HealthLawProf Blog

Editor: Katharine Van Tassel
Akron Univ. School of Law

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Saturday, April 18, 2009

Some Stem Cell Restrictions Lifted

The New York Times reports on President Obama's new approach to federal financing of human embryonic stem cell research.   Gardiner Harris writes,

The Obama administration announced Friday that it planned to lift some but not all federal financing restrictions on human embryonic stem cell research, drawing criticism both from abortion opponents and from scientists who had expected a more liberal policy.

Guidelines proposed by the National Institutes of Health to carry out an order made last month by President Obama would allow research with federal financing only on stem cells derived from surplus embryos at fertility clinics. The money would still be prohibited for stem cell lines created solely for research purposes and for embryos created through a technique known as therapeutic cloning.

During the campaign last year, Mr. Obama said he supported “therapeutic cloning of stem cells,” a policy his administration rejected Friday. A White House spokesman, Reid Cherlin, said the president “directed N.I.H. to formulate the best method for moving forward with stem cell research, both ethically and scientifically,” in an independent process. 

Many scientists praised the new guidelines as an expected compromise.  “I think it’s a big step forward,” said Richard O. Hynes, a cancer researcher at the Massachusetts Institute of Technology, “although there are aspects of stem cell research that will still be outside federal funding.”

Others called the proposed rules a sellout.  “I’m disappointed,” said Dr. Irving Weissman, the director of the Stem Cell Biology and Regenerative Medicine Institute at Stanford. Dr. Weissman accused the health institutes of “putting this ideological barrier in the way” of treating disease. . . .

Sitting on more than $10 billion in stimulus money, health institute officials have been eager to expand financing for stem cell research. Under restrictions put in place by President George W. Bush, just 21 stem cell lines have been eligible for federal financing. But researchers using private money have created more than 700 stem cell lines, some with specific diseases or mutations, many of which may now be eligible for federal financing.

Some scientists said new rules requiring that donors be informed of all options could render too many new cell lines ineligible. And the rules could make ineligible for future federal financing even some cell lines approved by Mr. Bush.

Dr. George Q. Daley, the director of the stem cell transplantation program at Children’s Hospital Boston, said his team had used private financing to create 15 stem cell lines from poor-quality embryos that clinicians had told couples they should discard. Not all couples may have been told that they could donate the weakened embryos to other couples, a requirement under the new guidelines.  “My major concern,” Dr. Daley said, “is grandfathering all those medically important lines” made under less stringent consent policies, including some approved by Mr. Bush.

The announcement on Friday is likely to kick off a rush of applications from scientists eager for federal support for stem cell research. The health institutes has approved 20 such proposals for financing, although the projects have been delayed until the stem cell guideline is finalized. . . .

In fiscal year 2008, the health institutes financed 260 research projects, at a cost of $88 million, that involved stem cell lines approved by Mr. Bush.

The new guidelines will be published next week in the Federal Register, and the health institutes then will accept comments for 30 days. The rules are to be final by July 7.

Some in Congress have promised to introduce legislation that would allow financing of more stem cell lines. Representative Diana DeGette, Democrat of Colorado, said in a statement that the proposed legislation would “promote all forms of ethical stem cell research.” A statement from Representative Michael N. Castle, Republican of Delaware, said there was “opportunity for more expansive guidelines.”  Staff members for both lawmakers said they could not describe details of the legislation or whether it would seek to legalize federal financing of research using embryos created by therapeutic cloning. . . .

April 18, 2009 | Permalink | Comments (0) | TrackBack (0)

Friday, April 17, 2009

Strength of Placebo Response Based on Personality

Some researchers at McGill University recently issued the results of a study completed on the level of response to a placebo that various personalities had.   According to a story in the New Scientist Health, personality type does in fact impact the degree of response to a placebo that an individual experiences.  Ewen Callaway writes,

If rollercoasters and rock concerts sound fun but leave you with a headache, a drug-free sugar pill might be all that's needed to soothe you.  Thrill-seekers enjoy a stronger placebo response than people with more restrained personalities, new research shows.

