Dear Silicone Survivors and Friends:

As the saga of the tumor markers continues, we have found no evidence of a

return of the cancer. One surgery and some polyps later, I am still not

convinced that any cancer exists.

LEGAL INFORMATION: The Nevada Supreme Court yesterday upheld a $4.1

million jury verdict for Charlotte Mahlum, a 41-year- old Elko, Nevada

woman, for injuries sustained as a result of the rupture of her silicone

gel breast implants. The jury verdict is the first in the nation to be

upheld on appeal against Dow Chemical Company, the parent corporation of

Dow Corning Corporation, which filed for bankruptcy in May of 1995. Ms.

Mahlum had Dow Corning breast implants in 1985. By 1991, she was

experiencing extreme fatigue, joint aches, loss of nerve sensation and

seizures. When removed in 1993, the left implant was found to be ruptured,

spilling gel and liquid silicone into her body. She originally filed suit

against both Dow Corning and Dow Chemical, but when Dow Corning filed for

bankruptcy, thus stopping the case against it, she proceeded to trial

against Dow Chemical alone. In October, 1995, a unanimous jury awarded her

and her husband $4.1 million in compensatory damages and $10 million in

punitive damages. On appeal, the Nevada Court held that there was

sufficient evidence for the jury to find that Dow Chemical, which conducted

much of the early safety testing on silicones for Dow Corning, was

negligent in its testing of the liquid silicone used in Dow Corning's

breast implants. In upholding the jury verdict for compensatory damages, a

majority of the Court concluded that Dow Chemical "could have published its

knowledge of the potentially hazardous biological affects of liquid

silicone. Such publication would have put the medical community on notice

of the potentially significant dangers that could result from implantation.

Unfortunately, Dow Chemical failed to take any of these actions. Instead,

it continued to market Dow Corning breast implants outside of the United

States and to reap the financial benefits of Dow Corning's domestic sales."

Although a majority of the Court held that there was no liability for

punitive damages, and thus reversed that portion of the jury's award, the

Chief Justice dissented on this point. He wrote that "there is no reason

why the jury could not have properly considered that Dow Chemical did, in

fact, conceal known dangers of silicone breast implants from persons whom

Dow Chemical knew were going to be using the dangerous product. From the

conclusion that Dow Chemical was concealing known dangers, the jury could

reasonably have concluded from the facts of this case that Dow Chemical did

so "willfully and deliberately" and hence in "conscious disregard of the

safety of others."

Boston attorney, Fredric L. Ellis, who was lead trial counsel for the

Mahlums and argued the appeal to the Nevada Supreme Court, stated, "This is

a tremendous victory for the thousands of women who have been injured by

this medical device and hopefully will send a powerful message to other

corporations who put profits before safety." Ms. Mahlum, stated that she

was thrilled by the Court's decision and that justice has finally been

served. The verdict, with interest, is worth approximately $5.4 million.

Source Ellis & Rapacki

Martin Griffith, Reno, NV. (AP): Dow Chemical will ask the Nevada Supreme

Court to reconsider its decision to uphold a $4.2 million award to a Las

Vegas woman in a breast-implant case, a company spokesman said. The court

ruled 4-1 on Thursday that Charlotte Mahlum wasn't entitled to $10 million

in punitive damages. But in a 3-2 vote, it kept intact $4.2 million in

compensatory damages, affirming the jury's conclusion that the silicone

implants made Mahlum sick. The jury also found that Dow Chemical had a

duty to ensure the safety of the implants made by Dow Corning, once the

largest maker of silicone implants. Dow Chemical owns 50 percent of Dow

Corning.

Dow Chemical spokesman John Musser said courts in California, New York and

Michigan have examined essentially the same evidence and determined Dow

Chemical was not liable for Dow Corning's implants. "We believe the court's

finding is unprecedented and inconsistent with previous court rulings

across the country," Musser said Friday. The Nevada ruling could

effectively make any consultant who does testing on behalf of a client

responsible for that client's product, he added.

Bill Miller, Washington Post Staff Writer, 1/5/98: A federal jury awarded

$10 million yesterday to a Washington lawyer who claimed that the silicone

breast implants she received 21 years ago have caused a serious disease

that threatens to permanently disable her. Brenda G. Meister contended

that leaking implants caused her to develop scleroderma, a debilitating

illness that affects connective tissue. Since the disease was diagnosed in

1987, a decade after she got the implants, numerous problems have

developed, according to her doctor. Her skin has hardened, her fingers have

swollen, and calcium deposits the size of tennis balls

have formed in her back and hips, causing her to walk with a limp.

The verdict against Bristol-Myers Squibb Co. goes against the tide of

recent decisions in breast-implant cases, which have tilted in favor of

manufacturers. Bristol-Myers hadn't lost in nearly six years, prevailing

in its last six jury cases. But the jury in U.S. District Court here was

not swayed by the company's arguments and found that Meister's implants led

to her disease. "This should be a tremendous encouragement to women to

keep fighting," said Robert L. Weltchek, one of Meister's attorneys.

"That's the message." James Conlon, an attorney for

Bristol-Myers, called the verdict "an aberration" and said the company will

ask Judge William B. Bryant to set it aside. He said the verdict is "very

inconsistent with the state of the science." The award

comes a month after a panel of scientists appointed by a federal judge in

Alabama issued a well-publicized report finding no definite ties between

the devices and numerous diseases. After the report came out, an official

from Bristol-Myers declared, "Breast implants are safe." Bryant did not

permit the panel's report, which came out during the trial, to be used as

evidence.

The jury was persuaded by Meister's doctor, who testified that he had

concluded "with absolute certainty" that her implants led to scleroderma.

Meister, 56, who lives in Arlington, declined to comment on the verdict.

Her implants were manufactured by Medical Engineering Corp., a firm based

in Racine, Wis., that was acquired in 1982 by Bristol-Myers. Her lawsuit

alleged that Medical Engineering made a defective and "unreasonably

dangerous" product. It blamed Bristol-Myers for failing

later to adequately warn women of potential hazards. According to her

lawsuit, both companies intentionally deceived women by making false

representations about the safety of implants. The jury sided with Meister

on each of those allegations. However, the panel, nine women and one man,

rejected her bid to obtain millions more in punitive damages, saying she

failed to prove malice or outrageous conduct.

