than just assess risk of individuals and cream skim. It acts, most importantly, as a sector where new technologies are introduced more rapidly and diffused, such as CAT scans in the U.S. a couple of decades back. Without a private safety valve, single-payer systems are prone to react too slowly to the public demand for new medical procedures.

            --A possible brake on medical innovation: This is rightly a contested point, but a system paid for mostly with tax dollars is more likely to be parsimonious, to say the least, in paying for new kinds of services.

           --Administrative chaos. If single-payer is adopted, will private insurers stick around to process claims, as they do for Medicare and for self-insured companies? I doubt it. This isn’t just a sop to insurers but a practical assessment of what it would mean to set up a wholly new relationship between doctors, insurers, and patients in the U.S.

            --Lack of socially acceptable ways to control costs. When doctors get fee schedules, they ramp up utilization, which then leads to further budget caps and overt restraints on care. Such hard caps aren’t likely to be tolerated either by doctors or insured patients in this country.

It’s not a distraction to the cause of universal coverage to discuss these points. If they aren’t aired thoroughly by proponents, they will be used as ammunition by foes. And not only by opponents of universal coverage but by single-payer proponents as well. Anyone who even dips a toe into these debates knows the self-righteous hostility that greets anything that smacks of apparent compromise when single-payer is questioned—even valid criticism of Canada and Great Britain or the existing Medicare program, with its overly expensive fee-for-service structure. (Take a glance at any health care thread on Kevin Drum’s Political Animal, for instance.) 

The entire commentary as well as the comments are very helpful and provides lots of information for further progress in this area. Thanks to Ezra Klein for pointing out this terrific piece. [bm]

March 9, 2006 | Permalink | Comments (0) | TrackBack (0)

New Article in Support of HSAs

If you are interested in reading a positive review of Health Savings Accounts, check out the new article by Clive Crook in the Atlantic Monthly entitled, The Poison Pill.  He states,

Here is a basic principle: if costs are to be better controlled, some medical services must be either forgone or denied. The key question: Who decides? Top-down rationing—as in Britain's health service—is one approach. Consumer-driven health care—where patients decide for themselves what they can afford—is another.

 

In the United States, where almost all privately financed health care is provided by employers through tax-sheltered insurance plans, neither of these curbing mechanisms is in place. There is no government monopoly, and, with employers paying for their insurance, most patients need not concern themselves much with the cost of their treatments. The result is that this country spends more per person on health care than any other—15 percent of the national income, compared with a rich-country average of 9 percent.

 

This enormous extra cost doubtless saves or significantly improves many lives. It supports a remarkable pace of innovation. And nothing is wrong in principle with a country spending proportionally more of its income on health care as it gets richer. But the system includes plenty of waste. It delivers services that cost more to provide than they would be worth to the patient if the patient were paying. And millions of Americans with low-paying jobs have no insurance: their employer does not provide it, they cannot afford to buy their own, and they are not poor enough to qualify for Medicaid. So America's health outcomes, in the aggregate, are only fair by international standards, and are not nearly as good as they should be, given what the country spends.

 

The administration and the economists it listens to want to control costs by mobilizing consumers. If the tax advantage for employer-provided insurance were removed or offset, and if more people bought their own policies, Americans would lean more toward plans with low premiums and plenty of cost-sharing (high deductibles and high co-payments). In this way, health insurance would be more like real insurance—a protection against serious financial risk—and less akin to a utility payment plan. Patient-consumers would have the incentive they lack at present to force costs down. The administration has proposed some reforms with this notion in mind.

 

This kind of approach draws two objections—one largely false (though widely advanced), the other valid. The false objection is that patients are too ignorant to be intelligent consumers of medical services. It is all too complicated, this argument goes. Necessary health expenditures would be cut as well as unnecessary ones. Some even question whether there is any such thing as an unnecessary health expenditure. It is not as though people go to the doctor for fun, they point out; people do it only when they have to. If you restrict access by directly confronting people with the costs, their health will suffer.

