Stem cells and cloning.

The United States' failure to work out a comprehensive and comprehensible set of policies on stem cell research and human cloning is emblematic of a wider, international failure. In an excellent review piece in this week's issue of The Lancet, Carol A. Tauer (Univ. of Minn.) surveys the wreckage and suggests a new approach to forging a consensus.

Mixing science & politics (again).

In an editorial in this week's issue, the editors of the British medical journal The Lancet take the Bush Administration to task for its new policy by which DHHS'

Office of Global Public Health will choose which, if any, US Government scientists can serve as advisers to WHO. Instead of going directly to the experts they want as technical advisers, as WHO has done in the past, the organisation must now provide the Office of Global and Public Health, which is headed by a political appointee, with "terms of reference" for each proposed consultation--a process that it concedes "will require a minimum lead-time of 3 weeks". A written directive goes on to remind WHO that US Government employees are required "to serve as representatives of the US Government at all times and advocate US Government policies".

A spokesman for the HHS strongly denied charges that this newly resurrected policy represents any attempt by the Bush administration to exercise political control over the exchange of scientific information, describing it instead as a method "to create accountability" and to ensure that WHO works with appropriate experts. He said that agency heads have not always been aware of the consulting activities of their employees, and that no specific cases prompted the action.

The editors allow as how HHS' denials ring a little hollow in light of this administration's demonstrated willingness to shade the truth when science doesn't quite fit its political plans. I like the editors' suggestions for ways the Bushites can prove their sincerity:

But let us give the Bush administration the benefit of the doubt. If this move is meant to provide accountability, let us have some from HHS. First, to dispel any perception of divided loyalties, put a career civil servant, not a political appointee, in charge of the process. Then, to ensure proper public accountability, let HSS put on its website names of those consultants WHO asked for, whether HHS agreed with the requests or approved someone else, and the rationale for the decision. Finally, disclose all of the evidence: how long did the approval process take, and at what cost? The public, whom the administration claims to be protecting, can then decide whether this policy streamlines or obfuscates the process of global scientific consultation, and whether it is a good use of the government's time--and taxpayers' money. We would guess not.

2 new cases from Texas Supreme Court.

The Texas Supreme Court had a pretty heavy opinion day on Thursday and handed down a couple of cases of potential interest to health care providers. Providers prevailed in both actions, thus maintaining a winning streak in the Supreme Court that must stretch back years.

Utica National Insurance Co. of Texas v. American Indemnity Co., ___ S.W.3d ___ (Tex., No. 02-0090, July 9, 2004): majority opinion; dissenting opinion.
Mid-Cities Surgi-Center employed a scrub technician who stole fentanyl, an anesthetic, from the surgical center. Apparently using the same syringe, the technician removed fentanyl from the glass ampules in which it was stored, injected himself with the drug, then injected saline solution back into the ampules to hide his theft. He then re-sealed the ampules with super glue and re-wrapped them with cellophane to further hide his crime. Because the technician was infected with Hepatitis C, his use of a dirty syringe allegedly contaminated the ampules. A number of patients who received fentanyl injections, including the four plaintiffs in this lawsuit, subsequently tested positive for Hepatitis C. Plaintiffs sued Mid-Cities Anesthesiology, P.A., a professional association of ten doctors who practiced anesthesia at the surgical center, and the association's member anesthesiologists. The patients alleged numerous negligent actions against the doctors' association and its members, including negligence in "failing to properly secure anesthesia narcotics" and in "exposing patients to contaminated medication." The association's professional liability insurer originally assumed defense of the suit, but later became insolvent. The Texas Property and Casualty Insurance Guaranty Association (TPCIGA) then assumed its obligations.

