Volume 62, No. 8 August 2006
The problems bedeviling American medicine are well
understood, writes the general manager of health care and life
services for IBM. Costs are growing faster than revenues, and in
the U.S. more people are dying of medical errors than of AIDS,
homicide, and car crashes put together, she states.
"This has become quite literally a matter of life and
death." Fortunately, we have "reached a consensus on at least one
solution: We need to wire our entire health-care infrastructure
into an intelligent national network. Doing so will transform the
quality of care, while streamlining and automating the economics
of health care to produce dramatic cost savings...." The vision
is shared by Hillary Clinton and Bill Frist (Carol Kovac, "Toward
a Digital Health-Care Ecosystem," Wall St J 10/25/05).
And by Newt Gingrich and many others AAPS News, September 2003, December
"The potential for third-party geniuses to extract data and
figure out what it all means is almost limitless," writes Richard
B. Warner, M.D., President of the Kansas Medical Society. "It may
hold as much promise as x-ray vision."
In wartime or "extreme disasters" like Hurricane Katrina,
"advanced expert systems" could track patients' symptoms;
determine possible causes of an outbreak; assess response
effectiveness; and direct scarce resources to where they are most
needed. "Intuitively we know," Gingrich says, that evacuees of
M.D. Anderson died of lack of information, not just cancer. All
we need is a President Eisenhower, who "forced the country to
act" to build the interstate highway system (Newt Gingrich,
Center for Health Transformation, June 29, 2006).
For peacetime and chronic diseases, there's the Archimedes
system invented by heart surgeon and mathematical genius David
Eddy, M.D., to overcome the limitations of the human mind. It
seeks to model human biology in equations, make treatment
recommendations, and figure out what each approach costs. Its
mathematical lever moves vast amounts of data in virtual trials
on virtual patients. It works at least ten times "better than the
current model, which is called thinking," according to Dr.
Richard Kahn, chief scientific officer at the American Diabetes
Association. Real trials, in contrast, cost millions of dollars
and may be obsolete by the time the results come in years later:
Up to one-third of them lead to conclusions that are later
overturned (BusinessWeek online 5/29/06).
System Must Be Universal, Interoperable
As Linda Gorman points out, we can already have instant
electronic records no Congress required. Everybody can buy a USB
flashstick, tested for ruggedness and reliability by millions of
teenagers. Doctors and hospitals can put your medical records on
it using the national document interchange standard: Adobe
Acrobat. Moreover, we already have Wal-Mart and Home Depot with
their telephones and network of contacts to divert supplies to a
distressed region, rather than a "dumb, bug-ridden hunk of
Nevertheless, writes James Knight, M.D., CEO of Consumer
Directed Health Care, the government wants doctors to spend tens
of thousands of dollars on new, unproven technology; learn how to
spend time entering data they already know; and be responsible
for the security of that data at the risk of going to jail all
without additional pay.
Without interoperability, "the government can't rummage
through everyone's records at will," Gorman explains.
Interoperability enables data mining, which has already
proved its potential. It made UnitedHealthcare Group what it is
today. Only 25% of United's profits come from its HMO business.
In 1993, it sold its Diversified Pharmaceutical Services to Smith
Kline Beecham for $2.3 billion, agreeing to provide access to its
pharmaceutical data mining operation data.
Data mining enables organizations to create reports of
quality indicators, which they can use to drive practice changes
(Richard Reece, HealthLeaders Media 6/27/06).
If public report cards are to work, "participation must be
mandatory and quality measurements...must be universally
adopted," write Rachel Werner and David Asch. Otherwise, "the
sickest patients will be shifted from rated to unrated providers"
2005;293:1239-1243) as shown in New York.
Despite attempts at risk adjustment, public reporting of
hospital outcomes for coronary artery bypass and angioplasty in
New York has resulted in denial of services to high-risk
patients, according to 83% of practitioners participating in a
survey. Additionally, there is evidence that high-risk patients
are being referred to nonreporting states. Cleveland Clinic, for
example, demonstrated a significantly higher-risk population
referred from New York than from any other state, beginning at
the time the reporting requirement went into effect (Zoltan
Turi, JACC 2005:45:1766-1768).
