HealthLawProf Blog

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]

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]

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]

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

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]

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]

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]

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]

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]

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]

Psychiatrists, the DSM-IV, and Big Pharma

The New York Times reports today that more than half the psychiatrists who contributed to the canonical DSM-IV had financial connections to drug companies:

The percentage was higher — 100 percent in some cases — for experts who worked on sections of the manual devoted to severe mental illnesses, like schizophrenia, the study found. But the authors, from Tufts University and the University of Massachusetts, were not able to establish how many of the psychiatrists were receiving money from drug companies while the manual was being compiled.

Lisa Cosgrove, the study's lead author, who is a psychologist at the University of Massachusetts in Boston, said that although the study could not prove that the psychiatrists' ties influenced the manual's development, "what we're saying is it's outrageous that the manual doesn't have a disclosure policy."

But other experts scoffed at the idea that commercial interests had influenced either the language or content of the manual. "I can categorically say, and I was there every step of the way, that drug-company influence never entered into any of the discussions, whatsoever," said Dr. Michael First, a psychiatry professor at Columbia, who coordinated development of the current D.S.M.

Okay . . . I feel much better now.  [tm]

WSJ: We're Getting Better At Accepting Death

According to a piece in today's Wall Street Journal, as our population ages, we are getting better at accepting the reality and inevitability of death [link should work for the next 7 days]. This might be true of the Journal's readership, but as a member of 5 hospital ethics committees, I don't see much evidence of a cultural shift toward acceptance. [tm]

Federal Court Rules Docs Don't Have to Report Teen Sex

The AP is reporting tonight (AP/CNN) that District Judge J. Thomas Marten in Wichita, Kansas, ruled Tuesday that "that abortion clinic doctors and other professionals are not required under Kansas law to report underage sex between consenting youths."  The Kansas City (MO) Star reported Wednesday that General Kline says an appeal is "very likely."

Judge Marten's 39-page opinion is here (PDF).  As reported by AP:

The ruling by U.S. District Judge J. Thomas Marten was a setback for Kansas Attorney General Phill Kline, an abortion foe.

Kline contended that a 1982 Kansas law requiring doctors, teachers and others to alert the state and law enforcement about potential child abuse covers consensual sex between minors. He argued that the law applies to abortion clinics, and later extended that to other health professionals and teachers.

The Center for Reproductive Rights challenged that interpretation in court, and the judge sided with the organization. Kline said he had not decided whether to appeal.

AG Kline's initial (brief) statement on the ruling is here.

The Center for Reproductive Rights' comment on the ruling is here.  According to their press release:

The judge recognized that, "Automatic mandatory reporting of illegal sexual activity involving a minor will change the nature of the relationship between a health care provider and the minor patient to some degree," and that studies establish that the kiss and tell policy would cause "a significant decrease in minors seeking care and treatment related to sexual activity."

The American Medical Association and numerous other major medical groups, including the American Society for Adolescent Psychiatry and American Psychiatric Association, oppose Kline’s policy because it would deter teenagers from seeking health care and counseling, including contraceptive services and information on prevention of sexually transmitted diseases. These medical organizations filed a friend-of-the-court brief supporting the plaintiff’s case.

The New York Times' report is here.

[tm]

Costco Prescription Drug Plan

Jamie Court, a blogger at Huffingtonpost.com, has an interesting piece about an LA Times article about seniors buying prescription drugs at Costco for less than the prices available on their Medicare Part D plans.  He writes,

How is it that Costco, a lean and efficient but still for-profit company, can provide consumers with prescription medications for a lower price than a government program subsidized by hundreds of billions, yes billions, of taxpayer dollars? The only possible answer is that the privatized prescription drug "benefit" being forced on U.S. seniors is meant chiefly to pour profits into Big Pharma, not to help Medicare recipients get a better bang for their pharmaceutical buck.

The LA times story by Valerie Reitman describes seniors who shopped hard to find what looked like the best Medicare Part D benefit for them, only to go to Costco to pick it up and find out that the discount chain's over the counter price was less than they would be charged under Part D. Martin Brower, 77, found that his blood pressure medication would cost him $1.32 per pill, and be limited to 30 pills, under his "benefit." Costco would sell him, without subsidy, 100 pills for $1.13 each. Other examples followed.