 

Well, such evidence as there is says that when patients have to pay a direct share of health-care costs, they do buy fewer medical services—but also that the effect of this on health outcomes is small. This was the principal finding of the RAND Health Insurance Experiment of the 1970s and early 1980s, still the largest health-policy study ever conducted in the United States. (Its findings are often quoted, but not always accurately.) One of the researchers, in a summary of the results on the RAND Web site, put it like this: "The additional care with free care may have had little marginal value besides relief of temporary anxiety and symptoms. In fact, free care led to more self-reported diseases and worry, especially among the initially well and rich ... There seems to be little [health] cost to increasing cost sharing within the range studied by the experiment and enormous potential savings."

For some comments on this  article, see Kevin Drum. [bm]

March 9, 2006 | Permalink | Comments (0) | TrackBack (0)

HIPAA: Criminal Conviction

http://www.usdoj.gov/usao/txs/releases/March2006/060307-Ramirez.pdf

Lesson #1: Don't sell personal health information in violation of HIPAA.  The penalties are really stiff (up to 10 years in the slammer and up to $250,000 in fines).  When you consier the lousy $500 the defendant was going to be paid for the health information in question, the risk-to-benefit ratio is way out of whack.  And anyway, it's just plain wrong.

Lesson #2: If you're going to violate lesson #1, try to avoid selling the health information of an FBI agent to a confidential source of information to the FBI.  It's virtually guaranteed not to end well.

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March 9, 2006 | Permalink | Comments (0) | TrackBack (0)

Public Health Law Bench Book

Here's news (from this week's CDC Public Health Law News) of a really terrific project:

“CDC, judicial officials meet to discuss public health law bench books”
The CDC Public Health Law News        (03/06/06)        Staff

CDC officials met last week with state judges, court administrators, and judiciary executives in Atlanta to discuss progress on a series of bench books (rapid reference manuals for judges) for public health emergencies and other acute public health problems. Professor Mark Rothstein, of the University of Louisville’s Institute for Bioethics, Health Policy and Law, hosted the meeting in collaboration with the CDC Public Health Law Program. Judges, court administrators, and judiciary executives from the U.S. Department of Justice and 10 states discussed how to create public health law bench books that judges can use to quickly check the requirements of relevant statutes, cases, and procedures during emergencies, when extensive legal research might be impossible. “In emergencies, judges will provide the leadership for the justice system,” said Judge Linda Chezem of Indiana, who wrote a public health law bench book for her state under a cooperative agreement between CDC and the University of Louisville Institute. “It is essential to create an inventory of public health laws in each state [that judges can use for immediate reference],” she said. Participants at the meeting discussed methods for getting state bench book projects off the ground, including obtaining funding, forming advisory committees, consulting with experts, and other key actions. The Indiana bench book was published in June 2005. A bench book for Kentucky will be published soon, and a bench book for Arizona is pending.

[Editor’s note: To see the Indiana bench book, visit http://www.publichealthlaw.info/state_materials_indiana.htm.]

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March 9, 2006 | Permalink | Comments (0) | TrackBack (0)

NEJM: Free Article on SCOTUS and the Purposes of Medicine

The New England Journal doesn't do this real often, but today they have put at least one article on their web page for free download:

The table of contents says another article is available for free download, but it is in fact available only to subscribers (Congress, Controlled Substances, and Physician-Assisted Suicide — Elephants in Mouseholes, George J. Annas, J.D., M.P.H.).  Annas concludes his discussion of Gonzales v. Oregon with the observation that the case "should be a major comfort to physicians, for two reasons":

First, the majority of the justices found great significance in the fact that the Oregon statute sets procedures for physicians to follow and explicitly trusts that they will follow them in the exercise of medical judgment. Thus, the Court's characterization, in the California medical marijuana case, of some physicians as potential criminals now seems limited to physicians involved in drug trafficking of the type included in the Controlled Substances Act. Second, this opinion strictly limits the jurisdiction of the DEA with regard to physicians to those involved in drug trafficking. Physicians who treat terminally ill patients or patients with cancer at any stage of their illness have never had much to fear from the DEA; now they have nothing to fear from it. As Quill and Meier might put it, to the extent that "for better or worse, the DEA sets the tone and drives perceptions about legal risk associated with prescribing Schedule 2 drugs for seriously ill and dying patients," the tone should be nothing but supportive of keeping patients free of pain and discomfort.

