Monday, December 29, 2008

VM4 December: Laborist Staffing Requires Careful Attention

Laborists have ethical obligations to their patients and professional obligations to their patients’ obstetricians.

Commentary by Louise P. King, MD, JD, and George D. Wendel Jr., MD

Mrs. Lawrence arrived at a large, urban hospital in active labor at 23 4/7 weeks. She was a patient of Dr. Greene but registered under the care of Dr. James, a laborist employed by the hospital. Mrs. Lawrence was carrying an extremely low-birth-weight fetus with a poor prognosis. When the fetal heart tracing became non-reassuring, Dr. James counseled her to undergo an emergent cesarean delivery. Just as Mrs. Lawrence was being prepped for the surgery, Dr. Greene arrived and took issue with the laborist's decision. She believed her patient had been poorly counseled about the prognosis for the fetus and maternal morbidity associated with a classic cesarean section at such an early stage of gestation.

Learning Objective: Understand the ethical obligations laborists owe their patients and the professional obligations they owe their patients’ obstetricians.

Dr. Greene questioned whether the laborist had been completely unbiased in her decision making. After all, Dr. James worked for the hospital that stood to benefit from a lengthy, yet reimbursable NICU stay. Drs. Greene and James found themselves at an impasse. Dr. Greene sought to re-establish care for her patient; but the patient, by now, was adamant that she wanted a cesarean delivery to “save her baby.”


Commentary

The practice of obstetrics and gynecology has changed dramatically in recent years. Traditionally, obstetricians were available at all hours for every patient's labor and delivery. Today, patients often choose their obstetricians based on whether they are routinely available at delivery. Perhaps in response to the unique demands of obstetrics, physicians are leaving practices at younger ages, discontinuing obstetric services, and choosing other specialty training. Surveys of those in practice show an increase in professional dissatisfaction, poor personal relationships, and burnout [1]. Given the extensive demands of a traditional obstetrics practice and the higher costs of medical liability insurance for obstetrics, it is no surprise that there are fewer obstetricians and gynecologists in solo practice.


Introduction of Laborists

The laborist was introduced largely to address time demands. Laborists are hospitalists employed by larger hospitals to manage the care of walk-in patients, those in labor, or those with emergent gynecological issues. They are there to deliver babies of patients whose physicians are affiliated with the hospital when those physicians are unavailable. Laborists typically work in shifts but may make rounds on patients admitted to their service. Introduced primarily to reduce the workload for obstetricians, laborists may also improve hospital safety, inasmuch as they are immediately available on the labor unit to address dysfunctional labor or a non-reassuring fetal-heart tracing. Finally, by reducing the time and stress burden on practicing obstetricians, laborists lower the risk of errors that occur when physicians are overworked [1, 2].

Despite the obvious benefits of employing laborists in hospitals, their presence can prompt ethical and legal complications, as this case illustrates. In the scenario, three separate relationships arise among the laborist, treating obstetrician, and patient. Similar complex relationships have existed before in obstetrics, namely among the certified nurse midwife, consulting obstetrician, and patient. But in the past the roles have been more easily defined, with the obstetrician providing care in an emergency or directing care as needed in an uncomplicated delivery. In many instances, the midwife works as a member of the obstetrician's team in his or her office unless it is necessary to transfer the patient out of the birthing center and into the care of a physician [2].

But here, the laborist and treating obstetrician are both independent physicians, who, at the outset of treatment, created separate and coexistent contractual relationships with the patient. Apart from each of their ties to the hospital, they have no formal ties to each other. During an uncomplicated delivery it is likely that the hospitalist would proceed without much need to consult the treating obstetrician. In a complicated, emergent situation such as that proposed in this scenario, consulting the treating physician may be impractical. Does Dr. James have an ethical or legal duty to consult with the treating physician? How is this duty affected by Mrs. Lawrence and Dr. Greene's patient-physician relationship? Stated another way, what duty does Dr. James have to honor the treating relationship between Dr. Greene and Mrs. Lawrence?


Laborist, Treating Physician Relationship

To answer these questions, assume that a laborist functions like an emergency physician. According to the Code of Ethics for Emergency Physicians proposed by the American College of Emergency Physicians, when interacting with a patient's primary care physician, the emergency physician should “cooperate with the primary care physician to provide continuity of care that satisfies the needs of the patient and minimizes burdens to other providers” [3]. Applied to the current case, this statement suggests that the laborist has an ethical and professional duty to contact the primary care physician and ascertain his or her plan regarding emergent intervention for each patient in every instance possible.

But this analogy does not completely capture the complexities of obstetrical practice. Drs. James and Greene can reasonably disagree about the best course for Mrs. Lawrence. Although the prognosis for this infant is poor, predictions of a long-term outcome for any neonate, especially one with very low birth weight early in gestation, are far from perfect [4]. In an 18-to-22-month follow-up of neonates delivered at 22 to 25 weeks gestation, Neonatal Research Network investigators found that 49 percent had died, 61 percent had died or had profound impairment, and 73 percent had died or had some impairment [5]. They concluded that consideration of multiple factors is likely to promote treatment decisions that are less arbitrary, more individualized, more transparent, and better justified than decisions based solely on gestational-age thresholds.


Duty to Counsel the Patient?

Presenting this type of probability data to expectant mothers is challenging. Parents want to know exactly what will happen to their child—a question that can almost never be answered. Each patient has a different cultural understanding and brings different moral values to thinking about the long-term consequences for a child born severely prematurely. Hence, counseling a patient regarding interventions at the cusp of viability is extremely difficult [5]. Ideally, the patient would have discussed her child's prognosis and personal beliefs in detail with her treating physician. One could argue that, even in the context of an emergency, a well-informed patient has enough information at her disposal to decide between a cesarean delivery and expectant management followed by a vaginal delivery.

The most conscientious physician cannot prepare a family for every possible occurrence at each gestational age, however. Even if a family is educated about the risks of a preterm delivery, those risks and possible outcomes can change during gestation over weeks and even days. Labor and delivery situations are unlike the typical cases an emergency-medicine resident confronts in a patient at the end of life. Many patients with terminal illness have had months to prepare and educate themselves about their disease and prognosis. Although their condition changes over months and years, the disease itself is fairly static, and they have time to digest its implications. Some have living wills that make the process easier. At the very least, an emergency physician can resuscitate a patient at the end of life per a family's request and consider withdrawal of care at a later time.

