FDA Consumer July-August 1995

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   VOL. 29 No. 6 JULY-AUGUST 1995
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Table of Contents

Features

   -- FDA's Forensic Center: Speedy, Sophisticated Sleuthing
   Thirty chemists and three biologists in Cincinnati spearhead FDA's efforts to
   unravel the scientific mysteries of tamperings and other criminal activities.
   Their careful observations have high-tech help.

   -- Thwarting Skin Cancer with Sun Sense
   Skin cancer is now about as common as all other cancers combined.
   Fortunately, early diagnosis is easy, and most types are highly curable. But
   prevention is also easy and more desirable.

   -- Not a Cure-All: Eye Surgery Helps Some See Better
   Growing numbers of people are having eye surgery to correct nearsightedness.
   How effective are these procedures? What are the risks? And will refractive
   surgery by laser rather than knife offer any extra benefits?

   -- Conditions Men Get, Too
   Breast cancer, osteoporosis, and eating disorders are three maladies often
   thought of as "women's diseases." This stereotype often prevents men who
   contract them from getting the help they need.

   -- Making It Easier to Read Prescriptions
   What looks like gobbledygook to most laypersons and has been Latin shorthand
   to many medical professionals is now being replaced by clearer ways to write
   prescriptions to avoid medication errors.

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Departments

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

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

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

    Summaries of Court Actions
                         Cases involving seizure, criminal and injunction
                         proceedings.


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FDA's Forensic Center: Speedy, Sophisticated Sleuthing

   by Isadora B. Stehlin

   By the time the mouse and its Pepsi-can coffin reached FDA, Fred L. Fricke
   and his team of chemists and microbiologists didn't have much to work with.

   The mouse, found dead in a can of Diet Pepsi in New York, had already been
   examined by Pepsi officials. From there it went to a veterinarian on the East
   Coast. Next stop was a pathologist in Utah. Finally, the dissected mouse was
   sent to Fricke at FDA's Forensic Chemistry Center in Cincinnati.

   Fortunately, the mouse's teeth were still intact. "We measured the spacing
   between the teeth and the pattern of bite marks on the can," explains Karen
   A. Wolnik, director of the center's inorganic chemistry branch. "From those
   measurements it was determined that his lower teeth had left marks on the
   inside of the can and his upper teeth had gnawed the outside, right at the
   pull-tab opening."

   Wolnik says that pattern demonstrated the mouse had been inside the can when
   it bit the lid. But because the can lid with the pull-tab opening is in one
   intact piece throughout manufacturing, the mouse couldn't have bitten the lid
   or gotten into the can until after it was opened. The evidence was used to
   convict a tamperer who had falsely claimed to have found the mouse inside the
   can when she opened it. (Under the Federal Anti-Tampering Act, it is a felony
   to tamper with foods, drugs, devices, cosmetics, and other consumer
   products.)

   "Every week we get something that's suspected tampering," says Fricke,
   director of the forensic center. "It never slows down."

   FDA established the center in 1989 to provide the agency with a team of
   forensic science experts who can respond immediately to all tampering
   incidents and provide expert advice and scientific evidence to FDA officials.
   The 30 chemists and three biologists unravel the scientific mysteries of
   tamperings and other criminal activities involving FDA-regulated products
   through careful observation and high-tech instruments.

   The center has inorganic chemistry and organic chemistry branches. The
   organic branch uses organic analytical detection methods--such as infrared
   spectroscopy, gas and liquid chromatography, and mass spectrometry--to
   separate and identify the components of mixtures. The inorganic branch uses
   tools such as digital image analysis and scanning electron microscopy to
   detect physical evidence of tampering or counterfeiting, and ion
   chromatography, atomic absorption, and inductively coupled plasma
   spectrometry to measure inorganic components of mixtures. (See accompanying
   article.)

   Most cases require the expertise of both branches. "There's no division [of
   responsibilities] that's really sacred," says R. Duane Satzger, director of
   the organic branch. "When we get a case, both branches sit down and talk
   about it and decide how to address the situation."

   For example, he explains, a syringe might first be examined by the inorganic
   group. Wolnik's staff would use light microscopy to examine the syringe. If,
   during this examination, they observed some kind of liquid in the needle of
   the syringe, Satzger's staff would use chromatographs or mass spectrographs
   to identify the liquid. Electron microscopy might be used to detect
   decomposition and other physical changes to the syringe that might have
   occurred if the syringe had been submerged in soda or come in contact with
   poison.

   Tylenol, Grapes and Cyanide

   In 1980, Fricke, Satzger and Wolnik worked at the forensic center's
   predecessor, FDA's Elemental Analysis Research Center in Cincinnati, where
   they conducted research and developed procedures for detecting toxic and
   nutritional trace elements in foods and drugs.

   In 1982, when the first Tylenol tampering occurred, FDA chemists developed
   elemental "fingerprinting" techniques that allowed the authorities to trace
   the cyanide back to the manufacturer and the distributor. "The identity and
   relative amounts of various elemental constituents in a suspect sample form a
   distinct pattern that can be used for comparison with other samples, much
   like actual fingerprints," explains Wolnik.

   The next few years saw more cases of cyanide in Tylenol and other pain
   relievers, as well as other types of tampering. "We applied the
   "fingerprinting" techniques to various poisons," says Fricke. They also
   developed "fingerprints" for inorganic substances such as metal and glass.

   By the time cyanide was discovered in Chilean grapes in 1989, the center had
   developed expertise in detecting cyanide and other poisons in drugs and
   processed foods. But they had very little knowledge about what effect the
   cyanide would have on the fruit and vice versa. Would the poison become more
   or less toxic? Would it do something to the fruit that would be obvious to
   consumers?

   "We didn't have a lot of answers at that time about what would happen," says
   Fricke. To keep FDA from being caught off-guard in the future, the agency
   redirected the focus of Fricke's lab from elemental to forensic research.

   The lab's primary function shifted to research on what happens when poisons
   are added to foods and drugs. The "fingerprinting" technique used for
   comparing items of evidence was expanded to include many chemicals. In
   addition, the lab began developing screening methods for poisons so it could
   respond rapidly to any suspected tamperings. Since then, the lab has
   developed techniques to screen for more than 250 of the most toxic poisons
   commonly available to the public.

   The forensic lab is also the only laboratory facility in FDA especially
   equipped for, and experienced in, ultra-trace elemental analysis. Using a
   specialized type of mass spectrometry called inductively coupled plasma/mass
   spectrometry, the lab's chemists can find contaminants in amounts as small as
   parts per trillion.

   Tracking Down the Source

   There are three points at which a foreign object or other contaminant can get
   into a product.

   *    During manufacturing. "There are legitimate things that can go wrong
   during manufacturing," says Wolnik, "and there are rare occasions of employee
   sabotage."

   *    While the product is in distribution. These are cases in which someone
   tampers with a product and returns it to the store shelf looking as untouched
   as possible so the purchaser is unlikely to detect the tampering. Frequently
   the perpetrator has a single victim in mind but tries to make the crime look
   like random tampering. "It's a crime similar to blowing up an airplane to
   kill one person," says Wolnik.

   *    After purchase. Those are the false report cases, such as the false
   claims of Pepsi tamperings during the summer of 1993.

   Many clues help the forensic lab's people zero in on the time and place of
   contamination, including the amount of physical deterioration of foreign
   objects, the breakdown of poisons into chemical components, and physical
   measurements of containers. But they won't tell the public what those clues
   are. "We don't want to hand out a blueprint to would-be tamperers," says
   Fricke.

   The process for identifying poisons and other chemical contaminants is
   something the scientists will share. Separation of the different chemical
   components of a mixture is one of the most frequent techniques used and
   requires some type of chromatography.

   Chromatography separates complex mixtures by measuring migration rates of
   component molecules through columns and through coatings on chromatography

   plates. "We'll compare those components with a control and we'll be looking
   for differences," explains Satzger. "We won't try to identify everything in
   the sample. So if there are 20 components that we can separate in the suspect
   sample and only 18 in a control, we'll zero in on those two extra
   components."

   Identification usually requires infrared spectroscopy or some form of mass
   spectrometry. Gas chromatography/mass spectrometry is used for volatile
   components. Liquid chromatography/mass spectrometry is the usual choice for
   nonvolatile ones. Ion chromatography and atomic spectrometry are used for
   inorganic components.

   Even after suspect components are identified, the sleuthing may not be over.
   Sometimes components that show up in lab tests are part of a bigger picture.

   "We've done studies to show that when you put sodium hypochlorite (bleach) in
   soft drinks it breaks down into several different components," says Wolnik.
   "So we look for elevated breakdown products of the sodium hypochlorite.
   That's where the sophistication [of our lab] comes in. Any lab can run a test
   for bleach in soft drinks. But if they don't find any bleach it doesn't
   necessarily mean bleach wasn't in there. It just means that [the bleach] may
   have been changed by the material."

   Even when the final lab results are in, FDA's work may not be done. "A lot of
   what we do isn't the be all and end all," says Wolnik. "It just really helps
   focus the investigation. We work closely with [FDA] agents and investigators
   so we know what kinds of questions they're interested in answering. As we
   learn things, we provide information to the investigators which may help
   direct their investigation."

   Leftovers

   One of the toughest obstacles the forensic lab faces is the condition of
   samples when they reach the lab. Like the mouse in the Pepsi can, samples
   have frequently been studied by other authorities first, leaving very little
   for the forensic lab to work with.

   "It's infrequent that we get the sample first," says Wolnik. "That alone
   makes our analysis difficult. We have to spend some time thinking about what
   analyses we want to do, and what order we want to do them in. We can't afford
   to waste what little sample is left."

   Another problem is damage or contamination of the samples. For example,
   Wolnik says during the 1982 Tylenol tampering incident, the medical examiner
   unintentionally contaminated the cyanide from some of the poisoned capsules
   with sodium during his analysis. He then sent the contaminated capsules to
   FDA.

   "In forensics, you want the evidence as close to the condition in which it
   was originally found as possible, and you want to preserve that," says
   Wolnik.

   That was not the case on March 19, 1993, when Bobby Joe Johnston of Oklahoma
   City, suffered burns to his lips and tongue after drinking from a can of
   Pepsi. The hospital where he was treated took a sample of Pepsi from the can
   and determined it was highly caustic. The hospital called the fire
   department, which retrieved the can and the rest of the six-pack Johnston had
   purchased. The fire department treated the cans as hazardous materials
   instead of forensic evidence, however.

   "They put the five unopened cans in a glass container, set the open can on
   top of the others, and went home for the weekend," says Wolnik. "When they
   checked it on Monday, the corrosive material had eaten through the open can
   and dribbled onto and through another can, causing the second one to explode.
   When we finally got the sample, we had to reconstruct what came from the
   contaminated can and what came from the other previously unopened can. It
   ended up being fairly tricky."

   However, the lab was eventually able to confirm that sodium hydroxide (lye)
   had been added to the can after it was opened and could not have been in any
   of the unopened cans. "We did studies to see how long it would take [for
   sodium hydroxide] to eat through a can," says Wolnik. The FDA chemists found
   that highly caustic solutions such as lye ate through the can in a matter of
   hours. "That proved that it couldn't have happened during manufacturing."
   Johnston was convicted of tampering on June 3, 1993.

   Beyond Tampering

   While tampering cases are the main focus of the forensic lab, there are other
   activities--such as illegal sale and use of unapproved drugs, counterfeit
   drugs, and economic fraud--that require the lab's expertise.

   For example, the drug clenbuterol, which isn't approved in the United States
   for any use in either people or animals, is sometimes used illegally in show
   animals, including cattle, pigs and sheep to increase muscle. If those
   animals are subsequently slaughtered, anyone who eats the tainted meat might
   experience symptoms such as increased heart rate, muscle tremors, dizziness,
   nausea, fever, and chills. "We developed methods to analyze animal retinas
   for clenbuterol residues," says Fricke. This is significant, he explains,
   because while clenbuterol residues may show up in various tissues, almost any
   use will leave residues in the retina.

   Counterfeit products require a combination of high-tech analysis to compare
   ingredients with the real product and careful study of the labels and
   packages.

   The lab has uncovered evidence to support charges of economic fraud as well.
   Two such cases involved substandard stainless steel on imported surgical
   instruments and purported nutritional products that didn't contain any of the
   listed ingredients.

   The procedures and techniques the forensic lab has developed better prepares
   the agency to meet these types of emergencies. Still, "every sample that
   comes in is like a separate research project," says Fricke. "We have to
   decide what procedures and methods to apply, and there still are many cases
   that require new procedures. And, always, we have to do this as quickly as we
   can."

   Isadora B. Stehlin is a staff writer for FDA Consumer.


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  HIGH-TECH TOOLS

   FDA's forensic scientists use a number of analytical methods, including:

   Chromatography (thin-layer, gas, liquid, and ion)
   Separation of complex mixtures based on physical and chemical interaction
   with a solid adsorbent material (for example, activated carbon, alumina gel,
   or silica gel) on a plate or in a column.

   Mass Spectrometry
     Identification of chemical structures and quantitative elemental analysis
   based on the mass of ionized (charged) molecules, ionized fragments of
   molecules, and ionized elements.

   Infrared Spectroscopy
   Measurement and identification of molecules by means of the molecules'
   interaction with infrared radiation.

   Atomic Spectroscopy
   Determination of elements based on the emission or absorption of
   electromagnetic radiation (for example, ultraviolet and visible light) by
   atoms.

   Capillary Electrophoresis
   Separation of chemicals by movement through a glass capillary tube in a
   solution under the influence of an electric field.

   Microscopy (light and electron)
   Production of magnified images of objects using light or electrons.

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Thwarting Skin Cancer with Sun Sense

   by Carolyn J. Strange

   "This looks like skin cancer," the dermatologist told the woman as he
   examined the spot on her leg. Later, after removing the tumor and several
   other precancerous growths from her face and hands, he looked her in the eyes
   and said, "You've had enough sun."

