HealthLawProf Blog

More on the Poling Vaccine Ruling: A Critic Speaks

The New York Times has an editorial today by Paul A. Offit, chief of the infectious diseases division of the Children’s Hospital of Philadelphia, who is highly critical of the recent Poling vaccine award.  He views the case as one of compassion winning out over the science and is highly critical of the court's failure to require that the evidence meet not only scientific standards but the preponderance of evidence standard.  He writes,

On March 6, Terry and Jon Poling stood outside a federal courthouse in Atlanta, Ga., with their 9-year-old daughter Hannah and announced that the federal government had admitted that vaccines had contributed to her autism. The news was shocking. Health officials at the Centers for Disease Control and Prevention and at the American Academy of Pediatrics have steadfastly assured the public that vaccines do not cause autism. Now, in a special vaccine claims court, the federal government appeared to have said exactly the opposite. What happened?

The answer is wrapped up in the nature of the unusual court where the Poling case was heard. In 1986, after a flood of lawsuits against vaccine makers threatened the manufacture of vaccines for children, Congress created the National Vaccine Injury Compensation Program, financed by a tax on every dose of vaccine. . . .

If, at a trial in a special court, a preponderance of scientific evidence suggested that a vaccine caused one of these problems, a family would be compensated quickly, generously and fairly. Because no one could sue vaccine makers without going through this special court, the number of lawsuits against vaccine makers fell drastically.

The system worked fine until a few years ago, when vaccine court judges turned their back on science by dropping preponderance of evidence as a standard. Now, petitioners need merely propose a biologically plausible mechanism by which a vaccine might cause harm — even if their explanation contradicts published studies. . . . 

In 2000, when Hannah was 19 months old, she received five shots against nine infectious diseases. Over the next several months, she developed symptoms of autism. Subsequent tests showed that Hannah has a mitochondrial disorder — her cells are unable to adequately process nutrients — and this contributed to her autism. An expert who testified in court on the Polings’ behalf claimed that the five vaccines had stressed Hannah’s already weakened cells, worsening her disorder. Without holding a hearing on the matter, the court conceded that the claim was biologically plausible.

On its face, the expert’s opinion makes no sense. Even five vaccines at once would not place an unusually high burden on a child’s immune system. The Institute of Medicine has found that multiple vaccines do not overwhelm or weaken the immune system. And  although natural infections can worsen symptoms of chronic neurological illnesses in children, vaccines are not known to.

“There is no evidence that children with mitochondrial enzyme deficiencies are worsened by vaccines,” Salvatore DiMauro, a professor of neurology at Columbia who is the nation’s leading expert on the disorder, told me. Indeed, children like Hannah Poling who are especially susceptible to infections are most likely to benefit from vaccines.

Supporters of the Vaccine Injury Compensation Program argue reasonably that the program should err on the side of overcompensation — a relief valve that is needed in a society that mandates vaccines. But there is a price for this largesse. In the past few years, parents of 4,800 autistic children have filed claims to the vaccine court which have yet to be heard. And average awards in other recent vaccine cases have been more than $800,000. Furthermore, because uncompensated claims in vaccine court can spill into state courts, the Poling decision will likely draw more personal-injury lawyers to the fray. “It’s a beginning,” said Kevin Conway, a Boston-based lawyer who represents more than 1,200 families with vaccine injury claims.

The vaccine court should return to the preponderance-of-evidence standard. But much damage has already been done by the Poling decision. Parents may now worry about vaccinating their children, more autism research money may be steered toward vaccines and away from more promising leads and, if similar awards are made in state courts, pharmaceutical companies may abandon vaccines for American children. In the name of trying to help children with autism, the Poling decision has only hurt them.

New Cell Phone Studies - Time to Stop Talking

The UK Independent reports on the results of several new studies on long-term cell phone use - the headline says that they could be more dangerous than smoking.   The  newspaper reports, 

 

Mobile phones could kill far more people than smoking or asbestos, a study by   an award-winning cancer expert has concluded. He says people should avoid   using them wherever possible and that governments and the mobile phone   industry must take "immediate steps" to reduce exposure to their   radiation. The study, by Dr Vini Khurana, is the most devastating indictment yet   published of the health risks.

It draws on growing evidence – exclusively reported in the IoS in October –   that using handsets for 10 years or more can double the risk of brain   cancer. Cancers take at least a decade to develop, invalidating official   safety assurances based on earlier studies which included few, if any,   people who had used the phones for that long.

Earlier this year, the French government warned against the use of mobile   phones, especially by children. Germany also advises its people to minimise   handset use, and the European Environment Agency has called for exposures to   be reduced.

Professor Khurana – a top neurosurgeon who has received 14 awards over the   past 16 years, has published more than three dozen scientific papers –   reviewed more than 100 studies on the effects of mobile phones. He has put   the results on a brain surgery website, and a paper based on the research is   currently being peer-reviewed for publication in a scientific journal.

He admits that mobiles can save lives in emergencies, but concludes that "there   is a significant and increasing body of evidence for a link between mobile   phone usage and certain brain tumours". He believes this will be "definitively   proven" in the next decade.

Noting that malignant brain tumours represent "a life-ending diagnosis",   he adds: "We are currently experiencing a reactively unchecked and   dangerous situation." He fears that "unless the industry and   governments take immediate and decisive steps", the incidence of   malignant brain tumours and associated death rate will be observed to rise   globally within a decade from now, by which time it may be far too late to   intervene medically. . . . 

Late last week, the Mobile Operators Association dismissed Khurana's study as "a   selective discussion of scientific literature by one individual". It   believes he "does not present a balanced analysis" of the   published science, and "reaches opposite conclusions to the WHO and   more than 30 other independent expert scientific reviews".

       

Schizophenia Linked to Genetic Mutations

The Washington Post and other news outlets reported last week on a new study in the journal Science which examines a potential link between certain gene mutations and schizophrenia.  The Washington Post's Rick Weiss states,

Patients with schizophrenia are three to four times as likely as healthy people to harbor large mutations in genes that control brain development, and many of those glitches are unique to each patient, researchers reported yesterday.  The findings are forcing scientists to rethink the reigning model of how genes and environment conspire to cause the debilitating disease, which affects about 1 percent of the population worldwide.  In part, scientists said, the new view is daunting because it suggests that many people with schizophrenia have their own particular genetic underpinnings.

