HealthLawProf Blog

The Hamdan Decision

Although not technically a health law decision, Ramdan v. Rumfeld is a decision that improves the public health of the United States is you read "public health" broadly to include the protection of our constitutional values and the rule of law.  SCOTUSblog has a great discussion and examination of Hamdan and Firedoglake has a wonderful write-up as well wilth links to many other discussions around the web concerning the decision.    [bm]

Solving Childhood Obesity

You were thinking that encouraging more exercise and fast food might be the only answer.  Well, apparently there are more creative minds at work than mine and they have developed new heavier toys to help with the childhood obesity problem.  CNN reports on this development:

Researchers at Indiana State University in Terre Haute tried a small experiment to test the effects of having kids play with heavier toys. They found that 10 children ages 6 to 8 burned more calories and had higher heart and breathing rates when they moved 3-pound toy blocks instead of unweighted blocks.

So could adding a small weight to stuffed animals and other toys help kids get fit?

"This is not going to solve the obesity problem," said John Ozmun, a professor who did the study with graduate student Lee Robbins. "But it has a potential to make a positive contribution."

Some experts caution that children could hurt themselves trying to lift too much too soon and said more activity is preferable to heavier toys. But all agree childhood obesity is a big problem. . . .

Kara Tucker, youth development coordinator for the National Institute for Fitness and Sport in Indianapolis, said active playing helps youngsters work out without realizing it.

Weighted toys might be another way to sneak in exercise, but not everyone thinks a 3-pound stuffed animal sounds like fun.

Rambunctious kids could throw heavy toys at playmates, said Celia Kibler, president of Funfit, a family fitness club in Maryland. Kibler also fears children could hurt themselves if they lift too much weight before their bodies are fully developed.

"I think that can be more dangerous than beneficial," she said. "There's so much activity that a child can do that can keep them in shape without the use of weights. That's what they should be concentrating on."

The study's authors stressed that their report is a starting point, and involved only a few children under very controlled circumstances.

Weighted toys in the real world would have to be designed to be safe while holding a child's interest, said Ozmun, acting associate dean of Indiana State's College of Health and Human Performance. . . .

"Having a 3-pound teddy bear may not only help with strength, but with balance and coordination," he said.

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Second Hand Smoke

The U.S. Surgeon GeneralRichard H. Carmona issued a report earlier this week that concludes that there exists no safe level of second-hand smoke.  The report is entitled, The Health Consequences of Involuntary Exposure to Tobacco Smoke: A Report of the Surgeon General.   In sum, it states that nonsmokers exposed to scondahnd smoke at home or work increase their risk of developing heart disease and lung cancer by as much as 30 percent.  The report further finds that even brief exposure to secondhand smoke can cause immediate harm and that the only way to protect nonsmokers is to eliminate smoking indoors. 

A news release from the Department of Health and Human Services states, 

“The health effects of secondhand smoke exposure are more pervasive than we previously thought,” said Surgeon General Carmona, vice admiral of the U.S. Public Health Service. “The scientific evidence is now indisputable: secondhand smoke is not a mere annoyance. It is a serious health hazard that can lead to disease and premature death in children and nonsmoking adults.” Secondhand smoke contains more than 50 cancer-causing chemicals, and is itself a known human carcinogen. Nonsmokers who are exposed to secondhand smoke inhale many of the same toxins as smokers. Even brief exposure to secondhand smoke has immediate adverse effects on the cardiovascular system and increases risk for heart disease and lung cancer, the report says. In addition, the report notes that because the bodies of infants and children are still developing, they are especially vulnerable to the poisons in secondhand smoke.

“The good news is that, unlike some public health hazards, secondhand smoke exposure is easily prevented,” Surgeon General Carmona said. “Smoke-free indoor environments are proven, simple approaches that prevent exposure and harm.” The report finds that even the most sophisticated ventilation systems cannot completely eliminate secondhand smoke exposure and that only smoke-free environments afford full protection. . . . .

“Our progress over the past 20 years in clearing the air of tobacco smoke is a major public health success story,” Surgeon General Carmona said. “We have averted many thousands of cases of disease and early death and saved millions of dollars in health care costs.” He emphasized, however, that sustained efforts are required to protect the more than 126 million Americans who continue to be regularly exposed to secondhand smoke in the home, at work, and in enclosed public spaces.

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Rush's Doctors

As you are now probably more aware than you ever wanted to be, Rush Limbaugh, the conservative radio host who recently had made headlines for his legal problems surrounding his addiction to oxycontin, was detained at U.S. customs and found to have a bottle of Viagra in his physician's name.  Setting aside Rush's potential legal problem, I did find it interesting that his attorney, Roy Black, stated that the  prescription was written in his doctor's name "for privacy purposes." I have never been offered such a service by my physician (and really haven't we all had some medications prescribed that we didn't want our names on)  . . .  and doesn't HIPAA already provide some privacy protection in this arena. . . .   

Well, it turns out the physicians may be in a little trouble for their help in protecting Rush's privacy in this manner.  Talkleft reports on a recent article in the Florida Sun-Sentinel  and quotes that paper stating:

Florida civil rules governing doctors and pharmacists require that the true patient's name and address are on the label, according to two attorneys and a Florida Medical Association spokeswoman.

Doing otherwise "is technically a violation of dispensing and prescribing by the doctor," said Allen R. Grossman, a Tallahassee attorney who defends physicians in disciplinary cases. Grossman formerly was general counsel to the Florida Board of Medicine, which licenses and oversees doctors.

TalkLeft continues by discussing the issue. 

           Other Florida experts, including those involved with professional and medical boards weigh in:

"The department is aware of it and we'll have more information on that later," board spokeswoman Thometta Cozart said. However, the three professionals said state civil rules forbid doctors from prescribing drugs without a name or under a third person's name, as a way to prevent people from passing medicine to others.

