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FDA Consumer magazine (September 1996)
VOL. 30 No. 7 SEPTEMBER 1996
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Features

How Folate Can Help Prevent Birth Defects
Adequate intake of folate, a B vitamin, is so important in preventing
birth defects that FDA is requiring it be added to bread and other grain
products.

Glimmer of Hope for People with ALS
Two drugs have recently become available to treat amyotrophic lateral
sclerosis, also known as Lou Gehrig's disease. Though neither medication
comes close to being a cure, they provide a ray of hope to patients with
this neurological disease.

Boning Up on Osteoporosis 
Osteoporosis leads to about 1.5 million fractures each year, mostly of
the hips, spines and wrists of older women. New treatments, changing
attitudes, and improving technology are helping to brighten the outlook
for women--and men--who may experience this bone condition in their
later years.

Hair Today, Gone Tomorrow 
Hair where fashion dictates hairlessness frustrates many folks. A
variety of products, with varying degrees of easy use and safety, are
available for those seeking social smoothness.

Outsmarting Poison Ivy and Its Cousins 
Prevention is the first line of defense against poison ivy, oak, and
sumac. But if preventive measures fail, over-the-counter and
prescription medications can help deal with the rash until it runs its
course. 


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Departments


Updates 

The latest information on FDA-related issues, gathered from FDA Press
Releases, Talk Papers, and other sources.


Notebook 

A potpourri of items of interest gathered from the Federal Register and
other sources.



Investigators' Reports 

Selected cases illustrating regulatory and administrative actions--such
as inspections, recalls, seizures, and court proceedings--by FDA's
regional and district offices across the country



Summaries of Court Actions 

Cases involving seizure, criminal and injunction proceedings.



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How Folate Can Help Prevent Birth Defects

by Paula Kurtzweil 

If you plan to have children some day, here's important information for
the future mother-to-be: Think folate now.

Folate is a B vitamin found in a variety of foods and added to many
vitamin and mineral supplements as folic acid, a synthetic form of
folate. Folate is needed both before and in the first weeks of pregnancy
and can help reduce the risk of certain serious and common birth defects
called neural tube defects, which affect the brain and spinal cord.

The tricky part is that neural tube defects can occur in an embryo
before a woman realizes she's pregnant. That's why it's important for
all women of childbearing age (15 to 45) to include folate in their
diets: If they get pregnant, it reduces the chance of the baby having a
birth defect of the brain or spinal cord.

"Adequate folate should be eaten daily and throughout the childbearing
years," said Elizabeth Yetley, Ph.D., a registered dietitian and
director of FDA's Office of Special Nutritionals. 

There are several ways to do this: 


 * Eat fruits, dark-green leafy vegetables, dried beans and peas, and
   other foods that are natural sources of folate.

 * Eat folic acid-fortified breakfast cereals.

 * Take a vitamin supplement containing folic acid.

Folate's potential to reduce the risk of neural tube defects is so
important that the Food and Drug Administration is requiring that by
1998, food manufacturers fortify enriched grain products with folic
acid. This will give women another way to get sufficient folate: by
eating fortified breads and other grains.

Nutrition information on food and dietary supplement labels can help
women determine whether they are getting enough folate, which is 400
micrograms (0.4 milligrams) a day before pregnancy and 800 micrograms a
day during pregnancy.

Neural Tube Birth Defects 

The technical names of the two major neural tube birth defects reduced
by adequate folate intake are anencephaly and spina bifida. Babies with
anencephaly do not develop a brain and are stillborn or die shortly
after birth. Those with spina bifida have a defect of the spinal column
that can result in varying degrees of handicap, from mild and hardly
noticeable cases of scoliosis (a sideways bending of the spine) to
paralysis and bladder or bowel incontinence. With proper medical
treatment, most babies born with spina bifida can survive to adulthood.
But they may require leg braces, crutches, and other devices to help
them walk, and they may have learning disabilities. About 30 percent
have slight to severe mental retardation.

The national Centers for Disease Control and Prevention estimate that
about 2,500 infants with spina bifida and anencephaly are born each year
in the United States.

Other maternal factors also may contribute to the development of neural
tube defects. These include: 

 * family history of neural tube defects
 * prior neural tube defect-affected pregnancy
 * use of certain antiseizure medications
 * severe overweight
 * hot tub use in early pregnancy
 * fever during early pregnancy
 * diabetes.

Any woman concerned about these factors should consult her doctor.

Folate Link 

Scientists first suggested a link between neural tube birth defects and
diet in the 1950s. The incidence of these conditions has always been
higher in low socioeconomic groups in which women may have poorer diets.
Also, babies conceived in the winter and early spring are more likely to
be born with spina bifida, perhaps because the mother's diet lacks fresh
fruits and vegetables--which are good sources of folate--during the
early weeks of pregnancy.

In 1991, British researchers found that 72 percent of women who had one
pregnancy with a neural tube birth defect had a lower risk of having
another child with this birth defect when they took prescription doses
of folic acid before and during early pregnancy.

Another study looked at folic acid intake in Hungarian women. The
evidence indicated that mothers who had never given birth to babies with
neural tube defects and who took a multivitamin and mineral supplement
with folic acid had less risk in subsequent pregnancies for having
babies with neural tube defects than women given a placebo.

These studies led the U.S. Public Health Service in September 1992 to
recommend that all women of childbearing age capable of becoming
pregnant consume 0.4 mg of folate daily to reduce their risk of having a
pregnancy affected with spina bifida or other neural tube defects.

That corresponds to FDA's Daily Value for folic acid, which is 400
micrograms for nonpregnant women, as well as children 4 and older and
adult men. For pregnant women, the Daily Value jumps to 800 micrograms.
Daily Values are dietary reference numbers used on the Nutrition Facts
panel on food labels to show the amounts of various nutrients in a
serving of food.

Many women between 19 and 50 get only 200 micrograms of folate a day,
according to the U.S. Department of Agriculture.

Folate Sources 

Folate occurs naturally in a variety of foods, including liver;
dark-green leafy vegetables such as collards, turnip greens, and Romaine
lettuce; broccoli and asparagus; citrus fruits and juices; whole-grain
products; wheat germ; and dried beans and peas, such as pinto, navy and
lima beans, and chickpeas and black-eyed peas.

Under FDA's folic acid fortification program, the agency is requiring
manufacturers to add from 0.43 mg to 1.4 mg of folic acid per pound of
product to enriched flour, bread, rolls and buns, farina, corn grits,
cornmeal, rice, and noodle products. A serving of each product will
provide about 10 percent of the Daily Value for folic acid. Whole-grain
products do not have to be enriched because they contain natural folate.
Some of the natural folate in non-whole-grain products is lost in the
process of refining whole grains.

The fortification regulations become effective Jan. 1, 1998, although
manufacturers may begin folic acid fortification immediately, as long as
they adhere to the regulations.

Folate also can be obtained from dietary supplements, such as folic acid
tablets and multivitamins with folic acid, and from fortified breakfast
cereals.

A study reported in the March 9, 1996, issue of The Lancet, suggested
that folic acid, the synthetic form of folate, may be better absorbed
than folate found naturally in foods. Christine Lewis, Ph.D., a
registered dietitian and special assistant in FDA's Office of Special
Nutritionals, said, "This is a complex and poorly understood issue, and
more data are needed."

Finding Foods with Folate 

Certain information on food and dietary supplement labels can help women
spot foods containing substantial amounts of folate. Some labels may
claim that the product is "high in folate or folic acid," which means a
serving of the food provides 20 percent or more of the Daily Value for
folic acid. Or the label may say the food is a "good source" of folate,
which means a serving of the food provides 10 to 19 percent of the Daily
Value for folic acid. The exact amount will be given in the label's
Nutrition Facts panel.

Some food and dietary supplement labels may carry a longer claim that
says adequate folate intake may reduce the risk of neural tube birth
defects. Products carrying this claim must: 

 * provide 10 percent or more of the Daily Value for folic acid per
   serving

 * not contain more than 100 percent of the Daily Value for vitamins A
   and D per serving because high intakes of these vitamins are
   associated with other birth defects

 * carry a caution on the label about excess folic acid intake, if a
   serving of food provides more than 100 percent of the Daily Value for
   folic acid. FDA has set 1 mg (or 1,000 micrograms) of folate daily as
   the maximum safe level. There are limited data on the safety of
   consuming more than 1 mg daily, and there may be a risk for people
   with low amounts of vitamin B12 in their bodies--for example, older
   people with malabsorption problems, and people on certain anticancer
   drugs or drugs for epilepsy whose effectiveness can diminish when
   taken with high intakes of folate.

 * list on the label's Nutrition or Supplement Facts panel the amount by
   weight in micrograms and the %Daily Value of folate per serving of
   the product. This information, which appears toward the bottom of the
   panel, along with the listing of other vitamins and minerals, can be
   used to compare folate levels in various foods and supplements.

Optional information may appear with the health claim to let consumers
know about other risks associated with neural tube birth defects, when
to consult a doctor, other foods that are good sources of folate, and
other important messages about neural tube defects.

Other Considerations 

The claim about folate cannot imply that adequate folate intake alone
will ensure a healthy baby, since so many factors can affect a
pregnancy.

Women should bear this in mind when contemplating pregnancy, advises
Jeanne Latham, a registered dietitian and consumer safety officer in
FDA's Office of Special Nutritionals. "Folate can make a significant
contribution," she said, "but it's no guarantee of a healthy baby."

Genetics plays a role, as do other healthful prenatal practices, such as
eating an all-around good diet. But unlike genetics, diet is a risk
factor women can modify to their--and their baby's--advantage, said
Jeanne Rader, Ph.D., director of the division of science and applied
technology in FDA's Office of Food Labeling. 

"Folic acid is one of many nutrients needed in a healthy diet for women
of childbearing age," she said. "A well-balanced diet with a variety of
foods can provide all those nutrients, including adequate amounts of
folate."

Women have options for reaching the folate intake goal: They can get the
necessary nutrients and calories both before and during pregnancy by
eating a well-balanced diet, keeping in mind folate-rich foods,
nutrition experts say. Folic acid-fortified grain products, including
breakfast cereals, will help, too. Dietary supplements are another
source of folate. Any one or a combination of these options for ensuring
adequate folate can help assure women of childbearing age that, if they
become pregnant, their babies will be off to a healthy start.

Paula Kurtzweil is a member of FDA's public affairs staff. 


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More Information

For more information on having a healthy baby, contact:

Maternal and Child Health Clearinghouse
5600 Fishers Lane, Room 18A-55
Rockville, MD 20857
(703) 821-8955

March of Dimes Birth Defects Foundation
1275 Mamaroneck Ave.
White Plains, NY 10605
(914) 428-7100
Voice mail only: (914) 997-4750
World Wide Web: http://server.triplesoft.com/marchofdimes/ 

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Glimmer of Hope for People with ALS

by Eleanor Mayfield 

Sunday, May 2, 1939, will be forever remembered in the annals of
baseball as the day New York Yankees' first baseman Lou Gehrig
voluntarily benched himself, ending a streak of 2,130 consecutive games.

For months the once-great player's game had been in decline. His
reflexes were off. He stumbled, fumbled, and struggled to hit or catch
the ball. No one understood why, least of all Gehrig himself.

A few weeks after Gehrig benched himself, doctors diagnosed his illness
as amyotrophic lateral sclerosis (ALS), a progressive disease of the
central nervous system that remains incurable to this day.

Two years later, on June 2, 1941, Gehrig died at the age of 37. The
disease that took his life became known to Americans as Lou Gehrig's
disease. His consecutive games record stood for 56 years until it was
broken by the Baltimore Orioles' Cal Ripken Jr. on Sept. 6, 1995.

In the years since Gehrig's death, many drugs have been tried for the
treatment of ALS. For 54 years, none was found to be effective. But one
recent drug approval and the granting of early access to another drug
give reason for hope.

The Food and Drug Administration approved Rilutek (riluzole) in December
1995. It was the first drug found to have an effect, albeit a modest
one, on the course of ALS. In clinical trials conducted in the United
States and Europe, the drug appeared to prolong patients' survival by
about three months.

Before the agency approved Rilutek, the drug had been made available to
more than 3,000 ALS patients in the United States under the Treatment
IND (investigational new drug) program. This program gives patients
access, under certain circumstances, to promising investigational new
drugs for serious and life-threatening diseases for which there is no
adequate treatment.

A second drug, Myotrophin (somatomedin C), was granted a Treatment IND
by FDA last June 24. Myotrophin is a recombinant insulin-like growth
factor that appears to prevent neuron loss and promote neuron
regeneration in animal studies. The drug has been studied in humans
since 1992 in two completed international trials and a third ongoing in
Japan. FDA granted treatment IND status to Myotrophin based on the
results from the drug's first trial in humans, which indicated the drug
has a modest effect in reducing the rate of disease progression.

Disabling and Often Deadly 

More than 30,000 Americans have ALS, according to the ALS Association, a
nonprofit organization that supports ALS research and public and patient
education about the disease. Around 3,000 to 5,000 new cases of the
disease are diagnosed every year.

Although ALS can strike at any age, it usually appears between the ages
of 40 and 70. Men and women of all ethnic and racial groups are about
equally affected.

The disease attacks the motor neurons, nerve cells in the brain and
spinal cord that control the body's voluntary muscles. As the motor
neurons begin to die, the muscles weaken and shrink. Early symptoms of
ALS may include unusual fatigue and clumsiness, muscle weakness, slurred
speech, and difficulty swallowing. 

