November 2000


COALITION OF SILICONE SURVIVORS
    2739 W. 23rd St., Greeley, CO 80634
    Lynda Roth - (970) 506-9288 Fax (970) 506-9288 (call first) e-mail: :
coss@siliconesurvivors.net
Website: http://www2.privatei.com/~coss/coss

 November 1, 2000

Dear Silicone Survivors and Friends:

This is our third periodic newsletter. Note address change. There is again
much to report.  We continue to lose our sisters to this disease.  I hear
about a few more every month, and heaven knows, this is just the tip of the
iceberg. Close to home, we lost Ellen Mohney of Pueblo since our last
newsletter. Some of you will remember that her trial in Colorado Springs
was one of the first that we lost.  Seems like an eternity since then.

Check out the Nov. 20th issue of Glamour Mag. for a great article on saline
implants.

We have 4 copies of the Social Security Disability Book "How to get it, How
to keep it" that are available for $14 each, including postage.  We have 1
copy of the Immune System Booklet, "Life, Death, and the Immense System"
for $10, including postage.  And, we have 6 copies of John Bryne'' book on
the Swansons, "Informed Consent" for $10 each, including postage.  To order
these, send a check to COSS, 2739 W. 23rd St., Greeley, CO 80634.

LEGAL INFORMATION: This is the conclusion and finding of Judge Hood's court
on the Dow Corning appeal: The Court is very much aware that numerous
interested parties have waited over five years for the resolution of this
matter since the Debtor filed its petition for bankruptcy in May 1995 and
that many more who filed actions against the Debtor before it filed for
bankruptcy have waited a much longer period of time. Depending on how the
parties in this matter proceed after reviewing this Court's decision, the
wait may be longer. However, the Court notes that in this country's
judicial system, with its rules and procedures enacted by Congress, all
parties, including the thousands of personal injury claimants, the many
other creditors, the Government, the Debtor and other interested parties,
are allowed the opportunity to pursue any claims and arguments they believe
they may have to the fullest extent possible under the law and the judicial
system. The United States' Constitution and the rules and laws governing
the judicial system, although they may not be perfect, were enacted to
ensure that all parties' due process rights are observed by the courts.
This Court is aware that this case is one of the largest mass tort
bankruptcy actions ever filed in this country's judicial system and that
many lives are affected by the outcome of the case. This Court has
attempted to ensure that all the litigants and parties before it have had
the opportunity to fully present their concerns within the procedural rules
and laws governing the action and the judicial system. The Court will
attempt to do so in the future. The Court is mindful that many parties with
the assistance of the Courts' Special Master have attempted to negotiate a
consensual agreement in this case; some have been successful and some have
not. However, the Court has observed that the parties before this Court and
the Bankruptcy Court have worked diligently on behalf of their clients'
interest and, if proceeding pro se, on their own behalf, to ensure that
their rights are protected. This Court commends all the parties involved in
this matter for their patience and hard work.=20

For the reasons set forth above, the Court AFFIRMS the Bankruptcy Court's
November 30, 1999 Order Confirming the Joint Amended Plan and REVERSES the
Bankruptcy Court's December 21, 1999 Opinion on the release and injunction
provisions issue. The Case Management Order is entered in Master Docket
Case No. 00-CV-00001-DT.

Detroit, Jim Suhr, AP, 11/13/00: A federal judge on Monday ruled that women
opposed to a $3.2 billion settlement over silicone breast implants may not
sue Dow Corning Corp.'s corporate parents. The ruling reverses a bankruptcy
judge's opinion that negotiators said crippled the deal. The 168-page
ruling by U.S. District Judge Denise Page Hood set aside federal Bankruptcy
Judge Arthur Spector's opinion last December, which the settlement's
backers complained changed pivotal terms of the deal he approved weeks
earlier.

Barring additional appeals, Hood's ruling sets the stage for the case's
claimants to begin receiving compensation, Dow Corning spokesman T. Michael
Jackson said.  "This really will let the process move forward and allow
claimants to receive payment for their claims," Jackson said. "We hope that
with this positive ruling that those who filed objections will not file
further appeals."  But a lawyer who was among those fighting the
settlement's no-lawsuit release said more appeals are planned. Geoffrey
White represents a group of women in Nevada, where that state's supreme
court has upheld damages against Dow Chemical Co., one of Dow Corning's
corporate parents, over silicone implants, opening the door for similar
lawsuits.  White said Monday's ruling left him "disappointed but not
defeated." White said he would take the matter to the 6th U.S. Circuit
Court of Appeals in Cincinnati and predicted that would not be the end.

"One side or another will appeal this to the U.S. Supreme Court," he said.
"Judge Hood has taken away those rights of those people who voted no on the
plan," White said.  During an April hearing, Dow Corning attorney George
Tarpley told Hood that Spector's opinion should be set aside as "an error
of law" that, if allowed to stand, could doom the settlement that took
years to reach and was approved by 94% of the 112,774 women who last year
voted on it.  The companies and lawyers for women who voted in favor of the
settlement argued that Spector's opinion changed terms of the settlement he
approved Nov. 30 as part of Dow Corning's $4.5 billion plan to emerge from
Chapter 11 bankruptcy.  That plan included a $3.2 billion settlement of
claims by more than 170,000 women blaming various health problems on
silicone implants once made by the company.

But in his December opinion, Spector said women opposed to the deal may sue
Dow Corning's parent companies. He said that he lacked the power to release
the parent companies from future liability and that the settlement wasn't
designed to grant such a release anyway.  Hood ruled otherwise, saying
Spector "went beyond the bankruptcy code to find that it had no authority
to issue an injunction against those who did not accept the plan" as part
of a bankruptcy matter she called "an unusual case."  "This court is aware
that this case is one of the largest mass tort bankruptcy actions ever
filed in this country's judicial system and that many lives are affected by
the outcome of the case," Hood wrote.  "This court has attempted to ensure
that all litigants and parties before it have had the opportunity to fully
present their concerns with the procedural rules and laws governing the
action and the judicial system.  The court will attempt to do so in the
future."

Tarpley had told Hood that Dow Corning, a 50-50 joint venture between Dow
Chemical and Corning Inc., was prepared to begin paying claimants, if
Spector's opinion was reversed.  "It serves no purpose whatsoever to pay
out $3 billion over a number of years only to have this litigation continue
in other forms, as it did before bankruptcy," Tarpley told Hood. "We want
to shut down litigation. If we're gonna pay money for it, we want it over
with."=20

What this means: On November 13, 2000, the Honorable Denise Page Hood,
United States District Judge, issued a 168-page opinion relating to the
appeals from and motions regarding the Bankruptcy Court's November 30, 1999
Confirmation Order in the Dow Corning Corporation chapter 11 proceeding.
Judge Hood also issued various
orders relating to the appeals and motions, including Case Management Order
No.1.  Judge Hood affirmed the Bankruptcy Court's November 30, 1999
Confirmation Order finding that the Bankruptcy Court did not err in its
conclusion that the classification of the various claims was proper and
that the claimants within a class received equal treatment.  Judge Hood
further affirmed the Bankruptcy Court's finding that the Amended Joint Plan
of Reorganization was proposed by the Debtor Dow Corning and the Official
Committee of Tort Claimants in good faith and is in the best interests of
the creditors.

Judge Hood reversed the Bankruptcy Court's December 21, 1999 Opinion
regarding the release and injunction provisions concluding that the
Bankruptcy Court did not have the authority to issue an injunction and that
the release and injunction provisions set forth in the Plan applied to all
claimants who accepted and rejected the Plan."

If that is clear as mud, then the decision by Judge Hood means that the
plan goes forward as voted on and that the decision by Judge Specter to
release the parties that voted against the plan is overturned.  This will
undoubtedly be appealed, so expect to wait a year or more for any $$.

Please feel free to contact one of the Telehelp information numbers or
websites listed for further information. Dow Corning Bankruptcy Telehelp
and Other Information Sources List: Dow Corning Bankruptcy Case General
Information Line: 800-651-7030 (recorded message); Implant Information
Center:  800-442-5442;  Bankruptcy Court Information Line:
800-222-7198;  TCC Mailing Address: Tort Claimants Committee, P.O. Box
61406,                         Houston, Texas  77208-1406.  TCC website:
                www.tortcomm.org   Dow Corning website:
www.implantclaims.com  Daticon Systems, Inc. Mailing Address:  P.O. Box
6003, Gales Ferry, CT 06335-6003.  Those outside of the United States may
access the foregoing numbers by calling collect to (718) 361-4500.

For inquiries not involving Dow Corning but the different legal case
generally referred to as the MDL Class Action and Revised Settlement
Program, you should contact different numbers: MDL Hotline: 800-887-6828;
MDL Claims Center: 800-600-0311 (outside the U.S. call 713/951-9106)  MDL
Claims Center Mailing Address:  P.O. Box 56666, Houston, Texas 77256.

>From Judge Pointer's Page: 12/8/99--INAMED settlement checks in the amount
of $725 mailed by the Claims Office to the almost 45,000 qualifying
claimants, starting December 8, 1999.  This is a one-time payment, paying
to these claimants and no further claims can be honored by the Claims
Office...Claimants should understand they gain nothing by failing to
negotiate their check; that is, they will still be precluded from pursuing
claims against McGhan, Inamed, and CUI even if they don't negotiate their
check.  If you did not file before summer, 1999, you are left out of this
settlement, although I think CUI were filled with Dow gel and should file
notice of intent to get in as a material claimant for their settlement
(they are in bankruptcy).

If you have not already filed a claim with DC: "If you have any questions,
including how to file the Notice of Intent (let's you in even at this late
date with full rights if everything goes right) or to find out whether a
claim was filed on your behalf by a co-debtor (manufacturer of other
implants you had), you or your attorney, please write to the Tort
Claimants' Committee, Box 61406, Houston, TX 77208-1406. You can also send
your questions by fax :1-713-752-2199."

"When writing to the Tort Claimants Committee, please include your current
and former names, current and former addresses, Social Security Number and
your Claim Number with Dow Corning, if known. If you filed a claim with Dow
Corning on or before 1-15-97, you should have received a postcard around
March, 1997 with your claim number and confirming what date your claim was
received: IT MUST HAVE BEEN RECEIVED ON OR BEFORE 1-15-97 -- keep this
"Gold Card" safe or proof. If you do have the postcard and it verifies your
claim was received on or before 1-15-97, it is unnecessary to file the
Notice of Intent."

Spanish women have joined into the legal arena to fight over the Trilucent
implants they received.  More and more women and countries are finding that
these implants were defective.

London Observer, Anthony Browne, 8/3/00 London: In an attempt to strike
back at the rising tide of patients' complaints, British doctors are
threatening to sue complaining patients for defamation.  The threat of
prosecution is being used by dozens of doctors, midwives, dentists and
opticians.  Patient watchdog groups warn that the strategy threatens to
undermine the government's attempts to improve National Health Service
standards and make medical professionals more accountable to the public.
Many patients, who might not be able to afford to defend themselves in a
legal action and do not qualify for legal aid, have been forced to withdraw
their complaints, while others have ended up with huge legal costs.=20

In some hospitals, officials who handle National Health Service complaints
are warning patients not to lodge one or they will face legal action. The
findings have emerged from a survey by the Association of Community Health
Councils (local health-care watchdogs), after it had been deluged with
calls from patients asking for legal advice.=20

The survey found that in more than 20% of health facilities, doctors have
threatened to sue patients for libel or slander for daring to
complain. Donna Covey of the council association said, "We are appalled
that, no matter how unjustified the health-care professional thinks the
complaint is, they use this sort of threatening behavior to stop the
complaint going ahead."  The survey found dozens of cases in which patients
had withdrawn complaints, even though they are protected by "legal
privilege," which means the doctor has to prove malice to win. But the mere
threat of legal action, and the costs involved, warned many patients off.

Some of the cases:  One patient complained about her doctor, who phoned her
at home, saying he would sue her for defamation of character. She withdrew.
One general practitioner said he would sue a patient for defamation unless
certain statements in the complaint were removed or amended.  A midwife
sued a patient for defamation, but dropped the action before the case was
heard. The complainant was left with a large legal bill.

