The Vice President of Therapeutics Development at the Cystic Fibrosis Foundation, Dr. Michael Boyle, was called in to testify last week in front of the House Energy and Commerce Committee’s Subcommittee on Health. In front of an audience of lawmakers, Dr. Boyle emphasized the need for passing H.R. 209 or the Ensuring Access to Clinical Trials Act (EACT). If passed by the Committee, HR 209 will be permanent legislation that will allow patients to take part in clinical trials without worrying about compromising their health benefits.
The EACT follows the Improving Access to Clinical Trials Act (IACT) of 2009, effectively making the latter permanent if passed by the Committee. The IACT allows patients diagnosed with rare diseases such as cystic fibrosis to receive up to $2,000 every year as compensation for participating in clinical trials and be spared from any deductions in their Supplemental Security Income (SSI) and Medicaid benefits. The IACT, which was originally championed by the CF Foundation, is currently due to lapse on October 5, 2015.
“There are more clinical trials underway this year for new CF treatments than ever before. We must ensure that nothing puts this research at risk and that no one with CF is excluded from participating in clinical trials for potentially life-saving treatments,” said Boyle. “The Cystic Fibrosis Foundation urges Congress to pass the Ensuring Access to Clinical Trials Act without delay.”
Dr. Boyle shared his experience at Johns Hopkins University Hospital when he still practiced as a physician full time. His work would expose him to cystic fibrosis patients in dire conditions, and contrastingly to patients that have improved in many ways by participating in clinical trials. His testimony included a thought-provoking story of a male CF patient who had decided not to join a clinical trial for a drug that would have been very effective for the type of CF he was diagnosed with, all because the compensation of $750 would compromise his SSI and Medicaid. Unfortunately, most hospital review boards do not allow willing participants to forgo the compensation, and the man passed away from disease complications 4 months later.
The EACT passed a vote in the Senate last July 16, 2015. It was introduced by Senators Ron Wyden (D-OR), Orrin G. Hatch (R-UT), Edward J. Markey (D-MA), and Sherrod Brown (D-OH) in the Senate and Representatives Lloyd Doggett (D-TX), Tom Marino (R-PA) and Jim McGovern (D-MA) in the House.
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