Virtually anything that encourages what has been termed "a palliative ethic of care" has strong public support and is supported by the Court as well. This attitude is probably why, although all nine justices agree that Congress has the constitutional authority under the Commerce Clause to outlaw the prescription of controlled substances for physician-assisted suicide at any time, there has been no movement in Congress to do so. The lack of Congressional reaction to the opinion may also reflect the overwhelming condemnation on the part of the public of Congress's attempt to interfere with the medical (and legal) judgments about the treatment of Terri Schiavo.

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March 9, 2006 | Permalink | Comments (0) | TrackBack (0)

Antitrust Development

From the Antitrust Practice Group over at the American Health Lawyers Association comes this note:

Fifth Circuit Grants NTSP Emergency Motion for Stay of Final Order

On February 1, 2006, the United States Court of Appeals for the Fifth Circuit (Fifth Circuit) granted North Texas Specialty Physicians' (NTSP) January 26, 2006, Emergency Motion for Stay of Final Order of the Federal Trade Commission Pending Judicial Review (Motion). The stay will remain in effect 90 days from the date the petition for review was granted, pending further order of the Fifth Circuit.

The NTSP case is currently on appeal to the Fifth Circuit from an FTC ruling that NTSP had violated the antitrust laws by collectively negotiating with health plans on behalf of its member physicians. Previously, on January 20, 2006, the FTC had agreed to stay enforcement of portions of its order: Paragraph IV.B (generally requiring that NTSP terminate its preexisting contracts) and Paragraph IV.C (generally requiring that NTSP notify physicians of termination requests from payors). The FTC had not agreed to stay the other provisions of the Order: Paragraph II (generally requiring that NTSP refrain from negotiating the terms on which physicians deal with payors, refrain from dealing or refusing to deal with payors, and refrain from exchanging information among physicians regarding dealings with payors); Paragraph III (generally requiring that NTSP notify the FTC before acting as a messenger or agent); Paragraph IV.A (generally requiring that NTSP transmit copies of the Order and Complaint to its employees, physicians, and payors); Paragraph IV.D (generally requiring that NTSP transmit copies of the Order and Complaint to subsequent employees, physicians, and payors; and publicize the Order and Complaint); Paragraph IV.E (generally requiring that NTSP file compliance reports); Paragraph IV.F (generally requiring that NTSP notify the Commission of proposed changes to its structure); Paragraph V (generally requiring that NTSP notify the FTC of address changes); Paragraph VI (generally allowing the FTC access to documents and employees); and Paragraph VII (stating a 20 year duration for the Order).

NTSP made a number of factual assertions in support of its motion, including its position that cost-containment and quality improvement processes from its risk contracts will "spill-over" to its non-risk contracts, that payors may contract with its physicians outside of NTSP, and that rates offered by payors to NTSP were equal to or less than those offered to other physicians. NTSP argued that the FTC based its case against NTSP on what NTSP termed the "all-or-nothing principle" (that an independent physician association must be willing to messenger all payor offers), and that when the FTC modified its Opinion regarding this principle, it should have modified its Order accordingly. According to NTSP, the FTC did not adequately consider a Rule of Reason approach in its analysis and failed to fulfill its burden of showing a relevant market. NTSP expressed disagreement with the FTC's treatment of all of NTSP's conduct as "concerted action." NTSP indicated that the FTC's Order prevented NTSP from communicating even "benign" or "objective" information to its patients. According to NTSP, the FTC's failure to stay its "termination notice provision," even though it stayed the "contract termination provision" pending appeal, would cause confusion among patients. (The contract termination provision required NTSP to terminate its non-risk contracts, at the latest, within one year of the effective date of the Order.) Finally, NTSP asserted that the FTC's Order interfered with NTSP's right to commercial free speech and right to contract.