It's About the Money
A federal advisory panel is "spending summer
cooking up standards" for utilization and lab data
transmission. They are boiling down 570 standards to 92
sets of "cookbooklike instructions" (modernhealt
Such standards will support a new mode for
provider payment: evidence-based case rates (ECRs). One
model is called PROMETHEUS, which is designed to work
both for integrated delivery networks and individual
The process will surely reduce errors defined as
"undesired variations in practice" as well as costs. And
all through "rationalizing" care, not rationing it.
The current trend is to look for answers to
medical problems in information technology rather than an
understanding of disease and its causes. Bruce Charlton of
the University of Newcastle upon Tyne calls it "statistical
malpractice": it is "brilliantly clever" but "fundamentally
Big databases, Charlton writes, are a sign "not of
rigour but of poor control." Basic scientists quip that if
statistics are needed, you need to go back and do a better
The perils of statistics include averaging
qualitatively different instances to produce nonexistent
artefacts. The root of most statistical malpractice is the
breaking of mathematical neutrality and introducing causal
assumptions without scientific justification: "science by
sleight of hand."
Medicine is deluged, Charlton writes, with "more
or less uninterpretable `answers' generated by heavyweight
statistics operating on big databases of dubious validity"
(J R Coll Phys London 1996;30:112-114).
While physicians voluntarily adopt evidence-based
medicine (EBM) standards when convinced that they are
an improvement, changes in practice are slow. EBM
experts seek to streamline the process "by having the law
empower a handful of experts to dictate which sources of
information clinical practitioners must revere and which
can be safely ignored," writes Linda Gorman
(Independence Institute Issue Backgrounder IB-2004-F).
The gold standard is the randomized controlled
trial. But one study of RCTs for surgery showed that only
half of them had sample sizes large enough to detect
treatment differences as great as 50%. Underpowered
RCTs, Gorman notes, are "an attractive justification for
arbitrary rationing decisions."
RCTs can do harm. If physicians were forced to
follow the guidelines from the ALLHAT study, nonblack
men would be placed on a regimen that increased their
risk of death by 3 to 6% in the study, Gorman points out.
It's about money and power, she concludes.
Physicians deviating from EBMs would be prime targets
for trial lawyers. "EBM shifts the power to determine
medical practice from clinicians who deliver care to
patients to people in government and academia who
manage to get appointed to the right committees."
Moreover, the developers of guidelines stand to make
considerable money by selling them.
The compulsion to digitize all human activity
mirrors the "tulipomania" of the 17th century, writes
Marian Chester Coombs. Prolonged suspension of disbelief
can spring up periodically even among the most
enlightened of peoples.
"The worship of Information and other forms of
digitalia is as superstitious as any form of idolatry. But
misinformation is worse than no information, and
disinformation is worse still; and digitomania
unfortunately lends itself equally well to all three"
(Chronicles, June 2005).
"The evidence-based medicine initiative
involves a technocratic takeover of the practice of medicine
through data collection, guideline creation, clinical
surveillance, pay-for-performance strategies, and centralized
decision-making. In short, EBM is aimed at stopping the
heart of health care the compassionate, first-do-no-harm,
to-my-own-patient be true ethics of medicine."
Twila Brase, R.N., quoted in Health
Care News 2/1/05
Nominating and Resolutions Committee
The Nominating Committee, chaired by Chester
Danehower, M.D., presents the following slate:
President Elect: Tamzin Rosenwasser, M.D.,
Secretary: Charles McDowell, Jr., M.D.,
Treasurer: R. Lowell Campbell, M.D.,
Directors: John H. (Tim) Boyles, Jr., M.D.,
Centerville, OH; Curtis Caine, M.D., Brandon, MS;
James F. Coy, M.D., Cape Coral, FL; Lawrence R.