It's too early to prescribe phoney pain treatments based on personality tests, says neuroscientist Petra Schweinhardt, of McGill University in Montreal, whose team tested 22 male university students. But if confirmed in larger trials, her team's findings could help pharmaceutical companies avoid testing experimental drugs on people with strong placebo responses, she says.

Her team injected a pain-inducing saline solution into the left and right legs of willing volunteers for 20 minutes. "It's a dull pain, a dumb pain, it's aching, it's annoying," she says.  Before the injection, her team told volunteers they were testing an experimental analgesic cream – really just skin lotion. To make the ruse more believable, researchers said they would test one leg with the treatment and one leg with a non-medicated lotion. . . .

"We really told them the whole story in order to counteract any doubts in the treatment," Schweinhardt says.  Volunteers then rated their pain across both trials, and the difference amounted to the placebo response.  Not everyone got pain relief from the placebo, but those that did scored higher on tests that gauge sensation-seeking personalities. These characteristics explained about a third of the differences in placebo responses between volunteers.

"The fact that they show a pretty strong correlation between a personality trait and strength of placebo response, I do find interesting," says Jon Stoessl, a neurologist at the University of British Columbia, who has studied placebo response in patients with Parkinson's disease. But he notes that a person's placebo response can change over time and varies depending on the condition, so personality alone probably won't explain his or her response. "If whatever condition you're suffering from is severe on one occasion and really a minor nuisance on another occasion, that could affect the degree of placebo response," he says. . .


April 17, 2009 | Permalink | Comments (0) | TrackBack (0)

The "have it your way" entitlement view of health care

Andrew Sullivan at the Atlantic Monthly has been writing on the costs of health care and had this reader response about Americans view of health care and what the reader called "the Burger King" mentality of health care.  From Mr. Sullivan's blog,

Your reader's response to Megan got a lot closer to the core of the problem with healthcare costs.  I am a physician in an emergency room in New York City, and every day I see tons of cash needlessly flying out the door due to "the Burger King factor."  American patients often come to the ER with very minor complaints - back pain for which they have not even tried tylenol, nasal congestion for two days, itchy mosquito bites, and so forth.  All of them expect something from you, quickly, for their trouble - and it must meet their preconceptions or they will accuse you of ripping them off.

Many of them become virtually incandescent with anger if they aren't given some kind of medical test that they (or one of their friends) thinks is a good idea, but they don't really need.  They insult you, they threaten you, they loudly announce that they're going to call their lawyer or the hospital administrator, etc.  Sometimes we stand up to them, and sometimes we're too exhausted to fight.  Sometimes it's just easier to get the x-ray on the patient with back pain rather than take the abuse and argue with them for 40 minutes and then have them send an angry letter to the review board. Others are simply beyond the pale and can't put anyone else ahead of themselves.  Some are incensed that I have to see a critically ill patient before I see them, because "I got here first."  People will literally interrupt cpr to scream that they want a sandwich or something to eat NOW.  People want a blood test, a cat scan, an EKG, anything in exchange for their time.  People will quote TV shows as medical authorities.   All of us have our favorite 'placebo' methods to try and gratify these patients, from ultrasounding their skulls (safe, dramatic, shows nothing but costs nothing) to pointing an ultraviolet flashlight into their maalox before they drink it.    It's our version of wearing a wooden mask and shaking a rattle - we hate it, and patients love it.

The amazing thing is that when needless tests come back negative, the patient is completely satisfied. There is never a sense of regret, or how much money they just wasted, but rather one of accomplishment, even if they still have the same problem they walked in with. . . .


April 17, 2009 | Permalink | Comments (0) | TrackBack (0)

Thursday, April 16, 2009

Personalized Gene Research Slow

The New York Times has an interesting article concerning two studies in the New England Journal of Medicine that discuss the issues scientists are facing as they attempt to make use of the decoded human genome.  Nicholas Wade writes,

The era of personal genomic medicine may have to wait. The genetic analysis of common disease is turning out to be a lot more complex than expected.  Since the human genome was decoded in 2003, researchers have been developing a powerful method for comparing the genomes of patients and healthy people, with the hope of pinpointing the DNA changes responsible for common diseases.

