MEMOIR OF A JUNK SCIENTIST

[Guest guest]

MEMOIR OF A JUNK SCIENTIST

BY

BERNARD M. PATTEN, MD, FACP, FRSM

The former President of the American Society of

Plastic and Reconstructive Surgery called me a junk

scientist. My lame, but honest, reply is that I am a

junk scientist because I have, for the last fifteen

years, been studying a piece of junk. That's what the

silicone breast implant was and is. Let me explain:

It all started years ago, never mind how many, when I

decided to switch my program at Columbia College from

American History to premed. My career seemed to go

pretty well for a time. I graduated from Columbia

College summa cum laude and second in my class of 725

students. Thence I went to Columbia's College of

Physician and Surgeons where I also graduated second

in my class. They elected me to AOA, the national

medical honor society in my junior year, and I took

the Mosby Prize for Scholarship at graduation. After

internship at Cornell Medical Center - The New York

Hospital, I returned to Columbia for residency in

neurology and eventually, by unanimous vote of the

faculty was elected Chief Resident in Neurology at the

Neurological Institute of New York. After a fellowship

year in human memory at Columbia, I went to NIH where

I became the assistant chief of Medical Neurology and

did neurological consultations for the clinical center

and many times for the United States Senate. So far so

good. Not a bad start for a junk scientist, wouldn't

you say? Along the way I published over 100 papers in

peer reviewed journals, gave over 500 lectures to

national and international audiences and received many

prizes and awards for research in Parkinson's Disease

(I was there with Dr. C. Cotzias when the first

dose of DOPA was given) and Myasthenia Gravis (I was

there with Dr. King Engel when we pioneered the immune

suppressive treatments) as well as a listing in the

usual places such as Who's Who in America, Who's Who

in the World, Who's Who in Health and Medical

Education, Who's Who in Science and Engineering and so

forth. I had a loving wife who was also a physician

and two children and four cats and, yes, as

unfashionable as it may be to admit, I was happy.

Happy, that is until that fatal day when I decided to

leave the sacred groves of NIG to take a job as Chief

of Neuromuscular Diseases and eventually Vice Chairman

of Neurology at the Baylor College of Medicine in

Houston, Texas. Soon after that mistake my troubles

began.

At Baylor I made friends with Dr. Gerow, one of

the two inventors of the silicone breast implant.

explained that he and Cronin wanted to do

something with plastic surgery that would match the

artificial heart the Dr. Debakey was working

on, something that would draw national attention to

themselves the way NASA, situated only 40 miles south

of Baylor, got national attention. First, they tried

direct injections of silicone into tissues to make

bigger breasts and the results were, of course, a

disaster. I saw lots of these women in consultation.

They were by and large the wives of medical students

who had volunteered for the experiments. The silicone

caused marked fibrosis, hard, painful, disgusting

looking breasts which the women were ashamed to show.

All others who tried to directly inject silicone into

human tissue have gotten the same terrible local

complications proving that silicone is not inert but

is biologically active enough to cause severe local

inflammatory reactions. The interesting thing that

escaped my attention at the time was that most of

these wives also had weird neuromuscular and

rheumatologic diseases including myasthenia gravis,

polymyositis, small fiber sensory neuropathy and

Sjogren's syndrome. In many cases, the autoimmune

diseases required treatment and I applied the

treatments the best I could without thinking that

there might be a connection between the silicone and

the autoimmunity. Because direct injection gave awful

results, Gerow and Cronin decided to enclose the

silicone in a elastomer bag and put the bag into the

breast area to make big breasts. A lot of people

thought the idea absurd, almost obscene, but it did

give the promise of what some women wanted and it was

quick giving immediate results. Of course, there ware

lots of problems with the surgery including infections

and herniation of the implant through the incisions

and multiple redos because the implant had ruptured or

shifted or had developed a baseball hard capsule or

the woman wanted still larger and larger breasts and

so forth. But the local complications Gerow and Cronin

could handle. Besides whether you put implants in or

you took them out or you changed them, the surgeon

still got paid.

