COALITION OF SILICONE SURVIVORS
2739 W. 23rd St., Greeley, CO 80634
Lynda Roth - (970) 506-9288 Fax (970) 506-9288 (call first) e-mail:
coss@privatei.com
Website: siliconesurvivors.net
February 1, 2003
Dear Silicone Survivors and Friends:
LEGAL INFORMATION: OCTOBER 7, 2002: The United States Supreme Court ruled
today denying the request by certain Nevadan objectors to hear their appeal
(i.e., the legal term is a request for certiorari and this was denied).
This means that the Supreme Court will not hear any appeal at this time on
the Dow Corning bankruptcy Settlement Plan.
December 11, 2002, presiding U.S. District Court Judge, Denise Page Hood,
issued two orders in the Dow Corning bankruptcy case. The first Order
authorized the mailing of claim form packages to be mailed during the week
of February 18, 2003. These forms are the forms claimants will use to apply
for settlement benefits and compensation.
The second Order is a 36 page Opinion in which the Court found that there
was sufficient evidence in the record to support the release and injunction
provisions in the joint plan of reorganization. In other words, all appeals
were denied, although some have been appealed again to a higher court.
STATUS OF APPEALS: Two appeals were filed to Judge Hood's December 11, 2002
Order approving the settlement plan. The appeals were filed on behalf of 1)
certain Nevada claimants, and 2) certain Austrailan claimants. The sole
issue on appeal is whether the release of third party non-debtors (i.e.,
such as shareholders and insurers of the debtor Dow Corning) is legally
valid. The Court of Appeals for the Sixth Circuit has not set a schedule
for when the appeals will be heard. The TCC and Dow Corning are filing a
motion requesting that the court expedite the appeals. If granted, this
could mean a quicker, perhaps final decision in the bankruptcy case. Once
there is a final decision, claims can be paid.
CLAIM FORM PACKAGE MAILING
On December 11, 2002 order, Judge Denise Page Hood entered an order that
allows claim form packages to be mailed to all claimants and law firms
during the week of February 18, 2003. These packages will contain forms for
you to submit proof of your product identification and to apply for
settlement benefits. The packages may take anywhere from 2-10 days to
arrive after they are mailed during the week of February 18th, so please
allow time for them to be delivered to you or, if you are represented, to
your attorney. The Settlement Facility is currently planning a series of
meetings in different cities around the U.S. in March 2003 to help
claimants better understand the settlement benefits and claims process. As
soon as we have complete information about these meetings, we will post it
on this website.
The Settlement Facility recently learned that the mailing vendor, R.R.
Donnelly and Sons Company, prematurely and inadvertently mailed some claim
form packages to approximately 40 law firms. The law firms that received
the claim form packages have been directed by Judge Hood not to open or
copy the claim form materials, and has ordered the claim form packages to
be returned to the mailing vendor immediately. The Settlement Facility has
taken appropriate action to ensure that no claims will be accepted by it
prior to the mailing date of February 18, 2003.
THE SETTLEMENT FACILITY'S CLAIMS ASSISTANCE PROGRAM ANNOUNCES MEETINGS FOR
CLAIMANTS: The Claims Assistance Program in the Settlement Facility has
announced a series of claimant meetings beginning in late February and
continuing through March 2003. A complete list of the meetings is posted
below. The meetings are intended to provide information and assistance to
all claimants on the terms of the settlement, how to complete the claim
forms and apply for settlement benefits, and what will happen when you
submit your forms. Meet the new Claims Administrator, Elizabeth "Wendy"
Trachte-Huber, and other representatives of the Settlement Facility and
representatives of the Tort Claimants' Committee. If you cannot attend the
meeting, the Settlement Facility will post the entire presentation on its
website in late February 2003.
The meeting schedule is:
1. Thursday, February 27, 2003, meeting in Phoenix, Arizona at the Sheraton
Crescent Hotel, 2620 West Dunlap Avenue. The meeting will begin at 5 p.m.
local time.
2. Monday, March 3, 2003, meeting in Denver, Colorado at the Adam's Mark
Hotel, 1550 Court Place. The meeting will begin at 1 p.m. local time.
3. Wednesday, March 5, 2003, meeting in Baton Rouge, Louisiana at the
Radison Hotel and Conference Center, 4728 Constitution Avenue. The meeting
will begin at 1 p.m. local time.
4. Friday, March 14, 2003, meeting in Houston, Texas at the HCCS Building,
3100 Main Street. The meeting will begin at 1 p.m. local time.
5. Monday, March 17, 2003, meeting in Dallas, Texas at the Wyndham Anatole
Hotel, 2201 Stemmons Freeway. The meeting will begin at 8 a.m. local time.
6. Tuesday, March 18, 2003, meeting in New York City, New York at the
Millennium Broadway, 145 West 44th Street. There will be two meetings: the
first will be from 8 - 11 a.m. local time, and the second meeting will be
from 1 - 3 p.m. local time.
7. Monday, March 24, 2003, Meeting in Miami, Florida at the JW Marriott
Hotel, 1109 Brickell Avenue. The meeting will begin at 2 p.m. local time.
8. Wednesday, March 26, 2003, meeting in Los Angeles, California at the
Sheraton Gateway Hotel, 6101 West Century Blvd. The meeting will begin at 8
a.m.
9. Thursday, March 27, 2003, meeting in Las Vegas, Nevada at the Alexis
Park Resort Hotel, 375 East Harmon Avenue. The meeting will begin at 8 a.m.
local time.
10. Monday, March 31, 2003, meeting in Chicago, Illinois at the Embassy
Suites Chicago Waterfront, 511 North Columbus Drive. The meeting will begin
at 8 a.m. local time.
11. Wednesday, April 2, 2003, meeting in Atlanta, Georgia at 265 Peachtree
Center Avenue. The meeting will begin at 1 p.m. local time.
TCC TO HOST MEETINGS FOR ATTORNEYS: The TCC will host two meetings for
attorneys to review the criteria and information for the Settlement Plan.
All attorneys /paralegals representing claimants in the Dow Corning
bankruptcy case are invited.
The meeting schedule is:
1. Monday, February 10, 2003 in Dallas, Texas at the Hyatt Regency DFW
inside the DFW International Airport. The meeting will begin at 1 p.m.
local time and will focus on settlement benefits for Classes 5, 7 and 9.
