HICNet Medical News Digest      Wed, 15 Jun 1994        Volume 07 : Issue 27

Today's Topics:

  [FDA] Breast Implant Update
  [FDA] Striking Back at Stroke
  [FDA] Advisory Committee Reevaluates Tamoxifen Prevention Trial
  [FDA] Combination Tuberculosis Drug Approved

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                        Editor: David Dodell, D.M.D.
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                             Associate Editors:

E. Loren Buhle, Jr. Ph.D. Dept. of Radiation Oncology, Univ of Pennsylvania

       Tom Whalen, M.D., Robert Wood Johnson Medical School at Camden

        Douglas B. Hanson, Ph.D., Forsyth Dental Center, Boston, MA

             Lawrence Lee Miller, B.S. Biological Sciences, UCI

            Dr K C Lun, National University Hospital, Singapore

             W. Scott Erdley, MS, RN, SUNY@UB School of Nursing

      Jack E. Cross, B.S Health Care Admin, 882 Medical Trng Grp, USAF

  Albert Shar, Ph.D. CIO, Associate Prof, Univ of Penn School of Medicine

  Martin I. Herman, M.D., LeBonheur Children's Medical Center, Memphis TN

   Stephen Cristol, M.D., Dept of Ophthalmology, Emory Univ, Atlanta, GA

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Date: Wed, 15 Jun 94 06:52:26 MST
From: mednews (HICNet Medical News)
To: hicnews
Subject: [FDA] Breast Implant Update
Message-ID: <4DsyNc9w165w@stat.com>

                      BREAST IMPLANT UPDATE

      FDA has been receiving inquiries in advance of its June 2
public hearing on a proposal to require manufacturers of saline-
filled breast implants to submit data showing safety and
effectiveness before the products can continue to be marketed.  The
hearing will focus on the status of the manufacturers' studies,
reports of independent research, consumer and professional
concerns, and the timing of the requirement for submission of the
data.  FDA has also received inquiries on the status of silicone
gel-filled breast implants.  The following is a summary of the main
issues and may be useful in responding to inquiries.
     Saline-filled and silicone gel-filled breast implants were
already on the market when FDA began regulating medical devices in
l976.  Like other devices that were grandfathered under the Medical
Device Amendments of l976, breast implants were allowed to remain
in use with the understanding that FDA would later require
manufacturers to submit evidence of product safety and
effectiveness.
     Saline-filled breast implants are silicone envelopes filled
with salt water.  Currently, only saline-filled breast implants are
commercially available for both breast augmentation and
reconstruction.
     The short and long-term safety of saline implants has not been
established.  It is known that the implants can leak or rupture,
requiring further surgery for replacement.  Other known risks
include infection, capsular contracture, interference with
mammography, and altered breast sensation.  In addition, because
the envelope is made of a silicone elastomer, there is concern
about any systemic problems that may be related to exposure to
silicone.
      In a January l993 proposed rule, FDA notified manufacturers
of saline-filled implants that the agency intended to require
submission of data demonstrating product safety and effectiveness,
and that each company's products would have to receive agency
approval to allow continued marketing.
     At its June 2 public hearing, FDA will solicit public comment
on the timing of this requirement, which could affect availability
of the products.  The agency will consider this testimony in
determining when to promulgate the final rule.
     FDA also has asked the manufacturers to present testimony on
the status of their clinical studies on saline implants, including
patient enrollment.
     In regard to silicone gel-filled implants, none are available
commercially.  This type of implant is available only as part of a
clinical study, and currently only for breast reconstruction.
Mentor Corp. of Santa Barbara, Calif., is at this time the only
manufacturer allowed to conduct clinical studies of silicone gel-
filled implants.
     Manufacturers currently are gathering data on women who
already have breast implants in order to provide important
information about long-term effects of the implants.
     The agency advises potential implant recipients to discuss
risks with their doctors before undergoing implant surgery, and
to read carefully the patient information that accompanies the
products.
     The record of hearing will remain open until July 5, l994.
Written comments may be submitted to the Dockets Management Branch
(HFA-305), Food and Drug Administration, Room. 1-23, 12420 Parklawn
Drive, Rockville, MD 20857.



