COALITION OF SILICONE SURVIVORS

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

Lynda Roth - (303) 469-8242 Fax (303) 466-4084 e-mail: coss@siliconesurvivors.net

Website: http://www.siliconesurvivors.net

May 1998

Dear Silicone Survivors and Friends:

THE 'SAFE' SALINE BREAST IMPLANT?

by Lynda Roth

I can hardly pick up a newspaper or a

magazine without finding an article or an ad

about breast implants. If they are not

decrying the 'greed' of the attorneys or the

'misinformed' women, they are advertising

other forms of silicone implants. I see ads for

chin, cheek, pectoral, and saline breast

implants everywhere. I shudder every time I

see one of these, for I know that someone,

somewhere, will think that these products are

safe and will have this surgery.

I hear everyday from women who only had

saline (saline-filled, silicone breast implants)

and are extremely ill. One woman who, with

her sister, wrote a book (Betrayed, by Gloria

Bywalec & Anna Marie Rzeppa) had saline

implants for only 15 months. She is

extremely ill with noticeable tremors and

neurological problems. She believed the

manufacturers and the doctors when they

told her that these devices could not harm

her. I have heard from other women who

have had these devices for as long as 18-20

years and they are extremely ill with all kinds

of fungal, autoimmune, and neurological

problems.

There has never been an FDA approved

breast implant. I know many women have

believed that these devices must be safe or

they would have been removed from the

market, but this is simply untrue. In 1994,

the FDA listed the currently understood risks

of Saline-filled breast prostheses. On April

20, 1995, the Department of Health & Human

Services issued a new bulletin for women

who were considering saline (silicone-shell)

implants. Risks included deflation (common),

more difficulty visualizing breast tumors in

mammography, capsular contracture

(hardness, very common), calcium deposits

in the tissue around implants (hard to

distinguish from calcification in breast cancer

formations), repeat surgeries, infection,

hematoma, delayed wound healing, changes

in nipple sensation (common), shifting of the

implants (up, down, sideways under the

armpit), and swelling and/or joint pain or

arthritis-like pain, general aching

(fibromyalgia), unusual hair loss, unexplained

or unusual loss of energy (chronic fatigue),

less resistance to colds and flu, swollen

glands and lymph nodes, rashes, memory

problems, headaches, muscle weakness or

burning, nausea and/or vomiting, and irritable

bowel syndrome (alternating diarrhea and

constipation).

In addition to these, women who have had

long or short term saline-filled silicone

prostheses have had many other problems.

These include: Spontaneous rupture or one

or both implants, multiple ruptures with

immediate deflation and many surgeries,

extremely hard breasts, fungal infections in

the nails, vagina, mouth, and rectal areas,

implants containing any number of fungal,

viral, or bacterial organisms (some as yet

unnamed, and some very deadly--saline

solution is dated and was never intended for

implantation inside the human body),

defective implants with faulty valves, skin and

nipple necrosis (death), antibodies to silicone

and many other antibodies, multiple chemical

sensitivities (in addition to silica and silicone

in the shell, there may be as many as 25

other chemicals of which the shell is

comprised), foreign body reactions

immediately around the implant, severe

neurological problems including a Multiple

Sclerosis type syndrome, and even death.

In addition, Health & Human Services raised

the issue of the safety of breast feeding

infants when implants are present. This is a

grave concern to groups like ours, since early

studies show that children of mothers with

any type of implant may be at greater danger

for autoimmune illnesses.

Why, you ask, would the FDA allow unsafe

implants to remain on the market? We have

asked this question often! The FDA receives

a great deal of pressure from industry to

allow products on the market. Manufacturers

of saline-filled silicone breast implants have

until June of 1998 (probably have now gotten

a delay on this!!) to demonstrate the safety

and efficacy of these devices. If they cannot

prove that they are much safer than the

silicone gel-filled devices, they will be

removed from the market (presumably, but

with industry and cancer group pressure, who

knows?)

We hear the argument that there is silicone in

food, medicine, in the environment (not true,

silica is in the environment, and is a known

carcinogen when inhaled in too much

quantity), and that we are exposed to it all the

time. While this is somewhat true, those

sources are not in our bodies 24 hours a day,

7 days a week, for years. Also, a chemical in

our digestive tract is entirely different than a

chemical or toxin in our blood, lymph, and

nervous system. Our immune systems

naturally reject foreign objects. What

happens when you get a glass splinter in

your finger? It becomes inflamed. So does

tissue around implants, and this sets up a

chronic inflammatory condition in our entire

bodies.

Every type of silicone implantable device has

caused the same inflammatory response in

humans. This includes cheek, chin,

testicular, penile, joint replacement, TMJ

implants, tubal ligation clips, silicone sheaths

used in surgery and even the Norplant Birth

Control Device. There are numerous

lawsuits on the Norplant device. I wonder

when we began to think that placing foreign

objects in human bodies was a natural

extension of plastic or reconstructive

surgery? Did these doctors check with

biochemists and biologists, who surely would

have told them that there would be

tremendous immune responses? If you don't

believe this, ask a biologist. I did, and he

confirmed this information.

Saline implants were, and are, included in the

global settlement and in the new revised

settlements. Why would they be included if

the manufacturers were not aware of the

many problems and defects these devices

have? Why would women have to sign away

their right to ever sue the manufacturers (if

they currently receive a saline implant) if the

manufacturers did not know of the dangers

and wish to protect themselves?

Women and girls, husbands and fathers,

sisters and brothers, educate yourselves and

your families to the dangers of implanting any

(I repeat, ANY) foreign body inside of your

own body. There are many ways to improve

your looks and your self-esteem without ever

resorting to this often tragic option. Find out

the facts. Contact any one of the groups on

the internet or nationwide for more

information before you have any cosmetic

surgery. The life you save may surely be

your own or that of someone you love!

This is an article I wrote a few years ago. I

find it timely, considering the number of

women getting saline implants! Contribute

your story to our newsletter to share!!

UPCOMING EVENTS: We are not aware

of any upcoming events. When we have

information on these, we will let you know!

OF INTEREST: Nashville, TN. (AP)

Country singer Loretta Lynn is warning

women about the dangers of silicone breast

implants. ôYou women out there that have

breast implants, it is dangerous. Have them

jerked out,'' Lynn says in the April 21 issue of

Country Weekly magazine. The 63-year-old

entertainer had her 25-year-old implants

removed in January because of leaking

silicone that had attached to nerve endings,

her rib cage, backbone and tissue. ôIt was a

mess. It went all over,'' Lynn said. Without

surgery, ôI would have died.'' Tammy

Wynette, who recently died, is thought to

have had breast implants!!

LEGAL: Sharon Andrews, Court Reporter:

Why Am I Left With Nothing? Experts charge

anywhere from $150 to $300 per hour,

whether they are writing a report, checking

background information, or testifying in court,

and, they also charge expenses such as

travel, phone bills, etc. You have no way of

knowing whether they spent as much time as

they claim, although you can request

verification of any expenses they might

charge to you. If you have had your case

transferred state to federal court, it is not as

simple as sending in a form. All of the

pleadings: original complaint, interrogatories,

answers, et cetera, all have to be done

completely over, and the filing fees are much

higher. Generally, expenses charged to the

plaintiff involve paying for court reporting

services (depositions and copies); making

more than one copy of anything; postage and

shipping expenses; phone call charges;

exhibit preparation; expert witness fees, etc.

The list of items that are charged as

expenses is extensive and the attorney does

not need to check with you before incurring

most of the charges. The 1/3 or 1/2 fee you

agreed to pay the attorney in the event you

win your case in court or whether you settle

prior to going to court only relates to the

attorney's fee for himself. It's somewhat like

paying them an hourly rate. They may make

money by actually putting in less time, as

when the 1/3 is divided by the normal hourly

rate. For example, say the attorney normally

charges $100 an hour (ha, ha -- it's usually

more like $250 an hour, but I'm using $100

for purposes of this example).

