Coalition of Silicone Survivors
http://www.siliconesurvivors.net/newsletters/jun.02.news.html
~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~
June 2002 news (Lynda Roth, Sat Feb 22 10:00:54 2003)
COALITION OF SILICONE SURVIVORS 2739 W. 23rd St., Greeley,
CO 80634 Lynda Roth - (970) 506-9288 Fax (970) 506-9288 (call first) e-mail: : coss1@qwest.net Website: http://www2.privatei.com/~coss/coss
June 1, 2002
Dear Silicone Survivors and Friends:
Since the court had held the appeals hearing (June
14, '02) and a ruling will probably not be issued for at least 30 days, we are putting this newsletter out with the
latest information that we have. It would be nice to be able to report that we will receive some funds soon, but I do
not expect any payouts until at least next June (2003).
We continue to lose wonderful women. One that I knew since
the early '90's, Alice Cooke of Ohio, died recently. I hear about at least one woman a month that has lost her life
due to silicone poisoning. It does not get easier.
LEGAL INFORMATION: Please feel free to contact one of the Telehelp
information numbers or websites listed for further information. Dow Corning Bankruptcy Telehelp and Other Information
Sources List: Dow Corning Bankruptcy Case General Information Line: 800-651-7030 (recorded message); US Bankruptcy
Court Information Line: 800-222-7198; Dow Corning Info. Line: (800) 997-1700.
TCC Mailing Address: Tort Claimants
Committee, P.O. Box 61406, Houston, Texas 77208-1406. TCC website: www.tortcomm.org Phone: (713) 547-2271. For the actual Dow Corning website: www.implantclaims.com The settlement facility website is: www.dcsettlement.com
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.
For inquiries not involving Dow Corning but the different legal
case generally referred to as the MDL Class Action and Revised Settlement Program, you should contact different numbers:
MDL Claims Center: 800-600-0311 (outside the U.S. call 713-951-9106) MDL Claims Center Mailing Address: P.O. Box
56666, Houston, Texas 77256.
If you have not filed a claim for implants other than Dow Corning, Cox-Uphoff, Mentor,
McGhan, or Bioplasty (ie. 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.
UPDATED JUNE 18, 2002: This is an update
on the hearing before United States District Judge Denise Page Hood on Friday, June 14, 2002 in Detroit. The hearing
concerned objections and appeals filed by certain Nevada and Australian claimants and several pro se claimants (claimants
who are representing themselves without an attorney). These objectors argued that the Dow Corning Settlement Plan
could not legally release Dow Chemical, Corning and subsidiary companies of Dow Corning from liability for Dow Corning's
breast implants. The objectors want the ability to collect money from Dow Corning in the Settlement Plan AND also be able
to sue Dow Chemical and/or other related companies outside of the bankruptcy court proceedings. In January 2002, the
6th Circuit Court of Appeals addressed their objections and ruled that the release of liability of the non-debtor companies
under a bankruptcy reorganization plan was permissible. In other words, the 6th Circuit court ruled that Dow Chemical
and the other related companies could be released from liability for Dow Corning's breast implants as part of a reorganization
of Dow Corning in bankruptcy. The 6th Circuit Court Âsent the case back to Judge Hood for further proceedings to determine
if the trial record contained facts that support the release of liability in this case. Specifically, the 6th Circuit
Court ordered the District Court Judge to determine if there were facts in evidence regarding:
"whether there is
evidence that Dow Corning and Dow Chemical for example have an identity of interests such that a lawsuit against Dow Chemical
is, in essence, a lawsuit against Dow Corning or will deplete the assets of Dow Corning;
" whether Dow Chemical
and the other non-debtor companies contributed substantial assets to the Settlement Plan in exchange for the release;
"whether
the release of liability of Dow Chemical is essential to Dow Corning's ability to emerge from bankruptcy free of liability
from claims by Dow Chemical;
"whether the Settlement Plan provides a way to make sure that the claimants affected
by the release will be paid; and
"whether the Settlement Plan provides an opportunity for claimants to litigate
in court and be paid in full.
Written briefs and objections on the "release" issue were submitted to Judge Hood
earlier this year. The Tort Claimants Committee believes that the trial record has sufficient facts in evidence to justify
the release of Dow Chemical and the other related companies in this case. The hearing on June 14th was to allow all
parties to make any additional oral arguments regarding the release of liability issue. The release of Dow Chemical, Corning
and the subsidiary companies is the ONLY issue left to resolve in the pending appeals.
Judge Hood heard the oral
arguments and indicated that she would like to move quickly in issuing a ruling. We do NOT know when she will issue her
ruling. We will post any news or developments on this issue on the website.
SETTLEMENT WITH U.S. GOVERNMENT ANNOUNCED
AT THE HEARING
During the June 14th hearing, the Tort Claimants Committee and Dow Corning announced that they had
successfully negotiated a settlement with the United States Government. The U.S. Government informed the Court that it
was in the process of obtaining final approval from the various federal agencies and hoped to have the necessary signatures
within approximately 30-45 days. To recap, the U.S. Government filed claims in the bankruptcy alleging that it paid
money to doctors and hospitals on behalf of women who had Dow Corning implant related treatment (such as removal of a
Dow Corning breast or other type of implant or medical treatment for illnesses caused by ÂDow Corning implants). The
U.S. Government sought to recover these types of medical expenses directly from Dow Corning under various Medicare recovery
provisions. The U.S. Government has objected to the Settlement Plan since it was announced in 1998, and has filed appeals
to the 6th Circuit Court of Appeals.
Theproposed settlement will settle and release from liability Dow Corning
and all "Personal Injury Claimants" (i.e., persons who filed an implant-related claim) for any payments they receive
from Dow Corning, the Settlement Facility or Litigation Facility. For claimants who filed an implant claim in the
bankruptcy case and received Medicare or other type of medical assistance for your Dow Corning implants, this means that
if you receive any money from the Dow Corning settlement plan regardless of whether you settle your claim or litigate
your case in court you will NOT have to pay or repay any money to the U.S. Government for claims arising pursuant
to Medicare Secondary Payer Statute or the Medical Care Recovery Act.
EXAMPLE: If you received Medicare or Medicaid
coverage (or medical coverage from the Department of Veteran Affairs, Department of Defense or Indian Health Services)
for medical treatment related to your implant, AND you receive a payment from the Dow Corning Settlement Plan, then you
will NOT be required to repay the U.S. Government back for those medical expenses.The proposed settlement releases
claimants and Dow Corning from this obligation. If you do not receive any payments from the Dow Corning Settlement
Plan, then the U.S. Government may still pursue you for reimbursement of any compensation you received from other implant
companies for your Medicare medical expenses (i.e., you do not qualify to receive any money from the Dow Corning Settlement
Plan but you received money from the MDL or from a settlement with one of the implant companies, then you are still
responsible to reimburse the U.S. Government for any Medicare implant- related expenses).
If you received Medicare
or Medicaid coverage for a breast implant, you have a breast implant made by Dow Corning AND another breast implant made
by someone else AND you receive any money from the settlement plan regardless of whether you settle your claim or
litigate your case in court you will not have to pay or repay any money to the U.S. Government EXCEPT THAT the U.S.
Government may assert a claim for any costs it incurred for paying for the removal of the non-Dow Corning breast implant.
EXAMPLE:
If you received Medicare or Medicaid coverage (or medical coverage from the Department of Veterans Affairs, Department
of Defense or Indian Health Services) for medical treatment related to your implant, AND have a Dow Corning breast
implant and an implant made by Bristol, AND you receive money from the Dow Corning settlement plan, then you will NOT
be required to repay any of that money to the U.S. Government except for costs the U.S. Government incurred for removal
of your non-Dow Corning breast implant.
A hearing on the proposed settlement with the U.S. Government will be held
on July 18th in Detroit. We will post all updates and developments on this website. www.tortcomm.org
Sincerely, Dianna Pendleton, Counsel to the TCC
I contacted Patrick Hughes to ask about this recent hearing,
and this was his comment: "As I understand it, Friday's hearing was unfortunately uneventful in that there were no
rulings issued. The sense was that Judge Hood is prepared and wants to rule soon, but apparently wanted to allow some
pro se claimants to first have the chance to present some additional arguments and briefing by month end before doing
so. As a result, we may not see any rulings for 30 days. The request is that she rule based on the current evidence
before her and to confirm that the plan and releases are adequate and supported to allow the plan to be implemented. But
the opposition remains, and a request by the Nevada claimants has been made for the Supreme Court to review the matters
before there are further proceedings below. That is where we are for now."
So, if you are wondering, the appeals
are still in progress and we do not expect all of them to be resolved until 2003 sometime.
Here's the latest from
the Nevadans re Appeals, etc.: Unlike the U.S. Government, the Nevadans did not seek a second hearing before the 6th Circuit
Court of Appeals and ask for them to reconsider. It should be remembered that the 6th Circuit did not find that there
were "unusual circumstances" that would justify, on the record, what Dow Corning and the Tort Claimants' Committee
tried to do in this case, namely wipe out the Nevadans' claims against the non-bankrupt Dow Chemical. However, the Nevadans'
victory in the 6th Circuit is not a complete victory unless and until the U.S. Supreme Court resolves the conflict in
the Circuit Courts of Appeals in this country and rules that, regardless of "ununusual circumstances," a non-bankrupt
party like Dow Chemical is not entitled to the benefits of bankrtupcy law (e.g., a free ticket out of litigation) without
undergoing the burden of filing bankruptcy itself.
So, rather than wait till the end of the upcoming hearings before
Judge Hood (held June 14th) where the TCC and Dow Corning get a "third bite" at the apple in hopes of showing Judge
Hood that "unusuual circumstances" exist to allow Dow Chemical to ride Dow Corning's coattails out of litigation -
- the Nevadans sought to speed up that process by filing a Petition for Certiorari (akin to an appeal) to the U.S.
Supreme Court asking them to rule, like Judge Spector ruled, that a bankruptcy court does not have the legal power to
extinguish the liability that a non-bankrupt party (Dow Chemical) owes to non-consenting creditors who refuse to go
along with this charade (the Nevadans).
While Petitions for Certiorari are routinely denied by the U.S. Supreme Court,
the Nevadans hope their Petition will be the exception to the rule. And, while we have every confidence that Judge Hood
will conclude that no "unusual circumstances" exist to wipe out the Nevadans' claims against Dow Chemical, we have
asked the U.S. Supreme Court to intervene at an early stage in hopes of short-circuiting the necessity of such a hearing,
which would be followed by an inevitable round of appeals by whoever the losing parties are following such a hearing.