At the same time, the study shows that new screening techniques can find and differentiate among those various mutations. In the long run that could help doctors choose the best medications for individual schizophrenics and speed the development of drugs tailored to certain patients' needs.  "If the genetics tells us that schizophrenia is really 10 different disorders, then let's have 10 treatments that optimize the outcomes for everyone and not just use the same drugs for everybody," said Thomas Insel, director of the National Institute of Mental Health, which helped fund and conduct the study. The work also offers evidence that autism shares some genetic roots with schizophrenia.

"Take away schizophrenia's hallucinations and delusions," said Jon McClellan, a child psychiatrist at the University of Washington and a leader of the study, published in yesterday's online issue of the journal Science, "and the symptoms that remain, the lack of social interest and withdrawal, are what we call autism. There is clearly an intersection of the brain systems involved."

. . . . The genes implicated are diverse, but many are known to play crucial roles in how the brain gets wired early in life. Normally that process starts with a huge overproduction of neurons, followed by a controlled winnowing that leaves only those that have made proper connections.

"Changes in these genes could bias the way circuits get sculpted out and could perhaps lead to a brain in which signals that would normally get filtered out don't get filtered out," which could interfere with thinking and prompt hallucinations, Insel said.

Lights Out Tonight

Dear Earth Hour US Supporters,

Thank you for your suggestions, energy and enthusiasm. We are both
thrilled and overwhelmed with the outpouring of support for this
historic climate change initiative.

First, here is a quick look at Earth Hour. On March 29, 2008, from 8pm
to 9pm, local time, participants around the globe will join together
to literally turn off the lights to offer leadership and symbolize
their commitment to finding climate change solutions.

Earth Hour is a global event, created to symbolize that each one of
us, working together, can make a positive impact on climate change--no
matter who we are or where we live. It is intended to bring together a
diverse group of community, government, corporate and nongovernmental
organizations to heighten awareness about climate change and to
inspire consumers and businesses to take practical actions to reduce
their own carbon footprints.

We at WWF are hard at work pulling together downloadable content and
promotional materials that individuals, communities, groups, and
business can use to get the message out about Earth Hour. We are
targeting the beginning of February to have that content available on
our global WWF Earth Hour website. Please check back then.

In the meantime, showcase your commitment to finding climate change
solutions by making a personal pledge to reduce your own carbon
footprint at worldwildlife.org/earthhour.

Warm regards,

Meg Pearce

Project Director, Earth Hour US
World Wildlife Fund

Socialized Medicine

The Washington Post's Jacob Hacker has an interesting piece on socialized medicine and how it might be time to retire the fear that the word generates.  He writes,

"Socialized medicine" is the bogeyman that just won't die. The epithet has been hurled at every national health plan since the New Deal -- even Medicare, which critics warned would strip Americans of their freedom.

And now it's back. Republicans from President Bush on down have invoked the specter of socialism in denouncing Democrats' attempts to expand publicly funded health insurance for children. Erstwhile GOP presidential contenders Rudy Giuliani and Mitt Romney lambasted the health plans of the leading Democratic candidates for mimicking "the socialist solution they have in Europe" (Giuliani) and trying to impose "a European-style socialized medicine plan" (Romney). The presumptive Republican nominee, Sen. John McCain, hasn't used the S-word yet, but after sewing up the nomination in early March, he criticized Democrats for intending "to return to the failed, big-government mandates of the '60s and '70s to address problems such as the lack of health-care insurance for some Americans."

Never mind that nobody is proposing to turn doctors into public employees and hospitals into government institutions -- the literal meaning of socialized medicine. The slogan gets its punch because it invokes a visceral public fear: that government involvement will drive up costs and drive down quality, wrecking the economy and damaging your health. Expanding government's role, the naysayers insist, will destroy what McCain calls "the world's best medical care."

But the critics have it backward. The best American medical care is indeed extremely good, but much of our system falls short -- especially when you consider how costly it is, how heavy a burden it places on employers and families, and how many it excludes. And far from being a threat, getting the government more involved in health care would actually reduce costs, improve quality and bolster the U.S. economy -- which helps explain why public insurance is the secret weapon in both of the leading Democratic candidates' plans. If socialized medicine means doing what our public-insurance programs and other nations' health systems do to control costs, expand coverage and improve the quality of care, it's high time for a little socialization.

To see the advantages of public insurance, just look at the program that once prompted the fiercest charges of socialized medicine, Medicare. Since the introduction of cost controls in the 1980s, Medicare's expenditures have grown at a substantially slower rate than spending on private insurance, according to a recent analysis by the health-care experts Cristina Boccuti and Marilyn Moon. And despite Medicare's comparative frugality, the program's beneficiaries express greater happiness with their coverage than do privately insured patients in surveys of consumer satisfaction. . . .

Indeed, by some measures, U.S. health care looks downright lousy. A six-country study by researchers at the Commonwealth Fund, a health-care think tank with a generally liberal bent, concludes that the United States "scores particularly poorly on its ability to promote healthy lives, and on the provision of care that is safe and coordinated." Meanwhile, a recent analysis of 19 rich nations by Ellen Nolte and C. Martin McKee of the London School of Hygiene and Tropical Medicine found that the United States has the highest rate of "amenable mortality" before age 75 (the odd term of art for deaths that could have been prevented with timely care) -- and that we're falling farther behind. . . .

It's time, in other words, to embrace a government role in health care, rather than run from it. . . .  That's wise, because the only proven way to provide good affordable care to all Americans over the long run is to expand public insurance.

