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Vaccine Manufacturers and Breast Implant Manufacturers: Same Game, Same Strategies. A Mere Coincidence?



 
 
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Old August 27th 07, 05:37 PM posted to sci.environment,talk.politics.medicine,misc.kids.health,alt.support.breast-implant,misc.health.alternative
Ilena Rose
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Posts: 1,139
Default Vaccine Manufacturers and Breast Implant Manufacturers: Same Game, Same Strategies. A Mere Coincidence?

Note from Ilena: I have posted this many times in the past, as it
became clearer and clearer that the "pro-silicone" & vaccination
industries were joined together using the same quackwatch/junkscience
strategies and people to try to augment the industries failing images.
http://breastimplantawareness.blogspot.com
http://ilenarose.blogspot.com
Health Lover

www.breastImplantAwareness.org

Vaccine Manufacturers and Breast Implant Manufacturers:
Same Game, Same Strategies. A Mere Coincidence?
by Michael R. Hugo, Esq.
http://consumerlawpage.com/article/vaccine.shtml
--------------------------------------------------------------------------------

The Consumer Law Page is pleased to honor this work by attorney
Michael Hugo. His compelling analysis comparing the misconduct of
vaccine and breast implant manufacturers is commended to you.

Mr. Michael Hugo, a respected advocate, legal scholar and caring
practitioner, stands in the vanguard of American lawyers who are
advocates for the public good. He serves as a leader in the
plaintiff's committee on breast implant litigation and is highly
regarded for his conscientious commitment to the cause of justice for
victims of corporate abuse.

This article was first published by the Association of Trial Lawyers
of America in its 1996 Boston Convention Syllabus where it was
discovered by The Consumer Law Page. We are extremely pleased to have
Mr.Hugo's permission to reprint his work here. We salute his
distinguished efforts on behalf of the victims of breast implants and
we commend him as a leader in the legal profession to be emulated by
all aspiring attorneys.

It is indeed appropriate that he makes his office in historic Faneuil
Hall, a stone's throw from the site of the Boston Massacre and the
home of America's most distinguished lawyers whose clients included a
new nation at its birth.

To Mr. Hugo and his colleagues fighting for the cause of women and
children victimized by medical devices, vaccines and drugs, our
highest compliments for your vigilant efforts on the side of human
justice. Godspeed in your efforts to achieve justice for the victims
of corporate abuse. You are a tribute to the legal profession.

Richard Alexander, Publisher
The Consumer Law Page
October 26, 1996


--------------------------------------------------------------------------------

I. Introduction

If pertussis vaccine is administered to children who have pre-existing
conditions or have had a severe reaction to a previous administration,
the result can be devastating. Pediatricians must be ever vigilant.
For manufacturers of vaccine to allay the fears of pediatricians by
suggesting that DTP is safe is one thing; for them to do so under the
auspices of a reputable peer reviewed journal, by authors who fail to
disclose their financial interest, is quite another.

II. Revealing Critical Conflicts of Interest Regarding DTP

One such journal, the Journal of the American Medical Association
(JAMA) ran an article several years ago. [1] In an editorial run in
the same issue, the writer sought to convince readers that pertussis
vaccine encephalopathy was a "myth." [2] The editorial was authored by
James D. Cherry, M.D., the leading defense expert witness in vaccine
litigation. Dr. Cherry failed to disclose his significant financial
ties to Lederle Laboratories, Wyeth Laboratories, Connaught
Laboratories, Parke-Davis & Company, or Eli Lilly & Company -- the
major DTP vaccine manufacturers in this country. Similarly, Dr. Edward
Mortimer, of Case Western Reserve School of Medicine, failed to
disclose his ties to the industry in the underlying article that
appeared in the same issue. [3] JAMA authors must sign a statement
that they have no financial interest in the subject matter, including
"consultancies" between the author and the manufacturer of the drug
being reported. There is an editorial policy of JAMA concerning
ethical and financial conflicts of interest. In any publication, the
integrity of the articles is a direct function of the integrity of the
authors. As peer reviewers for JAMA, Drs. Cherry and Mortimer [4] have
been entrusted to ensure the scientific integrity of the works they
review for that journal. The obligation of a journal's editorial board
members is to come forward with information concerning potential
ethical violations prior to the publication of an article in the
journal if they know of the existence of such conflicts.

