The U.S. Constitution may still recognize, in the Fifth Amendment, the right not to be deprived of life, liberty, or property "without due process of law." In current jurisprudence, however, these rights are by no means unalienable. They are subject to many contingencies especially the need to preserve federal regulatory schemes.

Sitting en banc, the D.C. Circuit Court of Appeals reversed a 15-month-old decision upholding the right of certain patients to access certain potentially life-saving drugs not yet approved by the Food and Drug Administration (Abigail Alliance for Better Access to Developmental Drugs v. Eschenbach).

The Alliance is named for Abigail Burroughs, whose squamous cell carcinoma of the head and neck was diagnosed at age 19. She was denied investigational drugs and died at 21.

The majority of the initial three-judge panel had found that the due-process clause protects the rights of terminally ill patients to "make an informed decision that may prolong life" by using drugs found in Phase I trials to be safe enough for further research [emphasis added].

The court relied heavily on the Cruzan decision: if a patient has a right to choose certain death by declining sustenance, does she not have the right to choose drugs that might prolong life? It distinguished Abigail from the unanimous 1979 Supreme Court decision on laetrile, which concluded that Congress had made no exception in the FDA law for terminally ill patients. Laetrile had not undergone Phase I testing.

Now the dissenting minority, Judges Judith Rogers and Douglas Ginsburg note that Americans have certain "fundamental" rights, as "to fornicate" or "to perform varied sexual acts in private"; the court must apply "strict scrutiny" to governmental interference. But for "nonfundamental" rights, any rational basis for restrictions will suffice. The Ninth Amendment has been rendered a nullity (Roger Pilon, Wall St J 8/10/07).

The right at issue was recast in the en banc ruling as "the right to access experimental and unproven drugs in an attempt to save one's life." This right is nonfundamental as it presumes the existence of a relatively new regime. Only in 1951 did Congress create a category of prescription drugs. In 1962, it started requiring extensive, costly efficacy tests.

What's Really at Stake

The whole legitimacy of the FDA would be undermined by a decision in favor of the Abigail Alliance, observes George Annas, M.D., J.D.. of the Boston University School of Public Health (NEJM 357:408-413). Moreover, "[I]f patients have a right to autonomy, why isn't the requirement of a government- licensed physician at least as burdensome as the requirement of the FDA's approval of an investigational drug?"

The FDA, in response to Abigail Alliance, proposes to expand its compassionate-use program, which "was developed as a kind of political safety valve to provide enough exceptions to save their basic research rules." Individuals might be disinclined to volunteer as research subjects, and risk receiving a placebo, if they had direct access to a drug. This would undermine the collective good. And without scientific evidence from controlled trials, how can any choices be informed?

Upholding the initial Abigail ruling would have been a "huge, huge, devastating decision," said former FDA deputy commissioner William Schultz (NEJM 355:437-440).

The Washington Legal Foundation plans to seek review by the U.S. Supreme Court (www.wlf.org).

The FDA will prevail, Annas predicts. There is no constitutional right to access unapproved drugs, and even if there were, the government has "the same compelling interest in approving drugs as it has in licensing physicians."

Although "the right to choose is a central right of patients," he believes that "the choices can and should be limited to reasonable medical alternatives, which themselves are based on evidence."

When the government assumes responsibility for payment for medical choices, the balancing act involves not only scientific evidence but the best use of societal resources. With "universal" coverage, Canadian style, the right to use private resources for approved treatment is also restricted. Lengthy delays have spurred litigation over interference with fundamental rights (Chaoulli, Murray, and now McCreith [p4]).

We need to recognize a right to medical self-defense, writes AAPS past president Robert Cihak (NewsMax.com 2/18/07).

The Next Level

The balancing act could potentially become universal in the sense of being global as in "A Proposed Model for Global Health Governance" by Lawrence Gostin, J.D., of the Johns Hopkins School of Public Health (JAMA 298:225-228).

The principles include objectives, such as reducing global health disparities; stakeholder obligations; data gathering; enforcement; and ongoing scientific analysis on cost-effective interventions, as by an intergovernmental panel on global health, like the intergovernmental panel on climate change (IPCC), composed of prominent experts.

The IPCC goal is global energy rationing, controlled by an international bureaucracy. Global health rationing will face some of the same obstacles, such as "deep resistance to creating obligations to...transfer wealth." But "[c]ooperative action for global health, like action to address global warming, benefits everyone by diminishing collective vulnerabilities."

Weighed against either the U.S. federal government or all of humankind, Abigail and her cancer are nullities. False promises of safety, security, equality, and health are crushing individual rights to liberty and even to life itself.

