HealthLawProf Blog

Editor: Katharine Van Tassel
Akron Univ. School of Law

A Member of the Law Professor Blogs Network

Saturday, April 30, 2005

New Diabetes Drug from Poisonous Lizard

The New York Times reports on a new diabetes drug derived from a poisonous lizard (click on NYT link to see photo) that received Food and Drug Administration approval. 

The drug, called Byetta, will be the first in a new class of drugs to reach the market for Type 2 diabetes, the form that usually occurs in adults. Studies have shown it can help control blood sugar and also help people lose a few pounds. The drawback for patients is that the drug must be injected twice a day and nearly half the people who use it suffer nausea, at least initially. . . .

Byetta is a synthetic version of a peptide, or small protein, found in what has been variously described as the saliva or the venom of the Gila monster, a poisonous lizard that lives in the Southwest and Mexico.

The discovery was made in the early 1990's by Dr. John Eng, a researcher at the Veterans Affairs Medical Center in the Bronx, who was working on a way to discover new hormones. He realized the Gila monster hormone was similar to glucagon-like peptide 1, an incretin hormone produced in the human digestive tract.

The Department of Veterans Affairs declined to patent the substance, saying it was not directly relevant to veterans, so Dr. Eng patented it by himself. He then tried in vain to license it to a drug company before finding Amylin. Amylin in turn licensed rights to Lilly in 2002 for payments that could eventually reach $325 million. Both companies plan to sell the drug in the United States and split the profits evenly.

[bm]

April 30, 2005 | Permalink

Friday, April 29, 2005

Paul Krugman and Health Care Continued

In today's New York Times, Paul Krugman continues his series on health care.  His focus concerns the private sector influence on our health care system.  Maternal and Child Health has some further helpful  observations.  [bm]

April 29, 2005 | Permalink

The Perfect Practice Patient

The New Yorker's Annals of Medicine column this week contains an interesting overview on the use of the simluator to help medical school students and practicing physicians refine their skills. 

At most schools, medicine is still taught largely as it has been for centuries, with students and young doctors serving as apprentices to veteran physicians. Training begins with textbook descriptions of cases and is followed, in the second or third year of medical school, by instruction at the patient’s bedside, an approach known as “See One, Do One, Teach One”: the student or intern observes the diagnosis and treatment of a particular disorder and is encouraged to take charge the next time a similar case occurs.  .  .  .

However, the apprenticeship model is becoming increasingly difficult to sustain. As insurers reduce reimbursements to hospitals, senior doctors are under pressure to focus on revenue-generating work—treating sick people and conducting procedures—rather than on teaching. Moreover, in order to cut costs, operations and therapies that once took place over several days are now performed in a few hours, or in outpatient settings. As a result, students are spending less time with individual patients and have fewer opportunities to observe a case from diagnosis to resolution. Some life-threatening conditions, such as anaphylactic shock or a ruptured aortic aneurysm, occur infrequently enough that a trainee may become a licensed physician without encountering such disorders or mastering the skills to treat them. Health care may be unique among high-risk fields in that learning takes place largely on human beings.

Dr. David Gaba, an anesthesiologist who directs a simulation center at the Veterans Affairs Palo Alto Health Care System, and who teaches at the Stanford University School of Medicine, created one of the first patient simulators nearly twenty years ago, in an effort to change the way physicians are taught. Gaba estimates that fewer than half of the medical schools in the United States routinely use the devices today. (meti, a Florida company that is one of this country’s principal manufacturers of high-tech medical simulators, says that it has sold more than sixty to schools in the past eight years.) “You wouldn’t get on an airplane unless the pilot had been trained in a flight simulator and certified to use the new instruments on a jet,” Gaba told me. “Why would you place yourself in the hands of a doctor who hadn’t proven his competency and been certified on a simulator?”