Dr. Cherry has been actively reviewing DTP cases on behalf of the
pharmaceutical manufacturers since the early 1980s. He was a
collaborator in the UCLA/FDA study carried out in the late 1970s. That
study revealed an incidence of 1:1750 seizures and an additional 1:750
hypotensive hyporesponsive episodes within 48 hours following DTP
administrations. The study was originally funded to examine 50,000
administrations of DTP, but was terminated after 15,752 DTP and 784 DT
administrations. The study was plagued by an unacceptably high
incidence of seizures in the first 1500 doses. Dr. Larry Baraff, the
principal investigator of that study, reported to Wyeth Laboratories
on September 6, 1978, that DTP vaccine has produced 5:1500 (1:300)
generalized seizures, all in infants under six months of age which is
below the usual lower limit defined for febrile seizure disorders.
There had been 2:1500 (1:750) incidents of hypotensive hyporesponsive
shock collapse.[5]

Following the completion of the UCLA/FDA study, Dr. Cherry was named
associate editor of the Report of the American Academy of Pediatrics
Committee on Infectious Diseases, known as the Red Book. He served
under Dr. Jerome O. Klein, the editor, and Dr. Vincent A. Fulginiti,
the chairman of the committee, and is a current member of the JAMA
editorial board.

At about this time, in December of 1981, Dr. Cherry was contacted by
Patrick Hast, a lawyer representing Parke Davis in a DTP case. So
began his participation in hundreds of lawsuits on behalf of
defendants being sued for vaccine liability.[6] Dr. Cherry recently
began a presentation at the National Institutes of Health (NIH) with
an unpublished slide of an elephant that had various parts depicting
the factions in the vaccine injury controversy. He selected the anus
as the lawyers.[7] In 1988, Dr. Cherry estimated that he was making
about $50,000 per year testifying for manufacturers, based on an
hourly fee of $200, in about 90 cases. Today. he charges over $260 per
hour and has reviewed hundreds of cases.[8]

In addition to these sums, Dr. Cherry has attained $400,000 in grant
funds for UCLA, much of which is applied to his research, expenses,
and salary. Although this sum is applied to his department at UCLA,
Dr. Cherry eventually receives the benefit of most of it. Dr. Cherry's
department has also recently received $450,000 in unrestricted funds
he calls a "gift," from Lederle. This was so designated to allow Dr.
Cherry free access to more of the money.

When confronted with his failure to declare this money on his JAMA
financial disclosure form which he signed prior to publication of his
editorial, Dr. Cherry, a member of Lederle¹s editorial board, told a
television reporter, "I don't know what I signed." Following the
airing of the television news story on WHDH Television in Boston, the
Los Angeles Times, Dr. Cherry's home-town newspaper, viewed the
WHDH-TV film and contacted Dr. Cherry for further comment. From the
time WHDH spoke with him to the time the Los Angeles Times contacted
him, Dr. Cherry amended his response, telling the Los Angeles Times,
"When I signed this thing, I actually thought about it and read it
sort of carefully because I know this is a sensitive area. As it turns
out, I did think about this. I thought this is generic, not really
specific."

The rationale behind the "generic" comment is explained in the Los
Angeles Times as Dr. Cherry's belief that his article did not concern
Lederle's product in specific, but referred to pertussis vaccines in
general. Because he is a consultant for Lederle, Cherry did not
believe it was necessary to declare the existence of the funding. He
stated, "[t]his particular editorial relates in no way to a specific
manufacturer, it relates to the pertussis vaccine." Lederle, one of
two United States manufacturers, is by far the largest supplier of DTP
in this country. While WHDH-TV has discussed Dr. Cherry's ties to
Lederle only, Dr. Cherry has also taken grant money and consulted for
Wyeth Connaught, Parke Davis, Merrell Dow, Burroughs-Wellcome, and
Connaught Canada. Additionally, Dr. Cherry has shared his manuscripts
with the legal department of at least one manufacturer prior to
submission for peer review and publication. How can he claim that he
is not in conflict?