This method, called a genomewide association study, has proved technically successful despite many skeptics’ initial doubts. But it has been disappointing in that the kind of genetic variation it detects has turned out to explain surprisingly little of the genetic links to most diseases.  A set of commentaries in this week’s issue of The New England Journal of Medicine appears to be the first public attempt by scientists to make sense of this puzzling result.

One issue of debate among researchers is whether, despite the prospect of diminishing returns, to continue with the genomewide studies, which cost many millions of dollars apiece, or switch to a new approach like decoding the entire genomes of individual patients.  The unexpected impasse also affects companies that offer personal genomic information and that had assumed they could inform customers of their genetic risk for common diseases, based on researchers’ discoveries.

These companies are probably not performing any useful service at present, said David B. Goldstein, a Duke University geneticist who wrote one of the commentaries appearing in the journal.  “With only a few exceptions, what the genomics companies are doing right now is recreational genomics,” Dr. Goldstein said in an interview. “The information has little or in many cases no clinical relevance.” . . .

The problem addressed in the commentaries is that these diseases were expected to be promoted by genetic variations that are common in the population. More than 100 genomewide association studies, often involving thousands of patients in several countries, have now been completed for many diseases, and some common variants have been found. But in almost all cases they carry only a modest risk for the disease. Most of the genetic link to disease remains unexplained. . . .  

April 16, 2009 | Permalink | Comments (0) | TrackBack (0)

Fun Ad: Encouragement to Exercise and Eat Right

Here is a funny adverstisement meant to encourage physical fitness.  I hate to say it but I can think of people who might be tempted to behave the way that these individuals did when the escalator broke down. Click here.

Thanks to my wonderful colleague, Professor Rachel Smith. for the link.

April 16, 2009 | Permalink | Comments (0) | TrackBack (0)

Wednesday, April 15, 2009

Taxing Soda Pop: Increasing the War on Junk Food

William Saleton, writing at Slate.com, is quite upset that there exists some movement for a tax on sugared soda pop.  He states, 

The food police are closing in on their next target: a soda tax.

New York City's health commissioner, Thomas Frieden, is leading the way. He's the guy who purged trans fats from the city's restaurants and made them post calorie counts for menu items. Lately he's been pressuring food companies to remove salt from their products.

Now he's going after soda. Writing in the New England Journal of Medicine, Frieden and Kelly Brownell, the director of Yale's Rudd Center for Food Policy and Obesity, propose a penny-per-ounce excise tax on "sugared beverages." That's nearly $3 per case. Why so much? Because this tax, unlike the petty junk-food taxes of yesteryear, is designed to hurt. Its purpose is to discourage you from buying soda, on the grounds that soda, like smoking, is bad for you.

Persuading Americans to regulate soda the way we regulate cigarettes won't be easy. Isn't soda a kind of food? Isn't food a good thing? And isn't it a matter of personal choice? Doesn't taxation to control people's eating behavior cross a fundamental line of liberty?

In their article, Frieden and Brownell methodically attack these objections. Going well beyond science, they lay out a political battle plan for the war on junk food. . . .

April 15, 2009 | Permalink | Comments (0) | TrackBack (0)

National Journal's Health Reform Discussion

The National Journal hosts a discussion/debate on health reform and how to pay for it at its website.  Some of the contributors includes:  Jason Rosenbaum, Deputy Director of Online Campaigns, Health Care for American Now; Uwe Reinhardt, James Madison Professor of Political Economy, Professor of Economics and Public Affairs; Karen Davis, President, The Commonwealth Fund; John C. Goodman, President and CEO, National Center for Policy Analysis; Henry J. Aaron, Bruce and Virginia MacLaury Senior Fellow, The Brookings Institution; and Marian Wright Edelman, President, Children's Defense Fund as well as several others. 