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

Date: Wed, 15 Jun 94 06:53:14 MST
From: mednews (HICNet Medical News)
To: hicnews
Subject: [FDA] Striking Back at Stroke
Message-ID: <FFsyNc10w165w@stat.com>

Striking Back at Stroke
by Evelyn Zamula

     At the time, the president's personal physicians believed it
was necessary to keep from the public the truth about the
president's health. With the second World War not yet won, they
would neither confirm nor deny that he was ill and told no one,
not even his family, that he had serious heart problems and blood
pressure as high as 260/150. But Americans could see for
themselves that the president was failing rapidly. The signs of
it were in his face, and in the reduced vigor of his voice.
Still, it came as a shock when Franklin D. Roosevelt died of a
massive cerebral hemorrhage nearly 50 years ago.
     President Roosevelt was one of 129,144 Americans who died of
stroke in 1945. Today, with a population almost twice as large,
about 150,000 people die of the half million who are stricken
each year. Another 200,000 are left with some disability.
Although the statistics are looking better, stroke remains the
third leading cause of death, preceded only by heart disease and
cancer.
     A stroke is damage to brain cells resulting from an
interruption of the blood flow to the brain. The brain must have
a continual supply of blood rich in oxygen and nutrients for
energy. Although the brain constitutes only 2 percent of the
body's weight, it uses about 25 percent of the oxygen and almost
75 percent of the glucose (sugar) circulating in the blood.
Unlike other organs, the brain cannot store energy. If deprived
of blood for more than a few minutes, brain cells die from energy
loss and from certain chemical interactions that are set in
motion. The functions these cells control--speech, muscle
movement, comprehension--die with them.
     Dead brain cells can't be revived, but in recent years the
Food and Drug Administration has approved new drugs that may
prevent stroke in susceptible people and in those who have
already had a stroke.
     The majority of strokes are caused by blockages in the
arteries that supply blood to the brain. (These are called
ischemic strokes or infarctions, just as a heart attack--in which
the heart muscle is deprived of blood--is called myocardial
infarction.) The blockages may be caused by a clot, or thrombus,
that forms on the inner lining of a brain or neck artery already
partly clogged by atherosclerotic plaque--deposits of fat-
containing materials and calcium.
     Although atherosclerosis, or hardening of the arteries, is
primarily a disease of the elderly, the process may begin as
early as childhood. Autopsies of soldiers who died in the Korean
and Vietnam wars showed that atherosclerosis was already evident
in the arteries of many of the young men.
     A blood clot formed in another part of the body may also
cause stroke. Usually, a wandering clot like this--called an
embolus--breaks off from plaque in an artery wall, or originates
in the heart.
     Emboli may form in rheumatic heart disease, after a heart
attack, or during atrial fibrillation, an abnormal heart rhythm.
Instead of beating forcefully to fill the ventricles (the larger
heart chambers that pump blood to the lungs and throughout the
body), the atria (smaller heart chambers) beat irregularly and
don't empty fully, causing blood to stagnate in the heart and
form clots. If one lodges in a brain artery, a stroke results.
     The most serious kinds of stroke occur not from blockage,
but from hemorrhage, when a spot in a brain artery weakened by
disease--usually atherosclerosis or high blood pressure--ruptures
or begins to leak blood. If an artery inside the brain ruptures,
it is called a cerebral hemorrhage. When a blood vessel on the
brain's surface ruptures, filling the space between the brain and
the skull with blood, it is known as a subarachnoid hemorrhage.
This type of stroke may also be caused by an aneurysm, a section
of the artery wall so thin that it may balloon out and burst,
especially when high blood pressure is present. (In many cases,
people are born with these fragile spots in a brain artery wall,
or may develop weak spots in arteries due to malformed blood
vessels or hemorrhagic disease.)
     Not only does the part of the brain served by the blood
vessel die in hemorrhagic strokes, but blood may spurt out so
forcefully that surrounding brain cells are damaged. A large clot
may form and press on adjacent brain tissue, increasing pressure
inside the skull and causing swelling. Hemorrhagic strokes
account for less than 20 percent of all types of strokes, but are
far more lethal, with a death rate of over 50 percent.
     Strokes caused by emboli or hemorrhage usually strike
suddenly, with little or no warning, and do all their damage in a
matter of seconds or minutes. In thrombotic strokes, symptoms
often progress by steps. A slight clumsiness on arising in the
morning may be followed by loss of half the field of vision in
both eyes by breakfast time (which the victim may not be aware
of) and an inability to speak. Paralysis in one arm may be
followed in the course of several hours or a day or so by
complete paralysis on that side of the body.