TPCIGA tendered the suit for a defense and coverage to the Association's general liability insurer at the time of the litigation, American Indemnity, which denied coverage because it was not the insurer at the time the infections occurred. TPCIGA then tendered the suit to the Association's general liability insurer at the time the plaintiff's became infected, Utica National, which denied coverage based upon an exclusion in its policy for "[b]odily injury . . . due to rendering or failure to render any professional service." After TPCIGA and American Indemnity settled the claims, they brought suit against Utica National for defense and settlement costs. The trial court granted motions for summary judgment by TPCIGA and American Indemnity, holding that Utica National's exclusion for professional services did not preclude coverage and awarded judgment against the defendant for the defense costs and full settlement costs, with attorney's fees and pre- and post-judgment interest.  The Court of Appeals in Austin affirmed.

Held: Reversed in part and remanded. The policy excludes coverage only when the insured has breached the standard of care in rendering those professional services. In this case, the allegations in the pleadings raised both the possibility that the treating doctors were negligent in their administration of the drug and the possibility that the doctors' association was negligent in the storage of that drug. Because the plaintiffs alleged both professional and non-professional negligence, the general liability insurer had a duty to defend the underlying suit in this case under the eight-corners doctrine. But because a fact issue exists about whether the patients' injuries were caused at least in part by the doctors' rendition of professional services, in which event Utica National's policy would not cover the doctors' association, the Supreme Court remanded the indemnity claims to the trial court for further proceedings.

Justice Hecht dissented in an opinion joined by Justice Owen. The essence of his opinion is set out in the following passage: "I cannot see how it is remotely possible for a physician to be negligent in preserving the purity of medications administered to patients by himself and those with whom he associates and yet not be in breach of a professional standard of care. Thus, I would hold that the patients' claims were for professional liability, against which Utica had no obligation under its CGL policy to defend or indemnify. The Court does not foreclose this result but remands for fact findings. If I am correct C if the association and its members could not have been negligent without violating a professional standard of care C the outcome will eventually be the same."

Martinez v. Val Verde County Hospital District, ___ S.W.3d ___ (Tex., No. 03-0611, July 9, 2004): opinion.

Kaelyn Martinez, age 3, underwent a tonsillectomy at the Val Verde Regional Medical Center. Kaelyn’s parents, Marcus Martinez and Mary Koog, filed suit a little over two years after the operation, individually and on behalf of Kaelyn, against the Val Verde County Hospital District (which operates as the Medical Center) and others.  The Hospital District is a governmental unit immune from suit under the Texas Tort Claims Act, Tex. Civ. Rem. & Pract. Code § 101.001 et seq., but Martinez and Koog invoked the Act's exception for liability based upon the use of tangible property,
id. § 101.021(2).

The Act requires that a governmental unit receive notice of any claim against it within six months of the incident giving rise to the claim unless it already has actual notice. Id. § 101.101. The Hospital District first received notice of the claims of Kaelyn and her parents six months and twenty-two days after Kaelyn’s surgery, and Martinez and Koog did not contend that the Hospital District had actual notice before then. Accordingly, the Hospital District filed a plea to the jurisdiction, asserting that because it did not receive notice as
required by the Act, its immunity from suit was not waived, and the court lacked subject matter jurisdiction of the claims against it. The trial court sustained the plea and ordered the case dismissed with prejudice.

The parents argued (1) that the notice requirements of the Act are not jurisdictional and therefore the trial court had subject matter jurisdiction of their claims, and (2) that the notice provision of the Act should be tolled if the claimant is a minor, unless the statute clearly states that its time limits are not tolled during a claimant's minority. The court of appeals held that Kaelyn’s minority did not toll the six-month period for giving notice.  The court also ruled that notice is not a condition of the Act’s waiver of immunity that should be raised in a plea to the court's jurisdiction but instead is an affirmative defense that should be raised by motion for summary judgment. The court therefore reversed the trial court’s dismissal for want of jurisdiction and remanded the case for further proceedings.