It's like the government subsidizing me to pay full price at Brooks Brothers but refusing to help me pay half price for the same suit at Costco.

Perhaps the time has come for a hard look at Medicare Part D - not only is it confusing but costly not only for the government but also for the people it is supposed to be helping.  [bm].

Bubonic Plague in LA

The AP reports on the first case of bubonic plague in LA in over twenty years.  The report states,

A woman was hospitalized earlier this month with bubonic plague, the first confirmed human case in Los Angeles County in more than two decades, health officials said Tuesday.

The woman, who was not identified, was admitted April 13 with a fever, swollen lymph nodes and other symptoms. A blood test confirmed she had contracted the bacterial disease. The woman was placed on antibiotics and is in stable condition, the Los Angeles County Department of Health Services said.

Bubonic plague is not contagious, but if left untreated it can morph into pneumonic plague, which can be spread from person to person. Bubonic plague is usually transmitted to humans from the bites of fleas infected by dead rodents.

Health officials suspect the woman was exposed to fleas in her central Los Angeles home, said Dr. Jonathan Fielding, the county's director of public health. The woman's family was also placed on antibiotics as a precaution, but there's no evidence they were infected.

The case is unusual because it occurred in an urban area, Fielding said. Most bubonic plague outbreaks happen in rural communities.

Health officials said there was no cause for panic because the disease is not easily transmissible.

[bm]

Doctor's Salaries

Erza Klein has an interesting post and graphic on how much doctors should be paid for their services.  He writes:

Doctors, to some extent, work for the public good.  Why shouldn't the country subsidize their education -- particularly if they go into high-need specialties or work in inadequately served areas -- but lower their pay?  Or at least allow for many more nurse practitioners?  As part of it, we can follow this doc's advice and use the power of the state to restore job quality for doctor's, allowing them to turn their attention from paperwork and bureaucratic haggling and back to patient care.  Because the truth is, our nation's doctors are great, but they're not twice as good as Germany's, or Canada's, or Japan's.  Not near it.  Our rates of negligent malpractice remain high, and our outcomes are no better.  And being a doctor shouldn't be about the money anyway, though the cost of following that route has ensured it will be.  We've scattered perverse incentives all about, and offering a more affordable path and enjoyable career in return for somewhat lower salaries would go far towards fixing them.

Please check out his website to see the difference in salaries between doctors in the United States and doctors in other developed countries.[bm]

WSJ: "Government-Funded Care Is the Best Health Solution"

The title of this post is only a little misleading.  The quoted headline did appear in the Wall Street Journal today, but not as the position of the editorial board of the paper, simply as the title of a piece by occasional columnist Benjamin Brewer, M.D. ("The Doctor's Office").  Whatever the merits might be for a single-payer government health insurance program (and I think the good doctor nails the argument right on the head), it's ironic that his opinions appeared on the same day, and in the same paper, as a page-one story about the $1.7 billion in stock options racked up by the CEO of UnitedHealth, which makes its money negotiating around the inefficiencies of the present system. The story is here (might require a paid subscription, though I am told the link will work for the next 7 days; if you want the article, I can e-mail it to you).  [tm]

All Va. Hospitals Will Have Medical-Directive Forms by Today

According to the Richmond Times-Dispatch, all Virginia hospitals will have advance-directive forms available for patients as of today.  This is heralded as a kind of breakthrough.  Isn't this more or less required by the federal Patient Self-Determination Act ("information" about patients rights is usually understood to include making the forms available upon request)?  What am I missing? [tm]

Single Payer Health Care System: New Advocates - Doctors

The Washington Monthly points out this piece in the Wall Street Journal in which Dr. Benjamin Brewer discusses the merits of a single payer health care system and his view that it provides the best answer to our health care woes.  He writes: 

The solution that would really put health-care dollars, and providers, to their best use would be a single-payer system -- namely, government-funded health coverage for all.

It took me a while to conclude that a single-payer health system was the best approach. My fear had been that government would screw up medicine to the detriment of my patients and my practice. If done poorly, the result might be worse than what I'm dealing with now.