8/18/00: Jury rules in favor of woman who sued over breast implant.  A St.
Louis Circuit Court jury awarded $4.5 million to a woman who blamed medical
problems on a silicone-gel-filled breast implant found ruptured  when a
doctor removed it.  Jurors ordered the implant's manufacturer, Medical
Engineering Corp., to pay Yvonne Haltom $2.25 million each in actual and
punitive damages in the product liability case. Her lawyer, Jeff Lowe,
said Haltom, 57, of St. Louis, first got breast implants in 1982 because of
a  mastectomy of her right breast. In 1993 she had inflammation in her left
breast, which a doctor blamed on silicone that leaked from the implant.
Lowe said Haltom later had reconstructive surgery using abdominal tissue.
Defense lawyers blamed surgical complications on Haltom's smoker's cough,
which they said  strained the abdominal area where tissue was removed.
Medical  Engineering, which produced implants under the name Surgitek, is a
subsidiary of  Bristol-Meyers Squibb Co.=20
(A few women do actually win!!  Lynda)

MULTIMILLION AWARD IN TRIAL WON BY A WOMAN PLAINTIFF:   Dr. Saul Puszkin,
Lecturer of Pathology and Scientific Director of the Health Sciences
Consultant Group at Columbia University College of Physicians  and Surgeons
in NY, had the pleasure of savoring a vindication for all his efforts in
showing that Silicone Gel Breast Implants are capable to induce 'Local
Injury in the Breast' as well as 'Profound Pathological Complications'.
This vindication came about when the jury in a trial in St. Louis, which
took place on August of this year, came out with a multimillion verdict for
the plaintiff woman, Mrs. Haltom and for her lawyer, Mr. Jeffrey Lowe of
St. Louis, MO. An additional multimillion verdict for punitive damages was
also awarded when the same jury who found the Manufacturer,
Bristol/Myers-Squibb (Surgitek), guilty of having manufactured a deficient
product for human use.=20

Dr. Puszkin testimony was deemed by all the jurors, who spoke after the
trial, as the most professional, professorial, most informative, and very
clear and convincing. The jurors very well understood what silicone gel
does to the body when it is present as infiltrated droplets in the tissues
of the breast, as well as inside the lymph nodes.  Dr. Puszkin testimony
was presented to the jury in the form of high quality photographic prints,
which were then projected onto a large screen.  The defense counsel for the
manufacturer tried to play down the significance of Dr. Puszkin findings
without any success. They also tried to discredit Dr.  Puszkin credentials,
but failed again in front of the jurors.=20
     =20
Dr. Puszkin credits were deemed by all the jurors as impressive. They
learned that Dr. Puszkin had been a tenured Professor of Pathology and a
recipient or a large amount of Research Funds instituted by the US Congress
and distributed to him through the National Institutes of Health. Dr.
Puszkin has published more than 160 articles which include peer reviewed
papers, chapters in books and abstracts of his presentations all over the
world.   Dr. Saul Puszkin, can be reached through the Internet at his
E-mail  address: SaulP2000@aol.com  Otherwise, by writing to his mail
address: at  Audubon Building, Columbia University P&S, Broadway 3960, New
York, NY 10032.  His voice phone number is 212-342-7272.=20

WASHINGTON (Reuters) 11-13-00: The Securities and Exchange Commission is
formally investigating breast implant maker Mentor Corp., according to a
regulatory filing on Monday.  The investigation comes after a request
earlier this year by the chairman of the U.S. House Commerce Committee, who
asked the SEC to check Mentor's denials about a Food and Drug
Administration investigation.  In April, Representative Tom Bliley, a
Virginia Republican who chairs the House panel that oversees the FDA, asked
the SEC to probe whether Mentor misled investors in a statement denying
there was a criminal investigation into possible irregularities in a study
of breast implants.

Mentor, the Santa Barbara, Calif.-based medical products maker, disclosed
the investigation in a quarterly earnings statement filed with SEC.  "The
company is cooperating fully with the SEC's investigation," Mentor said in
the filing. =20

MEDICAL INFORMATION: Philadelphia (Reuters Health) 11/1/00.  Fibromyalgia
Patients Have Longer 'Pain Memories':  Fibromyalgia patients experience
more pain than other people because their bodies "remember" the pain
longer, according to Dr. Roland Staud, from the University of Florida, in
Gainesville, and colleagues. "In normal patients, we cannot elicit pain
with  [minor] stimuli," Dr. Staud said. But fibromyalgia patients retain
the memory of pain very well. And they "sum-up" the pain, "so each
successive stimuli increases the sensation and it lingers...much longer."
Dr. Staud and colleagues looked at 59 fibromyalgia patients and 65 matched
controls without fibromyalgia. The subjects' average age was 44 years and
most were female.  The researchers applied intense heat to different parts
of the subjects' hands for 2- to 5-second intervals and studied their
response. The findings were presented here at the annual scientific meeting
of the American College of Rheumatology. The researchers found that
fibromyalgia patients had stronger responses to the heat stimuli than
control subjects, regardless of the interval between heat applications.
This suggests a problem with the central pain processing function in
fibromyalgia patients, according to Dr. Staud. Fibromyalgia patients also
felt pain in a more widespread area compared with the controls, he added.
This is probably related to genetic or individualized mechanisms, and
results in a greater sensation of pain. Dr. Staud is hopeful that the study
findings will make physicians take fibromyalgia patients' complaints more
seriously. "It's completely unclear to me why other pain problems, such as
chronic back pain, are accepted in the medical community, while
fibromyalgia is not," he said. "Now we are able to provide evidence for
central nervous system abnormalities in chronic pain syndromes like
fibromyalgia."=20

Oct. 16, 2000 (Ivanhoe Newswire): Early detection of breast cancer leads to
a better cure rate.  Now doctors may have a way to improve early detection
in high-risk women.  A new procedure called ductoscopy will allow doctors
to look directly into the milk ducts where most breast cancers develop.
The procedure will also help surgeons decide precisely how much tissue to
remove.

Ductoscopy uses a thin, flexible fiber-optic tube.  It's inserted into the
opening of the nipple.  The lens on the end of the tube gives the surgeon a
direct, enlarged view of the inside of the ducts.  Researchers from Johns
Hopkins School of Medicine tested the scope's success. In the 55 women
studied, all of whom had already identified cancerous or precancerous
changes, the device identified 75% of the abnormal growths.  In 38% of the
patients, the new procedure was able to identify spread that was not
detected by other diagnostic techniques.  With the older procedures, the
doctor would have had to remove more tissue than necessary.  Doctors say
ductoscopy allows them to see what they could only estimate before.  Breast
cancers generally begin in the milk duct and extend toward the nipple.  The
extension cannot be detected on mammogram or felt.  This causes problems in
determining where the cancer ends and normal tissue begins.   Details of
the study are reported in the most recent issue of the Journal of the
American Medical Association.

Dangerous Legal Drugs Kill Too!  Here's just yet another reason to give our
body the nutrients it needs to function properly so we will not have to
take any of these prescription drugs ever!  Dr  Barry Charles, M.D. has
written an article on the Hazards of Modern Medicine: An Overview Based on
a Selection of Findings from More than 7,000 Articles, Reports, and
Scientific Research Studies in the Medical Literature.  He writes:
"Iatrogenic Illness (disease produced as a result of medical treatment) is
now recognized as a health hazard of global proportions. Medline (the
computerized medical research database of the United States National
Library of Medicine) includes over 7,000 articles, reports, and scientific
research papers since 1966 that show a substantial number of patients
suffer treatment-caused disorders and adverse drug reactions. These harmful
effects, which can be serious and even lethal, are associated with every
facet of modern medicine including drugs, other medical therapies,
diagnostic procedures, and surgery."=20

The following articles in June 3, 1999 New York Times show a major
recognition and concern with the side effects of modern medicines.  New
York Times Articles: June 3, 1999 The Boom in Medications Brings Rise in
Fatal Risks With more prescriptions being written, the nation's health care
system is overwhelmed, creating a growing risk that patients will be killed
or injured by adverse reactions or mistakes. THE ERRORS Medication Threat
Often Lies in Use. There are a variety of ways that people can be killed or
injured by their medicine. Outright mistakes, some experts say these
medication errors account for one-third to one-half of all cases. Known
side effects, including dangerous interactions between drugs, are another.
Unforeseen side effects, which do not turn up in testing but become
apparent after a drug comes into widespread use, are a third. =20

Collectively, these are known as "adverse drug events," and in recent
months the FDA has been troubled by a series of them, including these:
Posicor, a drug for high blood pressure, was withdrawn from the market last
year, but not because it was harmful on its own. Rather, Posicor became
lethal in combination with a number of other drugs, so many that the FDA
believed that doctors and consumers could not keep abreast of the risks.
Agency officials said that 24 people taking Posicor in the 11 months it was
on the market had died, and that two or three of those deaths were directly
linked to Posicor, although a spokeswoman for Roche Laboratories of Nutley,
NJ, the drug's manufacturer, has said "no causal link" was demonstrated.
The diabetes drug Rezulin, approved two years ago, can cause liver damage,
which prompted the FDA to issue repeated warnings to doctors to closely
monitor patients taking it. But an agency investigation found that doctors
were not listening; only 2.7% of patients taking Rezulin for three months
were being monitored the way the agency had recommended. At a hearing in
March, the FDA and Rezulin's manufacturer, Parke-Davis, a division of the
Warner-Lambert Company of Morris Plains, NJ agreed that 43 people had
suffered acute liver failure that was possibly due to the drug; of these,
28 died. A panel of independent scientific experts has recommended that the
drug be prescribed only to patients who do not respond to other therapy.=20

The arthritis drug Celebrex, which was approved by the FDA in January and
has already been prescribed to more than two million people, is repeatedly
being confused by doctors and pharmacists with two other drugs: Cerebyx, an
anti-seizure medication, and Celexa, an antidepressant. The agency has
already received 41 reports of the wrong prescription being filled; in one,
an 81-year-old woman wound up taking two antidepressants for a month  "We
haven't had any serious injuries, thank goodness," said Dr. Jerry Phillips,
the FDA official who keeps tabs on medication errors, referring to
Celebrex. He is trying to persuade the Monsanto Company, which manufactures
the drug, to change Celebrex's name, a difficult task given that the
company has spent tens of millions of dollars advertising and promoting the
medication.=20

At the same time, Dr. Phillips said, the food and drug agency is planning
to install computer software that will analyze proposed drug names to avoid
such confusion in the future.  But at least one expert, Dr. Leape of
Harvard, said it should have taken that step years ago. "The FDA has
essentially focused on the safety of the product, whereas the major threat
has to do with safety of use and misuse," Dr. Leape said. "Their point of
view has been that it is safe and effective when used as directed, and the
directions are on the label, so read it. We have come to them repeatedly
and said; 'That is not enough. People make mistakes, even when it is all
there.' "=20

NY, 9/05/00 (Reuters Health) - Autoimmune disorders such as multiple
sclerosis, rheumatoid arthritis, and type 1 diabetes are among the leading
causes of death among American women under age 65, according to Connecticut
researchers.  But the role autoimmune diseases play in mortality rates has
gone unrecognized due to the way the list of the leading causes of death is
compiled, the study authors say.  'The significant contribution of
autoimmune diseases to mortality has gone unrecognized,' state Dr. Stephen
J. Walsh and Laurie M. Rau of the University of Connecticut Health Center
in Farmington.

Autoimmune diseases, where the immune system mistakenly attacks the body's
own tissues, are more common in women. The researchers explain that because
these disorders are not classified the same way as other conditions such as
heart disease or cancer, many autoimmune disorders are not in the list that
physicians use when recording cause of death.   Walsh and Rau examined
national mortality data for 1995 from the Centers for Disease Control and
Prevention, looking for mention of 24 different autoimmune disorders. They
found that when the statistics were broken down to identify these
conditions, autoimmune disorders were among the 10 leading causes of death
among women in all age groups under 65. The findings appear in the
September issue of the American Journal of Public Health.

Another reason that these diseases do not show up in the lists prepared by
the National Center for Health Statistics, explain the authors, is that
many doctors do not list chronic conditions as the direct cause of death
when completing death certificates.  Other research has found that about 5%
of American women have an autoimmune disorder, Walsh and Rau report. 'Our
study reflects the effects of that level of prevalence on mortality among
young and middle-aged women,' they add.  'Together, the prevalence and
mortality estimates support the contention that the etiology, diagnosis,
and treatment of autoimmune diseases constitute important issues in women's
health,' the researchers conclude.  SOURCE: American Journal of Public
Health 2000;90:1463-1466.

NY, 8/21/00 (Reuters Health): The use of implants for immediate breast
reconstruction after cancer surgery is a long-accepted practice. However,
researchers in Belgium are now raising concerns about what happens to
patients with implants who require postoperative radiation as additional
therapy.  Writing in a recent issue of Plastic and Reconstructive Surgery,
Drs. E. Vandeweyer and R. Deraemaecker of the Universite Libre de
Bruxelles, describe their review of six such patients.  "All of the
patients who received irradiation demonstrated poor to fair results," the
authors note. Specifically, all the patients who received radiation therapy
developed capsular contracture, a condition characterized by hardening of
the implant.  Capsular contracture can result in pain and disfigurement. As
reported by Vendeweyer and Deraemaecker, "five of the implants were
displaced, and breast symmetry was judged to be suboptimal in all patients
who received radiation."  Based on their analysis of the medical literature
and given the disappointing outcomes for these patients, the researchers
conclude "that for good cosmetic results, immediate breast reconstruction
using implants is not recommended for patients who require (additional)
radiation therapy."

In an accompanying discussion, Dr. V. Leroy Young of Washington University
School of Medicine in St. Louis, Missouri, said he agrees "that tissue
expanders or alloplastic implants should not be used for immediate breast
reconstruction in patients likely to receive post-operative radiation
therapy." He suggests that "these patients are better served with an
autologous tissue reconstruction." In this type of tissue reconstruction,
women have reconstruction carried out using their own tissue as a method of
forming the new breast. "Similarly," he adds, "delayed reconstruction after
radiation therapy to the chest wall is also best performed with autologous
tissue."
Source: Plastic and Reconstructive Surgery 106:56-58, 59-60.

Cause of Chronic Sinusitis Found: Almost 37 million people in the US suffer
from chronic sinusitis. The usual treatment is antibiotics, which provide
only a temporary relief. The problem invariably comes back, often worse
than before. Sometimes antihistamines are used, usually with similarly poor
results. According to this study, the reason these drugs do not work is
because the problem is caused not by bacteria, but by a fungus. Out of 210
patients with chronic sinusitis, almost all (202) had fungi in their mucus.
 The authors think that the majority of patients with chronic sinusitis
have a fungal infection and an immune reaction to fungus. Since antibiotics
are ineffective against fungi, they are not only not helpful, but may even
be harmful because they destroy the beneficial bacteria (Lactobacillus
acidophilus, Bifidobacterum bifidus, etc.) that protect us against the
proliferation of fungi.