Further, it was necessary for the Nevadans to file said Petition to preserve their objection to that portion of the
6th Circuit ruling which said that in rare and unusual circumstances a company like Dow Chemical might be able to get
a release from liability without filing for bankruptcy. (While I disagree with the philosophy behind the Nevadans
claims, as over 94% of women voted for the bankruptcy settlement, I totally support their right to appeal these decisions.
This is what America is about! Lynda)
This is a response to a question about Mentor ruptures and the Dow Bankruptcy.
"Unfortunately there is no rupture benefit in the Dow Corning plan for anyone other than those who have implants actually
made by Dow Corning. So only those seeking to litigate--itself a hard road as you can imagine given the Dow's tenacity--would
have an opportunity to try to recover for a rupture and even then it would be extremely difficult given the fact the
Dow Corning did not make the actual implant and thus might have no legal responsibility for a rupture, as opposed to possible
consequences arising from gel that Dow Corning may have supplied. And as you may already know, in a litigation context
rather than settlement, the gel claims face huge hurdles even aside from causation, given the bulk supplier defense
that other makers have successfully used to obtain a summary judgment. Regards. Patrick L. Hughes Haynes and Boone,
L.L.P. 1000 Louisiana, Suite 4300 Houston, Texas 77002 713-547-2550 (direct) 713-236-5401 (direct fax) 713-547-2000
(main number)
MEDICAL INFORMATION:. San Francisco (Reuters Health) 11/16/01: Brain Scans Show Increased Pain Sensitivity
in Fibromyalgia: - Brain scans have revealed that women with fibromyalgia differ from depressed women in their sensitivity
to pain, researchers reported here on Wednesday at the American College of Rheumatology's annual meeting. Because nearly
half of fibromyalgia patients have had clinical depression at some point in their lives, some doctors consider the
condition to be a physical manifestation of an underlying mood disorder, said Dr. Leanne R. Cianfrini, a psychology researcher
at the University of Alabama at Birmingham.
"Because fibromyalgia doesn't have a clear-cut etiology, it leads many
rheumatologists to interpret their pain as a simple physical manifestation of an underlying depression," she said.
"This can be frustrating and counterproductive to patients." To see if there are physiological differences between
patients with fibromyalgia and patients with depression, the investigators compared pain thresholds and brain activity
among 21 women with fibromyalgia, 8 women with depression and 22 healthy women. Dr. Cianfrini and colleagues administered
pressure calculated to be a level above each woman's pain threshold to three points on the women's bodies. The women
were asked to evaluate their pain levels. The researchers also used brain imaging to measure blood flow during reports
of pain.
The investigators found that the women with fibromyalgia had lower pain thresholds and reported more
pain after pressure stimulation than the healthy women. The fibromyalgia patients also showed greater activation of brain
structures that process pain. The pain threshold and experience of pain among the depressed women was similar to that
of the healthy women, the study found. "We can't deny depression is associated with fibromyalgia, and it may exacerbate
it," Dr. Cianfrini said. "But depression does not seem to be a necessary factor." In a similar study, Dr. Richard
H. Gracely, a research psychologist at the National Institutes of Health, presented findings on how the brains of fibromyalgia
patients react to pain.
Dr. Gracely and colleagues used functional MRI to compare fibromyalgia patients with
healthy patients experiencing pain. The research team found that patients with fibromyalgia who were given relatively
low levels of pressure seemed to experience the same amount of pain and subsequent brain activity as healthy people
experiencing high levels of induced pain. "One of the big issues of pain patients is credibility they don't have the luxury
of physical signs; nobody believes they have what they say," Dr. Gracely said. However, these findings provide physical
evidence to confirm what fibromyalgia patients report, he added.
Some Quit Joint Replacement Settlement (AP) Cleveland:
About 120 patients who experienced faulty hip and knee replacements plan to opt out of a $1 billion settlement in
a class action lawsuit. Nearly 3,500 patients nationwide who received faulty artificial joints made by Austin, Texas-based
Sulzer Orthopedics are covered by the settlement. Parent company Sulzer Medica, located in Switzerland, said Thursday
that it will negotiate to reduce the number of patients opting out of the settlement. Sulzer's lead counsel, Richard
Scruggs, has said that patients who choose to pursue litigation independently could bankrupt the company.
Those
who got the implants replaced without complications will each receive about $200,000 under the settlement. The payment
will be higher for patients with complications. About $40,000 of each patient's share will go toward attorney fees.
Cleveland U.S. District Judge Kate O'Malley approved the settlement last week following a two-day hearing. In December
2000, the company was forced to recall thousands of artificial joints due to a manufacturing problem that had contaminated
some with an oily residue. The substance prevented the new joint from bonding with patients' bones. The agreement
specifies that Sulzer Medica should pay $725 million toward the settlement.
Residual Capsule and Intercapsular
Debris As Long Term Risk Factors by Dr. Pierre Blais: Contamination of the space between the capsule and the implants
by micro- organisms, silicone oils, degradation products and gel impurities constitutes a major problem which potentiates
the risk of implants. Such problems include inflammation, infection, deposition of mineral debris, as well as certain
auto-immune phenomena. These problems can be present when implants are in situ (in the body) and are often attributable
to the implant. The logical expectation is that, upon removal of the implants, adverse effects will cease. This is an
unjustifiably optimistic view. It is well documented from case histories that removal and or replacement of implants
without exhaustive debridement of the prosthetic site leads to failure and post surgical complications.
Plastic
surgery procedures tend to favor speed and immediate cosmetic results. For these reasons, leaving or "reusing" tissue
from an existing capsule may seem more "gratifying" However, adverse effects resulting from the practice are widespread
but have not been well documented. Typically, patients who require removal of faulty implants and undergo immediate re-implantation
in the same prosthetic site habitually relapse with the same problem which motivated the previous surgery; the most common
example is exchange of implants and/or sectorizing or bisecting the capsule without removing it completely.
Such
patients rarely achieve a significant capsular correction and habitually return for more similar surgery. A more illustrative
situation is that where patients do not receive replacement implants. They form the basis of knowledge for evaluating
the risks that arise from remaining capsules. An example is described in a paper published in 1993 (Copeland, M.,
Kessel, A., Spiera, H., Hermann, G., Bleiweiss, I. J.; Systemic Inflammatory Disorder Related To Fibrous Breast Capsules
After Silicone Implant Removal; Plastic and Reconstructive Surgery: 92 (6), 1179-1181, 1993): reported problems derived
primarily from immune phenomena and inflammatory syndromes with pain, swelling, serologic abnormaladies and alarming
radiologic presentation. Numerous similar cases have been noted amongst implant patients but have not been theobject of
publications. Some are cited in FDA Reaction Reports. Others appear in theU.S. Pharmacopoeia Reporting Programs.
A
residual capsule is not a stable entity. It may collapse upon completion of surgery and remain asymptomatic for some time,
however, it will fill with extracellular fluid and remain as a fluid-filled space with added blood and prosthetic
debris. As the wall matures and the breast remodels to accommodate the loss of the prostheses, the capsular tissue shrinks.
Water as well as electrolytes are expelled gradually from the pocket or else the mixture is concentrated from leakage
of water from the semi-permeable capsular membrane wall.
In most cases, calcium salts precipitate during that stage
and may render the capsule visible as a radiodense and speckled zone in radiographic projections. Prosthetic debris
is also radiodense and may be imaged to further complicate the presentation. The average size of the residual capsules
after 6-12 months is in the 2-7 cm range: most are compact, comparatively small and dense. Surgical removal should present
no difficulty for most patients if adequate radiographic information is available.
Later stages of maturation include
the thickening of the capsule wall, sometimes reaching 0.5-1cm. Compression of the debris into a cluster of nodules
which actually become calcified follows for some patients. A few mimic malignancies. Others appear as small "prostheses"
during mammographic studies. They are alarming to onocologists and are habitually signalled for further studies or
biopsies by oncologic radiologists.
In light of the present knowledge and considering the probable content of the
residual closed capsules, an open or needle biopsy is not advisable. The risks of releasing significant amounts of hazardous
contamination and possibly spreading infective entities outweighs the advantage of the diagnostic. At any rate, such
a capsule requires removal for mitigation of symptoms and a more direct surgical approach appears more economical and
less risky.
In summary, a capsule with a dense fibro-collagenous wall behaves as a bioreactor. Worse yet, it
is fitted with a semi-permeable wall that may periodically open to release its content to the breast. The probability
of finding the space colonized with atypical micro-organisms is elevated and the control of infective processes by
classic pharmacologic approaches is difficult if not impossible.
Such closed capsular spaces may be comparable
to "artificial organs" of unpredictable functions. Their behavior will depend on the content and the age of the structure,
its maturity and the history of the patient. There is a high probability that these capsules will continue to evolve for
many years, adding more layers of fibro-collagenous tissue and possibly granulomatous material. If bacterial entities
are present within the capsule space, they can culminate in large breast abscesses with will resist conservative treatments.
Even
with less active capsules containing mostly oily and calcitic debris, the thickening of the wall leads eventually to solid
"tumor-like structures" and are, by themselves, alarming on auscultation and self examination. At best, such structures
are unique environments for protein denaturation and aberrant biochemical reactions with unknown long-term consequences.
Pierre
Blais, Ph.D. Innoval 496 Westminster Ave. Ottawa, Ontario Canada KeA 2V1 Phone: (613) 728-8688 Fax: (613) 728-0687
12/25/01
(CNN) -- Imagine getting only three or four hours of sleep a night for eight years. Then having a pain as severe as
a toothache throughout the entire body at the same time. Add to that the feeling that memory is fading.
That's what
life can be like for people who suffer from chronic fatigue syndrome (CFS), says Dr. Jacob Teitelbaum, an internist who
specializes in treating this mysterious illness. This is a serious disease that can destroy people's lives," says Teitelbaum,
who directs the Annapolis Research Center for Effective Fibromyalgia and CFS Therapies in Annapolis, Maryland. He became
interested in the illness after succumbing to it in medical school in 1975. "There was not even a name for it back
then," recalls Teitelbaum, who says he battled the disease for years before being cured.
Poorly understood and
difficult to diagnose: Characterized by debilitating fatigue that doesn't improve with bed rest, chronic fatigue syndrome
usually is accompanied by a number of other symptoms, including muscle pain, weakness, memory impairment, joint pain and insomnia,
according to the Centers for Disease Control and Prevention.
