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FDA Consumer magazine

VOL. 30 No. 1
JANUARY-FEBRUARY 1996
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Features

How to Give Medicine to Children
Vigilance is key to making sure that medicines help, rather than hurt,
children. Caregivers need to always be alert to several factors,
including drug interactions, proper dosage, and possible tampering.

Looking for a Libido Lift? The Facts About Aphrodisiacs
People looking for magical love potions are likely to be disappointed
and defrauded. But real help for impotence does exist in several forms,
including a recently approved prescription drug.

Losing Weight Safely
Though millions of Americans are dieting at any given time, obesity in
this country is on the rise. What's the reason for this seeming paradox?
Is there any safe way to take weight off and keep it off? 

On the Teen Scene: Young People Talk with FDA Commissioner About Smoking
On a recent radio talk show, FDA Commissioner Kessler chatted with
teenagers about what roles they think their friends and advertising play
in getting youngsters started smoking cigarettes.

Testicular Cancer: Survival High with Early Treatment
Cancer of the testicles accounts for only 1 percent of all cancers, yet
it is the most common cancer among young men. It is now highly curable
if treated early, but men need to look for the warning signs.


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Departments



Updates 

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



Consumer Forum 

Letters to the editor of FDA Consumer magazine.



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 will not appear in this issue of FDA Consumer
magazine. This department will return in the March issue. 



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How to Give Medicine to Children

by Rebecca D. Williams

"Open wide ... here comes the choo-choo."

When it comes to giving children medicine, a little imagination never
hurts.

But what's more important is vigilance: giving the medicine at the right
time at the right dose, avoiding interactions between drugs, watching
out for tampering, and asking your child's doctor or the pharmacist
about any concerns you may have.

Whether it's a prescription or over-the-counter (OTC) drug, dispensing
medicine properly to children is important. Given incorrectly, drugs may
be ineffective or harmful.

Read the Label

"The most important thing for parents is to know what the drug is, how
to use it, and what reactions to look for," says Paula Botstein, M.D.,
pediatrician and acting director of the Food and Drug Administration's
Office of Drug Evaluation III. She recommends that a parent should ask
the doctor or pharmacist a number of questions before accepting any
prescription:


 * What is the drug and what is it for?
 * Will there be a problem with other drugs my child is taking?
 * How often and for how long does my child need to take it?
 * What if my child misses a dose?
 * What side effects does it have and how soon will it start working?

It's also a good idea to check the prescription after it has been
filled. Does it look right? Is it the color and size you were expecting?
If not, ask the pharmacist to explain.

Check for signs of tampering in any OTC product. The safety seal should
be intact before opening. Also, parents should be extra careful to read
the label of over-the-counter medicines.

"Read the label, and read it thoroughly," says Debra Bowen, M.D., an
internist and director of FDA's medical review staff in the Office of
OTC Drugs. "There are many warnings on there, and they were written for
a reason. Don't use the product until you understand what's on the
label."

Make sure the drug is safe for children. This information will be on the
label. If the label doesn't contain a pediatric dose, don't assume it's
safe for anyone under 12 years old. If you still have questions, ask the
doctor or pharmacist.

Children are more sensitive than adults to many drugs. Antihistamines
and alcohol, for example, two common ingredients in cold medications,
can have adverse effects on young patients, causing excitability or
excessive drowsiness. Some drugs, like aspirin, can cause serious
illness or even death in children with chickenpox or flu symptoms. Both
alcohol and aspirin are present in some children's medications and are
listed on the labels.

Younger and Trickier

The younger the child, the trickier using medicine is. Children under 2
years shouldn't be given any over-the-counter drug without a doctor's
OK. Your pediatrician can tell you how much of a common drug, like
acetaminophen (Tylenol), is safe for babies.

Prescription drugs, also, can work differently in children than adults.
Some barbiturates, for example, which make adults feel sluggish, will
make a child hyperactive. Amphetamines, which stimulate adults, can calm
children.

When giving any drug to a child, watch closely for side effects.

"If you're not happy with what's happening with your child, don't assume
that everything's OK," says Botstein. "Always be suspicious. It's better
to make the extra calls to the doctor or nurse practitioner than to have
a bad reaction to a drug."

And before parents dole out OTC drugs, they should consider whether
they're truly necessary, Botstein says.

Americans love to medicate--perhaps too much. A study published in the
October 1994 issue of the Journal of the American Medical Association
found that more than half of all mothers surveyed had given their
3-year-olds an OTC medication in the previous month.

Not every cold needs medicine. Common viruses run their course in seven
to 10 days with or without medication. While some OTC medications can
sometimes make children more comfortable and help them eat and rest
better, others may trigger allergic reactions or changes for the worse
in sleeping, eating and behavior. Antibiotics, available by
prescription, don't work at all on cold viruses.

"There's not a medicine to cure everything or to make every symptom go
away," says Botstein. "Just because your child is miserable and your
heart aches to see her that way, doesn't mean she needs drugs."

Dosing Dilemmas

The first rule of safety for any medicine is to give the right dose at
the right time interval.

Prescription drugs come with precise instructions from the doctor, and
parents should follow them carefully. OTC drugs also have dosing
instruction on their labels. Getting the dosage right for an OTC drug is
just as important as it is for a prescription drug.

Reactions and overdosing can happen with OTC products, especially if
parents don't understand the label or fail to measure the medicine
correctly. Similar problems can also occur when parents give children
several different kinds of medicine with duplicate ingredients.

"People should exercise some caution about taking a bunch of medicines
and loading them onto a kid," Botstein says.

Pediatric liquid medicines can be given with a variety of dosing
instruments: plastic medicine cups, hypodermic and oral syringes, oral
droppers, and cylindrical dosing spoons.

Whether they measure teaspoons, tablespoons, ounces, or milliliters,
these devices are preferable to using regular tableware to give
medicines because one type of teaspoon may be twice the size of another.
If a product comes with a particular measuring device, it's best to use
it instead of a device from another product.

It's also important to read measuring instruments carefully. The numbers
on the sides of the dosing instruments are sometimes small and difficult
to read. In at least one case, they were inaccurate. In 1992, FDA
received a report of a child who had been given two tablespoons of
acetaminophen rather than two teaspoons because the cup had confusing
measurements printed on it. The incident prompted a nationwide recall of
medicines with dosage cups.

The following are some tips for using common dosing instruments:


 * Syringes: Syringes are convenient for infants who can't drink from a
cup. A parent can squirt the medicine in the back of the child's mouth
where it's less likely to spill out. Syringes are also convenient for
storing a dose. The parent can measure it out for a babysitter to use
later. There are two kinds of syringes: oral syringes made specifically
for administering medicine by mouth, and hypodermic syringes (for
injections), which can be used for oral medication if the needles are
removed. For safety, parents should remove the needle from a hypodermic
syringe. Always remove the cap on the end of all syringes before
injecting the medication into the child's mouth. The cap can pop off in
the child's mouth and create a choking hazard. FDA is working with
manufacturers to eliminate the safety hazards posed by the caps. Until
then, parents must be extra cautious when using capped syringes.

* Droppers: These are safe and easy to use with infants and children too
young to drink from a cup. Be sure to measure at eye level and
administer quickly, because droppers tend to drip.

* Cylindrical dosing spoons: These are convenient for children who can
drink from a cup but are likely to spill. The spoon looks like a test
tube with a spoon formed at the top end. Small children can hold the
long handle easily, and the small spoon fits easily in their mouths.

* Dosage cups: These are convenient for children who can drink from a
cup without spilling. Be sure to check the numbers carefully on the
side, and measure out liquid medicine with the cup at eye level on a
flat surface.

FDA Proposes New Regulations

FDA is working on changing the labels of over-the-counter medications to
make them more eye-catching, easier to read, and consumer-friendly. One
such label appears on the recently approved OTC version of children's
Motrin.

For prescription drugs, FDA took measures in December 1994 to provide
more information to health-care providers about use of those products in
children. This rule was final in January 1995.

The agency now lets prescription drug manufacturers base pediatric
labeling on data extrapolated from adequate and well-controlled adult
studies, together with other information about safety and dosing in
children. This is allowed as long as the agency concludes that the
course of the disease and the drug's effects are sufficiently similar in
children and adults.

Presently, most prescription drugs do not contain pediatric doses on
their labels. A 1979 regulation required full clinical trials in
children as the basis for pediatric labeling. Doctors who need to
prescribe those drugs to children do so based on their own experience
and reports in medical literature. The new regulations will give
health-care providers more information to prescribe medicine for
children safely.

In addition, FDA is taking steps to increase the numbers of drugs being
tested in children, and the agency is working closely with the National
Institute of Child Health and Human Development to conduct pediatric
studies.

The goal of FDA's changes is to help ensure that whenever a child
receives medication, it is as safe and effective as possible.

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


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Aspirin and Children

Remember those orange-flavored baby aspirin tablets? They're not usually
for kids anymore.

Children and teenagers should never take aspirin, or products containing
aspirin or other salicylates, if they have chickenpox or flu symptoms or
are recovering from these or other viral illnesses. Such aspirin use has
been associated with Reye syndrome, a rare but serious condition that
can cause death.

"The incidence of Reye syndrome has dropped dramatically," says Debbie
Lumpkins, an FDA microbiologist in the Office of OTC Drugs, "but that
doesn't mean it can't still happen."

FDA has proposed adding a more descriptive warning label on aspirin and
other products containing salicylates. The label would describe symptoms
of Reye syndrome in more detail than it does now.

To reduce fever safely in children, use acetaminophen or ibuprofen products.

--R.D.W.

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Looking for a Libido Lift?
The Facts About Aphrodisiacs

by Tamar Nordenberg

The moon is nothing
But a circumambulating aphrodisiac
Divinely subsidized to provoke the world
Into a rising birth-rate
--from A Sleep of Prisoners by Christopher Fry

In the pursuit of sexual success and fertility, the moon, and everything
under it, has been touted as an aphrodisiac by some person or culture.
Love potion peddlers stop at nothing to sell their sexual wares. "I'll
make you the same promise that my wife made to me," says Theodore
Maximillian in the provocative brochure for his "Maxim" product. "I'm
going to cure your impotence immediately!" Maxim "acts as a potent
aphrodisiac," according to the advertisement.