FDA: Cost-Effectiveness and Death Toll

Dale Gieringer estimated the number of lives lost owing to FDA-imposed delays (relative to the approval process in foreign countries) and lives saved by keeping unsafe drugs like thalidomide off the market. In a typical decade, delays cost 21,000 120,000 lives, and saved 5,000 10,000. At a cost of $4.4 million per lost life, the annual cost of FDA regulation was estimated to be $49 billion, for benefits of $7 billion (Christopher Conover, Cato Policy Analysis 527, Oct 4, 2004).

Using a "bottom-up" approach, Conover estimated the total cost of all health services regulation to exceed $339 billion per year, for benefits of $170 billion. These costs kill about 22,000 Americans each year, he calculates, exceeding by 4,000 the number (18,000) attributed to lack of health insurance.

Invisible Victims

While politicians focus on what Arnold Kling calls "the universal distraction," the toll of invisible victims mounts. Kling lists the future victims of the financial unsoundness of Medicare "the most important problem in health care policy today"; the victims of "the licensing cartel, which lowers productivity and raises costs"; and the victims of wasteful medical expenditures "promoted by consumer insulation from costs, which in turn is promoted by incentives embedded in the tax system." Add these to victims of regulatory excess.

He advocates a return to insurance, instead of insulation. Universal coverage, he says, reinforces our cultural taboo against paying for medical services (www.tcsdaily.com 8/7/07).

Time Bomb: the $90 Trillion Elephant

To put the unfunded liabilities of Medicare and Social Security in perspective, consider (Wash Times 7/2/07):

Incentives to Die

In a new political satire, Boomsday by Christopher Buckley, baby boomers born between 1946 and 1964 are to be offered tremendous incentives to "voluntarily transition" (commit suicide) by age 75. If only 25% do so, Social Security and Medicare will supposedly become solvent.

Hospice "An Underutilized Option"

In 2004, one-third of Americans who died were receiving hospice care. Median survival in hospice is 26 days. Less than half the patients have terminal cancer; nearly 40% of admissions are for cardiac or pulmonary disease, stroke, debility, or dementia (NEJM 357:321-327).

Frederic M. ("Mac") Ball, R.I.P.

A member of AAPS since 1961 and president in 1977, Frederic M. Ball, M.D., an internist from Charleston, SC, died recently. Dr. Ball was a generous supporter of Private Practice magazine, edited by Francis A. Davis, M.D., and of the international private doctors' group Iatros, as well as AAPS.

AMA Rejects Proposal to Restrict Data

Despite impassioned pleas from proponents, the AMA House of Delegates defeated three proposals about physician prescribing data. Two would have expanded or simplified the Physician Data Restriction Program, which allows physicians to opt out of having their information sold to data miners. One would have banned such information sharing outright. The AMA apparently does not wish to jeopardize some $40 million in revenue from the Physician Masterfile.

Everybody In; Doctors Out

Out of a population of 32 million, 3.2 million Canadians are trying to find a primary care doctor. Canada ranks 24th of 28 major industrialized countries in doctors/1,000 people.

"Government-run health care in Canada inevitably resolves into a dehumanizing system of triage, where the weak and the elderly are hastened to their deaths by actuarial calculation," writes native Canadian Sally Pipes (NY Daily News 7/6/07).

In almost-universal-care Massachusetts, primary physicians have no idea how they could care for 550,000 newly insured people if they seek checkups and other routine covered services. The Massachusetts Medical Society reports that 49% of internists are declining to accept new patients. Boston's top three teaching hospitals say 95% of their doctors in general practice have halted enrollments (Wall St J 7/25/07).

Definitions

The goal is to "ensure that all Americans have affordable, quality health insurance, while protecting current government programs...." Linda Gorman explains the terms.

Affordable: individuals should never have to pay more than 10% of income on "health care," including medical and dental care and counseling, even if working part time and skiing the rest. Protecting programs: allowing them to continue to rip off providers and poorly serve patients while remaining exquisitely responsive to select interest groups plus raising taxes no matter what that does to the productive sectors of the economy. Quality insurance: comprehensive coverage, guaranteed issue, poorly tested "evidence-based" standards, lots of worthless "educational" programs.

Also, efficiency means collapsing everything into one big government-run system; promoting inefficiency means allowing some competition to occur. And compromise means moving closer to a single, government-run system.

Basic health care, something socialized systems are supposedly better at, is "anything I need," writes Greg Scandlen, and non-basic health care is "anything you need."

AAPS Calendar

Sep 6, 14. Arizona chapter, F. Edward Yazbak, M.D.
Oct 10-13. 64th annual meeting, Cherry Hill, NJ.

