A White Paper on Safety and Choice in Medicine Prepared for the Great Lakes College of Clinical Medicine and the American Preventive Medical Association by Terry Chappell, MD

Introduction

As with most industries in the United States, the health care industry consists of three major components:

1. Concentrated Economic Interest

2. Government Regulatory Bodies

3. Consumers

The relationship between these components is illustrated in Figure 1.

Our health care system features the most advanced technology in the world, which can result in dramatic, sometimes spectacular health benefits. We can transplant organs, manipulate genes, crush arterial plaque, kill cancer cells, wipe out a wide variety of bacteria with a single new antibiotic, replace joints with man-made materials, and save the lives of newborns that can be held in the palm of a hand.

At the same time, compared with other developed countries, our health care system is burdened with high infant mortality, low life expectancy, large numbers of disabled citizens and many patients under treatment who continue to suffer from chronic degenerative diseases. Although not listed by the National Center for Health Statistics, the fourth leading cause of death in our country is complications from drugs prescribed by doctors in hospitals,1 and the ninth leading cause of death is bypass surgery.2 The number of people who die of side effects from their cancer chemotherapy and radiation is high enough that a significant number of patients refuse these therapies. The widespread use of non-steroidal, anti-inflammatory drugs (NSAID’s), like ibuprofen, has significantly increased the number of patients both with bleeding peptic ulcers and contributed to the rising number with kidney failure requiring dialysis.3 It is estimated that 2 million people are hospitalized annually from medication side effects.1 Bacterial superbugs are developing resistance to our most powerful antibiotics. After an impressive 30-year gradual decline in cardiac mortality, reports from the annual meeting of the American Heart Association in 1999 tell about cardiologists trying to determine why heart disease deaths are beginning to rise again.

There are substantial risks inherent in becoming a health care consumer in the United States. These risks are under-appreciated by all of the three components of the system, but perhaps feared most by Consumers. Both technology itself and the complications that sometimes occur with its use have contributed to this inherent risk and to the high cost of medical care.

Figure 1. The Components of the Health Care System in the United States.

Figure 2. The result of Increasing Consumer Access to Complementary and Alternative Medicine.

According to an Institute of Medicine report in November 1999,4 there are between 44,000 and 98,000 deaths each year due to medical mistakes in hospitals. This compares to 14,088 deaths from guns in 1998 and 43,400 from motor vehicle accidents.

This report quickly generated Congressional hearings and statements of concern from our President, a revision of the American Hospital Association policy to reduce errors, and a warning that the Joint Commission on Accreditation of Healthcare Organizations will now conduct unannounced inspections.

The question is whether these immediate responses will provide substantial solutions to a very difficult problem. It would appear that a more fundamental change in the system to reduce medical risk might be required.

The purpose of this white paper is illustrated in Figure 2. A few simple actions by the legislative bodies of the government that would have negligible cost to taxpayers could result in more choices for prudent patients and Consumers that could dramatically increase the safety of the health care system. Side benefits might include increased information for better-informed decisions, less cost, and the potential for improved outcomes.

Approximately 45% of non-institutionalized Americans have one or more chronic health condition,5 which in turn increases their risk for premature death or decreased productivity. This accounts for three-fourths of the annual total health care expenditures in the United States. Not only is the conventional treatment for these conditions only moderately successful, but conventional treatments might increase the medical risk to patients with their potential side effects.

In the United States, the number of people over the age of 65 is expected to triple over the next 30 years.10 Pharmodynamics change significantly as people age. Drugs are metabolized much slower, and some tissues such as the nervous system become more sensitive to their effects. On average, a person 65 years of age or older takes seven prescription drugs daily. Very few scientific studies have examined the net effects of various combinations of medications. Even though most drug interactions between two specific agents are known, these interactions are often missed by practicing physicians. Many additional unknown interactions are likely when multiple medications are used. In effect, the majority of patients who take more than one medication at a time could be considered experimental subjects. The actual practice of medicine is not as scientific as it appears on the surface. This presents obvious hazards to Consumers, especially since most of their doctors do not appreciate that there might be unforeseen problems with polypharmacy.