"That would be considered a fraudulent prescription," said Lisette Gonzalez Mariner, a spokeswoman for the Florida Medical Association, the trade group for doctors. "You cannot do that. It's not commonly done and that's illegal." Likewise, pharmacists cannot dispense drugs to someone other than the name on the prescription label or their representative, said attorney Edwin Bayo, a former general counsel of the Florida Board of Pharmacy licensing board.

On another issue, I haven't heard much about any potential insurance fraud concerns but there may be some problems with having someone else's name on your prescription with regard to insurance as well. [bm]

FDA's Enforcement Declines

According to a story in the New York Times, a new study reveals that the Food and Drug Administration has cut back its enforcement efforts rather dramatically in recent years.  The Times states,

A 15-month inquiry by a top House Democrat has found that enforcement of the nation's food and drug laws declined sharply during the first five years of the Bush administration.

   

For instance, the investigation found, the number of warning letters that the Food and Drug Administration issued to drug companies, medical device makers and others dropped 54 percent, to 535 in 2005 from 1,154 in 2000.

The seizure of mislabeled, defective or dangerous products dipped 44 percent, according to the inquiry, pursued by Representative Henry A. Waxman of California, the senior Democrat on the House Government Reform Committee.

The research found no evidence that such declines could be attributed to increased compliance with regulations. Investigators at the F.D.A. continued to uncover about the same number of problems at drug and device companies as before, Mr. Waxman's inquiry found, but top officials of the agency increasingly overruled the investigators' enforcement recommendations.

The biggest decline in enforcement actions was found at the agency's device center, where they decreased 65 percent in the five-year period despite a wave of problems with devices including implantable defibrillators and pacemakers. . . . .

Aside:  You would think that Vice President Cheney would be concerned by this news.  The article continues,

David K. Elder, the director of the agency's Office of Enforcement, explained that the F.D.A. had increasingly focused on the most serious violations.

"As a result of F.D.A.'s focus on those firms and those violations that present the highest risk to consumers and public health," Mr. Elder said in a statement, "the agency has taken prompt, targeted and aggressive action against firms that are in violation of law."

Jack Calfee, a resident scholar at the conservative American Enterprise Institute, said the decline in the statistics was meaningless because most of the violations involved paperwork problems.  "I doubt that it makes a significant difference in the safety of drugs or other products," Mr. Calfee said.

Mr. Waxman began his inquiry after Congressional hearings in 2004 suggested that the agency was partly to blame for a shortage of flu vaccines. His staff requested thousands of documents from the F.D.A.  The investigation found that by almost every measure, enforcement actions had significantly declined from 2000 to 2005. The lone exception was in the number of products that had to be recalled from the market: that increased 44 percent. "Since one of the goals of an enforcement system is to deter violations and keep dangerous products off of the market," the report said, "the increase in recalls is not a hallmark of effective enforcement."

Hope everyone stays healthy because this doesn't look like good news in the long run.  [bm]

Buffett's Billions and Health Care

With all the rather depressing news in the world, the Buffett billions and all the good that the Gates' Foundation will be able to do with the money were some welcome cheer.   The New York Times reports,

Warren E. Buffett's $31 billion gift to the Bill & Melinda Gates Foundation will help the foundation pursue its longstanding goal of curing the globe's most fatal diseases, Mr. Gates said yesterday, along with improving American education.

The foundation hopes to use the enormous gift, among other things, to find a vaccine for AIDS, Mrs. Gates said. And Mr. Gates went further, saying that while he might be "overly optimistic," he believed there was a real shot at finding cures for the 20 leading fatal diseases, as well as ensuring that every American has a chance at a decent education.

"Can that happen in our lifetime?" Mr. Gates said, sitting next to Mr. Buffett at the New York Public Library, where the gift was formally announced after news of it broke on Sunday. "I'll be optimistic and say, Absolutely."

But Mr. Gates acknowledged that spending the money effectively would be difficult. The scientific tasks the foundation has set for itself in fields like malaria and tuberculosis take time as well as money, because they require years of laboratory work followed by years of clinical trials, sometimes ending fruitlessly. Improving American education — once better ideas have been found — can take just as long. . . .

Mr. Buffett, for his part, said he saw no need to tinker with the foundation's essential goal: improving the lot of poor people elsewhere in the world without regard to their color, religion or other differences.

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Pay for Performance Medicine

Ezra Klein has an interesting post on the pay for performance medicine (P4P) idea.  He states,

. . . .  Our surgeons may be on the cutting edge (thanks folks, I'll be here all week), but stepping back a bit from the frontier, the vast majority of care is either inefficiently delivered, or simply forgotten. Studies show that we receive only about 55 percent of the recommended treatments for most serious complaints -- and we're not talking CAT scans here, but easy lifesavers, like aspirin and beta blockers after a heart attack. America offers the world's best care for its most exotic and complicated problems, but if you're unlucky enough to suffer something more mundane, you're better off in a host of other hamlets.

The policy response here is something called pay For Performance medicine, or P4P. At base, the incentives in our system are to offer treatments, particularly intensive ones. It's called fee-for-service, and it offers no incentives for quality care or low intensity (aspirin) treatments. P4P, by contrast, pays based on outcomes, on percentage of suggested care delivered (for a fuller explanation, see this reviewended. Utilizing more than 200 hospitals and 38 states, Medicare instituted P4P systems, paying based on treatment quality and comprehensivity and offering bonuses for outcome improvement. The results? Not only did care get better, but it got cheaper. "2004 hospital costs for pneumonia patients were $10,298 for patients who received a low number of the care measures and $8,412 for those who received a high amount. Hospital costs for heart bypass surgery patients also varied widely, with those receiving a low number of measures costing $41,539 while those who had the highest amount cost $30,061."