If the attorney's cut is $33,000 from a

$100,000 settlement and he/she only put in

100 hours ($10,000), then he/she made a

profit of $23,000 over and above his/her

usual and customary charge. If he/she

actually put in 400 hours, then he/she would

lose money ($7,000). They don't lose money

very often. Generally, they will bail out of a

case (settle it) before they get to that point.

Please do not harbor the illusion that they are

working for you and your best interest. It is

simply NOT the case. Most people don't

understand that the 1/3 or 1/2 split comes off

the top; that is, before the expenses are

deducted. Far more often than not, by the

time the percentage is taken out and then the

expenses are subtracted, the plaintiff is left

with close to nothing. It's not the least bit

unusual at all. That's why it is so often said

that the only people who end up making any

money are the attorneys. It's, oh, sooo right!

Sign me, "Soon to be ex-Court Reporter"

(Some attorneys are really quite ethical and

keep the expenses as low as possible. Some

will actually lower their fees so that the

woman comes out with a better settlement.

Comment by Lynda).

Toronto, 4/24/98: Canadian women harmed

by faulty silicone breast implants are a step

closer to receiving compensation after courts

in Ontario and Quebec on Friday approved a

class action settlement with Baxter

Healthcare, (part of Baxter International Inc.)

The $22-million settlement, reached 2/98,

applies to women in Ontario and Quebec who

received Heyer-Schulte implants, mfg. or

distributed between 9/1/71 and 3/30/84 or

who resided in Ontario and Quebec as of

June 23, 1994 but received their Heyer-

Schulte implants elsewhere. Although

Deerfield, Illinois-based Baxter Healthcare did

not manufacture the implants, it acquired the

liability of the defunct Heyer-Schulte in 1984.

Heyer distributed the implants under a variety

of names. More than 3,000 women could

receive compensation, with the amount

depending on the number of claimants and

their medical conditions and levels of

disability.

AP, Bay City, Greta Guest: Dow Corning

Corp. went before a federal bankruptcy court

judge Monday seeking approval for its $3-

billion plan to settle breast implant claims.

Lawyers for women suing the company were

expected to argue during the three-day

hearing before U.S. Bankruptcy Court Judge

Arthur Spector in favor of a larger $3.8-billion

settlement, paid out more quickly than the

company proposes. But the company said it

believed the women would accept its offer. "I

believe this is a credible plan that if put out to

a vote will be approved by breast implant

claimants," Dow Corning attorney Barbara

Houser told the judge in her opening

statement. Houser said that if Spector

approves the deal, it would take 45 days to

print and mail ballots to the women. Dow

Corning, co-owned by CorningInc. and Dow

Chemical Co., filed for bankruptcy protection

in 1995 under the weight of tens of

thousands of breast implant claims. Most

claims have alleged that that women suffered

connective tissue disorders, such as

rheumatoid arthritis, scleroderma and lupus,

caused by silicone gel leaking from the

implants. The company says many scientific

studies have concluded that they do not

cause such diseases. "We do not believe

breast implants cause disease," said Dow

Corning spokesman Michael Jackson. The

$3-billion offer, to be paid out over 16 years

to some 177,000 women worldwide, would be

part of the Midland-based company's $4.4-

billion plan to pay its debts and return to

financial health. In November, Spector

rejected an earlier company plan to give $2.3

billion to women. While the company

proposes paying the women over 16 years,

the women's attorneys argued in their $3.8-

billion proposal that the settlement be paid

over three years.

Daily News, Cheryl Wade: Bay City A judge

has told parties in the Dow Corning Corp.

bankruptcy case to meet and iron out their

differences over DCÆs reorganization plan.

U.S. Bankruptcy Judge Arthur Spector

finished two days of hearings on the

company's third plan. Lawyers for U.S. and

foreign women with breast implants and for

insurance companies and hospitals, said the

company's $4.4 billion settlement offer wasn't

good enough. The company is offering $3

billion to settle with 177,000 women with

implants, and $1.4 billion to satisfy

commercial creditors, mostly banks.

Spector set no time limit for the parties to

finish talking, but told lawyers to contact him

next week to see if they should come back to

court before the next scheduled date of April

30. Dow Corning filed for Chapter 11

bankruptcy protection in 1995 after

thousands of women sued the company,

claiming silicone breast implants made them

sick. Dow Corning denies implants cause

disease, but stopped making the implants.

Under the reorganization plan, women could

be eligible for settlements of $1,000 to

$200,000, depending on their medical

conditions. More money could be available to

those whose uninsured medical bills exceed

$200,000. The money would be paid over a

16 year period. Women could settle with Dow

Corning or sue separately. Bankruptcy law

allows Dow Corning to file its own plan,

subject to Spector's approval. Lawyers for

women with implants filed an outline of their

own plan, and asked Spector to allow the

women's plan to be filed. Spector said he

wouldn't rule on the request to waive Dow

Corning's exclusive right to have a plan at

least for now. Instead, he said he was leaving

the door open for lawyers to work out

differences.

Post-8/84 McGhan Announcement: On April

3, 1998, the 11th Circuit Court of Appeals

dismissed, on motion by the appellants, the

two remaining appeals that had suspended

the payment obligations of 3M, Union

Carbide, and McGhan/INAMED respecting

distributions under the Revised Settlement

Program based on "post-8/84 McGhan

implants". This Court has directed the Escrow

Agent to begin distribution ASAP of the 80%

of these settlement payments that are, under

the RSP, the responsibility of 3M and Union

Carbide. It is anticipated that by the end of

this month those payments, that is, 80% of

the approved amounts, will be mailed to the

approved post-8/84 McGhan claimants. The

court will also be issing an order directed to

McGhan/INAMED calling for the payment of

their 20% share of the amounts distributable.

It is anticipated that McGhan/INAMED will

respond that they are unable to meet their

obligations under the RSP and that

McGhan/INAMED will then be declared in

default under the RSP. If this default occurs,

post-8/84 McGhan implant recipients who

had been participating in the RSP would then

be free to pursue cases/claims against

McGhan and INAMED. It is, however, further

anticipated that there would then be a

presentation to the court of a proposed

"limited-fund" Rule 23(b) mandatory class

settlement involving all claims against

INAMED and its various subsidiaries (such

as McGhan), which national counsel for the

plaintiffs believe might maximize the potential

benefits recoverable by implant recipients

from the INAMED group of defendants. Any

such proposed "limited-fund" class recovery

would have to be reviewed by the court and

could only be approved after appropriate

notice to (& hearing of objections from) the

affected class-members. Further information

regarding any such proposed limited-fund

mandatory class settlement will be provided.

Caruso Law Offices is currently accepting

cases from women who believe their attorney

committed malpractice in the handling of their

breast implant claim. While most attorneys

did an excellent job representing their clients,

some attorneys did not. Call Caruso Law

Offices at (800) 657-9292 for a free

telephonic consultation with an attorney.

Caruso Law Offices has been representing

women with breast implants since 1992 in the

old Global Class Action, the Revised

Settlement, the Mentor/Bioplasty settlement

and in private litigation.

Las Vegas (Business Wire): 4/16/98: Inamed

Corp. announced that it has entered into an

agreement with Minnesota Mining &

Manufacturing Corp. (3M) to resolve certain

indemnity claims by 3M arising from the 1984

sale of its plastic surgery business to

McGhan Medical Corp. This agreement

requires INAMED to pay a sum to 3M and to

assume certain limited indemnification

obligations in the future. The agreement

with 3M, however, is subject to INAMED

obtaining Court approval of a provisional

class settlement of INAMED's breast implant

litigation, which was announced last week.