Huntoon, M.D., Lake View, NY; James L. Pendleton,
M.D., Bryn Athyn, PA; Mark Schiller, M.D., San
To be considered, Resolutions must be
submitted to AAPS in writing no later than August
After Orthopaedics Northeast of Wayne, IN,
notified its local vendor that it was changing its software,
the vendor unilaterally cancelled its support contract.
Soon, the clinic's system started crashing on a daily basis
and was once inoperable for a week. After the system went
down for good, it was found that someone had entered
through a "back door" left by system designers.
At the University of Washington, a hacker
penetrated hundreds of servers, gaining access to medical
records, financial data, passwords, and more. He roamed
the system for 18 months before being detected. Repairing
the breach required wiping the hard drives of more than
200 PCs, among other laborious measures. The team also
had to notify authorities, employees, and outside affiliates.
It decided not to notify individual patients since the hacker
apparently hadn't used or disclosed their records
(HIPAA Compliance Alert 3/13/06).
"No. 2 Preventable Killer" Debunked
After announcing that "obesity" had killed
400,000 people in 2000, a 33% increase since 1990, the
CDC had to admit to a "methodologic flaw." There were
actually only 26,000 obesity-related deaths annually, an
error of about 1,400%. Most interestingly, the new study
found that 86,000 "overweight" people lived longer than
people of normal weight. And one study found that weight-
related risks declined with age, disappearing at age 74.
Public policy, however, such as launching the Fat
Police, admits of no error. We claim to
know while in fact we rarely do. The CDC
director called the error a "lesson in humility."
Will "the people in Washington with the power to
impose solutions to the problems of life on all of us [make]
their new watchword `humility'?" asks Donald Henninger.
"Fat chance," he says (Wall St J
Sep 13-16. 63rd annual meeting, Embassy
Suites, Scottsdale, AZ.
AHIC Imbalance Doesn't Matter, Gov't
In its motion to enter judgment against the AAPS
challenge to the American Health Information Community
(AHIC), the government does not dispute the AAPS claim
that AHIC lacks balance. Rather, it asserts that the issue
is "not justiciable." AAPS v. U.S. Dept of
HHS, Civil Action No. 1:06cv00319(ESH).
In the Federal Advisory Committee Act (FACA),
Congress requires that committees be balanced, but does
not define "fairly balanced," nor does it specify how such a
membership is to be achieved. It would first have to
determine which of a myriad of potential views have to be
As the Court has no principles to apply to resolve
the issue, HHS asks the Court to rule against AAPS as a
matter of law. Additionally, it does not argue that the
AHIC subcommittees comply with FACA, simply that they
shouldn't have to. After the fact, probably in response to
the lawsuit, AHIC identified a privacy expert (see FAQs at
pertaining to the lawsuit are posted at www
AAPS thanks the American Health Legal
Foundation for financial support for the litigation.
Dr. Nucklos Released on Bail Pending
Convicted for opioid treatment of three patients
who claimed to have chronic pain, William Nucklos, M.D.,
age 58, was sentenced to serve 20 years in prison. The trial
court having failed to act on his application for bail
pending appeal, the Court of Appeals for the 2nd District
of Ohio granted it.
The appeals brief, posted under "Judiciary" in the AAPS Hall of Shame, points to
numerous shocking injustices in this case. AAPS President
Kenneth Christman, M.D., introduced a resolution asking
the Ohio State Medical Association to investigate the
criteria and methods used by prosecutors in charging
physicians who treat chronic pain, and also to write or join
an amicus brief in support of overturning the Nucklos
verdict. OSMA declined to act. Rev. Jesse Jackson wrote
letters to members of the Court, expressing concerns about
racial discrimination (Dr. Nucklos is black, and not a
single black person sat on the jury), among other issues.
