A friend sent them info below .... any suggestions?

[Guest guest]

>

>

> Rogene, I asked the Senate Health Committee

> to look at the

> " BIG PICTURE " but last

> article tells me they are not going to do that. I

> just don't know what else

> to send them that will open their eyes.

>

> Any suggestions?

>

> A letter and packet of information (175 pages more

> or less) was sent to:

>

>

>

> United States Senate Committee on Health,

>

> Senator Mike Enzi, Senator Judd Gregg, Senator

> Kennedy, Senator Bill

> Frist, Senator Dodd, Senator Lamar

> , Senator Tom

> Harkin, Senator Burr, Senator Barbara

> Mikulski, Senator ny

> Isakson, Senator Jeffords, Senator Mike

> DeWine, Senator Jeff Bingaman,

> Senator Ensign, Senator Patty Murray, Senator

> Orrin Hatch, Senator Jack

> , Senator Jeff Sessions, Senator Hillary Rodham

> Clinton, Senator Pat

>

>

>

> As the FDA considers relaxing restrictions on the

> use of silicone it is

> more important than ever that we know the full

> story! PLEASE INVESTIGATE!

> Lets make sure that the chemicals we allow to be

> placed in the human body

> will do no harm!

>

>

> " Implanted and injected women and their children

> have been DENIED testing

> for toxic chemicals, heavy metals, silicone, ionized

> platinum, bacteria and

> fungi. "

>

>

>

> I am writing to you in an appeal for justice.

> Innocent United States

> citizens are suffering injury and disfigurement at

> alarming rates from toxic

> chemical exposure, and toxic heavy metal poisoning

> from supposedly safe

> products, and are incurring millions of dollars of

> health care expense each

> year, much at taxpayer expense. What is happening is

> criminal, and should be

> investigated as such.

>

>

>

> For many decades manufacturers have sold products,

> such as silicone

> gel/saline, single-lumen (saline mixed with silicone

> gel) and double-lumen

> adjustable breast implants.

>

>

>

> They have argued that silicone is safe, weather the

> implant ruptures or not,

> silicone leaks and migrates to every organ in the

> body. The catalyst used to

> manufacture the silicone for silicone gel and

> silicone elastomer for

> gel-filled and saline-filled implants was platinum

> chloride, a highly

> reactive molecule and precursor to the chemotherapy

> agent cisplatin. Some

> manufactures use Tin as a catalyst for saline-filled

> implants.

>

>

>

> It is recognized by the scientific community that

> " platinum salts "

> (chloroplatinic acid) can cause systemic disease in

> humans as a result of

> toxic and/or hypersensitivity reactions.

>

>

>

> Dr. Ray Biagini, Director Research

> Scientist/Research Toxicologist at

> CDC/NIOSH states that soluble salts of platinum are

> the most potent chemical

> sensitizers known to man.

>

>

>

> THERE IS NO KNOWN WAY TO GET IONIZED PLATINUM AND

> SILICONE OUT OF THE BODY.

>

>

>

> Saline Implants have leaky valves, shell defects

> (rupture). Micro Organisms

> accumulate over many years. As a result, with time,

> the closed space fills

> with a complex mixture of bacteria, fungi, algae,

> and slimes. Organisms

> Found In Such Environments Include: Pseudomonas

> Aeruginosa, Pseudomonas

> Putida, Streptococci, Spivarum, CoccidioidesImmitis,

> Papilloma Viri, Herpes

> Simplex, Aspergillus Fumigatus, Aspergillus

> Boufardi, Aspergillus Niger,

> Bacteroides Fragillis, Curvularia, Staphylococci,

> Mycobacterium Chelonei,

> Mycobacterium Fortuitum, Mycobacterium Tuberculosis,

> Mycobacterium Avium,

> Alternaria Tenuis, Rhodotorula Glutinis,

> Penicillium Notatum, Microsporum

> Epidermophyton, Ricophyton, Candida Albicans,

> Proteus Mirabillis, Propioni

> Bacterium Acne, Serratia Marcescens as well as their

> metabolites and toxins.

>

>

>

> The chemicals that are used in the manufacturing

> process, and that remain in

> the finished product, are deadly. The chemicals that

> are present include

> heavy metals such as platinum, which in the ionized

> form used in the

> manufacturing process is so deadly that the Federal

> Government has

> determined that NO AMOUNT is safe in the human body.