The illness is thought to affect 500,000 to 800,000 Americans,
according to health officials, though some advocates say the number of sufferers is much higher. Whatever its prevalence,
the condition is poorly understood and difficult to diagnose. Unlike other diseases, a blood test can't determine definitively
if a patient has the condition, Teitelbaum says. Moreover, many symptoms are common to other diseases so doctors first
must rule out other explanations for the illness. But Teitelbaum says many doctors don't recognize the condition when
they see it. He likens treatment to the early days of multiple sclerosis and polio. Those diseases were not immediately
recognized as serious medical conditions, he says, but dismissed as the effects of psychological problems.
As many
as 90 percent of patients who have the disease have not been diagnosed and are not being treated, according to the Chronic
Fatigue and Immune Dysfunction Syndrome (CFIDS) Association of America, an advocacy group. The group recently surveyed
8,100 medical professionals across the United States and found that 77 percent of them said the amount of education doctors
receive about the condition is inadequate. "Unfortunately for most patients, the standard treatment is to be told, 'There's
nothing wrong with you,'" Teitelbaum says. Other advocates agree problems exist. "There are seriously ill patients out
there who are being dismissed as malingerers or hypochondriacs," says Jill McLaughlin, executive director of the
National CFIDS Foundation, a grass-roots organization that works to raise awareness and promote research of chronic fatigue
syndrome.
What's in a name? One of the main reasons chronic fatigue syndrome isn't taken as seriously as other
diseases, advocates say, is the name itself. Once a sufferer of chronic fatigue syndrome, Dr. Jacob Teitelbaum specializes
in treating patients with the illness. "No matter how much you describe it, the name undermines every definition you
can give of the illness because fatigue isn't an illness," McLaughlin says. "You can't convey the clinical severity of
a disease whose name connotes tiredness." Kim Kenney, CEO of the CFIDS Association of America, agrees. Often, she
says, people don't grasp the impact of the condition until they see the dramatic change in a sufferer who was once healthy.
But there are other difficulties.
The disease was discovered in the early 1980s around the same time as AIDS. But
unlike AIDS, no causative agent such as HIV has been found that can become a target of research, Kenney says. "There is
no body count" to capture public attention, she says. "People who die from [chronic fatigue syndrome] -- it's often
suicide that's involved," Kenney says. "They've lost family, friends, jobs and choose not to go on anymore."
Focus
on more research: So what can be done to help people who suffer from a debilitating condition that few doctors recognize
or understand? First and foremost, advocates say, is a need for more research. Doctors must determine what causes
the condition, a virus, immune system dysfunction, hormone dysfunction, brain abnormalities or other factors, before they
can find a cure. In the meantime, patients have to make due with a patchwork of treatments that target various symptoms.
Typically,
patients initially are treated for insomnia since sleep disruption often makes other symptoms worse. They're also given
pain medication and treated for any infections. Teitelbaum focuses on proper nutrition and on regulating the activity
of the hypothalamus, a "control center" in the brain that affects sleep, hormones, immune function and other functions.
Even alternative therapies such massage, cognitive therapy or lifestyle adjustments can be helpful, Kenney says. But
raising awareness about the nature of the disease, advocates say, is as important as funding research and improving treatment.
"It's a serious illness. It's a complex illness. It impacts nearly every system in the body," Kenney says. "It's worth
learning more about because chances are somebody you know is dealing with it."
12/27/01 (Reuters Health) NEW YORK: Women
treated with tamoxifen, no therapy, or radiotherapy, after undergoing breast-conserving lumpectomy all have similar median
disease-free survival rates, Japanese researchers report. Dr. T. Tominaga, from Toyosu Hospital, and colleagues randomly
assigned 112 women, who underwent lumpectomy for breast tumors 2 cm in diameter or smaller, to no therapy or to 20 mg
tamoxifen for 2 years. For women who received no treatment the median 5-year disease-free survival rate was 86.0%
and for women receiving tamoxifen it was 78.5%, a non-significant difference (p= 0.308). The difference in overall survival
at 5 years was not significantly different between the group (92.5% no treatment versus 94.3% tamoxifen, p = 0.745),
the researchers found.
When Dr. Tominaga's team retrospectively studied 70 patients who had opted for radiotherapy
after lumpectomy, 5-year disease-free survival and overall survival was comparable to the tamoxifen and no treatment groups
combined, according to their report in the November issue of Clinical Drug Investigations. Median 5-year disease-free
survival rates were 82.2% in the combined groups and 86.6% in the radiotherapy group (p = 0.352). There was also no difference
in the median overall survival between the combined groups and the radiotherapy group (p = 0.224), they note.
"Our
findings suggest that breast cancer patients may not always require radiotherapy after breast-conserving surgery, although
the generally favorable prognosis of patients treated in this study and the low number of tumor recurrences did not
allow the equivalence of the treatment regimens to be proved statistically," Dr. Tominaga and colleagues comment. "However,
because of this finding, and the facts that local tumor recurrences have been reported at 10 to 15 years after radiotherapy
and that its late-onset adverse effects after 20 to 30 years are unclear, the development of newer treatment methods
to replace radiotherapy is needed." Clin Drug Invest 2001;21:775-782.
Maggie Fox, 12/10/01: A new class of breast
cancer drug seems to work even better than the standard tamoxifen in fighting the disease, at least in some women, researchers
said on Monday. They said it was too soon to say if the new drugs, called aromatase inhibitors Fox says should replace
tamoxifen as a favored drug, but they shrank tumors better and helped more women survive. London Several studies presented
at a breast cancer conference in San Antonio show one brand of aromatase inhibitor called Femara, made by Swiss drugmaker
Novartis under the generic name letrozole, may work in a wider range of women than tamoxifen. "Letrozole is associated
with a higher rate of tumor shrinkage, and a better one- and two-year survival than tamoxifen," Duke University's Dr.
Matthew Ellis, who presented one study to the conference, said in a telephone interview.
Femara is a member
of a new class of drugs called aromatase inhibitors, which work differently from tamoxifen to prevent certain kinds of
breast cancer. Tamoxifen is made under the name Nolvadex by AstraZeneca Plc but is now available generically as well. "It
has a very simple mechanism of action that is not prone to the problems that tamoxifen is," Ellis said. "It reduces the
ability of the body to make estrogen." About 80 percent of women with breast cancer have what is called estrogen receptor
positive cancer - caused by the female hormone's effect on cells.
Ellis, working with researchers in Germany, Spain,
France and Britain, followed 324 women taking either tamoxifen or Femara. They saw tumors shrink in 60 percent of
women taking Femara for four months, compared to 41 percent of women taking tamoxifen. Breast cancer is the second biggest
cancer killer of women in the industrialized world, after lung cancer. It kills 40,000 women each year in the United
States.
New drugs block estrogen better: "Although our results are preliminary, letrozole appears to block estrogen more
effectively than does tamoxifen, suggesting that letrozole may work for women whose tumors are relatively resistant to
tamoxifen," Ellis, who is a paid consultant to Novartis, which also funded the study, said in a statement. In a second
study, Dr. Martine Piccart of the Jules Bodet Institute in Brussels, Belgium, and colleagues followed 453 women taking
Femara and 454 taking tamoxifen.
Overall median survival was 34 months with Femara and 30 months with tamoxifen.
Piccart said 64 percent of patients were alive two years after starting Femara, compared to 58 percent of tamoxifen patients.
Ellis' team worked with women whose breast cancer had progressed to the late stages, but another study presented at
the conference showed a related drug, Arimidex, could help women with early breast cancer. Made by AstraZeneca under
the generic name anastrozole, Arimidex also reduced breast cancer deaths. After a median of 30 months' treatment and 33
months of follow-up, 317 of 3,125 women given Arimidex suffered relapses, compared to 379 of 3,116 women taking tamoxifen
- a 17 percent reduction.
"This advance is as important for women fighting early breast cancer as the advent
of tamoxifen was 20 years ago," Michael Baum of University College Hospital in London, who presented the results, said.
"The results of the (latest) study ... may support the use of anastrozole, rather than tamoxifen, as the future treatment
of choice," he added.
Tamoxifen mimics some of the action of estrogen and by doing so blocks its cancer-causing
effects - usually. But sometimes it does not, and tamoxifen can increase the risk of a very rare form of cancer of the
uterus. Femara and related drugs stop the action of an enzyme called aromatase, which converts androgen, a precursor
hormone, into the female hormone estrogen.
Women taking letrozole make almost no estrogen. Tamoxifen has been shown
to reduce cases of breast cancer in healthy women who are known to have a high risk of the disease. The researchers
said it was too soon to tell if the new drugs would have the same effect. A third company, Pharmacia, makes an aromatase
inhibitor called Aromasin. (Personally, I was offered tamoxifen when I had breast cancer, I read the research and refused
to take it. I probably would feel the same way about the other drugs. Women who do chemotherapy are chemically forced
into menopause, and that alone decreases dramatically the amount of estrogen in their bodies. Lynda)
The peri-implant
breast capsule: an immunophenotypic study of capsules taken at explantation surgery. J Biomed Mater Res 2001;58(1):88-96
(ISSN: 0021-9304) Kamel M; Protzner K; Fornasier V; Peters W; Smith D; Ibanez D Laboratory of Bone and Joint Pathology,
Department of Anatomic Pathology & Cytology, Wellesley Central Site, St. Michael's Hospital, University of Toronto,
Toronto, Canada.
Silicone-based breast implants continue to be the focus of many studies attempting to correlate
implant failure to clinical and pathological factors. Routine pathology of peri-implant capsule is extensively described
in the literature. The actual significance of the cellular events remains unconfirmed, particularly with reference
to clinical outcome. This study reviews our experience with explanted capsules. The study makes specific reference
to the immunohistochemistry of the cells participating in the capsule and the significance of the immunophenotypic characterization
of these cells to clinical outcome. The use of a wide selection of immunomarkers for T and B lymphocytes and histiocytes
provided no supporting evidence for local cell participation in the capsule, which may indicate the presence of an
immunological reaction present in the capsule at the time of explantation. One was only able to confirm the presence of
a low-grade inflammatory process and progression to fibrosis and calcification over time. Statistical correlation
was obtained only between Baker grade of capsular contracture and CD3/CD68 immunomarker positivity. CD45RO did show
correlation with pain. No correlation was demonstrated with calcification. The results obtained in this study highlighted
the need for further investigations into the mechanism of histiocyte and fibrocyte recruitment and activation in the
capsule, a possible source of pain and contracture, which is a serious long-term clinical finding leading to the necessity
for explantation.
Aetna Coverage Policy Bulletins: Subject: Breast Implants/Removal: Policy: Aetna U.S. Healthcare
covers the removal of breast implants for patients who meet the following selection criteria.