As the disease progresses, patients gradually lose the use of their
hands, arms, legs, and neck muscles, ultimately becoming paralyzed. They
can speak and swallow only with great difficulty. However, thinking
ability, bladder and bowel function, sexual function, and the
senses--sight, hearing, smell, taste, and touch--are unaffected. 

About half of people with ALS die within three to five years of
diagnosis. In rare cases, a person may survive with the disease for many
years (see accompanying article). The usual cause of death is failure of
the diaphragm muscles that control breathing. Some individuals with ALS
choose to prolong their lives by using a ventilator, but prolonged use
of a ventilator may increase the risk of death from an infection such as
pneumonia.

No single test can diagnose ALS. Because of the slow onset of the
disease, it can be difficult to diagnose in the early stages, said
Jeffrey Rothstein, M.D., Ph.D., associate professor of neurology at
Johns Hopkins University School of Medicine in Baltimore. Johns Hopkins
is one of the nation's leading centers for ALS research.

"We do a number of tests to rule out other diseases that might mimic
ALS. Because it's a fatal disease, you want to be absolutely certain of
your diagnosis. The patient is generally about 20 to 50 percent into the
disease by the time it is diagnosed," he said. 

Cause a Mystery 

Doctors have known about ALS since 1874 (it was first identified by a
French physician, J.M. Charcot), but its cause remains a mystery.
Inability to pinpoint the cause of ALS has hindered efforts to find an
effective treatment, said Marc Walton, M.D., Ph.D., a medical officer in
the clinical trials division of FDA's Center for Biologics Evaluation
and Research.

Doctors once thought that ALS might be caused by the same virus that
causes polio and that exposure to polio would increase the risk of ALS,
said Ralph Kuncl, M.D., Ph.D., associate professor of neurology at Johns
Hopkins. However, he said, no evidence has been found to support this
theory.

Another conjecture was that an environmental toxin might cause ALS. This
theory arose in part because some places--the South Pacific island of
Guam and parts of Japan--have somewhat higher than normal rates of ALS. 

The cicad nut, a traditional food in Guam, contains toxic substances
capable of killing motor neurons, said Kuncl. "But the toxicity level is
not enough to cause the degeneration seen in ALS."

The "surprisingly uniform" incidence of ALS in the rest of the world
"would not be expected if the disease were caused by an environmental
toxin," Kuncl added. However, the reason for the increased rate of ALS
in Guam and Japan remains unknown.

Some doctors believe that ALS is an autoimmune disease--that is, a
disease in which the body attacks itself with antibodies normally
produced to protect against infection. In ALS, according to this theory,
antibodies attack and kill the motor neurons. However, "very potent
autoimmune therapies have been tried in ALS and have all failed to alter
the course of the disease," said Rothstein.

Another theory is that ALS is caused by toxic levels of glutamate in the
brain. Glutamate is a constituent of protein that cells in the body use
to help break down food and build up body tissues. In the central
nervous system, nerve cells (neurons) use glutamate to communicate with
one another.

Because too much glutamate can be toxic, the brain usually regulates the
substance, keeping levels to those needed for body functioning.
Abnormally high levels of glutamate have been found in the cerebrospinal
fluid (the clear watery fluid that surrounds the brain and the spinal
cord) of some patients with ALS. 

In experiments, scientists have found that a protein responsible for
removing excess glutamate from the brain appears not to work properly in
people with ALS. They theorize that toxicity resulting from excessive
glutamate might be killing motor neurons. The death of these cells leads
to progressive muscle wasting in patients with ALS. One of the
characteristics of Rilutek is that it inhibits the release of glutamate
in the brain.

Rilutek is taken by mouth. Everyone who takes the drug must be monitored
regularly for signs of Rilutek's most important side effect, a rise in
the level of liver enzymes, which indicates abnormal liver function.

The drug's labeling states that treatment should be discontinued if
liver enzymes increase to 10 times their normal level.

About five out of every 100 people who get ALS have an inherited, or
familial, form of the disease; that is, one or more of their immediate
family members--parents, brothers, sisters, or grandparents--also have
the disease. Children of people with familial ALS have a fifty-fifty
chance of developing the disease themselves.

In 1993, scientists identified a gene that, when defective, is
associated with some cases of familial ALS. This gene carries the
operating instructions for a protein whose function is to neutralize
cell-damaging substances called free radicals. Some scientists think
that when the gene is defective, an excessive buildup of free radicals
may kill motor neurons.

However, this genetic mutation is found in only about one-fifth of
people with familial ALS, according to Rothstein, and it has not been
detected in anyone with the sporadic (noninherited) form of the disease,
which is far more common.

Searching for Treatments 

Even if the cause of the disease is eventually found, the development of
effective treatments presents enormous challenges, said Rothstein. "The
drugs have to be potent and they have to get into the nervous system,
which has a very tight barrier--the blood-brain barrier--that prevents
entry by many drugs."

Some doctors think that neurotrophic growth factors, substances produced
by the body that stimulate nerve cells to grow and multiply, may be
useful for treating ALS. These substances can now be produced in the
laboratory using the techniques of biotechnology. Myotrophin is one such
factor. 

"No one thinks that neurotrophic factors, or the lack of them, cause
ALS," said Rothstein. "But in animal experiments they seem to work quite
well in preventing injury to motor neurons."

FDA's Walton said the agency is working with investigators and the
drugs' manufacturers to try to design trials "that will tell us as
quickly and efficiently as possible whether or not these products can be
effective in the treatment of ALS." 

Until more effective drugs are developed and approved to treat ALS,
measures to improve patients' mobility and quality of life remain the
mainstay, said Rothstein. "Nutrition is very important. A recent study
in Italy showed increased survival in ALS patients who received good
nutrition using a feeding tube.

"There's also a mask that patients can use to assist their breathing,
and physical therapy can help to make them more comfortable. A speech
pathologist can help them to learn different swallowing techniques as
their swallowing muscles become weaker. Support groups for patients and
their families are also very important."

On Sept. 6, 1995--the day Cal Ripken Jr. broke Lou Gehrig's record for
consecutive games played--the Baltimore Orioles and the Johns Hopkins
Medical Institutions announced the launch of the Cal Ripken/Lou Gehrig
Fund for Neuromuscular Research.

Ticket sales to the record-breaking game and an Orioles contribution
raised $2 million for the fund. Kuncl said the money will support
research at Johns Hopkins on neuromuscular diseases, with an emphasis on
ALS.

Johns Hopkins' Rothstein said that though the drugs available do not
thus far seem to give dramatic improvement, he is not discouraged.

"This is against the background of decades when no drug ever did
anything for the disease. Initial therapies for many diseases, like
leukemia and other cancers, had the same kind of effect ... a modest
increase in survival. But they were followed by better therapies that,
over time, increased patients' survival.

"It's a daunting task, but I envision that some day it will be possible
to develop drugs that will not only stop motor neurons from dying but
replace them and reverse the course of ALS."

Eleanor Mayfield is a writer in Silver Spring, Md. 


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Exceptional Survivor

The brilliant British theoretical physicist Stephen W. Hawking, who is
probably best known to the general public as the author of A Brief
History of Time, is one of a very few people who have survived for many
years with amyotrophic lateral sclerosis (ALS). 

Hawking, now 54, was diagnosed with ALS in 1963 when he was a
21-year-old graduate student at Cambridge University in England.

Hawking's life demonstrates that ALS impairs neither intellect nor
sexual function. His work on the origin and nature of the universe has
been, in the words of biographers Michael White and John Gribbin,
"ground-breaking and revolutionary." Hawking also married and fathered
three children after his diagnosis.

In 1985, after suffering a windpipe blockage, Hawking had a breathing
device surgically implanted in his throat. The surgery resulted in the
loss of his voice. He now "speaks" by using a voice synthesizer
connected to a computer that he operates by squeezing a switch in his
hand.

In Stephen Hawking: A Life in Science, White and Gribbin write that
Hawking has a very strong personality and has "never [given] in to the
symptoms of ALS more than he is physically compelled to."

--E.L.M. 

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Boning Up on Osteoporosis

by Carolyn J. Strange 

Consider an insidious condition that drains away bone--the hardest, most
durable substance in the body. It happens slowly, over years, so that
often neither doctor nor patient is aware of weakening bones until one
snaps unexpectedly. Unfortunately, this isn't science fiction. It's why
osteoporosis is called the silent thief.

And it steals more than bone. It's the primary cause of hip fracture,
which can lead to permanent disability, loss of independence, and
sometimes even death. Collapsing spinal vertebrae can produce stooped
posture and a "dowager's hump." Lives collapse too. The chronic pain and
anxiety that accompany a frail frame make people curtail meaningful
activities, because the simplest things can cause broken bones: Stepping
off a curb. A sneeze. Bending to pick up something. A hug. "Don't touch
Mom, she might break" is the sad joke in many families.

Osteoporosis leads to 1.5 million fractures, or breaks, per year, mostly
in the hip, spine and wrist, and costs $10 billion annually, according
to the National Osteoporosis Foundation. It threatens 25 million
Americans, mostly older women, but older men get it too. One in three
women past 50 will suffer a vertebral fracture, according to the
foundation. These numbers are predicted to rise as the population ages.

Osteoporosis, which means "porous bones," is a condition of excessive
skeletal fragility resulting in bones that break easily. A combination
of genetic, dietary, hormonal, age-related, and lifestyle factors all
contribute to this condition.

Changing attitudes and improving technology are brightening the outlook
for people with osteoporosis. Nowadays, many women live 30 years or
more--perhaps a quarter to a third of their lives--after menopause.
Improving the quality of those years has become an important health-care
goal. Although some bone loss is expected as people age, osteoporosis is
no longer viewed as an inevitable consequence of aging. Diagnosis and
treatment need no longer wait until bones break.

There is no cure for osteoporosis, and it can't be prevented outright,
but the onset can be delayed, and the severity diminished. Most
important, early intervention can prevent devastating fractures. The
Food and Drug Administration has revised labeling on foods and
supplements to provide valuable information about the level of nutrients
that help build and maintain strong bones. FDA has also approved a wide
variety of products to help diagnose and treat osteoporosis, including
several just last year.

Bone Life 

Bone consists of a matrix of fibers of the tough protein collagen,
hardened with calcium, phosphorus and other minerals. Two types of
architecture give bones strength. Surrounding every bone is a tough,
dense rind of cortical bone. Inside is spongy-looking trabecular bone.
Its interconnecting structure provides much of the strength of healthy
bone, but is especially vulnerable to osteoporosis.

"We tend to think of the skeleton as an inert erector set that holds us
up and doesn't do much else. That's not true," says Karl. L. Insogna,
M.D., director of the Bone Center at Yale School of Medicine, New Haven,
Conn. Every bit as dynamic as other tissues, bone responds to the pull
of muscles and gravity, repairs itself, and constantly renews itself.

Besides protecting internal organs and allowing us to move about, bone
is also involved in the body's handling of minerals. Of the 2 to 4
pounds of calcium in the body, nearly 99 percent is in the teeth and
skeleton. The remainder plays a critical role in blood clotting, nerve
transmission, muscle contraction (including heartbeat), and other
functions. The body keeps the blood level of calcium within a narrow
range. When needed, bones release calcium.

A complex interplay of many hormones balances the activity of the two
types of cells--osteoclasts and osteoblasts--responsible for the
continuous turnover process called remodeling. Osteoclasts break down
bone, and osteoblasts build it. In youth, bone building prevails. Bone
mass peaks by about age 30, then bone breakdown outpaces formation, and
density declines.

The skeleton is like a retirement account, but in our skeletal "account"
we can deposit bone only during our first three decades. After that, all
we can do is try to postpone and minimize the steady withdrawals.
Osteoporosis is the bankruptcy that occurs when too little bone is
formed during youth, or too much is lost later, or both.

"You've got to get as much bone as you can and not lose it," Insogna
says. "The most important risk factor for osteoporosis is a low bone
mass."

"The upper limit of bone mass that you can acquire is genetically
determined," says Mona S. Calvo, Ph.D., in FDA's Office of Special
Nutritionals. "But even though you may be programmed for high bone mass,
other factors can influence how much bone you end up with," she says.
(See "Reducing Your Risk.") For instance, men tend to build greater bone
mass, which is partly why more women face osteoporosis.

But there's another reason. With the decline of the female hormone
estrogen at menopause, usually around age 50, bone breakdown markedly
increases. For several years, women lose bone two to four times faster
than they did before menopause. The rate usually slows down again, but
some women may continue to lose bone rapidly. By age 65, some women have
lost half their skeletal mass. Because the changes at menopause increase
a woman's risk, many physicians feel it's a good time to measure a
woman's bone density, especially if she has other risk factors for
osteoporosis.

"The best way to gauge a woman's risk for osteoporotic fracture is to
measure her bone mass," says Insogna.

Routine x-rays can't detect osteoporosis until it's quite advanced, but
other radiological methods can. FDA has approved several kinds of
devices that use various methods to estimate bone density. Most require
far less radiation than a chest x-ray. Doctors consider a patient's
medical history and risk factors in deciding who should have a bone
density test. The method used is often determined by the equipment
available locally. Readings are compared to a standard for the patient's
age, sex and body size. Different parts of the skeleton may be measured,
and low density at any site is worrisome.

Bone density tests are useful for confirming a diagnosis of osteoporosis
if a person has already had a suspicious fracture, or for detecting low
bone density so that preventative steps can be taken.

"There's a profound relationship between bone mass and risk of
fracture," says Robert Recker, M.D., director of the Osteoporosis
Research Center at Creighton University, Omaha, Neb.

