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FDA Consumer Magazine
VOL. 31 NO. 5
JULY-AUGUST 1997


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Features

Dieter's Brews Make Tea Time a Dangerous Affair
The active ingredients in dieter's teas--herbal laxatives--won't help
you lose weight, and may cause cramps, diarrhea and even more severe
problems.

When Summertime Gets Too Hot to Handle
Hot fun in the summertime can sometimes have serious, even lethal,
consequences. But a few simple precautions can prevent heat-related
illness.


A Dose of Clear Directions for Rx Drug Users
The simple--and uninformative--phrase "use as directed" will give way to
detailed information in nonmedical language on all prescription drugs
under a new voluntary plan FDA will monitor.



Bulking Up Fiber's Healthful Reputation
"Beans, beans, the musical fruit. The more you eat, the more you toot."
Fiber--with all its many contributions to health--deserves more respect
than that.



Incontinence Can Be Controlled
Urinary incontinence can devastate a person's quality of life. But
myriad treatment options, including two new devices FDA approved in
1996, can bring the quality back.



On the Teen Scene: Overcoming the Deficit of Attention Disorder
Teens with attention-deficit/hyperactivity disorder need more than
adults yelling at them to pay attention. Drugs and coping skills can
help them succeed in school and life.




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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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Dieter's Brews Make Tea Time
A Dangerous Affair

by Paula Kurtzweil

A cup of hot herbal tea may feel soothing to the soul, but instead of
soothing the body, some herbal teas can make you sick.

This is especially true with so-called dieter's teas, herbal teas
containing senna, aloe, buckthorn, and other plant-derived laxatives
that, when consumed in excessive amounts, can cause diarrhea, vomiting,
nausea, stomach cramps, chronic constipation, fainting, and perhaps
death.

In recent years, FDA has received "adverse event" reports, including the
deaths of four young women, in which dieter's teas may have been a
contributing factor.

As a result, FDA is advising consumers to follow package directions
carefully when using dieter's teas and other dietary supplements
containing senna, aloe, and other stimulant laxatives. Consumers should
seek medical attention for persistent diarrhea, abdominal cramps, and
other bowel problems to prevent more serious complications.

The agency may consider requiring manufacturers to place a warning about
the products' potential side effects on the products' labels. Some
manufacturers already are doing so voluntarily.

These products--bought in health food stores and through mail-order
catalogs, for example--often are used for weight loss based on some
consumers' belief that increased bowel movements will prevent absorption
of calories, thus preventing weight gain. However, a special committee
of FDA's Food Advisory Committee concluded in 1995 that studies show
that laxative-induced diarrhea does not significantly reduce absorption
of calories. This is because the laxatives do not work on the small
intestine, where calories are absorbed, but rather on the colon, the
lower end of the bowel.

Juice drinks and tablets also may contain stimulant laxatives. FDA
usually regulates these products as foods under the Federal Food, Drug,
and Cosmetic Act. If the products are represented as dietary
supplements, they are regulated under the Dietary Supplement Health and
Education Act of 1994.

Stimulant Laxatives

The stimulant laxative teas and dietary supplements FDA is most
concerned about contain one or more of the substances senna, aloe,
rhubarb root, buckthorn, cascara, and castor oil. These plant-derived
products have been used since ancient times for their ability to promote
bowel movements and relieve constipation. Several, such as cascara,
senna and castor oil, also are available as over-the-counter drug
laxatives and are regulated as drugs.

Some of these substances also are used in much smaller quantities as
natural flavorings in other foods. As such, they are regulated by FDA as
food additives or "generally recognized as safe" substances. FDA has not
received any information suggesting that these substances pose a hazard
when used in the amounts normally needed to provide flavoring.

Except when used solely as flavorings, the names of these plant
substances appear in the ingredient list on the label of these products.
Dieter's teas and similar products often list the substances at or near
the top because they often are the main ingredients. FDA proposed in
December 1995 to require manufacturers to declare dietary ingredients,
including proprietary blends, in descending order of predominance by
weight on product labels. In the proposed rule, the substance would have
to be given by its common or usual name: for example, Tinnevelly senna
followed by its Latin name, Cassia angustifolia.

Most consumers who use dieter's teas and similar products know that the
products have laxative properties, according to health professionals
familiar with the products, even though the product labeling does not
specifically state the term "laxative." Instead, the labeling may
promote the product as a natural bowel cleanser. Sometimes it may not
reflect the laxative qualities at all.

The product labels may not directly state that the products are for
weight loss, although some allude to it. For instance, some products use
the terms "dieter's," "diet," "trim," or "slim" in their names. Others
may carry information on weight-loss practices, mentioning consumption
of the product along with the weight-loss practices. Some of the teas
are labeled as "low-calorie." Unless sweetened, they provide essentially
no nutrients and no calories.

According to Ara DerMarderosian, Ph.D., professor of pharmacognosy
(study of medicinal products in their crude, or unprepared, form) and
medicinal chemistry at the Philadelphia College of Pharmacy and Science,
users favor the products because they believe that the products may cost
less and taste better than over-the-counter laxatives and because they
are easy to buy. In addition, he said, people with eating disorders,
such as bulimia and anorexia nervosa, may like the products because they
act quickly and produce loose, watery stools. Unfortunately, this
practice is not only useless for losing weight but can be dangerous for
people on severely restricted diets.

Writing in the January 1996 American Druggist, DerMarderosian and his
colleague Sharon Brudnicki, a registered pharmacist also with the
Philadelphia College of Pharmacy and Science, noted that some users like
dieter's tea and other stimulant laxatives for their purported "body
cleansing" ability.

DerMarderosian was a member of the FDA Food Advisory Committee's 1995
special task group on stimulant laxative substances in food.

Adverse Effects

Reports filed with FDA indicate that users tend to experience adverse
effects when they misuse the products by, for example, steeping the tea
longer than product labeling recommends or drinking more than the
recommended amount. The reports indicate three types of adverse events:

  * Short-term: stomach cramps, nausea, vomiting, and diarrhea lasting
    several days. These symptoms are likely to occur in first-time users
    who drink more than the recommended amount.

  * Chronic: chronic diarrhea, pain and constipation due to laxative
    dependency, which causes a sluggish bowel. In one report to FDA, a
    person who reported using herbal products with stimulant laxatives
    for decades suffered severe pain and constipation from loss of colon
    function and required surgery to remove the colon. People who
    develop chronic problems usually have used these types of products
    for years.

  * Severe: fainting, dehydration and electrolyte disorders (for
    example, low blood potassium, a condition that can cause paralysis,
    irregular heartbeat, and possibly death). People who develop severe
    problems tend to be those who are nutritionally compromised, partly
    as a result of drastic reductions in food intake--for example,
    rigorous weight-loss dieters and people with the eating disorders
    anorexia nervosa and bulimia. Four deaths reported to FDA involved
    women with a history of such medical problems. According to
    information presented at a 1995 meeting of FDA's Food Advisory
    Committee, these herbal stimulant laxatives may have been a
    contributing factor in their deaths.

Label Warning

At the 1995 meeting, the advisory committee's task group agreed that
dietary supplements containing stimulant laxatives can have adverse
effects and that a label statement would be helpful in warning consumers
about the risks and reducing the incidence of these adverse effects. The
group proposed this label warning:

"NOTICE (or WARNING): Contains herbs (insert name of herbs) that can act
as stimulant laxatives. Prolonged steeping time can increase the risk of
adverse laxative effects, including: nausea, vomiting, abdominal cramps,
and diarrhea. Chronic use of laxatives can impair colon function. Use of
laxatives may be hazardous in the presence of abdominal pain, nausea,
vomiting, or rectal bleeding. Laxative-induced diarrhea does not
significantly reduce absorption of food calories. Acute or chronic
diarrhea may result in serious injury or death."

The full advisory committee concurred with the recommendations.

California has taken steps to require a similar warning label statement
on all food products containing stimulant laxatives sold in that state.
Some manufacturers have begun to carry the state's drafted warning
statement on their food products. FDA will monitor products sold
nationally to be sure that their labels carry information similar to
that required in California.

Consumer Action

The California warning advises all users of these types of dietary
supplements to:


  * Read and follow package directions carefully.

  * Stop using the product if diarrhea, loose stools, or stomach pain
    develop.

  * See a doctor if frequent diarrhea develops.

  * See a doctor before using the product if the user is pregnant,
    nursing, taking medication, or has a medical condition.

Consumers should report adverse effects associated with use of laxative
teas or supplements to FDA by calling or writing to their local FDA
office, listed in the blue pages of the telephone book under U.S.
Government, Department of Health and Human Services, Food and Drug
Administration. They also may write to FDA at 5600 Fishers Lane,
HFC-160, Rockville, MD 20857.

The report should include:


  * name, address and telephone number of the person who became ill

  * name and address of the doctor or hospital providing medical
    treatment

  * description of the problem

  * name of the product and store where it was bought.

Consumers also should report the problem to the manufacturer or
distributor listed on the product's label and to the store where the
product was bought.

FDA encourages health professionals to report serious adverse reactions,
too, if the reaction appears related to the patient's use of dieter's
teas or similar products. Health professionals can call FDA's MedWatch
adverse event and product problem hot line at (1-800) FDA-1088.

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

FDA Consumer magazine (July-August 1997)
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When Summertime Gets Too Hot to Handle

by Rebecca D. Williams

On the morning of July 7, 1996, a 74-year-old woman was found dead under
her kitchen table in Fort Worth, Texas. A victim of heatstroke, she was
using only a single fan to cool the house. She hadn't turned on her air
conditioner to save money on the electric bill, her sister later told
police.

The temperature inside the house was over 38 degrees Celsius (100
degrees Fahrenheit).

Last summer, seven people died of heatstroke in Texas. In the big heat
wave of 1980, 78 people died.

"Heat has always been a health problem for Texas," says David Vaughan of
the Texas Department of Health in Austin. "We get some real scorchers."

Texas and other southern states have the highest rates of heat illnesses
and deaths, but such deaths can occur nearly anywhere. Typically, about
240 people in the United States die from heat illnesses each year,
according to the national Centers for Disease Control and Prevention.
During heat waves, that number has risen to as high as 1,700.

Heatstroke is one of several maladies known as heat illness. The others
are heat syncope, heat cramps, and heat exhaustion. All of them occur
when the body's ability to regulate its own heat is impaired, either
because of exercise or exposure to hot temperatures. Certain health
conditions and medications also increase the likelihood of heatstroke.

But, says Elizabeth Koller, M.D., an outdoor enthusiast and
endocrinologist in FDA's Center for Drug Evaluation and Research,
"Heatstroke is entirely preventable." Yet when it strikes, it becomes
life-threatening.

"If someone is overheating, you have only minutes to do something about
it," she says. "You have to cool them down as quickly as you can. Once
their brain is overheated, that's it."

Body Heat Control

Our bodies are like car engines. They chug along, producing heat in the
process. The skin and blood are like the cooling system of the car.
Blood warms up as it passes through muscles and tissue. It carries extra
heat to the surface of the skin, where the surrounding air cools it.

Unlike an engine, however, our bodies have the benefit of sweat, a very
efficient cooling liquid. For example, a pearl-sized bead of sweat can
cool nearly one liter (about 1 quart) of blood 1.8 C (1 F), using 580
calories in the process.

But in hot, humid weather, sweat doesn't work as well. The surrounding
air is already warm and heavy with humidity, and it cannot absorb extra
heat and sweat. So the body begins to warm up, and the heart begins
pumping more blood to the skin to release the extra heat. Even if you
sit still, your heart will beat faster. Have you ever felt tired after a
day spent lounging on the beach? That fatigue comes from your heart
working overtime to cool your body. If you sweat a great deal of water
and lose enough minerals, you could develop one or more heat illnesses.

The mildest, most common heat syndrome is called heat cramps. It usually
occurs in people who have been exercising in hot, humid weather. As the
victim sweats, minerals are excreted from the body. This mineral
depletion causes muscles to contract in slow, painful spasms lasting one
to three minutes, usually after the person has stopped exercising. A
person with heat cramps needs fluids, extra salts, a cooler environment,
and rest.

A second syndrome is heat exhaustion (it has also been termed heat
syncope or heat collapse). This syndrome occurs when a person has lost
either too much water or too much salt through sweating. Depending on
the cause, the victim may or may not have an elevated temperature. In
either case, he or she will feel thirsty, nauseated, headachy, weak, and
confused. The victim may soon pass out, pulse racing. A heat exhaustion
victim needs to lie flat in a cool place, with water and electrolyte
fluids to drink as soon as he or she regains consciousness. Intravenous
fluids might be necessary.

Danger: Heatstroke

The most dangerous heat illness is heatstroke. Heatstroke is a
life-threatening medical emergency. The victim may develop headache,
slurred speech, dizziness, faintness, hallucinations, seizures, and may
even become comatose. Body temperature soars to 40 C (104 F) or more.
The person becomes so dehydrated that the skin no longer sweats and is
hot and dry to the touch.

There are two types of heatstroke: classic and exertional. Classic
heatstroke occurs in individuals who don't sweat normally, either
because of a disease or certain medications. Without normal sweating,
it's difficult for a person to handle hot, humid weather. The typical
victim of classic heatstroke is an older adult who lives without air
conditioning and has underlying health problems, such as heart disease
or diabetes.

Classic heatstroke can take two or three days to develop, but it is very
dangerous. Studies have shown that even a few hours of air conditioning
each day can prevent the condition.

Exertional heatstroke, on the other hand, happens quickly--often after
only a few hours of exercise. The skin is able to sweat, but the body
still overheats because of the combination of hot weather, extra
activity, and dehydration. Exertional heatstroke victims are usually
young, otherwise healthy people, such as runners and football players.

Exertional heatstroke has long been studied by the military. The U.S.
Marines at Parris Island, S.C., for example, have studied heat illness
among new recruits. They found that even though soldiers train in the
early morning and are required to drink lots of water, as many as 2
percent of them will suffer heat illnesses during the summer months, and
about 1 percent in the winter. The risk of exertional heat injuries
depends on the heat and humidity, the soldier's fitness level, and
whether or not the person is used to hot weather.

