January 1999
Dear Silicone Survivors and Friends:
Thanks for all the cards, letters, calls and e-mails regarding my recent
cancer scare!! So far all is normal on the biopsies. I will let you know
what happens in January when I re-do the tumor markers. I have included a
section on tumor markers in this newsletter for those who are interested in
this important topic.
UPCOMING EVENTS: Jan. 17: Judge Spector's Court will hear objections to
the Dow Bankruptcy settlement. Attorneys will bring most of these
objections for big corporations that will be affected by this settlement.
Attorneys will bring a few for claimants for Dow Corning or other
manufacturers breast implants. I expect the court to accept this proposal
as it is fairly similar to the MDL RSP that was approved for other
manufacturer's implants.
LEGAL INFORMATION: Houston: Jurors cleared prominent attorney John O'Quinn
and two associates of allegations that they improperly solicited business
from the families of those killed and injured in a 1994 USAir crash near
Charlotte, N.C. "The system works," O'Quinn declared after 12 jurors found
in favor of him and lawyers Benton Musslewhite and Carl Shaw. The three
were accused in a State Bar of Texas lawsuit of using $100,000 to find
"runners" who would in turn locate victim's families after the USAir crash
on July 2, 1994. The crash killed 37 people and injured 14. O'Quinn,
57, has earned a fortune in breast-implant lawsuits and was one of five
private attorneys who helped land the state's $17.3 billion settlement with
tobacco companies.
>From Attorney Jill Whitbeck: As to how Dow Chemical is getting out of this
without paying anything, I'll try an explanation. Dow Chemical, as did the
other manufacturers (such as Baxter, 3M and Bristol), filed a co-debtor
claim in the bankruptcy under Rule 3005 looking to Dow Corning to
contribute toward the settlements they have already, or anticipate having
to in the future, pay out. So, if Dow Chemical paid a settlement, they
would look to the bankruptcy funds to be paid back. So, in the end, the
money comes from Dow Corning anyway. That is how Dow Chemical is getting
bankruptcy protection when they are FAR from bankrupt and have not and will
not pay one cent into the bankruptcy fund. A legal technicality they have
taken to its full advantage. If the bankruptcy goes through as written
now, and you opt in to the plan rather than opting out, Dow Chemical will
be completely released from all liability and your case in Judge Hood's
court in Michigan will be dismissed. The Spitzfaden and Mahlum verdicts
(Spitzfaden has not concluded to a monetary judgment) come out of the $400
mil litigation fund set aside for those who opt-out of the bankruptcy and
pursue litigation. It remains to be seen if that portion of the plan will
remain unchanged. Also, Dow is pushing for a "common causation" trial for
all opt-outs. If they win common causation, it's all over. If they fail,
it goes on to the individual to prove their individual causation and then
damages.
MEDICAL INFORMATION: Tumor Markers: Cancer Facts: National Cancer
Institute National Institutes of Health: Tumor markers are substances that
can often be detected in higher-than-normal amounts in the blood, urine, or
body tissues of some patients with certain types of cancer. Tumor markers
are produced either by the tumor itself or by the body in response to the
presence of cancer or certain benign (noncancerous) conditions. This fact
sheet describes some tumor markers found in the blood. Measurements of
tumor marker levels can be useful--when used along with x-rays or other
tests--in the detection and diagnosis of some types of cancer. However,
measurements of tumor marker levels alone are not sufficient to diagnose
cancer for the following reasons: Tumor marker levels can be elevated in
people with benign conditions. Tumor marker levels are not elevated in
every person with cancer, especially in the early stages of the disease.
Many tumor markers are not specific to a particular type of cancer; the
level of a tumor marker can be raised by more than one type of cancer.
In addition to their role in cancer diagnosis, some tumor marker levels are
measured before treatment to help doctors plan appropriate therapy. In some
types of cancer, tumor marker levels reflect the extent (stage) of the
disease and can be useful in predicting how well the disease will respond
to treatment. Tumor marker levels may also be measured during treatment to
monitor a patient's response to treatment. A decrease or return to normal
in the level of a tumor marker may indicate that the cancer has responded
favorably to therapy. If the tumor marker level rises, it may indicate that
the cancer is growing. Finally, measurements of tumor marker levels may be
used after treatment has ended as a part of followup care to check for
recurrence. Currently, the main use of tumor markers is to assess a
cancer's response to treatment and to check for recurrence. Scientists
continue to study these uses of tumor markers as well as their potential
role in the early detection and diagnosis of cancer. The patient's doctor
can explain the role of tumor markers in detection, diagnosis, or treatment
for that person. Described below are some of the most commonly measured
tumor markers.
Prostate-Specific Antigen: Prostate-specific antigen (PSA) is present in
low concentrations in the blood of all adult males. It is produced by both
normal and abnormal prostate cells. Elevated PSA levels may be found in the
blood of men with benign prostate conditions, such as prostatitis
(inflammation of the prostate) and benign prostatic hyperplasia (BPH), or
with a malignant (cancerous) growth in the prostate. While PSA does not
allow doctors to distinguish between benign prostate conditions (which are
very common in older men) and cancer, an elevated PSA level may indicate
that other tests are necessary to determine whether cancer is present. PSA
levels have been shown to be useful in monitoring the effectiveness of
prostate cancer treatment, and in checking for recurrence after treatment
have ended. In checking for recurrence, a single test may show a mildly
elevated PSA level, which may not be a significant change. Doctors
generally look for trends, such as steadily increasing PSA levels in
multiple tests over time, rather than focusing on a single elevated result.
Researchers are studying the value of PSA in screening men for prostate
cancer (checking for the disease in men who have no symptoms). At this
time, it is not known whether using PSA to screen for prostate cancer
actually saves lives. The National Cancer Institute-supported Prostate,
Lung, Colorectal, and Ovarian Cancer Screening Trial is designed to show
whether the use of certain screening tests can reduce the number of deaths
caused by those cancers. For prostate cancer, this trial is looking at the
usefulness of regular screening using digital rectal exams and PSA level
checks in men ages 55 to 74. Researchers are also working on new ways to
increase the accuracy of PSA
tests. Improving the accuracy of PSA tests could help doctors distinguish
BPH from prostate cancer, and thereby avoid unnecessary followup
procedures, including biopsies.
Prostatic Acid Phosphatase: Prostatic acid phosphatase (PAP) is normally
present only in small amounts in the blood, but may be found at higher
levels in some patients with prostate cancer, especially if the cancer has
spread beyond the prostate. However, blood levels may also be elevated in
patients who have certain benign prostate conditions or early stage cancer.