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On a lighter note

In case you need a pick me up after depressing news, check out the cuteoverload.com website for overwhelming warm fuzzies.
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Oath Betrayed

Stephen Miles, a medical ethicist has written a' new book, "Oath Betrayed," discussing how some in the medical profession participated in torture during this War on Terror and its coverup.  Andrew Sullivan of Time magazine has a brief review and the excellent editors at TalkLeft have some further discussion.   Here is a brief excerpt from the Time magazine article by Mr. Sullivan:

One of Defense Secretary Donald Rumsfeld's first instructions for military interrogations outside the Geneva Conventions was that military doctors should be involved in monitoring torture. It was a fateful decision — and we learn much more about its consequences in a new book based on 35,000 pages of government documents obtained under the Freedom of Information Act. The book is called Oath Betrayed (to be published June 27) by medical ethicist Dr. Stephen Miles, and it is a harrowing documentation of how the military medical profession has been corrupted by the Bush-Rumsfeld interrogation rules.

One of those rules was that a prisoner's medical information could be provided to interrogators to help guide them to the prisoner's "emotional and physical strengths and weaknesses" (in Rumsfeld's own words) in the torture process. At an interrogation center called Camp Na'ma, where the unofficial motto was "No blood, no foul," one intelligence officer testified that "every harsh interrogation was approved by the [commander] and the Medical prior to its execution." Doctors, in other words, essentially signed off on torture in advance. And they often didn't inspect the victims afterward. At Abu Ghraib, according to the Army's surgeon general, only 15% of inmates were examined for injuries after interrogation.

 

Some of the medical involvement in torture defies belief. In one of the few actual logs we have of a high-level interrogation, that of Mohammed al-Qhatani (first reported in TIME), doctors were present during the long process of constant sleep deprivation over 55 days, and they induced hypothermia and the use of threatening dogs, among other techniques. According to Miles, Medics had to administer three bags of medical saline to Qhatani — while he was strapped to a chair — and aggressively treat him for hypothermia in the hospital. They then returned him to his interrogators. Elsewhere in Guantánamo, one prisoner had a gunshot wound that was left to fester during three days of interrogation before treatment, and two others were denied antibiotics for wounds. In Iraq, according to the Army surgeon general as reported by Miles, "an anesthesiologist repeatedly dropped a 2-lb. bag of intravenous fluid on a patient; a nurse deliberately delayed giving pain medication, and medical staff fed pork to Muslim patients." Doctors were also tasked at Abu Ghraib with "Dietary Manip (monitored by med)," in other words, using someone's food intake to weaken or manipulate them.

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Number of Uninsured Drops

The KaiserNetwork.Org reports on a study showing that the number of uninsured last year was 41.2 million.  It reports that this is a small improvement over 2004.  Thanks to Ezra Klein for the cite - he also has some further thoughts on the study.  [bm]         

South Dakota's Abortion Ban

This week's New Yorker runs a piece by Cynthia Gorney about South Dakota's abortion ban entitled, "Letter from South Dakota:  Reversing Roe."  The law bans abortion except where the life of the mother is threatened.  Opponents to the law have run a successful petition drive to place the law on the ballot this fall for the citizens of that state to vote on whether they want to keep such a ban.  The article  provides an interesting overview of the current state of the abortion debate and demonstrates how the South Dakota law has divided some within the pro-life movement.  The New Yorker article is not available on-line but an interesting interview between Ms. Gorney and Mr. Ben Greenman discussing abortion and the South Dakota law may be found here.   

More Humane Lethal Injections

The New York Times reports today on how doctors have worked to make lethal injections for death penalty inmates more humane.  The Times states,

. . . . medical experts say the current method of lethal injection could easily be changed to make suffering less likely. Even the doctor who devised the technique 30 years ago says that if he had it to do over again, he would recommend a different method.

Switching to an injection method with less potential to cause pain could undercut many of the lawsuits. But so far, in this chapter of the nation's long and tangled history with the death penalty, no state has moved to alter its lethal injection protocol.

At the core of the issue is a debate about which matters more, the comfort of prisoners or that of the people who watch them die. A major obstacle to change is that alternative methods of lethal injection, though they might be easier on inmates, would almost certainly be harder on witnesses and executioners.

With a different approach, death would take longer and might involve jerking movements that the prisoner would not feel but that would be unpleasant for others to watch.

The care and concern for the witnesses strikes me as a bit out-of-place.  The article discusses the pending lawsuits in many states concerning the current method of lethal injection and whether it is an unconstitutional cruel and unusual punishment.   In response to the lawsuits and these new techniques, the article says that some states may change their procedures to avoid future liabililty.  Overall, it is a rather depressing subject and I understand why many doctors refuse to participate in executions.  [bm]

Pediatric Cancer Stories

One of the reasons that I enjoy living in Cincinnati is the wonderful Children's Hospital Medical Center.  Last night PBS had a wonderful program, entitled, "Lion in the House," concerning Children's Hospital and some of the pediatric cancer patients it has treated.  It was a very moving program that addresses the issues facing the children and their families as well as the physicians, nurses and other caregivers who treat them.  Here is a brief abstract of the program:

A LION IN THE HOUSE follows the stories of five exceptional children           and their families as they battle pediatric cancer. From the trauma           of diagnosis to the physical toll of treatment, this series documents           the stresses that can tear a family apart as well as the courage of           children facing the possibility of death with honesty, dignity and           humor. As the film compresses six years into one narrative, it puts           viewers in the shoes of parents, physicians, nurses, siblings, grandparents           and social workers who struggle to defeat an indiscriminate and predatory           disease.

These are some truly inspiring people.  The PBS website has further information about the program and also provides some helpful biographies.  [bm]

Update your favorites

Majikthise points out that Effect Measure (the terrific public health policy blog)has moved and joined a network of science blogs.  You should check it out - there are many wonderful websites with terrific information there.  [bm]

For Profit/Not-for-Profit Quality Issues

Erza Klein points out a new study published in the Health Affairs journal and summarized briefly here that shows that not-for-profit hospitals and nursing homes provide a higher quality of care.  From the summary:

For-profit nursing homes and hospitals on average provide an inferior quality of care compared with their nonprofit peers, according to an extensive review of studies published on Tuesday.

Authors writing in the journal Health Affairs found that a systematic analysis of 162 studies of nonprofit versus for-profit health care providers supports the concept that a facility's ownership status makes a difference in outcomes and in the cost of health care.