Held: Affirmed. As to the appellants' tolling argument, the Supreme Court, per Justice Hecht, observed, "One can believe, as the court of appeals did, that it is unfair to require a minor who cannot sue to give the notice required by the Tort Claims Act, but the State is not required to waive immunity from suit at all. The fairness or wisdom of the waiver is not our province to decide."

French ban human cloning.

According to the International Herald-Tribune, France has banned human cloning (now punishable by up to 30 years in prison and a fine of over US$ 9 million). They also suspended their ban on stem cell research on human embryos for five years. AP reports (courtesy of the Seattle Post-Intelligencer) that the prison term is 20 years. It also says that the new bioethics law, originally introduced by the Socialist government almost 3 years ago, does not include a provision that would have made it legal for a widow to be impregnated with an embryo created when her husband was still alive.

Studies Look at Health Care in the U.S.

The N.Y. Times ran a short article in today's paper surveying some of the emerging theories, and the developing consensus, among health care economists. After reviewing the usual benchmarks that place the United States at or near the bottom of developed countries in health-care measure despite spending more, and more per capita, than the others, author Jeff Madrick, continues:

What may surprise readers, and certainly surprised this writer, is that Americans, by paying so much more, do not have many more services. In fact, according to recent research, they typically have fewer. Consider the number of doctors. In 2001, the United States had 2.7 doctors per 1,000 people, compared with a median of 3.1 in the countries in the Organization for Economic Cooperation and Development. France, accused of having a doctor shortage in last summer's heat wave, had 3.3 per 1,000.

Also, consider the number of hospital beds. The United States has only 2.9 hospital beds per 1,000 people, compared with the O.E.C.D. median of 3.9. Germany has 6.3. The United States is also behind in the actual days spent in a hospital and hospital admissions per capita. These are not necessarily bad in themselves, but the question is why we spend so much.

The reason for the high level of American spending, argue the researchers - Uwe E. Reinhardt of Princeton and Peter S. Hussey and Gerard F. Anderson of Johns Hopkins - is that American doctors and hospitals charge much more. Americans also usually pay significantly more for drugs, they say, and administration expenses are exorbitant.

OIG's statement re: Scully, the CMS chief auditor, and the price of Medicare reform.

The Acting Principal Deputy Inspector General's statement is on the OIG website. Chairman Grassley released a brief statement about the IG's report and posted it to the Senate Finance Committee's website. The IG's statement says the report has been forwarded to the Secretary of HHS, but so far there's nothing in that agency's web site about the report. The folks who should be really upset at this are the Republicans who relied on CMS' budget projections when they cast their votes in favor of Medicare last fall. Where's the noise?

Also, OIG may have concluded that Scully broke no laws, but apparently the nonpartisan Congressional Research Service concluded otherwise. At least, that's what Rep. Charlie Rangel said in a letter to the chairman of the House Ways and Means Committee, in which he quotes from the CRS report that he (Rangel) requested. So far, at least, the CRS report itself seems not to be available on the Web.

According to Rangel's letter, the laws in question are 5 U.S.C. § 7211, §§ 618 and 620 of P.L. 108-199 [NOTE: see 118 Stat. 354-55 (pp. 352-53 of 455)], 42 U.S.C. § 1317, and 5 U.S.C. § 2302(b)(8).

For a great summary of the issues, the responses, and the next steps for this controversy: Kaiser Family Foundation's Daily Health Policy Report.

Health Affairs' mega-med-mal issue.

The July/August issue of Health Affairs was released today, and it's a doozy: half the issue is devoted to observations, empirical studies, and prescriptions for what is universally described as a medical-malpractice crisis. Here are some of the highlights (from the free previews and abstracts on the journal's web site):

• The Forgotten Third: Liability Insurance And The Medical Malpractice Crisis, William M. Sage [Abstract]:
  Although the most visible manifestations of medical malpractice involve patient safety and the legal process, the availability and affordability of liability insurance largely determine the direction of medical malpractice policy. Scientific and industrial developments since the first modern malpractice crisis in the 1970s reveal major problems with the structure and regulation of liability insurance. Comprehensive reforms that approach medical malpractice insurance as a health policy problem are needed, and the Medicare program may have a major role to play.