CMS Can Exclude Providers for Noncompliance

You don't have to be convicted of fraud to be excluded from government programs; under new regulations "CMS could seek program exclusion in cases where providers do not comply with technical billing and coding requirements and for whom other interim sanctions have not worked" (BNA's Health Care Fraud Report 8/1/07). This is supposed to be a "last resort" for recalcitrant providers who are costing the system a lot of money. There is some flexibility for CMS to advocate for a provider, as when loss of certain services could create access problems for beneficiaries, especially in rural areas.

New Stark Rules Pending

Proposed regulations, if implemented, could require the reconsideration and renegotiation of thousands of existing provider-physician agreements that were carefully crafted to comply with current rules. The proposed rule generally represents a retreat to earlier, more conservative positions (ibid.). Specialties likely to be involved in equipment leases are most at risk (MCA 7/23/07).

Office Managers at Risk of Fraud Conviction

Office managers and perhaps billing services involved in coding decisions could be held criminally liable, if the healthcare fraud conviction of James Boesen stands. Boesen was office manager for his brother, an ENT surgeon, who was jointly tried with him. A district judge overturned the convictions on the basis of insufficient evidence. Then an appeals judge reinstated the jury verdict, holding that "[The judge] made his own credibility judgments without regard to the government's best interests." If not reversed, that decision "will set an alarming precedent for office managers" (ibid.).

Do-It-Yourself Tort Reform

Tort reform is stalled in Congress. Damage limits as in California have not reduced frivolous lawsuits; doctors are actually sued more often there. In Louisiana, lawsuits must go to a screening panel first and the winner, usually the doctor, has to pay the costs. Doctors are seeking better ideas. Medical Justice, founded by neurosurgeon Jeffrey Segal, M.D., files countersuits against proponents of meritless lawsuits, among other methods (Wall St J 7/12/07). It has also developed contract language to help protect against internet defamation. A 10% discount on membership is available to AAPS members.

NPI Errors Causing Claims Rejection

Errors made on applications for the NPI, such as incomplete information on other identifiers, are now causing Medicare claims to be rejected. Providers must keep a copy of information they entered into the National Plan and Provider Enumeration System, NPPES. For common errors, see www.cms.hhs.gov/MLNMattersArticles/downloads/SE0725.pdf.

CMS cannot compel an opted-out physician who is a noncovered entity to obtain an NPI. It remains to be seen whether market pressures will force physicians to do so. Minnesota is the first state to pass a law requiring physicians to file all claims electronically. By 2009, physicians there will either have to go 100% cash or become a HIPAA-covered entity.

"Futile" Care Denied

In Texas, hospitals have the legal right to refuse to provide care they determine to be "futile," despite the wishes of the patient or family, or the willingness of a physician to provide the care. Care includes food and water.

The case of an 18-month-old boy with a progressive neurometabolic disorder, Leigh's disease, caused legislators to reconsider the Texas Advance Directives Act, which allows a family only 10 days to find a facility willing to accept the patient before care is terminated. Emilio Gonzalez's mother wanted him to have a tracheotomy and a feeding tube to sustain him until he finally succumbed to his illness as he did while awaiting a hearing on a constitutional challenge to the law in the Travis County Probate court.

Initially, the proposed law would have instituted a policy enacted in 11 states requiring hospitals to continue wanted life- sustaining treatment until a transfer can be completed. It looked as though the bill would pass until the Texas Catholic Conference, probably hearkening to hospitals, unexpectedly testified in favor of a substitute bill that extended the 10-day period to 21 days. This would have been meaningless, writes Wesley J. Smith, because Texas hospitals generally honor each other's futile-care determinations and refuse transfers. The law did not pass; hospitals are urged to be more "sensitive."

"Boiled down to its essence, Futile Care Theory is a form of ad hoc health-care rationing that is at least partly designed to address the problem of tight resources in an era of managed care," Smith writes (National Review Online 5/2/07).

While physicians may say that treatment causes "unwarranted suffering," ventilator patients can always be made comfortable, writes Robert Truog, M.D. Still, concern about excessive expense "may be an ethically legitimate reason to refuse continued treatment to patients like Emilio."

"Health care is not an unlimited resource, and physicians have an ethical obligation to ensure that it is distributed fairly." He deplores the failure of the U.S. to "adopt a systematic approach to allocating resources across the health care spectrum" although he also notes that the monetary savings from consistently denying "futile" life support would be "trivial."

Truog acknowledges that the Texas law "relies on a due- process approach that is more illusory than real." Hospital ethics committees are not a "jury of peers" (NEJM 356:1- 3).

There are numerous other cases nationwide. Doctors at Memorial Hermann said that a feeding tube would be pointless in a 91-year-old patient with Alzheimer's: "her digestive system wasn't able to process the solution [food]." But Edith Pereira's daughter Zee Klein fought for her mother's life and she died 8 months after the hospital declared her care to be futile (Houston Chronicle 5/6/07).