By contrast, the decision to perform an emergency-cesarean delivery for fetal distress must be made and acted upon in a matter of minutes. As described by Ann Drapkin Lyerly, the morbidity associated with a classic cesarean delivery (vertical incision involving the contractile portion of the uterus) performed at very early gestational age, as well as that associated with emergent anesthesia, are significant [6]. Dr. James presumably believed that Mrs. Lawrence's child had “enough of a chance” to justify emergent intervention and presented the options to Mrs. Lawrence with this bias. Once given the chance to save her baby, it is unlikely that Mrs. Lawrence would be able to consider any other option as reasonable or acceptable. Dr. James would have served his patient better by allowing her to speak with her treating physician who is more familiar with her case and better equipped to counsel her.

In such an emotionally charged situation, Dr. Greene's assertion that Dr. James may have been motivated by financial concerns is surely counterproductive and possibly inaccurate. It brings to light, however, the perception of bias that is bound to occur when a physician is employed by a hospital to deliver babies. Medicaid reimburses care for infants sent to the neonatal intensive care unit (NICU) regardless of the mother's funding status during her pregnancy. Thus, NICU infants might be considered by some to be a reliable source of revenue for hospitals. The addition of laborists to a hospital team could be justified financially by an increase in walk-in deliveries and the consequent reimbursement, with the knowledge that some of the babies will need prolonged, expensive NICU stays. Theoretically, there is some financial incentive, therefore, for a laborist employed by the hospital to encourage deliveries of extremely preterm infants rather than advising maternal transport to another NICU or expectant management. Even assuming that a laborist would not be unduly influenced by this possible incentive, which is likely, it is better for the treating physician to counsel the patient regarding her option to avoid even the appearance of bias.

In sum, although it adds a level of complexity to interactions between the laborist and patients in labor and delivery, the laborist has a duty to preserve the established relationship between the treating obstetrician and patient. This is especially true in emergent situations that arise early in gestation when decision making is difficult and requires an established rapport with the patient to facilitate the best possible outcome. Following this principle will allow obstetricians to retain continuity of care for their pregnant patients (long praised as a strength of our specialty field) while addressing the needs of the obstetrical workforce and alleviating some of pressures that have driven physicians from our specialty.


References

Weinstein L. The laborist: a new focus of practice for the obstetrician. Am J Obstet Gynecol. 2003;188(2):310-312.

Wells CE. Personal communication. October 1, 2008.

American College of Emergency Physicians. Code of ethics for emergency physicians. 2008. http://www.acep.org/practres.aspx?id=29144. Accessed on October 27, 2008.

Voss W, Neubauer AP, Wachtendorf M, Verhey JF, Kattner E. Neurodevelopmental outcome in extremely low birth weight infants: what is the minimum age for reliable developmental prognosis? Acta Paediatr. 2007;96(3):342-347.

Tyson JE, Parikh NA, Langer J, et al. Intensive care for extreme prematurity—moving beyond gestational-age thresholds. N Engl J Med. 2008;358(16):1672-1681.

Lyerly AD. Reframing neutral counseling. Virtual Mentor. 2008;10(10):635-639. http://virtualmentor.ama-assn.org/2008/10/ccas3-0810.html.

Louise P. King, MD, JD, is a third-year resident at Parkland Memorial Hospital in Dallas, in obstetrics and gynecology. Prior to becoming a physician, Dr. King practiced law that specialized in constitutional, criminal, and indigent legal matters.

George D. Wendel Jr., MD, is a professor and residency program director of obstetrics and gynecology at the University of Texas Southwestern Medical Center in Dallas. He is a maternal-fetal medicine subspecialist with research interests in clinical obstetrics and sexually transmitted diseases.


Related in VM
A Transition in Obstetrics, December 2008
Reframing Neutral Counseling, October 2008

Wednesday, December 24, 2008

Where Are the Cures?

Scientists call the gulf between a biomedical discovery and new treatment 'the valley of death.'
Sharon Begley
NEWSWEEK
From the magazine issue dated Nov 10, 2008

It has been years since Hans Keirstead worked his biological magic, injecting stem cells into rats with severed spinal cords and thus making them walk almost normally. But the real miracle—since other experiments, too, have cured paralysis in lab animals—is that Geron Corp. plans to test the technique in people next year. Between Keirstead's experiment and Geron's trial lie these obstacles: Keirstead, a professor at the University of California, Irvine, had to invent instruments to squirt the stem cells into spinal cords ("what do we academics know about developing medical devices?" he asked me), find someone to try the technique in monkeys ("I know two researchers who handle monkeys; you have to get in line"), ramp up production of the stem cells ("it meant going from pipettes to this massive hydraulic setup") and … well, more industrial-strength biology that he wasn't trained in, that the government rarely funds and that brings exactly zero glory to a university scientist. "We hacked through the jungle and paved the road," Keirstead said. "But how many others are willing to do that?"

Going by how few discoveries in basic biomedical research get turned into treatments and cures, the answer is very, very few. The nation's biomedical funding and training system are set up to do one thing, and they do it superlatively: make discoveries. That is what scientists dream of, that is what gets them published in leading journals (the coin of the realm in academia) and that is what gets them grants from the National Institutes of Health. Here's what doesn't get them any of those: the grunt work that Keirstead did to turn his spinal-cord breakthrough into something that can be tried in patients.

These barriers to "translational" research (studies that move basic discoveries from bench to bedside) have become so daunting that scientists have a phrase for the chasm between a basic scientific discovery and a new treatment. "It's called the valley of death," says Greg Simon, president of FasterCures, a center set up by the (Michael) Milken Institute in 2003 to achieve what its name says. The valley of death is why many promising discoveries—genes linked to cancer and Parkinson's disease; biochemical pathways that ravage neurons in Lou Gehrig's disease—never move forward.

The next administration and Congress have a chance to change that, radically revamping the nation's biomedical research system by creating what proponents Richard Boxer, a urologist at the University of Miami, and Lou Weisbach, a Chicago entrepreneur, call a "center for cures" at NIH. The center would house multidisciplinary teams of biologists, chemists, technicians and others who would take a discovery such as Keirstead's and nurture it along to the point where a company is willing to put up the hundreds of millions of dollars to test it in patients. The existence of such a center would free scientists to go back to making important discoveries, not figuring out large-scale pipetting, for goodness' sake. "There is a sense among disease philanthropies that something like this is what needs to happen," says Katie Hood, CEO of the Michael J. Fox Foundation for Parkinson's Research. "It's a huge opportunity for a new administration."