The treatment for both classic and exertional heatstroke is the same:
Cool the victim as quickly as possible with whatever means
available--for example, wet sheets, a fan, or ice under the armpits.
(While the military routinely uses ice to cool heatstroke victims, some
studies have shown this can also cause frostbite.) Give the victim
liquids, if possible, and get medical attention immediately. Early
treatment increases a heatstroke victim's chance of survival.

Who's at Risk

Certain health conditions increase a person's risk of heat illness.
Obesity, sweat gland diseases, diabetes, dehydration (a shortage of body
fluids), malnutrition, low blood pressure, and heart disease all make it
difficult for the body to regulate heat. In many instances, patients
have more than one of these conditions. Older adults, especially, are
more likely to have multiple health problems.

Older adults also are more likely to take medicines that impair the
body's ability to regulate heat. Some drugs slow sweat production. These
include anticholinergics (used to treat Parkinson's disease),
antihistamines (for allergies), phenothiazines (tranquilizers),
tricyclic antidepressants, and diuretics (for high blood pressure). Some
restrict blood flow to the skin, impairing the body's ability to release
heat. These include cardiovascular drugs, such as vasoconstrictors and
beta blockers.

If you or someone you know lives without air conditioning and takes any
of these medicines, ask a doctor or pharmacist about the medicine's
possible ill effects in hot weather.

Also at risk are people who use illicit drugs, such as LSD, cocaine and
amphetamines. These drugs increase muscle activity and body heat.
Excessive alcohol use greatly increases a person's risk for heat
illness, too. Alcohol causes the body to excrete water, leading to
dehydration.

People who are unable to move about easily--for example, disabled,
homeless, and very poor people--are at a higher risk for heat illness
because they often cannot afford air conditioning or get to a place that
has it. Also, children under 2 can be prone to heat illness because
their small bodies cannot regulate body heat as efficiently as older
children or adults can. They also may not be able to escape hot places;
every summer there are tragic reports of young children who die of
heatstroke because they are left in locked automobiles even for short
periods.

A victim of heat exhaustion or heatstroke needs immediate medical
attention. The important thing is speed: The faster the victim is cooled
and rehydrated, the better his or her chance for survival.

Says FDA's Koller, "If people have heatstroke, they really need to get
care quickly. This is truly a medical emergency."

Rebecca D. Williams is a writer in Oak Ridge, Tenn.


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Preventing Heatstroke

"... At harvest time, the boy went out one morning to join his father,
who was in the field with the harvest workers. Suddenly he cried out to
his father, 'My head hurts! My head hurts!' ... The servant carried the
boy back to his mother, who held him in her lap until ... he died."
--2 Kings 4:18-20

In what may be one of the oldest accounts of heatstroke, the Bible tells
of this ailment's deadly end. Luckily for the boy, the prophet Elisha
was near, and the scripture recounts a miraculous rising from the dead.

It's still possible to survive heatstroke, but it's far easier to
prevent it. Here's how:

  * Take it easy, especially if you are over 65, on any heart or blood
    medication, or are overweight. Don't make any changes with your
    medications without your doctor's OK. Don't exert yourself in the
    summer heat. Exercise in an air-conditioned building if possible.

  * If you exercise outdoors in the summer, do so in the early morning
    or late evening hours when it's cooler.

  * Get used to hot weather slowly. When exercising or doing some other
    activity outdoors in hot weather, start slowly and gradually
    increase the time each day. Studies have shown that getting used to
    the hot weather gradually increases the body's ability to sweat
    freely without losing salts. It takes about two to four weeks of
    exercising in the heat before you'll become acclimatized.

  * Drink lots of water in the summer. If you're exercising, that means
    about 1 liter (about 1 quart) every hour. If you're just puttering
    in the garden, take a large jug of water with you, and sip it
    continuously. Don't rely on thirst to tell you when to drink; people
    often don't feel thirsty until they're a little dehydrated. Sports
    drinks and special rehydration fluids are OK, but studies have shown
    that water alone, combined with a normal amount of dietary salt
    prevents dehydration in most people. Do not take salt tablets,
    unless advised to by a doctor, because the excess amount of sodium
    in them can increase the risk of kidney damage.

  * Wear a hat with a broad brim to protect you from the sun and loose
    clothing to allow sweat to evaporate.

  * Wear sunscreen. A sunburn will inhibit your skin's ability to sweat.

  * Stay in an air-conditioned environment on hot days. If that's not
    possible, take cool baths, spray yourself with water frequently, and
    sit in front of a fan. If you feel faint, call for emergency medical
    attention.

--R.D.W.


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Heatstroke Risk

In hot weather, these factors can put you at risk for heatstroke:

  * exercise, especially if you're not physically fit

  * heavy clothing

  * living on upper floors of a building without air-conditioning

  * not drinking enough fluids, leading to dehydration (shortage of body
    fluids)

  * drinking too much alcohol

  * obesity

  * tiredness

  * older age (65 and over)

  * high outdoor humidity

  * lack of wind

  * medical conditions--including alcoholism, neurologic lesions,
    cardiovascular disease, skin or sweat gland diseases that inhibit
    the skin's ability to sweat, diabetes, chronic obstructive pulmonary
    disease, hyperthyroidism, hypokalemia (potassium deficiency),
    infections that cause fever, and taking certain medications for
    psychiatric illnesses.

--R.D.W.

FDA Consumer magazine (July-August 1997)


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A Dose of Clear Directions for Rx Drug Users

by Tamar Nordenberg

More than four centuries ago, doctors were considered omnipotent, and
the ethical statutes of England's Royal College of Physicians
instructed: "Let no physician teach the people about medicines, or even
tell them the names of the medicines, particularly the more potent ones
... for the people may be harmed by their improper use."

While doctors today are more forthcoming, many patients still have a
hard time getting important information about the drugs their doctors
prescribe. In a time when Corn Flakes, over-the-counter Tylenol, and
even Alpo dog food come with easy-to-understand information about proper
use, many prescription drugs still come with only a "Use as Directed"
sticker for patients. The rest of the labeling is for the medical
professional, in language that may be difficult for lay people to
understand.

This lack of information for patients may be one reason for the recent
finding, published in 1992 in the Journal of Clinical Pharmacy and
Therapeutics, that about half of prescription drugs don't work as
intended because they are improperly used.

Noncompliance can have tragic consequences. Missed doses of heart
medications, for example, may lead to cardiac arrest. And missed doses
of anti-glaucoma medicines can lead to eye nerve damage and blindness.

To help avoid medication problems, a new "Action Plan for the Provision
of Useful Medicine Information" was unveiled in January 1997 to provide
more and better information to patients.

Simple, Relevant Information

Under the action plan, health professionals will voluntarily provide
prescription drug information to patients in the form of leaflets
written in simple language.

Useful prescription drug information must reach at least 75 percent of
patients by the year 2000, in keeping with the Department of Health and
Human Services goal under its Healthy People 2000 program. By 2006, the
information must reach at least 95 percent of patients. If these goals
aren't met, FDA may require the information by regulation.

The plan was developed with the input of health professionals and
consumer, government and industry representatives.

"Working together and using today's computer technology," said Secretary
of Health and Human Services Donna Shalala when she approved the plan,
"we can make prescription information more widely available, more
understandable, and more relevant for each individual patient."

The action plan calls for the written information to include the
condition(s) for which the drug is used, directions for taking the drug
correctly, and possible side effects. Doctors or pharmacists can add
information about an "off-label" use--a use that is not approved by
FDA--if it is written based on an individual patient's needs.

Health professionals are responsible for getting the information to
patients. FDA is available for technical assistance and will work to
educate the public about the plan, according to Thomas McGinnis, a
pharmacist and FDA's associate director of pharmacy affairs.

FDA will survey consumers nationwide in the year 2000 and again in 2006
to determine if the goals have been met. The agency will evaluate
samples of the patient labeling to make sure it provides the required
information in simple language. (See "Is the Labeling Useful?")

FDA has tried before to provide prescription medicine information to
consumers. A rule the agency proposed in 1979 would have required
manufacturers to include leaflets known as patient package inserts, or
PPIs, with 10 prescription drugs or drug classes. The rule was withdrawn
in 1982 to allow private organizations time to provide the information
voluntarily.

In the next decade, FDA research showed minimal progress in getting
good-quality medication information to patients. So, in 1995, FDA
proposed a rule, commonly called MedGuide, that set forth goals for the
distribution of useful prescription drug information to consumers and
would have required manufacturers to include drug information for the
patient when a product posed a serious health risk.

In August 1996, Congress passed legislation that put the MedGuide
proposal on hold to provide another opportunity for private achievement
of the MedGuide goals. The action plan is the private sector's framework
for achieving those goals.

Labeling Lacking

Currently, manufacturers provide patient information for about 40
prescription drugs or drug classes. FDA requires patient information for
some drugs, including oral contraceptives and isoproterenol inhalation
products used by asthmatics. Manufacturers voluntarily provide
FDA-reviewed patient labeling with some other products, such as Accutane
(isotretinoin) for acne and Halcion (triazolam) for insomnia.

A 1997 FDA survey found that 67 percent of consumers were getting some
written information with their prescription drugs, up from 54 percent in
1994.

But the surveys don't take into consideration the quality of the
information. "The materials being given to consumers are very variable,"
McGinnis says. "Some are very poor, some are very good, and some are
in-between. Most of the information out there now is going to have to be
beefed up to meet the action plan criteria."

By increasing patients' knowledge about their drug therapies, the action
plan aims to help patients take their drugs correctly. Improper use of
prescription drugs leads to unnecessary illnesses, emergency room
visits, hospital admissions, and deaths. FDA estimates extra health-care
costs from preventable drug-related illnesses to be at least $20 billion
a year. (See "Medication Mishaps.")

In addition to instructions for proper use, the information sheets will
address a drug's risks and side effects, according to McGinnis. By
telling patients what to look for and what to do if they see warning
signs, the information may help patients recognize side effects earlier,
before serious damage is done.

"These drugs are risky--they wouldn't be prescription drugs if they
weren't--and patients have a right to know what the risks are," McGinnis
says.

Some groups representing the pharmaceutical industry and health
professionals have expressed concern to FDA that informing patients of
risks and side effects may hurt compliance by scaring consumers out of
taking the drug as prescribed. To this, McGinnis replies, "We've heard
that argument, but we've never seen it supported scientifically."

Empowering the Patient

Written information sheets cannot replace the advice of a health
professional. But there are some barriers to communication between
patients and health professionals, according to David Schulke, director
of policy and regulatory affairs at the American Pharmaceutical
Association. "There are financial pressures that cause doctors and
pharmacists to talk to more patients in less time, giving less time to
each patient."

Because of the competing demands on health professionals' time, written
information is especially important. "The piece of paper becomes a
back-up, a safety net that patients can keep with them and refer to for
information," says consumer advocate Arthur Levin, director of the
Center for Medical Consumers.

Patients sometimes need to take on a very active role in their own
health care, according to McGinnis. "FDA is hoping the additional
information will help the patient feel less inhibited about asking
questions," he says. "We hope it will encourage patients to become more
involved, along with their physician, pharmacist or nurse."

Tamar Nordenberg is a staff writer for FDA Consumer.


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Medication Mishaps

Accupril and Accutane. The drug names sound pretty similar, but they are
prescribed for very different conditions. Accupril (quinapril
hydrochloride) is used to treat high blood pressure and heart failure.
Accutane (isotretinoin) is for certain types of severe acne.

You wouldn't want to take Accutane for a heart condition by mistake. But
a patient could be given the wrong drug by accident. Confusion can arise
from similar drug names or packaging, a prescriber's poor handwriting,
misinterpretation of an abbreviated drug name, or an incorrect data
entry into the computer.

To prevent avoidable accidents, FDA's Center for Drug Evaluation and
Research compares drug names to see if a change is needed to avoid
confusion.

"FDA's goal is to try to catch the potential for error before the
product is marketed," says Sharon Smith Holston, FDA's deputy
commissioner for external affairs. "Later, if we get reports of errors,
we will work with the manufacturer to correct the problem by making a
change in the packaging, labeling or name."

Patients themselves can prevent certain types of drug errors. The
National Council on Patient Information and Education recommends asking
your health professional at least these six questions about a
prescription medication:

  * What is the name of the medicine and what is it supposed to do?

  * How and when do I take it, and for how long?

  * What foods, drinks, other medicines, or activities should I avoid
    while taking this medicine?

  * Are there any side effects, and what should I do if they occur?

  * Will this new prescription work safely with the other prescription
    and nonprescription medicines I am taking?

  * Is there any written information available about the medicine?

Patients who get drug information in writing as well as orally, says FDA
pharmacist Thomas McGinnis, are much more likely to notice if the drug
they got isn't for the condition they went to the doctor about or if it
may be dangerous if taken with certain foods or another medication.

If a medication error occurs or is suspected, a health professional may
report it, in confidence, to FDA's MedWatch program at (1-800) FDA-0178
or the U.S. Pharmacopeia's Medication Errors Reporting Program at
(1-800) 23-ERROR.

--T.N.


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


Is the Labeling Useful?

To be acceptable under the action plan, the information given to
patients must be scientifically accurate, unbiased, specific, complete,
understandable, up-to-date, and useful.

"The criteria aren't set in stone," says FDA pharmacist Thomas McGinnis.
For example, the format may have to be adjusted for some populations.
For the elderly, whose eyesight may be declining, the type may have to
be larger.

How will FDA determine if labeling is "useful"? The agency will look for
specific information, including:

  * medicine name

  * critical warnings (prominently displayed)

  * conditions for which the product is used

  * circumstances under which the product shouldn't be used and
    directions about what to do if one of these circumstances applies
    (for example, "Talk to your health care professional before taking
    this medication if any of these apply to you.")

  * drugs, foods and activities that should be avoided while taking the
    medication, and other precautions necessary to take the medicine
    properly

  * symptoms of adverse reactions possibly related to the drug

  * risk, if any, of developing a drug tolerance or dependence

  * instructions for proper use, including the usual doses, instructions
    if a scheduled dose is missed, special instructions (for example,
    whether to take with food or water), and what to do in case of an
    overdose

  * storage instructions

  * general information, including a statement encouraging discussion
    with a health-care professional and a statement that the drug should
    not be given to others.

  * a statement that the patient labeling does not contain all possible
    information about the medicine and that the health-care professional
    has more information.