2. Monday, March 10, 2003 in London, England at the RSA Conference
Facilities, 8 John Adam Street. The meeting will begin at 1 p.m. local time
and will focus on settlement benefits for Classes 6.1, 6.2, 7, 10.1 and 10.2.
Questions about the claimant meetings should be sent to the Settlement
Facility's Claims Assistance Program at: info@sfdct.com or by calling
1-866-874-6099. Questions about the attorney meetings should be sent to the
TCC at: info@tortcomm.org.
If you have a change of name or address, send it to: Settlement Facility
DCT, P.O. Box 52429, Houston TX 77052. Their phone #: (866) 874-6099 for
the US and Canada, other countries dial (713) 874-6099. You must submit
address or name changes in writing. You must also submit any name change or
address change to: Bankruptcy Claims Administration Facility, P.O. Box
7500, Midland, MI 48641-7500.
If you have not filed a claim for implants other than Dow Corning,
Cox-Uphoff, Mentor, McGhan, or Bioplasty (i.e. Bristol-Myers, etc.) and you
are now ill, late registration for the MDL-926 Revised Settlement Program
(Long-term diseases only) you have until Dec. 15, 2010 to file. If you
filed under the long-term disease category and were paid for less than 100%
disability and you are now 100% disabled, you may refile in a higher
category. If you filed in a fixed amount category in levels ABC, you may
not refile even if you are worse. I know this sounds confusing. The MDL
Claims Center #, above, will be useful in making this clearer.
Dec. 26, 2002: (AP) State Supreme Court to weigh in on 3M breast implant
case: The State Supreme Court will hear 3M Co.'s appeal in a lawsuit over
who should pay the costs of breast implant litigation. The high court's
decision to review a Minnesota Court of Appeals ruling was announced on its
Web site Thursday. In September, the appeals court spared a group of
insurance companies from having to reimburse the Maplewood-based company as
much as $100 million for breast implant-related cases.
About two dozen insurance companies argued they were not in breach of their
contracts with 3M, contending the injuries that were claimed had occurred
outside of coverage periods. 3M entered the breast-implant business in 1977
through its purchase of a small California-based company. 3M sold the
breast-implant line in
1984, but it was named in hundreds of lawsuits in the 1990s that contended
silicone implants caused serious physical problems.
In 1994, 3M took a $35 million pretax charge against earnings to cover some
of the lawsuit costs and looked to its insurers to pay much of the rest.
About 100 agreed and roughly 100 did not. 3M paid the costs, then sued the
companies for reimbursement. Overall, 3M claims its defense and settlement
costs exceeded $1 billion.
Federal Judge Dismisses Norplant Damage Claims: It began with a bang and
ended with a whimper. At the height of the litigation over the Norplant
contraceptive device, 50,000 women had claims seeking potentially millions
in damages. Then, the case essentially was dormant for almost three years
while most plaintiffs settled out of court for a payment of $1,500 each.
Now, a ruling handed down on Aug. 14 by a federal judge in Texas granted
partial summary judgment to the makers of Norplant and dismissed the claims
of most of the remaining 3,000 women, leaving only 10 plaintiffs to pursue
their cases.
The ruling by U.S. District Judge Richard Schell of the Eastern District of
Texas in Beaumont is a victory for pharmaceutical company Wyeth, formerly
known as American Home Products, which for eight years fought allegations
that it failed adequately to warn women and their prescribing physicians of
dangerous side effects of Norplant, a long-term birth control device
consisting of six plastic capsules implanted under the skin. The plaintiffs
in the suits collectively claimed that they suffered from almost 1,000
different side effects since the device went on the market in 1991.
Wyeth defense attorney F. Lane Heard III, a partner in Williams & Connolly
in Washington, D.C., refers questions to a company spokesman at Wyeth
headquarters in Madison, N.J. "We're pleased with the ruling," says
spokesman Doug Petkus. "It's a positive step toward final resolution of
this matter." He declines further comment.
Schell's ruling affects plaintiffs represented by the firms of Provost *
Umphrey of Port Arthur, Texas; Parker & Parks, also of Port Arthur; Ness,
Motley of Mount Pleasant, S.C.; and Sybil Shainwald of New York City.
Christopher Parks of Parker & Parks, listed in courts records as an
attorney for the plaintiffs, and representatives of Ness Motley did not
return several calls seeking comment by press time. D'Juana Bellue Parks,
the lawyer Provost * Umphrey says handled the Norplant case, and Shainwald
were out of their offices last week and could not be reached for comment.
'EXOTIC CONDITIONS': Beginning in 1994, thousands of women sued Wyeth and
distributors of Norplant in state and federal courts, alleging they
suffered from one or more of 26 side effects -- including headaches, nausea
and irregular menstrual bleeding -- listed as possible adverse reactions in
the device's labeling or from at least one of 950 other side effects,
described in Schell's ruling as "exotic conditions," that weren't listed.
Exotic conditions included polyarthralgia, fibromyalgia and rheumatoid
arthritis.
According to Schell's ruling, the company responded that the learned
intermediary doctrine required it to warn only prescribing physicians about
the dangerous propensities of Norplant, not each individual patient, and
that there was no evidence that Wyeth had failed to do that. In addition,
the company claimed, there was no link between its product and the
so-called exotic conditions.
All the actions filed in federal courts were transferred in 1994 to
Schell's court for consolidated pretrial handling as a multidistrict
litigation case called In Re: Norplant Contraceptive Products Liability
Litigation, or MDL No. 1038. The judge denied a motion to certify the
matter as a class action, saying that he first would hold several small
trials, called bellwether trials.
A small number of plaintiffs were selected for three trials, and discovery
was conducted in the first one. Wyeth then moved for summary judgment,
contending that even if its labeling was inadequate -- and Wyeth said it
wasn't -- the plaintiffs had failed to show that the supposed inadequate
warnings about the 26 adverse effects had led to their alleged injuries.
Schell granted the motion in the spring of 1997, finding that the learned
intermediary doctrine applied to the claims and that the plaintiffs failed
to prove that their physicians would not have prescribed Norplant if the
warning labels had been different.
The 5th U.S. Circuit Court of Appeals upheld Schell's decision in 1999.
After that ruling, Wyeth filed motions with Schell for partial summary
judgment asking for dismissal of claims by all plaintiffs who allegedly
suffered any of the 26 adverse side effects or the exotic conditions.
