COALITION OF SILICONE SURVIVORS

    P. O. Box 129  Broomfield, CO 80038-0129

    Lynda Roth - (303) 469-8242   website: http://www.siliconesurvivors.net

   e-mail: coss@siliconesurvivors.net

November 1998

Dear Silicone Survivors and Friends:

You may wonder why the newsletter is late (even later than the last two

months).  I have been dealing with some personal health issues.  Hopefully

by next month I can tell you that I am better.  My cancer blood test is

elevated and they found a lump in my remaining breast.  There is also a

suspicious polyp on my cervix.  I will know more by December about what is

happening. Please  Send some positive vibes and prayers my way for the next

few weeks.

UPCOMING EVENTS: Mid-November is supposed to see the release of the

information by the Science Panel appointed by Judge Pointer.  We hope this

happens and that it will benefit our silicone sisters and other silicone

survivors.

LEGAL:  WASHINGTON (Reuters): A provision requiring health insurance plans

to cover reconstructive surgery for breast cancer patients was included in

the sprawling spending bill passed by Congress and signed by President

Clinton on Wednesday. The bill requires any plan that covers mastectomies

also to cover reconstructive surgery after the cancerous breast is removed.

"The bottom line is reconstructive surgery is not cosmetic, it's a

necessary part of the continuum of care for breast-cancer treatment,'' said

Rep. Sherrod Brown, an Ohio Democrat who backed the measure. Sponsors had

wanted to include broader language that would also have banned "drive-by''

mastectomies, giving women the option of remaining in a hospital for 48

hours instead of having outpatient surgery. But that provision was not

included in the bill.

BAY CITY: Dow Corning Corp.'s plan to pay off thousands of claims from

women who say silicone breast implants made them ill could be made public

just after Election Day.    Dow Corning has maintained there is no

scientific evidence linking the implants to disease, but has  agreed to pay

$3.2 billion to the women. Attorneys representing the company & women with

implants have been in negotiations for months to work out the plan. The two

sides have been meeting with federal mediator Francis McGovern, a Duke

University professor, since last fall.  In a telephone conference Thursday,

McGovern  said the two sides resolved all but one issue. "Now there is one

remaining issue of which I am aware," McGovern said. It was unclear  what

that issue was.  The parties have scheduled a meeting in Chicago to resolve

the remaining issue, McGovern  said. "If that is successful, I will report

immediately  to the court and we will anticipate a plan being filed by the

end of the month."  McGovern suggested Oct. 27 as a possible day to

announce completion of the plan.

But Barbara Houser, lead attorney for Dow Corning, told The Midland Daily

News it might be better to wait until Nov. 4, the day after the general

election.  "We hope to generate some good publicity about finally filing a

proposed joint plan," Houser said. She said the Monday and Tuesday of

election week    would be a difficult time and she didn't want  the story

to get lost in the shuffle.  After the plan is filed, Spector must schedule

a   hearing for comments on the plan's explanation, which is called a

disclosure statement. Spector said that hearing could come before

Christmas.  Ballots for women and others to vote on the plan could be

mailed in early 1999, he said. (Don't hold your breath!!)  The following is

a news clip.

Free Press Business Writer  (Boaz Herzog) Midland-based Dow Corning Corp.

expects to emerge from bankruptcy by the middle of next year, its chairman

said Tuesday. The company filed for bankruptcy in 1995.  Most of the

contentious issues have been resolved in a proposed $3.2-billion settlement

between Dow Corning and lawyers representing recipients of silicone breast

implants, Chairman Richard Hazleton said in a news conference before

addressing the Economic Club of Detroit.   (Phone # for the DC implant

settlement Hotline with the latest info from DC regarding Dow. 1-800-651-7030)

MIDLAND, MI.: Dow Corning Corp. could release details of how much it will

compensate thousands of women who claim silicone breast implants made them

ill, the company's chairman said (Nov. 5th.)    Richard Hazleton said he

believes the women

will find the settlement package satisfactory, given what he calls its

flexibility and options more abundant than earlier plans filed by the

company. the company and attorneys for the 170,000 affected women have

worked to transform the deal's basics into a detailed "disclosure

statement." That spells out the settlement's specifics, including payouts

for the women.  Hazleton said Dow Corning has received feedback from the

women's attorneys about what they consider the most important features for

their clients.                      "That translates into their support for

this," Hazleton told the Midland Daily News (Nov. 6th). "That will go a

long way toward ensuring acceptance by claimants." The plaintiffs'

attorneys told Dow Corning they wanted enough money available to pay claims

"as rapidly as they could be processed."

MEDICAL INFORMATION: NY, Oct 15 (Reuters): The number of cases of

non-Hodgkin's lymphoma, chronic lymphocytic leukemia, and testicular tumors

increased in three predominantly agricultural counties in western Ireland

over the past decade, researchers report in the Journal of Epidemiology and

Community Health. The increase may be at least partly a result of increased

exposure to agricultural chemicals.

London, Oct 7 (Reuters) Patricia Reaney: British scientists have identified

chemicals used in toiletries that mimic the effects of estrogen, the female

hormone that has been linked to a drop in sperm count and an increase in

breast and testicular cancers.  The compounds have been widely used in

cosmetics and toiletries for decades. The chemicals, which have been

approved for use in preservatives known as parabens in toiletries, are

found in thousands of products ranging from sunblocks and cosmetics to baby

creams. They prevent the products from spoiling but are also responsible

for causing allergic reactions such as skin rashes, swelling and itching.

Sumpter and his colleagues found that when the substances were injected

under the skin of animals in laboratory studies they caused adverse

reactions.  Their research will be published in the next issue of the

journal, Toxicology and Applied Pharmacology.

Reporters Fired For Telling The Truth About RGBH Milk Hormone: Two veteran

news reporters for Fox TV in Tampa, Florida have been fired for refusing to

water down an investigative report on Monsanto's controversial milk

hormone, rBGH (recombinant bovine growth hormone). Monsanto's rBGH is a

genetically-engineered hormone sold to dairy farmers who inject it into

their cows every two weeks to increase milk production. In recent years,

evidence has accumulated indicating that rBGH may promote cancer in humans

who drink milk from rBGH-treated cows. It is the link between rBGH and

cancer that Fox TV tried hardest to remove from the story.   In the fall of

1996, award-winning reporters Steve Wilson and Jane Akre were hired by WTVT

in Tampa to produce a series on rBGH in Florida milk. After more than a

year's work on the rBGH series and three days before the series was

scheduled to air starting February 24, 1997, Fox TV executives received the

first of two letters from lawyers representing Monsanto saying that

Monsanto would suffer "enormous damage" if the series ran. WTVT had been

advertising the series aggressively, but canceled it at the last moment.

