AAPS News – Aug 2005

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of American Physicians and Surgeons, Inc.
A Voice for Private Physicians Since 1943
Omnia pro aegroto

Volume 61, No. 8 August 2005

IT AND CENTRAL PLANNING

Centrally planned utopias have been such disastrous failures
throughout the world to date that the very word “socialism” has
an aura of disrepute. But the ideal refuses to die.

Information technology (IT) has helped revitalize hope that
at least one barrier to socialism the knowledge gap might be
overcome. The results of all clinical trials can be processed by
computer (if they pass peer review, of course), and the results
amalgamated into practice guidelines that clinicians throughout
the world can access instantly. The outcomes of billions of
clinical encounters can feed back data to refine the guidelines.
Treatment will become evidence-based, high and uniform in
quality, and error-free, while costs are contained. Or else.
Nonconformists can be identified and forced to “harmonize” or be
purged from the system.

Physicians, unfortunately, are still in the “Dark Ages,”
opines Senator Hillary Clinton, and are slow to adopt this
wondrous tool. More than half (57%) of Medicare fee-for-service
visits are to physicians who use IT for no more than one of five
clinical functions: obtaining treatment guidelines, sharing data
with other physicians, accessing patient notes, generating
preventive treatment reminders, or electronic prescribing (Center
for Studying Health System Change, 7/7/05). Only 9% of the
practices use electronic prescribing.

The Frist/Clinton bill (S. 1262), the Health Technology to
Enhance Quality Act, would establish in statute the Office of the
National Coordinator of Health Information Technology, which was
announced by President Bush in 2004; direct government agencies
to adopt “uniform health care quality measures”; and provide $125
million per year in grants for interoperable health information
systems.

Despite the sales pitches about “helping” physicians save
money and serve patients better, the true goals of IT and its
Siamese twin, evidence-based medicine (EBM), appear to be to
serve a national health system. The views of proponents are
revealed in the Jan/Feb issue of Health Affairs:

“What makes sense from the narrow viewpoint of an individual
physician and patient might not make sense from the broader
viewpoint of a program or population” (p. 15).

“Nonadherence to practice guidelines remains the major
barrier to the successful practice of [EBM]” (p. 18).

“Major variation in accepted clinical practices is
considered a third major issue facing the contemporary U.S.
health care field” (p. 19).

“Decisions on how to handle the explosive field of medical
innovation…translate directly into…decisions [on] who gets
what care, on what terms” (p.29).

“OECD countries increasingly tend to view supply-side
controls as potent but crude, necessary but insufficient for
rational allocation of technologies” (p. 35).

“One major barrier to the adoption of EBM is the
overwhelming support for the preservation of the physician-
patient relationship” (p. 134).

The system view, not the patient-centered view, dominates.
The goals are ambitious: a 30% reduction in Medicare spending
during a period of large expansion of government-funded benefits.
Rationing is needed, of course: should there be focus groups as
in England to prioritize expensive enzyme replacement therapy and
diabetes nurse programs, over tea and biscuits, to make it all
“fair”?

New York State just stripped the scientific clothing from
the Medicaid rationing wolves, writes Dr. Lawrence Huntoon. EBM
has been redefined as a cost-cutting device rather than a
scientific and medical tool. The NY Dept of Health will partner
with the Oregon Center for Evidence-Based Policy (MSSNY News
of New York
, June 2005).

As rule by bureaucratic diktat might provoke some
resistance, even in increasingly apathetic American physicians,
the IT strategy is more subtle. Physicians whose practices are
retrospectively identified as “outside the norm” would “have the
opportunity to justify why…a service is needed,” explained
Wendy Long, Medical Director of TennCare. Or physicians, like
college professors, could be given a “report card” based on
patient ratings or conformance to guidelines. Such methods of
control could be described as “driving from the back seat.”

Another way to get physicians to adopt IT is through patient
pressure. Using the iHealthRecord account with Medem, founded in
1999 by the AMA and other medical associations, patients can type
in their own health record. Physicians, of course, may not want
to rely totally on a patient-edited record. About 100,000
physicians subscribe to Medem’s website (AP 5/23/05).