Although PAP was originally found to be produced by the prostate, elevated
PAP levels have since been associated with testicular cancer, leukemia, and
non-Hodgkin's lymphoma, as well as noncancerous conditions such as
Gaucher's disease, Paget's disease, osteoporosis, cirrhosis of the liver,
pulmonary embolism, and hyperparathyroidism.
CA 125: CA 125 is produced by a variety of cells, but particularly by
ovarian cancer cells. Studies have shown that many women with ovarian
cancer have elevated CA 125 levels. CA 125 is used primarily in the
management of treatment for ovarian cancer. In women with ovarian cancer
being treated with chemotherapy, a falling CA 125 level generally indicates
that the cancer is responding to treatment. Increasing CA 125 levels during
or after treatment, on the other hand, may suggest that the cancer is not
responding to therapy or that some cancer cells remain in the body. Doctors
may also use CA 125 levels to monitor patients for recurrence of ovarian
cancer. Not all women with elevated CA 125 levels have ovarian cancer. CA
125 levels may also be elevated by cancers of the uterus, cervix, pancreas,
liver, colon, breast, lung, and digestive tract. Noncancerous conditions
that can cause elevated CA 125 levels include endometriosis, pelvic
inflammatory disease, peritonitis, pancreatitis, liver disease, and any
condition that inflames the pleura (the tissue that surrounds the lungs and
lines the chest cavity). Menstruation and pregnancy can also cause an
increase in CA 125.
Carcinoembryonic Antigen: Carcinoembryonic antigen (CEA) is normally found
in small amounts in the blood of most healthy people, but may become
elevated in people who have cancer or some benign conditions. The primary
use of CEA is in monitoring colorectal cancer, especially when the disease
has spread (metastasized). CEA is also used after treatment to check for
recurrence of colorectal cancer. However, a wide variety of other cancers
can produce elevated levels of this tumor marker, including melanoma;
lymphoma; and cancers of the breast, lung, pancreas, stomach, cervix,
bladder, kidney, thyroid, liver, and ovary. Elevated CEA levels can also
occur in patients with noncancerous conditions, including inflammatory
bowel disease, pancreatitis, and liver disease. Tobacco use can also
contribute to higher-than-normal levels of CEA.
Alpha-Fetoprotein: Alpha-fetoprotein (AFP) is normally produced by a
developing fetus. AFP
levels begin to decrease soon after birth and are usually undetectable in
the blood of healthy adults (except during pregnancy). An elevated level of
AFP strongly suggests the presence of either primary liver cancer or germ
cell cancer (cancer that begins in the cells that give rise to eggs or
sperm) of the ovary or testicle. Only rarely do patients with other types
of cancer (such as stomach cancer) have elevated levels of AFP.
Noncancerous conditions that can cause elevated AFP levels include benign
liver conditions, such as cirrhosis or hepatitis; ataxia telangiectasia;
Wiscott-Aldrich syndrome; and pregnancy.
Human Chorionic Gonadotropin: Human chorionic gonadotropin (HCG) is
normally produced by the placenta during pregnancy. In fact, HCG is
sometimes used as a pregnancy test because it increases early within the
first trimester. It is also used to screen for choriocarcinoma (a rare
cancer of the uterus) in women who are at high risk for the disease, and to
monitor the treatment of trophoblastic disease (a rare cancer that develops
from an abnormally fertilized egg). Elevated HCG levels may also indicate
the presence of cancers of the testis, ovary, liver, stomach, pancreas, and
lung. Pregnancy and marijuana use can also cause elevated HCG levels.
CA 19-9: Initially found in colorectal cancer patients, CA 19-9 has also
been identified in patients with pancreatic, stomach, and bile duct cancer.
Researchers have discovered that, in those who have pancreatic cancer,
higher levels of CA 19-9 tend to be associated with more advanced disease.
Noncancerous conditions that may elevate CA 19-9 levels include gallstones,
pancreatitis, cirrhosis of the liver, and cholecystitis.
CA 15-3: CA 15-3 levels are most useful in following the course of
treatment in women diagnosed with breast cancer, especially advanced breast
cancer. CA 15-3 levels are rarely elevated in women with early stage breast
cancer. Cancers of the ovary, lung, and prostate may also raise CA 15-3
levels. Elevated levels of CA 15-3 may be associated with noncancerous
conditions, such as benign breast or ovarian disease, endometriosis, pelvic
inflammatory disease, and hepatitis. Pregnancy and lactation can also cause
CA 15-3 levels to rise.
CA 27-29: Similar to the CA 15-3 antigen, CA 27-29 is found in the blood
of most breast cancer patients. CA 27-29 levels may be used in conjunction
with other procedures (such as mammograms and measurements of other tumor
marker levels) to check for recurrence in women previously treated for
stage II and stage III breast cancer. CA 27-29 levels can also be elevated
by cancers of the colon, stomach, kidney, lung, ovary, pancreas, uterus,
and liver. First trimester pregnancy, endometriosis, ovarian cysts, benign
breast disease, kidney disease, and liver disease are noncancerous
conditions that can also elevate CA 27-29 levels.
Lactate Dehydrogenase: Lactate dehydrogenase is a protein found throughout
the body. Nearly every type of cancer, as well as many other diseases, can
cause LDH levels to be elevated. Therefore, this marker cannot be used to
diagnose a particular type of cancer. LDH levels can be used to monitor
treatment of some cancers, including testicular cancer, Ewing's sarcoma,
non-Hodgkin's lymphoma, and some types of leukemia. Elevated LDH levels can
be caused by a number of noncancerous conditions, including heart failure,
hypothyroidism, anemia, and lung or liver disease.
Neuron-Specific Enolase: Neuron-specific enolase (NSE) has been detected
in patients with neuroblastoma; small cell lung cancer; Wilms' tumor;
melanoma; and cancers of the thyroid, kidney, testicle, and pancreas.
However, studies of NSE as a tumor marker have concentrated primarily on
patients with neuroblastoma and small cell lung cancer. Measurement of NSE
level in patients with these two diseases can provide information about the
extent of the disease and the patient's prognosis, as well as about the
patient's response to treatment. Cancer Information Service Toll-free:
1-800-4-CANCER (1-800-422-6237).
Stop, You're Killing Me: Health and Medical Issues in the News: The FDA
seems to suffer from chronic ills that weaken its ability to safeguard
Americans' health. (Nicholas Regush, ABCNEWS.com): The killers are
cutting off blood flow to a federal agency that's entrusted with ensuring
the safety & effectiveness of medical devices, pharmaceuticals, and other
health products and warning the public about their potential risks.
Congress is crippling the U.S. Food and Drug Administration on behalf of
powerful manufacturers who want their products rubber-stamped quickly so
they can get them to market. And when some of these highly profitable,
hastily evaluated products fail and people die, these same manufacturers
can rest assured that the FDA will move like a snail, and sometimes not at
all, to ban their further sale. Sometimes it takes ages before the FDA
even gets involved and issues warnings about a troublesome product. A
classic recent example of FDA foot-dragging were the delayed warnings, in
the face of mounting evidence, about the risky use of Viagra by people with
certain heart problems.