An aphrodisiac is a food, drink, drug, scent, or device that, promoters
claim, can arouse or increase sexual desire, or libido. A broader
definition includes products that improve sexual performance. Named
after Aphrodite, the Greek goddess of sexual love and beauty, the list
of supposed sexual stimulants includes anchovies and adrenaline,
licorice and lard, scallops and Spanish fly, and hundreds of other
items.

According to the Food and Drug Administration, the reputed sexual
effects of so-called aphrodisiacs are based in folklore, not fact. In
1989, the agency declared that there is no scientific proof that any
over-the-counter aphrodisiacs work to treat sexual dysfunction.

Countering Cultural Views

FDA's findings clash with a 5,000-year tradition of pursuing sexual
betterment through use of plants, drugs and magic. Despite FDA's
determination that OTC aphrodisiacs are ineffective--and sometimes even
dangerous--people continue the optimistic quest for drug-induced sexual
success.

Several principles help demystify some cultural views about
aphrodisiacs. Sometimes the reason for an item's legendary reputation is
obvious. It's easy to imagine how the sex organs of animals such as
goats and rabbits, known for their procreativeness, have achieved their
esteemed status as love aids in some cultures.

Chilies, curries, and other spicy foods have been viewed as aphrodisiacs
because their physiological effects--a raised heart rate and sometimes
sweating--are similar to the physical reactions experienced during sex.
And some foods were glorified as aphrodisiacs based on their rarity and
mystery. While chocolate was once considered the ultimate aphrodisiac,
the reputation wore off as it became commonly available.

Many ancient peoples believed in the so-called "law of similarity,"
reasoning that an object resembling genitalia may possess sexual powers.
Ginseng, rhinoceros horn, and oysters are three classical examples.

The word ginseng means "man root," and the plant's reputation as an
aphrodisiac probably arises from its marked similarity to the human
body. Ginseng has been looked on as an invigorating and rejuvenating
agent for centuries in China, Tibet, Korea, Indochina, and India. The
root may have a mild stimulant action, like coffee. There have been some
experiments reporting a sexual response in animals treated with ginseng,
but there is no evidence that ginseng has an effect on human sexuality.

The similarity of the shape of the rhinoceros horn to the penis is
credited for its worldwide reputation as a libido enhancer. The horn
contains significant amounts of calcium and phosphorus. The addition of
the food to a deficient diet could improve general physical vigor and
possibly lead to an increased sexual interest. But in most Americans'
diets, which are usually not lacking calcium or phosphorus, the small
quantities usually consumed would not affect physical performance.

Because Aphrodite was said to be born from the sea, many types of
seafood have reputations as aphrodisiacs. Oysters are particularly
esteemed as sex aids, possibly gaining their reputation at a time when
their contribution of zinc to the nutritionally deficient diets of the
day could improve overall health and so lead to an increased sex drive.

Shortage of Studies

There is no proof that ginseng, rhinoceros horn, or oysters have an
effect on human sexual reaction. But might some foods and OTC drugs
eventually be proven to affect sexual appetite? Some big obstacles exist
to answering this question. The placebo effect is one scientific
stumbling block.

"The mind is the most potent aphrodisiac there is," says John Renner,
founder of the Consumer Health Information Research Institute (CHIRI).
"It's very difficult to evaluate something someone is taking because if
you tell them it's an aphrodisiac, the hope of a certain response might
actually lead to an additional sexual reaction."

Because the psychological complications are absent in animals, some
studies have been done on the effect of certain drugs on animals' sexual
activity. One substance that was tested extensively in animals is
yohimbine. Obtained from the bark of an African tree, yohimbine has been
used for centuries in Africa and West India for its supposed aphrodisiac
properties. It supposedly works by stimulating the nerve centers in the
spine that control erection. FDA called the results of preliminary
animal studies "encouraging," but animal studies cannot be relied on to
show the effectiveness of the drug in humans.

In people, the only available evidence is anecdotal and subjective. To
scientifically measure sexual stimulation, a valid human study would
have to be performed in the laboratory, comparing a placebo (an inert
pill with no active ingredients) to the test aphrodisiac. Preferably,
neither the researchers nor the patients would know who was getting the
test substance. Because of cultural taboos, few such studies have been
undertaken.

A second obstacle to obtaining proof of aphrodisiac effects is that some
drugs may not actually have specific sexual effects, but may change a
person's mood and therefore seem to be an aphrodisiac. For example,
alcohol has been called a "social lubricant." People drink for many
reasons, including to relax, reduce anxiety, gain self-confidence, and
overcome depression. Because sexual problems can be caused or worsened
by psychological stress, moderate drinking might seem like a sexual
enhancer. In fact, it merely lessens inhibitions.

Alcohol is actually a depressant, and so, as the porter in Shakespeare's
Macbeth observed, it "provokes the desire, but it takes away the
performance." And drinking too much actually decreases desire.

No Quick Fix

Despite the lack of scientific evidence of safety and effectiveness, the
fraudulent OTC love potion industry thrives to this day. Marketers use a
"blatant snake-oil approach," according to CHIRI's Renner. He estimates
that the aphrodisiac sellers, who do much of their business by
mail-order, take in revenues in the hundreds of millions of dollars a
year.

FDA sends warning letters to companies that make aphrodisiac claims,
stating that the agency may take further regulatory action if the
violations continue. "In the health fraud area, when they get a warning
letter, most people take their profits and run," says Joel Aronson,
director of FDA's division of nontraditional drugs. "They don't want to
get into a legal battle with the agency because it could involve
protracted, expensive litigation."

Aphrodisiac experimentation isn't just a rip-off--it can be deadly.
Spanish fly, or cantharides, is probably the most legendary
aphrodisiac--and the most dangerous. Made from dried beetle remains, the
reported sexual excitement from Spanish fly comes from the irritation to
the urogenital tract and a resultant rush of blood to the sex organs.
But Spanish fly is a poison that burns the mouth and throat and can lead
to genitourinary infections, scarring of the urethra, and even death.

To avoid being taken for their money or their lives, individuals with
sexual problems should seek a physician's advice. A lack of sexual
energy or ability in men or women could be caused by something as simple
as stress or a medication one is taking, or as serious as an underlying
condition like diabetes or high blood pressure.

A doctor can diagnose a sexual problem and recommend treatment. If
necessary, a doctor can prescribe a drug to treat sexual dysfunction.
Testosterone replacement therapy is one prescription option for men
whose natural testosterone level is not within the normal range, but its
serious potential side effects call for a physician's supervision. For
those with an impotence problem that isn't caused by low testosterone
levels, the new "Caverject" injection may be the answer.

"People will continue to have false hopes of finding easy ways of
resolving their problems," says Aronson. And so the hunt for the elusive
love drug persists. A universal aphrodisiac may never be found, but
experts agree that what's good for your overall health is probably good
for your sex life too.

A good diet and a regular exercise program are a more dependable path to
better sex than are goats' eyes, deer sperm, and frogs' legs. A good
mental state is equally important.

Maybe the wishful search for a cure-all drug should be abandoned in
favor of an easier, more reliable mechanism: the erotic stimulation of
one's own imagination. To quote renowned sex expert "Dr. Ruth"
Westheimer, Ed.D.: "The most important sex organ lies between the ears."

Tamar Nordenberg is a lawyer with the Office of the Director in FDA's
Center for Drug Evaluation and Research.


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First Impotence Drug

For the 10 million to 20 million American men who suffer from impotence,
the Food and Drug Administration's July 6, 1995, approval of Upjohn
Company's prescription drug Caverject (alprostadil) may prove to be
life-altering. Caverject is the first prescription drug approved for
impotence, and is expected to successfully treat 70 to 80 percent of
patients.

The drug provides an alternative to devices previously approved by FDA.
A vacuum device involves placing a cylinder-like device and attached
pump over the penis. By using the pump, blood is drawn into the penis,
creating an erection. A constriction band is then placed at the base of
the penis to maintain erection. A second treatment option, the penile
implant, involves the surgical placement of cylinders in the penis and
is available in a variety of designs. (See "Inflatable Penile Implants
Under Scrutiny" in the January-February 1994 FDA Consumer.)

FDA approved Caverject to treat impotence caused by neurological,
vascular or psychological dysfunction. While psychological factors such
as anxiety and depression can lead to sexual dysfunction, more than 85
percent of impotence cases have a physical cause, according to the
Impotence Institute of America. A complete physical examination is
important so that any underlying condition can be diagnosed and treated.
Some common causes of impotence are diabetes, arteriosclerosis
(hardening of the arteries), and high blood pressure. Also, impotence
has reportedly been caused by 16 of the 200 most commonly prescribed
drugs, including drugs for high blood pressure, heart disease, and
depression.

Caverject is self-injected into the penis shortly before sexual
intercourse. The drug creates an erection by relaxing the smooth muscle
tissue and dilating the major artery in the penis, which enhances the
blood flow to the penis.

The drug's most common side effect is penile pain. Other side effects
include bleeding at the injection site and an unhealthy, prolonged
erection of four to six hours. --T.N.


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Losing Weight Safely

by Marilynn Larkin

Americans trying to lose weight have plenty of company. According to a
1995 report from the Institute of Medicine (IOM), tens of millions of
Americans are dieting at any given time, spending more than $33 billion
yearly on weight-reduction products, such as diet foods and drinks.

Yet, studies over the last two decades by the National Center for Health
Statistics show that obesity in the United States is actually on the
rise. Today, approximately 35 percent of women and 31 percent of men age
20 and older are considered obese, up from approximately 30 percent and
25 percent, respectively, in 1980. 

The words obesity and overweight are generally used interchangeably.
However, according to the IOM report, their technical meanings are not
identical. Overweight refers to an excess of body weight that includes
all tissues, such as fat, bone and muscle. Obesity refers specifically
to an excess of body fat. It is possible to be overweight without being
obese, as in the case of a body builder who has a substantial amount of
muscle mass. It is possible to be obese without being overweight, as in
the case of a very sedentary person who is within the desirable weight
range but who nevertheless has an excess of body fat. However, most
overweight people are also obese and vice versa. Men with more than 25
percent and women with more than 30 percent body fat are considered
obese. 