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


To Get a Copy of the Action Plan

Keystone Center
http://www.nyam.org/keystone/
[phone]


To Get More Information About the Action Plan

Kimberly Edgerly
FDA Office of Consumer Affairs (HFE-88)
5600 Fishers Lane
Rockville, MD 20857
(1-800) 532-4440
(10 a.m. to 4 p.m. Eastern time, Monday through Friday)

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

Bulking Up Fiber's Healthful Reputation

More Benefits of 'Roughage' Are Discovered

by Ruth Papazian

Because it causes gas, bloating, and other uncomfortable side effects,
fiber may be the Rodney Dangerfield of food constituents. But with more
and more research showing that a high-fiber diet may help prevent
cancer, heart disease, and other serious ailments, roughage has started
to get some respect.

The problem is that most Americans don't get enough fiber to realize its
potential benefits. The typical American eats only about 11 grams of
fiber a day, according to the American Dietetic Association. Health
experts recommend a minimum of 20 to 30 grams of fiber a day for most
people.

The Food and Drug Administration has recognized fiber's importance by
requiring it to be listed on the Nutrition Facts panel of food labels
along with other key nutrients and calories. And, based on scientific
evidence, the agency has approved four claims related to fiber intake
and lowered risk of heart disease and cancer.

The most recent claim, approved in January 1997, allows food companies
to state on product labels that foods with soluble fiber from whole oats
may reduce heart disease risk when eaten as part of a diet low in
saturated fat and cholesterol. Foods covered include rolled oats, oat
bran, and whole-oat flour.

FDA concluded that the beta-glucan soluble fiber of whole oats is the
primary component responsible for lowering total and LDL (low-density
lipoprotein), or "bad," blood cholesterol in diets including these foods
at appropriate levels. This conclusion is based on a scientific review
showing a link between the soluble fiber in whole-oat foods and a
reduction in coronary heart disease risk.

The other three claims, allowed since 1993, are:

  * Diets low in fat and rich in fiber-containing grain products,
    fruits, and vegetables may reduce the risk of some types of cancer.

  * Diets low in saturated fat and cholesterol and rich in fruits,
    vegetables, and grain products that contain fiber, particularly
    soluble fiber, may reduce the risk of coronary heart disease.

  * Diets low in fat and rich in fruits and vegetables, which are
    low-fat foods and may contain fiber or vitamin A (as beta-carotene)
    and vitamin C, may reduce the risk of some cancers.

Found only in plant foods, such as whole grains, fruits, vegetables,
beans, nuts, and seeds, fiber is composed of complex carbohydrates. Some
fibers are soluble in water and others are insoluble. Most plant foods
contain some of each kind.

Some foods containing high levels of soluble fiber are dried beans,
oats, barley, and some fruits, notably apples and citrus, and
vegetables, such as potatoes. Foods high in insoluble fiber are wheat
bran, whole grains, cereals, seeds, and the skins of many fruits and
vegetables.

<Picture omitted: [Foods considered by some Americans to be high in fiber]>

Fiber's Health Benefits

What can fiber do for you? Numerous epidemiologic (population-based)
studies have found that diets low in saturated fat and cholesterol and
high in fiber are associated with a reduced risk of certain cancers,
diabetes, digestive disorders, and heart disease. However, since
high-fiber foods may also contain antioxidant vitamins, phytochemicals,
and other substances that may offer protection against these diseases,
researchers can't say for certain that fiber alone is responsible for
the reduced health risks they observe, notes Joyce Saltsman, a
nutritionist with FDA's Office of Food Labeling. "Moreover, no one knows
whether one specific type of fiber is more beneficial than another since
fiber-rich foods tend to contain various types," she adds.

Recent findings on the health effects of fiber show it may play a role
in:

  * Cancer: Epidemiologic studies have consistently noted an
    association between low total fat and high fiber intakes and reduced
    incidence of colon cancer. A 1992 study by researchers at Harvard
    Medical School found that men who consumed 12 grams of fiber a day
    were twice as likely to develop precancerous colon changes as men
    whose daily fiber intake was about 30 grams. The exact mechanism for
    reducing the risk is not known, but scientists theorize that
    insoluble fiber adds bulk to stool, which in turn dilutes
    carcinogens and speeds their transit through the lower intestines
    and out of the body.

    The evidence that a high-fiber diet can protect against breast
    cancer is equivocal. Researchers analyzing data from the Nurses'
    Health Study, which tracked 89,494 women for eight years, concluded
    in 1992 that fiber intake has no influence on breast cancer risk in
    middle-aged women. Previously, a review and analysis of 12 studies
    found a link between high fiber intake and reduced risk.

    In the early stages, some breast tumors are stimulated by excess
    amounts of estrogen circulating in the bloodstream. Some scientists
    believe that fiber may hamper the growth of such tumors by binding
    with estrogen in the intestine. This prevents the excess estrogen
    from being reabsorbed into the bloodstream.


  * Digestive disorders: Because insoluble fiber aids digestion and adds
    bulk to stool, it hastens passage of fecal material through the gut,
    thus helping to prevent or alleviate constipation. Fiber also may
    help reduce the risk of diverticulosis, a condition in which small
    pouches form in the colon wall (usually from the pressure of
    straining during bowel movements). People who already have
    diverticulosis often find that increased fiber consumption can
    alleviate symptoms, which include constipation and/or diarrhea,
    abdominal pain, flatulence, and mucus or blood in the stool.


  * Diabetes: As with cholesterol, soluble fiber traps carbohydrates to
    slow their digestion and absorption. In theory, this may help
    prevent wide swings in blood sugar level throughout the day.
    Additionally, a new study from the Harvard School of Public Health,
    published in the Feb. 12 issue of the Journal of the American
    Medical Association, suggests that a high-sugar, low-fiber diet more
    than doubles women's risk of Type II (non-insulin-dependent)
    diabetes. In the study, cereal fiber was associated with a 28
    percent decreased risk, with fiber from fruits and vegetables having
    no effect. In comparison, cola beverages, white bread, white rice,
    and french fries increased the risk.


  * Heart Disease: Clinical studies show that a heart-healthy diet (low
    in saturated fat and cholesterol, and high in fruits, vegetables and
    grain products that contain soluble fiber) can lower blood
    cholesterol. In these studies, cholesterol levels dropped between
    0.5 percent and 2 percent for every gram of soluble fiber eaten per
    day.

    As it passes through the gastrointestinal tract, soluble fiber binds
    to dietary cholesterol, helping the body to eliminate it. This
    reduces blood cholesterol levels, which, in turn, reduces
    cholesterol deposits on arterial walls that eventually choke off the
    vessel. There also is some evidence that soluble fiber can slow the
    liver's manufacture of cholesterol, as well as alter low-density
    lipoprotein (LDL) particles to make them larger and less dense.
    Researchers believe that small, dense LDL particles pose a bigger
    health threat.

    Recent findings from two long-term large-scale studies of men
    suggest that high fiber intake can significantly lower the risk of
    heart attack. Men who ate the most fiber-rich foods (35 grams a day,
    on average) suffered one-third fewer heart attacks than those who
    had the lowest fiber intake (15 grams a day), according to a Finnish
    study of 21,903 male smokers aged 50 to 69, published in the
    December 1996 issue of Circulation. Earlier in the year, findings
    from an ongoing U.S. study of 43,757 male health professionals (some
    of whom were sedentary, overweight or smokers) suggest that those
    who ate more than 25 grams of fiber per day had a 36 percent lower
    risk of developing heart disease than those who consumed less than
    15 grams daily. In the Finnish study, each 10 grams of fiber added
    to the diet decreased the risk of dying from heart disease by 17
    percent; in the U.S. study, risk was decreased by 29 percent.

    These results indicate that high-fiber diets may help blunt the
    effects of smoking and other risk factors for heart disease.

  * Obesity: Because insoluble fiber is indigestible and passes through
    the body virtually intact, it provides few calories. And since the
    digestive tract can handle only so much bulk at a time, fiber-rich
    foods are more filling than other foods--so people tend to eat less.
    Insoluble fiber also may hamper the absorption of calorie-dense
    dietary fat. So, reaching for an apple instead of a bag of chips is
    a smart choice for someone trying to lose weight.

    But be leery of using fiber supplements for weight loss. In August
    1991, FDA banned methylcellulose, along with 110 other ingredients,
    in over-the-counter diet aids because there was no evidence these
    ingredients were safe and effective. The agency also recalled one
    product that contained guar gum after receiving reports of gastric
    or esophageal obstructions. The manufacturer had claimed the product
    promoted a feeling of fullness when it expanded in the stomach.

An Apple a Day and More

Recent research suggests that as much as 35 grams of fiber a day is
needed to help reduce the risk of chronic disease, including heart
disease. A fiber supplement can help make up the shortfall, but should
not be a substitute for fiber-rich foods. "Foods that are high in fiber
also contain nutrients that may help reduce the risk of chronic
disease," Saltsman notes. In addition, eating a variety of such foods
provides several types of fiber, whereas some fiber supplements contain
only a single type of fiber, such as methylcellulose or psyllium.

To fit more fiber into your day:

  * Read food labels. The labels of almost all foods will tell you the
    amount of dietary fiber in each serving, as well as the Percent
    Daily Value (DV) based on a 2,000-calorie diet. For instance, if a
    half cup serving of a food provides 10 grams of dietary fiber, one
    serving provides 40 percent of the recommended DV. The food label
    can state that a product is "a good source" of fiber if it
    contributes 10 percent of the DV--2.5 grams of fiber per serving.
    The package can claim "high in," "rich in" or "excellent source of"
    fiber if the product provides 20 percent of the DV--5 grams per
    serving.

  * Use the U.S. Department of Agriculture's food pyramid as a guide. If
    you eat 2 to 4 servings of fruit, 3 to 5 servings of vegetables, and
    6 to 11 servings of cereal and grain foods, as recommended by the
    pyramid, you should have no trouble getting 25 to 30 grams of fiber
    a day.

  * Start the day with a whole-grain cereal that contains at least 5
    grams of fiber per serving. Top with wheat germ, raisins, bananas,
    or berries, all of which are good sources of fiber.

  * When appropriate, eat vegetables raw. Cooking vegetables may reduce
    fiber content by breaking down some fiber into its carbohydrate
    components. When you do cook vegetables, microwave or steam only
    until they are al dente--tender, but still firm to the bite.

  * Avoid peeling fruits and vegetables; eating the skin and membranes
    ensures that you get every bit of fiber. But rinse with warm water
    to remove surface dirt and bacteria before eating. Also, keep in
    mind that whole fruits and vegetables contain more fiber than juice,
    which lacks the skin and membranes.

  * Eat liberal amounts of foods that contain unprocessed grains in your
    diet: whole-wheat products such as bulgur, couscous or kasha and
    whole-grain breads, cereals and pasta.

  * Add beans to soups, stews and salads; a couple of times a
    week, substitute legume-based dishes (such as lentil soup, bean
    burritos, or rice and beans) for those made with meat. * Keep fresh
    and dried fruit on hand for snacks.

"So many foods contain fiber that it's really not that hard to get your
intake up where it should be," Saltsman says.

Ruth Papazian is a writer in Bronx, N.Y., specializing in health and
safety issues.


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


Slow Going

A word of caution: When increasing the fiber content of your diet, it's
best to take it slow. Add just a few grams at a time to allow the
intestinal tract to adjust; otherwise, abdominal cramps, gas, bloating,
and diarrhea or constipation may result. Other ways to help minimize
these effects:

  * Drink at least 2 liters (8 cups) of fluid daily.

  * Don't cook dried beans in the same water you soaked them in.

  * Use enzyme products, such as Beano or Say Yes To Beans, that help
    digest fiber.

--R.P.

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

Incontinence Can Be Controlled

by Carolyn J. Strange

No one wants to talk about it. Patients don't bring it up. Physicians
don't ask. Meanwhile, millions suffer in silence as urinary incontinence
erodes their quality of life. When it is discussed, all too often,
patients are told--incorrectly--that it's a normal consequence of aging
and that they should just get used to it. Misconceptions about
incontinence abound among health-care professionals and the public
alike.

At least 13 million Americans experience urinary incontinence, the
involuntary leakage of urine sufficient to be a problem, and 11 million
of them are women, according to the National Institute of Diabetes and
Digestive and Kidney Diseases (NIDDK). Incontinence is also more common
in older people. It's not surprising that about half of nursing home
residents are incontinent since it's a major cause of
institutionalization, according to numerous sources. But that doesn't
mean it's a normal part of being a woman or of aging.

"Incontinence is never normal at any age," says Neil Resnick, M.D.,
chief of gerontology at Brigham and Women's Hospital, Boston, and an
associate professor of medicine at Harvard Medical School. "It's
treatable in the vast majority of people, most of whom have full
continence restored. Most of the remaining people can at a minimum be
improved," he says.

Despite its prevalence, urinary incontinence is widely underdiagnosed
and underreported, and many health-care providers remain uneducated
about it, according to a 1996 clinical practice guideline update from
the Agency for Health Care Policy Research. It's also expensive.
Americans spent about $27.8 billion on incontinence in 1995, according
to NIDDK. The health-care impact is likely to increase as the baby
boomers age.

Fortunately, the outlook is improving. This new generation of patients
is less willing to let shame and embarrassment silence them, some
doctors say. And there are more treatment options than ever before,
including two new devices FDA approved just last summer. Treatment can
improve the quality of life for millions of people.

"Patients are so overwhelmingly grateful--it's a thrill," says James M.
Cummings, M.D., assistant professor of surgery in the division of
urology at Saint Louis University School of Medicine. "Even if you only
improve them some, even if you don't make them dry, they're still very
grateful because they see a big difference in their lives."

Quality of Life

That's important because a variety of medical, emotional and social
problems often accompany incontinence. Rashes, skin infections, pressure
sores, and urinary tract infections are among the complications that can
result from incontinence. More devastating are sleep disturbances,
restricted social interactions, reduced sexual activity, loss of
self-esteem, and depression. Employment may become difficult or
impossible. Some people quit going out altogether, and many of the joys
of life fade away.

"This is a problem of major magnitude, even though it's not something
people die from like cancer or heart disease," Cummings says.