Many treatment choices that have potential to dramatically increase safety for Consumers are in the field of complementary and alternative medicine (CAM). Some of these treatments are already being utilized by 50-69% of Consumers, despite considerable resistance from Concentrated Economic Interest and Government Regulatory Bodies. CAM also has a huge potential to reduce costs and increase effectiveness. By reducing the barriers against CAM, Congress and State Legislatures could move the whole health care system in the direction of safety. By facilitating the integration of CAM into the practice of medicine, these legislative bodies could cause fundamental change that would likely have much greater benefit to Consumers than the current attempts to fine tune the existing system, which features the powerful links between Concentrated Economic Interest and Government Regulatory Bodies.

Concentrated Economic Interest

Just as Eisenhower warned the nation about the Military-Industrial Complex, others have become concerned about the Medical-Pharmaceutical-Industrial Complex. Concentrated Economic Interest in the medical field includes interactions among pharmaceutical companies, organized medicine, hospitals, medical schools and insurance companies, especially managed care. Some might include the food industry, but it will be kept separate for the purposes of this paper.

While all of these groups have addressed safety concerns to a degree, especially with peer-review activities, they have acted together to establish an accepted body of knowledge and practice that protects their financial interest. For example, they set guidelines for the appropriate indications for coronary artery bypass surgery and then do more than indicated. Insurance companies pay for the procedures, and medical schools depend upon the revenues. Grayboys has demonstrated that approximately 75% of coronary bypass surgeries and even more diagnostic angiograms are unnecessary,6 according to published clinical guidelines. For patients 65 years of age or older who suffer a myocardial infarction, the New England Journal of Medicine reports7 that the much higher use of cardiac procedures such as angiograms, angioplasty and bypass surgery in the United States as opposed to Canada resulted in no significant difference in long term death or disability rates. A group of Mayo Clinic cardiologists looked at sex differences in the evaluation of unstable angina, and found that the use of cardiac procedures was lower in women.8 To their surprise, however, when all factors were taken into account, the men had a 21% excess risk of cardiac events than the women, who had received less attention from the system.

Physicians are not always aware of the increased risk they are creating for patients by ill-considered or unjustified remarks. With the intention of motivating the patient to get the treatment thought best by the physician, the latter will sometimes exaggerate the seriousness and risk of death of a condition. Grayboys notes that doctors will use emotional terms such as "widow-maker" to convince patients to consent to a bypass procedure that really isn’t indicated. Physicians too often put themselves in a dominant role, when the therapeutic decision should be made by the patient, after a thorough discussion of the pros and cons of all the options. Third parties can be manipulated as well. The American Medical News reported9 on a survey published in the Archives of Internal Medicine in which 58% of internists felt it was appropriate to lie to insurance companies about the severity of a patient’s condition to achieve insurance reimbursement for bypass surgery, when the patient in actuality did not meet the guidelines for such surgery.

Formal clinical practice guidelines are being established by representatives of Concentrated Economic Interest and Government Regulatory Bodies. These guidelines may be viewed as double-edged swords. On one hand, they describe the evidence available for evaluating and treating certain medical conditions, which certainly can be useful to busy clinicians. On the other hand, the guidelines usually exclude CAM from consideration, they rapidly become outdated, and they do not take into account the uniqueness of each individual patient and his or her condition. Clinical guidelines are not meant to be accepted blindly or to constrain physicians from using broad clinical judgement. In practice, however, the pressures of the marketplace, the regulatory atmosphere, and the threat of malpractice accusations tend to convert clinical guidelines into instruments of conformity that might work against the interests of Consumers.