Readings repeated at intervals of a year or more can determine the rate
of bone loss and help monitor treatment effectiveness. However,
estimates are not necessarily comparable between machine types because
they use different measurement methods, cautions Joseph Arnaudo, in the
Center for Devices and Radiological Health. "You always want to go back
to the same machine, if you can," he says.

Another new test provides an indicator of bone breakdown. Last year, FDA
approved a simple, noninvasive biochemical test that detects in a urine
sample a specific component of bone breakdown, called NTx. Clinical labs
can get results in about 2 hours. The NTx test, marketed as Osteomark,
can help physicians monitor treatment and identify fast losers of bone
for more aggressive treatment, but the test may not be used to diagnose
osteoporosis.

Expanding Treatment Options 

Physicians and patients now have more treatment options than ever. Under
FDA guidelines, drugs to treat osteoporosis must be shown to preserve or
increase bone mass and maintain bone quality in order to reduce the risk
of fractures. "We want to be sure that the bone is normal or stronger
than it was," says Gloria Troendle, M.D., deputy director of the
division of metabolism and endocrine drug products in FDA's Center for
Drug Evaluation and Research.

Before last year, the only choices were the hormones estrogen and
calcitonin. While enthusiasm for new weapons against osteoporosis is
warranted, one of the old ones is still the top choice.

"Estrogen remains the first thing that women should consider," says
Insogna, because the hormone not only helps prevent osteoporosis, but
also protects against heart disease.

"If you think about what's missing at menopause, it's the hormones,"
says Paula Stern, Ph.D., a pharmacologist at Northwestern University
Medical School, Chicago, Ill.

Estrogen replacement therapy is the best prevention for the drop in bone
mass at menopause, and there are more ways to take it than ever. But
it's not for everyone. Because estrogen increases the risk of certain
cancers and other diseases, taking it may not be appropriate, or it may
be given in combination with another female hormone, progesterone, which
can also cause undesirable side effects. A woman and her doctor need to
carefully weigh the risks and benefits. According to the National
Osteoporosis Foundation, a woman's risk of developing a hip fracture is
equal to her combined risk of developing breast, uterine and ovarian
cancer.

Women who can't or don't want to take hormones--some 30 to 50
percent--have other treatment avenues. Last summer, calcitonin treatment
became much easier when FDA approved a nasal spray. Calcitonin, one of
the hormones responsible for regulating the level of calcium in the
blood, inhibits osteoclasts, the bone dissolvers. The drug, marketed as
Miacalcin, is a potent, synthetic version of the hormone, and has been
shown to slow and reverse bone loss. The stomach quickly destroys the
drug, so before the spray was available, calcitonin had to be injected
every day or two.

Last fall, FDA also approved the first nonhormonal treatment for
osteoporosis. Alendronate, marketed as Fosamax, falls within a class of
drugs called bisphosphonates, which hinder bone breakdown remodeling
sites by inhibiting osteoclast activity. In clinical trials lasting
three years, alendronate increased the bone mass as much as 8 percent
and reduced fractures as much as 30 to 40 percent, depending on skeletal
site. Lengthier studies are ongoing.

"Since it's so free of side effects it's a very welcome addition to the
armamentarium. But the truth is, we still need a better treatment," says
Recker. "We need a drug that will build back bone major league."

"All the drugs approved so far are things that just stop bone turnover.
They're not really stimulating more bone production," says Troendle.

Bone mass increases because even though osteoclasts can't start new
remodeling sites, osteoblasts continue filling in existing cavities.
Increases in bone mass are most pronounced in the first year or two
after treatment begins, then taper off. Any gain is helpful, even if it
doesn't continue, because increases in bone mass help reduce fracture
risk. But experts would like to encourage even greater gains.

Fluoride, known for fighting dental cavities, stimulates bone building,
but early studies in osteoporosis patients found that the structure of
the new bone was abnormal and weaker than normal bone. Gastrointestinal
side effects were also a problem. Investigators are working to find a
formulation and dosage regimen that will result in building normal bone.

Drugs Not Enough 

Calcium and vitamin D supplements are an integral part of all treatments
for osteoporosis. Everyone should make sure they get enough of these two
nutrients, but especially those at risk for osteoporosis. Attention to
diet and exercise are important not only for treatment, but also for
prevention.

"If you go to the doctor and get a prescription, and that's all you do,
you're probably not going to be helped very much," Recker says. His
prevention clinic is staffed by a physical therapist, a nutritionist,
and a nurse, who help people increase their physical activity, improve
their diets, and make their homes safer by reducing the risk of falling.
"Those three people do more to help the patients than I do with my
prescription pad," Recker says.

Calcium intake is critical, and those who need it the most--younger
women and girls--don't get enough. (See "Calcium (Ac)Counts.") But
calcium alone can't build bone. Without vitamin D, calcium isn't
sufficiently absorbed. Most people get enough vitamin D because skin
produces it in sunlight. But people confined indoors who have a poor
diet--which includes many older Americans--or who live in northern
latitudes in winter may be deficient.

A lifelong habit of weightbearing exercise, such as walking or biking,
also helps build and maintain strong bone. The greatest benefit for
older people is that physical fitness reduces the risk of fracture,
because better balance, muscle strength, and agility make falls less
likely. Exercise also provides many other life-enhancing psychological
and cardiovascular benefits. Increased activity can aid nutrition, too,
because it boosts appetite, which is often reduced in older people. The
biggest reason older people don't get enough calcium, Recker says, is
that they simply don't eat much.

"The truth is, you don't have to do very much to get most of the
benefits of exercise," Recker says. He suggests 30 minutes of brisk
walking five days a week. Add a little weightlifting, and that's even
better. It's always smart to ask your doctor before starting a new
exercise program, especially if you already have osteoporosis or other
health problems.

Brighter Horizons 

"A number of new things seem to be in the offing, eventually to come to
us, and we're looking forward to getting some additional treatments for
osteoporosis," says Troendle.

Uses of existing drugs may be broadened. Early drug trials are often
conducted with patients who have severe disease, often after a fracture
has occurred or bone loss is quite serious. Some studies under way are
testing to see if certain drugs are effective in less severe cases, if
they can be started sooner, or used in combination.

The search for bone-building drugs continues. Some naturally occurring
bone-specific growth factors have been identified and their use as drugs
is being investigated. "The way I visualize the ideal future is that
we'll be able to give Drug X that builds up bone to where it's stronger
and the risk of fracture is no longer present, then Drug Y maintains it
by preventing breakdown," says Stern.

In the realm of devices, researchers are exploring the use of ultrasound
to assess bone health. Such tests would eliminate radiation exposure and
probably cost less. The study of risk factors also continues. "We
consider that to be the research that has the greatest public health
significance," says Sherry Sherman, Ph.D., of the National Institute on
Aging. Last fall, the institute launched the Study of Women's Health
Across the Nation, a large-scale national examination of the health of
women in their 40s and 50s. Researchers expect to learn a great deal
about the factors affecting women's health during these transitional
years and beyond. Studies of genetics, biochemical markers, and life
habits are already turning up new insights.

Osteoporosis has been described as an adolescent disease with a
geriatric onset, highlighting the importance of beginning to take
steps--in exercise and diet--early in life to reduce its disabling
impact in later years.

Carolyn J. Strange is a science and medical writer living in Northern
California. 


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


Reducing Your Risk

A host of factors can affect your chances of developing osteoporosis.
The good news is that you control some of them. Even though you can't
change your genes, you can still lower your risk with attention to
certain lifestyle changes. The younger you start, and the longer you
keep it up, the better. Here's what you can do for yourself: 

 * Be sure you get enough calcium and vitamin D.
 * Engage in regular physical activity, such as walking.
 * Don't smoke.
 * If you drink alcohol, do so in moderation.

A sedentary lifestyle, smoking, excessive drinking, and low calcium
intake all increase risk. Although coffee has been suspected as a risk
factor, studies so far are inconclusive.

Other factors are beyond your control. Being aware of them can provide
extra motivation to help yourself in the ways you are able, and aids you
and your doctor in health-care decisions. These risk factors are: 

 * being female: Women have a five times greater risk than men.

 * thin, small-boned frame

 * broken bones or stooped posture in older family members, especially
   women, which suggest a family history of osteoporosis

 * early estrogen deficiency in women who experience menopause before
   age 45, either naturally or resulting from surgical removal of the
   ovaries

 * estrogen deficiency due to abnormal absence of menstruation (as may
   accompany eating disorders)

 * ethnic heritage: White and Asian women are at highest risk,
   African-American and Hispanic women are at lower, but significant,
   risk.

 * advanced age

 * prolonged use of some medications, such as excessive thyroid hormone;
   some antiseizure medications; and glucocorticoids (certain
   anti-inflammatory medications, such as prednisone, used to treat
   conditions such as asthma, arthritis and some cancers).

Risk factors may not tell the whole story. You may have none of these
factors and still have osteoporosis. Or you may have many of them and
not develop the condition. It's best to discuss your specific situation
with your doctor.


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


Calcium (Ac)Counts

Your skeletal calcium bank has to last through old age. Frequent
deposits to this retirement account should begin in youth and be
maintained throughout life to help minimize withdrawals. Most women get
much less calcium than they need--as little as half.

Nutritionists recommend meeting your calcium needs with foods naturally
rich in calcium. Adequate calcium intake in childhood and young
adulthood is critical to achieving peak adult bone mass, yet many
adolescent girls replace milk with nutrient-poor beverages like soda
pop. "Bone health requires a lot of nutrients and you're likely to get
most of them in dairy products," says Connie Weaver, Ph.D., who heads
the department of food and nutrition at Purdue University, Indiana.
"They're a huge package rather than just a single nutrient." With so
many low-fat and nonfat dairy products available, it's easy to make
dairy foods part of a healthy diet. People who have trouble digesting
milk can look for products treated to reduce lactose. A serving of milk
or yogurt contains about 350 milligrams (mg) of calcium. Fortified
products have even more.

"People who don't consume dairy foods can meet their calcium needs with
foods that are fortified with calcium, such as orange juice, or with
calcium supplements," says Mona S. Calvo, Ph.D., in FDA's Office of
Special Nutritionals. Other good sources of calcium are broccoli and
dark-green leafy vegetables like kale, tofu (if made with calcium),
canned fish (eaten with bones), and fortified bread and cereal products.

Nutrition labels can help you identify calcium-rich foods. But keep in
mind that the label value is a guideline based on a FDA's Daily Value
for calcium, which is 1,000 mg, and your calcium needs may be greater,
Calvo says.

What about too much calcium? As much as 2,000 mg per day seems to be
safe for most people, but those at risk for kidney stones should discuss
calcium with their doctors. Calcium is critical, but even a high intake
won't fully protect you against bone loss caused by estrogen deficiency,
physical inactivity, alcohol abuse, smoking, or medical disorders and
treatments.

--C.J.S. 


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


To Learn More

For more information, contact:

 * National Osteoporosis Foundation, 1150 17th St., N.W., Suite 500,
   Washington, DC 20036; (202) 223-2226; World Wide Web:
   http://www.nof.org/. For locations of your nearest bone density
   testing sites, call (800) 464-6700.

 * Osteoporosis and Related Bone Diseases National Resource Center
   (ORBD-NRC); (800) 624-BONE; TDD: (202) 223-0344.

 * Older Women's League (OWL), 666 11th St., N.W., Suite 700,
   Washington, DC 20001; (202) 783-6686.

 * North American Menopause Society, c/o University Hospitals of
   Cleveland, Department of Obstetrics and Gynecology, 11100 Euclid
   Ave., Suite 7024, Cleveland, OH 44106; (216) 844-8748; World Wide
   Web: http://www.menopause.org/.

 * American Association of Retired Persons (AARP), 601 E St., N.W.,
   Washington, DC 20049; (202) 434-2277; World Wide Web:
   http://www.aarp.org/.

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


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

Hair Today, Gone Tomorrow

by Marian Segal

Hair where hair oughtn't be, according to the current dictates of
American fashion, raises many an eyebrow. And so, for cosmetic reasons,
millions of women, and a growing number of men, spend millions of
dollars each year on products and services that promise smooth, silky
skin free of "unsightly," "excessive" body hair.

For do-it-yourselfers, a variety of home-use hair removal products are
available over the counter. These include shaving creams, foams, and
gels; waxes; chemical depilatories; and electrolysis devices.
Professionals at beauty and skin care salons and in dermatologists'
offices provide waxing, electrolysis, and, most recently, laser
treatments to remove hair. On April 3, 1995, FDA cleared the first laser
for this use.

The cost, safety, effectiveness, and ease of use of the various methods,
as well as the area and amount of hair growth to be treated, are some
factors to weigh in choosing a method and deciding whether to go to a
professional. Often, different methods are better suited for different
areas.

FDA's Office of Cosmetics and Colors in the Center for Food Safety and
Applied Nutrition regulates chemical depilatories, waxes, and shaving
creams and gels. (The Consumer Product Safety Commission regulates
razors.) These products, says John E. Bailey Jr., Ph.D., acting director
of the office, are classified as cosmetics, defined as substances
applied to the body to alter the appearance, promote attractiveness,
cleanse, or beautify.

The agency's Center for Devices and Radiological Health regulates
electrolysis equipment and lasers.

Shaving 

Shaving is by far the most common method of hair removal for both men
and women. Men have been shaving their beards and mustaches for
thousands of years, but cosmetic hair removal in women was relatively
uncommon until after World War I. Now, many American women routinely
shave their legs and underarms.