One of the most egregious injustices was failure
to reveal exculpatory evidence: Dr. David Romano, a
prosecution witness, had also been deceived by one of the
Of the several physicians who had all prescribed
for these patients, only Dr. Nucklos was charged. One of
the patients had been discharged by Dr. Nucklos when he
received word of "doctor shopping." All had plausible
histories of pain.
About 95% of the trial transcript had nothing to
do with the charges, but rather with highly prejudicial
uncharged "bad acts." The prosecution alleged that there
was a civil judgment against Dr. Nucklos for $600,000 of
fraudulent charges. In fact, this dispute, still unresolved,
concerns correct charges entered by Dr. Nucklos that his
billing service increased on its own. The amount involved
is about one-tenth the amount stated.
The judge who permitted the character
assassination to proceed had a disqualifying conflict,
having recently served as an assistant to the prosecutor.
The evidence was insufficient to support a conviction. The
jury instructions were improper. Sentencing was based on
inadmissible "bad act" evidence introduced to inflame the
jury. For all these and other reasons, justice demands a
new trial before an impartial tribunal.
Medical Staff Bylaws Alert
One set of medical staff bylaws that came to our
attention has a clause specifically saying that the bylaws do
not constitute a contract. There is simply a vague
statement that both the board of directors and medical
staff are obligated by law to use "fairness" in dealing with
persons bound by the bylaws but no specific procedures
are spelled out.
There seems to be a growing trend for hospitals
to try to exempt themselves from following the bylaws,
while enforcing them against physicians, but the above is
the most blatant example of a power grab that we have
seen to date.
Final Rule on Medicare Enrollment
On Apr 21, CMS published a Final Rule
establishing new enrollment procedures for all providers
and suppliers except those who opt out of the Medicare
The period that would result in deactivation of
billing privileges because of failure to submit a Medicare
claim was lengthened from 6 to 12 months.
Applicants must already furnish a National
Provider Identifier (NPI) on CMS form 855, even though
the deadline for obtaining an NPI is not until May 23,
2007. Applicants will have to enclose a copy of the NPI
One of the most controversial provisions is the
need to validate enrollment information every 5 years. This
will be phased in, recognizing that a large number of
physicians who bill Medicare have never completed an
application. Enrollees who never before submitted a form
855 will have to do so now, along with a vast amount of
information. CMS asserts the right to do a site visit to
validate the information.
The CMS 855 requires the applicant to agree to
recoupment of Medicare overpayments, which could
preempt subsequent legal arguments about the obligation
to return a particular payment.
The Final Rule expands CMS authority to deny
enrollment. "The possible reasons for denial are so broad
that CMS could find grounds for denial in nearly any
situation," state Karen Lovitch and Sarah Whipple (BNA's
AAPS has helped many physicians opt out of
To view CMS form 855i, see www.cms.hhs.gov
Court Limits Protected Speech for
The First Amendment does not protect public
employees from being disciplined for statements made in
the course of their official duties, ruled the U.S. Supreme
Court in Garcetti v. Ceballos, U.S., No. 04-
Richard Ceballos argued that his comments to his
supervisor about whether a deputy sheriff had lied to
obtain a search warrant constituted protected free speech.
A 5-to-4 majority held that the Constitution protects
neither public nor private employees from employer
discipline. A decision for Ceballos would commit the
judiciary to permanent interventions in the conduct of
government operations, the Court said.
Tom Devine of the Government Accountability
Project said that the decision has the effect that a govern-
ment worker could be protected if he talked to journalists,
but fired if he talked to his boss. Justice Kennedy stated
that legislation, such as whistleblower protection and labor
codes, is available to those who seek to expose wrongdoing
Double Standard. The AMA has been
issuing proclamations about the ethics of physicians'
accepting gifts from pharmaceutical companies.
Meanwhile, last year the AMA earned $44.5 million (16%
of its total revenue) from sales of its database products,
including the "AMA Masterfile," which contains
information on all physicians, including non-AMA
members, from medical school onward. The AMA sells
information to entities like IMS Health (operating revenue
$1.75 billion), which sells to pharmaceutical companies and
others. Drug companies track physicians' prescriptions,
and sometimes confront physicians with their history to
pressure them to order more of a particular drug.