Monsanto's second letter warned of "dire consequences" for Fox if the

series aired as it stood. (How Monsanto knew what the series contained

remains a mystery.) According to documents filed in Florida's Circuit Court

(13th Circuit), Fox lawyers then tried to water down the series, offering

to pay the two reporters if they would leave the station and keep mum about

what Fox had done to their work. The reporters refused Fox's offer, and on

April 2, 1998, filed their own lawsuit against WTVT.   Steve Wilson has 26

years' experience as a working journalist and has won four Emmy awards for

his investigative reporting. His wife, Jane Akre, has been a reporter and

news anchor for 20 years and has won a prestigious Associated Press award

for investigative reporting.   No one will be surprised to learn that

powerful corporations can intimidate TV stations into re-writing the news,

but this case offers an unusually detailed glimpse of specific intimidation

tactics and their effects inside a news organization. It is not pretty. 

It has been well-documented by Monsanto and by others that rBGH-treated

cows undergo several changes: Their lives are shortened, they are more

likely to develop mastitis, an infection of the udder (which then requires

use of antibiotics, which end up in the milk along with increased pus), and

they produce milk containing elevated levels of another hormone called

IGF-1. It is IGF-1 that is associated with increased likelihood of human

cancers.  The U.S. FDA approved rBGH for use in cows in 1993 but the

approval process was controversial because former Monsanto employees went

to work for the FDA, oversaw the approval process, then went back to work

for Monsanto. Monsanto is notorious for marketing dangerous products while

falsely claiming safety.

The entire planet is now contaminated with hormone-disrupting,

cancer-causing PCBs, thanks to Monsanto's poor judgment and refusal to be

guided by early scientific evidence indicating harm. The 2,4,5-T in Agent

Orange, the herbicide that has brought so much grief to tens of thousands

of Vietnam veterans, is another example of Monsanto's poor judgment and

failure to heed scientific evidence to prevent harm. Critics says rBGH is

just one more example of Monsanto's monumentally poor judgment. When Wilson

and Akre asked Monsanto officials to respond to these allegations of past

poor judgment, Monsanto had no comment.  rBGH was never properly tested

before FDA allowed it on the market. A standard cancer test of a new human

drug requires two years of testing with several hundred rats. But rBGH was

tested for only 90 days on 30 rats. This short-term rat study was submitted

to FDA but was never published. FDA has refused to allow anyone outside FDA

to review the raw data from this study, saying it would "irreparably harm"

Monsanto.  Therefore the linchpin study of cancer and rBGH has never been

subjected to open scientific peer review.  The law required Monsanto to

notify the FDA if they received complaints by dairy farmers such as Charles

Knight.  But four months after Knight complained to Monsanto, FDA had heard

nothing from Monsanto. Monsanto's explanation? Despite a series of visits

to Knight's farm & many phone conversations, Monsanto officials say it took

them four months to figure out that Knight was complaining about rBGH.

There are problems with this substance.  Men with elevated rBGH are 4 times

more likely to have prostate cancer.  Canadian government officials say

they believe Monsanto tried to bribe them with offers of $1 to $2 million

to gain approval for rBGH in Canada. Monsanto officials say the Canadians

misunderstood their offer of "research" funds.

Marshall Space Flight Center: A NASA-Stanford University team is in the

preliminary stages of developing a smart probe that can be used for breast

cancer detection and analysis.  The probe is designed to see a lump,

determine by its features if it is cancerous and then quickly predict how

the disease may progress.  Researchers say surgeons may be able to insert

the computerized tool's needle-like tip into breast lumps to make instant

diagnoses and long-term cancer predictions.  This device will permit us to

make real-time, detailed interpretations of breast tissue at the tip of the

needle, said Robert Mah of NASA's Ames Research Center, Moffett Field, CA.

Mah works in the Ames Neuroengineering Laboratory.  The instrument may

allow health care providers to make expert, accurate diagnoses as well as

to suggest proper, individualized treatment, even in remote areas.  To

enable the instrument to recognize cancer and predict its progress, we use

special neural net software that is trained and learns from experience, he

said.

Scientists can teach the breast cancer diagnosis device to predict how

aggressive the disease may be.  We hope to use this device not only to

detect cancer, but to understand the nature of an individual cancer, said

Dr. Stefanie Jeffrey, Assistant Professor of Surgery and Chief of Breast

Surgery, Stanford University School of Medicine, Stanford, CA.  This

information may help us determine the distinctive features of a malignancy

and how the disease may progress; more knowledge about the cancer may guide

us to better individualizing treatment.  Jeffrey and Mah are working

together to develop the new device. The researchers say that once the smart

probe has been adequately tested in the laboratory, Dr. Jeffrey will begin

testing the device on human beings, perhaps by early 1999.  Ultrasound will

help guide the doctor to properly insert the smart probe into a breast

lump, said Dr. Robyn Birdwell, Assistant Professor of Radiology, Breast

Imaging Section at Stanford.

The computer software uses pattern recognition to look for tell-tale

characteristics of the lump, Mah said. The same technology used in the

portable, smart probe could be used in other instruments to help in

diagnosing and treating cancers found in other parts of the body, including

the prostate and colon, neuroengineering team computer engineer Alex

Galvagni said.  The breast cancer tool is a spinoff from a computerized

robotic brain surgery assistant that was previously developed by

neurosurgeon Dr. Russell Andrews & Mah.  The larger brain surgery device is

a simple robot that can learn the physical characteristics of the brain and

may soon give surgeons finer control of surgical instruments during

delicate brain operations.

Restless Legs Syndrome, (the most common disorder you've never heard of.")