Schell put a decision on hold after the two sides said they were holding
settlement talks. In August 1999, Wyeth-Ayerst Laboratories, a subsidiary
of American Home Products, agreed to pay $1,500 to any American woman who
filed suit before March 1 of that year. Over the next three years, about
32,000 plaintiffs accepted the offer, and about 2,960 either rejected it or
failed to respond, according to Schell's ruling.
In his Aug. 15 ruling, Schell applied the learned intermediary doctrine to
cases involving the 26 side effects listed on warning labels. He also
dismissed the other cases, writing, "Notably, in the three years since
Defendants filed this motion for partial summary judgment, Plaintiffs have
not produced a shred of evidence or expert testimony that supports an
association between Norplant and any of the exotic conditions."
The decision essentially ends the litigation except for 10 cases in which
Schell ruled that New Jersey law governs. He suggested that those cases be
transferred to the jurisdictions in New York and Illinois where they were
filed originally.
The ruling follows a decision by Wyeth in late July to discontinue
marketing Norplant in the United States. Petkus says the decision was
primarily due to the short supply of certain components of the product and
not to the litigation. Says Petkus, "Wyeth will continue to research and
develop other contraceptive methods in the future."
Bay City (AP): A U.S. bankruptcy judge who has been on the bench here for
18 years and oversaw Dow Corning Corp.'s Chapter 11 reorganization has not
been reappointed. Arthur Spector, 52, was first appointed to the
$133,000-a-year position in
1984, then reappointed to a 14-year term in 1988. His last day on the job
will be March 24. Circuit Executive James A. Higgins of the 6th U.S.
Circuit Court of Appeals said a panel of the 21-judge court decided not to
reappoint Spector. The 6th Circuit, which covers Michigan, Kentucky, Ohio
and Tennessee, is based in Cincinnati. The Appeals Court oversees judicial
appointments. "There was no given reason," Higgins said. Higgins said it
was rare that a judge not be reappointed to the position, which a judge
usually keeps until retirement. Spector was the judge in Dow Corning's
$4.5-billion plan to emerge from bankruptcy. As part of that plan, Spector
approved a $3.2-billion settlement of claims by more than 170,000 women who
blamed health problems on silicone implants once made by the company. A
message seeking comment was left at Spector's chambers Monday. The Bay City
court handles cases in the Northern Division of the Eastern District of
Michigan. The district's three other bankruptcy judges are based in
Detroit, where the bulk of the cases are filed.
MDL info.: U.S. Seeks Share of Breast Implant Payout:11th Circuit to hear
reimbursement bid. Nine years and at least $1 billion ago, class action
plaintiffs settled their claims with makers of silicone breast implants.
But one rather weighty party remains unhappy with the deal -- the U.S.
government.
Lawyers with the U.S. Department of Justice have argued since the
settlement was announced in 1994 that taxpayers should be reimbursed for
Medicare payments made on behalf of women who claimed implants caused them
to get sick. Lower courts have disagreed, but on Friday a three-judge panel
of the 11th U.S. Circuit Court of Appeals will hear oral arguments on the
matter.
Exactly how much is at stake is unclear. Because of the intimate nature of
the breast implants, the settlement kept the names of the plaintiffs
confidential. The government claims that this makes it impossible to figure
out which members of the class received the Medicare benefits it wants
reimbursed.
Lawyers for the implant makers respond that the government has much of that
information in its own files and that it failed to ask for the information
in a timely or systematic way. Moreover, they argue that federal law does
not entitle the government to collect insurance reimbursements from
defendants.
A federal judge in the Northern District of Alabama, where the class case
was based, agreed with the defendants and dismissed the government's suit
in 2001 because the government could not identify the women who got
Medicare money.
MDL SETTLEMENT from 1994: Overall, hundreds of thousands of women settled
their claims in the 1994 settlement with implant makers Baxter Healthcare
Corp., Bristol-Myers Squibb Co., Minnesota Mining and Manufacturing Co. and
Union Carbide Chemical & Plastics Co. At least $1 billion has been paid out
to claimants, according to Atlanta lawyer Ralph I. Knowles Jr., who chairs
the plaintiffs' steering committee.
Last year, another implant maker, Dow Corning, settled with the government
for $9.8 million as part of its Chapter 11 bankruptcy reorganization. The
other implant makers haven't budged -- setting up Friday's argument before
11th Circuit Judges Gerald B. Tjoflat, R. Lanier Anderson III and a
visiting jurist, 7th Circuit Senior Judge Richard D. Cudahy.
At issue are federal statutes called the Medical Secondary Payer
provisions, which were designed to save money by requiring Medicare
recipients to exhaust all available insurance coverage before resorting to
Medicare coverage. The provisions hold that Medicare should be reimbursed
when a payment could have been made under a liability insurance plan. Under
these provisions, the government sued Baxter, Bristol-Myers Squibb, 3M and
Union Carbide -- and the escrow agent for the settlement fund.
Last year, however, Judge Edwin L. Nelson in Birmingham, Ala., dismissed
the case, concluding that the defendant implant makers were not insurance
companies susceptible to the reimbursement provisions of the federal law.
Moreover, he found that the government's case had to be dismissed because
it failed to identify the Medicare recipients. In re: Silicone Gel Breast
Implants Product Liability Litigation, 174 F. Supp. 2d 1242 (N.D. Ala.,
Sept. 26, 2001).
On appeal, government lawyers argue that Nelson's decision "reflects a
misunderstanding" of the Medical Secondary Payer provisions and that the
government was entitled to discovery to find out which class members
received Medicare benefits. The defendant companies fall under the
provisions because they are self-insured, according to the government's brief.
Alisa B. Klein of the Justice Department's civil division appellate staff
is expected to argue Friday on behalf of the government. The defendant
companies -- represented by five law firms -- have tapped Maureen E.
Mahoney of the Washington office of Latham & Watkins to argue on their
behalf on appeal. A onetime law clerk to then-Associate U.S. Supreme Court
Justice William H. Rehnquist, Mahoney served in the solicitor general's
office during the first Bush administration. She also was picked for a
federal district court judgeship, but the Senate never acted on her
nomination.
The defendants' brief responds that the government never has petitioned
properly for access to the claimant and that the Medical Secondary Payer
provisions were designed to reach insurers, not alleged tortfeasors such as
the implant makers.