If the AMA were to stop licensing the Masterfile
for this purpose, "it would separate itself from the
practice, but its revenue would decline" and data would be
purchased from others (N Engl J Med
Lawrence R. Huntoon, M.D., Ph.D., Lake
Danger! If someone would please explain
to me why data mining my bank transactions or
international telephone numbers called is a Bad Thing
Dangerous to My Constitutionally Protected Privacy, while
mining my medical records is a Good Thing, I could
finally get a good night's sleep.
Apparently some people really believe that my
physician is more dangerous to me than my local terrorist
Linda Gorman, Independence Institute,
VA Electronic Medical Records. The
VA's vaunted EMR system may be wonderful, but the VA
won't allow anyone on the outside to verify this claim. The
VA never provides medical information on its patients
when we fax a signed release-of-information request.
Never. When I need records from the VA, I have the
patient collect them, and many times it is very difficult for
him to do so. Because of the VA's secrecy, I do not believe
the glowing reports on its chronic disease management
system even though published in reputable journals. Also,
what the VA will care for, based on the veteran's service-
connectedness, is ever diminishing and longer delayed.
Robert S. Berry, M.D., Greeneville,
Error Free. People in Washington,
D.C., never admit that they don't know something, nor do
they ask questions. To find something out, they make a
statement and wait to be contradicted. If they are at a bus
stop and don't know whether it's the right one, they may
say, "The C bus stops here." Someone else will pipe up
and say, "No, the C bus stops over there." The first
speaker says, "Well, yes, that's what I meant."
Greg Scandlen, Consumers for Health Care
Government Tries to Recall Information.
In a letter from the Department of the Army, we were
notified that personal information was inadvertently
provided in an abstract table and published. The
information was removed from the internet, and we were
asked to remove p 130S from the October 2005 supplement
to Chest and mail it back in a self-
addressed stamped envelope: "you may have a legal and/or
ethical duty of confidentiality with respect to this
information." Where does the buck stop, if merely
receiving a journal creates a duty?
Debi Carey, Lexington, KY
Eavesdropping. One night I met with a
computer consultant in the education building next door to
a hospital, on the issue of security. He turned on his
scanning equipment to monitor the hospital's broad band.
Encrypted data and messages started popping up. He
described his encryption busting program, saying that in a
few hours of monitoring he could easily crack the whole
system. He could also have done it from a parking lot 50
feet away. There is no such thing as computer security if it
is on broad band.
Thomas W. LaGrelius, M.D., Torrance,
Funding Medical Care. There are three
types of housing: government (possibly nice at first, but
soon substandard); rental (no down payment, but no
equity, and subject to inflation); and ownership. Medical
care is similar. Health insurance is like a rental. Once you
stop paying your premium, perhaps because you are too
sick to work, you are out and you have nothing to show
for it. Ownership is the American ideal; you build up
equity, have an inflation hedge, and what you fix up you
keep. Health Savings Accounts are a start. The new
paradigm will be medical timeshares; you own part of the
hospital. It will have to begin offshore because of
government roadblocks in the U.S.
Alieta Eck, M.D., Somerset, NJ
No Guarantees. Even with the power to
print money, govern-ments bankrupt their nations. There
is no guarantee that health insurers will be around to
fulfill their obligations. We need less reliance on financing
mechanisms that make promises that they cannot keep or
private practice could be destroyed.
Joseph Lee Pugh, Diamondhead, MS
U.S. Socialized Medicine. Group health
insurance in the U.S. today is quasi-socialism because the
government gives it a tax preference over other forms of
risk sharing, such as associations. This allows
redistribution of wealth from young to old. In a free-
market system, unless a member of a group that agrees to
share wealth (family, clan, or faith), no young person
would ever agree to share health risk with an old person.
Steven Bassett, Oak Park, IL