NTSP noted that its contracts affected 13 health plans, 550 physicians, and hundreds of thousands of patients. On February 2, 2006, NTSP filed a Petitioner's Reply to Federal Trade Commission's Opposition to Emergency Motion for Stay of Final Order.

Access a copy of NTSP's Motion, NTSP's Reply to FTC's Opposition, and Order of the Fifth Circuit

While we're at it, here's the link to the FTC's Final Order, the subject of the Fifth Circuit's emergency stay.  [tm]

March 9, 2006 | Permalink | Comments (0) | TrackBack (0)

Wednesday, March 8, 2006

Oncologists, Reimbursement Policy, and . . . Cancer Drugs

The New York Times has a good article in today's paper on a study published in Health Affairs (abstract) concerning the impact of reimbursement practices on oncologists' choice of cancer drugs.  The Kaiser Daily Health Policy Report summarizes it as follows:

Payment System for Oncologists Influences Choice of Treatment, Study Says 

     The current reimbursement system for chemotherapy medications administered to cancer patients might affect the treatments that oncologists use, according to a study published in the current issue of Health Affairs, the New York Times reports. Medicare and private health insurers reimburse oncologists for the full cost of the chemotherapy medications administered intravenously in their offices, although oncologists can obtain discounts of as much as 86% on the price of the treatments. As a result, oncologists "can profit from the sale of chemotherapy drugs," the Times reports. Oncologists maintain that they use the profits to cover operational costs and to allow cancer patients to receive chemotherapy medications in their offices, rather than in hospitals. However, Medicare and private health insurers have begun efforts to reduce the amount of profits that oncologists can receive through reimbursements for chemotherapy medications.

Study Details
For the study, researchers from the University of Michigan and Harvard University examined Medicare reimbursement rates for different chemotherapy medications and how oncologists treated 9,357 advanced cancer patients ages 65 and older between 1995 and 1998. The study finds that oncologists "who were more generously reimbursed" for chemotherapy medications "prescribed more costly chemotherapy regimens to metastatic breast, colorectal and lung cancer patients." Reimbursement rates did not affect whether oncologists favored chemotherapy medications over other treatments, according to the study. Oncologists "have more control over the agents chosen" because of a lack of clinical evidence about the relative effectiveness of chemotherapy medications, study co-author Joseph Newhouse, a professor of health policy and management at Harvard, said. However, Joseph Bailes of the American Society of Clinical Oncology said that oncologists decide which chemotherapy medications to use based on clinical evidence, not reimbursement rates, adding that evidence exists to indicate which treatments are more effective for different stages of cancer (Abelson, New York Times, 3/8).

The study is available online.

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March 8, 2006 | Permalink | Comments (0) | TrackBack (0)

More on Pharmacists' Conscience Clause

I expressed some frustration the other day at not being able to find a good cite (or site) to nail down the American Pharmaceutical Association's policy statement on pharmacists' conscientious refusal to fill prescriptions they find to be morally objectionable (this was in the context of Plan B emergency contraception).  Prof. Maxine Harrington at Texas Wesleyan has come to my rescue with this web address: http://tinyurl.com/ooyad.  At page 6 there is this entry of a 2004 amendment by the APhA House of Delegates to an 1998 policy:

2004/1998
Pharmacist Conscience Clause
1. APhA recognizes the individual pharmacist’s right to exercise conscientious refusal and supports the establishment of systems to ensure patient’s access to legally prescribed therapy without compromising the pharmacist’s right of conscientious refusal.
2. APhA shall appoint a council on an as needed basis to serve as a resource for the profession in addressing and understanding ethical issues.
(JAPhA 38(4): 417. July/August 1998)

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March 8, 2006 | Permalink | Comments (0) | TrackBack (0)

Upcoming Conference on Censorship and IRBs

On April 6 and 7th, Northwestern University School of Law is hosting what looks to be an interesting conference entitled, "Censorship and Institutional Review Boards."   A description of the conference states,

This conference will explore the threat to the First Amendment freedoms and to acacemic freedom from Institutional Review Boards ("IRBs"). IRBs are established by universities,   under federal regulations, for prior review of research. Before a professor or student can do research on human subjects, he must submit a research proposal to an IRB for its approval. Although IRBs rarely deny permission outright, they require modification of about 80 percent of submitted proposals. Even when research is "exempt," IRBs     usually require it to be registered. Indeed, IRBs keep records of approved, disapproved, and registered research for examination by federal officials.