Don't take my word for it. The Lewin Group, a well-respected health-care consulting firm, recently estimated the potential impact of a health plan I've developed with the support of the Economic Policy Institute. The proposal -- which resembles the plans of the leading Democrats, whom I've advised -- requires employers either to cover their workers or to contribute to the cost of their workers' coverage. Workers whose employers make the contribution will be enrolled in a public plan modeled after Medicare. Like those covered by Medicare, they will have the option of purchasing regulated private insurance instead. According to the estimates, this proposal would cover all but a tiny sliver of the non-elderly population -- about half through the new federal system and half through employers. Yet it would actually reduce national health spending, cost the federal government an eminently reasonable $50 billion a year (about what the Medicare drug benefit costs) and save states and employers big money.

How is it possible to cover everyone without driving up costs? The one-word answer is "government" -- specifically, government's ability to lower service prices, streamline administration and get a better deal on drugs, thus reducing medical inflation over time. And these are only the direct savings. Reducing the burden of health care on employers will allow them to compete more effectively (and on a level playing field) with foreign producers. Just as important, making coverage affordable for everyone will allow people to change jobs or start their own businesses without the fear of catastrophic costs or the hassle, expense and inadequacy of individually purchased coverage.

Maybe socialized medicine doesn't sound so bad after all.

Thanks to Erza Klein for the cite.

Happy Birthday Viagra!

Yes, Viagra has been around for ten years.  For some reason, perhaps all the spam e-mail I continue to receive, it seems like it has been around for so much longer.  The Wall Street Journal's Health Blog has a post to mark this special occasion but notes, as is fitting a financial newspaper that the drug hasn't lived up to what some thought was its profit potential.   Jacob Goldstein writes,

Ten years ago today, the FDA approved Viagra. The drug became an instant cultural icon, and sales took off immediately, prompting some optimistic analysts to predict that annual sales could reach $20 billion some day, the WSJ reported at the time.

Viagra turned into a world-famous brand, a legend that shifted the notion of what the pharmaceutical industry can do and defined a new category of lifestyle medicines. But sales of the Viagra, though solid, haven’t lived up to the early hype — under $2 billion a year world-wide for the last several years, less than sales of humbler Pfizer drugs like the painkiller Celebrex, not to mention Lipitor.

Why the chasm between the idea of Viagra, a global megabrand, and the sales figures for the pills themselves? Part of it is that Viagra now has competitors, Levitra (from Bayer, GlaxoSmithKline and Schering-Plough) and Cialis (from Lilly). But even collectively, the sales of the drugs never came close to the early predictions. Abraham Morgentaler, a Harvard urologist who wrote a book called The Viagra Myth, suggests that no pill could ever live up to Viagra’s hype. . . . .

“Relationships are complicated, sex is complicated, and sometimes when there are issues in the relationship, the bedroom is the place where the most obvious failures are,” he says. “But being able to have a hard penis isn’t necessarily going to solve the relationship problem.”

Many of his patients realized that only after trying the drug. Apparently, other patients realized it too — about half of patients nationwide who have gotten Viagra prescriptions have never gone back for a refill, Morgentaler says. In some cases, he suggests, nature may be best left to its own devices. . . .

They also post their favorite Viagra ad. 

Disability, Reproduction and Parenting Symposium

Saint Louis University School of Law will hold an interesting and informative one-day symposium, "Disability, Reproduction and Parenting," on Friday, April 4, 2008 at their law school.  It is the 20th Annual

Saint Louis University Health Law Symposium, sponsored by the Saint Louis University Journal of Health Law & Policy and the Center for Health Law Studies.  Below is a brief description:

 

The desire to form a family and have a child has long been central to many people’s idea of a good life. It has also long been surrounded by stigma for people with disabilities -- whether parents, prospective parents or children -- who continue to face barriers to the full enjoyment of reproductive autonomy, parenting and family life. Against this backdrop, advances in technology such as assisted reproductive technologies and prenatal diagnostic techniques represent the potential for increased access to informed reproductive choice but also for the increased stigmatization of individuals with actual or perceived disabilities. Available care, services and support often reflect an inaccurate understanding of what it means to be disabled, for both parents and children. This Symposium will examine the impact of these issues on parents, prospective parents and children living with disabilities.

 

All are welcome, and the full brochure can be found at http://law.slu.edu/conf/parenting/index.html
The symposium looks great with many terrific speakers and a complex topic that will benefit from such intelligent examination.  Thanks to Elizabeth Pendo for the information.

 

Job Posting: Director for Law Library and Information Technology

Cincinnati Seeks Director for Law Library and Information Technology

The University of Cincinnati College of Law is looking to hire a Director for Law Library and Information Technology.  As the position announcement explains, this is an exciting opportunity to join our small public law school at a wonderful point in its 175-year history.  Under the leadership of our new dean and university president, with an outstanding, collegial, and supportive faculty and staff, and a top-notch student body, the new director will have all the tools and resources necessary to help implement the College's ambitious strategic plan.

Qualifications: Applicants for the Director’s position must have a J.D. degree from an ABA-accredited law school and a M.L.S. or M.L.L. degree from an A.L.A.-accredited institution. A minimum of seven years of professional experience as a law librarian is required. Such experience should include an active leadership role in an academic law library and the administration and management of information technology within a law school. Teaching experience, a publication record, and contributions to the profession are also desirable. Salary will be commensurate with qualifications and experience. In appropriate cases, the Director may be considered for a tenured or tenure-track appointment to the faculty.

Please submit a letter of interest, a detailed resume listing qualifications and experience, and the names, addresses, telephone numbers and e-mail addresses of at least three professional references who may be contacted. For fullest consideration, please submit materials by April 15, 2008. The review of materials will begin immediately and will continue until the position is filled. Apply to this position through the University’s on-line website. Go to www.uc.edu/hr, click on “job seekers”, and apply for position #28UC0633.

Please email ([email protected]) or call me (513) 556-0115 if you would like to find out more about this wonderful opportunity.

Advanced Look at US News Rankings

I cannot vouch for the accuracy of this data but others with blogs are posting it as the advanced ranking from US News that will be available to all on Friday.  The pdf file for the top 100 schools can be found here.  I am not a fan of the rankings but I understand that most everyone is curious to know where their school happens to fall this year. 