"Their work should lay to rest claims that little distinguishes nonprofit versus for-profit health care," University of Michigan professor Jill Horwitz wrote in editorial also running in the policy journal.

 

The analysis found a pattern of differences between nonprofits and for-profits in cost, quality and accessibility, said Bradford Gray, a principal research associate at the Urban Institute -- a nonprofit research group -- and lead study author.

For-profit ownership is climbing in most sectors of health, from hospitals to hospice care. For example, for-profit hospitals accounted for 11 percent of all hospitals in the early 1990s and now account for 16 percent.

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Supreme Court Grants Cert. to Partial-Birth Abortion Ban Act

From Willamette Law Online – Willamette University College of Law comes the news that the Supreme Court has granted certiorari in the Gonzales v. Planned Parenthood case.  The Ninth Circuit opinion can be found here:  435 F.3d 1163 (9th Cir. 2006); http://caselaw.lp.findlaw.com/data2/circs/9th/0416621p.pdf

Here is the Williamette Law Online summary of the case:

The United States Court of Appeals for the Ninth Circuit held that the Partial-Birth Abortion Ban Act is unconstitutional on three grounds,invalidated the law, and permanently enjoined enforcement of the law in its entirety.

 

Immediately after President George W. Bush signed the Partial-Birth Abortion Ban Act (Act), 18 U.S.C. Sec 1531(b)(1), into law in 2003, thePlanned Parenthood Federation of America, Inc. (Planned Parenthood) filed suit, claiming that the Act violates constitutionally guaranteed rights.

The City and County of San Francisco successfully intervened as a plaintiff. In 2004, the United States District Court for the Northern District of California (District Court) found the Act unconstitutional on three grounds and entered a permanent injunction against its enforcement. First, the Act was held to impose an undue burden on a woman’s right to choose to terminate pregnancy before viability because it creates a substantial risk of criminality for virtually all abortions performed after the first trimester. Second, the District Court found the Act unconstitutionally vague. The District Court reasoned that the Act’s use of unrecognized medical terms inhibits fair notice to physicians and encourages arbitrary enforcement. Finally, the District Court held that the Act’s failure to include a health exception is unconstitutional. The United States Court of Appeals for the Ninth Circuit (Court of Appeals) affirmed the District Court’s decision, stating the Act unconstitutional on all three grounds and also affirmed enjoinment of the Act’s enforcement in its entirety as the proper remedy. The United States Supreme Court granted Certiorari. [Summarized by Viva Foley.]

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Probabilities in Health Care

Erza Klein has a great post entitled, "The Problem with Probabilities," discussing the medical dilemma faced by one individual to demonstrate the probabilities issue.  He writes:

"Nice illustration of a constant medical dilemma by Ogged, who happily appears to be stomach-cancer free:

the debate hadn't been between those recommending a gastrectomy and those favoring a follow-up endoscopy, but between those favoring a follow-up endoscopy and those who wanted to send me home and tell me to forget the whole thing. The latter group was convinced that the original finding were just a strange anomaly--not a mistake, exactly, but not worth worrying about. Older, more cautious doctors eventually brought everyone around to the consensus that they couldn't take even the small chance that I do have cancer lightly, so a follow-up is warranted. But even the doctor I talked to "officially" said "we don't expect to find anything."

So much of medicine is probabilistic. If you wanted to really cut costs, you'd take a coldly statistical view of the whole thing, with those who ended up on the wrong side of the numbers regrettable sacrifices. As a society, we're not ready or willing to do that -- and rightly so. But this is the essential conflict: politicians and hospital administrators look at the global budget, while doctors and patients look at the individual's health. The latter militates for constantly seeking the lowest possible error, the former for going with the statistics and saving money where you can.. . . ." [bm]

 

Childhood Obesity

National Public Radio's Diane Rehm show had a terrific discussion about the causes and potential solutions to the childhood obesity issues facing this nation.  It is entitled, "Fighting Childhood Obesity.  Click here for an interesting listen.  [bm]

La. Governor Signs S.D.-Style Abortion Ban

From Jurist comes this news:

Governor Kathleen Blanco [official website] of Louisiana signed a bill [PDF text; SB 33 summary] Saturday that could ban most abortions in the state. The bill, which would apply to all abortions except when the life of the mother is threatened, will take effect only if the US Supreme Court [official website] overturns the 1973 Roe v. Wade [text] decision or if the US Constitution is amended to allow states to prohibit abortions. The Louisiana Senate [official website] unanimously approved the bill [JURIST report] earlier this month.

Blanco said in a statement [text] that while she had hoped the bill would include additional exceptions for victims of rape and incest which did not pass, "the central provision of the bill supports and reflects my personal beliefs." The law is similar to South Dakota legislation [JURIST report] approved in March. Reuters has more.

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Breast Feeding Debate

On Tuesday, the New York Times had a focus on the wonders of breast feeding.  I was surprised how much the government appears to be encouraging breast feeding.  The article states,

There is no black-box label like that affixed to cans of infant formula or tucked into the corner of magazine advertisements, at least not yet. But that is the unambiguous message of a controversial government public health campaign encouraging new mothers to breast-feed for six months to protect their babies from colds, flu, ear infections, diarrhea and even obesity. In April, the World Health Organization, setting new international bench marks for children's growth, for the first time referred to breast-feeding as the biological norm.

"Just like it's risky to smoke during pregnancy, it's risky not to breast-feed after," said Suzanne Haynes, senior scientific adviser to the Office on Women's Health in the  Department of Health and Human Services. "The whole notion of talking about risk is new in this field, but it's the only field of public health, except perhaps physical activity, where there is never talk about the risk."

A two-year national breast-feeding awareness campaign that culminated this spring ran television announcements showing a pregnant woman clutching her belly as she was thrown off a mechanical bull during ladies' night at a bar — and compared the behavior to failing to breast-feed.

"You wouldn't take risks before your baby's born," the advertisement says. "Why start after?"