These dummy patients are quite realistic and it makes sense that doctors should be practicing techniques and learning how to treat a variety of ailments on them rather than experimenting on the rest of us.  Unfortunately as the article points out, the fake patients are very expensive.  Perhaps medical malpractice insurance companies can be persuaded to purchase some of these simulators for medical schools to help increase quality of care and prevent malpractice.  [bm

April 29, 2005 | Permalink

Thursday, April 28, 2005

Elderly and Medicinal Marijuana

TalkLeft:  The Politics of Crime blog has an interesting LATimes article on the elderly and medicinal marijuana use.  The blog editor notes, "There's something fundamentally wrong with a government that would deny pain relief to the elderly."  He also links to past discussions of the Raich v. Ashcroft case and predicts a decision sometime soon.   [bm]

April 28, 2005 | Permalink

Fun Doctor/Drug Rep Cartoon

With all the news concerning direct-to-consumer advertising and the influence of pharmaceutical ads and reps on the physician-patient relationship, this Dilbert cartoon seemed very appropriate.  Thanks to GruntDoc for the cartoon.  Click on the cartoon to see the larger image.  [bm]

April 28, 2005 | Permalink

National Council on Disability and Emergency Planning

On April 15, 2005, the National Council on Disability released a report calling for immediate changes in emergency planning for people with disabilities.   The report entitled, “Saving Lives: Including People with Disabilities in Emergency Planning, provides an overview of the ways in which the Federal Government should act to ensure that the emergency planning infrastructure it builds will include the waide range of people with disabilities in emergency preparedness, disaster relief, and homeland security programs.  The NCD press release accompanying the report states,

All too often in emergency situations the legitimate concerns of people with disabilities are overlooked or swept aside. In areas ranging from the accessibility of emergency information to the evacuation plans for high-rise buildings, great urgency surrounds the need for responding to the concerns of people with disabilities in all planning, preparedness, response, recovery, and mitigation activities. The homeland security terrorist event of September 11, 2001, as well as the recent energy blackouts in the U.S. Northeast and Midwest and, more recently, the natural disaster hurricane events in Florida and the tsunami event of December 26, 2004, underscore the need to pay attention to the concerns raised in this report,” Lex Frieden (NCD chairperson) concluded.

The decisions the Federal Government makes, the priority it accords to civil rights, and the methods it adopts to ensure uniformity in the ways agencies handle their disability-related responsibilities are likely to be established in the early days of an emergency situation and be difficult to change if not set on the right course at the outset. By way of this report, NCD offers advice to assist the Federal Government in establishing policies and practices in these areas. This report provides examples of community efforts with respect to people with disabilities, but by no means does it provide a comprehensive treatment of the emergency preparedness, disaster relief, or homeland security program efforts by state and local governments.

Further discussions on the Saving Lives report may be found here.  [bm]

April 28, 2005 | Permalink

Wednesday, April 27, 2005

Direct-to-Consumer Ads and the Public's Health

This week's edition of the Journal of the American Medical Association contains an article entitled, " Influence of Patients' Requests for Direct-to-Consumer Advertised  Antidepressants: A Randomized Controlled Trial" by Richard L. Kravitz; Ronald M. Epstein; Mitchell D. Feldman; Carol E. Franz; Rahman Azari; Michael S. Wilkes; Ladson Hinton; Peter Franks.  Not surprisingly, they conclude that patient requests for medication has a important impact on the physician-patient relationship and that the advertising that occurs to encourage such discussion has both positive and negative effects.

There is further discussion of this topic in an editorial by Dr. Matthew Hollon in the same edition of JAMA in which he writes about the impact of direct-to-consumer ads on the public's health.  Dr. Hollon concludes,

As Bodenheimer - asked, "What if millions of parents were prompted by a TV spot to ask their physicians about asthma action plans to help in the self-management of their children’s asthma, an intervention shown in a Cochrane review to improve outcomes?" The answer seems clear. Concise, coherent, evidence-based messages, delivered using the most sophisticated techniques of Madison Avenue, unbiased by the motivation to turn a profit, and funded by either a tax on DTCA or an alternative financing scheme will benefit the public’s health. These public service messages could supplement the haphazard approach to health promotion that relies on occasionally helpful and intermittently harmful advertisements that play to a patient’s vulnerability and appeal to the desire to assert control over a potential outcome—advertisements that, first and foremost, sell prescription drugs. 

If such a strategy proves untenable, then at a minimum, the FDA should expect that pharmaceutical companies improve the educational nature of DTCA by further developing and adhering to appropriate standards to facilitate regulatory efforts.  In addition, the FDA should be adequately funded to accomplish its regulatory function.  Last, because the safety of a new drug cannot be known with certainty until it has been on the market for several years, and since drug withdrawals occur more than two thirds of the time within 3 years of release, the FDA should consider a moratorium on advertisement of drugs directly to consumers for 3 years after initial market release. 

[bm]

Update:  The Washington Post has a further discussion of the study discussed in JAMA as well as reactions from lawmakers and physicians.