Restless Legs Syndrome (RLS) is a movement disorder characterized by

unusual sensations that occur typically deep within the legs, occasionally

in the arms and infrequently in other body parts.  These sensations compel

the sufferer to move the affected extremity to achieve relief.  Because RLS

is worse during the evening and at night, it can lead to severe insomnia

and excessive daytime sleepiness.

RLS can be idiopathic (without a known cause) or can be related to an

underlying condition such as iron deficiency, renal failure or peripheral

neuropathy. "RLS may also occur during pregnancy, but the symptoms

generally resolve with delivery.   A related disorder, periodic limb

movements in sleep (PLMS) or periodic limb movement disorder (PLMD), is

characterized by episodes of jerking of the limbs during sleep and

sometimes while awake. Restless legs syndrome (RLS) can be a serious

disorder and is treatable. Persons suspecting that they may have RLS should

consult a qualified healthcare provider. Literature concerning RLS that is

distributed by the Restless Legs Syndrome Foundation, Inc.

Do you have restless legs syndrome? These statements have been developed to

help you decide if you should seek the help of your healthcare provider. If

you answer yes to two or more of these statements, you may indeed have

restless legs syndrome (RLS).  1. Before I fall asleep, I develop an

unpleasant or creepy, crawly sensation in my legs.  (Sometimes, I get this

same feeling in other parts of my body).   2. In order to relieve this

sensation, I get up and walk, do deep knee bends, take a hot or cold bath,

massage my legs, or perform some other activity.  3. I develop this

unpleasant or creepy, crawly sensation when I sit for a period of time such

as when watching television or a movie, riding in the car, attending the

theater or my place of worship, or participating in a meeting.   4. The

sensations bother me most in the evening or at night.  5. I often have

trouble staying asleep or falling asleep.  6. My bedpartner tells me that I

jerk my legs (or my arms) when I am asleep; sometimes, I    have

involuntary leg jerks when I am awake.    7. I frequently feel tired or

fatigued during the day.  8. No medical tests have revealed a cause for my

sensations.  9. I have other family members who experience these same

sensations.  If you are found to have RLS, you are not alone. Researchers

estimate that up to 3% to 8% of the U.S. population has RLS. Most of these

people have a mild form  of the disorder, which may cause few, occasional,

or less-severe symptoms, but RLS severely affects the everyday lives of

tens of thousands of individuals.

Primary Features of RLS:  Restless legs syndrome is a neurologic disorder

with four primary features. An adult with RLS will typically have all of

these primary features. The bothersome (usually not painful), sensations in

the legs produce an irresistible urge to move. Some words used to describe

these sensations include creeping, burning, itching, pulling, or tugging.

(These sensations also occasionally occur in the arms.) Sharp, pins and

needles, or numb are not usual descriptive terms.   Symptoms are worse or

exclusively present when the afflicted individual is at rest, and the

sensations are typically lessened by voluntary movement of the affected

extremity.   Symptoms are worse in the evening and at night, especially

when the individual lies down.  Movements of the toes, feet, or legs (known

as restlessness) are typically seen when the afflicted individual is

sitting or lying down in the evening. This restlessness may be seen as

"fidgetiness" or

"nervousness."  Because RLS symptoms tend to worsen during the evening

hours, the sensations and need to move the affected limb can cause

difficulty in falling asleep. Approximately 80% of people with RLS will

also have periodic limb movements during sleep (PLMS). PLMS are jerks that

typically occur 20 to 30 seconds apart, on and off throughout the night.

The affected individual is usually unaware of the repetitive jerks or the

accompanying partial arousals that disrupt sleep.  Although most people

with RLS have PLMS, most people with PLMS (especially the elderly) do not

have other features of RLS.  Chronic sleep deprivation and its resultant

daytime sleepiness can affect your ability to work, to participate in

social activities and to partake in recreational pastimes.  It can also

cause mood swings which can affect your personal relationships. RLS may

have different but perhaps overlapping causes (genetic or a secondary

disorder) or RLS can be idiopathic (without a known cause).

The transmission of the genetic form of RLS has not been determined but

appears to occur in an autosomal-dominant pattern. In other words, children

born to a parent with RLS have a significantly increased risk of acquiring

this disorder. The disorder is not sex linked, which means that RLS occurs

with equal frequency in males and females.  You may have a secondary cause

for RLS, which includes associated factors and medical conditions that,

when present, aggravate the underlying RLS. Several of these conditions

appear to create transient, or temporary, symptoms of RLS. If you drink

caffeine-containing beverages, such as coffee, tea, hot chocolate and soft

drinks, you may experience an increase in symptoms of an underlying RLS.

These symptoms usually decrease in frequency or may even disappear when you

eliminate caffeine from your diet.

During pregnancy, particularly during the last few months of pregnancy, up

to 15% of women develop RLS. After delivery, their symptoms often, but not

always, vanish. We've known for over 30 years that anemia and low levels of

iron are associated with symptoms of RLS. Chronic conditions-such as

diabetes, peripheral neuropathy (damage to the nerves in the hands and

feet), alcoholism, Parkinson's disease, kidney failure and rheumatoid

arthritis may induce a longer-lasting RLS. Recent literature also points

toward an association between RLS & symptoms of attention-deficit

hyperactivity disorder.  If you have a secondary condition, such as an iron

or vitamin deficiency that is causing or contributing to your symptoms of

RLS, these symptoms will tend to decrease in intensity or frequency once

your anemia or iron deficiency is treated or improves. With any of the

chronic conditions, you will often experience symptoms of RLS as long as

your chronic condition persists.  If you have no family history of RLS and

no underlying or associated conditions causing the disorder, your RLS is

said to be idiopathic, meaning without a known cause.