For patients who
have undergone either cosmetic augmentation mammoplasty or breast reconstruction following a medically necessary mastectomy
(e.g., mastectomy for breast cancer or a prophylactic mastectomy), removal of breast implants is covered for ANY of
the following indications: 1) Breast cancer, or 2) Extruded implants, or 3) Implants complicated by recurrent infections,
or 4) Implants with Baker Class IV contracture associated with severe pain, or 5) Implants with severe contracture that
interferes with mammography, or 6) Ruptured silicone gel-filled implants.
For patients whose breast reconstruction
followed a medically necessary mastectomy (i.e., mastectomy for breast cancer or a prophylactic mastectomy), breast
implant removal is also covered for these additional indications: 1) Baker Class III contracture, or 2) Ruptured saline
implant. Removal of ruptured saline-filled breast implants is not covered for patients who have previously undergone cosmetic
breast augmentation mammoplasty. If any of the above coverage criteria for removal of a breast implant is met unilaterally,
Aetna will also cover removal of the implant in the other breast if both implants are removed at the same time. Requests
for removal of breast implants for any of the following indications should be referred to a medical director for review:
1) Breast malposition or asymmetry; 2) Baker Class II contracture; 3) Baker Class III contracture that does not follow
a medically necessary mastectomy; 4) Removal of breast implant due to patient anxiety about developing an autoimmune disease;
5) Implant removal for biopsy of breast mass that has not been proven to be cancerous; or 6) Implant removal for a
mastectomy or lumpectomy that can be performed with the implant in place. Silicone implant removal for autoimmune disease:
Aetna U.S. Healthcare does not cover any of the following because an FDA panel concluded that there was no convincing
evidence linking silicone implants to the development of autoimmune disease:
1) Removal of silicone implants for
autoimmune disease unless the patient meets one or more of the selection criteria listed above (e.g., rupture of silicone-gel
filled implant, etc.); 2) IgG testing in connection with silicone implants (the development of IgG antibodies is neither
specific to silicone implants nor indicative of autoimmune disorders).
Reinsertion of breast implants: Although
Aetna U.S. Healthcare covers the removal of breast implants for medical indications even if the implants were originally
inserted for cosmetic purposes, Aetna will not pay for the reinsertion of new breast implants in this situation. We will
provide coverage for insertion of initial breast implants and for the replacement of breast implants inserted following
a medically necessary mastectomy (i.e., mastectomy for breast cancer or a prophylactic mastectomy).
Baker Classification:
Class I augmented breast feels soft as a normal breast, Class II augmented breast is less soft and implant can be palpated,
but is not visible, Class III augmented breast is firm, palpable and the implant ( or distortion ) is visible, Class
IV augmented breast is hard, painful, cold, tender, and distorted.
Application to Products: Unless indicated otherwise
above, this policy applies to all fully insured Aetna U.S. Healthcare HMO, POS and PPO plans and to all other plans,
unless a specific limitation or exception exists. For self-funded plans, consult individual plan sponsor benefit descriptions.
If there is a discrepancy between this policy and a self-funded customer's plan of benefits, the provisions of the benefits
plan will govern. With respect to fully insured plans and self-funded non-ERISA (e.g., government, school boards,
church) plans, applicable state mandates will take precedence over either. Unless otherwise specifically excluded,
Federal mandates will apply to all plans. With respect to Medicare and Medicaid members, this policy will apply unless
Medicare and Medicaid policies extend coverage beyond this Coverage Policy Bulletin. HCFA's Coverage Issues Manual
can be found on this website: www.hcfa.gov/pubforms/06_cim/ci00.htm
Washington, 11/19/01 (AP): Major reversal on product originally deemed too risky. The Food and Drug Administration
made an unprecedented about-face Monday, approving a gel that promises less internal scarring for women undergoing
certain surgeries even though regulators originally deemed the product too risky. A study of 281 women found 5.6 percent
of Intergel recipients suffered an infection at the surgical site, versus just 2.9 percent of women who received standard
surgical treatment, the FDA warned. THE FDA had initially rejected Lifecore Biomedical Inc.'s Intergel, which promises
to reduce internal scarring from certain gynecologic operations. The reason: In studies, women given the gel during
open pelvic surgery had only one fewer internal scar but almost twice the risk of infection as women given standard
treatment. Lifecore argued that Intergel was better than that, citing study results that suggested even if women did have
internal scars, they were smaller and less severe when their surgeons used the lubricating gel.
So Lifecore
became the first company to test a new law ordering the FDA to allow appeals without making manufacturers go to court.
The government picked a panel of independent scientists to review the Intergel decision. These mediators ruled in
September that the FDA had erred and should approve Intergel and the agency did. Still, the FDA's approval announcement
was lukewarm at best. The agency called use of Intergel "reasonably safe," and provided surgeons with a list of warnings
restricting how it should be used.
The gel, formally named Gynecare Intergel Adhesion Prevention Solution, is intended
to reduce adhesions, internal scar tissue that can cause chronic pain or intestinal obstruction. Various adhesion-preventing
treatments already are sold, but Intergel is the first liquid one. It is only for use during open gynecologic operations
not the increasingly common "keyhole" surgeries where doctors operate through a small incision, the FDA warned. Nor
is it for women with abdominal or pelvic infection, or who have cancer or are pregnant.
Also, the FDA warned, a
study of 281 women found 5.6 percent of Intergel recipients suffered an infection at the surgical site, versus just 2.9
percent of women who received standard surgical treatment. "We don't care how it got approved, we just care that it
got approved," responded Lifecore President Jim Bracke. "They'll be watching us carefully for safety and that's fine.
It'll prove out."
The FDA's mediators ruled that agency scientists used too harsh a statistical interpretation
in judging Lifecore's U.S. studies, and wouldn't consider better data from Europe, where the product has been sold for
several years. The case shows the government established "a fair and impartial appeals mechanism" and "that industry
could get a fair shake," said FDA ombudsman Les Weinstein, who arranged the potentially precedent-setting appeal.
He said he was surprised that no other companies have sought similar mediation. But one veteran FDA watcher called the
Intergel saga "a very dangerous precedent," questioning why outside scientists who reviewed the product for one day
were trusted more than FDA's own scientists who had pored over Lifecore data for months. FDA rejects few medical products,
and "needs to be strong enough to stick with its guns" when it does, said Dr. Sidney Wolfe of the consumer advocacy group
Public Citizen. Intergel should begin selling in February and cost about $200, said Minnesota-based Lifecore.
CHICAGO,
Nov. 26 - The Associated Press and Reuters contributed to this report: A new technique may allow women who have had a
cancerous lump removed from a breast to complete radiation treatment in a single session, without the six straight
weeks or more of therapy now required, researchers reported Monday. The experimental treatment could make lumpectomy,
a breast-saving type of cancer surgery in which only the lump is removed, available to many more women who would otherwise
have to undergo mastectomy, or removal of the entire breast.
"If this new technique is proved effective, it should
make lumpectomy available to many more patients," said Dr. Jayant Vaidya, a surgeon at University College London in
England who led the study. "Early tests are promising." Many women who are diagnosed with early breast cancer decide against
a lumpectomy because they cannot spend six weeks receiving daily radiation treatments, he said. Mastectomies typically
do not require radiation. Mastectomies are often the only option for women who live far from cancer treatment centers
or find the standard radiation schedule unworkable.
Concentrated radiation dose: An experimental technique called
intra-operative radiotherapy uses a miniature radiation probe right after a lumpectomy. The probe is inserted inside
the cavity created by the removal of the tumor, and radiation equivalent to six weeks of doses is emitted for about
25 minutes. The technique was just as effective as six weeks of radiation in preliminary results from Vaidya's study of
29 women, which was prepared for presentation at a meeting of the Radiological Society of North America.
The
women all underwent lumpectomies for tumors of less than about 1½ inches. About half got the single dose and half received
the standard six weeks of radiation. All have remained cancer-free during 1½ years of follow-up. Since peak time for
cancer recurrence is two to four years after treatment, it is too soon to call the technique a success, said Dr. LaMar
McGinnis, senior medical consultant for the American Cancer Society. But "so far, so good," Vaidya said.
Jeffrey
Tobias, a tumor specialist at University College London, said: "We believe this is going to work. Most cancer recurrences
occur immediately adjacent to the tumor - an area which receives radiation with this method." Dr. Paula Schomberg,
a Mayo Clinic radiologist, said the approach requires more study. "It would certainly be advantageous if there was some
way to replace an extended course of radiation with a shorter course, for patient convenience," she said. "It remains
to be seen whether it's safe to do that."
The report said the technique is not sufficient for a form of breast cancer
called lobular carcinoma, which accounts for up to 15 percent of all breast cancers. Vaidya said victims of such cancer
still need an extended period of radiation but the radiating sphere can be used initially.
Westport, CT (Reuters
Health) 11/06/01: Obesity and smoking significantly increase the risk of complications following transverse rectus abdominus
myocutaneous (TRAM) flap breast reconstruction, according to a report presented at the 70th annual scientific meeting
of the American Society of Plastic Surgeons in Orlando, Florida. Active and former smoking and obesity are linked
to significantly higher rates of single and multiple flap complications," Dr. Ivica Ducic of Georgetown University in
Washington, DC told Reuters Health. He and colleagues retrospectively analyzed the risk factors associated with donor
site and flap complications in 224 women who underwent pedicled TRAM flap breast reconstruction over a period of 10
years.
Obesity is a significant risk factor for overall donor site and flap complications, as well as multiple
flap complications, delayed wound healing and minor flap necrosis, Dr. Ducic noted. Fifteen percent of the women in
the study were obese (BMI over 30). Another 38% were overweight (BMI between 25 and 30), but Dr. Ducic's team found that
being overweight was not a significant risk factor for any complications. "Active smoking significantly increases
the risk of multiple flap complications, flap infection, and delayed wound healing," Dr. Ducic said. The researchers
identified 15.5% of the women as current smokers. Dr. Ducic's group also found an increased risk of multiple flap complications
and delayed TRAM wound healing in the 17.5% of women who were former smokers, which was defined as not smoking for
at least 4 weeks. The investigators identified no significant risk factors for any complication from presurgery radiation
and chemotherapy or the use of double pedicled TRAM flaps. "TRAM is a reasonably safe procedure in properly selected patients,"
Dr. Ducic told Reuters Health. These findings suggest that physicians could help patients reduce their risk factors by
counseling them to quit smoking and to reduce their BMI to below 30 before undergoing TRAM flap breast reconstruction.
11/16/00,
Delayed Diagnosis for Ovarian Cancer Can Cost Lives: Symptoms Exist, but Both Patients and Doctors Often Ignore Them.