Many people who diet fail to lose weight--or, if they do lose, fail to
maintain the lower weight over the long term. As the IOM report,
"Weighing The Options: Criteria for Evaluating Weight-Management
Programs," points out, obesity is "a complex, multifactorial disease of
appetite regulation and energy metabolism." 

Because many factors affect how much or how little food a person eats
and how that food is metabolized, or processed, by the body, losing
weight is not simple. For example, recent studies suggest a role for
genetic makeup in obesity. This area is still controversial, and more
studies will be needed before scientists can say with certainty that a
person's genes may set limits on how much weight can be lost and
maintained. 

Yet many people persist in seeking simple cures to this complex health
problem. Lured by fad diets or pills that promise a quick and easy path
to thinness, they end up disappointed when they regain lost weight.

"When it comes to weight loss, if something sounds too good--or too
easy, or too delicious--to be true, it probably is," says Victor
Herbert, M.D., J.D., professor of medicine and director of the Nutrition
Center at the Mount Sinai School of Medicine and Bronx VA Medical
Centers in New York City, and member of the board of directors of the
National Council Against Health Fraud. "If a weight loss claim is
sensational, it is not true; if it is true, it is not sensational."

No Shortcuts

"There are no shortcuts--no magic pills," adds Lori Love of the Food and
Drug Administration's Center for Food Safety and Applied Nutrition.
Losing weight sensibly and safely requires a multifaceted approach that
includes setting reasonable weight-loss goals, changing eating habits,
and getting adequate exercise. Appetite suppressants (diet pills) or
other products may help some people over the short term, but they are
not a substitute for adopting healthful eating habits over the long
term.

The first step in losing weight safely is to determine a realistic
weight goal. Two types of tables are commonly used as guidelines. One is
the weight-for-height table developed in 1990 by the U.S. Department of
Agriculture and the Department of Health and Human Services. This table
offers a range of suggested weights for adults based on height and age.

Another table uses body mass index (BMI), a mathematical formula that
correlates weight with body fat. In 1993, the National Institute of
Diabetes and Digestive and Kidney Diseases developed a table that
correlates height, weight and BMI. 

A physician or other health provider can help you set a reasonable goal
with these tables. To reach the goal safely, plan to lose 1 to 2 pounds
weekly by consuming approximately 300 to 500 fewer calories daily than
usual (women and inactive men generally need to consume approximately
2,000 calories to maintain weight; men and very active women may consume
up to 2,500 calories daily).

Moderation, Variety and Balance

After determining a reasonable goal weight, devise an eating plan based
on the cornerstones of healthful eating--moderation, variety and
balance, suggests Herbert. 

"Moderation means not eating too much or too little of any particular
food or nutrient; variety means eating as wide a variety as possible
from each, and within each, of the five basic food groups; and balance
refers to the balance achieved by following moderation and variety, as
well as the balance of calories consumed versus calories expended," he
explains. To lose weight, fewer calories should be consumed than
expended; to maintain weight loss, the number of calories consumed and
expended should be about the same.

The five basic food groups and the recommended number of servings from
each are incorporated into the Food Guide Pyramid developed by USDA and
HHS. These groups are (1) bread, cereal, pasta, and rice; (2)
vegetables; (3) fruits; (4) milk, yogurt and cheese; and (5) meat,
poultry, fish, dry beans, eggs, and nuts. A sixth group (fats, oils and
sweets) consists mainly of items that are pleasing to the palate but
high in fat and/or calories; these should be eaten in moderation.

Using the Food Label

To help consumers plan a healthful diet, FDA and USDA have revamped food
labels. By law, most food labels now must display a Nutrition Facts
panel containing information about how the food can fit into an overall
daily diet. Nutrition Facts state how much saturated fat, cholesterol,
fiber, and certain nutrients are contained in each serving. Serving
sizes must now be based on standards set for similar kinds of food, so
the nutritional value of similar products may be compared.

On the food label, percentDaily Value shows what percentage of a given
nutrient is provided in one portion for daily diets of 2,000 and 2,500
calories. 

Whether or not a given food fits into a weight-loss diet depends on what
other foods you eat that day. For most people, the goal is to select a
variety of foods that together add up to approximately 100 percent of
the Daily Value for total carbohydrate, dietary fiber, vitamins, and
minerals; total fat, cholesterol and sodium each may add up to less than
100 percent.

This system permits a good deal of flexibility. No food is inherently
"bad"; it is the total diet for the day that counts. You may compensate
for an occasional rich dessert or serving of fried food by eating foods
that are low in fat, oil or sugar for the rest of the day. However,
high-fat foods should be limited, because they can quickly use up a
day's supply of calories without providing high percentages of vital
nutrients.

Simple modifications in food selection and preparation allow you to
include traditional favorites and snacks within the context of a
healthful weight-loss diet; for example, select 1 percent or skim milk
products instead of those made with whole milk, lean cuts of meat and
poultry, and nonfat frozen yogurt instead of ice cream. Low-fat plain
yogurt may be substituted for sour cream in dips, dressings or spreads;
reduced-fat cheeses may be used instead of those made from whole milk.
Broil, roast or steam foods instead of frying.

Look on the nutrition label for words such as "low," "light" or
"reduced" to describe the calorie and fat content per serving. These
foods must have significantly fewer calories or significantly less fat
than similar products that do not make these claims. Foods that are
advertised as "low in cholesterol" also must be low in saturated fat. 

Foods that claim to contain fewer calories or less fat than similar
servings of similar products must show the difference on the label. For
example, on a container of low-fat cottage cheese, the label would show
that a serving of the low-fat product contains 80 calories and 1.5 grams
of fat while regular cottage cheese contains 120 calories and 5 grams of
fat per serving.

Include small portions of desserts or high-fat snacks rather than
attempting to cut them out altogether. Eliminating favorite foods may
result in cravings that can lead to binge eating and weight gain.

Avoid low-calorie fad diets that exclude whole categories of food such
as carbohydrates (bread and pasta) or proteins (meat and poultry). These
diets may be harmful because they generally do not include all nutrients
necessary for good health. "Every fad diet that demands an unusual
eating pattern, such as emphasizing only a few types of foods, deviates
from one or more of the guidelines of moderation, variety and balance,"
says Herbert. "The greater the deviation, the more harmful the diet is
likely to be."

Exercise

Regular exercise is important for overall health as well as for losing
and maintaining weight. There is evidence to suggest that body fat
distribution affects health risks. For example, excess fat in the
abdominal area (as opposed to hips and thighs) is associated with
greater risk for high blood pressure, diabetes, early heart disease, and
certain types of cancer. Vigorous exercise can reduce abdominal fat and
thus lower the risk of these diseases.

A half hour of brisk walking or other aerobic activity three times
weekly can help the body use up calories consumed daily as well as
excess calories stored as fat. Weight-bearing exercises also help tone
muscles and may reduce the risk of osteoporosis.

Diet Pills

The 1991/1992 Weight Loss Practices Survey, sponsored by FDA and the
National Heart, Lung, and Blood Institute, found that 5 percent of women
and 2 percent of men trying to lose weight use diet pills. Products
considered by FDA to be over-the-counter weight control drugs are
primarily those containing the active ingredient phenylpropanolamine
(PPA), such as Dexatrim and Acutrim. PPA is available OTC for weight
control in a 75-mg controlled-release dosage form, when combined with a
restricted diet and exercise.

Using diet pills containing PPA will not make a big difference in the
rate of weight loss, says Robert Sherman of FDA's Office of OTC Drug
Evaluation. "Even the best studies show only about a half pound greater
weight loss per week using PPA combined with diet and exercise," he
adds. Sherman cautions that the recommended dosage of these pills should
not be exceeded because of the risk of possible adverse effects, such as
elevated blood pressure and heart palpitations.

Since PPA is also used as a nasal decongestant in over-the-counter cough
and cold products, consumers should read the labels of OTC decongestants
to see if they contain PPA. They should not take PPA in two products
labeled for different uses.

Sherman notes that FDA has received a small number of reports indicating
that PPA use might be associated with an increased risk of stroke. A
large-scale safety study was begun in September 1994 to explore the
possibility. Based on available data, the agency does not believe that
an increased risk of stroke is a concern when PPA is used at recommended
dosages.

Weight-Loss Programs

Many people turn to weight-loss programs for help in planning a daily
diet and changing lifestyle habits. The IOM report provides guidelines
for evaluating the potential effectiveness of such programs.

"To improve their chances for success, consumers should choose programs
that focus on long-term weight management; provide instruction in
healthful eating, increasing activity, and improving self-esteem; and
explain thoroughly the potential health risks from weight loss,"
according to the report. Consumers should also demand evidence of
success. If it is absent or consists primarily of testimonials or other
anecdotal evidence, "the program should be viewed with suspicion."

IOM recommends that potential clients be given a truthful, unambiguous,
non-misleading statement about the program's approaches and goals, and a
full disclosure of costs. The cost breakdown should include initial and
ongoing costs, as well as the cost of extra products.

The basic tenet of weight loss--to eat fewer calories than you burn and
to stay active--is easy to say but, like most lifestyle changes, not so
easy to do. With realistic goals, and a commitment to losing weight
slowly, safely and sensibly, the chances of long-term success improve
dramatically.

Marilynn Larkin is a writer in New York City.


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


Obesity a Disease

Obesity is now considered a disease--not a moral failing. According to a
new report from the Institute of Medicine, "obesity is a heterogeneous
disease in which genetic, environmental, psychological, and other
factors are involved. It occurs when energy intake exceeds the amount of
energy expended over time. Only in a small minority of cases is obesity
caused by such illnesses as hypothyroidism or the result of taking
medications, such as steroids, that can cause weight gain." 

Public health concerns about this disease relate to its link to numerous
other diseases that can lead to premature illness or death. The report
notes that overweight individuals who lose even relatively small amounts
of weight are likely to:

 * lower their blood pressure (and thereby the risk of heart attack and
   stroke)

 * reduce abnormally high levels of blood glucose (associated with
   diabetes)

 * bring blood levels of cholesterol and triglycerides
   (associated with cardiovascular disease) down to more desirable levels

 * reduce sleep apnea, or irregular breathing during sleep

 * decrease the risk of osteoarthritis of the weight-bearing joints

 * decrease depression

 * increase self-esteem.

