Mr. Chairman, I thank the gentleman for yielding, allowing me an opportunity to speak about this issue here before us. I want to thank Mr. Waxman and the committee for reporting an excellent bill. The Whistleblower Protection Enhancement…
Mr. Chairman, I thank the gentleman for yielding, allowing me an opportunity to speak about this issue here before us.
I want to thank Mr. Waxman and the committee for reporting an excellent bill. The Whistleblower Protection Enhancement Act is a long overdue piece of legislation that will go a long way towards correcting some of the abuses of the past and updating the whistleblower protection system to face the challenges of the present.
For too long protections passed by Congress for good-faith whistleblowers have been chipped away by executive agencies and the courts. Court decisions have limited the scope of whistleblower protections in a way that betrays the spirit of the original law. This bill will clarify the rights of whistleblowers, including the right to a prompt court proceeding if their employer challenges their right to the protection.
The bill also protects whistleblowers who work in the national security sector or who work for Federal contractors. This is a critical provision. Under current law, national security employees have next to no protection if they are retaliated against for reporting waste or corruption. This is an extremely dangerous situation. If corruption or abuse of power is happening in our intelligence and security agencies, it should be a concern for all Americans. Employees who report abuses in these sectors are doing a service to our national security. I am glad to see that this bill would finally protect them.
I am also pleased to see protections strengthened for Federal contractors. The growth of contracting under the current administration has been astronomical. Under President Bush the Federal Government is now spending nearly 40 cents of every discretionary dollar on contracts with private companies, a record level. Much of this money has been spent without any kind of oversight that would apply within a Federal agency.
Protection for whistleblowers in the contracting sector is key for improving congressional oversight and bringing potential waste and mismanagement under control.
Let me be clear. This bill doesn't just protect whistleblowers. It protects all Americans.
As chairman of the Oversight and Investigations Subcommittee of the Energy and Commerce Committee, I know that every congressional investigation relies on the willingness of individual witnesses to speak up about what they have seen. These individuals risk their careers and their reputations to expose instances of corruption, waste, and abuse within our government. We owe them a debt of gratitude for their courage. This bill is an important step towards making sure that those individuals have the protection they deserve.
Mr. Chairman, I offer an amendment.
Mr. Chairman, thank you for allowing me an opportunity to address my amendment, and I thank the Rules Committee for making my amendment in order. I want to recognize Mr. Waxman, Mr. Braley, Mr. Davis, and others of the Government Reform Committee for advancing a good bill, and I want to thank Mr. Markey for his help with this amendment and for his previous work in protecting the right of government scientists to publish their findings.
One of the most important sections of H.R. 985 deals with protecting the integrity of the scientific process by shielding whistleblowers who report tampering with government scientific investigations. My amendment would enhance whistleblower protection by including in the list of reportable actions any attempt to suppress the right of government scientists to publish or announce their findings in peer reviewed journals or public meetings with their fellow scientists.
In science, one of the strongest signs of credibility in a study is that the scientists are given a right to publish their rights freely, whatever those results may be. Completed studies are
submitted to peer-reviewed journals for consideration, allowing the scientific community at large to review, challenge and incorporate new findings.
The peer review process is a critical step in the development of scientific knowledge, and the transparency inherent in the process is one of our strongest safeguards against corrupted or misleading scientific claims.
Scientific studies funded by the taxpayers should be held to this same high standard. Political pressure on scientists to suppress or hide the results of their research is a direct attack on the public interest, and employees who report suppression of their scholarly publications should be given the same protection as those who report other kinds of corruption or abuse of authority.
My amendment would protect science in the public sector and has been endorsed by the Union of Concerned Scientists, a leading nonprofit organization dedicated to issues of scientific integrity.
Congress has already had some experience with this issue. In November 2004, the Senate Finance Committee heard testimony from Dr. David Graham, the whistleblower in the Vioxx case. Dr. Graham described how senior managers within the Office of Drug Safety of the FDA attempted to block publication of his study on the dangers of Vioxx, even going so far as to call the editors of The Lancet, a prestigious medical journal, to attack Dr. Graham's work.
Dr. Graham's case is not an isolated incident. In a recent survey by the Union of Concerned Scientists, 150 of 279 government scientists reported some sort of political interference with their work. When asked whether they believed they were free to publish results that might go against the political positions of their agency, a majority of those scientists who answered the question felt they were not free to publish.
We all know how important good science is in helping us make good public policy. As chairman of the Subcommittee on Oversight and Investigations, I am especially aware of the critical role whistleblowers have in rooting out abuses of power and aiding Congress in its oversight responsibilities.
My amendment helps to make the important scientific integrity section of the base bill more comprehensive and more clear. My amendment will protect the public's right to know the results of publicly funded research, and will help make a good bill even better.
Mr. Chairman, I reserve the balance of my time.
Mr. Chairman, I will be brief.
I sat for 12 years on the Energy and Commerce Committee, Oversight and Investigations, and I cannot tell you how many times we have dealt with scientists who have come forward under a whistleblower status, or will call us up in cases like the Vioxx that I mentioned.
