[Congressional Record Volume 145, Number 72 (Tuesday, May 18, 1999)]
[Senate]
[Page S5480]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




      PARTICIPATION IN CLINICAL TRIALS--A BASIC HEALTH CARE RIGHT

  Mr. KENNEDY. Mr. President, a recent article in the New York Times 
demonstrates the importance of clinical trials in treating cancer and 
the serious problems that patients and researchers are now facing 
because of the lack of adequate enrollment in these trials.
  Clinical trials are the primary means of testing new therapies for 
serious diseases. In fact, these trials may be the only available 
treatment for patients whose conditions have failed to respond to 
conventional therapies.
  The survey by the American Society of Clinical Oncologists discussed 
in the article found that less than five percent of cancer patients in 
the country are enrolled in clinical trials--although 20 percent are 
eligible to participate and would often receive better quality care if 
they did. As the article points out, ``Patients who participate receive 
at least state-of-the-art treatment and often get to take advantage of 
otherwise unavailable approaches.''
  Several barriers exist to enrolling patients in clinical trials. But 
a critical element is the increasing reluctance of HMOs and other 
managed care plans to allow their enrollees to participate in such 
trials or to pay the routine hospitals costs of their participation is 
a critical element. Until recently, health insurance routinely paid for 
the doctor and hospital costs associated with clinical trials. But 
managed care is reducing that commitment. Today, managed care plans 
often will not permit their patients to enroll in clinical trials, and 
they will not pay for their participation when they choose to do so on 
their own.
  The American Association of Health Plans--the HMO trade association--
has recognized that plans should encourage patients to participate in 
clinical trials, where medically appropriate. But, too often, there is 
little or no participation.
  The decision to enter a clinical trial should be made by the treating 
physician and the patient. Yet the survey showed that only about half 
of eligible patients are even told such trials are available.
  S. 6, the Patients' Bill of Rights, and its companion bill, HR 358, 
require health insurance plans to allow their enrollees to participate 
in quality clinical trials sponsored by the NIH, the Department of 
Defense, and the Veterans Administration. The lack of access 
highlighted by the article clearly demonstrates the need for passage of 
the Patients' Bill of Rights. Without the protections in that bill, 
patients will not be guaranteed the right to participate in these life-
saving trials. Virtually every major cancer group in the nation has 
endorsed the Patients' Bill of Rights, and highlighted the clinical 
trials provision as a major reason for enactment.
  Patients are dying and cures of the future are being delayed. 
Patients deserve this opportunity for life. The rights guaranteed in 
the Patients' Bill of Rights are essential for patients with cancer, 
congestive heart failure, lupus, Alzheimer's Disease, Parkinson's 
Disease, diabetes, and many other deadly illnesses. Every day we delay 
more patients suffer. Congress has an obligation to act.
  I ask unanimous consent that the article from the New York Times may 
be printed in the Record.
  There being no objection, the article was ordered to be printed in 
the Record, as follows:

                [From the New York Times, May 16, 1999]

     Few Take Part in Cancer Tests, Slowing Research, Survey Finds

       Atlanta, May 15 (AP).--Fewer than 5 percent of cancer 
     patients in the nation take part in experiments to test new 
     treatments, a figure at least four times lower than ideal if 
     the most pressing cancer questions are to be answered 
     quickly, according to a survey released today.
       ``We need clinical trials to know what works and what 
     doesn't,'' said Dr. Allen Lichter, president of the American 
     Society of Clinical Oncology.
       Cancer experts almost universally endorse the need for 
     patients to participate in formal studies, but data on how 
     many do so have been scarce. So the oncology society, the 
     nation's largest group of cancer practitioners, commissioned 
     a survey of about 7,000 of its members and released the 
     results at its annual meeting here.
       The survey found that about 40,000 Americans--3 percent to 
     5 percent of those found to have cancer each year--are 
     enrolled in studies of the disease. Far more patients could 
     take part in the experiments, which doctors call clinical 
     trials, the study found.
       The survey estimated that about 20 percent of cancer 
     patients would be eligible to participate in the studies 
     taking place of their kinds of conditions.
       Dr. Ezekiel Emmanuel of the National Institutes of Health, 
     the study's primary author, said doctors should try to enroll 
     the entire 20 percent.
       The experiments typically test new medicines or 
     combinations of drugs to see whether they work better than 
     standard approaches. Patients who participate receive at 
     least state-of-the-art treatment and often get to take 
     advantage of otherwise unavailable approaches.
       Only about half of eligible patients are told the studies 
     are available. And only 20 percent of cancer specialists have 
     time set aside to do this kind of cancer research.
       The survey found that a doctor's cost of enrolling and 
     keeping a single patient in a clinical trial averages $2,000.
       The National Cancer Institute, the single largest sponsor 
     of these studies, pays doctors $750 a patient for this work, 
     while pharmaceutical companies' average payment is about 
     $2,500.




                          ____________________