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
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5. Hoffman C, et.al. Persons with chronic conditions:
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6. Grayboys TB, et.al. Results of a second-opinion program
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7. Tu JV, et.al. Use of cardiac procedures and outcomes
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