I also received an e-mail from the ABA Journal concerning their recent article examining the rankings process.  The e-mail encourages individuals to participate in a discussion about the rankings.  Below is the e-mail:

Because you’re a blogger who is a member of the legal education community, we thought you and your blog’s readers would be interested in an ABA Journal cover story about U.S. News & World Report’s law school rankings that was posted today (http://www.abajournal.com/magazine/the_rankings_czar/). And we’re holding a live online chat next month with the rankings czar from U.S. News in which you can participate.

Robert Morse, the man who created the law school rankings for U.S. News, offers an olive branch to law school deans who have long complained about the effect of the rankings on legal education. “Deans are welcome to call me or come by my office in Washington,” Morse says. “I want to work with them to improve the rankings.”

Some deans and former deans think they should engage the magazine, rather than just complain about it. “I think rankings need to be changed, and the only way that will happen is if law school deans sit down with Bob Morse for honest discussion,” says Nancy Rapoport, who resigned as dean of the University of Houston Law Center after her school dropped almost 20 points in the rankings. “I would attend a meeting like that without hesitation.”

This year’s U.S. News law school rankings are scheduled to be released this Friday, March 28.  Morse will be taking questions from the public on ABAJournal.com on Friday, April 11, from 3 to 4 p.m. ET. We hope you and your readers will participate.

AFL-CIO Study on What Americans Are Willing to do for Health Insurance

This morning, NPR's Morning Edition ran a brief story on the some of the results of the AFL-CIO's survey of what Americans were willing to do for health insurance.  Many responded that they had stayed in jobs they did not enjoy and without a future, one individual discussed how her son joined the National Guard and spent a year in Iraq.  These should not be choices that people have to make in order to get health insurance.  Here is the AFL-CIO website with further information on their survey.

Pregnant Women as Temporarily Disabled?

Feministing has a post concerning a recent, failed piece of legislation in California that would have labeled women in their third trimester as temporarily disabled so that they could qualify for disabled parking spaces.  While I appreciate the sentiment, why not just have some extra parking spaces just like my local drug store does, for expecting moms.  Anyway, here is blogger Samhita's take on the legislation,

A Republican California assemblyman proposed a bill that would deem pregnant women "temporarily disabled" in the third trimester of their pregnancy and allow them access to handicapped parking. The bill failed, but I think this is really interesting.

The classification of differently-abled people is usually pretty stigmatizing. Disability rights activists have talked about the problem with being overly protective of differently-abled people while overlooking systemic problems in the care of people with disabilities and the lack of appropriate legislation to protect their individual rights.

People with disabilities are constantly fighting against a misinformed public, discrimination and the often erroneous belief that differently-abled people are helpless and can't make decisions for themselves. It is not OK, but we can agree that these assumptions are prevalent. So if that is the case, and we have politicians that want to classify pregnant women as "disabled" these same misconceptions apply on some level. There is then the belief that pregnant women are unable to take care of themselves, make choices for themselves, etc. Is the answer for society's mistreatment of both differently-abled people and pregnant women legislation that will classify women as "temporarily disabled?". . . .

PatientsLikeMe Website

The New York Times reported on Sunday about a new website, PatientsLikeMe, that permits patients to share medical data and learn more about treatments, drug doses, clinical trials and symptoms of a variety of diseases.  The website raises some interesting issues including how the internet distributes data to patients perhaps encouraging self-medication as well as the privacy concerns from the public sharing of such health data (with some quotes from Professor Mark Rothstein).

  At first glance, the Web site looks like just any other online community, a kind of MySpace for the afflicted. Members have user names, post pictures of themselves and post updates and encouragements. As such, it’s related to the chat rooms and online communities that have inhabited the Internet for more than a decade.

But PatientsLikeMe seeks to go a mile deeper than health-information sites like WebMD or online support groups like Daily Strength. The members of PatientsLikeMe don’t just share their experiences anecdotally; they quantify them, breaking down their symptoms and treatments into hard data. They note what hurts, where and for how long. They list their drugs and dosages and score how well they alleviate their symptoms. All this gets compiled over time, aggregated and crunched into tidy bar graphs and progress curves by the software behind the site. And it’s all open for comparison and analysis. By telling so much, the members of PatientsLikeMe are creating a rich database of disease treatment and patient experience. . . .

Yet even doctors who consider themselves advocates of online medical information raise concerns about patients self-medicating or self-treating. Erik Ensrud, a neurologist at Brigham and Women’s Hospital in Boston, specializes in many of the diseases that PatientsLikeMe focuses on. “The nervous system is the most complicated system in the body,” he says. “It’s so often much more difficult to quantify and study than we think it will be.” . . .

For decades, our personal health information has been protected largely by disorganization and chaos, suggests Mark Rothstein, a bioethics and health-policy professor at the University of Louisville. But now, with major health-maintenance organizations and hospitals finally adopting electronic records, fallow storerooms of paper records are being converted into neat and portable digital form. “Technology is racing ahead of society,” says Rothstein, who advises the Department of Health and Human Services on electronic privacy. “If this is sensitive information — sexual history, mental illness, substance abuse — even if nothing bad happens, people are subject to stigma and embarrassment.” . . . .

PatientsLikeMe upends this dialectic; in technology terms, it routes around the problem. Since the company is an opt-in service and not a health-care provider, Hipaa doesn’t apply. Good thing, really, since the site identifies members’ cities and their ages, two of Hipaa’s 18 prohibited categories of personal information.  But Hipaa is extraneous not just legally but philosophically as well. Many PatientsLikeMe members volunteer even more information from those 18 categories. They not only post their photos but also post photos of their children and spouses. They add brief autobiographies and describe their conditions in precise detail — including potentially embarrassing particulars on sexual function, bladder control or constipation. And though they all have user names, most go by their first names on the site’s forums.

PatientsLikeMe’s privacy policy clearly states that this sharing carries risks. It acknowledges that since anybody can register at the Web site, anybody can look at member profiles. It makes clear that there’s no guarantee that registered members are, in truth, who they say they are. And it nods to the fact that, yes, this is a business, not a public service — some personally identifiable information may be sold to “approved vendors.” But this is boilerplate. The most striking notice is the company’s Openness Philosophy, a manifesto posted prominently on the site.

