Fw: Representative Blunt Speech on BI Research & Info Bill

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----- Original Message -----

From: " ilena rose " <ilena@...>

Sent: Friday, November 16, 2001 5:16 PM

Subject: Representative Blunt Speech on BI Research & Info Bill

> ~~~ thanx Kim ~~~

>

>

> BLUNT BILL TO EXPAND BREAST IMPLANT RESEARCH & INFORMATION SUBJECT OF

> COMMITTEE HEARING Momentum is with us to help patients make

informed

> medical decisions --

>

> Washington, DC -- Southwest Missouri Congressman Roy Blunt today

> outlined his legislation designed to provide more thorough and accurate

> information about the health risks of silicone breast implants during a

> hearing before the Health Subcommittee of the Energy and Commerce

> Committee.

>

> Blunt was joined by a number of women affected by silicone implants,

> including Kim Hoffman, a Southwest Missourian who first shared her tragic

> experience with implants with Congressman Blunt three years ago. Hoffman

> s personal story helped emphasize the need for better information and more

> oversight by the Food and Drug Administration (FDA).

>

> The support from my colleagues on the Energy and Commerce Committee,

> along with the help of the women who have joined us today, indicate that

> the momentum is with us to help patients make informed medical decisions,

> Blunt said.

>

> The Breast Implant Research and Information Act (HR 1961), introduced by

> Blunt and Congressman Gene Green (D-TX) in May, would:

>

> " Require the National Institutes of Health (NIH) to intensify their

> research into the health implications of breast implants; " Expand

> and intensifies FDA efforts to disseminate accurate, current data about

> implants; " Strengthen FDA post-market evaluations of saline implants,

> and " Require the FDA to complete an ongoing criminal investigation of

an

> implant manufacturer accused of data manipulation in its trials of

> breast implants.

>

> Blunt s opening statement before the Health Subcommittee follows. # # #

> Statement of Congressman Roy Blunt

> Breast Implant Research and Information Act

> Health Subcommittee November 15, 2001

>

> Mr. Chairman: I want to thank you for your leadership in joining with me

> and fellow Commerce Committee member Gene Green to bring the Breast

Implant

> Research and Information Act before the Health Subcommittee for a hearing.

> Members of Congress are routinely inundated with statistics, and the topic

> of this bill generates its own list. More than 40,000 women are expected

> to die this year because of breast cancer, the second ranking cause of

> cancer deaths. It is estimated that 83,000 women had breast

reconstruction

> following mastectomies last year, and almost 200,000 adverse reactions to

> implants have been reported to the FDA. Those are significant numbers,

but

> more importantly behind each number is face, a family and a fractured

life.

>

> It is easy to be overwhelmed by such numbers. We can allow ourselves to

> become numb to the enormity of the problem. It is not so easy when we

come

> face to face with the people those statistics represent.

>

> Today you will hear from Kim Hoffman from Southwest Missouri who came to

my

> office three years ago and shared her tragic experience of going from a

> successful business owner to a disabled person in a matter of months

> because of implants. She underwent six surgeries in two years and

> eventually lost her business, her home, her health and her pride because

of

> what she believed was a routine medical decision.

> You will hear from Pam Noonan who survived the trauma of cancer and the

> treatment that followed, only to fall victim ironically to the implants

> that she hoped would allow her to return to a normal life.

>

> These women are but two faces behind the numbers. There are many others

> who could share similar tragic stories. Some of those are in this hearing

> room today including actress McDonough, who may be better known by

> many of us as Walton on the TV series the The Waltons but who has

> also appeared on ER, Ally McBeal, Diagnosis Murder and

> - Texas Ranger . Her career was interrupted by Lupus which she

attributes

> to implants.

>

> You will also hear today from Dr. Zuckerman, an academician with

> credentials from Yale, Harvard and Washington University who also

> worked as a staffer on Capitol Hill for over a decade to forge stronger

> programs on women s health. She brings a unique perspective on the Food

> and Drug Administration s oversight role in approving implants even when

> the agency found complication rates as high as 73 percent after only three

> years.

>

> Mr. Chairman, the Breast Implant Research and Information Act improves

> women s health options in three critical areas:

>

> Informed Consent: This bill does not attempt to stop physicians from

> prescribing implants or from women seeking them. What it does do is to

> insure that when a woman, and perhaps other significant loved ones in her

> life, make the decision, she has the best and most recent scientific

> research available to her. I have heard >from woman after woman that she

> based her decision on inaccurate information and general assurances, not

on

> sound science. Individuals considering this surgery need to know about

> complication rates and the fact that these devices have to be replaced

> periodically. Our medical community must do better.

>

> In light of the controversy surrounding implants, two years ago the State

> of Missouri became the first state to require informed consent prior to

> implant surgery including a 5-day waiting period and specific state

> approved materials to be given to the patient. Rather than creating a

> conflicting patchwork of state regulations, Congress can work to ensure an

> accurate portrayal of the risks associated with these implants, regardless

> of where the patient lives.

>

> Post Market Research: When the FDA s advisory panel recommends approval

of

> drugs or devices to the agency, they often do so with carefully worded

> conditions on follow-up studies. The truth is that the post market

> research is rarely, if ever, reviewed to determine whether it is completed

> and whether the additional research reveals additional problems. When the

> pre-market panel approved saline implants, they also required additional

> research. This bill will require the FDA to report on the status of those

> recommendations every six months for two years after this bill is enacted.

> The follow-up research conducted by the companies on their products

> deserves the same FDA scrutiny which was paid to the research conducted

> for the initial approval of their device.

>

> Post market research is especially important since there is increasing

> anecdotal data showing that significant implant problems do not appear

> until the patient has had the implants for six years or more.

>

> Coordinated Activity: This bill also utilizes the existing resources

within

> the National Institutes of Health to bring together the work being done by

> seven different institutes and offices. Once lines of communication are

> opened between the units, we expect there to be improved interdisciplinary

> research either within the NIH itself or through outside research.

>

> Mr. Chairman, women who are facing the trauma of breast cancer and

> mastectomy do not need to be made a victim for a third time because of

> inadequate information to make a decision, inadequate follow-up on

research

> and inadequate focus within the government s own health agency. This

bill

> will insure that our mothers, our wives, our sisters and our daughters

will

> have the necessary information to make wise life changing medical

> decisions. END-

>

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>

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>

>

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