Age of onset: Though RLS is often diagnosed in people between the ages of

50 and 60, the symptoms typically appear much earlier. Many people who are

ultimately found to have RLS have had the disorder for many years and often

have sought help from multiple healthcare providers who did not recognize

or properly treat the disorder.  Many people with RLS, particularly those

with the genetic form of the disorder, can trace their symptoms back for

several years, often to childhood. They were frequently thought to have had

"growing pains" or to have been "hyperactive" because they couldn't sit

still or were constantly "fidgeting."   Because RLS has such classic

symptoms, the disorder is most often diagnosed on the basis of medical

history. After ruling out other medical conditions as the cause of your

symptoms, your healthcare provider can make the diagnosis of RLS by

listening to your description of the sensations. Two symptoms are

particularly noteworthy: an inescapable urge to move the affected limbs and

an increase in the severity of the sensations while at rest.  No laboratory

test confirms your diagnosis of RLS; however, a thorough examination,

including necessary laboratory tests, can reveal temporary disorders, such

as iron deficiency, that may be associated with RLS. Some people (including

those with PLMS and without the abnormal limb sensations of RLS) will

require an overnight testing of sleep to determine other causes of the

sleep disturbance. Any underlying medical conditions should be adequately

evaluated and treated before attempting to treat your symptoms of RLS. If

an underlying iron or vitamin deficiency is found to be the cause of your

restless legs, supplementing with iron, vitamins E or B12, or folate (as

indicated) may be sufficient to relieve your symptoms. Because the use of

even moderate amounts of some minerals (such as iron, magnesium, potassium,

and calcium) can impair your body's ability to use other minerals or can

cause toxicity, you should use mineral supplements only on the advice of

your healthcare provider.

The use of some medications seems to worsen the symptoms of RLS. These

drugs include calcium-channel blockers (used to treat high blood pressure

and heart conditions), most antinausea medications, some cold and allergy

medications, major tranquilizers (including haloperidol and

phenothiazines), and the antiseizure medication, phenytoin. A recent report

indicates that medications used to treat depression increase the symptoms

of RLS. Ironically, some people seem to have an improvement in their

symptoms of RLS with the use of antidepressive medications.  It is more

often the case, however, that the use of antidepressive medications worsens

the symptoms of RLS.

Lifestyle changes involve determining, on an individual basis, which habits

and activities worsen or improve your symptoms of RLS. A healthy balanced

diet, with vitamin supplementation as necessary, is important in reducing

the severity of your RLS. Though caffeine consumption may initially appear

to relieve your symptoms, your use of caffeine most likely only delays, and

often intensifies, your symptoms to a time later in the day. The best

solution is to avoid all caffeine-containing products, including chocolate

and caffeinated beverages such as coffee, tea, and soft drinks. The

consumption of alcohol and the use of tobacco products increases the span

or intensity of symptoms for most individuals; again, refraining from the

use of alcohol or tobacco is your best solution.

Because fatigue and drowsiness tend to worsen the symptoms of RLS,

implementing a program of sleep hygiene should be a first step toward

resolving your symptoms. Sleep hygiene involves having a cool, quiet, and

comfortable sleeping environment, going to bed at the same time every

night, arising at the same time every morning and obtaining a sufficient

number of hours of sleep to feel well rested. Because of the circadian

component of RLS, you may find that you achieve your best sleep later in

the 24-hour cycle than is the societal norm, for example, you may find that

sleeping from 2 a.m. until 10 a.m. works best for you and you should not

feel "lazy" if you need to sleep later in the day.  Good sleep hygiene also

involves a program of regular, moderate exercise. Typically, sleep experts

recommend that exercise should take place at least six hours before bedtime

to avoid an adverse impact on your sleep; however, many people with RLS

find that exercises, such as using a stationary bike or a treadmill,

immediately before bedtime are useful. Other people find that performing

isometric exercises for a few minutes (i.e., standing with your back

against a wall and your knees bent as if sitting in a chair) helps to

fatigue the muscles and is helpful. Excessive exercise, on the other hand,

often intensifies the restlessness. Experiment with a variety of exercise

programs and develop your own routine. You'll soon find what works best for

you.   Self-directed activities that counteract your sensations of RLS

appear to be very effective, although temporary, solutions to managing the

disorder. You may find that walking, stretching, taking a hot or cold bath,

massaging your affected limb, applying hot or cold packs, using vibration,

performing acupressure and practicing relaxation techniques (biofeedback,

meditation, or yoga) may help reduce or relieve your symptoms. You may also

find that keeping your mind actively engaged through activities such as

reading a gripping novel, performing intricate needlework or playing video

games helps during times that you must stay seated, such as when you are

traveling. Unfortunately many, if not most, cases of RLS either initially

do not resolve with the treatment of underlying disorders and the

implementation of lifestyle changes or, over time, the symptoms progress so

that relief is insufficient with these methods. In either case, the

institution of pharmacologic therapy may become necessary.

Benzodiazepines work by toning down the central nervous system and thereby

allowing you to sleep even though some of your movements and sensations may

continue. These drugs are most effective for relieving the nighttime

symptoms of RLS and, therefore, are used either at bedtime in addition to a

dopaminergic agent or for individuals who have primarily nighttime

symptoms. The most commonly used benzodiazepine is Klonopin. Side effects

of benzodiazepines include daytime drowsiness or confusion, particularly in

elderly individuals. This drowsiness may impair your ability to operate

machinery, including a motor vehicle. If you take benzodiazepines, you

should refrain from consuming alcohol.  Benzodiazepines may produce

physical or psychological addiction, so you should consult with your

healthcare provider before increasing the dose or discontinuing this type

of medication.

The primary and first-line treatment for RLS is with dopaminergic agents

which work in the central nervous system by enhancing the levels of

dopamine, a chemical that the body naturally produces and that regulates

the delivery of messages between cells in the nervous system. While these

medications are the same drugs that are used to treat Parkinson's disease,

RLS is not a form of Parkinson's disease but is a distinct neurologic

condition.  A newer drug, pergolide mesylate (Permax), is showing great

promise in treating RLS. Recent studies have shown that this medication is

as effective as Sinemet and has much less potential for causing

augmentation (10% for Permax vs. 80% for Sinemet). What happens with

augmentation is this: the usual dose of Sinemet (or other drug) will allow

you to obtain relief from your symptoms so that you will be able to sleep

at night, but the sensations, the need to move, and the restlessness will

develop, frequently with an increased intensity, earlier in the day, during

the afternoon or even during the morning. The disadvantages of Permax are

that it is more expensive than Sinemet and it has not been used as long so

that physicians are less familiar with prescribing this drug. The primary

side effects are dizziness, nausea, and nasal congestion.  Bromocriptine

mesylate (Parlodel) is another dopaminergic agent that is used to treat

RLS. Results of studies regarding the effectiveness of bromocriptine are

mixed, although individual patients have reported good results.  Permax and

Parlodel should be started at low doses and increased very slowly to

decrease the potential side effects. Several anticonvulsant drugs have been

tested for use in treating RLS. Anticonvulsants appear to work by

decreasing your sensory disturbances (the unpleasant sensations) and your

urge to move. These drugs are particularly effective for some, but not all,

patients with marked daytime symptoms, particularly people who have pain

syndromes associated with their RLS. Gabapentin (Neurontin) is the

anticonvulsant that has shown the most promise in treating the symptoms of

RLS.  Possible side effects of gabapentin include dizziness, sleepiness,

fatigue, increased appetite, and unsteadiness. The sedative properties of

gabapentin may impair your ability to operate heavy machinery, including a

motor vehicle.