Knowles and Fredric L. Ellis of Boston's Ellis & Rapacki, among others,
also submitted a brief on behalf of the plaintiffs' steering committee. The
brief shows that while the plaintiffs' lawyers were in obvious conflict
with the defendants over the merits of the original case, they agree now
that the settlement fund should not be disturbed by the government. Leigh
Anne Hodge of Birmingham-based Balch & Bingham is expected to argue on
behalf of the escrow agent.
Perhaps the strongest argument the anti-government forces have comes from a
decision the 5th Circuit issued in December, well after the parties in the
11th Circuit filed their briefs. Ruling in a Texas case, a three-judge
panel affirmed a lower court ruling against the government that it was not
entitled to Medicare reimbursement from an alleged tortfeasor in a medical
malpractice case. Thompson v. Goetzmann, No. 02-10198 (5th Cir., Dec. 17,
2002).
MEDICAL INFORMATION:. Importance of Water. Are you drinking enough? We all
know that water is important but I've never seen it written down like this
before. 75% of Americans are chronically dehydrated. In 37% of Americans,
the thirst mechanism is so weak that it is often mistaken for hunger. Even
MILD dehydration will slow down one's metabolism as much as 3%. !
One glass of water shuts down midnight hunger pangs for almost 100% of the
dieters studied in a U-Washington study. Lack of water is the #1 trigger of
daytime fatigue.
Preliminary research indicates that 8-10 glasses of water a day could
significantly ease back and joint pain for up to 80% of sufferers. A mere
2% drop in body water can trigger fuzzy short-term memory, trouble with
basic math, and difficulty focusing on the computer screen or on a printed
page.
Drinking 5 glasses of water daily decreases the risk of colon cancer by
45%, plus it can slash the risk of breast cancer by 79%, and one is 50%
less likely to develop bladder cancer. Are you drinking the amount of water
you should every day?
FDA Strengthens HRT Warning: (AP) Millions of post-menopausal women who are
confused about whether to continue hormone replacement should consult with
their doctors, the government said Wednesday.
The Food and Drug Administration issued that bit of guidance, and announced
new labeling requirements for estrogen and estrogen with progestin
products, after reviewing data from a landmark study that raised concerns
about the risks of using the popular pills.
That study, sponsored by the National Institutes of Health, was halted
abruptly last July after researchers found that the risks, particularly
increased risk of heart attacks and breast cancer, from long-term use of
the hormone replacement products outweighed the health benefits.
FDA Commissioner Scott McClellan said Wednesday that the agency was issuing
revised consumer labeling to reflect the study findings and requiring all
makers of estrogen and estrogen with progestin products, including patches
and topical medications, to update their product labels.
The new labeling requirement includes a new boxed warning highlighting the
increased risks for heart disease, heart attacks, strokes and breast
cancer. The warning also emphasizes that these products are not approved
for the prevention of heart disease. The patient information leaflet inside
the product package also will be updated. But McClellan also stressed that
post-menopausal women who are confused about whether to continue the
treatment consult their health care provider about what's best for them.
"There are risks and benefits that women need to consider in their
individual circumstances," he said during a telephone conference call with
reporters. "Women should consult their physicians and find the therapy
regimen that works best for them."
Some 10 million post-menopausal women in the United States use estrogen and
combination estrogen-progestin products to cope with the
often-uncomfortable symptoms of menopause, such as hot flashes and vaginal
dryness, as well as to prevent osteoporosis, according to the FDA.
Curr Rheumatol Rep 2002 Aug;4(4):293-8 Books
An Association of Silicone-gel Breast Implant Rupture and Fibromyalgia.
Brown SL, Duggirala HJ, Pennello G.
US Food and Drug Administration, Epidemiology Branch, Center for Devices
and Radiological Health, HFZ-541, 1350 Piccard Drive, Rockville, MD 20850,
USA. syb@cdrh.fda.gov
Silicone-gel breast implant rupture is common. Silicone-gel from ruptured
implants may escape the scar capsule that forms around breast implants and
become "extracapsular silicone." Our previously published study found that
women with extracapsular silicone gel were at higher risk of reporting that
they were diagnosed with fibromyalgia. There has been a limited number of
studies addressing this association in the literature. Some studies
addressing the issue of silicone breast implants and connective tissue
disease specifically exclude patients with fibromyalgia from the sample or
do not include the syndrome in the analysis. Case series describing
fibromyalgia in patients with implants have been published, but many of
these papers lack information on extracapsular silicone and are not
representative because the patients are typically from referral
populations. In addition, most studies do not have control groups of women
without implants for comparison or do not distinguish between saline and
silicone implants. Additional observational studies of women from
nonreferral populations are necessary to validate an association. These
studies should provide information on how the rupture is diagnosed, state
whether the rupture extended beyond the capsule, and provide an appropriate
control group for comparison. The findings from such studies may be
important to physicians as they describe potential risks associated with
implants to their patients. These findings should also be important for
regulatory decision making on silicone-gel breast implants.
Clin Rheumatol 2002 Jun;21(3):215-9 Related Articles, Books, linkup
A prospective study on silicone breast implants and the silicone-related
symptom complex.
Contact CM, Swaak AJ, Obdeijn AI, Van Der Holt B, Wai RT, Van Geel AN,
Eggermont AM. University Hospital Rotterdam/Daniel den Hoed Cancer Centre,
Rotterdam.
This cohort study prospectively evaluated the prevalence of the
silicone-related symptom complex (SRSC) in relation to antinuclear
antibodies (ANA) and magnetic resonance imaging (MRI) of silicone breast
implants (SBI) 1 year after implantation. A total of 57 women undergoing
mastectomy followed by immediate breast reconstruction (IBR) and SBI
between March 1995 and March 1997 at the University Hospital
Rotterdam/Daniel den Hoed Cancer Centre, were prospectively evaluated. Just
before and 1 year after IBR the sera of these women were tested for the
presence of ANA and they were screened for the prevalence of SRSC-related
symptoms by questionnaire. All prostheses were evaluated by MRI 1 month and
1 year after IBR. Just before operation 11% of the women had a Sjogren's
score of more than 2, whereas 30% had such a score 1 year after IBR ( P =
0.01). One year postoperatively women had significantly more
RA/Raynaud's-related complaints: 21% preoperatively versus 40% 1 year after
IBR ( P = 0.03). Within the undefined complaints-related group 19% had a
score of 2 or more preoperatively and 33% 1 year after IBR ( P = 0.09).
