Medical error: does it kill 195,000 annually?

When the IOM study, To Err Is Human (report brief), came out in 1999, it caused an uproar with its estimate that as many as 95,000 Americans a year die as the result of preventable medical error. According to HealthGrades, that estimate would have been twice as large if the IOM had included (1) failure to diagnose and treat a serious medical problem in time and (2) unexpected death in a low-risk hospitalization. HealthGrades bases its estimate on a review of 37 million Medicare records. Their report is HealthGrades Quality Study: Patient Safety in American Hospitals (July 2004).

Health care reform redux.

Tonight's Democratic National Convention kick-off will be punctuated by a lot of applause lines.  One of the biggest will be for health care reform.  The Clintons proved in 1993 just how volatile this issue can be, but the National Coalition on Health Care -- which claims to represent nearly 100 of the nation's largest businesses, unions, provider groups, insurers, pension funds, and other groups -- may have demonstrated last week that the country is at last ready to focus on access to care, as well as cost and quality.  From The Commonwealth Fund's "HealthBeat" for July 26:

A broad coalition of insurers, consumers, providers, labor unions, and other groups warned today that absent a dramatic overhaul of the health system in the near future, premiums will soar and the number of uninsured will rise sharply. Soaring health costs are reducing economic growth and new jobs, corporate profits, the competitiveness of corporations, and the viability of pensions, said the National Coalition on Health Care. . . .

The coalition said that if policymakers fail to act, premiums for family coverage will top $14,500 in 2006, and the number of uninsured will reach 51 million that year. In addition, the deficit will rise by trillions of dollars in coming decades, it added. The coalition calls for legislation covering all Americans within two or three years of enactment. Health cost increases should be brought in line with cost increases in other parts of the economy within five years. "Today's report is politically significant because it shows that there is broad support across most sectors of the economy and society, and across party lines for tough, system-wide reform," said coalition co-chair Paul Rogers, former Democratic House member from Florida. The coalition's honorary co-chairs are former Presidents Clinton, Bush, and Carter.

The NCHC's report, "Building A Better Health System," is worth a read.  As the Executive Summary makes clear, the Coalition has done a good job of identifying the most glaring needs of the health care system.  What remains to be seen is whether they -- or anyone else -- have a plan to implement the group's five specifications:

1. Health Care Coverage for All
• to be achieved within two to three years after the passage of legislation
• defined core benefit package
• employers and individuals able to purchase supplemental coverage beyond core package
• options for insuring all Americans include
     - employer mandates (supplemented with individual mandates as necessary)
     - expansion of existing public programs that cover subsets of the uninsured
     - creation of new programs targeted at subsets of the uninsured
     - establishment of a universal publicly financed program
• mandatory participation
• subsidies for less affluent

2. Cost Management
• within five years, bring increases in the costs and premiums associated with the core benefit package into alignment with increases in per capita gross domestic product
• increase the value for patients that is generated by any given level of health care spending
• measures include:
     - providing more and better information for patients, providers, and purchasers
     - improving quality and outcomes of care and reducing amount of unnecessary and injurious care
     - building national information technology infrastructure for health care
     - modernizing and simplifying administration
• urgent need for cost relief requires short-term constraints:
     - rates for reimbursing providers for care encompassed by core benefit package and
     - only after those rates take effect, limits on increases in insurance premiums for coverage defined by that package
• to facilitate comparisons, insurers required to set premiums separately for core benefit package and supplemental coverage

3. Improvement of Health Care Quality and Safety
• accelerated development of an integrated national information technology infrastructure for health care, including:
     - protocols for electronic patient records, prescription ordering, and billing
     - standards to protect privacy
     - mechanisms to incentivize and provide capital for the upfront investments necessary to build the infrastructure
• measures of process and outcomes quality to improve accountability and help payers and patients make better choices
• independent national board, with members drawn equally from public and private sectors, to coordinate public and private efforts to improve quality of care
• board also responsible for coordinating development of national practice guidelines
     - guidelines to be based on reviews, by panels of leading health care professionals, of research on impacts of technologies and procedures
- guidelines could be cited in malpractice cases as evidence of best medical practice
• board to update core benefit package to reflect changes in practice guidelines

4. Equitable Financing
• measures to reduce or eliminate cost-shifting across categories of insurance programs and payers
• mechanisms or sources that could be used, individually or in combination, to fund program costs include:
     - general revenues
     - earmarked taxes and/or fees
     - contributions required from employers
     - contributions required from individuals and families
• financial obligations to be adjusted, or subsidies provided, based on relative ability to pay for less affluent individuals, families, and employers