Refusing to Withhold Food a Crime in Britain

Lord Falconer, the Lord Chancellor of England, has warned physicians that they could go to prison or face big compensation claims from family members with a financial interest in the patient's death if they don't carry out an advance directive to withhold food and water. Doctors may declare themselves conscientious objectors, but must refer the patient to someone who will carry out the directive. Patients "driven by fears of meddlesome medical treatment," might tick a box on a form without understanding the facts, warned Dr. Peter Saunders (www.thisislondon.co.uk 11/17/06).

Correspondence

Universal Care Fails. I expected the Buffalo News, a very liberal newspaper, to have a litany of praises for Michael Moore's movie Sicko and a story on how wonderful universal care is for Canadians. I was shocked to read the headline story on July 29 about a man who almost certainly would be dead now had he waited to receive "universal care" for his brain tumor. He had an MRI done in Buffalo rather than waiting 4 months in Ontario. Armed with a study that showed a possibly malignant tumor, Lindsay McCreith headed home to Canada. The next available appointment with a neurosurgeon was in 3 months. Back to Buffalo he went for a biopsy that showed low- grade astrocytoma, which was immediately removed. Reimbursement was refused because he failed to get pre-approval which also takes months. McCreith is now suing the government for violating his right to life, liberty, and security, the same approach taken by Dr. Jacques Chaoulli in Quebec. Each province has it own ban on private insurance. If successful in Ontario, this would be a big win for freedom in medicine in Canada. The trial is scheduled soon.
Lawrence R. Huntoon, M.D., Ph.D., Lake View, NY

What Is Quality? Reading Zen and the Art of Motorcycle Maintenance I learned that Quality is the obverse of the coin that says Caring. You won't go for quality without having caring. And caring looks for quality. It is a Gestalt thing, a heart thing, a thing you know is right. Without "art," you will never get it. Moreover, you will be subject to people who will pick your actions apart by trying to get you to mechanize the motions as if you were to be reproduced and stamped out like another Toyota. Once you give them a hint that there's a formula, they will take it and run with it.
Jack Tidwell, M.D., Columbus, GA

Leftists and "Choice." Universal coverage advocates who see individual mandates as a step along the way are hostile to any consumer-directed product that does not have first-dollar coverage. Their idea of choice is three government plans with deductibles ranging from $100 to $500, or an HMO v. a PPO. They don't understand that a high deductible is balanced by low premiums, or that subsidizing people who are already paying for their own care without insurance will raise costs. They just want the government to take over medicine.
Linda Gorman, Independence Institute, Golden, CO

The Way Out. The current system of employer-provided insurance cannot be sustained much longer, but single payer would be far worse. The federal and state governments need to get out of routine health care. Local communities need to set up local clinics for the poor, and community hospitals as well. Funding should be 99% personal and local not some giant bureaucratic system that siphons off money all the way down from the payer so that very little reaches the people who actually provide the services.

People will value health insurance only when they realize that have to pay for services if something bad happens.
Alieta Eck, M.D., Somerset, NJ

Who's Uninsured? The press will never report it, but the problem of the uninsured is far and away a problem of Latin immigrants, both legal and illegal. About 40% of this population is uninsured. Why? The American system of health insurance is not part of their culture. They don't understand it (who can blame them?). But they do understand paying cash.
Greg Scandlen, Consumers for Health Care Choices

The Bourgeoisie. American socialists resent that their precious issue of "health care for the masses" still depends on small business owners. They consider solo and small-group physicians to be petty capitalists anachronous remnants of the early stages of capitalism. Despite talk to the contrary, socialists would readily accept an outwardly unsocialized corporate medicine, Wal-Mart style. It is much easier to nationalize one large corporation than to deal with thousands of unruly small-shop owners. Sadly, the majority of physicians are still in denial about this only AAPS has had the courage to acknowledge the current status for what it is.
Walter Borg, M.D., Lafayette, LA

Inhibiting Innovation. One reason for slow uptake of information technology in medicine: buyers may wait to buy for fear that government standards will make the purchased product obsolete. Developers may be afraid to invest much until they see where the government is going. Instead they spend their efforts in rent-seeking.
Donna Kinney, CPA, Texas Medical Association

Philosophical Short Circuit. The concept of individual freedom and its responsibilities seems never to be a consideration in leftists' thought processes. All social issues are problems to be solved by a class of intellectuals who will "protect" the Great Unwashed whether they want it or not from both predatory capitalists and their own stupidity. The question is never whether the government should intervene, but what form the intervention should take. Having gained control of education and the media, leftists have plenty of "useful idiots" (voters and strategic allies) who are mesmerized by the promises of justice and equality.
Frank Timmins, Dallas, TX