Of course, losing excess weight is also likely to improve appearance,
which is a strong motivation for many people.

To order a copy of the IOM report, call (1-800) 624-6242 (in Washington,
D.C., call 202-334-3313). The cost is $30 plus $4 shipping and handling.

--M.L.


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

On the Teen Scene:
Young People Talk with FDA Commissioner About Smoking



The Clinton Administration has proposed measures to significantly reduce
the number of children and teenagers who become addicted to cigarettes
and smokeless tobacco. FDA published a proposed regulation for those
measures in the Federal Register of Aug. 11, 1995.

The measures include: reducing children's easy access to cigarettes by
requiring age verification and face-to-face sale; eliminating mail-order
sales, free samples, self-service displays, and sale of single
cigarettes and packages with fewer than 20 cigarettes; banning outdoor
advertising within 1,000 feet of schools and playgrounds; permitting
black-and-white text-only advertising in publications with significant
numbers of readers under 18; prohibiting sale or giveaway of products,
like caps, that carry cigarette or smokeless tobacco brand names or
logos; prohibiting brand-name sponsorship of sporting or entertainment
events; and requiring industry to fund a public education program to
prevent children from smoking.

On Aug. 28, 1995, FDA Commissioner David A. Kessler, M.D., was a guest
on National Public Radio's "Talk of the Nation" to discuss smoking with
several teenagers. Here are excerpts from that broadcast, hosted by Ray
Suarez.)



Ray Suarez: Do you smoke cigarettes? Have you ever smoked cigarettes?
Can you remember when and how you started? If you're like most smokers,
past and present, you would have started young, at an age when you
legally weren't even allowed to buy tobacco. The statistics say an adult
smoker goes into training in the teen years. Someone who reaches
adulthood without becoming a smoker is unlikely ever to become one.
We have an unusual hour of the program for you today, a conversation on
youth and smoking. Dr. David Kessler, the commissioner of the Food and
Drug Administration, is with us in Washington along with a group of 20
young people from the D.C. Metropolitan area, a group of older and young
teens, nonsmokers, smokers and ex-smokers. Dr. Kessler, I'm curious
about what's behind your campaign. I think it's fair to say, among all
the threats to public health, this is the one you've been most out front
on, most associated with in the public mind. Why?

David A. Kessler, M.D.: Ray, one in five Americans will die from a
smoking-related illness. Each day, 3,000 kids begin to smoke, and of
those 3,000 about 1,000 will go on to die from a smoking-related
illness. This is, without a doubt, the most important public health
problem facing us. It's also the most preventable. Despite what the
tobacco executives say, smoking is very addictive. And it's this window
of addiction during the teenage years that's very important to
understand, because what the president has done is to try to take steps
to close that window. Most kids who smoke, seven out of ten when you ask
them, say they regret ever having started.

Suarez: What do the studies say about which kinds of teens are most at
risk to make this a lifelong habit?

Kessler: There is a study called "Youth Targets, 1987" and it was
prepared for the sister company of R.J. Reynolds in Canada, and this is
how that document, prepared by certain consultants for the tobacco
industry, views teenage smoking: They divided teenagers into different
categories: tomorrow's leaders, big city independents, quiet conformers,
the TGIF group, insecure moralists, and small town traditionalists.
Those were just some of the terms they used. And their own research
found that it was the TGIF group that had the highest incidence of
smoking. This is almost one-third of youth. It says males predominate.
Achievement in leadership is not a goal for this group compared with
others. Typical of their attitudes and values are, "I would not rather
read a book than go out. I do not think my life is a success." Now, that
doesn't mean that everybody who starts to smoke is in that group. But
they have the information on where smoking is more common.

Suarez: Well, our studio guests spend a lot more time in high schools
than either you and I do. And I'd love to hear what some of them have to
say about who smokes in your school, in your neighborhood, among your
friends and peers. Who wants to get us started?

[Laughter]

Regiana: I'm 14. I think that the people that try to be cool with the
people--that's usually how it starts, with peer pressure. 

Suarez: And you are not a smoker.

Regiana: No, I'm not a smoker.

Suarez: When Dr. Kessler was describing the TGIF crowd, did any of you
recognize people you know from school in that description?

Brian: I'm 18. I went to high school in Los Angeles, and attitudes over
there are very different about smoking. The people in my high school who
started smoking typically came from a broken home, and to them, their
peer group was more important than just about anything, and smoking to
them was part of their peer group. And they did it because it was cool,
because it was hip, because they saw people in magazines smoking. These
are more the Bohemian kids, kind of the beatnik kids, and to them it was
kind of a group identification.

Leah: I'm 16. I've been smoking for quite some time, and I know when I
first started, because I started so young it was a peer thing, and it
was because I wanted to hang out with the older crowd, and the older
crowd was smoking at the time. But I smoke now and it's strictly my
choice. And I think I have pretty high goals for myself. I'd like to be
a pretty big leader in what I do.

Kessler: How old were you when you started to smoke?

Leah: About 8 or 9.

Kessler: Do you know about the health risks at all?

Leah: When I had my first cigarette, no, I had never heard anything
about it. I have a lot of people in my family who smoke and, of course,
at the time that they were smoking and I had started, none of them were
dying of it yet.

Kessler: Do you believe you would ever have a risk, a chance of getting
sick from smoking?

Leah: Oh yeah. My family is now dying of it. A lot of my family members
have died from cancer and smoking-related [causes].

Kessler: Why do you continue to smoke?

Leah: It's a habit now.

Kessler: Tell me a little about the habit.

Leah: It's very addictive, like they say. It's a very addictive drug.

Kessler: When you started at 8 or 9, did you think you would get hooked?

Leah: No. When I first started I figured, okay, one cigarette is not
going to hurt me. And then, you know, one cigarette a day isn't going to
hurt me. Two cigarettes a day isn't going to hurt me.

Kessler: Did you think you would be able to quit?

Leah: Yeah.

Kessler: Have you tried to quit?

Leah: Many times. 

Kessler: And you failed?

Leah: Miserably.

Kessler: The tobacco industry has known about teenagers who smoke, and
their consultants did studies called "Project 16" [and] "Project
Plus/Minus." [They reported] that around the ages of 11 to 13 there is
peer pressure exerted by smokers on nonsmokers, that serious smoking
really starts about 14, 15 years of age, that starters no longer
disbelieve the dangers of smoking, but they almost universally assume
that these risks will not apply to themselves because they themselves
will not become addicted. But addicted they do indeed become. And once
there is acceptance that addiction is taking place, thoughts of quitting
most often follow. They continue to write that the desire to quit seems
to come earlier now than before, even prior to the end of high school.
In fact, it often seems to take hold as soon as the recent starter
begins to see that he is hooked on smoking. However, the desire to quit
and actually carrying it out are two quite different things. Once you
sense you're hooked, only then do you have some desire to really quit.
And then the problem is, it's too late. Does that seem to be correct?

Leah: Yeah. In a sense. I think it depends, like everybody has been
saying, on the group you hang out with, the group you want to hang out
with.

Suarez: We have some people in our audience who quit. Let's hear from
them.

Tyler: I'm 16 years old. I started smoking maybe about two years ago in
my freshman year of high school, and I did it mainly because it was my
choice. Some of my friends smoked and some of them didn't. I didn't do
it to hang out with anyone, but I think maybe I did it to tick my
parents off or my way of rebelling, maybe. I only smoked for about three
months, and during those three months, I think I became quite addicted.
But stopping: My parents watched me and I was not allowed to go anywhere
or do basically anything until I had proven to them that I had quit. So
they kind of cut off my supply of getting any cigarettes. And after
about six months after that, I hadn't had a cigarette because I had
almost no way of getting to one.

Kessler: Is it really a choice issue? That's what the tobacco industries
want you to believe. And I think you can argue that the decision to
smoke your first cigarette is a matter of choice. But this is a product
that addicts its users. It's a marketplace that's sustained by
addiction. What choice is there once you've really become addicted?
Isn't it much harder to quit? When you picked up your first cigarette,
did you say, "I'm going to smoke this one and 10,000 or 20,000 or
100,000 more?"

Leah: No. It was my choice at first. That very first cigarette was my
choice, and maybe even the second one. But now I've been smoking so long
and I've smoked so much. I can try to quit, you know. That's a choice I
can make. But, you know, the wanting and the needing of the cigarette
isn't a choice anymore.

Kessler: We talked a little about peer pressure. What's behind that peer
pressure? Do you think advertising plays any role?

Leah: I don't think it's such a large factor. 

Kessler: What brands of cigarettes do the smokers in the room smoke?

Katie: I personally smoke Marlboro Lights.

Jocko: Marlboro regs.

Kessler: Any other smokers with brands?

Unidentified panelist: I smoke Marlboro regs also.

Kessler: Three Marlboros. Any other brands?

Third Panelist: I sometimes smoke Camels.

Kessler: Camels, Marlboros. What are the three most heavily advertised
brands of cigarettes? What's your guess?

Panelists: Marlboros.

Kessler: Marlboro.

Panelists: Camels.

Kessler: Camel.

Panelists: And Newport.

Kessler: And Newports. What's the three most common brands among
teenagers?

Panelists: Marlboros and Newport.

Kessler: [And] Camel. Do you think that's by accident? What's the most
common brands among adults? The generic brands. Adults want to buy the
cheapest cigarette. Here's a picture of Joe Camel. What kind of message
do you think the tobacco industry is trying to send? 

Anandas: I'm 18 years old. And I think it's part of the image that
they're trying to portray. I think, whether or not to be cool, a way of
feeling they belong in that crowd.

Kessler: The tobacco industry spends $6.2 billion a year promoting their
product. Why do you think they do that?

Robert: I'm 13. I think they do it so they can attract young smokers,
and they know if they smoke when they're young, they're more likely to
keep smoking until they're older.

Suarez: To join the conversation, give us a call. We're joined now by
Heather, who's in Tallahassee, Florida. 

Heather: I'm 25.

Suarez: Are you a smoker?

Heather: Yes, I am, and I wish that I had never started. And I wanted to
tell the kids in your audience that have started smoking to quit now, no
matter how bad it makes them feel, because the longer you go on, the
harder it gets.

Kessler: How old were you when you started?

