[Congressional Record Volume 142, Number 117 (Friday, August 2, 1996)]
[Senate]
[Pages S9563-S9564]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

      By Ms. SNOWE (for herself and Mrs. Feinstein):
  S. 2024. A bill to amend the Public Health Service Act to provide a 
one-stop shopping information service for individuals with serious or 
life-threatening diseases; to the Committee on Labor and Human 
Resources.


         The one-stop shopping information service act of 1996

  Ms. SNOWE. Mr. President, today, I rise to introduce a vital piece of 
legislation which will help people with serious or life-threatening 
diseases obtain the information they desperately need about clinical 
trials. Easy access to this information is critical, because clinical 
trials provide cancer patients with potentially promising treatments 
which are otherwise unavailable and which may be on the cutting edge of 
medical research.
  In June of this year, I convened an important hearing with my 
colleagues, Senators Connie Mack and Dianne Feinstein, Cochairs of the 
Senate Cancer Coalition, to address recent developments in breast 
cancer treatments and research. We convened our hearing on the eve of 
the Seventh Annual National Race for the Cure, a race that raises 
millions of dollars each year for breast cancer research and education 
efforts.
  During the hearing, we heard testimony from breast cancer advocates 
on the difficulty patients and physicians face in learning about 
ongoing clinical trials. One witness, representing Breast Cancer Action 
in California, testified about the need for ``One Stop Shopping'' to 
find out what is available in terms of clinical trials for cancer 
treatments. She testified that the existing Cancer Information Service 
at the National Cancer Institute is helpful but underfunded, and 
provides only partial information because it lists only publicly funded 
trials. It does not list, however, the 300-plus clinical trials of 
private pharmaceutical companies, producing a major knowledge gap.
  This witness contrasted this difficulty faced by cancer patients with 
the ease with which AIDS patients obtain information about clinical 
trials. As the result of a 1988 amendment to the Public Health Service 
Act, AIDS patients need only dial a 1-800 number in order to obtain 
information about all clinical trials--both Government financed and 
private pharmaceutical trials. If you have cancer or some other life-
threatening illness, however, you must rely upon your doctor's 
knowledge about clinical trials, which is likely to be limited. 
Moreover, information contained on commercial databases are costly to 
access, difficult to use or understand, and often incomplete.
  Since this hearing, I have heard similar complaints not only from 
cancer patients, but from patients suffering from a wide range of 
severe or life-threatening illnesses. Today, I rise to introduce 
legislation to rectify this knowledge gap.
  My bill is based closely on the existing language in the Public 
Health Service Act which created the AIDS database and which has been 
so successful in making information about AIDS clinical trials 
available to those who need it. Modeled on that language, my bill 
establishes a data bank of information on clinical trials and 
experimental treatments for all serious or life-threatening illnesses. 
The one stop shopping information service will include a registry of 
all private and public clinical trials, and will contain information 
describing the purpose of the trial, eligibility criteria for 
participating in the trial, as well as the location of the trial. The 
bill also requires HHS to set up information systems, including a toll-
free number, for patients, doctors, and others to access this critical 
information. The database will also include information on the results 
of experimental trials, enabling patients to make fully informed 
decisions about medical treatment.

  Imagine facing a deadly disease and not having access to information 
about the latest treatment options. Imagine enduring great pain and not 
having access to a centralized source of information about existing 
clinical trials which may relieve your suffering or extend your life. 
Imagine the arduous effort needed to gather information about these 
clinical trials in order to potentially benefit from cutting-edge 
treatments.
  Then consider what this legislation will do for Americans. People 
with cancer, Alzheimers' disease, Parkinsons, cystic fibrosis, advanced 
heart disease, multiple sclerosis, or any other serious disease will be 
able to dial a 1-800 number from their home phone and access the 
information they need about clinical trials underway across the Nation. 
They will also be able to obtain information about the results of 
experimental trials, helping them to make treatment decisions.
  All parties will benefit from this legislation. First and foremost, 
it encourages patient choice and informed decisions. But pharmaceutical 
companies will also benefit, because this legislation will allow for 
easier and quicker recruitment of individuals willing to participate in 
experimental trials, expediting the approval process for 
investigational new drugs. And the National Institutes of Health and 
the Food and Drug Administration will be better able to serve the 
public.
  This one-stop shopping service will provide hope to countless 
Americans. But most importantly, it will help to save lives and reduce 
the suffering of Americans who are stricken by serious or life-
threatening illnesses. We know from experience that this language 
works. I call for the speedy enactment of this legislation which will 
be of enormous benefit to countless Americans in times of extraordinary 
need, and I urge my colleagues to support this important bill.
  Mrs. FEINSTEIN. Mr. President, today, with Senator Snowe, I am 
introducing a bill to set up a toll-free service so that people with 
life-threatening diseases can find out about research projects that 
might help them.
  Today there are thousands of serious and life-threatening diseases, 
diseases for which we have no cure. For genetic diseases alone, there 
are 3,000 to 4,000. Some of these are familiar, like cancer, 
Parkinson's disease, and multiple sclerosis. Others are not so common, 
like cystinosis, Tay-Sachs disease, Wilson's disease, and Sjogren's 
syndrome. Indeed, there are over 5,000 rare diseases, diseases most of 
us have never heard of, affecting between 10 and 20 million Americans.
  Cancer kills half a million Americans per year. Diabetes afflicts 15 
million Americans per year, half of whom do not know they have it. 
Arthritis affects 40 million Americans every year. 15,000 American 
children die every year. Among children, the rates of chronic 
respiratory diseases--asthma, bronchitis, and sinusitis--heart murmurs, 
migraine headaches, anemia, epilepsy, and diabetes are increasing. Few 
families escape illness today.