Thready Pulse: But since the FDA still has some twitch left, there are
occasional desperate cries from within, from employees who still care about
the Public Interest. The latest example: when the Washington-based Public
Citizen Health Research Group surveyed 19 FDA medical officers anonymously,
they identified 27 new drugs that they believed should never have been
approved. These FDA employees, who oversee drug safety
reviews, attributed the risky-drug OKs to pressure from Congress and
manufacturers to speed up the process. Only a handful of the scores of
drugs approved each year are truly life-saving, giving the lie to the
supposed need to speed up drug evaluation rather than carefully consider
potential dangers.) Naturally, the drug industry lit into the Public
Citizen survey of FDA medical officers, calling it biased, and thus
championing the FDA speed-up policies of their congressional pals whom they
help to re-elect.
Internal Divisions: One product that flew through the FDA "fast-track"
process was the diabetes drug Rezulin, now associated with at least 33
deaths in this country and Japan due to liver damage. There is strong
medical opinion that the world could have lived without Rezulin or, at
least, that its prescription should have been restricted to a
small number of special cases. But due to promotional efforts by medical
"product champions," more than 1 million Americans now take Rezulin. This
week, in a two-part series, The Los Angeles Times reported that FDA senior
officials dismissed the concerns of a medical reviewer who warned of strong
evidence that Rezulin could cause liver damage and opposed its approval.
The FDA took the reviewer off the case. Why am I not surprised? Disputes
between product reviewers and senior officials at the FDA are really old
news. This agency, which bills itself as the best of its kind in the world,
actually has a dubious track record. A number of government oversight
reports have blasted the agency for miserably failing to do its job of
protecting consumers.
Decline and Fall: In 1991, for example, a 15-member panel headed by
Charles Edwards, president of Scripps Clinic and Research Foundation and a
former FDA commissioner, concluded that the FDA's problems were so severe
that they posed a threat to Americans' health. The panel said the FDA
needed stronger enforcement powers, better management, better-trained
employees, more funds, improved laboratory equipment and more authority in
government. During 12 years of Reagan and Bush, the FDA had the stuffing
knocked out of it. Since the late 1970s, seizures, injunctions and
prosecutions by the agency have slowed to a trickle. Its reputation was
further tarnished in 1989 when some of its drug reviewers were found to
have taken bribes. By the time Dr. David Kessler settled into running the
FDA, senior managers didn't even have proper records of proposed
regulations: some 400, ranging from the size of type on drug packages to
standards for fibrilators, had never been acted on. And a 1992
congressional hearing produced evidence that medical- device reviewers were
often undercut or ignored when they failed to recommend approval of a
product, because some managers viewed non-approvals as jeopardizing their
goal, a high approval rate.
Kessler the (Anti) Hero: For much of his reign, Kessler was viewed as an
American hero. Carefully orchestrated FDA media campaigns set in motion
several crusades, targeting food safety violations, improper drug
advertising, breast implants and tobacco. This did give some new life to
the FDA, raising morale and self-confidence half a notch in dealing with
certain sectors of industry, which had grown accustomed to having a freer
hand. With the help of key members of Congress, however, industry fought
back, arguing that the FDA was, in effect, killing people by moving slowly
on the evaluation of drugs and medical devices. This was, and still is,
pure bull, but the media and the public bought it and so did numerous
organizations of patients with life-threatening diseases, which, in some
cases, are funded by drug manufacturers. Now that Kessler is gone to the
Ivory Tower (Yale Medical School) and the White House feeds on its
political victory on tobacco and ignores a dying FDA, the agency is in the
doldrums, and some of its better employees are looking
elsewhere for jobs. The FDA has a new commissioner, Dr. Jane Henney, but
she's not likely to fight the big boys and girls on the Hill. At this rate,
the FDA will soon become a corpse. (Nicholas Regush produces medical
features for ABCNEWS. In his weekly column, published Wednesdays, he looks
at medical trouble spots, heralds innovative achievements and analyzes
health trends that may greatly influence our lives.)
Washington, DC: Many Food and Drug Administration (FDA) medical officers
say the safety and efficacy standards for approving new drugs have been
lowered in the past few years, allowing many drugs to be approved which
should not have been, according to a Public Citizen's Health Research Group
study released today. The study, FDA Medical Officers Report Lower
Standards Permit Dangerous Drug Approvals, surveyed FDA medical officers,
physicians responsible for the primary reviews of New Drug Applications for
drugs, to determine their opinions about recent changes in the drug
approval process. "Our findings are shocking by any yardstick," said
Dr. Sidney M. Wolfe, Director of Public Citizen's Health Research Group and
co-author of the study. "Subtle and not-so-subtle pressure is being brought
to bear on FDA physicians who dare to question a drug's safety. Sometimes
their safety objections are simply ignored or overruled." Nineteen medical
officers identified 27 new drugs that they reviewed in the past three years
and thought should not be approved but were approved anyway. 17 medical
officers described the current standards of FDA review for safety and
efficacy as "lower" or "much lower" compared to those in existence prior to
1995.
The study, conducted in September and October 1998, followed the setting of
two all-time FDA records. First, the largest number of new drugs was
approved in any two-year period (92 in 1996 and 1997). Second, a record
three new prescription drugs (all among the record-setting 92) were banned
in a 12-month period because they were too dangerous to be allowed to stay
on the market. For all three: dexfenfluramine (Redux), mibefradil (Posicor)
and bromfenac (Duract), data available prior to approval raised
significant safety concerns and the drugs did not represent any significant
advances over drugs already on the market. In the study released today,
eight medical officers reported 14 instances in the past three years in
which they had been instructed,
usually by the Office Director, not to present their own opinion or data to
an FDA Advisory Committee when to do so might have reduced the likelihood
that a drug would be approved.
"These findings from FDA's own reviewing physicians provide an alarming
insight into the recent change in culture at the FDA, a change
seriously jeopardizing the health of American patients by allowing drugs
which would likely have been rejected in the past to get approved despite
doubts about their safety or effectiveness," said Dr. Peter Lurie,
co-author of the report. The study quotes the disturbing words of one
medical officer who said: "In the last two years, I recommended that two
drugs not be approved. They were both approved without consulting me. This
never happened before. In one case, the drug did not meet the standards set
up by the division, so they nullified the standards." In another case, a
medical officer wrote that a high-ranking FDA official had said,
"Everything is approvable. We can use the label creatively to lower the
problems." The study also found that: Twelve medical officers identified
25 different new drugs that they reviewed in the past three years that in
their opinion had been approved too fast. Nineteen medical officers stated
that the pressure on them to approve a greater proportion of new drugs was
"somewhat greater" or "much greater" compared to the period prior to 1995.