   More and more people are hearing similar messages from their doctors. Viewed
   as an undeclared epidemic by dermatologists, skin cancer is the most
   prevalent of all cancers, and it's increasingly common. About a million
   Americans will develop skin cancer this year.

   "Skin cancer is now about as common as all other cancers combined," says
   Martin A. Weinstock, M.D., Ph.D., director of Brown University's
   Dermatoepidemiology Unit and Chief of Dermatology at the Providence (R.I.)
   Veterans Affairs Medical Center. And there's no evidence that the epidemic
   has peaked.

   But there is a bright side. Skin cancer is quite curable when treated early.
   More than 90 percent of skin cancers are completely cured. Even better, it's
   largely preventable, simply by avoiding sun and sunlamp exposure.

   As more consumers become sun smart, they're finding new ways to protect
   themselves. For example, FDA has cleared for marketing one manufacturer's
   clothing for sun protection. Eating a healthier diet can't hurt--less fat,
   more fruits, vegetables and grains--and preliminary studies indicate it may
   help. And the National Weather Service provides a measure of ultraviolet (UV)
   exposure with its UV Index, which is part of the daily weather forecast for
   many cities.

   Experts agree that sunlight, particularly the UV wavelengths, damages the
   skin. UV radiation causes the obvious short-term damage seen in a sunburn or
   a tan, as well as the long-term damage that accumulates with each exposure.
   Not only is there no such thing as a safe tan, "There's no known safe amount
   of sun," Weinstock says.

   Americans are getting the message. Increasingly, we're protecting ourselves
   from the sun, according to a 1994 survey commissioned by the American Academy
   of Dermatology. But we're not all sun savvy yet. Only 2 in 5 people
   consistently use sunscreen whenever they're in the sun. Fewer people say they
   sunbathe, but about 1 in 5 adults still does. And some people have the
   mistaken impression that sunlamps or tanning salons are somehow better or
   safer than natural sunlight. They aren't. No matter what the source, UV
   exposure increases your risk of skin cancer. (See "Sunlamps--Not a Bright
   Idea.")

   There are three main types of skin cancer. Melanoma is the least common but
   most serious because this killer is responsible for three-quarters of the
   nearly 10,000 skin cancer deaths per year. The other two types--basal cell
   and squamous cell carcinomas--are often referred to together as non-melanoma
   skin cancer. Basal cell cancer is by far the most common skin cancer,
   followed by squamous cell carcinoma, which can also become a killer. Between
   1980 and 1989, the incidence of non-melanoma skin cancers increased 65
   percent, and melanoma 21 percent. And skin cancer is striking at ever younger
   ages. One-quarter of the more than 30,000 people expected to develop melanoma
   this year will be 39 or younger.

   A fourth type of growth, actinic or solar keratosis, is also of concern
   because it can progress into cancer. It's the most common pre-malignant skin
   condition, occurring in more than 5 million Americans.

   UV's Double Whammy

   While there's no question that UV damages DNA, scientists had long suspected
   that it delivers a double whammy. Recent research supports that idea.
   Developing skin cancer is at least a two-step process, involving initiation
   and promotion of malignant growth. "UV plays both roles," says Douglas Brash,
   Ph.D., a biophysicist at Yale University School of Medicine. In studies with
   mice, Brash and colleagues showed that UV harms a mechanism for repairing
   cell damage. Once the repair system is impaired, cells become increasingly
   vulnerable to injury. Subsequent UV exposures just make matters worse, and
   can initiate malignancy.

   After UV exposure, the repair mechanism normally directs damaged cells to
   commit suicide. That's why skin peels after a sunburn. "It's a mop-up
   operation," says Brash. But previously damaged cells with a malfunctioning
   repair system escape this mop up. Genetic damage accumulates as normal cells
   die and abnormal ones survive.

   Brash said the level of UV used in their experiments was about equivalent to
   exposure from a day at the beach. Skin doesn't have to be badly sunburned, he
   said, adding that such damage also accumulates with chronic, everyday
   exposure.

   To increase awareness of the damaging potential of UV radiation, the
   Environmental Protection Agency and the National Weather Service developed
   the UV Index. Besides skin cancer, UV radiation also increases the risk of
   cataracts and certain other eye problems, and can suppress the immune system.

   And although dark-skinned people are generally less likely to get skin cancer
   than light-skinned people, they are just as susceptible to cataracts or
   immune suppression.

   The UV Index number, ranging from 0 to 10+, indicates the amount of UV
   radiation reaching the Earth's surface during an hour around noon. (See "UV
   or not UV.") It's forecast daily for 58 cities, based on local predicted
   conditions. The UV Index is valid only for about a 30-mile radius from the
   city, and, as with any forecast, local variability in cloud cover and other
   factors may change actual levels experienced. But it serves as a reminder to
   take precautions against UV exposure.

   For many people, sunscreens are the first line of defense.

   "With most sunscreens it's important to apply them before you're in the sun,"
   says FDA microbiologist Jeanne Rippere, who evaluates over-the-counter drugs,
   including sunscreens. They should be applied liberally, and reapplied at
   least every two hours (more often if you're sweating) or after swimming or
   toweling off. Sunscreens are rated by an SPF (sun protective factor) number,
   which is a multiplier of your skin's exposure time before burning. For
   example, an SPF of 4 means you can stay in the sun four times longer before
   burning than if you were wearing no sunscreen. Keep in mind that you can't
   add SPF numbers. If an SPF 4 product gives you an hour in the sun, reapplying
   won't give you another hour. Your time's up. If you want longer exposure,
   next time use a higher SPF before going into the sun.

   Something else to remember is that two types of UV radiation reach the Earth,
   UVA and UVB. Both contribute to skin damage, including skin cancer. There are
   no "safe" UV rays. But the SPF numbering system was devised as a guide to
   protect against sunburn, which is caused mostly by UVB. Because sunscreens
   allow you to stay out in the sun longer without burning, you may be
   increasing your exposure to UVA.

   FDA has not approved a rating system for UVA protection because experts
   haven't reached a consensus as to what constitutes a good test. FDA is
   working to develop one, but until such a test exists, there's no way to
   compare products or verify claims made for UVA protection. Manufacturers are
   allowed to claim UVA or broad-spectrum protection on a product, as long as it
   contains an ingredient that absorbs UVA.

   The American Academy of Dermatology recommends that everyone use a
   broad-spectrum sunscreen having an SPF of at least 15, and advises consumers
   to check for ingredients that screen UVA: benzophenone, oxybenzone,
   sulisobenzone, titanium dioxide, zinc oxide, and butyl
   methoxydibenzoylmethane (also called avobenzone and known by the trade name
   Parsol 1789).

   "People should not depend totally on sunscreens," Rippere says.

   While sunscreens protect against sunburn, they don't necessarily prevent
   cancer. If you use sunscreens to spend more time in the sun, your skin could
   collect about the same total exposure to damaging radiation. So it's still a
   good idea to stay out of the sun at midday, and to protect yourself with a
   wide-brim hat and clothing.

   Wear Some Shade

   Clothing offers the advantages of even, non-sticky protection that you don't
   have to remember to reapply. But many summer-weight fabrics don't give enough
   protection. Some are well below the minimum SPF 15 that dermatologists
   recommend. And fibers like cotton offer even less protection when wet.

   "You can't just put on any old shirt and expect it to protect you," says
   Julian Menter, Ph.D., research professor of medicine at Morehouse School of
   Medicine in Atlanta, Ga. "Fabrics can differ greatly in their ability to
   shield you from UV radiation."

   The ideal sun protective fabrics are lightweight, comfortable, and protect
   against exposure even when wet. Clothing that is labeled or promoted as
   providing protection against the sun or limiting exposure to UV rays is
   considered a medical device and is regulated by FDA. Sun Precautions, Inc.,
   of Seattle, Wash., has received FDA clearance to market its Solumbra clothing
   for sun protection and is allowed to claim an SPF of 30 for its products.


   In an experiment with mice, Menter and colleagues compared a so-called
   "typical" summer clothing fabric (a tightly woven cotton used in a gardening
   shirt) with the Solumbra fabric, a proprietary, tightly woven synthetic. With
   an SPF of 6.5, the cotton fabric protected mice against short-term UV
   effects, but it didn't protect against long-term skin damage, including skin
   cancer. In fact, the incidence of tumors in these mice was comparable to that
   of the mice who received no UV protection. Mice not subjected to any UV
   radiation and the mice protected by the Solumbra fabric showed no signs of
   skin damage.

   How do fabrics block UV? "It's a combination of factors--fabric thickness,
   composition of the fiber itself, and especially tightness of weave," says
   Deborah F. Lumbardo, an FDA biomedical engineer. Dye can be a factor too, she
   says.

   "But remember that you still need to be using sunscreen on whatever areas are
   exposed," Lumbardo says.

   Inside-Out Protection?

   Some studies estimate that diet may be involved in 40 to 60 percent of all
   cancers. More specifically, a high-fat diet has been implicated in colon and
   breast cancers. In animal studies, a high fat intake increased the likelihood
   of skin cancer after exposure to UV radiation, while switching to a low-fat
   diet after exposure reduced the incidence of skin cancer.

   Homer S. Black, Ph.D., a researcher at the Veterans Affairs Medical Center in
   Houston, and his colleagues found a dietary effect in humans as well. In
   their study, published in the New England Journal of Medicine, a low-fat diet
   decreased the incidence of actinic keratosis in non-melanoma skin cancer
   patients. "The risk factors for actinic keratosis and non-melanoma skin
   cancer are basically the same," says Black.

   The high-fat group ate their usual diet, consuming 36 to 40 percent of their
   caloric intake as fat, about average for Americans. In the low-fat group, no
   more than 20 percent of total caloric intake was fat. Overall, the high-fat
   group had a nearly five times greater risk of developing one or more actinic
   keratoses during the two-year study.

   "Reduced incidence of this common skin tumor is just another added benefit to
   a long litany of those that can be attributed to a low-fat diet," Black says.

   The National Academy of Sciences recommends a diet in which 30 percent or
   less of the calories come from fat. The National Cancer Institute, the
   American Cancer Society, the American Heart Association, and other health
   organizations support this recommendation.

   Although many researchers are studying the effects of certain vitamins and
   various other nutrients on skin cancer, it's too soon to make specific
   recommendations. But so far, the research trends point toward what we already
   know to be a healthier diet--less fat, more fruits, vegetables and grains.

   Once cancer develops, early detection and treatment are the best defense. Get
   familiar with your skin and your own pattern of moles and freckles with
   monthly skin self-exams. If any growth, mole or discoloration appears
   suddenly or begins to change, or if a sore appears that doesn't heal, see a
   dermatologist.

   For any type of skin cancer, treatment involves removing the lesion, usually
   in an outpatient procedure. The treatment goal is to remove or destroy the
   growth completely with as little damage as possible to healthy tissue.
   Doctors evaluate numerous factors in planning treatment. Considerations
   include type of cancer, tumor size and location, extent of disease, whether
   it's new or recurrent, potential for scarring, and the patient's overall
   health.

   Types of surgery include cryosurgery (destruction by freezing), laser surgery
   (using a laser beam to cut away or vaporize growths), and curettage and
   electrodessication (using a spoon-like blade to scoop out the growth,
   followed by destruction of surrounding tissue with an electric needle).
   Occasionally, other treatments, such as radiation therapy or chemotherapy,
   may be used alone or in combination.

   Even after successful treatment, people who have had skin cancer remain at
   increased risk of developing it again. Protecting their skin from UV exposure
   is critical in helping to prevent a recurrence. It should become a life-long
   habit.

   Carolyn J. Strange is a science writer in Saratoga, Calif.


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  SUNLAMPS--NOT A BRIGHT IDEA

   Like the sun, sunlamps give off UV radiation--both UVA and UVB--and can be
   harmful. Exposure to UV radiation from sunlamps adds to the total amount of
   UV radiation your skin accumulates during your lifetime, and increases the
   risk of skin cancer. Other risks include premature skin aging, skin and eye
   burns, allergic-type reactions, cataracts, reduced immunity, and blood vessel
   damage.

   FDA has a radiation safety performance standard for sunlamp products. Such
   products must have a warning label, an accurate timer, an emergency stop
   control, and include an exposure schedule and protective eyewear.

   Tanning devices aren't recommended for anyone, and should never be used if:

   *    You sunburn easily and don't tan. Skin that doesn't tan in the sun
   probably won't tan with sunlamps either.
   *    You get frequent cold sores. UV radiation may cause them to appear more
   frequently.
   *    You're taking medicines that can make you more sensitive to UV
   radiation. Check with your doctor or pharmacist.

   If you choose to ignore the risks and seek an indoor tan, follow all the
   safety precautions. Stick to your time limit. Be sure to wear the goggles
   provided, making sure they fit snugly and aren't cracked.

   Remember that there's no safe tan and there's no safe UV radiation. That's
   why tanning devices are best avoided altogether.

   --C.J.S.


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  UV OR NOT UV?

   It's a good rule of thumb to guard against overexposure whenever sunlight is
   strong enough that you can see your shadow. But you can't rely on your
   perception of brightness and shadows to gauge UV exposure because your eyes
   can't see UV wavelengths. Up to 80 percent of UV radiation can pass through
   clouds. The UV Index can help.

   While you should always guard against UV exposure, be extra vigilant when the
   UV Index is 5 or higher. Remember that exposure doesn't come only from
   above--snow, sand, water, and even concrete reflect UV radiation. Also, UV
   radiation increases at higher elevations. The UV Index for mountain cities
   takes this into account, but keep it in mind if you travel.

   Protect your eyes and skin from UV radiation with these simple safeguards:
   *    Wear a wide-brim hat to protect your eyes, ears, face, and the back of
   your neck.
   *    Wear sunglasses that block 99 to 100 percent of UV radiation. Check the
   label.