The record is interactive: “It reaches out to you and tells
you things you need to know,” said Medem CEO Edward Fotsch.
Physicians can get disease management and medication adherence
programs by subscription, and the public has access to patient
information selected by medical societies.

Utilizing such sites requires a computer like the ones most
people already have. The systems envisioned by IT advocates,
however, require an investment of about $150,000 in computers and
software, and massive changes in office workflow.

Despite the formidable cost, the government wants small
offices on-line. Otherwise, “patients are going to miss big
chunks of their data,” said federal IT coordinator David Brailer,
“and it frankly won’t be that useful to doctors” mainly to
doctors of central planning, who intend to control and allocate
every aspect of medicine, with no escape hatches.

Will IT and the elite, government-sanctioned committees
that define “evidence” and write guidelines become the man
behind the curtain, as doctors are assumed to have the brains of
scarecrows?


Disease Management Doesn’t Decrease Spending

One way in which EBM and IT are hypothesized to control
costs is through disease-management programs for the chronically
ill. However, an analysis released by the Congressional Budget
Office (CBO) in October 2004 suggested that such programs could
even raise costs if applied to a broad population. According to
Sen. Don Nickles, Chairman of the Committee on the Budget, “The
few studies that report cost savings do so for controlled
settings and generally fail to account for all health care costs,
including the cost of the intervention itself.”

Can We Do Without Paper?

In the computer age, paper has supposedly been “relegated to
the background.” Nonetheless, the demand for printers and paper
continues to grow. Everybody wants “hard copy.”

The Vatican Library has the right idea, says Linda Gorman.
“It says it will get rid of its books once it is confident that
computer-generated data storage will last 500 to 1,000 years.”
Computer media are vulnerable to thieves, hard-drive crashes,
forgotten passwords, viruses, worms, hackers, evildoers with
authorized access and obsolescence. How many have a 5.25-inch
floppy disk drive, a tape drive from say 1999, a machine that can
read DEC tape, or an IBM cardreader?

Checking Insurers’ Records

Of some 9,000 people who saw the records that insurers share
with each other this year, 300 to 400 found errors, according to
MIB group. You can get a free copy of your report once a year by
calling (866) 692-6901.

“Quality” Measures

Pressure to score well on a quality measure say an on-time
departure can encourage British Airways to fly across the
Atlantic on three engines or a plane to fly to Vietnam empty
instead of bringing desperately needed supplies.

Nearly 8 of 10 New York cardiologists said that public
reporting of data would make them less likely to treat severely
ill patients (LA Times 6/13/05).

“Academic papers debate whether it is even possible to
measure health care quality,” writes Linda Gorman. Still, “a
number of groups are flogging various quality measures. Though
their public relations packages focus on the good they will do
for consumers, their real audience is legislatures and other
third-party payers who focus on budgets. Any group that can embed
its quality measure in regulatory language stands to earn a tidy
cash flow by selling and reselling the expertise required to
compute it” (HCPC Bulletin, November 2003).

R.I.P. Tad Lonergan, M.D.

Long-time AAPS member Tad Lonergan, a family physician, died
at the age of 72 in a car crash on July 4. One of three
physicians in Desert Hot Springs, CA, he operated the Basic
Medical Clinic, treating patients for $30 if they could pay, and
free if they could not. He fought tirelessly for freedom in
medicine and the integrity of the medical profession, refusing to
be called a “health-care provider.” He will be sorely missed.

Nominating and Resolutions Committee Reports

Chairman Chester Danehower, M.D., presents the following
slate for consideration at the annual meeting:

President Elect: Robert Gervais of Mesa, AZ

Secretary: Charles McDowell, Jr., of Alpharetta, GA

Treasurer: R. Lowell Campbell of Corsicana, TX

Directors: Drs. John H. Boyles, Jr., of Dayton, OH; John
Dwyer of Chicago, IL; W. Daniel Jordan of Atlanta, GA; Mark
Kellen of Rockford, IL; Tamzin Rosenwasser of Venice, FL; and
Mark Schiller of San Francisco, CA.