Las Vegas, (Business Wire), 1/12/99: INAMED Corp. announced that a fairness

hearing was held yesterday by federal Judge Sam C. Pointer Jr. in

Birmingham, Ala., to consider final approval of the settlement agreement

relating to the class action breast implant litigation. During the course

of the hearing, the court heard presentations from counsel for the class

plaintiffs and the company, as well as comments and objections from class

members or their representatives who attended the hearing. The court also

heard testimony from the plaintiffs' financial adviser, and received a

report on the status of efforts to conclude the resolution of an indemnity

claim asserted by 3M Corp. against the company, which is a condition to the

settlement agreement.

At the conclusion of the fairness hearing, Judge Pointer deferred any

decision on whether to grant final approval of the settlement agreement.

The parties expect to report back to the court within the next two weeks on

the final status of the efforts to resolve the 3M indemnity claim. 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.

January 22, 1999, Dow Corning Corp. is one step closer to getting a

bankruptcy reorganization plan out to creditors for a vote. On Thursday

attorneys slogged through another day of arguments for and against the

plan's disclosure statement, including complaints from the plan's most

vocal opponents, commercial creditors. One major hurdle was crossed when

the attorneys representing hospitals and physicians said they were

satisfied with the document, which will serve as the guide for plaintiffs

to vote on the wording for Dow Corning's reorganization plan. However,

attorneys for the Williams Township-based silicone manufacturer spent most

of the afternoon arguing with attorneys representing commercial creditors

about interest rates the plan attaches to Dow Corning's repayment of loans

and securities.

Commercial creditors say the rates are too low, and that if not adjusted

they stand to lose tens of millions of dollars. Some of the commercial

creditors are banks and other financial institutions that had loaned money

to Dow Corning prior to the company filing for bankruptcy in May 1995.

Commercial creditors represent about $375 million of the billions Dow

Corning owes claimants. New York attorney Donald Bernstein opened

arguments for the commercial committee by saying, "A plan that is as

fundamentally flawed ... should not be going out for a vote." "You've got a

class of creditors who's going to vote against this plan," he added. Dow

Corning, however, didn't budge on a complaint from commercial creditors

over the interest rate proposed for back loans.

Dow Corning proposes to pay a federally determined "legal" interest rate of

6.28 percent on loans it stopped paying interest on when the company filed

for Chapter 11 in 1995. Commercial creditors argued that Dow Corning is a

solvent company and should therefore be subject to a "substantially higher"

"contract" rate of accrued interest, meaning an interest rate that would

have been in effect with a bank when the company filed for bankruptcy

protection. The commercial creditors committee estimated that the

difference in interest rates could cost its clients between $150-200

million. As a result, they said the disclosure statement is misleading

because it reads commercial creditors will be "paid in full" but doesn't

take into account the conflicts over interest rates.

In another matter, Dow Corning agreed Thursday to clarify in the disclosure

statement how interest rates for future securities payments will be

determined. The committee for commercial creditors argued that the

disclosure statement should give specifics on how and when interest rates

for senior notes would be determined. The committee had feared that market

rates when the plan is confirmed might not be in line with rates at the

time the securities are issued.

Barbara Houser, Dow Corning's lead bankruptcy attorney, said she thought

the plan implied that interest rates for the securities could be readjusted

if found not in line with market rates. However, she said the company will

add the provision to its documents. Deliberations were to continue today,

and U.S. Bankruptcy Judge Arthur J. Spector possibly ruling on Thursday's

arguments.

Today's hearing was also expected to address complaints of individual

claimants who are part of a tort committee representing breast implant

recipients. As well, Spector intended to address his own concerns about the

proposed disclosure statement. The disclosure statement explains the

logistics behind Dow Corning's $4.5 billion global settlement to the more

than 400,000 creditors in the case, including the approximately 180,000

women who claim silicone-gel breast implants made them sick. The guide

has to be accepted before creditors will be allowed to vote on the

reorganization plan to move the company out of bankruptcy proceedings.

And without balloting and a subsequent hearing to confirm the votes, the

plan can't take effect.

MEDICAL INFORMATION: NY (Reuters Health): The discovery of a gene that

plays a critical role in the development of shock due to serious infections

may help physicians identify patients at risk and lead to new ways of

preventing this type of shock, according to a report in the journal Science.

What's In A Name? Richard A. Knox (The Boston Globe) 12/14/98: It says

a lot about chronic fatigue syndrome in 1998 that a main topic at a

national conference on the subject in Cambridge recently was what to call

the elusive disorder. A spirited two-hour debate on whether to junk the

current name was "very polarizing," says one researcher. Patients and their

advocates insist that the "fatigue" label is pooh-poohed and joked about

among those who haven't experienced chronic fatigue syndrome, also called CFS.

"The name sounds so trivial. People think, 'Well, I get tired by Friday

afternoon too," says K. Kimberly Kenney, executive director of the North

Carolina-based Chronic Fatigue and Immune Dysfunction Syndrome Association

of America. "The illness is much more devastating than the name would

imply." No less a public health figure than Philip Lee, the former U.S.

assistant secretary of health and human services, declares it's time to

change the name. Scientists in the field are sympathetic. After all, they

have put up for years with colleagues who look askance at their research on

such an ill defined (read: "imaginary?") disorder. But, researchers

counter, what do we call it when we can't yet agree on what its essence is?

Is it at bottom a brain disease? A metabolic disorder? An immune

derangement? There's evidence for all and consensus on none. "There's

unanimity on one point: The current name is really bad because it

trivializes the illness," says Anthony Komaroff of Harvard Medical School,

one of the most respected CFS researchers. "But we don't know enough to

choose the right name. And we'd damn well better get it right and be

prepared to live with it for the next decade." Whatever it's called,

whatever it is, there is new evidence that many more people suffer from

it, in the most strictly defined terms, than many people think, or than

previous studies had demonstrated. A new $1.7 million study by the

Centers for Disease Control and Prevention, the largest and most rigorous

ever on CFS, has found that the syndrome afflicts 183 out of every 100,000

Americans from ages 18 to 69. By contrast, the previous CDC study found

between four and nine cases per 100,000 people.