Pharmaceutical companies pay medical schools to do research on their new drugs. When the drugs are approved by the FDA, the drug companies promote them vigorously with detail people who visit physician offices and by placing expensive advertisements in the journals of organized medicine. The revenues from these ads are a large part of the total income for the journals, creating a potential conflict of interest. Insurance companies are pressured by the marketplace to provide the latest drug therapies, which are almost always more expensive than previously available drugs, even if the improved benefits are questionable. Unless the new agent has demonstrated a clear advantage, a prudent physician would better serve his or her patients by utilizing drugs or natural substances whose safety and efficacy are already well established.

The Concentrated Economic Interest has no reason to encourage CAM because they would be losing market share. CAM services are usually provided outside hospitals and medical schools. CAM products generally cannot be patented, so there is little profit incentive for pharmaceutical companies to fund research and development costs. Many CAM products are prepared by a growing number of compounding pharmacists throughout the country. There has been considerable pressure from the Concentrated Economic Interest to limit the capabilities of these pharmacists to supply patients with medical prescriptions from their CAM physicians.

Organized medicine has called for more research on CAM, which is admirable. However, the demand for such research before CAM becomes accepted is problematic. The same quality and quantity of research is required for approval of specific claims by CAM therapies as for prescription medications. The difference is that drug companies can recoup their research costs by charging high prices for their patented drugs, while patents are often not available for most CAM therapies, because they are natural substances. There is very little profit incentive for doing CAM research, and thus the large studies required have not been accomplished.

Furthermore, the individuals who are most qualified to perform clinical trials are usually associated with medical schools. This is particularly true in the field of CAM, where the research is more difficult to perform, because combination therapy is common and there are more variables to consider. Medical school scientists have not performed extensive research in CAM, in large part due to a lack of funding incentives but also because they have not consulted with CAM practitioners who are experienced with the therapies. In other words, Concentrated Economic Interest insists that therapies cannot be accepted until extensive research is done, but the CEI scientists who are qualified to do the research do not perform the necessary clinical trials – a Catch-22.

Even when the research is accomplished, there is considerable bias in the publication of the results. Recently, a British group sent identical articles to some of the most prestigious medical journals worldwide. The only difference was that one of the articles featured a drug and the other a CAM product. The article that was about a drug therapy was three times as likely to be accepted for publication as the one about the CAM product.

Another sector of Concentrated Economic Interest consists of the company executives who select the type of insurance coverage offered to their employees. It is estimated that more than 10% of all hospital admissions are due at least in part to occupational and environmental factors.10 These factors can range from low level exposures such as lead to massive hazards as from a chemical spill. The insurance policies usually omit coverage for the branches of CAM that are best suited for detoxification and desensitization from heavy metal and chemical exposures, namely EDTA chelation therapy and Environmental Medicine. By controlling access to this type of medical care through the pursestrings, companies sidestep their responsibility to the detriment of Consumers.

Insurance companies might logically be favorably inclined toward some forms of CAM because the therapies might prove to be less expensive and the companies can recover their costs by adjusting their premiums. They have in fact expressed interest in capturing the considerable dollars spent out of pocket by millions of Consumers on CAM each year. The major roadblock has been how to certify practitioners and identify procedures to be covered so that they know how to set premiums that insure profits. Thus most companies continue to refuse coverage for the vast majority of CAM, even if those therapies have been effective for individual patients. The stated reasons are that CAM therapies are "not usual and customary" or are not "medically necessary." Peer-reviewers that make the determinations to deny such claims come exclusively from Concentrated Economic Interest, in particular from the companies themselves and from organized medicine, and they are commonly biased against CAM prior to their reviews. A recent settlement with the State of Texas forced Aetna to disclose how they make such decisions and to be more fair in implementing them.