   *    Protect as much of your skin as possible with clothing.
   *    Use sunscreen with an SPF of 15 or higher. Reapply every two hours and
   after swimming.
   *    Avoid midday sun--10 a.m. to 2 p.m.--when UV radiation is strongest.

   --C.J.S.


   ___________________________________

  WEATHER SERVICE UV INDEX

UV Index        Exposure
Number          Level
0 - 2             minimal
3 - 4             low
5 - 6             moderate
7 - 8             high
9 - 10+           very high

   ___________________________________


Not a Cure-All: Eye Surgery Helps Some See Better

   by Marian Segal

   "Men seldom make passes at girls who wear glasses," Dorothy Parker observed
   in 1926. True or not, when the writer penned her now famous line, the only
   alternative to glasses was poor sight. Things are rosier--but not perfect--in
   1995.

   Today, growing numbers of women and men alike are opting for refractive eye
   surgery to correct their myopia (nearsightedness) in hopes of abandoning
   their glasses or contact lenses. The most common procedure is called radial
   keratotomy, or RK, and the National Eye Institute says about 250,000 are done
   each year in the United States, up from 30,000 just five years ago.

   Pursuit of a mate, however, is not cited by either gender as major motivation
   for surgery. A report by the American Academy of Ophthalmology published in
   the July 7, 1993, issue of Ophthalmology states: "In two studies,
   approximately 75 percent of the patients who were interviewed about their
   reasons for seeking radial keratotomy stated that they wished to see well
   without physical dependence on ... spectacles or contact lenses. Patients
   also sought radial keratotomy to improve their performance in profession or
   sport, to improve cosmetic appearance, for simple convenience, or at times to
   meet the visual requirements for occupations such as law enforcement and
   firefighting."

   David Euley, a 52-year-old Darnestown, Md., kitchen designer and home
   remodeler, began to consider RK when he found himself becoming increasingly
   frustrated with his glasses, particularly at work.           "It was
   difficult to go back and forth from blueprints to taking measurements to
   working on a computer," he says, adding that he needed a separate
   prescription for computer work.

   Euley talked with several ophthalmologists before deciding to have the
   surgery last December. Interviewed four months later, he was delighted with
   the results: "This is the first time in 25 years I've been able to see the
   titles on television without glasses. I can read license plates. I can see
   the deer in my backyard. And my glasses are sitting on a shelf somewhere."

   Six incisions in each cornea (the clear covering over the front of the eye)
   left Euley with uncorrected vision improved from 20/800 in both eyes to 20/20
   in the right and 20/25 in the left. (A person with 20/40 vision, for example,
   would see an object from 20 feet that another with perfect
   vision--20/20--could see at 40 feet. Some people see even better than 20/20.)

   RK is often done in the doctor's office. As in Euley's case, surgeries on
   each eye are usually scheduled a few weeks apart, as a precaution in case
   there are complications. The patient is given anesthetic eye drops to numb
   the eye. Using a high-precision diamond blade knife, the surgeon makes from
   four to eight spoke-like incisions in the cornea, while the patient focuses
   on the light of the operating microscope. The surgery takes about 10 to 15
   minutes.

   I Can See Clearly Now

   Euley can read those license plates without glasses now because the incisions
   changed the shape of his corneas. Normally, the cornea and lens bend light
   rays to focus directly on the retina--the tissue at the back of the eye that
   receives the image. If the cornea or lens is too rounded, or the eyeball is
   elongated, the light focuses in front of the retina, blurring distant
   objects. RK reduces or eliminates the myopia by flattening the cornea and
   redirecting the light to focus on the retina.

   The patient may have some pain or discomfort for 24 to 48 hours after
   surgery, possibly requiring medication. Glare, starbursting, or a halo
   effect, especially at night, is common for a few months and occasionally
   persists a year or more. Vision also commonly fluctuates during the day, with
   acuity best in the morning and diminishing somewhat at night. This decreases
   in severity during the first year, but may last for many years.

   Notwithstanding some claims to the contrary, RK is not a cure-all. (The
   Federal Trade Commission is investigating the problem of misleading claims in
   advertisements.) Reputable ophthalmologists will tell prospective patients
   the procedure is not completely risk-free, and perfect vision cannot be
   guaranteed.

   Is RK Safe and Effective?

   "FDA does not regulate radial keratotomy because it is a medical procedure,
   not a medical device," says Emma Knight, an ophthalmologist and medical
   reviewer with FDA's Center for Devices and Radiological Health. "The knife
   used in RK had been cleared by the agency for general corneal surgery."

   The National Eye Institute (NEI), however, concluded from a 10-year study
   called "Prospective Evaluation of Radial Keratotomy (PERK)" that RK is

   "reasonably safe and effective &hellip; with serious complications being
   rare."

   All patients in the study had -2 to -8 diopters and could be corrected to
   20/20 vision or better with glasses or contact lenses. (A diopter is the unit
   of measurement of spectacle or contact lens power. A minus value indicates
   nearsightedness; plus indicates farsightedness, or hyperopia. Euley's
   correction was -3.25 diopters.)

   Results of the NEI-sponsored multicenter trial were reported by study
   investigator George Waring III, M.D., and colleagues in the October 1994
   Archives of Ophthalmology. Among 374 patients (with 693 operated eyes) who
   returned for the 10-year follow-up:  *       70 percent said they did not
   wear glasses or contact lenses for distance vision. *        53 percent had
   20/20 vision without glasses. *      85 percent had at least 20/40 vision
   without glasses--the acuity most states require for driving without glasses.
   *    Of the total 793 eyes operated (including data from the most recent
   examination of those who didn't return for the 10-year follow-up), 143 lost
   one line of best spectacle-corrected vision on the standard eye chart, 19

   lost two lines, and four lost three lines. (Best corrected vision in all but
   16 eyes was 20/20--they previously had better than 20/20 corrected vision.
   Thirteen eyes were corrected to 20/25 and three to 20/30.) This means that,
   although eyesight without glasses was improved from pre-surgery acuity,
   residual nearsightedness could not be corrected with glasses to pre-surgery
   acuity, probably due to haze or other effect of surgery. *   38 percent of
   patients were corrected within one-half diopter of the predicted result; 60
   percent were within 1 diopter.  *    43 percent developed "hyperopic
   shift"--a gradual change toward farsightedness (1 or more diopters between 6
   months and 10 years) at a younger age than would be expected.

   The cornea is weakened by radial keratotomy, increasing the risk of eye
   rupture from physical trauma. According to the article by the American
   Academy of Ophthalmology, however, there have been reports of severe eye
   trauma without damage to the incision wounds. The report also says that
   potentially blinding complications, such as corneal infection or perforation
   are rare.

   More recent studies using newer RK techniques have achieved better optical
   results, says Peter Hersh, M.D., director of keratorefractive surgery at

   Montefiore Hospital, Bronx, N.Y.

   Surgeons have designed improved methods for calculating the number and length
   of incisions and the diameter of the optical zone (the central clear zone
   that has no cuts) that will produce the best results in a given patient, he
   says.

   "We've had numbers reported as high as 95 percent or so for 20/40 as the
   procedure has evolved," Hersh says. "The most important variable is patient
   age. Younger patients tend to heal their incisions better and more quickly,
   and therefore get less of an effect. Also, patients with lower degrees of
   myopia do better than high myopes," he says. Some other factors that may be
   considered when determining surgical procedure include corneal curvature,
   topography and thickness, and ocular pressure.

   The Laser Method

   An alternative to radial keratotomy that may soon become available in the
   United States is photorefractive keratectomy, or PRK.

   In this procedure, the surgeon operates an excimer laser programmed to

   deliver bursts of ultraviolet light that vaporize precisely targeted corneal
   cells. The effect, as in RK, is to flatten the cornea. Also like RK, PRK
   takes about 15 minutes and is done under topical anesthesia.

   Last October, FDA's ophthalmic devices advisory panel recommended conditional
   approval of one firm's excimer laser for refractive surgery, pending
   reformatting and reanalysis of some of the data. The panel also asked the
   manufacturer to submit a training program for surgeons and a patient
   information booklet.

   "This is the first time the agency has critically assessed safety and
   effectiveness data of any device for refractive surgery," says FDA's Knight,
   "and the meeting was long and full of debate."       The primary differences
   expressed by panel members concerned effectiveness criteria. Some felt the
   laser was somewhat more precise than RK, and so the criteria should be
   tighter than what the community had accepted for RK, Knight says. "We may
   decide there shouldn't be one single criterion, but that it's important
   instead for patients to know their probability of achieving, say, 20/20,

   20/25 or 20/40," she says. For instance, Knight explains, "Someone who can't
   see the clock beside the bed might be very happy with 20/40 vision--being
   able to get around without glasses except maybe to drive, whereas someone
   with very low myopia probably won't be happy if they have to wear glasses
   after surgery. It really depends on patient expectation."

   According to the American Academy of Ophthalmology, RK results are best in
   patients with low to moderate nearsightedness and generally is not
   recommended for people with a correction higher than -5 diopters. Data
   presented at the meeting indicate that PRK may be effective for people with
   myopia too severe for RK.

   Mary Taylor had her first PRK in November 1993. The highly myopic 42-year-old
   Winchester, Va., woman had worn glasses since second grade. Her correction
   was -9.5 diopters in one eye and -10 in the other.

   "I tried contacts a few times, but never really got comfortable with them,"
   she says, "and, although I didn't especially mind wearing glasses, I was
   bothered by how helpless I felt without them. The thought of losing them if
   something happened while I was driving or swimming--even if I had a spare

   pair--was always a worry in the back of my mind."

   Taylor says she received about 700 laser bursts at periodic intervals during
   the procedure. Then the doctor put a soft "bandage" contact lens in her eye
   to be worn the next few days until the surface cells healed. She was given a
   nonsteroidal anti-inflammatory eyedrop for pain and a prescription for
   additional pain medicine, if needed.

   "That first day I felt a mild discomfort, like a residual scratchiness after
   removing a piece of sand from the eye. It was gone when I woke up the next
   morning," Taylor says. Although her vision improved greatly immediately, it
   took about a month or two, she says, before she was seeing 20/20. Six months
   after the first operation, she returned for surgery in the second eye.

   As of October 1994, according to Taylor's doctor, her vision was 20/25
   without glasses and 20/20 with glasses, and her correction was -0.75 diopter.
   Taylor says she still has some trouble with night glare and needs glasses to
   drive at night, but she's delighted with the results. "For the first time in
   my life that I could remember, I could see my feet in the shower," she says.

   RK vs. PRK

   Jeffrey Robin, M.D., has a unique perspective on RK and PRK. Head of the
   department of refractive surgery at the Cleveland Clinic, Robin has done both
   procedures on patients in clinical trials and has, himself, undergone both
   procedures.

   "I've worn glasses since I was eight, and started wearing contact lenses when
   I was 17 or 18," Robin says. "I went through many pairs of lenses--tore them,
   slept in them. I was not a good contact lens patient and I detested wearing
   my glasses, basically because I didn't perceive I was seeing well with them,"
   he says.

   About four years ago, at age 35, Robin had an 8-incisional RK in his right
   eye. A year later, he had PRK in the left. He felt only minor, temporary
   discomfort after both surgeries, but says that before anti-inflammatory drops
   were used with PRK, that procedure often produced intense post-surgery pain.

   "With RK, vision is almost instantaneously improved--I went from about 20/800
   to better than 20/20 the morning after surgery," Robin says. "After PRK, I
   had better than 20/20 after about 10 days to two weeks. The big difference
   with the laser is that the correction is solid--there's no visual
   fluctuations and really no starbursting like you get with RK. Except for the
   couple of weeks after my RK when I used night driving glasses, I haven't worn
   glasses since. I've almost forgotten I ever wore them."

   Hersh and Robin agree that PRK may prove more effective than RK for higher
   myopia and may carry less risk for substantial complications such as
   infection or cataract. Also, hyperopic shift has not been seen with PRK, nor
   is the cornea weakened as it is in RK. On the other hand, Robin says, "we
   have 15 or 16 years of experience with RK as opposed to about four years with
   PRK. Between 1 million and 2 million Americans have had RK and probably only
   4,000 to 5,000 have had PRK, so we kind of know the warts--the good and bad

   sides--of RK whereas we don't really know all those things with our more
   limited experience with PRK."

   Both refractive surgeries are considered cosmetic procedures and are not
   covered by insurance. Robin says that RK generally varies from $600 to $1,500
   per eye and laser surgery costs around $2,000 per eye.

   Prospects for 20/20 in 2020

   Visions of a world entirely without glasses in the foreseeable future are
   probably premature; refractive surgery is not for everyone.          "From a
   medical standpoint, we are most concerned about people who have wound healing
   problems," Robin says, "because in all these procedures, the results are
   ultimately affected by two things--what we do as surgeons, and then how the
   patient's body reacts to the laser or knife wounds."

   For this reason, patients with connective tissue diseases such as rheumatoid
   arthritis or lupus erythematosus probably would not be good candidates, nor
   would people who are taking oral corticosteroids or immunosuppressive drugs
   or who are immunosuppressed from illness such as HIV infection. People with
   severe eye diseases, such as poorly controlled glaucoma, macular disease,
   retinal problems, extremely dry eyes, and certain corneal problems likely
   would be ruled out also.

   Robin, Hersh and Knight all agree that people who are not comfortable with
   the possibility that they may still need glasses or contact lenses at least
   part-time after surgery are probably not good candidates. Prospective
   patients should carefully weigh their hoped-for benefits against the
   calculated risks. After all, no surgeon can guarantee 20/20 vision except for
   hindsightedness.

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


   ___________________________________

  NEW PROGRESS WITH AN OLD IDEA

   Refractive surgery is not a new idea. Little wonder, since about one-fourth
   of the world's population is nearsighted--about 63 million in the United
   States alone. According to a report in the October 1994 Archives of
   Ophthalmology on the results of a 10-year study on radial keratotomy, the
   procedure was first described by European ophthalmologists in the late 1800s.
   It was further developed in Japan in the 1940s and 1950s, evolved into its
   modern form in Russia in the 1960s and 1970s, and was first done in the
   United States in 1978.