Biomedical scientists I spoke to are wary of using NIH money for a new center for cures. They worry that it would divert dwindling funds from the basic research that is their pride and joy and, indeed, the basis for those hoped-for cures. Given current fiscal realities, scientists are right to be worried. But while basic research is necessary for finding new treatments, it is not sufficient. (While the NIH budget was doubling, the number of new-drug approvals fell from 53 in 1996 to 18 in 2006.) When I asked Kierstead if he ever wondered how many promising leads are gathering dust between the covers of research journals because no one is willing or able to push them forward, he said, "I don't wonder. I know it's the case." Why? Because "curing disease is a byproduct of the [NIH] system and not a goal," says FasterCures' Simon. Most scientists don't want to and don't have the skills to translate a discovery into a treatment; researchers at a dedicated center would try to do that full-time.

Some disease foundations have paved the way, turning themselves into mini-centers for cures. The pioneering Myelin Repair Foundation, which funds research on treatments for multiple sclerosis, actively manages the five scientists at five universities whom founder Scott Johnson hand-picked, requiring them to share data almost as fast as they collect it, mandating collaboration and pushing discoveries through the valley of death. For instance, a test-tube finding is quickly tested in a mouse model; contractors are hired to develop ways to scale up a discovery of how to turn stem cells into myelin-making cells that could help MS patients.

There is lots of talk these days about increasing the nation's spending on infrastructure, such as roads and bridges, to lift the economy out of its doldrums. Me, I'd be willing to put up with potholes in exchange for a new administration spending serious money to take the discoveries taxpayers have paid for and turn them into cures.

URL: http://www.newsweek.com/id/166856

Monday, December 22, 2008

VM3 December: Planning End-of-Life Conversations: Hospitalist and Primary Care Physician Roles

Primary care physicians can help hospitalists plan end-of-life conversations with patients or patients’ families.

Commentary by Mary Ehlenbach, MD

At the end of a busy day in her pediatric clinic, Dr. Smith was going to visit the Johnson family. Even though she and her partners now admitted their patients to the pediatric hospitalist service at the nearby children's hospital, Dr. Smith still visited her patients there whenever her clinic schedule permitted. She had been notified by the emergency department earlier that day that Claire, the Johnsons' third child, had been admitted with a fever and dehydration. Dr. Smith knew the Johnson family well—she had taken care of their older children, both healthy, for the past 7 years, and had gotten to know Mr. and Mrs. Johnson even better during Claire's first year of life.

Learning Objective: Understand how primary care physicians can help hospitalists plan end-of-life conversations with patients or patients’ families.

Claire was born healthy, but stopped making developmental progress at age 6 months. By the time Claire was 1 year old, an extensive workup showed that she had a rare, progressive metabolic disorder. Despite strictly adhering to a special diet and routinely seeing subspecialists, Claire continued to decline. Feeding problems resulted in the need for placement of a gastric tube and Claire's development never progressed beyond that of a 6-month old. Now 4 years of age, Claire had been hospitalized several times for metabolic crises associated with mild infections. Specialists had told the Johnsons that Claire would never walk, talk, or eat by mouth.

While Dr. Smith had never had a discussion specifically about end-of-life issues with the Johnsons, she knew that they wanted Claire to stay out of the hospital as much as possible and hoped she would not have to undergo medical interventions that would cause her to suffer. In light of this admission, Dr. Smith knew the time had come to talk with the Johnsons about goals of care and, specifically, code status for Claire.

Dr. Smith stopped at the nurses' station to review Claire's chart before meeting with the Johnsons. She was surprised to discover that the pediatric hospitalist caring for Claire had already documented a detailed discussion about code status and what medical interventions, if necessary, the Johnsons wanted Claire to have. Dr. Smith recognized the hospitalist, Dr. Adams, sitting at the nurses' station, and decided to approach her. Dr. Adams was surprised that Dr. Smith was interested in this aspect of Claire's care.

“Usually, primary care physicians leave these discussions to us,” said Dr. Adams. “It can be a bit awkward to have conversations about end-of-life issues with someone you've never met before, but we do it so often that it has become second nature with families of patients like Claire. Most primary care physicians don't like to talk about dying during a 20-minute clinic visit.”


Commentary

End-of-life discussions can be difficult for both physicians and patients. “See one, do one, teach one” is a paradigm entrenched in the culture of medical education. Some argue that this method is insufficient for mastering any skill, but studies suggest that medical students and physicians-in-training are expected to discuss end-of-life issues with patients without even experiencing the meager educational benefit of this 3-step method [1]. Medical students and housestaff generally have not acquired sufficient mentoring to conduct end-of-life conversations with patients and families even though some attending physicians believe they are the responsibility of less-experienced members of the team [1, 2].

Ill-prepared physicians who have end-of-life discussions with patients and families are at a high risk of miscommunicating. If a physician does not have a clear understanding of the likelihood of success and complications of cardiopulmonary resuscitation, he or she may inaccurately present the expected clinical course to the patient and family. The risks and benefits of other life-prolonging interventions, such as intubation and mechanical ventilation, may also be inaccurately represented. And even physicians who draw a balanced, accurate picture of the outcomes of these interventions often mistakenly assume that their sick and vulnerable patients or worried families have “heard” and understood the message, when in reality neither party understands the other.

An equally serious mistake on the part of a physician who is not equipped to have end-of-life discussions is underestimating the integral role that a family's values and beliefs play in making goals-of-care decisions [3]. Here, it is not a matter of patients not understanding what doctors are saying, but of the doctor not hearing or understanding how the patient's or family's end-of-life values guide their thoughts [4]. If patients and physicians are thinking and talking about the end of life in different terms with different vocabularies, care plans are bound to be confusing to the medical team and unsatisfying to the family.

On the other hand, a physician who has had a long-term relationship with a patient and family often understands the role their belief system plays in their life. Religious, cultural, and personal convictions are key factors in helping patients and families make end-of-life decisions [3]. Here, the primary care physician has the advantage of a perspective over time and can gauge the evolution of the illness, as well as the degree to which patients and families have accepted the reality of the illness and thought about death. A trusted primary care doctor need not have up-to-the-minute information on the patient's condition to provide valuable support and counseling to families who are overwhelmed by the decisions they confront.

Some primary care physicians may feel that discussing end-of-life wishes during a routine clinic visit is inappropriate. Barriers to the conversation in the outpatient setting include: (1) lack of time, (2) feeling that such a dialogue will upset a patient or family if the condition is stable or improving, and (3) general discomfort or lack of skill in communicating on the topic. Yet it can be very helpful to the patient and family to introduce this subject when a crisis is not impending. Broaching this topic during a clinic visit can give surrogate decision makers more insight into a patient's wishes [6] and make a primary care physician aware of when a patient or family (e.g., families with children with complex medical needs) may be struggling with these decisions. A multidisciplinary approach—involving a palliative care team, nurse, and social worker—can further mitigate against communication errors and help the patient and family in making a decision that accords with their values and belief system [5].