Eventually, Baylor accumulated the first and the

largest series of implanted women in the world and as

the neurologist that Gerow knew and presumably

trusted, I got the referrals of the women who had

complaints referable to muscles, nerves, spinal cord,

or brain. And there were many of them, a

superabundance. Probably from 1986 to 1993 I

personally saw and examined over 2000 such women.

Their stories were all quite similar: Sometime after

the implantation, they felt weak and tired, developed

morning stiffness, excessive fatigue, dry mouth, dry

eyes and dry vagina. Most also had hot painful tender

breasts with contractures. I made it my business to

examine the breasts of all these women and got pretty

good at detecting ruptures, spills, and enlarged local

lymph nodes. There were many women with amazingly

anesthetic nipples which Gerow told me was because T4,

the nerve to the nipple, had been cut on insertion of

the larger implants through the axillary approach.

Quite a few women had severe sharp shooting chest

pains simulating heart attacks. Gerow had an answer

for that too: On insertion the implant forms a

physical barrier to the regrowth of severed nerves

causing neuroma formation. We even biopsied a few

cases and proved the neuromas were present and

published two papers on chest pain in implanted women.

One paper appeared in Emergency Medicine and one

appeared in the Southern Medical journal. But the

thing that impressed me the most about the local

situation was that the implant, in this selected group

of women that I saw, had failed miserably to deliver

what it had promised. Beautiful breasts they were not.

In fact, the opposite was true: The implant had made

satisfactory breasts horribly deformed and ugly.

I did complete physical examinations on each of the

women and found that they all seemed to show much the

same general pattern; they had skin rashes, cold

fingers and toes, dry eyes and dry mouths, and they

were weak. We weren't sure how strong a woman should

be so I sent out a medical student to get pinchometer

and gripometer measurements in normal and hospitalized

women. The results confirmed that implanted omen, the

ones referred to me at any rate, were, in relation to

their peers matched for age and sex, objectively weak,

usually scoring less that 50% of the controls on the

dynamometer measurements. On neurological examination

I found that ladies had more than the usual trouble

with simple mental status tests such as proverbs,

subtractions, serial sevens, naming the presidents and

so forth. That could have been because they came from

poor education backgrounds, which they did by and

large. Except, even some high powered women who had

completed graduate school, Judges in Houston courts

for instance, the former assistant postmaster general

and other women of achievement in journalism and

science, also did poorly on these tests. Gait and

station testing showed most couldn't do a push up or a

sit up and most had glove and stocking sensory loss

suggesting they had neuropathy.

Laboratory tests confirmed that the women seemed to

have something autoimmune though just what that was we

couldn't say. There were lots of abnormal autodirected

antibodies including ANA and rheumatoid factors and

antinerve antibodies but none of the ladies actually

fit into the currently accepted diagnostic criteria

for the diseases usually associated with those

antibodies.

Almost all the women who had cognitive complaints had

decreased cerebral flood flows as measured by research

physicians as part of the NIG approved Baylor-

Methodist Cerebral vascular research center grant.

Almost all had positive tear tests proving the ladies

really did have dry eyes.

Most of the patients had surgical indications for

implant removal and I followed them during and after

the surgery. I personally reviewed the slides on all

tissues removed and gradually learned to identify free

silicone in tissue, polyurethane, and the dense

inflammation with foreign body giant cells that

surrounds the implant. We documented with pictures the

gross appearance of massive silicomas larger than

softballs and capsules thicker than magazines. We kept

track of the relations of examination results before

to what happened after surgery. In general, women with

polyurethane implants did lousy and got worse after

explantation. Women who had massive spills of silicone

had teams of surgeons laboring over nine hours fail to

get all the silicone out. That group also did poorly.