According to a report in the Journal of the American Medical Association in 1999.11 physicians routinely fail to involve patients adequately in medical decisions by informed consent. Only 9% of 1057 patient encounters met the authors’ criteria for informed decision-making. The risks were not presented adequately by physician to patient, nor was the full spectrum of therapeutic choices discussed. In New Jersey, a recent court decision determined that a physician must present all choices to the patient, even if the doctor disagrees with one or more of the therapies.

Government Regulatory Bodies

The Federal Drug Administration has the authority for approval of therapeutic claims and for assurance of safety for medications and for dietary supplements. In regards to medications, the FDA has been criticized because it has had subsequently to recall many medications that the agency had approved, due to deaths and complications, and also because the drug approval process has been so slow and cumbersome.12 In recent years the time interval for drug approval has been reduced by half. Some of the more recent withdrawals include "Phen-phen" diet pills that caused cardiac valvular disease, a popular antihistamine (Seldane) which caused fatal arrhythmias when given with common anti-biotics, a calcium channel blocker (Posicor) that increased the toxicity of many other drugs, and a NSAID for arthritis and pain (Duract) that led to liver failure and the need for liver transplants.

As for dietary supplements, the FDA has full statutory authority to regulate and approve specific claims, but generally refuses to do the latter. Congress passed the Dietary Supplement Act of 1994, which required the FDA to approve reasonable claims. The FDA refused to comply, and on January 15, 1999 the Court of Appeals determined in Pearson vs. Shalala that the FDA’s restrictive health claim rules were unconstitutional and a violation of the Administrative Procedure Act. Still, the FDA refuses to encourage truthful information about dietary supplements, which would in fact increase the reliability and safety of these products. Despite a huge number of scientific studies on oral vitamin and mineral supplements, the FDA has approved only a handful of health claims related to their use. With two or three exceptions, these supplements have proved to be so safe that even without the information denied to them by the FDA, Consumers have not suffered serious side effects from taking them. The FDA has continued to block the availability of reliable nutritional information and products to Consumers. This activity is certainly supportive of similar activities of the Concentrated Economic Interest and the giants of the pharmaceutical industry.

The Federal Trade Commission has two roles, consumer protection and anti-trust. Recently in regards to CAM, the FTC has come under the influence of representatives of Concentrated Economic Interest, notably a small group of doctors who call themselves "quackbusters." This group has opposed practically every CAM therapy used in this country. The FTC has responded with attacks on professional societies who teach and advocate CAM, while ignoring the FTC anti-trust role. The FTC’s "consumer protection" actions to suppress CAM have served to protect the reimbursable health care monopoly of organized medicine and Concentrated Economic Interest.

In 1998, the FTC demanded copies of everything printed for several years by the American College for Advancement in Medicine, a professional medical society that teaches its physician members about CAM with an emphasis on EDTA chelation therapy. The FTC found one booklet that appeared briefly on a website that said that chelation therapy was an effective treatment for vascular disease with the disclaimer that other members of the medical profession disagreed. The FTC demanded and received a consent order from ACAM that generated considerable adverse publicity and put the organization under FTC supervision for 20 years. If ACAM had refused to sign the consent order, they were committed to a prolonged legal battle that would have cost an estimated 2 million dollars and would have bankrupted the organization. Even a victory would have been suicidal. The actions of the FTC in this case were severely criticized in a March 10, 1999 Congressional Government Reform Committee hearing, chaired by Representative Dan Burton.

The FTC has used similar tactics to demand consent orders from other CAM groups, including chiropractic. No matter how strong the defensive arguments, none of these organizations have the financial resources to combat the deep pockets of Government Regulatory Bodies.

The Federation of State Medical Boards uses the same small group of "quackbusters" as consultants in regard to CAM. As a result, the FSMB labeled almost all CAM as "questionable medical therapies," and they worked with the FTC and the Association of States Attorneys General to set policies to prosecute physicians who dared to offer CAM to their patients.13 Once again, Government Regulatory Bodies worked in concert with Concentrated Economic Interest to the detriment of Consumers, many of whom were interested in choosing CAM, largely due to safety factors.