5. Simplified Administration
• assurance of coverage for all Americans and establishment of core benefit package to create consistent set of ground rules and reduce variations that now draw time and resources away from protection and advancement of health
• creation of an integrated national information technology infrastructure – including electronic patient records, prescription ordering, and billing – to reduce administrative complexity, costs, and medical errors
• national practice guidelines to reduce variability of care and billing and improve quality of care

The Coalition can't be faulted for failing to think big.  Specifically, its report sets out three premises that underlay their detailed specifications:

Health care reform must be a national priority.
Comprehensive health care reform is long overdue. Every year that reform is delayed, tens of millions of Americans live in peril, without health insurance; millions are harmed, and hundreds of thousands die needlessly, because of sub-standard care; and health care costs continue to spiral ever upwards.

The Coalition’s specifications are meant not just to encourage and help to frame a national debate about health care reform, but to create momentum for the passage of legislation. These specifications are an expression of operational intent: Our member organizations are determined to work with other organizations and with policymakers in both parties to secure the reforms described here.  Yes, we need a vigorous debate about health care policy — but what we really need is action, and soon.

Health care reform must be systemic.
The Coalition’s specifications were developed not as a shopping list of potential stand-alone initiatives, but as a linked series of targets, criteria, and options — meant to be adopted concurrently and to work together.  The vast American health care sector is exquisitely and elaborately interconnected. Partial or piecemeal reforms, even those conceived and implemented with the best of intentions, can produce unanticipated adverse consequences far from the focus or locus of those targeted reforms.

For example, a dramatic expansion of access, implemented without accompanying measures to improve quality and manage costs, could produce an overloaded health care system that delivers worse care (albeit to more people) at higher costs.  Similarly, constraints on costs (and reimbursements for care), pursued in isolation,
could compromise both access and quality.

A system is a set of institutions and processes that function together to achieve defined objectives. The Coalition’s specifications were designed to serve multiple goals simultaneously. We began our development of recommendations by agreeing on five core principles for reform (which appear below as section headings for our specifications).  Then, as our deliberations proceeded, we continuously revisited and recalibrated our recommendations to make sure that the individual components fused together into a sensible systemic strategy.

We believe that a systemic approach can increase not only the substantive
coherence of reform, but also its political feasibility. Thus, if constraints on health care cost increases were proposed in isolation, providers might understandably anticipate that their revenues going forward would be diminished. By contrast, if those same constraints were conjoined in a systemic strategy with an assurance of
coverage for all Americans and financing for their care, providers would receive payment for care that they now provide, with little or no compensation, to uninsured patients.

Health care reform must be system-wide.
The Coalition is calling for system-wide reforms, not for changes that would apply to only some payers, patients, or providers.  Unless reform is system-wide, gains in some sectors or for some groups are likely to be offset by losses elsewhere.  There is, in addition to this practical consideration, another compelling argument for making certain that reform is system-wide.  America is already a nation of health care haves and have-nots.  Reform should aim to assure that all Americans receive excellent
health care and are able to enjoy the quality of life and peace of mind for which such care is essential. Piecemeal reform that helps some categories of people to the detriment of others would not take us closer to an optimal health care system and could actually make it harder to attain.

Patient safety, quality bill heads to conference

Thanks to AHLA's Health Law Highlights for this summary of last week's events on the long-delayed patient safety and quality bill:

The Senate approved July 22 legislation intended to improve patient safety by promoting medical error reporting (Congressional Record). The "Patient Safety and Quality Improvement Act" would encourage voluntary error reporting by protecting patient safety data from disclosure so that healthcare providers could report medical errors without fear of being sued. The Senate Committee on Health, Education, Labor and Pensions unanimously approved S. 720 last year, while the House passed a similar bill in March 2003 (H.R. 663). [In parliamentary terms, the Senate incorporated S.720 in H.R. 663, as an amendment and then passed H.R. 663. So now the two versions of H.R. 663 go to conference to be reconciled.] The legislation was prompted by a 1999 Institute of Medicine Report [To Err Is Human] that found as many as 98,000 people die each year as a result of preventable medical errors.

FDA, preemption, & tort reform.

Preemption is one of those issues -- along with issue and claim preclusion, exhaustion of remedies, and justiciability -- that only a lawyer can love. It's technical, messy, and a one-way ticket to Palookaville for plaintiffs unlucky enough to bump up against it in their state-law-based tort suits.

Preemption starts off easy: Under the Supremacy Clause, federal laws take precedence over state laws. When a state law is inconsistent with federal law (whether in statutes, treaties, court decisions, or the Constitution), the state law gives way to the federal.

