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Improving Access To Clinical Trials Act Of 2009

Floor Speech

Location: Washington, DC

Improving Access To Clinical Trials Act Of 2009


Mr. MARKEY of Massachusetts. I thank the gentleman from Washington State so much, and I thank my friend from Florida (Mr. Stearns), my cosponsor of this legislation and my cochair of the Congressional Cystic Fibrosis Caucus, for his incredible work in helping to bring this moment into being.

The Improving Access to Clinical Trials Act will enable more individuals with rare diseases to participate in clinical trials offering hope for cures to devastating diseases like cystic fibrosis. This bill is urgently needed.

Current eligibility requirements for Medicaid and Supplemental Security Income shut out many disabled and low-income Americans from participation in potentially lifesaving clinical trials. That is because, in accordance with current ethical standards, many clinical trials offer modest compensation for patient participation, which can average around $500. Low-income patients with rare diseases face a serious barrier to taking part in drug trials, as the modest fee they receive for participation counts towards their eligibility for Supplemental Security Income and Medicaid and can push their income above the established caps. This forces patients to choose between receiving the essential benefits they need to live and the opportunity to participate in a clinical trial that could improve their condition and offer hope for a cure. This is a cruel choice that no one should have to make.

The bill we are considering today addresses this situation by allowing Medicaid recipients and individuals who receive Supplemental Security Income to participate in clinical trials to provide compensation without the risk of losing their benefits, and by excluding up to $2,000 in compensation a patient receives from a clinical drug trial from his or her income calculation for Supplemental Security Income and Medicaid eligibility.

Our bill applies to rare disorders, which are defined as diseases affecting less than 200,000 people in the United States. There are more than 6,000 rare disorders that, taken together, affect approximately 25 million Americans. Examples of rare diseases include ALS, Crohn's disease, cystic fibrosis, Huntington's disease and Parkinson's disease.

The House version of this bill, which Mr. Stearns and I introduced more than a year ago, has 141 bipartisan cosponsors. The Senate version we are considering today, which included Medicaid eligibility in addition to SSI, passed the Senate by unanimous consent on August 5. The Congressional Budget Office has determined that the bill has no cost to the Federal Government. While there is no cost to the government, for millions of Americans the benefits could be enormous--the chance to receive treatment that could dramatically improve their health.

For scientific research, clinical drug trials are an essential part of the process for searching for treatments for diseases. When testing treatments for rare diseases in particular, researchers need patient participation from a significant percentage of patients with each disease in order to produce valid results. Consequently, researchers often struggle to recruit enough patients.

Today, we are working to eliminate one of those barriers to participation by opening clinical trials for rare diseases to those on Medicaid and Supplemental Security Income.

This could produce dramatic advancements towards a cure for rare disorders, including cystic fibrosis. There are approximately 30,000 people living in the United States with cystic fibrosis today. In the 1950s, children with CF usually didn't live past the age of kindergarten. Now, CF patients live productive lives with a median age of 37, thanks to advances in medical research just over the last 40 years.

More than 30 potential therapies are in the CF drug development pipeline today, more than in the entire history of CF research, and many are being tested in clinical trials.

In the next 2 to 3 years, we will need more than 7,000 CF patients to participate in clinical drug trials. Three thousand CF patients participated in drug trials last year. Nearly 50 percent of the CF population receives public benefits, including SSI and Medicaid.

The SPEAKER pro tempore. The time of the gentleman has expired.

Mr. McDERMOTT. Mr. Speaker, I yield the gentleman an additional 2 minutes.

Mr. MARKEY of Massachusetts. Listen to that again: Nearly 50 percent of the CF population receives public benefits, including SSI and Medicaid.

While the average clinical trial compensation amount for a cystic fibrosis drug is $700, an individual with cystic fibrosis often has medical expenses totaling nearly $80,000 per year. Clinical research is critical to our progress towards curing rare diseases such as cystic fibrosis, especially at a time of tremendous opportunity and hope in medical research.

The bipartisan Improving Access to Clinical Trials Act will encourage patients suffering from rare diseases to participate in promising clinical research that may lead to cures, better treatment, and ultimately, saved lives, without having to worry that they could lose SSI benefits.

Our bill has been endorsed by more than 120 organizations, including the Cystic Fibrosis Foundation, the Biotechnology Industry Organization, the National Health Council, and Research!America.

Research is medicine's field of dreams from which we harvest the findings that give hope to millions of Americans that the disease that runs through their family's history may finally be cured. That is what this bill is all about, ensuring clinical trials are conducted that give families hope.

Again, I want to thank the gentleman from Florida and the leaders of the Ways and Means Committee for all of the work that you have done in making this a possibility. I urge an ``aye'' vote.


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