But increasingly I've come to believe that if done right, health care in America could be dramatically better with true single-payer coverage; not just another layer -- a part D on top of a part B on top of a part A, but a simplified, single payer that would cover all Americans, including those who could afford the best right now. Representatives and senators in Washington should have to use the same system my patients and I do were they to vote it in.

Doctors in private practice fear a loss of autonomy with a single-payer system. After being in the private practice of family medicine for 8 1/2 years, I see that autonomy is largely an illusion. Through Medicare and Medicaid, the government is already writing its own rules for 45% of the patients I see.

The rest are privately insured under 301 different insurance products (my staff and I counted). The companies set the fees and the contracts are largely non-negotiable by individual doctors.

The amount of time, staff costs and IT overhead associated with keeping track of all those plans eats up most of the money we make above Medicare rates. As it is now, I see patients and wait between 30 and 90 days to get paid. My practice requires two full-time staff members for billing. My two secretaries spend about half their time collecting insurance information. Plus, there's $9,000 in computer expenses yearly to handle the insurance information and billing follow up. I suspect I could go from four people in the paper chase to one with a single-payer system.

It would be simpler and better for the patient, and for me, if the patient could choose a doctor, bring their ID card with them, swipe it in a card reader at the time of service and have the doctor get paid on the spot with electronic funds transfer.

The Washington Monthly link provides access to comments on this piece - beware that some comments contain strong language.  [bm]

Women and Rest

Newsweek has an interesting cover story on women and the sleeping disorders called, The Quest for Rest,"   There are a suprising number of reasons that men and women may not be sleeping well and the article points out that taking sleeping pills may not be the best answer.  It states,

The craving for sleep has fueled a huge demand for sleeping pills—with more than $2 billion in annual sales, according to IMS Health, a pharmaceutical information and consulting company. Expect more options in the next few years. Drug companies are working hard to target areas of the brain that induce sleep. But taking a sleeping pill can actually make it harder to find out what's really going on. "People are starting to think about these things as though they are painkillers you take for a headache," says Dr. Meir Kryger, author of "A Woman's Guide to Sleep Disorders." "I personally don't think it's a good development." Kryger says a patient should get a diagnosis before starting any treatment, and sleep medications should never be the first or only line of defense. Although the current generation of drugs—products such as Ambien, Lunesta and Rozerem—don't have the addictive potential of the older sleep medications, patients need to follow their doctors' instructions carefully. These drugs work best to help people get over short-term sleep problems, such as after the death of a family member or some other stressful event.

[bm]

Healing Hearts

Some hopeful news on this Holiday weekend, Slate.com reports

"A girl's failing heart healed itself while she used a donor heart. Ten years ago, when she was a toddler, her heart was too big and weak, so doctors gave her a donor heart but left the original one inside her, still connected. Recently, her body rejected the donor organ, and when they opened her up, they found that the original organ had fixed itself. Reactions: 1) It's a miracle. 2) It's a tribute to the doctors who left the original heart inside her, just in case. 3) It validates the theory that some failing hearts suffer from inflammation and can recover if simply allowed to rest."

[bm]

The Abortion Pill

Here is a great post found on Reason.com on the alledy dangers posed by the abortion pill, Ru-486: 

The abortion pill has never made for polite dinner conversation, but the discussion has grown particularly unpleasant since women started dropping dead. In mid-March, citing two new incidents, the FDA put the pill's possible death toll at six.  Senator Jim DeMint (R-S.C.) calls Mifepristone a "deadly drug that kills pregnant women," Rep. Chris Smith (R-N.J..) calls it a "a classic case where the politics of abortion has trumped women's health," and American Life League President Julie Brown simply asks "How much longer must we tolerate such insanity?"

Not much longer, if Congressmen in both houses have their way. In March, legislators in both houses revived the RU-486 Suspension and Review Act, a golden oldie from '03, which would force the FDA to withdraw the drug.

The debate has carried the rhetoric of a public health scare into the abortion debate, but the battle lines are etched into familiar ideological territory. Touting the drug's toxicity are abortion opponents, while Planned Parenthood swears by its safety. Both sides are accusing the other of mixing morals and medicine: Abortion opponents say that if the drug were not a P.C. touchstone, it would have been yanked years ago, while pro-choicers claim the religious right's concern for women's health is pure smokescreen.