>

>

>

>

> Exposure to ionized platinum, silicone, heavy metals

> and toxic chemicals

> cause such diseases as Multiple Chemical

> Sensitivity, Multiple Sclerosis,

> Lupus, Connective Tissue Disease, Scleroderma,

> Sjogren's Syndrome,

> Fibromyalgia, Arthritis, Thyroid, Chronic Fatigue

> Syndrome, Leukemia, DNA

> Changes, Immune Dysfunction, Autoimmune Disorder,

> Loss of Memory, Loss of

> Smell and Taste, Organ Calcification, Neurological

> Disorders. Compounding

> the problem, ionized platinum and toxic chemicals

> involved readily cross the

> placental barrier, unpublished research document

> that significant amounts of

> ionized platinum are present in the milk of nursing

> mothers, so even the

> unborn future generations of poisoned mothers will

> be affected.

>

>

>

> Although we, the victims, are just finding out about

> the toxicity of the

> products we have been exposed to, the companies that

> are manufacturing these

> products have known for as much as 40/50 years that

> their contaminated

> products can, and are, killing and maiming people.

> Rather than face the

> problem, many companies, such as Dow

> Corning/Chemical are actively engaged

> in covering up and hiding their complicity. They

> have withheld evidence from

> the FDA and others, and have quietly been buying up

> the labs that could test

> for things such as ionized platinum. Of the few

> recipients of silicone

> products who have managed to be tested for ionized

> platinum, significant

> concentrations have been found in many.

>

>

>

> The United States has jurisdiction over the chemical

> companies that are

> injuring her citizens. These products are being sold

> in every state. The

> time has come to support an independent

> investigation into the suffering of

> the victims, and to hold the guilty responsible.

> PLEASE issue a call for an

> independent investigation to hold responsible those

> who have caused so much

> suffering. Criminal indictments are harsh, but so is

> the suffering and death

> that has resulted from the negligence of marketing

> untested products and the

> cover-up to hide the evidence.

>

>

>

> Sincerely,

>

>

>

>

>

> Sent to: (Senate Health Committee) Plus the 175

> pages or more in the binder

>

> 1. Dow's List of Studies /92 - from the evidentiary

> files of breast implant

> litigation ~ 12/30/92

>

> 2. Canadian Research Funding - from the evidentiary

> files of breast implant

> litigation ~ 10/1/92

>

> 3. Canadian request for research funding & Dow

> response- from the

> evidentiary files of the breast implant litigation ~

> 5/22/92

>

> 4. BMS donates to PSEF - from the evidentiary files

> of the breast implant

> litigation ~ 1/6/93

>

> 5. More on Birth Defects - from the evidentiary

> files of breast implant

> litigation ~ 12/11/92

>

> 6. Penile Concerns - from evidentiary files of

> breast implant litigation ~

> 8/27/92

>

> 7. Congressman Seeks Dow Corning Hearings ~ 7/24/95

> ~ Question about 1995

> article

>

> 8. 1993/ Articles on Possible Link to Autoimmune

> Disease - from the

> evidentiary files of breast implant litigation

>

> 9. 1992 NY Medical School says- Need more studies-

> From the evidentiary

> files

>

> 10. Study: Immunopathologic effects of silicone

> breast implants ~ May 1995

>

> 11. Enormous amounts of Info regarding Studies in

> silicone and silica

>

> 12. Immunogenic Dysfunction Silicone Breast Implants

> and Immunogenic

> Dysfunction

>

> 13. Study: fibrous capsules formed around silicone

> breast implants with

> special focus on local immune reactions

>

> 14. Breast Implants Linked to Cancer, Lung Diseases,

> and Suicide

>

> 15. Cover-Up..... An Internal memorandum that

> discloses the Dow Strategy for

> the Breast Implants Cover-Up ~ June 24, 1991

>

>

>

>

>

>

>

> September 16, 2005

>

>

>

> My letter has the information summarized that the

> packet contains,

> documents, letters, articles, testimonies, from

> toxicologist, pathologist,

> chemist, immunologist, allergist, researchers and

> some of the recent

> studies. Even CDC notified the FDA.

>

>

>

> It was sent to you because there are a Million or

> more sick people that want

> to know why the FDA let this happen, KNEW and did

> nothing to stop it.

