[Congressional Record (Bound Edition), Volume 150 (2004), Part 17]
[Extensions of Remarks]
[Page 23426]
[From the U.S. Government Publishing Office, www.gpo.gov]




           THE ``FAIR ACCESS TO CLINICAL TRIALS (FACT) ACT''

                                 ______
                                 

                         HON. EDWARD J. MARKEY

                            of massachusetts

                    in the house of representatives

                       Thursday, October 7, 2004

  Mr. MARKEY. Mr. Speaker, I rise today to introduce the Fair Access to 
Clinical Trials (FACT) Act. This bill is designed to ensure that the 
public has complete and accurate information about the drugs and 
devices they use.
  Recent revelations in the press and in the oversight hearings 
conducted by the Energy and Commerce Committee's Oversight and 
Investigations Subcommittee have raised serious concerns that some 
companies in the pharmaceutical and medical device industries have 
failed to properly disclosed important information from the public 
about the safety of certain drugs or medical devices. For example, 
there is now evidence that several pediatric anti-depressant trials 
that produced important new adverse information about the safety of 
certain drugs were not released to the public. The public is now 
demanding to know why these trials never saw the light of day. Although 
much attention has focused on disclosure problems involving the effects 
of certain anti-depressants on young people, the problem of selective 
disclosure and publication is not limited to a specific type of drug or 
scenario--the same concerns exist whether we are talking about drugs to 
treat depression, heart disease or arthritis, or even a medical device 
that would be implanted into the human body.
  I am sure that some clinical trials do not become part of the medical 
literature for innocent reasons. But we cannot ignore the possibility 
that some studies were and continue to be intentionally buried by 
companies who are worried about the impact of a negative trial on their 
bottom line. Regardless of the motivation, however, the fact remains 
that we don't know what trials are currently being conducted, so it is 
impossible to determine whether the companies and researchers are 
actually telling us the whole truth about their drugs and devices or 
whether they are painting a distorted picture of their products by 
picking and choosing which trials they want to reveal.
  This creates two huge problems.
  The first is that in order for doctors to make good medical decisions 
and provide their patients with the best possible care, they need to 
have access to complete and sound scientific data.
  The second is that when people enroll in clinical trials they give up 
a certain control of their own personal medical decisions, willingly 
taking experimental drugs and subjecting themselves to potential harm 
in the belief that their participation in the studies will add to the 
advancement of medical knowledge and potentially unlock the secrets of 
disease. But if a researcher or a company that sponsors a trial does 
not publicize the results, the knowledge gained from putting those 
participants at risk remains forever buried in some researcher's 
computer. That information will not be available to doctors, or to 
other medical researchers, who could use it.
  In order to ensure that clinicians have all the information they need 
in order to make sound medical decisions, uphold the ethical 
responsibility to patients and protect public health, I am proud to 
join with the gentleman from California, Mr. Waxman, to introduce the 
Fair Access to Clinical Trials (The FACT Act) a bill to create a 
mandatory, public, federal registry of all clinical trials.
  The FACT act will require researchers to register their clinical 
trials in a federal registry before starting them and report the 
results of those trials at the conclusion. The federal database will 
include both federal-funded and privately-funded clinical trials so 
that clinicians, patients and researchers will be able to know the 
universe of clinical trials on a particular drug and have access to the 
results of those trials. Our bill also establishes strong enforcement 
mechanisms, including monetary penalties of up to $10,000 per day for 
manufacturers who refuse to comply.
  The registry established under the bill is intended to meet all of 
the minimum criteria for a trial registry set out by the International 
Committee of Medical Journal Editors, and will satisfy the American 
Medical Association's call for the results of all clinical trials to be 
publicly available to doctors and patients. Our legislation has been 
endorsed by the New England Journal of Medicine and the Elizabeth 
Glaser Pediatric AIDS Foundation.
  The FACT act will ensure that patients have the tools they need to 
make informed decisions, maintain the integrity of the medical 
community, and protect the health of their patients and our families.
  I look forward to working with everyone concerned about this 
important issue so that we end up with a system that preserves a robust 
system of research and ensures robust system of disclosure.

                          ____________________