April 27, 2005 | Permalink

Carle and Tax-Exempt Status

According to the News-Gazette Online (Champagne, Illinois), the Champaign County Board of Review is recommending that the state deny property tax-exempt status for five Carle Foundation Hospital properties.  The loss of this status is estimated to cost the Carle Foundation approximately $2 million.  The article states,

In a 14-page brief, the county board of review said that 0.5 percent of Carle's revenues go toward providing charity care and that the hospital charges the low-income uninsured its highest list prices. Carle Foundation also files a "large number of lawsuits" against patients who are unable to pay their medical bills and does not publicize its charity care program well, the brief said.      Carle's charity care program provided $1.3 million in charity care in 2003, while the Carle Foundation had $312 million in income and a profit of nearly $33 million, the report said.  "It appears that accumulation of capital is a higher priority than is providing charity care to all who need it," the report said.

It is interesting to see local level officials actively paying attention to charity care and tax-exempt status.  The article reports that this is not the first time that the County Board has denied tax-exempt status to a medical center.  Of course, there exist other more high-profile cases documenting efforts of a variety of indivdiuals, including Richard Scruggs, to revoke tax-exempt status from hospitals. [bm]

Thanks to Professor Fred Harris for this update.

   

April 27, 2005 | Permalink

National Academy of Sciences Draws Up Ethics Guidelines for Embryonic Stem Cell Research

From the NAS: April 26 -- To ensure that human embryonic stem cell research is conducted responsibly and in an ethical manner, the National Academies have developed guidelines for such research. The new report says that institutions conducting stem cell research should establish oversight committees to make sure the guidelines will be followed.
Press Release
Full Report
Presentation Slides

As reported in The New York Times today, the guidelines developed in response to "a lack of leadership by the federal government."  The article describes the key provisions:

The academy's guidelines would impose limits on three kinds of experiment that involve incorporating human embryonic stem cells into animals. Undesired consequences could follow if human cells were to become incorporated into the sex cells or the brains of animals. In the first case, there is a remote possibility that an animal with eggs made of human cells could mate with an animal bearing human sperm. To avoid human conception in such circumstances, the academy says chimeric animals should not be allowed to mate.

A second possible hazard is that the human embryonic stem cells might generate all or most of an animal's brain, leading to the possibility of a human mind imprisoned in an animal's body. Though neuroscientists consider this unlikely, it cannot be ruled out, particularly with animals closely related to people, like monkeys and apes. The academy advises that human embryonic stem cells not be injected into the embryos of nonhuman primates for the time being.

Third, like many previous committees, the academy says human embryos should not be grown in culture for more than 14 days, the time when the first hints of a nervous system appear.

The academy advises that all institutions conducting human embryonic stem cell research set up local committees, including scientific experts and members of the public, to review all experiments. And it says a national committee should be formed to update regulations and relax the constraints if warranted by new evidence.

The academy  also says that donors, including women who donate unfertilized eggs, should not be paid.

[tm]

April 27, 2005 | Permalink

SCOTUS Run-Down

There aren't many health-law cases pending this Term in the Supreme Court of the United States -- no ERISA blockbuster, for example, after three big cases in the past four years.  From my quick perusal of the case list at Northwestern's Medill School of Journalism, however, here's the run-down on what's still on the docket, along with some hopefully helpful links.