A clean razor with a sharp blade is essential for a safe and comfortable
shave. Skin should never be shaved dry; wet hair is soft, pliable, and
easier to cut. Contrary to what many believe, shaving does not change
the texture, color, or rate of hair growth.

Depilatories 

"Depilatories act like a chemical razor blade," Bailey says. Available
in gel, cream, lotion, aerosol, and roll-on forms, they contain a highly
alkaline chemical--usually calcium thioglycolate--that dissolves the
protein structure of the hair, causing it to separate easily from the
skin surface.

"It's very important to carefully follow the use directions for
depilatories and to do a preliminary skin test both for allergic
reaction and sensitivity," Bailey says. "Hair and skin are similar in
composition," he explains, "so chemicals that destroy the hair can also
cause serious skin irritations--possibly even chemical burns--if left on
too long."

"The concentration of calcium thioglycolate is generally kept as weak as
possible to avoid skin irritation, yet strong enough to work in a
reasonable amount of time," says Stanley R. Milstein, Ph.D., special
assistant to the cosmetics and colors director. "Contact with the skin
is kept to somewhere between 4 and 15 minutes, depending on how fine or
coarse the hair is."

Consumers should be sure to read the product label and select the
formulation appropriate for the intended use, because skin sensitivity
varies on different parts of the body. Some depilatories are for use
only on the legs, for example, while others are safe for more sensitive
areas, such as the bikini line, underarms and face.

Depilatories should not be used for the eyebrows or other areas around
the eyes, or on inflamed or broken skin. To minimize the chance of skin
irritation, they should not be applied more often than recommended on
the product label.

Although cosmetics are not subject to premarket approval, FDA can take
action against products that are found to cause harm.

"If we find an adverse reaction is occurring under recommended use
conditions, and not because of misuse by the consumer, we can pursue any
number of actions, depending on the severity and prevalence of the
problem," says Bailey.

For example, he says, "A depilatory might cause second- or third-degree
burns, and possibly scarring, if its formula is too strong or if an
inactive ingredient in the product heightens its effect. In that case,
FDA may, after evaluating the problem, initiate regulatory action such
as seizure or injunction against the product or the firm to stop further
manufacture."

Tweezing and Waxing 

While depilatories remove hair at the skin's surface, "epilatories,"
such as tweezers and waxes, pluck hairs from below the surface. Waxing
and tweezing may be more painful than using a depilatory, but the
results are longer lasting. Because the hair is plucked at the root, new
growth is not visible for several weeks after treatment.

Tweezing is impractical for large areas, however, because it is such a
slow process. Women mostly use tweezers for shaping eyebrows and
removing facial hair.

Waxing, too, is mostly done to shape the eyebrows and remove hair on the
chin and upper lip, says Brenda Ruffner, a cosmetologist in Rockville,
Md., although, she says, many women also have their legs, underarms, and
bikini line waxed.

"Men usually come in for treatment on their chest or back," Ruffner
says. "I have male clients who are bodybuilders and want their skin to
look smooth for competitions. And some men are uncomfortable with the
hair on their back or are embarrassed by it," she says.

Epilatory waxes are also available over the counter for home use. They
contain combinations of waxes, such as paraffin and beeswax, oils or
fats, and a resin that makes the wax adhere to the skin. There are "hot"
and "cold" waxes.

With hot waxing, a thin layer of heated wax is applied to the skin in
the direction of the hair growth. The hair becomes embedded in the wax
as it cools and hardens. The wax is then pulled off quickly in the
opposite direction of the hair growth, taking the uprooted hair with it.

Cold waxes work similarly. Strips precoated with wax are pressed on the
skin in the direction of the hair growth and pulled off in the opposite
direction. The strips come in different sizes for use on the eyebrows,
upper lip, chin, and bikini area.

Labeling of over-the-counter waxes cautions that these products should
not be used by people with diabetes and circulatory problems, who are
particularly susceptible to infection. Waxing--and tweezing as well--can
leave the skin sore and open to infection. Waxes should not be used over
varicose veins, moles, or warts. They should not be used on the
eyelashes, inside the nose or ears, on the nipples or genital areas, or
on irritated, chapped, sunburned, or cut skin. A small area should be
tested for sensitiv ity or allergic reaction before treating the entire
area. Some hair removal experts recommend professional waxing for the
best results.

Electrical Epilators 

Two types of devices use electric current to remove hair: the needle
epilator and the tweezers epilator.

"Needle epilators introduce a very fine wire close to the hair shaft,
under the skin, and into the hair follicle," explains Anthony Watson, a
materials engineer in FDA's Center for Devices and Radiological Health.
"An electric current travels down the wire and destroys the hair root at
the bottom of the follicle. The loosened hair is then removed with
tweezers. Every hair is treated individually."

Needle epilators are used in electrolysis. Because this technique
destroys the hair follicle, it is considered a permanent hair removal
method. The hair root may persist, however, if the needle misses the
mark or if insufficient electricity is delivered to destroy it.

"Also," Watson adds, "the stimulus for hair growth in an area is never
permanently removed. For instance, you can't control hormonal changes
that cause new growth. Most people would probably define permanent as
'never comes back,' but from a medical standpoint that may not be
practical."

Successful electrolysis usually requires considerable time and money.
Mona Wexler, an electrologist in Bethesda, Md., says she is careful to
explain the process to her clients at their first appointment.

"Electrolysis requires a series of treatments over a period of time.
It's not just a one-, two- or three-time thing," she says. "For example,
the process for a forearm takes a series of appointments once a week for
about a year. You may have a first clearing of both forearms in about
eight hours of treatment over two months. After that, you have to catch
the hairs that are coming in on a different cycle of growth. For the
best results, you want to treat each hair during its active growing
stage."

Electrolysis may not always be the best approach, Wexler adds: "Some men
who begin electrolysis to get rid of the hair on their back soon stop,
because it can be a huge, costly, and very time-consuming job, depending
on the amount of hair."

More often, she says, men are treated for the area between the eyebrows,
around the outside of the ears, and the shoulders.

"Women mostly come in for facial hair--the lip, chin, eyebrows, and
neck, but I also do a tremendous amount of body work--bikini line,
abdomen, breast, forearms, underarms," says Wexler.

The major risks of electrolysis are electrical shock, which can occur if
the needle is not properly insulated; infection from an unsterile needle
or other infection control problem; and scarring resulting from improper
technique.

There are no uniform standards governing the practice of electrology.
Only 31 states require electrologists to be licensed, and, among those,
the licensure requirements vary.

"Training requirements vary from as few as 120 hours to 1,100 hours,"
says Trudy Brown, president of the International Guild of Professional
Electrologists. "Some states may require continuing education classes,
others not, and there are no national standards for testing," she adds.

Two organizations--the American Electrology Association and the Society
of Clinical and Medical Electrologists--have certification programs,
however, both based on a written exam, Brown says. A list of licensed
and certified electrologists is available from the International Guild
of Professional Electrologists, 202 Boulevard St., Suite B, High Point,
NC 27262; (800) 830-3247.

Home-use electrolysis devices work the same way as those for
professional use and carry the same health risks. The risks are not very
great, however, FDA's Watson says, because the voltages and currents for
the home-use devices are not very high. Neither the home-use nor the
professional devices use great amounts of current, he adds.

The American Medical Association's Committee on Cutaneous Health and
Cosmetics says the success of electrolysis self-treatment depends
largely on the condition of the hair and skin, the equipment, and the
level of skill developed. The committee recommends limiting
self-treatment to readily accessible areas, such as the lower parts of
the arms and legs. Because working on facial hair requires use of a
mirror, and, therefore, reversed movements, this area is best done by a
professional.

Like needle epilators, tweezers epilators use electric current to remove
hair. The tweezers grasp the hair close to the skin, and applied current
travels down the hair shaft to the root. And, like needle epilators,
electric shock is possible if the tweezers touch the skin instead of
grabbing the hair. Tweezers epilator manufacturers can claim permanent
hair removal if they can provide supporting data. 

"Tweezers epilators are relatively new," Watson says, having been
brought into the market only about 20 years ago. "Because they don't use
a needle, they are supposed to be less painful than the older devices,
which have been around for more than a hundred years," he says. 

Needle epilators are exempt from premarket notification; tweezers
epilator manufacturers, however, must submit to FDA data showing their
devices are substantially equivalent to similar devices already on the
market. FDA is currently reviewing this policy.

"On Aug. 14, 1995, FDA published a Federal Register notice requesting
manufacturers of tweezers epilators to submit safety and effectiveness
data," Watson says. "After the information is analyzed, the agency will
decide what kind of clearance will be required for these devices."

Laser 

Hair removal entered the "laser age" last year when FDA cleared the
ThermoLase Softlight laser, manufactured by Thermotrex Corporation,
based in San Diego.

"The Softlight is essentially a standard dermatological laser similar to
others already on the market for treating skin lesions and removing
tattoos," says Richard Felten, a senior reviewer in FDA's Center for
Devices and Radiological Health.

With the ThermoLase method, a proprietary topical black-colored solution
is applied to the treatment area before the laser is scanned across it.

"The solution penetrates the hair follicles, and the black material in
it preferentially absorbs the laser wavelength, which heats and destroys
the follicles," Felten explains.

Three-month clinical trials of the ThermoLase process showed at least a
30 percent reduction of hair on treated areas in 60 to 70 percent of
people treated. Manufacturers must limit claims of laser treatment
permanence to results substantiated by the clinical data. Thermotrex,
therefore, can claim that its laser process causes hair reduction for up
to three months after treatment.

Some side effects can be expected whenever a laser is used to treat the
skin, Felten says. These include redness, caused by heating the tissue;
possibly some darkening of light-complexioned skin and lightening of
dark-complexioned skin; and a risk of some scarring in some patients.

"Usually the treated area is covered to prevent infection during the
healing period, and then kept covered with a moist solution for a period
of time," Felten says, adding that sunlight should be avoided during
healing also, to avoid a change in pigment.

A prescription device, the laser must be used under a licensed
practitioner's direction. At press time, the Softlight laser was in use
at several spas in San Diego and Dallas and in physicians' private
practices, says ThermoLase's manager of Softlight, Rick Episcopo.
Episcopo says clients may report a stinging in sensitive areas, such as
the upper lip, but mostly a sensation of warmth.

Cosmetic hair removal can be quick and easy or time-consuming and
somewhat uncomfortable. It can be costly or inexpensive. But, for just
about anyone who so desires, there's a way to get rid of the hair you
don't want.

Marian Segal is a member of FDA's public affairs staff.

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Outsmarting Poison Ivy and Its Cousins

by Isadora B. Stehlin 

Pamela Lillian Isley can manipulate plants in unexplained ways. They
bend to her will, growing and threatening the environment and
society--at least in Gotham City. In the world of Batman, the fictional
Isley is better known as the beautiful criminal Poison Ivy. Her alias is
fitting. Just as she is the bane of Batman's existence, in the real
world the poison ivy plant--along with its cousins poison oak and poison
sumac--is the bane of millions of campers, hikers, gardeners, and others
who enjoy the great outdoors.

Approximately 85 percent of the population will develop an allergic
reaction if exposed to poison ivy, oak or sumac, according to the
American Academy of Dermatology. Nearly one-third of forestry workers
and firefighters who battle forest fires in California, Oregon and
Washington develop rashes or lung irritations from contact with poison
oak, which is the most common of the three in those states.

Usually, people develop a sensitivity to poison ivy, oak or sumac only
after several encounters with the plants, sometimes over many years.
However, sensitivity may occur after only one exposure.

The cause of the rash, blisters, and infamous itch is urushiol
(pronounced oo-roo-shee-ohl), a chemical in the sap of poison ivy, oak
and sumac plants. Because urushiol is inside the plant, brushing against
an intact plant will not cause a reaction. But undamaged plants are
rare.

"Poison oak, ivy and sumac are very fragile plants," says William L.
Epstein, M.D., professor of dermatology, University of California, San
Francisco. Stems or leaves broken by the wind or animals, and even the
tiny holes made by chewing insects, can release urushiol.

Reactions, treatments and preventive measures are the same for all three
poison plants. Avoiding direct contact with the plants reduces the risk
but doesn't guarantee against a reaction. Urushiol can stick to pets,
garden tools, balls, or anything it comes in contact with. If the
urushiol isn't washed off those objects or animals, just touching
them--for example, picking up a ball or petting a dog--could cause a
reaction in a susceptible person. (Animals, except for a few higher
primates, are not sensitive to urushiol.)

Urushiol that's rubbed off the plants onto other things can remain
potent for years, depending on the environment. If the contaminated
object is in a dry environment, the potency of the urushiol can last for
decades, says Epstein. Even if the environment is warm and moist, the
urushiol could still cause a reaction a year later.

"One of the stories I tell people is of the hunter who gets poison oak
on his hunting coat," says Epstein. "He puts it on a year later to go
hunting and gets a rash [from the urushiol still on the coat]."

Almost all parts of the body are vulnerable to the sticky urushiol,
producing the characteristic linear (in a line) rash. Because the
urushiol must penetrate the skin to cause a reaction, places where the
skin is thick, such as the soles of the feet and the palms of the hands,
are less sensitive to the sap than areas where the skin is thinner. The
severity of the reaction may also depend on how big a dose of urushiol
the person got.

Quick Action Needed 

Because urushiol can penetrate the skin within minutes, there's no time
to waste if you know you've been exposed. "The earlier you cleanse the
skin, the greater the chance that you can remove the urushiol before it
gets attached to the skin," says Hon-Sum Ko, M.D., an allergist and
immunologist with FDA's Center for Drug Evaluation and Research.
Cleansing may not stop the initial outbreak of the rash if more than 10
minutes has elapsed, but it can help prevent further spread.