>

>

>

> 234,187 Adverse reports to FDA on Breast implants as

> of April 30 2002. This

> figure does not include the sick children from their

> injected or implanted

> mothers.

>

>

>

> " Implanted and injected women, their children and

> men have been DENIED

> testing for toxic chemicals, heavy metals, silicone,

> ionized platinum,

> bacteria and fungi. "

>

>

>

> As the FDA considers relaxing restrictions on the

> use of silicone it is more

> important than ever that we know the full story!

> PLEASE INVESTIGATE! Let's

> make sure that the chemicals we allow to be put in

> the human body will do no

> harm!

>

>

>

> We want you to look at the whole big picture not

> just a very small section.

>

>

>

> 774 pages about platinum researching the archives

> from the CD from the PLO

> in Birmingham, documents and letters sent to FDA,

> NIH, other places and

> people that should have looked into the platinum

> issue instead they hid it.

>

>

>

> Silica feared as the next asbestos. It is very toxic

> no matter who the

> manufactures are.

>

>

>

> Silicone Toxicity: overexposed to the product, which

> could lead to silicosis

> " a disabling, non-reversible and sometimes fatal

> lung disease " . Other

> problems can include lung cancer, pulmonary

> tuberculosis, airways diseases,

> autoimmune disorders, (The term 'autoimmune disease'

> refers to a varied

> group of more than 80 serious, chronic illnesses

> that involve almost every

> human organ system) and chronic renal disease.

> Calcification of organs,

> collagen diseases, female and male ratios,

> Hypothyroiditis, Peripheral

> neuropathy, Central neural toxic neuropathy,

> Cervical and axillary

> lymphadenopathy, Fibromyaligia, Myocytis, Fatigue,

> Night sweats, Hair loss,

> Abdominal pain, Pulmonary hypersensitivity with

> dyspnea, Emotional

> instability, Joint and tendon pain, Multiple

> chemical sensitivity (reaction

> to an array of other substances), Food and inhalant

> sensitivities, Skin

> problems. and more.

>

>

>

> A saline-filled breast implant has a silicone rubber

> shell of

> polysiloxane(s), such as polydimethylsiloxane and

> polydiphenylsiloxane, .

> which is inflated with sterile isotonic saline.

> Silicone implants ALSO had

> saline in some of them. The sterile saline used as a

> filler is injection

> grade.

>

> *Shelf- life and storage conditions for Intravenous

> saline: 2 YEARS at a

> temperature NOT exceeding 25C.

>

>

>

>

>

> Conflict concerns raised on FDA panels

>

>

http://www.northjersey.com/page.php?qstr=eXJpcnk3ZjczN2Y3dnFlZUVFeXky...

>

<http://www.northjersey.com/page.php?qstr=eXJpcnk3ZjczN2Y3dnFlZUVFeXkyOSZmZ2

>

JlbDdmN3ZxZWVFRXl5Njc3NTAyOSZ5cmlyeTdmNzE3Zjd2cWVlRUV5eTI=>

>

>

> Thursday, September 22, 2005

> ASSOCIATED PRESS

>

> WASHINGTON - Senators asked Congress's investigative

> arm Wednesday to look

> into the Food and Drug Administration's practice of

> letting scientists serve

> on its advisory panels even if they have conflicts

> of interest.

>

> " We are concerned about the process that supports

> FDA's decisions to waive

> conflicts-of-interest rules for scientists with

> financial ties to the

> manufacturers of the products under consideration,

> or their competitors, "

> senators said in a letter sent Wednesday to the

> Government Accountability

> Office.

>

> It was signed by Sen. Mike Enzi, R-Wyo., the

> chairman of the Health,

> Education, Labor and Pensions Committee, and panel

> members M.

> Kennedy, D-Mass., and Durbin, D-Ill.

>

> Members of FDA advisory committees are required by

> law to be free of

> conflicts of interest concerning products they

> discuss and recommend for

> approval. The FDA, however, can grant a waiver if an

> adviser's scientific

> expertise outweighs the risk of a conflict, or if

> the financial interest is

> small.

>

> " These practices appear to have undermined the

> public's faith in the

> objectivity and fairness of FDA's advisory

> committees, " the senators said in

> the letter.

>

> Senators noted allegations of conflicts among the

> FDA panels that studied

> -2 inhibitors - painkillers that have potential

> heart risks - and

> silicone gel-filled breast implants.