The new study was based on 90,000 residents of Sedgwick County, Kan., where

Wichita lies, one-quarter of the county's population. Researchers

identified about 4,000 people who said they suffered serious fatigue for a

month or more, and interviewed them in greater depth. Among those, 500

appeared to have the syndrome; researchers persuaded 300 of these to

undergo physical exams and laboratory tests.

Of the 300, a panel of physicians decided that 39 had bona fide CFS by the

most stringent definition. That definition requires at least six months of

severe unexplained fatigue plus four or more of these symptoms: impairment

in short-term memory or concentration; sore throat; tender lymph nodes in

the neck or armpit; muscle pain; pain in multiple joints without

inflammation; unusual headaches; unrefreshing sleep; and long-lasting

malaise following exertion.

The most striking new information from Wichita is that CFS rates are much

higher among women than men, 303 cases per 100,000 for all adult women, 340

cases for white women. To put the rates in context, chronic fatigue

syndrome in adult women appears to be less common than diabetes (which is

more than three times as prevalent) or high blood pressure (66 times more

prevalent). But it is roughly three to five times more common than lung

and breast cancer. (CFS is not considered a fatal disease, although it

often disables victims for years.) Judging from the new prevalence rates,

there may be roughly 314,000 adult Americans suffering from the syndrome.

(Estimates of CFS in adolescents and children would add another 40,000 or

so.) A firmer estimate will have to await further analysis by CDC

researchers, taking into account the prevalence of the syndrome within

specific age groups.

One clear lesson from Wichita is that the great majority of sufferers are

currently undiagnosed. Only six of the 39 patients identified there had

been diagnosed with CFS.

The Wichita findings, which were echoed by another new study of 27,000

Chicago households, have a number of important ramifications. "It's a

very large study. And it was done by the CDC, and people implicitly trust

data that comes from the CDC," Komaroff says. "It shows that CFS is more

common than many people had imagined." Nancy Klimas, a CFS authority at

the University of Miami, predicts that "the new prevalence data will

interest drug companies" in trying to develop drugs to treat it, because

the numbers suggest a substantial market. "Those guys will get little

dollar signs in their eyes when we talk about CFS," Klimas says.

When it comes to discovering what causes the syndrome or how to treat it,

the Cambridge conference shows that researchers are still like the blind

men and the elephant: no one has a clear picture of the whole beast yet.

Data are accumulating that the syndrome involves a chronic viral infection.

The lead candidate is human herpesvirus-6, which is suspected of damaging

the fatty sheath that surrounds nerves, among other possible effects; but

many believe there is no single viral culprit. Similarly, evidence is

mounting that the target organs are the hypothalamus and pituitary gland in

the lower brain and the adrenal glands, which sit atop the kidneys and

secrete stress hormones.

Recent studies of Gulf War veterans suggest that some individuals get CFS

or a very similar syndrome after exposure to stress or environmental

toxins. "There's accumulating evidence that there's something wrong with

the brain," Komaroff says. "The way I have put it together is that these

syndromes all ultimately affect changes in neurochemistry in the brain. In

CFS, my unproven bet is that chronic low grade infection with a variety of

agents causes it in most patients, and maybe toxins do in some."

On a similar note: Washington, 12/23 (AFP): Eight years after Gulf War, US

officials are launching trials aimed at treating undiagnosed symptoms known

as Gulf War syndrome common to US, British, and Canadian veterans. The

Pentagon and Department of Veterans Affairs are spending 20 million dollars

on randomized, controlled studies they hope will address complaints

reported among personnel who served in the Gulf. The trials will begin in

January, Department of Veterans Affairs spokesman Terry Jemison said. The

US program comprises two clinical trials at veterans' hospitals across the

country, using antibiotics in one study and exercise and behavior therapy

in the other.

The first will enroll 450 veterans with mycoplasma fermentans, which

officials describe as a "hypothesized infectious cause" of undiagnosed

symptoms. They will take the antibiotic doxycycline for 12 months. The

second trial will enroll 1,356 veterans suffering fatigue, memory problems,

and muscle and joint pain, to be treated with behavior therapy and

exercise. Nearly 697,000 Americans served in the Persian Gulf in the year

after Iraq's August 1990 invasion on Kuwait. About 12% have experienced

persistent, unexplained illness since. The British Defense

Ministry estimates that nearly 2,000 veterans could seek compensation for

health damages.

Breast Implant Removal Usually Should Include Capsulectomy, Surgeon

Advises: Although thousands of women have breast implants removed each

year, there is little information on whether to remove the scar tissue that

forms around them. Therefore the journal Plastic and Reconstructive Surgery

asked V. Leroy Young, M.D., to make recommendations in its September 1998

issue. Young, a professor of plastic and reconstructive surgery at

Washington University School of Medicine in St. Louis, drew upon his

experience of removing more than 300 implants during the past eight years.

He also reviewed the medical literature, though few papers came to light.

The body reacts to implants by walling them off in a sac of scar tissue

called a capsule, which sometimes becomes as hard as an eggshell. "Most of

the time, we recommend that the capsule should come out as well, though

there are certain circumstances where it does not need to be removed or

only a portion can be removed," Young says.