Elaine Zablocki WebMD Medical News, Reviewed by Dr. Pamela R. Yoder: Vague symptoms, such as abdominal bloating and
gastrointestinal upset, may be a sign of ovarian cancer and should not be ignored, according to a study in the Nov. 15
issue of Cancer.
Ovarian cancer is often called a "silent killer," according to study author Barbara A. Goff,
MD, who is with the University of Washington department of obstetrics and gynecology in Seattle. She writes that the
disease is usually not detected until an advanced stage because it has been thought that most women with ovarian cancer
don't have specific symptoms. In fact, ovarian cancer does produce symptoms, but both patients and doctors may not
give them proper attention.
Goff and colleagues surveyed more than 1,700 women with ovarian cancer and found
that 95% of them did experience symptoms before their diagnoses, most often increased abdominal size, abdominal bloating,
abdominal pain, and fatigue. Other symptoms included indigestion, constipation, back pain, and change in urination
frequency. Most importantly, only a quarter of the women experienced specific pelvic symptoms, such as pelvic pain or
pain with intercourse.
Today, all women know that a breast lump is a warning sign for breast cancer, something
you don't ignore. Now women need to become aware that vague abdominal symptoms possibly could point to an ovarian tumor
or the spread of a cancerous tumor. About one in five of the women who took the survey ignored their symptoms at first.
When the women did go to see the doctor, 30% said they had been given an incorrect diagnosis such as stress, depression,
or irritable bowel syndrome. Still, more than half of them did get a correct diagnosis in less than three months from
the time they first talked to the doctor; 11% waited more than a year.
One in five of the surveyed women believed
doctors' attitudes toward their symptoms were a barrier to accurate diagnosis. Among the women who weren't diagnosed
for more than a year, almost half felt one of the reasons was their provider's attitude. "Women must pay attention to
these symptoms and go to a doctor if they have them. Consumers sometimes have to be an advocate for themselves," says
Anil Sood, MD, assistant professor of gynecologic oncology at the University of Iowa College of Medicine in Iowa City.
James
Fiorica, MD, agrees. "The message from this study is, don't ignore these symptoms. Don't assume it's just some virus.
See your physician and ask if these symptoms could be due to ovarian cancer." Fiorica is program leader of the gynecologic
oncology program at the H. Lee Moffitt Cancer Center and Research Institute and professor at the University of South Florida,
both in Tampa.
A pelvic exam is one of the most valuable tools we have to diagnose ovarian cancer, say both Fiorica
and Sood. It allows the physician to feel with the fingers to see whether there's an ovarian mass. It helps the doctor
decide whether further tests, such as ultrasound, are needed. A pelvic exam must probe the rectum as well as the vagina,
Sood emphasizes. "You can miss 25% of ovarian masses if you don't do a rectal exam. Of course, not every woman with
abdominal bloating will turn out to have ovarian cancer. Still, a pelvic exam, including a digital rectal exam, is such
a simple thing to do. It should be part of every good physical exam." However, about a third of the surveyed women
said when they first discussed their symptoms with the doctor, no pelvic exam was done. "Physicians need to comprehend
the potential significance of these symptoms," Sood says. "If a woman finds her doctor doesn't perform a pelvic exam,
she should feel free to seek out someone who does." "It is so critical that patients not ignore this," Fiorica says.
"At a bare minimum, have a pelvic done. Then the physician can decide if anything additional is needed. If we take these
steps, hopefully we can detect these cases earlier, and cure more of them."
NY 10/31/01 (Reuters Health) Merritt
McKinney: Scientists announced on Wednesday that they may have identified how the autoimmune disease lupus destroys
the central nervous system. Antibodies produced by the disease seem to kill nerves by latching on to a receptor on neurons,
according to a report in the November issue of the journal Nature Medicine. The discovery eventually may lead to new
therapies for the disease, one of the investigators told Reuters Health. In people with lupus, or systemic lupus erythematosus
(SLE) as it is officially known, the immune system loses the ability to differentiate between its own cells and outside
invaders, and antibodies attack healthy cells. The condition can vary widely in severity, manifesting as skin rash
and arthritis or leading to damage to the kidneys, heart, lungs and brain to varying degrees. There is no cure. The disease
disproportionately affects women, particularly those of childbearing age and of African or Asian descent. If the central
nervous system is affected, the resulting damage can cause a variety of problems including headache, paranoia, mania,
schizophrenia and stroke. Exactly how lupus antibodies kill nerve cells has been a mystery, however.
Now Dr. Betty
Diamond, of Albert Einstein College of Medicine in New York, and colleagues have discovered in experiments with human
tissue and mice that lupus antibodies latch on to a common receptor found on nerves. Once the antibodies attach to
these receptors--known as the NR2 subunits of the NMDA receptor--they trigger the death of neurons. The research eventually
may lead to new therapies for lupus, one of the study's co-authors told Reuters Health. "New insights into disease
mechanism often lead to new therapeutics," said Dr. Bruce T. Volpe, of the Burke Medical Research Institute of Weill
Medical College of Cornell University in White Plains, New York. "Our work suggests a new hypothesis for the clinical
symptom of cognitive decline in patients with lupus," he said. "Now we need to test it. "He explained that the antibodies
"cross react" with ordinary molecules in the body, meaning that they recognize the molecules by mistake. This "accidental
recognition" may destroy the cell, Volpe said. Now that researchers have formulated a new hypothesis about how lupus damages
the nervous system, there are many questions to answer, according to Volpe. The next steps, he said, include seeing
how frequently the nerve-killing antibodies are present in people with lupus and whether the presence of the antibodies
is linked to neurological symptoms. It will also be important to find out whether the process of cross-reactivity, or
accidental recognition, is involved in other immune diseases that affect the nervous system, Volpe said. The authors
of an accompanying editorial agree that the research may open the door to new treatments if it is confirmed. And future
research may show that similar types of "cross-reactivities" also play a role in other types of lupus-related tissue
damage, according to Drs. Brian L. Kotzin and Elizabeth Kozora, of the University of Colorado Health Sciences Center
in Denver. But the editorialists caution that the results of the experiments, which included samples from only a few lupus
patients, are preliminary. Source: Nature Medicine 2001;7:1175-1176,1189-1193. Westport, CT (Reuters Health) 10/01/01
Women with implanted medical devices are more likely to develop undifferentiated connective tissue disease (UTCD)
than women without these devices, according to a report published in the American Journal of Epidemiology for October
1. Previous studies have failed to find a link between silicone-containing implants and specific autoimmune diseases
such as scleroderma or other rheumatic diseases, the authors note. However, the statistical power of many of these studies
may have been limited in that relatively rare diseases and exposures were examined.
In the current study, Dr. David
Schottenfeld, from the University of Michigan at Ann Arbor, and colleagues compared the device exposure history of
205 women with UTCD with that of 2095 control women without such disease. Women who had received any type of silicone-containing
device were 2.81 times more likely to develop UTCD than women who had not received a device, the authors state. An
elevated risk was noted with silicone breast implants, in particular, but the association was not significant. Implantation
of non-silicone-containing devices was also associated with a significantly increased risk of UTCD, the researchers note.
In fact, women who had received artificial joints were 5 times more likely to develop UTCD than those who had not. On
average, women had received their implant at least 4 years prior to developing UTCD, the investigators point out.
There was a "suggestive relation" between duration of exposure and incremental risk of UTCD. Am J Epidemiol 2001;154:610-617.
April
18, 2002: A new report by a panel of international experts casts doubt on long-standing claims that hormone replacement
in postmenopausal women can prevent or treat a variety of ills, including heart disease, Alzheimer's disease, major
depression, urinary incontinence and broken bones due to osteoporosis. While hormone therapy is the most effective way
to relieve menopausal symptoms such as hot flashes and night sweats, scientific evidence is insufficient to support
its use for the other problems, according to the report, which is to be published in June. And the hormones have well-documented
drawbacks, including an increased risk of blood clots and gallbladder disease and, with prolonged use, breast cancer.
About
20 percent of women who reach menopause naturally use hormone replacement at least temporarily, according to the North
American Menopause Society. The figure is higher for women who reach menopause early because of surgery to remove
their ovaries. Hormone replacement usually consists of estrogen plus another hormone, progestin, or, for women who have
had hysterectomies, estrogen alone.
Given the known risks and limited benefits of hormone treatments, the report
says, each woman and her doctor should weigh her medical history carefully in deciding whether she really needs it. Drugs
to lower cholesterol and blood pressure are better for reducing the risk of heart disease for many women, and other
nonhormonal drugs work better in preventing fractures. That advice departs from decades of medical practice: Many
women and their doctors assumed that taking estrogen at menopause was a way to preserve youth and health.
American
women spent $2.75 billion on hormone replacement in 2001, according to IMS Health, a company that tracks drug sales. Premarin,
a form of estrogen replacement therapy, was the third most commonly prescribed drug in the United States last year
with more than 45 million prescriptions dispensed. The new report, called the International Position Paper on Women's
Health and Menopause, was financed by the National Institutes of Health and the Giovanni Loren Zini Medical Science Foundation
of Italy. The full report, which is book-length, is to be issued by the National Heart, Lung and Blood Institute,
but the chapter on hormone replacement and other treatments was published early and distributed at a symposium at
the National Institutes of Health. Researchers who worked on the report said some of its findings might shock doctors
and patients.
Dr. Vivian Pinn, director of the NIH Office of Research on Women's Health and a co-editor of the
report, said many people, including doctors, had believed that hormone replacement would prevent heart disease and strokes
and help women live longer. But, she said, "as we're learning more from long-term studies and better defined studies
over the past few years, all these things we've thought about the wonders of hormone replacement may not be holding
up under scrutiny." Dr. Nanette Wenger, chief of cardiology at Grady Memorial Hospital in Atlanta and editor of the report,
said that until fairly recently many doctors simply told women: " 'Take this. You'll look better. You'll feel better.'
People acquiesced. There was no questioning." "Given the fact that hormone replacement has been around for half a
century, it's really only in the last decade that we've begun to get stringent scientific evidence from randomized controlled
trials," Wenger said. "And in many areas there have been enormous surprises." For instance, Wenger said, three recent
controlled trials have found that, rather than protecting women from heart attacks and strokes, hormone replacement
increases their risk. Last year, the American Heart Association said women should not regard hormone replacement as
a means of treating or preventing heart disease. Even though hormones can help lower bad LDL cholesterol and raise good
HDL cholesterol, the group said statin drugs were far better at doing so. Hormone replacement can prevent bone loss
from osteoporosis, and some studies have suggested it reduces the risk of fractures. But bone loss resumes after a
woman stops taking hormones. Moreover, no large randomized controlled trials have determined whether the treatment reduces
fractures. The Food and Drug Administration has approved hormone therapy to prevent osteoporosis, but not to treat
it.