In the case of Claire Johnson, it would have been beneficial for Dr. Smith, who has known Claire's family for several years, to have initiated a formal end-of-life discussion with the Johnsons in the outpatient setting before Claire became acutely ill. The Johnsons would have been introduced to the topic, had a chance to consider their options, and felt better prepared when Dr. Adams initiated the conversation. Dr. Adams then could have focused on explaining pertinent clinical information to guide the Johnsons through decision making in their emotionally fraught state. Alternatively, if Dr. Smith felt she could not do the best job discussing Claire's end-of-life decisions with the Johnsons, she could have referred them to palliative-care services before this hospitalization.

Dr. Smith's participation in the end-of-life discussion that Dr. Adams had with the Johnsons would have proved valuable. As a hospitalist, Dr. Adams' daily practice exposes her to patients and families like the Johnsons during serious, acute illnesses, so she may have been more prepared than Dr. Smith to discuss the details of resuscitation, CPR survival, and complication statistics. She may have felt more comfortable overall having this conversation with patients and families. But Dr. Smith could have supported the Johnsons, making sure they felt comfortable in introducing their values and belief system into the goals-of-care decision making. It may be difficult to coordinate an end-of-life discussion with a hospitalist and a clinic-based primary care physician when a patient is hospitalized with an acute illness, but both parties can work to arrange such a meeting if it seems to be in the best interest of the patient and family.


References

Tulsky JA, Chesney MA, Lo B. See one, do one, teach one? House staff experience discussing do-not-resuscitate orders. Arch Intern Med. 1996;156(12):1285-1289.

Wear D. “Face-to-face with it”: medical students' narratives about their end-of-life education. Acad Med. 2002;77(4):271-277.

Kelly WF, Eliasson AH, Stocker DJ, Hnatiuk OW. Do specialists differ on do-not-resuscitate decisions? Chest. 2002;121(3:)957-963.

Deep KS, Griffith CH, Wilson JF. Discussing preferences for cardiopulmonary resuscitation: what do resident physicians and their hospitalized patients think was decided? Patient Edu Couns. 2008;72(1):20-25.

Agich GJ, Arroliga AC. Appropriate use of DNR orders: a practical approach. Clev Clin J Med. 2000;67(6):392, 395, 399-400.

Handy CM, Sumalsky DP, Merkel CK, Ury WA. The surrogate's experience in authorizing a do not resuscitate order. Palliative and Supportive Care. 2008;6:13-19.

Mary Ehlenbach, MD, is a pediatric hospitalist at Mary Bridge Children’s Hospital in Tacoma, Washington. Her research interests include the care of medically complex children, family-centered care, and teaching medical students and residents.


Related in VM
Discussing Code Status with Patients and Their Families, September 2006

Sunday, December 21, 2008

The Abortion Wars Get Technical

Women have few rights at all when doctors can legally misinform them or deny service entirely.
Dahlia Lithwick
NEWSWEEK
From the magazine issue dated Dec 15, 2008

What does it tell us about the state of the abortion wars, that battles once waged over the dignity and autonomy of pregnant women have morphed into disputes over the dignity and autonomy of their health-care providers? Two of the most pitched battles over reproductive rights in America today turn on whether health workers can be forced to provide medical services or information to which they ethically object. But as we learn from these fights, our solicitude for the beliefs of medical workers is selective: abortion opponents will soon enjoy broader legal protections than ever. Those willing to provide abortions, on the other hand, will enjoy far fewer. And women seeking reproductive services will be more caught up than ever in the tangle between the two.

The first dispute concerns a new rule purporting to protect the "right of conscience" of American health-care workers. Under a new midnight regulation crammed through by the Bush Department of Health and Human Services and poised to become law any day now, any health-care worker may refuse to perform procedures, offer advice or dispense prescriptions, if doing so would offend their "religious beliefs or moral convictions." Congress has protected the right of physicians to opt out of providing abortions for decades. This new rule, which President-elect Obama can overturn (although it may take months), is far broader. It allows one's access to birth control, emergency contraception and even artificial insemination to turn on the moral preferences of a pharmacist, nurse or ambulance driver.

The second dispute involves a South Dakota law that went into effect last summer after an appeals court lifted a preliminary injunction. The law requires physicians providing abortions to read from a state-mandated script advising the patient that she is about to "terminate the life of a whole, separate, unique, living human being" with whom she has an "existing relationship." The doctor must have her patient sign each page of a form indicating that she has been warned of the "statistically significant" risks of the procedure, including "increased risk of suicide ideation and suicide." These "risks" are almost completely unsupported by the scientific literature. A new comprehensive study released by Johns Hopkins found "no significant differences in long-term mental health between women in the United States who choose to terminate a pregnancy and those who do not." The disparity between the empirical data and the mandatory script thus forces physicians into a Hobson's choice between providing patients with accurate medical information, and possible license suspension and misdemeanor charges.

Reading the new HHS regulations together with the mandatory South Dakota "script," one can only conclude that those same health providers who cannot be compelled to perform an abortion may nevertheless be compelled to deliver misinformation about it. The freedom and autonomy of doctors who oppose abortion are protected by law. But those willing to provide abortions can be forced to deliver a state message with which they completely disagree. Both the HHS's right-of-conscience rules and the South Dakota script purport to clarify the complex legal relationship between health provider and patient, but each instead confuses and obfuscates settled law. The HHS rule, as written, is so ambiguous that nobody can say for certain which health-care workers or medical procedures are covered, beyond establishing that both categories are broadly expanded beyond those protected by existing right-of-conscience laws. The rule even fails to define abortion, leaving open the possibility that anyone who thinks birth control is abortion may decline to dispense it, turning every visit to the ER or the pharmacy into a spin of the constitutional roulette wheel.

A recent article in the New England Journal of Medicine similarly blasts the South Dakota script for introducing novel and confusing legal language about "human beings," "constitutional rights" and "relationships" into a medical conversation between doctor and patient, concluding that these words are there "to intimidate pregnant women with vaguely described and legal-sounding consequences."

Almost completely missing from this fascinating legislative discussion of what health workers might be forced to do and say with respect to reproductive rights are the reproductive rights themselves. Whether we like it or not, the right to birth control, emergency contraception and—under most circumstances—abortion is still constitutionally protected. But these are not services a woman can provide for herself, which leaves her with few rights at all when her doctors are empowered by law to misinform her, withhold advice or deny services altogether. Even beyond the problem of subordinating a woman's rights to her doctor, however, there looms a larger question for health-care workers themselves: if they are indeed seeing their rights and freedoms either hugely expanded or severely restricted based solely on which side they've chosen in the culture wars, they might properly wonder whether any of them are truly free at all.