Slate.com's Sydney Speisel has slightly different point of view and believes that breast feeding and its benefits may be overstated.  He states,

Nursing is credited with preventing infants from getting cancer, allergic diseases, Crohn's disease, cavities, SIDS, and with improving IQ. For mothers, it's also asserted to prevent diabetes, certain cancers, and postpartum depression. In most cultures, however, vast differences—economic, educational, ethnic, psychological, biological—separate women who choose to breast-feed from women who choose formula-feeding. These differences are exaggerated when researchers compare, as they commonly do, the babies of women who breast-feed exclusively for six months and those who exclusively formula-feed for that length of time. The difficulty of doing research on humans thus poses a particular problem for studies of breast-feeding. Breast-fed babies may on average have higher IQ scores, say, but is the difference because of the breast-feeding or some other factor, like coming from a family with a higher income level or more education or fewer siblings? In the studies that have been done to date, untangling the observed effects is a nearly impossible exercise in subjective judgment. That's especially the case for evaluating subtle effects like IQ level, or the much later development of childhood cancer, allergies, or tooth decay.

Other benefits of breast-feeding seem pretty clear and incontrovertible. Large-scale studies in the developing world have reported a striking drop in infant mortality as formula-feeding is replaced by nursing. But while the role of breast-feeding in preventing infection is real, it is also widely misunderstood.

When you ask a bunch of doctors about how breast-feeding prevents infection, they get it wrong—I know they do, because I've asked the question. Doctors tell you that colostrum (produced in the first three days or so after a baby is born) and breast milk are full of maternal antibodies. Next, doctors say that these maternal antibodies are absorbed into the infant's blood circulation and thus serve to protect infants from disease.

That's the correct description of the immunology of breast-feeding for most mammals. It's also true that human colostrum and milk are rich in maternal antibodies—colostrum is pretty much antibody soup. And babies take in these antibodies as they nurse. But human babies are never able to absorb maternal antibodies from milk or colostrum into the bloodstream, except perhaps in the minutest amounts. Maternal antibodies in milk and colostrum protect against infection—but only locally, working inside the baby's gastrointestinal tract. . . .

None of this is my discovery. It was well-known, even commonplace, in the immunological literature of 40 years ago. But as the field turned to other matters, these findings just sort of fell out of fashion (though I've certainly come upon plenty of modern papers whose authors understand the idea). Because of the modern aversion to looking at older research, a surprisingly large number of doctors, especially nonimmunologists, have either forgotten this aspect of human immunity or never knew about it. And perhaps nobody wanted to bring the older findings to light for fear that doing so might discourage breast-feeding. (I can assure you that I feel some trepidation as I write this.)

What should we make of the facts about the immunobiology of lactation? First, it bears repeating that even if the immunological benefits are often overstated, there is clear and obvious benefit to breast-feeding in most of the developing world. Second, though it is harder to demonstrate in a scientifically satisfying way, there are probably other biological benefits. And there are surely economic reasons to give babies human milk instead of formula, which costs between $1,500 and $3,000 a year. In the developing world, the economic case against formula-feeding might be as potentially lifesaving as the immunological one: Money stolen from a poor family's budget for formula will not be available for food, housing, education—or even soap.

In the end, though, I find myself falling back on the same logic (or lack of logic) that appealed to me when my babies were born. Biologically speaking, it seems as if breast-feeding ought to be better for babies. At the same time, I am strongly convinced that there are two kinds of nutrition, physical and psychological, and that both are equally important. This conviction persuades me that it's better for a mother to formula-feed her baby pleasurably than to breast-feed and hate it. Fortunately, the majority of mothers enjoy nursing. But not all. Some women don't like to nurse, and others, even with the best help, find it physically difficult or daunting or intolerably uncomfortable. Sometimes, also, babies just aren't good nursers. In the end, I always encourage a mother to choose the feeding method that is most satisfying to her.

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Chinese Prisoners and Organ Donors

CNN's Anderson Cooper had a story on last night concerning the Chinese use of prisoners as organ donors.  From the Anderson Cooper website:

There are 90,000 people waiting for organs in the United States. Many of them will die before they ever get close to a transplant. Eric DeLeon of San Mateo, California, did not want to be one of them.

Eric was diagnosed with liver cancer last year. Because he had nine tumors, he was taken off the U.S. transplant list. Doctors considered him a poor candidate for survival.

"I just knew that cancer was going to grow and spread throughout my body and I thought I would be another statistic," Eric told me recently.

So Eric and his wife Lori searched the Internet to check out other transplant options. He found a transplant service in China that promised to find him a healthy liver in a matter of weeks. Eric mortgaged his home and paid $110,000 for a new liver. Two weeks later, he arrived in Shanghai. A couple weeks after that, he had his new liver.

Eric is not alone in looking to China for a new organ. We're told that tens of thousands of foreigners are paying for transplant surgery in China. The problem is those organs may be cut from an executed death row prisoner without consent. That's not all. Some organs are said to have been removed before the prisoner took his last breath in order to keep the organs as fresh as possible.

According to a recent editorial, the Chinese government has defended its program.  Thanks to TalkLeft for the heads up on this story.  Truly the wrong answer to the organ shortage. 

Colombo on Hospital Property Tax Exemption in Illinois

Courtesy of Paul Caron & TaxLawProf blog:

John D. Colombo (Illinois) has published  Hospital Property Tax Exemption in Illinois: Exploring the Policy Gaps, 37 Loy. U. Chi. L.J. 493 (2006).  Here is the Conclusion:

The analysis presented in Part IV of this Article illustrates that the question of what doctrinal tests the court should employ to govern property tax exemption for hospitals and other health care providers is far more complex than popular press accounts might lead one to believe or than the Illinois courts may have realized. One can hardly blame the courts, however, for lacking the expertise in health care or tax policy to appropriately recognize the pitfalls inherent in interpreting property tax exemption rules. Even the Internal Revenue Service, whose job it is to think more comprehensively about tax policy and its far-reaching effects, has fallen into a similar trap.