Tamoxifen:   A Major Medical Mistake?  Sherrill Sellman: Nexus Magazine,

June/July 1998: Once praised for its benefits in preventing breast cancer

recurrence, the lucrative pharmaceutical drug tamoxifen is now implicated

in causing dangerous side-effects, including other types of cancers.  In

the early 1970's, a shameful chapter closed on the widespread use of a

known carcinogenic and endocrine-disrupting drug called DES

(diethylstilboestrol), the first synthetic, non-steroidal estrogen drug.

Against the advice of its creator, Sir Charles Dodd, between four and six

million American and European women and 10,000 Australian women innocently

used DES for the prevention of miscarriage and pregnancy complications.  In

addition, DES became a popular though unproven drug for a variety of other

conditions. It was used for the suppression of lactation, the treatment of

acne, the treatment of certain types of breast and prostatic cancer, and as

an inhibitor of growth in young girls, an estrogen replacement in menopause

and a "morning after" pill.  It would take 30 years to accept what

laboratory tests had indicated as early as 1938, that DES was a highly

dangerous and harmful drug. It was reported that, 20 years after taking

DES, mothers had a 40 to 50% greater risk of breast cancer than non-exposed

mothers. In addition, the children of DES mothers showed a high incidence

of reproductive abnormalities, miscarriages, vaginal cancer, testicular

cancer, sterility and immune dysfunction. In fact, it is feared that

repercussions of this drug will be felt for generations to come.

The irony of this entire debacle is that the medical establishment finally

acknowledged that DES was useless in preventing miscarriages. Thus, DES,

another disastrous experiment on women, was added to the long list of major

medical blunders.  Out of this early research, a new drug appeared on the

horizon which would be soon be heralded as a shining star in the war

against the growing epidemic of breast cancer. In the late 1960's the

pharmaceutical industry developed a drug

called "tamoxifen". As a synthetic, non-steroidal compound with

hormone-like effects (many of which are poorly understood), tamoxifen has a

similar structure to DES. In fact, it was observed that tamoxifen caused

the same abnormal changes seen in cells of women taking estradiol and DES.

This similarity raised alarm bells for some.

Pierre Blais, well known as a drug researcher who was ejected from Canada's

health protection bureaucracy when he spoke out about silicone breast

implants, describes the story of tamoxifen as "the story of modern drug

design which produces garbage drugs". He says, "Good drug design ceased,

unfortunately, in the 1930s." Tamoxifen, Blais asserts, "...is a garbage

drug that made it to the top of the scrap heap. It is a DES in the making."

Blais's dire predictions were ignored with the promise of a potential drug

treatment for breast cancer.

Tamoxifen was first approved by the US Food and Drug Administration (FDA)

for use as a birth-control pill, however, it proved to induce rather than

inhibit ovulation. Although tamoxifen didn't work as a contraceptive, it

was found to lower mammary cancer rates in animals. Animal studies showed

that tamoxifen prevented estrogen from binding to receptor sites on breast

tissue cells. Tamoxifen also reduced the incidence of breast cancer in

rodents after administration of a breast-carcinogenic substance.  This

discovery provided the impetus to study its effects in treating human

breast cancer.

Estrogen is the common link between most breast cancer risk factors, i.e.,

genetic, reproductive, dietary, lifestyle and environmental. It both

stimulates the division of breast cells (healthy as well as cancerous) and,

especially in its 'bad' form, increases the risk of breast cancer. Thus,

hormonal drugs such as tamoxifen that block the effects of estrogen on the

breast were expected to reduce the risk of breast cancer recurring in women

treated for breast cancer. Tamoxifen acts as a weak estrogen by competing

for estrogen receptors much as phyto-estrogens do. Like phyto-estrogens,

tamoxifen has mild estrogenic properties but is considered an anti-estrogen

since it inhibits the activity of regular estrogens. More accurately,

tamoxifen is an estrogen-blocker. It fights breast cancer by competing with

estrogen for space on estrogen receptors in the tumor tissue. Every

tamoxifen molecule that hooks onto an estrogen receptor prevents an

estrogen molecule from linking up at the same site. Without a steady supply

of estrogen, cells in an estrogen-receptor- positive (ER+) tumor do not

thrive and the tumor's ability to spread is reduced. (4) However, tamoxifen

exhibited two conflicting characteristics. It could act either as an

anti-estrogen or as an estrogen. Therefore, while tamoxifen is

anti-estrogenic to the breast, it also acts as an estrogen to the uterus

and, to a lesser extent, the heart, blood vessels and bone. So, although it

initially showed the tendency to counter breast cancer recurrence, it would

soon be revealed that it also promoted particularly aggressive uterine and

liver cancers, caused fatal blood clots and interfered with many other

functions.

Doctors, however, were quick to jump on the tamoxifen bandwagon, turning a

blind eye to its more injurious tendencies. Starting in the 1970's

oncologists began using tamoxifen to treat women with cancer, often in

combination with other drugs, radiation or surgery such as lumpectomy and

mastectomy, with modest success. Like DES, tamoxifen's benefits were then

extended for use as a preventive against osteoporosis and heart disease.

Today, doctors are treating about one million American breast cancer

patients with tamoxifen, about 20% of them for more than five years. As

studies published in the New England Journal of Medicine in 1989 and the

Journal of the National Cancer Institute in 1992 showed, women with breast

cancer who took tamoxifen reduced their chances of developing cancer in the

other breast (contralateral cancer) by about 30% to 50%. These findings

would later be challenged.