Dr. Mortimer, one of the co-authors of the Griffin study, has also
failed to reveal a conflict of interest. Dr. Mortimer has testified
that he participated in many case reviews for DTP manufacturers. He
failed to disclose that, as a member of the AAP Red Book Committee, he
participated in a policy decision to testify on behalf of the
manufacturers in DTP suits. He testified under oath that:

Several years ago, because of the increasing number of litigation over
DTP, members of the so called Red Book Committee . . . agreed in a
sense that we would sort of divide up the cases to try to help the
manufacturers in these lawsuits, and therefore I and a number of my
colleagues agreed to serve as expert witness[es].[9]

Dr. Mortimer has gone on at least three trips to Japan on behalf of
Wyeth Laboratories. Like Dr. Cherry, he has appeared in litigation for
most of the manufacturers, and has lectured to Wyeth's team of defense
attorneys on how to better defend themselves against the
vaccine-damaged children. Dr. Mortimer has also consulted for Lederle
on a large scale. He has lectured to their legal staff and assisted
them with defense strategies. In addition, he has lectured lawyers for
Connaught and Parke Davis in similar strategy sessions. Dr. Mortimer
failed to disclose this to the JAMA in the submission of his
manuscript, notwithstanding the position of trust bestowed upon him as
a member of peer review staff.

The casual mention accorded the endowment of the chairs occupied by
Drs. Griffin and Ray, as Burroughs-Wellcome Scholars in
Pharmicoepidemiology at Vanderbilt University is also an incomplete
statement of the truth. The article should have mentioned that
Burroughs-Wellcome is the largest supplier of DTP vaccine to the
United Kingdom.

It should also be mentioned that Dr. Griffin, notwithstanding her
connection to that DTP manufacturer, is also a member of the Institute
of Medicine¹s Committee to Review the Adverse Consequences of
Pertussis and Rubella Vaccines. This is supposed to be an impartial
and uninfluenced committee. During his prefatory remarks at the public
meeting of the committee held on January 10, 1990, the chairman of
that committee, Dr. Harvey V. Fineberg, stated:

I wanted to emphasize that the committee is dedicated to seeking the
scientific basis of evidence and will not be influenced by political,
financial, or legal considerations.[10]

These are not doctor versus lawyer issues. These are doctor-patient
issues. Politics and self interest must never take a part in such
considerations.

III. Cover-Ups Involving Silicone Breast Implants

Similarly, and more recently, the manufacturers of silicone breast
implants have affected the medical literature in an attempt to color
the studies in a light most favorable to their litigation agenda. Some
of America's largest companies have spent millions of dollars
attempting to persuade the public that breast implants do not cause
disease despite the growing body of evidence demonstrating that
silicone breast implants do, in fact, cause harm. The manufacturer¹s
position is based on two seriously flawed population-based studies
that purport to show a lack of causal connection between breast
implants and disease.

Similar to that of the vaccine manufacturers, this campaign has two
purposes. The first is to improve its position in the litigation over
breast implants by attempting to persuade the public that implants are
safe. The second, and more devious reason, is to divert public
attention from the fact that they sold a medical device intended for
long-term implantation in the human body without any testing to
determine whether it was safe or defective. Indeed, the information
they possessed raised serious questions about the safety of implants,
but the companies elected to put profit before public safety. Contrary
to the manufacturers' media oriented assertions, there was and is
compelling scientific evidence that silicone breast implants cause
atypical diseases in women -- diseases that can be seriously
debilitating and come with tremendous cost to the individual and
society. Most of this information comes from studies conducted by the
manufacturers before implants were marketed. Moreover, the breast
implant controversy is another tragic example of the way in which
women have been injured by inadequately tested products.