Wenger said doctors had long assumed that hormone replacement would help older women who suffered from urinary
incontinence. "But now two trials show no improvement, and there may be a worsening," she said. "So many of the earlier
presumptions, as they come to trial, do not show evidence of benefit," Wenger said. Dr. Deborah Grady, a professor of
epidemiology and medicine at the University of California San Francisco, said, "A decade ago I thought preventive
hormone therapy should probably be prescribed to most postmenopausal women, except those at high risk for breast cancer."
As lead author of the 1992 guidelines on hormone replacement for the American College of Physicians, she incorporated
that view into the guidelines. But now, she says, "there have been major changes in the way we use hormone therapy."
Today, Grady said, "rather than prescribing it for most postmenopausal women, I prescribe it for symptoms, for which it
is far and away the best treatment."
ALTERNATIVE MEDICINE: San Diego, CA (AP) -- Studies exploring the effects
of specific foods on the brains of animals found that diets rich in spinach and blueberries may help stave off age-related
declines in rats' mental abilities. Rats fed a diet rich in spinach reversed a normal loss of learning that occurs
with age, according to a study by researchers at the University of South Florida. The study was presented at the Society
for Neuroscience's annual meeting in San Diego this week.
Rats fed a normal diet that contained 2 percent freeze-dried
spinach learned to associate the sound of a tone with an oncoming puff of air faster than those fed regular rat chow,
the study found. The test measured the interval between the sound of the tone and when the rats blinked, and was designed
to test the ability to associate two distinct but related events. The speed of the reaction has been shown to decline
with age in rodents, rabbits and humans. Spinach is rich in antioxidants, which scientists say can block the effects
of free radicals. Studies suggest the lifelong accumulation of free radicals in the brain is linked to mental declines
in old age and is also a probable factor in Alzheimer's and Parkinson's diseases. "This is a preclinical finding of significant
interest that now needs to be tested in humans," said Dr. Paula Bickford of the University of South Florida, an author
of the study.
Blueberries are also rich in antioxidants. A study by researchers at the University of Houston at
Clear Lake and the Universidad Nacional Autonoma de Mexico found that blueberries may help fight age-related declines
in rats' memories. Aging rats that were fed a blueberry-supplemented diet for four months tested as well as younger
rats in their abilities to recognize objects after an hour. Aging rats fed a normal diet failed to recognize the objects.
"This research has rather hopeful implications for prevention of neurological or psychological disorders in our increasingly
aging population," said Dr. David Malin of the University of Houston, Clear Lake. The brains of the rats in the experiment
are being analyzed to determine whether blueberries slowed brain degeneration.
Fat-fighting fat shows promise: from
Consumer Reports on Health, 06/01. The supposed wonder fat is conjugated linoleic acid (CLA), a type of polyunsaturated
fat found, in small amounts, in dairy products, beef, and other meats. It's also widely available in several major brands
as a concentrated dietary supplement (Nature Made CLS and Nature's Way Tonalin XS-CLA) sold in health food stores
and via the Internet. Numerous studies in animals have shown that CLA can help make them leaner by reducing body fat,
increasing muscle mass, or both. Now studies are starting to show that the pills may work in humans, too.
In a
clinical trial published in the Journal of Nutrition, Norwegian researchers randomly assigned 60 overweight volunteers
to take either CLA supplements or placebo pills; all were encouraged to exercise but told not to diet. After 12 weeks,
two of the three higher-dose CLA groups had lost significant amounts of body fat (6% and 4%, respectively). Overall, the
CLA groups lost more fat (though not significantly more weight) than the placebo group.
A second clinical trial,
not yet published, found that taking 3 grams of CLA daily for six months helped people who were dieting and exercising
not only lose fat but also build muscle. That's important, since dieting tends to eliminate muscle along with fat,
that lose of calorie-hungry muscle can undermine efforts to maintain weight loss by lowering the body's metabolism,
or basic calorie-burning rate. And replacing fat with muscle can make you look slimmer even if you don't lose weight.
Researchers
theorize that CLA may work either by helping to draw fat out of the body's fat cells or by inhibiting their incorporation
of additional fat, thereby redirecting food calories into muscle rather than fat cells.
Of course, a few small,
relatively brief human studies are hardly enough to establish that CLA can help overweight people retool their physique.
Moreover, the optimal formulation and dosage of the pills as well as their long-term safety are unknown. So while CLA
looks promising for trimming down (and possibly other health benefits, too), our consultants say there's not enough
human research to warrant recommending the pills.
Also from Consumers Reports on Health 05/01: Green foods for
the eyes: Eating lots of leafy greens may help you keep seeing clearly as you age, according to two recent studies.
Previous research has tentatively linked the destructive chemical process known as oxidation to cataracts, or clouding
of the lens of the eye. The recent studieseach from researchers at Harvard, roughly a decade long, and including tens
of thousands of peopletend to bolster that link.
The studies found that men and women with the highest dietary
intake of the plant substances lutein and, to a lesser extent, zeaxanthin, had roughly a 20 percent lower risk of
serious cataracts. (Lutein and zeaxanthin are cousins of betacarotene, all in the carotenoid family; they're the only
carotenoids found in the lens of the eye.) Further, the studies linked spinach and either kale or broccoliall high
in luteinwith reduced cataract risk.
Those findings bolster the argument for eating plenty of highly nutritious,
dark-green vegetables. However, it's too soon to recommend taking lutein supplementsa lesson learned from the betacarotene
saga, where research has found benefits from the carotenoid in foods but usually not in pills.
Genitourinary syndrome
and fibromyalgia: by R. Paul St. Amand, M.D. , 4560 Admiralty Way, Suite #355, Marina del Rey, CA. 90292 (310) 577-7510:
Over the course of some forty years, treating the entity Fibromyalgia, we had documented that many of our women patients
had repeated bouts of vaginal and urethral symptoms. Since these symptoms like the rest responded to our treatment
of we did not think in terms of a separate syndrome. Fibromyalgic individuals complain a lot. Ordinarily, the most overwhelming
symptoms are the aches and pains striking anywhere in the musculoskeletal system. They are devastatingly tired, nervous,
tense, irritable, depressed, awaken frequently and cannot get back to sleep; all this is accompanied by poor memory
and concentration forcing re-reading of material simply to grasp its gist. Very commonly, headaches arise from the back
of the occiput and neck, sweep over to the front, frequently involve but one-half though frequently, all of the head.
Often present are: dizziness, experienced as a fleeting, wavery sensation but sometimes true spinning, known as vertigo;
eye complaints of irritation such as dryness and perhaps morning mattering and excessive tearing; blurring for a few minutes
often requires repeated re-focusing. Occasionally, rapid twitching of the eyelids (blepharospasm) is felt. Flushing and
sweats are common as are nasal congestion, bad or metallic tastes, ringing or fluttering sounds in the ears, numbness
anywhere but often only of the hands and feet. Patients are often diagnosed with the "irritable bowel syndrome" or "spastic
colon" which consist of gas, bloating, nausea in waves, cramps and alternating constipation or diarrhea.
In addition
to the above, women will often note burning on urination, persistent or fleeting, and vaginal irritation or discharge.
If pelvic pain level allows intercourse, vulval or introital chafing, rawness or burning follows. Excessive vaginal
mucus often follows and may permit a medium for frequent yeast infections. Others may suffer repeated bladder infections.
At other times, similar symptoms arise but urinalyses are clear and no bacteria can be cultured. These people are
often told they have "interstitial cystitis." This cluster of symptoms is now known as "Vulvar Pain Syndrome (VPS)"
or Vulvodynia. A subset of these women have a more specialized complaint called Vestibulitis, or vulvar vestibulitis-which
refers to pain and irritation in the area of the entrance to the vagina. In my experience, all the women I have examined
with the Vulvar Pain Syndrome have had Fibromyalgia.
After forty years in working with Fibromyalgia some things
seem apparent. I think it is inherited, mainly effects women (80% of patients) and has scattered effects over most
of the body. I also think this is an illness caused by the excess accumulation of something which causes affected cells
in any given system to malfunction. Since this situation occurs almost anywhere and involves many locales at once,
multiple symptoms evolve. I suspect that the abnormality is chemical and merely due to the excess retention of some
normal body constituent(s) which evoke no inflammatory response and, initially, no permanent damage. Therefore, all laboratory
tests and X-rays are normal. I assume Fibromyalgia is caused by one or more defective genes since I have treated
as many as three generations of some families with this diagnosis. It is unusual not to obtain a history of similar complaints
or of osteoarthritis in older family members. So common is this information as to make me suspect that osteoarthritis
is often the natural sequel of long-standing Fibromyalgia. Some mutations seem more rapidly symptomatic than others
and cause symptoms in early life. Other, less-impacting, genetic alterations only slowly effect patients at very variable
ages and levels of severity. Thus we have treated five four-year old children, several others in the pre- teens but most
patients are more mature at onset. The youngest usually have a bilateral family history of Fibromyalgia, "rheumatism"
or osteoarthritis. There is often a history of growing pains as a child, "migraine" headaches in the teens and progressive
aching in highly variable cycles after that. At first, long gaps between attacks are usual causing physician and patient
to miss the connection. Eventually, symptoms merely cycle from bad to worse and allow no more good days. Many people
have been diagnosed as having "chronic fatigue syndrome," EBV infection, systemic candidiasis etc. All we have seen,
so-grouped, have been fibromyalgic.
My approach to this illness is controversial. It is not the conventional one
outlined and followed by rheumatologists. I do not follow the diagnostic guidelines of eleven out of eighteen predetermined,
tender points since it is usual to find many more, several not in the anticipated locations. I definitely do not agree
with the accepted treatment approach since that is mostly an attempt to control symptoms. Though I cannot change our
genetic makeup, I believe we are attacking at the next, best level: the proximal cause of the illness, and by that, seeking
ultimate, maximally-obtainable relief.
Once my patients helped me stumble into an effective treatment for Fibromyalgia
it seemed proper to form a theory to fit the results. However incorrect this might prove later, I present the following.
