[Congressional Record Volume 150, Number 126 (Thursday, October 7, 2004)]
[Senate]
[Pages S10728-S10731]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

      By Mr. DODD (for himself, Mr. Kennedy, Mr. Johnson, and Mr. 
        Wyden):
  S. 2933. A bill to amend the Public Health Service Act to expand the 
clinical trials drug data bank; to the Committee on Health, Education, 
Labor, and Pensions.
  Mr. DODD. Mr. President, I rise today to introduce the Fair Access to 
Clinical Trials (FACT) Act. I want to begin by thanking Senator 
Kennedy, Senator Johnson, and Senator Wyden for joining me in 
introducing this legislation. Our bill will create a clinical trials 
registry--an electronic database--for drugs, biological products, and 
medical devices. Such a registry will ensure that physicians, the 
general public, and patients seeking to enroll in clinical trials have 
access to basic information about those trials. It will require 
manufacturers and other researchers to reveal the results of clinical 
trials so that clinically important information will be available to 
all Americans, and physicians will have all the necessary information 
to make appropriate treatment decisions for their patients.
  Events of the past several months have made it clear that such a 
registry is needed. Serious questions have been raised about the 
effectiveness and safety of antidepressants when used in children and 
youth. It has now become clear that the existing data indicates that 
these drugs may very well put children at risk. However, because the 
data from antidepressant clinical trials was not publicly available, it 
took years for this risk to be realized. In the meantime, millions of 
children have been prescribed antidepressants by well-meaning 
physicians. While these drugs undoubtedly helped many of these 
children, they also led to greater suffering for others.
  Unfortunately, antidepressants are just one example of a story that 
has become all too common. In the case of antidepressants, negative 
data might actually have been suppressed, and if this is discovered to 
be the case, those responsible should be dealt with harshly. However, 
because of what is known as ``publication bias,'' the information 
available to the public and physicians can be misleading even without 
nefarious motives. The simple fact is that a study with a positive 
result is far more likely to be published, and thus publicly available, 
than a study with a negative result. Physicians and patients hear the 
good news, but rarely the bad news. In the end, the imbalance of 
available information hurts patients.
  Our bill would correct the imbalance of information, and prevent 
manufacturers from suppressing negative data. It would do so by 
expanding clinicaltrials.gov, an existing registry that is operated by 
the National Library of Medicine (NLM). Currently, clinicaltrials.gov 
includes information for patients seeking to enroll in clinical trials 
for drugs to treat serious or life-threatening conditions. The FACT Act 
would expand the registry to include all trials (except for preliminary 
safety trials), and would also require the submission of results data. 
At the same time, the bill would ensure that clinicaltrials.gov 
continues to operate as a resource for patients seeking to enroll in 
trials.
  Our legislation would enforce the requirement to register trials in 
two ways. First, by requiring registration as a condition of 
Institutional Review Board (IRB) approval, no trial could begin without 
submitting preliminary information to the registry. This information 
would include the purpose of the trial, the estimated date of trial 
completion, as well as all of the information necessary to help 
patients to enroll in the trial.