Government Regulatory Bodies have proposed legislation and rules to limit the number of prescriptions that a compounding pharmacy can prepare for patients from another state, even though such regulation does not apply to mail order pharmacies that supply prescription drugs. This is another example of the interaction of Concentrated Economic Interest (in this case, drug companies who fear loss of market share for their products) and Government Regulatory Bodies.

Medicare has acted as a Government Regulatory Body by refusing to pay for CAM and through its campaign against fraud. Those doctors who provide CAM are in a bind because there are no codes for CAM in the Current Procedures and Terminology text, which all doctors must use. This code book is published by the AMA and is one of the most profitable endeavors of this medical society, representing organized medicine. Even though the AMA claims only about 30% of physicians in the United States as members, it has a monopoly on the coding system that was granted by Medicare and the insurance industry. If a CAM doctor is in Medicare, he or she is required to submit every service with a code. Since there are no codes for CAM, he or she must choose the closest one available. If Medicare disagrees with the code chosen, the doctor might well be accused of fraud and fined more than $100,000 or even sent to prison.

The Health Insurance Portability Act of 1996 extended fraud and abuse charges to insurance claims. It made unintended clerical errors in coding into potential felonies with huge penalties. The act further disrupted the patient-physician relationship by giving financial incentives for patients to turn in their doctors for irregularities. Although all doctors are affected, CAM doctors are more vulnerable to attack than conventional physicians due to the same code book problems generated by the interaction of Medicare with Concentrated Economic Interest and organized medicine.

The American Board of Medical Specialties has consistently refused to recognize specialties in CAM, even if those specialties have functioning Boards of Examiners that offer written and oral examinations with high standards. In turn many Medical Boards and elements of Concentrated Economic Interest, such as insurance companies, do not recognize specialties not listed by the ABMS. Thus, despite their attempts to achieve and document a standard of excellence, CAM specialists have been kept out of the recognized health care network and Consumers have suffered.

In addition to its role in establishing clinical guidelines as discussed above, the National Institutes of Health is responsible for funding most non-pharmaceutical company research in the United States. The NIH spends about 1/2 of one percent of its funds on CAM research. Everyone agrees that more research is urgently needed on CAM. Congress has established first an Office of Alternative Medicine, then a Center for Complementary and Alternative Medicine. According to a Stanford University survey,14 69% of the public is using CAM, and yet the NIH refuses to send out the numerous requests for proposals that are needed and medical school researchers in turn have been reluctant to file the necessary applications for funding.

CAM has been thoroughly embraced and accepted by the American public. And yet Government Regulatory Bodies continue to obstruct access to vital information and useful therapies, and they are doing very little to encourage and fund the research that is needed.

The Safety Potential of Complementary and Alternative Medicine

Compared to the estimated 106,000 deaths per year due to appropriately prescribed medications in hospitals,1 there are few if any deaths each year due to appropriately prescribed nutritional supplements.

Tens of thousands of patients are forced to go on renal dialysis or have life-threatening gastro-intestinal bleeding due to physician-prescribed NSAID’s.3 No one dies of glucosamine sulfate supplements, which compare favorably to NSAID medications in treatment effectiveness for osteoarthritis.15

A few years ago as many as 50,000 people died of an anti-arrhythmia drug used for ventricular extra heartbeats that doctors are reluctant to treat today, because the treatment appears to be more hazardous than the problem.16 Magnesium supplements can often correct this condition without any side effects.17

The standard treatment for benign prostatic hypertrophy is surgery, which carries a small risk of death and a high incidence of impotence, or long-term use of medications like Proscar, which are expensive, questionably effective, and can cause side effects. Saw palmetto supplements often improve function with much less expense, without the side effects, and without the risk of surgical morbidity and mortality.18

Recurrent ear infections are often treated with multiple antibiotics and eventual surgical insertion of tubes. Bacterial resistance to antibiotics for otitis media, but also for other conditions, is an unfortunate but common consequence. Further, there is small risk of damage to tympanic membranes with tube insertion. Food allergy testing and treatment frequently determines the cause of this problem and is much safer.19

Dr. Mark, of the CAM residency program at the University of Arizona Medical School, has suggested that perhaps doctors should be required to take medications themselves before prescribing them to others so they can appreciate the side effects.