That may be the only easy thing about the doctrine. Figuring out what counts as a federal/state conflict, and then determining how broadly preemptive the federal law should be, can be very tricky.

Case in point: the federal laws that regulate drug and medical devices. Should the fact that a manufacturer has jumped through the hurdles of the federal Food, Drug and Cosmetic Act ("FDCA") to prove the safety and efficacy of its drug or device mean that an injured plaintiff cannot sue the manufacturer under state tort law, on the theory that "regulation" of these manufacturers by state tort law should be deemed preempted by the federal statutory regulation of drugs and devices that is already in place? With devices, it's particularly tricky, because medical devices are assisgned to "classes" based upon their potential harm to the user. Class I devices present the least potential harm and are subject to the least regulatory control. Class III devices, on the other hand, go through the most exacting level of agency regulation. When it comes to preemption of state tort law, different levels of regulation might very well be viewed in a different light and produce different results.

In 1996, the Supreme Court had an opportunity to consider the preemptive effect of federal law in a Class III device case. In Medtronic v. Lohr, the Court had to figure out the preemptive effect of language added to the FDCA by the Medical Device Amendments of 1976:

Except as provided in subsection (b) of this section, no State or political subdivision of a State may establish or continue in effect with respect to a device intended for human use any requirement (1) which is different from, or in addition to, any requirement applicable under this chapter to the device, and (2) which relates to the safety or effectiveness of the device or to any other matter included in a requirement applicable to the device under this chapter.

The Court concluded that -- despite the relative rigor with which Class III devices are regulated -- the federal statutory language did not preempt state-law claims for negligent design, negligent manufacture, and failure to warn. Primary among the the Court's reasons was the absence of any federal cause of action for injured consumers, so that acceptance of the manufacturers' argument that state law claims are preempted would have left plaintiffs with no remedy whatsoever. It was also important to the Court that with respect to the device involved in this case, Medtronic did not actually go through the high hurdles of Class III regulation, because it successfully claimed that its device was "substantially equivalent" to other peviously approved devices.

Since 1996, the FDA has taken the position that federal law is not broadly preemptive when it comes to state laws that would hold manufacturers to a higher standard than the federal one -- in effect arguing that federal law sets a floor when it comes to design, manufacturing practices, and labeling, but not a ceiling. Starting in 2002, however, the Bush Administration has taken the position that federal law is broadly preemptive and sets both a floor and a ceiling. The result of this shift can be seen in opinions like the Third Circuit's last Tuesday in Horn v. Thoratec Corp. (No. 02-4597), in which the court -- relying heavily on a brief filed by the Bush Administration as friend of the court -- concluded that Medtronic was not controlling precedent and the plaintiff's state tort claims were preempted by the federal law. The principal reason for dissing Medtronic was the fact that the device in the Horn case had in fact gone through the rigorous pre-market approval process for Class III devices rather than rely on the generic requirements that apply to devices that seek marketing approval under the "substantial equivalence" test.

Although this distinction appears to have been on the Supreme Court's mind in Medtronic and has much to recommend itself as a matter of statutory text and regulatory policy, its broad application to claims such as Mrs. Horn's (and numerous other plaintiffs who have been bounced out of court by the Bush Administration's zealous advocacy on behalf of manufacturers) represents a new chapter in the Bush Administration's pursuit of "tort reform," a chapter that leaves many injured patients and their survivors with no relief at all. "Compassionate conservatism"? Hah! Meanwhile, you can read about the shift and its political implications in a good article by Robert Pear in today's New York Times.

Death penalty & psychotropic drugs.

On July 21st, U.S. District Judge Royal Fergeson (U.S. District Court for the Western District, Pecos Division) granted a Texas death-row inmate's petition for habeas corpus relief in an 80-page opinion that (1) blows the state's case out of the water; (2) includes harrowing accounts of prosecutorial misconduct and ineffective assistance of counsel; (3) depicts the Texas Court of Criminal Appeals (our highest state court for the review of criminal convictions) as incompetent, uncaring, or both; and (4) declares unconstitutional the administration of antipsychotic drugs to the defendant without his knowledge or consent during the pre-trial and trial despite the fact that the defendant showed no symptoms of psychosis. The result of that last item was that during the guilt and punishment phase of the trial, the defendant was noticeably without facial expression or other affect, making him appear to be supremely indifferent to the charges, the evidence, the trial, or much of anything else.