  Once the trial is completed, the researcher or manufacturer is 
required to submit the results to the registry. If they refuse to do 
so, they are subject to monetary penalties or, in the case of federally 
funded research, a restriction on future funding. It is my belief that 
these enforcement mechanisms will ensure broad compliance. However, in 
the rare case where a manufacturer does not comply, this legislation 
also gives the Food and Drug Administration (FDA) the authority to 
publicize the required information.
  Let me also say that any time you are collecting large amounts of 
data and making it public, protecting patient privacy and 
confidentiality must be paramount. Our legislation would in no way 
threaten that privacy. The simple fact is that under this bill, no 
individually identifiable information would be available to the public.
  I believe that the establishment of a clinical trials registry is 
absolutely necessary for the health and well-being of the American 
public. But I would also like to highlight two other benefits that such 
a registry will have. First, it has the potential to reduce health care 
costs. Studies have shown that publication bias also leads to a bias 
towards new and more expensive treatment options. A registry could help 
make it clear that, in some cases, less expensive treatments are just 
as effective for patients.
  In addition, a registry will ensure that the sacrifice made by 
patients who enroll in clinical trials is not squandered. Many patients 
would be less willing to participate in trials if they understood that 
the data are unlikely to be made public if the results of the trial are 
negative. We owe it to patients to make sure that their participation 
in a trial will benefit other individuals suffering from the same 
illness or condition.
  The problems associated with publication bias have recently drawn 
more attention from the medical community, and there is broad consensus 
that a clinical trials registry is one of the best ways to address the 
issue. Accordingly, the American Medical Association (AMA) has 
recommended the creation of such a registry, and the major medical 
journals have established a policy that they will only publish the 
results of trials that were registered in a public database before the 
trial began. Our legislation meets all of the minimum criteria for a 
trial registry set out by the International Committee of Medical 
Journal Editors.
  To its credit, the pharmaceutical industry has also acknowledged the 
problem, and has created a registry to which manufacturers can 
voluntarily submit clinical trials data. I applaud this step. However, 
if our objective is to provide the public with a complete and 
consistent supply of information, a voluntary registry is unlikely to 
achieve that goal. Some companies will provide information, but others 
may decide not to participate. We need a clinical trials framework that 
is not just fair to all companies, but provides patients with peace of 
mind that they will receive complete information about the medicines 
they rely on.
  The American drug industry is an extraordinary success story. As a 
result of the innovations that this industry has spawned, millions of 
lives have been improved and saved in our country and around the globe. 
Because of the importance of these medicines to our health and well-
being, I have consistently supported sound public policies to help the 
industry to succeed. This legislation aims to build upon the successes 
of this industry, and help ensure that the positive changes to our 
health care system that prescription drugs have brought are not 
undermined by controversies such as the one now surrounding 
antidepressants, which is at least in part based on a lack of public 
information. This bill will help ensure that new and innovative 
medicines will be used by well-informed patients.
  I look forward to working with industry, physicians, the medical 
journals, patient groups, and my colleagues to

[[Page S10729]]

move this legislation forward. This bill has already been endorsed by 
the National Organization for Rare Disorders, Consumers Union, the 
Elizabeth Glaser Pediatric AIDS Foundation, and the American Academy of 
Child and Adolescent Psychiatry. I thank these organizations for 
lending their expertise as we crafted this legislation, and I ask that 
a copy of their letters of endorsement be included in the Record after 
this statement.
  Clinical trials are critical to protecting the safety and health of 
the American public, and for this reason, trial results must not be 
treated as information that can be hidden from scrutiny. Recent events 
have made it clear that a clinical trials registry is needed. Patients 
and physicians agree that such a registry is in the interest of the 
public health. I urge my colleagues to support this legislation, and I 
am hopeful that it will become law as soon as possible.
  There being no objection, the letters were ordered to be printed in 
the Record, as follows:
  Mr. President, I ask unanimous consent that letters of support be 
printed in the Record.
                                         National Organization for


                                         Rare Disorders, Inc.,

                                     Danbury, CT, October 7, 2004.
     Hon. Christopher Dodd,
     U.S. Senate, Washington, DC.
       Dear Senator Dodd: The National Organization for Rare 
     Disorders (NORD) is honored to support your efforts to 
     establish a centralized and comprehensive registry of both 
     public and privately funded clinical research. The ``Fair 
     Access to Clinical Trials Act of 2004'' will provide the 
     mechanism whereby patients, including those living with rare 
     diseases, will have access to ALL clinical research data--
     both positive and negative--something NORD has supported for 
     many years.
       There are over 25 million Americans currently living with 
     one of the 6,000 known rare diseases. Unfortunately, for most 
     of these diseases, little, if any, research is conducted. 
     Thus, finding a trial is like trying to locate a needle in a 
     massive haystack. Without your help, patients will continue 
     to struggle to somehow find a clinical trial in the hopes 
     that a therapy to alleviate symptoms or cure their disease 
     may someday be found.
       NORD also applauds the ``FACT Act'' because it will 
     penalize industry when they purposefully and willfully hide 
     negative data only to their bottom line. It is unconscionable 
     to think that harmful information has been shielded from 
     patients and healthcare providers, causing irreparable harm, 
     and sometimes death.
       Senator Dodd, NORD thanks you for your continuing concern 
     about the health and welfare of all Americans. We will work 
     with you to ensure that the ``Fair Access to Clinical Trials 
     Act of 2004'' becomes a reality.
           Sincerely.
                                                  Diane E. Dorman,
     Vice President.
                                  ____