There were no deaths attributed to Ornish’s intensive lifestyle modification program or to the use of intravenous EDTA chelation therapy last year, both of which have been advocated by CAM as effective treatments for coronary artery disease. There were an estimated 35,000 deaths due to surgical attempts to treat coronary artery disease.2 Ornish’s program has been well documented to have the capability to reverse atherosclerosis.20 There is a considerable body of published research on the use of chelation therapy to treat vascular disease that has accumulated over the last 50 years,21-23 although no good, large-scale, controlled clinical trials that would prove its effectiveness without a doubt, have been completed. The 1999 Government Reform Committee hearing chaired by Congressman Burton mentioned above questioned why the government had not encouraged or conducted clinical trials on chelation therapy when more than 1 million people have received treatments and a large percentage has apparently benefited. On January 20, 2000, the NIH began exploring the feasibility of a large, double-blind clinical trial on the use of chelation therapy for coronary artery disease.

Chappell did a survey of leading CAM physicians, asking what were the five most effective CAM therapies in their experience.24 Respondents listed membership in 40 different CAM societies and affiliation with 18 medical schools. The most common therapies listed in order of frequency were intravenous EDTA chelation therapy, treatment of food allergies, oral nutritional therapies, intravenous nutritional therapies, and the treatment of gut dysbiosis (an imbalance of the normal bacteria and yeast in the intestinal tract). Not only are most of these therapies hardly ever the subject of funded research, but also they have tremendous potential to be much safer than conventional treatments, to reduce costs, and to improve outcomes for a wide variety of difficult-to-treat medical conditions. If the medical profession wants to live up to its stated goal of Evidence-based Medicine, then it is imperative that there is a commitment to accumulate evidence on the most promising therapies, not just the ones that are easiest to study, least controversial, or fit comfortably into Concentrated Economic Interest.

One of the primary arguments used by medical boards and Government Regulatory Bodies is that the use of unproven therapies, such as most of those in CAM, causes harm by depriving patients of the proven therapies in conventional practice. This argument is totally unscientific, because there are few if any studies that examine the risk of refusing to undergo conventional therapies. Furthermore, the argument presupposes that conventional treatments are well documented by good science. This presupposition is challenged by Eddy, who alleges that no more than 30% of conventional treatments are proven by scientific studies.25 Even more important, while the FDA requires both safety and effectiveness studies, most of the education and publicity about conventional therapies have focused on effectiveness. There has been insufficient attention to safety and risk. Because CAM treatments are so much safer than conventional therapies in most cases, they do not have to be as effective in order to be a reasonable choice for patients. In fact the use of several CAM therapies for chronic degenerate diseases prior to considering some of the higher risk conventional treatments might substantially improve safety in medicine, while still achieving good individual patient outcomes.

Proposed Government Actions

Legislative bodies and the court system can both mitigate the harm done to Consumers by the interaction between Concentrated Economic Interest and Government Regulatory Bodies. Legal actions in the courts are beyond the scope of this white paper and will not be proposed. While such legal actions might be appropriate, the primary action plans to greatly increase safety in medicine should generate from legislative bodies.

Congress has already made a significant step forward with the Dietary Supplement Act of 1994. This act affirmed control of the regulation of supplements by the FDA, but also stated that the FDA could not arbitrarily suppress truthful information about the effects of dietary supplements. The FDA has been slow to comply with this law, and it is important that the FDA be forced to fulfill the intent of Congress.