“Currently, most health-care data is inaccessible due to privacy regulations or proprietary tactics,” it declares. “As a result, research is slowed, and the development of breakthrough treatments takes decades. . . . When you and thousands like you share your data, you open up the health-care system. . . . We believe that the Internet can democratize patient data and accelerate research like never before.” . . .  That pretty much defines pragmatism, and it exemplifies these strategic information-for-benefit exchanges people make like taking a blood test to get life insurance or consenting to a background check to secure a new job. Only now, at places like PatientsLikeMe, information has a currency that’s far more liquid than ever. Converted into data and bundled with information from those like us, private information can be invested for both immediate gains and long-term returns.  And there’s a fortunate side effect to converting your health history into data — it strips it of metaphor, of secrecy, of stigma. It becomes concrete, manageable and valuable. . . . .

PatientsLikeMe raises many more questions and quandaries than it answers.  Joe Heyman, a practicing physician in Amesbury, Mass., and the chair-elect of the A.M.A.’s board of trustees, praises the potential benefits of a tool like PatientsLikeMe for patients. He’s just uncomfortable with who’s minding the toolbox. “The idea of them is a wonderful thing,” he says. “But you know, as a physician I have a code of ethics. We have licensing boards and accreditation and all these people keeping an eye on us.” Heyman suggests that if physicians themselves aren’t sole stewards of the patient data — his first choice — then there should be some national standards or a law that covers a company like PatientsLikeMe that traffics in such data.

Heyman is also uncomfortable with how PatientsLikeMe encourages patients to take their medical information and then act on it. “Sometimes patients misunderstand what a doctor says to them,” he says, “so by the time it gets to the third or fourth party it’s like a game of telephone. It’s not as reliable as coming from the horse’s mouth.”

Heyman may be speaking from the perspective of the injured party — PatientsLikeMe could be seen as a direct challenge to physicians’ omniscience — but there’s still something to his concerns. PatientsLikeMe not only lets members track their disease; it also tacitly encourages them to take action. While PatientsLikeMe advises users to consult a doctor before changing their treatments or dosages — patients can print out an exhaustive status report, replete with graphs and charts, to take on doctors’ visits, and personal physicians can register as caregivers on the site — there will inevitably be patients who treat the Web site’s apparent rigor and depth as a substitute for a physician’s training and expertise.

Erik Ensrud, the neurologist at Brigham and Women’s Hospital, worries that patients could spot an animal study or early-stage trial investigating an off-label usage of a drug and then start taking that drug in the hope that the researchers are onto something. “Even if a treatment seems promising, it could result in a very serious reduction in lifespan,” he suggests. “We’re talking survival.” . . .

Measles in California and Vaccine Exemptions

On Friday, just after I finished taking my son, recently turned 5, to the doctor for his three vaccinations, I read an article in the New York Times about how many parents don't feel the need to protect their children in this way - which is extremely unfortunate for the rest of us.  The Times article reports,

In a highly unusual outbreak of measles here last month, 12 children fell ill; nine of them had not been inoculated against the virus because their parents objected, and the other three were too young to receive vaccines.

The parents who objected to their children being inoculated are among a small but growing number of vaccine skeptics in California and other states who take advantage of exemptions to laws requiring vaccinations for school-age children. The exemptions have been growing since the early 1990s at a rate that many epidemiologists, public health officials and physicians find disturbing.

Children who are not vaccinated are unnecessarily susceptible to serious illnesses, they say, but also present a danger to children who have had their shots — the measles vaccine, for instance, is only 95 percent effective — and to those children too young to receive certain vaccines. . . .

Every state allows medical exemptions, and most permit exemptions based on religious practices. But an increasing number of the vaccine skeptics belong to a different group — those who object to the inoculations because of their personal beliefs, often related to an unproven notion that vaccines are linked to autism and other disorders.  Twenty states, including California, Ohio and Texas, allow some kind of personal exemption, according to a tally by the Johns Hopkins University.

“I refuse to sacrifice my children for the greater good,” said Sybil Carlson, whose 6-year-old son goes to school with several of the children hit by the measles outbreak here. The boy is immunized against some diseases but not measles, Ms. Carlson said, while his 3-year-old brother has had just one shot, protecting him against meningitis. “When I began to read about vaccines and how they work,” she said, “I saw medical studies, not given to use by the mainstream media, connecting them with neurological disorders, asthma and immunology.”
Ms. Carlson said she understood what was at stake. “I cannot deny that my child can put someone else at risk,” she said. . . . . 

“If you have clusters of exemptions, you increase the risk of exposing everyone in the community,” said Dr. Omer, who has extensively studied disease outbreaks and vaccines. . . . .  “The very success of immunizations has turned out to be an Achilles’ heel,” said Dr. Mark Sawyer, a pediatrician and infectious disease specialist at Rady Children’s Hospital in San Diego. “Most of these parents have never seen measles, and don’t realize it could be a bad disease so they turn their concerns to unfounded risks. They do not perceive risk of the disease but perceive risk of the vaccine.”

Dr. Sawyer and the vast majority of pediatricians believe strongly that vaccinations are the cornerstone of sound public health. Many doctors view the so-called exempters as parasites, of a sort, benefiting from the otherwise inoculated majority. Most children get immunized to measles from a combined measles, mumps and rubella vaccine, a live virus. . . .

Recent news that a federal vaccine court agreed to pay the family of an autistic child in Georgia who had an underlying mitochondrial disorder has led some skeptics to speculate that vaccines may worsen such conditions. Again, researchers say there is no evidence to support this thesis.  Alexandra Stewart, director of the Epidemiology of U.S. Immunization Law project at George Washington University, said many of these parents are influenced by misinformation obtained from Web sites that oppose vaccination. . . .