                                              Consumers Union,

                                                  October 7, 2004.
     Hon. Christopher J. Dodd,
     Hon. Edward M. Kennedy,
     Hon. Tim Johnson,
     Hon. Ron Wyden,
     U.S. Senate, Washington, DC.
       Dear Senators Dodd, Kennedy, Johnson, and Wyden: Consumers 
     Union, the non-profit publisher of Consumer Reports magazine, 
     commends you for introducing the ``Fair Access to Clinical 
     Trials Act of 2004'' (FACT Act). The legislation would create 
     a mandatory publicly available national registry of all 
     clinical trials involving drugs, biological products, and 
     devices. This bill would enable consumers, doctors, and other 
     health care providers to make appropriate decisions about 
     care based upon more complete and accurate safety, efficacy, 
     and comparative-effectiveness data.
       The recent episode involving Paxil, one of the most popular 
     antidepressants on the market, underscores a potentially 
     dangerous information gap in drug regulation: the ability of 
     drug manufacturers to effectively conceal study results that 
     reveal their products to be ineffective or potentially 
     hazardous. The number of U.S. children taking antidepressants 
     has more than doubled since the early 1990s. In the past 
     year, new evidence has emerged suggesting a possible 
     connection between children starting antidepressant treatment 
     and an increase in suicide risk. The public was disturbed to 
     learn that Paxil's manufacturer, GlaxoSmithKline, submitted 
     three studies to the FDA when it sought approval for 
     pediatric use. The only one of the three studies that showed 
     that Paxil worked for depression was published in the Journal 
     of the American Academy of Child and Adolescent Psychiatry. 
     This article disguised evidence of potential suicidal 
     thoughts by calling them ``emotional lability.'' However the 
     two additional negative Paxil studies were never published in 
     any journal. Meanwhile, doctors continued to prescribe Paxil 
     for children--an estimated 2.1 million prescriptions in 2002 
     alone.
       Your legislation would begin to close the gap in the 
     disclosure of information discovered during clinical trials. 
     It would require trial sponsors to register publicly and 
     privately funded clinical trials of drugs, biological 
     products, and medical devices. The registry will further the 
     goal of transparency by making information publicly available 
     about trials, including: the purpose of the trial; whether 
     the trial focuses on an unapproved use; a description of 
     primary and secondary outcomes to be studied; the estimated 
     completion date; the actual completion date (and the reasons 
     for any difference from the estimated completion date); a 
     summary of the trial results; adverse events observed during 
     the investigation; and a description of the protocol followed 
     in the trial.
       Under the bill, before receiving Federal funding, a 
     principal investigator would be required to certify that it 
     will comply with the bill's registration requirements. 
     Failure to submit trial result information could result in 
     its inability to receive future federally funded contracts. 
     Sponsors of privately funded trials also would be required to 
     disclose the same information, or face potential civil 
     penalties. If any trial sponsor fails to comply with the 
     registration requirements, the Secretary of the Department of 
     Health and Human Services is directed to disclose in the 
     registry that the sponsor has failed to turn over trial 
     results.
       Strong incentives and penalties must be in place in order 
     to ensure that pharmaceutical companies do not suppress 
     negative safety or efficacy information in order to boost 
     their profits. These practices are unacceptable, and we look 
     forward to working with you to ensure transparency for 
     clinical trial results, and to create even stronger 
     incentives and penalties in the legislation to remove any 
     financial motive clinical trial sponsors may have to hide 
     important health information from consumers.
           Sincerely,
                                               Janell Mayo Duncan,
                               Legislative and Regulatory Counsel,