Tamoxifen is now recommended for all pre-menopausal women with

hormone-positive cancers, as well as for most postmenopausal women with

breast cancer and/or a growing number of women with hormone-negative

cancers. Tamoxifen is currently used by more women with breast cancer than

any other drug. Tamoxifen (brand name Nolvadex) is now the most widely

prescribed cancer medication in the world. It generated revenues of US $265

million in 1992. By 1995, worldwide sales of Nolvadex reached $400 million.

And at Australian $90 for one month's supply, it doesn't come cheap (the

Australian Pharmaceutical Benefits Scheme covers $70). Tamoxifen was

developed by UK-based Imperial Chemical Industries (ICI), one of the

world's largest multinational chemical corporations. Zeneca, an ICI

subsidiary, is responsible for manufacturing and marketing the hormone and

is now the world's largest cancer-drug company.

It is no surprise that ICI's profits come from playing both sides of the

cancer industry. ICI's agrochemical division, which includes Zeneca,

manufactures chlorinated and other industrial chemicals including

herbicides. All are poisonous; many are known endocrine-disrupters that

have been incriminated as causes of breast cancer. ICI's profits swell by

manufacturing chemicals that on the one hand cause breast cancer and on the

other hand reputedly cure breast cancer.

Limited Benefits of Tamoxifen: Tamoxifen's benefits are determined by

several factors:  Postmenopausal women who are ER-positive (have a positive

estrogen receptor status) get the most benefit. For postmenopausal women

who are ER-negative, the benefits appear to outweigh the risks.  For

pre-menopausal women who are ER-positive, it's a tough call. Potential

benefits are small.  Pre-menopausal women who are ER negative receive

virtually no benefit. Tamoxifen is more effective in women who have cancer

in their lymph nodes than in those whose nodes are cancer-free.  In 1992

the Lancet published a review of a number of studies in which a total of

30,000 breast cancer patients were randomly assigned either to take

tamoxifen or not. The average patient in this collaborative study was

followed up for between 5-6 years. Of the patients taking tamoxifen, 74.4%

survived, as compared with 70.9% in the non-tamoxifen group, a less than

impressive improvement. The report found that the group helped most

consisted of post-menopausal women with ER-positive status. The study went

on to report that pre-menopausal women who are ER-negative had absolutely

no benefit from taking tamoxifen.  Despite tamoxifen's proven ability to

reduce breast cancer recurrence in postmenopausal women, major studies have

shown that tamoxifen reduces death from breast cancer only marginally.  The

majority of women who take tamoxifen live no longer than women who do not

take it.  Furthermore, some breast cancers learn how to use tamoxifen to

stimulate their growth.

The benefits of tamoxifen are limited. Virtually all women who take it

become resistant within five years. A recent randomized controlled study

showed that tamoxifen reached its maximum protective effect on breast

tissue with women who took it for five years. Taking it for five more years

didn't offer any more protection, and may actually have caused more

cancers. In other words, after a while the breast cells become resistant to

tamoxifen and actually start to be fed by it.  This result surprised the

researchers. According to Dr. Susan Love, author of Dr. Susan Love's

Hormone Book: "This is a dramatic example of why you need good, long-term

studies. If we had based all of our recommendations on the five-year data

without doing further studies, we would have had women taking tamoxifen

forever. So convinced were we that tamoxifen was a wonder drug that the

only reason researchers did the later study at all was to prove it wrong.

Luckily, we found out that we were wrong in time to prevent doing further

damage. We have learned, not for the first time, that more isn't always

better."

Tamoxifen's Dark Side: While the initial findings of tamoxifen's role in

breast cancer treatment seemed so promising, as with so many of the

synthetic hormone drugs, further research presented grave concerns for its

widespread use. In fact, the MIMS Annual lists 25 adverse reactions to

tamoxifen: some of these can be fatal. Menopausal Symptoms: Tamoxifen often

induces menopausal symptoms in menstruating women. About half of these

women experience hot flushes. Fluid retention and weight gain occur in

about 25% of  women and can be controlled by reducing the dose.  Vaginal

discharge and vaginal atrophy are additional symptoms. Some studies have

also found that pre-menopausal users are at risk of developing accelerated

bone-mineral loss & osteoporosis. Menstrual irregularities also occur in

pre-menopausal women. Amenorrhea (absence of the menstrual cycle) often

results and can be permanent.   Eye Damage: According to a 1978 study in

Cancer Treatment Reports and another published in Cancer in 1992, about 6%

of women taking even low-dose tamoxifen suffer damage to the retina and

corneal opacities and decreased visual acuity. Irreversible corneal and

retinal changes can occur in those taking 20 mg. Of tamoxifen twice a day

(twice the usual dose). These changes may have no immediate effect on

visual acuity, but may predispose the eyes to later problems including

cataracts.  Blood Clots: Tamoxifen irritates the walls of the veins, and

inflammation (a natural healing response to irritation) follows. The

constant irritation and inflammation weakens the veins, causing bleeding,

clotting, thrombophlebitis and, in the worst cases, obstruction of the

blood vessels serving the lungs, which can be deadly and can occur with

little warning. The incidence of thrombophlebitis in women using oral

contraceptives is generally regarded as significant (1 in 2,000); however,

with tamoxifen it's 30 times greater."

Several studies, including one reported to the FDA's Oncological Drugs

Advisory Committee by the National Surgical Adjuvant Breast and Bowel

Project in 1991, showed that the risk of developing life-threatening blood

clots increases about seven times in women taking tamoxifen. (6)

Psychological Symptoms: Depression has been reported as a potential

side-effect of tamoxifen in 30 percent of women. Cases have been reported

of an inability to concentrate.  It is important that patients observe

their moods and mental states. If it is suspected at tamoxifen is causing

depression or lack of concentration, it is suggested that a period of

tamoxifen avoidance be considered.   Other Symptoms: Tamoxifen can trigger

asthma attacks in some sensitive patients. Changes to the vocal cords

resulting in impairment of singing and speaking abilities are occasionally

caused by tamoxifen. Carcinogenic Effects: It wasn't long before laboratory

studies showed that tamoxifen acted as a carcinogen. It has been found that

tamoxifen binds tightly and irreversibly to DNA, the genetic blueprint of a

cell, causing a cancerous mutation to take place. Even Australia's

conservative National Health and Medical Research Council (NHMRC) warned

that no amount of tamoxifen is safe when it comes to carcinogenic effects.