I have two questions: (1) What do you suppose the U.S. Court of Appeals for the Fifth Circuit will do with this on appeal? (2) What did the physicians who ordered the daily doses of Haldol and Perphenazine think they were doing?

Drug reimportation: video conference.

The Alliance for Health Reform and Kaiser Family Foundation put on a 1.5 hour conference on reimportation yesterday. The video plus PowerPoint slides are available here. Of especial note are the slides from Donna Vogt and Susan Thaul (both of the Congressional Research Service) comparing and contrasting the competing bills, which are:

• HR 2427 (not yet available; try here) (Gutnecht)
• S 2307 (Grassley)
• S 2328 (Dorgan)
• s 2493 (Gregg)

Unfortunately, the slides presented by Tom McGinnis, Director of Pharmacy Affairs, FDA, aren't included on the Kaiser web site (above) or the Alliance's web site (though the Alliance site has a wealth of supplemental materials). The slides may eventually show up on the FDA web site, but until then, there's the July 14 testimony of William K. Hubbard, Associate Commissioner for Policy and Planning, FDA, before the Senate Judiciary Committee.

FTC/DOJ: Abolish CON laws.

It had to happen sooner or later: One of the mainstays of federal health care policy for 20 years -- state Certificate of Need (CON) laws -- are now being vilified by the joint FTC/DOJ task force on competition in health care. The group also counseled states not to pass laws that authorize collective bargaining by physicians (too late, in the case of Texas, but our law is so cumbersome and intrusive that it has been virtually a dead letter since its enactment) and was critical of state regulation of pharmacy benefit managers and state-mandated health insurance benefits.

The DOJ/FTC report was issued today and can be found here.

Long-term care: crisis.

Molly Ivins isn't the first, only the latest, in a long and growing line of commentators who see long-term care as The Next Big Thing in health care. This part of the health care industry is woefully undercaptalized and underdeveloped, and if things seem bad at the local nursing home now, wait until the Boomers start hitting those places (the oldest Boomers start turning 60 next year). Molly's most recent column highlights the problem. (For the next few days, it'll pop up when you click here. After that, click on the Archive window "To See Earlier Columns" and then click on July 20, 2004.)

Other recent coverage of this issue gives a glimpse into the looming crisis: "Long-Term Care Tests Governors" (Olympia (Wash.) Olympian) . . . "Congressional Briefing on Long-Term Care Alternatives" (U.S. Newsire) . . . Deborah Stone: "Shopping for Long-Term Care" (Health Affairs) . . .

JCAHO hit in GAO report for CMS.

If you can understand the title of this post without a translator, you're a true health-law nerd!

As the Associated Press reports today (courtesy of the Indianapolis Star), the Government Accountability Office (GAO (formerly the "General Accounting Office")) has filed a report that is extremely critical of the performance of the Joint Commission for Accreditation of Healthcare Organizations (JCAHO (formerly the Joint Commission for the Accreditation of Hospitals)) in its role as the designated Medicare accreditation-surveyor for the Centers for Medicare and Medicaid Services (CMS (formerly the Health Care Financing Administration). (The link to the GAO report is probably not a stable address; if it stops working, try here.)

The report includes the following:

JCAHO’s pre-2004 hospital accreditation process did not identify most of the hospitals found by state survey agencies in CMS’s annual validation survey sample to have deficiencies in Medicare requirements. In comparing the results of the two surveys, CMS considered whether it was reasonable to conclude that the deficiencies found by state survey agencies existed at the time JCAHO surveyed the hospital. In a sample of 500 JCAHO-accredited hospitals, state agency validation surveys conducted in fiscal years 2000 through 2002 identified 31 percent (157 hospitals) with deficiencies in Medicare requirements. Of these 157 hospitals, JCAHO did not identify 78 percent (123 hospitals) as having deficiencies in Medicare requirements. For the same validation survey sample, JCAHO also did not identify the majority -- about 69 percent -- of deficiencies in Medicare requirements found by state agencies. Importantly, the number of deficiencies found by validation surveys represents 2 percent of the 11,000 Medicare requirements surveyed by state agencies in the sample during this time period. At the same time, a single deficiency in a Medicare requirement can limit the hospital’s capability to provide adequate care and ensure patient safety and health. Inadequacies in nursing practices or deficiencies in a hospital’s physical environment, which includes fire safety, are examples of deficiencies in Medicare requirements that could endanger multiple patients.