No payment to 3M will become due sooner

than April 30, 1999, or 90 days after the

Court's final order with respect to the class

settlement becomes non-appealable,

whichever is later.

The cost of this agreement with 3M is already

incorporated in the anticipated $35 million

charge against INAMED's 1997 results of

operations, which was announced last week.

INAMED is a global surgical and medical

device company engaged in the

development, manufacturing and marketing

of medical devices for the plastic and

reconstructive, bariatric and general surgery

markets. Contact: INAMED Corp., Richard G.

Babbitt or Ilan K. Reich, 702/791-3388.

1/3/98, Sheryl Gay Stolberg,Washington. The

FDA tackled the thorny issue of financial ties

between doctors and the pharmaceutical

industry, requiring that physicians who test

new drugs and medical devices disclose

whether they have received stock, consulting

fees or other financial support from the

manufacturers. The regulations come more

than six years after the inspector general of

the Department of Health and Human

Services faulted the agency for failing to

impose financial disclosure requirements,

saying their absence left the government

vulnerable to fraud and abuse. Critics said

the new rules, which take effect in a year,

were long overdue. "That they had no policy

on this is shocking," said Michael Jacobsen,

executive director of the Center for Science

in the Public Interest, a Washington-based

advocacy group. "It's critical that the FDA

know this information and it's also important

that the public know."

For the most part, however, the public will not

know; the agency has decided that doctors'

financial information will routinely be kept

private. Exceptions will be made only when

the agency determines that a potential

conflict might have influenced the outcome of

a study; in that case, the panel of outside

experts that advises the agency on whether

to approve new drugs or medical devices will

be informed. "We want to err on the side of

protecting the individual," said Sharon Smith

Holston, the agency's deputy commissioner

for external affairs, ôunless we feel that the

public interest outweighs the privacy interest."

Pharmaceutical & biotechnology companies

routinely ask doctors in academia and private

practice to participate in testing of their new

products. There are no rules prohibiting those

doctors from investing in the companies (this

is particularly true with small biotechnology

firms) or from being hired as consultants. In

fact, that occurs with some regularity.

"Everybody in a university setting is getting

some type of compensation," said Alan

Goldhammer, an official with the

Biotechnology Industry Organization, which

represents 750 biotechnology companies.

"You may have an investigator who may be a

consultant for you. He may be an expert, and

you want him conducting your clinical trials."

Mrs. Holston, the food and drug official, said

she did not think such arrangements routinely

influenced investigators' judgments. But, she

said, "we have heard about financial interests

that we would probably have liked to have

known about."

An article published in The New England

Journal of Medicine last month found that

financial interests do apparently affect

doctors' views. As a window into the

question, the authors examined the debate

over the safety of calcium-channel

antagonists, which are used to treat

hypertension. They found that those who

supported the use of the antagonists were

significantly more likely than those who were

critical to have relationships with companies

that manufactured them.

Under the new rules, the FDA must be

informed when researchers have any

proprietary interest, like a patent, in the

products they are studying. The agency also

wants to know whether clinical investigators

have more than $50,000 equity in a drug

company during the time of their studies or

for one year afterward, or whether the

company has given the researcher more than

$25,000 in consulting fees, grants or

equipment during the time of the study or for

one year afterward. Goldhammer, of the

biotechnology organization, said his group

did not oppose the new rules. "Our members

are fully supportive," he said. "Our reading is

that it appears to be very reasonable."

Another major trade group, the

Pharmaceutical Manufacturers Association of

America, declined to comment, saying its

lawyers had not yet reviewed the new

regulations. Financial disclosure has long

been a requirement at the major medical

journals, including The New England Journal

of Medicine, where scientists publish their

work. Arthur Caplan, director of the Center

for Bioethics at the University of

Pennsylvania, said that in adopting similar

rules, the FDA had taken an important step,

but not a dramatic one. Both he and Mrs.

Holston said they did not think that the rules

would discourage financial ties between

doctors and industry. "Disclosure is

something minimally we should all expect,"

Caplan said. "But we have not yet had a

discussion about what is too much conflict

and what arrangements are unacceptable.

Disclosure is this country's solution to conflict

of interest and I don't think it goes far

enough."

Three New York physicians have agreed to

stop injecting liquid silicone into patients,

following and FDA investigation into the illegal

practice. Norman Orentreich, MD, David S.

Orentreich, MD, and Michael A. Kalman, MD,

of the Orentreich Medical Group in New York

City signed a consent decree last February

agreeing to stop using injectable silicone.

Use of the product is illegal because it is

neither approved by FDA for marketing or for

experimental investigation. "Consumers

should know that liquid silicone injections

have never been scientifically evaluated for

safety and effectiveness," said, David A.

Kessler, MD. "People who undergo these

injections are exposing themselves to

unknown, potentially dangerous risks." FDA

Consumer.

MEDICAL INFORMATION: Washington,

DC (AP), 1/26/98, The Pentagon violated

federal rules in giving an encephalitis vaccine

to American soldiers in Bosnia in 1996,

raising questions about how the Defense

Department performs medical research, the

Food and Drug Administration says. The

FDA, already probing problems stemming

from experimental drugs given to Gulf War

soldiers, ordered the Pentagon last month to

submit detailed procedures to ensure it will

follow FDA safety rules. The Pentagon

missed the Jan. 12 deadline, the FDA said,

but has promised a response soon. ôWe

want it resolved correctly and appropriately,

because none of us knows when there will be

the need to have another deployment'' in

which soldiers need experimental drugs, said

FDA senior policy analyst Bonnie Lee. The

Pentagon is working ôto improve compliance

during such circumstances in the future,'' said

Defense spokesman Lt. Col. Tom Begines.

But he stressed that the violations were

minor and that the encephalitis vaccine has

been given safely to millions of Europeans as

well as to the U.S. soldiers.

The issue first arose after Gulf War troops

received two experimental drugs as

protection against chemical and biological

warfare, when the FDA waived usual

requirements that let Americans choose

unapproved therapies only after being fully

informed of the risks. But the FDA says the

Pentagon violated its rules requiring that

troops be told the drugs were experimental

and that strict health records be maintained

to catch side effects. The drugs now are

under scrutiny for possible links to so-called

Gulf War syndrome.

The Pentagon acknowledged problems, but

in July the FDA said it had broken the rules

again while vaccinating nearly 4,000 soldiers

in Bosnia against tick-borne encephalitis.

The FDA does not consider the vaccine

dangerous. it is widely used in Europe but

not here because tick-borne encephalitis is

not a U.S. problem. Still, soldiers were

inadequately warned about side effects and

the fact that the vaccine was not FDA

approved and the 1996 vaccinations were not

properly recorded in many soldiers' medical

records, the FDA said. It cited a pattern of

violations that it will consider in debating how

to regulate future Defense Department

research.

1/ 29/98 Washington (CNN), Eugenia

Halsey: Many foods regularly eaten by young

children, such as apples, peaches, popcorn

and commercial baby food, often contain

trace amounts of a pesticide that exceed

federal safety standards, an activist group

claimed Thursday. Representatives of the

food industry call the allegations irresponsible

and deny the food is unsafe. Every day,

according to Richard Wiles of the

Washington-based Environmental Working

Group, more than 1 million children under

age 6 eat an unsafe dose of

organophosphates, a type of pesticide. The

group says organophosphates have the

potential to cause subtle, long-term damage

to the brain and nervous system.

EPA: Benefits outweigh potential risks The

U.S. Environmental Protection Agency said it

hasn't had a chance to study the report, but

that it's reassessing the safety of

organophosphates and has placed them at

the top of a list to be reviewed under a new

food safety law. At the same time, the EPA

stresses that parents should not stop giving

their children fruits and vegetables because

the benefits far outweigh any risks.