There were no new cases of ANA positivity 1 year after IBR. The linguine
sign was seen by MRI in three implants: one 1 month after IBR and two 1
year after IBR. There was no relation to changes in SRSC expression and
these MRI findings. In conclusion, 1 year after SBI implantation women had
more SRSC-related complaints, especially Sjogren's and RA/Raynaud's.
Moreover there was no correlation between elevated SRSC expression and
changes in the presence of ANA or changes in MRI of the SBI 1year after IBR.
Potential Cause of Arthritis Discovered
Boston (Reuters) - In a finding that could lead to new treatments for
arthritis, U.S. researchers said on Wednesday that naturally occurring
carbohydrates may be the elusive cause of the debilitating illness.
The carbohydrates, known as glycosaminoglycans, appear to activate cells
that are part of the body's immune system, causing the painful inflammation
that afflicts hundreds of millions of people around the world, they said.
"This study shows that rheumatoid arthritis may result from the body's
mishandling of its own carbohydrates that, under normal circumstances,
would not be interpreted as a threat," said Julia Wang, the study's lead
researcher.
Wang, who presented her research at the national meeting of the American
Chemical Society, said her finding has come under heavy attack because it
challenged the conventional thinking that peptides -- little pieces of
protein -- are responsible for auto-immune diseases like arthritis. "The
concept that carbohydrates can be responsible for auto-immune diseases is
completely new," she told Reuters. "People simply don't want to recognize
it. They've been taught peptides are responsible, which is understood."
Although there have been promising advances in treating the symptoms of
arthritis, its causes have remained a mystery.
"The problem is that people have been trying to search to understand
arthritis by sticking to the old dogma, but that hasn't solved the
problem," said Wang, a researcher at Boston's Brigham and Women's Hospital
in Boston and a professor at Harvard Medical School.
The new research marked the first time glycosaminoglycans, a major
component of joint cartilage, joint fluid, connective tissue and skin, have
been associated with the condition.
Wang said she and her colleague Michael Roehrl studied the effects
glycosaminoglycans had on mice, which subsequently experienced arthritic
symptoms including swelling, inflammation and joint damage. She also looked
at human tissue taken from arthritis patients and found the same type of
cells that bind to GAGs.
Wang said subsequent research would most likely focus on developing drugs
aimed at stopping the growth, expansion or adhesion of immune cells that
react to glycosaminoglycans.
John Mekalanos, professor and chairman of microbiology and molecular
genetics at Harvard Medical School, called the research extremely
promising. "We are clearly a step closer to understanding the causes of a
disease that has left the medical community with unanswered questions and
many patients with discomfort and pain," he said in a statement.
Neurotoxin Discovered in Chronic Fatigue Syndrome: Needham, MA November 17,
2002 -- Research sponsored by the National CFIDS Foundation was formally
announced at the International Symposium on Toxins and Natural Products in
Okinawa, Japan on November 17-19, 2002 by Dr. Yoshitsugi Hokama. The
research, for the first time, discovered ciguatoxin, a potent neurotoxin,
in the blood of Chronic Fatigue Syndrome patients.
"Chronic ciguatera poisoning has already been suggested as a scientific
model for Chronic Fatigue Syndrome (CFS)," stated Dr. Hokama. Ciguatoxins
are potent, heat stabile, non-protein, lipophilic sodium channel activator
toxins and are recognized as some of the most potent biological toxins
known. They produce dramatic neurological manifestations, such as
peripheral sensory or motor symptoms (including paresthesias, pain,
burning, tingling, numbness), central symptoms such as headache, autonomic
dysfunction and also affect multiple body systems (gastrointestinal,
immune, hepatic, cardiovascular) and the muscles.
Many CFS patients in the study had higher levels of the toxin than the
patients with cancer, hepatitis or acute ciguatera poisoning. Quantitative
assay results range from 1:5, the lowest toxin level, to 1:160, the highest
toxin level. All CFS samples gave titres of at least 1:20, with the
majority of titres from 1:40 to 1:160.
Dr. Hokama presented his preliminary findings in a lecture titled "Acute
phase lipids in sera of various diseases: Chronic Fatigue Syndrome,
ciguatera, hepatitis, and various cancer with antigentic epitope resembling
ciguatoxin as determined with Mab-CTX." Dr. Hokama is a Professor in the
Department of Pathology at the John A. Burns School of Medicine at the
University of Hawaii at Manoa. He is a
world expert in the area of fish toxins with hundreds of peer reviewed
publications to his credit. Hokama developed the Membrane Immunobead Assay
test for patient sera, using a specific monoclonal antibody for ciguatera
toxin (Mab-CTX). His current research into Chronic Fatigue Syndrome and a
ciguatera toxin connection was funded by the National CFIDS Foundation's
research grant program.
Gail Kansky, President of the National CFIDS Foundation, said, "We believe
this to be a significant breakthrough. CFS, which has come to include
myalgic encephalomyelitis, is a very severe illness that has not received
adequate funding or appropriate medical attention. Although there are still
many unanswered questions and much work to be done, research efforts will
ultimately turn the tide in the understanding of this disease and allow
patients to receive appropriate medical therapies. We are indebted to Dr.
Hokama and his colleagues for providing this monumental first step." For
more information on this study or Chronic Fatigue Syndrome, please contact:
The National CFIDS Foundation 103 Aletha Road Needham, MA 02492 phone:
781-449-3535 fax: 781-449-8606
January, 2003: Patients seeking Botox injections to reduce wrinkles should
beware of unscrupulous practitioners who use silicone instead of Botox,
leaving patients with a "witch's chin", a Thai dermatologist has warned.
Sagging at the chin: Dr Prawit Sisalbutr was quoted by The Nation newspaper
as saying some local clinics dupe their patients by promising cut-rate
treatments to give a youthful appearance. "Some illegal practitioners use
silicone instead of Botox because it is cheaper," Prawit said. "The
silicone will later cause the skin to look uneven and bumpy and in some
cases will gather at the chin (creating a point) like a witch's chin."
ALTERNATIVE MEDICINE:
3 natural, safe ways to reduce the risk caused by elevated Homocysteine
levels in your blood.