If you've been exposed to poison ivy, oak or sumac, if possible, stay
outdoors until you complete the first two steps:

 * First, Epstein says, cleanse exposed skin with generous amounts of
   isopropyl (rubbing) alcohol. (Don't return to the woods or yard the
   same day. Alcohol removes your skin's protection along with the
   urushiol and any new contact will cause the urushiol to penetrate
   twice as fast.)

 * Second, wash skin with water. (Water temperature does not matter; if
   you're outside, it's likely only cold water will be available.)

 * Third, take a regular shower with soap and warm water. Do not use
   soap before this point because "soap will tend to pick up some of the
   urushiol from the surface of the skin and move it around," says
   Epstein.

 * Clothes, shoes, tools, and anything else that may have been in
   contact with the urushiol should be wiped off with alcohol and water.
   Be sure to wear gloves or otherwise cover your hands while doing this
   and then discard the hand covering.

Dealing with the Rash 

If you don't cleanse quickly enough, or your skin is so sensitive that
cleansing didn't help, redness and swelling will appear in about 12 to
48 hours. Blisters and itching will follow. For those rare people who
react after their very first exposure, the rash appears after seven to
10 days.

Because they don't contain urushiol, the oozing blisters are not
contagious nor can the fluid cause further spread on the affected
person's body. Nevertheless, Epstein advises against scratching the
blisters because fingernails may carry germs that could cause an
infection.

The rash will only occur where urushiol has touched the skin; it doesn't
spread throughout the body. However, the rash may seem to spread if it
appears over time instead of all at once. This is either because the
urushiol is absorbed at different rates in different parts of the body
or because of repeated exposure to contaminated objects or urushiol
trapped under the fingernails.

The rash, blisters and itch normally disappear in 14 to 20 days without
any treatment. But few can handle the itch without some relief. For mild
cases, wet compresses or soaking in cool water may be effective. Oral
antihistamines can also relieve itching.

FDA also considers over-the-counter topical corticosteroids (commonly
called hydrocortisones under brand names such as Cortaid and Lanacort)
safe and effective for temporary relief of itching associated with
poison ivy.

For severe cases, prescription topical corticosteroid drugs can halt the
reaction, but only if treatment begins within a few hours of exposure.
"After the blisters form, the [topical] steroid isn't going to do much,"
says Epstein. The American Academy of Dermatology recommends that people
who have had severe reactions in the past should contact a dermatologist
as soon as possible after a new exposure.

Severe reactions can be treated with prescription oral corticosteroids.
Phillip M. Williford, M.D., assistant professor of dermatology, Wake
Forest University, prescribes oral corticosteroids if the rash is on the
face, genitals, or covers more than 30 percent of the body. The drug
must be taken for at least 14 days, and preferably over a three-week
period, says FDA's Ko. Shorter courses of treatment, he warns, will
cause a rebound with an even more severe rash.

There are a number of OTC products to help dry up the oozing blisters,
including: 

 * aluminum acetate (Burrows solution)
 * baking soda
 * Aveeno (oatmeal bath)
 * aluminum hydroxide gel
 * calamine
 * kaolin
 * zinc acetate
 * zinc carbonate
 * zinc oxide

Desensitization, vaccines, and barrier creams have been studied over the
last several decades for their potential to protect against poison ivy
reactions, but none have been approved by FDA for this purpose.

Right now, prevention seems the best treatment, unless you plan to take
lessons from Batman's bane with Poison Ivy's name.

Isadora B. Stehlin is a member of FDA's public affairs staff. 


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


Getting Rid of the Plants

Poison ivy, oak and sumac are most dangerous in the spring and summer,
when there is plenty of sap, the urushiol content is high, and the
plants are easily bruised. However, the danger doesn't disappear over
the winter. Dormant plants can still cause reactions, and cases have
been reported in people who used the twigs of the plant for firewood or
the vines for Christmas wreaths. Even dead plants can cause a reaction,
because urushiol remains active for several years after the plant dies.

If poison ivy invades your yard, "there's really no good news for you,"
says David Yost, a horticulturist (specialist in fruits, vegetables,
flowers, and general gardening) with the state of Virginia. The two
herbicides most commonly used for poison ivy--Roundup and Ortho Poison
Ivy Killer--will kill other plants as well. Spraying Roundup (active
ingredient glyphosate) on the foliage of young plants will kill the
poison ivy, but if the poison ivy vine is growing up your prize
rhododendron or azalea, for example, the Roundup will kill them too, he
says.

Ortho Poison Ivy Killer (active ingredient triclopyr), if used
sparingly, will kill poison ivy but not trees it grows around, says
Joseph Neal, Ph.D., associate professor of weed science, Cornell
University. "But don't use it around shrubs, broadleaf ground cover, or
herbaceous garden plants," he says. Neal explains it is possible to
spray the poison ivy without killing other plants if you pull the poison
ivy vines away from the desirable plants and wipe the ivy foliage with
the herbicide, or use a shield on the sprayer to direct the chemical.

If you don't want to use chemicals, "manual removal will get rid of the
ivy if you're diligent," says Neal. You must get every bit of the
plant--leaves, vines, and roots--or it will sprout again.

The plants should be thrown away according to your municipality's
regulations, says Neal. Although urushiol will break down with
composting, Neal doesn't recommend that because the plants must be
chopped into small pieces first, which just adds to the time you're
exposed to the plant and risk of a rash. "It's a health issue," he says.

Never burn the plants. The urushiol can spread in the smoke and cause
serious lung irritation.

The American Academy of Dermatology recommends that whenever you're
going to be around poison ivy--trying to clear it from your yard or
hiking in the woods--you wear long pants and long sleeves and, if
possible, gloves and boots.

Neal recommends wearing plastic gloves over cotton gloves when pulling
the plants. Plastic alone isn't enough because the plastic rips, and
cotton alone won't work because after a while the urushiol will soak
through.

--I.B.S. 


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


Identification Please

Unfortunately, poison ivy, oak and sumac don't grow with little picture
ID badges around their stems, so you have to know what to look for. The
famous rule "leaves of three, let it be" is good to follow, except that
some of the plants don't always play by the rules and have leaves in
groups of five to nine. To avoid these plants and their itchy
consequences, here's what to look for. 

Poison Ivy

 * grows around lakes and streams in the Midwest and the East

 * woody, ropelike vine, a trailing shrub on the ground, or a
   free-standing shrub

 * normally three leaflets (groups of leaves all on the same small stem
   coming off the larger main stem), but may vary from groups of three
   to nine

 * leaves are green in the summer and red in the fall

 * yellow or green flowers and white berries



Poison Oak

 * eastern (from New Jersey to Texas) grows as a low shrub; western
   (along the Pacific coast) grows to 6-foot-tall clumps or vines up to
   30 feet long

 * oak-like leaves, usually in clusters of three

 * clusters of yellow berries



Poison Sumac

 * grows in boggy areas, especially in the Southeast
 * rangy shrub up to 15 feet tall
 * seven to 13 smooth-edged leaflets
 * glossy pale yellow or cream-colored berries

--I.B.S. 

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


Updates


Added Use for Heart Device
Approved in Six Days 

Only six days after FDA received the application, the agency approved
for wider use an implantable device that restores normal heart rhythm in
heart attack patients. It is the first such approval worldwide.

The Guidant implantable defibrillator was originally approved by FDA in
1988 for patients who have had at least one cardiac arrest or have
recurrent and sustained rapid heartbeat despite treatment with the best
available drugs. These people are at high risk of sudden death.

FDA gave the additional approval last May 15 for a large new group of
patients--about 10 percent of heart attack patients--who also are at
high risk of sudden death from abnormal rapid heartbeat (ventricular
arrhythmia) but who have had no obvious symptoms. These patients'
arrhythmias can be detected by electrocardiograph, and usually they are
treated with drugs. However, 30 percent of these patients die from
ventricular arrhythmia within two years.

In a five-year clinical study, such patients implanted with the Guidant
defibrillator had 54 percent fewer deaths than those treated with drugs.
The significant results prompted the sponsor to stop the study early so
that all patients would be eligible to receive the device.

The Guidant defibrillator is about the size of a cassette tape and is
implanted in the abdomen or chest and linked to the heart with wire
leads. It can be programmed to deliver small, swift pacing signals to
fit patients' needs.

It is made by CPI Guidant Corp., of St. Paul, Minn.

(For more about defibrillators, see "A Gentler Jolt and Tickle for
Trembling Hearts," in the April 1994 FDA Consumer.) 

Stroke Treatment Approved

The first therapy shown to improve recovery and decrease disability in
adults after the most common kind of stroke was approved by FDA after
less than three months of review time.

Activase (alteplase), previously licensed to dissolve clots in heart
attacks and in the artery leading to the lungs, received approval last
June 18 for the additional use of dissolving blood clots that block
blood flow to the brain in ischemic strokes. Activase is a genetically
engineered version of tissue plasminogen activator (t-PA).

Because therapy with Activase must start within three hours of stroke
onset, it is important that people with stroke symptoms seek medical
attention as soon as possible. Bleeding in the brain must be ruled out
by cranial computerized tomography (CT) scan before Activase treatment
can begin. The treatment is not approved to treat hemorrhagic strokes,
caused by bleeding into and around the brain.

Yearly, about 500,000 Americans have strokes, with about 150,000 dying
as a result. Of these strokes, about 400,000 are ischemic and the rest
are hemorrhagic.

The licensing of Activase for ischemic stroke follows a unanimous
recommendation for approval by FDA's Peripheral and Central Nervous
System Drugs Advisory Committee last June 6.

Activase is manufactured with recombinant DNA technology by Genentech,
Inc., of South San Francisco. 

Test Predicts Risk of HIV Progression

A new test to predict the risk of HIV disease progression in infected
patients has been licensed by FDA. The test is not labeled for use as a
screening test for HIV or as a diagnostic test to confirm HIV infection.

The Amplicor HIV-1 Monitor Test measures blood levels of HIV-1--the
strain of human immunodeficiency virus responsible for most HIV
infections in the United States. It is the first licensed HIV-1 test
using polymerase chain reaction (PCR) technology. PCR replicates
millions of copies of genetic material (RNA) from HIV-1. The amplified
RNA is tagged with color indicators so it can be measured. This
technology enables more precise measurement than is possible with other
approved technologies.

FDA licensed the test last June 3, less than seven months after
receiving the manufacturer's application. Licensing was based on
laboratory studies showing the test could measure HIV RNA in the blood,
and on clinical data showing HIV blood levels correlated with disease
progression

Laboratory studies showed the test was specific for HIV-1--that is,
other unrelated viruses or organisms did not cause a false positive
result (indicating the presence of HIV-1). Also, in an analysis of 495
samples known not to be infected with HIV-1, none was falsely positive.

In two small clinical studies, the test was used to measure viral levels
in patients with advanced HIV disease who either had not received
antiviral drugs or had received AZT (zidovudine, marketed as Retrovir)
in combination with other antivirals for less than 16 weeks. Viral
levels that were high before treatment or that increased fivefold after
eight weeks of therapy correlated with disease progression to AIDS or
AIDS-related infection or death.

In two additional clinical studies, the test was used to evaluate the
effectiveness of antiviral therapy. Patients had been treated with AZT
and were currently receiving the protease inhibitor saquinavir (marketed
as Invirase) in combination with other drugs, such as AZT or DDC (also
known as zalcitabine and marketed as Hivid). The test showed decreased
levels of HIV-1 RNA in patients who received combination therapies.

The studies did not, however, show if changes in viral RNA levels are
related to clinical responses to drug therapy. Last March, FDA's Blood
Products Advisory Committee supported approval of the test for prognosis
of HIV-infected patients, but recommended additional studies to
determine how physicians could use the test to monitor the results of
therapy. FDA required these studies, now under way, as a condition of
licensing.

The manufacturer is Roche Diagnostic Systems Inc., Branchburg, N.J. 

New Type of Drug for Ovarian Cancer

The first member of a promising new class of antitumor drugs has been
approved by FDA to treat ovarian cancer that has progressed after
first-line treatment.

Hycamtin (topotecan), approved last May 29, belongs to the class of
drugs called camptothecins, which inhibit an enzyme called
topoisomerase-I.

Results from two multicenter clinical trials showed that the drug
reduced ovarian tumor size in 17 percent of 337 patients for an average
of about five months. That response was at least as good as that seen in
patients treated in one of the studies with Taxol (paclitaxel), another
ovarian cancer drug.

Because Hycamtin is associated with neutropenia (a temporary drop in
white blood cells that makes it difficult for the body to fight
infections), some patients may require hospitalization and antibiotics.

Other side effects include thrombocytopenia (a decrease in blood
platelets that can lead to excessive bleeding), anemia, nausea, and
vomiting.

Hycamtin is marketed by SmithKline Beecham of Philadelphia. 

Second Breast Cancer Drug from Yew Tree

A second cancer-fighting drug derived from the Pacific yew tree has been
approved by FDA.

Taxotere (docetaxel), a semi-synthetic drug containing derivatives of
the evergreen tree's needles, was approved last May 14 for women whose
advanced breast cancer has progressed despite standard cancer treatment
regimens. The first drug derived from the Pacific yew, Taxol
(paclitaxel), is approved to treat ovarian and breast cancer.

Taxotere's approval was based on several studies, including three trials
in the United States and Europe that showed the drug can shrink tumors
in some breast cancer patients.

