By Judy Holland, Hearst Newspapers
WASHINGTON -- The patients rights' legislation that passed by the
Senate last week held some good news for cancer patients seeking to
participate in federal clinical trials.
In some instances, the bill would require managed care providers
to pay for costs related to the trials.
A patient in a clinical trial agrees to undergo an experimental
treatment so researchers can test a new drug, device, or
combination of already approved treatments that have shown promise.
Such trials are often the last recourse for patients who haven't
been helped by traditional therapies.
While the drug company or the manufacturer picks up the cost of
the new treatment, other expenses such as hospitalization, extra
tests and additional doctor visits often are not paid for by either
the drug company or the patient's managed care plan.
Many would-be trial participants are deterred from taking part
because those extra expenses -- for an extra CT scan or a surgical
procedure that might be needed to monitor potential affects of a
new treatment -- can run into the thousands of dollars.
The Senate measure would require some managed care providers to
pay ``routine patient costs'' of cancer clinical trials sponsored
by the National Institutes of Health, the Department of Veterans
Affairs or the Department of Defense.
Federal researchers are now conducting more than 2,000 cancer
clinical trials. Such trials may have as few as a dozen
participants or as many as 30,000.
Sen. Connie Mack, R-Fla., the prime sponsor of the proposal,
claimed that cost is the primary reason that only 2 percent of
cancer patients agree to take part in clinical trials.
Mack is a survivor of melanoma. His wife, Priscilla, is a breast
cancer survivor and their daughter, Debbie, is a cervical cancer
survivor. Mack lost his younger brother, Michael to melanoma, his
mother died of esophageal cancer and his mother died of kidney
cancer.
Sen. Barbara Boxer, D-Calif., complained that valuable medical
research is being jeopardized because, she said, HMOs are cutting
back on paying costs associated with clinical trials.
``We are starting to see fewer clinical trials because HMOs
won't pay,'' she said. ``That not only hurts the patients but
stands in the way of research.''
Mack likens participants in clinical trials to astronauts who
are willing to risk their lives to push science into new frontiers.
``Cancer clinical trials are one of the most beneficial ways
doctors can determine which treatments are most effective against
cancer,'' Mack said. He said the new bill ``breaks down the cost
barrier and ensures that our family, friends and loved ones are not
shut out from receiving promising new treatments simply because of
cost.''
The Senate measure would apply to 48 million people who receive
health care coverage through large employers who insure themselves
by funding their own claims and hiring a managed care provider to
administer the plan.
It would not apply to 113 million people with private insurance.
And it would not apply to hundreds of clinical trials conducted by
pharmaceutical companies and academic medical centers.
The House has yet to consider patients' rights legislation.
Mary McCabe, director of the office of clinical research
promotion for the National Cancer Institute, the nation's chief
cancer funding agency, said the Senate legislation is ``very
important good news for the oncology community. It's an opportunity
both for patients and for researchers to conduct clinical trials
and get important answers to cancer questions.''
The Senate rejected a proposal sponsored by Sen. Christopher J.
Dodd, D-Conn., that would have required health plans to pay costs
connected with all federally sponsored clinical trials, including
clinical trials of diseases such as AIDS, Parkinsons and Alzheimers
disease, multiple sclerosis, diabetes and Lupus.
Sens. Bill Frist, R-Tenn., a physician who takes a leadership
role on almost all health-related legislation, said Republicans
decided to limit the coverage to cancer patients because they
didn't ``want to impose exorbitant costs'' on managed care
providers.
Frist said the Democratic proposal ``opens the door so broadly
it has the potential for premiums to skyrocket.'' He said there
isn't enough data on clinical trials for diseases other than cancer
to know how much the associated costs could be.
The GOP legislation would set up a panel to determine by 2000
which ``routine patient costs'' should be paid by insurers.
Carmella Bocchino, vice president for medical affairs for the
American Association of Health Plans, which represents the managed
care industry, says it's unclear how much money is involved in
``costs associated with routine patient care.''
``You could put five people in a room and ask them to define
routine patient care and you'd get six different answers,'' she
said. ``There could be a whole slew of tests'' needed to take part
in a trial.