Are Other Health Effects of Silica Exposure Being Overlooked?  By David F.
Goldsmith, Ph.D., Public Health Institute.  The National Conference to
Eliminate Silicosis March 23-25, 1997 in Washington DC enjoyed a splendid
turnout of over 600 attendees. In my opinion, the conference attention on
silicosis to the exclusion of discussion of other silica health effects was
very shortsighted. However, I was delighted by the opening remarks by NIOSH
Director, Dr. Linda Rosenstock, who pointed out that we now know that
silica exposure is a risk factor for several "new" conditions, and that
deliberations should be expanded to consider other health problems such as
cancer, autoimmune diseases, nephritis and other kidney diseases, and
tuberculosis. =20

What is the evidence for these other conditions? Last month the
International Agency for Research on Cancer (IARC) changed the
classification of silica from 2A (probable human carcinogen) to 1 (known
human carcinogen). The change to IARC Type 1 means that occupational silica
dust exposure is considered like other known human carcinogens such as
asbestos, vinyl chloride, radon daughters, smoking, and DES. It means that
companies are likely to change their Material Data Safety Sheets (MSDS),
that workers need to be informed, and that where there are alternatives to
silica (such as sandblasting) that they need to be sought out. The change
in IARC status does not mean that the controversy about carcinogencity is
over, but it does mean that the evidence is sufficient to convince a group
of IARC experts that silica increases the risk of lung cancer.
Furthermore, it goes a long way to meeting the criteria for causation we
use in epidemiology. There is other evidence to suggest that silica is
linked to stomach cancer, lymphatic cancers, and skin cancer, though the
IARC focus was on pulmonary malignancies.

The other health effects are not "new," but we now have good epidemiology
studies of recent vintage showing that silica exposure (with and without
silicosis) is linked with several autoimmune conditions which previously
there were only case studies: rheumatoid arthritis, scleroderma, Sjogrens'
syndrome, and lupus. There is also accumulating epidemiology evidence that
occupational silica exposure is linked with kidney diseases such as
nephritis and end-stage renal disease.  With a narrow focus on silicosis,
we tend to overlook serious conditions that often accompany
silicosis--silicoTB and cor pulmonale (enlargement of the heart muscle).

Although these two secondary effects of silicosis are declining in the U.S.
(as is silicosis), they remain killers of relatively young workers in
developing countries and in China and former Soviet Union. Sadly we also
must acknowledge the epidemic of acute and accelerated silicosis that
descended upon Mexican workers in the Midland-Odessa, Texas area in the
early part of the 1990s, some 60(!!) years after the Gauley Bridge
disaster. These men were vastly overexposed to silica, without any
protection, in several oil pipe sandblasting operations, and they have many
of the autoimmune ailments as well as fatal silicosis.  Thus, the silicosis
prevention we all hope to achieve should include these other diseases:
cancer, autoimmune illnesses, kidney diseases, and TB. Furthermore, the
employees we need to communicate with about this hazard must receive
information in languages of the workers at risk.

Fosamax can cause liver damage: Fosamax (alendronate) is a medication
approved for the treatment of osteoporosis. Like all medications, it has
side effects, such as gastro-intestinal upset, eye damage and even kidney
failure. According to a case described in the New England Journal of
Medicine, we now have to be aware of a new side effect - liver failure.
Doctors from Israel describe a 71-year-old woman who has developed liver
damage 2 months after starting Fosamax. She had no prior history of any
liver problems, including hepatitis or cirrhosis. If you are taking
Fosamax, ask your doctor to check your liver function at regular intervals.
 The New England Journal of Medicine 2000;343:365-366.

UK: Department of Otolaryngology, St James's University Hospital, Leeds,
UK. Candida species have the propensity to colonize and erode into the
surface of silastic causing a loss of function. Colonization of silastic
tracheo-oesophageal speaking-valves is an important cause of valve failure
post-laryngectomy: the exact nature of the colonization is unknown and
light microscopic studies have not been reported previously.
Microbiological examination of scrapings taken from the colonized
oesophageal surface of failed speaking valves was arranged before
sectioning for light microscopy. Conventional ultrathin sectioning of
silastic was difficult, therefore 15 micrometre sections were cut after
cooling the material to -30 degrees C. These sections were then stained
with toluidine blue; Candida species taking up the stain. Microbiological
examination of the colonies confirmed the predominance of Candida species
in the biofilm. Light microscopy of the 15 micrometer sections revealed
that the Candida colonies had invaded the silastic. This work demonstrates
that the colonization of the silastic valve prosthesis in the oesophageal
area is due predominantly to Candida species which actively invade the
structure of the silastic. This is an important cause of speaking-valve
failure post-laryngectomy.=20

United Kingdom: 9/2/00: MSPs demanded that a Scottish factory be banned
from distributing breast implants.  The Department of Health confirmed a
team of experts are inspecting the site "as a matter of urgency".  The
inquiry was ordered after the Daily Record alerted the Department of Health
to the fact that implants from the factory had been banned in the US after
an inspection team visited.  But the Biosil plant in Cumbernauld,
Dunbartonshire, is continuing to make and distribute implants.  Nationalist
MSP Kay Ullrich said: "The least that should be done is to stop the
distribution and use of these implants pending a thorough investigation
into the factory."  Tory MSP Mary Scanlon said: "In view of previous scares
over breast implants, it is vital to ensure that such products are seen to
be totally safe."

On Monday we revealed how a team of scientists from the US government's
Food and Drug Administration visited the factory in April.  After the
two-day inspection, the experts sent an eight-page warning to managers at
the plant condemning its manufacturing procedures. The Department of
Health's Medical Devices Agency in London is sending a team to the plant,
and has been in contact with the US agency.  A report is expected soon.

Diagnostic Criteria for Restless Legs Syndrome (RLS) (780.52-5):
International Classification of Sleep Disorders Criteria (1990; Rev. 1997):
1. The patient has a complaint of an unpleasant sensation in the legs at
night or difficulty in initiating sleep. 2.      Disagreeable sensations of
"creeping" inside the calves are present and are often associated with
general aches and pains in the legs. 3. The discomfort is relieved by
movement of the limbs. 4. Polysomnographic monitoring (sleep study)
demonstrates limb movements at sleep onset.  5. There is no evidence of any
medical or mental disorders that account for the movements.  6. Other sleep
disorders may be present, but do not account for the symptom. =20

If you have not done so, be sure to tell your qualified healthcare provider
the symptoms you have covered in Section #1. The majority of RLS/PLMD
patients should be on their way to restful nights with their qualified
healthcare provider's help. This article makes it clear that much help and
many treatments are available for RLS and/or PLMD sufferers.  Section #1:
1.     Symptoms of RLS/PLMD: A. Introduction: Results of the National Sleep
Foundation's 1999 poll showed that 7% of the participants (who represent a
cross section of adults in America) reported RLS symptoms every night or
almost every night. Yet, only 2% were told by their physician that they
have Restless Leg Syndrome. RLS symptoms, which are severe enough to be
disruptive to the patients' lives, probably occur more often than diabetes
and asthma. Another study reported over 15% might have RLS symptoms but for
many, this might only be occasionally.  Approximately 80% of RLS patients
experience involuntary limb jerks while they are sleeping and possibly
while awake. This condition is known as Periodic Limb Movement Disorder
(PLMD). PLMD may also occur independent of RLS. For those with only PLMD,
this article should prove helpful. The results of the NightWalkers' Survey
of 138 RLS patients reported by A. S. Walters, MD (Edison, NJ, USA), et al.
Neurology, Jan. 1996, stated initial lack of diagnosis or misdiagnosis by a
physician was common and the symptoms were often thought to be psychogenic
whatever the age of onset. In some cases, young age-onset RLS was severe
from the start. For younger patients whose symptoms were serious enough to
seek medical attention, misdiagnosis included 'growing pains' and attention
deficit hyperactivity disorder.  Most participants in the survey stated
that their symptoms were mild at onset and then progressed. In the older
age-onset patients, misdiagnoses included skin irritation, arthritis, and
malingering. A remission of symptoms of a month or more occurred in at
least 15% of the individuals.=20

More than 50% of the respondents know of one or more first-degree relatives
who have RLS. Five of the 33 (15%) patients had RLS initially triggered by
diabetic peripheral neuropathy or lumbosacral radiculopathy. Lumbosacral
radiculopathy encompasses a number of spinal problems. The most common is a
herniated disc(s).  Unless they have Secondary RLS/PLMD (caused by another
condition), related to end-stage renal disease, pregnancy, anemia, and/or a
low ferritin level (measure of the body's storage of iron), or is
drug-induced; RLS/PLMD is typically a life-long problem. Two-thirds report
the gradual worsening of their symptoms as time passes. Sufferers should
start learning more about RLS/PLMD, as soon as possible.   There is much
help and treatments available so that the vast majority of RLS/PLMD
patients, with appropriate medical care, lead normal lives and have
consistent restful nights.

B. Description of RLS Symptoms: Patients often describe symptoms of
Restless Legs Syndrome as creepy, crawly feelings, that many say feel like
bugs or worms, water moving, and/or a humming that might be accompanied by
aching, tingling or grabbing. The incidence of RLS/PLMD increases with age.
RLS symptoms can also be any unpleasant change in feelings in the legs,
especially in the area of the calves (possibly in the arms or elsewhere
also). Many RLS patients have difficulty describing their symptoms. The
sensations are felt deep within the legs and perhaps elsewhere; not in the
skin. The very unpleasant sensations associated with RLS are worse at night
while relaxing, such as sitting or lying down, and are alleviated
temporarily by movement or exercise. Patients experience an irresistible
urge or compulsion to move the affected limb(s) in conjunction with these
unpleasant feelings. However, some RLS patients report that an urge or
inner feeling of restlessness occurs without precipitating sensations. At
some point, they do experience RLS symptoms as described.=20

Although the feelings are usually not described as "pain," they are
excruciating nonetheless. Approximately 20% or more of RLS patients
describe the sensations as painful, in some cases intense. Most Restless
Leg patients report unpleasant sensations in both legs, but it is common
for one side of the body to be more affected than the other.  The
sensations in the more affected leg (side) may vary over time.        In
cases where only one leg (or side of the body) is affected with RLS
symptoms, it common to have a peripheral neuropathy in that leg or side. In
patients that have RLS in the feet, they also frequently have a neuropathy.
A peripheral neuropathy in the same limb(s) in which RLS symptoms are
experienced, might make the symptoms worse.  Approximately 20% to 30%,
usually the more severely affected RLS patients, also have the sensations
in their arms and less frequently, in the trunk or elsewhere. Some
medications, including many sold over the counter, can make RLS/PLMD
symptoms worse and/or cause them to occur during the day and spread to
other areas of the body. RLS and/or PLMD can occur at any age and affect
children and elderly alike. Two surveys of RLS patients indicated that
approximately 33% experienced their first symptoms by the age of 10 and
almost 40% before the age of 20. One small study indicated that inherited
RLS occurs more often in women than men. Having met hundreds of RLS
patients, it seems to be evenly distributed among men and women. It can
strike any race or nationality.=20

C.  When RLS Symptoms Are Worst: RLS symptoms are worse in the evening or
at night and early morning hours. RLS patients usually find that their
symptoms disappear between 4:00 AM to 6:00 AM. This may not hold true for
those with severe cases or those with aggravating conditions (i.e. anemia
and/or a low ferritin level) or when medications are being taken that
worsen their symptoms. The symptoms usually follow a circadian rhythm (a
repeated cycle of physiologic phenomena, such as sleeping, being awake and
eating, that bring about changes in body chemistry and slight changes in
temperature).=20

D. Symptoms Periodic Limb Movement Disorder: As mentioned, 80% or more of
RLS patients also have Periodic Limb Movement Disorder (PLMD). Periodic
limb movements (PLMs) are defined as stereotyped, periodic movements of the
legs and/or upper limbs during sleep and possibly while awake. Periodic
Limb Movements in Sleep (PLMS) were called nocturnal myoclonus. This has
been replaced with PLMS, because the movements are slower than true
myoclonic ones.  PLMD can also be referred to as Periodic Limb Movement
Syndrome, Periodic Limb Movements in Sleep (PLMS), Periodic Limb Movements
during Wakefulness (PLMW). and by patients as 'Jerking Legs' or 'Twitching
Legs'. PLMS might be a precursor of RLS. However, PLMS is common,
particularly in older age.

Studies have documented that the frequency and intensity of a person's PLMD
symptoms increase with age. Those who experience periodic limb movements
while awake, usually experience more severe symptoms while sleeping. In a
recent study of 30 PLMD patients whose laboratory reports were available
(approximately 80% of RLS patients have PLMD), 37% were low normal or
deficient in B-12. Also, 20% to 25% of RLS/PLMD patients have been found to
be low on ferritin (indication of the body stores of iron). See Section
#2-G&H.  PLMD is defined as 5, or more, involuntary movements per hour,
although this might be low. Periodic Limb Movements in Sleep (PLMS) may
also be accompanied by Sleep Apnea, which can have serious health
consequences. At the RLS patient's request, a sleep partner can help by
counting the number of limb movements in an hour and observe if the RLS
patient temporarily stops breathing and snores while asleep. In addition to
the symptoms of RLS, please tell your qualified healthcare provider about
any other symptoms reported by your sleep partner.

PLMD is referred to as "Mild," if the limb movements occur 5 to 24 times
per hour and result in mild insomnia or daytime sleepiness; "Moderate," if
they are 25 to 49 times per hour and result in moderate insomnia or daytime
sleepiness; and "Severe," if the they are greater than 50 times per hour
with 25 arousals an hour and result in severe insomnia or daytime
sleepiness.  Treatment of patients with only PLMD, if causing arousals that
result in excessive daytime fatigue and sleepiness, is often similar to
treatment for RLS. Any differences are noted throughout this article.

E. Diagnosing RLS and/or PLMD: RLS is usually diagnosed on the basis of its
classic symptoms, as described by the patient. No laboratory tests or sleep
studies confirm a diagnosis of RLS. Generally, once the RLS symptoms are
treated, the Periodic Limb Movements (PLMs) resolve also.  A sleep study
might be helpful in diagnosing the severity of PLMs for patients with only
this disorder. Since PLMs are not always of clinical significance, a sleep
study will help to confirm if this is the reason for otherwise unexplained
excessive daytime sleepiness and fatigue and/or whether perhaps another
sleep disorder exists. Many patients with PLMD are asymptomatic,
particularly if most of the movements are not associated with arousals.
Patients may not realize the arousals are disrupting their sleep pattern
though. A clue is unexplained daytime sleepiness and fatigue.=20

F. Other conditions easily confused with RLS/PLMD: Some painful conditions
have restlessness and other features of RLS. However, in general, these
conditions do not get worse at rest, are not alleviated temporarily by
movement, nor is there an irresistible urge or compulsion to move the
affected limb(s).