Food safety defended: Jay Vroom, a

spokesman for The American Crop

Protection Association that represents the

pesticide industry, says the allegations are

not based on scientific data. "They are

politically motivated and they have the

potential of unfortunately and unnecessarily

scaring parents who have to make critical

choices about what to feed our children," he

said. Major baby food manufacturers also

defended the safety of their products, saying

they make sure infants are not exposed to

unsafe levels of pesticides. The industry also

says it has banned or severely restricted the

use of organophosphates on crops used for

baby food. Still, sources say, the Clinton

administration is likely to take a tough stance

on these pesticides and will probably prohibit

some uses in certain foods or in the home.

1/30/98, London, (Reuters) Patricia Reaney:

Medical experts believe cases of hepatitis C

have reached epidemic proportions and

predict the lingering liver disease will kill more

people than AIDS over the next two decades.

ôHepatitis C has emerged from obscurity as a

disease familiar to only a few experts to being

recognised as a major public health problem

world-wide,'' Dr Adrian Di Bisceglie said in a

report in The Lancet medical journal. The

professor of internal medicine at the

University School of Medicine in St Louis, MO

and other experts believe deaths from

hepatitis C will triple in the next 20 years.

Many infected with the blood-borne virus will

require liver transplants and ôbetween one

and four percent of sufferers will develop liver

cancerö, he said.

There is no vaccine against the virus and

sufferers are advised not to drink alcohol

because it exacerbates the deterioration of

the liver. ôHepatitis C is now the major cause

of liver disease requiring liver transplantation

among adults in most countries. In the USA,

the Centres for Disease Control and

Prevention have estimated that hepatitis C is

responsible for 8,000 to 10,000 deaths each

year,'' Di Biscegile added. The development

of reliable diagnostic tests have shown how

widespread the disease is but because few

victims show symptoms, it is often detected

during routine health examinations or when

donating blood. Between one to two percent

of the population in most developed countries

is infected with the virus but the numbers are

much higher in some parts of eastern Europe

and Africa.

ôEgypt seems to have one of the highest

prevalence rates of all, approaching 15

percent of the general population,'' said Di

Bisceglie. The virus is a particular danger to

intravenous drug users. Screening has

reduced infection through blood transfusions

but cases of sexual transmission and from

mother to child have been reported. Doctors

at the University of Verona in Italy said in a

report in the New England Journal of

Medicine on Wednesday that all sufferers

should be vaccinated against the related but

less serious hepatitis A virus which can

dramatically increase their risk of dying.

Hepatitis A is found in food and drink

contaminated by faecal material. Di Bisceglie

said the antiviral drug interferon had reduced

symptoms in up to 20 percent of patients with

hepatitis C who were treated for six months.

In some cases the virus disappears from the

blood and the inflammation of the liver is

reduced.

Center For The Advancement Of Health,

1/26/98: Natural Killer Cells Need A Good

Night's Sleep: Disrupted sleep may be

weakening the immune systems of elderly

widows and widowers, new findings suggest.

Researchers at the UPMC Health Systems

(UPMC) Western Psychiatric Institute and

Clinic in Pittsburgh studied 29 patients aged

40 to 78 who were seeking treatment for

bereavement-related depression. Each

patient spent three nights in a sleep lab as

part of a double-blind, placebo-controlled

study of the treatment of bereavement-

related depression between 1995 and 1996.

None of the subjects had any infectious

illnesses at the time and all were

experiencing their first lifetime episode of

major depression.

Analysis of their blood samples showed that

those whose sleep had been disrupted had

decreased levels of natural killer cells

(NKCs), which take their name from the way

they help destroy illness-causing cells. A

decreased NKC count indicates a weakened

immune system and a body more vulnerable

to illness. The study, published in the

January-February issue of Psychosomatic

Medicine, "provides the first direct evidence

that...sleep disruptions are associated with

the stress-immune relationship in humans,"

the researchers write. "Stress-related

intrusive thoughts and avoidance behaviors

were associated with greater time spent

awake during the first sleep cycle which, in

turn, was associated with lower numbers of

circulating NKCs."

The findings prove that maintaining good

sleep is important for the elderly to maintain

health, according to the primary author,

Martica Hall, PhD, of the University of

Pittsburgh Medical College's Department of

Psychiatry. She said the findings show the

importance of developing interventions that

reduce illnesses caused by stress-related

sleep disruptions. Although sleep disruptions

associated with bereavement or other

stressful life events may play an important

role in illness susceptibility, Hall said, it is not

yet known whether doctors can improve

patients' health by improving their sleep. "We

know that it is better to treat the underlying

problem, bereavement-related depression,

than to simply treat the symptom, disturbed

sleep, with a sleeping pill," Hall said. "The

potential health benefits of treating

bereavement-related depression, including its

sleep disruptions, is one of the research

avenues we are now following."

Arlington Heights, 4/13/98 (PR Newswire):

The number of women having breast

augmentation increased three-fold between

1992 and 1997, says the American Society of

Plastic and Reconstructive Surgeons

(ASPRS). In 1992, 32,607 women sought

the procedure while the number jumped to

122,285 in 1997. The ASPRS study provides

statistics on the procedures performed by

member plastic surgeons certified by the

American Board of Plastic Surgery. "One

likely reason for the marked increase is that

1992 was the height of the silicone gel breast

implant controversy, so women may have

been hesitant to undergo the procedure back

then," notes ASPRS President Dennis Lynch,

M.D. "Although silicone gel is no longer

widely used for implants, studies have shown

no conclusive evidence that silicone gel

implants are linked to connective tissue

disease," Dr. Lynch continues. "ASPRS

members' primary concern is the health of

their patients and we are working with the

FDA and other health organizations to

determine if silicone gel implants pose any

health threat to women."

The recently released ASPRS study also

provides age brackets of breast

augmentation patients: ôSixty percent of

women who had breast augmentation in 1997

were between the ages of 19 and 34. Just

over one-third are between the ages of 35

and 50. More information on breast

augmentation can be located through the

ASPRS web site. In-depth information on

virtually all aspects of plastic surgery

statistics is located on the internet at:

www.plasticsurgery.org in the National

Clearinghouse of Plastic Surgery Statistics or

by calling the media relations manager at

847-228-9900 ext. 349. Consumers may call

the Plastic Surgery Information Service at

800-635-0635 for more information.

1/2/98, London, (Reuters), Patricia Reaney

British researchers said on Monday they had

developed a new scanning technique that

could lead to less surgery for women with

breast cancer. Using special antibodies that

attach themselves to cancerous cells and a

tiny amount of radioactivity, it can determine

whether malignant cells have reached the

lymph nodes under the armpit and are more

likely to spread to other parts of the body.

Up until now the only sure way of knowing if

nodes are malignant was to remove them in

a painful operation and examine them in a

laboratory.

The new technique, developed by doctors

from the Imperial Cancer Research Fund

(ICRF) and St Bartholomew's Hospital in

London, will give doctors an indication if

surgery to remove the nodes is necessary

and eliminate the need for an operation in

women with no sign of cancer spread. ôIf a

node is positive it can be removed and

looked at by pathology to double check if

cancer is present. That way we can tell

women in advance exactly how extensive

their breast cancer operation is going to be,''

Keith Britton, head of the ICRF Nuclear

Medicine Unit, told a news conference.

Results of a pilot study of 29 breast cancer

patients, published in the British Journal of

Cancer, showed it was 90 percent correct in

predicting cancer spread.

The results need to be confirmed with other

studies and the technique will be used in

other clinical trials. But Britton said it would

not be available to all breast cancer patients

until it is licensed to a commercial company.

ôIt is a phenomenon of the modern age that it

has to go through a commercial process in a

capitalist society,'' he told the news

conference. ôThe commercial market is very

small because it is less viable on a

commercial basis than a blood pressure

tablet,'' he added. The scanning method

uses monoclonal antibodies (MAbs) designed

by ICRF scientists that locate and stick to

cancer cells. The MAbs are armed with a

tiny amount of radioactivity and injected into

the patient. ôPictures are taken twice over 24

hours using a gamma camera and a

computer then compares the two images

showing the probability of a tumour being

there,'' Britton explained.