In California there is a law called "Proposition 65" that requires the

state to publish and maintain a list of all known carcinogens. In May 1995,

the state's Carcinogen Identification Committee voted unanimously to add

tamoxifen to its list.  Following suit, in 1996 the World Health

Organization formally designated tamoxifen a human carcinogen, grouping it

with 70 other chemicals, about one quarter of them pharmaceuticals, that

have received this dubious distinction. Liver Cancer and Liver Disease:

Tamoxifen is toxic to the liver, and there have been reports of acute

hepatitis in patients treated with tamoxifen. Liver damage has occurred in

every animal given tamoxifen. According to Gary Williams, medical director

of the American Heart Foundation, tamoxifen has been shown in animal

studies to be a "rip-roaring" liver carcinogen, inducing highly aggressive

cancers in about 12% of rats.   The latest human studies show a six-fold

increase in liver cancer among women taking tamoxifen for more than two

years." Liver failure and tamoxifen-induced hepatitis, although rare, have

been reported. Even Zeneca admits that tamoxifen is a liver carcinogen,

while nevertheless aggressively promoting its use.

Uterine (Endometrial) Cancer: As early as 1967, ICI scientists noted that

"tamoxifen persists for some days in the uterus". In rats, a tamoxifen

metabolite (a breakdown compound almost similar in structure to the

original) was found to influence the uterus to be more receptive to

estrogen. (The more estrogen, the greater the chance of unnatural

cell-division leading to cancer.) ICI also reported liver carcino-genicity

of tamoxifen as well as both ovarian and testicular tumors in mice in its

description of the drug in the standard Physicians Desk Reference.  Uterine

growths such as polyps, tumors, endometrial thickenings and cancers occur

in a significant number of women taking tamoxifen. One study detected

abnormal endometrial cells in subjects the day after the first tablet was

taken.  Pre-cancerous uterine and endometrial changes were seen in 10% of

the women taking tamoxifen in a recent study. The higher the dose of

tamoxifen and the longer it is taken, the greater the risk of changes.

Women taking the standard dose of 20 mg. for two years run a risk of

uterine cancer that is 2 to 3 times greater than normal. After five years,

the risk is 6 to 8 times greater.

In February 1996 a review by the International Agency for Research on

Cancer, composed of scientists from various countries, definitively

concluded that "there is sufficient evidence to regard tamoxifen as a human

carcinogen that increases a woman's risk of developing cancer of the

endometrium, the inner lining of the uterus".  A large Swedish study

linking tamoxifen to uterine cancer forced Zeneca to send letters in April

1994 to 380,000 physicians across the USA, in defense of the drug. The

Swedish researchers had studied 1,371 breast cancer patients who took 40

mg. per day for two to five years and found that there was a six-fold

increase in uterine cancer among those patients who took tamoxifen when

compared to 1,327 who did not. A second study involving patients who took

20 mg. per day (the recommended dose) also showed a marked increase in

uterine cancers compared with the control group.  (I refused this drug

about 8 years ago when I had breast cancer!!)

ALTERNATIVE MEDICINE).  NY (October 28): Vitamins have been increasingly

used to prevent and treat a variety of skin disorders. A new study in the

October issue of the Journal of the American Academy of Dermatology

suggests that vitamins A, C and E are increasingly important because of

their antioxidant capabilities.  Antioxidants have been the center of much

media attention in recent  years due to their ability to stabilize

reactive, potentially-harmful free radicals in the body. Free radicals are

thought to be the cause of many diseases from cancers to colds. The free

radicals damage a person's DNA, causing unwanted changes in the basic

building blocks of cells. This damage can often be prevented, and sometimes

reversed,

with the healing properties of antioxidants.  The three antioxidants most

commonly found in antioxidant supplements are vitamins A, C and E. Each

works independently and in conjunction with other vitamins to reduce the

effects of free radicals. "There have been so many conflicting media

reports that it is often difficult for the public to understand what the

antioxidants can and cannot do to help people maintain good health," said

Karen Keller, MD, the lead author of the study. "We did a comprehensive

review of the scientific literature to determine how vitamins A, C and E

can help dermatologists improve patient care."  Vitamin A is found in many

yellow and green vegetables, egg yolk, butter, liver and fish oils.

Retinoids, the active ingredient in  Vitamin A, (more commonly known as

retinol) are found in topical skin creams, lotions and ointments.

Retinoids, whether synthetic or natural, have many important biological

effects such as regulating growth and differentiation in cells, diminishing

malignant cell growth and strengthening the immune system. Most retinoid

research has focused on acne treatments, the main treatment use of the

compound since 1971. Recently, multiple controlled studies have shown that

retinoids can reduce and prevent wrinkles, brown spots and actinic

keratoses. Patients reported noticeable improvement in skin texture and

tone after starting a retinoic acid treatment program. The positive results

can be reversed, however, if the patient discontinues topical application

of the retinol products. At one time, retinoids were only available in

prescription treatments. Now, many retinoids are available in

over-the-counter preparations.  Vitamin A was also found to have positive

results when used as a treatment for stretch marks, psoriasis, lichen

planus and other disorders relating to the hardening of the outer layer of

the skin. A close relative of vitamin A, beta-carotene also functions

naturally as a free radical scavenger to protect cells. Beta-carotene and

vitamin A may work together to generate positive results for patients. It

is most commonly found in green leafy vegetables, carrots, cantaloupes,

sweet potatoes, squash, meat, butter and cheese.  Ascorbic acid, found in

vegetables and citrus fruits, is more commonly called vitamin C. This

water-soluble molecule is considered by researchers to be the most

important antioxidant in numerous cellular activities. It acts as an

antioxidant by scavenging and quenching free radicals throughout the body.

Vitamin E is present in vegetables, oils, seeds, corn, soy, whole wheat

flour, margarine, nuts, and some meats and dairy products. The antioxidant

properties of vitamin E are well-documented, especially in relation to

plasma and red blood cells. Vitamin E may also be important in reducing

sunburn severity, as well as the lines and wrinkles associated with sun

exposure.

