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ConsumerV O L . 2 1 N O . 4 M A Y 1 9 8 7
Why Women Don't Get Mammograms (And Why They 5Should)Mammography is the best way to detect breast cancer while it'sstill curable. But only between 5 percent and 15 percent of thewomen who should get a mammogram do so. There are manyreasons why women avoid this exam, but none of themoutweighs the benefits.
Trave lers ' Adv isory : Malar ia St i l l Threatens Much of Globe 8A million Americans travel each year to parts of the world wheremalaria is prevalent. Some bring it home. There are stepstravelers can take, before and during their journeys, to ward offthis st i l l -dreaded disease.
T a k i n g a L o o k a t E y e E x a m s 1 4Good eyesight is a priceless treasure, and one important way tohelp preserve it is through regular eye exams. In fact, the eyescan often provide clues to the condition of the entire body.
N u t r i t i o n a n d t h e A t h l e t e 1 8Whether you're an iron man or a weekend warrior on the tenniscourts, good nutrition should be a big part of your game plan.While there's no special food or vitamin pill that can make anall-star out of an also-ran. a healthy diet can help you bring outyour best.
K n o w t h e R i g h t W a y t o T a k e Y o u r M e d i c i n e s 2 2Taking your medicine isn't always a simple thing. Some drugs.should be taken on an empty stomach; others after a meal. Andwhat if you forget a dose? It's no wonder half of us takemedications the wrong way. Here's some easy-to-swallow adviceon how to do it right.
Warming to the Idea: Heat Research May Help Hearts, 25Kidneys, and Man's Best FriendFor FDA researcher Paul Ruggera, it started as a simple projectto measure body heat in a cancer experiment. But, by the timehis work is done, doctors may have a new tool for kidneytransplants, hypothermia treatment, and open-heart surgery forinfants and, yes, dogs.
U p d a t e s 2
C o n s u m e r F o r u m 4
T h e N o t e b o o k 2 8
I n v e s t i g a t o r s ' R e p o r t s 2 9
S u m m a r i e s o f C o u r t A c t i o n s 3 2
OtisR. Bowen, M.D.Secretary, U.S. Department ofHealth and Human Services
Frank E. Young, M.D.Commissioner of Food and Drugs
.lohii A. Norris, J.D., M.B.A.Deputy Commissioner of Foodand Drugs
Jack W. Mar t i nA.ssociate Commissioner forP u b l i c A f f a i r s
W i l l i a m M . R a d o s / E d i t o r
Jesse R. Nichols/Art Director
Cover De.sign; Paul Salmon
- m iI n s i d e F r o n t C o v e r P h o t o
The eyes are "the windows of thesoul, " wrote Guillaume de Salluste,Seigneur du Bartas in 1578. To learnhow eye exams can help us preserveour precious gift of sight, see page 14.
t-DA Consumer t May 1987 / I
updates
Some Not-So-Bad News on Caffeine
Among the bad news about caffeine that's been reported in recent years is that when it's fed to pregnantrats, their unborn babies grow slower than normal. Nowsome good—or at least better—news: Those babiesmake up for lost time almost completely within six daysof b i r th .
Animal studies have suggested that force-feeding caffeine to pregnant rats causes birth defects and delayedskeletal development in their offspring. When put in thepregnant rats' drinking water, caffeine causes delayedskeletal development, but not birth defects.
Delayed skeletal development means the offspring donot grow as fast as those whose mothers do not get caffeine. This effect is found at levels of caffeine that, forpeople, are comparable to just two cups of coffee a day.
But a new FDA study had some relatively optimisticfindings. Delayed skeletal development was again seenin unborn rat fetuses and newborn rats whose motherswere given caffeine in their drinking water through day20 of gestation (about two days before birth). But thedelayed development almost entirely reversed itself bythe time the babies were 6 days old.
New Drug Helps Hemophiliacs
FDA has approved a drug to reduce bleeding in hemophiliacs who must have teeth extracted.
Hemophiliacs have a hereditary deficiency of certainblood proteins, or factors, that help clot the blood. Because of this, they may bleed for a long time followingtooth extract ion.
The drug, tranexamic acid, blocks the enzymes thatdissolve clots, thus helping the hemophiliac's weakclots to survive. The drug can lessen or eliminate theneed for transfusions of blood-clotting factor.