The entire article is worth a read.  I really dislike all the politcs that seem to outweigh the science in the health arena these days.  Thanks to the Washington Monthly for the heads up on this post. [bm]

Time to Give Up Those Yummy McDonald Fries

Erza Klein reports on a new study found in the New England Journal of Medicine (unfortunately not available for free) that reminds us again how unhealthy fast food, which contains many grams of trans fat, is for us.  It turns out that not only is fast food food unhealthy, but it is particularly unhealthy here in the United States because it contains even more of those unhealthy trans fats.  According to the study, as reported by the Associated Press's Linda Johnson: 

Order french fries or hot wings at a McDonald's or a KFC in the United States and you're more likely to get a super-sized helping of artery-clogging trans fats than you would be at their restaurants in some other countries.

A study of the fast-food chains' products around the world found remarkably wide variations in trans fat content from country to country, from city to city within the same nation, and from restaurant to restaurant in the same city.

The researchers said the differences had to do with the type of frying oil used, and the main culprit appeared to be partially hydrogenated vegetable oil, which is high in trans fats.

“I was very surprised to see a difference in trans fatty acids in these uniform products,” said one of the researchers, Dr. Steen Stender, a cardiologist at Gentofte University Hospital in Hellerup, Denmark, and former head of the Danish Nutrition Council. “It's such an easy risk factor to remove.” . . .

At a New York City McDonald's, a large fries-and-chicken-nuggets combo was found to contain 10.2 grams of the trans fat, compared with 0.33 grams in Denmark and about 3 grams in Spain, Russia and the Czech Republic.

At KFCs in Poland and Hungary, a large hot wings-and-fries order had 19 grams of trans fats or more, versus 5.5 grams for wings and fried potato wedges in New York. But in Germany, Russia, Denmark and Aberdeen, Scotland, the same meal had less than a gram.

A large order of french fries at a New York City McDonald's contained 30 percent more trans fat than the same order from an Atlanta McDonald's.

No wonder we have an obesity problem here.  [bm]

 

New Orleans Health Care Post-Katrina

The New England Journal of Medicine has a great article on post-Katrina health care in New Orleans.  The article is entitled, "After the Storm - Health Care Infrastructure in Post-Katrina New Orleans, authored by Ruth E. Berggren, M.D., and Tyler J. Curiel, M.D., M.P.H.  Here is a brief excerpt:

Although many citizens have yet to return, area hospitals are scrambling to meet local needs. The population of metropolitan New Orleans is approximately 24 percent smaller than before the hurricane, but only 15 of 22 area hospitals are open, with 2000 of the usual 4400 beds. According to data from the Times-Picayune, before the storm, New Orleans had only 3.03 hospital beds per 1000 population, as compared with the average of 3.26 per 1000 for U.S. cities; today, there are 1.99 per 1000. "The number one current problem is total hospital capacity," says Joseph Uddo, chief of general surgery at East Jefferson General Hospital in neighboring Jefferson Parish. "Emergency department patients can't move into the hospital because beds aren't available. We have no surge capacity." 

Moreover, open hospitals must deliver ever greater amounts of uncompensated health care. Patrick Quinlan, chief executive officer (CEO) of the Ochsner Clinic Foundation, says uncompensated care in his facility has tripled since Katrina. "Many people have lost their jobs, and we have throngs of transient workers in town without health insurance," reports Les Hirsch, CEO of Touro Infirmary. Reimbursement for uncompensated care has yet to come, and, Hirsch notes, there is "a huge debate regarding how best to have uncompensated care dollars follow the patients, rather than following the hospitals."

Common themes at all facilities include complications in patients with untreated chronic diseases, particularly hypertension, diabetes, and AIDS (see box). "These people come in with extremely severe problems," notes Alfred Abaunza, chief medical officer of West Jefferson Medical Center. "Diabetics have been off their insulin for six months. They come to us in diabetic ketoacidosis." 

Many believe that mortality has also increased substantially, although specifics are difficult to obtain — the Louisiana Department of Health is still struggling to complete the compilation of 2005 data. As a crude indicator, there were 25 percent more death notices in the Times-Picayune in January 2006 than there were in January 2005. Stress exacerbating underlying health problems is blamed for some deaths. Post-traumatic stress disorder and suicide remain tangible public health issues. There are insufficient numbers of mental health facilities and care providers to deal with the crisis.