It is my suspicion that the defective genes cause retention of something that should be excreted by the kidneys in sufficient
amounts to maintain appropriate, inner cell levels. Phosphate retention is a likely suspect though oxalates or other
normal metabolites could be culprits or accomplices. We have tested twenty-four hour, urine collections before and after
instigating treatment in a few patients. An increase mainly in the excretion of phosphate but also of oxalates and calcium
occurred. My theory, simplistically stated, is that minimal phosphate retention year after year is leading to gradual
excesses. An elevated phosphate in the blood is not tolerated since it would depress calcium levels. The parathyroid
glands will not allow this and phosphate must be spread evenly not only in body fluids but also within cells. This accumulation
of negatively charged phosphates (possibly oxalates and/or other anions) demands retention of positively charged,
cations, most probably calcium but also sodium and possibly others. The excess intracellular phosphate depresses formation
of energy (ATP) in the cells' "power stations," the mitochondria. Calcium is drawn into the cell's fluid compartment to
chemically buffer phosphate. This would initially cause the cell to over-achieve its designated function. However,
the cells' deprivation of sufficient energy (ATP) would not allow extrusion of calcium from cellular fluid into appropriate
storage bins. The afflicted cell then could no longer adequately perform its usual chores and thus, varying degrees of
cellular and system apathy develops. Afflicted individual would obviously experience complaints referable to the obtunded
areas.
We have learned that any medication used for treating gout by causing urinary excretion of uric acid, also
works for Fibromyalgia though no connection exists between the two conditions. A gradual evolution in our use of various
agents finally led us to Guaifenesin, which has minimal effects on uric acid and would not be effective for gout. Guaifenesin
has been used only to liquify mucus. It is present in small amounts in many cold preparations such as Robitussin or
other cold and cough preparations. For our patients, it has proven the most effective treatment to date. In a cyclic
manner, the illness undergoes reversal several times faster than it developed. Unfortunately this reproduces all the symptoms
of the condition that are often worse than before since this acceleration involves many areas simultaneously. Gradually
and progressively more good days appear, cluster and finally restore the patient to normal if no permanent damage has
occurred.
Those of you with vulvodynia and the entire complex of genitourinary symptoms are being presented with
this topic for your information. We have seen so many patients with your complaints as part of Fibromyalgia that it would
be simple for me to assume it is but one disease. However, I should also emphasize that I am an endocrinologist, not a
gynechologist---so my experience has been limited to a degree.
We have treated a few thousand patients with Fibromyalgia,
many before a name was available for the disease. These individuals taught us the symptoms and the approach to treatment
by their own, very personal observations. I too have this condition as do my three daughters and two sisters--it is
my father's legacy! I hasten to repeat that this treatment is not for wimps since in most patients symptom reversal is
intense. However, health so attained becomes ever more valued since one will always remember the years of horror.
An excellent foundation supports women with these problems. They have seminars in various parts of the country and are
well-acquainted with FM. I suggest anyone with these problems contact and consider joining this excellent organization.
The address: The Vulvar Pain Foundation Post Office Drawer 177 Graham, North Carolina 27253 Phone: (910) 226-0704 Fax
: (910) 226-8518 http://www.vulvarpainfoundation.org
(I don't necessarily agree that fibromyalgia is heriditary, because many of us with toxicity did not have family
histories of it, but his theory and treatment are interesting. Lynda.
Policosanol: This is something I recently
discovered, so thought I would share it with all of you. Since I had my chest dumped full of silicone, my cholesterol
has never returned to normal. This information may repeat itself somewhat, as I gathered it from three sources.
A
newly discovered supplement, policosanol, can lower cholesterol as efficiently (and often better) than prescription drugs
such as Lipitor. It takes up to 12 weeks to show results, but there are no known side effects (no liver damage, as
can occur with statin drugs). Dosage is 2-10 mg. tablets at nighttime. I found them at the most reasonable price in bottles
of 120 tablets (30 day supply) on a website: www.smartbomb.com
Policosanol: Taking cholesterol management to a higher level: Ten years of research has shown that Policosanol
decreases the body's production of cholesterol and assists the removal of cholesterol from blood. Clinical trials
have proven that Policosanol can: Reduce total cholesterol levels, Reduce LDL*cholesterol levels ie "bad", cholesterol
Increase HDL cholesterol levels, ie. "good" cholesterol, Reduce LDL /HDL cholesterol ratios, Having balanced levels
of HDL and LDL cholesterol is very important in the maintenance of normal health cholesterol. Positive effects of Policosanol
on cholesterol levels can be expected to occur within 8 weeks.
How does Policosanol compare with other treatments?
Fish oils ~ in large doses (10-12,1 gram capsules a day),fish oils significantly reduce triglycerides (fats in the
blood), but have little effect on cholesterol. Garlic ~ trials with garlic have been inconsistent and show only marginal
effects on cholesterol. Dosages are typically between 2 to 5 grams of fresh garlic equivalent. As margarines containing
plant sterols work on inhibiting the absorption of dietary cholesterol, they don't impact the 75% of cholesterol produced
by the body.
Policosanol: How sugar can could help reduce high cholesterol: What is policosanol? Policosanol is
a natural product, derived from the waxy coating of sugar cane, now available to lower high blood cholesterol. What is
policosanol's effect on cholesterol? Policosanol has been shown to be effective in lowering both total cholesterol and
low density lipoprotein (LDL) cholesterol, the so-called 'bad' cholesterol. It has also been shown to increase levels
of the 'good' type of cholesterol, high density lipoprotein (HDL) cholesterol. Why is LDL cholesterol important? The level
of LDL in a person's blood is linked to atherosclerosis (narrowing of the blood vessels due to build up of lipids,
sometimes known as 'hardening of the arteries'). Having a high level of LDL cholesterol puts a person at risk of having
coronary heart disease. Why is HDL cholesterol important? HDL is called the 'good' cholesterol as it can actually help
carry cholesterol away from the arteries to the liver, where it is processed and excreted from the body. A relatively
high proportion of HDL in your total cholesterol level may be beneficial in reducing the risk of coronary heart disease.
Policosanol can increase levels of HDL, the good cholesterol.
How does policosanol work? Doctors have not yet discovered
the exact mechanism of action by which policosanol lowers LDL cholesterol, but superficially it seems to be similar
to that of other cholesterol-lowering drugs. It appears to decrease the production of cholesterol in the body and also
increase clearance of LDL cholesterol from the bloodstream. Other effects of policosanol: Policosanol has also been shown
to reduce the stickiness of blood platelets. Blood platelets are the cells that congregate at sites of bleeding in
the body and stick to each other to form a plug which stops the bleeding. They also release chemicals to attract more
platelets and promote formation of a clot. This is usually a beneficial effect in the body, particularly when we are injured.
This mechanism can also contribute to the formation of clots in narrowed blood vessels which become damaged where
cholesterol and fats have built up. So, if the blood platelets are reduced in stickiness which is what policosanol achieves
there is less chance of a clot (thrombus) forming.
How effective is policosanol at reducing cholesterol? Total cholesterol
a single daily dose of 5 mg to 10 mg of policosanol has been shown in some studies to significantly reduce total cholesterol
by between 8 per cent and 18 per cent. LDL cholesterol (bad cholesterol) in some studies a single daily dose of 5
mg to 10 mg of policosanol reduced LDL cholesterol by between 11 per cent and 28 per cent compared with the level before
treatment. The reduction in LDL cholesterol with 10 mg of policosanol was comparable to results obtained with low-doses
of statins a class of cholesterol-lowering drugs, such as pravastatin and simvastatin. HDL cholesterol (good cholesterol)
in other studies a single daily dose of 5 mg to 10 mg of policosanol increased HDL cholesterol by between 17 per cent
and 29 per cent.
These results were achieved after a treatment period of 8 weeks and were maintained when policosanol
was given after that period. How safe is policosanol? Policosanol has been used overseas for nearly 10 years. So far,
2 large studies have looked at nearly 30,000 people taking between 5 mg and 15 mg of policosanol daily for 2 to 5 years
and monitored them for adverse effects. Only 48 patients stopped taking policosanol because of a side effect a rate
of less than one in 100. The most common side effect was weight loss.
Is policosanol suitable for me? Professor
Leon Simons, Associate Professor of Medicine and Consultant Physician in Sydney, states: 'Given the safety and efficacy
profile, policosanol would seem to be indicated, in addition to standard dietary advice: In patients with mild hypercholesterolaemia;
as an alternative to low dose statin; and in situations where statins cannot be used.'
What is policosanol? It's
a group of eight or nine solid, waxy compounds (long-chain alcohols) extracted from the sugar cane that reduce cholesterol
levels. These compounds are collectively called policosanol, of which the most prominent member is a molecule called
octacosanol. Because your own body makes much more cholesterol than you typically consume, restricting dietary cholesterol
is often an insufficient means of regulating blood cholesterol levels. There is a growing body of evidence demonstrating
that policosanol has benefits on a par with those of the cholesterol-lowering drugs known as statins, the best-known
examples of which are lovastatin,* simvastatin, and pravastatin. Policosanol is very effective at lowering the blood cholesterol
in hyperlipidemic patients - individuals with high levels of lipids (fatty molecules), such as cholesterol. It appears
that policosanol and statins function in much the same way to inhibit the natural formation of cholesterol in your
body. Thus, daily supplementation with policosanol, as clinical research has demonstrated, results in a significantly
improved blood cholesterol profile. Happily, that generally translates into improved cardiovascular health as well.
Lovastatin occurs naturally in red yeast rice, a traditional food of Southeast Asia. In the form of dietary supplements,
red yeast rice provides many of the benefits of the statin drugs.
Whjy restricting dietary cholesterol doesn't work.
Every cell in your body requires cholesterol to function properly. This molecule is essential for forming cell membranes
and is an important precursor for creating other compounds, such as vitamin D (to build and maintain healthy bones), the
sex hormones (estrogen and testosterone, for example), and the bile acids (used for digestion). Because cholesterol
is so important, your liver ensures that it is made in sufficient amounts to provide for all these functions. In fact,
your liver makes about three times as much cholesterol (normally about 600 mg/day) as you consume in your food (the dietary
recommendation is 200 mg/day). Because your own body makes much more cholesterol than you typically consume, restricting
dietary cholesterol is often an insufficient means of regulating blood cholesterol levels. Restricting your fat intake
is far more important, because fats are the primary source of the cholesterol your body produces.
COMMENTARY:
Dr. Zuckerman's Testimony, House Committee on Energy and Commerce 11/15/01: My name is Dr. Diana Zuckerman and I am president
of the National Center for Policy Research for Women & Families. Our organization is a nonprofit think tank dedicated
to improving the lives of women and families by explaining and disseminating medical and scientific research information.
I
am honored to be on this panel with Congressman Roy Blunt and these courageous women, to talk about the need for H.R.
1961, a bill that will help to ensure and protect women's health and well being. The Breast Implant Research and Information
Act calls for more research on breast implants. I am here to tell you why this bill is so essential. Breast implants
have been sold in this country for almost 40 years, but we still know very little about their long-term health risks.
