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.

Catholic nonprofit hospital fights to regain tax exemption in Illinois.

The big news before the recent rash of hearings into and lawsuits against tax-exempts was the decision by Illinois' Department of Revenue affirming the Champaign County Board of Review's determination that the Provena Covenant Medical Center in Urbana was not sufficiently charitable in its operations and no longer deserved to be exempt from local property taxes. The saga is described today in a Wall Street Journal article (requires paid subscription). The Champaign News-Gazette ran a good summary of the case in February after the Department of Revenue handed down its decision. An earlier WSJ article is also available on the web page of the Association of Healthcare Philanthropy.

U.S. health care outcomes compare poorly with other developed nations.

Bob Herbert, in his column in today's N.Y. Times, with a substantial assist from the research of Dr. Barbara Starfield at Johns Hopkins, documents the comparative rankings of this country's health outcomes (e.g., low birth weight percentages, neonatal mortality, infant mortality, life expectancy at age 1 and at age 15):

"Of 13 countries in a recent comparison, the United States ranks an average of 12th (second from the bottom) for 16 available health indicators."

[Dr. Starfield] said the U.S. came in 13th, dead last, in terms of low birth weight percentages; 13th for neonatal mortality and infant mortality over all; 13th for years of potential life lost (excluding external causes); 11th for life expectancy at the age of 1 for females and 12th for males; and 10th for life expectancy at the age of 15 for females and 12th for males.

The standard rejoinder is that the U.S.'s relatively poor showing in such comparisons is not a direct result of a poor health care delivery system but instead is due to the effects of poverty, differences in educational opportunities, and similar "background" effects that can't be cured by the health care system. At some point, however, our leaders (and those, like John Kerry, who aspire to be) need to come to grips with the organization, finance, and delivery of health care in this country. We have the most technically advanced health care in the world, and centers of excellence widely distributed across the country. But that doesn't translate into access and affordability:

The U.S. has the most expensive health care system on the planet, but millions of Americans without access to care die from illnesses that could have been successfully treated if diagnosed in time. Poor people line up at emergency rooms for care that should be provided in a doctor's office or clinic. Each year tens of thousands of men, women and children die from medical errors and many more are maimed. . . .

To get a sense of just how backward we're becoming on these matters, consider that in places like Texas, Florida and Mississippi the politicians are dreaming up new ways to remove the protective cloak of health coverage from children, the elderly and the poor. Texas and Florida have been pulling the plug on coverage for low-income kids. And Mississippi recently approved the deepest cut in Medicaid eligibility for senior citizens and the disabled that has ever been approved anywhere in the U.S.

Even the affluent are finding it more difficult to obtain access to care. For patients with insurance the route to treatment is often a confusing maze of gatekeepers and maddening regulations. The costs of insurance are shifting from employers to employees, and important health decisions are increasingly being made by bureaucrats and pitchmen interested solely in profits.

In the maddening din that passes for a national conversation in this country, distinguished voices like Dr. Starfield's are not easily heard.

Echoing so many other patient advocates, she continues to call for movement on two crucial needs: coverage for the many millions who currently do not have access to care, and the development of a first-rate primary care system, which would bring a sense of coherence to a health care environment that is both chaotic and wildly expensive.

Maybe the reforms described recently by Porter and Teisberg in the May-June Harvard Business Review are the way to go, though I see precious little in their proposal that directly addresses the uninsured, and primary care is only obliquely addressed.

Hospital billing practices reviewed.

It's an old and familiar story for anyone with any experience as a physician, pharmacist, hospital exec, patient, or patient's parent or spouse. (Have I left out anyone?) Routine, 2-hour surgery is billed at $25,652.14, with 4-figure charges for mysteriously named items, astronomical pricing codes for everyday items (the medical equivalent of the Defense Department's $700 hammer), and plain old everyday errors. It's described in a story in yesterday's Washington Post, which relates billing practices to, among other things, the Congressional inquiries into nonprofit hospitals' business practices and the recent class action lawsuits challenging the nonprofits' record in providing charity care (more on these developments here).

Latest marketing ploy from Big Pharm?

As reported in today's N.Y. Times (requires paid subscription), Schering-Plough's been sending 5- and 6-figure checks, unbidden, to physicians "in exchange for an attached 'consulting' agreement that required nothing other than his commitment to prescribe the company's medicines." (Kind of makes you nostalgic for the days when they thought they could buy the loyalty of physicians for the price of a lobster salad lunch once a month.) According to the article, there are several federal investigations looking into the marketing practices of several large drug companies (e.g., Johnson & Johnson, Wyeth and Bristol-Myers Squibb), including a Boston-based look into Schering-Plough.