Lithwick is a NEWSWEEK contributing editor and a senior writer for Slate. A version of this column also appears on Slate.com.

URL: http://www.newsweek.com/id/172593

Friday, December 19, 2008

The Power of Statins

A new study supports the effectiveness of a drug treatment, and prompts a Harvard cardiologist to change the way he practices medicine.

Richard T. Lee, M.D.
Newsweek Web Exclusive

By now, virtually everyone who owns a television knows how heart attacks happen, or thinks they do: an excess of cholesterol, especially the kind called LDL (low-density lipoprotein) leaves deposits of plaque on artery walls, narrowing the passage for bloodflow until a clot comes along to block it entirely. This concept led to the development of cholesterol-lowering statins, such as Mevacor (lovastatin), Zocor (simvastatin), Pravachol (pravastatin), Lipitor, Lescol and Crestor. Increasingly, however, researchers are focusing on another culprit that also plays a key role: inflammation, which can make artery plaques rupture, very often the trigger that turns artherosclerosis into a heart attack.

Now a large international study (the JUPITER trial) lends support to that idea and also shows that the same statins that control cholesterol also act to reduce inflammation. (Strictly speaking, the trial only tested one such drug, Crestor, whose manufacturer, AstraZeneca, paid for the study.) JUPITER included nearly 18,000 seemingly healthy volunteers in prime heart-attack age—men age 50 and over, women age 60 and older. While their LDL cholesterol levels were healthy, the volunteers all had above-normal levels of C-reactive protein, or CRP, a sign of inflammation. (Normal CRP is below 1 milligram per liter; the volunteers all showed levels above 2.) Half of the volunteers took a daily 20mg tablet of Crestor; the rest took a placebo. LDL cholesterol levels dropped by roughly half and the CRP levels dropped by about a third in the statin group. In the placebo group, LDL and CRP levels didn't budge.

Even more impressive, there were about 50 percent fewer heart attacks and strokes in the statin group than in the placebo group. Unlike many earlier trials using statins, JUPITER included a large number of women, Hispanics, and blacks. Each of these groups benefited from statin therapy as much as white men.

JUPITER has changed my thinking about the high-sensitivity CRP test and about when to prescribe statins. Like many cardiologists across the country, I am now recommending the test more often. (The hospital in which I work receives patent revenue from the test, but I do not.) The CRP test is not for everyone, though. If someone already has been diagnosed with heart disease, the test adds little or no useful information, because the implications for treatment aren't clear yet. The same is true for those at very low risk—people younger than the volunteers in the JUPITER study, without other risk factors for heart disease.

The test is most useful for people in the middle of the risk curve. A high CRP level is a factor that may weigh on the side of starting statin therapy; a low reading may be taken by some as an indication it's not needed. How do you know where you stand? Risk tools such as the Framingham score and Your Disease Risk estimate your chances of having a heart attack in the next 10 years. (For links to these tools, go to health.harvard.edu/newsweek.) There are other considerations. Statins are expensive—a year's supply of Crestor or one of its competitors can cost more than $1,500. And although millions of people take them safely, they can cause pain in some people, and in rare cases muscle damage and, possibly, memory loss. To put the numbers from the JUPITER study into perspective, during the two-year trial, 1.5 percent of the participants who were taking the placebo had a heart attack or stroke, compared with 0.7 percent of those taking Crestor. That means 25 people would have to take a statin for five years to prevent one cardiovascular event. As treatments go, that's not bad, but it doesn't mean we should be putting statins in the water supply.

There are other ways you can fight inflammation than by taking a statin: If you smoke, stop. If you are overweight, shed some pounds. Adopt a Mediterranean-style diet based on fruits, vegetables, whole grains, nuts, and olive oil. Eat more fatty fish. Exercise almost every day. Get enough sleep. Reduce stress.

If you have heart disease or are at high risk for it, taking a statin and adopting healthful lifestyle changes make sense, even if your LDL is in the normal range. If you are a man age 50 or greater, or a woman age 60 or greater, and you are healthy but have a high CRP, the JUPITER results suggest you could benefit from the same strategy.

In 2009, researchers will be testing other ways to detect inflammation besides CRP, and developing genetic tests that may be more accurate predictors of heart-attack risk than the tools now in use. New drugs against inflammation are also in the works. The best approach, though, is something available to everyone today—living well to prevent atherosclerosis from ever taking hold.

Lee is associate editor of the Harvard Heart Letter and a cardiologist at Brigham and Women ' s Hospital and Harvard Medical School. For more information, go tohealth.harvard.edu/newsweek.

URL: http://www.newsweek.com/id/172696

Wednesday, December 17, 2008

HPV Vaccine can Prevent Genital Warts in Men


Study results bolster drugmaker’s plan to market shots to boys

The Associated Press
updated 1:28 p.m. ET, Thurs., Nov. 13, 2008

ATLANTA - For the first time, an expensive vaccine aimed at preventing cervical cancer in women has proven successful at preventing a disease in men, according to a study released Thursday by the vaccine’s maker.

The disease is genital warts — sexually transmitted, embarrassing and uncomfortable — but not life-threatening.

Still, the results are expected to bolster a likely bid by the vaccine’s manufacturer, Merck & Co. Inc., to begin marketing the vaccine to boys, experts said. Merck plans to ask the government for that approval later this year.

“This opens the door to a wonderful opportunity to prevent illness,” said Anna Giuliano, a researcher at the H. Lee Moffitt Cancer Center in Tampa, Fla., who worked on the Merck study. The research results were being presented Thursday at a medical conference in Europe.

The focus was Merck’s vaccine, Gardasil, which is given in three doses over six months and is priced at about $375.

The vaccine targets the two types of HPV, or human papillomavirus, believed to be responsible for about 70 percent of cervical cancer cases, and two other types that cause most genital warts. HPV is spread through sex.

In 2006, the U.S. government licensed the vaccine for use in girls and women ages 9 to 26. Males can spread the virus, but the vaccine was not licensed for them because there was no evidence it prevented disease in men.

Though about 40 other countries have approved the vaccine for males, there still is no medical proof Gardasil prevents penile cancer or other HPV-associated cancers in men. There also is no evidence it prevents men from spreading HPV to women.

The new study involved about 4,000 males ages 16 to 26 in nearly 20 countries. Results showed the vaccine was 90 percent effective in preventing genital warts, with only 15 cases of persistent infection in the vaccinated group, compared to 101 cases in a group that was given a fake vaccine.