The sources of this pressure were identified as the Office Director, Center
Office, the pharmaceutical industry, the Congress and the medical officers'
own Division Directors. "For FDA officials to ignore this information from
its own medical officers is to continue on the current perilous course in
which far too many me-too drugs are approved, despite questions about their
safety or efficacy, only to be banned after enough people are injured or
killed," Wolfe and Lurie concluded. (Comment: I recommend that, unless the
situation is life threatening, we only take drugs that have been out on the
market for at least 5 years. That way, we will not take the risks shown by
new drugs approved too hastily by the FDA!)
Delaware, Ohio, Dec. 3 (PRNewswire): The successful clinical trial of a
breakthrough therapy for the often-fatal disease scleroderma has just been
published in the leading British medical journal, "The Lancet." Performed
at Harvard Medical School and sponsored by The Road Back Foundation and the
National Institutes of Health, the study examined the effects of
Minocycline on 11 patients suffering from this rare but increasingly common
disease. Written by Drs. Christine Le, Alejandro Morales and David
Trentham, the Lancet article reports that nine patients improved
substantially and two-thirds of those completing the study were in full
remission -- free of all disease activity.
A painful, disfiguring disease, scleroderma afflicts some 400,000
Americans. In its diffuse form, it often attacks the lungs, heart,
kidneys, and liver. It also thickens the skin, causing pain and crippling
disfigurement. Until now, the disease has been regarded by most physicians
as untreatable, with two thirds of its victims dying within ten years of
onset. "Those who finished a year of treatment had clear-cut, demonstrable
evidence of improvement," said Dr. David Trentham of Boston's Beth Israel
Deaconess Hospital. "We were pleasantly surprised by the results of this
safe and highly, highly effective treatment for a disease that previously
offered little hope."
"No therapy has ever promised the kind of results reported by these Harvard
physicians," said Pat Ganger, president of The Road Back Foundation, an
international organization founded to sponsor scleroderma research and
education. "Until publication in this prestigious peer review journal,
patients and doctors have relied upon anecdotal evidence that this safe,
simple therapy can remit and reverse scleroderma." One of the earliest
examples of such evidence was Ganger's own case history: she is a recovered
diffuse scleroderma patient who credits antibiotic therapy with saving her
life. Scleroderma joins a growing family of rheumatic diseases proven to
respond favorably to antibiotic therapy. Minocycline has been pronounced
"safe and effective" in the treatment of rheumatoid arthritis, with the
majority of patients reporting substantial improvement and remission rates
as high as one in three. The results of the Road Back Foundation's study
are also reported in two books by Henry Scammell, "Scleroderma: The Proven
Therapy That Can Save Your Life" and "The New Arthritis Breakthrough"
published by M. Evans, New York, 1998.
12/8/98 Hollywood, FL: A 62-year-old woman is accused of disfiguring at
least four women by giving them injections designed to erase their
wrinkles. Former Hollywood cosmetologist Louissa Gustafson is charged with
practicing medicine WITHOUT a license, grand theft, fraud and battery. Four
women complained after developing cysts and other disfiguring facial
features. They say Gustafson claimed to be a doctor when she injected them
with silicone, collagen and other products to treat wrinkles. Investigators
say she performed the procedures in her home and charged up to four
thousand dollars per patient.
Chicago: Panel Questions Safety of Studies: People in medical studies are
inadequately protected from risks, with hazards often poorly explained and
scientists often snared in conflicts of interest, a panel of experts says.
Federal regulations designed to ensure human subjects' safety are outdated
and limited in reach, the panel said in Wednesday's edition of The Journal
of the American Medical Association. Further, the review boards at medical
centers whose job it is to oversee human safety in studies are often
under-trained, overburdened and swamped with paperwork, according to the
panel from the Center for Bioethics at the University of Pennsylvania
Health System.
"The current system is straining and in danger of falling apart," said
Arthur L. Caplan, a co-author and director of the center. "It costs too
much, is too bureaucratic and doesn't give the kind of protection to
subjects that people have a right to expect." Caplan said the first step
should be to gather data on what happens to research subjects and on how
review boards do their work of overseeing patient safety, Caplan said.
Then, steps need to be taken, including possible federal legislation, to
streamline the system under which research is conducted and to strengthen
the rules that govern it, Caplan and his colleagues wrote. Currently, the
only regulations are the ones developed 17 years ago by the Department of
Health and Human Services and the Food and Drug Administration and they
only apply to government-funded research. "If you're privately funded, you
can ignore all those rules and that's a major problem," Caplan said.
Medical centers increasingly get funding from drug companies and other
for-profit entities rather than the federal government, the ethicists
wrote. Concerns have mounted that researchers may be paid by the number of
subjects they enroll, which gives them an incentive to put the sponsor's
interest ahead of the subjects' interests, they said.
Also, the forms used to obtain subjects' consent to be studied have "become
vehicles for reducing legal liability for researchers and institutions,
rather than empowering subjects to make good choices about being in
research," Caplan said. "They're also too long, too technical, and most
importantly too abstract," he said. "If no one reads it, or if there's no
intent to talk to subjects about what really happens in research, there's a
problem." He said people who serve on institutional review boards need to
get out of board rooms and talk with study subjects, a goal that their
heavy bureaucratic workloads may currently make impossible.
Radiologic Study of Breast Implants Disputes That Silicone "Gel Bleed" Is
Normal; Finds Some Polyurethane-coated Implants May Be More Likely to
Rupture: Chicago (11/30/95): Silicone gel on the surface of a breast
implant points to implant rupture, and some implants coated with
polyurethane are more likely to rupture than similar uncoated implants,
according to studies presented during the 81st Scientific Assembly and
Annual Meeting of the Radiological Society of North America (RSNA). "It
should be noted that, in our opinion, silicone 'oil bleed' on the surface
of an implant is normal, as opposed to silicone 'gel bleed,' which is not,"
said Michael S. Middleton, PhD, MD, assistant clinical professor of
radiology, University of California, San Diego. "It should also be noted at
this stage that our findings are based upon our observations of patients
presenting for magnetic resonance [MR] breast implant evaluation at our
institution." The studies also offered guidelines for improving the
accuracy of MR imaging of breast implants. "There are medical, surgical and
legal consequences of diagnosing whether or not a breast implant has
failed," said Dr. Middleton. "Our role as radiologists is to approach the
problem objectively and describe as accurately as possible the status of an
implant. The patient and her physician can then have information about the
implants that may be useful in deciding whether they should be removed."