• A Mediation Skills Model To Manage Disclosure Of Errors And Adverse Events To Patients, Carol B. Liebman and Chris Stern Hyman [Abstract]:
  In 2002 Pennsylvania became the first state to impose on hospitals a statutory duty to notify patients in writing of a serious event. If the disclosure conversations are carefully planned, properly executed, and responsive to patients’ needs, this new requirement creates possible benefits for both patient safety and litigation risk management. This paper describes a model for accomplishing these goals that encourages health care providers to communicate more effectively with patients following an adverse event or medical error, learn from mistakes, respond to the concerns of patients and families after an adverse event, and arrive at a fair and cost-effective resolution of valid claims.


• Improving The Medical Malpractice Litigation Process, Catherine T. Struve
  [Abstract]:
  Critics charge that judges and juries are incompetent to address medical liability issues. Some advocate shifting authority away from ordinary judges and juries, either by appointing "expert" decisionmakers, such as "medical screening panels" or specialized "medical courts," or by instituting caps on damages. Problems with the tort liability system may weigh in favor of a shift to a no-fault administrative compensation system. If the current fault-based system is retained, however, policymakers should not adopt half-measures by creating "expert" panels or "expert" courts. Rather, they should better equip the existing decisionmakers to deal with liability and damages questions.


• Caring For Patients In A Malpractice Crisis: Physician Satisfaction And Quality Of Care, Michelle M. Mello, David M. Studdert, Catherine M. DesRoches, Jordon Peugh, Kinga Zapert, Troyen A. Brennan, and William M. Sage [Abstract]:
  The rhetoric of malpractice reform is at fever pitch, but political advocacy does not necessarily reflect grassroots opinion. To determine whether the ongoing liability crisis has greatly reduced physicians’ professional satisfaction, we surveyed specialist physicians in Pennsylvania. We found widespread discontent among physicians practicing in high-liability environments, which seems to be compounded by other financial and administrative pressures. Opinion alone should not determine public policy, but physicians’ perceptions matter for two reasons. First, perceptions influence behavior with respect to practice environment and clinical decision making. Second, perceptions influence the physician-patient relationship and the interpersonal quality of care.


• Are Damages Caps Regressive? A Study Of Malpractice Jury Verdicts In California, David M. Studdert, Y. Tony Yang, and Michelle M. Mello [Abstract]:
  Caps on damages have emerged as the most controversial legislative response to the new malpractice crisis. We analyzed a sample of high-end jury verdicts in California that were subjected to the state’s $250,000 cap on noneconomic damages. We found strong evidence that the cap’s fiscal impact was distributed inequitably across different types of injuries. In absolute dollar terms, the reductions imposed on grave injury were seven times larger than those for minor injury; the largest proportional reductions were for injuries that centered on pain and disfigurement. Use of sliding scales of damages instead of or in conjunction with caps would mitigate their adverse impacts on fairness.

Scully pressured actuary, didn't break law: OIG reports

According to a report in this afternoon's "Daily Dose" (by Modern Healthcare), the DHHS OIG has concluded that Tom Scully did, indeed, pressure the CMS chief actuary to withhold the true price tag ($524 billion over 10 years) of the Medicare prescription drug benefit from Congress last fall. More than that, the Administration's earlier (and affirmatively false) figure of $395 billion was allowed to stand, because of Republicans in Congress who announced they would not support a reform package that cost more than $400 billion. No action will be taken against Scully, who no longer works for the government (he's in the DC office of Alston & Bird), and the OIG has further concluded that no criminal laws were violated. Congress itself is looking into that question, so time will tell. This story broke with the announcement that the OIG would be testifying about its conclusions before Sen. Grassley's Senate Finance Committee this afternoon. (Nothing about this appears on the committee's web site, on the OIG's "current testimony" web page, or -- needless to say -- Alston & Bird's web site as of 4:00pm today.)