But the policy problems identified above are real, and they demand the serious attention of the legislature, rather than piecemeal attention by courts followed by a spasm of legislative action when newspaper headlines roar. Without such consideration, the process of individual adjudication by litigation almost certainly will result in ill-conceived tax and health policy as a by-product of defining charitable property tax exemption. The people of Illinois (and other states where these issues may arise) and the uninsured who are directly affected by these policy decisions deserve better.

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AMA: Policing Salt

The American Medical Association wants the food instrustry to reduce the amount of sodium in processed foods by at least 50 percent and and wants the Food and Drug Administration to place warning labels on foods that are high in salt.  According to an article at cnn.com:

On a voice vote, AMA delegates adopted the policy at their five-day annual meeting, which ends Wednesday. Getting the food industry to gradually reduce sodium content in foods by at least half over the next decade is the goal of the new policy.

The policy also calls for the AMA to ask the FDA to revoke the "generally recognized as safe" (GRAS) status of salt.  . . . .

The American Heart Association recommends limiting sodium intake to less than 2,300 milligrams daily, or less than about one teaspoon, but the average daily intake among U.S. adults is nearly double that amount, the report said.

The AMA report said there is overwhelming evidence that excessive sodium intake is a risk factor for hypertension and may be an independent risk factor for other cardiovascular problems.

More than 30 percent of U.S. adults have high blood pressure, and cardiovascular disease is the nation's leading cause of death.

For an overview of some of the other policy positions the AMA adopted at its annual conference, including increasing mental health services on college campuses, promoting new methods to increase organ donation, and a temporary moratorium on direct-to-consumer advertising on new prescription drugs, click here. [bm]

 

Emergency-Care Shortage

The Institute of Medicine issued several reports on its recent major investigation concerning the nation's emergency-care system and concluded the system is "at its breaking point."  From the Institute's website:

The Institute of Medicine's Committee on the Future of Emergency Care in the United States Health System was convened in 2003 to examine the state of emergency care in the U.S., to create a vision for the future of emergency care, including trauma care, and to make recommendations to help the nation achieve that vision.  Their findings and recommendations are presented in three reports::

1. Hospital-Based Emergency Care: At the Breaking Point explores the changing role of the hospital emergency department and describes the national epidemic of overcrowded emergency departments and trauma centers.
2. Emergency Medical Services At the Crossroads describes the development of Emergency Medical Services (EMS) systems over the last forty years and the fragmented system that exists today.
3. Emergency Care for Children: Growing Pains describes the unique challenges of emergency care for children.

The Associated Press summary of the reports states:

That ERs are overburdened isn't new. But the probe by the IOM, an independent scientific group that advises the government, provides an unprecedented look at the scope of the problems — and recommends urgent steps for health organizations and local and federal officials to start fixing it.

Topping that list is a call for coordinating care so that ambulances don't waste potentially lifesaving minutes wandering from hospital to hospital in search of an ER with room. The idea is to set up regionalized systems that manage the flow much like airports direct flight traffic. That also should direct patients not just to the nearest ER but to the one best equipped to treat their particular condition — making sure stroke victims go to stroke centers, for example.

Other recommendations:

_Congress should establish a pool of $50 million to reimburse hospitals for the unpaid emergency care they provide to the poor and uninsured.

_Congress should ensure that more of the nation's disaster-preparedness funding goes to the hospitals and emergency workers who will provide that care. Typical government grants to hospitals for bioterrorism preparation are $5,000 to $10,000 — not enough to equip one critical-care room. When it comes to getting ready for a bird flu outbreak, few hospitals even have the ventilation equipment needed to isolate patients. And emergency medical services received only 4 percent of the $3 billion distributed by the Department of Homeland Security in 2002 and 2003 for emergency preparedness.

_The board that accredits the nation's hospitals should establish strong guidelines to reduce crowding and ambulance diversion.

The report states that the demand for emergency care has increased dramatically over the past decade while the number of ambulance services, hospital capacity and emergency workers dropped.

I am not hopeful that Congress will act on this report -- seems that flag burning prevention is a bigger priority  -- but perhaps I will be pleasantly surprised.  [bm]

Health News for Alcohol and Coffee Lovers

Scientists published a study in this  Monday's Archives of Internal Medicine demonstrating that coffee may help offset liver damage caused by alcohol abuse.  Heavy drinkers of alcoholic beverages who also drank lots of coffee were less likely to develop cirrhosis.  According to an AOL news report:

In a study of more than 125,000 people, one cup of coffee per day cut the risk of alcoholic cirrhosis by 20 percent. Four cups per day reduced the risk by 80 percent. The coffee effect held true for women and men of various ethnic backgrounds.

It is unclear whether it is the caffeine or some other ingredient in coffee that provides the protection, said study co-author Dr. Arthur Klatsky of the Kaiser Permanente Division of Research in Oakland, Calif.

Of course, there is a better way to avoid alcoholic cirrhosis of the liver, Klatsky said.

"The way to avoid getting ill is not to drink a lot of coffee, but to cut down on the drinking" of alcohol, he said.

The participants ranged from teetotalers, who made up 12 percent of the total, to heavy drinkers, who made up 8 percent. The researchers calculated the risk reductions rate for the whole group, not just the drinkers.

NPR's morning edition reports further on this study  Researchers are attempting to find out what about coffee provides protection for the liver and to discover why certain heavy drinkers are more likely to develop the liver disease than others.  Finally, the researchers warn that coffee drinking does not eliminate all the harms of heavy drinking. [bm]

Selecting and Ranking Physicians

    Kent Sepkowitz, a physician writing for Slate.com, discusses magazine rankings of doctors that seem to be growing in popularity.  Although perhaps not as controversial as the US News and World report rankings of law schools, he provides some critique of the ranking process for physicians and also then gives his own commonsense selection critieria when looking for a doctor.  He states,

About this time every year, doctors across New York City begin to cast a wary eye at local newsstands. When the bundle of New York magazine's "Best Doctors" issue drops onto the pavement, torture commences for the city's prim and laconic physician class. (Other cities get their chance at other times of year.) It's high school all over again, a life lived at the mercy of cruel arbiters of who is up and who is down. To their credit, I suppose, the compilers of the Best Doctors list define worthiness with more objectivity: They poll local doctors and ask whom they would refer a family member to. With this quasi-statistical information in hand, they go behind closed doors and construct the dreaded list.