To be considered, Resolutions must be submitted to AAPS
in writing no later than August 15
.

Quality, or Death

Hilaire Belloc writes (Economics for Helen, 1924):

In any civilisation you will find a certain
amount of things which are regarded as necessaries….
[I]t is thought that human beings must not be allowed
to sink below a certain level…. This does not mean
that no one is allowed to starve or die of insufficient
warmth. It means that any particular civilisation…has
its regulation minimum and lets men die rather than
fall below it.

At the local state university commuter school in Colorado,
Linda Gorman writes, one may not enroll even for a single credit
without buying “suitable” health insurance (defined as a
deductible less than $1,000 and covering childbirth, contracep-

tion, free STD testing, and free primary care visits) or
enrolling in the expensive “free” school clinic. “We must realize
that health insurance is more important than education or a job.”

Nor may one buy medical care from an unlicensed
practitioner, a nonaccredited facility, or a vendor of nonap-

proved remedies or nutritional supplements.

And if one’s “quality of life” falls too low? One could
become ineligible for medical care or even food and water
(AAPS News, July 2005).
Handicapped newborns may be euthanized in the Netherlands (AAPS
News of the Day 12/2/04).
In the U.S., fewer and fewer disabled infants are born because of
prenatal screening and eugenic abortion. Perhaps 70% of Down-
syndrome fetuses have been aborted since 1989. It is suggested
that eugenics could be the reason that Hillary Clinton and others
oppose the ban on partial birth abortion. In a 2003 exchange with
Sen. Santorum, “[Sen. Clinton said] there had to be an exemption
for disabled children being aborted as opposed to healthy
children being aborted.” Women should not be “forced” to carry a
“child with severe abnormalities” (Neumayr G, “The new eugenics:
one of America’s cures for disability is death,” Amer
Spectator
, June 2005).

AAPS Calendar

Sept 21-24, 2005. 62nd annual meeting, Arlington, VA.

Oct 22, 2005. SEPP meeting in Pittsburgh, www.sepp.net.

Sept 13-16, 2006. 63rd annual meeting, Phoenix, AZ.


Takings Clause Gutted by U.S. Supreme Court

In a 5:4 decision in Kelo et al. v. City of New
London
, the U.S. Supreme Court ruled that private property
may be seized under the power of eminent domain for the use of
another private party. “Public use,” which once meant public
ownership or use by the public as with a highway, public
utility, or stadium has been redefined to mean private use that
also accomplishes some “public purpose” such higher tax revenues.

Petitioners will have their homes demolished to serve the
purpose of “park support” (probably parking) for the New London
Development Corporation (NLDC), a private, tax-exempt entity.
NLDC generated a plan to develop 90 acres to “complement the
facility that Pfizer was planning to build, increase tax and
other revenues, encourage public access to and use of the city’s
waterfront, and eventually `build momentum’ for the
revitalization of the rest of the city.”

In a dissenting opinion, Justices O’Connor, Rehnquist,
Scalia, and Thomas stated that the decision abandons a long-held
basic limitation on government power. “Under the banner of
economic development, all private property is now vulnerable to
being taken and transferred to another private owner, as long as
it might be upgraded,” the dissent observed.

Because “nearly any lawful use of real private property can
be said to generate some incidental benefit to the public,” the
Court’s decision “does not realistically exclude any
takings.”

TRICARE Violates Takings Clause, AAPS Argues

When private property is condemned under the eminent domain
power of government, “just compensation” must be paid. In a case
concerning an attempt by TRICARE to force a physician to accept a
much reduced fee, rather than the customary fee that the patient
had agreed to pay, AAPS argues that the Takings Clause is
violated. The physician does not accept TRICARE and could not
reasonably have expected the patient to be a TRICARE beneficiary.