Peter Orzag, Director of the Office of Management and Budget, responds to some of the commentators here


 

April 15, 2009 | Permalink | Comments (0) | TrackBack (0)

Tuesday, April 14, 2009

Repair Health Care - Receive $10 Million

The New York Times brings our attention to a worthy and lucrative endeavor to reform our health care system.  Although Catherine Rampell reports the story - she seems less than hopeful about a positive outcome.  She writes,

The X Prize Foundation and the health insurance company WellPoint will give $10 million to whoever can come up with the best new health care system for the United States. According to a news release, the purpose of the contest is to help reinvent “the health care system in a bold, measurable and scientific fashion to enable dramatic improvement in health care value in the United States.” The parameters of the contest will be announced, and available for public comment, next week.. . .  I don’t know how possible it will be to win the Health Care X Prize.

Never say never, but I’m not sure there’s much left to be discovered in the quest to find ways to restructure the health care system. It seems that policy wonks of all stripes agree that our current infrastructure and its rising costs are unsustainable. And it also seems that just about every possible alternative system is already on the table. But the stakeholders just can’t agree on which permutation to choose, mostly because some faction is always ideologically opposed to the means needed to get to any particular end (such as raising taxes, or having greater government involvement in price-setting, or deregulating, or greater limiting access to health care…).

In other words, the problem probably isn’t imagination; it’s politics, or at the very least philosophy. . . . .


Ezra Klein further notes the politics of the reform effort, 

I don't think all the relevant stakeholders are ideologically opposed to certain outcomes. Many of them are also professionally unable to accept them. Wellpoint, for instance, would be rather disadvantaged by a system that no longer required Wellpoint's involvement. So that would seem to bias the contest from the outset. Indeed, it seems the X Prize people are selling off their credibility in order to secure Wellpoint's funding for this stunt.

On the other hand, there's a depressing symmetry between this contest and the actual path health reform is going to take. Here, a particular stakeholder is funding a particular organization to come up with a solution. Over in Congress, a lot more stakeholders fund a lot more campaign organizations and the beneficiaries of those campaign organizations will be responsible for coming up with a solution. If anything, there's a comforting transparency and reassuring purity to the industry capture in the X Prize contest that the congressional process sadly lacks.

April 14, 2009 | Permalink | Comments (0) | TrackBack (0)

Reproductive Health Discussion

National Public Radio's Fresh Air program hosted an interesting interview with Michelle Goldberg on her new book - The Means of Reproduction:  Sex, Power, And The Future of the World.  A brief overview is here: 

In her new book The Means of Reproduction: Sex, Power, And The Future of the World, Journalist Michelle Goldberg argues that granting reproductive rights to women internationally can help to control overpopulation, banish poverty and slow the spread of AIDS.

Goldberg is also the author of the bestseller Kingdom Coming: The Rise of Christian Nationalism. She previously worked as a senior writer for Salon.com and her work has appeared in Rolling Stone, The Guardian and The New Republic. In 2008, The Means of Reproduction won the J. Anthony Lukas Work-in-Progress Award.

April 14, 2009 | Permalink | Comments (0) | TrackBack (0)

Monday, April 13, 2009

Health Law Scholars - Call for Papers

Healthlaw_toc The Center for Health Law Studies at Saint Louis University and The American Society of Law, Medicine & Ethics (ASLME) are pleased to announce the 2009 Health Law Scholars Workshop

The Health Law Scholars Workshop is a collegial forum in which faculty new to health law and bioethics scholarship present works-in-progress and receive in-depth advice from experienced scholars and teachers in the field of health law and bioethics. Each author’s work-in-progress accepted for the Health Law Scholars Workshop will be read in advance by several faculty members in relevant fields. During the Workshop weekend, each author presents his or her paper to the full group.  After extensive oral feedback from the readers, the floor is opened for a sustained exchange between the presenter and full group.

