HealthLawProf Blog

Editor: Katharine Van Tassel
Akron Univ. School of Law

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Wednesday, April 26, 2006

Increase in the Number of Uniinsured Americans

Kate Steadman at HealthyPolicy blog posts the latest findings of the Commonwealth Fund, a  a New York-based private health care policy foundation.  For an overview of the Commonwealth Fund's findings, see the Houston Chronicle here.  They demonstrate that in 2005 the number of middle-income Americans who lacked ehalth insurance for part of the year rose to 41%.  We seem to be moving in the wrong direction on this issue and something tells me the $3.00 price of gasoline is not going to help people save money to pay for health insurance. 

The entire study paints a rather bleak picture for midle-class America.  [bm]

April 26, 2006 | Permalink | Comments (0) | TrackBack (0)

Tuesday, April 25, 2006

Patients Often Unreliable Predictors of Their Own End-of-Life Treatment Preferences

First, we're told that a third of the time family members can't predict the end-of-life treatment preferences of their loved ones [abstract; pdf (requires subscription)].  Then, we learn that physicians typically misjudge the end-of-life treatment preferences of elderly patients (see, e.g., Journal of Family Practice, Nov 1993 v37 n5 p469(7)).  Now, here comes an article in this week's Archives of Internal Medicine [subscription required; abstract] that tells us patients themselves, at least 20 percent of the time, misjudge their actual treatment preferences at the end of life. The policy preference these articles seem to point toward is increased use of designated surrogate decision makers (i.e., through medical powers of attorney) and decreased reliance on living wills, which are typically executed before a patient has received a terminal diagnosis. [tm]

April 25, 2006 | Permalink | Comments (0) | TrackBack (0)

Trusting the Pharmaceutical Companies

Kevin Drum of the Washington Monthly points to a great article in the LA Times by Shannon Brownlee discussing the manner in which the United States permits drug companies to fund the clnical trials into a drug's safety and effectiveness.  She is not impressed with their research.

Researchers scoff at the notion that that their scientific integrity is for sale. Certainly most researchers aren't corrupt, but their institutions are guilty of allowing the drug industry to manipulate medical science.

Meanwhile, industry-funded research is failing to provide the clinically useful answers physicians and patients need in order to pick the best treatment. Which drug is right for which patient? What are the risks? Are the added benefits of a new, expensive drug worth the cost? If not, should insurance companies and Medicare be paying for them?

If we want answers to such questions, the public is going to have to start paying for them. Earlier this year, a $44-million National Institutes of Health study found that drug makers' claims notwithstanding, not one of the five newer antipsychotic drugs offered any meaningful improvement over an older drug that cost up to 10 times less.

But the study looked at only one category of drug. If we want high-quality medical care, dozens of other drugs — as well as medical devices and non-drug treatments — should be subjected to the same noncommercial scrutiny.

Because the FDA has been flunking, the NIH might seem like the most obvious agency to fund such studies, but it isn't set up to do the job. The institutes spend only a tiny fraction of their $30-billion annual budget on clinical research, and they have historically focused on basic science, not on studying the safety and effectiveness of drugs.

What's needed is a new Institute for Effective Medicine, which would need to be modeled on the Federal Reserve Board or the Securities and Exchange Commission to protect it from political pressure. Its mission would be threefold. It would serve as a new, independent source of research dollars for medicine. It would provide independent evaluation of data generated by industry. And it would oversee the creation of clinical practice guidelines, a manual of proven "best practices" for physicians devised entirely without industry influence.

Interesting solution to what seems to be a problem with our current drug approval process.  [bm]

April 25, 2006 | Permalink | Comments (0) | TrackBack (0)

AIDS Update

As many of you are aware, last week the Vatican announced that it would study whether condoms may be condoned because they prevent the spread of serious diseases. This move has been lauded by some in the church, and has been advocated most particularly by Cardinal Martini.  According to the Toronto Star:

In an interview with the Italian weekly l'Espresso, Cardinal Carlo Maria Martini called such condom use a "lesser evil" among couples in which one partner has HIV/AIDS that could be passed to the other.

"Of course we must do every thing we can to fight AIDS," Martini said. Married couples, he said, have a responsibility to protect each other."Therefore, using a condom would be considered a minor sin and in particular in the case of married couples where the use of a prophylactic would protect the partner and ultimately themselves."The statement is in direct contradiction to the Vatican's position, which holds that condoms should never be used, even to stop AIDS spreading from one married partner to another. Last year, shortly after being named to the position, Pope Benedict XVI also said condoms should not be used to prevent the spread of AIDS in Africa, where most of the world's AIDS deaths occur. The Pope said fidelity and abstinence were the only way to tackle the disease. "The traditional teaching of the church has proven to be the only failsafe way to prevent the spread of HIV/AIDS," Benedict said last June during a meeting with African bishops.Martini, considered at the time as a close runner-up in last year's papal election, appeared to break with the Vatican on this issue as well.