“A physician’s time and skills are every bit as much
property as the other intangible interests held to be protected
by the Fifth Amendment,” writes AAPS General Counsel Andrew
Schlafly in an amicus brief.

If the government finds the free-market transaction that
occurred to be “repugnant to the public interest, then at a
minimum the public rather than Plaintiff should bear the economic
loss,” Schlafly states. “The Fifth Amendment prevents the
government from simply taking Plaintiff’s services against his
will and then imposing the true economic cost on Plaintiff
alone.”

The government cannot simply say that its fee schedule
constitutes “just compensation,” argues Schlafly. “There would
need to be a condemnation hearing. And how could the government
declare this year’s compensation to be just, and then lower the
fees next year (inflation adjusted)?”

OIG Excludes 9 Providers a Day

During the 6-month period from Oct 31, 2004 to Mar 31, 2005,
the Office of Inspector General excluded 1,695 providers,
convicted 258, and imposed civil fines on 105, 10% more than
during the same period last year. The agency strengthened
relationships with state auditors and Medicaid Fraud Control
Units. Next initiative: scrutinizing lab panels for unnecessary
tests (Medicare Compliance Alert 6/27/05).

DEA Chills Pain Prescriptions

While untreated pain cost American businesses more than $100
billion in 1995, 40% of California doctors said that their fear
of an investigation affects how they treat chronic pain.

The DEA put a legal prescription drug, OxyContin, in the
same class as illicit drugs for the first time in 2002. The DEA
claims there is an “epidemic” of OxyContin abuse, based on 464
“OxyContin-related deaths,” including 146 “OxyContin verified
deaths” in 2000. Regardless of other circumstances, a death is
Oxycontin-verified if there is a tablet in the GI tract or pills
at the crime scene, or if a family member or witness even
mentions OxyContin. Taking the statistics at face value, that is
2.5 “verified” deaths per 100,000 prescriptions.

The DEA’s Diversion Control program is a self-financing,
autonomous law enforcement agency, largely unaccountable to
Congress. It is funded by licensure fees, asset forfeitures, and
extra appropriations. Even if charges are never filed, a police
department can bring a civil action against a doctor to recover
the cost of an investigation.

The DEA continues to lower its evidentiary standards, making
it nearly impossible for many doctors to determine what is and
isn’t permitted.

See Libby RL, “Treating Doctors as Drug Dealers: the DEA’s
War on Prescription Painkillers,” Cato Policy Analysis 545, Jun
16, 2005, www.cato.org.
A CD or DVD on “The Politics of Pain Management” includes a
presentation by Dr. Libby, available at www.aapsonline.org/shop
.

Proposed HIPAA Enforcement Rule Issued

The Proposed Rule, which will apply to all aspects of HIPAA,
was published in the Federal Register of Apr 18, 2005. Covered
entities should note the following:

A “violation” is defined to mean “a failure to comply with
an administrative simplification provision.” It is specifically
noted that “this proposed definition would make no distinction
between commissions and omissions” (p. 20229).

Each member of an affiliated covered entity bears joint
and several liability
if it is impossible to discover which
covered entity was responsible. This is especially likely in the
event of a failure to act, say to appoint a privacy officer.

The amount of penalties that can be imposed depends
critically on definitions, such as “identical requirement”
($25,000 maximum for each), as there are overlapping and repeated
requirements. Another upper limit is the ability of the entity to
pay without going out of business.

The Secretary has the authority to seize accounts receivable
or any future payments owing from federal health programs.

The covered entity bears the burden of proof with respect to
affirmative defenses or challenges to the amount of a fine.

Until now, enforcement has been complaint-driven, but the
Secretary has unlimited authority to investigate even in the
absence of any complaints.

The agency exempts itself, by assertion, from all the laws
and regulations that would require a detailed impact analysis,
such as the Regulatory Flexibility Act.

AAPS comments are available at www.aapsonline.org.