No serious side effects were reported. The research is continuing, but these results reflect how the men were doing about 30 months after the injections, on average.

The results are “very exciting,” but it’s not clear they will be enough to persuade many American families to get their teenage boys vaccinated, said Dr. Maura Gillison, an HPV researcher at Johns Hopkins University who was not involved in the Merck study.

She noted that only 1 in 4 girls have gotten the vaccine so far, despite compelling medical studies that indicate the shots prevent female cancers.

“When parents are sitting in a room discussing with a pediatrician whether to vaccinate their child against anything, they’d like to know what the potential benefit is. A parent might say, ’I’m not inclined to vaccinate my child to prevent a benign genital wart,”’ she said.

Government officials have been awaiting this interim analysis from Merck. They are eager to see additional information that may come later on the vaccine’s effect on precancerous lesions, said Dr. Lauri Markowitz, an HPV expert at the U.S. Centers for Disease Control and Prevention.

“It’s obviously encouraging data, but the policy makers will be looking at a variety of different issues,” including how cost-effective the shot would be if used in males, said Markowitz, a medical epidemiologist.

HPV causes at least 20,000 cases of cancer in the U.S. each year. Cervical cancer is the most common type, but about a quarter of cancers occur in men, including penile, anal and even head and neck cancers.

© 2008 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.
URL: http://www.msnbc.msn.com/id/27697369/

Monday, December 15, 2008

VM2 December: Shared Decision Making: Physicians’ Duties to Patients and Other Physicians

Resident physicians have a duty to patients when they suspect that an attending physician’s treatment decision has risks about which the patient is unaware.

Commentary by Dawn Brezina, MD

Drs. Johnson and Blake were grabbing a quick bite in the hospital cafeteria. Both were second-year residents in internal medicine, but on different teams. Dr. Johnson's team was headed by a hospitalist (Dr. Norwood), while Dr. Blake's team was headed by rotating attending physicians who came through for 2-week, in-house assignments and then went back to their regular academic and clinic responsibilities. For the current, 2-week block, the general internal medicine attending was Dr. White.

Learning Objective: Understand resident physicians’ duty to patients when they suspect that an attending physician’s treatment decision has risks about which the patient is unaware.

In conversation, Dr. Johnson brought up a patient he had been especially concerned about for several days. “Remember the patient I told you about with cirrhosis? Mr. Hanson? His ascites and edema are out of control. We tapped him just 2 days ago and the fluid's already reaccumulating. When we rounded this morning, Dr. Norwood had us order a transjugular intrahepatic portosystemic shunt (TIPS) for him. It's scheduled for tomorrow morning. I sure hope it gives the guy some relief; he's not looking good.”

“Funny you should bring up that case,” his friend said. “Mr. Hanson is one of Dr. White's clinic patients so I asked Dr. White if we had time to stop by Mr. Hanson's room this morning, even though he isn't assigned to our team, because you had mentioned him the other day. We did stop in and, when Dr. White saw the TIPS order, he launched into quite a lecture.”
“Why? What about?” Dr. Johnson asked.

“Oh, Dr. White said that he's sure it's a good decision from the hospital's point of view; the hospital can discharge Mr. Hanson and free up a bed. But then Mr. Hanson goes home, starts getting confused and not taking his meds, and shows up in the clinic. Poor Mr. Hanson has just traded his ascites for encephalopathy.”

“That sounds like a reasonable argument against doing it. What do you think?” Dr. Johnson asked.

“I'm not sure.” Dr. Blake said. “I'd like to hear them discuss it, to be truthful.”
“Right,” said Dr. Johnson. “Like you want to be the one to go to Dr. Norwood and suggest that this is a great ‘teaching moment' and that he and Dr. White should examine this clinical decision together for our edification.”


Commentary

This is an interesting scenario that highlights questions in ethical decision making in caring for hospitalized patients. Central to this issue, particularly for patients with very serious illnesses, are the potential risks and benefits of the specific intervention. Dr. Johnson seemed surprised to learn of the significant risk of post-TIPS portosystemic encephalopathy. And Drs. Norwood and Johnson have ordered this procedure without discussing the risk to the patient.

Until about 1990, an attending physician's active participation on the general medicine service was limited, and the service was essentially run by house staff. The attending physician was available, reviewed all charts, and helped when asked. Nevertheless, he or she was able to bill for all interventions the patients received. In that model, not all patients routinely benefited from the more-experienced physician's knowledge. On the other hand, senior residents and interns felt a sense of ownership and responsibility for their patients. The new legislation made it illegal for the attending physician to bill for patient care unless he or she could document having directed the care. The attending physician's role in patient care decisions increased as a result of the new reimbursement legislation, and house staff autonomy eroded, sometimes causing residents to feel less responsible for patient-management decisions.

In our case scenario, the teaching service team appears to have a hands-on attending physician, Dr. Norwood, who ordered the TIPS intervention without discussion. One of Dr. Norwood's residents, Dr. Johnson, discovered information at lunch with his friend that could greatly impact the clinical course for the patient—and in time to do something about it—which creates an obligation for him to act on the information. TIPS may be the correct course, but if a reasonable doubt exists, the decision should be examined.

The patient needs to have some voice in this decision also. Diuretic-refractory ascites is one indication for TIPS, but the patient must be aware of the subsequent risk for encephalopathy. The most sacred premise in medical decision making is recommending what is best for the patient—and that may not be the same for every patient. Is the patient so miserable he welcomes the relief offered by the procedure, or is he deathly afraid of encephalopathy?
Presumably, it fell to Dr. Johnson to explain the TIPS decision to Mr. Hanson, but we are not told that he did.

Another aspect of hospital care is communication with the patient's primary doctor. Unless a procedure is emergently needed, consultation with the primary care physician is always an asset to decision making. Drs. Norwood and Johnson should have routinely contacted the physician Mr. Hanson saw in the clinic—Dr. White—for recommendations at the time the decision was being considered. This is not only courtesy; it is essential for follow-up management. Dr. White was correct—the patient may very well come to the clinic with encephalopathy in 3 weeks.

Dr. White incidentally discovered that Mr. Hanson was scheduled for a procedure that he believed would adversely affect his life—but it appears he only mentioned it to the house staff team. Dr. White even suggested that the decision was made from “the hospital's point of view” in order to “free up a bed,” and presumably he was still content to walk away and wait for the patient to show up at the clinic, “having traded his ascites for encephalopathy.” Unless Dr. White intervened after his “lecture” to the residents, his action is unconscionable. Having seen Mr. Hanson in the clinic, Dr. White had an obligation to intervene on Mr. Hanson's behalf, if he truly believed the plan of care was not in his patient's best interest.