Of course, it may seem only reasonable that a researcher should get permission before doing research on human subjects, but IRBs raise important First Amendment questions. In particular, there is reason to fear that in establishing a system of getting prior permission, the regulations on IRBs create a system of licensing speech and the press. The primary federal regulations on IRBs collectively known as the "Common Rule" - define "research" as a "systematic investigation" designed to produce "generalizable knowledge," which is understood to be knowledge of the sort published by researchers (45 CFR Part 46). Moreover, the regulations impose the system of  administrative licensing on much research that consists solely of reading, talking, asking questions, and printing and distributing surveys. Under these regulations, IRBs interfere with much academic inquiry and expression, and they have had the effect of almost shutting down some fields of study. In short, the regulations on IRBs deserve attention, for they appear to establish a sweeping system of prior administrative censorship that bears a remarkable resemblance to the licensing of the press that the First Amendment most centrally forbade.

PARTICIPANTS:

      Participants include: Elmer Abbo (Chicago), Dale Carpenter
      (Minnesota), Robert Charrow (Greenberg, Taurig; D.C.),
      Fredric Coe (Chicago), Harold Edgar (Columbia), Richard
      Epstein (Chicago), Joel Frader (Northwestern), Kate
      Gottfried (Tufts), Melvin Guyer (Michigan), Philip
      Hamburger (Columbia), David Hyman (Illinois), Jack Katz
      (UCLA), Renee Lerner (George Washington), James Lindgren
      (Northwestern), William Marshall (Duke), Jonathan Moss
      (Chicago), John Mueller (Calgary), Richard Shweder
      (Chicago), James Weinstein (Arizona State), Roy Weiss
      (Chicago), and Todd Zywicki (George Mason).

      PAPERS:

      The conference papers will be published by the Northwestern
      University Law Review, and the conference is supported by
      Northwestern University School of Law, the John M. Olin
      Program in Law and Economics at the University of Chicago,
      and the MacLean Center for Clinical Medical Ethics at the
      University of Chicago.

      PROGRAM:  For the program, see:

                     http://irbinfo.blogspot.com/


      REGISTRATION/FURTHER INFORMATION:

      Attendance is free, but please register ahead of time
      with:

      CONTACT:       Marjorie Holme
      Email:         MAILTO:mholme@uchicago.edu

      For other information, please contact:

      CONTACT:       Philip Hamburger
      Email:         MAILTO:hamburger@law.columbia.edu

[bm]

 

March 8, 2006 | Permalink | Comments (0) | TrackBack (0)

New Health Care Reality TV

I have not been following the reality television craze too closely (although I must admit that when I babysit my nieces and nephews,  I have been exposed to American Idol).  Well, just in case you felt that you had missed out on reality television and its impact on popular culture  --  there is a new medical reality television show coming soon on an ABC station near you entitled, "Miracle Workers".  According to the promo,

Each week, the show will feature two stories of ordinary people who do not have the network, access to the necessary medical community or in some cases the resources to these procedures. Their seemingly overwhelming medical problems will be taken in hand by a renowned team of medical specialists. The patients' lives will be transformed before viewers' eyes as the professionals employ cutting-edge medical technology to heal those who need it most. The team will not only restore the patients' health, but their hope in living a whole life again.

The series will show the patients' entire journey, from first consultation with their team of doctors, to the medical procedure itself, to the effect this life-changing event will have on them and their loved ones. State-of-the-art special effects will take viewers inside the patients' bodies, showing in detail the incredible medical transformation taking place.