Women with high titers of antiGM1 antibodies got

progressively worse and sent down hill often dying of

a weird neuromuscular disease that resembled a

combination of dermatomyositis, lupus, rheumatoid

arthritis, motor sensory neuropathy, Sjogren's

syndrome, and amyotrophic lateral sclerosis with,

believe it or not, signs and symptoms of multiple

sclerosis! Women who had minor spills that surgeons

could remove and those with intact implants did the

best. Most in that group recovered within two years.

Three of these who had had complete remissions of well

documented diseases got tired of living with small

tits and made the mistake of getting reimplanted.

The diseases, as predicted, roared back thus

fulfilling Koch's postulates. We found that the

incidence of ruptured implant correlated with the

severity of autoimmune disease. The proven rupture

rate for our series of severely ill women with the

Multiple sclerosis, for instance, exceeded 70%. We

published our results in eight papers covering

everything we could think of from the local to

systemic problems. Under separate cover, I will send

some reprints of those to you. The citations of all

papers appear in Medline. My fellows, Britta and Glen,

and I presented our data at national and international

meetings including the World Federation of Neurology

and the American Neurological Association and the

American Academy of Neurology. The Southern Medical

Society and the Texas Neurological Society gave us

several awards for clinical research and encouraged us

to dig further.

In many cases, our reports hit the front pages of USA

Today, The New York Times, The Wall Street Journal and

so forth. Little did I realize that that publicity

would hurt us. Nor did I realize, until it was too

late, how much it would hurt.

About 1986 Dow-Corning paid me $4,800 to consult with

them about their product. I told them what we were

finding and I told them especially about my concern

about the rupture rate (50% ruptures in ten years on

average) and the severe local complications we had

seen due to ruptures. I urged them to set up some form

of free clinic to care for the injured women and to

make cowardly amends for what they had done.

Some months later they told me I was wrong and that

the implant caused no such problems. We went back to

the drawing boards and redid much of the research only

to discover the same things we had discovered before.

I estimate the pause caused by the misinformation

received from the company delayed our progress for two

years. As it was misinformation, because to my

chagrin, I learned on my way to Washington to testify

before the expert panel of the FDA, while reviewing

the secret company documents supplied to me by the

FDA, that the company clearly knew as far back as 1976

that silicone spread, caused local inflammation, and

in some animals resulted in autoimmune diseases. I

appeared before the panel a shaken man. The people who

had hired me as a consultant had deceived me. How

naive I had been.

The rest as they say is history. FDA took implants off

the market for cosmetic augmentation. TV began to do

shows about how bad a scientist I was. Gerow staggered

under the weight of over 13,000 malpractice suits

against him and Baylor. Trustees called Doctor ,

the resident of Baylor, about a program about me put

on by CNN. Frontline even said in a voice over that I

was under investigation by the FBI for Medicare fraud.

I was not, not then, not ever. But multiple

investigations were conducted on the basis on

anonymous complaints to the Texas Board of Medical

Examiners.

Seven so far have been dismissed after years of

investigation and reinvestigation. Every slide I ever

showed in any scientific meeting was seized and

investigated as possible evidence against me.

Criminals broke into my office and stole research data

related to implants. The biopsy laboratory was broken

into and slides and reports on implanted patients

looked into. A man posing as my fellow copied the

brain scans and charts of over 200 patients, a theft

of medical records never solved. Death threats arrived

in the mail. People phoned in threats.

One plastic surgeon said I was part of a communist

conspiracy to deprive American women of their

implants. And, yes, a dead decapitated animal, a

rabbit not a horse, arrived at the doorstep, just like

in the movies.

Baylor restricted my teaching saying that they

couldn't prevent my research but they sure could stop

me from talking to students, interns, and residents

about implants. They were careful to mention that they

were not restricting my research because they

recognized the rights of a tenured associate professor

to publish what he wished. And they affirmed that they

wished me to continue my teaching in every other

aspect just as before. However, the chairman of the

department soon came upon the idea that he could stop

my seeing implanted women. I protested but Baylor

administration remained intransigent. So realizing the

futility of trying to make further progress, I bowed

out.