This annoucement may be of interest to the authors of an interesting and well written new article, entitled, "AIDS Prevention, Treatment and Legal Rights: Local Strategies for a Global Disease" by Tapen Sinha, Instituto Tecnológico Autónomo de México (ITAM) - Division of Actuarial Science, Statistics and Mathematics; University of Nottingham - Nottingham University Business School, and Bradley J. Condon, Instituto Tecnológico Autónomo de México (ITAM) - Administracion; Bond University School of Law April 2006, explores prevention and treatment efforts in the fight against AIDS. 

Here is the brief abstract:   

AIDS is a global disease. Prevention, treatment and human rights protection must all form part of any comprehensive AIDS strategy.

Prevention, treatment and human rights protection are inter-related issues. For example, the rights of women affect their ability to use prevention strategies. Moreover, the stigma associated with HIV/AIDS, together with a lack of legal protection against discrimination, may deter people from seeking testing and treatment. Prevention, treatment and human rights strategies must also be adapted to suit the conditions in different parts of the globe. Variations in cultural values, affected groups, infection rates, legal systems, economic resources, and human resources mean that HIV/AIDS must be considered in specific contexts.

This paper examines the use and absence of these three strategies in different regional contexts in developing and developed countries: South Africa, Brazil, Thailand, Japan and Australia. We examine AIDS strategies from a multidisciplinary perspective that considers legal issues, political issues, and demographic issues.

The entire article is available here:   

http://papers.ssrn.com/sol3/papers.cfm?abstract_id=896962

April 25, 2006 | Permalink | Comments (0) | TrackBack (0)

Monday, April 24, 2006

The Mumps are back!

Slate.com has a good overview of the recent outbreak of mumps in the midwest and discusses one potential cause of the outbreak -

No vaccine is perfect, however. The worst mumps epidemic in 17 years is currently sweeping through a heavily vaccinated population in the Midwest. Nearly 1,000 cases have been reported in Iowa since March, and hundreds more in seven other states. A single dose of mumps vaccine—the recommended dosage in Iowa before 1991—protects about 80 percent of those who get it; two doses, the norm today, confers 90 percent immunity. The Iowa outbreak is concentrated in college students, about one-third of whom had not gotten two doses of vaccine as children. Mumps is more serious in older kids and adults—about a fifth of infected men get swollen testicles, as well as the disease's trademark symptom of a swollen neck; women get sore breasts. Outbreaks in vaccinated populations tend to be less serious, though, and only about 20 people have so far been hospitalized, according to Julie Gerberding, director of the Centers for Disease Control.

The CDC is investigating the origins of the Midwest outbreak. The agency has no clear answers yet, but it may be that these mumps cases are linked to an earlier vaccine scare in Britain. In 1998, gastroenterologist Andrew Wakefield published a report in the medical journal Lancet in which he suggested that the MMR vaccine (called that because mumps protection is nearly always packaged together with vaccines for measles and rubella) caused autism. The article has since been withdrawn and the link between the vaccine and autism disproved. But vaccination rates plunged in the United Kingdom for a few years, resulting in a mumps epidemic of 100,000 cases since 2004. The mumps virus circulating in the Midwest is the same type as the British epidemic strain, though it is too common a variant for scientists to be certain, at this point, of a definitive link.

.[bm]

April 24, 2006 | Permalink | Comments (0) | TrackBack (0)

Insurance Blues

Kevin Drum from the Washington Monthly highlights a L.A. Times editorial concerning the lack of regulatory controls on insurance out-of-pocket caps: 

Lucky you, if you don't know what your out-of-pocket cap is. And if you're like every single healthy person I've queried, you probably don't. But you should know, because the out-of-pocket cap is the most important part of your policy, meant to stave off financial disaster in case of catastrophic medical expenses.

The worried well, however, tend to be remarkably ignorant about medical insurance. Policy wonks keep arguing about market competition and consumer choice. But healthcare for the sick isn't a market because choice disappears. You can't shop around for generic drugs when you have cancer. Whatever chemical treatment the doctor suggests, it almost certainly will be a brand name costing several thousand dollars a month.

My out-of-pocket cap is $7,500, which means that after I reach $7,500 in co-payments, Blue Cross pays 100% of my medical expenses for the rest of that year — except for the $30-per-brand-name prescription I have to pay the pharmacy after I reach my $500 annual deductible for drug coverage. According to the policy, it's supposed to be a $30 co-payment for a month's supply, but a new anti-nausea drug I was taking for weekly chemo costs $285 for just three pills, so Blue Cross made me go to the drugstore and fork over $30 every seven days.