Young adds that capsule removal is a neglected topic. "I think it just got

overlooked," he says. "Therefore many plastic surgeons don't know whether

to remove capsules when they remove implants." About 1 million American

women have breast implants, most of which are filled with silicone gel. The

usual reasons for removing or replacing them are implant rupture or

contraction of the capsule, which can shrink over time, making the breast

round and hard. Less common reasons are infection of the breast, fear of

autoimmune reactions to silicone or the desire to change to another size of

implant. As well as taking out the implant, the surgeon may cut away the

capsule, leaving only breast tissue. This procedure, capsulectomy, requires

a larger incision and adds about $1,000 to the total cost. Young says

capsulectomy should accompany implant removal when: 1)The implant won't be

replaced: Capsules left in place may appear as abnormal masses on

mammograms. 2)The new implant will occupy a different position with

respect to the chest wall muscle. In this case, leaving the capsule in

place might create fluid-filled cavities that could become infected. 3)The

implant will be replaced by a larger implant. The capsule has contracted,

and another implant will be put in. The breast will be much softer after

reimplantation if the capsule is removed. 4)The capsule is very thick or

calcified. About 30% of implants calcify after 10 or more years. 5)The

implant has ruptured, especially if it was filled with silicone gel. 6)The

new implant has a textured surface. Such implants need to be in contact

with normal tissue for the texture to exert its effect. 7)The area around

the capsule is infected. 8)A tumor has developed in or next to the

capsule. Some women also may want to request a capsulectomy to improve

silicone removal, Young says, though he notes that 20 epidemiological

studies have failed to link health problems to silicone implants. A report

issued Dec. 1, 1998, by a federal court-appointed panel also found no

connection between silicone breast implants and disease.

Capsulectomy is not a good idea, Young adds, when the capsule is flimsy,

the implant is touching the skin or silicone has migrated into the armpit,

where there are major nerves and blood vessels. In these cases, capsule

removal might damage healthy tissues. "The bottom line," Young says, "is

that the benefit of removing the capsule should be greater than the risk."

(Or maybe it would challenge the skill of the surgeon??!!) Note: For more

information, refer to: Young VL, "Guidelines and Indications for Breast

Implant Capsulectomy," Plastic & Reconstructive Surgery 102(3), 884-891,

September 1998.

A Physiologically Based Pharmocokinetic Model for Toluenediamine Leached

from Polyurethane Foam-Covered Implants. The article is highly technical

but explains why the FDA now claims that TDA is more dangerous than

previously thought. TDA slowly releases and does not have a one year half

life as previously thought due to the plasma protein binding that occurs

within the body from the TDA. Due to the bonding, TDA is released much

slower than previously thought and this UNFORTUNATELY causes a longer

half-life and a higher distribution of volume. To obtain the study call one

of the authors and leave the name of the study and your name and home

address speaking, slowly and spelling your name and address into the tape

machine. The study previously named was reprinted from Environmental Health

Perspective Volume 106, Number 7, July, 1998. Call either Harry Bushar

(301) 827-4361 or Joseph Hutter (301) 827-3949 or Hoan-My Do Luu (301)

827-3940 to obtain your copy of this study. These three people are the

authors of the study. Allow two weeks for delivery.

Formaldehyde risk found in many products, Kathleen Fackelmann, 1998 USA

Today, 4/4/98: A new study, the first of its kind in a decade, shows that

many commonly used home products give off substantial amounts of

formaldehyde, a possible carcinogen. Formaldehyde, which is often

used in the production of building materials, cosmetics, home furnishings

and textiles, is a colorless gas that can cause burning or itching of the

eyes or nose, and wheezing. Some scientists believe repeated exposure may

increase a person's risk of developing cancer. Thomas J. Kelly of the

Battelle Memorial Institute in Columbus, Ohio, and his colleagues tested 55

products, from wrinkle-free shirts to latex paint. They placed each

product in a closet-sized monitoring chamber for 24 hours and measured the

formaldehyde in the air. An acid-cured wood floor finish, a product that

gives wood floors a high-gloss shine, was the worst offender in the study.

Right after application, "you get a big surge of formaldehyde," Kelly

says. Homeowners typically hire a contractor to apply this finish. After a

full day of drying, it still gave off high levels of formaldehyde, Kelly &

his colleagues report in the Jan. 1 Environmental Science & Technology, a

journal published by the American Chemical Society. The fingernail

hardener commonly used at home or in nail salons gave off a surprisingly

high amount of formaldehyde, Kelly says. Nail polish also emitted

formaldehyde. But in both cases, the emissions dropped off quickly as

the polish or hardener dried.

Latex paint gave off only small amounts of formaldehyde, Kelly notes. But

freshly applied paint remains a potential problem because it is applied

over huge surface areas in the home, he says. Other common products that

released the chemical included permanent press clothing, such as shirts and

bedsheets. The wrinkle-free coating gives off formaldehyde, he says. The

study showed that pressed-wood products, which are used in the construction

of houses and furniture, also gave off this chemical, but at levels lower

than reported in an earlier study. Manufacturers have been working to

reduce the formaldehyde, Kelly says.

How much formaldehyde is too much? Scientists haven't determined an

acceptable level, says Peggy Jenkins, an indoor air expert at the

Sacramento-based California Environmental Protection Agency's Air Resources

Board, which funded the study. But she says it's a good idea in general to

try to reduce exposure.

Fortunately for consumers, that's not difficult. Some common-sense steps

can reduce the amount of formaldehyde in the air, Kelly says. Apply wet

products, such as latex paint or nail polish, in a well-ventilated room, he

says. After such products are fully dry they emit much less formaldehyde.

In addition, there are floor and cabinet finishes that seal off the

formaldehyde.

Kelly suggests washing permanent-press clothing before you wear it or hang

it in the closet. The formaldehyde emissions from wrinkle-free shirts

dropped by 60% after they had been washed just once. Consumers who want

guidelines on formaldehyde in the home can call the California Air

Resources Board at 916-322-8282 or visit the agency's Web site at

www.arb.ca.gov.

On doors, on shirts, formaldehyde emissions of some common products

(calculated in micrograms emitted per square meter of the product per

hour). All wet products were tested 24 hours after application.

"Acid-cured wood floor finish, 11,000; Fingernail hardener, 300; Latex

paint, 9 * Particleboard, 240; Fiberboard cabinet door, 360; Cabinet door

with acid-cured finish, 460; Plywood, 4; New permanent-press shirts, 110;

Washed permanent-press shirts, 42. Material presented constitutes opinion

of Steven J. Milloy.

Another kind of drug problem: A medical report in 1998 estimated that

adverse reactions to prescription drugs are killing about 106,000 Americans

each year, roughly three times as many as are killed by automobiles. This

makes prescription drugs the fourth leading killer in the U.S., after heart

disease, cancer, and stroke. The report included only drugs that were given

properly and under normal circumstances, excluding drugs that were

administered in error or taken in attempted suicides. (When errors of

administration are included, the death toll may be as high as 140,000 per

year. Such errors include prescribing the wrong drug or the wrong dosage;

giving medications to the wrong person; giving medications to the right

person but in the wrong quantities or the wrong frequencies, and so forth.)