He said other antibodies are already being

used in the United States and Canada but the

ICRF's is the latest generation. In addition to

determining the need for surgery, Rob

Carpenter, a surgeon at St Bartholomew's,

said the technique could also be an important

prognostic tool. ôAnything that removes an

area of uncertainty is beneficial,'' he said. An

estimated one in 12 women will develop

breast cancer sometime during their life. It is

the most common form of cancer among

women and mainly strikes those over the age

of 60. Although the number of cases are still

increasing, thanks to new screening

methods, earlier detection, chemotherapy

and hormone treatments following surgery,

the number of people who die from the

disease is decreasing.

Jackson, MS. Spitting in a cup to diagnose

breast cancer may be years away, but

current research makes it seem like a real

possibility. Dr. Charles Streckfus, a

University of Mississippi Medical Center

scientist, has a new grant to elaborate on a

pilot study that reported cancer markers in

saliva for the first time. Streckfus, professor

of diagnostic sciences in the School of

Dentistry, received a James A. Shannon

Director's Award from the National Institutes

of Dental Research (NIDR) to test saliva in

160 women to see if certain markers indicate

the presence of breast cancer.

This study, funded for $62,500 from NIDR,

follows preliminary work in which 28 women

were tested. Those results indicated sufficient

correlation to warrant further study, Streckfus

said. The pilot study, in fact, was the first

report of cancer markers in saliva and the

first observation of elevated levels among

women with breast cancer. The markers

were at very low levels or nonexistent in

women who did not have cancer and

significantly elevated in patients who had

cancer. The cancer markers Streckfus is

testing for are CA 15-3, a cancer antigen,

EGFR, a growth factor receptor, Cathespin-

D, and Waf 1, an oncogene. Oncologists at

the Medical Center enlisted their patients as

volunteers. The larger collaborative project

will enroll four groups of women: those who

have never had breast tumors, those who

have had non-malignant breast tumors, those

who have cancer in the breast only and those

whose breast cancer has spread to other

parts of the body.

"Our pilot test was small. We only tested 28

women. This larger study will allow us to look

at variables such as the size of the tumor.

We know from our small study that the saliva

test is sensitive and can detect the presence

of these markers in women with breast

cancer. Now we'll make sure of its specificity,

whether it will pick up cancer and nothing

else," Streckfus said. "That's the crux of a

good diagnostic test." Streckfus, one of

several "spit doctors" in the country, decided

several years ago that the same markers

scientists looked for when they pulverized a

tumor specimen had to be present in blood

and saliva. "The technology has just gotten

so much better in the last few years. We're

able to detect amounts much smaller than

we've ever been able to detect before.

Sometimes it's like looking for a grain of salt

in a swimming pool full of water." The

Shannon award, half of which comes directly

from the NIH director's budget, is designed to

fund promising research projects that could

be the basis for larger-scale research. "If we

get good results from this series of patients, I

think we'll be in a position to do a much larger

study with many more patients," Streckfus

said. "And if we get really lucky, this work

could ultimately mean that a home test for

breast cancer could be developed."

A simpler test for diagnosis of recurrence

could also be a boon for patients who've had

radical mastectomies. "Obviously, those

patients can't have mammograms," Streckfus

said. The results of Streckfus' preliminary

study were published in the Journal of the

American Dental Association and reported at

the Southwest Oncology Group meeting in

October & at a meeting of the Gerontological

Society of America in November.

"Someday, women may be able to be

screened for breast cancer at health fairs,"

Streckfus said.

Silicone granulomatous, lymphadenopathy

and siliconomas of the breast. Source:

Histology of Histopathology, Æ97 Oct;12(4):

1003-11. Author(s): Vaamonde R; Cabrera

JM; Vaamonde-Martin RJ; Jimena I; Marcos

Martin J.: In this study, two histologically-

distinct cases of granulomatous

lymphadenitis induced by dimethyl-

polysiloxane (silicone polymer) implants were

studied. Four and six years after implant, and

following surgery for breast cancer, painful

homolateral axillary adenopathies were

observed and biopsied. In both cases,

histological examination led to a diagnosis of

"silicone-induced granulomatous adenitis"

requiring removal of implants. Foreign-body

granulomas (siliconomas) were observed in

surrounding tissue with no apparent rupture

of implant capsules; however, visible

retraction, hardening and scattered

calcifications were noted. The presence of

silica was revealed by incineration of a

number of biopsied lymph nodes, a technique

not hitherto used in the study of this

pathology. A review is offered of the literature

available. Author's Address: Dept. of

Morphological Sciences, College of Medicine,

University of Cordoba, Spain.

The Sunday Times, January 11, 1998,

Scandal of nip and tuck cowboys, By Paul

Nuki and Andrew Alderson. Many of Britain's

best known private clinics are using

unqualified plastic surgeons to carry out

operations which in some cases are leaving

patients scarred and disfigured. The centers,

which boast in glossy magazines and

brochures that they use accredited

specialists, in fact employ doctors who have

nothing more than the most basic general

medical qualification. In one case uncovered

by a Sunday Times investigation a GP with

no specialist surgical qualifications, and who

was jailed for smashing a glass in a man's

face, left a woman patient scarred for life

after a liposuction operation went wrong. The

recent boom in "cowboy" clinics, which use

hard-sell tactics for facelifts, breast

enhancements and nose restructuring, is

causing anger and frustration among the

medical profession.

In a letter leaked to The Sunday Times,

Professor David Sharpe, president of the

British Association of Aesthetic Plastic

Surgeons (BAAPS), highlighted his concerns

to Mattie Alderson, director-general of the

Advertising Standards Authority (ASA). "Our

association is aware of a large number of

very unscrupulous organizations who

advertise frequently in the back of women's

magazines. Many of these organisations

have been responsible for disfigurement and

complications in patients who they have

obtained through misrepresentation of their

accreditation." However, the letter reveals

the pressures placed on respectable

surgeons not to "disparage" unaccredited and

incompetent colleagues who cause

"heartache and misery" to gullible patients. "It

would be against GMC (General Medical

Council) ethical guidelines for us to criticize

other surgeons, even though know that many

are insufficiently qualified & misrepresenting

their abilities."

An estimated 65,000 people a year undergo

surgery to improve their appearance and

experts say that up to 20% of those operated

on need corrective surgery later, placing a

considerable burden on the National Health

Service. Last month Eda Watson was paid

$20,000 in compensation after suing the

Transform Medical Group (which has 18

clinics nationwide) and Dr. Thomas Amadeus

Kleran Norton, for negligence and breach of

contact over a liposuction operation. After

taking legal action, Watson learnt that in 1984

Norton had been jailed for nine months after

admitting illegally obtaining morphine to feed

an addiction. He was also found guilty of

wounding after smashing a glass into the

face of a man who was left scarred for life.

Watson, 53, from Sheffield, South Yorkshire,

who paid $6,000 for the operation, said: "I

assumed I would be operated on by a

qualified plastic surgeon. But in the event I

was operated on by someone without those

surgical qualifications. I woke up in agony

during the operation and have been left

disfigured ever since." In recent months the

ASA has upheld numerous complaints

against private clinics for exaggerating their

status and the qualifications of their staff.

The complaints were brought by Asem

Mohammed, a former patient who is

campaigning to clean up the industry.

The Pountney Clinic in Hounslow, West

London, has had at least three adjudications

against it after advertising itself as "the

leading cosmetic surgery hospital in Europe,

employing surgeons with extensive plastic

and cosmetic surgical experience gained in

the NHS." Last week the clinic was still

making the same unfounded claims. When a

reporter asked if its staff were fully qualified

plastic surgeons, he was told: "Yes, indeed.