"The antioxidant properties of these three vitamins may work when applied

topically to fight signs of photoaging," noted Dr. Keller. "Many patients

note improvement in skin texture, wrinkles and age spots while using these

products. The role of supplements as a method of obtaining these vitamins

is still being researched." The effects of vitamins A, C and E in the

prevention and treatment of skin cancers show that each works independently

to reduce skin cancers. They also work together to help prevent the

formation of new lesions. Vitamin A was effective in the treatment of some

premalignant and malignant skin conditions. The current consensus is that

it probably does not cure skin cancer, but treatment may prevent the

formation of new lesions as long as therapy is continued. This was true for

a variety of skin cancers ranging from malignant basal cell carcinomas to

premalignant actinic keratoses lesions when treated with oral retinoids.

One study found that regular supplements of both vitamins A and E were

associated with a 70% reduced risk for basal cell carcinomas. In addition,

an increase in dietary vitamin C has been shown to reduce UV-induced tumors

in mice.

Wound healing is an important indicator of skin health. To enhance wound

healing, it is important that patients receive adequate amounts of each

vitamin. Patients whose bodies are vitamin A deficient experience

diminished wound healing, which is correctable by vitamin A

supplementation. Vitamin C is considered critical in wound healing because

it acts as a cofactor for several enzymes, which stabilize collagen.

Through its antioxidant and anti-inflammatory effects, topical vitamin E

may enhance wound healing, although the benefits remain controversial. More

research is needed to determine if and how vitamin E supports the wound

healing process. While it is important that everyone receives the

recommended daily allowances of vitamins and minerals, there is no research

to suggest that mega-doses of vitamins A, C and E provide enhanced

benefits. In fact, mega-doses of vitamins A and E, as well as beta

carotene, build up in the body and may cause serious adverse reactions

ranging from headaches to birth defects to altered immunity at high levels.

"It is important that people eat a variety of foods every day to receive

the needed antioxidants," advised Dr. Keller.

The American Academy of Dermatology is the largest and most influential

society representing physicians who specialize in treating skin, hair, and

nail conditions.   Reference Note: Keller, K.L., M.D.; Fenske, N.A., M.D.;

Uses of Vitamins A, C, and E and Related Compounds in Dermatology: A

Review, Journal of the American Academy of Dermatology, October 1998, pp.

611-625. (Note:  Even the Federal Government admeitted, in 1936, that our

soils were too depleted to provide us the necessary vitamins in our food.)

Canadian Press (Kevin McGran, Toronto: The Health Department's protection

branch is                 winding up its public review of Canada's various

food and drug laws in Toronto this week with a movement afoot to allow

U.S.-style health claims on Canadian food                  labels.  A major

food industry lobby group wants changes to the Food and Drug Act that would

allow labels to hype the health benefits of some foods in connection with

various illnesses. "There's a definition for a food, and there's a

definition of a drug. As soon as you link a food to a disease, it's

reclassified in this country as a drug," said Curry.  "No one ever

anticipated back in the '50s you would be adding fortificants to products

and then want to talk about them. (The law) needs to be modernized and

Health Canada is going through that."

Majority of Americans Use Alternative Therapies: According to Dr. Wes

Alles, of Stanford University, speaking to the Complementary and

Alternative Medicine Conference,  69% of Americans surveyed said they used

alternative medicine in the past year. 18% said that they had used massage

therapy, 17% had used chiropractic

therapy and 14% had used folk medicine during the past year. 36% had

self-administered vitamin therapy and more than 30% had used herbal

medicine. When asked whether alternative medicine worked, 81% using

chiropractic, 69% using massage therapy, 63% using acupuncture and 49%

using herbal  medicine reported that these therapies cured or relieved

their symptoms considerably.

IMPORTANT:   Minneapolis (Business Wire) Oct. 26, 1998--NovaMed, Inc.

NASDAQ announced the introduction of its Enhanced Novagold mammary

prosthesis ("breast implant") to markets currently served by the Company

outside of North America. The Enhanced Novagold represents a product

upgrade from the currently marketed Novagold breast implant with an

increase in the viscosity of the filling material.  The Enhanced Novagold

breast implant is an alternative-fill breast implant that utilizes a

patented filling material that is comprised of a PVP-based hydrogel.

Polyvinylpyrrolidone (PVP) is a polymer material that has been used in

medical and pharmaceutical products, cosmetics and food for decades. The

use of PVP in breast implants, over traditional sources of fill material

such as saline or silicone gel, offers many advantages. The Company's PVP-

hydrogel is more radiolucent than either saline or silicone gel and is many

times more viscous than either saline or soy oil filling materials. The

Enhanced Novagold PVP-hydrogel filling material is also osmotically

balanced within the body, so that fluctuations in implant volume should not

occur over time.  (You just knew they would try something else, didn't you??)

The Novagold breast implant is currently marketed in Europe, Asia, Central

and South America and other countries where the device has been registered

and the CE mark accepted as a mark of quality. Over 7,000 devices have been

sold to date. Although the Novagold is not presently available in the

United States, Canada, Australia or Japan, the Company has held preliminary

discussions with the US Food and Drug Administration ("FDA") for the

purpose of eventual clearance for sale in the United States through the

realization of IDE (Investigational Device Exemption)/PMA (Pre-Market

Approval) submissions. The Company is also in the process of investigating

with the FDA the prospect of introducing a saline filled inflatable product

to the US market place further to a 510k regulatory pathway.

The Company operates from two facilities, one located in Minneapolis,

Minnesota, the other in Monheim, Germany. The component parts of the

Novagold breast implant are manufactured at the Company's facility in

Minneapolis, Minnesota and then shipped to the Company's facility in

Germany for final manufacture, assembly and distribution. Research and

development is conducted from both facilities. The Company has invested

heavily in research and development over the last four years to produce the

Enhanced Novagold. (No comment necessary??!!)

PERSONAL COMMUNICATION: My fax is broken (and has been for two months).  I

can send out, but not receive.  If you would like to make a donation to

help fix it, it is a $200 repair.  I simply cannot find a way to come up

with that money right now!!

THIS MONTH'S POEM: No room for a poem this month!!  Sorry!!  I hope to be

more on time with the newsletter and have a poem next month.

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

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