In a series of papers and scientific exhibits documenting nearly four years
of research, Dr. Middleton presented the results of MR imaging and a review
of medical records of nearly 1,200 patients. In 155 operations that were
attended personally by Dr. Middleton, preoperative MR findings for
single-lumen silicone gel-filled implants were compared with findings after
surgical removal of the implants. A single-lumen implant has one cavity
enclosed by a single shell.
Silicone Gel Bleed: "Often, implants are called 'normal' when silicone gel
is seen on the surface of the implant, and that gel is referred to as
'bleed'," Dr. Middleton said. "In our experience, silicone gel on the
surface of an implant is a sign that silicone gel has migrated through a
hole or tear in the shell, and therefore that the implant has ruptured."
Dr. Middleton noted that it is normal for silicone oil to bleed through an
intact implant shell. However, silicone oil is a thin, non-sticky lubricant
that can usually be distinguished from silicone gel at surgical removal.
The researchers examined 303 single-lumen silicone gel-filled breast
implants that had been surgically removed with Dr. Middleton in attendance,
and compared the observations at surgery to the preoperative MR findings.
Among the 107 implants that were determined as ruptured at MR imaging on
the basis of the presence of silicone gel outside the implant shell,
silicone gel outside the implant shell was observed at surgery in 103
cases. Of those, 53 were diagnosed as 'uncollapsed rupture' with MR
imaging. In 26 of the 53 cases, a hole or tear in the shell was reliably
observed through which silicone gel could be seen to extrude. In the
remaining cases, the possibility that an existing shell defect was
exacerbated by the physicians who removed or examined the implants could
not be excluded. "In many cases, silicone gel on the surface of an implant
is called 'gel bleed' as opposed to rupture," Dr. Middleton said. "However,
on the basis of our observations, when we see silicone gel on the surface
of an implant, we conclude that it is most likely to be in a state of
uncollapsed rupture."
"There is also some dispute about the meaning of the term 'implant
rupture'," Dr. Middleton said. "Sometimes an implant will not be called
ruptured unless it is empty of most or nearly all of the gel it originally
contained. We have observed, however, that implants can be in a state of
uncollapsed rupture in which they are not yet empty of their silicone gel.
Most silicone gel has a very heavy consistency, and it often does not
easily flow out of a broken implant. In our experience, these cases of
uncollapsed rupture are more common than cases of collapsed rupture. "To
call a ruptured but uncollapsed implant 'gel bleed' may be a disservice to
the patient," he said. "She may want to know before surgery whether or not
the implant has ruptured to help her decide whether or not she wants it
removed, and calling uncollapsed rupture 'gel bleed' may deny her that
information."
Experience with Polyurethane-coated Implants: The researchers also observed
that some polyurethane-covered gel-filled implants manufactured after about
1981 ruptured at a greater rate than similar uncoated implants in patients
presenting to their institution for breast implant evaluation with MR
imaging. MR imaging was performed in 775 patients with 1,503 single-lumen
silicone gel-filled implants, including 179 coated with polyurethane and
1,324 that were not coated. MR imaging diagnosis was considered reliable
for 168 of the coated implants and 1,217 of the uncoated implants. An
implant was classified as ruptured when silicone gel was detectable outside
the implant shell on MR images. "The rupture rate for
non-polyurethane-coated implants that had been implanted for between 10 and
12 years was 31%, compared to 91% for polyurethane-coated implants of the
same age," Dr. Middleton said.
"We cannot yet say whether our observations are applicable to all breast
implant patients," Dr. Middleton said. "The rates we are observing are
probably higher than for the general population of implant patients, since
our patients are pre-selected for having suspected problems. Nonetheless,
our data suggest that, in general, some polyurethane-coated implants may be
more likely to rupture over time than are non-polyurethane-coated
implants." He noted that MR studies in which the diagnosis is positive for
rupture are accurate 99% of the time, with use of current techniques at his
institution.
Improving Diagnosis of Implant Failure: Some pitfalls in diagnosis
described by Dr. Middleton: * Not knowing the type of implant being imaged.
"The appearance of an implant on MR and the determination of whether or not
it is intact can vary depending on the type of implant," he said. "For
example, normal single-lumen implants can look on MR exactly like
double-lumen implants with the saline gone from their outer lumen.
Sometimes double-lumen implants in which the gel from the inner lumen has
entered the outer lumen--but the gel is still inside the implant as a
whole--can look exactly like a single-lumen implant that has ruptured. We
have seen a normal triple-lumen implant called ruptured because it was
mistakenly thought to be a single-lumen implant." A triple-lumen implant is
one in which there is an inner and a middle gel-filled lumen, as well as an
outer saline-filled lumen. Dr. Middleton and his co-investigators have
identified 247 different styles of breast implants that have been
distributed by the various manufacturers over the past 35 years, which they
believe constitute most of the implants that have been available. "We have
often found it important to obtain the original medical record and to
understand the nature of the implant so as to properly interpret the MR
findings," he said.
"Mistaking an under-filled implant with one that has ruptured. "Some
implants are intentionally under-filled with less silicone gel than usual
to make them softer," Dr. Middleton said. "Compared to more fully filled
implants, under-filled implants often have more internal lines seen on MR
images, which represent in-folding of the implant shell. We have seen cases
when these abundant internal lines have been mistakenly interpreted as a
sign of implant rupture. This normal appearance of under-filled implants
should not be confused with a particular pattern of wavy internal lines,
sometimes dubbed the 'linguini sign' that indicates reliably than an
implant has ruptured and has been mostly emptied of its gel." "Failure to
distinguish soft-tissue silicone from other normal and abnormal breast
findings. "Conditions and/or water-like structures such as inflammation,
hematoma, blood vessels, or breast cysts or masses can mimic the appearance
of silicone that has traveled outside the implant and into soft tissues,"
Dr. Middleton said. "We perform most of our MR imaging with a technique
called 'water suppression' so that silicone appears bright against a dark
background. If the water suppression technique fails, which sometimes
happens, a 'silicone suppression' sequence often is useful. True
soft-tissue silicone should appear bright on water-suppression images and
dark or nearly the same as surrounding tissues on silicone-suppression
images. Any other appearance indicates that the suspected abnormality may
not represent silicone."
"Breast implant rupture may also be diagnosed using ultrasound," Dr.
Middleton said. "Ultrasound is a reliable technique to diagnose collapsed
implant rupture, but uncollapsed rupture can be difficult to detect using
that technique. At this time, considering all factors, it is our opinion
that magnetic resonance imaging performed with adequate equipment and
technique is the best way to diagnose breast implants non-invasively, but
ultrasound in experienced hands can also be very good. However, ultrasound
is very operator dependent, and the learning curve for accurate diagnosis
with acceptable sensitivity is probably long compared to MR." The
co-author of the papers and scientific exhibits is Michael P. McNamara,
Jr., MD.