Distinguishing a Stroke from a TIA
     Any evidence of disruption of blood supply to the brain
(such as inability to grasp with one hand or difficulty speaking)
that lasts longer than 24 hours may be used to diagnose stroke.
Effects of a stroke can range in severity from a slight one-sided
facial sagging that disappears within two weeks to inability to
walk or loss of control of bodily functions that lead to long-
term problems such as incontinence. The kind of disability a
stroke victim is left with depends on the location and extent of
brain damage.
     An incident involving physical symptoms that last less than
24 hours (usually not longer than a few minutes or hours at most)
and leave no permanent disability is called a transient ischemic
attack (TIA) or "ministroke." A TIA is a signal that the brain's
blood supply has been temporarily interrupted, either from small
clots that lodge in a tiny brain artery and then dissolve
spontaneously, or from briefly reduced blood flow in narrowed
arteries.
     The most commonly reported symptoms of a TIA include
temporary difficulty in speaking or understanding the speech of
others; minor numbness or weakness of the face, arm or leg on one
side of the body; unsteadiness, dizziness or falls; and blurred
vision or sudden blindness in one eye that may last a few
minutes. A TIA may occur shortly before a stroke occurs, or may
be a predictor of future stroke. Some individuals have repeated
attacks of TIAs without any serious consequences, but these
symptoms should not be ignored and need immediate medical
attention.

Resourceful Brain
     The brain is resourceful. After brain swelling goes down
following a stroke, small blood vessels around the blocked area
enlarge to allow more blood flow to the damaged section. Some
incapacitated cells may recover partially or completely. In many
cases, other brain cells can assume the functions of the damaged
ones. This is especially true of infants and young children,
whose nervous systems are still developing.
     "Less than 1 in every 50,000 newborns suffers a stroke
caused by clots that travel from the fetal or placental
circulation around the time of birth," says Rebecca Ichord, M.D,
a pediatric neurologist at Johns Hopkins University Hospital,
Baltimore, Md. "Newborn infants do remarkably well and have less
long-term disability than an adult with a comparable injury. Even
though part of the brain is damaged, infants have other healthy
brain cells that aren't dedicated to any particular function as
yet, and these take over for the damaged cells."
     Each of the two hemispheres of the brain controls the
opposite side of the body. Paralysis on the right side of the
body means that the left side of the brain (the dominant
hemisphere in a right-handed person) is injured. As speech and
language are associated with areas in the left brain, individuals
with left-brain damage may have trouble with speaking and
understanding, a condition called aphasia.
     A right-brain stroke may leave persons with a paralyzed left
side and spatial-perceptual deficits--difficulty in judging
distance, size, position, and speed. They may not know whether
they're standing or sitting upright or leaning. Because they may
cholesterol diet benefits not only the coronary arteries, but
arteries throughout the body, including those supplying blood to
the brain.
~    Cigarette smoking. Many studies have shown a relationship
between smoking and strokes. If you smoke, try to stop.
~    Heavy alcohol consumption. Chronic alcoholism and very heavy
drinking are risk factors for both thromboembolic and hemorrhagic
stroke, as well as increased mortality from stroke. Some studies
show that moderate alcohol consumption may protect against
cerebrovascular disease by raising HDL levels and helping prevent
excessive blood clotting. But alcohol consumption should be
limited to no more that one or two drinks a day, a drink being
defined as 12 ounces of beer, 4 ounces of wine, or 1.5 ounces of
80-proof spirits.
~    Diabetes. People with diabetes--especially women--have
almost double the risk of stroke. Diabetes causes atherosclerosis
earlier in life and of greater severity. Besides damaging blood
vessels, diabetes appears to interfere with the normal breakdown
of fibrin, a plasma protein that holds blood clots together.
~    TIAs. If you have any evidence of a TIA--a sudden buckling
of one leg leading to a fall, temporary blindness in one eye,
slurred speech--tell your doctor immediately.
~    Family history. If a parent or sibling has had a stroke or
TIA, you may also be at increased risk. It's not known whether
this increased risk is inherited or from unhealthy family
lifestyles.
~    Men have a higher stroke risk than women, and blacks have a
higher stroke risk than people of other races.
     Since age, gender, heredity, and race can't be changed, it's
wise to work on the stroke risk factors that can be altered, such
as high blood pressure, high cholesterol levels, cigarette
smoking, and heavy alcohol consumption.