1)    AKATHISIA: Akathisia is a frequent side effect of antipsychotic
(neuroleptic or lithium) and other drugs which have an impact on the
dopamine system. This syndrome consists of subjective (feeling of inner
restlessness and the urge to move), as well as objective components
(rocking while standing or sitting, lifting feet as if marching on the spot
and crossing and uncrossing the legs while sitting). Many patients suffer
from lower limb akathisia while others demonstrate involvement of other
body segments. Akathisia might frequently appear while patients are seated.
In rare cases, akathisia can effect only one side of the body without any
discernible cause, such as a brain lesion.

2. Dopamingeric Drugs: Lack of Movement Symptoms: Some physicians think
RLS/PLMD patients, who do not have their symptoms helped by dopaminergic
agents, may have been misdiagnosed or have an associated condition that
inhibits the drug's effectiveness. Leg cramps are a separate medical
problem from RLS/PLMD. Leg cramps or painful spasms can occur for a variety
of reasons. 3) Neuropathise: RLS patients with coexisting neuropathies
often feel sensations such as burning or freezing pain, prickling,
numbness, the sensation of wearing an invisible "glove' or "sock," aching,
tingling and/or electric shock-like feelings, shooting and/or stabbing
pains. Patients experiencing only the symptoms of neuropathy should not
assume they have RLS. Pain from a neuropathy may exhibit itself similar to
RLS symptoms, in that the pain will often increase at night and might be
slightly alleviated by movement. The minimum requirement a for diagnosis of
RLS for those with a neuropathy is an urge to move the affected limb, with
the focus of that urge on the legs that is worse while at rest and in the
evening or at night. Other typical symptoms of RLS explained in this
Section should also be considered for the diagnosis.=20

3.  Painful Legs and Moving Toes: This disorder can result in burning pain
near the surface of the feet. This disorder has variable pain and constant
writhing movement of the toes. The symptoms can be worse at night and might
respond to narcotics.  For more on this, research RLS on the internet. (End)

August 31, 2000, Diana Zuckerman, Ph.D. - (202) 216-9507 Salwa Nassar,
(202) 216-9507: FDA Warns of Dangers of Breast Implants: Washington, DC:
More than 190,000 problems from breast implants have been officially
reported to the Food and Drug Administration (FDA), according to a new
consumer booklet that the FDA has published on its website.  The reports
included 123 deaths.  For the first time, the FDA also has made photographs
of adverse implant outcomes available on its website.  The photos include
breasts that are disfigured from having implants that were removed and not
replaced.  A little known risk of implants is that the breast tissue
stretches out of shape, and that implants cause permanent damage that will
be obvious if they are removed.  This is depicted in one of the
photographs.  Other photos depict capsular contracture (a hard and
mis-shapened breast) and deflation.  "The number of reported adverse
reactions is amazingly high, since most medical problems are not reported
to the FDA" according to Dr. Diana Zuckerman, President of the National
Center for Policy Research for Women and Families, a nonprofit research
think tank.  "It is especially shocking that more than one-third of the
reports are for saline implants, most of which have been sold in the last
few years.  The photographs help illustrate how disfiguring augmentation
can be.  A cosmetic product should not cause disfigurement to so many=
 women."

Experts estimate that the FDA receives one complaint for every 10 or more
problems, but 190,000 complaints would potentially represent more than 10%
of the estimated 1.5 million women with breast implants. The FDA approved
saline breast implants in May, but has never approved silicone gel implants
as safe or effective.  FDA officials have expressed concern that potential
patients needed to be warned of the risks.  The new consumer booklet
provides much clearer warnings to reconstruction and augmentation patients
than previous FDA efforts.

The FDA booklet also warns women about some lesser-known problems:
Inability to obtain health insurance coverage is a risk; some women are
unable to get any insurance, others have no coverage for breast-related or
implant-related problems. "Toxic Shock Syndrome is described as a
potentially life-threatening result of implant surgery and infection.
Additional surgeries can be expensive, pose health risks, and do not
guarantee a good cosmetic outcome.  Implants interfere with mammography;
mammograms cost more for implant patients, but are less likely to be=
 accurate.

This online information is an important first step in informing consumers"
stated Dr. Zuckerman.  We urge the FDA to publicize these efforts widely as
soon as possible, rather than just putting it up quietly during the last
week of August."

The FDA booklet and photographs are listed separately on the FDA internet
site at: www.fda.gov/cdrh/breastimplants.  The CPR website has additional
information at www.cpr4womenandfamilies.org.

CPR is a nonprofit, nonpartisan organization dedicated to improving the
lives of women and families by using objective, research-based information
to encourage new, more effective programs and policies.  Diana Zuckerman,
Ph.D., Executive Director. National Center for Policy Research for Women
and Families, 1444 Eye Street, NW, Suite 900, Washington, DC 20005

http://www.lef.org/magazine/mag99/may99-cover.html LE Magazine 5/99:
TAMOXIFEN: Cancer Causing Drug Approved For Healthy Women: Despite what you
might have heard, the use of tamoxifen for breast cancer prevention is
highly controversial. The drug has not been proven to prevent breast
cancer. And while its long-term effects on healthy women are unknown,
tamoxifen's cancer causing properties are well documented.  In a stunning
move, the Food and Drug Administration approved the use of tamoxifen
(Nolvadex) chemotherapy for healthy women with no evidence of breast
cancer. The approval came after almost two decades of wrangling over
research that cost American taxpayers hundreds of millions of dollars,
created fraud, prompted a congressional hearing, and spanned great
controversy. The FDA's decision-announced on October 30, 1998-allows Zeneca
Pharmaceuticals to tap into a market potentially worth 36 billion dollars
annually. The decision allowing the drug to be sold for breast cancer
prevention was made despite objections from women's health organizations
and researchers around the world. When the advisory committee recommending
approval was asked whether the tamoxifen prevention study demonstrated that
the drug had "a favorable benefit-risk ratio for the prevention of breast
cancer in women at increased risk as defined by the study population," it
said "no" unanimously. Yet, the FDA approved tamoxifen for healthy women
anyway.

Tamoxifen is a synthetic estrogen blocker-one of many that have been around
since the early '70s that once had potential as birth control pills. Like
diethylstilbestrol (DES) tamoxifen blocks estradiol, but also like DES, it
has estrogenic properties that cause cells to grow. Despite its dual
personality, tamoxifen has been successfully used to prevent recurrence of
breast cancer in women who are estrogen-receptor positive. Using tamoxifen
in cancer patients is one thing; using it in healthy women is another.
Tamoxifen is a well-known carcinogen which causes DNA strand breaks. This
is an accepted feature of standard chemotherapy where the overriding
concern is to keep cancer cells from growing. Carcinogens have not
traditionally been an accepted part of preventive medicine, however. The
FDA's decisions to allow the sale of tamoxifen and certain
cholesterol-lowering drugs (notably the peroxisome inhibitors clofibrate
and gemfibrozil) to healthy people marks the first time that drugs with
cancer-causing potential have been approved as health enhancements. We
believe this marks a dangerous new trend in drug approval.

The paucity of data makes the approval of tamoxifen for prevention
particularly questionable. Approval was based on a single study run at
various hospitals around the United States under the auspices of the
National Cancer Institute (NCI). An outgrowth of the "National Surgical
Adjuvant Breast and Bowel Project" (NSABP) begun in the '80s, the study was
about 10 years shy of producing any meaningful information, according to
one expert. Two similar European studies reported no preventive effect of
tamoxifen. The FDA rejected these studies as irrelevant because they were
too small (3500 people combined).=20
The Hype: There was no statistical difference in survival for the women
taking tamoxifen versus women taking placebo in the NCI study. The
justification for Zeneca's claim of a 50% reduction in breast cancer lies
in the difference between a 1.4% incidence of cancer in women taking
tamoxifen versus a 2.7% incidence in those taking placebo. The price of
that 1.3% difference was very dear. Tamoxifen doubled the risk of
endometrial cancer for women under 50. It quadrupled it in women over 50.
In short, what a healthy woman over 50 got when she took tamoxifen was a
proven four times higher risk of endometrial cancer in  return for an
unknown amount of risk reduction for breast cancer in the short term. And
that's not all. Thirty-five tamoxifen-takers developed blood clots in the
lung, and three of them died. The risk of cataracts was doubled, and almost
half the women participating rated the side effects as "quite a bit or
extremely bothersome." Technically, tamoxifen also doubled the risk of
suicide (two on tamoxifen versus one on placebo). Worth it? Well, there was
a 0.4% reduced risk of a certain type of bone fracture.

"Women of color" got a more definite picture of what tamoxifen could do for
them. Their risk of breast cancer was doubled. However, this wasn't played
up in the media because too few "women of color" were enrolled in the study
to make the statistics significant. The eighteen-page report of the study
published in the Journal of the National Cancer Institute glanced over the
issue in three sentences, and even making the numbers sound promising.=20

Other Studies Find No Benefit:  Two European studies reported interim
findings about the same time as the NCI study, which wrapped up early. Both
found no preventive effect of tamoxifen in healthy women. The authors of
the NCI study devoted considerable space to discrediting these two European
trials. One of the studies was conducted at the Royal Marsden Hospital in
England; the other at the European Institute of Oncology in Italy.
Together, these two studies had more women on tamoxifen much longer than
the American study where only 25% of the participants took the drug five
years or longer. Unlike the American study which was halted before
long-term effects could be discovered, these studies are ongoing so as to
get a picture of what tamoxifen does in the long run. Although both the
advisory committee and the FDA dismissed them as unimportant, the studies
have in fact produced new information about tamoxifen.=20

It appears that women who take hormone replacement therapy plus tamoxifen
may have some benefit. However, some of the data indicate that if a woman
took hormone replacement therapy before she entered the study, she is at
higher risk for breast cancer. This hints at the yet unexplored interaction
between tamoxifen and synthetic estrogens in the environment, including
synthetic hormone replacement therapy. At present, no one knows what
happens when a synthetic estrogen blocker with estrogenic potential is
given to women exposed to synthetic estrogens.

Tamoxifen-Induced Cancer: While no conclusions can be drawn from the study
on whether tamoxifen can prevent breast cancer, conclusions can be drawn
about tamoxifen's ability to cause endometrial cancer. About a thousand
published studies deal with tamoxifen and endometrial (or uterine) cancer.
An analysis of several large studies shows that tamoxifen approximately
doubles a woman's risk for uterine cancer when used for one to two years,
and quadruples it at five years. While this may be an acceptable risk for
women diagnosed with breast cancer (or a woman without a uterus), it is an
unacceptable risk for healthy women with no evidence of cancer.=20

Early on in the Marsden trial, one hundred eleven women were examined for
evidence of uterine changes. All of them had increased cell growth.
Thirty-nine percent had evidence of abnormal cells, with 16% having
abnormal cell growth, and 8% having polyps. In another study at City of
Hope, endometrial changes were seen in 35 women taking tamoxifen for breast
cancer. Polyps were found in 23. Eleven underwent hysterectomies.=20

Tamoxifen is also associated with stomach and colorectal cancer. Some data
indicates that prior treatment with hormones adds to this risk. What is
especially chilling is the likelihood that the risk of cancer with
tamoxifen may be a function of total lifetime dose. In other words, the
longer you take it, the higher the risk. Women taking tamoxifen longer than
five years are reported to have a high incidence of various cancers.
Despite the statistics Dr. Norman Wolmark, head of the study, advises women
to start taking tamoxifen as soon as they discover they are at high risk
for breast cancer. Don't wait, he urges. Age thirty-five has been
designated as the age to start worrying.

Potential for New Cancers:  In rats and mice, tamoxifen activates liver
enzyme cytochrome p450 like most other chemical rcinogens. This originally
led researchers to believe that tamoxifen would be a classic carcinogen.
However, it was later shown that tamoxifen is metabolized differently in
humans than in rats. Tamoxifen does not appear to be a liver carcinogen in
humans. However, researchers in Japan did CT scans on the livers of 66
patients taking tamoxifen for three to five years, and found that 36% of
them had a fatty liver. The condition was not readily detectable: liver
enzymes were elevated in only about half of the women. The researchers
recommended regular scans for women taking tamoxifen, yet neither the FDA
nor Zeneca has alerted women.

Damage to the p53 tumor suppressor gene has been demonstrated in animals
given tamoxifen. Whether this occurs in humans is not known. Tamoxifen also
induces cancer genes in rats. But, again, this data is not available for
humans. Monkeys given tamoxifen for a week show far less DNA damage than
what shows up in rats. And when human liver cells are treated with
tamoxifen, they also exhibit far less DNA damage than what occurs in rats.
While less DNA damage is better than more DNA damage, it does not equate
with no DNA damage. Damaged DNA is a feature of cancer, and should be
further investigated before tamoxifen goes into healthy women.

One very troubling aspect of tamoxifen treatment of healthy women is the
effect pretreatment with tamoxifen chemotherapy might have on cancer should
it subsequently develop. There is concern that tamoxifen pretreatment might
make a cancer more aggressive or harder to treat. Particularly regarding
the genetic mutation known as BRCA, questions remain as to what tamoxifen
can do. BRCA is a DNA repair gene. The effect of taking a DNA-damaging drug
on top of a mutated repair gene is not known. There are also unanswered
questions about what effect pretreatment might have on a person's ability
to respond to chemotherapy should cancer subsequently develop. None of
these questions were answered in the one study on which approval was based.