Washington: (AP): Business and insurance groups are furious over proposed
Clinton administration rules that would force them to make quicker
decisions about paying for care and make it easier for unhappy patients to
take cases to court. It's another dispute in the debate over how much
control the government should exert over HMO's. Because Congress this year
considered but did not pass legislation that would regulate managed care,
the Clinton administration says it is doing its best to institute changes
on its own. President Clinton and congressional Democrats have said HMO
legislation will be at the top of their priority lists next year.
New York, Dec. 14 (Bloomberg): The cancer drug cyclophosphamide appears to
have substantial benefits for patients with autoimmune disorders like lupus
and rheumatoid arthritis, which were previously considered untreatable.
Researchers from Johns Hopkins Oncology Center gave high doses of the drug
to eight patients with autoimmune disorders, which cause the body's immune
system to attack its own tissues and organs. Although none of the patients
responded to previous treatments, five went into complete remission and two
had partial remission using cyclophosphamide, the study found. Four
patients remain disease-free after a year, while another two continued to
improve after 12 months of therapy. All were able to reduce their drug
levels, with three stopping therapy altogether. The study appears in the
December Issue of Annals of Internal Medicine.
New York-based Bristol-Myers sells cyclophosphamide under the brand name
Cytoxan, while many others sell inexpensive generic versions. It is
considered part of the standard chemotherapy treatment for cancer patients.
While other researchers are studying use of the drug plus bone marrow or
stem cell transplants in patients with autoimmune diseases, this study
shows the transplants may not be necessary, the researchers said. Indeed,
the transplants hold risks of their own, which can be avoided, they said.
Dr. Richard Jones, associate professor of oncology and director of Bone
Marrow Transplantation at Johns Hopkins, compared drug therapy with
cyclophosphamide to rebooting a computer. The immune system of patients
with autoimmune diseases has been taught faulty information, to attack its
own tissue.
SCARY INFORMATION: Functional siloxanes for antiperspirant applications:
Silicones have been used in personal care products since the 1950s, and in
antiperspirants and some deodorants since the mid-1970s. In general, the
term "silicone" has been associated with raw materials whose molecular
structure includes Si-O-Si backbone, in the personal care industry,
cyclomethicone and dimethicone immediately come to mind. In today's
performance-focused personal care marketplace, "functional siloxane" may be
a more appropriate term for this family of materials. The name carries a
dual meaning, based on structure as well as performance: when methyl,
alkyl, phenyl, polyether or other functional groups are attached to the
siloxy backbone, they in turn ascribe specific performance functions to the
resulting materials.
The greatest volume use of functional siloxanes in the personal care
industry has been as carriers for active ingredients in antiperspirant
sticks; in fact, cyclomethicone is responsible for the birth and rapid
growth of this product form. In other antiperspirant and deodorant
applications, functional siloxanes have served as lubricants and aesthetics
enhancers. In the past few years, silicone use in the antiperspirant and
deodorant segment has increasingly focused on high-tech functionality, with
silicones acting as emulsifiers, residue reducers and rheology enhancers.
Although still crucial to overall product aesthetics, the more traditional
silicone role of "feel-good" additive has recently been overshadowed by
silicones acting as high-performance ingredients. Major functional
siloxanes for underarm applications include: Cyclomethicone, the generic
name for a cyclic version of polydimethylsiloxane, is available in several
forms, depending on the number of dimethyl siloxy ([CH.sub.2]-SiO) groups
in the material's ring structure. The most common forms are based on 4, 5,
and 6 dimethyl siloxy groups. With larger ring size, the material becomes
less volatile and more perceivable on the skin, and it has a lower freezing
point. This class of compounds has the distinct advantage of 100 percent
evaporation on the skin (no residue remains) and low heat of evaporation
(which provides a non-cooling effect). Cyclomethicones are used in all
antiperspirant delivery systems except clear antiperspirant sticks, and
they have found limited use in deodorant products. Use levels range from 10
% for aesthetic effects to 70 % when cyclomethicone is used as a carrier
for active ingredients in stick products. Cyclomethicone based on six
dimethyl siloxy units is growing in popularity because it has a high vapor
pressure and is less volatile, characteristics that are advantageous for
soft solid product forms.
Dimethicone: This class of functional siloxanes is based on linear dimethyl
siloxy chains ranging from as few as two to more than 1,500 repeating
dimethyl siloxy groups. As molecular weight increases, the silicone
increases in viscosity and can be perceived more easily on the skin.
Dimethicones are used primarily to minimize the effects of residue from
antiperspirant actives, to lubricate valves and extrusion mechanisms, and
to reduce tackiness and enhance aesthetics. The most commonly used
varieties are those with viscosity ranges between 0.65 and approximately
1,000 cSt.
Dimethiconol: These materials are based on linear dimethyl siloxy chains
with molecular weights greater than 500,000. Although these functional
siloxanes are still classified as fluids, they are extremely viscous.
Because they can be difficult to handle in their neat form, they are
available as blends in other functional siloxanes (e.g., cyclomethicone or
dimethicone). Very low use levels are required in formulations, where they
provide a smooth, silky, lubricating feel. These silicones also serve as
de-misting agents for aerosol applications. A new use for these
high-viscosity siloxanes is to add bodying (viscosity) effects to
water-in-cyclomethicone emulsions. Less than 1 % dimethiconol is required
to achieve this effect.
Silicone Formulation Aids: These unique water-in-cyclomethicone and
water-in-oil emulsifiers(1) are the result of polyether substitutions on
the basic dimethyl siloxy chain. The flexibility of the siloxane backbone
and its low surface tension allow for near-zero interfacial tension between
the two phases, without the need for high shear or temperature. Use levels
are typically below 1 percent and can approach 0.3 %. New products using
this technology include clear, extrudable gels that contain as much as 80
percent water in the internal phase. Carter Wallace began this trend more
than 15 years ago with Glide-On[R], and Gillette entered the market in the
early 1990s with its Gillette Series[R]. Today, most marketers in the U.S.
offer at least one SKU in this product form.
Phenyltrimethicone: This class of functional siloxanes is based on the
addition of a phenyl
group to a low-molecular-weight siloxy molecule. Benefits include increased
organic compatibility, high refractive index and elegant skin feel. The
high refractive index of the material allows easier matching with the
refractive index of the antiperspirant actives, thus minimizing their
whitening effect, thus minimizing their whitening effect upon drying of the
cyclomethicone carrier. Recommended use levels for phenyltrimethicones are
between 5% and 10%.
