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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."