While many parents meet deep resistance and even hostility from pediatricians when they choose to delay, space or reject vaccines, they are often able to find doctors who support their choice. . . .  “I don’t think it is such a critical public health issue that we should force parents into it,” Dr. Sears said. “I don’t lecture the parents or try to change their mind; if they flat out tell me they understand the risks I feel that I should be very respectful of their decision.”

Some parents of unvaccinated children go to great lengths to expose their children to childhood diseases to help them build natural immunities. In the wake of last month’s outbreak, Linda Palmer considered sending her son to a measles party to contract the virus. Several years ago, the boy, now 12, contracted chicken pox when Ms. Palmer had him attend a gathering of children with that virus. “It is a very common thing in the natural-health oriented world,” Ms. Palmer said of the parties.  She ultimately decided against the measles party for fear of having her son ostracized if he became ill. . . .

While the laws vary from state to state, most allow children to attend school if their parents agree to keep them home during any outbreak of illnesses prevented by vaccines. The easier it is to get an exemption — some states require barely any paperwork — the more people opt for them, according to Dr. Omer’s research, supported by other vaccine experts.

There are differences within states, too. There tend to be geographic clusters of “exempters” in certain counties or even neighborhoods or schools. According to a 2006 article in The Journal of The American Medical Association, exemption rates of 15 percent to 18 percent have been found in Ashland, Ore., and Vashon, Wash. In California, where the statewide rate is about 1.5 percent, some counties were as high as 10 percent to 19 percent of kindergartners. . . .

Organ Transplant Waiting List Problems

The Washington Post reports today on the list of individuals waiting for organ transplants and reports that many on the waiting list are actually ineligible.  Rob Stein writes,

The list of patients waiting for organ transplants, which is widely used to promote organ donations, includes thousands who are ineligible for the operations, according to statistics kept by the national network that manages the allocation of organs.    

More than a third of the nearly 98,000 patients on the list at any one time are classified as "inactive," meaning they could not be given an organ if it became available because they are too sick, or not sick enough, or for some other, often unexplained, reason.

Although the need for organs far outpaces the supply, critics say the large number of inactive patients on the list may signal that potential recipients are languishing in limbo too long and that including them could mislead potential donors, recipients and policymakers about the magnitude of the need.

Officials at the United Network for Organ Sharing (UNOS), which oversees the transplant system under a federal contract and provided a breakdown of its waiting list at the request of The Washington Post, defend the practice. Many patients are inactive for only short periods because of temporary complications or other issues that are often resolved, they say.  But critics note that a significant number of patients have been inactive for more than two years and may never become eligible. . . .

The revelation comes at a time when advocates of organ donation have come under fire for using increasingly aggressive strategies to obtain organs, justifying their efforts by citing the long and steadily growing waiting list.  "Part of the argument for the push to get more people to be donors, and for expanding the types of procedures that we do to get organs, is there's all these people waiting for organs and dying in the meantime," said Joan McGregor, a bioethicist at Arizona State University. "If the number is not accurate, that's giving people the false impression that the situation is more serious than it is. It's deceptive."

The advocates, however, say that there are compelling reasons to keep many inactive patients on the list and that the continuing shortfall in organs overshadows any questions about them.  "Whether it's 75,000 or 100,000, there are still far more people who need transplants than can get them," said Robert Higgins, president-elect of UNOS. "None of this changes the fact that there is a significant number of people who die waiting."

Of 97,772 patients on the waiting list as of Feb. 29, which officials said provided a representative snapshot, 32,014 -- nearly 33 percent -- were inactive.  The proportion of inactive patients varied with the type of organ, ranging from nearly 26 percent of those needing livers to nearly 69 percent of those waiting for a pancreas. Nearly 33 percent of those waiting for kidneys, the transplant most often sought, were inactive.  Most inactive patients had been ineligible for at least a year -- and often for more than two years. More than 55 percent of the patients on the list for hearts, and nearly 49 percent waiting for livers, had been inactive for more than two years. Nearly half of those waiting for kidneys had been inactive for at least a year -- and nearly a third for more than two years. 

"I could expect people to be on there for months potentially," said Arthur L. Caplan, a University of Pennsylvania bioethicist. "But more than two years? What's that about?" . . . .
"This raises the question about whether the transplant centers are doing their jobs," Caplan said. "If I've been on the inactive list for two years, my question is, 'What has been done to either get me on the active list or take me off the list?' " . . . .

The size of the list could be particularly important to people who are considering becoming a "living donor" by donating a kidney or a piece of their lung, liver or pancreas -- a practice that has spurred intense debate over whether such donors are fully counseled about the risks. Exaggerating the size of the list is also unfair to active recipients, said Luebke, who donated a kidney to her sister in 1994.  "It plays on the psyche of the person who's on the wait list," she said. " 'Am I up against 74,000 or 50,000?' " . . . .

"I don't believe there is any reason to be concerned about this," said James F. Burdick, who heads the division of transplantation at the federal Department of Health and Human Services. "I don't think there's anything that indicates that patients are not getting a fair shake."

Others noted that the size of the list is often used in lobbying efforts to seek funding or to change organ-procurement policies. Donation advocates are campaigning to revise state laws to make it easier to obtain organs in ways some say may sacrifice the needs of dying patients and their families.  "It does help the political cause to push for legislation and policies to increase donor rates to use the bigger numbers," Caplan said. "It's not the accurate and truthful thing to be doing." Advocates are also pushing a controversial strategy for obtaining organs from patients who are not yet brain-dead, known as donation after cardiac death, or DCD.  "The push for DCD is based solely on the idea that we have a huge disparity of organs," said Gail Van Norman, an anesthesiologist and bioethicist at the University of Washington.  "But if 30 percent of the names are the list are inactive, the data isn't a true reflection."

 

The Washington Post provides further data here (showing chart of waiting list for organs) and here (article discussing new aggressiveness to procure organs for donation).   

Recycling "Single Use" Medical Equipment: Common Practice?

The Wall Street Journal ran a piece this past week discussing how many medical providers apparently re-use various medical equipment to save money.  Not just any medical equipment - but medical equipment labeled "single use."  Sounds a little "iffy" to me - even though I understand the profit-motive of the medical device companies. Journalist Laura Landro reports,

In a bid to save costs and stem a rising tide of medical waste, hospitals are recycling a growing number of medical devices labeled as single-use, from scissors and scrubs to the sharp blades surgeons use to saw through bones. 