Alkylmethylsiloxane: This new technology is based on the replacement of a
methyl group on the siloxy molecule with a larger alkyl group, ranging from
[C.sub.6] to as high as [C.sub.45]. The higher the alkyl chain length, and
the greater the alkyl-to-silicone ratio, the higher the melting point of
the material. As example, [C.sub.30-45] [alkylmethicone.sup.2] has evolved
as a key additive in antiperspirant soft solids and sticks to enhance
viscosity without the waxy, draggy feel typically associated with organic
materials. Recommended use levels are between 1% and 10%. A new market
entry that incorporates this technology is Elida Faberge's Ultra Dry Sure
Cream. Use of this class of functional siloxane is expected to expand
significantly in the antiperspirant and deodorant market segment. (1) Dow
Corning[R] 3225C Formulation Aid and Dow Corning[R] 5200 Formulation Aid
(2) (2) Dow Corning[R] AMS-C30 Wax (I recommend reading all ingredients on
cosmetics and purchasing them at a health food store.)
ALTERNATIVE MEDICINE: NY, 12/23/98 (Reuters): Canadian scientists have
detected environmental pollutants known as aromatic amines, chemicals known
to cause breast cancer in rats, in human breast milk, according to a report
in the American Chemical Society's journal Chemical Research in Toxicology.
But the researchers say that the nutritional benefits of breast milk
continue to outweigh the risks. The pollutants were found in milk samples
from 31 nursing mothers who live in Ontario. Aromatic amines (AAs) are
used in manufacturing plastics, such as polyurethane foams, dyes,
pesticides and pharmaceuticals, according to the scientists. Environmental
sources of these chemicals include industrial waste, air and water
pollution, tobacco smoke, and diet. Surprisingly, however, among the
mothers whose breast milk was sampled, the levels of AAs did not vary
between smokers and nonsmokers. "Chronic exposure of the general population
to AAs is a matter of public health importance," write the authors. "The
presence of AAs in human milk implies that breast ductal epithelial cells,
the target of mammary carcinogens, are also exposed."
But in a statement, researcher P. David Josephy said, "Our results should
in no way be taken to discourage breastfeeding, which has great health
benefits for babies regardless of these trace contaminants." Because
hormonal and genetic risk factors account for less than half of breast
cancer cases, many scientists suspect that environmental chemical exposures
may be implicated. The researchers hope to enlarge their research to
include women in other geographical areas. SOURCE: Chemical Research in
Toxicology December 21, 1998.
Rheumatoid Arthritis Sufferers: More than two million people, mostly women,
suffer from rheumatoid arthritis. It's caused by chronic inflammation
around the joints and results in pain, swelling and stiffness. There is
currently no cure for the disease, but doctors in Texas say an ancient
Chinese herb may help treat the disease. Billie Fricke has known the pain
of rheumatoid arthritis for more than 20 years. On some days, even simple
movements hurt. "It's difficult to pick up a full glass of water," says
Billie. She's tried every type of remedy, even taking shots of gold for
five years, but nothing gave her relief from the daily pain. "Some things
worked for a little while," she says. Her doctor, Peter Lipsky, is part of
a team at the University of Texas Southwestern studying the effects of an
ancient Chinese remedy called Thunder God Vine. "When you have an
inflammatory response, your body mounts a response to what it perceives as
a threat," says Dr. Lipsky. "Basically the Chinese herbal remedy is
precisely a roadblock to inflammation." Dr. Lipsky says one of the
benefits to Thunder God Vine is it targets only the area of inflammation
and has very few side effects. "It has a very precise molecular target,
which we've been able to identify and which has convinced us that this is
an important new approach to therapy," he says. Billie has been taking the
drug for just over three months, and it didn't take long for her to believe
in the ancient remedy. "When I first got on it, I immediately started
feeling better. I don't mean my joints all stopped hurting or anything. I
just mean I felt better," says Billie.
Doctors are currently recruiting test subjects who have rheumatoid
arthritis and who have had no success with other treatments. The trials
are taking place only at the University of Texas Southwestern in Dallas.
Participants in the study must be in Dallas for the six months they're
involved in it. To find out if you qualify to take part in the study, call
(214) 648-3466. If you would like more information, please contact: UT
Southwestern Medical Center, 5323 Harry Hines Blvd., Dallas, TX 75235-8577.
(214) 648-3466
IMPORTANT: Another Too Good To Be True???!!!: Breast Enhancement Tablet
Makes Unusual Christmas Gift; Sales for All-Natural Product Almost Double
During Holiday Season. BUSTING OUT ERDIC Founder and President of Busting
Out, De'Naie Walker, 29, has made Erdic (an all-natural, European breast
enhancement tablet) available in the United States exclusively through her
Dallas-area based company and its licensed distributors. Call Busting Out,
Inc. (888) 528-7868
(AP) Dallas, TX. Nov. 19 (PRNewswire): With the gift giving season in full
swing, sales for an all-natural, European breast enhancement tablet used to
develop firmer, fuller breasts have increased over 40 percent, according to
figures calculated by Busting Out, Inc., the company which distributes
Erdic in the United States. Men are buying Erdic in record numbers as a
thoughtful and personal gift for their significant other. (Better than
implants, if it works!!)
FDA STATS: From 1985 until September 10, 1998, FDA received 127,500
adverse reaction reports for silicone gel-filled breast implants. During
the same time period, there have been 49,661 adverse reaction reports for
saline-filled implants. (There may be some duplicate reports.) The greater
number of reports for silicone gel-filled implants does not necessarily
mean that there are more problems with this type of implant but may reflect
that more women received silicone gel-filled implants than saline-filled
implants.
Is it true that FDA has received reports of deaths associated with breast
implants? What does this mean? As of September 10, 1998, FDA had received
118 reports of deaths allegedly related to breast implants. The reports are
not confirmed by autopsy and they do not show that breast implants
necessarily caused the deaths. In fact, in some cases, the actual cause of
death wasn't specified. So it would actually be more accurate to say that
FDA has received reports of women who died
and also had breast implants. For those reports that specified the cause
of death, what did the women die from? A few of the reports related the
cause of death to the surgical procedure for implants. This included
problems with anesthesia during surgery, or deaths from surgical
complications such as hemorrhage or infection. The reports did not show
that the implants themselves caused the reported deaths. What about cases
of cancer or immune-related disorders like rheumatoid arthritis and
scleroderma? There were a few reports of women dying of the complications
of diseases such as these, but since these illnesses occur in people with
and without the implants, there is no evidence that the implant actually
caused the illnesses or the deaths. According to the scientific studies
done so far, women do not have a significantly greater risk of illness,
including scleroderma, rheumatoid arthritis and cancer, or death if they
have breast implants. (Surgery has its own risks, but that is a separate
issue.)
If the reports of problems are not verified, what good are they? FDA's
database of adverse reports is most useful as an early warning system when
the hazards of a device are previously unknown. FDA also uses the database
of adverse events to follow trends and look for signals that further
follow-up could be needed. If I experience a problem, should I report it?