   Despite RK's long history, refractive surgery is still in its "early
   toddlerhood," says Jeffrey Robin, M.D. Head of the department of refractive
   surgery at the Cleveland Clinic, Robin foresees a broader spectrum of
   procedures, pending laser approval, that will include RK, PRK, and others now
   under study.

   "There's a growing menu of approaches that can potentially help people with a
   variety of refractive errors--low, moderate and high nearsightedness,
   farsightedness, and even presbyopia [farsightedness associated with aging],"
   he says, noting that surgeons are also combining the knife and laser
   techniques to try to achieve better accuracy and effectiveness, especially
   for very nearsighted people.

   For example, in an experimental procedure called laser in situ keratomileusis
   (LASIK), the surgeon uses a knife to cut a flap of corneal tissue, lases
   targeted cells beneath it, and then replaces the flap.

   "Possible advantages of LASIK are better results with high myopia, less
   chance of scarring and haze, faster recovery, and less pain than simple PRK,"
   says FDA's Emma Knight, M.D., an ophthalmologist with the agency's Center for
   Devices and Radiological Health. "From FDA's standpoint, we want to know not
   just if LASIK is a good enough procedure, but if it is as good or better than
   PRK. So we've asked people to do randomized studies."

   --M.S.



Conditions Men Get, Too

   by John Henkel

   Seymour Kramer noticed a patch of what looked like blood on his pajama top
   three years ago and thought he had cut himself. But he wasn't scratched. His
   doctor tested the discharge and told the New Jersey man he had breast cancer.

   Dan, 70, a retired Michigan engineer who asked that his last name not be
   used, was pulling weeds three years ago. For no apparent reason, he fractured
   two vertebrae. Doctors told him his bones were wasting away. He has
   osteoporosis.

   As a teenager, Gary Grahl was obsessed with having a trim, "athletic" body.
   The Wisconsin resident shunned food and exercised excessively. Sometimes he'd
   do situps and pushups for three hours before school. He ate little and shrank
   from 160 to an unhealthy 104 pounds. Over a six-year period, he was
   hospitalized four times. Now 26, Grahl says he is "completely recovered" from
   his eating disorder.

   What do these men have in common? They all suffer from illnesses typically
   thought of as "women's diseases." Breast cancer, osteoporosis, and eating
   disorders all occur in men, too, though their prevalence is much greater in
   the female population. As a result, many men, unaware that the diseases
   affect both sexes, may fail to recognize symptoms. Likewise, doctors and
   families often don't suspect these illnesses. This can delay therapy and make
   disorders difficult to treat.

   Medical experts say men may shy away from seeking medical treatment for
   disorders they feel are unmasculine. In support groups, men use terms like
   "very scared" and "ashamed" to describe initial feelings about their
   illnesses. Others express frustration at the difficulty in finding
   information and therapy.

   Osteoporosis

   High on the list of such conditions is osteoporosis. Though women are four
   times more likely to acquire it, about 5 million men in this country have
   osteoporosis, according to the National Osteoporosis Foundation. A disorder
   in which bones become weakened, osteoporosis is sometimes called the "silent
   disease" because it has no symptoms. It often manifests itself in fractures
   of the hip, wrist, spine, and other bones. Among both sexes, it is
   responsible for 1.5 million fractures a year.        Scientists are still
   piecing together just how osteoporosis develops, but it is well known that a
   key factor is deficiency of the mineral calcium. Leo Lutwak, M.D., Ph.D., a
   medical officer in FDA's Center for Drug Evaluation and Research, emphasizes
   that calcium intake over a person's lifetime is crucial to preventing bone
   loss. Ideally, he says, a diet adequate in calcium starting in childhood "can
   maximize peak bone mass," helping to ensure strong bones and make
   osteoporosis less likely. The revised food label that went into effect in
   1994 can help consumers pinpoint calcium-rich foods (see the May 1993 issue
   of FDA Consumer).

   About 99 percent of the body's calcium is stored in bones and teeth. Bone is
   continually being broken down and rebuilt. If the amount of calcium absorbed
   equals the amount lost, a state of balance occurs. When calcium absorption is
   greater than losses, the body accrues a "positive balance" that it can use
   for bone growth and repair. But when dietary intake of calcium can't meet the
   body's needs, the body draws the mineral from bones to allow a constant
   bloodstream supply. Ultimately, the breakdown process can exceed deposits,
   causing a possible reduction in bone mass and density.

   Osteoporosis is seen less often in men than in women for several reasons. Men

   generally have greater bone mass than women, and in males, bone loss begins
   later and advances more slowly. But men do have a hormonal drop-off in
   testosterone similar to women's reduction of estrogen after menopause.
   Testosterone may diminish as a result of hypogonadism, a condition marked by
   decreased function of the testicles. Testosterone levels may naturally become
   lower as a man ages.

   "Loss of sex hormone results in accelerated bone loss in whomever it occurs,
   whenever it occurs, for whatever reason," says Michael Kleerekoper, M.D.,
   deputy associate chairman of internal medicine at Wayne State University.
   "Whether that translates to osteoporosis depends on how much bone you have
   when the loss begins and how quickly you lose it." Women find relief from
   osteoporosis with estrogen therapy, and some men respond to testosterone
   injections. But successes with hormone therapy come most often from "seeing
   young men in the early stages" of the condition, Kleerekoper says.

   Another therapy shown to slow bone breakdown and reduce pain associated with
   fractures attributed to osteoporosis is the drug calcitonin, marketed as
   Miacalcin or Calcimar. FDA has not approved these drugs specifically for men,
   though some doctors prescribe them to males if they feel the patient will
   benefit. Currently under study for osteoporosis treatment are sodium

   fluoride, which some researchers think may help increase bone mass; vitamin
   D, which helps the body absorb calcium; and a nasal spray version of
   calcitonin.

   Dan, the Michigan osteoporosis patient, receives biweekly testosterone
   injections and takes daily supplements of 1,500 milligrams of calcium with
   vitamin D. He also exercises in a swimming pool, where water provides a
   beneficial resistance to movement. He says his two fractured vertebrae three
   years ago made him realize that osteoporosis gives no warnings.

   Factors that raise the risk of osteoporosis include cigarette smoking,
   alcohol consumption in excess of two drinks a day, advanced age, and an
   inactive lifestyle.

   Eric, 45, says years of inactivity helped bring on his osteoporosis. In his
   early 20s, the New York resident (who asked that his last name not be used)
   had several sports accidents that seriously impaired his mobility. An eating
   disorder in college also encouraged development of the condition, he
   suspects. Now, his bone loss is so severe that "anytime I have an x-ray, the
   doctors go into shock," he says. He risks injury by simply taking a walk and
   cannot stand barefoot on a hard floor without excruciating pain. He is taking
   calcitonin, which he hopes will stabilize his bone loss and allow him to do
   more walking.

   Though osteoporosis cannot be cured, it can be slowed down and steps can be
   taken to prevent it. The National Osteoporosis Foundation suggests these
   preventive measures:
   *    Eat a balanced diet rich in calcium.
   *    Exercise regularly, especially in weight-bearing activities.
   *    Don't smoke.
   *    If you drink alcohol, do so in moderation.

   Breast Cancer

   Primarily associated with women, breast cancer also occurs in men, although
   rarely. According to the American Cancer Society (ACS), men will make up
   1,400 of the 183,400 new cases of breast cancer expected in 1995.

   Men typically do not perform breast self-examinations to detect tumors, and
   doctors do not ordinarily examine men for breast cancer during physicals.
   Unlike women, men do not get routine mammograms. Consequently, a tumor may be
   present and go undiscovered.

   As with breast cancer in women, symptoms include the presence of a breast
   lump that is usually firm and painless. The nipple can have an abnormality
   such as retraction, crusting, or a discharge. Patients frequently are over
   60.

   Seymour Kramer was 70 when a gooey, bloodlike discharge from his nipple
   prompted him to seek medical attention. After analyzing the secretion,
   doctors told him he had breast cancer and recommended a lumpectomy, in which
   the nipple and a small amount of breast tissue are taken out. He also had
   several lymph nodes removed, and he underwent five weeks of radiation therapy
   to help ensure that residual cancer cells were killed. Though his prognosis
   appears very good, Kramer won't say he's been cured. But he expresses
   optimism: "Just because I had cancer doesn't mean my life is over."

   The ACS says risk factors for male breast cancer include:
   *    hyperestrogenism, or abnormal secretion of the hormone estrogen
   *    Klinefelter's syndrome, a male disorder characterized by reduced or
   absent sperm production, small testicles, and enlarged breasts
   *    gynecomastia, or enlargement of the male breast.

    Though medical professionals typically don't recommend detection exams for
   the general male population, doctors may advise men with gynecomastia to
   perform periodic breast self-examinations.

   Because in men the disease is often detected at an advanced stage when the
   tumor has spread, radical mastectomy--removal of breast tissue and pectoral
   muscle--is often the initial treatment. But if the cancer is found before it
   spreads to surrounding tissue or to the lymph nodes, a lumpectomy can be
   performed. Radiation sometimes is used without surgery, but the verdict is
   still out on its effectiveness. As in Kramer's case, radiation also can be
   employed after surgery to reduce the chance of local recurrence and to
   relieve symptoms in advanced cases. If cancer has spread into the lymph
   nodes, some physicians use chemotherapy. A therapeutic "tumor vaccine" for
   men and women to treat breast cancer that has already spread is in clinical
   trials now.

   Possible complications after surgery or radiation include decreased shoulder
   function, fluid retention in the arm, and pain or stiffness in the operated
   or radiated area. The ACS emphasizes that besides tending to the physical
   consequences of breast cancer therapy, "attention should be paid to the
   psychological aftereffects."

   Patients also need follow-up monitoring--including regular exams, blood
   chemistry, imaging (such as magnetic resonance imaging), and bone scans--to
   discover any recurring tumors quickly.

   Kramer says his experience of being blindsided by the disease put him on "a
   crusade" to inform men and medical professionals about breast cancer in
   males. "During a routine physical exam, I think doctors should run their
   hands across a man's breast to see if there's anything irregular," he says.
   "I'm not saying men have to go out and get wholesale mammograms. But [as a
   rule] doctors don't do this [touch test] and men don't inspect themselves.
   Those men who are not aware need to be shocked into the fact that, 'Hey,
   guys, this could happen to you.'"

   Eating Disorders

   Though many people associate eating disorders with women, these illnesses
   also occur in males. In one disorder, anorexia nervosa, the person limits
   food intake to the point of starvation. In another, bulimia nervosa,
   sufferers alternate between eating large amounts of food and ridding the body
   of it through vomiting or laxative use. About half of those with anorexia
   also have bulimia symptoms.

   According to the National Association of Anorexia Nervosa and Associated
   Disorders (ANAD), men make up about 1 million of the 8 million Americans with
   eating disorders.

   "It's a myth that these are illnesses of rich, white, perfectionist women,"
   says Chris Athas, ANAD vice president. "Just as a man or woman may become an
   alcoholic, either may fall victim to an eating disorder."

   Medical professionals say the disorders most often surface during the teen
   years, but in rare cases, men as old as 60 and boys as young as 8 can be
   afflicted. In both sexes, the illnesses can lead to lifelong medical and
   psychological complications. An estimated 6 percent of cases result in death.

   Most people find it difficult to halt the behavior without professional
   assistance. Though some men ultimately seek help, many continue untreated
   with the disorders, often for years, and sometimes for a decade or more.

   Diagnosis is complicated by a reluctance some men have to seek medical help
   for disorders that are "still primarily women's," Athas says. "We live in a
   'macho' society. Many men simply are ashamed to have an illness of this
   type." Thus, they suffer in silence.

   Another problem, says ANAD, is that a great number of doctors and health-care
   professionals are not trained to identify or treat male eating disorders,
   especially anorexia. Families, too, often fail to see the diseases' symptoms.
   The illnesses then can progress to a more advanced stage where they are
   harder to treat.

   During recovery, men sometimes are unwilling to participate in support-group
   sessions because the groups are mostly female. "Men as a whole are not
   comfortable in eating disorder support groups," says Athas. "But we encourage
   them to go anyway."

   Unlike many women, who acquire eating disorders because they "feel" fat, men
   often are medically obese at some point in the illness and feel pressure to
   be thin. Sometimes athletic activities induce this struggle to be lean,
   prompting not only the eating disorder but also compulsive exercising. Men
   also may adopt disease behaviors when teased or criticized about being fat at
   critical development stages, such as puberty.

   Treatment can be very effective, according to Arnold Andersen, M.D., an
   expert on eating disorders in men who has written a book on the subject. He
   describes a regimen of inpatient or outpatient hospital treatment, depending
   on the illness severity. Conditions such as anemia or depression are treated,
   and patients gradually relearn proper eating habits. Treatment also usually
   includes psychotherapy, which helps patients understand why they have the
   illness.

   One antidepressant drug, Prozac (fluoxetine hydrochloride), is under review
   by FDA as a treatment for bulimia. Other antidepressants also are being
   studied. One, Wellbutrin (bupropion), was shown to induce seizures in both
   anorexia and bulimia patients. Doctors sometimes prescribe tricyclic drugs--a
   class that includes Elavil (amitriptyline), Tofranil (imipramine), and
   Norpramin (desipramine). FDA has approved tricyclics for other uses but not
   specifically for eating disorders. However, doctors may prescribe approved
   drugs for "off-label" uses if, in their judgment, the patient will benefit.

   Patients also undergo what Andersen calls "nutritional rehabilitation," which
   allows them to regain a desirable body weight. Treatment is followed by
   weeks, months, even years of follow-up to ensure complete recovery.