The entire article is an eye-opening read into the many issues that face the medical community in New Orleans.  It is available free at the NEJM website and there is an additional audio file containing an interview with the authors here.  Thanks to JIm Tomasewski for the heads up on this website. [bm]

Just for Fun --

Thought you might enjoy this:  Bunnies

Pharmaceutical Companies Inventing Diseases?

BBC News has an article reporting on a study which critiques pharmaceutical companies (everyone's favorite target these days) for allegedly inventing diseases to make a profit.  Here is an excerpt:

Disease-mongering promotes non-existent diseases and exaggerates mild problems to boost profits, the Public Library of Science Medicine reported.

Researchers at Newcastle University in Australia said firms were putting healthy people at risk by medicalising conditions such as menopause.

But the pharmaceutical industry denied it invented diseases.

       

                                         

Report authors David Henry and Ray Moynihan criticised attempts to convince the public in the US that 43% of women live with sexual dysfunction.

They also said that risk factors like high cholesterol and osteoporosis were being presented as diseases - and rare conditions such as restless leg condition and mild problems of irritable bowel syndrome were exaggerated.

The report said: "Disease-mongering is the selling of sickness that widens the boundaries of illness and grows the markets for those who sell and deliver treatments.

Thanks to Majikthise for this website and please see Pandagon for further comments.  [bm]

Stolen Childhoods

For your information: 

Greetings,

The Lewis Walker Institute recently hosted three days of programming around
Stolen Childhoods, a feature-length documentary on global child labor that
examines the plight of 246 million poor and exploited working children around the world.  Told from their vantage point, the film enters the world of children who are enslaved, abducted, sexually exploited, starved, and/or forced to work under the worst possible conditions.  Their youth stolen, these children of color are denied education and deprived of their innocence, in many cases, by industries
which rely upon child labor to keep production costs low and profits high. Lest we think that the destruction of young lives is confined to urban centers or is a remote problem about which we can do little, the final segment of Stolen Childhoods, filmed in rural Texas, reveals the impact of
labor exploitation on American children who cannot attend school as long as there are crops to be harvested.  In that seasonal labor is a vital element of American agricultural economy, and the exploitation of Hispanic laborers is a social and political concern of moment, we must ponder the many new ways racism presents itself as we also consider how to improve the lives of
children of color at home and abroad.  . . . .

For your convenience, I have included a link to the Stolen Childhoods
website

http://www.stolenchildhoods.org/mt/index.php


Finally, this program comes with my highest recommendations.  I hope you
will consider showing Stolen Childhoods at your school or community
organization in the near future.  Please call upon me if I can provide you
with further information about this important film.


Educating head, heart, and hand,

Deborah H. Barnes, Ph.D.
Associate Professor of Africana Studies
Director
Lewis Walker Institute for the Study of Race and  Ethnic Relations Welborn
Hall Mail Stop:  5236 Western Michigan University Kalamazoo, MI  49008
(269) 387-2141
deborah.barnes@wmich.edu

Obesity

William Saletan at Slate.com writes a brief article about the latest research concerning obesity (most obese people fail to realize that they qualify as obese).  He states,

In a study, they (obese individuals) accurately calculated their height and weight but classified themselves as overweight, not obese. By contrast, more than 70 percent of overweight and normal-weight people accurately classified themselves. Interpretations: 1) Fat people don't know the numerical threshold of obesity. 2) They know it but don't want to admit they're fat. 3) We're getting so fat we've lost all perspective on what fat is. (For Human Nature's previous update on our slipping standards of fatness, click here.)

Saletan has other interesting health-related articles posted at the Human Nature section of Slate.com. 

