[This landmark bill has changed its numbers several times since we first
wrote about it as S-2140. I have substituted the current Senate bill number,
S-1035, throughout. For more information on the thinking behind this bill
see Berkley Bedell's speech.]
On May 13, [1994] Sen. Thomas A. Daschle (D-SD) introduced the Access
to Medical Treatment Act (S-1035 formerly S-2140) to the 103rd Congress.
This landmark bill would permit any American to be treated by a health
care practitioner with any non-toxic method the patient desires.
It is a daring ³freedom of choice² manifesto, introduced at a time when
much of the proposed health reform legislation threatens to restrict patients¹
rights.
The bill was inspired by Berkley Bedell, the former Democratic Representative
from Iowa who has been a driving force behind the OfÞce of Alternative
Medicine (OAM) of the NIH. In 1986, Bedell was forced to leave the US
Congress because of Lyme Disease, and later contracted prostate cancer.
He has been successfully treated with non-conventional approaches, and
is currently well.
In the bill, as introduced, a ³health care practitioner² is deÞned as
³any properly licensed medical doctor, osteopath, chiropractor, or naturopath.²
(It is hoped that other alternative specialists, such as acupuncturists
and homeopaths, will be added later.)
There are many safeguards in the bill to prevent it from being used
to knowingly sell or promote worthless or toxic medicines. The main provisions
of S-1035 are as follows:
The practitioner agrees to treat the patient with the approaches in
question.
The administration of the treatment falls within the scope of the
doctor¹s practice.
There is no evidence that the treatment, when taken as prescribed,
presents a danger to the individual.
In the case of a food, drug, or device that has not been approved by the
Food and Drug Administration (FDA), the individual would have to be informed
of this fact.
In addition, the food, drug, or device (or the information accompanying
it) would have to contain the following strong warning label:
"This food, drug, or device has not been proved safe and effective
by the Federal Government and any individual who uses such food, drug,
or device does so at his or her own risk."
In addition, the willing patient would have to be fully informed about
the nature of the new treatment, including its contents; any reasonably
foreseeable side effects that may result; and the results of past use
of the treatment by health care practitioners. Aside from the information
contained in this informed consent form, no claims are to be made as to
the treatment¹s efÞcacy. The prospective patient would be required to
sign a statement that he or she has been fully informed of the above,
and still desires that treatment.
Practitioners will be allowed to make accurate and truthful statements
about the treatment at seminars, conventions or similar meetings, or in
recognized scientiÞc journals, provided that the researchers have no Þnancial
stake in the treatment other than what they receive for administering
it to individual patients.
On the other hand, the practitioner would be bound to immediately report
any adverse side effects to the Secretary of Health and Human Services.
PROTECTION FOR DOCTORS?
One important provision for innovative health practitioners is Sec. 6,
which states the following: "A licensing board that issues licenses to
health care practitioners may not deny, suspend, or revoke the license
of a health care practitioner solely because such practitioner provides
treatment" covered in this Act. It is not yet clear how this Federal legislation
will affect the disciplinary process, most of which is handled at the
state level by boards of medical examiners. In any case, the Act will
not exempt doctors from the ordinary laws that apply to malpractice or
incompetence. In mid-June, this legislation was discussed by the Senate
Committee on Labor and Human Resources, chaired by Sen. Edward E. Kennedy
(D-MA). There was some talk about attaching this bill to Kennedy¹s health
reform proposal. But although at least four Senators highly favorable
towards alternative medicine‹Claiborne Pell (D-RI), Tom Harkin (D-IA),
Barbara Mikulski (D-MD) and Orrin G. Hatch (R-UT)‹all sit on that committee,
this incorporation did not happen. One knowledgeable source has told us
that the main reason was Kennedy¹s desire to expedite his health reform
bill in a ³clean² (i.e., unencumbered) form.
ROLE OF THE FDA
In the Concept Paper in support of the bill, Sen. Daschle points out
that the FDA approval process, as currently constituted, strongly discourages
innovation. "The time and expense currently required to gain FDA approval
of a treatment," he wrote, "works to limit participation in this system
to large pharmaceutical companies."
Nevertheless, in Daschle¹s opinion, the FDA¹s role would not be changed
by S-1035. The bill"³would not dismantle or appreciably change the current
operations of the FDA or the conventional medical community. The FDA would
still have responsibility for certifying treatments as safe and effective,"
he adds. In addition, "consumer protections are an essential element of
the bill." All treatments administered under this legislation must not
pose a danger to the patient. The focus of S-1035, quite wisely, is not
on any particular drug or method, but on the rights of patients, some
of whom are seriously ill or even dying, to receive their treatments of
choice. It is meant once and for all to do away with an intolerable situation
in which Americans cannot receive certain medications, or are forced to
go to unreasonable lengths, flee abroad, or even break the law to receive
harmless treatments that possibly could help. Freedom of choice, says
the South Dakota Democrat, is one of the bedrock principles upon which
our nation rests. This bill¹s purpose is to restore basic democratic rights
to the realm of medicine. "This legislation stems from the conviction
that an individual suffering from a life-threatening or otherwise serious
disease should not be denied access to a non-conventional treatment...."
