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.
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
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
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
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.
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
The U.S. GDP in 2007: $14 trillion;
U.S. public debt: $8.8 trillion;
Net worth, US households and nonprofits: $56.2 trillion;
Market capitalization of the S&P 500: $12.7 trillion.
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
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
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).
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
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
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
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-
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
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
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
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