Recycling medical devices labeled for single use is legal as long as certain Food and Drug Administration guidelines are followed. But the practice, which involves shipping devices to reprocessing facilities to be cleaned, sterilized and tested for reuse, has raised concerns about safety. Medical device makers say their single-use products are just that, and pose a higher risk of failure and harm when recycled. Reprocessing companies, hospital associations and environmental groups counter that the devices they reprocess are as safe as new thanks to modern sterilization methods, cost 40% to 60% less, and can eliminate thousands of tons of waste from landfills.

In January, after reviewing eight years of FDA data, the Government Accountability Office weighed in with a report concluding there is no evidence that reprocessed single-use devices create an elevated health risk for patients. About 100 devices -- just 2% of all devices labeled for single use -- are now reprocessed.

But while the GAO report tilts the debate strongly in favor of reprocessing and opens the door to more widespread use, device makers are sticking to their guns. They are lobbying in several states for legislation that would require health-care providers to obtain "informed consent" from a patient before using a reprocessed device during a procedure. Utah already has approved liability protections for original equipment makers, and other state bills include measures that would free original manufacturers from liability if a reprocessed device fails and causes injury or death.

Device makers maintain that their products labeled for single use aren't designed to hold up to harsh sterilization chemicals and processes. Even when the devices are sterilized, blood, tissue or other bodily fluids on porous surfaces and in tiny crevices could allow transmission of viral and bacterial infections, they say. In general, "single-use devices present an increased safety risk to patients because they are designed for optimal performance and safety in a single patient," says Tara Federici, vice president of technology and regulatory affairs at AdvaMed, a trade group that represents leading device makers.

For example, heart stabilizers, the devices used to position a beating heart during surgery, have hollow tubes and other parts that device manufacturers say could harbor blood and tissue and become weakened during reprocessing in ways that might not be evident during inspection. A study by the University of Minnesota of stabilizers made by Medtronic Inc. found that while new devices showed little or no manufacturing debris, a majority of reprocessed devices had corroded parts and traces of human hair and protein, bringing into question the effectiveness of the reprocessing efforts.

Last year, the FDA began requiring that reprocessed heart stabilizers undergo more rigorous premarket clearance reviews, and a Medtronic spokesman says the company plans to repeat the tests to see if the more stringent requirements improve performance. Until then, he says, the company stands by its position that the devices can't safely be reprocessed.

The Association of Medical Device Reprocessors, a trade group whose members reprocess the majority of devices, counters that it recycles only products made from rigid, hard metals or durable polymers and plastics that can safely be reused between two and five times, depending on the device. The group has petitioned the FDA to require new heart stabilizers to undergo the same premarket review as reprocessed ones, because the device itself is high-risk. Since 2001, the group notes, there have been 73 adverse events reported to the FDA involving devices used to stabilize the heart, including incidents in which pieces have broken off and fallen into the chest cavity.

Dan Vukelich, president of the group, says reprocessed devices can be safer in some cases because each must be inspected before reuse, while original manufacturers test new devices only in batches. He also contends that device makers label many products as single-use merely to be able to sell more new devices to hospitals and thwart competition -- a contention that medical device makers dismiss.

About $31.5 billion of single-use medical devices are sold annually in U.S. hospitals and surgery centers, of which around $150 million are recycled, according to Ascent Healthcare Solutions, a leading reprocessing company. John Grotting, Ascent's chief executive, estimates that about $3.6 billion of single-use devices are safe for reprocessing, which could save the health-care industry about $1.8 billion a year. Ascent hospital customers eliminated about 1,684 tons of waste from their local landfills last year, a 31% increase over 2006, by using reprocessed devices, Ascent says. . . . .

"Single-use labeling is a real scam for a lot of devices, and by not using reprocessed devices where possible it is wasteful and not environmentally responsive, since these items have to be disposed of as biomedical waste," says Kenneth Kizer, a consultant and former undersecretary for health at the U.S. Department of Veterans Affairs. "The reuse of medical devices that are labeled for single-use only is a well-established and safe practice regulated by the FDA and utilized by most of the top-ranked hospitals in the country."

Dr. Kizer testified last year at a congressional hearing that the VA could save up to $30 million in 2008 by using reprocessed medical devices. The VA, with 153 hospitals, has had a longstanding policy against the use of reprocessed devices on the grounds that it can't determine if they are safe, noting that manufacturers didn't design them to be used more than once and don't provide instructions on cleaning and sterilizing the devices. A spokesman says the VA reviews the policy from time to time but has no plans to change it at present.

The FDA has stepped up its oversight of reprocessing, including more plant inspections, after new legislation in 2002 began requiring devices to be labeled if they are reprocessed. The FDA says it is working on a new strategy for monitoring and communicating information about reprocessed devices, and conducting research on "acceptable" single-use device-cleaning criteria. . . .

Not quite sure about this money saving technique - I fear that it could lead to the situation we see in Nevada with all kinds of medical devices being "recycled" with harmful impacts. 

 

 

Fellowship Opportunities for Aspiring Law Professors

Professor Paul Caron of the TaxProfBlog provides an excellent listing of the many fellowship opportunites that individuals interested in teaching law may wish to research and pursue.  I know that many law students do not immediately think of teaching but it is a good resource that they may wish to consult in the future and some Alumni of your schools may wish to learn more about these opportunties.

Supreme Court Receives Request to Hear Sperm Donor Case

Law.com/Associated Press reports on a case recently presented to the United States Supreme Court.  The article states,

A Topeka, Kan., man wanting parental rights to children conceived with sperm he donated is taking his case to the U.S. Supreme Court. Attorneys for Daryl Hendrix on Monday filed an appeal with the Court, seeking to overturn a Kansas Supreme Court ruling last year.