Homocysteine (pronounced: "ho-mo-sist-een"), a naturally occurring amino
acid (a building block of protein) produced by your body.
High blood levels of homocysteine have been linked with cardiovascular
diseases, including heart attract and stroke. Also studies state that an
increased homocysteine level is a strong independent risk factor for the
development of dementia and Alzheimer's disease.
The factors leading up these degenerative diseases such as heart attack,
stroke dementia and Alzheimer's disease progressively develop over many years.
The mechanism by which homocysteine causes damage to the arteries and veins
though not yet fully understood, does appear to have similar damaging
effects as elevated cholesterol. Just as you can have a blood test to check
your cholesterol levels you can also request that your homocysteine blood
levels be monitored. There is an ongoing debate about safe levels of
homocysteine the latest being below 5 or 6 as being ideal. You may have to
ask your medical practitioner specifically for the blood test to check your
levels.
3 Natural, safe ways to reduce your homocysteine levels.
1. Eating more fresh fruit and vegetable (especially green leafy
vegetables) can help lower your levels of homocysteine by increasing the
amount of folic acid in your diet. The best sources of Folic acid are fresh
nuts, green leafy vegetables, whole grains, citrus fruit, bananas and root
vegetables.
* The requirements of Folic acid vary with age and generally increase as we
age; there also times of high demand such as those that are pregnant and
lactating. Others that have an increased demand for Folic acid are the
elderly, alcohol drinkers', women taking the contraceptive pill and some
drug medications.
2. Specific vitamins have been shown to reduce homocysteine levels
including Folic acid, which can be taken in tablet form.
Recommended doses: range from 1 to 4 milligrams per day.
* Vitamin B12 and B6 help the body to process homocysteine and folic acid.
Recommended dose: B12, 500-to 2,000 mcg daily
B6 100 mg daily.
The higher doses would be used in event of specific therapy to reduce
identified elevated homocysteine levels.
3. I add this one with a warm smile, the final important factors to assist
you with reducing the risk associated with elevated homocysteine levels:
"Common Sense": Lets us keep that factor operating at all times, we already
know that there have been other factors identified with the risk of the
degenerative diseases mentioned and we have been made aware of the steps we
can take to reduce those risk. They include maintaining sufficient fitness
levels, making sure you get adequate rest and relaxation. Manage your
stress levels and follow those tried and tested natural health principles
laid down centuries ago.
Though some of the research findings can be alarming particularly if you
have a family history of cardiovascular disease or the other mentioned
degenerative diseases. I would encourage you to remain calm and I would
like to congratulate you for taking the time to explore the possible
solutions to a potentially dangerous situation.
You have been introduced to some of the simple safe natural methods that
will improve you your health in the short term and have the added benefit
of prevention of those degenerative diseases in the long term. Investing in
your health is the wisest investment you could make.
COMMENTARY: FDA keeping lid on case involving Irving manufacturer:
9/03/2002, Dallas Morning News/ Jim Morris: Washington: Four years ago, the
Food and Drug Administration began a criminal investigation of Mentor
Corp., a breast-implant manufacturer whose factory in Irving had fallen
into disfavor with FDA inspectors. The inquiry, conducted by the FDA's
Office of Criminal Investigations, remains open. But that's about all
anyone outside of the agency knows about it.
"We would love to get a better indication of what the focus might be," said
Josh Levine, Mentor's senior vice president for sales and marketing. "We
have asked repeatedly." Mentor says that any deficiencies at the plant were
minor and long ago corrected.
Others suspect the problems are more serious. In January 2000, James Austin
Templer quit his job as a Dallas-based FDA compliance officer because, he
said, he came to believe that the Mentor investigation was a "sham,"
intended to keep inquisitors at bay.
Ryan Donnell: James Austin Templer, who worked for the FDA, called the
Mentor inquiry a sham. "The agency has gone out of its way to ensure that
the public does not know" about potential health hazards associated with
Mentor's products, Mr. Templer said. Members of the House Energy and
Commerce Committee have been pressing the FDA for information, to little
avail. "I'm questioning just how 'active' this 'active investigation' is,"
said Rep. Roy Blunt, R-Mo. Another committee member, Rep. Gene Green,
D-Houston, said there could be hearings if answers aren't forthcoming.
What is going on at Mentor's Texas plant, which supplies saline- and
silicone gel-filled implants to women throughout the United States and
Canada? Because the FDA is not talking, implant recipients and would-be
recipients are left to wonder whether the products are safe. And Mentor is
left operating under a cloud, which the company would like lifted before it
asks the FDA to remove restrictions on silicone implants.
The FDA would not discuss the investigation with The Dallas Morning News.
Interviews with Mentor officials, Mr. Templer and others indicate that it
involves the company's manufacturing practices, its handling of an
FDA-required clinical study, or both. Headquartered in Santa Barbara,
Calif., Mentor completed the move of its U.S. manufacturing operation from
Goleta, Calif., to Skyway Circle North in Irving in the summer of 1994.
In 1995, the FDA began inspecting breast-implant factories to determine
whether they were making sterile, uniform products and keeping records of
patient complaints. (The agency was still smarting from charges that it had
been slow to respond to concerns about silicone implants, which some
patients and physicians had blamed for debilitating illnesses.)
Mentor fared poorly in its inspection, said Mr. Templer, who worked in the
FDA's Dallas district office. "They found a whole lot of problems," he
said, and a warning letter was issued at his urging. The letter stated that
Mentor, among other things, had not investigated implant failures or
patient complaints in a timely fashion.
Because of the criminal investigation, the FDA will not publicly release
Mentor inspection reports dating to 1995. Clarke Scherff, the company's
vice president for regulatory compliance, said that FDA inspectors made
routine observations about the Irving plant during each of the reviews and
that Mentor took appropriate action.
Mr. Scherff said he was told the plant was in full compliance with FDA
regulations after the most recent inspection in February. Mr. Levine said
the agency had never expressed doubts about the safety of Mentor's
implants. "If there had been any question at all, even a remote question,
they would have shut us down," he said.
Employee allegations: From 1995 through 1999, however, current and former
Mentor employees brought Mr. Templer a range of allegations. Saline
implants equipped with a certain type of valve tended to leak, they said,
and silicone implants may have been contaminated with platinum and
polyurethane. Some patients' complaints were not being noted, the
informants alleged, and manufacturing processes were not being properly
validated to ensure product uniformity.