     Washington Office.
                                  ____


                                        Elizabeth Glaser Pediatric


                                              AIDS Foundation,

                                                  October 7, 2004.
     Hon. Christopher J. Dodd,
     U.S. Senate, Washington, DC.
     Hon. Tim Johnson,
     U.S. Senate, Washington, DC.
     Hon. Edward M. Kennedy,
     U.S. Senate, Washington, DC.
     Hon. Ron Wyden,
     U.S. Senate, Washington, DC.
       Dear Senators Dodd, Kennedy, Johnson and Wyden: On behalf 
     of the Elizabeth Glaser Pediatric AIDS Foundation, I would 
     like to commend your leadership in introducing the ``Fair 
     Access to Clinical Trials Act of 2004'' (The FACT Act) and 
     offer our strong endorsement of your efforts to establish a 
     publicly accessible registry of clinical trials, including 
     important pediatric studies.
       The Foundation was created more than 15 years ago to help 
     children with HIV/AIDS and is now the worldwide leader in the 
     fight against pediatric AIDS and other serious and life-
     threatening diseases affecting children. In 2000, the Glaser 
     Pediatric Research Network was founded as an affiliate of the 
     Foundation, with the goal of advancing vital clinical 
     discoveries on behalf of all children. Through a partnership 
     among five pre-eminent academic medical centers, the Network 
     is currently supporting clinical drug trials and other 
     pediatric studies on a range of conditions affecting children 
     such as obesity, cancer, osteoporosis, and rare bleeding 
     disorders.
       As longstanding advocates of testing drugs for use in 
     children, we welcome the dramatic increase in pediatric 
     studies that has resulted from the enactment of both 
     incentives and a pediatric testing requirement. However, 
     simply conducting pediatric research is insufficient if the 
     results of that research are not made fully available to 
     pediatricians, parents, and researchers. By making clinical 
     trial information publicly accessible in a timely way, the 
     FACT Act will serve as a critical next step in improving the 
     safety and efficacy of medicines used by children.
       We are particularly pleased that the FACT Act acknowledges 
     the unique circumstances and contributions of non-profit 
     sponsors of research. Your attention to the need to ensure 
     the continued viability of critical research partnerships 
     between non-profit and for-profit funders is very much 
     appreciated. In addition, as we continue our efforts to 
     improve the availability of medical devices designed for 
     children's unique needs, we applaud your inclusion of device 
     clinical trials in the scope of the registry.
       Thank you again for your commitment to ensuring that 
     important safety data from pediatric and adult clinical 
     trials is available to improve public health. We look forward 
     to working with you in the 109th Congress to secure 
     bipartisan support for and passage of this important 
     legislation.
       Sincerely,
                                                       Mark Isaac,
     Vice President, Policy and Communication.
                                  ____

                                       American Academy of Child &


                                        Adolescent Psychiatry,

                                  Washington, DC, October 7, 2004.
     Hon. Christopher Dodd
     U.S. Senate, Washington, DC.
       Dear Senator Dodd: On behalf of the American Academy of 
     Child and Adolescent Psychiatry (AACAP), thank you for your 
     efforts to improve the health of children, adolescents and 
     adults through better access to

[[Page S10730]]

     clinical trial data. Legislation that you are sponsoring, the 
     Fair Access to Clinical Trials (FACT) Act, will ensure that 
     physicians, including child and adolescent psychiatrists, 
     patients and parents have all available knowledge about a 
     medication's safety and effectiveness, so that they can make 
     informed decisions about treatment options.
       The AACAP is pleased to have been at the forefront of 
     calling for a national clinical trails registry. Research is 
     key to understanding the cause of depression, especially in 
     children and adolescents, and access to all research findings 
     will help clinicians develop the most effective treatment 
     plans. It is this principle that led the AACAP and the 
     American Psychiatric Association (APA) to urge the American 
     Medical Association to join their call for a national 
     registry, which it did earlier this year.
       Again, we thank you for sponsoring the Fair Access to 
     Clinical Trials Act. We are encouraged by the support for 
     this bill and are eager to work with you to ensure its 
     passage. Please contact Nuala S. Moore, Asst. Director of 
     Government Affairs, at 202.966.7300, x. 126, if you have any 
     questions concerning clinical research or other children's 
     mental illness issues.
           Sincerely,
                                             Richard Sarles, M.D.,
                                                        President.