The potential of JCAHO’s new hospital accreditation process to improve the detection of deficiencies in Medicare requirements is unknown because the process was just implemented in January 2004. JCAHO plans to move from using announced to unannounced surveys in 2006, which would afford JCAHO the opportunity to observe hospitals’ operations when the hospitals have not prepared in advance to be surveyed. In addition, the pilot test of the new accreditation process was of limited value in predicting whether it will be an improvement over the pre-2004 process in detecting deficiencies. Limitations in the pilot test included that hospitals were not randomly selected to participate; that observers from JCAHO accompanied each surveyor, thus possibly affecting surveyors’ actions; and that JCAHO evaluated the results instead of an independent entity.

CMS has limited oversight authority over JCAHO’s hospital accreditation program because the program’s unique legal status effectively prevents CMS from taking actions that it has the authority to take with other health care accreditation programs to ensure satisfactory performance. For example, requiring JCAHO’s hospital accreditation program to submit to a direct review process or placing the program on probation while monitoring its performance. Further, CMS relies on a measure to evaluate how well JCAHO’s hospital accreditation program detects deficiencies in Medicare requirements that provides limited information and can mask problems with program performance, uses statistical methods that are insufficient to assess JCAHO’s performance, and has reduced the number of validation surveys it conducts.

The AP story provides a little more detail:

Many of the overlooked problems related to fire safety, while others involved substandard care.

In a Texas hospital, a patient died after receiving a double dose of narcotics in the emergency room. A California hospital lacked "a sanitary environment to avoid sources and transmission of infections and communicable diseases and failed to develop a system for ensuring the sterilization of medical instruments," the report said.

Predictably, JCAHO isn't pleased with the report:

Commission President Dennis O'Leary said his group made sweeping changes to the accreditation process earlier this year.

"In our view, it is irresponsible to alarm the public using statistics that have little meaning," O'Leary said in response to the GAO report.

What the AP story doesn't say (and I can't find it in the GAO report, either) is that in the 20+ years JCAHO has been in the "deeming" business with CMS, a few provisionally accredited hospitals have been denied full accreditation, but no fully accredited hospital has ever lost its accreditation. (If any reader can cite me an example that disproves this statement, I'd love to see it.) Long viewed as a toothless tiger by many in the industry, JCAHO ought to feel the sting of this GAO report. And, as denials go, President O'Leary's face-saving comment that "we're better than that now" isn't much of one.

Genetic screening and . . .

Amy Harmon has a good article in today's N.Y. Times about genetic screening -- pre- and post-conception -- and (i) the lack of uniform professional standards for when to offer screening, (ii) the lack of government regulation of the field, and (iii) the growing belief that prospective parents are entitled at least to the information about which tests are available, which ones are covered by insurance, and what the risks are whichever way parents decide to go. Right now, its the Wild, Wild West, but the combined forces of consumer demand, tort law's search for evolving professional standards, and the self-protective instincts of professional societies suggest that there's going to be a new marshal in town, sooner rather than later.

Drug reimportation.

Here's a terrific audio report from Congressional Quarterly's Capitol Hill Bureau Chief Mary Agnes Carey on the status of the House and Senate reimportation bills, the prospects of anything coming out of this week's markup session, and the political angle on this issue in 2004. If you have trouble opening the audio file, here's a link to the transcript of this broadcast.

Blame the lawyers.

Today's on-line Wall Street Journal has the results of an interesting survey about Americans' concerns over health care quality (requires subscription). 

Public concern about medical, surgical and diagnostic errors is high and many Americans have doubts about the ability of medical institutions to prevent these types of errors, according to the latest WSJ Online/Harris Interactive health poll.

Sixty-three percent of those polled say they are "extremely concerned" or "very concerned" about medication errors, such as receiving the wrong medicine, that can take place in a hospital. And more than half of respondents are extremely or very concerned about surgical errors.

And the source of this problem?  According to Vice-President Cheney (as reported by Ceci Connolly in today's Washington Post, and brought to my attention by former student Jonathan Childers):

"This problem doesn't start in the waiting room," Cheney said in remarks released by the campaign. "It doesn't start in the operating room. The problem starts in the courtroom."

With lawsuits on the rise and multimillion-dollar awards making headlines, physicians and many Republicans say limiting damages is the solution to the broader challenges confronting the U.S. health system. In their analysis, capping damages will lead to lower malpractice premiums, which will reduce doctors' use of unnecessary tests and procedures, known as defensive medicine. Those improvements will result in better care at a lower cost, enabling more people to buy coverage, they say.

Here's the quote you will hear over and over again from the Administration between now and the November election: "When it comes to the legal crisis in American health care, the Kerry-Edwards ticket is on the side of personal-injury trial lawyers, and the Bush-Cheney ticket is on the side of doctors and patients." Easy on the ears, easy on the brain. Sure beats having an actual plan to deal with this country's health care problems, doesn't it?