Several additional actions by Congress and State Legislatures could have a profound effect on the safety of the health care delivery system to Consumers. Please refer again to Figure 2. This white paper urges that the following proposals be enacted:

Proposals for Congress

1. Pass the Access to Medical Treatment Act. This legislation has already been introduced in Congress. It would insure that doctors would not be prosecuted for offering therapies approved in other countries but not available in the United States, as long as the patient grants informed consent and the results of the treatment are reported to the National Center for Complementary and Alternative Medicine.

2. Establish Federal Guidelines for certification of CAM practitioners. It is very important that such certification be done by organizations that teach or are experienced in each particular therapy. Many professional organizations already offer such certification. Their programs should be fully accepted, as long as they meet the guidelines.

3. Increase the percentage of funding to NIH for CAM. Considering the percentage of Consumers who currently use the therapies and the many more who could benefit greatly by choosing the safer therapies offered by CAM, a much higher portion than 1/2 of one per cent should be allocated in the NIH budget to CAM. NIH has begun to encourage applicants to study CAM, but greater support by Congress would accelerate this process considerably.

4. Be certain that fraud and abuse statutes do not apply to CAM just because its procedures are not included in the AMA’s CPT code books. Congress needs to pass legislation to include CAM codes in the CPT books or establish a separate system for CAM.

5. Protect compounding pharmacists. Congress should protect the ability of these specialists to mix and provide prescriptions for CAM physicians and their patients. Many of the substances prescribed offer a unique potential of benefit to patients with minimal risk and are unavailable from other sources.

Proposals for State Legislatures

1. Nine states have enacted laws to protect physicians who offer CAM to patients from selective prosecution by their medical boards just because they provide these services. Similar legislation to recognize CAM as a legitimate part of the practice of medicine is needed in all states. The results of therapy should be measured by objective testing and by improved quality of life, rather than adherence to published clinical guidelines.

2. State legislatures should mandate that at least one member of the Medical Board be a doctor who practices CAM so that this emerging field of medicine is appreciated and not suppressed.

3. State legislatures should follow the lead of New Jersey’s Supreme Court and insist that adequate informed consent must include all choices of therapy, including those of CAM, even if the physician does not personally advocate some of the therapeutic choices.

Conclusions and Results

If Congress and State Legislatures enact the simple recommendations of this white paper, the public will benefit greatly. As shown in Figure 2, the health care system will move substantially in the direction of safety. Taking a few simple steps to insure that Consumers have access to reliable CAM information and to appropriate treatment, will offer them a choice. There already is sufficient evidence that many CAM treatments deserve to be among the available choices in a good health care system. Additional research will further elucidate which combinations of treatments offer the best chance of success for various conditions.

Not everyone should be forced to choose the therapy that works for the majority in clinical trials. Treatments that do not do as well statistically may still be the best choice for an individual patient with unique circumstances. An individual certainly should have the right to choose a safer therapy, even if that therapy has less chance of a successful outcome. In a free society, citizens should not be forced to undergo significant risk, such as taking potentially toxic drugs (the 4th leading cause of death) or submitting to bypass surgery (the 9th leading cause of death). Informed consent should present patients with all reasonable options that CAM and Conventional Medicine have to offer, even if some of the techniques are as yet unproven by definitive clinical trials.

By moving the health system toward safety and insuring a reasonable choice that includes CAM, there will be less Concentrated Economic Interest domination, less Government Regulatory Body interference with the health concerns of Consumers, and substantially less interaction between these two forces to the detriment of Consumers. The public will be able to make use of the best treatments that our incredible technology has to offer, while improving safety by making informed choices from a diverse list of CAM and conventional medical therapies. CAM will become integrated with conventional medical care with the immediate benefit of decreased risk and greater safety, and with the additional potential to lower costs and improve outcomes.