To my expert eye, every year the New York survey gets it about half right: Half of the selections are first-rate doctors, no doubt about it. Another 25 percent are people whom I don't know well (though I have my doubts), and 25 percent are certifiable duds—doctors who (hopefully) haven't seen a patient in years but have risen to the lofty realm of high society and semi-celebrityhood. . . .

What's so bad about this sort of thing? After all, Who's Who and its progeny operate a similar scam. I would argue, though, that by adopting the guidebook approach, Best Doctors (or Best Lawyers or Best Dentists) fails the public by making a false promise. The real problem at hand—how do you find a reliable professional whose services you very much need—can't be solved as readily as picking a restaurant or health club. You can't run a Zagat-style survey and get worthwhile results. Nor can you pay people to crash the car and then rate the product. The Best Doctors approach—asking other doctors to name the colleagues they trust enough to send a family member to—sounds like it ought to work. But it doesn't.

To begin with, the list is heavily influenced by backslapping, back-stabbing, and old-fashioned old-boyism. Powerful medical departments are too generously represented while oddball offices or people are gone with the wind. Even if that weren't the case, however, the list would be mostly useless.

How do I know? Friends and family are always asking me for the name of a good doctor. I think long and hard. I consider their ages, sexes, the doctor's experience and office location and background, the doctor's and the putative patient's outside interests, the ages of their respective children and the careers of their respective spouses, their hair color, office color, office furniture. I think of everything I can think of.

And still, almost every time, my friends and relatives rue my choice. The endeavor is like setting up a blind date. It should work, right? You know the guy a long time, your wife knows the woman a long time; everybody likes everybody. But then comes the date and splat!—a disaster—plus the original friendships become frayed with silent accusation: You thought I would like her?

The doctor-patient relationship is just that, a relationship, full of all the nonsense and idiosyncrasy that defines the genre. It's why good doctoring has a magic quality, like a good friendship. The intricacy of this symbiosis also is why a "best doctor" can't be determined by asking a bunch of professors whom they might send their brother-in-law to.

Which is not to say the search for a solid doctor is hopeless—just that the guidebook approach has made the task more complicated than it needs to be. Below is my simple one-two-three approach. It's even in glossy-magazine format.

1) Trust your instincts: There are lots of rotten doctors, really really lousy ones, wretched souls you wouldn't want to know as people, much less trust with your health. But they aren't any harder to suss out than the schmucks you meet in everyday life. If your gut says run, then run.

2) Don't trust your instincts if a scalpel is involved: Subjective impression is meaningless when selecting a surgeon. Craft should trump your desire to like them; in fact, it's OK to hate your surgeon. You simply need him to cut and sew very intelligently. So always select the surgeon who has already done the most iterations of whatever procedure you need. Stated in Zagat-ian terms: Which restaurant do you want to go to—the one with the line or the one that sits empty?

3) Shop around: Diagnosticians, sensitive (and craftless) souls that we are, succeed only if we connect. A doctor who is beloved by one person can be a disaster for the next. Think of who ended up marrying whom—there simply is no accounting for taste. So look before you buy. Yes, it takes time, it takes money, it is humiliating and ridiculous and maybe just a sinister plot to give doctors more business. Do it anyway, and do it when you are well.

Magazine "best" lists are a good read for choosing things that don't much matter, like fitness clubs and pizza and a summer vacation spot. But when it comes to the basics—health, education, and welfare—no one but a best-list maniac would seek counsel from the printed page. And for the maniacs, well, we can only hope that someone out there is polishing up a survey on the 10 best ways to cure a best-list addiction.

[bm]

50-State Legislative Survey

Here's the current issues survey of state legislative activities of interest to state medical boards, courtesy of the Federation of State Medical Boards.  Covered issues:

• Continuing Medical Education
• Criminal Background Checks
• Laser Regulation
• Medical Director Overview by State
• Medical errors/patient safety
• Pain management
• Physician profiling
• Regulation of office-based surgery
• Resident Licensure and Post Graduate Training Programs
• Telemedicine licensure

  [tm]

The Donut Hole

No, not the yummy kind, unfortunately the donut hole in the Medicare Part D program (as you may recall, the program provides coverage for a subscriber's prescription drugs until he reaches a certain dollar limit, then it pays nothing (the hole), the program does start paying again but only after the subscriber has paid several thousand dollars of his own money to cover the costs of his prescription drugs) is about to become apparent to many new subscribers -- I don't think the result will be a pleasant one.  The New York Times has an article by Robert Pear on the impact of the donut hole  on Texas residents -

On May 2, Mr. Flores paid $20 for Plavix, a blood thinner used to reduce the risk of heart attack and stroke, and Medicare paid $109.62. But when he refilled the prescription at the end of May, he was in the coverage gap, so he had to pay the full amount, $129.62.

Mr. Flores is angry with Medicare, with his drug plan and even with the pharmacists who try to help him. He says no one told him about the coverage gap when he signed up.

Vanessa M. Recio, a pharmacist at Saenz Medical Pharmacy in Mission, Tex., said: "All I do all day is talk to angry patients. I process insurance claims and try to solve problems with Medicare."

The Times piece points out some of the other difficulties that individuals continue to have with Part D - including immigrants and pharmacists who have problems processings claims.  The Washington Monthly has a further examination of the politics of the  donut hole issue.  [bm]   

Hospital Disaster Preparedness Hearings

It's not technically new, but it's new to me: from the Subcommittee on Oversight and Investigations of the House Committee on Energy and Commerce, hearings on January 26 on "Hospital Disaster Preparedness: Past, Present and Future."  No transcript available yet, but the link will appear on the hearing page when it is; meanwhile, filed testimony is available.  Interesting stuff for you public health law classes.  [tm]

The Market for Cadaveric Tissue

AP (Yahoo) has a story about the poorly unregulated market in cadaveric tissue that will curdle your blood.  I am stunned that the FDA has done as poor a job of oversight as it has:

The federal agency responsible for tissue safety, the

Food and Drug Administration, is well aware of the problems. Yet, many experts believe the rules the FDA enacted last year as a long-promised overhaul fall short of providing the level of oversight needed.