Do pediatricians need lawyers in order to provide good care?

That's the tantalizing question in an article in the July 2004 issue of Pediatrics. The full article isn't available on the web, but an abstract is:

PEDIATRICS Vol. 114 No. 1 July 2004, pp. 224-228

--------------------------------------------------------------------------------

SPECIAL ARTICLE

Why Pediatricians Need Lawyers to Keep Children Healthy
Pediatricians recognize that social and nonmedical factors influence child health and that there are many government programs and laws designed to provide for children’s basic needs. However, gaps in implementation result in denials of services, leading to preventable poor health outcomes. Physician advocacy in these arenas is often limited by lack of knowledge, experience, and resources to intervene. The incorporation of on-site lawyers into the health care team facilitates the provision of crucial legal services to vulnerable families. Although social workers and case managers play a critical role in assessing family stability and finding appropriate resources for families, lawyers are trained to identify violations of rights and to take the appropriate legal steps to hold agencies, landlords, schools, and others accountable on behalf of families. The incorporation of lawyers in the clinical setting originated at an urban academic medical center and is being replicated at >30 sites across the country. Lawyers can help enhance a culture of advocacy in pediatrics by providing direct legal assistance and case consultation for providers, as well as jointly addressing systemic issues affecting children and families. Until laws to promote health and safety are consistently applied and enforced, pediatricians will need lawyers to effectively care for vulnerable children.
--------------------------------------------------------------------------------
Barry Zuckerman, MD, Megan Sandel, MD, MPH, Lauren Smith, MD, MPH and Ellen Lawton, JD

From the Department of Pediatrics, Boston Medical Center/Boston University School of Medicine, Boston, Massachusetts

Medicine and literature.

Catching up on some reading . . . the May 22 issue of The Lancet continues its series of articles by (or, in earlier installments, about) physician-writers with a truly splendid piece by Brazilian physician and author Moacyr Scliar. All are available for free (albeit with a brief registration form). Here are all the articles in this series that I know of:

• Moacry Scliar
• Martin Winckler
• Richard Selzer
• Jerome Groopman
• Perri Klass
• John Murray
• Phil Whitaker
• Jed Mercurio
• Khaled Hosseini
• Samuel Shem
• Atul Gawande
• Rita Charon
• Cecil Helman
• Jonathan Kaplan

I hope students in the Law, Literature & Medicine class I teach with Patty Hicks will get the chance to read a few of these.

Meanwhile, permit me this idle speculation: Where have all the serious lawyer-writers gone? Most seem to have settled for the easy bucks of mass-market pot-boilers with an option on the screenplay, soon to be a major motion picture opening in theater near you. Scott Turow is the exception - a gifted writer whose mysteries transcend the genre by lifting the entire enterprise up a level or two. My Scottish compadre, Sandy McCall-Smith, has done the same with his successful series on Mma. Precious Ramotswe of Botswana and her No. 1 Ladies Detective Agency. For another generation, Louis Auchincloss was comfortable writing serious fiction, and his near-contemporary was the poet Archibald MacLeish. And . . . ?

Health reform and the presidential election.

Last month (June 5), the British medical journal The Lancet hopefully titled its editorial on U.S. health care and the November election, "Bush vs Kerry: health is a critically decisive issue" (free). After surveying the relatively tepic health-reform proposals of both the Bush and the Kerry camps, however, and reminding us that the Clintons' experience in 1993 has probably turned ambitious health reform into one of the many "third rails of American politics," the editorial doesn't seem to hold out much hope for anything major in this election cycle. Voters themselves, "say they are for health reform, most, being middle class, have health insurance, and have, in the past at least, proved to be reluctant to support changes that they fear might drive up their own costs or threaten their benefits." So, in the great American tradition of doing the right thing only after all other alternatives have been exhausted, the editorialists conclude: "But as the current health-care crisis continues, and as more and more middle-class Americans see their out-of-pocket expenses rise and their benefits threatened, voters may be ready to heed calls for far more fundamental reform than either candidate now dares to propose."