Those who do not understand all the requirements might be
best advised to remain noncovered, allowing HHS to focus its
attention on the estimated 2.5 million covered entities under its
statutory jurisdiction. Whether one can revert to a noncovered
status is an unanswered question.


Correspondence

Opt Out Now. Although they may not have read
the AAPS Medicare survey, last taken in 2003, I believe
government bureaucrats probably did read the AMA survey of
January 2005, which showed that 38% of physicians plan to
decrease the number of new Medicare patients they accept. If
reimbursements fall as they are scheduled to do so 25 to 30%
cumulative cuts over the next 6 years physicians who want to
stay financially viable will respond by reducing their Medicare
load. The government will attempt to offset this normal market
response by imposing more regulations making it difficult or
impossible for physicians to dismiss any Medicare patients
currently treated. As seniors begin to experience access problems
and complain to their congressman, I envision “Continuity of
Care” laws being proposed. Private insurers will follow the
government’s lead by placing “Continuity of Care” clauses in
their contracts. Physicians will find it hard to argue against
such a concept. A brilliant scheme worthy of social engineers
intent on controlling others.

Lawrence R. Huntoon, M.D., Ph.D., Lake View, NY

No-Escape Rule Proposed. A rule that the Medicare
bureaucracy attempted to force on physicians in the Northwest,
and eventually the rest of the country, would have prohibited
physicians from dismissing a Medicare patient from their practice
for any reason, including violence against physicians
and staff. Medicare was taking the position that the violent
patient was a protected class, just like the hearing-impaired or
limited-English-proficiency patient. Just as they were supposed
to supply a signer or a translator, at their own expense,
physicians were supposed to supply their own bodyguards. It was
quite a struggle for medical societies to get Medicare to back
down. Private insurers, who always follow Medicare’s lead, were
set to impose that rule even before Medicare did.

Russell W. Faria, D.O., Newport, OR

Standards. Good standards evolve after lots of people
use them voluntarily. It takes years to codify the ASTM standards
for materials, products, systems, and services. If a standard is
good, private entities use it. Otherwise, they don’t.

This does not appear to be the way in which proponents of
electronic medical records (EMRs) want to proceed. I can only
conclude that they are not in favor of evidence-based methods in
this case. Why not? Only two hypotheses make sense to me: (1)
Their champions are data enthusiasts who have no idea how large
systems can screw up in practice. (2) Certain groups want a
standard data architecture now because they need it to
provide the control infrastructure for national health care.

Linda Gorman, Independence Institute, Englewood, CO

Medicare Adds $200,000 to Overhead. In order for me to
accept Medicare, I would have to add three full-time employee
equivalents, and a total of $200,000 to my costs. There is no way
that I can provide affordable care to the uninsured (now 60% of
my practice) and take Medicare. Medicare-eligible patients,
paying privately, make up 3% of my practice. Instead of opting
out, it might have been a better business decision to refuse
Medicare patients entirely in my practice, considering the paltry
number willing to pay. Then I could work part-time in the ER to
maintain my ER skills. However, I would make less money per hour
working in the ER than in my clinic and would still have the
fixed costs of the clinic.

Robert Berry, M.D., Greeneville, TN

Why Not HSAs at Birth? Only reactionary, status-quo-
loving wonks could resist. Lifetime insurance, probably never
needed, like most insurance. No political fights over what’s
covered. Generic, cheap, purchased on the open market like an
airline ticket. No problem when changing jobs.

Kids getting to retirement age won’t even know what Medicare
was, or have any reason to care.

Herbert Rubin, M.D., Los Angeles, CA

Doctor’s Choice. I think that EMRs can provide
significant benefits although probably not through the system
chosen by CMS central planners. Each doctor should be allowed to
use the system he chooses, even if it’s a crayon on butcher
paper. It’s not the government’s business.