Notation

This white paper was written by Terry Chappell after a "think tank" session at the Great Lakes College of Clinical Medicine in September of 1999. The meeting was chaired by Jim Turner, who is a prominent Washington DC attorney and chairman of the board of directors for Citizens for Health, a consumer organization, and by James Carter, who recently retired from the School of Public Health at Tulane University. Dr. Chappell is currently on the board of directors of both GLCCM and the American Preventive Medical Association. Many participants at this meeting and at subsequent meetings contributed significantly to this paper.

Resources:

Great Lakes College of Clinical Medicine

800-286-6013

Fax 312-266-3685

American Preventive Medical Association

800-230-2762

Website: www.apma.net

Correspondence:

Terry Chappell, MD

122 Thurman St.

P.O. Box 248

Bluffton, Ohio 45817 USA

References

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2. Nash RA. The biomedical ethics of alternative, complementary and integrative medicine. Alt Therapies 1999;5:92-95.

3. Fields TS. J Am Geriatrics 1999;47:507-511.

4. Richardson W. (panel chairperson) To err is human: building a safer health system. Institute of Medicine, Nov, 1999.

5. Hoffman C, et.al. Persons with chronic conditions: their prevalence and costs. JAMA 1996;276:1473-1479.

6. Grayboys TB, et.al. Results of a second-opinion program for coronary artery bypass grafting surgery. JAMA 1987;258:1611-1614.

7. Tu JV, et.al. Use of cardiac procedures and outcomes in elderly patients in the United States and Canada. NEJM 1997;336:1500-1505.

8. Roger VL, et.al. Sex differences in evaluation and outcome of unstable angina. JAMA 2000;283:646-652.

9. Foubister V. New study confirms: doctors willing to lie for coverage. AM News 1999;42:1,52-54.

10. Fauci AS, et.al., editors. Harrison’s Principles of Internal Medicine, 14th Edition. McGraw-Hill 1998.

11. Braddock C III, et.al. Informed decision-making in outpatient practice. JAMA; Dec 22-29, 1999.

12. Friedman MA, et.al. The safety of newly approved medicines: do recent market removals mean there is a problem? JAMA 1999;281:1728-1734.

13. Edwards DA, et.al. The Federation of State Medical Boards policy statement on health care fraud: a critical analysis. J Adv Med 1999;12:209-219.

14. Complementary and Alternative Medicine at the NIH. Fall, 1998;5:5.

15. Lopes Vas A. Double-blind clinical evaluation of the relative effectiveness of ibuprofen and glucosamine sulfate in the management of osteoarthritis of the knee in outpatients. Curr Med Res Opin 1982;8:145-149.

16. Moore TJ. Deadly Medicine. Simon & Schuster 1995.

17. Roden DM. Magnesium treatment of ventricular arrhythmias. Am J Cardiol 1989; 63:43-46.

18. Champault G, et.al. A double-blind trial of an extract of the Serenoa repens in benign prostatic hyperplasia. Br J Clin Pharmacol 1984;18:461-462.

19. Green RG. Diet and otitis media. Can Fam Physician 1983;29:15.

20. Ornish D, et.al. Intensive lifestyle changes for reversal of coronary artery disease JAMA 1998;208:2001-2007.

21. Olmstead SF. A critical review of EDTA chelation therapy in the treatment of occlusive vascular disease. (a monograph) Merle West Center for Medical Research 1998.

22. Chappell LT, Stahl JP. The correlation between EDTA chelation therapy and improvement in cardiovascular function: a meta-analysis. J Adv Med 1993;6:139-160.

23. Cranton EM, Frackelton JP. Free oxygen radical pathology and EDTA chelation therapy mechanisms of action. J Adv Med 1998;11:277-310.

24. Chappell LT. Research priorities in complementary medicine: a survey of experts in the field. J Adv Med 1999;12:201-208.

25. Eddy DM. Should we change the rules for evaluating medical technologies? In Modern Methods of Clinical Investigation. National Academy of Science Press 1990.


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