Boy in the Bubble

Tonight, your local PBS station will mostly likely be showing, "The Boy in the Bubble" as part of the American Experience series.  It looks to be an interesting program that will discuss some of the complex ethical issues raised by the boy with no immune system and the medical treatment he received.  From the PBS website,

When David Vetter died at the age of 12, he was already world famous: the boy in the plastic bubble. Mythologized as the plucky, handsome child who had defied the odds, his life story is in fact even more dramatic. It is a tragic tale that pits ambitious doctors against a bewildered, frightened young couple; it is a story of unendingly committed caregivers and resourceful scientists on the cutting edge of medical research. This American Experience raises some of the most difficult ethical questions of our age. Did doctors, in a rush to save a child, condemn the boy to a life not worth living? Did they, in the end, effectively decide how to kill him?

[bm]

Spice Up Your Life

A Reuters report informs us of recent studies showing that certain spices may help kill certain cancers.  According to the report, 

Ginger can kill ovarian cancer cells while the compound that makes peppers hot can shrink pancreatic tumors, researchers told a conference on Tuesday.

Dr. Rebecca Liu, an assistant professor of obstetrics and gynecology at the University of Michigan Comprehensive Cancer Center, and colleagues tested ginger powder dissolved in solution by putting it on ovarian cancer cell cultures.

It killed the ovarian cancer cells in two different ways -- through a self-destruction process called apoptosis and through autophagy in which cells digest themselves, the researchers told a meeting of the American Association for Cancer Research.

"Most ovarian cancer patients develop recurrent disease that eventually becomes resistant to standard chemotherapy, which is associated with resistance to apoptosis," Liu said in a statement.

"If ginger can cause autophagic cell death in addition to apoptosis, it may circumvent resistance to conventional chemotherapy."

and for those of you who prefer to spice up food with chili peppers:

A second study found that capsaicin, which makes chili peppers hot, fed to mice caused apoptosis death in pancreatic cancer cells, said Sanjay Srivastava of the University of Pittsburgh School of Medicine.

"Capsaicin triggered the cancerous cells to die off and significantly reduced the size of the tumors," he said.

The spicy compound killed pancreatic tumor cells but did not affect normal, healthy pancreas cells, researchers told the AACR meeting.

Last year the same team reported similar results with pancreatic cells in lab dishes. Pancreatic cancer is highly deadly, killing 31,000 of the 32,000 it will be diagnosed in this year.

Last month researchers in Los Angeles reported that capsaicin killed prostate tumor cells. Other studies have shown that turmeric, a yellow spice used widely in Indian cooking, may help stop the spread of lung cancer and breast cancer in mice.

Of course, keep in mind that: 

Experts point out that many compounds shown to stop cancer in mice are not nearly as effective in human cancer patients.

Thanks to Pandagon for the website!  [bm]

Website with Great Debates

If you have an interested in following some of the more recent debates concerning health care reform and the Medicare part D program, you may want to check out Drug Bill Debacle at the TPMCafe.  It has many terrific contributors and provides great perspectives on some of the health policy issues of today.  [bm]

As El Salvador Goes, So Goes South Dakota

There's an interesting article in today's N.Y. Times magazine on the legal regime in El Salvador that polices that country's total ban on abortions.  Fairly chilling . . . .   [tm]

Plan B: A Brief History

Majikthise, one of my favorite bloggers, has posted a history of emergency contraception.  She states,

Scientifically validated emergency contraception (EC) didn't exist until 1974. Dr. Albert Yuzpe, a Canadian OB-GYN, developed and tested the first EC regimen in 1974. Planned Parenthood explains:

The ECP regimen first approved by the U.S. Food and Drug Administration (FDA) is called the Yuzpe Regimen, named for Canadian Professor A. Albert Yuzpe who, in 1974, published the first studies demonstrating the safety and efficacy of ECPs. The Yuzpe regimen consists of combined oral contraceptive pills that contain the hormones estrogen and progestin taken in two doses Our story begins in 1974 when emergency contraception was as innovative as rocket science.

The FDA declared the Yuzpe regimen safe and and effective in 1997 and approved an Yuzpe-based EC kit in 1998. Plan B got FDA approval in 1999.

The drug marketed under the name "Plan B" is a major advance on the Yuzpe regimen. Plan B is the first progestin-only emergency contraceptive pill on the US market.

As you know, the FDA denied over-the-counter status for Plan B in late 2003.  She provides some updated history of where the controversy is now.  [bm].