Medicine is the process of diagnosis combined with therapeutic decision making. Routine illnesses, such as community-acquired pneumonia, are essentially treated by a decision tree and do not require detailed discussion. Likewise, when a patient is being evaluated, no extensive discussion, other than explaining what the anticipated work-up will entail, is needed prior to low-risk diagnostic procedures, such as ultrasound and lab work. On the other hand, therapeutic interventions that carry risks for complications or compromised lifestyle require patient understanding and agreement. No one would start chemotherapy or radiation therapy without extensively explaining to the patient the risks and benefits anticipated from this therapeutic option. Clearly, the TIPS treatment option was not discussed with Mr. Hanson before it was ordered.

Anyone's best interest can only be assessed after considering his or her fears and desires. Some people are bold risk takers and willing to try aggressive management with high risks. Others would rather live with the illness than undergo painful procedures. Patients should be given information in a way they can understand, followed by the physician's recommendations. With that data, the patient may express his or her personal concerns and desires for the anticipated course of treatment.

In this scenario, it appears that Mr. Hanson was not included in the risk/benefit analysis of the planned TIPS procedure. Actually, not even the house staff were included in the discussion. There are several types of shunts used in the TIPS procedure. The larger the shunt, the more likely the patient is to develop encephalopathy. In some cases, the shunt can later be reversed or, in some institutions, it can subsequently be mechanically reduced—these options might greatly influence the patient's decision to proceed or not.

Other concerns include the reliability of the patient. If Mr. Hanson is unable to comply with the post-procedure medication regimen, as Dr. White suggested, the risk of encephalopathy increases. This is another important reason for including the primary care physician in the decision analysis—he or she may have better insights concerning the likelihood that the patient will successfully manage follow-up care.

The hospital's interest plays a role in patient care decisions but is not the primary concern. Patient length of stay is important, especially in the present environment of declining hospital revenues, and hospitalists are encouraged to move patients to the outpatient setting as soon as possible. That said, if this were, in fact, the motive to proceed with the TIPS rather than inhospital diuresis, that would be a great disservice to Mr. Hanson—who is trusting that the decisions will be made in his best interest—and could be deemed unethical.

Dr. Johnson already knows the correct ethical course. He should go to Dr. Norwood—with data in hand on TIPS procedures—and suggest that this is a great “teaching moment.” Open discussion between Drs. Norwood and White would undoubtedly prove helpful to the house staff involved. Perhaps even more importantly, the discussion would be a great benefit to Drs. Norwood and White.

Dawn Brezina, MD, is a member of the Duke University clinical faculty and Hospitalist Program at Durham Regional Hospital, Duke University Health System in North Carolina. She received a medical degree from the University of Miami Miller Medical School and is ABIM board certified in internal medicine. Her areas of interest include pre-operative and peri-operative management and pre-operative clinic.


Related in VM
Indications for Use of TIPS in Treating Portal Hypertension, December 2008

Sunday, December 14, 2008

Breast Changes Tell Whether Treatment Works: Study

Sat Dec 13, 2008 8:04am EST
By Maggie Fox, Health and Science Editor

WASHINGTON (Reuters) - It may be possible to predict which breast cancer patients will be helped by tamoxifen based on changes in so-called breast density, researchers reported on Saturday.
Women with dense breasts -- a term meaning they have more non-fatty tissue -- are known to have a higher risk of breast cancer and the study suggests that lowering density using tamoxifen also lowers the chances tumors will come back.
Women whose breasts became noticeably less dense after a year or so of taking tamoxifen had a 63 percent reduced risk of breast cancer, the team of British researchers told a breast cancer meeting in San Antonio, Texas.
"It is important to find a way to predict who will respond to tamoxifen, and changes in breast density may constitute an early indicator of benefit," said Jack Cuzick of the Wolfson Institute of Preventive Medicine in London.
He said about 10 percent of women have dense breasts. Such breasts are harder to read on mammograms but there is evidence the tissue in their breasts may be more cancer-prone.
"Women with dense breasts are typically at four to five times the risk of developing breast cancer than women without dense breasts," Cuzick told reporters in a telephone briefing.
Cuzick's team had conducted one of many studies that showed high-risk women who took tamoxifen were at least 40 percent less likely to either develop breast cancer, or to have it come back.
They went back and looked at all the mammograms of the more than 1,000 women who took part in the study.
If a woman's breast density did not change during the treatment, she was much more likely to develop cancer despite taking tamoxifen, Cuzick told the meeting.
TWO-THIRDS REDUCTION
"Women who lost 10 percent or more in breast density -- 40 percent of the women getting tamoxifen -- had a 63 percent, almost a two-thirds, reduction in all breast cancer," he told the briefing.
Cuzick stressed the study only looked at tamoxifen and not at other treatments, such as the newer drugs known as aromatase inhibitors. But he said it validated the idea of using breast density as a way of telling whether a treatment is working, whether tamoxifen or something else.
"If a woman doesn't show breast density dropping within a year or so, you might want to consider other therapy," Cuzick said.
In another report, a team at the Mayo Clinic in Rochester, Minnesota said they found some clues as to why dense breast tissue is more likely to develop tumors.
Dense breast tissue contains more cells believed to give rise to breast cancer, Dr. Karthik Ghosh told the meeting.
Dr. Celine Vachon and colleagues found that dense breast tissue has more aromatase enzyme than non-dense tissue. This is significant because aromatase helps convert hormones into estrogen, which can fuel breast cancer development.
"If aromatase is differentially expressed in dense and non-dense breast tissue, this could provide one mechanism by which density may increase breast cancer risk," Vachon said in a statement.

Saturday, December 13, 2008

No butts about it — fecal transplants work for some

By JoNel Aleccia

Before she got so sick with a Clostridium difficile infection, Vicki Doriott would have been as disgusted as anyone at the idea of a fecal transplant.

Infuse her gut with someone else’s stool? Through a tube in her nose? No, thanks.

But in June 2004, Doriott was actually relieved to show up at a Duluth, Minn., clinic, where doctors sent samples of her husband's excrement sliding into her stomach – and apparently cured the infection that threatened to ruin her life. 

Image: Body Odd

“When those toxins are in your body, you kind of feel like you’re close to death,” said Doriott, 52, an accountant from Eau Claire, Wis., who spent nearly six months battling recurrent bouts of the nasty intestinal bug known as C. diff.  “Nothing else I tried worked.”