Because damage to the retina of the eye was observed during animal studies with the drug, the labelingrecommends an eye examination before and duringtreatment if treatment lasts for more than several days.Usually the patient starts taking the drug one day beforethe extraction and continues to take it two to eight daysa f t e r .
Kab iV i t rum o f S tockho lm w i l l manu fac tu re t ranexamic acid, and KabiVitrum Inc. of Alameda, Calif.,will distribute it under the trade name Cyklokapron.
(For more about hemophilia, see "Hemophilia HasOutlasted the Czars" in the June \9%A FDA Consumer.)
We're Spicier
Americans are spicing their lives with more variety, alook at some spice production figures shows. Accordingto the Spice Trade Association, production and importsof a dozen spices have grown tremendously since the1950s. Here, from anise to turmeric, is how 1959 compares with 1986 (figures are in thousands of pounds):
I t e m 1 9 5 9 1 9 8 6
A n i s e 6 0 3 1,847
Capsicums (peppers) 5,165 14,389
Cassia (cinnamon) 13,600 25,665
Celery 2,677 5,679
C o r i a n d e r 2,575 5,705C u m i n 3,353 8,029
F e n n e l 4 6 7 4,916
L a u r e l 2 7 3 1,223
Oregano 1,907 11,699
♦Paprika 9,083 14,056
Sage 2,024 4,620T u r m e r i c 1,879 2,281
♦Imports only
For more on our eating habits, see "America'sChanging Diet" in the October 1985 FDA Consumer.
Treating Calluses and Corns
Salicylic acid is the only over-the-counter (OTC)drug that is safe and effective for removing corns andcalluses, according to an FDA-proposed rule.
The FDA proposal (formally called a tentative finalmonograph) is based on the recommendations of theAdvisory Review Panel on OTC Miscellaneous External Drug Products. The proposal, published in the Feb.20 Federal Register, is part of an ongoing review ofOTC drug products by FDA.
For products where the drug is applied on a medicated disk, pad or plaster, the recommended concentration of salicylic acid is 12 percent to 40 percent. Aconcentration of 12 percent to 17.6 percent is recommended for salicylic acid when the com and callus re-
2 / May 1987 / FDA Consumer
mover is in a liquid form.Since these liquids are usually flammable, the agency
proposes that the labeling contain an appropriate warning such as "extremely flammable" or "combustible."
Although the advisory panel recommended salicylicacid only for hard corns, FDA concluded that the drugwas also safe and effective for soft corns, based on theresults of three studies that were submitted to the
agency after the panel had finished its report. Hardcorns are dry and are usually located on the outside ofthe little toe or on the upper surfaces of the other toes.Soft corns are moist and are found between the toes.
According to the proposal, the following 13 ingredients are not generally recognized as safe and effective: iodine, ascorbic acid, acetic acid, allantoin,belladonna, chlorobutanol, diperodon hydrochloride,ichthammol, methylbenzethonium chloride, methyl salicylate, panthenol, phenyl salicylate, and vitamin A.
(For more about corns and calluses, see "Caring forCorns, Bunions, and Other Agonies of De-Feet" in theJune 1985 FDA Consumer.)
Con tamina ted Cosmet i cs
A New Jersey cosmetic manufacturer has recalledeye makeup made during the past two years because ofpossible contamination with bacteria and mold.
Tests by FDA found harmful bacteria that couldcause serious eye injuries—even blindness—in samplesof blue and brown mascara manufactured by Tori Laboratories Inc. of Perth Amboy, N.J. Samples of Tori'seye liner and eye shadow also were found to containbacter ia and mold.
The mascara, liquid eye liners, and eye shadowswere sold in bulk and in consumer-size units under thebrand names Ana Orsini, Annabelle, Eve's, Lauren's,and On Stage Cosmetics. The products also may havebeen sold under distributors' labels, which includeAOR Cosmetics of Brooklyn, N.Y., Regent Industriesof Montreal, Canada, Gem International of Brooklyn,N. Y., and Make Up Center Ltd. of Hackensack, N.J.Tori does not use lot numbers.
The recalled mascara is packaged in quarter-ounceplastic tubes with a mascara brush and comes in pink,black, blue and brown. The liquid eye liner comes invarious colors and is packaged in quarter-ounce plastictubes with an applicator brush. The powder eyeshadow, also in various colors, comes in a plastic compact with no brush.