Heather: Thirteen.

Kessler: What was it like when you started?

Heather: I did it because I was kind of a goody-goody and that was one
way for me to rebel without having to cause my parents all kinds of
heartache, although it's done that too.

Kessler: Did you ever try to quit when you were a teenager?

Heather: I tried to quit several times in college, and it's very
difficult, very difficult. Most of my friends are smokers now. I've got
that constant smoking around me.

Kessler: When you hear the tobacco executives say that nicotine is not
addictive, what do you think about that?

Heather: I think they're full of crap. And it's that combination of peer
pressure, the advertisements that get into your subconscious so you're
totally not even aware that they are advertising to you, and, you know,
that need for teenagers to feel that they belong. And there you go,
you've got a whole new smoking population.

Kessler: What do you think we can do to help reduce teenagers from ever
starting?

Heather: Get rid of the vending machines, for one thing, because that is
the A-number one way for kids to get cigarettes. And induce penalties on
people for selling them. Right now, they don't penalize store owners,
they only penalize the individuals, at least in the state of Florida.
And that doesn't work, because they'll just fire the individual that
sold the cigarettes to the minor and hire somebody new and start the
cycle over again. They need to penalize the store owners.

Kessler: Well, when you were 13 and 14 and starting to smoke, where did
you get your cigarettes?

Heather: Vending machines and clerks at your local gas station down on
the corner.

Suarez: Now, it's interesting. Heather, thanks for joining us. Heather
identified advertising as an important factor. And we have a couple of
black teenagers in our panel here in the studio. They are getting the
same advertising messages that everybody else is getting and, in some
arguments, even more in the billboards in their area.

Kessler: Twenty years ago, both white and black high school seniors,
about 25 percent, smoked. Today, only 5 percent of African American high
school seniors smoke cigarettes compared to 25 percent [of white high
school seniors]. 

Suarez: Well, let's hear from some of you.

William: I'm 14. And most of the kids in my school, the ones that
smoked, were those who weren't involved in a lot of activities; they
weren't involved in sports or anything, and they were bored a lot of the
time, and those were basically the ones that smoked.

Kessler: Can you play sports and smoke?

Ashley: I play sports. And most of the people in my school who play
sports do not smoke. They'll smoke over the summer. I have a lot of
friends, and they'll say, "Well, I'll smoke over the summer and then
I'll quit for the school year so I can start my sports again." But
basketball and football [players], most of them don't smoke. But I've
noticed a lot of soccer players do smoke.

Erin: I'm 15. I'm a very serious athlete. I play lacrosse and soccer.
And in my school if they find out that you do smoke, you're off the
team. It's just like that with drugs and alcohol. They sort of group it
altogether. It doesn't stop most people. But like there's this girl in
our school and she used to run track. She was a state champion, and she
started smoking when she was a sophomore, and now she doesn't do
anything. She's like a total bum mentally. I mean, she had really bad
asthma, and it totally tore up her lungs.

Suarez: Let's go back to the phones in Emeryville, California. Jason,
you've been patient.

Jason: I'd like to say to David Kessler that I think he's probably one
of the only people in government that I respect right now. He's really
decided what he's going to do and is doing it. And I'd also like to say
that I started smoking when I was about 9, I think, 'cause my sister's
friends gave me a cigarette to smoke as a joke, and I started. I
probably didn't smoke again until I was about 11. But then I started
smoking Marlboros, and I smoked Newports for awhile, but then I switched
to Camels, so that was a cross, all of them. I'm 22. I quit about 12
months ago when my girlfriend was pregnant and we decided to have a
baby. She was quitting, so I decided I should quit too. At first, it was
pretty tough; then it got easier. But it's still--it's still there.

Suarez: How long has it been now, Jason?

Jason: It's been about a year now. My daughter is 2 months, so it's been
little less than a year.

Suarez: We've got about a minute left, Dr. Kessler, and I'm wondering
whether you see much hope now that cigarette use is starting to go up
among teens. It isn't a matter anymore of telling them that it's going
to be bad for them, because they are told that, and they're starting to
smoke anyway. What is the answer? Is it more on the preventive side
then? The enforcement side?

Kessler: The president spelled out what I think most Americans view as
reasonable steps aimed at teenagers. It's not going to eliminate it
entirely, but it would reduce easy access to cigarettes, and also to
reduce that appeal, the glamour, the fun, the independence, the messages
that we're constantly bombarded with. During the teenage years, if we
can get young people through that window [period] without having them
start, we really can save lives.

(FDA Consumer thanks NPR for permission to excerpt portions of this show
for publication.)

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

Testicular Cancer:
Survival High with Early Treatment

by John Henkel

Glenn Knies wasn't thinking the worst when he felt the abnormality in
his groin area 11 years ago. It was probably a hernia, he guessed.

He had just finished working out. In the shower, he noticed his right
testicle seemed enlarged.

"I thought I had strained something," says Knies, an insurance adjuster
in Schwenksville, Pa. He was 23 and barely out of college at the time.

"I wasn't having any discomfort or symptoms to speak of," he says. "I
was strong as ever, and there was nothing else to indicate a problem."

He mentioned the condition to his mother, a nurse, who urged him to see
a urologist quickly. She suspected something more serious than a hernia
was bothering her son.

His doctor determined the enlargement was cancer, and he removed Knies'
right testicle, the standard first-line treatment for testicular tumors.
Later, after tests showed that cancer may have spread to the lymph nodes
deep within the abdomen where the testicles drain, doctors also removed
the nodes.

But the lymph nodes were "clean," free of cancer, Knies says. It was the
first sign that he probably was going to be OK, that his doctor likely
had gotten all the cancer after removing the testicle. To make sure, a
regimen of regular examinations followed--monthly at first, tapering off
to annually after five years. Eleven years later, he still has a yearly
exam but considers himself a cancer survivor.

Most Common Cancer in Young Men

Cancer of the testicles--egg-shaped sex glands in the scrotum that
secrete male hormones and produce sperm--accounts for only about 1
percent of all cancers in men, according to the National Cancer
Institute. About 7,000 Americans were expected to get the disease in
1995, with an estimated 325 deaths. Compared with prostate cancer,
estimated to kill 40,400 of its 244,000 victims in 1995, testicular
cancer is relatively rare. However, in men aged 15 to 34, it ranks as
the most common cancer. For unknown reasons, the disease is about four
times more common in white men than in black men.

Only 15 years ago, a diagnosis of testicular cancer was grim news. Ten
times as many patients died then as now. But dramatic advances in
therapeutic drugs in the last two decades, along with improved
diagnostics and better tests to gauge the extent of the disease, have
boosted survival rates remarkably. Now, testicular cancer often is
completely curable, especially if found and treated early.

The Food and Drug Administration has approved several drugs to treat
testicular cancer, including Ifex (ifosamide), Vepesid (etoposide),
Velban (vinblastine sulfate), Blenoxane (bleomycin sulfate), and
Platinol (cisplatin).

Many medical professionals regard Platinol as the "magic bullet" for
treating certain forms of testicular cancer. FDA approved the
platinum-based drug for use after surgery or radiation. Platinol almost
always is used in combination with other chemotherapy drugs.

"[Platinum-based treatment] is truly the great success story for
solid-tumor chemotherapy," says S. Bruce Malkowicz, M.D., co-director of
urologic oncology at the University of Pennsylvania Medical Center.
These drugs have helped cut testicular cancer's death rate and bolster
its cure rate, he says, adding that many patients "respond very nicely"
to platinum-based drug treatments, which are effective even when cancer
has spread beyond the testicle.

"That is not a death sentence," Malkowicz says. About 70 percent of men
with advanced testicular cancer can be cured, according to the National
Cancer Institute.

Detection and Diagnosis

Most testicular tumors are discovered by patients themselves--either by
accident, as Knies did, or while performing a self-examination on each
testicle. "The usual presentation is of an enlarged, painless lump,"
says Malkowicz. "Occasionally there can be pain." The lump typically is
pea-sized, but sometimes it might be as big as a marble or even an egg.

Besides lumps, if a man notices any other abnormality--an enlarged
testicle, a feeling of heaviness or sudden collection of fluid in the
scrotum, a dull ache in the lower abdomen or groin, or enlargement or
tenderness of the breasts--he should discuss it with a physician right
away. These symptoms can be caused by conditions other than cancer. But
only a doctor can tell for sure, and it is critical to seek attention
promptly.

Physicians have various methods to help diagnose testicular cancer.
Often a physical exam can rule out disorders other than cancer. Imaging
techniques can help indicate possible tumors. One such method is
ultrasound, which creates a picture from echoes of high-frequency sound
waves bounced off internal organs. Malkowicz calls this method "a
painless, noninvasive way to check for a mass."

But the only positive way to identify a tumor is for a pathologist to
examine a tissue sample under a microscope. Doctors obtain the tissue by
removing the entire affected testicle through the groin, a procedure
called inguinal orchiectomy. Surgeons do not cut through the scrotum or
remove just a part of the testicle, because if cancer is present, a cut
through the outer layer of the testicle may cause the disease to spread
locally. Besides enabling diagnosis, testicle removal also can prevent
further growth of the primary tumor.

Nearly all testicular tumors stem from germ cells, the special
sperm-forming cells within the testicles. These tumors fall into one of
two types, seminomas or nonseminomas. Other forms of testicular cancer,
such as sarcomas or lymphomas, are extremely rare.

Seminomas account for about 40 percent of all testicular cancer and are
made up of immature germ cells. Usually, seminomas are slow growing and
tend to stay localized in the testicle for long periods. It was a
seminoma that struck former Philadelphia Phillies first baseman John
Kruk at age 33 in 1994. His right testicle was removed, and doctors say
his prognosis is good.

Nonseminomas are a group of cancers that sometimes occur in combination,
including choriocarcinoma, embryonal carcinoma, and yolk sac tumors.
Nonseminomas arise from more mature, specialized germ cells and tend to
be more aggressive than seminomas. According to the American Cancer
Society, 60 to 70 percent of patients with nonseminomas have cancer that
has spread to the lymph nodes.

Cancer Stages

Physicians measure the extent of the disease by conducting tests that
allow the doctor to categorize, or "stage," the disease. These staging
tests include blood analyses, imaging techniques, and sometimes
additional surgery. Staging allows the doctor to plan the most
appropriate treatment for each patient.