They are all fellows of the Royal College of

Surgeons (FRCS), which is the highest you

can go." In fact, none of the three doctors

used by the clinic, Phillp Yates Graham,

Saifeddin Khan and Armando Philip Ernest

Cason, is on the register of specialist

clinicians held by the GMC. Furthermore,

concern over the misuse of the FRCS

qualification led to the introduction in 1991 of

nine surgical qualifications denoting specialist

skills in particular fields, including plastic

surgery.

Other claims made last week by clinics

including the Belveder in London, was that

they employed "fully qualified cosmetic

surgeons." However, the term is

meaningless, the RCS does not recognize

cosmetic surgery as a specialty and only

holds exams for the specialism of plastic

surgery. The Pountney and Belvedere clinics

yesterday denied misleading prospective

patients. A spokesman said: "We are not

involved in plastic surgery and that term

should not be used. We specialize in

cosmetic surgical procedures in which all our

doctors are fully experienced, and we do that

very well." David Hinchliffe, the Labour

chairman of the Commons all-party select

committee on health, said he was alarmed by

the findings of the paper's investigation and

would raise his concerns with Frank Dobson,

the health secretary, this week. Source of

info.: Margo Cameron & Shirley Goodner,

The Networker.

1/16/98 Westport: Dextromethorphan, an

ingredient in some cough medicines, has

been shown to cause birth defects and fetal

death in chicken embryos exposed to

concentrations relative to those typically

taken by humans, according to a paper in the

January issue of Pediatric Research. Dr.

Thomas H. Rosenquist and colleagues at the

University of Nebraska gave chicken

embryos various doses (5/50/ or 500

nanomoles/deciliter) of this drug over three

consecutive days. More than half of those

given the highest dose died, while about one-

eighth of the survivors developed congenital

defects including "...neural tube defects such

as spina bifida, facial defects similar to cleft

palate, as well as cranial defects," a

University press release explains.

ôDextromethorphan was also highly lethal at

50dc, the team writes in the Pediatric

Research paper. According to Rosenquist,

these findings add weight to recently reported

findings from the Baltimore-Washington

Infant Study in which a history of cough

medicine use emerged as a risk factor for

congenital malformations. ôWe found that

dextromethorphan causes defects so early in

the development of the embryo that in many

cases the woman wouldn't even know she is

pregnant," Rosenquist said in the statement.

"We feel that a single dose is capable of

causing a birth defect and that, ultimately, it

could be the cause for a woman to have a

miscarriage."

Dextromethorphan suppresses cough by

acting on receptors in the adult central

nervous system. But in embryos, the drug

appears to "knock out" the receptors, thus

leading to the defects. Further study is

needed, but in the meantime, Rosenquist

suggests that pregnant women be advised

not to use dextromethorphan-containing

cough medicine. "Although we used chicken

embryos in our study, modern molecular

biology shows that the same genes regulate

early development in virtually all species -

from insects to worms to humans," said

Rosenquist. "Based on this, it can be

predicted that the effects dextromethorphan

had on the chicken embryos also would occur

in human babies." Source: Pediatric

Research (1998;43:1-7) (Reuters)

NY (Reuters): Scientists say fetal exposure to

environmental pollutants such as dioxins and

polychlorinated biphenyls (PCBs) may

impede neurological development, lower

adult IQ and increase the risk for attention

deficit hyperactivity disorder (ADHD).

"Exposure to certain synthetic compounds,

including dioxins and PCBs, during the

perinatal period can impair learning, memory

and attentional processes in offspring,"

concludes a report led by Dr. Peter Hauser of

the Baltimore Veterans Affairs Medical

Center in Maryland. The study, published in

the current issue of the journal Toxicology

and Industrial Health, was based on a review

of the scientific literature devoted to the

subject. Hauser and his colleagues believe

that both dioxins and PCBs may slow

intellectual development by disrupting the

normal activity of thyroid hormones,

hormones necessary to neurological growth.

The researchers speculate that PCBs are

"substances that are capable of producing.

changes in the developing nervous system

but are without any effects when

administered to adult animals," including

humans. They believe the "fetus is more

sensitive to the thyroid-disrupting effects of

dioxin-like compounds."

Mass environmental poisonings, such as

those occurring in Japan in 1968 and Taiwan

in 1979, have shed light on the direct effects

of dioxins upon the developing fetus. "In both

countries," the researchers say, "perinatal

exposures of children to contaminations were

shown to result in (postnatal) developmental

delays and impaired cognitive functions." And

they say that most of "these high-level

perinatal exposures resulted in hyperactivity,"

a hallmark of ADHD.

A genetic disorder called "resistance to

thyroid hormones" (RTH) is known to produce

similar symptoms in both children and adults.

The researchers believe RTH could serve as

a study "model" for the impact of

environmental pollutants upon fetal

development. RTH is caused by specific

genetic mutations that make it either difficult

or impossible for protein receptors in the

nervous system to "recognize" specific

thyroid-secreted hormones. Hauser's team of

researchers reports that one of their previous

studies found that "children with resistance

(to thyroid hormones) had a 10-fold higher

likelihood of the diagnosis of ADHD than their

unaffected siblings." And they say IQ scores

were 10 points lower on average in RTH

children compared with their healthy siblings.

The study authors urge further studies

comparing the effects of genetically-based

RTH with those of environmentally-linked

fetal dioxin contamination, "to help elucidate

the role of thyroid hormone and the thyroid

receptor in brain development." Such studies

might help researchers better understand

both conditions, and "provide guidance for

treatment and prevention." Source:

Toxicology and Industrial Health (1998;34:85)

Charlene Laino, MSNBC: A new study adds

to mounting evidence that viruses can trigger

the chronic muscle weakness and neurologic

impairment of multiple sclerosis. The study,

which appears in the December issue of the

journal Nature Medicine, found that a strain

of the common herpes virus may be

associated with the unforgiving disorder in

which the body attacks its own tissues.

æWeÆve suspected a possible role for a virus

in MS for quite some time and these results

certainly point to this particular virus.Æ

Steven Jacobsen, National Institute of

Neurological Disorders and Stroke. The

study, the first to suggest a link between

herpes and MS, points to the potential role of

anti-herpes drugs in treating the often

untreatable disorder, experts said.

ôWe expect that currently available anti-viral

treatments, or example, acyclovir, might one

day be applied successfully to MS,ö said

Steven Jacobson, chief of viral immunology

at the scientists at the National Institute of

Neurological Disorders and Stroke in

Bethesda, MD. and the studyÆs principal

investigator. ôWeÆve suspected a possible

role for a virus in MS for quite some time,

and these results certainly point to this

particular virus.ö In the study, more than

one-third of MS patients had detectable

levels of active human herpes virus-6 (HHV-

6) in their blood, Jacobson reported.

As many as 350,000 Americans are affected

by MS, which most often strikes between the

ages of 20 and 40 and is characterized by

muscle weakness, visual disturbances and,

eventually, disability and paralysis. MS is

characterized by the inflammation and

eventual destruction of myelin tissue, the

protective covering of the nerve cells in the

brain and spinal cord. HHV-6 appears to

speed up the breakdown of the protective

myelin covering, Jacobson said, causing

symptoms to worsen. The next step, he said,

is to figure out why infection with such a

common virus causes disease in so few

people. A different strain of the virus that

causes genital herpes, HHV-6 causes the

common childhood illness roseola. It is not

sexually transmitted. HHV-6 is present in 90

percent of the adult American population as a

result of infection during the first few years of

life, Jacobson noted. In MS, the virus, which

has been dormant for years, is somehow

reactivated, he said.