  Mr. JOHNSON. Mr. President, today I join several of my colleagues in 
introducing a very important piece of legislation that will improve 
access to information about prescription drugs for patients and their 
doctors. Today Senators Dodd, Kennedy and Wyden and I are introducing 
the Fair Access to Clinical Trials Act, or FACT Act. I want to commend 
my colleagues for their hard work on this legislation. I also want to 
thank them for their commitment to ensuring that finally, objective, 
unbiased information can be put in the hands of consumers and doctors, 
reducing negative outcomes, improving patient care and ultimately 
reducing costs of medications.
  It is unacceptable that today, much of the information consumers and 
doctors rely on to make decisions about the medications they use are 
based on incomplete information. Patients are often swayed by direct-
to-consumer drug advertisements. Doctors must rely on the information 
they learn at drug company sponsored conferences, and in peer reviewed 
journals that publish largely the success stories. But what about the 
untold stories? What about the clinical trials that were discontinued 
by drug companies because the data appeared to not be going in the 
right direction? What about the studies that are part of an application 
for a new drug that may show a negative result? And what about trials 
that have been conducted to study the appropriateness of an off-label 
use? Today, physicians and their patients do not have access to any of 
this important information, and that must change now.
  The lack of access to this information can have real, devastating 
effects on patients. We have all heard the stories in the papers in 
recent months. We have heard about New York Attorney General Eliot 
Spitzer's lawsuit, which charged GlaxoSmithKline with suppressing the 
publication of studies suggesting that its antidepressant drug Paxil 
could increase the risk of suicide among adolescents. Further 
investigation of this issue has found that some manufacturers of 
antidepressants highlighted positive findings in tests on youngsters 
while playing down negative or inconclusive ones.
  We have just recently learned that the arthritis medication Vioxx was 
pulled off the market, due to negative study findings, and just 
yesterday learned that over 27,000 sudden cardiac deaths and heart 
attacks may have been caused. While Merck did the right thing by 
pulling the drug after learning of clinical trial, they were under no 
obligation to share this information with consumers or the medical 
profession. Drug companies have lobbied to ensure that only the Food 
and Drug Administration gets this information and, even then, some drug 
companies simply discontinue studies that they do not think will 
reflect favorably on their product.
  What doctors advocating the development of a comprehensive clinical 
trial registry have indicated is that without ready access to all 
experimental data, good, bad and indifferent, they cannot hope to know 
what is the best treatment for their patients. Our legislation will get 
at that very issue, by requiring that clinical trials are registered in 
a database that is accessible to the public.
  This bill will create a comprehensive clinical trial database, which 
will require that all trials for drugs, biologics, and medical devices 
be registered in the database in order to obtain approval from a U.S. 
Institutional Review Board to move forward with any study. Researchers 
will be required to disclose basic information about a study initially, 
so that consumers can be aware of studies while they are underway.
  Once trials are completed, the bill requires that the results of 
those studies be made available to doctors and patients. There is 
significant time allowed in the bill for researchers to publish their 
results, prior to them being made public in the database. Submission to 
this database will be mandatory for all federally funded and non-
federally funded trials, and strong enforcement mechanisms are 
incorporated into the bill.
  Making the results of clinical drug trials public is not only a good 
consumer right-to-know or rather need-to-know issue, but it is also the 
ethically responsible thing to do. Patients enter trials for the good 
of science. It is our obligation to ensure that their sacrifices 
provide for the greater good of the public health. Publicizing the 
results of those studies is a step in that direction. Patients 
enrolling in clinical trials often know up front that the likely chance 
of directly benefiting from a treatment is unknown. But patients are 
also told that even if they do not experience a positive outcome, 
doctors can learn from the results, which will advance science in the 
long term.
  This legislation is strongly supported by the National Organization 
for Rare Disorders, Consumers Union and the Academy of Child and 
Adolescent Psychiatry. I urge my colleagues to support this important 
legislation which is long overdue.
  Mr. KENNEDY. I am pleased today to introduce the Fair Access to 
Clinical Trials or FACT Act. This needed legislation will improve the 
information available to patients and their families about the medical 
treatments they receive. For too long, drug companies have been able to 
hide damaging data that show their new wonder drug is not really the 
wonder they claim it to be. That practice ends on the day the FACT Act 
is enacted. From that day forward, consumers, doctors and researchers 
will have access to the results of clinical trials, so they can make 
informed decisions about treatment options.
  No patient should ever die because they didn't get the information 
they needed on the medications they rely on to protect their health.
  The legislation we introduce today is offered by a strong group of 
Senators and Representatives from across the nation. I commend my 
colleague, Senator Dodd, for his leadership in the Senate on this 
important measure. Senator Dodd has a strong and lasting commitment to 
improving the health and health care of all our citizens, and 
particularly for the youngest and most vulnerable. I am also pleased to 
join Senator Ron Wyden and Senator Tim Johnson in introducing this 
proposal, and I commend them for their commitment and skillful 
leadership in this area.
  Our colleagues in the House of Representatives are today introducing 
almost identical legislation, and I commend our colleagues, 
Representative Ed Markey and Representative Henry Waxman, for their 
tireless efforts on this important issue.
  As part of the FDA Modernization Act, Congress directed the 
Department of Health and Human Services to establish a registry of 
clinical trials. This provision was well timed, because it coincided 
with the rapid expansion of internet use. As a result, the National 
Library of Medicine has established a web site, clinicaltrials.gov, 
that is intended to contain information on all clinical trials for 
serious and life threatening diseases.
  Sadly, recent studies show that drug manufacturers are not complying 
with the requirement to list even basic information on the trials they 
conduct. A recent study showed that only 48 percent of the required 
cancer trials were properly submitted to the registry, and rates for 
other serious diseases were in the single digits. As a result of this 
shameful failure, patients are being denied important information on 
clinical trials in which they may be eligible to participate.