Traditionally, people with incontinence have turned to various absorbent
products, as well as deodorants, disinfectants, and skin-care products.
The average person with incontinence spends $3,941 annually on the
problem, according to NIDDK. Experts emphasize that absorbent products
are not the only recourse for incontinence. Although absorbent products
can be used as adjuncts to treatment or when treatments fail, people
should understand the various treatment and management options available
to them. Then, in consultation with their physicians, patients can
decide which options best suit their lifestyle.

Also, dependence on absorbent products may decrease a person's
motivation to seek medical help. That delay could be dangerous because
certain serious conditions can cause incontinence--for example, tumors
of the brain, spinal cord, bladder, or prostate. These tumors aren't
common, but they're treatable only if found early. In any case,
incontinence is a symptom that something has gone wrong.

Water Works

<Picture omitted: [urinary system in men and women]>

Normally, the kidneys continually filter blood, removing waste and
producing urine, which travels down tubes called ureters into the
bladder, a muscular sac behind the pelvic bone. The bladder expands to
store urine and contracts to expel it. The tube that empties the bladder
is the urethra. A valve-like sphincter muscle encircles the top of the
urethra at the bladder neck, preventing leakage. Spinal nerves
coordinate the actions of the bladder and the sphincter.

Infants empty their bladders by reflex. When the bladder fills and
stretches beyond a certain point, it signals the spinal cord, which
triggers the sphincter to relax and the bladder to contract. Young
children gradually develop control over this process. Bladder stretching
registers consciously as discomfort, and the brain learns to suppress
the reflex. The more the bladder stretches, the more urgent the desire
to urinate.

Incontinence can occur for many reasons. Urinary tract infections,
vaginal infection or irritation, constipation, and certain medications
may cause temporary incontinence. A variety of other problems can cause
persistent incontinence: weakness of the bladder, the sphincter, or the
muscles that support the bladder; overactive bladder muscles; a blocked
urethra (from prostate enlargement or surgery); neurologic disorders;
and immobility. Anything that damages the nerves or muscles at the
bottom of the pelvis, or the pelvic floor, increases the risk.
Anatomical differences between the sexes affect the underlying causes
and the tendency for certain types of incontinence to develop.

There are several types of incontinence:

  * Stress incontinence, the most prevalent type, is common in women who
    have gone through childbirth because the muscles have been
    stretched. As the name suggests, urine may escape during a cough,
    laugh, sneeze, or any activity that temporarily increases pressure
    within the abdomen and thus on the bladder--even if the bladder
    isn't full.

  * Urge incontinence is the involuntary loss of urine associated with a
    strong desire to urinate. The person can't control urination long
    enough to get to the toilet in time.

  * Mixed incontinence, the coexistence of stress and urge incontinence,
    is more common in older women. Often one is more bothersome than the
    other.

  * Overflow incontinence is the result of chronic urine retention in
    people who can't empty their bladders. The bladder is always full,
    leading to frequent or constant dribbling. It's more common in men,
    often because of an obstruction such as an enlarged prostate.
    Removing the obstruction restores continence. This type of
    incontinence can also occur as a result of nerve damage.

  * Unconscious or reflex incontinence is the loss of urine without
    warning or sensory awareness. It's usually the result of
    neurological disease or injury.

  * Functional incontinence occurs in people with normal urinary control
    who can't get to the toilet in time because their movement is slowed
    by arthritis or other physical or mental disorders.

Diagnosis and Treatment

The first step toward successful treatment is to determine the type of
incontinence and the cause. A doctor's evaluation usually includes a
physical examination, medical history, and urine tests. The patient may
be asked to keep a bladder record and may be referred to a urologist or
urogynecologist for more specialized follow-up testing.

Treatment options fall into four broad categories--behavioral, devices,
medications, and surgery. Generally, those options that are least
invasive, dangerous or expensive are tried first.

Behavioral options require patients to learn new behaviors to help them
regain control over urination. Behavioral methods work best with
motivated patients willing to invest time and effort. Success rates are
high for those who persist--most improve and many become dry. Behavioral
treatments are generally free of side effects, noninvasive, and don't
limit further treatment options.

For people with urge incontinence, bladder or habit training can help
reassert control over the bladder. The patient is instructed to urinate
at intervals, say, every hour or so. After achieving dryness for a few
days, the interval increases. This cycle continues until the patient
attains an acceptable interval of several hours. Other steps may include
eliminating dietary caffeine and reducing fluids in the evening to
improve sleep. Limiting overall fluid intake is not recommended,
however, to avoid dehydration.

The goal with stress incontinence is to increase resistance in the
sphincter and urethra. Most women see significant improvement, and many
achieve dryness, with pelvic muscle exercises (PMEs), also known as
Kegel exercises. PMEs are performed by tightening the pelvic floor
muscles as if to control urination or defecation. Patients are generally
told to sustain a contraction for at least 10 seconds, followed by an
equal period of relaxation. The exercises should be performed about 30
to 80 times a day for at least eight weeks. Older adults may require
longer training. Sometimes PMEs are combined with biofeedback to help
establish better awareness of muscle function.

"Patients should not give up on the exercises too quickly," stresses Rao
Nimmagadda, Ph.D., in FDA's urology devices branch.

It may take awhile to determine whether PMEs help. And, as with any
exercise program, the beneficial effects last only as long as the
exercise continues. For some people, electrostimulation via a small
rectal or vaginal probe may help in building or maintaining muscle tone.
These devices passively exercise the pelvic floor muscles with painless
electrical pulses.

New Devices

Two new treatment methods became available last summer, when FDA
reviewed for marketing two new prescription devices for stress
incontinence in women. UroMed Corp., of Needham, Mass., makes both the
Reliance Urinary Control Insert, sometimes called a urethral plug, and
the Miniguard Patch. The Reliance Insert is a single-use, balloon-tipped
cylinder about one-fifth the size of a tampon that's placed in the
urethra with an applicator. A gentle push fills the small balloon inside
the bladder with air. The balloon holds the device in place and prevents
leakage. When the woman wishes to urinate, she pulls a string to deflate
the balloon, then removes the insert. After urinating she may insert a
new device.

Since the device is inserted into the urethra, it is associated with a
fairly high infection rate. According to the manufacturer, urinary tract
infections were more common during the first month of the trial and
diminished as women learned how to use the device.

"It's not for everybody. It has to be individualized," says Grannum
Sant, M.D., chair of urology, Tufts University School of Medicine, in
Boston, who helped test the device. For women in the clinical trial,
inserting the device became easy, Sant says, and their quality of life
improved considerably as they resumed aerobics, biking, dancing, and
other physical and social activities. Many women, Sant says, will
probably use the device only during activities they know cause leakage.
"In real life it's not going to be used constantly around the clock like
we did in the study. Therefore the complication rate and discomfort
rate--which was acceptable--is going to be even less," Sant says.

The other new device, the Miniguard Patch, is expected to be on the
market later this year. It is a completely external, single-use foam pad
a little bigger than a postage stamp. The patch is coated with a
gel-like adhesive on one side and fits between the labial folds over the
opening of the urethra, where it provides opposing pressure and a
barrier to leakage. The patch is removed for urination and a new one
applied afterwards.

For women used to wearing cumbersome pads, "The patch is a neater way of
doing it. They don't feel so bulky," says Patricia Burns, Ph.D., a
registered nurse and dean of the School of Nursing at the University of
South Florida, in Tampa. Burns, who also maintains an incontinence
practice, helped test the device.

Other Treatments

Medications are another treatment option. "I found in my practice that a
lot of people can be treated with medication," says Dan Shames, M.D., a
urologist in FDA's reproductive and urologic drug products division who
had a clinical practice for nearly 20 years.

In general, the drugs available are approved only for urge incontinence.
These include anticholinergics, such as propantheline, and
antispasmodics such as oxybutynin. They work by relaxing the bladder
muscles to stop abnormal contractions.

Unfortunately, some drugs have numerous side effects, such as severe dry
mouth, blurred vision, and constipation. "A lot of people stop using
them because they can't handle the side effects at the level that gives
them relief," Shames says. But, he adds, drug companies are trying to
develop drugs that work as well or better with fewer adverse effects.
"There are more approval requests for new drugs for incontinence," he
says.

Some women don't experience incontinence until after menopause, and for
them estrogen replacement may help. The hormone estrogen plays a role in
keeping the lining of the urethra plump and toned.

In some cases, surgery to correct anatomical problems or implant devices
remains the best treatment. Most people do not need surgery, but of
those who do most become continent again. For example, surgery can
remove blockages. Or sometimes collagen is injected around the urethra.
Collagen, a naturally occurring structural protein, is used to add bulk
to the surrounding tissue, thus narrowing the urethra and increasing
resistance to urine flow. This method seems to work better in women.

For women with stress incontinence, other surgery options include
improving the bladder neck position, and supporting or replacing
severely weakened pelvic muscles. People with extremely small bladders
may be candidates for an enlargement operation. Implanting an artificial
urinary sphincter may be appropriate in some people. For people who are
incontinent because of faulty nerves to the bladder, an implanted
stimulation device is under investigation.

A last alternative is one of two types of catheters. Both are placed
into the bladder through the urethra to drain the bladder. The Foley
catheter is left in place; with an intermittent catheter, the patient
inserts it as needed.

Education Is Key

Despite how prevalent and treatable incontinence is, a variety of
national and international professional organizations, including the
National Institutes of Health, have noted a lack of professional and
public knowledge about incontinence and its treatment. "Most physicians
have never had any education about incontinence," Resnick says.

Sant agrees, but he has noticed the beginning of an encouraging trend.
"We're seeing a change in the approach, not only on the part of
physicians, but also in the expectations and demands of the
patients--which I think is excellent," Sant says. "Women are now saying,
'Look, we don't have to live with this.'"

Apparently, the word is spreading that incontinence is neither
inevitable nor shameful but instead treatable or, at least, manageable.

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


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


Facing Facts About Urinary Incontinence


Myth: There's nothing that can be done about it.

Fact: There's a lot that can be done. In the majority of cases,
continence can be restored or improved with behavioral techniques,
devices, drugs, or surgery.


Myth: Incontinence is a normal consequence of aging.

Fact: Incontinence is never normal at any age, according to Neil
Resnick, M.D., chief of gerontology at Brigham and Women's Hospital,
Boston. Age-related changes in the lower urinary tract may make older
people more likely to experience incontinence, but for most older
people, even the very old and frail, incontinence can be treated
successfully.


Myth: The only successful treatment is surgery.

Fact: The majority of patients can be helped with other treatments.


Myth: Incontinence is inevitable for women who have given birth.

Fact: Giving birth can injure or weaken the pelvic region, but that
doesn't mean incontinence is inevitable. Exercises often help.


Myth: A little leakage sometimes, such as during a sneeze or cough, is
no big deal. It's not worth telling the doctor about.

Fact: If urinary leakage is troubling at all, it's worth mentioning to
the doctor. People can learn to manage the problem--or be free of it
altogether.


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


Where to Turn for Help

Here are some organizations that can give additional information and
support.

National Association For Continence (formerly Help for Incontinent
People)
P.O. Box 8310
Spartanburg, SC 29305-8310
(1-800) BLADDER
http://www.nafc.org/

Simon Foundation for Continence
Box 815
Wilmette, IL 60091
(1-800) 23-SIMON

Agency for Health Care Policy and Research
Publications Clearinghouse
P.O. Box 8547
Silver Spring, MD 20907
(1-800) 358-9295
http://www.ahcpr.gov/

National Kidney and Urologic Diseases Information Clearinghouse
3 Information Way
Bethesda, MD 20892-3580
[phone]
http://www.niddk.nih.gov/Brochures/NKUDIC.htm

(The source for the illustration in this article was The American
Medical Association Encyclopedia of Medicine, 1989)

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

Attention Disorder: Overcoming the Deficit
Abuse of Attention Deficit Drug Can Be Deadly

by Dixie Farley

"I really see a difference in my grades. Without it, I don't think about
things. I can't pay attention."
--Christy Rade, 16, Des Moines, Iowa, commenting in the Aug. 26, 1996,
Des Moines Register on her treatment for attention-deficit/hyperactivity
disorder (ADHD) with Ritalin, the brand name for the stimulant medicine
methylphenidate.

"Teens Learn Dangers of Ritalin Use; 19-Year-Old Man Dies After Snorting
Stimulant at Party"
--a headline in the April 24, 1995, Roanoke Times & World News, Roanoke,
Va.



If, like Christy Rade, you're taking stimulant medicine for ADHD, you
are not alone. In mid-1995, about 1.5 million school-age youngsters did
so, reported Daniel Safer, M.D., and colleagues in Pediatrics, December
1996.

But, as the Virginia headline points out, abuse of this medicine can be
deadly.

In ADHD, brain areas ruling attention and inhibition don't work very
well. Most children with ADHD are inattentive, impulsive and
hyperactive. In teenagers, the hyperactivity often quiets to a
restlessness. For some, paying attention is their biggest problem.
Others are mainly impulsive and hyperactive.

The Food and Drug Administration has approved several stimulant
medicines for treating ADHD: methylphenidate (Ritalin and generics),
dextroamphetamine (Dexedrine and generics), methamphetamine (Desoxyn),
and an amphetamine-dextroamphetamine combination (Adderall). FDA
recently restricted another approved stimulant, pemoline (Cylert), to
secondary use, as it can cause liver failure.

The drugs stimulate the central nervous system, but no one knows exactly
how they work in treating ADHD.

"Stimulants have been used to treat ADHD for over three decades," says
Nicholas Reuter, FDA associate director for international and domestic
drug control affairs. "And the amount used has increased steadily during
that period. Methylphenidate is the most widely used."

Not everyone with ADHD requires or responds to stimulant treatment.

Risk of Abuse

Because stimulant medicines have a high potential for abuse, the U.S.
Drug Enforcement Administration has placed stringent controls on their
manufacture, distribution and prescription. For example, DEA requires
special licenses for these activities, and prescription refills aren't
allowed. States may impose further regulation, like limiting the number
of dosage units per prescription.

DEA has repeatedly urged greater caution in use of these drugs,
especially in light of their abuse among adolescents and young adults.

Ritalin's manufacturer, Ciba-Geigy Corp., began a campaign in March 1996
to reduce abuse. In nationwide mailings to doctors and pharmacists, the
firm called attention to the risk of abuse and cautioned doctors to be
especially careful in diagnosing ADHD. Enclosed were behavior rating
scales for doctors to use and handouts for patients, parents and school
nurses.