Docket Number Case Name Oral Argument Lower Court Question Presented
03-1237 Merck KGaA v. Integra Lifesciences I, Ltd., et al. April 20, 2005 Court of Appeals for the Federal Circuit (June 6, 2003) Drugs, patents: Did the Federal Circuit err in concluding that the drug-research safe harbor (which Congress incorporated into federal patent laws in 1984 to encourage development and expedite introduction of pharmaceuticals and to insulate drug research from charges of infringement so long as the research is "reasonably related to the development and submission of information" to the Food and Drug Administration) does not protect animal studies of the sort that are essential to the development of new drugs, where the research will be presented to the FDA, and where barring the research until expiration of the patent could mean years of delay in the availability of life-saving new drugs?
03-1454 Ashcroft, John, Atty. Gen., et al. v. Raich, Angel McClary, et al.  Nov. 29, 2004 9th Circuit Court of Appeals (Dec. 16, 2003) Medicinal marijuana: Whether the Controlled Substances Act, 21 U.S.C. 801 et seq., exceeds Congress's power under the Commerce Clause as applied to the intrastate cultivation and possession of marijuana for purported personal "medicinal" use or to the distribution of marijuana without charge for such use?
04-623 Gonzales, Alberto, Atty. Gen., et al. v. Oregon, et al. 2005-06 term 9th Circuit Court of Appeals (May 26, 2004) Physician-assisted suicide: Whether the Attorney General has permissibly construed the Controlled Substances Act, 21 U.S.C. 801 et seq., and its implementing regulations to prohibit the distribution of federally controlled substances for the purpose of facilitating an individual's suicide, regardless of a state law purporting to authorize such distribution?
04-1084 Gonzales, Alberto (US Atty Gen.) v. O Centro Espirita Beneficiente Uniao Do Vegetal, et al. 2005-06 term 10th Circuit Court of Appeals (Nov. 12, 2004) (en banc) Public health, Sacramental hoasca, Religious Freedom Restoration Act:  Whether the Religious Freedom Restoration Act of 1993, 42 U.S.C. 2000bb et seq., requires the government to permit the importation, distribution, possession, and use of a Schedule I hallucinogenic controlled substance, where Congress has found that the substance has a high potential for abuse, it is unsafe for use even under medical supervision, and its importation and distribution would violate an international treaty?

[tm]

April 27, 2005 | Permalink

Tuesday, April 26, 2005

Public Health Perspectives

Maternal and Child Health links to an excellent article by Arahu Castro and Paul Farmer entitled, "Understanding and Addressing AIDs-Related Stigma: From Anthropological Theory to Clinical Practice in Haiti," that addresses the stigma associated with health care for AIDs.  It is a wonderful read and would be great for use in a public health course.  [bm]

April 26, 2005 | Permalink

Questions about Obesity

Majikithise has an interesting and entertaining post on the conflicting data concerning the harms of obesity.  She concludes by stating, "Pundits and interest groups are exploiting the Flegal study as an excuse to sneer at public health iniatives, malign the CDC, and to downplay the seriousness of the obesity epidemic."  This mirrors my thoughts.  [bm]

Update:  Erza Klein also has a post concerning the obesity studies and the media response.

April 26, 2005 | Permalink

Quality of Life vs. Sanctity of Life

There's an interesting set of mini-essays in the April 24 Indianapolis Star by Peter Schwartz, David Orentlicher, and Fr. Joseph Rautenberg . . . end-of-life decision making, disability and suffering, courts and legislatures . . . [tm]

April 26, 2005 | Permalink

Man Who Advertised For Liver Dies

Todd Kramptiz, the Houston newlywed who advertised for a liver transplant on billboards throughout the Southwest, died at the hospital where he received his liver transplant 8 months ago.  The Houston Chronicle story by Leigh Hopper does a good job of providing the background and the pros and cons of gaining access to a donor organ by advertising for a directed donation.  According to the article, "The controversy prompted the United Network for Organ Sharing, which oversees organ allocation, to recommend in November that hospitals discourage patients from soliciting organs, and if possible, refuse to perform such transplants."  A January 2005 memorandum, however, seemed to take a slightly more studied view of living-donor solicitation.  [tm]

April 26, 2005 | Permalink

Monday, April 25, 2005

Making a Buck off Law Professors

Paul Caron at TaxLawProf  alerts us to a startling new development, he writes: 

Buying Law Review Articles on Amazon.com

Orin Kerr and Larry Ribstein have flagged what I think is a pernicious development in our profession: Amazon.com is now selling law review articles for $5.95 per shot.  Their inventory of articles for now appears to be incomplete -- for example, Amazon.com lists for sale on my author page not only six of my books but just one of my articles, Affirmative Refraction: Grutter v. Bollinger Through the Lens of The Case of the Speluncean Explorers, 21 Constitutional Commentary 63 (2004) (with Rafael Gely)(previously blogged here).

As one who fights with law reviews to retain the right to post my articles on SSRN so they can be downloaded for free, I am worried that the new amazon venture will give law reviews yet another reason to try to restrict the ability of authors to post their work on SSRN.  As many readers know, Lawrence Lessig recently publicly pledged that he will no longer publish law review articles until the reviews stop insisting on the exclusive right to authorize the publication, reproduction, and distribution of articles, which they in turn sell to Lexis and Westlaw.  I do not know the business deal Amazon has worked out for the sale of articles, but the system is seriously broken when professors are denied the right to make their scholarship freely available and everyone else in the distribution chain is making a buck off of their intellectual property.