The Vice-President's physician.

This week's New Yorker has an article by correspondent Jane Mayer on VP Cheney's physician's battle with addiction. The New York Times and The Washington Post picked up the story in this morning's editions, too. Specifically, the physician who famously declared Cheney fit for office four months before Cheney suffered his fourth heart attack has been battling an addiction to narcotics for nine years. Last month, he was removed as chair of George Washington University Medical Center's Department of General Internal Medicine and from the Veep's health care staff.

Mayer does a good job detailing the extent of the physicians' purchases and, inferentially, his impairment:

According to pharmacy records and customer invoices, in July, 2000, for example, the month that Malakoff wrote the letter certifying Cheney’s good health, he purchased thirty bottles of a synthetic narcotic nasal spray called Stadol from two mail-order drug-supply companies. Stadol, which can be addictive, is ordinarily used to treat migraine headaches. Each bottle contains an estimated fifteen doses. In the previous two months, he had bought eighteen bottles. In August, he bought twenty-eight more bottles. During the two-and-half-year period ending in December, 2001, Malakoff spent at least $46,238 online on Stadol and such medications as Xanax, Tylenol with codeine, and Ambien.

That's 76 bottles (and 1140 doses) in 5 months. The guidelines for prescribing the drug call for 1 dose, followed by another dose in 60-90 minutes if there is no relief from the first dose, followed by additional 2-dose sequences as needed every 3-4 hours, so Cheney's doc's 7.5 doses per day (assuming he consumed all 1140 doses during the five-month period that he placed his orders) are within the prescription guidelines for the drug. Adding Schedule III-IV drugs like Xanax, Tylenol with codeine, and Ambien, however, suggest a serious problem. (It's unclear, though, how much of the other drugs he was taking. At $92 a bottle (from drugstore.com) he would have spent $41,400 on Stadol during the two-and-a-half-year period described in Mayer's article, leaving only about $5,000 for other drug purchases.)

The issue in all this isn't the fall of a presumably talented physician into the clutches of a dastardly affliction, tragic as that is. The questions raised by Mayer's article, explicitly or implicitly, are:

• Whether the GWU administration responded appropriately when they learned of their colleague's addiction. Even though prescribing under another physician's name and DEA number, which is apparently how these prescriptions were obtained, is a civil and cirminal offense, it appears that GWU informed neither the DC licensing board nor the DEA.


• In addition to the public's legitimate interest in the health of high-ranking public officials, does the public have a similar interest in the health of the health providers who care for those public officials and pronounce them fit for office?

Medical ethicist: Honesty isn't always the best policy.

Daniel Sokol, a medical ethicist of the Imperial College Faculty of Medicine, London, has an interesting piece in the International Herald Tribune defending the use of deception in the rare case in which honesty (i.e., respecting a patient's autonomy) might lead to death or serious harm -- that is, when truth-telling is clearly not in the patient's best interests. Sokol's presentation is pretty standard fare, and most ethicists and clinicians, I suspect, would agree with his article. It's important, however, to keep this exception to the principle of respect for autonomy within bounds, lest the exception swallow up the rule.

Sokol's short piece doesn't provide much guidance for one of the more perplexing debates in medical ethics: whether it's ever ethical to prescribe a placebo for a therapeutic purpose. (Good bibliography here.) Conventional wisdom has it that the placebo effect is lost when the patient is told that she is getting a sugar pill or other inert substance, so the efficacy of the placebo depends upon deception. Sokol allows for the deception when necessary to avoid significant harm ("nonmaleficence"); would his argument also allow for deception in order to achieve a therapeutic benefit ("beneficence")? The overwhelming consensus among ethicists appears to be "no," yet the practice seems to persist among practitioners for what appears to be a variety of reasons. This piece by Gregory Loeben does a nice job of making the case against deception to produce a benefit for the patient.

