WASHINGTON - Oct. 17, 2018 - PRLog -- Lawmakers at both the federal and state level acknowledge the critical nature of breaking patient barriers to cancer clinical trials and pass two separate bills. This action gives cancer patients a better chance at life through accessing potentially life-saving breakthrough medical advancements.
Congress approved, and President Trump signed, the House Appropriations Committee Fiscal Year 2019 Labor, Health and Human Services, Education Funding Bill, which includes a directive to the National Cancer Institute (NCI) to implement "a new pilot initiative to investigate the impact of providing navigation and direct patient expense reimbursement associated with participation in cancer clinical trials on cancer clinical trial enrollment, retention, patient outcomes, and research outcomes, including among underrepresented and minority communities." Read the language in its entirety here on page 52 of the Labor Report.
The inclusion of the language follows an intensive effort by Lazarex Cancer Foundation with members of congress to bring this problem forward. A bi-partisan letter proposing the report language was submitted to the Appropriations Committee in March 2018. The effort was led by Chairman Pete Sessions of the House Rules Committee (R-Dallas) and Representative Jamie Raskin (D-Bethesda) and was co-signed by 12 additional members of Congress. Chairman Tom Cole of the Appropriations Subcommittee worked closely with Chairman Sessions and Lazarex.
Just after the passage of the nation's spending bill, lawmakers in the Pennsylvania state legislature unanimously approved HB126 designed to improve access to clinical trials for cancer patients in that state. The bill, also initiated and supported by Lazarex, clarifies that reimbursing patients for the out of pocket expenses necessary to travel to a clinical trial site are not to be considered inducements. Governor Wolf is expected to sign the bill.
A national study in 2015 found that patient households making less than $50,000 annually were 30% less likely to participate in clinical trials. This disparity threatens one of the most basic ethical underpinnings of clinical research: the requirements that the benefits of research be made available equitably among all eligible individuals.
Meanwhile, some corporations, individuals, public and private foundations, health care providers, and other stakeholders are hesitant to contribute to, or accept funds from, programs organized to alleviate financial burdens faced by patients who wish to participate in clinical trials and their caregivers, due to concerns that the FDA and or other federal regulators would view the payments made from those funds as prohibited inducements for patients to receive the health care services provided during clinical trials.
"This bill makes it clear that Pennsylvania is 'open for business' in improving participation in cancer trials. Hopefully this will encourage the biotechnology and pharmaceutical industry to partner with Lazarex to make a difference here in Pennsylvania," said Lieutenant Governor Mike Stack – a leader on the two-year Pennsylvania effort.
Lazarex Founder Dana Dornsife added, "So many people were instrumental in passing this bill. I can't possibly name them all here but I want to thank the following as without their efforts and support this would not have ever happened: Governor Tom Wolf, Senator Jake Corman, Senator Joe Scarnati, Senator Kim Ward, Senator Lisa Baker, Senator Andy Dinniman, Senator Jay Costa, Senator Judy Schwank, Senator Pat Browne, Speaker Mike Turzai, Rep. Warren Kampf, Rep. Ryan Warner, Rep. Martina White, Rep. Marguerite Quinn, John Fry, President of Drexel University, Dr. Bob Vonderheide, Director of the Abramson Cancer Center at Penn, and Dave Wilson and Chris Beck in the Government Affairs shops of Drexel and Penn respectively."
Congressman Pete Sessions said, "All of us have been touched by cancer, either through a loved one or through the experience of a personal diagnosis. I look forward to working with my colleagues to continue to support cancer research so that one day we can finally defeat this fast spreading disease and live in a cancer-free world."
All cancer treatments must complete a clinical trial before becoming FDA approved. Many cancer patients for whom standard treatment has failed are eligible for clinical trials that offer potentially life-saving drugs but aren't aware of that option or must decide between living expenses and hope. Why? For a variety of reasons, doctors do not refer patients to trials, and clinical trial sites are often inconveniently located making travel to them both difficult and financially burdensome.
Dornsife continued, "We are thrilled to finally be making progress with this important issue and grateful to all lawmakers who stepped up. If we don't have fully enrolled clinical trials with a diverse pool of patients, life-sustaining treatments are not possible. Clinical trials are the pathway to new treatments. But when you have only 3% of cancer patients enrolling in clinical trials and about 50% of clinical trials failing because they can't enroll enough patients, the pathway is blocked. That's why Lazarex raised this issue at the federal and state levels."
Lazarex is the only non-profit in the United States that assists patients with finding clinical trials and reimburses them for the out of pocket travel costs involved in getting to those clinical trials. In its 11 years, Lazarex has financially assisted more than 3,500 patients in clinical trials. Earlier this year, at the urging of Congress working with Lazarex, the U.S. Food and Drug Administration (FDA) changed its official guidance, issuing new language allowing pharmaceutical companies to reimburse patients for travel costs to get to clinical trials, although not all trial sponsors do this.
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