Taken properly, Ritalin in and of itself is not addictive, says Wendy
Sharp, M.S.W., a social worker and researcher at the National Institute
of Mental Health's child psychiatry branch. So people with ADHD do not
get addicted to their stimulant medicine at treatment dosages, she says.
"There have been unfortunate cases reported in the press, however, of
teenagers who have taken Ritalin from other kids and snorted it, like
cocaine."

According to Reuter, "Although methylphenidate production and
availability have increased dramatically since 1990, national drug abuse
surveys indicate that the abuse level and associated public health
consequences remain below that of other stimulant medicines such as
cocaine, amphetamine and methamphetamine."

Patricia Quinn, M.D., a developmental pediatrician in Washington, D.C.,
and author of many books on ADHD, adds, "There's actually less substance
abuse in people diagnosed with attention deficit disorder who take
medication and do well than in the general population. Adolescents I've
worked with are trying to straighten out what's going on."

Diagnosing Difficulties

About 30 percent of young people with ADHD aren't diagnosed until middle
school or later, says Quinn. These students are very bright, she says.
"The more intelligent you are, the better you cope--until stressors in
the environment outpace your ability to cope. Maybe your disorder
becomes a problem in high school when you have only lecture classes, or
in college when you have to do everything for yourself and go to class,
too."

By the time someone with undiagnosed ADHD gets to middle school or high
school, the main complaint is classroom underachievement rather than
hyperactivity or distractibility, Quinn says. Some people shorten the
name to ADD when it affects older people. "But you shouldn't assume that
everyone who is underachieving has ADHD."

And, not everyone with attention difficulty has ADHD.

For example, when Linda Smith (not her real name) was 16, she had
extreme difficulty concentrating. ADHD was suspected. Thorough
examination, however, revealed the culprits were anxiety, depression and
a sleep disorder, which are improving under a treatment plan that
includes medicines and counseling.

Narrowing a diagnosis to ADHD requires more than a single visit to the
doctor. Substantial detective work by the doctor involves talking not
only to the patient, but also to the parents and to nurses and teachers
at the patient's various schools.

"I ask to see all report cards from kindergarten on," Quinn says.
"Teachers usually comment, 'He would do so much better if he could only
pay attention.' One mother said of her son in high school, 'One day in
first grade, he came home without shoes. He didn't know where he put
them.' Kids with this disorder lose their jackets, shoes. So he had
symptoms early on."

There is no biological test for ADHD. Doctors base their diagnosis on
guidelines set by the American Psychiatric Association. (See "Diagnostic
Guidelines.")

Deciding to Use Stimulants

Stimulant treatment begins as a "trial," so you and your parents should
tell the doctor regularly about improvements, such as handling school
tasks better, and any side effects. The most common side effects are
nervousness, sleep difficulty, and appetite loss. Less common are skin
rash, nausea, dizziness, headache, weight loss, and blood pressure
changes. Immediately report such serious effects as confusion, breathing
difficulty, sweating, vomiting, and muscle twitches, which may signal
too high a dose.

With this information and further examination, the doctor can determine
the most effective dose that causes no, or only tolerable, side effects.

Patients who need stimulant medicine only for paying attention may not
need it at all during weekends and summer vacations. If their difficult
subjects are in the morning, a morning dose may be enough most days.
Other patients need stimulant medicine much more often.

Stimulants are not for everyone with ADHD. For example, they shouldn't
be used in someone with marked agitation, a twitching known as a tic, or
the eye disorder glaucoma.

And like all medicine, stimulants pose risks. Whether to use stimulants
is a case-by-case decision based on how the benefit stacks up against
the risk.

In January 1996, FDA announced that in studies of rodents given
methylphenidate, the drug produced a "weak signal" for the potential to
cause liver cancer. The cancer occurred in male mice but not in female
mice or rats. At FDA's request, Ciba-Geigy informed doctors and, along
with other methylphenidate manufacturers, added the findings to their
drugs' labeling.

Accompanying health problems like depression may require other medicines
or psychotherapy.

"Individual therapy for ADHD may not be helpful," Sharp says. "Probably
the most beneficial treatment for ADHD involves the entire family
system, and behavior management is usually a large part of this
treatment."

Some people have linked ADHD to sugar and food or color additives.
"Research in this area has raised questions and contributes to
understanding," says Catherine Bailey, an FDA science policy analyst.
"But the idea that individual food substances cause ADHD is unproven.
Still, if people want to avoid substances they perceive as problems,
they should be sure to read food labels."

Moving Forward

Scientists don't know exactly what causes ADHD, but it tends to affect
several in a family. When an identical twin has ADHD, the other usually
does, too. Sharp had recruited twins for research to help clarify this.

While more males than females have ADHD, the gender gap is narrowing.
Males taking medicine for the disorder outnumbered females 10 to 1 in
1985 but only 5 to 1 in 1995, the authors of the 1996 Pediatrics article
stated.

Probably the hardest part of having ADHD is accepting the diagnosis,
Quinn says. She stresses the importance of looking at everything else
that's good in your life.

"The disorder is part of who you are and, yes, you have to control it,"
she says. "But it doesn't define you. It's okay to have attention
disorder, so long as you know what to do about it."

Dixie Farley is a staff writer for FDA Consumer.


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


Helping Yourself

The first step toward dealing successfully with ADHD is to learn as much
as you can about the disorder, the pros and cons of stimulant treatment,
and strategies for self-help.

If you have ADHD, self-help skills can be critical to your success in
high school and college, and later on with your career. In her book
Adolescents and ADD, Gaining the Advantage, developmental pediatrician
Patricia Quinn, M.D., advises, "Set realistic goals. Be honest about
your strengths and weaknesses." These tips from her book may help.



Taking Responsibility

Talk to the school nurse.

  * Bring up your concerns.

  * Ask if students with ADHD meet to share ideas. If not, ask how to
    start a group.

  * Ask the nurse to help your teachers understand your diagnosis and
    provide classroom support, such as more time for tests and a front
    seat away from distractions. People with disabilities or certain
    impairments are entitled to free, appropriate public education under
    the Individuals with Disabilities Education Act of 1990, Section 504
    of the Rehabilitation Act of 1972, and the Americans with
    Disabilities Act of 1990. If your ADHD isn't being accommodated
    under these laws, ask the school nurse how to find out if it can be.

Be careful taking medicine.


  * Ask about your school's policy on taking medicines at school.

  * When parents deliver your medicine, be sure the prescription label
    lists your name, diagnosis, medicine name, dose, and, especially,
    when to take it.

  * Until taking doses on time gets routine, make notes to yourself or
    set your watch alarm.

  * To prevent mix-ups, always tell the person giving you the medicine
    your full name, see that the bottle is yours, and make sure you get
    the correct number of tablets.

  * Report side effects to your parents or the nurse.

  * Never "help out" someone else by sharing your medicine.


Improving School Work

Manage note-taking.

  * Write on every other line to leave room for ideas you might add later.

  * Leave out unimportant words, like "the" and "an."

  * List some abbreviations of your own at the front of your notebook
    for reference.

  * Ask a friend to take notes over carbon paper to provide a copy for
    you.

  * Ask teachers to let you have a copy of their notes.

  * Make an audio-cassette recording of lectures, especially before
    tests.

Understand what you read.

  * Read while you are fresh.

  * Decide what you're looking for. Then skim the material, noting
    pictures and graphs and reading the headings and bold print.

  * List unfamiliar words, then look them up. Get help if you don't
    understand a meaning.

  * Read assigned questions before the material. Then write answers as
    you read along.

  * Highlight or underline important information on your study sheets.

  * Read the material again.

Improve written assignments.

  * Use a computer with a spell-check. Writing on a computer can also
    help you organize your thoughts.

  * To check spelling without a computer, start at the bottom of the
    page and move up.

Improve math assignments.

  * If you start to feel lost in a unit, tell your teacher, advisor or
    tutor immediately, as each new math concept builds on what you've
    already learned.

  * Leave space between examples. Line up the numbers in columns
    carefully.

  * Check each math solution before handing it in, especially on tests.

  * Practice math in the summer with worksheets or summer school.

Study smarter.

  * Study with a partner.

  * Use your textbook's headings and subheadings for a study outline.

  * Put important information on cards or audiotape for reviewing.

  * Organize your notes and worksheets by topic. Study some each night.

  * Allow two nights for review before a test.

  * Get plenty of sleep the night before a test.

  * If you get anxious when you can't answer a test question, stop and
    take deep breaths. Then jot down some facts you do know, which may
    trigger the answer.

  * Discuss your school routine and grades with your advisor weekly or
    even daily.

(Adolescents and ADD, Gaining the Advantage is published by Magination
Press, New York, N.Y.; telephone [phone].)


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


Diagnostic Guidelines

According to the American Psychiatric Association, a diagnosis of ADHD
must meet the following guidelines:

  * The patient must often have:

either six of these inattention symptoms:

  * does not pay close attention to details or makes careless mistakes

  * has difficulty sustaining attention in activities

  * does not seem to listen when spoken to directly

  * does not follow through on instructions and fails to finish duties

  * has difficulty organizing tasks and activities

  * avoids, dislikes, or is reluctant to do tasks requiring sustained
    mental effort

  * loses things necessary for tasks or activities

  * is easily distracted

  * is forgetful in daily activities

or six of these hyperactivity or impulsiveness symptoms:

  * fidgets with hands or feet or squirms in seat

  * leaves seat in classroom or other times when remaining seated is
    expected

  * inappropriately runs about or climbs excessively or, in older
    patients, feels restless

  * has difficulty playing or taking part in leisure activities quietly

  * is "on the go" or acts as if "driven by a motor"

  * talks excessively

  * blurts out answers before questions have been completed

  * has difficulty awaiting turn

  * interrupts or intrudes on others, such as butting into conversations
    or games.

  * Symptoms must continue six months and be more frequent and severe
    than normal.

  * Evidence must show significant damage to social, academic or work
    functioning.

  * Some damage must occur in at least two settings, such as home and
    school.

  * Some damaging symptoms must have occurred before age 7, even with a
    later diagnosis.

  * The symptoms must not be due to another disorder.


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


More Information

ADD Warehouse
(1-800) 233-9273
World Wide Web: http://www.addwarehouse.com/

Attention Deficit Information Network
475 Hillside Ave., Needham, MA 02194
[phone]

Children and Adults with Attention Deficit Disorders
499 N.W. 70th Ave., Suite 101, Plantation, FL 33317
(1-800) 233-4050
World Wide Web: http://www.chadd.org/

National Attention Deficit Disorder Association
(1-800) 487-2282
World Wide Web: http://www.add.org/

National Institute of Neurological Disorders and Stroke
(1-800) 352-9424
World Wide Web: http://www.ninds.nih.gov/

National Institute of Mental Health
Room 7C-02, 5600 Fishers Lane, Rockville, MD 20857
[phone]
World Wide Web: http://www.nimh.nih.gov/

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

Updates

Court Upholds FDA Authority
To Regulate Tobacco Products

FDA has the authority under the Federal Food, Drug, and Cosmetic Act to
regulate cigarettes and smokeless tobacco, but not their advertising and
promotion, according to a recent federal court decision.

Several companies, including cigarette and smokeless tobacco
manufacturers and sellers, had sued FDA regarding its rule on children
and tobacco.

Judge William Osteen of the U.S. District Court for the Middle District
of North Carolina ruled on April 25 that FDA may:

  * prohibit the sale of cigarettes and smokeless tobacco products to
    minors

  * require retailers to check the photo I.D. of purchasers under age 27

  * prohibit self-service displays and vending machines where children
    can access them

  * prohibit free cigarette samples

  * prohibit the sale of "kiddie packs" of less than 20 cigarettes

  * require a statement on cigarette and smokeless tobacco packages of
    the product's established name, intended use, and age restriction.

The first two provisions took effect Feb. 28. The rest were scheduled to
go into effect Aug. 28 but have been put on hold pending further orders
by the court.

The government has appealed the court's finding that FDA lacks the
authority to regulate the advertising and promotion of tobacco products.

"This is a fight we cannot afford to lose," President Clinton said on
the day of the court decision. Each day, Clinton said, 3,000 young
people become regular smokers, and 1,000 of them will have their lives
cut short as a result.


New NCI Recommendations
For Mammography Screening

The National Cancer Institute has issued updated recommendations for
mammography screening to detect breast cancer. Mammography is x-ray
examination of the breast.

According to the new recommendations:

  * Women 40 to 49 should have mammography screening every one to two
    years if they are at average risk for breast cancer.

  * Women 50 and older also should be screened every one to two years.

  * Women at higher risk of breast cancer should seek expert medical
    advice about possible screening before age 40 and about the
    frequency of screening.

  * Along with mammograms, a clinical breast examination by a
    health-care provider should be included as part of regular, routine
    health care.

Breast cancer is the second leading cause of cancer deaths in American
women; about 44,000 women are expected to die from the disease this
year.

Performed correctly, mammography is the most effective way to detect
breast cancer early, often locating small tumors that cannot yet be
detected by touch.

High-quality mammography can find 85 to 90 percent of breast tumors in
women over 50. Widespread screening of women this age, followed by
prompt treatment when needed, can reduce cancer deaths by up to 30
percent. Also, if the cancer is detected early enough, before it has
spread, the woman may choose treatment that preserves her breast.

Because of concerns about inadequate mammography quality at some
facilities, Congress in 1992 passed the Mammography Quality Standards
Act. Facilities now must be certified by FDA as having met quality
standards for x-ray images, equipment, and personnel and must be
inspected annually. (See "Mammography Facilities Must Meet Quality
Standards" in the March 1994 FDA Consumer.)

Legislation was introduced in April to reauthorize the act, which will
otherwise expire this year.

FDA has certified more than 10,000 mammography facilities. For a list of
their names and locations, go to http://www.fda.gov/cdrh/faclist.html on
FDA's Web site. Or call the National Cancer Institute's toll-free cancer
information service at (1-800) 4-CANCER.


Laser Treatments OK'd
For Tooth Decay, Astigmatism

Less dental pain and fewer eyeglasses. That may be the result with two
new medical uses for lasers now available: the first dental laser for
use directly on teeth to treat tooth decay and a laser, already approved
for some nearsightedness cases, to treat astigmatism.