July 4: George III & George II.

Cheers to the N.Y. Times editorial editors for running Barbara Ehrenreich's brilliant op-ed, "Their George and Ours." As she works her way through the Declaration of Independence's bill of particulars against George III, the parallels to our own present leaders' policies keep mounting. They will catch some flak for running this piece, I'll wager, but who can object to the closing three paragraphs:

But it is the final sentence of the declaration that deserves the closest study: "And for the support of this Declaration . . . we mutually pledge to each other our Lives, our Fortunes and our sacred Honor." Today, those who believe that the war on terror requires the sacrifice of our liberties like to argue that "the Constitution is not a suicide pact." In a sense, however, the Declaration of Independence was precisely that.

By signing Jefferson's text, the signers of the declaration were putting their lives on the line. England was then the world's greatest military power, against which a bunch of provincial farmers had little chance of prevailing. Benjamin Franklin wasn't kidding around with his quip about hanging together or hanging separately. If the rebel American militias were beaten on the battlefield, their ringleaders could expect to be hanged as traitors.

They signed anyway, thereby stating to the world that there is something worth more than life, and that is liberty. Thanks to their courage, we do not have to risk death to preserve the liberties they bequeathed us. All we have to do is vote.

Mammalian cloning continues to pose safety concerns.

From the BBC, there's a story today about U.S. researchers from Cornell who reported to the European Fertility Conference in Berlin that mouse experiments comparing assisted reproduction techniques with cloning showed "significantly impaired development in the cloned embryos compared with those derived from more conventional ART techniques and this has made us more convinced that reproductive cloning is unsafe and should not be applied to humans." The article quotes the executive director of the European Society of Human Embryology and Reproduction: "There is absolutely general agreement that reproductive cloning should be banned. It's clear from all the available experiments that it's much too dangerous." Researchers conduct research, and technologists exploit technology, because scientific challenges exist to be conquered. For the time being, only the most reckless will attempt to clone humans for reproduction, but when the safety issues is tamed, we will have to give serious consideration to the non-safety objections to reproductive cloning that were raised by the President's Council on Bioethics.

Has the U.S. lost its capacity for outrage?

That's the question I asked myself after reading Art Caplan's piece in Newsday today. Art tells the tale of the recent meeting in Denver of the American Society of Concierge Physicians: "Concierge medicine is a special, high-end form of medical care that guarantees that if you need treatment you will get it, without a hassle, seven days a week-but only for an extra fee. If you can pay amounts that range from $20 to thousands of dollars a month, you can guarantee that your phone calls will be promptly returned by your doctor and that you'll get special attention whenever you're admitted to a hospital." He contrasts the "quality medicine for the rich" philosophy of the ASCP with TennCare's recent cutbacks to the state's Medicaid program:

It is making over its state Medicaid program known as TennCare. If this program gets implemented, many of the poor, elderly, children and disabled in Tennessee who rely on Medicaid will be told simply to get over it. And other hard-pressed states may well follow suit.

Gov. Phil Bredesen, a former HMO entrepreneur, sees the challenge of health care for the poor in Tennessee in very stark terms. In a speech last February, the governor described the state Medicaid program as nothing more than an open checkbook that is continuously being raided by "doctors and hospitals and advocates" who "decide what is needed."

Caplan's opening paragraph provides a fitting close, as well: "Just how bad is the state of health care in America? Well, consider two recent developments that shine a spotlight on a system that was already showing signs of severe distress, even before the Supreme Court decided to let HMOs off the legal hook. In Colorado the rich are paying what amount to bribes to make sure that they are at the head of the line when it comes to getting health care, and in Tennessee the poor are basically being told to get lost."