Other concerns are present. Tamoxifen is an estrogen blocker. Estrogen is a
chemical messenger throughout the body, not just in the breast. The brain,
gut, lung, liver and other organs have estrogen receptors. No one currently
knows the effect of long-term suppression of estrogen on these organs.
Paradoxically, tamoxifen also has estrogen-promoting potential (which may
account for its ability to cause endometrial cells to grow). What effect
blocking estrogen on one hand, and promoting it on the other, will have on
various organs in the long run is not known.

Scientists have been able to create tamoxifen-dependent tumors in rats.
They wrote in a 1993 report: "following cessation of tamoxifen
administration, almost one-third of the tumors regressed and more tumors
appeared. Resumption of tamoxifen administration resulted in regrowth of
some tumors and regression of the new tumors."
Estrogen is crucial during pregnancy. Levels rise and fall at specific time
intervals. No one knows whether tamoxifen can affect a future pregnancy.
Tamoxifen was originally considered as a birth control pill because it
interferes with the ability of the uterus to sustain a pregnancy. It is not
clear whether tamoxifen's effects cease when a woman stops taking it. The
work of a prominent tamoxifen researcher indicates that tamoxifen's effects
are long lasting. Could it affect pregnancy? Nobody knows.

Putting a Face on Approval: One might ask why tamoxifen was approved when
so many serious questions remain. The FDA didn't approve tamoxifen by
itself. It had help from a group known as an "advisory committee." By law,
advisory committee members are not supposed to have financial interests in
the company that manufactures the drug they're advising on. In addition,
advisory committees are supposed to be made up of people with "diverse
professional education, training and experience." This is so that they
bring different points of view to the table. In recent years, advisory
committees have recommended approval for a number of dangerous drugs. The
public should be aware that participants in the approval process are
frequently paid consultants to drug companies.

The committee that endorsed tamoxifen was composed of 11 people, eight of
whom are doctors who routinely test emotherapies. Some, including Richard
L. Schilsky, Derek Raghavan and Robert F. Ozols, accept grants from drug
companies. Others such as Kim A. Margolin, Kathy S. Albain and Janice P.
Dutcher test chemotherapeutic drugs with taxpayer money through the
National Cancer Institute (NCI).  The tamoxifen committee represented very
little diversity. Its role as an independent body was also questionable.
Ozols and Schilsky have both collaborated on studies with doctors who
conducted the tamoxifen study.=20

One of the committee members, Richard Simon, works at the National Cancer
Institute, which conducted the study.  Simon is a typical example of the
type of person currently sitting on advisory committees. A statistician by
training, Simon's forte is number crunching-not breast cancer.  In the
past, Simon argued for not stopping trials early. In an editorial published
in the Journal of Clinical Oncology, he used the example of clofibrate to
illustrate his point. (Clofibrate is a cholesterol-lowering drug whose
effects appeared promising during the early stages of the Coronary Drug
Project. If the study had been prematurely stopped, as the tamoxifen study
was, the real picture would not have emerged: clofibrate is no better than
placebo in reducing heart-related mortality. By the end of the study it was
shown that clofibrate caused a 44% increased mortality from cancer and
other causes). Studies must not be stopped early, Simon argued. His
pen-and-ink arguments melted away, however, when it came to tamoxifen,
which he supported.  The public expects committee members to be impartial.
Yet before he ever sat on the tamoxifen committee, Simon had attacked data
showing tamoxifen causes increased risk of colorectal and stomach cancer.
The motivation for the attack is not known. He failed to respond to a
request to clarify his position.

FDA Review Falls Short: In light of all that had occurred, the FDA had
valid reasons to carefully review all the data from the prevention trial.
It did not. In fact, the agency may have set a record for fast review.
According to Dr. Susan Honig who was in charge, the FDA received the final
data on tamoxifen on August 4th, four weeks before the advisory committee
hearing on September 2nd. Originally, the FDA was sent submissions missing
crucial data. According to the transcript of the advisory committee
hearing, the agency reviewed 625 of the 6681 case report forms of the women
who got tamoxifen. (Case report forms are the actual record of what
occurred to the patient, as filled out by healthcare workers who actually
interacted with her. This is distinct from data summaries created by the
drug manufacturer). Reviewing case forms is important, as numerous
investigators on drug trials have been caught falsifying data. Given that
it was already known that data had been falsified in tamoxifen trials, it
would seem crucial for the FDA to review a substantial number of the case
report forms. Instead, it held a committee meeting four weeks after
receiving data from the trial, and announced its approval four weeks later.

Committee Rejects Monitoring of Women on Tamoxifen: One might wonder how a
committee that refused to endorse the statement that tamoxifen has a
favorable risk/benefit ratio for the prevention of breast cancer would
ultimately approve tamoxifen for the prevention of breast cancer. The
answer lies in semantics. A review of the record shows that the committee
refused to use the word "prevention" but reframed the issues until they
could recommend approval. The actual recommendation of the committee is
that tamoxifen be approved for the "risk reduction of the short-term
incidence of breast cancer in women at increased risk as defined by the
study population." Despite the refusal of the committee to recommend
tamoxifen for prevention, the American Cancer Society and the media
immediately hailed tamoxifen as a breast cancer prevention drug.

And despite evidence that tamoxifen causes endometrial cancer, the
committee rejected advising women to undergo endometrial testing while on
tamoxifen. During the discussion among committee members, George W. Sledge
Jr., a drug researcher, stated his belief that such testing would be
nothing more than an employment act for OB-GYNs. The committee agreed with
Sledge and voted not to warn women to have endometrial testing. They also
nixed yearly eye examinations for cataracts. The issue of warning women
about blood clots never came up, although the committee felt the FDA should
ask someone to look into it further.=20

After the committee finished with tamoxifen, they went on to another
hearing about the drug, Herceptin. Drs. Schilsky and Raghavan's
conflicts-of-interest were duly noted for the record. While the hype sounds
good, tamoxifen has not been proven to prevent breast cancer. Two studies
show it doesn't, and numerous studies show it increases a woman's risk of
endometrial cancer. Everyone would like to believe that merely taking a
pill will keep them from getting cancer. Unfortunately, such a pill has
never been invented. There are steps, however, that a woman can take to
decrease her risk of breast cancer that do not involve drugs.

Washington (Reuters): Allegations that cellular phones cause brain cancer
make for alarming headlines but scientific studies so far have found no
clear link between the popular devices and the disease, experts say.  New
charges emerged Thursday as a Maryland neurologist filed an $800 million
lawsuit against nine companies and organizations claiming his malignant
brain tumor was caused by cell phone usage. =20

Studies in humans and animals have not found evidence that the radiation
emitted by cell phones, used by an estimated 100 million Americans, play a
role in the development of brain tumors. "We've got a fair amount of
evidence, and it doesn't point to a hazard," said John Moulder, a radiation
biologist at the Medical College of Wisconsin.  Still, the studies have not
put the issue to rest. Some researchers say the findings raise enough
questions to merit further investigation. The Food and Drug Administration,
which regulates devices that emit radiation, says it cannot rule out any
harm even though evidence shows no risk.

To support his claim that cell phones are harmful, the neurologist who
filed suit Thursday cited a 1994 study on rats that showed breaks in DNA, a
possible sign of future cancer, after the animals were exposed to
radiation.  "It's a really tough issue," said Robert Tufel of the National
Brain Tumor Foundation. "We don't want to unduly alarm the public but some
of the information we have read is very compelling."  The foundation
recommends that people take precautions such as limiting phone time or
using an earpiece to put distance between themselves and the phone "until
this is resolved," Tufel said.=20

To try and settle lingering questions, the FDA, with funding from the cell
phone industry, is planning new studies. But those results are not due for
three to five years.  The debate started in 1993 when a Florida man alleged
cell phone use caused his wife's brain tumor. Since then, scientists have
studied the effects of cell phone radiation on animals and looked at brain
tumor rates in people who used cell phones.  Brain cancer strikes about six
in every 100,000 people in the United States each year. Human studies have
shown no significantly higher rates of brain cancer among cell phone users,
although one did find that tumors appeared more often on the same side of
the head where the phone was used.

Tests showing breaks in animal DNA have not been replicated, Moulder said.
Additional studies may not provide complete answers. It is impossible for
scientists to completely rule out anything as a cause of cancer, meaning
that no studies will ever be able to fully clear cell phones of a role in
the disease, Moulder said. "There is no method for proving that something
does not cause cancer. You try to prove that it does, and when you have
failed enough times

PARENTS TESTIFY THAT MMR VACCINE LIKELY CAUSED  AUTISM IN CHILDREN : CDC
Officials Say There is no Scientific  Evidence to Support The Alleged Link.
 4/7/00: The Philadelphia  Inquirer.    Distraught parents told a
congressional committee that a vaccine aimed at preventing measles, mumps
and rubella likely caused their children to become autistic.  But various
experts, including officials from the U.S. Centers for Disease Control and
Prevention said there was no scientific evidence to support the alleged
link between autism and the so-called MMR vaccine.   They warned that such
false information could lower immunization rates and leave the nation
vulnerable to a measles epidemic like the one that killed 123 children,
including nine in Philadelphia, in 1990-91.   "If as a result of reading
about this hearing, some parents choose to withhold or delay vaccines for
their children, their tragedy could be profound, said Dr. Paul Offit, chief
of infectious disease at Children's Hospital of Philadelphia and a member
of the CDC advisory panel that decides what vaccines will be recommended
for American Children. =20

The debate came during a daylong hearing in Washington before the House
Committee on Government Reform, chaired by Rep. Dan Burton, R.-Ind.
Burton, who also has been holding hearings on the military's controversial
anthrax vaccine, said his grandson, Christian, became autistic after
getting the MMR vaccine.   "I can't believe that's just a coincidence" he
said,  adding that scientists who say that autism is a genetic disorder are
"just  nuts."   Burton came under fire from Rep. Henry Waxman D-Calif. the
committee's ranking minority member, for using the committee hearing as a
bully pulpit to promote an unproven - and dangerous notion.  This hearing
was called to establish a point of view - a point of view established by
the chairman," Waxman said. =20

The MMR vaccine, developed by Merck & Co. had become the cornerstone of
pediatric health in the United States.  It involves one shot that protects
children against three diseases that used to be among the leading causes of
death and disability.  Typically babies are vaccinated at 12 months and
given a booster when they turn 4. Two developments have prompted the notion
that MMR vaccine may cause autism. =20

One is an apparent rise in the prevalence of autism, from about 5 cases per
10,000 births to 12 cases per 10,000 births between 1966 and 1985 according
to federal officials.   But Coleen Boyle head of the CDC's disabilities
branch, told  the committee that the apparent rise in the autism rate may
be due to expanded definitions of autism and greater public awareness of
the disorder rather that an  actual increase in the incidence of the
problem.    Another factor fueling the debate is a controversial small
study by Andrew Wakefield a British gastroenterologist, who found that 8 of
12 children developed autism soon after getting the MMR vaccine.
Wakefield defended his work before the committee but his findings were
rebutted by Dr. Brent Taylor, another British physician, who studied 498
children with autism in North London and found no connection with the MMR
vaccine.  He said Wakefield's work had had a major effect on public
confidence in the vaccine, with immunization rates in England dropping from
about 90% in 1995 to 75% last year.  "The same thing could happen in the
United States," Taylor said. =20

Autism is a brain-based developmental disorder in which children typically
engage in repetitive behaviors such as rocking, speak little or not at all,
and make little eye contact, seemingly immersed in their own private world.
 The cause of the disorder is not clear, but numerous genes have been
implicated.   During the hearing Burton assailed Offit's credibility,
suggesting that the infectious disease expert from the children's hospital
should not be allowed to sit on the CDC's advisory board because he is
currently developing a vaccine in collaboration with Merck.  The vaccine is
against rotavirus, which causes severe diarrhea among children.   But Dr
Benjamin Schwartz, a CDC vaccine official said the 12 member board required
scientists to disclose any financial ties that might give the appearance of
a conflict.  He said the agency sought out experts like Offit because they
are the most knowledgeable about infectious disease and the vaccines to
prevent them.  (Single vaccines do not seem to cause the problem with
Autism, according to the British study.  Measles, Mumps and Rubella
inoculations are all available as single vaccines; it appears to be the
combination of these injections that may cause the problem.)

Toronto, 9/20/00: PRNewswire: The US Centers for Disease Control  (CDC)
yesterday presented data at the Interscience Conference on  Antimicrobial
Agents and Chemotherapy (ICAAC) that supports data presented  earlier by
Dr. Bart Classen, an immunologist at Classen Immunotherapies,  proving
vaccines cause insulin dependent diabetes.  Earlier this month, Dr. Bart
Classen presented data at the  International Public Conference on
Vaccination, which proved vaccines are the largest cause of insulin
dependent diabetes in children. This data included  data from a prospective
randomized clinical trial in Finland showing  vaccinated groups had a
statistically significant, 17%, increased risk of  diabetes after 10 years
follow up.  Further analysis of people receiving newer, more potent,
hemophilus vaccine indicated that these hemophilus vaccines increased the
risk of diabetes by about 25%.  The CDC's study  indicated that 247 of 260
diabetics received the hemophilus vaccine compared  to 733 of 780 controls.
 This indicates the hemophilus vaccines associated with an odds ratio of
1.22 or an approximately 22% increased risk of diabetes, almost identical
to what Classen found.

Dr. Classen has published both animal and human data with several different
vaccines that immunization starting in the first month of life was
associated with an decreased risk of diabetes while immunization starting
after the second month of life is associated with an increased risk of
diabetes.  Classen has published data from both New Zealand and Italy that
the Hepatitis B vaccine, when given after 2 months of life, is associated
with an approximately 50% increased risk of diabetes.  The CDC only
published part of their data on the hepatitis B vaccine.  The CDC found the
 hepatitis B vaccine was associated with an overall decreased risk of
diabetes (relative risk 0.92) which is consistent with an large percent of
those vaccinated receiving the vaccine at birth.  The CDC however found
that those immunized starting after 2 months of life were at a 60%
increased risk of developing diabetes than those immunized starting in the
first month of life (.88/.52).  The CDC's hepatitis B vaccine data is thus
also consistent  with Classen's finding.