   Men in support groups for eating disorders, as well as those for breast
   cancer and osteoporosis, say the public gradually is becoming more aware that
   these disorders can occur in men. They also say there's a long way to go.
   Some think doctors need to be enlightened. Others bemoan the lack of
   research. But most seem to agree that men should be educated about the
   disorders and how to detect them.

   As breast cancer patient Seymour Kramer says: "Men need to get the word that,
   yes, this is a woman's disease. But you're not immune. It can happen to you."

   John Henkel is a staff writer for FDA Consumer.


   ___________________________________

  FOR MORE INFORMATION

   Sources of information and support for the disorders described in this
   article include:

      National Association of Anorexia Nervosa and Associated Disorders, Box 7,
      Highland Park, IL 60035--Offers free programs to help victims and
      families, including counseling, support groups, health-care referrals, and
      a newsletter; telephone (708) 831-3438.

      National Osteoporosis Foundation, 1150 17th St., N.W., Suite 500,
      Washington, DC 20036--Will send information packet and can refer patients
      to support groups; telephone (1-800) 223-9994.

      The Cancer Information Service, 550 N. Broadway, Suite 300, Baltimore, MD
      21205-2004--Will provide information on male breast cancer and can refer
      callers to cancer centers and support groups; telephone (1-800) 4-CANCER.

   ___________________________________

Making It Easier to Read Prescriptions

   by Dixie Farley

   Sig: I tab po qid pc & hs

   Unless you have a medical background, that bunch of letters probably looks
   like gobbledygook. In fact, it's several abbreviations for Latin terms used
   on prescriptions (see chart), in this case telling the pharmacist, "Label the
   container for this patient's medication with the following instructions: Take
   one tablet 4 times a day, after meals and at bedtime."

   But if some health professionals get their way, prescriptions may soon be
   easier to read--and therefore safer, since improved readability helps prevent
   medication mix-ups.

   In separate efforts, the Food and Drug Administration and the American
   Medical Association recently urged medication prescribers to take new
   precautions with prescriptions.

   Patients should take precautions, too, says Thomas McGinnis, R.Ph., associate
   director for pharmacy affairs at FDA. "If the directions written on a
   prescription seem confusing, ask your doctor or pharmacist to explain, until
   you fully understand how to take the medication."

   The Rx

   The Drug Enforcement Administration requires that prescriptions for
   controlled substances (drugs regulated by the Federal Controlled Substances
   Act) state the patient's name and address, date, name of the prescribed drug,
   dosage strength and form (such as 10-milligram tablets), amount to be
   dispensed, directions for use, number of allowed refills, and the
   prescriber's name, address, DEA registration number, and signature.

   States may make additional requirements. And they regulate the information on
   other prescriptions.

   Since September 1993, for instance, all Texas prescriptions have had to
   include the intended use of the drug, unless the prescriber decides this
   inclusion is not in the patient's best interest.

   "At the same time, we strengthened the confidentiality portion of our
   statute," says Steve Morse, R.Ph., assistant director of compliance with the
   Texas State Board of Pharmacy, in Austin. "The law makes it very clear that
   pharmacists may not share usage information except as the patient directs, or
   with other health-care professionals when the pharmacist determines that
   passing this information on would be in the best interest of the patient, or
   with certain regulators, such as DEA, as required by law."

   The Institute for Safe Medication Practices, in Warminster, Pa., also
   advocates putting the intended use on prescriptions, says pharmacist Michael
   Cohen, president of the institute. Many prescribers agree with this practice,
   Cohen says, while others argue against it. A number of states already require
   the use to be on drug orders for patients in long-term care facilities, he
   says.

   "There's no question in my mind," Cohen says, "that if the doctor generally
   included the drug's use on the prescription, most drug name mix-ups that
   occur would never happen."

   Look-Alike Names

   Mix-ups of drugs whose names look alike in handwriting or sound alike have
   also been a concern to FDA, which has received numerous reports. Jerry
   Phillips and other colleagues on FDA's Medication Error Subcommittee began
   tracking this type of medication error in June of 1992.

   "We review each report," Phillips says, "and, if warranted, we may call for
   the manufacturer to change a product's labeling and packaging, or even its
   name."

   Examples of look-alike names and the approximate number of reports are:
   *    Norvasc (amiodipine besylate) for high blood pressure, and Navane
   (thiothixene) for psychosis, 35 reports

   *    Levoxine (levothyroxine) for low thyroid, and Lanoxin (digoxin) for
   heart failure, 25 reports
   *    Prilosec (omeprazole) for duodenal ulcer, and Prozac (fluoxetine) for
   depression, 12 reports.

   In the February 1995 FDA Medical Bulletin, the agency advised printing or
   typing prescriptions for drugs with look-alike names. "It's the handwritten
   or verbal orders that have been misinterpreted," Phillips says. Including the
   diagnosis on these prescriptions also could help prevent mix-ups, he says.

   At FDA's request, Levoxine's manufacturer changed the name to Levoxyl. Also
   at FDA's request, Prilosec's name was changed in 1990 from Losec, which was
   being confused with the diuretic Lasix (furosemide).

   In addition, some doctors today may be able to send prescriptions directly to
   pharmacies by computer, bypassing handwritten prescribing.

   More Clarifying

   The American Medical Association, at its annual meeting in 1994, recommended
   ways to make prescription writing clearer.

   AMA's recommendations include:
   *    If handwriting is illegible, use a computerized medication order system,
   if available. Otherwise, print or type prescriptions.
   *    Write out instructions rather than use ambiguous abbreviations. (For
   example, write "daily" rather than "qd," an abbreviated Latin term for "every
   day," which could be misinterpreted as "qid," meaning "4 times a day," or
   "od," meaning "right eye.")
   *    Avoid vague instructions, such as "take as directed."
     *  Use the USAN-approved generic drug name, official name, or trademarked
   name if a specific product is required, rather than a locally coined name or
   unestablished abbreviated drug name. (For example, use "didanosine," the

   generic name of an AIDS drug, or its trade name, "Videx," instead of the
   abbreviation "DDI." USAN stands for United States Adopted Names, a
   nonproprietary designation for any compound used as a drug, established by
   negotiation between the manufacturer and the USAN Council.)
   *    Avoid apothecary or chemical symbols, such as "K," the chemical symbol
   for potassium.
   *    Use a leading "0" in decimals expressing less than one, as in "0.5 mL"
   (milliliter), but never an ending "0," as in "5.0 mL."
   *    Avoid decimals when possible. (For example, prescribe "500 mg"
   [milligrams], rather than "0.5 g" [grams].)
   *    Spell out the word "units" rather than write "u."
     *  Use the metric system.

   When verbal orders are necessary, AMA recommends that they be fully, clearly
   and articulately dictated, and then read back by the person receiving the
   order. (For example, say "three times daily," rather than the Latin
   abbreviation "tid.")

   While Latin terms such as "Sig," for signa ("write") or signetur ("let it be
   labeled"), are still commonly seen on prescriptions, prescribers who follow
   the new recommendations may soon retire some of these terms and otherwise
   clarify their drug orders. "Let it be labeled correctly" is the expected
   result.

   Dixie Farley is a staff writer for FDA Consumer.


   ___________________________________

  PRESCRIPTION SYMBOLS

   Latin served a good purpose on prescriptions when they were first written in
   the 1400s. Spread widely by Roman soldiers and traders, Latin was the main
   language of western Europe for hundreds of years. It was unlikely to change,
   because it was a "dead" language, and it was unlikely to be misinterpreted,
   because it was exact in its meaning. Of course, the patients who didn't know
   Latin probably didn't have the vaguest idea what they were taking.

   The only part of a prescription where Latin appears today, however, is in the
   directions for taking the drug. This use has become a kind of medical
   shorthand. (See chart.) Some of these abbreviated terms have the potential to
   cause medication errors because they look so similar in handwriting, so their
   use is on the decline.

   Where does the "Rx" for "prescription" come from? Its origins are given
   variously as an abbreviation of the Latin word "recipe," meaning "take," or
   as a representation of the astrological sign of Jupiter. This sign was placed
   on ancient prescriptions to invoke that deity's blessing on the medicine to
   help the person get well. More recently, the cross at the end of the "R" has
   been explained as a substitute period.

   --D.F.


   ___________________________________

  COMMON LATIN RX TERMS

Latin               Abbreviation             Meaning
ante cibum            ac                        before meals
bis in die            bid                      twice a day
gutta                 gt                        drop
hora somni            hs                       at bedtime
oculus dexter         od                        right eye
oculus sinister       os                        left eye
per os                po                       by mouth
post cibum            pc                      after meals
pro re nata           prn                      as needed
quaque 3 hora         q 3 h                    every 3 hours
quaque die            qd                       every day
quater in die         qid                     4 times a day
ter in die            tid                     3 times a day

   ___________________________________


                                    UPDATES

  THINK TWICE ABOUT EATING RAW OYSTERS

   For some people, eating raw oysters can cause serious illness--even death.
   The reason: Vibrio vulnificus, a bacterium that occurs naturally in Gulf of
   Mexico waters and oysters.

   The bacteria are not a result of pollution, so although oysters should always
   be obtained from reputable sources, such sources, clean waters, and high
   turnover of oysters in restaurants do not provide protection against the
   bacteria.

   Certain health conditions put people at high risk for infection. These
   conditions are:
   *    liver disease
   *    hemochromatosis, an iron disorder
   *    diabetes
   *    stomach problems
   *    cancer
   *    immune disorders, including infection with HIV
   *    long-term steroid use (as for asthma or arthritis).

   People who drink moderate to heavy amounts of alcoholic drinks also may be at
   increased risk. According to the 1993 Special Report to Congress on Alcohol
   and Health, and the National Institute on Alcohol Abuse and Alcoholism,
   drinking two to three alcoholic beverages each day can cause liver disease,
   which often has no signs or symptoms. People with liver disease are almost
   200 times more likely to die from Vibrio vulnificus infection than those
   without liver disease.

   Check with a doctor if you're unsure of your risk, and, if you're at
   increased risk, do not eat raw oysters. Fully cooking oysters kills the
   bacteria.

   For more information, call the FDA Seafood Hotline, (1-800) FDA-4010.

  FDA ORDERS STOP TO MARKETING OF QUININE FOR NIGHT LEG CRAMPS

   Less than a year after ordering a halt to the marketing of over-the-counter
   (OTC) quinine sulfate for night leg cramps based on its serious risks, FDA
   ordered a stop to the marketing of prescription quinine for this use because
   even under a doctor's care, its risks outweigh any possible benefits.

   In January, FDA sent warning letters to 44 companies stating that it is
   unlawful to market their quinine sulfate products for night leg cramp relief
   because FDA has not approved the drug for this use. By the end of March, all
   major manufacturers and distributors had stopped labeling their products for
   this use, including Marion Merrell Dow, the manufacturer of the original and
   best-known quinine drug, Quinamm.

   From 1969 through June 1992, FDA received 157 reports of health problems
   related to quinine use, including 23 that resulted in death. Nonserious
   problems included temporary sight and hearing disturbances, dizziness, fever,
   nausea, vomiting, and diarrhea. Serious problems included thrombocytopenia, a
   destruction of blood platelets that can lead to massive bleeding and
   sometimes death.

   After weighing the benefits and risks of OTC quinine sulfate for night leg
   cramps, FDA concluded that quinine is not safe and effective for this use
   because:
   *    No studies demonstrate that quinine is effective against night leg
   cramps.
   *    Night leg cramps are not a threat to life or health.
   *    Health risks outweigh any small potential benefits.

   Based on this finding, the agency published a rule in the Aug. 22, 1994,
   Federal Register prohibiting OTC marketing of the drug for leg cramps.

   FDA also proposed to stop OTC marketing of quinine for another use--to
   prevent or treat malaria. The public has until July 3 to comment on the
   proposal, published in the April 19, 1995, Federal Register. The agency based
   the proposal on its conclusion that physician monitoring is essential to the
   safe and effective treatment of this serious, potentially life-threatening
   disease. Written comments may be sent to: FDA Dockets Management Branch
   (HFA-305), Rockville, MD 20857.

  7 COMPANIES, FDA TEST HACCP

   Seven major food companies are working with FDA in a pilot program to test a
   procedure to enhance food safety.

   The pilot will help FDA determine if the approach, called Hazard Analysis
   Critical Control Point, or HACCP, is practical for wider application in the
   food industry.

   Under the HACCP plan, companies analyze their manufacturing processes to
   identify where problems are most likely to occur and where preventive
   measures need to be focused. The idea behind HACCP is to build safety into
   the manufacturing process, rather than rely on inspections and sampling to
   identify unsafe products after they've been made.

   Companies participating in the voluntary pilot program and their products
   are:
   *    Alto Dairy, Wapun, Wis.--hard cheese
   *    Campbell Soup Company, Camden, N.J.--refrigerated salad dressing
   *    Campbell-Taggart, Inc., St. Louis, Mo.--pan breads
   *    Con Agra, Omaha, Neb.--flour
   *    Ocean Spray Cranberries, Lakeville-Middleboro, Mass.--pasteurized juice
   *    Pillsbury, Minneapolis, Minn.--bakery products
   *    Hans Kissle Foods, Wilmington, Mass. (in cooperation with the
   Massachusetts Department of Health)--quiche

  BLOOD CENTER LICENSE SUSPENDED

   Serious violations of federal regulations designed to safeguard donors and
   the blood supply led to the suspension of blood product licenses for a
   regional blood center in Midland, Texas.

   FDA's suspension on April 20 of the establishment and product licenses of
   Midland County Hospital District, also known as Permian Basin Regional Blood
   Center, prevents the center from shipping blood or blood components
   interstate.

   An FDA inspection of the center from March 14 through April 11, 1995, found
   violations such as improper and unsterile blood collection and processing,
   inadequate follow-up of donor adverse reactions, inaccurate record-keeping,
   and inadequate staff training.

   The license suspension does not stop the center from procuring U.S.-licensed
   blood and blood components from another acceptable source, provided that
   appropriate measures are taken to ensure proper storage and distribution.