A nominating committee selects the papers to be presented at the Workshop. The committee looks for papers that have an original thesis and will contribute to scholarly literature. The Workshop is designed primarily to provide feedback on articles intended for spring submission to law review journals. The Workshop is not designed to review published work or papers already accepted for publication.

Those interested in presenting a health law or bioethics work-in-progress at the Health Law Scholars Workshop should submit a one-page abstract of the proposed paper together with a resumé to Mary Ann Jauer at Saint Louis University School of Law by May 1, 2009.

Because a blind selection process is used, please do not include the author’s name or institutional affiliation on the abstract.

SEND SUBMISSIONS TO:

Mary Ann Jauer, Program Coordinator, Center for Health Law Studies, Saint Louis University School of Law, 3700 Lindell Boulevard, St. Louis, MO 63108; 

Phone:    314.977.3067;  Fax:   977.3332;  Email:     jauerma@slu.edu

View the Scholars Workshop Brochure at law.slu.edu/healthlaw

April 13, 2009 | Permalink | Comments (0) | TrackBack (0)

Elder Mediation

National Public Radio's Morning Edition had an interesting discussion about the use of elder mediators to help families cope with elder care when disagreements arise among family members and between the elder parent and other caregiving relatives.  The brief overview of the program provides, 

They are disputes that can split apart families: Mom's left a pot on the stove again, so her daughters want her to give up her house. Dad's got more scrapes on his car, so his kids want to take away the car keys. Now there's a new option for families: Call in an elder mediator, like Rikk Larsen.  Larsen comes in as a neutral third party to help families negotiate difficult situations and choices. 

He talks about one case where an elderly father was getting forgetful and wasn't paying his monthly bills. His children — who lived far away — found out when the father's heat and electricity were turned off. But the elderly man got angry when the kids tried to help.  "Dad simply didn't want any of his kids to know how much money he had and how his finances were organized," says Larsen, and things were getting worse. One son insisted on going to court to get his father declared mentally incompetent, so the family could take control of the father's finances.  But after Larsen mediated, the brothers and sisters — along with the father — came up with a simpler solution. The father's accountant sent an assistant every couple of weeks to help the elderly man pay his bills.  "It became this kind of business meeting that the father had, and he got to maintain his dignity and his sense of control, and the bills got paid," Larsen says. . . .

April 13, 2009 | Permalink | Comments (0) | TrackBack (0)

Sunday, April 12, 2009

The Evolution of the Rabbit

Hope everyone is enjoying a great day!  Here is a lovely evoluationary tale about how we got the rabbits that we know and love today.  Thanks to DarkSyde from DailyKos for the site and the interesting information:

Rabbit Even as a young skeptic Easter Sunday was exciting for me. As children, my sisters and I could always count on finding a basket full of yummy chocolate treats waiting for us on Easter morning. How exactly the most important date in the Christian calendar came to be associated with an anthropomorphic pagan rabbit hiding colored candy eggs is a story for another day. But real rabbits also have a story. One every bit as interesting, and as fun for the whole family, as Peter Cottontail's.

Rabbits are mammals of course and at first glance they appear to fall in with squirrels, mice, chipmunks and a bunch of other adorable little critters that make up the most successful order of mammals on earth today: rodents. The first proto-mammals are often referred to collectively as cynodonts, some looked and acted an awful lot like modern rodents, and they really did lay eggs! Cynodonts appear in the fossil record during the Permian over 250 million years ago and slowly evolved into placental mammals that give birth to live young.

Unlike the familiar large mammals we know today, those rodent-sized pioneers didn't have to wait for dinos to fade into natural history before they could inherit the wind. They were already thriving along side the reptilian titans long before the solar system cruelly tossed a space mountain into the Yucatan 65 million years ago. As luck would have it, with their furry insulation, small size and short generations, varied diet, and warm burrows, small mammals were especially equipped to survive and adapt in the harsh aftermath of the K-T Extinction. And that’s where the rabbit picture gets fuzzy. . . .

April 12, 2009 | Permalink | Comments (0) | TrackBack (0)