Class actions suits against non-profit hospitals.

Julie Appleby has a review piece in today's USA Today. From the sidebar:

• Several high-profile law firms have filed 31 cases against non-profit hospitals and hospital chains since late June. The cases make similar allegations, including: Some hospitals violate an implicit contract with the government to provide charity care in exchange for tax-exempt status by charging uninsured patients more than the insured or aggressively pursuing debts from low-income patients.
• Some facilities have large cash reserves they should use to provide charity care.
• They allow for-profit entities, such as doctor groups, to use their facilities to earn a profit.
• Hospitals named include the Cleveland Clinic; New York-Presbyterian; Sutter Health in Sacramento; Advocate Health Care Network in Chicago; Phoebe Putney Health Systems in Albany, Ga.; Baptist Health Systems in Alabama; and Catholic Healthcare Partners in Cincinnati.

The article offers some quotations I haven't seen in previous reporting:

Patient advocates, who were the first to publicize some of the concerns now included in Scruggs' cases, have mixed thoughts on the lawsuits. "This is a huge wake-up call," says Claudia Lennhoff of the Champaign County Health Care Consumers group in Illinois.

They also worry about the financial effect of the cases on non-profits.

"Having more scrutiny of billing practices is a good thing, but the risk is we're not taking on big tobacco, we're taking on a vital service," says Mark Rukavina of the Access Project, a national resource center that works with local groups on health care issues. "It's an industry I want to preserve, not bring down."

Some health law attorneys are skeptical that Scruggs' arguments will succeed.

"The behaviors they're targeting (billing and collection practices against the uninsured) are atrocious in some circumstances, but they're not illegal," says Gregg Bloche, a law professor of health law at Georgetown University. "The suits will fail."

Nor do they think there is an implied contract between hospitals and the government.

"That's never been recognized in the law," says Stuart Gerson, a partner at Epstein Becker & Green in Washington, D.C., who represents a hospital being sued. "The idea of an individual citizen, a taxpayer, seeking to enforce charitable obligations is, at least, a very novel argument that finds little support."

If any laws are being broken by the common hospital practice of allowing for-profit doctors to use their facilities, or if facilities are improperly steering business to trustees' companies, those arguments should be heard by taxing authorities or federal and state antitrust or anti-kickback regulators, Gerson says.

The lawsuits are renewing debate over the legal and ethical responsibility the nation's non-profits have to provide charity care.

"The IRS has never been really clear about what the grant of tax-exempt status means," says attorney John Reiss of the law firm Saul Ewing in Philadelphia. "It's never been clear that it actually commits you to providing any particular amount of charity care or anything else."

Non-profit hospitals say they provide a variety of charitable services. Hospitals have different ways of classifying such care, with some saying charity is providing medical services to anyone who walks in the ER, regardless of their ability to pay.

Others consider write-offs for bad debt charity care or financing community services, such as supporting health clinics.

More on designer babies.

The Sunday Independent (U.K.) has a report in today's issue:

A two-year-old boy who needs urgent treatment to cure a rare and potentially fatal blood disorder is at the centre of a fresh row over creating "designer babies" with human embryos.

The Human Fertility and Embryology Authority (HFEA) is poised to relax its rules on using genetic screening for medical treatments on Wednesday. The decision will have profound consequences for the life of Joshua Fletcher and children like him.

Joshua suffers from a rare genetic defect called Diamond-Blackfan anaemia, one requiring regular blood transfusions. His parents, Joe and Julie Fletcher, from County Antrim, Northern Ireland, have asked the HFEA to permit the genetic selection of a healthy sibling to help cure him by using that baby to donate healthy stem cells.

The present HFEA rule prevents parents selecting embryos solely because that child will have desirable characteristics, even if they will save another life - the central issue in Joshua's case.

Two years ago, the HFEA was heavily criticised for rejecting a similar bid by the family of Charlie Whitaker, who suffered from the same disorder. His parents instead flew to Chicago for fertility treatment, and had a genetically matched son. . . .

The HFEA's possible relaxation of the rules in this field is already stirring up opposition:

At present, embryos can only be screened before implantation using a technique called pre-implantation genetic diagnosis if there is a significant risk that the baby will itself be born with a critical or extremely serious genetic condition. Using that child to then treat another child is currently seen by the HFEA as a secondary benefit of the technique.

