[Congressional Record Volume 141, Number 112 (Wednesday, July 12, 1995)]
[Extensions of Remarks]
[Pages E1424-E1425]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]


                  THE ACCESS TO MEDICAL TREATMENT ACT

                                 ______


                         HON. PETER A. DeFAZIO

                               of oregon

                    in the house of representatives

                        Wednesday, July 12, 1995
  Mr. DeFAZIO. Mr. Speaker, today I am introducing H.R. 2019, with 
Representatives Barton, DeLay, Cox, Hinchey, Kingston, Furse, Pallone, 
Norton, Owens, Smith (NJ), Lipinski, Velazquez, Evans, Dellums, 
Deutsch, Frazer, and Hilliard, the Access to Medical Treatment Act. 
This legislation will allow greater freedom of choice in the realm of 
medical treatments by making alternative treatments more accessible to 
the public.
  The Access to Medical Treatment Act represents a significant 
departure from the current paternalistic practice of medicine. It is 
based on two beliefs about our current health care system: First, the 
system limits patients' choices of medical treatments to conventional 
modalities; and second, the system effectively discourages the 
development of alternative therapies that could help treat illnesses 
that often are unresponsive to conventional medicine. This act opens up 
the health care system and market, under controlled conditions, to 
informed consumers.
  There is a compelling need for this legislation. Health care reform 
requires more than just access to conventional treatments. Real reform 
examines the fundamental premise and framework of our current medical 
system. As we confront escalating medical costs and struggle to contain 
Medicare and Medicaid spending, alternative medicine provides some 
affordable, less invasive, and effective answers, especially in the 
areas of long term and chronic illnesses.
  Canada, Germany, France, and other G-7 and EEC countries know the 
value of alternative medicine. In fact, many of these countries view 
alternatives as traditional and essential to their health care systems. 
The lessons learned abroad show that alternatives can be successfully 
incorporated into mainstream medicine. It's time that we shift our 
health care paradigm from a model of disease maintenance to one of 
wellness, prevention, and holistic care.
  The New England Journal of Medicine reported in January 1993, that 
more than one-third of Americans used alternative, nonconventional 
medical treatments. Many Americans, suffering from chronic, 
debilitating, and life-threatening illnesses, are turning to 
alternative medical treatments.
  Unfortunately, our current health care system effectively eliminates 
access to nonharmful alternative medical treatments that may help 
patients, complement conventional treatments, contain costs, and 
generate new 

[[Page E 1425]]
approaches to treating illness. Thousands of individuals abroad have 
legal access to these treatments.
  In an effort to protect the public, the Food and Drug Administration 
[FDA] has effectively restricted the proliferation of alternative 
therapies. Only large pharmaceutical companies can afford the time and 
expense--over $100 million--currently required to gain FDA approval of 
a treatment. The FDA's process effectively excludes potentially 
innovative contributions by individual practitioners, scientists and 
smaller companies. Many alternative treatments are combinations of 
natural products; thus, they are ineligible for patents. Without a 
patent, companies cannot recover the investment needed for the FDA 
approval process.
  I have met many doctors who could better treat their patients with 
this legislation and many patients who desperately want more treatments 
available to them. Former Congressman Berkley Bedell knows firsthand 
the importance of this legislation and served as a catalyst for its 
development. Former Congressman Bedell used a treatment that was 
nothing more than the processed whey of cow's milk to treat his Lyme's 
disease when costly conventional methods failed. After 2 months of 
taking regular doses of this processed whey, his symptoms disappeared. 
He estimates that the total cost for this alternative treatment was no 
more than a few hundred dollars. He credits this inexpensive treatment 
for his recovery. Unfortunately, this and many other safe alternative 
treatments are not available to the public because they have not passed 
the FDA approval.
  Mr. Speaker, there are Berkley Bedells all across our country who are 
desperate for cures that conventional medicine simply does not seem to 
effectively provide. The Access to Medical Treatment Act gives patients 
the right to obtain nonharmful alternative treatments that have not 
been approved by the FDA from state authorized medical providers. The 
intent of this bill is merely to extend freedom of choice to medical 
consumers under controlled situations and grant individuals access to 
alternative treatments that are currently offlimits. Practitioners who 
now use alternative, nonharmful treatments risk losing their licenses 
for trying to help their patients with unconventional treatments.
  As with any effort to challenge the status quo there is skepticism 
about the implications of opening up the market to alternative 
treatments. We have worked hard to develop a bill that gives patients 
and their health care practitioners the freedom necessary to treat 
their illnesses while including the protections necessary to safeguard 
consumers from dangerous treatments and unqualified practitioners.
  It is not my intention to dismantle the FDA or to weaken its 
authority to regulate the safety and efficacy of most drugs in this 
country. This legislation does not attack the FDA for the valuable role 
it plays in helping America maintain a topnotch, high-quality health 
care system. Unfortunately, the expensive and extensive FDA approval 
process does prevent low-cost, alternative treatments from gaining 
access to the market.
  The FDA would remain solely responsible for protecting the health of 
the Nation from unsafe and impure drugs. Before a treatment receives 
the Government's stamp of approval and has a claim of efficacy 
attached, it must make it through the FDA approval process.
  This bill requires full disclosure to patients of the contents and 
possible side effects of treatments. In addition, the strict claims 
section in this bill mandates that patients are notified that the drug 
has not been proven safe or efficacious by the Federal Government.
  The medical treatments prescribed must have no evidence of causing an 
adverse impact on individuals' health. However, if any treatment is 
found to cause harm, the treatment must be immediately reported to the 
Secretary of Health and Human Services and then any practitioner who 
continues use of the treatment is not covered under this act.
  Finally, the greatest concern expressed about this proposal is the 
issue of consumer protection. This is an essential part of this 
legislation and I, as much as anyone, want to protect sick and 
vulnerable individuals from negligent charlatans who would prey on 
their misfortunes and fears for personal gain. The Access to Medical 
Treatment Act is armed with these protections.
  In order to protect consumers, this bill limits those qualified to 
administer treatments to State authorized medical providers who are 
working within their scope of practice. Most importantly, the bill 
strictly regulates the circumstances under which claims regarding the 
efficacy of a treatment can be made. It prohibits all advertising and 
labeling claims and any other claims by individuals for whom the 
underlying intent of promoting the treatment might be linked to 
personal financial gain.
  There can be no marketing of any treatment administered under this 
bill. This eliminates the incentive for anyone to attempt to use this 
bill as a bypass to the process of obtaining FDA approval.
  I want to protect consumer safety, but I also want to promote 
consumer freedom of choice. Individuals, especially those facing life 
threatening and debilitating illness, should have the option of trying 
alternative treatments so long as they are informed of possible side 
effects and there is no evidence that the treatment is harmful. 
Patients must be given the keys to steer the course of their health 
with the assistance of trained health care providers. Permitting the 
administration of and access to alternative medical treatment extends 
freedom of choice to the realm of medicine.
  Opening the health care system to alternative treatment can help 
patients, complement conventional treatments, contain costs, and 
generate new ways to treating illness. This choice is one for the 
consumer, not the Federal Government.


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