FDA cleared the erbium YAG laser system for marketing May 7 to remove
tooth decay, prepare cavities for fillings, and roughen enamel to
improve bonding of restorations. Previous dental lasers were cleared for
use only on soft tissue like the gums, for curing restorations, and as
the heat source in some bleaching systems. (See "Lasers in Dentistry" in
the January-February 1995 FDA Consumer.)

In one study by the manufacturer, Premier Laser Systems, of Irvine,
Calif., more than 500 teeth were treated for decay with the laser and
then evaluated for damage to the tooth's nerve and blood supply. No
adverse events were reported. A second controlled study by the firm
involved some 125 patients with tooth decay. Half were treated with the
laser, and half with a high-speed drill. The laser was as safe and
effective as the drill in removing decay and preparing the teeth for
fillings, but patients treated with the laser were less likely to need
anesthetic for pain.

The laser system consists of a box-like laser console and a fiber-optic
cable with a dental handpiece at the end resembling a standard
high-speed drill. Like dental drills, the laser uses water or air to
cool the tooth and clean the surface during treatment. Dentists and
patients will need to wear goggles to protect their eyes.

FDA approved the Visx Inc. excimer laser April 24 for refractive surgery
to treat mild to moderate astigmatism in people 21 and older who also
have mild to moderate nearsightedness. Most nearsighted people also have
astigmatism, which prevents correct focusing. It is caused by uneven
curvature of the surface of the eye's cornea. The laser is not approved
for severe cases of these disorders. (See also "Not a Cure-All: Eye
Surgery Helps Some See Better" in the July-August 1995 FDA Consumer.)

FDA restrictions for the laser include:

  * Users must be medical practitioners who are experienced in corneal
    surgery and trained in laser refractive surgery for nearsightedness
    and astigmatism and in the calibration and use of the laser.

  * Patients considering the surgery must be given the manufacturer's
    patient information booklet reviewed by FDA that describes the
    procedure's risks and benefits.

  * Before surgery, patients must be told about correction alternatives,
    including eyeglasses, contact lenses, and other types of surgery.

  * In advertising and promoting the laser, the manufacturer may not
    compare it to any other laser or any other correction for
    nearsightedness or astigmatism.

Visx Inc. is located in Santa Clara, Calif.



Nicotine Inhaler Approved for Smoking Cessation

Smokers fighting the urge to light up have a new addition in the smoking
cessation arsenal--a prescription nicotine inhaler.

The Nicotrol Inhaler (nicotine inhalation system) allows smokers to
inhale the dose from a nicotine cartridge through a plastic mouthpiece.
The nicotine is absorbed into the body through the mucous membranes of
the mouth.

While the inhaler's ability to satisfy smokers' psychological needs for
the ritual of bringing hand to mouth is unknown, quit rates in clinical
trials with the inhaler were comparable to other smoking cessation
products already on the market.

The Nicotrol Inhaler, approved by FDA May 2, is manufactured by
Pharmacia & Upjohn Inc., Kalamazoo, Mich., and marketed by McNeil
Consumer Products, Fort Washington, Pa.



Temporary Wound Cover from Human Cells Approved

The first wound covering made with human cells has been approved by FDA
to temporarily cover severe burn wounds until a patient's own skin can
be transplanted.

Each year, about 51,000 Americans are hospitalized for serious burns,
and 5,500 die. Covering wounds quickly with temporary skin substitutes
can help prevent infection and minimize scarring and trauma.

The new Dermagraft-TC wound covering is grown in a laboratory from human
cells, then frozen and packaged. To use, the surgeon unfreezes the
temporary skin, then stretches it over the burn site. The surgeon
removes the temporary covering when the patient's own skin is ready to
be grafted, usually in 7 to 14 days.

Dermagraft-TC has not been tested in pregnant women or children under
age 2, or on burns from electrical or chemical causes or on the head,
hands, feet, or buttocks.

FDA's March 19 approval followed a recommendation from the General and
Plastic Surgery Panel of the agency's Medical Devices Advisory
Committee.

A study of 89 burn patients treated with Dermagraft-TC showed that it
covered burns as effectively as frozen cadaver skin from tissue banks.

FDA's safety review focused on the risk of disease transmission because
of the product's use of human cells. The cells met FDA guidelines for
cell testing. The cells were tested for known disease-producing
elements, such as bacteria, fungi and viruses. The final product was
tested for bacteria and fungi.

Some data raised the possibility of a higher risk of infection from the
Dermagraft-TC. At FDA's request, the manufacturer, Advanced Tissue
Sciences of La Jolla, Calif., will conduct a postmarket study of 200
patients to evaluate this risk.

(For more information on skin substitutes, see "Second Skins" in the
January-February 1997 FDA Consumer.)



First Home Test Cleared for Blood Clotting

Heart patients and others taking the blood-thinning drug Coumadin
(warfarin) to prevent clotting can now test for the drug's effect at
home with a prescription kit cleared by FDA.

Like other blood thinners, Coumadin is used to treat people with
artificial heart valves, irregular heartbeat, and other conditions that
lead to excessive blood clotting. These drugs have a "narrow"
therapeutic range: Too much blood thinner can cause hemorrhage, while
too little can allow clots to form and obstruct blood vessels, causing
stroke or death.

Using the ProTime Microcoagulation System, a patient pricks a finger to
draw a blood sample and runs the sample through a small, hand-held
electronic device that displays results on a screen.

FDA previously cleared the test, known as a prothrombin time (PT) test,
for use in doctors' offices, clinics, and nursing homes to check blood
coagulation. The home prescription version will be for use under a
doctor's supervision.

Previously, patients taking Coumadin had a PT test every one or two
months during regular visits to their doctor. With the new kit, they can
test themselves weekly, or as often as their doctor recommends. The
system stores the 40 most recent results with a date and time stamp,
enabling the doctor to review and interpret results and adjust the drug
if needed. Doctors can program the appropriate upper and lower
blood-clotting ranges for each patient.

FDA cleared the device after reviewing data on 84 patients at four
clinics. The patients had the professional laboratory PT test at the
clinics and also tested themselves with the home kit. Both types of
tests showed comparable results.

International Technidyne Corp., Edison, N.J., makes the ProTime
Microcoagulation System.



Proposal to Speed New Uses
For Drugs and Biologics

Ways to speed development of new and supplemental uses for approved
drugs and biological products using all available data to determine
effectiveness are being explored by FDA under a proposed plan.

FDA's "New Use Initiative--Evidence for Primary and Supplemental
Approvals," proposed March 13, gives industry clear guidance on when the
agency can determine effectiveness for a new use without the usual
standard of two new clinical trials.

In some cases, for example, FDA can rely on effectiveness information
extrapolated from existing data. In others, the agency can accept
evidence from a new single trial, as long as it is supported by existing
related clinical data, or adequate evidence from a single study at more
than one medical center.

The drafts, "Guidance for Industry: FDA Approval of New Cancer Treatment
Uses for Marketed Drug and Biological Products" and "Guidance for
Industry: Providing Clinical Evidence of Effectiveness for Human Drug
and Biological Products" are available from FDA by calling (1-800)
835-4709 or by visiting http://www.fda.gov/cber/guidelines.htm on the
agency's Web site.



GRAS Substances Proposal
Could Aid Food Data, Safety

An FDA proposal to replace a rule-making system with a simpler process
should increase food manufacturers' requests for agency affirmation that
food substances are generally recognized as safe (GRAS). More requests
would add to FDA's data on marketed foods. And less rule-making would
free agency resources for other food-safety issues.

The public can comment on the proposal, published in the April 17
Federal Register, until July 16.

If a food manufacturer determines a food substance is GRAS--that is,
generally recognized as safe by qualified experts--the company does not
need FDA approval before marketing. However, if a manufacturer wants FDA
affirmation that the substance is GRAS, the company currently must
submit a petition and go through lengthy rule-making.

Under FDA's proposal, a manufacturer would simply notify FDA of the GRAS
determination and provide evidence to support this decision. FDA would
evaluate the evidence and respond within 90 days. The proposal allows
for FDA to reevaluate the notification if new information indicates a
reason for concern.

The proposed simpler process would give manufacturers greater incentive
to inform FDA of their GRAS determinations. This, in turn, would
increase FDA's awareness of ingredients in the nation's food supply and
the cumulative dietary exposure to GRAS substances. FDA also could
redirect resources to food ingredient safety issues that may have a
greater impact on public health, such as those posed by novel proteins,
carbohydrates, fats, and oils.

Send written comments to the FDA Dockets Management Branch (HFA-305),
12420 Parklawn Drive, Room 1-23, Rockville, MD 20857-0001. The Federal
Register is available in some public libraries, and the proposal is
located at http://vm.cfsan.fda.gov/~lrd/fr970417.html on FDA's Web site.



Generic Premarin Not Approvable

Synthetic generic versions of the conjugated-estrogens drug Premarin
will not be approved at this time, FDA has concluded. The generics are
not shown to contain the same active ingredients as Premarin and,
therefore, are not shown to work the same in treating menopausal
symptoms and preventing osteoporosis.

Because generic drug makers do not have to repeat the clinical studies
used to develop the brand-name drugs, they must ensure their products
are as safe and effective by showing that the active ingredients are the
same and that they are bioequivalent--that is, absorbed and used by the
body in the same way as the original products.

Previously it was believed that two estrogens--sodium estrone sulfate
and sodium equilin sulfate--were Premarin's sole active ingredients. New
laboratory and clinical studies show this may not be the case. Other
components in Premarin may contribute to its effectiveness. These and
other findings, including a report by the agency's ad hoc working group
on conjugated estrogens, underscore the lack of precise knowledge about
Premarin.

FDA announced May 5 that Premarin must be better characterized before
its active ingredients can be definitely identified and that the
bioequivalence guidance for conjugated estrogens should be reexamined.
The guidance describes how to measure whether the rate and extent of
absorption in the blood of a generic version are equivalent to those of
Premarin.

The agency encourages the start of studies that will permit scientific
determination of the drug's active ingredients and provide a potential
for approval of generic versions.

(For information about estrogen replacement therapy, see "New Attitudes
Toward Menopause" in the March 1997 FDA Consumer.)



Free Reprints

  * Colds and Flu: Time Only Sure Cure (FDA) 97-1264
  * Controlling Asthma (FDA) 97-1265
  * Overcoming Infertility (FDA) 97-1269
  * Sulfites Safe for Most, Dangerous for Some (FDA) 97-2308

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 [phone]. Include the publication number.


Nearing the 5-A-Day Goal

Adults' Average Daily Intake of Fruits and Vegetables

        1989-91         3.9 servings
        1994            4.4 servings
        2000 Goal       5 to 9 servings

Adults' average daily intake of fruits and vegetables is closing in on
five servings, according to the U.S. Department of Agriculture's
Continuing Surveys of Food Intakes by Individuals. The National Cancer
Institute, which recently reported this data, and the Produce for Better
Health Foundation sponsor the National 5 A Day for Better Health
campaign to increase consumers' consumption of fruits and vegetables.
(See "Fruits and Vegetables: Eating Your Way to 5 A Day" in the March
1997 FDA Consumer.)

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


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. It is also available electronically through GPO Access
at the Government Printing Office.

Nicotine poisoning in children can result from exposure to nicotine
patches, which may retain up to 74 percent of nicotine after use,
according to a study at Harvard Medical School and several other medical
centers. Symptoms of nicotine poisoning include vomiting, nausea,
headaches, dizziness, and fatigue. Study authors advise parents to store
new patches in a locked cabinet and to dispose of used ones right away.
If a child is exposed to a patch, even briefly, remove the patch
immediately, wash the skin, and call a local poison center. ("Pediatrics
electronic pages," May 1997, at http://www.pediatrics.org/)

AIDS deaths have declined for the first time since the epidemic began,
according to the national Centers for Disease Control and Prevention.
During the first six months of 1996, AIDS deaths dropped 13 percent
compared with the first six months of 1995. CDC says the decline is
likely due to improved treatments and prevention efforts.

Overweight affects about 14 percent of children ages 6 to 11, 12 percent
of adolescents ages 12 to 17, and 35 percent of adults age 20 and over,
according to the third National Health and Nutrition Examination Survey
(NHANES), conducted by CDC from 1988 to 1994. This represents
significant increases in all age groups since the second NHANES, from
1976 to 1980. A surgeon general's report on physical activity and health
is available by calling toll-free (1-888) CDC-4NRG or visiting
http://www.cdc.gov/ on the World Wide Web. The USDA/DHHS "Dietary
Guidelines" are available for 50 cents from the Consumer Information
Center, Dept. 378-C, Pueblo, CO 81009, or can be obtained free from
http://odphp.osophs.dhhs.gov/ on the Web.

Whether prostate cancer will be fast- or slow-growing may be predicted
by how prostate-specific antigen (PSA) behaves in a man's blood,
according to researchers at the National Institute on Aging and the
Johns Hopkins University School of Medicine. This information can help
physicians decide which treatment--"watchful waiting," surgery, or
radiation--is best for prostate cancers diagnosed in early stages.
(Urology, March 1997)

Patients with moderate-to-severe asthma can greatly reduce their risk of
hospitalization by using inhaled steroids, especially if they also use
bronchodilators, according to a study at Brigham and Women's Hospital in
Boston. Researchers found a 50 percent reduced hospitalization risk in
those using inhaled steroids, and a 70 percent reduced risk in those
using the steroids and more than eight bronchodilator prescriptions a
year. (Journal of the American Medical Association, March 19)

Estrogen use may help older women avoid dry skin and wrinkling,
according to research at the University of California at San Francisco
involving 3,875 postmenopausal women ages 40 to 74. The researchers
found a 25 to 30 percent lower incidence of skin problems associated
with aging in women who used noncontraceptive estrogen. (Archives of
Dermatology, March 1997)

Companies using the term "healthy" on food labels will not have to
adhere to earlier published standards for sodium reduction until January
2000, according to an FDA final rule. The agency postponed the
standards, which were to take effect January 1998, to provide time to
review issues raised in a citizen's petition, such as a lack of consumer
acceptance of low-sodium foods and a lack of acceptable sodium
substitutes. The agency also plans to seek additional comment on the
petition. (FR April 1)

Information about proper prenatal care from the Health Resources and
Services Administration is now as close as your telephone. Call
toll-free (1-800) 311-2229 (English), or (1-800) 504-7081 (Spanish).