The proposal, which follows an HFEA rule review, has already provoked a fierce controversy over the religious and medical ethics of creating "made to order" babies simply to save another child's life. Critics claim embryo selection could easily lead to parents selecting babies because of their hair colour, gender or intelligence, and eventually to cloning.

Yesterday, a Christian think tank warned that an HFEA rule relaxation would be instantly challenged in the courts. Roger Smith, of the Centre for Bioethics and Public Policy, said: "The law says the welfare and best interests of the child being born has to be their primary consideration - not creating one life for the sake of another. That seems to us to be outside ethical boundaries."

The HFEA is also under intense pressure from fertility experts, parents and medical charities to soften its regulations after rejecting earlier bids by other families with Diamond-Blackfan anaemia. One family flew to the United States for treatment. Three further families with children with Diamond-Blackfan anaemia are preparing bids to the HFEA.

An HFEA spokeswoman said the authority could either reject the Fletchers' proposal or seek further information before making a decision.

Conceiving a child to save another.

An article in today's Arizona Daily Star discusses the practice of conceiving a child in order to produce a donor (bone marrow, cord blood . . . ), which the editors describe as "deeply controversial." In and of itself, it's hard to see where the moral objection, or the argument for regulation, comes in. The article identifies a few problems, only one of which focuses on the decision to conceive for the benefit of another:

•  Dr. Michael Graham, director of pediatric bone-marrow transplantation at University Medical Center (in Phoenix): "The underlying principle of medical ethics is that no person can exist solely for somebody else's benefit. So I worried about creating a child specifically to create a donor."  The key word in this Kantian objection is solely, which posits that the utilitarian reason for having another child is the only reason, rather than one of many.  The fact that a child is born for reasons that benefit others (parents who want the additional companionship in older age, a sibling who would otherwise be an only-child) hardly seems like a reason not to conceive, as long as the child will be valued, loved, and protected in his or her own right.
• Of course, that last notion does give one pause, certainly when you hear about a family that plans to put the "donor baby" up for adoption after the donation has occurred (so far, a hypothetical concern only).  Dr. Graham "was especially concerned about a North Carolina mother with a diseased child who took fertility drugs to try to have a 'donor baby,' even though she was divorced. She had twins, but neither turned out to be a match.  'So here are two more children in a split and strained family,' he said."  True, but that North Carolina mom could have had babies for any reason, or no reason at all, with the same result.  The question is how paternalistic do we want to be.
• In vitro fertilization raises other issues, at least for the Catholic church and others who object to the creation of multiple embryos, followed by genetic screening to identify the best match, and destruction of the unused embryos.

Interestingly, "some ethicists have argued it might be morally wrong not to have a donor or designer baby, if possible, when another child's life is at stake.  'In a situation that requires an intervention involving no sacrifice and no inconvenience by one child in order to save the life of another child, (this) is morally acceptable. It may even be morally required,' Dr. Merle Spriggs, head of the Ethics Unit at Royal Children's Hospital in Victoria, Australia, wrote in a British medical journal."

Reimportation bill stalls in Senate.

Ruby L. Bailey wrote a good piece on reimportation in yesterday's Detroit Free Press (provided here courtest of the San Jose Mercury News). In particular, she provided a concise comparison of the competing Senate bills:

COMPARING THE BILLS

Two U.S. Senate bills would allow drug importation into the United States from Canada and other countries. How they compare: Pharmaceutical Market Access and Drug Safety Act (Democrat-sponsored) [S.2328] 1. The FDA has 90 days to create rules permitting drug importation. U.S. pharmacies and drug wholesalers can import medicines from Canada in the first year and 19 other countries thereafter. Individuals could be shipped prescriptions from mail order or Web sites from FDA-approved Canadian pharmacies. 2. It's unlawful for drugmakers to limit supply or alter drugs to fail FDA standards. 3. A 1 percent user fee is imposed to fund FDA inspections. 4. Exporters to individuals must post a bond that they forfeit if they send unsafe drugs.

Safe Importing of Medical Products and RX Therapies Act (GOP-sponsored) [S.2493] 1. The FDA has one year to make safety recommendations before permitting imports from Canada and up to three years for 15 European Union countries. The FDA could ban drugs from some nations. 2. There is no provision making it unlawful to reduce supply or alter drugs to fail FDA standards. 3. A new, uncapped user fee program is established, paid for by all foreign and domestic businesses engaged in importation to pay for FDA inspections. 4. Licensing requirements and penalties are established for all online pharmacies that illegally conduct or solicit U.S. business.

Gary Hart: no joke.