In 1962, Dow Corning Corp., a joint venture of the Dow Chemical Co.
and Corning, Inc., introduced the first silicone breast implant. Prior
to the introduction of liquid silicone gel implants, women had liquid
silicone injected directly into their breasts. These injections
caused, in most if not all cases, severe complications. The liquid
based silicone gel implant was intended to remedy the problems caused
by direct injections of silicone.

These implants, promoted as being fit to last a lifetime, were
constructed of a rubberized silicone shell surrounding a silicone gel
which, in finished form, is 80 to 85 percent liquid silicone. By the
late 1960s, silicone manufacturers were aware that this silicone gel
would bleed out of the implants and migrate throughout the body.
Indeed, in 1965, one Dow Corning scientist wrote "we know that
something is getting out of the bag . . . ." And by 1980, the
manufacturers were aware that silicone gel would pass through breast
milk. The manufacturers never informed the public of these or other
findings that raised further serious questions about the safety of
implants.

The chemical makeup of silicone gel implants was virtually identical
to the chemical makeup of liquid silicone that was injected into the
breasts of women. The known complications associated with liquid
silicone injections included atypical immune diseases that the
researchers at the time termed "human adjuvant disease."

Silicone gel implants did not remedy the problems caused by direct
injections, and even caused other equally serious problems. The shell
was fragile; it permitted the silicone to leak out of the implant and
into the women¹s bodies and rupture under normal use. The gel, largely
made up of fluid, escaped from the shell and moved throughout the
woman's body.

Dow Corning was not alone in its discoveries. By the 1970s, all of the
manufacturers had become aware of a growing leakage and rupture
problem. Indeed, as plastic surgeons began to see complications in
their patients -- complications that appeared remarkably similar to
those seen with liquid silicone injections -- they expressed their
alarm to the manufacturers.

Notwithstanding these complaints, the manufacturers assured the
plastic surgery community that its concerns were unwarranted. They
repeatedly restated their position that silicone was biologically
inert and was safe for use, despite having no long-term studies to
support this claim.

Shockingly, while making those representations, the leading
manufacturer, Dow Corning, was engaged in a secret program, in
conjunction with its parent Dow Chemical Co., to utilize liquid
silicone as pharmaceutical drugs, vaccines, and insecticides. Indeed,
in the late 1960s and early 1970s, Dow Corning conducted a series of
research studies that concluded that silicone does stimulate the
immune system. This is in contrast to the position they now assert
that liquid silicone from their implants does not stimulate the immune
system.

At the same time, Dow Corning and Dow Chemical, to whom the other
manufacturers looked for leadership, were also investigating the use
of liquid silicone as insecticides, fungicides, and herbicides. The
same liquid silicone found in breast implants succeeded in killing
cockroaches. The public, and specifically the women who were being
induced to purchase implants, were never told of these studies, nor
the potentially toxic properties of the silicone.

Again, Dow Corning was not alone in its failure to look into possible
problems with the implants. One of its competitors, Heyer-Schulte, had
been an early manufacturer of intracranial hydrocephalic shunts. Prior
to introducing those shunts, undeniably medically necessary products,
Heyer-Schulte spent three years studying potential consequences. It,
like other manufacturers, did no such research on breast implants.

The manufacturers did not maintain any registries of implanted women
so that their health and complication rates could be tracked over the
years. Such registries are common among manufacturers of potentially
hazardous products. Michelin Tire Co. and Chrysler could not
accomplish a meaningful product recall without maintaining such
registries. Surely, a manufacturer of an implantable medical device
should be held to a standard at least as rigorous as that of an
automotive manufacturer or a software development company.

Even though the manufacturers put implants on the market without any
long term testing of their safety, the manufacturers had ample
evidence of local complications long associated with implants --
evidence they chose to ignore. For example, problems of contracture
(severe hardening of the breasts), rupture, bleeding, and migration of
the silicone to various parts of the body were well known to the
industry. When a medical device is implanted into a human body, a
capsule forms around the implant as part of the body's attempt to wall
off the implant. Such a reaction is not abnormal. With breast
implants, however, the manufacturers quickly learned that the capsules
were different. In many women (estimates as high as 80 percent), the
capsule, consisting of scar tissue, would tighten and compress the
implant, causing severe pain, hardening of the breasts, deformity,
and, in some instances, rupture of the implants.