Harm v. Benefit

The blog, TigerHawk, has an interesting article on how the FDA and our regulatory system views the harms that drugs cause as compared to the benefits that those same drugs may achieve.  The article is entitled, "The FDA, the Tysabri conundrum, and our cultural incapacity for single payor healthcare.  The article quotes extensively from a piece in today's Wall Street Journal concerning the FDA and MS that requires a paid subcription.  The blog writer states,

One of the biggest problems with our system for regulating pharmaceuticals is that we carefully measure all the harm a drug may have done, but do not weigh against it all the good it certainly can do. This asymmetry between sins of commission, which both the FDA and the tort system consider grave, and sins of omission, which neither take into account in any systematic way, means that it is very difficult to gain the approval of drugs that may do tremendous good for virtually all patients, but grievous harm to a tiny percentage of the people who take them. The risk to the tiny percentage overwhelms the benefits to the millions in the minds of risk averse bureaucrats, and the FDA prevents or delays the approval of the drug.

An example of this is the FDA's hanky-twisting over the multiple sclerosis drug Tysabri, which is orders of magnitude more effective against that nerve-killing disease than existing therapies. Unfortunately, Tysabri has been "linked" -- tenuously, at best -- with a rare brain infection in fewer than five patients out of the many thousands who have taken it. The FDA pressured Biogen and Elan to pull the drug last year, and it has not cleared the drug for relaunch notwithstanding the unanimous recommendation of a non-binding expert advisory panel. Why? Because it fears the quick death of one or two people more than it values the lifespans of hundreds of thousands of people.

I found the article very interesting and highly recommend it. Thanks to Ezra Klein for the cite.  Ezra Klein also has some thoughts about the article.  [bm]

GAO's Health-Related Reports, March 2006

The Government Accountability Office (formerly the General Accounting Office) is a wonderful source of information about how the government works (and a frequent source of story ideas for CBS' "60 Minutes").  And because most reports are the result of Congressional queries, they are some indication of what is on Congress' mind, as well.  Here are the health-related reports released in March 2006:

• Health Information Technology: HHS is Continuing Efforts to Define a National Strategy. GAO-06-346T, March 15, 2006 (17 pages). http://www.gao.gov/docdblite/details.php?rptno=GAO-06-346T
• Health Professions Education Programs. GAO-06-55, February 28, 2006 (42 pages). http://www.gao.gov/docdblite/details.php?rptno=GAO-06-55
• Long-Term Care Insurance: Federal Program Compared Favorably with Other Products, and Analysis of Claims Trend Could Inform Future Decisions. GAO-06-401, March 31, 2006 (52 pages). http://www.gao.gov/docdblite/details.php?rptno=GAO-06-401
• Medicaid Integrity: Implementation of New Program Provides Opportunities for Federal Leadership to Combat Fraud and Abuse. GAO-06-578T, March 28, 2006 (15 pages). http://www.gao.gov/docdblite/details.php?rptno=GAO-06-578T
• Medicare Durable Medical Equipment: Class III Devices Do Not Warrant a Distinct Annual Payment Update. GAO-06-62, March 1, 2006 (19 pages). http://www.gao.gov/docdblite/details.php?rptno=GAO-06-62
• Medicare Payment: CMS Methodology Adequate to Estimate National Error Rate. GAO-06-300, March 24, 2006 (42 pages). http://www.gao.gov/docdblite/details.php?rptno=GAO-06-300

[tm]

New Approach to Abortion Issue By Democrats

According to the Hill.Com, Senate democrats are pursuing a new strategy with regard to the abortion issue - to try to reduce the need for abortions through greater access to contraceptives.  The article states,

The Prevention First Act is sponsored by Senate Minority Leader Harry Reid (Nev.), one of few congressional Democrats considered anti-abortion. The bill, which Reid introduced at the start of the Congress, has the support of Sen. Hillary Rodham Clinton (D-N.Y.), presumptive front-runner in the 2008 presidential primary and 21 other Democrats.

 

The bill would prohibit group health plans from excluding contraceptive drugs, devices and outpatient services if they cover the cost of other prescription drugs and outpatient services. It would also require the secretary of health and human services to disseminate information on emergency contraception to healthcare providers and require hospitals receiving federal money to provide emergency contraception to victims of sexual assault.