According to the 1998 report, which analyzed the data from 39 separate

studies conducted over the last 32 years in U.S. hospitals, 3.2 out of

every 1000 (or 3200 per million) hospital patients die from adverse

reactions to prescription drugs. Of the 106,000 people killed each year by

prescription drugs in the U.S., 41% (43,000) were admitted to the hospital

because of an adverse drug reaction; the other 59% (63,000 people) were

hospitalized for some other cause but developed a fatal reaction to

prescription drugs they received while hospitalized. In the U.S. in 1994,

there were 33,125,492 hospital admissions.

The sale of prescription drugs has more than doubled in the U.S. during the

past 8 years. In 1990, Americans spent $37.7 billion on prescriptions; in

1997, national spending on prescriptions reached 78.9 billion.[3]

Prescription drugs are the fastest-growing portion of health-care costs,

having risen at the rate of 17% per year for the past few years. Urging

physicians to prescribe particular drugs, especially new drugs, is a huge

business. According to the NY Times, the sales force of the largest 40 drug

companies has "exploded" in recent years. In 1994, there were 35,000

full-time "detail people" employed by drug companies to visit doctors and

describe pharmaceutical products. By 1998, the number had grown to 56,000,

one sales person for every 11 physicians. Drug companies spent $5.3

billion in the first 11 months of 1998 sending their "detail people" into

doctors' offices and hospitals, plus another $1 billion putting on

"marketing events" for doctors.

Not all adverse reactions to new drugs can be anticipated or avoided under

the present system, according to medical experts. "It is simply not

possible to identify all the adverse effects of drugs before they are

marketed," say three physicians writing in the New England Journal of

Medicine. In fact, "Overall,

51% of approved drugs have serious side effects not detected prior to

approval."

Side effects from new drugs cannot be anticipated for 2 main reasons: (1)

Individuals vary greatly in their reactions to chemical substances; and (2)

drugs are tested rare side effects may not appear in such a small group but

may become painfully obvious when millions of people start taking the drug.

Even a few years ago, drugs reached a mass audience slowly, providing time

for unexpected side effects to show up in relatively small numbers of

people. But today drugs are marketed directly to consumers via TV, so a

huge market for a new product can be created quickly and side effects can

appear in large numbers of people. The sexual potency drug, Viagra,

provides an example of this phenomenon. Within a few months of its

introduction, several million people began taking Viagra, and many serious

side effects, including fatalities, suddenly appeared. Despite the

widespread knowledge that half of all new drugs will cause serious side

effects in some people, neither the government nor the drug companies

systematically collect information on adverse reactions to new drugs. "Even

when it is recognized that a new drug will be given to many patients for

many years, rarely are systematic post-marketing studies carried out."

In the U.S., there is no formal procedure for monitoring drug safety. If

physicians became aware that a new drug has killed or maimed one of their

patients, or caused an allergic reaction, they may report it but they also

may not. As reports filter into the U.S. Food and Drug Administration (FDA)

in hit-or-miss fashion, FDA can revoke the approval of a drug, and

sometimes does, but almost never quickly. In December 1997, the popular

non-sedating antihistamine terfenadine was withdrawn from the market

because a safer alternative existed without terfenadine's danger of a

potentially fatal heart arrhythmia (irregular heart beat). However, by that

time terfenadine had been on the market 12 years. Last September the FDA

took the diet drugs fenfluramine and dexfenluramine off the market because

of heart valve damage to 31% of those who took the drugs in combination

with another diet pill, phentermine (a combination known as fen/-phen)

Fenfluramine could also damage heart valves when taken alone. By the time

fenfluramine was banned, it had been on the market for 24 years.

A recent commentary by three doctors, published in the New England Journal

of Medicine, contrasted prescription drug safety with airline safety.

Airplanes are built, licensed and flown according to standards set by the

Federal Aviation Administration (FAA). But whenever a plane crash occurs,

different agency (the National Transportation Safety Board, or NTSB) steps

in to establish the facts and make recommendations for avoiding future

crashes. The assumption is that a second, independent agency is needed

because the FAA would have a conflict of interest investigating crashes of

planes it had approved and licensed. In drug safety, on the other hand,

there is only one agency. The Food and Drug Administration (FDA) approves

pharmaceuticals and it also has responsibility for investigating injuries

and deaths caused by those pharmaceuticals. As we have seen, FDA has a very

limited capacity to conduct surveillance studies so, in fact, they rely on

the drug companies to provide data on deaths and illnesses caused by their

own products.

According to a recent commentary in the Journal of the American Medical

Association, a competent drug safety program would have four parts: (1) A

program to monitor all adverse effects from prescription drugs and annually

report the number of injuries and deaths and their likely causes. Currently

no one keeps such statistics. (2) A program to monitor side effects from

new drugs. Presently, the FDA's Division of Pharmacovigilance and

Epidemiology (DPE) has a staff of 52 people, but only 8 of those have MD

degrees and only one has a Ph.D. in epidemiology. This small group collects

anecdotal information about side effects of new drugs, but hasn't the

resources to be systematic or thorough. The problem with anecdotal

information is that only about 1% of

adverse drug reactions get reported in this way. For example, the FDA

received an average of 82 reports each year about adverse reactions caused

by the drug digoxin. This relatively small number of reports seemed to

indicate that digoxin was not a big problem. However a systematic survey of

Medicare records revealed 202,211 hospitalizations for adverse reactions to

digoxin during a seven-year period.

When FDA's DPE identifies a drug problem, they can only pass the

information along to the division of FDA that approved the drug. That

division can require the manufacturer to develop additional information.