Meanwhile, Cronin stared to make rounds in the nude

and was discovered to be demented and Gerow, drinking

a lot, refused to have his protime checked. He had an

artificial aortic valve for which he took Coumadin.

His subsequent death from a cerebral hemorrhage

prompted me to formulate the following epigram:

The silicone implant was:

Bad for those who made them

Bad for those who put them in

Bad for those who got them in

And bad for those who did research on them.

God rest his soul. Before he died Gerow

predicted what subsequently came true: " The silicone

implant, born in Houston, will die in Houston. "

And so it is with a kind of wispy regret that I make

some suggestions to future scientists who might

consider doing implant research. First of all,

consider carefully, you men and women of the future,

and if you take my advice, don't do it. It isn't worth

it. More than one career has been ruined in this field

and others are sure to follow.

The companies have massive amounts of money to defame

even the most sincere and diligent researcher. The

chance that you will escape the same fate as me is

slim. But if the compulsion to do research that will

have a significant impact on the health of women for

our time and for all time is unavoidable, I suggest

you consider the following:

·Set up special free clinics to study women with

implants. These ladies have genuine medical problems,

which are not being addressed. Regardless of the cause

of their physical and mental diseases they need help

which they are not able to get at present because for

various reasons they are locked out of the medical

system.

·Repeat the epidemiological studies. Most of those

studies, by their own admission, are flawed. The Mayo

study more than the others. In fact, the Mayo study

was reported in the same section at the annual meeting

of the American Society of Plastic and Reconstructive

Surgery that I reported the complication of giving a

transfusion into an implant. At that meeting the

version was that there was a high incidence of

autoimmune disease in the implanted patients compared

to controls particularly Hashimoto's thyroiditis. For

some reason, partial deselection of evidence I

presume, that item never found its way into the Mayo

final report.

·Even forgetting about possible causation for the

moment, why not study intensively the mechanisms of

autoimmunity in patients with implants? At the time of

my retirement I had collected 51 cases of ruptured

implants in patients with multifocal brain infarctions

associated with antiphospolipid antibodies. Could that

be an accident?

·Follow all women with implants in a national

registry. Require that all have yearly screening

examinations for local and systemic complications.

History and physical examinations is all that is

needed for effective screening.Career researchers not

connected with the companies in anyway and not

connected with the business of installing or removing

implants in anyway should do the screening. The

companies have spent 26 million dollars on spin to

make themselves look good. Why not spend a similar

amount on some real unbiased research?

·Do animal studies injecting silicone mixed with blood

proteins into animals. The results, I predict, will

show that the animals develop autoimmune diseases.

" Medical Debate Over Implants Has a Dark Side Science:

Regardless of results, researchers studying the safety

of silicone gel implants have been targets of

harassment.

The Los Angeles Times

Los Angeles, Calif.

May 17, 1995

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

Authors: DAVID R. OLMOS

Authors: HENRY WEINSTEIN

Abstract:

[bernard M.] Patten says there was no mistaking the

message behind the rabbit-which had been decapitated.

The Baylor College of Medicine professor says he has

been the victim of constant harassment since

publishing a research paper last year that found a

possible link between silicone gel breast implants and

unusual chest pain in women. His laboratory at a

Houston hospital was broken into, he says, and

documents were stolen from his university office.

Police have no suspects. But Patten says the

cloak-and-dagger goings-on are part of an unseemly

behind-the-scenes backdrop to the impassioned debate

over breast-implant safety. Scientists stand accused

of allowing money to skew their research results.

Attorneys on all sides trade accusations of

harassment.

The skirmishes are evidence of disagreement over some

fundamental questions:

Do breast implants really pose a medical risk, as

hundreds of thousands of implant recipients and their

attorneys contend? Or have the dangers been overblown

by plaintiffs' attorneys in pursuit of million-dollar

damage awards, as implant suppliers and their

attorneys contend? "