                                The Bill

  The bill we introduce requires the Secretary of Health and Human 
Services to establish a ``one-stop shopping'' database, including a 
toll-free telephone number, so that patients and physicians can find 
out what clinical research trials are underway on experimental 
treatments for various diseases. Callers would be able to learn the 
purpose of the study, eligibility requirements, research sites, and a 
contact person for the research project. Information would have to be 
presented in plain English, not medicalese, so that the average person 
could understand it.


                        A Constituent Suggestion

  The suggestion for this information center came from Nancy Evans, of 
San Francisco's Breast Cancer Action, in a June 13 hearing of the 
Senate Cancer Coalition, which I cochair with Senator Mack. She 
described the difficulty that patients have in trying to find out

[[Page S9564]]

what experimental treatments might be available, research trials 
sponsored by the Federal Government, and by private companies. Most of 
them are desperate; most have tried everything. She testified that the 
National Cancer Institute has established 1-800-4-CANCER, but their 
information is incomplete. It does not include all trials and the 
information is often difficult for the lay person to understand.
  In addition, the National Kidney Cancer Association has called for a 
central database.


                         People in Serious Need

  To understand the importance of this bill, we have to stop and think 
about the plight of the individuals it is intended to help. These are 
people who have a terminal illness, whose physicians have tried every 
treatment they can find. Cancer patients, for example, have probably 
had several rounds of chemotherapy, which has left them debilitated, 
virtually lifeless. These patients cling to slim hopes. They are 
desperate to try anything. But step one is finding out what is 
available.
  One survey found that a majority of patients and families are willing 
to use investigational drugs--drugs being researched but not approved--
but find it difficult to locate information on research projects. A 
similar survey of physicians found that 42 percent of physicians are 
unable to find printed information about rare illnesses.


                          Help for Physicians

  Physicians, no matter how competent and well trained, also do not 
necessarily know about experimental treatments currently being 
researched. And most Americans do not have sophisticated computer 
hookups that provide them instant access to the latest information 
through commercial, government, or medical databases. Our witness, 
Nancy Evans, testified that she can find out more about a company's 
clinical trials by calling her stockbroker than by calling existing 
services.
  I have had many desperate families call me, their U.S. Senator, 
seeking help. Others have lodged their pleas at the White House. Others 
call lawyers, 911, the local medical society, the local chamber of 
commerce, anything they can think of. Getting information on health 
research projects should not require a fishing expedition of futile 
calls, good connections, or the involvement of elected officials.
  In 1988, Congress directed HHS to establish an AIDS Clinical Trials 
Information Service. It is now operational, 1-800-TRIALS-A, so that 
patients, providers, and their families can find out more about AIDS 
clinical trials. All calls are confidential and experienced 
professionals at the service can tell people about research trials 
underway which are evaluating experimental drugs and other therapies at 
all stages of HIV infection.


                       Improving Health, Research

  Facilitating access to information can also strengthen our health 
research effort. With a national database enabling people to find 
research trials, more people could be available to participate in 
research. This can help researchers broaden their pool of research 
participants.


                        Modest Help for the Ill

  The bill we introduce does not guarantee that anyone can participate 
in a clinical research trial. Researchers would still control who 
participates and set the requirements for the research. But for people 
who cling to hopes for a cure, for people who want to live longer, for 
people who want to feel better, this database can offer a little help.
  It should not take political or other connections, computer 
sophistication or access to top-flight university medical schools to 
find out about research on treatments of disease when you have a life-
threatening illness.
  Mr. President, I hope this bill will offer some hope to the millions 
who are suffering today and I hope Congress will act on the bill 
promptly.
                                 ______