However, "The most common corrective action is a change in the product

disclosure label or package insert." The question then becomes, are such

warnings effective? (3) The third part of a competent drug safety program

would make sure that safety information is being disseminated and heeded by

physicians. FDA currently has no such program. "The limited information

available, however, suggests that some important safety information--such

as boxed warnings on drug disclosure labels--either was not received or had

little effect. For

example, one outcome of the protracted debate over the safety of the

sedative triazolam was a new drug label warning that it

should be prescribed for only 7 to 10 days. Several years later an FDA task

force reported that 85% of the prescriptions were being written for longer

periods.... Neither the FDA nor any other agency has an organized program

to find out whether the important warning messages are achieving their

intended purpose of protecting the public and, if not, discovering the cause."

(4) The fourth part of a competent drug safety program would aggressively

seek out information about unsuspected adverse reactions to drugs. Instead

of waiting passively for anecdotal information to filter in, the government

needs to aggressively look for drug involvement in reported birth defects,

heart problems and other common disorders that are frequently caused by

prescription drugs. In the same way that the world's public health

specialists aggressively seek out new strains of influenza, FDA needs to be

aggressively seeking out new side effects of drugs.

Rather than strengthening the U.S. government's drug safety programs, the

present Congress has recently diminished the powers of the FDA to monitor

drug safety. Congress now allows drug companies to pay fees which FDA uses

to speed up the approval process for new drugs. As a result, during

1996-1997, FDA approved 92 new drugs for market -- twice the previous rate.

However, Congress specifically prohibited FDA from using any of the new

money for monitoring drug safety.

ALTERNATIVE MEDICINE: World Environmental Conference & Multiple Sclerosis

Foundation F.D.A. Issuing for Collusion With Monsanto: Article written by

Nancy Marklel. I have spent several days lecturing at the World

Environmental Conference on "Aspartame marketed as 'NutraSweet', 'Equal',

and 'Spoonful". In the keynote address by the EPA, they announced that

there was an epidemic of multiple sclerosis and systemic lupus, and they

did not understand what toxin was causing this to be rampant across the

United States. I explained that I was there to lecture on exactly that

subject.

When the temperature of Aspartame exceeds 86 degrees F, the wood alcohol in

Aspartame coverts to formaldehyde and then to formic acid, which in turn

causes metabolic acidosis. (Formic acid is the poison found in the sting of

fire ants). The methanol toxicity mimics multiple sclerosis; thus, people

were being diagnosed with having multiple sclerosis in error. The multiple

sclerosis is not a death sentence, where methanol toxicity is. In the case

of systemic lupus, we are finding it has become almost as rampant as

multiple sclerosis, especially Diet Coke and Diet Pepsi drinkers. Also,

with methanol toxicity, the victims usually drink three to four 12 oz. Cans

of them per day, some even more. In the cases of systemic lupus, which is

triggered by Aspartame, the victim usually does not know that the aspartame

is the culprit The victim continues its use aggravating the lupus to such a

degree, that sometimes it becomes life threatening. When we get people off

the aspartame, those with systemic lupus usually become asymptomatic.

Unfortunately, we can not reverse this disease. On the other hand, in the

case of those diagnosed with Multiple Sclerosis, (when in reality, the

disease is methanol toxicity), most of the symptoms disappear. We have seen

cases where their vision has returned and even their hearing has returned.

This also applies to cases of tinnitus. During a lecture I said "If you

are using Aspartame (NutraSweet, Equal, Spoonful, etc.) and you suffer from

fibromyalgia symptoms, spasms, shooting pains, numbness in your legs,

cramps, vertigo, dizziness, headaches, tinnitus, joint pain, depression,

anxiety attacks, slurred speech, blurred vision, or memory loss, you

probably have Aspartame Disease!" People were jumping up during the lecture

saying, "I've got this, is it reversible?" It is rampant. Some of the

speakers at my lecture even were suffering from these symptoms. In one

lecture attended by the Ambassador of Uganda, he told us that their sugar

industry is adding aspartame! He continued by saying that one of the

industry leader's sons could no longer walk - due in part by product usage!

We have a very serious problem. Even a stranger came up to Dr. Espisto (one

of my speakers) and myself and said, 'Could you tell me why so many people

seem to be coming down with MS? During a visit to a hospice, a nurse said

that six of her friends, who were heavy Diet Coke addicts, had all been

diagnosed with MS. This is beyond coincidence. Here is the problem. There

were Congressional Hearings when aspartame was included in 100 different

products. Since this initial hearing, there have been two subsequent

hearings, but to no avail. Nothing as been done. The drug and chemical

lobbies have very deep pockets. Now there are over 5,000 products

containing this chemical, and the Patent has expired!!!!! At the time of

this first hearing, people were going blind. The methanol in the aspartame

converts to formaldehyde in the retina of the eye. Formaldehyde is grouped

in the same class of drugs as cyanide and arsenic, DEADLY POISONS!!!

Unfortunately, it just takes longer to quietly kill, but it is killing

people and causing all kinds of neurological problems. Aspartame changes

the brain's chemistry. It is the reason for severe seizures. This drug

changes the dopamine level in the brain. Imagine what this drug does to

patients suffering from Parkinson's Disease. This drug also causes Birth

Defects. There is absolutely no reason to take this product. It is not a

diet product!!! The Congressional record said, "It makes you crave

carbohydrates and will make you FAT". Dr. Roberts stated that when he got

patients off aspartame, their average weight loss was 19 pounds per person.

The formaldehyde stores in the fat cells, particularly in the hips and

thighs. Aspartame is especially deadly for diabetics. All physicians know

what wood alcohol will do to a diabetic. We find that physicians believe

that they have patients with retinopathy, when in fact, it is caused by the

aspartame. The aspartame keeps the blood sugar level out of control,

causing many patients to go into a coma. Unfortunately, many have died.

People were telling us at the Conference of the American College of

Physicians, that they had relatives that switched from saccharin to an

aspartame product and how that relative had eventually gone into a coma.

Their physicians could not get the blood sugar levels under control. Thus,

the patients suffered acute memory loss and eventually coma and death.

Memory loss is due to the fact that asperity acid and phenylalanine are

neurotoxic without the other amino acids found in protein. Thus it goes

past the blood brain barrier and deteriorates the neurons of the brain. Dr.

Russell Blaylock, neurosurgeon, said, "The ingredients stimulates the

neurons of the brain to death, causing brain damage of varying degrees. Dr.