There are three stages of testicular cancer:

* Stage 1--Cancer confined to the testicle.

* Stage 2--Disease spread to retroperitoneal lymph nodes, located in the
  rear of the body below the diaphragm, a muscular wall separating the
  chest cavity from the abdomen.

* Stage 3--Cancer spread beyond the lymph nodes to remote sites in the
  body.

Through blood tests, doctors can check for tumor-associated markers,
substances often present in abnormal amounts in cancer patients.
Comparing levels of markers before and after surgical treatment helps
doctors determine if cancer has spread beyond the testicles. Likewise,
measuring marker levels before and after chemotherapy treatment can help
show how well the chemotherapeutic drugs are working.

FDA has approved a test that checks blood levels of alpha-fetoprotein
(AFP) as a tumor-associated marker. Other tests, such as those that
gauge levels of beta-human chorionic gonadotropin (bHCG) or lactate
dehydrogenase (LDH), are widely used as tumor-associated markers, but
FDA has insufficient data to approve these tests.

Imaging techniques provide doctors with pictures of internal organs,
giving visual clues to cancer staging. Chest x-rays can tell doctors if
disease has spread to the lungs. Lymphangiography allows the lymph nodes
to be visualized on an x-ray. CT scans create detailed views of cross
sections of the body and can indicate possible tumors at various body
sites.

Surgery to remove the retroperitoneal lymph nodes, into which the
testicles drain, often is necessary for testicular cancer patients.
Doctors examine lymph tissue microscopically to help determine the stage
of the disease. Also, removing the tissue helps control further cancer
spread.

Cancer Treatment

No one treatment works for all testicular cancers. Seminomas and
nonseminomas differ in their tendency to spread, their patterns of
spread, and response to radiation therapy. Thus, they often require
different treatment strategies, which doctors choose based on the type
of tumor and the stage of disease.

Because they are slow growing and tend to stay localized, seminomas
generally are diagnosed in stage 1 or 2. Treatment might be a
combination of testicle removal, radiation, or chemotherapy. But
surgical removal of lymph nodes usually is not necessary for seminoma
patients because this type of tumor is what the University of
Pennsylvania's Malkowicz calls "exquisitely sensitive" to radiation.
Normally directed to the retroperitoneal lymph nodes but sometimes to
other lymph nodes, radiation can effectively remove cancer cells there.
Stage 3 seminomas are usually treated with multidrug chemotherapy.

Though most nonseminomas are not diagnosed at an early stage, cases
confined to the testicle may need no further treatment other than
testicle removal. These men must have careful follow-up for at least two
years because about 10 percent of stage 1 patients have recurrences,
which then are treated with chemotherapy. Stage 2 nonseminoma patients
who have had testicle and lymph node removal may also need no further
therapy. Some doctors opt for a short course of multidrug chemotherapy
for stage 2 patients to reduce the risk of recurrence. Most stage 3
nonseminomas can be cured with drug combinations.

Side Effects

Any kind of cancer treatment can cause undesirable side effects. But not
all patients react the same way or to the same degree. One of the main
concerns of young men is how treatment might affect their sexual or
reproductive capabilities.

Removing one testicle does not impair fertility or sexual function. The
remaining testicle can produce sperm and hormones adequate for
reproduction. Removal of the retroperitoneal lymph nodes usually does
not affect the ability to have erections or orgasms. It can, however,
disrupt the nerve pathways that control ejaculation, causing
infertility.

Modern "nerve-sparing" surgical techniques have increased the odds of
retaining fertility. Many surgeons are abandoning a "total
scorched-earth policy where you take out every single lymph node,"
Malkowicz says.

"We now can limit the amount of dissection necessary to get a good
therapeutic cure, but not overdissect to disrupt every bit of nerves,"
he says, adding that "ejaculation can be preserved" in as many as 80
percent of cases.

Testicular cancer patient Knies points to his twin sons as proof that
though his reproductive capacity was temporarily lost, it was restored.

Chemotherapy can cause increased risk of infection, nausea or vomiting,
and hair loss. Not all patients experience these. Some drugs may cause
infertility, but studies have shown that many men recover fertility two
to three years after therapy ends. Radiation patients may experience
fatigue or lowered blood counts. Infertility may also occur, but this
usually is temporary.

Doctors emphasize that even though the cure rate is very high for all
types and stages of testicular cancer, many of the drastic measures
taken to cure later-stage disease can be avoided if the tumor is caught
early enough. The best way to do this is through regular
self-examination, a message that Knies says might be difficult to convey
to the prime risk group.

"You have a real sense when you're in your late teens and early 20s of
invincibility," he says. "The last thing you're thinking then is that
something can stop you. But as I know, it can."

John Henkel is a staff writer for FDA Consumer.


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


How to Examine the Testicles

"I never examined myself."

Pennsylvania resident Glenn Knies, 34, says he wasn't consciously
looking for possible cancer 11 years ago. He calls it "pure luck" that
he noticed an abnormality in the shower and sought medical attention.

Now a survivor of testicular cancer, Knies strongly urges men to examine
their testicles regularly.

Medical professionals say men can greatly increase their chances of
finding testicular tumors by testicular self-examination, or TSE.
Locating a tumor this way can boost the odds of early intervention and
total cure.

"Diagnosis of testicular cancer usually starts with self-discovery,"
says S. Bruce Malkowicz, co-director of urologic oncology at the
University of Pennsylvania Medical Center. He advises men of all ages to
do TSEs, not just those in the prime risk group of ages 15 to 34.

TSE is best performed after a warm bath or shower. Heat relaxes the
scrotum, making it easier to spot anything abnormal. The National Cancer
Institute recommends following these steps every month:

 * Stand in front of a mirror. Check for any swelling on the scrotum skin.

 * Examine each testicle with both hands. Place the index and middle
   fingers under the testicle with the thumbs placed on top. Roll the
   testicle gently between the thumbs and fingers. Don't be alarmed if one
   testicle seems slightly larger than the other. That's normal.

 * Find the epididymis, the soft, tubelike structure behind the testicle
   that collects and carries sperm. If you are familiar with this
   structure, you won't mistake it for a suspicious lump. Cancerous lumps
   usually are found on the sides of the testicle but can also show up on
   the front.

 * If you find a lump, see a doctor right away. The abnormality may not
   be cancer, but if it is, the chances are great it can spread if not
   stopped by treatment. Only a physician can make a positive diagnosis.

Knies says fear shouldn't keep men from doing the TSE. "And men need not
feel self-conscious about touching themselves there. It only takes a few
seconds for them to tell if everything's fine. If they find something,
they shouldn't be afraid to say something. Wishing it away isn't going
to make it go away." --J.H.

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

Updates



New Device Stops Bleeding Faster

A first-of-its-kind plug-like medical device is making it possible for
doctors to stem bleeding more quickly in patients who undergo
angioplasty and related procedures.

Nearly a million Americans each year have two procedures: angioplasty,
to unblock clogged arteries, and angiography, in which pictures of the
arteries are taken. In both procedures, a catheter is inserted into a
leg artery at the groin, threaded through to the heart, and then, when
the procedure is finished, removed, leaving a wound.

Doctors have traditionally applied pressure manually to the groin to
stop bleeding from the wound. The Vasoseal Vascular Hemostasis Device,
approved by FDA last Sept. 29, reduces the time of manual pressure in
most procedures. 

A study of 626 patients found that the inch-long plug stopped bleeding
about 75 percent faster than manual pressure and was equally as safe.
After angioplasty, the plug stopped bleeding in eight minutes, compared
to 30 minutes for manual pressure. After angiography, it stopped
bleeding in five minutes, compared to 18 minutes for manual pressure.

The device is inserted through a sheath that extends from the outside of
the leg to the artery surface. Only three to five minutes of manual
pressure are needed to stop the bleeding once the device has been
placed.

The plug, manufactured by Datascope Corp. of Montvale, N.J., is made of
bovine collagen and absorbed into the body in about six weeks. 

Laser Procedure for Nearsightedness

A new type of surgical procedure uses an ophthalmic laser system
recently approved by FDA to correct distance vision in people with mild
to moderate nearsightedness.

The procedure, photorefractive keratectomy (PRK), corrects
nearsightedness (myopia) using the SVS Apex Excimer Laser System, made
by Summit Technology, Waltham, Mass. FDA approved the system for PRK
last Oct. 20.

The laser delivers bursts of ultraviolet light that vaporize precisely
targeted corneal tissue (the clear part of the front of the eye). This
alters the corneal curvature, permitting light to focus properly on the
retina in the back of the eye. In a myopic eye, light focuses in front
of the retina, causing blurred distance vision.

PRK surgery takes about 30 minutes. The actual lasing itself, done under
local anesthesia, takes less than three minutes. In studies of about
1,600 healthy myopic eyes, the corneal surface healed in three days in
most eyes, and vision took at least three months to stabilize.

Most patients studied could be corrected to 20/20 vision or better with
glasses or contact lenses before surgery. Best corrected vision was
slightly worse after surgery in about 5 percent of patients and
significantly worse in less than 1 percent.

In 95 percent of eyes, vision without glasses was corrected to 20/40 or
better. In 65 percent, it was corrected to 20/20 or better. About 5
percent of patients continued to need glasses all the time for distance,
and up to 15 percent needed glasses occasionally, such as for driving.
Results were best in younger patients with lower degrees of myopia.

Some 63 percent of patients had mild corneal haze after surgery, and 10
percent experienced glare and halos around lights. These conditions
diminished or disappeared in most patients in six months.

PRK has not been shown effective for severe myopia, farsightedness, or
astigmatism. It should not be done on pregnant women, or on people with
uncontrolled vascular disease, autoimmune disease, or certain eye
diseases such as glaucoma. In the studies, people who previously had
radial keratotomy to correct myopia lost more vision from PRK than those
who had not had the other procedure.

Patients contemplating PRK to correct nearsightedness should carefully
consider the potential risks and alternative means of correction. PRK
cannot be reversed. Alternative choices to correct nearsightedness
include glasses, contact lenses, and radial keratotomy. 