Sean Parnell, Heartland Institute

The Cost of the EMR. I have checked out all three of
the most highly rated systems for solo practices needed to
fulfill the so-called benefits promoted by AAFP leadership. The
estimated price is $125,000, plus 6 months of seeing 20% fewer
patients to learn to use the system. There is no study showing
that EMRs improve patient outcomes. But when national health
insurance (HillaryCare) arrives, the ability of patients to vote
with their feet will probably be lost, and the governmnent will
need a way to weed out those of us who do not conform well enough
to federally dictated standards. Socialized medicine is already
here, just not fully in place, and with the acquiescence if not
active assistance of the medical community.

Everest A. “Tad” Whited, M.D., Pflugerville, TX

A Vicious Cycle. From actuary Jeremy Gold, on the need
for price transparency instead of regulation: Regulation leads to
bad measurement, which leads to bad contracts, which lead to bad
behavior (a.k.a. moral hazard), which leads to regulation, which
leads to bad measurement….

Gerry Smedinghoff, Phoenix, AZ


Legislative Alert

Codex Alimentarius, Nutritional
Supplements,

and Consumer Freedom

In 1963, the Codex Alimentarius Commission was created by
the Food and Agricultural Organization (FAO) and World
Health Organization (WHO) in order to develop food
standards, guidelines, and codes of practice under the Joint
FAO/WHO Food Standards Programme. The purported purpose of this
effort was to protect the health of consumers worldwide, ensure
fair trade practices in the international food market, and
promote the coordination and integration of food standards work
done by international government institutions and non-
governmental organizations.

The Commission has governmental representatives from across
the world, including Argentina, Australia, Brazil, Cameroon,
Canada, Cuba, the former Czechoslovakia, France, Germany, Ghana,
India, Kenya, the Republic of Korea, Malaysia, the Netherlands,
New Zealand, Poland, Senegal, Thailand, Tunisia, the United
Kingdom, the United States, and Russia. The Commission meets
every two years, either in Rome or in Geneva. The 28th meeting of
the Commission, held in Rome in July 2005, ratified the vitamin
and mineral supplement standards as the international standard.

Vitamins and minerals are just one area of interest and
focus of the Commission. It also deals with food labeling; food
additives; pesticide residues (maximum residue limits);
contaminants; methods of analysis and sampling; food hygiene;
food import and export inspection and certification systems;
residues of veterinary drugs; processed and quick frozen fruits
and vegetables; fish and fishery products; meat and meat
products; sugars, cocoa products, and chocolate; milk and milk
products. There are nine General Subject Committees including the
Codex Committee on Nutrition and Foods for Special Dietary Uses
(CCNFSDU), which is hosted by Germany. There are also 16
Commodity Committees, which have responsibility for developing
standards for specific goods or classes of food, for example, the
Committee on Fats and Oils, which is hosted by the United
Kingdom.

The FAO and WHO work to complement the efforts of Codex in a
number of ways, as by giving assistance to developing countries
to bring their standards up to the international level. The
agencies convene meetings of experts, who help to establish
national food control standards, conduct workshops and training
for developing countries, strengthen laboratory analysis and food
inspection capabilities, establish food control agencies, and
develop and publish training manuals for food inspection.

Of major interest to many Americans who use nutritional
supplements are the vitamin and mineral guidelines, which were
voted on the week of the Fourth of July. On July 3, Dr. Ed
Scarbrough
, U.S. Codex Office administrator and
administrative leader of the U.S. delegation, told the delegation
at its pre-meeting session that the Codex Commission Executive
Committee had endorsed the vitamin and mineral guidelines
recommended by the CCNFSDU. According to Jim Turner,
Chairman of Citizens for Health, a consumer health advocate who
attended the Codex meetings in Rome, “the endorsement of the
guidelines by the Executive Committee virtually ensured their
adoption by the full Commission.”