Gary Hart.  Mention his name and you are bound to get a snicker.  Donna Rice . . . "Monkey Business" . . .  But consider this from tomorrow's review (in the N.Y. Times) of his new book, The Fourth Power:

Few Americans have more right to say ''I told you so'' than Gary Hart. During the 1990's, when the foreign policy establishment was obsessed with Star Wars and other issues left over from the cold war, Hart headed a commission on national security with another former senator, Warren Rudman. Its report, issued early in 2001, warned of catastrophic terrorist attacks in which ''Americans will likely die on American soil, possibly in large numbers.'' Incredibly, the work of the Hart-Rudman commission was widely ignored by the press and the Bush administration.

''The Fourth Power'' builds on the many ideas of the commission, offering sweeping recommendations for how America should orient its foreign policy in the 21st century. Hart's timely central argument -- an alternative to both the neoimperialist impulses of the Bush administration and the creeping Kissingerian realism of the Kerry campaign -- is that the traditional military, political and economic powers of American foreign policy should be constrained by and imbued with a fourth power, America's unique principles. To those who advocate a crusading foreign policy of preemption to ''rid the world of evil'' and spread democracy -- even at the point of a gun -- Hart argues that the first casualty would often be America's moral authority: ''There is a vast difference between advocating, as I do, that America live up to its own principles and advocating, as the Bush administration does, that the rest of the world live up to America's principles.'' At the same time, Hart counters Kerry's retreat to a Kissinger-style foreign policy, based largely on America's interests, with a humble but still idealistic internationalism, with the spread of liberal democracy at its core. It's a call for nation building without Abu Ghraib.

In 1993, Hart sent President Clinton a memo arguing that the end of the cold war was the ideal occasion to reorient the military ''for new missions relating to hostage rescue, counterterrorism, low intensity conflict, guerrilla warfare and stabilization of new democracies.'' Much of this prescient document is reprinted as an appendix. We were told.

Readers respond to PAS column by Kristof.

As noted here recently, Nicholas Kristof wrote an op-ed piece lauding the Oregon Death With Dignity Act, which legalized physician-assisted suicide. Four readers respond in today's N.Y. Times. The responses range from the syllogistic (killing is wrong; suicide is a subset of killing; suicide is wrong) to the empathic. That latter category includes both sentiments both pro (PAS is a humane alternative to "the cruelty of a medical and legal system that requires keeping bodies going despite the wishes of suffering, hopelessly ill people") and con ("palliative care . . . is an invaluable alternative to euthanasia. Those with terminal illness need not end their own lives. Death with dignity is possible without hemlock"). Perhaps the least persuasive of the letters grounded its argument entirely in autonomy: "Terminally ill, competent adults should be allowed to die on their own terms." As an argument in favor of allowing patients who want to die to kill themselves, this argument works, but it's already legal in all 50 states to kill yourself. As an argument in favor of state-sanctioned and supported medicalized killing, autonomy falls flat. All but the most zealous proponents of patients' rights concede that autonomy has limits, which usually arise when a person's autonomous right to do X has consequences for others. Beating the autonomy drum for PAS fails to address the subtler problem of line-drawing that such a claim inevitably raises.

Assisted suicide and Ashcroft.

As previously noted here, John Ashcroft has tried to halt Oregon's "Death With Dignity" experiment by threatening action against any physician who participates in assisted suicide by writing a prescription for a drug that appears on the federal government's list of controlled substances. His legal theory appears to be that the exception allowing physicians to prescribe controlled substances within the practice of medicine allows the Attorney General to determine what constitutes the practice of medicine, and physician-assisted suicide doesn't fit his definition. A federal appeals court recently ruled that what constitutes "the practice of medicine" is something for the states to decide, not the Attorney General, and if Oregon says it includes PAS, then that's the end of the matter.

On Monday, Ashcroft's Justice Department sought reconsideration by the appellate court, which prompted a thoughtful op-ed piece by Nicholas D. Kristof in today's N.Y. Times. Even if you (like me) thought the Oregon law was a bad idea, this is worth reading. I admit that I've come around on this subject because of the Oregon experiment, and Kristof highlights important aspects of that experience quite well.

House votes to allow Canada drug imports.

The Associated Press is reporting (via Yahoo! News) that the House of Representatives voted 389-31 to approve a $16.8 billion appropriations bill for the Dep't of Agriculture and the FDA that includes a measure that would legalize prescription drug purchases from Canadian sources. That's the good news. The bad news: "The provision is not expected to remain in the final spending bill to be reconciled later by House and Senate negotiators, a Republican staff member said. . . . A nearly identical plan was passed by the House last year, only to be removed later in House-Senate negotiations."