Introduction Of The Improving Access To Clincal Trails Act Of 2009

Floor Speech

Mr. MARKEY of Massachusetts. Madam Speaker, I rise today to introduce the Improving Access to Clinical Trials Act. I would like to thank my colleague and fellow co-chair of the bipartisan Cystic Fibrosis Caucus, Mr. Cliff Stearns of Florida, for working with me on this important legislation.

Approximately 30,000 children and adults in the United States have cystic fibrosis, a life-threatening genetic lung disease for which there is no cure. In my home state of Massachusetts, nearly 800 families are affected by this horrible disease.

In the three years since we founded the bipartisan Congressional Cystic Fibrosis Caucus, I am proud to say that we have steadily increased the Caucus' membership and currently have 138 members, many of whom are joining us today as original cosponsors of this important bill.

Cystic fibrosis affects parents, who awaken in the middle of the night so they can pound on their child's chest to clear the abnormally thick, sticky mucus that makes breathing difficult. It affects their children, who cough and wheeze and are at constant risk for life-threatening lung infections. And it affects their loved ones, who want the child to have a healthy life but have to worry about the unpleasant alternative of a shortened life expectancy marked by frequent visits to the hospital.

But there is hope for these families. We are in a time of tremendous opportunity and hope in medical research. In the 1950s, children diagnosed with cystic fibrosis usually did not live long enough to enter kindergarten. Back then, there were no drugs for people with cystic fibrosis. Today, through advances in medical research, four respiratory drugs have been brought to market and the median age of survival is about 37 years.

These advances would not have been made without the important clinical research conducted by dedicated doctors and scientists from all around the world. In fact, there are more than 30 cystic fibrosis therapies currently in some stage of clinical trial research. Unfortunately, because cystic fibrosis affects a small population, many of these trials are having difficulties recruiting patients.

The Improving Access to Clinical Trials Act is designed to increase access to clinical trials for patients of rare diseases, like cystic fibrosis, by modifying Supplemental Security Income (SSI) eligibility rules. In accordance with established ethical standards, many clinical trials offer compensation for patient participation. Current eligibility rules for SSI count such compensation as income, making some individuals suffering from rare diseases ineligible for SSI benefits because compensation for participation in the trial would put their income over the SSI eligibility threshold. This forces patients to choose between participating in important clinical trials and keeping their SSI benefits--a cruel choice no one should ever have to make.

Our bill will encourage patients suffering from rare diseases to participate in promising clinical research that may lead to cures, better treatments, and ultimately, saved lives, without having to worry that they could lose the SSI benefits they depend on.

You know, they say that the most powerful four-letter word in the English language is HOPE.

Hope . . . that we can raise awareness of the families struggling with cystic fibrosis and other rare diseases.

Hope . . . that, through research, we will find better treatments and ultimately a cure.

Hope . . . that our children will have to turn to the history books to learn what cystic fibrosis was.

This bill will give hope to more patients who suffer from CF that they can access innovative therapies that could some day cure them of this dreadful disease.

I urge my colleagues to cosponsor and support this legislation.

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