[Congressional Record Volume 148, Number 44 (Thursday, April 18, 2002)]
[Senate]
[Page S2965]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

      By Mr. DASCHLE (for himself, Mr. Harkin, and Mr. Grassley):
  S. 2207. 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. DASCHLE. Madam President, last year I introduced S. 1378, the 
Access to Medical Treatment Act of 2001. This bill would allow patients 
to use certain alternative and complementary therapies not approved by 
the FDA.
  Alternative therapies constitute an increasingly accepted part of 
medicine. At the National Institutes of Health's Office of Alternative 
Medicine, scientists are working to expand our knowledge of alternative 
therapies and their safe and effective use. Additionally, more 
Americans are turning to alternative therapies in those frustrating 
instances in which conventional treatments seem to be ineffective in 
combating illness and disease.
  The Access to Medical Treatment Act support patient choice while 
maintaining important patient safeguards. It allows individuals, 
especially those who face life-threatening afflictions for which 
conventional treatments have proven ineffective, to try an alternative 
treatment. This is a choice rightly made by patients.
  Treatments covered under the Access to Medical Treatment Act must be 
prescribed by an authorized health care practitioner. 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 includes detailed informed consent requirements.
  The bill carefully restricts the ability of practitioners to 
advertise or market unapproved drugs or devices or to profit 
financially from prescribing alternative treatments. This provision was 
included to ensure that practitioners keep the best interests of 
patients in mind and to retain incentives for seeking FDA approval.
  The bill also 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.
  While I believe that S. 1378 would give patients important new 
choices in health care while maintaining strong consumer protections, 
there has been little discussion or attention given to the issue. 
Meanwhile, some advocates of greater access to alternative therapies 
have urged me to reintroduce a version of the Access to Medical 
Treatment Act similar to the one I and 13 other senators introduced 
during the 105th Congress in an effort to stimulate further discussion 
of this important policy issue. This measure includes less detail than 
S. 1378 but embodies the same goal of making alternative treatments 
more available to patients who want them.
  I continue to believe that S. 1378, with its detailed informed 
consent and practitioner reporting requirements, is the version of the 
Access to Medical Treatment Act that provides the appropriate vehicle 
for legislative debate, and I am hopeful that the bill Senators Harkin, 
Grassley, and I are introducing today will generate momentum to get 
that debate started.
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