I have an article I will include for the Record where a scientist said, ``FDA Called Journal to Block Vioxx Article.'' Thousands of people have died because a drug was put forth on the market because the scientist within the FDA was not allowed to publish the results of his study and was not allowed to speak at advisory panels.
We also see that in a drug called Ketek. It is a drug we continue to do investigation on, and we will have further hearings next week on it, how fraudulent studies were put forth before the FDA. The scientists knew it, and the FDA suppressed the evidence and allowed the drug to be approved, to the detriment and the death of many Americans.
And there is the drug Accutane which has many mysterious questions surrounding it, and people have not been allowed to testify at advisory panels which must approve a drug before it is put forth for public use.
This is a safety issue, and 150 of 279 government scientists reported political interference with their work.
My amendment protects the public right to know the results of taxpayer-funded research. What is wrong with that?
This amendment is a good amendment. It will make the bill better. I ask that my amendment be approved.
[From USA Today]
Scientist Says FDA Called Journal To Block Vioxx Article
(By Rita Rubin)
Just days before a medical journal was to publish a Food
and Drug Administration-sponsored study that raised concerns
about the safety of the arthritis drug Vioxx, an FDA official
took the unusual step of calling the editor to raise
questions about the findings' scientific integrity, suggests
e-mail obtained by USA TODAY.
Lead author David Graham says the call was part of an
effort to block publication of his research, an analysis of a
database of 1.4 million Kaiser Permanente members showing
that those who took Vioxx were more likely to suffer a heart
attack or sudden cardiac death than those who took Celebrex,
Vioxx's rival. Graham had reported his study in August at an
epidemiology meeting in France, but publication in a medical
journal would have exposed it to a wider audience.
Graham, associate director for science and medicine at the
FDA's Office of Drug Safety, says The Lancet, a medical
journal published in London, had planned to post the study on
its Web site Nov. 17, a day in advance of his appearance
before the Senate Finance Committee to testify about the
FDA's handling of Vioxx.
Merck had pulled the drug from the market Sept. 30 because
of safety concerns. Publication of the study could have
embarrassed the FDA, which was being criticized for not
warning patients sooner of Vioxx's cardiovascular risks.
Steven Galson, acting director of the FDA's Center for Drug
Evaluation and Research, said Sunday that Graham's charges
are unfounded. ``We didn't make any efforts to block
publication in The Lancet,'' he said. ``What we did is let
The Lancet know that the paper was submitted in violation of
the agency's clearance process.'' Graham had sought to
publish his study before getting the FDA's OK, Galson said.
And in a written statement, FDA Acting Commissioner Lester
Crawford said that Galson contacted Lancet editor Richard
Horton ``out of respect for the scientific review process.''
Galson said he would like to see the paper published some
day but didn't see the value of timing its release to the
Senate hearing, ``not exactly a scientific imperative.''
Graham says he pulled his paper at the last minute because
he feared for his job. Following is a chronology of the
events surrounding the paper's withdrawal:
Nov. 12. Galson called Horton to tell him that the FDA had
not cleared Graham's paper for publication. He then e-mailed
Horton a link to a document describing the FDA's internal
review process for journal articles. ``As you will see, there
are some ambiguities here,'' Galson said in his e-mail.
In a later e-mail to Horton that day, Galson brought up
points from a nine-page review of Graham's study by Ann
Trontell, deputy director of the FDA's drug safety office.
Galson and Trontell noted discrepancies between the article
submitted to The Lancet and an abstract of the study that had
been submitted in May for presentation at a second scientific
meeting, an American College of Rheumatology conference.
Trontell's review, which Graham had forwarded to Horton,
refers to ``potential charges of data manipulation.''
Graham says he had already explained the discrepancies to
his superiors at the FDA. After the abstract was submitted to
the rheumatology group, Graham says, he discovered two
problems: A computer program had misclassified the amount of
Vioxx some patients had taken; and one of his co-authors
noticed that an analysis Graham had done was incorrect.
Graham says the rheumatology group told him that it was too
late to correct the printed abstract, but that he could
present the corrected analysis at its annual meeting in
October, as he had at the epidemiology meeting in August
Nov. 14. In an e-mail to Galson, Horton wrote, ``You will
not be surprised if I say that I was a little taken aback to
get your call on Friday (Nov. 12). It is very unusual indeed
for a member of the employing institution of an author to
contact us in the middle of the review and publication
process of a manuscript.''
Horton wrote that Galson's call could be perceived as an
improper attempt to interfere with The Lancet's review
process. Raising the possibility that a scientist manipulated
data ``is an extremely serious allegation,'' Horton wrote.
``One could read such an allegation as an attempt to
introduce doubt into our minds about the honesty of the
authors--doubt that might be sufficient to delay or stop
publication of research that was clearly of serious public
interest''
Nov. 18. Graham told a Senate panel that the FDA is
``virtually defenseless'' against another ``terrible tragedy
and a profound regulatory failure'' like Vioxx.
Mr. Chairman, I reserve the balance of my time.
Mr. Chairman, I yield the balance of my time to the gentleman from Iowa (Mr. Braley).