[Congressional Record Volume 147, Number 112 (Friday, August 3, 2001)]
[Senate]
[Pages S8951-S8952]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

      By Mr. DASCHLE (for himself, Mr. Harkin Mr. Hatch, Mr. Inouye, 
        Mr. Johnson, and Mr. Reid):
  S. 1378. A bill to allow patients access to drugs and medical devices 
recommended and provided by health care practitioners under strict 
guidelines, and for other purposes; to the Committee on Health, 
Education, Labor, and Pensions.
  Mr. DASCHLE. Mr. President, today I am introducing the Access to 
Medical Treatment Act. I am pleased to be joined by Senators Harkin, 
Hatch, Inouye, Johnson, and Reid in this effort to increase 
individuals' freedom of choice in health care.
  Patient choice is a value often articulated in health care debates. 
Yet patients often do not have the right to choose potentially life-
saving alternative treatments. I want to thank Berkley Bedell, who 
formerly represented the 6th District of Iowa, for making me aware of 
the importance of this issue and for assisting in the development of 
this bill. This has been a multi-year effort, and he has worked 
tirelessly on it. Berkley has experienced first-hand the life-saving 
potential of alternative treatments. His story convinced me that our 
health care system discourages the use of alternative medicine 
treatment and thereby restricts the right of patients to choose.
  American consumers have already voted for expanded access to 
alternative treatments with their feet and their wallets. A 1997 study 
published in the Journal of the American Medical Association, JAMA, 
shows that 42 percent of Americans used some kind of alternative 
therapy, spending more than $27 billion that year. Americans made more 
visits to alternative practitioners than to primary care providers. 
According to a 1999 JAMA study, people sought complementary and 
alternative medicine not only because they were dissatisfied with 
conventional medicine but also because these therapies mirrored their 
own values, beliefs and philosophical orientation toward health and 
life.
  Alternative therapies are rapidly being incorporated into mainstream 
medical programs, practice and research. Indeed, at least 75 out of 117 
U.S. medical schools offer elective courses in alternative medicine or 
include alternative medicine topics in required courses. A 1994 study 
in the Journal of Family Practice revealed that more than 60 percent of 
doctors from a wide range of specialties recommended alternative 
therapies to their patients at least once. The National Institutes of 
Health now has a Center for Complementary and Alternative Medicine 
where research is underway to expand our knowledge of alternative 
therapies and their safe and effective use.
  Despite the growing demand for many types of alternative medicine, 
some therapies remain unavailable because they have not yet been 
approved

[[Page S8952]]

by the FDA. My bill would increase access to treatments that would 
normally be regulated by the FDA, but have not yet undergone the 
expansive and lengthy process currently required to gain FDA approval. 
Given the popularity of alternative medicine among the American public 
and its growing acceptance among traditional medical practitioners, it 
would seem logical to remove some of the access barriers that consumers 
face when seeking certain alternative therapies.
  The Access to Medical Treatment Act supports patient choice while 
maintaining important patient safeguards. It asserts that individuals, 
especially those who face life-threatening afflictions for which 
conventional treatments have proven ineffective, should have the option 
of trying an alternative treatment. This is a choice rightly made by 
the consumer, and not dictated by the Federal Government.

  All treatments sanctioned by this Act must be prescribed by an 
authorized health care practitioner who has personally examined the 
patient. The practitioner must fully disclose all available information 
about the safety and effectiveness of any medical treatment, including 
questions that remain unanswered because the necessary research has not 
been conducted.
  The bill carefully restricts the ability of practitioners to 
advertise or market unapproved drugs or devices or to profit 
financially from prescribing alternative treatment. This provision was 
included to ensure that practitioners keep the best interests of 
patients in mind and to retain incentives for seeking FDA approval. If 
an individual or a company wants to earn a profit from a product, they 
would be wise to go through the standard FDA process.
  I want to be absolutely clear that this legislation will not 
dismantle the FDA, undermine its authority, or appreciably change 
current medical practices. It is not meant to attack the FDA or its 
approval process. It is meant to complement it. The FDA should, and 
would under this legislation, remain solely responsible for protecting 
the health of the Nation from unsafe and impure drugs. The heavy 
demands and requirements placed upon treatments before they gain FDA 
approval are important, and I firmly believe that treatments receiving 
the Federal Government's stamp of approval should be proven safe and 
effective.
  The bill protects patients by requiring practitioners to report any 
adverse reaction that could potentially have been caused by an 
unapproved drug or medical device. If an adverse reaction is reported, 
manufacture and distribution of the drug must cease pending an 
investigation. If it is determined that the adverse reaction was caused 
by the drug or medical device, as part of a total recall, the Secretary 
of the Department of Health and Human Services and the manufacturer 
have the duty to inform all health care practitioners to whom the drug 
or medical device has been provided.
  This legislation will help build a knowledge base regarding 
alternative medicine treatments by requiring practitioners to report on 
effectiveness. This is critical because current information available 
about the effectiveness of many promising treatments is inadequate. The 
information generated through this Act will begin to reverse this 
information gap, as data are collected and analyzed by the Center for 
Complementary and Alternative Medicine at the National Institutes of 
Health.
  The Access to Medical Treatment Act represents an honest attempt to 
focus serious attention on the value of alternative treatments and 
overcome current obstacles to their safe development and utilization. 
In essence, this legislation addresses the fundamental balance between 
two seemingly irreconcilable interests: the protection of patients from 
dangerous and ineffective treatments and the preservation of consumers' 
freedom to choose alternative therapies. The complexity of this policy 
challenge should not discourage us from seeking to solve it. I am 
convinced that the public good will be served by a serious attempt to 
reconcile these contradictory interests, and I am hopeful the 
discussion generated by this legislation will help point the way to its 
resolution.
                                 ______