In fact, almost a million women had breast implants before the first epidemiological study was published about health
risks. Before then, there were just a few studies of rats and dogs, but no published studies of human beings.
In
1990, as a scientist working on what is now the House Reform and Oversight Committee, I started an investigation of the
FDA's regulation of breast implants. We found that the FDA had ignored the concerns of its own scientists by allowing
the sale of breast implants without requiring that the manufacturers prove that implants were safe. As a result of our
hearing, the FDA finally required the manufacturers to submit studies of silicone gel implants. Unfortunately, those
studies were so badly designed that they could not prove whether or not implants were safe.
In response to pressure
on both sides, the FDA did something they almost never do - they refused to approve implants but allowed them to stay
on the market as a "public health need." I think the last two months have shown us what a true public health need
is - and breast augmentation does not qualify. But, at the time, Congress went along with the FDA decision, but required
the NIH to conduct long-term research.
There were no studies of women with implants in 1990, but quite a few epidemiological
studies have been conducted since then. I have read all of them. Despite what you may have heard in the media, the research
and the report by the Institute of Medicine does not conclude that implants are safe -- to the contrary, they show
many serious problems related to implants. In fact, just a few months ago, three major new studies reported that women
who have breast implants are at significant risk for several debilitating and fatal diseases.
One study, conducted
by researchers at the National Cancer Institute (NCI) reported that women with implants were more likely to die from brain
cancer, lung cancer, other respiratory diseases, and suicide compared to other plastic surgery patients. A second
study, also by NCI, reported that women with breast implants are more likely to develop cancer compared to other women
their age. Both of these studies were of women who had either silicone or saline breast implants for at least 8 years.
In contrast, the studies showing no increase in disease for women with implants included many women who had implants
for short periods of time - even as short as one month. Obviously, cancer and autoimmune diseases do not develop that
quickly. A third study, conducted by scientists at the FDA, found that women with leaking silicone gel breast implants
are more likely to have several painful and potentially fatal autoimmune diseases. Implants were found to be increasingly
likely to break as they got older, and most implants were broken by the time they were 10-15 years old. This study
may provide an important clue: it is possible that illnesses reported by women with implants are a result of leaking implants
- which would explain why most women do not have systemic health problems until after they have had implants for several
years. At the same time that these new studies were released, the plastic surgery organizations announced that almost
300,000 American women got breast implants last year, most of them for augmentation. Although they don't boast about
it, their statistics also show that the number of teenage girls getting implants has more than doubled in the last 3 years.
These three new studies remind us that, although relatively few women become ill after having implants for a year
or two, we need to be concerned about the long-term dangers. And women who are considering implants deserve to be accurately
informed about the risks -- what is known, and what is not known. And yet, hundreds of thousands of women are deciding
to get implants because they mistakenly believe that implants are proven safe for long-term use.
The two studies
conducted by NCI were mandated by Congress. They were designed to answer two essential questions: 1) do breast implants
increase health risks and 2) do women with implants die at a younger age than other women? These are still the essential
questions and that is the purpose of H.R. 1961. I am especially pleased that this legislation requires studies of
women with implants after mastectomies. It is unfortunately true that not one single breast cancer patient was included
in the studies that the federal government has conducted thus far. I want you to know that Congress requested that mastectomy
patients be included in those studies, but the head of NIH at the time, Dr. Bernadine Healy, refused. It's too late to
fix those studies, but it is absolutely essential that studies of reconstruction patients be conducted as soon as
possible. At this point, most of what we know is based on the manufacturers' own studies, which show that one in four
reconstruction patients need to have at least one additional surgery within the first three years after getting saline
implants, and that other complication rates are also extremely high. We need to know what happens after three years,
and we need to tell breast cancer patients about these complications so that they can make an informed decision about
what would be best for them.
In addition to new studies, it would be very cost-effective for the NIH to continue
to study the breast augmentation patients in the NCI and FDA studies that I described a few minutes ago. At the time the
NCI studied the women's medical records, they had implants for at least 8 years. They have now had implants for at
least 11 years, so it is important to study what has happened - whether the cancer rates, autoimmune diseases, and death
rates of women with implants have increased or decreased in the last three years. Although I am especially concerned
about the lack of information about the long-term safety of reconstruction, I m also concerned about the thousands of
teenage girls that are getting breast implants every year. We don't know what will happen to those girls, but unfortunately
neither they nor their parents realize how little is known about long-term risks. It is time we answered that question.
And H.R. 1961 would help ensure that patients -- and teenage patients' parents -- know what the risks are well before
they decide whether or not to get implants.
In conclusion, I want to thank the Committee for holding this hearing,
and especially thank Congressman Blunt and Congressman Gene Green for their essential work on this legislation. And,
I thank the Committee members who have supported this legislation and shown respect and support for their constituents
who have courageously shared their experiences with implants. We need your continued help. If Congress doesn't require
that these important studies be conducted by NIH, it is unlikely that they ever will be. And so, we're counting on
this Committee to make sure that NIH moves forward as quickly as possible.
I hope the Committee will also undertake
a careful review of the role of the FDA regarding the lack of long-term safety data on breast implants. Breast implants
have been sold for almost 40 years, and yet the FDA has never required long-term safety data. They have not required that
patients be informed of the risks of implants. Meanwhile, more than 127,000 adverse reactions have been reported regarding
silicone gel implants and more than 65,000 for saline-filled implants - and yet the FDA has not even bothered to examine
them. As this Committee considers legislation to reform the FDA in the coming year, I urge you to include a provision
requiring long-term safety data for implanted medical devices that are already on the market. This is not like a new
medical product: women who have had implants for many years are available to be studied, and the FDA should be mandated
to do so.
I would be glad to answer any questions, and I invite staff to go to our website, http://www.center4policy.org, to read some of the medical and lay articles that we have written on the topic, and to link to FDA's consumer materials
about breast implants. Dr. Diana Zuckerman, Executive Director, National Center for Policy Research for Women and Families,
1444 I Street, N.W., Suite 900, Washington, DC, 20005
OFFERED WITHOUT COMMENT!! Pittsburgh, 11/20/01 (PRNewswire):
A new kind of silicone breast implant will be used in a clinical trial beginning at Magee-Womens Hospital that may
signal a return to silicone gel implants. The study, which is being undertaken by UPMC's division of plastic surgery,
will focus on the CoheSIL implant manufactured McGhan Medical Corp., a Santa Barbara, Calif.-based company that makes
both saline- and silicone- filled breast implants. "For a great many American women, breast reconstruction provides a
tremendous psychological, physical and emotional uplift following breast cancer surgery," said Kenneth C. Shestak,
M.D., F.A.C.S., study principal investigator and interim chairman of the division of plastic surgery at the University
of Pittsburgh School of Medicine. "And for many more, breast augmentation may lead to a more fulfilling life through better
confidence and an improved self-image."
The study is designed to examine the safety and efficacy of the new implant,
which contains a silicone gel and has a more durable casing than previous models. "Silicone has been considered by many
plastic surgeons to be a more desirable alternative to saline implants for breast augmentation and reconstruction,"
said Dr. Shestak, who is an associate professor of surgery. The CoheSIL implant is made of cohesive silicone gel and is
encased in a silicone shell that is designed to hold its shape better than the saline implants currently in wide use,
according to McGhan Medical Corp., a leading supplier of breast implants. In addition, a textured surface increases
tissue adherence to stabilize the position of each implant.
Magee-Womens Hospital is seeking to enroll at least 10
women who are considering breast reconstruction surgery and who will think about receiving the CoheSIL implants. Women
who enroll should not have undergone previous implant surgery. Study participants will be followed at specific time
intervals over a 10-year period and undergo thorough examination to determine the performance and durability of the implants.
In
the late 1980s, safety concerns prompted litigation regarding silicone breast implants, and eventually led to their withdrawal
for use in routine breast augmentation in the United States in 1992. However, links between the implants and a variety
of health problems have been disproved, according to large collaborative studies of the medical literature in the United
States and the United Kingdom. The U.S. Food and Drug Administration has designated the implants as Class III medical
devices, subject to FDA approval.
Dr. Shestak, a noted plastic surgeon who has done more than 1,000 implant procedures
during his 18-year career, said a review of virtually all studies published in peer-reviewed medical journals supports
the safety of silicone implants. Current studies also find no connection between the use of a silicone implant and
any known disease in humans. The National Academy of Sciences' Institute of Medicine (IOM) reported in 1999 that a similar
study review failed to find a basis for health concerns regarding silicone implants. "In the evaluation of epidemiological
data, the IOM report indicated that immunological diseases, cancer, neurological and other systems conditions did
not appear to be increased in women with breast implants when compared to women who did not have implants," Dr. Shestak
said.
A total of 940 patients will participate in the CoheSIL study at 47 centers nationwide, with about half enrolled
for augmentation and the remainder scheduled for reconstruction or revision surgery. The Magee study is restricted
to breast reconstruction cases. Women who are considering such breast surgery must be at least 18 years old and meet certain
other criteria to enroll in the CoheSIL trial. For more information on study requirements or to enroll, call Shane
Peters at Magee-Womens Hospital at (412) 641-4828.
Contact: Michele D. Baum, BaumMD@msx.upmc.edu, or Alan Aldinger, AldiAL@msx.upmc.edu,
+1-412-647-3555, or Fax: +1-412-624-3184, both of UPMC.
FOREIGN ISSUES: EU Issues Guidelines for Safer Breast Implants:
Brussels (Reuters) - The European Commission presented new guidelines for safer breast implants but stopped short
of calling for a ban on silicone. In a document approved on Thursday, the European Union's executive urged member states
to improve implant quality and make sure women were properly informed of the risks before undergoing surgery. ``Patients
should know the advantages and the disadvantages of implants and be given all the relevant information that allows
them to make a well informed and thoroughly considered decision,'' European Commissioner Erkki Liikanen said in a statement.
The Commission did not propose a ban on silicone implants, as women's health groups have demanded. A recent European Parliament
report said there was no clear scientific link between silicone gel breast implants and disease. Several studies to
determine whether silicone implants can be linked to cancer and other diseases have been inconclusive. However, the
parliamentary report said problems such as bleeding and ruptures did occur. Implants are made from a variety of materials,
including silicone, salt water and soybean oil. The US Food and Drug Administration banned silicone gel implants for
most women in 1992 because of safety concerns. In the 15-nation European Union, only France bans such implants. The
European Commission did not propose a minimum age requirement for breast implants but said member states could consider
recommending one.
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