The Miracle Workers team will include lead doctors Redmond Burke, a pioneering cardiac surgeon who performed New England's first heart lung transplant on a child; Billy Cohn, a cardiovascular surgeon who has been called the "Thomas Edison" of heart surgery for his impressive list of inventions that have changed surgery techniques; UCLA Medical Center nurse Janna Bullock and McLennan Community Recovery RN Tamara Houston.

I am not quite sure what to think of this.  The commentary from a number of health care blogs has been quite illuiminating  --  Kate Steadman (Healthy Policy Blog), Graham, (OverMyMedBody) and Ezra Klein.  Ms. Steadman writes about the show, 

It’s taking the uninsured and making them special cases to nurture and heal.  It’s ignoring the fact that 46 million people are in the same place as the two patients featured every week on this show.

It would be prohibitively expensive to rebuild every crumbling home across the nation, but the added cost of covering the uninsured is quite small.  There’s a variety of ways to go about it; some involving small changes, others monumental shifts.  But this problem isn’t uncurable; it’s not a fact of life (or doesn’t have to be).  It’s fixable.  This show could really make leaps and bounds for health care if it discussed these cases in the context of what they are: the lucky few of an addressable problem.  Every person in this nation deserves access to this kind of care, and there’s any number of ways we can go about ensuring that.  We should take that joy and hope the sick enjoy when they get adequate care, and use that as reason to cover everyone.

Instead Americans will blissfully sit in front of their television, eyes a little wet as the “miracles” progress, little thought given to the rest of the uninsured and how they’ll never see doctors like this.

It should be interesting to see how the public does react to the show. I must admit, it does make me a little queasy to think of uninsured people receiving health care because they make compelling television.  I cannot wait to hear what my health classes think of this.  [bm]

March 8, 2006 | Permalink | Comments (0) | TrackBack (0)

Tuesday, March 7, 2006

Call for Papers

For those of you thinking of, or currently working on, an article concerning a mental health law topic, please consider: 

Ninth Annual Conference of the International Center for the Study of Psychiatry and Psychology (ICSPP), in collaboration with the American University Washington College of Law: "Mental Health and the Law," October 7, 8 & 9, 2006, Washington, D.C.  Topics for presentation include (1) adult, child and parental rights, (2)"science of psychiatry" in the courts, and (3) non-drug treatment and treatment programs.  For more information/submission protocol www.icspp.org or contact James B. Gottstein, Esq., Conference co-chair jim@psychrights.org, 907-274-7686.

[bm]


March 7, 2006 | Permalink | Comments (0) | TrackBack (0)

Upcoming Disability Law Conference

Arlene S. Kanter writes,

We are pleased to announce the first  National Conference on the Employment of Lawyers with Disabilities which will be held May 22- 23, 2006 at the Renaissance Washington Hotel, in Washington, D.C.  This conference is the first of its kind and is sponsored by the  American Bar Association Commission on Mental and Physical Disability Law, in collaboration with the ABA President's Office and the Equal Employment Opportunity Commission. The registration materials for the Conference are now available on the ABA we! bsite at http://www.abanet.org/disability/events/06/nationalconference/home.html 

It looks like a great conference!

[bm]

March 7, 2006 | Permalink | Comments (0) | TrackBack (0)

SSRN: February's Top Health Law & Policy Downloads

No change in the standings since the end of last month . . . . here are the top downloads on the SSRN health law and policy list:

  1. Safe Storage Gun Laws: Accidental Deaths, Suicides, and Crime
    John R. Lott Jr. and John E. Whitley
    American Enterprise Institute (AEI) and University of Adelaide - School of Economics
    Date Posted:May 22, 2000
    Last Revised:June 10, 2002
    Working Paper Series
    8858 downloads
  2. Abortion and Crime: Unwanted Children and Out-of-Wedlock Births
    John R. Lott Jr. and John E. Whitley
    American Enterprise Institute (AEI) and University of Adelaide - School of Economics
    Date Posted:May 16, 2001
    Last Revised:June 5, 2001
    Working Paper Series
    5632 downloads
  3. Stability, Not Crisis: Medical Malpractice Claim Outcomes in Texas, 1988-2002
    Journal of Empirical Legal Studies, Vol. 2, pp. 207-259, 2005
    Bernard S. Black , Charles Silver , David A. Hyman and William M. Sage
    University of Texas at Austin - School of Law , University of Texas Law School , University of Illinois College of Law and Columbia Law School
    Date Posted:October 25, 2005
    Last Revised:January 23, 2006
    Accepted Paper Series
    1595 downloads
  4. What the Publisher Can Teach the Patient: Intellectual Property and Privacy in an Era of Trusted Privication
    Stanford Law Review, Vol. 52
    Jonathan Zittrain
    Oxford University
    Date Posted:March 9, 2000
    Last Revised:June 30, 2000
    Accepted Paper Series
    1212 downloads
  5. TRIPs, Pharmaceuticals, Developing Countries, and the Doha 'Solution'
    Alan O. Sykes
    University of Chicago Law School
    Date Posted:February 19, 2002
    Last Revised:March 7, 2002
    Working Paper Series
    939 downloads
  6. Unintended Consequences of Medical Malpractice Damages Caps
    NYU Law Review, Vol. 80, pp. 391-512, May 2005
    Catherine M. Sharkey
    Columbia University - Columbia Law School
    Date Posted:February 17, 2005
    Last Revised:June 1, 2005
    Accepted Paper Series
    810 downloads
  7. Incentives in Nonprofit Organizations: Evidence from Hospitals
    James A. Brickley and R. Lawrence Van Horn
    Simon School, University of Rochester and Simon School, University of Rochester
    Date Posted:February 14, 2000
    Last Revised:April 2, 2002
    Working Paper Series
    759 downloads
  8. Bayh-Dole Reform and the Progress of Biomedicine
    Law and Contemporary Problems, Vol. 66, No. 1
    Arti K. Rai and Rebecca S. Eisenberg
    Duke University School of Law and University of Michigan Law School
    Date Posted:November 23, 2002
    Last Revised:February 6, 2003
    Accepted Paper Series
    755 downloads
  9. Medical Problems and Bankruptcy Filings
    Norton's Bankruptcy Adviser, May 2000
    Elizabeth Warren , Teresa Sullivan and Melissa B. Jacoby
    Harvard Law School , University of Texas at Austin - Office of the Vice President and Dean of Graduate Studies and University of North Carolina at Chapel Hill - School of Law
    Date Posted:May 9, 2000
    Last Revised:July 29, 2000
    Accepted Paper Series
    613 downloads
  10. The TRIPS Agreement, Access to Medicines and the WTO Doha Ministerial Conference
    Frederick M. Abbott
    Florida State University College of Law
    Date Posted:October 8, 2001
    Last Revised:October 15, 2001
    Working Paper Series
    555 downloads

[tm]

March 7, 2006 | Permalink | Comments (0) | TrackBack (0)

Monday, March 6, 2006

Cancer Research Funds

The DailyKos blog has information about the recent decline in funding experienced by the National Cancer Institute.  He reports,

As Dr. Orac of Respectful Insolence reports, [T]he NCI budget for 2007 will represent not just a failure to keep up with inflation but a real cut in actual dollars for the second year in a row.

The total proposed budget for the NCI is 4.75 billion.  Or about what the war in Iraq costs every few weeks, based on known Congressional Appropriations and DoD data. DR Orac brings us some good news though: The President's budget doesn't cut any of the 120 million marked for Complementary and Alternative Medicine. That would include treatment based on acupuncture, prayer, meditation, and 'energy therapies'.

In fairness, it's not just cancer patients the White House feels are a lower priority on the budget ladder than Iraq. They feel the same about Kids' Health, Public Housing, and the victims of Katrina: Combined.

ps. Thanks to Tom and my apologies for failing to inculde the citation to the earlier Ohio wrongful birth case.

[bm]

March 6, 2006 | Permalink | Comments (0) | TrackBack (0)