U.S. Department of Agriculture school meal programs can now use yogurt
as a meat alternative, according to a final rule. Four ounces of yogurt
can substitute for one ounce of meat in breakfast, lunch or dinner in
the programs. (FR March 6)

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Investigators' Reports

FDA Uncovers Contaminated Covers

by John Henkel

A ready-made market for medical equipment covers awaited Joseph Cottone
and Bill O'Ryan when their company, American Medical Products (AMP),
started marketing the devices five years ago. Because hospitals needed
the covers to shroud instruments used in performing angioplasty and
other catheterization procedures, business was potentially lucrative.

But as FDA investigators learned, the devices sold initially were not
sterile, though their packaging clearly stated they were. Typically, the
manufacturer sterilizes the covers by gamma radiation before they are
sold; AMP's earliest covers did not undergo this process. FDA documented
that between April 10 and May 15, 1992, AMP sold about 4,440 nonsterile
covers to hospitals nationwide.

These covers, made of clear plastic with an elastic band around the
bottom to hold them in place, are used to cover fluoroscopes and other
x-ray equipment.

Because they are used in a sterile surgical field with catheters,
pacemakers, and other devices that actually enter the body, nonsterile
covers pose potential contamination hazards to patients.

For exposing patients to this risk, Cottone is now serving time in
federal prison. Judge Harold Murphy, of the U.S. District Court for the
Northern District of Georgia, sentenced Cottone in January to 22 months
in jail and three years' probation for conspiracy and providing a false
statement to FDA. According to the Department of Justice, the sentence
was one of the longest ever obtained in a device prosecution.

Bill O'Ryan, former financial backer of the company, testified against
Cottone at a grand jury hearing and at Cottone's sentencing. O'Ryan was
sentenced in January to two years' probation, including six months of
home confinement. He received a reduced sentence after cooperating with
authorities.

The case began when Marie Mathews, an investigator in FDA's Atlanta
district office, received a complaint in April 1992 from a competing
cover maker. The complainant claimed to know that a Clearwater, Fla.,
hospital had recently bought some of AMP's covers and that the covers
possibly were not sterile.

The following month, Mathews followed up on the tip and visited the
hospital. Officials there showed her invoices documenting the hospital's
purchase of AMP medical covers labeled as "sterile." In June, Mathews,
with fellow investigator Carol Selman, inspected AMP's facility in
Cartersville, Ga. Cottone, whose official title at the time was
operations manager, told Mathews that the company had not sold any
products until May 20, and he provided invoices showing that. Cottone
signed an affidavit swearing to the truth of this statement.

The AMP inspection also revealed violations of good manufacturing
practices (GMPs). "Among the things we found was rodent contamination
that came in contact with the raw materials used to make the covers,"
Mathews says.

The next day, the two investigators went to AMP's shipping contractor in
Atlanta. Officials there verified that they had shipped AMP medical
covers numerous times before May 20. Mathews went back to AMP's plant
and confronted Cottone with the shipper's information. At first, she
says, Cottone tried to explain the shipments by claiming that some of
the covers had been sent as samples and weren't intended to be sterile.
Eventually, he confessed to distributing nonsterile covers.

But Cottone held back some invoices because, Mathews says, "he wanted to
limit how much we knew. He was afraid he'd lose his remaining customers'
business if they got a call from FDA."

FDA tests of nonsterile cover samples from AMP showed the presence of
molds, yeasts, and other microorganisms, all considered unacceptable in
a sterile environment. Because surgeons may touch the covers with gloved
hands and then touch the catheter tube that is threaded into the body
for diagnostic purposes or to unblock clogged blood vessels, any
contamination on the covers could be transferred to the catheter and
into the patient's body.

FDA urged the company to recall its covers shipped before May 19, after
Mathews determined that AMP's contractor had begun sterilizing covers
shipped after May 19.

Cottone claimed a recall began June 17, 1992. But FDA investigators
found the recall to be ineffective. Cottone told Mathews he had called
his customers, but "in our checks of hospitals, virtually none had
received any recall notice," Mathews says. "The recall was a disaster."

On Jan. 20, 1993, the U.S. District Court for the Northern District of
Georgia entered a consent decree of injunction of AMP because of the GMP
infractions. The company was allowed to reopen several weeks later after
it corrected the violations.

On April 17, 1996, a grand jury indicted Cottone on 18 counts of
violations, including sales of misbranded and adulterated medical
devices and lying to a federal agent. Cottone pleaded guilty in April
1996 to two counts; the others were dismissed. His sentence was
"enhanced" partly because Cottone had a previous criminal record that
included drunk driving convictions. The sentencing judge also took into
account other factors, such as Cottone's obstruction of justice during
the investigation. This resulted in a stiffer sentence, says Mathews.
Judge Murphy said Cottone had been "wanton and reckless in his risk to
the patients exposed to these covers."

O'Ryan, in an interview with Mathews during the investigation, said he
and Cottone knew the covers were not sterile. He said selling the
devices was a "bad business decision" brought about because of "hard
times."

The company is still in business, but it is now called MC Medical and is
owned by Cottone's wife.

John Henkel is a member of FDA's public affairs staff.


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Plumber's Counterfeit Drug Operation Down the Tubes

A Brooklyn plumber who spent six months in prison for selling
counterfeit fertility drugs continues to serve out a three-year
probation. Convicted in 1995, David Braun also had to pay $725,000 to
the company whose two drugs were illegally copycatted.

FDA continues a multinational investigation of others who were involved
in the scheme, including the man FDA's Office of Criminal Investigations
suspects was the operation's "kingpin."

Braun's involvement was discovered in a three-month investigation in
which OCI agents gathered evidence showing that Braun ran a shell
company--an answering service with a fictitious name and address that
took orders for the fertility drugs Pergonal (menotropins for injection)
and Metrodin (urofollitropin for injection). The evidence showed that
Braun delivered fake copies of the drugs to U.S. drug wholesalers,
giving them huge discounts of as much as 20 percent off the average
wholesale price.

The manufacturer of genuine Pergonal and Metrodin, Serono Laboratories
Inc. of Norwell, Mass., contacted OCI in September 1993 to report that
some unusual-looking drugs and their packaging brought to the company's
attention had been tested and found to be counterfeited.

Serono also told OCI they had noticed an unexpected drop in sales of
Pergonal and Metrodin during the previous 18 months.

FDA "hit this investigation hard," says OCI Special Agent Brian
Krompasick, noting that 14 of OCI's New York agents, as well as agents
from Miami, Chicago, and Washington, D.C., were involved. "For the
public safety, we wanted to stop these drugs from going into the stream
of commerce."

While FDA knows of no injuries from the imposter drugs, the agency's
concern was that the drugs could pose a danger because they were not
manufactured according to FDA's safety and effectiveness standards.

Also, says OCI Special Agent Stephen Haynes, "It seemed likely the case
involved a sophisticated and organized network reaping millions of
dollars in fraudulent profit."

Braun was selling the fake fertility drugs for a wholesale price of
about $380 for a one-month's supply, compared with $460 for the real
Pergonal and Metrodin.

To catch Braun at work, OCI got the help of a major Serono distributor
who had been approached in September 1993 about buying the fakes. In
September and October 1993, the distributor arranged to have more than
$500,000 worth of the fertility drugs delivered. When they were
delivered, OCI seized all the batches, which were later tested and found
to be fakes.

The distributor--or agent Krompasick posing as the distributor's
accountant--was wired to record the conversations with Braun and other
suspected counterfeiters during the deliveries.

For additional evidence, FDA set up an undercover operation outside the
distributor's warehouse on Oct. 28, 1993.

While an OCI agent sat in his parked car, one of the suspected
counterfeiters arrived at the warehouse and couldn't find a legal
parking spot for his van. So he double-parked--right next to the agent's
car.

Outside the van, the suspected counterfeiters discussed the terms of the
deal with the distributor. "They were almost leaning on our car,"
Krompasick says. "Our agent was so nervous. He's in the car--police
radio and all--right under their noses."

After photos taken by the OCI agent were enhanced by an FBI lab,
Krompasick says, "it was undeniable that Braun and his van were at the
meeting."

But FDA wanted to find the source of Braun's drugs. So, as planned
beforehand, when the suspected counterfeiters' delivery man brought
another load of drugs to the warehouse, the cooperating distributor told
him that FDA was onto the scam, and he couldn't accept the delivery.

OCI agents then followed the delivery car as it left with the rejected
drugs. They saw the delivery man meet Braun in Brooklyn, where the two
loaded the boxes of drugs into Braun's van.

"Because of the heavy traffic and dark, we made the decision to arrest
Braun then and there," Krompasick says. "Braun was oblivious to the
surveillance; he didn't know what hit him."

While searching Braun and his van, OCI agents found his wallet with
identification, as well as blank invoices with the fictitious name and
address of the shell company and two metal dye stamps like those that
would be used to print the fraudulent packages.

"When we found those things, we knew we had one of our counterfeiters,"
Krompasick says.

Braun pleaded guilty to conspiracy to sell misbranded drugs and was
sentenced Nov. 8, 1995, in the U.S. District Court for the Eastern
District of New York. In addition to prison, probation, and the money he
was ordered to pay to Serono, he also had to perform 250 hours of
community service.

Within two weeks of Braun's arrest, Serono saw a recovery in sales. "It
appears we've shut this counterfeit group down," Krompasick says.

--Tamar Nordenberg


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


A Trail of Tiny Turtles

An anonymous tip led an FDA investigator into a Las Vegas pet store,
where he witnessed and stopped the sale of illegal pet turtles to a
woman with two young children.

FDA analysis later showed the store's turtles--about 30 of them, which
the pet store owner voluntarily handed over--carried Salmonella
bacteria. In humans, Salmonella can cause fever, diarrhea, and other
gastrointestinal problems; in severe infection, it can lead to other
complications, even death.

The laboratory finding was not unusual because turtles are well-known
carriers of Salmonella. The public health risk this presents was the
reason FDA banned sales of baby turtles to consumers in 1975. Young
children are especially vulnerable to Salmonella infection from turtles
because they like to hold the animals and then will stick their
fingers--sometimes even the turtles themselves--in their own or another
child's mouth. Babies also are vulnerable, usually through indirect
contact from parents or siblings.

Despite the dangers--and the ban--consumers continue to buy the baby
turtles as pets, not only in pet stores but at flea markets and street
fairs, as well, according to FDA's San Francisco district office. The
turtles sell for as much as $15 each in the Las Vegas area, said Luis
Chavarria, the investigator with FDA's Las Vegas resident post who
intercepted the turtle sale at the pet store last October.

Their appeal is strong, as Chavarria and other FDA personnel discovered.
"They're incredibly cute," Chavarria said. "They're the cutest things
you ever saw."

FDA personnel were so taken with the turtles that they decided to
videotape them for a news piece to warn consumers about the dangers of
baby pet turtles. At press time in May, all but 10 of the turtles had
died of natural causes, and the agency hadn't decided what to do with
the others.

Congress authorized FDA to regulate baby turtles in the early 1970s. At
that time, 15 million baby turtles were sold yearly in the United
States. Almost 5 percent of U.S. households had them as pets. And the
Centers for Disease Control (now the Centers for Disease Control and
Prevention) estimated that baby turtles accounted for 14 percent of
Salmonella illnesses yearly in the United States.

FDA's ban applies only to turtles with a shell length of 4 inches (10
centimeters) or less that are sold--or given away--to consumers. FDA
allows their use for scientific, educational and exhibition purposes and
for export to other countries.

None of those purposes was evident when Chavarria, responding to an
anonymous phone call, visited the Las Vegas pet store. He walked in to
hear a pet store employee pitching the sale of turtle supplies--with the
turtles thrown in as freebies--to a woman with young children. Chavarria
interrupted to explain the ban on small turtles, and the woman left the
store without taking any.

"The employee was very upset at my disrupting her business," Chavarria
recalled. "She called the store's owner right away."

The owner arrived within 15 minutes, and Chavarria explained the turtle
ban to him. Although he denied it initially, the owner eventually
admitted that he knew the sale of baby turtles to consumers was illegal,
Chavarria said. But when Chavarria told him he would have to destroy the
illegal turtles, as required under federal law, the owner balked.

"He said his employees wouldn't allow him to destroy the turtles,"
Chavarria said. "He wanted me to take them away."

Without a warrant, Chavarria couldn't confiscate the turtles, so he
arranged with the owner to take all the turtles for testing. The owner
signed an affidavit admitting to the sale of illegal turtles and
surrendered the turtles to Chavarria.

Chavarria took them to his office, and, as directed by FDA's San
Francisco district laboratory, planned to destroy the turtles by placing
them in the freezer overnight. Typically, live samples must be destroyed
before testing, and freezing is considered a humane way of destroying
turtles because the cold temperatures put them into a hibernating state.
Eventually, they die in their sleep.

But, Chavarria recalled, when he went to put the turtles in the freezer,
he couldn't do it. "They looked up at me with their little eyes. I
remembered buying them at the five-and-ten store when I was a child. I
couldn't put them in the freezer," he said.

So Chavarria shipped the turtles live by air to the San Francisco
laboratory. There, employees decided to keep the turtles alive for use
in a video.

To test the live turtles for Salmonella, Lorraine Humes, a
microbiologist with FDA's San Francisco laboratory, put the turtles into
lactose broth, a medium for testing food for Salmonella contamination.
She allowed the turtles to swim in the broth for five minutes and then
put them back in their aquarium. Tests of the broth showed the turtles
were carrying Salmonella.

FDA is offering a video of the testing to area TV stations to show
consumers how seemingly safe, cute turtles can actually be dangerous.

FDA is not aware of any illnesses stemming from turtles that may have
been sold by the Las Vegas pet store.

But, Chavarria said, "Baby turtles can create a lot of problems. So I
feel good about being able to prevent at least one customer from taking
turtles that, it turned out, came from a contaminated batch."

--Paula Kurtzweil


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Retired Sales Rep Sentenced
For Selling Rx Drug Samples

A retired drug company salesman became the sixth person convicted and
sentenced in an illegal money-making scheme to sell prescription drug
samples to retail pharmacists and others in the Buffalo, N.Y., area.