The vitamin and mineral guidelines that were developed
over eight years by the CCNFSDU treat nutrients as toxic
chemicals
, and call on the FAO/WHO Nutrient Risk Assessment
Project to set up consumption limits. Jim Turner observes:

The model that the Commission is using in developing
“upper limits” (maximum potencies) for each vitamin and
mineral formulation is based on a risk assessment model
used to assess the health risks of toxic chemicals and
environmental hazards rather than a nutritional science
model. The upper safe limit model, which is based on
norms and population groups instead of biochemical
individuality, attempts to set one safe and useful
value for all individuals rather than promote an
optimum nutrient intake level for each person. The
Commission, by setting maximum safe limits for vitamins
and minerals, is laying the foundation for creating
a prior restraint approach to regulating nutritional
supplements
.

This might and probably will lead to the requirement that
dietary supplements, especially new ones, receive regulatory
approval before being marketed. This approach is contrary to the
regulatory scheme established by U.S. law called DSHEA
(Dietary Supplement Health Education Act of 1994), which
acknowledged that nutrients are foods and presumed safe in the
absence of contrary evidence
. Turner said:

By setting these standards, and diminishing the value
of dietary supplements, Codex is supporting the
continued restrictions to disseminate truthful
information about the ability of foods and supplements
to prevent, alleviate, treat and cure many diseases.
Codex also is functioning on the mistaken notion that
most people who have access to a balanced diet can
obtain all of the nutrients they require from their
normal diet.

DSHEA was passed in 1994 because of pressure from more
than 2 million citizens who wanted to ensure they had safe and
secure access to herbs, vitamins, minerals, and other food-based
supplements. DSHEA was proposed in response to a 1992 FDA task
force report that announced the FDA s interest in removing
dietary supplements from the market as they represented
“disincentives for patented drug research.”

DSHEA s regulatory scheme was premised on the idea that
dietary supplements are food and therefore do not need FDA
permission to be sold. This was in contrast with pharmaceutical
agents that are generally considered toxic and require a lengthy
safety evaluation before they are available on the market.

Under DSHEA, the FDA has the authority to remove an herb
or dietary supplement from the market
, provided that the
agency shows that the supplement is a danger to the public. A
recent example was the withdrawal of ephedrine-containing
dietary supplements. In that case, the FDA was not able to prove
its case with empirical evidence, and a judge recently told the
agency to modify its stance.

The Codex guidelines are supposed to be just that:
guidelines, which do not yet have the force of law here in the
U.S. However, the World Trade Organization (WTO), which is
the successor multinational trade institution to the General
Agreement on Tariffs and Trade (GATT), has been given the
authority through the member nations to enforce global compliance
with all Codex standards. WTO can enforce Codex compliance via
trade sanctions. Member nations including the United States
agreed, upon signing the WTO treaty, to always allow the
standards and regulations of the WTO to supersede national
standards, laws, and regulations
.

According to Dr. Rima Laibow, Medical Director of
Natural Solutions Foundation and an AAPS member, who has been
following Codex closely and has read the 16,000 pages of reports:

Once Codex is adopted by a nation via “HARMonization”
or through the effects of the SPSA [another
international agreement], there is a “phase-in period”
during which the administrative structure of
implementation is established according to a strict
timetable. Bear in mind that in the United States,
nutrients are currently classified as foods and so have
no upper limits [under the 1994 Dietary Supplements
Health and Education Act (DSHEA)] and that any
substance not explicitly forbidden is permitted as a
nutrient in the United States. Under Codex, any
substance and any dosage not explicitly permitted by
Codex policy is banned as a nutrient
. The
difference is of major importance to Health Freedom.
DHSEA is good for health freedom. Codex is bad for
health freedom.

The effects of Codex implementation in member countries are
multifold. They include the following:

1. Codex eliminates truthful claims based on
legitimate science that nutrients may be used to prevent, treat,
or cure any disorder.

This effect seems to be one of the Commission’s primary
motivators. In fact, the EU observer of the CCNFSDU stated in the
Codex Alimentarius Commission meeting, 2003, that “food and
the prevention of diseases do not go together.”
He was
supported by the Chairman of the CCNFSDU, who said that
“drugs are to mitigate and prevent diseases, and that the
role of food supplements is to support the diet.”