Blaylock has written a book entitled "Excitotoxins: The Taste That Kills"

(Health Press 1-800-643-2665). Dr. H.J. Roberts, diabetic specialist and

world expert on aspartame poisoning, has also written a book entitled

"Defense Against Alzheimer's Disease" (1-800-814-9800). Dr. Roberts tells

how aspartame poisoning is escalating Alzheimer's Disease, and indeed it

is. As the hospice nurse told me, women are being admitted at 30 years of

age with Alzheimer's Disease. Dr. Blaylock and Dr. Roberts will be writing

a position paper with some case histories and will post it on the Internet.

According to the Conference of the American College of Physicians, 'We are

talking about a plague of neurological diseases caused by this deadly poison".

Dr. Roberts realized what was happening when aspartame was first marketed.

He said, "his diabetic patients presented memory loss, confusion, and

severe vision loss". At the Conference of the American College of

Physicians, doctors admitted that they did not know. They had wondered why

seizures were rampant (the phenylalanine in aspartame breaks down the

seizure threshold and depletes serotonin, which causes manic depression,

panic attacks, rage and violence). Just before the Conference, I received

a FAX from Norway, asking for a possible antidote for this poison because

they are experiencing so many problems in their country. This poison is now

available in 90 plus countries worldwide. Fortunately, we had speakers and

ambassadors at the Conference from different nations who have pledged their

help. We ask that you help too. Print this article out and warn everyone

you know. Take anything that contains aspartame black to the store. Take

the "NO ASPARTAME TEST" and send us your case history. I assure you that

MONSANTO, the creator of aspartame, knows how deadly it is. They fund the

American Diabetes Association, American Dietetic Association, Congress, and

the Conference of the American College of Physicians. The New York Times,

on November 15, 1996, ran an article on how the American Dietetic

Association takes money from the food industry to endorse their products.

Therefore, they can not criticize any additives or tell about their link to

Monsanto. How bad is this? We told a mother who had a child on NutraSweet

to get off the product. The child was having grand mal seizures every day.

The mother called her physician, who called the ADA, who told the doctor

not to take the child off the NutraSweet. We are still trying to convince

the mother t= hat the aspartame is causing the seizures. Every time we get

someone off aspartame, the seizures stop. If the baby dies, you know whose

fault it is, and what we are up against. There are 92 documented symptoms

of aspartame, from coma to death. The majority of them are all

neurological, because the aspartame destroys the nervous system.

Aspartame Disease is partially the cause to what is behind some of the

mystery of the Dessert Storm health problems. The burning tongue and other

problems discussed in over 60 cases can be directly related to the

consumption of an aspartame product. Several thousand pallets of diet

drinks were shipped to the Dessert Storm troops. (Remember heat can

liberate the methanol from the aspartame at 86 degrees F). Diet drinks sat

in the 120-degree F. Arabian sun for weeks at a time on pallets. The

service men and women drank them all day long. All of their symptoms are

identical to aspartame poisoning. Dr. Roberts says "consuming aspartame at

the time of conception can cause birth defects". The phenylalanine

concentrates in the placenta, causing mental retardation, according to Dr.

Louis Elsas, Pediatrician Professor - Genetics, at Emory University in his

testimony before Congress.

In the original lab tests, animals developed brain tumors (phenylalanine

breaks down into DXP, a brain tumor agent). When Dr. Espisto was lecturing

on aspartame me, one physician in the audience, a neurosurgeon, said, "when

they remove brain tumors, they have found high levels of aspartame in

them". Stevia, a sweet food, not an additive, which helps in the metabolism

of sugar, which would be ideal for diabetics, has now been approved as a

dietary supplement by the F.D.A. For years, the F.D.A. has outlawed this

sweet food because of their loyalty to Monsanto.

If it says "SUGAR FREE" on the label, DO NOT EVEN THINK ABOUT IT!!!!!!

Senator Howard Hetzenbaum wrote a bill that would have warned all infants,

pregnant mothers and children of the dangers of aspartame. The bill would

have also instituted independent studies on the problems existing in the

population (seizures, changes in brain chemistry, changes in neurological

and behavioral symptoms). It was killed by the powerful drug and chemical

lobbies, letting loose the hounds of disease and death on an unsuspecting

public. Since the Conference of the American College of Physicians, we

hope to have the help of some world leaders. Again, please help us too.

There are a lot of people out there who must be warned, please let them

know this information.

Mary Hladky, Florida Daily Business Reviews

12/29/98: Ten growers have been given court

approval to press racketeering charges against chemical giant DuPont for

allegedly withholding, covering up or destroying evidence that its

fungicide Benlate ruined crops. While numerous suits filed nationwide in

the past two years allege that DuPont engaged in racketeering, Miami-Dade

Judge Amy Steele Donner apparently is the first to rule that a jury can

decide the issue. The importance of the two Dec. 15 decisions, which deny

DuPont's request to dismiss the case, goes beyond forcing a large

corporation to defend itself against allegations of criminal activity,

including fraud,

perjury, and witness and evidence tampering. A pattern of such activity

would violate the state's Racketeer

Influenced and Corrupt Organizations (RICO) Act. Under the state's civil

racketeering law, if growers prevail at trial they will be able to obtain

triple whatever monetary damages a jury will award. Miami lawyer Harley

Tropin, who represents the 10 growers in Florida and Costa Rica, has not

set a dollar amount he is seeking, but said

it will be in the tens of millions.

"DuPont has filed motions to dismiss the case on every conceivable

grounds," Tropin said. "We are delighted Judge Donner has sifted through

all that and found that DuPont has to

defend its conduct before a jury." Tropin

and his legal team will ask Donner to set

a trial date at a Jan. 15 hearing. He expects the trial to begin this

summer. Lance Harke, who represents DuPont along with his partner Alice

Hector, said they plan to ask Donner to reconsider. "These suits were

brought more than five years after the

statute of limitations period," Harke said. Harke also said that Donner's

rulings don't necessarily clear the way for trial. He and Hector have

motions pending and others they plan to

file that could derail a trial, if Donner rules in their favor. Many of

the growers' claims, Harke said, are based on the way DuPont defended

itself at various trials across the country. That is improper, he said,

because how lawyers defend a client is protected and cannot form the basis

of a suit.