Each year, another germ is found to spread through tissue. Each year, the FDA inspects a smaller percentage of tissue businesses. Each year, another germ is found to spread through tissue. Each year, the FDA inspects a smaller percentage of tissue businesses.

When it does inspect, public health isn't always protected. In 2003, an FDA inspector saw that Biomedical Tissue Services — the now-notorious New Jersey company — wasn't documenting what it did with tissue unsuitable for transplant. The FDA let the matter drop after the company sent a letter saying it had fixed the problem. For two more years, thousands of people received tissue.

"I'm not surprised that a BTS (incident) occurred. And there will be others," said Areta Kupchyk, a former FDA lawyer who drafted rules that ultimately were adopted in watered-down form. "We continue to be at risk."

In a related AP story, you can read more about the potholes that plague this industry. [tm]

New Twist on Unauthorized Practice of Medicine

This item is from the Federation of State Medical Board's newsletter [links added by me]:

The executive directors of the Texas and Mississippi medical boards testified on June 6 before a U.S. House subcommittee investigating public health issues in the wake of a court ruling that found medical screening companies and physicians were diagnosing patients with silicosis for the purpose of referring them to law firms as plaintiffs in mass tort litigation.

The House Energy and Commerce Oversight Subcommittee is investigating screening practices for silicosis, a lung disease caused by the inhalation of silica dust, which occurs during mining and other industrial processes. Subcommittee members criticized the practices of RTS, Inc., N&M Inc., and Occupational Diagnostics, which conducted the screenings addressed in the June 2005 U.S. District Court opinion In Re: Silica Products Liability Litigation, MDL Docket No. 1553 (S.D. Tex., June 30, 2005).

Donald Patrick, M.D., J.D., executive director of the Texas Medical Board, testified to the issue regarding unlicensed practice of medicine. In Texas, he said, making a diagnosis falls under the definition of practicing medicine. Physicians seeing patients for screening companies who made the diagnosis of silicosis in those patients were practicing without a license. In Texas, Dr. Patrick emphasized, such practice is a felony. Mallan Morgan, M.D., executive director of the Mississippi State Board of Medical Licensure, testified the screening companies were operating without permission from their states.

In her opinion, U.S. District Court Judge Janis Graham Jack noted that only 12 doctors were responsible for the silicosis diagnoses of more than 9,000 plaintiffs involved in the case, nearly all of whom the physicians neither met, treated nor physically examined.

Other hearing dates on this topic are March 31 and March 8.  [tm]

New CLIA Brochure Available

Some news from CMS (this looks pretty good) . . . .

The Clinical Laboratory Improvement Amendments (CLIA) brochure has been updated and is now available in downloadable format on the Medicare Learning Network’s (MLN) Products page located at   http://www.cms.hhs.gov/MLNProducts/downloads/CLIABrochure.pdf .

The brochure includes an overview of CLIA, why it is important, how test methods are categorized, enrollment information, as well as information regarding the five types of laboratory certificates.  A hard copy of the brochure will be available early this summer and will be available for ordering on the MLN Publications Page at http://www.cms.hhs.gov/MLNProducts/MPUB/list.asp .

[tm]

New Report on Universal Health Care Coverage

According to a recent interim report of the Citizens' Health Care Working Group,  a 14-member committee representing consumers, the disabled, business and labor, and health care providers, Americans believe that "all Americans should have a set of health coverage benefits guaranteed by law." Those benefits should be "portable and independent of health status, working status, age (and) income."  The Citizens' Health Care Working Group was created by Congress in late 2003 and funded with $5.5 million.  Beginning in February of last year, the group traveled to 50 communities and heard from 23,000 people.  The Group's interim recommendations may be found here.  According to the Associated Press:

The committee describes its recommendations as a framework. The recommendations don't say who would pay for universal health coverage or how much it would cost. The concept of government-guaranteed coverage runs counter to the Bush administration's position that consumers should bear more responsibility for their initial medical expenses.

The group's findings will be officially presented to the president and Congress in the fall, but first comes 90 days of public comment. The president will submit to Congress his response, and then five congressional committees will hold hearings.

Some organizations are already suspicious of the Group's recommendations:

"It implies massive new funding sources, massive new laws would be needed," said Sarah Berk, executive director of Health Care America, an advocacy group that pushes free market approaches to health coverage. "We want universal access, but this report just pushes all the difficult problems onto somebody else's plate. It says government needs to do it all."

George Grob, the executive director of the Citizens' Health Care Working Group, said the group was not asked to say specifically how to get to universal coverage. However, the group did recommend that financing strategies be based on principles of fairness and shared responsibility. The strategies should draw on revenue streams such as enrollee contributions, income taxes, so-called "sin taxes" and payroll taxes, the report said.

"We're already paying for health care for everybody who gets it, including people who don't have health insurance coverage who are taken care of when they go to the hospital," Grob said.

[bm]

FDA Approves Cervical Cancer Vaccine

Today, the FDA aproved the cervical cancer vaccine, Gardasil, for use in girls and women ages 9 to 26 (oops - I am out-of-luck).  The Associated Press reports,

The vaccine works by preventing infection by four of the dozens of strains of the human papillomavirus, or HPV, the most prevalent sexually transmitted disease.

By age 50, some 80 percent of women have been infected.

Gardasil protects against the two types of HPV responsible for about 70 percent of cervical cancer cases. The vaccine also blocks infection by two other strains responsible for 90 percent of genital wart cases. The vaccine will be available by the end of the month, with a three-shot series costing $360.

Its manufacturer, Merck & Co. Inc., seeks similar approval e