Of course, these statements are contrary to thousands of
years of traditional medicine. Hippocrates said that “food is
medicine and medicine is food.” Modern science has repeatedly
shown the correlation between the beneficial use of dietary
supplements and health. And millions of Americans, who spend
billions of dollars on dietary supplements, believe them to be of
value to their health.

For those who have been following Codex for years now and
who support consumer health freedom, there is consensus that the
whole process is not driven by the desire to protect worldwide
consumers health or to increase free and fair trade, but rather
to protect the interest of the pharmaceutical industry and its
allies in various food-related industries. This consensus is
supported by Dr. Wong Ang Peng, who was present at the
November 2003 CCNFSDU meeting. Dr. Wong said:

We, the people of the world, have entrusted WHO, FAO,
and Codex Alimentarius to regulate on health measures,
to protect our health. If only the people knew….
Codex is not about health, it is about wealth. Codex
is not for public interest, it is for industrial
interest.
It was super sold out. It was super
hypocrisy.

Much of the regulatory scheme for dietary supplements from
Codex is based on the European Food Supplements Directive
(EFSD), which has been described by the Chairman of the
CCNFSDU, Dr. Rolf Grossklaus, as “the future face of
Codex.”

The EFSD inappropriately but intentionally classifies
nutrients as toxic chemicals, which are to be regulated as if
they posed an inherent danger to human health. According to the
EFSD, the available doses of approved dietary supplements are to
be no higher than those found in food. The word “approved” needs
to be stressed here. The EFSD has a positive list of legal
supplements. Those that are legal can only be sold in such low
doses as to possess little to no therapeutic value. The model
that the EFSD uses, which was adopted by Codex, is the risk
assessment model discussed above.

2. Codex defines the maximum allowable doses of any
permitted nutrients as the dose of that nutrient found in
food
, while the minimum allowable dosages are 15% of the
amount naturally occurring in foods. No dosage exceeding the
permitted upper limit may be used, with or without a
prescription.

3. Higher doses of permitted nutrients and other
nutrients not explicitly permitted would be classified as illegal
substances
and, as such, would be legally unavailable
under any circumstances.

4. The system for testing additional nutrients or
higher nutrient doses exists but is cost prohibitive.
It
is based on the pharmaceutical regulatory model and consist of
the following:

i. Theoretical exceptions exist for natural substances that
are submitted and accepted for testing by July 12, 2005, at a
cost of approximately $250,000 per submission.

ii. If accepted, a substance may undergo Phase 1, 2, and 3
testing as a drug.

iii. If, after testing, the substance is found to be
efficacious and safe, it may be marketed as a prescription drug.

iv. When prior permission to market as a drug expires, it
cannot be renewed or extended.

v. A substance successfully tested in this way may then be
prescribed at the tested dosage only and for the tested
conditions only.

Since natural molecules cannot be patented, potential
manufacturers are unable to recoup the high costs of testing

through later sales, and therefore it is highly unlikely that any
nutrients would even be able to go through the new regulatory
scheme.

With the guidelines as discussed above now adopted as
official Codex policy, it is just a matter of time before they
are implemented worldwide. With Codex now being the official
international standard for dietary supplements, it would not be
surprising to see movements by the FDA and members of Congress to
attempt through regulatory fiat or law to change the U.S. dietary
supplement regulatory scheme from DSHEA to Codex, ahead of any
efforts to force Codex through the WTO.

This example of international treaty superseding U.S. law
will have an impact on millions of American citizens.

For more information on the fight for consumer freedom,
visit www.citizens.org and www.healthfreedomusa. –

org.

Michael Ostrolenk is a member of the AAPS
government affairs team in Washington, D.C.

U.S. Constitution, Article VI: “This Constitution, and the
Laws of the United States which shall be made in Pursuance
thereof; and all Treaties made, or which shall be made, under the
Authority of the United States, shall be the supreme Law of the
Land; and the Judges in every State shall be bound thereby, any
Thing in the Constitution or Laws of any State to the Contrary
notwithstanding.”

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