[Congressional Record Volume 152, Number 44 (Friday, April 7, 2006)]
[Senate]
[Page S3390]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

      By Mr. HARKIN (for himself and Mr. Grassley):
  S. 2618. A bill to permit an individual to be treated by a health 
care practitioner with any method of medical treatment such individual 
requests, and for other purposes; to the Committee on Health, 
Education, Labor, and Pensions.
  Mr. HARKIN. Mr. President, I am pleased to join with Senator Grassley 
today to introduce the Access to Medical Treatment Act. The idea behind 
this legislation is to allow greater freedom of choice and increased 
access in the realm of medical treatments, while preventing abuses of 
unscrupulous entrepreneurs. The Access to Medical Treatment Act allows 
individual patients and their properly licensed health care providers 
to use certain alternative and complementary therapies not approved by 
the Food and Drug Administration (FDA), but that may be approved 
elsewhere. As more Americans seek out alternative and complimentary 
treatments for their health care, we need to be responsive. We need to 
see what works and what does not, but we also need to make sure that 
patients are protected, and are not misled about the potential benefits 
and risks of alternative treatments. The Access to Medical Treatment 
Act presents one option to help Americans make better choices, and it 
is my hope that this legislation can help spur a dialogue about the 
best way to promote access to safe and effective alternative medical 
treatments.
  Importantly, the bill contains an informed consent protection for 
patients, modeled after the National Institutes of Health's, NIH, human 
subject protection regulations. Under the protections provided for in 
the legislation, a patient must be fully informed, orally and in 
writing of the following: the nature, content and methods of the 
medical treatment; that the treatment is not approved by the FDA; the 
anticipated benefits and risks of the treatment; any reasonably 
foreseeable side effects that may result; the results of past 
applications of the treatment by the health care provider and others; 
the comparable benefits and risks of any available FDA-approved 
treatment conventionally used for the patient's condition; and any 
financial interest the provider has in the product. The consent 
documents will then become part of the patient's medical record.
  Providers and manufacturers are required to report to the Centers for 
Disease Control and Prevention, CDC, any adverse effects from 
alternative treatments, and must immediately cease use and manufacture 
of the product, pending a CDC investigation. The CDC is required to 
conduct an investigation of any adverse effects, and if the product is 
shown to cause any danger to patients, the physician and manufacturers 
are required to immediately inform all providers who have been using 
the product of the danger.
  Our legislation ensures the public's access to reliable information 
about complementary and alternative therapies by requiring providers 
and manufacturers to report the results of the use of their product to 
the National Center for Complementary and Alternative Medicine at NIH, 
which is then required to compile and analyze the information for an 
annual report. The bill also stipulates that the provider and 
manufacturer may make no advertising claims regarding the safety and 
effectiveness of the treatment of therapy, and grants FDA the authority 
to guarantee that the labeling of the treatment is not false or 
misleading.
  Mr. President, the goal of this legislation is to preserve the 
consumer's freedom to choose alternative therapies while addressing the 
fundamental concern of protecting patients from dangerous treatments 
and those who would advocate unsafe and ineffective therapies. I hope 
that we have struck the appropriate balance, and I welcome feedback 
from interested parties.
  It wasn't long ago that William Roentgen was afraid to publish his 
discovery of X-rays as a diagnostic tool. He knew they would be 
considered an alternative medical practice and widely rejected by the 
medical establishment. As everyone knows, X-rays are a common 
diagnostic tool today. Well into this century, many scientists resisted 
basic antiseptic techniques as quackery because they refused to accept 
the germ theory of disease. I think we can all be thankful the medical 
profession came around on that one.
  The underlying point is this: today's consumers want alternatives in 
many medical situations for them and their families. They want less 
invasive, less expensive preventive options. Americans want to stay 
healthy. And they are speaking with their feet and their pocketbooks. 
Mr. President, Americans spend $30 billion annually on unconventional 
therapies. That is one of the reasons we established the National 
Center for Complimentary and Alternative Medicine, NCCAM, at NIH in 
1998. As more Americans look for alternative courses of treatment, we 
needed to provide a way to see what works and what does not. This bill 
is another step in that direction.
  This legislation simply provides patients the freedom to use--with 
strong consumer protections--the complementary and alternative 
therapies and treatments that have the potential to relieve pain and 
cure disease. And it provides a means to see what works and what does 
not. I thank Senator Grassley for his continued leadership on this 
issue, and urge my colleagues to consider this bill.
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