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Thursday, September 17, 2009

Senate Introduces Bill to Boost Participation in Clinical Trials for Rare Diseases

Senate Introduces Bill to Boost Participation in Clinical Trials for Rare

Bill would remove financial penalties for participating in research studies

BETHESDA, Md., Sept. 16 /PRNewswire-USNewswire/ -- Four members of the United
States Senate introduced legislation today to allow patients with rare
diseases to participate in clinical drug studies without losing their
eligibility for public healthcare coverage, echoing a move by the House of
Representatives last month.

The "Improving Access to Clinical Trials Act" is co-sponsored by Senators Ron
Wyden (D-OR), Chris Dodd (D-CT), James Inhofe (R-OK) and Richard Shelby

Researchers who develop drugs to treat rare diseases such as cystic fibrosis
often struggle to recruit participants for clinical trials because of limited
patient populations. To compound the problem, current law prevents many people
who receive Supplemental Security Income (SSI) from accepting research
compensation because it would make them ineligible to continue receiving
government medical benefits. This financial penalty prevents significant
numbers of people with rare diseases from participating in clinical studies.

"For many suffering from rare diseases, access to clinical trials is their
best hope for treatment," said Senator Wyden. "This legislation will make sure
the small financial incentives these people receive will not be counted
against them if they are on SSI or Medicaid. Patients suffering from rare
diseases should not have to choose between their best hope for treatment or
losing benefits, nor be denied the access more financially fortunate patients

"For those living with a rare disease, clinical drug studies can offer a ray
of hope: access to cutting-edge medical technologies that may help treat or
even cure a serious illness," Senator Dodd said. "Currently, individuals who
receive public assistance often do not participate in compensated clinical
trials for fear of losing their Medicaid or Supplemental Security Income. This
legislation will remedy this inequity by ensuring that more Americans,
including those who receive public assistance, have access to these
potentially life-saving clinical drug studies."

"This bill allows patients with a rare disease to disregard up to $2,000 of
compensation received for participation in a clinical trial in their SSI and
Medicaid income calculations," said Senator Inhofe. "Though it will have a
negligible impact on the federal budget, it will make a dramatic difference in
the lives of those who will gain access to potentially life-saving treatments
by enrolling in clinical trials as well as all those in the future whose lives
will be improved by the medical advances that arise from this research.

"Scientists and researchers across our nation continually produce new
therapies that have the potential to save the lives of countless Americans who
suffer from life-threatening rare illnesses," said Senator Shelby. "These
patients should not be forced to choose between the health benefits they
desperately need and the opportunity to participate in a clinical trial that
could improve their medical condition. I am confident that this legislation
will open a pathway for more patients to receive life-saving treatments."

Fifty years ago, there were no drugs for people with CF and those with the
disease rarely lived to attend elementary school. Today, because of the Cystic
Fibrosis Foundation's focus on innovative and aggressive research, there are
more than 30 potential therapies in development, and the median life
expectancy is higher than 37 years.

SOURCE Cystic Fibrosis Foundation

Laurie Fink of Cystic Fibrosis Foundation, +1-301-841-2602; lfink@cff.org

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