I've examined concierge, or "boutique," medicine in this space before, and as recently as last week reported on a hospital in the tony Hamptons on Long Island that has offered "concierge emergency care" contracts to selected (and wealthy) residents in its service area. I understand the frustration physicians feel on the daily treadmill practicing "hamster medicine," as well as the doom and gloom many state CEO's feel as they contemplate the sinking of state budgets by seemingly boundless growth in the demand for health care dollars. But neither of the developments chronicled in Caplan's piece provides a viable answer to managed care woes or the problems of the indigent and the uninsured. In fact, what they both have in common is a set of blinders that allows the concierge docs and the state to say, "Screw the consequences. We're holding on to whatever we can keep for ourselves, despite the cost to the system."

PhRMA proposes guidelines for publication of negative clinical trial results.

As previously noted, this is generating a lot of interest on the part of the press, NYS Att'y Gen'l Eliot Spitzer, and others. (Kaiser Foundation's web page has a good summary of the various strands of this issue.) Now the drug industry's trade association, PhRMA, has revised its principles on the subject, according a story in today's Wall Street Journal (requires paid subscription). Click for the press release, a backgrounder on clinical trials, and "Principles on Conduct of Clinical Trials and Communication of Clinical Trial Results." The updated voluntary guidelines call for "timely communication of meaningful study results, regardless of the outcome of the study," and apply to clinical trials started after October 2, 2002.

Companies are currently required to publicize the results of trials only in connection with initial applications for marketing permission, but not in the post-marketing phase when drugs are tested for their efficacy in connection with other diseases or in comparison with other drugs. An editorial in today's Washington Post notes that pressure to publish negative results may backfire: "Forcing companies to publish results of all trials, as opposed to the fact of their existence, is more complicated, because a simple government regulation requiring publication of all results of all clinical trials might backfire and wind up discouraging companies from conducting any trials at all. For that reason, Congress -- not the New York courts -- needs to take up this issue again and look at incentives that might persuade companies to conduct more and better clinical trials, even if they aren't commercially advantageous. It should also consider establishing a routine, nationwide system of comparative drug testing, using university and other academic researchers. Any system that leads to the concealment or manipulation of research isn't serving doctors, patients or, in the end, even drug companies very well."

Lucky for Florida the antitrust laws don't apply to state action.

As reported in today's "Daily Dose" from Modern Healthcare: "Florida banned specialty hospitals aimed at a single condition and eliminated its certificate-of-need law for new adult open-heart surgery and angioplasty programs at general hospitals. The law, signed yesterday by Gov. Jeb Bush, also exempts from CON the addition of beds to existing structures, but a CON is still required for new structures. . . . 'There are no single-specialty niche hospitals in the state of Florida at this time, and this legislation would prevent any development,' [Ralph Glatfelter, Sr. VP at the Florida Hospital Association] said." Hospitals generally hate the competition from specialty hospitals, especially when the new entity is financed and/or organized by members of the general hospital's own medical staff. Some hospitals have succeeded in dodging the bullet by joining with their docs in a joint-ventured specialty hospital. For hospitals that lack the money or the good relationship with their physicians to pull off a joint venture, the new competition can be devastating. Florida's new laws -- SB 182 and HB 329 -- provide such hospitals with welcome relief from the competition.

Charity care and nonprofit hospitals: ABA teleconference materials (4/28/04).

Here's a page of good background materials on charity care and tax-exempt status generally, some policy considerations from Nancy Kane at Harvard's School of Public Health, and some local insights into Champaign County's decision to revoke the tax-exempt status of Provena Covenant Medical Center. After diligently scouring the Web, I have come up empty-handed in my search for a copy of the decision of the Illinois Department of Revenue in that case.

More on Provena Covenant.

The Kaiser Family Foundation's website has a good summary of the WSJ journal article mentioned below. The Champaign County Board of Review's decision is here. I'll get a link to the Illinois Department of Revenue's decision as soon as I can find it.