The CDC's study and analysis suffered from some obvious limitations  and
flaws.  The CDC studied only 260 diabetics and 780 controls while Dr.
Classen's studies typically have involved 100,000 people or more.  The
CDC's  study did not compensate for the interaction between the two
different  vaccines since people received both the hepatitis B vaccine and
the  hemophilus vaccine while Classen studied these vaccines separately.
The CDC  study was also limited because over 94% of controls were
vaccinated with the hemophilus vaccine while Classen performed studies
where almost none of the  controls were vaccinated.  The net effect is the
CDC's study did not have  the power of Classen's studies.  More importantly
the CDC's analysis was  flawed because the results were altered, after they
were calculated, to  compensate for a family history of diabetes.  This
practice that is  considered unorthodox in part because the CDC has many
different "fudge"  factors by which it can manipulate the results.  Last
year the CDC presented data from the same data HMO data source but
manipulated their results using a different variable to compensate for
breast feeding.  In 1997 the CDC also  presented an analysis on the
hepatitis B vaccine, also from the same HMO  data source, but did not use
either "fudge" factor.  In this study the  hepatitis B vaccine, when given
after 8 weeks of life, was associated with a  90% increased risk of
diabetes. The fact that the CDC manipulates similar  data in different
years using different "fudge" factors has raised suspicion  that their
analysis is severely flawed and their interpretations of the data  should
be viewed with caution.

Dr. Bart Classen presented data at the International Public Conference  on
Vaccination on September 10 that vaccines cause approximately 80% of  cases
of insulin dependent diabetes in children who have received multiple
vaccines starting after 2 months of life.  Children receive 10 or more
vaccines and many of these are associated with an increased risk of
diabetes.  Classen's data and other published data indicate the following
vaccines are associated with an increased risk of diabetes (increased
risk):  hepatitis B (50%), hemophilus (25%), tetanus (20%), diphtheria
(9%),  pertussis (25%), mumps- rubella (23%).  These findings are supported
by a  case control study performed in Europe.  The cumulative effect of all
these  vaccines on diabetes is tremendous.  Highly immunized sailors in the
US Navy  have been found to develop insulin dependent diabetes at a rate of
5.5 times  that of controls even though their rate of diabetes on entering
the Navy was equal to that of controls.
The US and other governments provide compensation for vaccine induced
injuries however there is a statute of limitations.  Insulin dependent
diabetes cost the patient about $1 million over their lifetime.  Many
diabetics have contacted Dr. Classen about receiving compensation from the
US government.  Information on this subject can be found on the Vaccine
Safety Website  http://vaccines.net

San Diego, CA 10/24/00 (Reuters): Researchers unveiled several studies here
on Monday showing how women made sterile from cancer treatments or radical
surgery may be able to avoid permanent menopause through the removal and
retransplantation of their own ovarian tissue into their forearms. This
type of tissue transplant has been around for a long time,  but was thought
to be impractical for ovarian tissue until better survival rates for young
cancer patients generated new interest, said Dr. John Schnorr, lead author
of a study presented here at the annual meeting of the American Society for
Reproductive Medicine.

His team at Eastern Virginia Medical School in Norfolk, Virginia, restored
ovarian function, menstrual cycles and egg production in monkeys whose
ovaries had been surgically removed. The investigators divided 16 monkeys
into three groups.  The first group had ovarian tissue transplanted into
the arms, the second had ovarian tissue placed in the arm and a growth
factor was administered, the third set, the control group, had only fat
tissue placed in the arm. This group's ovaries were frozen and the tissue
was transplanted back into the upper arm at the end of the study. Five, or
83%, of the six monkeys in the first group had functioning ovarian
transplants, meaning that stimulation of the transplants produced mature
eggs that could be used to produce offspring.  Two, or 40%, of the five
monkeys in the group treated with the growth factor had functioning
transplants as did two of the monkeys receiving the frozen ovarian tissue.
The researchers said hormone levels were also measured and confirmed their
results.  "This study demonstrates that the transplantation of both fresh
and frozen ovarian tissue can restore ovarian function and produce mature
eggs in primates," Schnorr said. =20

In a separate study, a team at Cornell University Weill Medical College
successfully transplanted a 35-year-old cancer patient's ovarian tissue in
her forearm, restoring egg development and hormone production.  The
researchers said they were able to retrieve eggs from the woman's arm for
in-vitro fertilization, although they have so far been unsuccessful in
achieving fertilization.

Schnorr noted that the success of the transplants in primates with
menstrual cycles offered promise for the development of procedures to
remove and transplant a woman's own ovarian tissue if she is at risk of
becoming sterile from chemotherapy, radiation therapy or other causes. The
technique could also be useful for women at high risk for ovarian cancer or
who anticipate delaying childbearing, Schnorr said.  "We are still trying.
It is very exciting to be able to utilize ovarian tissue in such a simple
fashion," said Dr. Kutluk Oktay, author of the
Cornell study.  Oktay said a second patient, with a benign ovarian cyst,
has also undergone the graft procedure.

'eHealthy News You Can  Use' October 29, 2000 - Issue 177 :  Current
Thyroid Testing  Inadequate - Here is more information from the British
Medical Journal  reinforcing the fact that the current "normal" range for
TSH (Thyroid  Stimulating Hormone) is too high. Large numbers of
individuals with clinical  symptoms of hypothyroidism are not being
diagnosed due to this  misunderstanding.

Flu Shots Not  Cost-Effective - A study in the Journal of the American
Medical  Association found that the flu shot is not cost-effective when
used in  adults.

Thermography for Breast  Cancer:  Thermographic breast screening is
brilliantly simple.  Thermography measures the radiation of infrared heat
from the body and  translates this information into anatomical images.

Breast Cancer  Awareness Month Story - Every October since 1985, the
recognizable symbol  of Breast Cancer Awareness Month, pink ribbons, are
displayed on TV, poster  and magazine advertisements as well as proudly
adorn women's lapels. Along  with all the other extravaganzas that take
place at this time there is  one subject that is usually given little, if
any attention - PREVENTION.  Could this have anything to do with the fact
that the month-long event  was created and still controlled by AstraZeneca,
the maker of  Tamoxifen?

GM Corn Scandal Continues  - The current controversy over unapproved
genetically modified corn winding  up in the food supply continues to grow.
The contamination was brought  to light after  Friends
of the Earth had  some taco shells tested and the unapproved for human
consumption StarLink  Corn was discovered. The following is a brief summary
of some events  surrounding this ongoing issue.

Anthrax Vaccine Saga: How Not  To Develop a Vaccine Program - Dr. Meryl
Nass's work, presented at the International Public Conference on
Vaccination 2000 in Arlington, Virginia.  Read about how this vaccine was
licensed in 1970, using limited safety  data and efficacy data obtained in
large part from a different anthrax  vaccine,  plus lots of other
fascinating information.

Cancer and IGF-1: Another  Reason to Avoid Milk - According to a recent
editorial in the British  Medical Journal, "The risk of cancer is higher
among people with raised  concentrations of insulin-like growth factor-I".
This adds more evidence as  to why milk should be avoided after early
childhood. Milk from synthetic growth hormone treated cows is even more
dangerous, as the levels of IGF-1  are even higher.

Cough Medicine May Cause  Stroke - An advisory committee to the US Food and
Drug Administration is  recommending that phenylpropanolamine (PPA), an
ingredient found in many  common over-the-counter cough and cold
medications and appetite  suppressants, be reclassified as unsafe, due to
the fat that it may increase the risk of hemorrhagic stroke.

IV Magnesium For  Asthma - Intravenous magnesium therapy may provide
"remarkable" benefit  to children with moderate to severe asthma, according
to a new double-blind  placebo-controlled study. I have known about the
benefits of IV magnesium and have been using this treatment for years.

Where to Complain  When Internet Companies Cause You Problems - Jesse
Berst's "Berst Alert" is the largest newsletter  on the Internet. It comes
out every day and is a must for those who are  interested in staying
current on computer news. This issue is a  wonderful resource list that you
will want to bookmark in your useful  list of resources to get results from
Internet Companies that do not  provide the service or results you expected.

FDA Asked to Ban Unapproved Fluoride Supplements for Children - A New
Jersey State Assemblyman is petitioning the FDA, for the second time in his
career, to  ban children's fluoride supplements, which have never been
officially  approved by the FDA.

UK Recalls Polio Vaccine Over 'Mad Cow' Fears - Britain's health service,
the Medicines Control Agency, (MCA), has recalled stocks of an oral polio
vaccine, due to  the fact that they may contain banned cattle products,
which are feared  to be contaminated with bovine spongiform encephalopathy
(BSE), better known  as "mad cow" disease.

 Older Birth  Control Pills May Cause Cancer - Older generation
birth-control pills may have significantly increased breast cancer risk
among some women who  took them. Although the risk was confined to women
who used "the pill"  prior to 1975, that doesn't necessarily mean that
newer versions won't  show the same or similar effects sometime down the=
 road.

Want to Know if You are Eating Genetically  Modified (GM) Food? There is a
great site where you can find out what  foods contain GM ingredients. The
site "True Food Shopping List: How  to Avoid Genetically Engineered Food"
was developed by Greenpeace and is  very comprehensive. So many foods now
have GM ingredients that it would  probably have been easier to list the
foods NOT containing any GM  ingredients.

Reduce Chances of Baby Having  Clubfoot - Pregnant women who undergo
amniocentesis in pregnancy have a  slightly increased risk of having an
infant with clubfoot, but delaying the  test slightly can significantly
reduce this risk. In addition, women who  smoke during pregnancy also have
an increased risk of having a baby with  clubfoot.

Water Fluoridation  Ineffective - When several regions in the former East
Germany halted the  artificial fluoridation of their water, many dental
authorities told people  to brace themselves for a significant rise in
dental caries (cavities).  However, as it turns out, they needn't have
worried at all, since dental  decay rates actually went down.

Bee Propolis Fights Dental  Plaque - Bee propolis helps prevent the
formation of dental plaque. This  effect seems to be due to its ability to
inhibit the activity of certain  enzymes, which synthesize glucans from
sucrose.

Antipsychotic Drugs Cause  Blood Clots - People who take antipsychotic
drugs, even those who are  young and otherwise healthy, face an increased
risk for potentially fatal  blood clots, researchers report. These findings
encompass a wide range  of medications for schizophrenia, manic-depressive
disorder, dementia,  autism, and other brain disorders.

More Aspirin Controversy -  Several recent reports have called into
question the benefits of daily  aspirin use in the prevention of
cardiovascular disease. Now comes new  questions about aspirin's
effectiveness at preventing thromboembolism and even more importantly about
the accuracy in the interpretation of  data that takes place in
peer-reveiwed scientific literature.

Fibrinogen Bad for the  Heart - Elevated levels of fibrinogen, a protein
synthesized by the  liver which is necessary for normal blood clotting,
increases the risk for  cardiovascular disease (CVD) and may be the
mechanism by which many recognized cardiac risk factors cause disease. In
addition, a new method  of testing fibrinogen levels may be superior to
previously used methods, and  provide more accurate and meaningful results.

Garlic May Prevent  Cancer - More evidence of the beneficial effects of
garlic. New research  shows that eating garlic seems to protect against
stomach and colorectal  cancer.

Death in Family Increases  Cancer Rate - Suffering a major loss, such as
the death of a loved one,  may play a role in how likely people are to
develop cancer or how quickly  people with cancer succumb to their illness.=
=20

Healthnews-subscribe@topica.com  The full newsletter is 20-40 pages long
and can be up to 250KB.

FDA banned ingredient: Which products are affected by the FDA's action to
ban phenylpropanolamine, or PPA? AcuTrim, Alka-Seltzer, Coricidin,
Dexatrim, Dimetapp, Robitussin, Tavist-D and Triaminic.  Also be careful of
products containing pseudoephedrine, such as Sudafed.  It may be the next
ingredient to be banned.

Type of Breast Cancer Surgery Has Little Impact on Quality of Life 8/31/00,
Katherine Arnold, Deputy News Editor, Dan Eckstein, (301) 986-1891, ext.
112: A new study reports that women whose breast cancer was treated by
mastectomy or mastectomy with reconstruction complained of more physical
symptoms after surgery than women treated by lumpectomy, but the groups did
not differ in their self-assessments of emotional, social, or role
functioning.=20

Study leader Julia Rowland, Ph.D., of the National Cancer Institute, and
colleagues, present their results in the Sept. 6 issue of the Journal of
the National Cancer Institute. They conclude that a woman's quality of life
after breast cancer surgery is more likely influenced by her age or
exposure to adjuvant therapy than what type of surgery she had. However,
women who had reconstructive surgery after mastectomy were most likely to
report that treatment had a negative impact on their sex lives (45.4%
versus 29.8% for lumpectomy and 41.3% for mastectomy alone).=20

The study involved detailed surveys of breast cancer survivors in Los
Angeles, Calif., and Washington, D.C. Women who had been diagnosed with
breast cancer from 1 to 5 years before study entry were identified through
a variety of mechanisms, including local tumor registries, physician
practices, and treatment clinic logs or charts. More than 6000 breast
cancer survivors were invited to participate in the study, about 60%
responded to the invitation, and a total of 1957 women completed
questionnaires. The questionnaire included a number of standardized
measures of health-related quality of life, body image, and physical and
sexual functioning.

