[Congressional Record (Bound Edition), Volume 155 (2009), Part 11]
[Extensions of Remarks]
[Page 15168]
[From the U.S. Government Publishing Office, www.gpo.gov]




  INTRODUCTION OF THE IMPROVING ACCESS TO CLINICAL TRIALS ACT OF 2009

                                 ______
                                 

                         HON. EDWARD J. MARKEY

                            of massachusetts

                    in the house of representatives

                         Monday, June 15, 2009

  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.

                          ____________________