   If the center develops a plan to correct the violations, FDA will review the
   plan and decide what further action should be taken.

  REPORT ON ROTAVIRUS VACCINE

   An investigational vaccine prevented more than 80 percent of the most severe
   diarrheal illnesses among infants caused by rotaviruses, according to a study
   reported in the Journal of the American Medical Association.

   The vaccine was developed and patented by the National Institute of Allergy
   and Infectious Diseases (NIAID), a part of the National Institutes of Health.

   An effective vaccine would annually prevent more than 1 million cases of
   severe rotaviral diarrhea in U.S. children under 5, including 65,000
   hospitalizations. In developing nations each year, moderate to severe
   rotaviral diarrhea affects 18 million youngsters, killing more than 870,000.

   The vaccine, RRV-TV, was developed in 1986 by Robert Chanock, M.D., Albert
   Kapikian, M.D., and others at NIAID's Laboratory of Infectious Diseases.
   Chanock is chief of the laboratory, and Kapikian is assistant chief. NIAID
   patented the vaccine in 1988.

   In the study, reported in the April 19 Journal of the American Medical
   Association, researchers at 23 U.S. medical centers compared a placebo to the
   RRV-TV vaccine, which uses four important human rotavirus strains, and to
   another investigational vaccine, the RRV-S1, which uses only one of the
   strains, serotype 1. Chanock and colleagues developed the RRV-S1 in 1985, and
   NIAID patented it in 1987.

   During the testing, both vaccines protected against serotype 1 disease, but
   only the RRV-TV protected against disease caused by the other strains during
   the second year after immunization, according to the report's authors, led by
   David Bernstein, M.D., of the J.N. Gamble Institute of Medical Research, in
   Cincinnati.

   Specifically, the two vaccines provided the following protection:
   *    all cases of rotaviral diarrhea--RRV-TV, 57 percent; RRV-S1, 40 percent
   *    less serious cases--RRV-TV, 49 percent; RRV-S1, 31 percent
   *    most severe cases--RRV-TV, 82 percent; RRV-S1, 73 percent
   *    episodes longer than three days--RRV-TV, 92 percent; RRV-S1, 36 percent
   *    cases requiring medical visits--RRV-TV, 78 percent reduction; RRV-S1, 67
   percent reduction.

   The researchers enrolled 1,006 healthy infants, ages 4 to 26 weeks, between
   August 1989 and February 1990. Of those enrolled, 898 received three oral
   doses of one of the vaccines or the placebo at least two weeks apart, with
   the final dose by age 30 weeks. The researchers followed the 898 children for
   one year and 864 for two years, until June 1991. Neither researchers nor
   parents knew which product a child received until the study ended.

   Through a cooperative research agreement with NIAID, Wyeth-Ayerst
   Laboratories, of Philadelphia, produced both vaccines for the study. The firm
   had requested to meet with FDA and, after that meeting, chose not to pursue

   developing the RRV-S1 vaccine product.

  GALLUP SURVEY SAYS CHILDREN AWARE OF HEALTHY LIFESTYLE

    American children have beneficial attitudes and behaviors about food,
   nutrition, and physical activity, according to a nationwide survey of
   children aged 9 to 15.

   The telephone poll, conducted by the Gallup Organization last November and
   December, queried 410 children about topics such as eating habits, parents'
   influence on diet, and the school's role in food and fitness.

   According to the poll:
   *    Ninety-seven percent agreed that a balanced diet is "very important" for
   good health, and 98 percent said the same about physical activity.
     *  Sixty-six percent said they like eating "many different kinds of foods,"
   while 74 percent agreed that eating "a lot of bread, cereal, and other grains
   is good for you."
   *    Sixty-four percent rated their own eating habits "good to excellent,"
   and 76 percent said the same about their parents' eating habits.
   *    Forty-nine percent said they eat meals with their families every day,
   while 13 percent said they eat with their families only once a week or less.
     *  Sixty-four percent agreed that foods good for them "don't taste good," a
   14 percent rise from a 1991 survey.
   *    Eighty percent want to do more physical activity this year.

   Children reported getting nutrition information from schools and teachers (90
   percent), parents (77 percent), television (64 percent), books (60 percent),
   and health professionals (59 percent).

   Survey results are encouraging, says Doris Derelian, Ph.D., president of the
   American Dietetic Association, a survey sponsor. "Children understand that
   they can enjoy a wide variety of foods eaten in moderation," she says.

   "Children need encouragement from their family, friends and teachers to ...
   participate regularly in moderate-to-vigorous physical activity," says Sylvia
   Rowe, president of the International Food Information Council, another survey
   sponsor.

   The third survey sponsor, the President's Council on Physical Fitness and
   Sports, will mail a free brochure to help children plan a healthy lifestyle.
   For a copy, send a self-addressed, stamped business-sized envelope to:

   10 Tips for You
   P.O. Box 1144
   Rockville, MD 20850

  NEW PUBLICATIONS AVAILABLE

   Five free publications are now available from FDA.

   They are two FDA Consumer reprints--one on prostate cancer, the other on the
   new food label; a poster on iron poisoning; a backgrounder on the new food
   label; and a brochure on mammography published by the Agency for Health Care
   Policy and Research.

   The publications and their FDA publication numbers are:

   *    Prostate Cancer: New Tests Create Treatment Dilemmas (FDA) 95-1220

   *    The New Food Label: Better Information for Special Diets (FDA) 95-2291

   *    Protect Your Child from Iron Poisoning (FDA) 95-1221P

   *    The New Food Label (BG 95-12)

   *    A Woman's Guide: Things to Know About Quality Mammograms (FDA) 95-8286

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

   ___________________________________

                                    NOTEBOOK

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

   Food label placement will be permitted greater flexibility on packaged foods,
   according to an FDA final rule effective last May 5. The rule allows the
   label to be placed on any panel that can be readily seen by the consumer in
   situations where the principal display and information panels cannot
   accommodate all required labeling information, and the package has a total
   surface area of more than 40 square inches. (FR April 5)

   Names of patients and those reporting to FDA adverse events associated with
   regulated products will not be disclosed by the agency, according to a final
   rule effective July 3, 1995. The rule helps maintain FDA's ability to collect
   information about safety risks of human drugs, biologicals, and medical
   devices. The rule also preempts state or local laws requiring disclosure of
   an individual's name. (FR April 3)

   Jaguar brand bicycle helmets, model 3060, are being recalled by Protective
   Technologies International, Inc. (PTI), because the helmet liners failed head
   impact tests and may not prevent injuries. In cooperation with the Consumer
   Product Safety Commission, PTI, the manufacturer, is recalling 25,000 helmets
   sold nationwide at Toys 'R' Us and Target stores from September 1994 to
   January 1995. Consumers should call PTI at (1-800) 515-0074 to receive a
   United Parcel Service tag to return the helmet. PTI will send consumers a new
   helmet that meets safety standards.

   A cumulative orphan products list is available from FDA. The list, updated
   monthly, identifies the drugs and biologics granted orphan status under the
   Food, Drug, and Cosmetic Act. Free copies are available from FDA, Office of
   Orphan Products (HF-35), Rockville, MD 20857; telephone (301) 443-4718. (FR
   April 19)

   Manufacturers of licensed biological products can find out about reporting
   changes in a Federal Register document, "Changes to be Reported for Product
   and Establishment License Applications; Guidance." The document provides
   manufacturers of licensed biological products guidance on manufacturing
   changes that don't need prior approval by FDA's Center for Biologics
   Evaluation and Research director and on changes that do need approval. (FR
   April 6)

   Over-the-counter products to treat pancreatic enzyme deficiency are not
   generally recognized as safe and are misbranded, according to an FDA final
   rule that takes effect Oct. 24, 1995. After that date, no such OTC products
   may be initially introduced or delivered for introduction into interstate

   commerce unless they have been approved by FDA. (FR April 24)

   Testicular prostheses can no longer be distributed unless the manufacturer or
   importer has filed with FDA a premarket approval application or a notice of
   completion of a product development protocol, according to an agency final
   rule effective last April 5. The prostheses are generic, surgically implanted
   medical devices intended to simulate the presence of a testicle within the
   male scrotum. (FR April 5)

   Homelessness and migrancy have been added to the list of predisposing risk
   conditions to qualify a person for the Special Supplemental Nutrition Program
   for Women, Infants and Children, according to a final rule from the U.S.
   Department of Agriculture's Food and Consumer Service. The rule was effective
   last April 19. (FR April 19)

   The Social Security Administration became an independent agency in the U.S.
   government's executive branch, according to a final rule effective last April
   14. Social Security, formerly a part of the Department of Health and Human
   Services, continues to be responsible for administering the old-age,
   survivors, and disability insurance and the Supplemental Security Income
   programs. (FR April 14)

   ___________________________________

                             INVESTIGATORS' REPORTS

Device Maker Receives Five-Year Sentence in Fraud Case

   by John Henkel

   A scheme to market ineffective medical diagnostic kits has landed a Pleasant
   Hill, Calif., man in prison for five years. Following a two-week jury trial,
   he was convicted on 21 felony counts of fraudulently marketing medical
   devices, wire fraud, mail fraud, falsifying clinical test data, and violating
   probation.

   Robert F. Hird, 50, formerly president of Diversified Diagnostics Inc. (DDI),
   also was ordered to pay $386,878.25 in restitution to three medical device
   firms he had defrauded. He began his prison term last March.

   Seven years earlier, Hird had pleaded guilty to medical device-related
   misdemeanor charges and was on probation when charged with the felony
   offenses in 1993.

   The previous conviction resulted from an FDA investigation in the mid-1980s
   of Biospec, a firm Hird then owned. The investigation showed that culture
   media manufactured by Biospec for laboratory identification of bacteria was
   adulterated and ineffective.

    FDA secured an injunction ordering the firm to stop selling the adulterated
   devices and later, through the Justice Department, filed a criminal action
   charging Hird with 16 misdemeanor counts. These included filing false
   documents and distributing adulterated devices.

   In September 1987, Hird pleaded guilty to the charges and received five
   years' probation, which included a stipulation barring him from participating
   in the manufacture of medical devices.

   By the time of the probation, however, Hird had already formed DDI and was
   seeking partners to produce and distribute various medical devices.

   The preceding April, before pleading guilty to the misdemeanor charges, Hird
   received FDA approval to market a kit called the Chromagen culture test. The
   device checks for strep throat by growing bacteria from a patient's throat
   swab on a culture plate and testing typical bacteria colonies with chemical
   reagents to confirm the presence of Streptococcus.

   In May 1988, FDA rejected Hird's application for approval of a similar device
   called the Chromagen direct test, designed to detect Streptococcus bacteria
   by applying chemical reagents directly to the throat swab. FDA told Hird that
   sale of the Chromagen direct test would be illegal.

   Despite this, Hird entered into an agreement in February 1988 with California
   Integrated Diagnostics (CID) for that company to assemble Chromagen direct
   test kits using chemical reagents made by DDI. During negotiations with CID,
   Hird falsely claimed that FDA had approved the Chromagen direct test. Unaware
   the kits were illegal, CID began assembling and delivering them to Hird.

   At the same time, Hird similarly misled officials from Port Washington,
   N.Y.-based Henry Schein Inc. (HSI) into believing FDA had approved Chromagen
   direct tests for marketing. As a result, HSI began test-marketing the devices
   and, in August 1988, signed an agreement with Hird's company giving exclusive
   license to make and sell products using DDI-developed technology, including
   the Chromagen direct test.

   DDI shipped the unapproved devices to HSI and collected approximately
   $600,000 for the kits, research and development, and loans. HSI distributed
   the test kits for about a year, unaware that they were not approved devices.

   By early 1989, FDA had received complaints claiming the Chromagen devices
   didn't work. The agency traced the devices to Hird's company and conducted an
   inspection of the facility between April and May 1989.

    The inspection revealed that the Chromagen device being sold was not cleared
   by FDA and that Hird had violated the terms of his earlier probation. FDA
   confronted Hird, who called HSI and told officials there about FDA's
   findings. HSI quickly cut off all business with Hird, stopped selling the
   test kits, and, in August 1989, sued Hird for civil damages. (The suit went
   to trial in January 1993, and in June of that year the court awarded HSI
   $300,000 in damages.)

   Hird then petitioned FDA to reconsider clearing the Chromagen direct test. In
   November 1989, the agency rejected the petition and, around the same time,
   referred Hird's case to the U.S. Probation Office in San Francisco. After a
   hearing, the case was referred to the U.S. Attorney's Office, which directed
   FDA to investigate the case further to determine the full extent of Hird's
   criminal activities.

   Between March and October 1991, Hird negotiated with Troy Biologicals, of
   Troy, Mich., to market the Chromagen direct test kit under the Troy label.
   Again, Hird falsely claimed that FDA had approved the test. Troy agreed to
   market the kits and bought 300 of them.

   That November, an HSI employee saw the Troy version of the Chromagen direct
   test, marketed as the Micro-Swab Strep Kit, and recognized it as Hird's
   uncleared, ineffective device. The employee notified FDA, which went to Troy
   and asked for documentation showing FDA had cleared the device. Troy
   contacted Hird, who faxed a fraudulent certification. FDA then prepared to
   seize devices on Troy's premises, but later found the inventory had been
   moved to a firm in Massachusetts that had invested in Hird's operations. In

   February 1992, U.S. marshals seized the kits from the Massachusetts company.

   Earlier, Hird had signed a marketing agreement with Bioclinical Systems Inc.,
   of Annapolis Junction, Md., to sell a device that tests for Chlamydia, a
   sexually transmitted bacterium. Between March 1989 and October 1990, DDI
   conducted studies needed to clear the device. Hird altered the study data to
   show the Chlamydia test to be more effective than actual test results
   demonstrated. Based on a review of documents submitted with the falsified
   data, FDA cleared the device in April 1991. Because the data were submitted
   by Bioclinical Systems and Hird's name was nowhere on the application, FDA
   officials were not suspicious.