Should be interesting to see how this plays out - I cannot believe that this will continue. [bm]

April 25, 2005 | Permalink

Ephedra Case

Here is a link to the Ephedra decision from last week, Nutraceutical Corp. and Solaray Inc. v. Lester Crawford, DVM, Acting Commissioner, U.S. Food and Drug Administration, et al.  In that case, the issue was whether the FDA overstepped its bounds under the Dietary Supplement Health and Education Act of 1994 by banning ephedra-containing products at all dosage levels.  Judge Tena Campbell of the U.S. District Court in Utah ruled the FDA did not sufficiently prove ephedra was unsafe to consumers in low doses, remanding the issue back to the agency for further rule-making.  The AmedNews has some further commentary on the case. [bm]

April 25, 2005 | Permalink

Public Health Post-September 11

The AmedNews has a story discussing the changes in public health funding and infrastructure post-September 11.  Some doctors are disappointed in the lack of true change and others are concerned about the focus of the spending.   

After the terrorist attacks of Sept. 11, 2001, and the anthrax scare that followed, it seemed that the nation's public health system, shabby from decades of neglect, finally might get its due. These two incidents did what numerous reports from esteemed institutions -- including the Institute of Medicine and the Centers for Disease Control and Prevention, as well as frequent declarations of need from the American Medical Association -- could not.

In a sense, public health had found not only the limelight but also a seeming pot of gold. Millions since have flowed from the federal government to state and local health departments.

"We're putting money in the hands of states and local communities so they can start building strong public health systems for responding to a bioterrorism attack," said then-Health and Human Services Secretary Tommy Thompson in a statement issued Jan. 31, 2002, that announced $1.1 billion in funding for bioterrorism preparedness.

Three years later, many physicians and public health officials are viewing the glass as both half full and half empty -- with new emphasis placed on crisis response but sometimes at the expense of chronic conditions.
It is interesting to see where money is, and is not, going and what results have been achieved so far.  [bm]

April 25, 2005 | Permalink

Sunday, April 24, 2005

New Medicare Policy - Fewer In-Person Appeals

The New York Times reports today on the Bush Administration's new policy for Medicare beneficiaries who wish to "obtain hearings in person before a judge when the government denies their claims for home care, nursing home services, prescription drugs and other treatments."  The future for Medicare appeals does not sound promising:

For years, hearings have been held at more than 140 Social Security offices around the country. In July, the Department of Health and Human Services will take over the responsibility, and department officials said all judges would then be located at just four sites - in Cleveland; Miami; Irvine, Calif.; and Arlington, Va.

Under the new policy, Medicare officials said, most hearings will be held with videoconference equipment or by telephone. A beneficiary who wants to appear in person before a judge must show that "special or extraordinary circumstances exist," the rules say. But a beneficiary who insists on a face-to-face hearing will lose the right to receive a decision within 90 days, the deadline set by statute.

The policy change comes as Bush administration officials are predicting an increase in the volume of cases, with the creation of a Medicare drug benefit expected to generate large numbers of claims and appeals. But in a recent study, the Government Accountability Office, an investigative arm of Congress, questioned the heavy reliance on videoconferences, saying that "beneficiaries are often uncomfortable using videoconference facilities and prefer to have their cases heard face to face."

I don't see how four hearing offices will be sufficient but perhaps I am being overly pessimistic.  I had not realized that Medicare drug benefit, in addition to being wildly expensive, would also have this type of side effect on the Medicare program.[bm]

April 24, 2005 | Permalink

The Economics of Covering the Uninsured

Brad Plumer' s, April 22, 2005 post entitled, "Screw the Uninsured," provides a provocative response to Paul Krugman's Friday column.  He reviews a number of arguments for covering the uninsured and concludes,

Okay, so this is a long post, but the brunt of it is: there probably isn't a good economic case to be made for covering the uninsured, although I'm obviously open to hearing one. Certainly there's a moral case to be made, and I think a overridingly powerful one, though I'm not sure how effective that's going to actually bringing change about. As Uwe Reinhardt once noted, the last time we had a budget surplus to spend, Americans chose tax cuts over helping the uninsured; no matter what the polls might say, our actual priorities seem pretty clear.

It is an interesting read with some research to back up his point.   [bm]

April 24, 2005 | Permalink