In the new study, the investigators detected

HHV-6 DNA, a marker of active virus

infection, in the blood of 15 of 50 MS

patients. All 47 healthy volunteers MS tested

negative for the presence of active HHV-6

viral infection. Additional testing for the

presence of HHV-6 virus in larger numbers of

MS patients as well as those with other

autoimmune disorders is under way.

From staff and wire reports 4/18/98,

University of Alabama, Birmingham: Sleuths

and other medical researchers looking

into a puzzling outbreak of brain tumors

at an Amoco Corp. research center say they

have made an important step toward finding

the cause of the problem. Since 1989, 17

cases of head tumors have turned up among

research and development workers at

AmocoÆs Naperville research center outside

Chicago. Seven of the victims have been

diagnosed with the deadly form of brain

tumor called glioma, all of them men, though

more than a third of the employees in the

complex are women. Four of the glioma

patients have died. At least five of the men

worked in Building 503. Most worked on the

building's third floor, and three were in one

laboratory. All seven worked in similar

chemical research projects, although mostly

not in the same place or at the same time.

That limits the scope of the investigation to

about 34 projects among the thousands

conducted at the center in the past 28 years.

''We're starting to see some patterns

emerge,' 'Michael S. Wells, Amoco's

manager of epidemiology, told the Chicago

Tribune. All seven men diagnosed with

gliomas worked in polymer research and

catalyst development, Wells said. At least

two overlapped on 34 projects, three of the

men worker on one project. Because all

worked on the same general subject area,

they probably used many of the same

materials: a wide range of metals. ''We know

that some metals are neurotoxins,'' Wells

said, adding none of the metals in these

projects have been linked to brain tumors.

Researchers from the Univerisity of Alabama

at Birmingham (UAB) and Johns Hopkins

University in Baltimore have been hired by

Amoco to solve the mystery. They

determined that seven cases would be within

a normal range of probability for the 8,000

people who have worked at the complex, but

that it is abnormal for so many

people to be affected in part of one building.

''That's about seven times higher than what

you'd expect,'' Wells said. UAB

epidemiologists began working on the

mysterious outbreak in 1996, soon after

Amoco closed and entire floor at its research

center after two employees there were

diagnosed with brain tumors. UAB

researchers Dr. Philip Cole & Elizabeth

Delzell are part of a team that is

world-renowned for industrial or occupational

epidemiology.

Epidemiology is a specialty of public health

that studies the incidence and distribution of

disease to help control it. In cases of

infectious disease such a food poisoning

outbreak, epidemiologists try to link illness to

the eating a certain kind of food, so the

source can be found. Cole and his UAB

colleagues do workplace epidemiology, to

see if factors in the factory, lab or office

relate to workers' diseases. Amoco's

research park in Naperville employed an

estimated 2,000 people in 1990, but

downsizing has cut the work force to 1,000

by 1996. Seventeen people worked on the

third floor before it was quarantined. Amoco

hired UAB to do a two-year study

checking the cause of death of every

employee who has worked in the lab since its

opening in 1970, interviewing all current and

former employees to find any cases of brain

tumors or other cancers and finding out what

chemicals the workers in the closed building

used. The UAB researchers also were to

compare the cases of workers who got brain

tumors with medical histories of lab workers

who did not get tumors. Earlier studies

monitored by the Mayo Clinic and the

University of Illinois-Chicago did not find a

link between the laboratories and the tumors.

Amoco officials said they moved the

Employees off the third floor because they

didn't want to take any more chances.

Washington, DC (Business Wire), 2/4/98

Americans are about to experience the food

industry's version of a fraternity prank. Frito-

Lay, Procter & Gamble and other companies

are about to start marketing fat-free foods

made with olestra, which causes diarrhea

and cramps and that rob the body of

nutrients. More than 2,000 people in

previous test markets have told P&G or the

Center for Science in the Public Interest

(CSPI) that olestra caused gastrointestinal

symptoms in themselves or relatives. At least

18 people experienced such severe

symptoms that they went to the hospital and

many others called their doctors. P&G says

that all those cases were just coincidences.

But Michael Jacobson, executive director of

the nonprofit CSPI, said, "It must be the

biggest coincidence in history that all those

people, shortly after eating olestra snacks,

experienced exactly the symptoms that

P&G's tests proved that olestra causes."

Based on earlier surveys, CSPI says that

about two percent of consumers per eating

occasion will experience adverse effects.

CSPI projects that olestra will cause adverse

effects in millions of people and severe

effects in tens or hundreds of thousands of

people. Mark Brown, CSPI's director of

toxicology, said, "From a public health

perspective, it is crazy to allow into the food

supply an additive that will almost certainly

cause an enormous amount of pain and

discomfort." CSPI maintains a toll-free hot

line (888) OLESTRA, for consumers to call if

they believe olestra made them sick. CSPI

provides the information on a confidential

basis to the FDA.

Olestra's serious long-term problem is that it

inhibits the body's absorption of carotenoids,

fat-soluble nutrients that experts believe

protect consumers from heart disease and

cancer. Walter Willett, chairman of the

nutrition department at the Harvard School of

Public Health, and Meir Stampfer, an

epidemiologist in that department, have told

the FDA that they estimate that widespread

use of olestra in snack foods alone could

cause several thousand deaths annually.

Because of olestra's effects on carotenoids,

Tim Byers, professor of preventive medicine

at the University of Colorado Health Sciences

Center, said, "Olestra-containing products

should come with a warning label stating: `Do

not eat this product with food.ö P&G

spokespersons have been feverishly trying to

persuade journalists and the public that two

new studies show that olestra doesn't cause

gastrointestinal problems. The company says

that the symptoms were equally common in

people who ate olestra chips or regular chips.

"Hogwash and junk science," scoffed CSPI's

Jacobson. "P&G's two recent studies were

designed to miss what its own previous

studies showed: that olestra causes diarrhea,

cramps, & other gastrointestinal symptoms."

Toxicologist Brown said, "Given the high

background rates of symptoms, it was

predictable even before the studies were

begun that 1 or 2 time consumption of olestra

would not have caused enough problems to

be detected. In an earlier, better P&G study

that retested people who suspected that

olestra caused problems, olestra was proven

to cause severe diarrhea, according to an

FDA medical officer." The FDA requires P&G

to add vitamins A, D, E and K to olestra, but

not beta-carotene, lycopene and other

carotenoids. If the FDA approves the use of

olestra in shortening, ice cream and other

foods, all the problems olestra causes would

be proportionately greater, warns CSPI. The

FDA requires products containing olestra to

bear a small notice that includes the

statement: "Olestra may cause abdominal

cramping and loose stools." Procter &

Gamble and Frito-Lay have urged the FDA to

eliminate the notice on small packages and

make it less visible on other packages. While

CSPI opposes olestra, it does not oppose

low-fat snacks or other fat substitutes. CSPI

advises people to buy any of the many

brands of baked potato or tortilla chips. "Not

only are they delicious and cheaper than

olestra chips," said Jacobson, "they are

perfectly safe."

CSPI is a nonprofit health-advocacy

organization that focuses on nutrition and

food safety. It is based in Washington, D.C.,

and is supported largely by the one million

subscribers to its Nutrition Action Newsletter.

ALTERNATIVE MEDICINE:

Nutraceuticals, or bioengineered food

products intended to provide specific health

benefits, are currently under development in

industrial research laboratories with a view

toward a new health-centered supermarket of

the future. At a press conference in New

York City on Friday sponsored by General

Nutrition Companies, Inc.(GNC), substances

ranging from dietary supplements to

nutritionally enhanced vegetables, grains,

eggs, and meats were touted as a potential

boon for disease prevention and healthful

living. However, some experts say the risks

inherent in the genetic remodeling of foods

and consumer preference for "natural" items

may pose persistent problems in the mass

marketing of nutraceuticals. Proponents of

the fortified products are optimistic. "We're

asking, 'is there a way that we can delay the

onset of diseases, maybe reduce the

symptoms and improve the quality of life

through better nutrition? We believe that

(nutraceuticals are) a viable scientific and

business proposition," Diana L. Twyman of

Monsanto Corporation told reporters at the

conference.