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

Date: Wed, 15 Jun 94 06:55:28 MST
From: mednews (HICNet Medical News)
To: hicnews
Subject: [FDA] Advisory Committee Reevaluates Tamoxifen Prevention Trial
Message-ID: <5isyNc11w165w@stat.com>

    Advisory Committee Reevaluates Tamoxifen Prevention Trial

     FDA's Oncologic Drugs Advisory committee, a group of outside
experts, today recommended that the tamoxifen breast cancer
prevention trial be continued with additional endometrial
monitoring to assure safety of women in the study.   The following
may be used to answer inquiries.
     In l990 an FDA advisory committee supported the concept of a
large long-term randomized study to determine the effect of
tamoxifen in healthy women and in l991 recommended that FDA allow
such a trial to proceed.
     The NCI-funded prevention study was designed to determine
whether tamoxifen can reduce the incidence of breast cancer in
healthy women who are at increased risk for this disease, and to
evaluate the risks and benefits of tamoxifen treatment in this
study population.   The trial is based on evidence that the drug
reduces the risk of a new cancer in the other breast in women
taking the drug after surgery for breast cancer.  The trial has
enrolled over 10,000 subjects since it began in 1992.
     In April l994, based on the latest data in a Swedish trial and
the B-14 trial conducted by the National Surgical Breast and Bowel
Project (NSABP), the drug's package insert was revised to relect an
updated warning on the increased risk of cancer of the uterus.  The
informed consent for the tamoxifen breast cancer prevention study
was also updated in early l994.
     The committee was asked to evaluate several questions.  They
discussed whether patients should be required to undergo
endometrial procedures and whether such procdures could be expected
to reduce uterine cancer morbidity and mortality.  The committee
concluded that no procedure was studied well enough to be
recommended but that the usefulness of various screening procedures
should be vigorously evaluated. They also discussed whether
revisions of the study design were necessary, such as limiting
duration of treatment, changes in the eligibilty criteria,
inclusion of a significant number of minorities and consideration
of increasing the sample size.  They concluded that no changes were
needed.
     FDA emphasizes that tamoxifen should not be used as a
preventive in women who have not had breast cancer outside of a
clinical trial.



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

Date: Wed, 15 Jun 94 06:56:15 MST
From: mednews (HICNet Medical News)
To: hicnews
Subject: [FDA] Combination Tuberculosis Drug Approved
Message-ID: <gksyNc12w165w@stat.com>

             Combination Tuberculosis Drug Approved

     We have been receiving inquiries about the approval of
Rifater, a product that combines three existing tuberculosis drugs
into a single tablet.  The drug is designed to decrease the number
of patients who do not comply with the standard long-term, multi-
drug regimen for treating tuberculosis.  The following may be
useful in answering questions.
     Rifater combines in one dose three first-line tuberculosis
drugs -- isoniazid, rifampin and pyrazinamide.  The fixed-dose
product was developed to simplify dosing, make it easier for
patients to take their medication and thus increase patient
compliance with the dosing regimen.  Noncompliance with the dosing
regimen has been a public health concern in the control of the
disease.
     Use of the combination drug should also slow emergence of
multi-drug-resistant tuberculosis, a problem in part attributable
to not following the dosing regimen.
     In addition, the use of Rifater will prevent inadvertent under
or overdosing of any of the three component drugs, and will
safeguard against patients deciding to stop taking one or two of
the three drugs.
     In a survey conducted by the Centers for Disease Control and
Prevention (CDC) in 1985-1986, more than 17 percent of tuberculosis
patients did not take their medications continuously.  In fact, one
out of every four patients  were still testing positive after six
months of being prescribed drugs for treatment.  In a recent survey
of tuberculosis in New York City, 33 percent of patients had
tuberculosis organisms resistant to at least one drug, and 19
percent had organisms resistant to both isoniazid and rifampin.
     Rifater has been used in Europe, Africa and Hong Kong since
the mid-1980s.  Nearly two years ago, FDA encouraged Marion Merrell
Dow, the drug's manufacturer, to seek U.S. marketing approval.
Since that time, FDA and the company have worked together to make
the drug available.
     The use of combination products such as Rifater in treating
tuberculosis has been recommended by CDC, the World Health
Organization and the Committee on Treatment of the International
Union Against Tuberculosis and Lung Disease.



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End of HICNet Medical News Digest V07 Issue #27
***********************************************

---
Editor, HICNet Medical Newsletter
Internet: david@stat.com                 FAX: +1 (602) 451-1165
Bitnet  : ATW1H@ASUACAD