 

Another thing working in insurance companies' favor is that cancer patients rarely have the energy to argue about such nickel-and-diming. I recently managed to spend a morning forcing my way through multiple disconnects and transfers on the Blue Cross 800 number, but I was eventually told that the company would probably reimburse me for the extra $90 a month I was paying for that weekly anti-nausea drug if I filled out the right forms. My far bigger worry is that out-of-pocket cap, which is essentially what insurance is for. To drastically raise it seems the definition of bad faith.

Or so I thought — until I began getting letters from Blue Cross in February announcing that it was retroactively disallowing the anti-cancer drug Avastin treatments it had been paying for since October, at $5,000 a pop every other week. It seems Blue Cross decided this new and expensive targeted therapy is experimental. (It looks as if Blue Cross is not asking to be repaid for my relatively unexperimental chemo, which had been costing about $2,500 every single week, but who knows?)

Avastin, which is officially approved only for treatment of colon cancer, is often as effective for lung cancer. So, insurance often pays for it — especially when patients are, as they say at the oncologist's office, running out of options. Therefore, I wasn't surprised Blue Cross had put up no argument for months — particularly when two CT scans since October showed that the Avastin/chemo combination had produced some tumor shrinkage and then stable disease. (It stopped working in March, so I've since moved on to a truly experimental therapy, which is free because the company that makes the drug pays.) I know Blue Cross is aware of the scans because it also sent a letter demanding more information about why the January one was necessary.

To decide after a therapy has proved beneficial that it's merely "investigational" and therefore should not be covered — that, actually, seems the definition of bad faith.

I am sure that many of you have had the pleasure of health insurance negotiations and know that such negotiations are both frustrating and demoralizing.  There must be a better way  . . . [bm]

April 24, 2006 | Permalink | Comments (0) | TrackBack (0)

Hawaiian Birth Ritual Gets Legislative Support

From the CDC's Public Health Law Newsletter:

“Hawaiian parents seek right for birth ritual”

Associated Press     (04/16/06)     Tara Godvin

http://www.startribune.com/484/story/377138.html

Hawaii legislators passed a unique bill after a hospital refused to give Kalehua and Kihapai Krug the placenta of their newborn daughter. The Krugs asked the hospital for permission to take the placenta, which is considered part of the child in traditional Hawaiian belief, but hospital officials said state rules prevented it. The traditional Hawaiian birth ritual involves planting the placenta in the earth, along with a tree that is observed over time and thought to reflect psychological and spiritual changes in the child. The hospital has frozen the placenta pending resolution of the issue. “That’s what they don’t understand. This is a part of my child in essence being held captive kidnapped,” said Mr. Krug. According to the National Conference of State Legislatures, no states currently have laws explicitly addressing the cultural practice, although some states, such as California, allow hospitals to set their own policies on the matter. The Hawaii rule prohibiting the practice dates back to 1990, and the state department of health was not initially aware of the conflict between the rule and the tradition. “The rules are in place for the health and safety of the public. And unfortunately this was an unforeseen consequence of those rules,” said state Health Director Chiyome Fukino. Hawaii state legislators, with the support of the State Health Department, have now passed a bill that would allow the placenta to be released to the birth parents.

The Hawaii law is HB2057 [text], signed into law on April 21.  I wonder what Tom Cruise makes of all this: http://blog.bioethics.net/2006/04/im-going-to-eat-placenta-says-father.html. [tm]

April 24, 2006 | Permalink | Comments (0) | TrackBack (0)

Humanities Invades Medical School Curriculum

From bioethics.net, this post:

At Some Medical Schools, Humanities Join the Curriculum

17 Apr 2006 - A growing number of medical schools are adding humanities to the usual forced march of physiology, pathology and microbiology. http://www.bioethics.net/News/?id=1734

The link is to an April 17 article in the N.Y. Times.  Permit some shameless self-promotion on this point.  I've been teaching a literature course at the University of Texas - Southwestern Medical School for the past 10 years, offered as an elective in Internal Medicine, Surgery, and Pediatrics to fourth-year medical students, together with third-year law students.  It's a fantastic way to give the students a humane and humanistic grounding in their chosen professions.  I recommend the humanities influence in medical education wholeheartedly. [tm]

April 24, 2006 | Permalink | Comments (0) | TrackBack (0)

The Latest from the Law Reviews

Links to Lexis [L] and WestLaw [W] are courtesy of the Marian Gould Gallagher Law Library at the University of Washington School of Law and its SmartCILP service. 