Doriott is among a growing number of people who’ve undergone the seemingly gross procedure in a  last ditch effort to restore normal bowel function after severe, recurrent C. diff infection. The little-known technique gained new fame last month when an episode of “Grey’s Anatomy” highlighted the quirky cure that helps 85 percent of those willing to try it.

By coincidence, the specialist who performs most of the fecal transplants in the nation, Dr. Tim Rubin of theDuluth Clinic Digestive Health Center, happened to be channel-surfing at the time. Rubin gave the TV docs a thumbs up in handling the procedure.

“They did very well,” said Rubin, a gastroenterologist.

About the only thing the docs at Seattle Grace got wrong was the method of the preparing the fresh, donated stool that repopulates the gut of C. diff infection sufferers with healthy bacteria. 

“They showed a doctor stirring up a bowl of brown stuff at the bedside and that’s not how it’s done,” said Rubin.

And he should know. As far as Rubin can tell, he and his senior colleagues are the only crew in the country who regularly perform the rare, but growing procedure, variously known as fecal transplant, stool transplant and fecal infusion. 

Since 2002, they’ve performed 64 poop transfers on patients with two or more incurable bouts of C. diff. It’s a technique first documented in the early 1990s by researchers in Norway investigating the best way to treat C. diff infection, which typically occurs when the normal flora in the gut is disturbed, most often by antibiotic use.

Rates of C. diff are skyrocketing in the U.S., where a recent study found 13 of every 1,000 patients in the nation’s hospitals are infected or colonized with the germ.

The antibiotics destroy good bacteria in the colon, allowing the C. diff to flourish. The bug can cause illnesses ranging from severe diarrhea and colitis to blood infection, and in worst cases, death. Most patients with C. diff can control it with powerful antibiotics such as metronidazole, sold as Flagyl, or vancomycin. But in about 20 percent of the cases, even those strong drugs don’t work.

That was the case for Doriott, who figures C. diff spores in her gut were activated when she had two rounds of antibiotics for a sinus infection and dental work within six months. 

“At its worst, I’d have diarrhea every 15 minutes,” recalled Doriott. “I’d be going for two or three days. I’d have a 103-degree fever. I couldn’t make it two steps from the couch.”

After months of exhaustion and illness, Doriott became desperate enough to consider the fecal transplants she’d heard about through research. She contacted Rubin in Duluth and made an appointment for the hour-long office visit.

Typically, patients ask a close household member, usually a spouse, to produce a sample of stool, which is tested for disease and infection. In Doriott's case, her husband, Jerry, 50, a civil engineer, was on tap.

On the day of the transplant, donors provide the feces, which is blended and filtered. A tube is fed through the patient’s nose into the stomach and several teaspoons of the sample are injected through it.

“I refused to look at it,” said Doriott. “All I felt was a coolness. It didn’t smell.”

Doriott said she felt better immediately and hasn’t suffered a C. diff relapse since the treatment. Other patients take a few weeks or even months to recover, Rubin said.

A 2003 case study of 18 patients who received fecal transplants found that two patients who were very ill died shortly after transplant. But of the remaining 16 patients, only one developed C. diff again, according to the study published in the Journal of Clinical Infectious Diseases.

Still, fecal transplant has yet to become a widespread treatment, Rubin said.

“You’re going to go to some places and they’re going to, no pun intended, pooh-pooh it,” he said.

Some scientists worry about controlling infection in donor stools and about finding a good way to handle and process the material, said Jennie Mayfield, a clinical epidemiologist at Barnes-Jewish Hospital at the Washington University School of Medicine in St. Louis, Mo.
And some doctors and patients are still squeamish about the procedure.

“It think it’s the kind of thing in the U.S. where people are talking about it, but people don’t want to go there yet,” Mayfield said. “They’d have to give me Valium.”

But Rubin and Doriott agreed that by the time patients are ill enough with C. diff to consider fecal transplants, neither the ick effect nor the potential for bad puns is a factor.

Dorriott, meantime, has managed to put the event behind her. “My husband doesn’t joke too much,” she said, “because he saw how sick I was.”

Thursday, December 11, 2008

Obama taps former Senate chief Daschle to head HHS

The nominee has proposed creating a federal health board to increase the transparency and value of health care spending.

By Doug Trapp, AMNews staff. Dec. 8, 2008.


Washington -- Praise for the nomination of former Senate Majority Leader Tom Daschle to be the next Dept. of Health and Human Services Secretary began even before President-elect Barack Obama's transition team confirmed the pick had been made.

At press time, Obama had not confirmed that Daschle would be his choice to head HHS. However, Democratic sources, speaking on condition of anonymity because they were not authorized to make announcements for the next administration, indicated that the South Dakota Democrat had accepted the president-elect's request to be the nominee. Also, Obama on Nov. 19 named Daschle to head the transition team's working group on health care. This means Daschle will be the incoming administration's point person on health care policy and legislative priorities.

The initial reaction to Daschle as the HHS nominee was largely positive. "Daschle would be an effective leader of the nation's health department," said American Medical Association Board of Trustees Chair Joseph M. Heyman, MD.

The nomination still requires Senate approval. Sen. Max Baucus (D, Mont.), chair of the Senate Finance Committee, said Daschle would be a great pick for HHS chief. "Daschle knows health care, he knows the Congress and the rhythms of the Senate in particular."

The Republican National Committee criticized Obama for using what they consider a loophole in his pledge not to appoint lobbyists to key positions in his administration. Daschle is not a registered lobbyist, but since 2005 he has been a special policy adviser on health care issues for the law firm Alston and Bird, which does lobby Congress.

Daschle served in the House from 1979 to 1987; the Senate from 1987 to 2005. He was Senate majority leader for part of 2001 and 2002 and continued to lead the party in the upper chamber until he lost his re-election bid in 2004. Since 2005 he also has been a fellow at the Center for American Progress, a liberal policy organization.

In 2007, Daschle joined former Senate majority leaders Howard Baker (R, Tenn.), Bob Dole (R, Kan.) and George Mitchell (D, Maine) to form the Bipartisan Policy Center. The organization is dedicated to finding bipartisan solutions on difficult policy issues, such as health care, and its recommendations on health reform are due by the end of this year.

Daschle also wrote a recent book on health system reform. Critical: What We Can Do About the Health-Care Crisis calls for more government analysis and regulation of health care spending. He proposes creating a federal health board that would set standards for the health care industry in much the way the Federal Reserve Board does for the financial industry.

Daschle writes that the government should pay more for high-quality care that leads to good outcomes and stop paying for unnecessary care. To this end, for example, the health board could sponsor comparative effectiveness research on medical treatments to help set evidence-based standards for federal health programs.