>

>

>

>

http://www.newsinferno.com/storypages/9-27-2005~006.html

>

> US Senators Ask GAO to Review FDA's

> Conflict-of-Interest Policy

> Date Published: September 27, 2005

> Source: Newsinferno.com News Staff

>

> Are the scientists who recommend approval of drugs

> for public use too close

> to the pharmaceutical industry? Some members of

> Congress would like to find

> out.

>

> U.S. Senator Mike Enzi, R-WY, Chairman of the Senate

> Health, Education,

> Labor and Pensions Committee and Senator M.

> Kennedy, D-MA, Ranking

> Member of the Committee, have asked the Government

> Accountability Office

> (GAO) to review the Food and Drug Administration's

> practice of providing

> conflict of interest waivers to members of its

> scientific advisory

> committees. Panel members on these committees are

> charged with recommending

> approval of drug and medical devices for public use.

>

> Enzi and Kennedy were joined in the request by

> Senator J. Durbin,

> D-IL. Senator Durbin is the Assistant Democratic

> Leader. In their letter,

> they say " We are concerned about the process that

> supports FDA's decisions

> to waive conflict of interest rules for scientists

> with financial ties to

> the manufacturers of the products under

> consideration, or their

> competitors. "

>

> Panel members are meant to provide the FDA with

> unbiased, independent, and

> professional advice. They are required to be free of

> conflicts of interest

> concerning any products they recommend for approval.

> However, the FDA can

> grant a waiver if they feel that an expert's

> participation is necessary, the

> financial interests are so small so as not to affect

> the individual's

> service, or if the need for the expertise outweighs

> the potential conflict

> due to financial interest.

>

> In the letter to M. , the Comptroller

> General, the Senators lay

> out the FDA's charter in regards to drug approval.

> " The Food and Drug

> Administration (FDA) has the important

> responsibility of ensuring that the

> drugs, medical devices, vaccines, and other products

> used by the American

> people are safe and effective. The scientific

> advisory committee system at

> the FDA is meant to provide the agency with

> unbiased, independent and

> professional advice on general scientific matters

> and issues related to the

> particular products or classes of products. The

> scientific expertise

> provided by the advisory panels is critical to FDA's

> ability to fulfill its

> mission of protecting public health. "

>

> " We are concerned about allegations with regard to

> FDA's use of waivers of

> the conflict of interest requirements, " the Senators

> continued. They

> provided two examples of such potential conflicts of

> interest. The first

> concerned the FDA's advisory panel on the safety of

> -2 inhibitors (such

> as Vioxx), where nearly one-third of the members

> received a waiver. The

> second example described allegations currently under

> review that one member

> of a panel considering the safety of silicone-gel

> breast implants received

> payments (either directly or indirectly) from the

> device industry.

>

> " These practices appear to have undermined the

> public's faith in the

> objectivity and fairness of FDA's advisory

> committees, " the letter stated.

> " Further, there are questions about transparency in

> FDA's procedures for

> forming advisory committees and granting waivers. "

>

> The Senators asked the GAO to examine the issue and

> address the following

> questions, among others:

>

> * Has the proportion of waivers grown over

> the past decade? How many

> of these waivers are for voting rather than

> non-voting panelists?

>

> * What process exists for determining if a

> waiver should confer

> voting or non-voting status?

>

> * Is there evidence that waivers influence

> voting? For example, is a

> member with a financial interest more likely to vote

> for the product under

> review (or against it) than a member without a

> financial interest?

>

> * FDA's decision to grant a waiver is often

> based on the need for

> the individual's expertise. What barriers exist to

> identifying qualified

> individuals without conflicts?

>

> * How does the FDA screen individuals it is

> considering for

> appointment to advisory committees for conflicts of

> interest? What

> procedures does the FDA have in place for

> identifying alternative

> individuals with minimal or no potential conflicts?

>

> * Are the agency's current disclosure

> statements transparent and

> appropriately detailed? How does FDA balance the

> needs for privacy and the

> requirements of FOIA (The Freedom of Information

> Act) versus the need for

> public disclosure of waiver agreements?

>

> According to Craig Orfield, Spokesman for the

> Health, Education, Labor and

> Pensions Committee, the GAO generally takes several

> months to respond to a

> request of this type. While no decision has been

> made to hold hearings on

> this topic, he left open that possibility.

>

>

>

>