Skin Patch Replaces Testosterone

A skin patch that can be placed on a variety of body sites to boost
testosterone levels has received FDA clearance as a treatment for
hypogonadism, a condition in which the body produces inadequate levels
of the hormone.

Called Androderm (Testosterone Transdermal System), the new patch can be
worn on the abdomen, back, thighs, or upper arm to help relieve symptoms
of both primary hypogonadism (disorders of the testes) and secondary
hypogonadism (disorders of the pituitary gland or hypothalamus area of
the brain). A previously approved patch can be applied only to a shaved
scrotum. Transdermal patches offer alternatives to testosterone
injections, a therapy administered every two to four weeks that can
create abnormal highs and lows in hormone levels. Androderm was cleared
for marketing last Sept. 29.

Only about 5 percent of the estimated 4 million to 5 million American
men with hypogonadism currently receive testosterone replacement
therapy. Symptoms of the disorder include sexual dysfunction (loss of
libido or impotence), fatigue, depressed mood, muscle wasting,
osteoporosis, or absence or regression of secondary male sexual
characteristics (muscle development, deep voice, or hair distribution).

In clinical trials, Androderm restored normal testosterone levels in 86
of 94 patients who completed the trials. The most common side effects
reported were temporary mild-to-moderate redness or itching at patch
sites.

Androderm is made by TheraTech Inc., of Salt Lake City, and is marketed
by SmithKline Beecham Pharmaceuticals of Philadelphia. (See also
"Testosterone: Key to Masculinity and More" in the May 1995 FDA
Consumer). 

First Liver Stent Approved

The first implantable liver stent was recently approved by FDA for
preventing recurrent bleeding from esophageal veins in people with
cirrhosis, a severe scarring of the liver caused by several different
diseases.

The Wallstent TIPS Endoprosthesis is a flexible metal stent that is
threaded into the liver by a catheter through a neck vein. The stent
then expands and remains in place so that the blood bypasses circulation
through the scarred liver, relieving blood pressure in the liver. If
untreated, this pressure can cause bleeding from veins in the esophagus
and could result in death. FDA approved the stent Sept. 29.

In a clinical study of 97 patients at eight sites in the United States,
the new stent successfully diverted blood from the liver in all but one
patient. Patients in the study had a significant improvement in survival
over that reported with abdominal surgery, and less bleeding after
treatment than that reported with alternative medical treatment.

In 1994, liver disease caused more than 119,500 U.S. hospitalizations
for conditions including chronic hepatitis and cirrhosis of the liver.
An estimated 8,000 to 10,000 patients in the United States may benefit
from the new stent.

The stent is manufactured by Schneider USA Inc. of Plymouth, Minn. 

Joint Task Force Targets Illegal Herb Imports

Eight government agencies, including FDA, have formed a joint task force
to end illegal importation by certain herbal medicine importers and
their foreign suppliers. Some of the substances imported are unapproved
drugs that pose a risk to the public health.

The Herbal Medicine Import Task Force consists of representatives from
FDA (San Francisco district office and Office of Criminal
Investigations), the U.S. Department of Justice, U.S. Customs Service,
U.S. Department of Agriculture, U.S. Environmental Protection Agency,
U.S. Fish and Wildlife Service, Internal Revenue Service, and the
California Department of Health Services. Other state counterpart
agencies contributed expertise and resources.

Investigations have revealed importation of:

 * misbranded or adulterated drugs

 * a toxic substance controlled under EPA regulations

 * noxious weeds posing a serious threat to U.S. grain crops

 * products violating the Convention on International Trade in
   Endangered Species of Wild Fauna and Flora.

Agents also found evidence of conspiracy to evade customs laws.

The U.S. attorney for the Northern District of California is
coordinating the effort, beginning with activities such as educational
mailings to community leaders, trade associations, and individual
importers and customs brokers. This will be followed by investigation of
persistent suspected criminal conduct and, where appropriate,
prosecutions.

The task force will work with local communities to identify underlying
problems and explore culturally sensitive solutions, within the
framework of applicable regulations and laws.

In addition, FDA's Los Angeles district office took part in a Fish and
Wildlife Service press conference last October to launch a consumer
education campaign on illegal importations and related health risks.
Community agencies, private groups, and the Los Angeles Unified School
District participated. FDA and the Fish and Wildlife Service are
exploring a possible partnership to monitor illegal importations. 

Recommendations for Vitamin A Intake

As a precautionary measure to prevent birth defects, FDA has issued
several recommendations for women of childbearing age regarding
excessive consumption of foods, including dietary supplements,
containing one form of vitamin A.

The vitamin form of concern is called preformed vitamin A. It is found
in animal products, primarily liver, and is also sometimes added to
fortified foods such as breakfast cereals and dietary supplements. The
products' ingredient listings should note the addition as, for example,
retinyl palmitate and retinyl acetate. Women need to limit their intakes
from these sources to about 100 percent of the Daily Value (5,000 IU).

On the other hand, beta carotene, a substance found naturally in plants
and which the body converts to vitamin A, is considerably less toxic.
Women of childbearing age are advised to choose fortified foods that
contain vitamin A in the form of beta carotene rather than preformed
vitamin A, whenever possible. The vitamin A in fruits and vegetables is
naturally in the form of beta carotene, and high intakes of vitamin A
from these sources is generally not of concern.

Vitamin A is an essential nutrient and, as with all nutrients, the good
health of women throughout childbearing years, including pregnancy,
depends on consuming appropriate amounts.

FDA offered these recommendations in response to an October New England
Journal of Medicine article on the possible relationship between some
types of birth defects and the consumption of vitamin A at levels at or
above 10,000 IU (or 3,000 Retinol equivalents). A relationship between
vitamin A intakes and birth defects has been known for some time, but
the level of vitamin A-associated birth defects in earlier studies was
much higher. 

Actual Consumption Pyramid

Actual U.S. diets make a top-heavy pyramid, compared with the USDA-HHS
Food Guide Pyramid. The latter recommends these daily intakes: 6-11
servings of bread, cereal, rice, pasta; 3-5 servings of vegetables; 2-4
servings of fruits; 2-3 servings of milk, yogurt, cheese; 2-3 servings
of meat, poultry, fish, dry beans, eggs, nuts; and only sparing use of
fats, oils and sweets. American diets come up particularly short in the
vegetable and fruit groups.

(Source: Eating in America Today, Edition II, A Dietary Pattern and
Intake Report commissioned by the National Live Stock and Meat Board) 


FDA Freebies

A new brochure and two new backgrounders are available free from FDA.
They are:

 * Protect Your Child from Iron Poisoning (FDA) 95-1225 (brochure)

 * Monosodium Glutamate (MSG) (BG 95-16)

 * Olestra and Other Fat Substitutes (BG 95-17).

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

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


Consumer Forum


Food Safety Comments


Your article "Can Your Kitchen Pass the Food Safety Test?" [in the
October 1995 FDA Consumer] is well written and should be very useful in
schools and other training. Just a couple of comments: I agree that the
home refrigerator should be at 40 F, but doubt that many of them are
actually that cold on the average. I had a very similar question to
Question #2 on a TV call-in show recently. The idea of cooling to room
temperature, then refrigerating dates back to the use of ice boxes for
refrigeration. With the limited amount of ice, in the long run it was
better to cool the food to room temperature to conserve ice. 

In your comment on Question 6 you mentioned pasteurized eggs but
probably should have clarified by stating that whole shell eggs are not
pasteurized, just the commercial liquid egg products used in commercial
products. There is some experimental work attempting to pasteurize whole
shell eggs, but to my knowledge it has not been successful. 

Thanks again for a good article. 

Richard H. Forsythe
President
Arkansas Research Management
Fayetteville, Ark.


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


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.


Certain FDA regulations would be eliminated under an agency-proposed
rule because they are obsolete or no longer necessary to protect the
public health. The elimination is a step to streamline the agency and
ease the regulatory burden on industry and consumers. The public has
until Jan. 11, 1996, to submit written comments to Dockets Management
Branch (HFA-305), FDA, Rockville, MD 20857. (FR Oct. 13)

Advisory committee annual reports from closed committee meetings are now
available from FDA. The meetings were held between Oct. 1, 1993, and
Sept. 30, 1994. Free single copies may be ordered from the Dockets
Management Branch (HFA-305), FDA, Rockville, MD 20857; telephone (301)
443-1751. (FR Oct. 11)

A monosodium glutamate adverse reactions report is available. "Analysis
of Adverse Reactions to Monosodium Glutamate (MSG)" was prepared for FDA
by the Life Sciences Research Office, Federation of American Societies
for Experimental Biology. Single copies cost $50 and may be purchased
from the Life Sciences Research Office, 9650 Rockville Pike, Bethesda,
MD 20814; telephone (301) 530-7030. (FR Oct. 3)

Neurotoxicity risk assessment guidelines for environmental agents have
been proposed by the Environmental Protection Agency. The proposed
guidelines are intended to direct future EPA evaluation of agents
suspected of causing neurotoxicity. Comments on the proposal will be
accepted until Feb. 1, 1996. For more information, contact Hugh A.
Tilson at (919) 541-2671. (FR Oct. 4)

Dental cavity prevention products sold over-the-counter are safe and
effective and not misbranded, according to an FDA final rule that will
take effect Oct. 7, 1996. After that date, no OTC dental product
containing an ingredient that is not recognized as safe and effective
may be introduced into interstate commerce. (FR Oct. 6)

Morbidity and Mortality Weekly Reports, CDC's weekly reports of health
data from state health departments, is now on the Internet. The address
on CDC's file transfer protocol server is ftp.cdc.gov. The address on
the World Wide Web is http://www.cdc.gov/epo/mmwr/mmwr.html. For more
information, telephone MMWR's editor at (404) 332-4555. (MMWR Oct. 13)

Hazardous substances and their health effects are discussed in 12
reports now available from the Agency for Toxic Substances and Disease
Registry. Copies of the reports can be purchased from the National
Technical Information Service, 5285 Port Royal Road, Springfield, VA
22151; telephone (1-800) 553-6847. (FR Oct. 25)

Folic acid can help prevent the birth defects spina bifida and
anencephaly, but many American women still are not aware of these facts,
according to the national Centers for Disease Control and Prevention. In
a telephone survey of 2,010 women, 52 percent of women reported hearing
or reading about folic acid. Of these, 9 percent answered that folic
acid helps prevent birth defects and 6 percent that folic acid helps
reduce the risk for spina bifida. Researchers also found that only 25
percent of nonpregnant women regularly consumed a vitamin supplement
containing 0.4 milligrams of folic acid, and only about 6 percent ate
breakfast cereal containing 0.4 mg of folic acid. (MMWR Sept. 29) 

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

Investigators' Reports


Paroled Clinic Operator
Sentenced on New Charges

by John Henkel

After a 10-day jury trial, a Diamondhead, Miss., man and his wife were
found guilty of conspiracy and wire fraud in their operation of a clinic
that dispensed unapproved treatments for people with AIDS and other
serious illnesses.