The racketeering suit against DuPont, which also alleges negligence, fraud

and breach of warranty, is a civil action. While the criminal racketeering

law is better known, similar evidence is

presented in civil and criminal cases. The difference is the standard of

proof; in a civil case a plaintiff need only convince jurors with a

preponderance of the evidence, rather than the more stringent criminal law

standard of guilt beyond a reasonable

doubt. Donner ruled on Oct. 28 that

DuPont must turn over to the growers' attorneys thousands of pages of

internal documents that the company unsuccessfully argued were confidential

and protected by attorney-client privilege. Those documents, which are

expected to bolster growers' contentions that DuPont knew it had a

defective product but withheld that

information, are to be turned over to Tropin in mid-January, and will be

part of the evidence presented at the racketeering trial.

DuPont has paid out an estimated $1 billion in some 1,400 claims since

1990 that the fungicide Benlate 50 DF destroyed

crops. Most of the suits had been settled or concluded by trial until

growers began returning to court two years ago,

asserting that they were entitled to more money because they learned

only after their cases concluded that DuPont had committed far more

extensive wrongdoing by withholding or destroying evidence. Although

DuPont recalled Benlate in 1991, the company has

consistently argued its product was not defective and did not cause

crop losses.

The appeals court concluded that the growers, as mandated by federal rules

of civil procedure, did not return settlement proceeds before suing anew.

Another problem for growers was that they had signed agreements

releasing DuPont and its attorneys from "any and all liability" as part of

their settlements. A similar case is pending before the 9th Circuit

Court of Appeals. The 11th Circuit decision does

not affect the Miami state court cases, Tropin said, because his grower

clients are first-time litigants who have never settled.

The behavior of DuPont and its lawyers has resulted in

sanctions by three judges, including Donner. In 1996, Donner signed a

strongly worded order in which she concluded that DuPont had acted in bad

faith, abused the judicial process and

destroyed evidence. DuPont's conduct, she wrote, was so egregious that she

had no choice but to strike its pleadings. That meant DuPont was liable for

damages. When the cases before Donner settled days later, she vacated her

order. The 11th Circuit threw out a $115

million discovery abuse sanction against DuPont in 1996 for procedural

reasons, but suggested a federal prosecutor should investigate.

Accordingly, a Macon, Ga., federal judge in November ordered a criminal

investigation of DuPont for possible obstruction of justice. The Supreme

Court of Hawaii recently upheld a finding that Benlate was defective, as

well as a $1.5 million sanction against DuPont for withholding test data.

(Does this sound familiar? Seems all these companies think they are above

the law!!)

IMPORTANT: Lancet, Kelly Morris, 12/19/98: A study by Public Citizen's

Health Research Group (Washington DC, USA) has found that FDA has approved

several new drugs recently against the judgment of its medical officers.

Released on Dec 2, the report says that inappropriate pressure from

Congress, industry, and senior FDA officials is creating "an atmosphere in

which the likelihood of drug approval is maximized". A record number of

new drugs were approved in the USA in 1996-97, and three of

these--dexfenfluramine, mibefradil, and bromfenac--were withdrawn within 12

months. In September and October this year, PCHRG anonymously surveyed FDA

medical officers; 53 of 172 (31%) responded. Among the study's findings

were 19 officers who identified a total of 27 new drugs "that they thought

should not have been approved but were approved". 34 officers noted that

the pressure on them to approve new drugs was "somewhat greater" or "much

greater" than that before 1995. Several officers reported instances when

they had been advised not to present their own opinion or data to an

advisory committee if this action would reduce the likelihood of approval.

"Subtle and not-so-subtle pressure is being brought to bear on FDA

physicians who dare to question a drug's safety", concludes Sidney Wolfe,

co-author of the study. Public Citizen can be found on the web at:

Drug Evaluation and Research, said that FDA would be taking "a thorough and

serious look" at the report.

1998 THE MORNING CALL Inc. Sybil Niden Goldrich, Co-founder, Command Trust

Network, West Los Angeles, CA. Implants hazardous to health (12/29/98):

To the Editor: The Dec. 3 editorial, "Implant study is one chapter," is

important because it contains a well-balanced view of the medical

controversy surrounding silicone breast implants. Although the

manufacturers wish to close this case, the fact remains no scientific

explanation has yet been found for the unusual groupings of ailments

afflicting thousands of women with ailments. Are they caused by silicone,

or not?

The lead researcher of the National Cancer Institute study due out next

spring, Dr. Louise Brinton, has said that the possibility of a

silicone-related disease "is not a closed book at all." Even before the

final verdict comes in, however, women should be informed that the implants

sold for nearly 30 years with a virtual "lifetime" guarantee have proved to

be dangerous in other ways. Implants leak, rupture and cause serious local

tissue damage. One of four women has had to undergo additional surgeries

within five years of receiving implants because of these problems,

according to the Mayo Clinic.

Meanwhile, the U.S. Food and Drug Administration last year undertook its

own review of the available scientific evidence and concluded that its

five-year ban on general sales of breast implants is still warranted. Until

the scientific debate is truly resolved, implants must be treated as a

hazardous product.

BOOKS: With Justice for None: Destroying an American Myth by Gerry

Spence: Synopsis The famed trial lawyer best known for his work in the

Karen Silkwood case here provides a penetrating, passionate look at the

American justice system. His message is urgent and provocative: American

citizens without wealth or power will rarely receive justice. Highly

recommended!

THIS MONTH'S POEM:

Too busy to write a poem

by Lynda Roth

Too much to do,

Too little time

It's a miracle that

I can make this rhyme!

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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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

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Chemical Sensitivities 3/98; Misc. Med. XII 4/98; Misc. Med. XIII 5/98;

Baylor Studies 6/98; Hyperbaric Oxygen 7/98; IOM Summaries 8/98; CFS 9/98;

Trace Metal Toxicology 10/98; Restless Leg Syndrome, Tamoxifen 11/98;

Letting Go With Love 12/98; Tumor Markers 1/99; Legal info. and info. on

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