At the highest tested dose, the drug shrank tumors in 42 percent of
patients for an average of six months. At this dose level, Taxotere,
like many cancer drugs, is associated with serious side effects,
including a decrease in white blood cell counts, fluid retention,
allergic reactions, and hair loss. At a lower dose, however, the drug
shrank tumors in 35 percent of patients for four months, and the side
effects were negligible.

The drug's labeling warns that patients should be premedicated to
prevent problems with fluid retention and allergic reactions. Certain
patients with liver dysfunction should not use Taxotere.

FDA granted Taxotere an accelerated approval based on clinical
improvements such as tumor shrinkage, rather than survival time or
quality of life. By basing accelerated approval on these partial
responses, and allowing more definitive data to be developed on clinical
endpoints after approval, FDA is giving patients earlier access to more
promising cancer therapies.

FDA may withdraw the approval of such products if postmarketing studies
do not verify clinical benefits. More extensive trials testing
Taxotere's clinical benefits are ongoing.

Taxotere is marketed by Rhône-Poulenc Rorer Inc., of Collegeville, Pa. 

Drug for Colon and Rectal Cancer

A new drug to treat advanced colon and rectal cancer was approved by FDA
just four days after an agency advisory committee recommended the
approval.

Camptosar (irinotecan) is for patients whose colorectal cancer has
recurred or progressed despite treatment with standard chemotherapy.
Approved June 17 as recommended by FDA's Oncology Drugs Advisory
Committee, Camptosar is the second in a promising new class of antitumor
drugs called camptothecins to be approved in three weeks. Camptothecins
work by inhibiting the enzyme topoisomerase-I.

Primary treatment for colorectal cancer is surgery, with or without
added chemotherapy or radiotherapy. However, the cancer recurs in about
half the patients. The drug Fluorouracil (5-FU), with or without
leucovorin (a compound related to the vitamin folic acid), is first-line
chemotherapy for patients with colorectal cancer that has spread.
However, by the time the cancer is diagnosed, it has already spread in
about half of the patients. Treatment options when the cancer does not
respond to first-line therapy are very limited.

In three studies of patients whose metastatic (spread) colorectal cancer
recurred or progressed despite chemotherapy, the new drug reduced tumor
size in about 13 percent of patients for an average of six months. Side
effects included diarrhea (in some cases, prolonged or severe enough to
require treatment) and leukopenia, a temporary drop in white blood cells
that reduces the body's ability to fight infections.

On the oncology advisory committee's recommendation, FDA granted
Camptosar accelerated approval based on clinical improvements such as
tumor shrinkage, rather than survival time or quality of life. The
committee also gave advice on additional studies to further evaluate the
safety and effectiveness of the drug. FDA may withdraw its approval if
postmarketing studies do not verify clinical benefits.

Camptosar is manufactured by Pharmacia & Upjohn Inc., Kalamazoo, Mich. 

First Drug for Rare
Parasitic Diseases 

The first drug to treat two rare parasitic
infections--neurocysticercosis (NCC) and hydatid disease--has been
approved by FDA.

Because only about 300 Americans get either disease each year, the new
treatment, Albenza (albendazole), is considered an "orphan" drug. This
designation provides incentives for companies that develop products for
disorders affecting fewer than 200,000 people in the United States and
its territories. FDA approved the drug June 12.

NCC is caused by pork tapeworm larvae and is considered the leading
infectious cause of seizures worldwide. People acquire the disease when
they consume tapeworm eggs, usually through contaminated food or water.
Seizures and headaches result when the disease involves brain tissue.
Symptoms may not develop for five years or longer following exposure.
Albendazole was shown to be effective in 40 to 70 percent of patients
with active cysts.

Cystic hydatid disease causes enlarging parasitic cysts in the liver,
lungs, abdominal cavity, brain, or bone. The cysts grow slowly and may
go undetected for years. Symptoms may be vague complaints of abdominal
fullness or may be more acute if the cyst ruptures. People contract the
disease by ingesting dog tapeworm eggs through close contact with
infected dogs. Albendazole was shown to eliminate hydatid cysts in
approximately 30 percent of patients and reduce their size in an
additional 40 percent.

Adverse effects may include diminished liver function and fewer white
blood cells. NCC patients may have headache, nausea, or vomiting;
hydatid disease patients may have abnormal liver function, abdominal
pain, nausea, or vomiting.

SmithKline Beecham Pharmaceuticals of Philadelphia makes Albenza. 

Glaucoma Drug Approved for Some Patients

An eye-drop treatment recently approved by FDA reduces glaucoma-related
eye pressure in patients who cannot use other treatments.

FDA based its June 5 approval of Xalatan (latanoprost) on study results
indicating patients treated with the drug for six months had reduction
in eye pressure equivalent to other glaucoma treatments. The approval
followed a recommendation for approval by the agency's Ophthalmic Drugs
Advisory Committee.

The once-a-day treatment may cause an unexplained gradual change in eye
color. Based on the committee's concern about this unusual side effect,
Xalatan's labeling tells patients and health-care providers about the
phenomenon and recommends use only by patients that can't tolerate or
don't respond to other treatments.

The manufacturer, Pharmacia & Upjohn Inc., of Kalamazoo, Mich., will
study the eye color change in postmarketing studies.

(See also "Guarding Against Glaucoma" in the November 1995 FDA Consumer.) 

Device to Lessen Incontinence

A disposable foam pad about the size of a quarter was cleared by FDA as
a device to help prevent urinary leakage in women with urinary stress
incontinence. It is available by prescription only.

The Miniguard is a triangle-shaped pad with adhesive coating on one
side, which the woman places over her urinary opening, where it forms a
seal.

Urinary stress incontinence is a condition in which urine leaks as a
result of physical stress, such as coughing, laughing, or lifting heavy
objects. The condition affects about 10 million people, mostly women.

Although the Miniguard does not stop leakage, it lessens its frequency.
In a study of 356 women, the average participant improved from about 14
leaks a week without the device to about five leaks a week with it.
Women with severe stress incontinence, who had about 34 episodes of
leakage a week, had only 10 leaks a week with the device. When urine
leaked in these women, the amount was smaller.

Because leaks are possible, women using the Miniguard need to wear panty
liners or pads for additional protection.

The device can be worn two to five hours at a time during the day and
throughout the night. When a woman needs to urinate, she peels the pad
off and discards it. After urinating, she puts on a new pad. The
Miniguard may be worn during exercise, although vigorous activity, such
as running, may move it out of position.

The product is not for women with urinary tract or vaginal infections or
local irritations. Also, it is not as effective in women who have had
surgery for their incontinence.

The Miniguard is made by Advanced Surgical Intervention, of Dana Point,
Calif. 

Treatment Slows MS

An injectable multiple sclerosis treatment recently licensed by FDA is
the second interferon treatment for relapsing MS, which affects about 30
percent of patients.

Multiple sclerosis is a chronic, often disabling disease of the central
nervous system that occurs when the protective covering of the nerve
fibers breaks down. In relapsing MS, symptoms can diminish or disappear
for months or years between flare-ups. (See "Multiple Sclerosis: New
Treatment Reduces Relapses" in the June 1994 FDA Consumer.)

The new treatment, Avonex (interferon beta-1a), is a genetically
engineered form of a naturally occurring protein in the body which is
vital to immune functions.

In a two-year clinical trial, patients receiving a weekly injection of
interferon beta-1a into the muscle were 37 percent less likely to have
physical disability than patients getting a placebo. Also, those
receiving interferon beta-1a had less frequent flare-ups and fewer
lesions. 

The most common side effect was flu-like symptoms, which diminished with
continued treatment. Interferon beta-1a did not appear to increase
depression, a side effect associated with some interferon products.
There were no reports of tissue death at the injection site, which
differentiates the product from Betaseron (interferon beta-1b), licensed
in 1993 to treat relapsing MS.

The May 17 licensing of Avonex follows a recommendation for approval by
FDA's Peripheral and Central Nervous System Drugs Advisory Committee.

The drug will be marketed by Biogen, Inc., of Cambridge, Mass. 

Unrealistic Claims for Eye Surgery Concern FDA, FTC

In response to inquiries and complaints about misleading promotion of
photorefractive keratectomy (PRK), a laser treatment for
nearsightedness, FDA and the Federal Trade Commission recently notified
the eye-care community that advertising and promotion for the procedure
should be truthful and substantiated.

In a joint letter sent May 7, 1996, the agencies said advertising or
promotion should contain enough information about the risks and
limitations of PRK to prevent deception, and consumers should be given
enough information about the surgery to make an informed decision.
Unrealistic claims such as "throw away your eye glasses" and
unsubstantiated claims about success rates could be misleading to
consumers.

In clinical studies, about 5 percent of patients who had PRK continued
to need glasses all the time for distance, and up to 15 percent needed
glasses occasionally, such as for driving. Best corrected vision (vision
with glasses) was slightly worse after surgery in about 5 percent of
patients.

In PRK, an excimer laser is used to reshape the cornea to improve mild
to moderate nearsightedness. The surgery is not reversible. Excimer
lasers have not been shown safe and effective for severe nearsightedness
(more than -7 diopters), farsightedness or astigmatism. People who need
reading glasses continue to need them after PRK. Also, PRK does not
prevent farsightedness associated with aging, so people may require
reading glasses as they age even if they have had the laser surgery.
Risks of PRK to the cornea beyond three years have not been studied.

Some doctors perform PRK on both eyes without a waiting period between.
Patient brochures developed by the laser manufacturers and reviewed by
FDA, however, recommend a three-month wait between eye surgeries to
allow vision to stabilize.

In addition, some surgeons perform a laser procedure called LASIK to
improve nearsightedness. FDA has not cleared lasers for this use,
however, and the devices cannot be promoted or advertised for it. 

Free Brochure and Reprints

A new low-literacy brochure about medical treatments is available free
from FDA. Also available free are new FDA Consumer reprints.

The publications and their numbers are: The Truth About Choosing Medical
Treatments (FDA) 96-1248 New Hope for People with Sickle Cell
Anemia(FDA) 96-1251 Seven Steps to Safer Sunning(FDA) 96-1252 How to
Give Medicine to Children (FDA) 96-3223.

To order single copies, write to FDA, HFE-88, Rockville, MD 20857. To
order 2 to 100 copies, write to FDA, HFI-40, at the same address, or fax
your order to (301) 443-9057. Include the publication number.


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

Notebook

The Notebook: a potpourri of items of interest gathered from FDA news
releases, other news sources, and the Federal Register (designated FR,
with date of publication). The Federal Register is available in many
public libraries.

Natural rubber-containing medical devices that may contact human tissue
must be labeled as latex and identified as a possible cause of allergic
reactions, according to a proposed FDA rule. Hypoallergenicity claims
also must be removed from such devices because the current test that
supports these claims addresses only chemical sensitivity, not protein
sensitivity. FDA is proposing the rule following several reports of
severe allergic reactions to a wide range of latex-containing medical
devices. Comments on the proposed rule should be sent by Sept. 23 to the
Dockets Management Branch (HFA-305), FDA, 12420 Parklawn Drive, Room
1-23, Rockville, MD 20857. (FR June 24)

Helping patients stop smoking is the topic of new guidelines for health
professionals mailed this past summer to the offices of 200,000
primary-care physicians by the U.S. Agency for Health Care Policy and
Research (AHCPR). The guidelines also are available in a consumer
version. For a free copy, call AHCPR at (1-800) 358-9295.

A new home page for FDA's Center for Drug Evaluation and Research is now
on the agency's World Wide Web site at http://www.fda.gov/cder/. The
home page offers information about drug approvals, recalls and
shortages, as well as the drug center's programs and policies.

Propylene glycol (PG), added to cat food, was excluded from "generally
recognized as safe" (GRAS) status in a final FDA rule effective June 3.
Manufacturers say PG helps prevent oxidation of components that could
affect nutritional properties of the food. But after reviewing currently
available information, FDA said "significant questions" remain about
PG's safety in cat food. (FR May 2)

Most of the artificial sweetener aspartame' s 23 listed uses were
replaced with a single-use category for food in a final FDA rule that
became effective June 28. FDA amended food additive regulations to allow
safe use of aspartame as a general-purpose sweetener. (FR June 28)

Medical device products that may deplete the Earth's ozone layer,
including those containing or manufactured with chlorofluorocarbons
(CFCs), must carry warning statements, according to an FDA interim rule
that became effective May 17. CFCs are allowed for some "essential"
medical device uses, such as in certain metered-dose inhalation devices
used to treat asthma. (FR May 3)

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

Investigators' Reports

A 'Washed-Up' Snake-Oil Scheme

by Paula Kurtzweil 

A California doctor and his partner viewed their homemade cancer
treatment as alternative medicine. But a judge declared it "snake oil."

FDA laboratory analysis indicated the treatment, called "Immunostim,"
contained substances found in common cleaning fluids, such as dish
detergent and toilet bowl cleaner. Patients paid as much as $7,500 per
treatment to have the product injected into their veins.

Lawrence Taylor, 72, has since had his medical license revoked by the
Medical Board of California, and his partner, William Stacey, 48, is
serving five years in the San Diego county jail for continuing to sell
Immunostim in violation of his probation.

The two men ran the Taylor-Stacey Center for Advanced Medicine in San
Diego between 1993 and 1994. Both were sentenced in 1995: Stacey for
selling an unapproved cancer treatment, and Taylor for a related but
lesser offense, maintaining a public nuisance. Stacey was resentenced
earlier this year.