FOOD AND DRUG LAW

  • DiNatale, Michael P. Comment. Patients beware: preemption of common law claims under the Medical Device Amendments. 39 J. Marshall Ll. Rev. 75-94 (2005).
  • Evans, Samantha. Note. The globalization of drug testing: enforcing informed consent through the Alien Tort Claims Act. (Abdullahi v. Pfizer, Inc., 2002 U.S. Dist. LEXIS 17436, S.D.N.Y. Sept. 16, 2002, vacated and remanded by, 77 F. App'x 48, 2d Cir. 2003, dismissed at 2005 U.S. Dist. LEXIS 16126, S.D.N.Y. Aug. 9, 2005.) 19 Temp. Int'l & Comp. L.J. 477-505 (2005). [L][W]
  • Fealk-Stickler, Lisa M. Comment. Regulating the regulators: the impact of FDA regulation on corporation's First Amendment rights. 39 J. Marshall L. Rev. 95-114 (2005). [L][W]
  • Ridgway, William E. Note. Realizing two-tiered innovation policy through drug regulation. 58 Stan. L. Rev. 1221-1250 (2006). [L][W]
  • White, Matthew. Comment. Conscience clauses for pharmacists: the struggle to balance conscience rights with the rights of patients and institutions. 2005 Wis. L. Rev. 1611-1648. [L][W]

HEALTH LAW AND POLICY

  • Cruz, Rommel P. The greatest source of wealth: Washington State's response to prenatal substance abuse. 41 Gonz. L. Rev. 1-27 (2005/06). [L][W]
  • Sen, Maya. Comment. Defining the boundaries of "personal injury". (Rainer v. Union Carbide Corp., 402 F.3d 608, 6th Cir. 2005.) 58 Stan. L. Rev. 1251-1265 (2006). [L][W]
  • Wickramasekera, Nimalka. Comment. Public use or experimental use: are clinic trials susceptible to another attack similar to that in ... (Smithkline Beecham Corp. v. Apotex Corp., 365 F.3d 1306, Fed. Cir. 2004.) 39 J. Marshall L. Rev. 149-169 (2005). [L][W]

MEDICAL JURISPRUDENCE

  • Davenport, Ashley A. Student article. Forgive and forget: recognition of error and use of apology as preemptive steps to ADR or litigation in medical malpractice cases. 6 Pepp. Disp. Resol. L.J. 81-107 (2006). [L][W]
  • Geller, Alisa L. In the aftermath of the Terri Schiavo case: resolving end-of-life disputes through alternative dispute resolution. 6 Pepp. Disp. Resol. L.J. 63-80 (2006). [L][W]
  • Sullivan, Matthew C. Comment. Tort reform: Mississippi's tort reforms as compared to other jurisdictions abroad--a sensible treatment protocol for the U.S. tort system ills or not? 19 Temp. Int'l & Comp. L.J. 507-534 (2005). [L][W]

[tm]

April 24, 2006 | Permalink | Comments (0) | TrackBack (0)

Sunday, April 23, 2006

Family Decision Making at the End of Life

For those of us who live outside New York, it's easy to forget that it is one of about a dozen states that do not allow family members to make end-of-life treatment decisions for patients who lack decision making capacity in the absence of a living will or medical proxy.  The most recent reminder is an editorial in today's New York Times in support of the Family Health Care Decisions Act, which in one version or another has been kicking around Albany since 1992.  A summary of A.5406 (and the identical S.5807) is here; the full text is here.

The current situation is pretty grim:

As things stand now, family members in New York have no legal authority to consent or object to medical treatment for an incapacitated adult in the absence of a signed health care proxy or other specific treatment instructions, such as a living will. A 1988 ruling by the state's highest court, the Court of Appeals, held that family members cannot make decisions about life-sustaining treatment.

Since only about 20 percent of New Yorkers have signed health care proxies or living wills, the Legislature's inaction perpetuates an untenable situation for health care providers and family members. In the vast majority of cases, families cannot even review the medical records of an incapacitated relative, much less withdraw life-sustaining treatment or have the patient transferred to a hospice.

With no family member legally authorized to speak for the patient, it is not uncommon for invasive and painful treatment to be prolonged unreasonably, while treatment that could make the final months more comfortable is denied.

Of course, having a family-friendly law is no guarantee that things will turn out well for the patient or the family (cf. the Schiavo-Schindler debacle), but for every bad case there are literally thousands of cases every week in which families are allowed to speak for their loved ones to ensure that they receive the end-of-life care they would have wanted.  [tm]

April 23, 2006 | Permalink | Comments (0) | TrackBack (0)