More than one half (57%) of the women who completed the survey underwent
lumpectomy, 26% had mastectomy alone, and 17% had mastectomy with
reconstruction. Women in the mastectomy with reconstruction group were
younger than those in the lumpectomy or mastectomy-alone groups (mean ages
=3D 50.3, 55.9, and 58.9, respectively); they were also more likely to have =
a
partner and to be college educated, affluent, and white. Reconstructive
surgery was of less benefit to body image than anticipated, since scores on
the body-image scale for the mastectomy with reconstruction group were
closer to those for the mastectomy-alone group than scores for the
lumpectomy group.

As expected, women in the lumpectomy group reported fewer problems with
their body image and feelings of sexual attractiveness than women in either
the mastectomy with reconstruction or the mastectomy alone groups.
Mastectomy patients, with or without reconstruction, experienced more
physical symptoms and more discomfort around the surgical site than women
who had a lumpectomy. These symptoms included the sensation of pins and
needles (reported as often in 13% of mastectomy-alone women) and numbness
(a common problem for 52% of the women who underwent breast
reconstruction). Almost twice as many mastectomy-alone (46.6%), as
lumpectomy (24.0%), or mastectomy with reconstruction (25.8%) group members
reported problems with arm
swelling.  The authors conclude that studies such as theirs can provide a
benchmark against which to measure progress toward improving not only
women's survival from breast cancer but also their quality of life after
breast cancer.

8/11/00 (HealthScout): Women who've had their wombs removed face a higher
risk of bladder trouble long after the operation, new research suggests.  A
study of studies by California doctors shows that women who undergo a
hysterectomy are up to 60% more likely to suffer urinary incontinence than
those who haven't had the procedure. What's more, the researchers say, the
bladder problems typically don't surface for one or two decades after the
operation.  The finding, which appears in The Lancet, should prompt doctors
to discuss the possibility of incontinence with their patients considering
hysterectomy, the researchers say. Currently, few do.

Some 600,000 women undergo hysterectomy every year, putting it second only
to Caesarian section as the most common major operation. By age 60, four in
10 American women have had one. In nearly every case the procedure is
intended to treat conditions such as fibroid tumors in their womb, pelvic
pain and vaginal bleeding. Major complications from hysterectomy are rare
and the death rate from it is about six per 10,000. But the operation can
damage nerves and tissues in the pelvis that could in theory lead to
incontinence. In practice, however, hysterectomy's impact on bladder
function is harder to pin down. Some studies have pointed to an increased
risk of incontinence from the procedure, while others that look at the
first two years after the operation have shown no effect at all.

Trouble after age 60: In the latest work, Dr. Jeanette Brown of the
University of California at San Francisco and her colleagues reviewed 45 of
these studies and
winnowed those down to a dozen that met rigorous criteria for scientific
merit.  Their so-called "meta-analysis" found that women who had their
hysterectomy before age 60 didn't appear to suffer more incontinence. But
those who had the operation after they turned 60 were 60% more likely than
normal to suffer bladder trouble. That translates to an absolute increase
in risk from 30% to 41%, the researchers say.

Dr. Deborah Grady, a UCSF epidemiologist and a co-author of the study, says
the age cutoffs aren't as important as what they imply: Since most women
have hysterectomies in their late 40s or early 50s, incontinence that crops
after age 60 is 10 to 15 years downstream from the operation. "It appears
to take a while to develop," she says. That's not surprising, says Grady,
considering urinary incontinence related to childbirth also occurs several
years after delivery. Unfortunately, she says, most doctors tell patients
about only the immediate side effects of hysterectomy surgery,  the small
risks of infection and blood loss, for example. "But they don't generally
talk about the risks of incontinence."

But Dr. Stephen Young, chief of urogynecology and pelvic reconstructive
surgery at the University of Massachusetts School of Medicine in Worcester,
says not all cases of incontinence are created equal. Many women, perhaps
15%,  experience significant pelvic sagging, called prolapse, that can lead
to bladder problems later in life.  "All I do in my clinical career, and
I'm very, very busy, is see women with prolapse and incontinence," says
Young, who is also a spokesman for the American Urogynecologic Society. As
a result, he says, real risk of incontinence due to hysterectomy may be
lower than what the California scientists believe.

What To Do: To learn more about hysterectomies, visit Plainsense. For more
information on incontinence, read this fact sheet from the National
Association for Continence. SOURCES: Interviews with Deborah Grady, M.D.,
professor of epidemiology, University of California, San Francisco; and
Stephen Young, M.D., chief of urogynecology and pelvic reconstructive
surgery, University of Massachusetts School of Medicine, Worcester.=20

ALTERNATIVE MEDICINE:   Mother Earth News, by Marguerite Lamb: In recent
years, we've been hearing a whole lot about antioxidants, chemicals that
neutralize harmful free radicals in our bodies. Free radicals are highly
charged oxygen molecules (having either one too many or too few electrons)
that are formed mainly as a natural byproduct of breathing, but also from
exposure to food additives and pesticides, UV light, cigarette smoke,
exhaust fumes, and chemical pollutants.  Not satisfied in their unstable
state, free radicals roam the body, stealing mates for their unpaired
electrons from unsuspecting cells. These biomolecular bandits have so far
been linked to dozens of illnesses, including cancer, arteriosclerosis, and
arthritis, as well as to premature aging.

Widely touted as "fountains of youth," antioxidants provide the best
defense against these scavengers--either by blocking their production or by
serving as biochemical kamikazes, allowing themselves to be ransacked by
free radicals in place of healthy cells.  Vitamins A, C, and E, along with
beta carotene (a precursor to vitamin A),
are the best-known antioxidants. But none of these make their way often
enough (and in sufficient quantities) into the Western diet, which tends to
be heavy on fats and carbs and low on antioxidant-rich fruits, veggies,
nuts, and seeds. Indeed, it is estimated that less than 10% of Americans
regularly consume five fruits or vegetables daily, the National Cancer
Institute's recommended minimum. Of course, supplements are always an
option, and in recent years both C and E have become bestsellers for
vitamin retailers nationwide. (Vitamin A can be harmful in very high doses,
and so folks tend to steer clear of this one in supplement form.)

But for those who prefer to get their nutrition out of the ground rather
than out of a plastic bottle, there's good news: the latest antioxidant
research is pointing to other natural sources that--with a sprinkle here
and a dash there--can easily be incorporated into the American diet. We're
talking here about herbs and spices.  "One way to see herbs is as compact
sources of the nutrients present in foods, with relatively little of the
space-consuming water and calorie content," says Lorilee Schoenbeck, N.D.,
a naturopathic physician in private practice at the Champlain Center for
Natural Medicine in Shelburne, Vermont. "When you look at herbs as highly
concentrated foods," she adds, "then it is not surprising that,
ounce-for-ounce, herbs often contain much higher concentrations of given
nutrients or chemical compounds. Frequently, though not always,
antioxidants are among these."  Their compact nature alone may give herbs
and spices an advantage over vitamin E, since most natural sources of this
important nutrient (plant oils, nuts, etc.) will add inches to your waist
faster than they'll replenish your antioxidant arsenal.

Medical botanist Jim Duke, Ph.D., among the world's foremost authorities on
healing plants, recommends leafy herbs in particular as potent sources of
antioxidants. "Green leaves in general are richer in antioxidants than
other plant parts, because that's where the oxygen is produced," he says.
Retired since 1995 from the United States Department of Agriculture, he
continues to maintain that agency's phytochemical database
(www.ars-grin.gov/duke/). "You can go to my database and ask how many, and
how much, of each antioxidant compound there are in some 3,000 herbs," says
Duke, who is also the author of The Green Pharmacy (Rodale Press, 1997), a
handy guide to plant-based remedies.

In Green Pharmacy, Duke advises drinking two antioxidant teas a day as part
of a broader fit-for-life plan. Some herbs suitable for steeping are
oregano, rosemary, bee balm, lemon balm, peppermint, sage, spearmint,
savory, and thyme, all of which have been shown to contain significant
levels of antioxidants.  These and other antioxidant-packed herbs and
spices can also be sprinkled in salads or used to flavor your favorite
vegetable, pasta, or meat dishes. Many can be found dried, crushed, and
packaged at the local grocery. But, as with fruits and vegetables,
fresh-from-the-garden herbs and spices are optimal, says Beverly Yates,
N.D., of the Center for Natural Health Care in Portland, Oregon. "Ideally,
people should consume freshly picked herbs and spices, preferably grown in
their own gardens so they know exactly what
the growing conditions are."

But while fresh may be best, it takes effort and patience to grow your own.
The nutritional supplement makers know (and are banking on) this, and as
word spreads about the antioxidant powers of herbs and spices, more and
more are showing up on store shelves in pill form. But are supplements a
good way to get your herbs?  "I agree with the conservative nutritionists
and AMA physicians that the best way to get [antioxidants] is through a
balanced diet," says Duke. "But how many Americans take time for a balanced
diet? Better they pop the
antioxidant pill than do without."=20

For Schoenbeck, whether or not a person should take antioxidant herbal
supplements depends on that person's overall health picture.  A 30-year-old
nonsmoking vegetarian who shops organic, exercises regularly, lives in a
rural area, and has no family history of heart disease, cancer, or any of
the other major diseases associated with free-radical damage can properly
skip the supplements, she says. But the 45-year-old city dweller who
smokes, eats processed foods, or has a strong family history of one of
the aforementioned diseases, should take his antioxidants any way he can
get them.

Still, Schoenbeck warns, antioxidants are no elixir. "Here in Western
society, it seems we're always looking for the fountain of youth--and the
magic bullet that will provide it," she says. "Antioxidants have existed as
long as food has. They have been quietly exerting their antiaging effects
on the people who consume healthy foods for generations. Our current
preoccupation with them as 'miracle cures' speaks more to how far we, as a
society, have gotten away from eating healthy food and living in nontoxic
environments than it does to their ability to prevent every disease
imaginable."  "Sometimes," adds Yates, "you see people smoking heavily, no
exercise, fast food all day, and so on, eating handfuls of antioxidants of
various kinds, thinking that they are being healthy and that the little
natural pills will undo the rest of their unhealthful, harmful habits. It's
like putting a Band-Aid on a hemorrhage; it is simply not enough in those
cases."=20

List of Antioxidants:  Many dozens of herbs and spices are known to contain
antioxidant compounds. Below is a list of just some of the more potent
ones. For advice on which to take and in what amounts, consult a trained
herbalist, naturopathic physician, nutritionist, or M.D. As a rule,
pregnant women should consult their obstetricians before taking any herbs.

BILBERRY: Compounds called anthocyanosides give bilberries their
antioxidant punch; this berry and its relatives blueberry, cranberry, and
huckleberry, can aid in protecting the eyes in particular from free-radical
damage. =20

SAGE: Another powerful antioxidant, but not to be overdone. According to
medical botanist Jim Duke, this spice contains a fair amount of thujone, a
compound that can cause convulsions if consumed in large quantities.=20

GARLIC: Yes, this blood-pressure-lowering, bad-cholesterol-busting bulb is
also a potent source of antioxidants.

GINGER: This age-old nausea remedy contains the antioxidant zingerone,
which, according to naturopathic physician Lorilee Schoenbeck, "protects
against oxidative damage to fats." Mince a few slices of fresh ginger root
and add to your favorite stir-fry.

ST. JOHN'S WORT (Hypericum): This mood-booster is also a good source of
antioxidants. "If you squeeze one of the little yellow flowers of the St.
John's wort plant," says Schoenbeck, "a dark red pigment will bleed from
the petals. This pigment is the result of Hypericum's very high content of=
 the
bioflavenoids rutin, hyperin, quercetin, and quercitrin, all of which act,
in part, as antioxidants. With 11.7% of its content in bioflavenoids,
Hypericum is one of the most concentrated herb sources of antioxidants."

ROSEMARY: Studies have shown this herb to be a powerhouse, endowed with the
potent antioxidant rosmarinic acid, plus about a dozen other
free-radical-zapping compounds. Use as a spice or in tea to help ward off
cancers, heart disease, and the effects of aging.

TURMERIC: Much has been written about the mighty antioxidant powers of this
bright orange-yellow Indian spice (which are due largely to a compound
called curcumin). Says Beverly Yates, N.D., "Turmeric is a potent
antioxidant and anti-inflammatory, used clinically to treat inflammatory
conditions like arthritis, muscle sprains and strains, and swelling due to
injury and trauma of all sorts, including surgery recovery and accidents."
Research also suggests that turmeric may help to ward off certain kinds of
cancers, while promoting vascular health.

MILK THISTLE: This herb has proven effective as a general liver tonic and
specifically as a liver detoxifier.

PEPPERMINT: Long heralded for its abilities to calm distressed digestive
tracts, this herb is now also earning a reputation as a powerful=
 antioxidant.

GREEN TEA: Green tea is chockfull of polyphenols, compounds that,
Schoenbeck notes, "have antioxidant capabilities greater than vitamin C and
E." Green tea has been linked to the prevention of stomach, colon,
pancreatic, lung, and breast cancer.

PURSLANE: Jim Duke gives this potherb/salad green high marks, describing it
in his Green Pharmacy (Rodale Press, 1997) as "exceptionally rich in
antioxidants," especially vitamins A, C, and E, as well as a compound known
as glutathione, an immune-system booster.

GRAPE SEED EXTRACT: "Grape seed extract blurs the line between nutritional
supplement and herb," says Schoenbeck, noting that it's been found "at
least 50 times more effective than vitamins C and E as an antioxidant."
It's available in supplement form.

OREGANO: Like rosemary, this traditional Italian spice brings the added
benefit of rosmarinic acid and more than a dozen other antioxidants. For
more info. on this, try the internet link at top of article.

Dry Eye Syndrome: Treatment by Supplementing the Body's Natural Oils: Dry
eye syndrome is a very common, but often extremely frustrating problem to
treat.  It causes a variety of symptoms, from irritation, burning and
itching, to blurred vision.  Recently, attention has been drawn to
nutrition and its affect on the maintaining the body's balance of natural
oils.  That' s where essential fatty acids come in.