If you believe that you have experienced a serious problem(s) related to
your breast implants, you should have your health professional report the
problem(s) to the FDA. We encourage consumers to report their adverse
events through their health professionals. Although reporting by physicians
or other health professionals is preferred, women may also report any
serious problem directly through the MedWatch voluntary reporting system.
(If you are participating in a study, you should be reporting problems to
your doctor so that information will be included in the study. However, if
you wish, you may also report a serious problem directly to MedWatch.
Please specify that the problem occurred while participating in an adjunct
study so that your report can be included in the appropriate database.) If
you want to report a problem directly to MedWatch, send a (SASE) Self-
Addressed Stamped Envelope to Lynda at the COSS address at top of
newsletter for a form.
If you are reporting a serious problem with a breast implant or implants to
MedWatch directly, include the following information: the event
or problem, described in detail; the manufacturer, model and
brand name of the implant; whether it is silicone or saline filled; the
year implanted and (if this applies) the year removed; position and size of
the implant; the reason implanted and the reason for removal (if this
applies); diagnosis by your physician (please include only information
confirmed by a physician's diagnosis); names of implanting and
diagnosing physicians; whether silicone has migrated, and if so, where and
how this has been confirmed; number of surgeries, etc.
You may attach records or other supporting material to the completed
MedWatch form if you think it will be helpful to FDA. Every voluntary
report is read individually and reviewed by a health professional at FDA,
who sends the reporter an acknowledgment letter. FDA will not contact you
again unless we need additional information. The report is analyzed, coded,
and is used to assist FDA in taking regulatory actions. FDA will follow up
on unusual adverse events. The data are evaluated for trends every few
months, and used to compile information for studies of adverse events with
breast implants.
THIS MONTH'S POEM:
Computer Disaster
By Lynda Roth
'Tis the week after Christmas
My house is a wreck
Computer parts are all scattered
Oh, what the heck!!
The newsletter is late
Because the computer broke
Costing $200
This is no joke!!
Burned up the hard drive
Working so hard!
It's replaced now
But I'm on my guard!
1999 will be better
That's all I can say
The computer is fixed, and the
Newsletter on its way!
AMEN!!
THE OPINIONS EXPRESSED IN THIS NEWSLETTER ARE THOSE OF THE EDITOR AND ANY
CONTRIBUTORS AND ARE NOT TO BE CONSTRUED AS MEDICAL OR LEGAL ADVICE. ANY
ARTICLES OR INFORMATION SUBMITTED MAY BE EDITED BECAUSE OF SPACE, CONTENT
OR GRAMMATICAL ERRORS.
LYNDA ROTH, EDITOR
PREVIOUS NEWSLETTER INFORMATION: Previous issues of newsletters available:
$2 each U.S., $3 Foreign. 1/93 is the first available issue. Please
indicate months' desired and proper sums. Some covered subjects:
Autoimmune 1/93; Fibromyalgia 2/93; Medical Testing 3/93; Sjogren's 4/93;
Vasculitis 4/93; Arthritis 5/93; Chronic Fatigue 6/93; Lupus 7/93;
Irritable Bowel Syndrome & Inflammatory Bowel Disease 8/93; Insurance 8/93,
9/93; Misc. Med. Info. 9/93; Multiple Sclerosis 10/93; Spasmodic
Torticollis 10/93; Hypoglycemia 11/93; Antibodies 12/93; Reflex Sympathetic
Dystrophy 1/94; Misc. Med. Info. II 2/94; Scleroderma 3/94; Costochondritis
4/94; Peripheral Neuropathy 4/94; Class Action 5/94; Fungal Infections
6/94; Hypercalcemia (low calcium) 7/94; Raynaud's Phenomenon 8/94;
Fibromyalgia Update 9/94; Sarcoidosis 10/94; Free Radicals 11/94; Porphyria
12/94; Interstitial Cystitis 1/95; Mixed Connective Tissue Disease 2/95;
Flap Procedures 3/95; Misc. Med. Info. 4/95; Thyroid Disease 5/95; Stress
6/95; Natural Healing 7/95; Adrenal Malfunctions 8/95; Multiple Myeloma
9/95; DHEA 10/95; Chelation Therapy 11/95; Sleep Disorders 12/95; Meniere's
Disease 1/96; 33 Tips to Improve Your Health 2/96; Amino Acids 3/96;
Enzymes 4/96; Minerals 5/96; Aluminum Toxicity, DHEA Update 6/96;
Addictions & Food Sensitivities 7/96; Misc. Med. Info. IV 8/96; Misc. Med.
Info. V 9/96; Misc. Med. Info. VI 10/96; Misc. Med. Info. VII 11/96;
Transcient Ischemic Attacks 12/96; Symptoms of Breast Implant Problems
1/97; Pap Tests 2/97; Parasitic Infections 3/97; B-Complex Deficiency
Syndrome 4/97; Myofascial Pain Syndrome 5/97; Inositol 6/97; Misc. Med.
Info. VIII 7/97; High Blood Pressure 8/97; Plaquenil 9/97; Misc. Med. Info.
IX 10/97; Misc. Med. Info. X 11/97; Gastroesophageal or acid reflux 12/97;
Smoking Dangers 1/98; Misc. Med. XI 2/98; Multiple Chemical Sensitivities
3/98; Misc. Med. XII 4/98; Misc. Med. XIII 5/98; Baylor Studies 6/98;
Hyperbaric Oxygen 7/98; IOM Summaries 8/98; CFS 9/98; Trace Metal
Toxicology 10/98; Restless Leg Syndrome, Tamoxifen 11/98; Letting Go With
Love 12/98; Legal info. and info. on Alternative Medicine Info. contained
in most issues.
NEWSLETTER SUBSCRIPTION INFORMATION Check your mailing label for expiration
date. The date is right after your name. We are unable to notify you
individually of expiration dates. If your expiration date says Jan '99,
that is the last newsletter you will receive without a renewal.
Please return bottom portion with check or Money Order for renewal or
include the pertinent information with check or M.O. for $25.
THANKS TO ALL WHO DONATED TO COSS IN 1998. WE ARE ABLE TO CONTINUE INTO
1999. MANY NEW WOMEN CONTACT US WEEKLY! PLEASE HELP US TO MAKE IT
THROUGH THIS NEW YEAR. WE SPENT $200 JUST THIS WEEK TO FIX THE
COMPUTER!!!! THE SILICONE PROBLEM GROWS WORSE INSTEAD OF BETTER. WE NEED
YOUR DONATION TO KEEP THE INFORMATION FLOWING IN 1999!!!!!!
the pertinent data with your check or money order.
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the US are tax-exempt and gratefully accepted.
LR
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