"If a company isn't manufacturing a product under a good state of control,
it's going to have a much higher rate of failure," said Mr. Templer, who
lives in Frisco. Some of the same informants were talking to Kim Hoffman,
who received Mentor's Siltex silicone implants in March 1995 and said she
began suffering from extreme fatigue, memory loss and a "burning, itchy
feeling" in her breasts.
Ms. Hoffman, who lives in Niangua, Mo., had the implants removed after
eight months, and her health, she said, gradually improved. But when she
tried to report her ailments to Mentor so they could be included in a
clinical study, she said, "they treated me like a litigation problem rather
than a patient and referred me to their lead counsel. They just blew me off."
Ms. Hoffman contacted the FDA and later began talking to current and former
Mentor workers, who told her that her and other women's health problems had
been excluded from the study, upon which the agency depends to monitor
complication rates.
"I was totally alarmed," Ms. Hoffman said. Her fear, she said, is that "bad
products are getting into the market and there's a breakdown in the
regulatory process that allows them to stay on the market." She has sued
Mentor, alleging that it knowingly made a defective product and negligently
conducted the study.
Mr. Scherff said he could not comment on Ms. Hoffman's allegations because
of the lawsuit. He did cite a 1999 FDA inspection report that concluded
patient "complaints received were handled [properly] and the appropriate
records maintained."
Mentor also has been named in a class-action lawsuit alleging that a valve
on its saline implant, used from 1984 to 1994, regularly failed. The
company's response: "There were no safety concerns with this product." The
valve, it said, was replaced with an even better device.
Throughout 1996 and 1997, Mr. Templer continued to interview informants and
pushed officials at FDA headquarters to force Mentor into compliance. In
May 1998, the company entered into a consent decree with the agency,
promising to subject itself to examination by outside experts and improve
its validation procedures.
"It was purely a documentation issue," Mr. Scherff said. Mentor used the
same validation techniques in Texas that it had in California, where the
district FDA office had no objection, he said. "The Texas FDA officials did
not agree that the validations were adequate," Mr. Scherff said, but found
nothing that suggested an "increased risk to women" and did not restrict or
halt sales.
Dr. Harlan Pollock, a Dallas plastic surgeon, said he had used Mentor's
products for years and had "always found this company to be very upfront
and ethical. I've been very pleased." Currently, only saline implants may
be used for purely cosmetic breast augmentation.
After some patients and researchers contended that silicone implants were
prone to leakage and caused disease, the FDA decreed in 1992 that the
products would be available only for breast reconstruction following cancer
surgery or to fix a congenital deformity or a prior implant problem.
Results of study: While some studies have continued to raise questions
about the safety of silicone gel, others notably, one published by the
Institute of Medicine two years ago have found no link between the
substance and cancer or other serious illnesses. Mentor officials say they
will ask the FDA, possibly next fall, to allow silicone implants to be sold
again for breast augmentation, a larger market than reconstruction.
Mr. Levine, of Mentor, said the company's implants are "unequivocally"
safe. But Ms. Hoffman and Mr. Templer, who began sharing information in
1998, said problems at the plant went beyond the paperwork issues that
company officials described.
According to a memorandum written by Mr. Templer in December 1999, for
example, one former Mentor employee said in an affidavit that she and her
supervisor had been fired "after they prepared a series of reports
regarding very high field failure rates in Siltex breast implants." She
also alleged that Mentor destroyed records that reflected negatively on its
products.
Mentor sued the woman for defamation after she made the allegations in an
unpublished letter to Forbes magazine in 1997. In the suit, which was
dismissed under confidential terms, the company denied the charges and said
the woman had been fired for "deficient job performance" and violating
company policies. Neither Mentor nor the woman would comment.
Mr. Templer and Ms. Hoffman were instrumental in getting the FDA to open a
criminal inquiry of Mentor in the summer of 1998. But by the end of 1999,
Mr. Templer had become suspicious and disheartened. He soon resigned.
Dr. Suzanne Parisian, former chief medical officer in the FDA's Center for
Devices and Radiological Health, said the agency had been reluctant to take
harsh actions against breast-implant manufacturers. "A whole culture has
grown up dependent on these devices," said Dr. Parisian, now a consultant
in Front Royal, Va. "The FDA is caught between a rock and a hard place."
OFFERED WITHOUT COMMENT!! News Flash!!! Silicone Implants Are Back With FDA
Approval: New York, NY -- (Internet Wire) -- 09/17/2002 -- On September 16,
2002, the FDA gave approval to Silimed Corporation to begin clinical
investigation of their silicone implants for breast augmentation,
reconstruction and revisions. New York City plastic surgeon, Dr. Steven
Herman, is medical director for one of their programs. Dr. Herman says,
?Silicone implants produce the best cosmetic result and most natural
feeling breasts.? Although used in many other countries, the FDA halted use
of the implants in 1991 for primary breast augmentation when questions were
raised about a possible connection with autoimmune disease or breast
cancer. Numerous studies since then have failed to demonstrate a link with
these diseases. This comes at an excellent time. Nothing better suggests
this than the fact that breast enlargement is now the most popular cosmetic
procedure in the country, after a decline in popularity throughout the
1990?s. Last year, almost a quarter million women nationwide opted for
breast augmentation, far surpassing the second most popular cosmetic
surgery, liposuction, which was performed on 180,000 patients. Dr. Herman
states that there will be numerous sites throughout the United States
approved for the use of these implants. Each site is staffed by a board
certified plastic surgeon(s) very experienced in this type of surgery. The
results will be carefully monitored by the FDA. For further information,
contact Diane Terman Public Relations at (212) 744-6055.
Investigators Find Repeated Deception in Ads WASHINGTON, Dec. 3 Some
companies have repeatedly disseminated misleading advertisements for
prescription drugs, even after being cited for violations, and millions of
people see the deceptive commercials before the government tries to halt
them, Congressional investigators said today.
The investigators, from the General Accounting Office, said Pfizer, for
example, had continued to make misleading claims in advertisements for its
cholesterol-lowering drug Lipitor, despite several letters from the Food
and Drug Administration in the last four years.