James Oral Boyce, 59, was sentenced last July 26 to five years of
imprisonment for each of nine counts, which will run concurrently. He
also must serve three years of supervised probation after release and
pay $113,243.25 in restitution to victims and family members. He is
barred from having interest in any medical venture in the future.

At sentencing, Boyce already was serving a five-year term in a
Mississippi state prison for violating probation, following a 1991
guilty plea of prescription forgery and drug possession with intent to
distribute. He must finish this term before beginning the federal
sentence.

Margaret Boyce, 51, received 24 months probation for each of two counts,
also to run concurrently. She must pay $8,800 restitution to victims and
family members, and is under home detention with electronic monitoring
for six months at a cost to her of $4.99 a day. She also must perform
200 hours of community service.

James Boyce formed Natural Options Inc. at his Diamondhead home in 1990.
Ostensibly, the business was for growing and selling tomatoes. But Boyce
also sold an unapproved oral drug he called HAD-A-PAIN, a form of
dimethylsulfoxide (DMSO), which has been approved only for external use
in a horse liniment and for intravenous treatment of interstitial
cystitis in humans.

In November 1992, after FDA's Minneapolis district office reported
seeing a magazine ad touting HAD-A-PAIN, an investigator in the agency's
Gulfport, Miss., resident post visited Boyce's operation. Boyce told FDA
he had stopped selling the drug because of poor sales. He also claimed
he was a medical doctor.

In July 1993, Mississippi state officials notified FDA that they
suspected Boyce was running a clinic that used unapproved devices,
drugs, and therapies. That same month, FDA began investigating the
clinic. "We found that Boyce was claiming to cure AIDS, cancer, multiple
sclerosis, arthritis, and other serious diseases," says James Blakely,
the Gulfport investigator.

In the clinic, which Boyce operated from July 1992 to August 1993, were
unapproved intravenous hydrogen peroxide injections, chelation therapy,
and drugs smuggled from Germany and Mexico. One drug used was Carnivora,
made from the juice of Venus' flytrap plants. Sold over the counter in
Germany, Carnivora is illegal in this country. The clinic also had an
ozone generator machine, used to introduce toxic ozone gas through a
vein or rectally. The gas, which has no known therapeutic value, can
prompt an embolism, or obstruction of a blood vessel.

Boyce never advertised the clinic, which at various times was known as
B. Boyce Clinic Inc., Natural Options Inc., and Hyperbaric Manufacturing
Co. Patients typically were desperately ill, seeking an alternative to
conventional treatment. They found the clinic by word-of-mouth or
through referrals from alternative-medicine practitioners. Interviews
with employees, clients and patients, along with information from seized
records, indicated that during the year the clinic was open, Boyce
charged patients a total of almost $500,000. One patient from Australia
paid $30,428 for 36 treatments. Patients often paid through wire
transfer of funds to Boyce's account.

In February 1993, Boyce hired a local physician, Sidney Wong, M.D., as a
consultant to add legitimacy to the clinic. Wong administered an initial
exam to selected patients at Boyce's direction for a flat $300 fee and
didn't see patients again. Boyce then took over treatment. (In December
1993, Mississippi suspended Wong's medical license for his involvement
but has since reinstated him.)

In August 1993, an FDA special agent called the clinic asking questions
under the guise of someone seeking help for her sick brother. Boyce told
the agent the clinic used ozone treatments, various European enzymes
(such as Carnivora), and hydrogen peroxide intravenous drips. Also used
was a diapulse machine, a radio-wave generating machine that emits radio
frequencies touted to treat various maladies. All Boyce's methods, drugs
and devices violated the federal Food, Drug, and Cosmetic Act and other
U.S. laws, as well as Mississippi state law.

When the FDA agent visited the clinic, Boyce said treatment would cost
$2,500 a week, with an additional $2,500 for enzyme treatment.

On Aug. 24, 1993, officials from FDA, U.S. Customs, and the state of
Mississippi executed search warrants on Boyce's offices and home. Among
items seized were a diapulse machine; about $10,000 worth of smuggled
and unapproved drugs; roughly $50,000 worth of prescription drugs and
devices; and patient and business records. Narcotics agents also
arrested Boyce for violating his earlier parole.

Through the entire clinic enterprise, Margaret Boyce abetted her husband
in his criminal activities and committed numerous federal violations.

John Henkel is a staff writer for FDA Consumer.


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


'Jogging' Drink Seized, Destroyed

With a farmer's folksy charm, Jack McWilliams went into small towns
across the country and told how a beverage he created had helped him
conquer his own heart disease and arthritis. The news media in those
towns ran prominently placed stories, and customers lined up to buy the
drink--to the tune of $9 million in business a year.

But the government didn't buy it. By law, the product--a mixture of
grape and apple juices and vinegar called Jogging in a Jug--was
considered an unapproved new drug due to claims McWilliams, 64, made for
it. Last July 18, FDA officials supervised the disposal of 13,320
half-gallon bottles of the juice, valued at $77,000. The federal
government had seized the product on May 19, 1994, because of its
unproven drug claims.

McWilliams, his son, Danny, and their firm, Third Option Laboratories of
Muscle Shoals, Ala., signed a consent decree last May 17 in the U.S.
District Court for the Northern District of Alabama. Under the terms of
the decree, Third Option must alert its retail distributors of the court
findings, including notification that the product cannot be "promoted,
labeled, or advertised" in a way that makes unsubstantiated health
claims.

The Federal Trade Commission, in a separate action, fined Third Option
$480,000 after charging the firm with making false health claims. FTC
also required Third Option to send all consumers who bought the product
a letter informing them of the charges.

FDA first became aware of Jogging in a Jug shortly after the product
debuted in the early 1990s. The agency received complaints about the
product's claims from state regulatory agencies, local government
officials, and consumers.

One of the company's main marketing strategies was to promote the
product through the news media. McWilliams received coverage in
newspapers and broadcast outlets.

"He would go into an area--usually a small community--and actually get
the press' attention by holding a news conference touting an amazing new
discovery," says Ray McCullough, a compliance officer in FDA's Nashville
district office. "Then, instead of an ad in the inside pages, he'd end
up with something better--a front-page article."

News stories about McWilliams, a dairy farmer, typically told of his
discovery that vinegar had reduced pain and symptoms of his own heart
disease and arthritis. He said taking vinegar could reduce the risk of
cancer in the internal organs. He suggested that 2 ounces of his product
a day could confer the same benefits.

Press accounts said that members of the last two generations of
McWilliams' family had used vinegar regularly and lived into their 90s.
In one article, McWilliams said that when pregnant women crave pickles,
they really are craving acetic acid, the main ingredient in vinegar.
McWilliams then used these press clippings as promotional literature.

In a warning letter dated March 27, 1992, FDA advised Third Option that
marketing the drink accompanied by articles containing therapeutic
claims violated food and drug law. Company representatives met with FDA
in April 1992 and agreed to stop making the claims. But over the
following months, FDA determined through complaints and reports that
Third Option still was making unlawful claims. On May 19, 1994, federal
marshals seized 13,320 bottles of the product, which remained stored for
a year while FDA and the firm negotiated a consent decree.

Third Option Laboratories is still in business and is working with FDA
on ways to market Jogging in a Jug legally.

--John Henkel


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


California Business Fined for Illegal Drug Use and Sales

A major U.S. calving operation and its owner were fined $80,000 for
using and selling illegal animal drugs smuggled into the country and
funneled through a massive underground network that extended nationwide.

U.S. Magistrate Judge Dennis Beck of the U.S. District Court for the
Eastern District of California fined Calftech Corp. of Tipton, Calif.,
$70,000 and its owner and president, Ted Greidanus, $10,000 on Sept. 20,
1994. The company and Greidanus had pleaded guilty May 19, 1993, to
charges of using gentamicin, an antibiotic that has not been approved
for use in animals, to treat calves and to charges of selling two
unapproved veterinary drugs to area ranchers.

The company raised 15,000 to 20,000 calves and sold them to veal
producers.

Calftech's and Greidanus' sentencing brings to 60 the number of people
and companies sentenced so far in an eight-year FDA investigation of
smugglers, distributors and users of illegal animal drugs. A special
unit of FDA, the National Animal Drug Investigation, traced the drugs'
entry into the United States to a New York firm that imported them from
Europe and China into Canada, from where they were smuggled into Iowa
and across the United States.

FDA identified Greidanus and his company as users and sellers of illegal
drugs through an investigation of a major animal drug dealer, Irving
Rossoff, D.V.M., of Illinois Antibiotics, Taylorville, Ill., in the
early 1990s. Rossoff was tried twice; both trials resulted in hung
juries.

By examining bank transactions, hotel receipts, telephone records, car
rental documents, and other various records and through interviews with
numerous people, including others who participated in the scheme, the
National Animal Drug Investigation team pieced together evidence showing
that Greidanus was present at the time previously identified illegal
drug transactions were going on.

FDA also learned that Greidanus concocted mixtures of various
antibiotics, marked them only as "white meds" and otherwise packaged
them without the required labeling information (such as directions for
use and recommended doses), and sold them to ranchers.

Unapproved drugs such as gentamicin pose a threat to an animal's health
because their safety and effectiveness have not been scientifically
proven. They also may endanger humans if they leave cancer-causing or
otherwise toxic drug residues in meat, milk or eggs from feed animals.

FDA has had no reports of injuries from people who ate meat or milk from
animals treated with the gentamicin.

--Paula Kurtzweil


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

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

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

Superintendent of Documents
Government Printing Office
Washington, DC 20402-9371.

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