[[Page S10731]]

  Action is long overdue to give the NIH and the FDA better ways to see 
that companies and researchers properly register the trials they 
conduct. The FACT Act will assure that any researcher or sponsor 
seeking to conduct a clinical trial will be required, as a condition 
for approval to conduct the trial, to submit information on that trial 
to the clinical trial registry. This common-sense provision will see 
that patients seeking to enroll in clinical trials will have access to 
a complete set of information on the trials for which they may be 
eligible. No patient should be denied access to a lifesaving clinical 
trial because the sponsor of the trial shirked their responsibility to 
submit information to the national registry.
  Ensuring that all trials are registered is important, but 
registration alone is not enough to see that patients get the 
information they need on the treatments they receive. We must also see 
that the results of clinical trials are included in the registry.
  The FACT Act requires researchers and clinical trial sponsors to 
submit the results of their trials to the registry. With a complete and 
comprehensive set of information, patients will be better able to 
evaluate the treatments they receive, and physicians will have access 
to complete information on the treatments they prescribe. The FACT Act 
requires companies to list the results of trials--even when they show 
that a product is less effective than its manufacturers want to claim.
  All of us are familiar with the way that drug companies hid 
information on potentially harmful side effects in children of 
antidepressants. Many of our Republican colleagues in the House 
forcefully criticized the FDA for failing to release information they 
possessed showing that these pills sometimes cause suicidal tendencies 
in the children who received them.
  The FACT Act addresses both of these serious concerns. It requires 
companies to list the results of their trials, and gives FDA the 
authority to impose civil monetary penalties on those who fail to do 
so. It also gives FDA the clear legal authority to release information 
on the results of a clinical trial if a company fails to do so. No 
longer will FDA face the terrible dilemma of knowing that it possesses 
information crucial to assuring public health and safety, but is unable 
to release that information to the public because of legal constraints. 
The FACT Act assures that FDA has the clear authority to take the steps 
it needs to take to protect public health.
  I urge Congress to take swift action on the proposals introduced 
today in the House and Senate. We have little time left in this 
session, but the measures introduced today have broad support from 
medical professional, consumer organizations and the publishers of 
professional journals.
  Some companies have already taken voluntary steps to release 
information on clinical trials. These voluntary efforts are 
commendable, but they are inadequate to give the public the 
comprehensive information they need and deserve. Voluntary reporting 
efforts on the companies' own web sites will not result in a single, 
central database that every patient can consult. Sporadic efforts by 
individual companies will not elicit the comprehensive information 
needed on all clinical trials--not just those of the few companies that 
participate in the voluntary initiative. And voluntary efforts 
undertaken now may not be sustained in the future, when the hot glare 
of public attention fades from this issue.
  To give patients and health professionals the information they need 
to improve the quality of medical care, we need a strong legal 
requirement to list comprehensive information on clinical trials in a 
single publicly accessible database. Patients and their families 
deserve the FACT Act, and I urge my colleagues to support it.
  Mr. WYDEN. Mr. President, today I join Senators Dodd, Kennedy, and 
Johnson in introducing the Fair Access to Clinical Trials Act of 2004. 
This legislation is an important milestone for patients and doctors 
around this country because it would create a centralized clinical 
trials registry by expanding the current clinical trials.gov website to 
provide not only information about clinical trials they might want to 
be part of, but also the results of those trials. If information is not 
provided so it can be posted on the website, serious penalties could be 
imposed, including a researcher losing their ability to get future 
Federal grants.
  It is vitally important that patients and their doctors have the 
information they need to decide upon the best treatment for them. As we 
all know, drugs are often the key treatment for many health problems. 
Good results about the safety and effectiveness of treatments are often 
trumpeted by drug companies and the media, but Americans are less 
likely to hear about clinical trial results that are not so good or 
truly negative. This legislation will ensure that everyone can get a 
fair picture of all results of clinical trials.
  I believe that this legislation strikes the delicate balance needed 
so that companies which create breakthrough drugs can keep their trade 
secrets, the important process of assuring peer review in medical 
literature can continue, and consumers, doctors and researchers can 
have access to the information they need to make sound decisions about 
their health care.
  Research is key in assuring health care improvements. Knowing the 
results of research is key in assuring better health care quality and 
improving decision-making by doctors and their patients. I believe that 
the expanded website created by this legislation will be an important 
tool in improving doctors' and patients' knowledge and decision-making 
that might well mean life or death for some patients.
                                 ______