Coupled with the contracture was the development of chronic
inflammation. All breast implants bleed, allowing silicone to escape
into the body, even if the implant shell does not rupture. At first
the manufacturers denied that the implants bled, but when faced with
uncontroverted evidence that liquid silicone was escaping from the
implant shell, they changed their marketing strategy, asserting that
"low bleed" was beneficial. Again, they had no medical or scientific
evidence to support such a claim.

But the local complications do not stop with contracture and chronic
inflammation. The shell of the implant was fragile and became
increasingly fragile in use as silicone fluids passed through the
shell and the shell interacted with body fluids. Doctors often had a
difficult time determining whether implants ruptured due to hardening
of the breasts, and rupture rarely showed up on mammography.

The consequences of ruptured silicone breast implants are serious and
deforming. The surgery to remove the ruptured implant and the
attendant loose gel can result in serious disfigurement because the
surgeon often must scrape and cut away large amounts of otherwise
viable breast tissue in order to excise the gel.

In recognition of the potential harm caused by liquid silicone, the
manufacturers admitted that ruptured implants should be removed. The
migrated silicone has been found, in large amounts, in lymph nodes,
knees, arms, and even, in a recent case, in spinal fluid. One woman
found silicone gel in her elbow, gel that had migrated from her
ruptured Heyer-Schulte implant. In fact, her plastic surgeon has
testified that he removed a half Dixie cup full of silicone from her
arm. Repeat surgeries to remove continuing evidence of silicone have
led to further disfigurement not to mention serious financial demands
on women.

IV. Autoimmune Conditions and Breast Implants

As painful as the disfigurement may be, an even more serious problem
exists -- silicone breast implants cause severe and debilitating
autoimmune conditions.

In the early 1960s, medical literature reported diseases and
conditions caused by liquid silicone injections. Many doctors who have
seen and attempted to treat women with these conditions believe that
this atypical autoimmune presentation is the result of a chronic
immune response to the silicone that the body is exposed to when the
implant bleeds or ruptures. Indeed, from the early manufacturer
studies to more recently published studies, the silicone gel and the
fluid contained therein has been proven to be a powerful booster of
immune response.

While the silicone fluid and gel have been proven to have their own
immune effects, even more disturbing is research conducted by both the
manufacturers and independent scientists demonstrating the breakdown
of the gel in the body and attendant formulation of even more toxic
substances. Recent studies show that the gel degrades into other
substances, including silica. Numerous epidemiological studies have
demonstrated that exposure to silica leads to a variety of autoimmune
conditions. Because it may take years for the body to break down
silicone into its constituent silica, symptoms in many women may not
surface until six to ten years or longer after implantation. This is
similar to the latency period for asbestos-related diseases, which at
times did not appear for decades.

Recent controlled epidemiology studies show that women with breast
implants have elevated antibodies, which are the most common markers
(indications of) for autoimmune disease. These studies used blood
samples from exposed women and compared them to double blinded
controls and have led to the conclusion that the serologic hallmarks
of autoimmune disease are found in women with implants and not in
women without implants. Similarly, one researcher has recently
published DNA/genetic susceptibility.

The symptoms of this atypical disease process include: sicca symptoms
(climically determined dry eyes, dry mouth, and dry vagina); joint
pains; muscle pains; and cognitive dysfunction. In its more serious
presentation, the disease includes central nervous system impairment
(often as a result of an immunological response), kidney failure, and
even death. The unique group of symptoms seen in women with breast
implants is not seen in the general population.

From animal studies, which demonstrate convincingly and unassailably
that silicone produces chronic immune response, to well-conducted
clinical studies, which report on the results of examinations and
evaluations of thousands of women with breast implants, to controlled
epidemiology studies proving elevated antibodies in implanted women,
the scientific evidence overwhelmingly shows that silicone breast
implants cause systemic disease. Moreover, the data submitted to the
Claims Office in Houston showing that one in ten women with breast
implants suffers from an atypical disease further bolsters this
conclusion.