The article interviewed 20 physicians about the details of the Schering-Plough scheme:

Schering-Plough's tactics, these people said, included paying doctors large sums to prescribe its drug for hepatitis C and to take part in company-sponsored clinical trials that were little more than thinly disguised marketing efforts that required little effort on the doctors' part. Doctors who demonstrated disloyalty by testing other company's drugs, or even talking favorably about them, risked being barred from the Schering-Plough money stream.

Makes you wonder about the company's view of the Medicare anti-kickback law (42 U.S.C. § 1320a-7b(b)), the marketing rules published two years ago by the industry's trade association, PhRMA, and DHHS/OIG's "Compliance Guidance for Pharmaceutical Manufacturers."

William Jewell College (Liberty, MO) adds bioethics major.

William Jewell College, according to a recent AP story (via the Lawrence (KS) Journal-World), has added a bioethics major. Two features of the story seem especially noteworthy:

• Kansas City planners see the major as an important phase in the emergence of KC as a biomedical research center: "The major will include study in biology, chemistry, and religion and philosophy, and it's being introduced as the Kansas City area positions itself to become a hub for biomedical research.
  
  "The Center for Practical Bioethics is in Kansas City, as is the Stowers Institute for Medical Research.
  
  "'I don't think there is any question it will be synergistic,' said Bill Duncan, president of the Kansas City Area Life Sciences Institute."
  
  As Dallas strives to establish itself as the Southwest's biomedical research center, it doesn't seem to have occurred to the powers that be that all this state-of-the-art research just might be complemented by an equally world-class ethics program.



• Best quote: "'I don't see it leading to great employability,' said Bill Bondeson, a medical ethics professor at the University of Missouri in Columbia," in response to William Jewell's reported "hope[] that its graduates will find a ready market for their degrees."

Professor Bill is undoubtedly correct, but if I were a medical-school admissions officer, a grad with this major would probably rocket right to the top of the list.

AMA beating the med-mal crisis drum loudly.

N.Y. Times op-editorialist Bob Herbert has followed up on last Monday's column with another swipe at those who claim that soaring med mal insurance premiums are the result of massive incrases in med mal payouts. This time, though, it's the AMA who gets rapped for feeding the frenzy. Claiming that 20 states are now in a med-mal insurance crisis (up from 12 in 2002), the AMA has conveniently mapped out the whole country for all to see which states are in crisis, which ones are showing problem signs, and which states are "currently okay" (apparently only 6 states are in this last category). An interactive version of the map, with anecdotes, a smattering of statistics, and a description of the current state of the health-care liability laws, can be found here.

In today's column, Herbert claims that the evidence has been misstated or skewed by the AMA, at least as respects Missouri, Florida, and New Jersey. I'd add Texas to the list of so-called crisis states where the evidence seems to point to the opposite conclusion. After the surge of filings to beat the September 1, 2003, effective date of our med-mal reform statute, new filings seem to have virtually dried up. There's been little or no reduction in premiums in tort-reformed states, though, and I am betting (with Bob Herbert) that the docs have been sold a bill of goods about the causes (and cures) for their insurance-premium crisis. For more information, and a slightly more balanced view, check out the GAO report on the alleged med-mal crisis, discussed here last August 1.

Parkland: public hospital blues.

The Dallas Morning News' Sherry Jacobson has been doing a fine job in two recent pieces (6/23, 6/24) covering Parkland's financial woes. Bottom line: Parkland's caught in The Big Squeeze: Federal law requires the hospital to provide emergency medical care to anyone who needs it, regardless of their county (our country) of residence. But state law requires other counties to reimburse Dallas only for care provided to indigents. And each county gets to define "indigency" as it sees fit. So Collin County, which long ago decided it did not want to tax its own residents for indigent health care, has defined indigency to top out at about $4,000 a year for a family of four (about 1/4 the federal definition of poverty). Any Collin County resident making more than that gets treated by Parkland at Dallas County's expense. What is wrong with this picture?

Discounting bills for uninsured patients: not as easy as it sounds.

The Wall Street Journal ran a good article (subscription required) Thursday on the difficult choices faces by hospital administrators when uninsured patients rack up hefty bills: Who should get a discount? And how much of the bill should be written off? Uninsured patients come in all shapes and sizes, and hospital policies are only a starting point for making the hard choices posed by uninsured patients.

More on tax-exemptions.

I particularly recommend a recent (June 22) publication by the staff of the Joint Committee on Taxation entitled "Description of Present Law Relating to Charitable and Other Exempt Organizations and Statistical Information Regarding Growth and Oversight of the Tax-Exempt Sector." It's a good overview of the tax-exempt industry and horn-book style overview of the legal basics.