Citing increased consumer awareness of the

link between diet and health, OmegaTech,

Inc. President Mark Braman said that the

food industry is "moving beyond reducing the

negative (components) in foods such as fat

and cholesterol, with a focus on adding

healthful components back into food.

Imagine a supermarket where each food

category is subdivided for consumers who

have back problems, are at risk for

cardiovascular disease, obesity, arthritis or

other diseases. Imagine great tasting foods

that help protect the body from major

diseases and environmental damage."

One example is an egg enriched with

docosahexaenoic acid, or DHA, a fatty acid

important in the functioning of the nervous

system, heart, and brain. "This egg delivers

nine times more DHA ...than a regular egg,"

asserted Braman. OmegaTech plans to

market the egg in the US soon. "We're on

the steep end of the learning curve about

health benefits and issues associated with

foods and supplements," said Dr. Mark

Dreher, director of scientific nutrition affairs at

Nabisco, Inc."The relationship between diet

and health is complex and in many areas a

scientific consensus does not exist," he

added, stressing the need for government

and industry "to assess the scientific basis for

safe food products and ingredients that

provide significant health benefits." Story by

Kathleen Splessabach, American Journal of

Epidemiology (1998;147:127-135)

CODEX - STILL ALIVE & WELL AND

THREATENING OUR HEALTH FREEDOM,

by Jan Rosenstreich: I have been writing

about CODEX for over a year. Some people

know all about this, while others are first

hearing about it. Here is a quick review

about what CODEX is all about: This is

excepted from the CODEX COMMISSION: A

NEW THREAT TO VITAMIN & SUPPLEMENT

AVAILABILITY (The following is by Ken

Anderson, 1496 Pritchard Rd, Evans,

Washington 99126, & is copied from

America's Promise Ministries news, PO Box

157, Sandpoint, Idaho 83864).

"Under GATT, the nations of the world can

and are being penalized heavily by the World

Trade Organization if they oppose the

decisions of Codex (which are influenced

heavily by the large drug cartels and

multinational corporations). " "Under GATT,

member nations (such as the United States)

must "harmonize" their rules governing the

manufacture of health products with new

international standards so as to be "in line"

with them." "Each nation can either accept

the dictates of the Codex Alimentarius

Committee on Nutrition and Foods for Special

Dietary Uses regarding labeling and

manufacture of dietary supplements, or it can

create its own standards, provided they

conform to GATT's standards on cost/benefit

analysis and on creating and reviewing

scientific data for risk assessment. This

could be the greatest threat to health

freedom in the world today! "

CODEX harmonization is spreading as many

countries are pushing through laws and

rulings to put them in line with the proposed

CODEX initiatives. There is a real threat that

people throughout the world will lose their

right to obtain the vitamins and supplements

they need at the potency and price they can

afford. There is a movement to classify

vitamins & supplements as prescription

drugs. This is already occurring in Norway,

Germany & Canada and spreading. There is

(was) a bill in the United States Congress

that would add harmonization language.

Read the following 2 articles for more

information and WHY you should be

concerned.

CODEX ALIMENTARIUS by Peg A Wright.

There is great DANGER that most of our

VITAMIN'S, supplements, and herbs may be

inaccessible in the very near future if we don't

act immediately! Any available vitamins other

than low RDA doses may require a Doctor's

prescription because they will be reclassified

as drugs. They will also be exorbitantly

priced. Many herbs and supplements may

be totally inaccessible. St. John's Wort will be

pharmaceutically reproduced and only

available through a Doctor's prescription

(through a company that has discovered this

process, they intend to go down the list and

pharmaceutically reproduce the most popular

and useful herbs.) In September the bill

passed in the Senate 98 to 2. In October it

was brought to the House of Representatives

with one hour's notice and was passed under

suspension (which means that no debate was

allowed and no Congressman was allowed to

propose and amendment to exclude dietary

supplements from this bill. The bill is

currently at Committee and will be back in the

House within days. (This was late last Fall).

Please read the following article for further

understanding of the Codex bill and THE

HARMONIZATION THREAT: CODEX

ALIMENTARIUS, by Ralph Metzner, Ph.D.

Dear All "Health-minded Americans are

presently facing the greatest threat to the

freedom of health choice ever before

encountered, through an organization known

as the UN/WHO CODEX... The Codex is in

reality an underhanded, politically motivated,

weakly disguised attempt by the international

pharmaceutical cartel to limit access to many

popular, safe and cost-effective nutritional

and herbal supplements in order to take

control of the alternative healthcare industry."

(from a letter by Mitchell Fleischer, MD, Univ.

of Virginia). It's part of the more general

take-over of the global economy by the

multinationals through WTO, courtesy of

GATT and NAFTA. An insidious bill, called

CODEX ALIMENTARIUS or the CODEX

LAW has already been sneaked through both

the Senate and House of Representatives in

record time. It has been passed by both

houses. The Codex is a nutrition code to set

worldwide standards for foods, drugs,

pesticides and their trade. The latest German

proposal includes the following provisions: 1.

No vitamin, mineral, herb or food supplement

can be sold for preventative or therapeutic

use. 2. None sold as a food can exceed

dosage levels set by the Commission. For

example, 50 mg of vitamin C is the top

dosage sold in Germany today. 3. CODEX

regulations for dietary supplements would

become legally binding in the USA through

the GATT Treaty, which would involve

enormous fines in America if we did not

comply. 4. All new dietary supplements will

be banned unless they pass the CODEX

approval process. You can imagine what

that means.

The wording in the Congressional Bill uses

the term "harmonization" which means that

most senators and congresspersons are

likely not aware of the implications. The

delegates that make up and decide on the

CODEX mandates are made up of 90% of

the giant Multi-national Pharmaceutical

corporations. The drug companies want to

monopolize and create pharmaceutical

versions of the Natural health food and

nutrient business throughout the world. An

example of the consequences: possession of

DHEA is now a felony in Canada with the

same penalty as that for possession of drugs.

You could go to jail for having DHEA in your

house. These bills passed the House and

Senate. Most of our congresspeople simply

think they are uninforceable in the US and did

not worry about their implementation. If you

believe in freedom to choose vitamins freely,

write: Dr. Elizabeth Yetley, FDA Office of

Specific Nutritionals; HFS-456, US FDA; 200

C Street, SW; Washington, DC 20204. Tel:

202-205-4168; Fax: 202-205-4168.

INFORMATION AVAILABLE: I continue

to find that my magnetic mattress and other

magnetics, along with coral calcium and

natural vitamins, minerals, enzymes, amino

acids, etc. are helping me with my healing

and staying well! If you need a good

program that will contribute to your healing

and wellness, contact me for information! I

was near death in 1991-93, now I am

functioning fairly well most of the time! I am

one of many who have found that wholistic

medicine is the answer! Call me (303) 469-

8242 for information about these products.

THIS MONTH'S POEM:

Plastic SurgeonÆs Refrain (Soy Bean Implants)

By Lynda Roth

If your life is a bore

And you donÆt feel pretty

Come see us now and

Have some new tofu titties.

We have the answer

To your deep despair

Some see how you look

With a brand new pair.

No guarantees for life

Just a quick fix

ItÆll cost you plenty

We donÆt do it for kicks!

If you have problems

DonÆt call us back

We wonÆt be around

For any of your flack!

Just get the boob job

And then go away

But before you leave

Be sure to pay!

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: Auto-immune 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. 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; MeniereÆs

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;

Legal info. and info. on Alternative Medicine Info.

contained in most issues.

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C.O.S.S. 05/01/98

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