What are Essential Fatty Acids?  Essential fatty acids (EFAs) are important
for the body's health.  Here's why:  EFAs produce energy, govern growth,
and are responsible for our vitality and mental state.  In fact, every cell
of the body needs fatty acids to thrive.  A deficiency of EFAs has been
linked to many diseases and disorders.  They are also believed to affect
how the body's glands produce oil.  Because of this, increasing the intake
of EFAs may improve conditions such as dry eyes and dry skin.

Some Fats are Healthy: The body does not produce EFAs, so they must be
supplied through diet. There are two basic categories of EFAs: Omega-3 and
Omega-6.  An ideal diet includes a ratio of four parts Omega-6 to one part
Omega-3.  The Omega-6 EFAs are found in raw nuts, (almonds, walnuts and
their oils), seeds (sesame, sunflower and their oils), borage oil, grape
seed oil, primrose oil, soybean oil, whole grains, and legumes.  Omega-3
EFAs are found in cold water fish such as salmon, mackerel, sardines, and
herring.  They are also in certain vegetables, flaxseeds, walnuts and
canola oil. It is essential to consume EFAs properly for the body to
receive their full benefit.  EFAs are destroyed with heat, causing free
radicals to form.  Free radicals are atoms with an unpaired electron.
Simply put, if not re-paired with their atoms, these electrons collide with
healthy cells and cause  damage.  Fatty acids are sometimes hydrogenated
into solids such as margarine.  The body converts this type of fat into
trans-fatty acids that are harmful and may increase the risk of
arteriosclerosis and other diseases.

How Can I Add EFAs to My Diet?  Flaxseeds provide one way to incorporate
EFAs into the diet.  They come in several forms: oil, capsules, and powder.
 Scientist Patricia Kane suggests grinding the seeds in a coffee grinder,
food processor, or blender, storing the unused portion in the freezer.  She
believes ground flaxseeds travel through the intestinal tract more slowly
and are better absorbed by the body.  Three tablespoons of ground flaxseed
are equivalent to two tablespoons of whole seeds.

The following is a suggested regimen: 2 tablespoons ground flaxseed 1 or 2
times daily.  12 almonds or pecans daily (Substituting peanuts for almonds
and pecans will  not produce the same result!)  3 evening primrose oil
capsules (500 mg) 2 or 3 times daily

Finding the right regimen appropriate for your body and incorporating it
into your lifestyle is key.  The ideal dosage for each individual varies
and is dependent on the severity of the symptoms.  Many find that blurred
vision caused by dry eyes is improved after just a few days.  Remember,
taking the proper dosage consistently is important for the best result. =20

EFAs and Dry Eye Syndrome: Adding EFAs to your diet can improve discomfort
from dry eyes and skin. Even though it may seem inconvenient at times, most
are so pleased with the improvement that supplementing the diet becomes a
small sacrifice. Information linking EFAs and dry eyes is not yet available
in medical literature.  However, there are many articles, books, and
studies that suggest EFAs can improve overall health by lowering serum
cholesterol levels and preventing and even reversing arteriosclerosis.
There is no perfect cure for dry eye syndrome, but taking these simple
steps, along with other treatments your doctor may suggest, can give relief
from the frustrating symptoms.

This information is provided solely as a public service and is based on
information presented by Paul Honan, MD at the American Society of Cataract
and Refractive Surgeons convention, Boston, MA, May, 2000.  The increased
caloric intake should be balanced with an appropriate exercise program.
Myra Cherchio, COMT, Senior Editor, StLukesEye.com
ON THE POLITICAL FRONT:  How about that election??!!  Sometimes just when
you think you've seen and heard everything=85=85.something new happens.
History in the making, that is what we are seeing.  I hope it turns out
best for all of us.
COMMENTARY: Westport, CT (Reuters Health) 10/ 25/00: Informed Consent
Clouded by Technology, Marketing Pressures.  The importance of informed
consent is being obscured by the pressures of the marketplace and issues
that exist only as a result of recent technological advances. A series of
articles in the Fall issue of the Journal of the American Medical Women's
Association reviews how the standards of informed consent, in the context
of women's health, can be met in the rapidly changing medical environment.
Nancy Neveloff Dubler, of the Albert Einstein College of Medicine, cites
breast augmentation surgery as a situation in which informed consent as
conventionally presented fails to protect patients.  In May of this year,
the Food and Drug administration approved saline implants for breast
augmentation.  However, the FDA stressed that the surgical procedure is
associated with relatively high complication and failure rates. "Here you
have culturally determined, market created, advertising-supported demand,"
Dubler told Reuters Health. She emphasized that sophisticated advertising
of skills and products to increase patient desire impedes physicians'
ability to present risks as clearly as they do benefits.

To counteract the enticement of sophisticated advertising, she suggests,
"Warnings should be presented as cleverly and professionally as the
advertisements." Statements of adverse outcomes should be placed within the
advertisements, Dubler said, "in bold face type!"  "I would extend this
rule to any medical procedure or product that is market driven, where there
are advertisements from physicians that help to create the demand," Dubler
added.

In another article, Dr. Dena S. Davis, of Cleveland State University, in
Ohio, reveals how convoluted informed consent can become when politics and
morality are involved, as is the case in the disposition of human embryos
created for the purpose of in vitro fertilization. She suggests that for
most individuals the embryo occupies a middle ground "between full
personhood and mere tissue."  Three organizations, the American Association
for the Advancement of Science, the National Institutes of Health, and the
National Bioethics Advisory Commission, have each issued policy statements
regarding when, how by whom, and to whom requests for embryo donation for
stem cell research should be made.  Dr. Gail Geller, of Johns Hopkins
University, and colleagues expand the notion of informed consent to include
process rather than a single event, especially when children are involved.
The investigators use as an example the benefits and risks of participating
in genetic susceptibility research.
=20
MORE COMMENTARY:  http://www.thenation.com/issue/980706/0706DOWI.HTM
Ames is an active adviser to The Advancement of Sound Science Coalition
(TASSC), a corporate-supported "watchdog coalition that advocates the use
of sound sciences in public policy." TASSC has about  900 members, 375 of
whom are scientists. The rest are executives from the chemical, oil, dairy,
timber, paper, mining, manufacturing and agribusiness industries seeking
ways to defend their products in media and the courts. TASSC's Web site
offers examples of "junk science," alongside a host of entries defending
bovine growth hormone, genetically engineered foodstuffs, dioxin,
electromagnetic fields and endocrine disrupting chemicals. On the site can
also be found almost every article Gina Kolata has written defending a
chemical or technology. In 1995 TASSC awarded Kolata its "Sound Science in
Journalism Award." Neither she nor the Times lists it among her awards and
citations.

Breast Implants and Breast Cancer: The topic she chose was silicone breast
implants. Breast implants are a contrarian's dream topic because there are
two distinct sides, both of which have sharpened their arguments during ten
years of massive litigation against Dow Corning, Bristol-Myers Squibb and
other manufacturers of the product. Pick either side and you're a
contrarian. Stories from the middle ground get less attention. Re-reading
Business Week, Newsweek and most daily newspaper coverage of silicone
breast implants, one finds a fairly balanced depiction of a now familiar
story from the corporate-medical complex: Manufacturer launches exciting
new product despite troubling animal research. Adverse reactions are
reported, but dismissed, either as anomalies or the result of bad medical
practice. Over the years complaints pour in from surgeons and their
patients--in this case describing implant ruptures, silicone migration,
connective tissue diseases and other disorders. Documents are discovered
showing that manufacturers knew of hazards before the product was launched.
Litigation ensues. People in misery blame manufacturers. Manufacturers
blame product liability lawyers. Cautious reporters wait for juries to=
 decide.

But Kolata didn't wait for verdicts. She weighed in with the manufacturers,
repeating many of the arguments they had made in court, and when juries
ruled for the plaintiff, as many did, she reported that they were willfully
ignoring scientific verities. To substantiate her position, she quoted Dr.
John Sergent saying, "I don't know a single, high-quality immunologist who
is convinced that there is a definable disease related to implants." She
did not mention that Sergent was a highly paid expert defense witness for
Dow and Bristol-Myers, and she went on to write scathing criticism of
doctors who accepted fees for testifying on behalf of plaintiffs.

To her credit Kolata found and exposed a few sleazy doctors who took
patient referrals, and fees, from plaintiff attorneys in return for
opinions that favored their clients. But from her expose of their behavior
she concluded that the entire case against Dow and others lacked merit and
that a handful of trial lawyers had driven a perfectly decent company into
bankruptcy. The presence of predatory lawyers and doctors does not,
however, negate the possibility that a product might be damaging. Upon
examining the evidence, juries found Dow Corning so guilty so often of
corporate malfeasance that the company was forced into joining a
settlement, for $4.2 billion, with the entire class of women who believe
their lives have been ruined or compromised by breast implants. Yet Kolata
chose to side with the company. "A Case of Justice, or a Total Travesty?
How the Battle Over Breast Implants Took Dow Corning to Chapter 11" blared
the June 13, 1995, headline over Kolata's article about the bankruptcy,
much of which read like Dow PR. An advertisement the company ran in a dozen
major newspapers during May 1995 claimed that "plaintiffs attorneys have
spawned a whole new industry from suing implant manufacturers." In her June
report Kolata bemoaned "a legal juggernaut [that] can take on a life of its
own, and bring a large and thriving company to its knees." If Kolata missed
the rather obvious point, intimated by Dow's CEO in Chemical Week magazine,
that the company's bankruptcy was intended to delay the remuneration of
claimants, investors did not. The first quarter after bankruptcy was
declared, Dow earnings broke all company records, and the stock has soared
with the rest of the market.

While researching a separate breast implant story that ran on June 22,
1995, under the headline "New Study Finds No Link Between Breast Implants
and Illness," Kolata contacted Dr. Gary Solomon at the Hospital for Joint
Diseases. Solomon had patients who had developed connective tissue
disorders following the rupture of breast implants. He was a natural
source, and nearby in New York. They spent hours on the phone during which
Solomon says he "walked her through nineteen published studies on the
relationship between silicone and joint diseases." Recalls Solomon, "One of
the studies I mentioned was negative. The others all indicated problems
with silicone. Ms. Kolata reported the negative, accurately I might say,
and ignored the other eighteen. And she quoted me citing the report in a
way that made me sound as if I believed there was no problem with breast
implants."

Solomon was furious. "She chose to ignore sound science that disproved her
point and grossly misrepresented my position. I went back and reread her
articles and it became clear that she had made up her mind about breast
implants four years earlier." Solomon wrote a letter to the editor,
addressed directly to executive editor Joseph Lelyveld, describing his
experience with Kolata. There was no answer, and his letter never ran. Nor
did a correction. In fact, the next time Dr. Solomon saw his name in the
Times was in an article under Kolata's byline "lumping me together with
physicians who charge exorbitant patient fees and side unfairly with breast
implant plaintiffs."

Evidence of Kolata's harsh treatment of those who disagree with her can
also be found in her October 1, 1997, review of an HBO documentary about
breast cancer. A few days before HBO aired the film, the producers sent
four videocassette copies to the New York Times. Although Kolata was not
sent a copy, TV critic Caryn James sent hers to Kolata. Rachel's Daughters:
Searching for the Causes of Breast Cancer portrays the pilgrimage of six
women with breast cancer who travel around the country investigating the
cause of their disease. The bulk of their inquiry is through dialogue with
almost two dozen scientists who study cancer. Yet Kolata's review, titled
"Trying to Place Blame When Breast Cancer Strikes," says "the women are far
removed from the universe of scientists."

Although breast cancer specialist Dr. Susan Love is quoted on camera
saying, "We have no idea what causes cancer," Kolata accuses the women who
seek Love's counsel of being "convinced that they were poisoned by their
toxic environment." In fact, most of the women return from their quest
deeply frustrated by the uncertainty of the scientists they have met. As
one 28-year-old woman with a full mastectomy puts it: "The scariest thing
was to walk away with no solid answers."=20

Kolata calls this "paranoid thinking" and derides women who regard
themselves as Rachel Carson's daughters (Carson died of breast cancer) as
emotional paranoiacs who should desert their suspicions that pesticides,
radiation, plastics and endocrine disrupters just might bear some
relationship to their illness and rely only upon scientists who believe
"that when evidence fails to support a hypothesis, the hypothesis should be
abandoned" (as opposed to keeping it alive as long as there is no clear
proof one way or the other). Kolata closes her review by proposing that a
prominent label be placed on the film: "Warning. What you are about to see
may be heart-wrenching, but it has little or no basis in fact."=20

When Caryn James forwarded the film, she might not have known that Kolata's
younger sister, Judi Bari, had recently died at 47 of breast cancer.
However, Bari's long struggle with cancer didn't seem to affect Kolata's
steadfast conviction that no environmental factors had been found to
explain her sister's death. "Judi strongly believed that her cancer was
environmentally induced," recalls her good friend Betty Ball, who says her
sister's coverage of cancer, in fact her general stance on environmental
issues, was deeply troubling to Bari, a committed forest preservationist
who, after successfully opposing several redwood timber sales, was
seriously injured in a 1990 car bomb attack

BOOKS: Silicone Survivors: Women's Experiences with Breast Implants: Gender
& Society; Thousand Oaks; Oct 1999; Constance L Chapple, University of
Nebraska, Lincoln; Abstract: "Silicone Survivors: Women's Experiences with
Breast Implants" by Susan M. Zimmerman is reviewed.  Full Text: Silicone
Survivors: Women's Experiences with Breast Implants. Philadelphia, PA:
Temple University Press. 1998, 225 pp., $59.95 (cloth); $19.95 (paper).

The decision to receive breast implants has often been regarded as a
personal decision between a woman and her doctor. Susan Zimmerman, in her
thought-provoking new book, suggests that the implant decision is not
solely a personal one. The decision to receive breast implants is entwi