   A month later, Bioclinical Systems began to suspect there was "something
   fishy about the data," says Alex McCormick, compliance officer in FDA's San
   Francisco district. Bioclinical ran its own tests and found the Chlamydia kit
   didn't work. In May 1991, after running further tests, the company notified
   FDA, which investigated the clinics Hird used for the trials. Comparing data
   sheets for patients on file at the clinics with Hird's submitted data, FDA
   officials determined that Hird had skewed the data. Hird had claimed a 94
   percent effectiveness rate for the test, but FDA found it to be 66
   percent--"not much better than flipping a coin," says McCormick.

   In September 1992, the U.S. Attorney's Office filed a probation revocation
   with the U.S. District Court for the Northern District of California. By that
   December, FDA and the U.S. Attorney's Office were examining further charges
   and negotiating with Hird for a possible plea bargain. Hird rejected a plea
   and was indicted in September 1993. In September 1994, a jury found him
   guilty on 21 felony counts, and he was sentenced the following December.

   Because the companies Hird worked with were unaware of the fraudulent aspects
   of the agreements, none was considered liable.

   John Henkel is a staff writer for FDA Consumer.
   ___________________________________

  CANADIAN FIRM GETS MAXIMUM FINE FOR SELLING MAIL-ORDER DRUGS

        A Toronto-based mail-order firm has received a $500,000 fine--the
   maximum amount allowed--in federal court for one count of shipping and
   selling an unapproved generic drug.

   Medicine Club International Inc. also was ordered by the U.S. District Court
   for the District of Maryland last Jan. 5 to pay nearly $340,000 for


   investigative costs incurred by the U.S. government. The firm must maintain a
   $1 million letter of credit that will be forfeited to the U.S. Treasury if
   the company manufactures, advertises or distributes adulterated or misbranded
   drugs during a five-year probation.

   The company, which also operated under the name Interpharm Inc., was
   affiliated with the major Canadian generic drug manufacturer, Apotex Inc.

   Medicine Club International practiced what is commonly called "off-shore
   pharmacy." From at least January 1991 to August 1993, the company routinely
   promoted and shipped more than 75 unapproved new drugs into the United States
   from Canada. Among the drugs were generic versions of Prozac (fluoxetine),
   used to treat depression; Retrovir (zidovudine), used to treat AIDS; and
   Tagamet (cimetidine), used to treat ulcers.

   The company took consumer orders over an 800 telephone number that it
   publicized through ads in U.S. newspapers, magazines, and direct mailings.
   The ads targeted the general public, as well as specific groups such as the
   male homosexual community, senior citizens, and veterans. Between January
   1991 and January 1992, ads ran in 24 different gay publications. Drugs were
   sold at greatly reduced prices and did not require a prescription. Quantities
   sold generally were limited to a three-month supply.

   By law, companies intending to market generic drugs in the United States must
   file an abbreviated new drug application (ANDA) with FDA and must be
   authorized to distribute or sell those products. Otherwise, FDA cannot ensure
   that such products have been properly manufactured and are effective.
   Medicine Club International had no ANDA on file and did not obtain
   authorization to sell the drugs. In addition, the drugs the firm sold require
   a prescription, but Medicine Club customers were not asked for one.

   FDA first became aware of the illegal activities in January 1991, when agency
   officials saw a magazine ad promoting the mail-order products. The company's
   ads implied that FDA permits such purchases under its "personal use" policy,
   which allows individuals to import some unapproved drugs for personal use
   under certain conditions.

   FDA traced the 800 numbers to Toronto and Montreal. From interviews with
   newspapers and magazines in which the ads appeared, investigators determined
   that Medicine Club International (then called Interpharm) was placing the ads
   and shipping products. An investigator from FDA's Buffalo district office
   bought drugs undercover from the 800 number. Over the next year, officials
   from nine other FDA field offices around the country bought drugs.

   Based on evidence collected, FDA sent Interpharm warning letters in early
   1992 telling the company to stop distributing the drugs. FDA also sent the
   company written notice that the mail-order products did not fall within the
   agency's "personal use" policy, which pertains only to products not available
   in the United States.

   But the drug sales continued. To elude FDA, the company changed its name and
   800 number. "They didn't heed our warning letters, and they dodged
   surveillance," says David Kiessling, investigator in FDA's Buffalo district
   office.

   In January 1993, the Federal Bureau of Investigation joined the
   investigation, and the next month, an FBI agent bought 100 fluoxetine tablets
   from Medicine Club International. That purchase formed the single count of
   shipping unapproved drugs under which the U.S. government secured a guilty
   plea in January 1995 from the firm.
    --John Henkel

  SHRIMP PROCESSOR GOES TO JAIL

        A Massachusetts businessman was sentenced to three years in prison
   followed by two years' supervised release for selling shrimp that had been
   illegally treated with chemicals.

   The sentencing last March 28 in the U.S. District Court for the District of
   Massachusetts followed an October 1994 conviction of Robert Randazzo, 49, and
   his firm, New England Shrimp Company, Ayer, Mass., on 101 counts. The charges
   included conspiracy, making false claims to the U.S. Department of Defense
   (DoD), distributing shrimp containing sodium hydroxide and sodium
   tripolyphosphate (STP), distributing Chinese shrimp fraudulently labeled as
   U.S. shrimp, and filing false tax returns.

   Something had "smelled fishy" to federal agents at the firm's processing
   plant for some time. But it wasn't until suspicious competitors as well as a
   former employee--fired because he refused to go along with New England
   Shrimp's illegal activities--complained to federal authorities in February
   1992 that FDA and other government agencies got the break they needed.

   Acting on the complaints, the Massachusetts U.S. Attorney's Office, DoD, and

   FDA assembled evidence needed to request a warrant to search the plant. In
   the early morning of June 30, investigators from FDA, DoD, U.S. Customs,
   National Marine Fisheries Service, and local law enforcement agencies headed
   to New England Shrimp to execute the search.

   "We had all met the day before to go over the details of the operation," says
   FDA Boston district investigator John Ridings. "The place was so large that
   everyone had to be assigned a specific area to search; the logistics were
   crazy."

   The search began shortly after 7 a.m., and investigators collected evidence
   for more than 14 hours. By the end of the search, 136 boxes had been filled
   with evidence, including production records, financial data, shipping
   records, memos, and correspondence. They were trucked away to safe storage
   areas at federal facilities. Also, more than 1.3 million pounds of shrimp,
   valued at $2.75 million, was seized.

   Investigation of the company's records and supporting testimony from former
   employees revealed how New England Shrimp, Randazzo, and former plant manager
   Daniel Canavan had conspired to violate federal laws.

   FDA's Boston district worked with the U.S. Attorney, DoD, Customs, and the
   Internal Revenue Service to consolidate the case against New England Shrimp.
   In early 1994, the government handed down a 101-count indictment.

   New England Shrimp had sold more than $3 million worth of STP-contaminated
   shrimp to DoD, despite contractual agreements with that agency prohibiting
   use of the chemical in the shrimp it buys. STP makes the shrimp retain water,
   increasing its weight and therefore its price, because shrimp is a
   weight-based commodity. Also, because STP was used in levels exceeding the
   limits allowed under good manufacturing practices, the product was regarded
   as unsafe for human consumption. There were no reports of illness from the
   shrimp, however.

   In April 1994, Canavan pleaded guilty to conspiracy to make false claims
   against the government in selling the shrimp to DoD, and conspiracy to sell
   adulterated and misbranded shrimp. He was sentenced to five months
   imprisonment followed by five months home detention. Randazzo, however,
   maintained he was innocent and went to trial in October 1994.

   During the trial, FDA seafood expert John Noonan demonstrated to the judge
   and jury how New England Shrimp changed grayish and black-striped shrimp
   harvested in China to look like pink shrimp from the Gulf of Mexico.

   Noonan soaked the Asian-harvested shrimp in containers of sodium hydroxide,
   chemically burning them to the pinkish-orange color more appealing to
   American consumers. New England Shrimp labeled and advertised the shrimp as
   Gulf shrimp.

   New England Shrimp Company is no longer in business.
   --Joseph Raulinaitis is a public affairs specialist with FDA's Boston
   district office.

  NEW YORK CATTLE DEALER CAUGHT SELLING ADULTERATED BEEF

        Cattle dealer George Zabadal, of Binghamton, N.Y., was taking a new tack
   rounding up cattle for slaughter. If a farmer wasn't around to sign a
   certificate declaring an animal free of illegal levels of drug residues,
   Zabadal just signed the farmer's name. His last such signing, for an animal
   that in fact had illegal residue levels, led him to promise to change his
   ways.

   Caught red-handed, Zabadal agreed to terms of a consent decree of permanent
   injunction for selling adulterated beef. U.S. District Judge Thomas McAvoy,
   Northern District of New York, signed the decree last Dec. 23. Zabadal agreed
   to set up and use a written records system--to be approved by FDA--designed
   to prevent the illegal marketing. In another decree, the farmer also agreed
   to improve his drug residue control procedures.

   Illegal antibiotic residues in meat can cause life-threatening allergic
   reactions in people sensitive to those drugs. In addition, they contribute to
   development of antibiotic-resistant strains of bacteria in people who eat or
   handle the meat.

   "This was a small case, but an important one," says John Thompson, a
   compliance officer with FDA's Buffalo district office. "It's the first animal
   tissue residue enforcement action we've taken against an animal dealer in New
   York. Maybe it will send a message to some others who aren't doing their best
   that FDA takes this problem seriously."

   On Feb. 26, 1993, William Chilton, an animal tissue monitor in FDA's Syracuse
   resident post, inspected Zabadal to investigate a report from the U.S.
   Department of Agriculture that one of the dealer's animals had illegal
   residue levels of penicillin and streptomycin. FDA permits no more than 0.05
   parts per million (ppm) of penicillin, but this sample showed 0.13 ppm. FDA
   allows 2.0 ppm of streptomycin, but the sample showed 21.17 ppm.

   USDA inspectors at each slaughtering site obtain tissue samples from the
   slaughtered animals for analysis at a USDA laboratory. The results are then
   transmitted to FDA by computer through USDA's Residue Violation Information
   System.

   During Chilton's inspection, he learned that for more than 40 years, Zabadal
   had been buying about 800 cattle a year from local farmers in New York and
   then delivering them for resale, usually to slaughter houses in Pennsylvania.
   "Zabadal admitted he deals mostly in 'down cows,'" Chilton says. "These were
   usually sick, lame or injured dairy cows, more likely than others to have
   been medicated. He had already received several warning letters from FDA and
   USDA for additional drug residue reports in the 1980s."

   Zabadal had certificates printed, Chilton says, stating that the animal
   hadn't been medicated or that proper withdrawal time had been observed before
   a medicated animal was offered for slaughter. "He had his farmers sign this
   before he'd buy their animals."

   Confronted with the new USDA report that found excessive residue levels in
   one of his cows, Zabadal showed Chilton a certificate signed by the source
   farmer, Paul Stephen Smith, of Smith Family Farms. Chilton made a copy of the
   certificate.

   In March 1993, Chilton inspected Smith. "I showed him the certificate,"
   Chilton says, "and asked, 'Is that your signature?' Smith answered, 'No. I
   never signed that.'" Chilton learned that Zabadal had in fact not even been
   at the Smith farm that day and that the cow wasn't even there, but at another
   farm about 70 miles away.

   Chilton confronted Zabadal with what Smith had said. Zabadal admitted he
   signed Smith's name, Chilton says, and that he did this often with his
   regular sources if a farmer wasn't available or didn't know about the
   animal's medication status.

   Chilton told Zabadal it was his responsibility to ask questions so that he
   would be certain of every animal's medication status and to always wait the
   appropriate drug withdrawal time.

   Then, in November 1993, FDA got a notice from USDA that a slaughtered Zabadal
   cow had an illegal penicillin residue level of 5.08 ppm. Chilton inspected
   Zabadal again, in January 1994.

   "Turns out," Chilton says, "Zabadal had gone to a cattle auction in Sennett,
   N.Y. When he would buy cows at these sale barns, he'd make no attempt to
   learn who the owner was to ask about the animal's medication status. But

   guess who had sold this cow--Paul Stephen Smith."

   Chilton again told Zabadal he needed to inquire further about these animals,
   to be certain he wasn't offering cows with illegal drug residues.

   In April 1994, Chilton reinspected Smith and found that his controls to
   prevent illegal residues were inadequate.

   On June 24, Smith signed a consent decree agreeing to develop a records
   system for administering drugs, a drug inventory and accountability system,
   and a system for giving drug records to the cattle buyers, who must certify
   receiving them. The decree was filed June 27 in the U.S. District Court,
   Western District of New York.

   In July, at FDA's request, a complaint for injunction was filed against
   Zabadal. The consent decree he signed in December requires a records system
   that tracks each animal's ear tag number; the date the animal is bought and
   the seller's name; the date any drug is given and its name, dose, and route
   of administration; each drug's pre-slaughter withdrawal time; and the date a
   medicated animal is sold and the buyer's name. Zabadal must obtain from the
   seller of a medicated animal a signed certificate indicating the animal is
   drug-free.