Their illegal activity was uncovered in an investigation by FDA, the San
Diego City Attorney's Office, the California Health Department, and the
Medical Board of California.

An anonymous caller first alerted FDA to Taylor and Stacey's use of
Immunostim in early 1994. At about the same time, two TV reporters who
had gone to the Taylor-Stacey clinic posing as relatives of AIDS
patients sent a videotape of their investigation to the San Diego City
Attorney's Office. The reporters, from the USA Network's "Case Closed"
show, were following up on a viewer complaint about Stacey's previous
activities in North Carolina. While there, he had treated AIDS patients
with Immunostim.

A month later, on March 22, 1994, the San Diego City Attorney's Office
filed criminal charges against Taylor and Stacey in San Diego Municipal
Court. Two days later, city police arrested the two men, and, as allowed
under state law, the Medical Board of California shut down the clinic.

That same day, with search warrants in hand, the group of local, state
and federal investigators searched the clinic, as well as the two men's
San Diego residences. The searches resulted in the seizure of five vials
of Immunostim and various documents related to the product, including
financial reports, patient records, and patient handbooks.

The Immunostim was sent to FDA's Forensic Chemistry Center in Cincinnati
for analysis. The laboratory identified trisodium phosphate, sodium
metasilicate, methyldodecylbenzyl trimethyl ammonium chloride, and
trimethyl ammonium chloride as the ingredients. No active drug
ingredient was present. The solution had an alkaline pH of 12.7.

Referring to the second edition of Comprehensive Review in Toxicology,
laboratory scientists found that the substances they identified matched
those found in disinfectants, toilet bowl cleaners, and automatic
dishwasher detergents.

Investigators, including Will Brannon, a special agent with FDA's Office
of Criminal Investigations, began interviewing Taylor's former patients
and their family members. The patients had come from throughout the
United States for treatment at Taylor's San Diego clinic.

From these interviews, investigators learned that many of Taylor's
patients had gone through conventional medical therapies with little or
no success and had subsequently been diagnosed with terminal diseases.
Taylor and Stacey often told patients their treatment would cure them.
Each treatment, administered for three to six hours four times a week
over a three-week period, consisted of a small amount of Immunostim
mixed with an approved intravenous (IV) solution infused into a vein.

Many of the patients' family members described the treatments as
painful. One woman, whose 34-year-old husband was treated with
Immunostim for lung cancer, recalled that during a second infusion, the
IV solution "leaked into the tissue" of her husband's hand.

"Immediately he began experiencing excruciating, burning pain," she
later wrote to the judge. "His pain intensified over the next several
hours, necessitating massive quantities of pain medication with little
relief." Several months later, she said, she rushed her husband to the
hospital after administering Immunostim to him at home. An emergency
room doctor prescribed injectable Demerol (meperidine), a narcotic
analgesic. The patient continued to take Demerol at home and didn't
regain use of his hand until almost a week later, the woman said.

Another woman, whose son underwent Immunostim therapy for brain cancer,
recalled nights when her son was "full of pain." She attributed the pain
to an "inflamed" infusion site. She recalled another cancer patient who
laid on the floor during treatment because "he was in too much pain to
sit."

Donald Stevenson, M.D., with the Scripps Clinic and Research Foundation
in La Jolla, Calif., reviewed patient records and said in his report to
the court that most patients treated with Immunostim experienced
inflammation of veins used for infusion. This led to "painful swellings"
and then complete closure of the veins, resulting in a hard knot where a
vein had previously existed, the doctor wrote. Patients' family members
who were interviewed by investigators recalled instances where clinic
employees had difficulty finding usable veins. The mother of one patient
recalled seeing another patient receiving the IV infusion through his
toe because clinic personnel couldn't find another vein to use.

Many patients reported that they spent considerable money, sometimes
their life savings, to receive the Immunostim therapy. Parents of one
cancer patient said they paid $5,000 for 12 treatments. The woman whose
husband suffered from lung cancer said they spent nearly $26,000 for
three courses of treatment. According to the San Diego City Attorney's
Office, Taylor and Stacey took in more than $670,000 from patients
receiving Immunostim during the 18 months the clinic was open in San
Diego.

Upon checking the men's backgrounds, investigators learned that Stacey,
who referred to himself as a Ph.D. chemist, probably had "a high school
education at most," said Tricia Johnson, the deputy city attorney who
prosecuted the case. The universities he said he attended had no records
of his having graduated, she said. Taylor was licensed as a general
practitioner. 

In a plea agreement, on May 12, 1995, Taylor and Stacey pleaded no
contest to the criminal charges.

On Aug. 18, 1995, Municipal Court Judge H. Ronald Domnitz sentenced
Taylor to a 150-day work-furlough facility with three years' probation,
fined him $2,000, and ordered him to pay the cost of the government's
investigation of the clinic. In addition, he ordered him, along with
Stacey, to pay restitution of $46,779 to nine of 108 former patients or
their families. By that time, more than half the patients had died,
presumably from their diseases. The nine who received restitution were
named in the complaint.

The judge also ordered Taylor to place a sign in his medical office in
letters at least 3 inches high with these words: "This office does not
treat cancer or AIDS patients unless referred by another physician."

The judge sentenced Stacey Oct. 17, 1995, to 18 months in jail with five
years' probation, fined him $3,000, and ordered him not to work in the
health-care industry or sell any health-care product. Stacey failed to
appear Oct. 31 to begin his jail sentence. An agent for Stacey's
bondsman, whom Stacey failed to repay, tracked Stacey to South Carolina,
where he apparently was still selling Immunostim. The agent notified
local police, who arrested him. The San Diego City Attorney's Office
extradited Stacey to California Dec. 21, 1995.

For violating his probation, the judge ordered Stacey last Feb. 29 to
serve five years in custody, the maximum allowed under the plea
agreement. 

Meanwhile, on Feb. 19, the Medical Board of California revoked Taylor's
medical license.

Paula Kurtzweil is a member of FDA's public affairs staff. 


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Importer Convicted of Attempted Bribery

The attempted bribery of an FDA official resulted in the arrest and
conviction of a New York seafood importer.

Bernard Kwang Myung of Coimex Seafood, a Brooklyn, N.Y., seafood
importing company, was fined $5,000 and sentenced to 18 months'
probation April 12 for offering a gratuity to a compliance officer in
FDA's New York district office. Offering a gratuity to a government
official is illegal. The attempted bribery revolved around imported
contaminated imitation scallops.

FDA's Northeast Regional Laboratory analyzed a shipment of the
importer's frozen imitation scallops (surimi) in July 1993, and found
the product contaminated with Listeria monocytogenes. This bacteria can
cause serious illness, particularly in pregnant women and their fetuses.
Cooking food kills Listeria. However, these imitation scallops were a
cooked processed product. Cooked processed products are often served
without any further cooking--in salad bars, for instance.

FDA initially detained the product on July 15, 1993, and determined that
all the firm's subsequent shipments would be automatically detained at
the port of entry. After Myung agreed to relabel the product with a
statement that included a warning about the need to cook the food and
cooking instructions, FDA allowed the scallops to enter the U.S. market.

However, with the arrival of shipments in January and May 1994, it
became clear to FDA that the company was routinely labeling the product
with the warning statement rather than trying to eliminate the bacteria.
FDA concluded that it would be more appropriate for the foreign
processor to manufacture a safe and wholesome product, without the need
for a warning about cooking the imitation scallops. So FDA denied the
importer's petition to relabel the product.

On Aug. 9, 1994, Myung visited FDA's New York district office and met
with compliance officer James Nelson to discuss how to deal with
detained shipments. During this meeting, Myung placed a white envelope
on Nelson's lap. Nelson realized right away that there was money in this
envelope and that Myung was attempting to bribe him. Nelson refused the
money, returning the envelope to Myung. Myung then told Nelson that at
least he should be allowed to take Nelson and his wife to dinner. Nelson
continued to protest and shook Myung's hand, indicating the end of the
meeting.

Nelson immediately reported the incident to his supervisor at the time,
Regina Feuchtbaum, former director of the district's import operations
branch, who, following FDA procedure, contacted the Department of Health
and Human Services' Office of Inspector General (OIG). OIG advised
Nelson to call Myung back for a meeting the next afternoon to discuss
the matter further. This meeting took place with Nelson wired so that
the conversation could be monitored and recorded. Myung once again
offered money to Nelson; this time, three $100 bills. OIG special
agents, listening in from another room, arrested Myung on the spot.

Myung pleaded guilty in the U.S. District Court for the Eastern District
of New York to presenting an illegal gratuity. U.S. District Judge
Raymond J. Dearie, who sentenced Myung, commended Nelson for his
actions. Nelson received the Inspector General's Integrity Award in
December 1994.

--Herman Janiger 


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Violations Uncovered at Army Blood Center

The U.S. Army voluntarily discontinued much of its blood collection at
Walter Reed Army Medical Center, Washington, D.C., in March while it
worked on correcting numerous blood collection violations.

Investigators with FDA's Baltimore district office uncovered the
violations while inspecting the Walter Reed blood center Sept. 28
through Oct. 17, 1995. Problems found included:

 * lack of proper equipment and supplies for blood drives
 * failure to maintain an up-to-date donor disqualification deferral list
 * improperly refrigerated whole blood
 * failure to investigate reactions to transfusions
 * lack of privacy for donors filling out blood donation questionnaires
 * failure to maintain equipment monthly as required.

The Army responded to FDA's findings in a letter last Dec. 18, but,
because of discrepancies between the Army's response and FDA's findings,
investigators returned to Walter Reed on Jan. 30, 1996. They found many
of the same problems, as well as new ones, including:

 * using out-of-date blood for transfusions

 * improperly maintaining the blood product irradiator, a device that
   exposes blood to radiation to reduce the risk of rejection when
   transfusing infants or a member of the donor's family

 * failing to verify repeat testing on samples testing positive for
   hepatitis B.

Last April 16, Army representatives met with FDA and told the agency
that as of March 18 it had discontinued all blood collections except for
autologous donations and plateletpheresis. In autologous donations,
individuals donate blood for their own use. Plateletpheresis is a
process in which platelets are removed from the donor's blood, and then
the rest of the blood is returned to the donor. The Army said it was
continuing these two types of collections because demand for them
couldn't be met from other sources.

The Army informed FDA that it was addressing the problems by:

 * having a blood quality assurance expert review all facets of the
   operation

 * retraining all blood bank staff

 * reviewing records for the last six months to determine whether any
   blood was inappropriately released

 * installing a new computer system.

The Army also said it would inspect North American Biological Inc.,
Miami, a company under contract to Walter Reed to test blood for
infectious diseases, to ensure that it was following regulations.

"We believe that if the Army's aggressive plans are vigorously pursued,
there will be no concern for the safety of Walter Reed's blood
products," said Ken Shelin, FDA's Baltimore district director.

FDA will reinspect later this fall.

--Dori Stehlin 


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


Unproven Medical Claims Land Men in Prison 

"It has been known to shatter cancer cells and AIDS cells in people." 

    --Salesperson for Life Energy Resources Ltd. (LER), Falconer, N.Y.,
      referring to the firm's REM SuperPro Generator.

"Your kid gets chicken pox, use the REM [SuperPro Generator]
immediately, and it will knock it out." 

    --Pascal (Pat) Ballistrea, LER distributor.

Two New York men are serving time in prison for making claims such as
these touting the electrical-shock-producing REM device as a cure-all
for many medical conditions. A third man is on probation for three
years.

In a felony prosecution for device health fraud, the three men--LER's
top distributors--were convicted and sentenced in 1993, 1994 and 1995,
for selling unapproved medical devices and drugs.

Their illegal activities came to light in a three-year undercover probe
by FDA, the U.S. Postal Inspection Service, and the U.S. Department of
Justice.

In prison are Ballistrea, of Williamsville, N.Y., and Michael Ricotta,
of Orchard Park, N.Y. Brian Strandberg, of Portland, Ore., who also
served as LER's national marketing director, received probation.

FDA first learned about LER on April 7, 1989, when an employee of a
Buffalo finance company contacted FDA's Buffalo district office to
report suspicions about the company. The employee said a salesperson for
LER had called to solicit financial backing for the company's REM
SuperPro Generator. Claiming the SuperPro could treat AIDS and cancer,
the LER salesperson had confided, "I'm saying this to you, but it goes
no further. I really can't say this to you." 

Later that month, FDA investigator Russ Davis inspected LER and learned
from Christopher Bradish, LER director of operations, that the firm
bought the REM SuperPro Generator and other electrical devices and
numerous drugs from Zoetic Inc., of St. Francisville, Ill., and marketed
them in a pyramid scheme to independent distributors, who sold them to
retail customers, who could themselves become distributors.

Davis learned from another man present, Frank Costanzo, that LER had 263
retail customers acting as distributors in 38 states. Costanzo was
president of the company that leased computers, software, and building
space to LER. He later also became LER chief executive officer. 

According to records Davis examined, LER sold the REM SuperPro for
$1,380. Directions for the device called for patients to place their
feet on metal pads, which were wired to allow an electrical current to
run through the body. The company also sold similar but less expensive
devices that produced less current than the REM SuperPro.

The drug products, including one called LifeMax Miracle Natural Balance
Body Creme, sold for about $7 to $55, according to the records.

Davis told Bradish and Costanzo about the complaint FDA had received,
adding that unproven medical claims misbrand a device, and selling
misbranded devices is illegal. According to Davis, Bradish said LER
instructs its distributors to use only official literature for
marketing, but added that because distributors run their own businesses,
he couldn't account for their actions. However, he said LER would
terminate agreements with distributors making claims not in the official
literature, and he would write to them all, reminding them of this and
cautioning them not to make the kind of AIDS and cancer claims reported
in the original complaint.