V. Conclusion

In 1991, facing a growing public outcry over implants and their
consequences, the president of Dow Corning Wright Co. wrote, "the
cover-up is going well." Since 1991, the manufacturers have
deliberately engaged in a campaign designed to misdirect public
attention and to cover up the very real and serious consequences that
women with implants suffer. The centerpiece of the manufacturers'
efforts has been the design and funding of several misleading
statistical studies. These studies were narrowly designed to look for
a limited set of classical diseases, rather than for the atypical
disease process now recognized to exist in thousands of women with
breast implants. The studies were reviewed, not by the company
scientists, but by the company lawyers in an effort to ensure that the
results would support the manufacturers' position in litigation.

Neither the much-touted Harvard Nurses' Study nor the oft-cited Mayo
study looked at the atypical disease process that the literature says
is caused by implants. Indeed, neither even address the issue of
whether silicone causes atypical disease and neither look at the issue
of latency. In fact, the Harvard study of 876 women included one woman
who had her implants for thirty days. More shockingly, however, that
study also included at least two women whose implants preceded the
date of invention of the device, according to the text of the study.
These two studies were carefully designed not to find the obvious, or
the truth.

The manufacturers' attempts to cover up the real science is consistent
with their pattern of covering up the real consequences of their
products.

Endnotes

1. M.R. Griffin et al., Risk of Seizures and Encephalopathy after
Immunization with Diphtheria-Tetanus-Pertussis Vaccine, 263 JAMA
1641-45 (1990).

2. J.D. Cherry, ŒPerussis Vaccine Encephalopathy: It is Time to
Recognize It as the Myth That It Is, 263 JAMA 1687-96 (1990).

3. Drs. Griffin and Ray are Burroughs-Wellcome Scholars in
Pharmicoepidemiology at Vanderbilt University School of Medicine.
Burroughs-Wellcome is the major DTP manufacturers in the United
Kingdom. Dr. Mortimer has long been the DTP vaccine consultant to
Wyeth Laboratories, and Parke Davis, former DTP manufacturers and
current litigants involving liability for their vaccine. In addition,
Dr. Mortimer has long been a consultant to Lederle Laboratories and
Connaught Laboratories, the sole commercial suppliers of DTP in the
United States.

4. The 1989 JAMA Peer Reviewers List, 263 JAMA 1687-96 (1990).

5. C.L. Cody et al., Nature and Rates of Adverse Reactions Associated
with DTP and DT Immunizations in Infants and Children, 68 PEDIATRICS
650-60 (1981).

6. Cherry, supra note 2, at 1680 (calling for a study free of the
influences of "special interest groups" and calling personal injury
lawyers a "uniquely destructive force").

7. National Institutes of Health, Status of Acellular Pertusis
Vaccines & Swedish Trial Update (Feb. 8, 1988).

8. Deposition of J.D. Cherry, M.D. at 49, Hardaway v. Metropolitan
Gov't of Nashville, et al., __________ (19__).

9. Deposition of E. A. Mortimer, M.D. at 11, Krause v. Aboussy, et
al., No. 82-1232, (Stark Cty., OH, September 6, 1984). 10 Opening
remarks at the Institute of Medical Division of Health Promotion and
Disease Prevention, Committee to Review the Adverse Consequences of
Pertussis and Rubella Vaccines, Public Meeting, January 10, 1990.
(Emphasis added.)

Richard Alexander is a specialist in personal injury litigation with
30 years in-depth experience. Emphasizing working relationships with
clients has led to an exceptional record of success. He has served as
a member of the Board of Governors of The State Bar of California,
President of the Santa Clara County Bar Association and the Board of
Governors of Consumer Attorneys of California. He is a founding member
of the National Association of Consumer Advocates, and heads Alexander
Hawes, LLP.
 




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