   FDA is monitoring both the dealer and the farmer.
   --Dixie Farley

   ___________________________________

                           SUMMARIES OF COURT ACTIONS

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

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

  SEIZURE ACTIONS

   Food/Contamination, Spoilage, Insanitary Handling

   PRODUCT: Canned tomatoes, canned peach slices, and canned grapefruit, two
   seizure actions, at Brooklyn, N.Y. (E.D.N.Y.); Civil No. CV-93-4917.
     CHARGED 10-29-93: All of the articles were exported from Canada as part of
   a salvage lot from a bankruptcy sale and were held at Federation Warehouse in
   New York, N.Y. The tomatoes were adulterated in that they were contained in
   dented, rusted, swollen, and leaking cans--402(a)(3); the peaches contained

   Geotrichum mold and were misbranded in that the labels expressed the net
   quantity of contents in terms of fluid measure rather than in terms of weight
   measure--402(a)(3) and 403(f). The grapefruit contained developed seeds, and
   the peaches contained pit fragments in excess amount of the applicable
   standard--403(h)(1).
    DISPOSITION: Default--articles destroyed. (F.D.C. 66764 and 66712; S. Nos.
   92-508-941 and 92-508-948; S.J. No. 1)

   PRODUCT: Crab meat, frozen, at Philadelphia, Pa. (E.D.Pa.); Civil No.
   87-6155.
   CHARGED 9-30-87: While held at Blue Grass Distribution Center in
   Philadelphia, Pa., the article was adulterated after interstate shipment in
   that the food contained Listeria monocytogenes--402(a)(1); the article was
   prepared, packed and held under insanitary conditions where the food was
   contaminated with Escherichia coli--402(a)(4); the article was misbranded in
   that the labeling of many of the cartons incorrectly identified the product
   as frozen shrimp instead of frozen crab meat--403(b); and the label failed to
   state the name and place of business of the manufacturer, packer or
   distributor--403(e).
   DISPOSITION: Default--article destroyed. (F.D.C. 65261; S. No. 87-441-827;
   S.J. No. 2)

   PRODUCT: Lobster meat, frozen, at Chicago, Ill. (N.D.Ill.); Civil No. 91C703.
   CHARGED 7-26-91: While at Americold Corporation in Chicago, Ill., the article
   was adulterated in that it consisted in part of a decomposed
   substance--402(a)(3).
   DISPOSITION: Default--article destroyed. (F.D.C. 66218; S. No. 91-575-999;
   S.J. No. 3)

   PRODUCT: Sturgeon in tomato sauce, perch-pike, stuffed eggplant in tomato
   sauce, and stellated sturgeon low-acid canned foods, at Brooklyn, N.Y.
   (E.D.N.Y.); Civil No. CV-92 4967.
   CHARGED 10-20-92: While held for sale at M & A International, Inc., in
   Brooklyn, N.Y., the articles were adulterated in that they were prepared and
   packed under conditions which might have rendered them injurious to health
   due to inadequate processing--402(a)(4); the perch-pike, eggplant in tomato
   sauce, and stellated sturgeon were misbranded before and after interstate
   shipment in that they were in package form and failed to bear labels
   containing the name and place of business of the manufacturer, packer or
   distributor--403(e)(1); the label of the eggplant in tomato sauce did not
   appear in English, and the labels of the stuffed eggplant and eggplant in
   tomato sauce were not expressed in terms of weight--403(f); the label for the
   perch-pike failed to identify the food by its common or usual
   name--403(i)(1); and all of the articles were made from two or more
   ingredients that were not listed on the labels by their common or usual
   names--403(i)(2).
   DISPOSITION: Decree--articles destroyed. (F.D.C. 66462; S. No. 92-638-500;
   S.J. No. 4)

   PRODUCT: White fragrant rice, at Los Angeles, Calif. (C.D.Calif.); Civil No.
   89 7136.
   CHARGED 12-11-89: While held for sale at PFC Foods, Inc., in Los Angeles,
   Calif., the article was adulterated in that it had been held under insanitary
   conditions where it might have become contaminated with filth--402(a)(4); and
   the article contained insects, insect pupae, insect larvae, and insect
   skins--402(a)(3).
   DISPOSITION: A consent decree of condemnation released the article to the
   claimant, who voluntarily destroyed and reconditioned parts of the article.
   (F.D.C. 65787; S. No. 90-556-488; S.J. No. 5)

   Drugs/Human Use

   PRODUCT: Amaphen with codeine No. 3 capsules, at Pittsburgh, Pa. (W.D.Pa.);
   Civil No. 86-1364.
   CHARGED 6-26-86: While held after interstate shipment at Trimen Laboratories,
   Inc., in Pittsburgh, Pa., the articles were new drugs without an approved new
   drug application--505(a) and (b).
   DISPOSITION: A summary judgment ordered the articles destroyed. (F.D.C.
   64732; S. No. 85-419-342; S.J. No. 6)

   PRODUCT: Colon Cleanser, Liv-Flush, Kidney Flush, Arthritis Nutrient Formula,
   Prostate Plus, Cata-Rx, and Aloe/Cranberry Flush, at Long Island City, N.Y.
   (E.D.N.Y.); Civil No. CV-91-4802.
   CHARGED 12-4-91: While held after interstate shipment at L&H Vitamins, Inc.,
   in Long Island City, N.Y., the articles were new drugs without an approved
   new drug application--505(a) and (b).
   DISPOSITION: A decree of forfeiture ordered the articles destroyed. (F.D.C.

   65955; S. No. 90-626-621; S.J. No. 7)

   PRODUCT: Hauck G-2 and G-3 capsules, at Alpharetta, Ga. (N.D.Ga.); Civil No.
   86-1305A.
   CHARGED 6-10-86: While held after interstate shipment at W.E. Hauck, Inc., in
   Alpharetta, Ga., the articles were new drugs without an approved new drug
   application--505(a) and (b); and the articles were misbranded in that their
   labeling failed to give adequate directions for use--502(f)(1).
   DISPOSITION: A summary judgment ordered the articles forfeited and condemned.
   The articles were destroyed. (F.D.C. 64698;  S. No. 82-482-515/516; S.J. No.
   8)

   PRODUCT: Liv-Flush, PressuRest, ProZaine, Kidney Flush, Heart-Ex, ChromMate,
   Blood Cleanser, Whole Dried Cranberry Fruit, Ester C., Bee Pollen, Kyolic,
   and PROZ Personal Oxygen System, at Brooklyn, N.Y. (E.D.N.Y.); Civil No.
   CV-91-4802.
   CHARGED 12-4-91: While held after interstate shipment at L&H Vitamins, Inc.,
   in Long Island City, N.Y., the articles were new drugs without an approved
   new drug application--505(a) and (b); the articles were misbranded while held
   for sale after shipment in that their labeling was false and misleading since
   they represented and suggested that the articles were safe and effective for
   their intended use--502(a); and the articles' labeling failed to bear
   adequate directions for use--502(f)(1). The Personal Oxygen System was
   misbranded while held for sale after shipment of one or more of its
   components--503(b)(4).
   DISPOSITION: A portion of the articles was seized on 12-23-91. A consent
   decree ordered the seized drugs condemned, forfeited and destroyed. Regarding
   the drugs that were not seized, the claimant affirmed they did not fill any
   orders after 12-23-91, they returned any monies received for such orders, and
   they returned to the vendors the articles it had in stock or which it might
   have subsequently received. Furthermore, the claimant informed the vendors
   that the government considered the articles unlawful. The claimant destroyed
   any remaining articles. (F.D.C. 66060; S. No. 90-600-481; S.J. No. 9)

   PRODUCT: Margensic No. 3 tablets, at Lafayette, La. (W.D.La.); Civil No.
   86-1353.
   CHARGED 5-29-87: While held after interstate shipment at Marnel
   Pharmaceuticals, Inc., in Lafayette, La., the articles were new drugs without
   an approved new drug application--505(a) and (b).
   DISPOSITION: A summary judgment ordered the articles destroyed. (F.D.C.
   64695; S. No. 85-314-085; S.J. No. 10)

   Drugs/Veterinary

   PRODUCT: Prozyme enzymatic protein supplement, at Kansas City, Mo. (N.D.Mo.);
   Civil No. 91-0595-CV-W-8.
   CHARGED on or about 7-2-91: While held for sale after interstate shipment at
   Veterinary Companies of America, Inc., in Kansas City, Mo., the article was
   adulterated in that it was an unsafe, new animal drug without an approved new
   drug application--501(a)(5); and the article was misbranded in that its
   labels failed to bear adequate directions for use--502(f)(1).
   DISPOSITION: Default--article destroyed. (F.D.C. 66159; S. No. 90-596-962;
   S.J. No. 11)

   Medical Devices

   PRODUCT: Lithotriptor Spark Plugs, at Frederick, Md. (D.Md.); Civil No.
   B-92-1849.
   CHARGED 7-1-92: While held at Frederick Self Storage, in Frederick, Md., the
   articles were adulterated in that they were class III devices that did not
   have an application for premarket approval--501(f)(1)(B); and the articles
   were misbranded in that the labeling failed to bear adequate directions for
   use, and they were not manufactured in a registered establishment--502(f)(1)
   and 502(o). DISPOSITION: A default decree of forfeiture condemned the
   articles, forfeited the rights and interests of the manufacturer, and ordered
   the articles destroyed. (F.D.C. 66430; S. No. 92-516-233; S.J. No. 12)

  CRIMINAL ACTIONS

   DEFENDANTS: Par Pharmaceuticals, Inc., at Baltimore, Md. (D.Md.); Criminal
   No. HAR-91-0433.
   CHARGED 12-6-91 by grand jury: Count 1: The defendant adulterated the drug
   Cloridine HCl in that it manufactured and processed the drug using methods
   and controls that did not conform to good manufacturing practices--301(a) and
   303(a)(2); Count 2: The defendant shipped in interstate commerce the generic
   drug megestrol acetate, which was adulterated in that the employees prepared
   and maintained false product batch records and manufactured the drug by
   adding an ingredient that was not included in the approved formula--301(a)
   and 303(a)(2).
   Counts 3-8: The defendant made false statements to FDA by (a) failing to
   accurately state the manner, order and instructions by which the drug
   thioridazine was milled and mixed, (b) failing to correctly show where the
   drug haloperidol was produced, (c) misrepresenting the batch size of the drug
   leucovorin calcium, (d) misrepresenting the batch and proportion size of
   lactose anhydrous NF, Starch 1500, povidone USP, Aerosil 200, stearic acid
   NF, zinc stearate, Green Caffine Granulation with Starch, and Orphengesic
   Forte, (e) falsely creating batch records of the drug methyldopa that did not
   reflect the unapproved addition of magnesium stearate, and f) recreating
   batch records, falsifying accelerated stability data, and laboratory reports
   of the generic drug triameterene/hydrochlorothiazide--18 U.S.C. 1001.
   Count 9: The defendant influenced, obstructed and impeded an inspection of
   its drug manufacturing facility in that its agents and employees falsely
   represented a batch of tablets to an FDA investigator in order to conceal the
   fact that the batch did not contain sodium bicarbonate and the fact that the
   product had not been submitted for bioequivalency testing--18 U.S.C. 1505.
   Count 10: The defendant adulterated the drug Tolazamide in that it failed to
   comply with good manufacturing practices, by preparing and maintaining false
   batch records--301(k) and 303(a)(2).
   DISPOSITION: Guilty plea; a $2,500,00 cumulative fine and a special
   assessment of $200 for each of the 10 counts. (F.D.C. 65712; S.J. No. 13)

   DEFENDANT: Padam Bansal, director of research and development, Baltimore, Md.
   (D.Md.); Criminal No. HAR-92-066.
   CHARGED 3-19-93 by grand jury: In connection with Par Pharmaceuticals, Inc.,
   defendant was charged with obstructing an FDA investigation by giving false
   and misleading testimony to the grand jury regarding the batch record for the
   drug triameterene/hydrochlorothiazide--18 U.S.C. 1503.
   DISPOSITION: Guilty plea; two years' probation, sentenced to six months home
   confinement, and ordered to pay a $50 special assessment. (F.D.C. 66533; S.J.
   No. 14)

   DEFENDANTS: Edward Boden Sr., Edward Boden Jr., and Roger Walsh Jr., Chicago,
   Ill. (N.D.Ill.); Civil Nos. 89 CR 645-1; 89 CR 645-2, and 89 CR 645-3.
   CHARGED 2-23-90 and 3-2-90 by a grand jury: Conspiracy by the three
   defendants to increase the sales and profits of Bodine's Inc., and their
   salaries by falsely representing that low-cost adulterated and misbranded
   products manufactured and sold by Bodine's Inc. were 100 percent pure orange
   juice products--301(a) and (k), and 303(b). Foods labeled as orange juice,
   orange juice from concentrate, and frozen concentrated orange juice were
   adulterated in that the orange juice and orange juice concentrate were
   omitted from the product and substituted with inferior and cheaper
   ingredients--402(b)(1) and 402(b)(2).
   DISPOSITION: Guilty pleas; Edward Boden Sr. was sentenced to two years in
   prison, a $250,000 fine, 1,000 hours of community service, five years'
   probation, and a special assessment of $150. Edward Boden Jr. was sentenced
   to two years' probation, a $200,000 fine, 200 hours of community service, and
   a special assessment of $125. Roger Walsh Jr. was sentenced to two years'
   probation and 200 hours of community service. (F.D.C. 64573, S. No.
   85-499-315; S.J. No. 15)

   DEFENDANT: John Sadlon, vice president of operations, Baltimore, Md. (D.Md.);
   Criminal No. HAR-92-0336.
   CHARGED 6-21-95 by grand jury: In connection with Par Pharmaceuticals, Inc.,
   defendant was charged with aiding and abetting in the interstate shipment and
   adulteration of the drug methyldopa in that it did not conform to good
   manufacturing practices--301(k) and 303(h).
   DISPOSITION: Guilty plea; ordered to pay a $3,000 fine and a $50 special
   assessment; two years' probation and 500 hours of community service. (F.D.C.
   66560; S.J. No. 16)

   DEFENDANT: Atul Shah, director of analytical research and developmental
   laboratory, Baltimore, Md. (D.Md.); Criminal No. HAR-92-0337.
   CHARGED 3-5-93 by grand jury: In connection with Par Pharmaceuticals, Inc.,
   defendant was charged with making false statements to the grand jury
   regarding the pilot batch of the drug triameterene/hydrochlorothiazide.
   DISPOSITION: Guilty plea; two years' probation and ordered to pay a $50
   special assessment. (F.D.C. 66561; S.J. No. 17)

   ___________________________________

   FDA Consumer magazine (July-August 1995)