Davis collected some of the official marketing literature, which said
the electrical devices could treat neuralgia, headache, jet lag, and
other conditions. These uses also are unproven medical claims, so before
departing, Davis informed the men that distribution of misbranded
products may result in legal sanction, such as seizure, injunction or
prosecution.

In 1989 and 1990, FDA continued to receive complaints about unproven
claims for the REM SuperPro. So, FDA decided to take action.

"We realized that the only way we were going to get them was to do an
undercover investigation," said Louis Kaufman, a compliance officer with
FDA's Center for Devices and Radiological Health.

Posing as distributors, investigators Steven Libel, Joan Trankle, and
Sherry Phillips, of FDA's Buffalo district office, and investigators
Edward Edmiston and Victor Meo, of FDA's Seattle district office,
infiltrated the LER organization. Libel, Trankle and Phillips centered
their efforts on Ricotta and Ballistrea in New York. Edmiston and Meo
investigated Strandberg in Portland, which is in FDA's Seattle district.
Ricotta, Ballistrea and Strandberg were singled out because they were
responsible for promoting LER's products.

The investigators bought LER's products and collected unofficial
literature, known as the "underground packet." The packet included
literature, audiotapes and videotapes of individuals claiming the
products could cure cancer, AIDS, and other diseases.

In secretly recorded meetings and phone conversations, Ricotta,
Ballistrea and Strandberg admitted sending underground materials to
down-line distributors for use in promoting the REM SuperPro for such
diseases as cancer and AIDS and the LifeMax Miracle Cream for such
medical conditions as osteoporosis and premenstrual syndrome.

To support LER's claims that the REM SuperPro cured cancer and other
diseases, the underground materials routinely referenced a book about
the SuperPro Generator, precursor to the REM SuperPro. The book
described work by the precursor's inventor, Royal Raymond Rife, who died
in 1971. "REM" reportedly stood for "Rife's Electromagnetic."

Meanwhile, on April 19, 1990, FDA investigators Mark Prusak and William
Lubas, who were not part of the undercover investigation, inspected
LER's facility in Falconer, N.Y.

Costanzo, now the chief executive officer, refused to let Prusak see
shipping and receiving records and distribution information and, when
questioned by the investigators, Costanzo denied reports that LER made
medical claims for its products. LER's Bradish said the devices were
sold for relaxation and stress reduction.

By February 1991, FDA had gathered enough evidence to forward its
findings to the Department of Justice.

On May 29, executing a search warrant at Ballistrea's house, FDA and the
Postal Service found a large amount of product literature and
videotapes. Although Ballistrea had sent undercover government
investigators numerous materials on LER products in 1990 and 1991, he
told the agents it had been more than a year since he had distributed
such materials.

A grand jury investigation began in the summer of 1991. U.S. Attorney
Dennis Vacco wrote, "Two of the more disturbing aspects of the
investigation are the fact that some cancer patients have been using
these devices without the knowledge of their physicians and as an
alternative to chemotherapy."

On Feb. 25, 1993, Strandberg pleaded guilty in the U.S. District Court
for the Western District of New York, in Buffalo, to two misdemeanor
counts of distributing an unapproved device. In a plea agreement, he
admitted knowing the REM SuperPro was not approved by FDA. He admitted
sending materials containing medical claims for the device to customers
and distributors.

Judge Leslie Foschio sentenced Strandberg on Dec. 21, 1993, to three
years' probation with 200 hours community service and fined him $500 and
a $50 special assessment.

On April 8, 1993, in the same court, the grand jury returned a 10-count
indictment against Ballistrea and Ricotta.

The trial began Oct. 9. After four days, however, a mistrial was
declared for Ballistrea, who was excused because of a back ailment. He
was tried later.

During Ricotta's trial, according to the Nov. 18, 1993, Buffalo News,
Ricotta denied selling the REM SuperPro for medical purposes, but he
said he believed the product was effective treatment for bone and colon
cancers, skin diseases, premenstrual syndrome, arthritis, bladder
diseases, angina, insomnia, herniated disks, tumors, Lou Gehrig's
disease, kidney ailments, emphysema, hearing problems, ear infections,
and other illnesses.

On Nov. 19, Ricotta was convicted of two felony and four misdemeanor
charges for conspiracy to defraud FDA, distributing an adulterated and
misbranded medical device (the REM SuperPro), and distributing an
unapproved new drug (LifeMax Miracle Cream).

On Feb. 2, 1994, Judge Richard Arcara sentenced Ricotta to three years,
five months in prison and three years' supervised release and fined him
$3,000 and a $200 special assessment.

"You are a menace and a threat to society," Judge Arcara told Ricotta,
as reported next day in the Buffalo News. "Your sales strategy targeted
the most vulnerable people, including those suffering from terminal
disease. ... It is especially cruel because, in many instances, it
proved false hope to people who had no hope."

After several hearings to determine whether Ballistrea was able to stand
trial, his trial finally began Nov. 10, 1994. On Dec. 14, he was
convicted of the same charges as Ricotta and of making false statements
to FDA and the Postal Service.

On Sept. 22, 1995, Judge Arcara sentenced Ballistrea also to three
years, five months in prison and three years' supervised release and
fined him $275 special assessment.

--Dixie Farley helped compile this article. 


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


Summaries of Court Actions

Summaries of Court Actions are given pursuant to Section 705 of the
Federal Food, Drug, and Cosmetic Act. Summaries of Court Actions report
cases involving seizure proceedings, criminal proceedings, and
injunction proceedings. Seizure proceedings are civil actions taken
against goods alleged to be in violation, and criminal and injunction
proceedings are against firms or individuals charged to be responsible
for violations. The cases generally involve foods, drugs, devices, or
cosmetics alleged to be adulterated or misbranded or otherwise violative
of the law when introduced into and while in interstate commerce.

Summaries of Court Actions are prepared by Food and Drug Division,
Office of the General Counsel, HHS, and are published by direction of
the Secretary of Health and Human Services.


SEIZURE ACTIONS

Food/Contamination, Spoilage, Insanitary Handling

PRODUCT: Beans with ginger, preserved, at San Francisco, Calif. (N.D.
Calif.); Civil No. C-94-1986-CW.

CHARGED 6-6-94: While held for sale after shipment in interstate
commerce at Wing Sing Chong Co., in San Francisco, Calif., the articles
were adulterated in that they contained rodent and other animal hairs,
insects, and insect and feather fragments--402(a)(3).

DISPOSITION: A default decree of condemnation and destruction ordered
the articles destroyed. (F.D.C. No. 66981; S. No. 94-665-453; S.J. No.
1)


PRODUCT: China pud tail-off shrimp, frozen, at Tampa, Fla. (M.D. Fla.);
Civil No. 95-570-Civ-T-24A.

CHARGED 4-13-95: While held for sale after shipment in interstate
commerce at Ocean Duke Corp., in Tampa, Fla., the articles were
adulterated in that they contained paint chips and metal
fragments--402(a)(3).

DISPOSITION: The articles were exported to the foreign supplier in Hong
Kong. (F.D.C. No. 67083; S. No. 95-681-861; S.J. No. 2)


PRODUCT: Fish, frozen, at Newark, N.J. (D.N.J.); Civil No. 94-9209(AJL). 

CHARGED 12-21-94: While held for sale after shipment in interstate
commerce at Newark Refrigerated Warehouse in Newark, N.J., the articles
were adulterated in that they contained Salmonella, a poisonous or
deleterious substance which might render them injurious to
health--402(a)(1). 

DISPOSITION: A consent decree of condemnation ordered the articles
destroyed. (F.D.C. No. 67046; S. No. 94-644-161; S.J. No. 3)


PRODUCT: Fish Maws and Shark Fins, dried, at San Francisco, Calif. (N.D.
Calif.); Civil No. C-94-1366-SC.

CHARGED 4-21-94: While held for sale after shipment in interstate
commerce at Wonkow Enterprises, Inc., in San Francisco, Calif., the
articles were adulterated in that they contained insects, rodent
excreta, and animal hairs--402(a)(3). The articles were also held under
insanitary conditions whereby they might have become contaminated with
filth--402(a)(4).

DISPOSITION: A consent decree of condemnation ordered the articles
destroyed. (F.D.C. No. 66959; S. No. 94-705-321; S.J. No. 4)


PRODUCT: Mushrooms, at Long Beach, Calif. (C.D. Calif.); Civil No.
CV-94-5503-SVW(SHX).

CHARGED 8-11-94: While held for sale after shipment into interstate
commerce at Great Central in Long Beach, Calif., the articles were
adulterated in that they contained staphylococcal enterotoxin, a
poisonous or deleterious substance which might render them injurious to
health--402(a)(1). The articles were also adulterated in that they were
prepared and packed under insanitary conditions whereby they might have
been rendered injurious to health--402(a)(4).

DISPOSITION: A default decree ordered the articles destroyed. (F.D.C.
No. 67007; S. No. 3016294; S.J. No. 5)


PRODUCT: Royal dinnerware harvest festival, at Eau Claire, Wis. (W.D.
Wis.); Civil No. 95C-0357-C.

CHARGED 5-18-95: While held for sale after shipment into interstate
commerce at Mid-America Tablewares, Inc., in Eau Claire, Wis., the
articles were adulterated in that they contained lead--402(a)(2)(C).

DISPOSITION: A consent decree of condemnation and destruction ordered
the articles destroyed. (F.D.C. No. 67086; S. No. 94-718-522; S.J. No.
6)


PRODUCT: Shrimp, frozen, at Dover, Fla. (M.D. Fla.); Civil No.
95-1412-CIV-T-17A.

CHARGED 8-25-95: While held for sale after shipment in interstate
commerce at Mercury Cold Storage, Inc., in Dover, Fla., the articles
were adulterated in that they contained Salmonella, a poisonous or
deleterious substance which might render them injurious to
health--402(a)(1). The articles were also adulterated in that they
consisted of decomposed shrimp --402(a)(3).

DISPOSITION: A default decree of condemnation and destruction ordered
the articles destroyed. (F.D.C. No. 67103; S. No. 95-711-532; S.J. No.
7)



Medical Devices

PRODUCT: Condoms, lubricated, at Paramount, Calif. (C.D. Calif.); Civil
No. 95-3074.

CHARGED 5-8-95: While held for sale after shipment in interstate
commerce at Handy Care in Paramount, Calif., the articles were
adulterated in that their strength differed from, or their purity or
quality fell below that which they represented to possess--501(c). The
articles were class III devices without an application for premarket
approval, and their packaging failed to bear a label containing the name
and place of business of the manufacturer, packer or
distributor--501(f)(1)(B) and 502(b)(1). The articles were also
adulterated in that they were not manufactured in a duly registered
establishment--502(o).

DISPOSITION: A default decree ordered the articles destroyed. (F.D.C.
No. 67077; S. No. 95-615-695; S.J. No. 8) 

INJUNCTION ACTIONS

DEFENDANTS: James' Seafood, Inc., and Elmer J. Perkins, at Lockport, La.
(E.D. La.); Civil No. 94-0784.

CHARGED 3-8-94: The defendants introduced or caused to be introduced
into interstate commerce adulterated crab meat--301(a). The crab meat
was adulterated in that it contained Listeria monocytogenes, a poisonous
or deleterious substance which might render it injurious to health, and
Escherichia coli, a filthy substance--402(a)(1) and 402(a)(3). The crab
meat was also adulterated in that it was prepared, packed or held under
insanitary conditions whereby it might have become contaminated with
filth, or where by it might have been rendered injurious to
health--402(a)(4).

DISPOSITION: The court granted an order of permanent injunction.
Subsequently, the defendants went out of business. (Inj. 1334 and 1334A;
S. No. 93-690-318; S.J. No. 9)


DEFENDANTS: Warner-Lambert Company, Melvin Goodes, and Lodewijk J.R.
DeVink, at Morris Plains, N.J. (D.N.J); Civil No. 93-3525.

CHARGED 8-17-93: The defendants introduced or caused the introduction or
delivery into interstate commerce of adulterated drugs--301(a). The
drugs were adulterated in that the methods used in, and the facilities
or controls used for, their manufacture, processing, packing, and
holding did not conform to and were not operated or administered in
conformity with current good manufacturing practice
requirements--501(a)(2)(B). The defendants also manufactured, processed,
packed, and labeled adulterated drugs-- 301(k). The defendants delivered
for introduction and caused the delivery for introduction into
interstate commerce new drugs without approved new drug applications
(NDAs), abbreviated new drug applications (ANDAs), or approved NDA or
ANDA supplements--301(d).

DISPOSITION: A consent decree of permanent injunction was filed. Six of
Warner-Lambert's manufacturing facilities were shut down except for the
manufacture of certain drug products which were permitted to be
manufactured under the decree. Subsequently, all facilities met the
terms of the decree and were fully reopened. (Inj. No. 1322; S. No.
92-637-081; S.J. No. 10)

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

FDA Consumer is the official magazine of the U.S. Food and Drug
Administration. Each issue contains in-depth feature articles written
for the general public on FDA-related health issues. The magazine also
includes reports from FDA's own investigators that go behind the scenes
to show how the agency protects the public from unsafe or worthless
products.

FDA Consumer is published monthly, except for combined issues for
July-August and January-February. Subscriptions are available for $15
per year by writing:

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Washington, DC 20402-9371.

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