At press time in May, Edward Mikula, of Cheektowaga, N.Y., was serving
seven months in federal prison for violating the Prescription Drug
Marketing Act of 1988. The law bars the sale, purchase, trade, or the
offer to sell, buy or trade prescription drug samples. Such practices
are considered hazardous because of the risk of counterfeit,
adulterated, misbranded, subpotent, or expired drugs being sold to
consumers. They also constitute fraud against legitimate prescription
drug sellers.

Mikula, a former Wyeth-Ayerst Laboratories sales representative who
retired from the company in 1987, was convicted in the U.S. District
Court for the Western District of New York in July 1996 and sentenced in
December. The evidence showed that between 1988 and 1993, he sold
prescription drug samples of Premarin, Procardia, Inderal, Lodine,
Feldene, Reglan, and others made by various companies, including
Wyeth-Ayerst, Lederle Laboratories, A.H. Robins Co., and Pfizer Labs, to
former business acquaintances, such as pharmacists and other
pharmaceutical purchasers.

"He sold anything he could get his hands on," said Raymond Kent, a
compliance officer in FDA's Buffalo district office.

Kent heads a team of FDA investigators that, along with FBI and Internal
Revenue Service agents, is "heavily investigating" the sale of
prescription drug samples in the Buffalo, N.Y., area, Kent said. Those
previously convicted and sentenced include pharmacists, a dentist, a
pharmaceutical salesman, and a retired hospital administrator.

Mikula's role in the scheme came to light earlier in the investigation
when his name was linked in documents and conversations with others.
Sifting through various records and piecing together various bits of
evidence, investigators learned that Mikula, according to a grand jury
indictment, met "on various occasions" with a co-conspirator to buy drug
samples from another co-conspirator. Mikula refused to name his
co-conspirators.

The indictment said Mikula and his co-conspirators sold drug samples in
their original packaging or in plastic sandwich bags and other
containers.

The indictment cited five instances in which Mikula received cash or
checks for amounts ranging from $500 to thousands of dollars for selling
drug samples. But, Kent said, "We don't know how much he made in all."

A previous defendant who pleaded guilty to his involvement in the
Buffalo-area drug diversion scheme and who spent time in a
minimum-security prison, earned an estimated $80,000 from his illegal
activities.

A grand jury handed down the three-count indictment against Mikula in
May 1995. He pleaded guilty to all three counts July 22, 1996.

Citing the "seriousness" of Mikula's offenses, his "misguided belief"
that it would be unfair to cooperate with the investigation, and his
apparent belief that he had "done nothing wrong," District Judge Richard
Arcara sentenced Mikula to the maximum allowed under sentencing
guidelines.

Upon completing his prison term, Mikula, who is in his early 70s, will
spend seven months under home confinement and serve one year of
supervised release. He also was fined $1,000.

FDA's investigation of the prescription drug diversion scheme continues.

--Paula Kurtzweil


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


Correction

In the Investigators' Reports article "Pharmaceutical Executives
Convicted" (March 1996), the jury's decision on the three counts against
Kirit R. Patel was reported incorrectly. The jury found Patel not guilty
on one count, but was not able to reach a verdict on the other counts.

FDA Consumer magazine (July-August 1997)


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

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: Rice, at Houston, Texas (S.D. Texas); Civil Action No.
H-96-1425.
CHARGED 5-3-96: While held for sale after shipment in interstate
commerce at Captain Charlie Seafood Co., in Houston, Texas, the articles
were adulterated in that they were held under insanitary conditions
whereby they might have been contaminated with filth--402(a)(4).
DISPOSITION: The articles were reconditioned. (F.D.C. No. 67140; S. No.
96-730-121; S.J. No. 1

PRODUCT: Rice, long grain, at Washington, D.C. (D.D.C.); Civil Action
No. 1:96CV00519.
CHARGED 3-15-96: While held for sale after shipment in interstate
commerce at Happy Valley Food, Inc., in northeast Washington, D.C., the
articles were adulterated in that they were held under insanitary
conditions whereby they might have been contaminated with
filth--402(a)(4).
DISPOSITION: The articles were reconditioned. (F.D.C. No. 67132; S. No.
96-655-220; S.J. No. 2

PRODUCT: Shrimp, frozen, at Tampa, Fla. (M.D. Fla.); Civil Action No.
94-1131-CIV-T-17C.
CHARGED 9-19-94: While held for sale after shipment in interstate
commerce at Americold Cold Storage in Tampa, Fla., the articles were
adulterated in that they consisted of decomposed shrimp--402(a)(3).
DISPOSITION: The shrimp were reconditioned into fish bait. (F.D.C. No.
66994; S. No. 94-557-490; S.J. No. 3

PRODUCT: Vegetarian mix, at Niles, Ill. (N.D. Ill.); Civil Action No.
94C-6103.
CHARGED 10-7-94: While held for sale after shipment in interstate
commerce at International Golden Foods, Inc., in Niles, Ill., the
articles were adulterated in that they were held under insanitary
conditions whereby they might have been contaminated with
filth--402(a)(4).
DISPOSITION: The articles were destroyed. (F.D.C. No. 67026; S. No.
94-741-152; S.J. No. 4



Drugs/Human Use

PRODUCT: Acne cream, at Wallingford, Conn. (D. Conn.); Civil Action No.
394CV00813.
CHARGED 5-19-94: While held for sale after shipment in interstate
commerce at Low Pharmaceuticals, Inc., in Wallingford, Conn., the
articles were adulterated in that they were new drugs without an
approved application--505(a). The articles were misbranded in that their
labeling failed to bear the established name of each active ingredient
and the directions for use--502(e) and 502(f)(1).
DISPOSITION: The articles were destroyed. (F.D.C. No. 66787; S. No.
93-660-001; S.J. No. 5

PRODUCT: Various articles of drugs, at Brooklyn, N.Y. (E.D. N.Y.); Civil
Action No. CV-96-1689.
CHARGED 4-9-96: While held for sale after shipment in interstate
commerce at Maxi International Trading Corp., in Brooklyn, N.Y., the
articles were adulterated in that they were new drugs without an
approved application--505(a). The articles were misbranded in that their
labeling failed to bear adequate directions for use--502(f)(1).
DISPOSITION: The articles were destroyed. (F.D.C. No. 67122; S. No.
95-646-441; S.J. No. 6



Medical Devices

PRODUCT: Stimulator, at Akron, Ohio (N.D. Ohio); Civil Action No.
5:95CV959.
CHARGED 4-28-95: While held for sale after shipment in interstate
commerce at Universal Management Services, Inc., in Akron, Ohio, the
article was adulterated in that it was a class III device without an
application for premarket approval--501(f)(1)(B). The article was
misbranded in that it was not included in a required list, and a notice
or other information regarding the article was not provided as
required--502(o).
DISPOSITION: The article was destroyed. (F.D.C. No. 67076; S. No.
95-739-449; S.J. No. 7



Cosmetics

PRODUCT: French bronze tablets, at Brooklyn, N.Y. (E.D. N.Y.); Civil
Action No. CV-88-1936.
CHARGED 6-18-88: While held for sale after shipment in interstate
commerce at FBNH Enterprises, Inc., d/b/a French Bronze Tablets, in
Brooklyn, N.Y., the articles were adulterated in that they were not hair
dyes, and they contained an unsafe color additive which had no
regulations in effect for its use--601(e) and 721(a).
DISPOSITION: The articles were destroyed. (F.D.C. No. 65450; S. No.
88-457-959; S.J. No. 8


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


CRIMINAL ACTIONS

DEFENDANT: Mark Dalen, at Clarendon Hills, Ill. (N.D. Ill.); Criminal
No. 96CR0691.
CHARGED 11-5-96: Count 1: The defendant introduced into interstate
commerce a cosmetic that was adulterated in that it contained an unsafe
additive--301(a) and 303(a)(1).
DISPOSITION: The defendant was sentenced to 36 months of probation and
ordered to pay a $1,000 fine. (F.D.C. No. 66512; S.J. No. 9

DEFENDANTS: International Nutrition and Gene Oden, at Las Vegas, Nev.
(D. Nev.); Criminal No. CR-5-95-27-PMP (LRL).
CHARGED: 2-3-95: Counts 1 to 4: The defendants introduced into
interstate commerce unapproved new drugs--301(d) and 303(a)(1).
DISPOSITION: International Nutrition, which was found guilty on all
counts, was sentenced to five years of probation and ordered to pay a
$60,000 fine. Defendant Gene Oden, who pleaded guilty to counts one and
two, was sentenced to five years of probation and ordered to pay a
$5,000 fine. (F.D.C. No. 66861; S.J. No. 10

DEFENDANTS: Arthur and Juanita Mallard, at Mobile, Ala. (S.D. Ala.);
Criminal No. 95-00193-AH.
CHARGED 2-15-96: Count 1: The defendants knowingly concealed property
belonging to Arthur Mallard from the U.S. Bankruptcy Court and
creditors--18 U.S.C. section 152.
Counts 2 to 3: Defendant Arthur Mallard, along with others, knowingly
devised a scheme to defraud and obtain money from purchasers of
Mallard's beauty products--18 U.S.C. section 1341.
Count 4: The defendants willfully attempted to evade the payment of
federal income tax by placing funds and property in the names of
nominees, by filing and causing the filing of false income tax returns,
by filing and causing the filing of a false bankruptcy petition, by
dealing in currency, and by other means--26 U.S.C. section 7201.
Count 5: Defendant Arthur Mallard knowingly subscribed to a false
federal income tax return by not reporting additional income--26 U.S.C.
section 7206(1).
Count 6: Defendant Arthur Mallard knowingly aided in the preparation of
a fraudulent federal income tax return--26 U.S.C. section 7206(2).
Counts 7 to 13: Defendant Arthur Mallard, with the intent to defraud and
mislead, knowingly devised a scheme to obtain money from purchasers of
over-the-counter preparations which were also unapproved new drugs
introduced into interstate commerce--505(a), 301(d), and 303(a)(2).
DISPOSITION: Defendant Arthur Mallard, who was found guilty on all
counts, was sentenced to 11 years of imprisonment and three years of
probation. He was also ordered to pay a $50,000 fine, a $650 special
assessment, and $39.95 in restitution. Defendant Juanita Mallard, who
was found guilty on counts 1 and 4, was sentenced to five years of
imprisonment and three years of probation. She was ordered to pay a
$10,000 fine and a $100 special assessment. (F.D.C. No. 66873; S.J. No.
11

DEFENDANT: Medicine Club International, Inc., at Ontario, Canada (D.
Md.); Criminal No. AW-94-0373.
CHARGED 9-27-94: Count 1: The defendant, with the intent to defraud and
mislead, introduced into interstate commerce an unapproved new
drug--301(d) and 303(a)(2).
DISPOSITION: The defendant pleaded guilty and was sentenced to five
years of probation and ordered to pay a $500,000 fine.
(F.D.C. No. 66581; S.J. No. 12

DEFENDANT: Warner-Lambert, at Morris Plains, N.J. (D. Md.); Criminal No.
DKC-95-0463.
CHARGED 11-28-95: Count 1: The defendant, with the intent to defraud and
mislead, failed to report information concerning the failures of
distributed batches of drugs to meet stability testing
specifications--301(e) and 303(a)(2).
DISPOSITION: The defendant pleaded guilty and was ordered to pay a $10
million fine. An individual was also indicted on five related counts. He
was found not guilty at trial on three counts, and the remaining counts
were dismissed. (F.D.C. No. 66419; S.J. No. 13


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


INJUNCTION ACTIONS

DEFENDANT: Charles A. Ellis d/b/a PIPA Laboratories, Inc., at
Roslindale, Mass. (D. Mass.); Civil No. 93-10127 WD.
CHARGED 1-22-93: The defendant introduced adulterated drugs into
interstate commerce--301(a) and 301(k). The drugs were adulterated in
that the methods used in, and the facilities and controls used for, its
manufacture, processing, packing, and storage were not in conformity
with current good manufacturing requirements--501(a)(2)(B).
DISPOSITION: A consent decree of permanent injunction was filed.
Subsequently, PIPA Laboratories, Inc., ceased operations. (Inj. No.
1284; S. No. 91-637-846; S.J. No. 14

DEFENDANTS: Laerdal Manufacturing Corp., and John Karpowicz, at
Tualatin, Ore. (D. Ore.); Civil Action No. 93-1141-FR.
CHARGED 12-1-95: The defendants introduced adulterated and misbranded
devices into interstate commerce--301(a) and 301(k). The devices were
adulterated in that the methods used in, or the facilities or controls
used for, their manufacture, processing, packing, and storage were not
in conformity with current good manufacturing requirements--501(h). The
devices were misbranded in that the defendants failed to file the
required medical device reporting information--502(t)(2).
DISPOSITION: The district court enjoined the defendants for failing to
furnish medical device reporting information. The corporate defendant
filed an appeal, and the appellate court affirmed the district court's
decision. Subsequently, the firm ceased operations. (Inj. No. 1326; S.
No. 93-591-710/3; S.J. No. 15

DEFENDANTS: Royal Baltic Ltd., Vladamir Furleiter, and Alexander
Kaganovsky, at Brooklyn, N.Y. (E.D. N.Y.); Civil Action No. CV-94-1178.
CHARGED 5-15-95: The defendants introduced into interstate commerce
adulterated fish--301(a) and 301(k). The fish was adulterated in that it
was prepared, packed and held under insanitary conditions whereby it
might have been rendered injurious to health--402(a)(4).
DISPOSITION: A consent decree of permanent injunction was filed. (Inj.
No. 1314; S. No. 92-647-646; S.J. No. 16


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


MISCELLANEOUS ACTIONS

ACTION: Bristol-Myers Squibb Co. v. Shalala and Kessler, at Washington,
D.C. (D.D.C.); Civil Action No. 1:94CV01516.
CHARGED 7-13-94: The plaintiff, a pioneer drug manufacturer, challenged
regulations authorizing approval of generic drugs for less than all
indications approved for the pioneer product.
DISPOSITION: The district court dismissed the complaint for lack of
constitutional standing. The plaintiff appealed, and the appellate court
reversed the lower court's decision. The appellate court held that FDA
may approve a generic version of a pioneer product when the pioneer
enjoys exclusivity over one or more, but not all, indications. (Misc.
No. 1040; S.J. No. 17

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