In a new report, the accounting office said that drug company advertising
appeared to produce a significant increase in the use of prescription
drugs, as well as higher drug spending. The report criticized delays in the
enforcement of federal standards for the accuracy of drug advertising and
attributed much of the delay to a recent change in procedure by the Bush
administration that lengthens the review process
The study estimates that at least 8.5 million Americans each year request
and receive prescriptions for specific drugs after seeing or hearing
advertisements for those products. The drugs cited in the report include
Flonase, an allergy drug; Prilosec, for ulcers and heartburn; and Actonel,
for osteoporosis.
Senator Susan Collins, a Maine Republican who was one of five members of
Congress who requested the study, said: "The evidence suggests that
consumers are paying a lot of attention to these ads, so it's imperative
that they be accurate. If the increase in utilization is based on false
claims, that's very troubling."
The report rejected a contention by critics of the pharmaceutical industry,
including many Democrats in Congress, who say drug companies spend more on
advertising than on research and development. Using data obtained mainly
from the drug industry, the report said that drug makers spent much more on
research. Last year, it said, companies spent $30.3 billion on research and
development and $19.1 billion on all promotional activities, including $2.7
billion for advertising aimed at consumers. But the report said that ad
spending rose at a far greater rate than spending on research.
Consumer advertising has shot up almost 150 percent since 1997, when the
Food and Drug Administration revised its guidelines to permit more ads, and
drug makers have shifted much of their spending from print media to
television, the report said.
The accounting office said that the recent change by the Bush
administration had "adversely affected" the government's ability to curb
deceptive ads, by significantly increasing the amount of time required to
issue a notice of violation. The new procedure has delayed enforcement
actions anywhere from 2 weeks to 11 weeks, the accounting office said.
Government lawyers have used that time to review the notices.
But Senator Collins said, "It takes so long to get letters issued by the
F.D.A. that the advertising campaign for a drug may have run its course
before the company receives a letter demanding corrective action."
Typically, when the F.D.A. finds that a drug advertisement is so
inaccurate, misleading or incomplete that it violates federal law and
regulations, the agency writes a letter instructing the manufacturer to
halt the ads. In November 2001, the Department of Health and Human Services
told the agency that it could not issue such letters until they had been
reviewed for "legal sufficiency and consistency with agency policy."
But, the report said, many advertisements "are on the air for only a short
time about one-fifth of them for one month, and about one-third for two
months or less." Under the new policy, it observed, misleading television
ads for prescription drugs can complete their "broadcast life cycle" before
the agency admonishes the manufacturer.
Since 1997, the report said, the F.D.A. "has issued repeated regulatory
letters to several pharmaceutical companies, including 14 to
GlaxoSmithKline, 6 to Schering Corporation and 5 to Merck & Company." Some
companies, it said, "have received multiple regulatory letters over time
for new advertisements promoting the same drug. "In its most recent letter
to Pfizer, on Aug. 12, the agency said that an advertisement in Time,
Reader's Digest, Good Housekeeping and other magazines was misleading
because it falsely suggested that Lipitor was safer than other statin drugs
used to lower cholesterol.
Vanessa McGowan, a spokeswoman for Pfizer, said: "We complied with F.D.A.'s
request. We pulled the ads and corrected them." Commenting on the report,
the Department of Health and Human Services acknowledged that it needed to
issue enforcement letters more quickly. But it said the letters had to go
through a rigorous legal review because "the F.D.A. cannot afford to be
considered a paper tiger."
Federal rules say drug ads must present a fair, accurate account of both
benefits and risks. From August 1997 to last August, the food and drug
agency issued 88 letters accusing drug companies of advertising violations
44 for broadcast advertisements, 35 for print ads and 9 that cited both
types of ads.
In many cases, the agency said, companies overstated the effectiveness or
minimized the risks of medicines. Last year, for example, the agency told
Procter & Gamble to halt certain commercials for its osteoporosis drug
Actonel after finding that information about the drug's risks was obscured
by "fast-paced, rapidly changing, distracting images" on the screen.
FOREIGN ISSUES: Breast Implant Settlement Reached with BMS: SYDNEY,
Australia (AP) U.S. pharmaceutical maker Bristol-Myers Squibb Co. has
reached an out of court settlement with a group of Australian women over
faulty breast implants manufactured by the company, a lawyer for the women
told a court Tuesday. Terms were not disclosed.
The New South Wales state Supreme Court was told that 87 women had agreed
to a confidential settlement following a decade of legal action, and one
other woman was still negotiating with the New York-based company.
Peter Cashman from law firm Maurice Blackburn Cashman, which has been
fighting breast implants cases since 1990, said the women's complaints
ranged from minor cosmetic and health problems to major illnesses,
including damage to their immune systems caused by the implants.
Cashman, who is forbidden by the agreement from disclosing the size of the
settlement, said the company had refused to accept that some of the medical
problems claimed by some of his clients were caused by the silicone implants.
A spokesman for Bristol-Myers Squibb's Australian subsidiary said he could
not comment on the settlement. ``It has been dealt with by our U.S. parent
company from the start,'' said spokesman Michael Moore.
Cashman is also representing another 1,300 Australian women who are
pursuing a decade-long case against the Australian subsidiary of another
U.S. breast implant manufacturer, Dow Corning Corp. The Dow Corning case
was to return to court Oct. 22.
THE OPINIONS EXPRESSED IN THIS NEWSLETTER ARE THOSE OF THE EDITOR AND ANY
CONTRIBUTORS AND ARE NOT TO BE CONSTRUED AS MEDICAL OR LEGAL ADVICE. ANY
ARTICLES OR INFORMATION SUBMITTED MAY BE EDITED BECAUSE OF SPACE, CONTENT
OR GRAMMATICAL ERRORS.
LYNDA ROTH, EDITOR
Previous newsletters: There are 2 issues each in 2000 and 2001 and one
issue in 2003 available at $3.00 each. Other prior newsletters are
available on our website.
DONATIONS TO COSS ARE TAX-DEDUCTIBLE!! WE WILL CONTINUE TO SEND OUT PACKETS
OF INFORMATION TO WOMEN. WE WILL CONTINUE TO SUPPORT THIS CAUSE. WE WILL
SEND PERIODIC UPDATES TO SUBSCRIBERS. WE CONTINUE TO MAINTAIN A WEBSITE
WITH BASIC AND OTHER INFORMATION FOR THOSE SEARCHING FOR HELP ON THE ?NET?.
The Coalition of Silicone Survivors is a non-profit organization. Donations
are tax-deductible in the US.
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