In a 4-2 opinion on Oct. 26, the Kansas court said a state law that doesn't give sperm donors any parental rights unless there's a written agreement is indeed constitutional. The court said the decision upholding the 1994 law was the first of its kind in the nation because no other state has ruled on a provision requiring a written agreement between mother and donor. . . . .

Hendrix's case is the result of a dispute he has with the mother, Samantha Harrington. Hendrix and Harrington were friends for a number of years, and he agreed to donate his sperm to help her become pregnant. Harrington gave birth to twins in May 2005. No written agreement was signed between them, although Harrington is an attorney.  People who donate sperm at a sperm bank must sign a waiver to parental rights, and Hendrix signed nothing, Leving said, adding that Hendrix planned to co-parent the children. Harrington has maintained that she always intended to be a single mother. . . .

Yikes! 

Better & Cheaper Health Care without Insurance

RNCentral.com blog has a great article by Chrisin Laun entitled, "How to: Get Better, Cheaper Health Care Without Insurance (25 Tips, Tricks and Resources)."  The list provides some valuable information for obtaining access to medical care such as:

1. Take advantage of walk-in clinics. Chances are, if you just have a head cold or need a refill on a prescription like birth control pills, you don't need to head into a full-fledged hospital or even a traditional doctor's office. These facilities tend to be cheaper and can suit the needs of most people for any minor illnesses or medical issues. Major retailer Wal-Mart has even announced plans to open their own clinic, allowing you to get a diagnosis for your cold while you're picking up some chicken soup. Many chain drugstores like Walgreens and CVS already have this kind of clinic on-site.
2. Consider alternative therapies. Chronic back pain and stress related illnesses, no matter how annoying they may be, may not always warrant a trip to the doctor's office. Many alternative therapies like massage and acupuncture can be just as effective and might save you a few dollars in the long run. Before starting any of these therapies, however, make sure you are in the proper condition to do so.
3. Try a nurse. Nurse practitioners can often give patients just as good of care as doctors, but at a much lower cost. When care from the two are compared, studies have shown that nurses often have more time to spend with patients and do just as good of a job diagnosing problems. . . . . 

I think that some of my students will find this helpful. The article also discusses ways to gain access to pharmaceuticals and medical equipment.  Thanks to Sally Thompson for this article and for information about rncentral.com.

OB/GYN Ethics Rule Upset HHS

Late last year, the American College of Obstetricians and Gynecologists (ACOG) issued new ethics guidelines. Among other things, the new guidelines provide that physicians "have the duty to refer patients in a timely manner to other providers if they do not feel they can in conscience provide the standard reproductive services that patients request."

National Public Radio's Morning Edition reported today and yesterday on the involvement of HHS and HHS's assertion that such guidelines may violate federal "conscience" laws.  In a letter to the American Board of Obstetrics and Gynecology (ABOG), Health and Human Services Secretary Michael Leavitt stated that ob/gyns who have moral objections to abortion should have no obligation to refer patients.  NPR interviewed several individuals about the controversy and Julie Rovner stated in her report yesterday the potential consequences from the failure to refer for both women and physicians,

Ob/Gyn Wendy Chavkin of Columbia University welcomes the new AGOG ethics statement. She's the immediate past chairwoman of Physicians for Reproductive Choice and Health.  "It says that if a physician has a personal belief that deviates from evidence-based standards of care they have to tell the patient that, and that they do have a duty to refer patients in a timely fashion if they do not feel comfortable providing a given service," Chavkin says.

She says it isn't just about abortion, but also about things like emergency contraception — high doses of regular birth control pills that can prevent pregnancy in most cases if taken within 72 hours. She points to a scenario in which a woman has been raped and shows up at the only health care facility in her area.  "And she comes upon some doctor who thinks that emergency contraception is the equivalent of abortion, which is incorrect, but nonetheless what this individual believes," Chavin says. "What this ACOG statement is saying is she should not be deprived of something that's needed right away to take care of her emergency situation."

But doctors who object to providing certain types of care — particularly abortion — also object to referring patients.  "I'm not going to refer someone to a hit man to put to death someone that's inconvenient in their life," says Joseph DeCook, a retired Ob/Gyn from Holland, Mich., and vice-president of the American Association of Pro-life Obstetricians and Gynecologists. "I wouldn't do that. This is the very same thing. I'm not going to refer a pregnant woman to a physician who will purposefully terminate her pregnancy — better known as purposefully kill the unborn child. I'm just not going to do it." . . . .

But it's not entirely clear that board certification would — or even could — be stripped from doctors who don't want to make abortion referrals. Officials from the certifying board weren't available for comment.  But Greg Phillips, a spokesman for ACOG, says that the November ethics opinion was just that — an opinion. He says it's not a formal part of group's code of ethics that board certified Ob/Gyns must obey.

The updated story by Ms. Rover provides a statement from Dr. Norman Gant, executive director of the certifying board, who claims that "HHS got it all wrong."

Gant, who didn't respond sooner because he was out of the office, backed up what ACOG spokesman Gregory Phillips said Tuesday, which is that the ethics committee opinion regarding referrals is not a binding portion of the college's ethics code, and therefore not a factor in the decision about board certification.

"We do not restrict access to our exams for anyone applying for initial certification, or maintenance of certification, based on whether they do or do not perform an abortion," Gant said. "We do not base this upon whether they do or do not refer patients to an abortion provider if they do not choose to do abortions."

Gant said he dictated a letter back to Leavitt to that effect Wednesday. He added that the board has long respected the fact that its members disagree on the abortion issue — more than a decade ago it removed abortion from the list of cases to be used in oral exams.  On the other hand, Gant, himself an Ob/Gyn, said he personally had no problem with the November ethics statement, particularly the idea that Ob/Gyns should be ethically bound to provide contraception.

So, all and all, this looks like a good use of HHS's time. . . . .

Stem Cells and Vision Treatment Updated

On Tuesday, NPR's morning edition ran the story discussing a new controversial treatment for infant blindness involving stem cells.  NPR's morning edition has followed up with an interview Dr. Mark Borchert who believes that the treatment is rather risky and possibly not producing the results that parents claim to see.   It did sound too good to be true. . . .