According to Tori, which also does business as TorreLaboratories Inc., the cosmetics were distributed to 44customers—beauty salons, discount and departmentstores, skin-care clinics, and cosmetics distributors—inNew York, New Jersey, Pennsylvania, Kentucky,South Carolina, Florida, Texas, California, Puerto Ricoand Canada.
An inspection by New Jersey officials of Tori's plantin Perth Amboy in early February revealed numerousunsanitary conditions that could pose a public healthhazard. The firm voluntarily closed the plant.
Although FDA has received no reports of injury,consumers should return these products to the place ofpurchase.
Veterinary Export OK'dFDA has issued its first approval to export a veterin
ary drug under new legislation that allows manufacturers to sell in other countries human and veterinarydrugs not yet approved for sale in the United States.
The approval, issued Feb. 5, for ivermectin tabletsfor dogs allows the manufacturer, Merck and Co. ofRahway, N.J., to ship the drug to Canada and Japan.Ivermectin, widely used around the world to treat parasitic infections, is approved for use in the United Statesfor other animals, but not in an oral tablet form fordogs.
The new legislation, which was signed into law Nov.14, 1986, specifies 21 countries having advanced drugregulatory systems to which products may be shipped.It requires that the applicant certify that the drug is approved for marketing in the importing country, that it isthe subject of an investigational exemption in theUnited States, that the manufacturer is actively seekingapproval in the United States, that an application for approval has not previously been denied, and that onlyquantities of the drug that may reasonably be sold willbe exported.
Unapproved drugs and unlicensed biologicals to treator prevent tropical diseases are not limited to the specified 21 countries. Requirements for these products include identifying the manufacturer, listing the countryor countries to which it is being exported, and providing credible scientific evidence, including the results ofclinical trials, that the product is safe and effective.
All products for which export approval is soughtmust be manufactured in accordance wi th Good Man
ufacturing Practices, must be appropriately labeled, and
FDA Consumer / May 1987 ! 3
updates (Continued)
must include on the outside of the shipping package the\Jnames of the countries to which export is authorized.Also, copies of agreements with importers must beprovided to show they consent not to reship the products to unauthorized countries, and production must notcompromise public health in the United States.
Emergencies Cost FDA $22 Million in '86During fiscal year 1986, FDA spent $22.74 million
on field emergencies, consumer complaints, and othermajor unplanned work. This represented about 20 percent of the agency's field resources and was the largestsuch use of these resources in recent years.
Fiscal year 1986, which ended last Sept. 30, also hadthe largest number of recalls in recent years—3,068.There were 2,085 in fiscal 1985 and 1,408 in 1984. Theincrease was due mainly to a large number of recalls offoods that contained sulfites or Yellow Dye No. 5 anddid not say so on their labels. (Sulfites, which are usedas preservatives in some foods, and the food colorYellow No. 5 can cause allergic reactions in some people. FDA requires that their use be noted on food labelsto alert those at risk.)
Also, in July 1986, FDA banned the use of sulfiteson raw fruits and vegetables. Enforcing the ban cost$ 2 . 7 1 m i l l i o n .
Of the $22.74 million spent on emergencies, Tylenoland other drug tampering incidents—whether threats,false reports, or actual tamperings—cost $2.85 million.Investigating allegations of glass in Gerber baby foodproducts and possible tampering of other baby foodscame to $1.39 mi l l ion.
Consumer complaints—which can range from checking a jar of peanut butter to investigating and ensuringthe recall of thousands of products—cost the agency$7.88 m i l l i on .
FDA's response to finding Listeria bacteria in softdomestic and imported cheeses cost $2.8 million. Aseparate problem with Listeria in Kraft ice cream barscost $372,000.
Dairy product safety—including investigations ofsalmonel losis and other outbreaks of i l lness—cost$2.67 million, and resolving the problem of heptachlorcontamination of milk and cheese, centered mostly inArkansas, came to $1.35 mi l l ion.
Other unforeseen problems included: investigatingand prosecuting illegal sales of anabolic steroids to athletes—$444,000; investigation of various adulterated
foods and drugs—$426,000; checking imported foodsfor effects of the Chernobyl nuclear accident—$220,000; and checking for heavy-metal contamination(lead and cadmium) in foods—$103,000.
C o n s u m e r F o r u mFDA's Global Impact
As two FDA employees on [special assignment] to,and one retired FDAer consulting for, the Food and Agriculture Organization of the United Nations (FAQ), weenjoyed reading your November 1986 article "FDA'sGlobal Reach to Protect Publ ic Heal th." The ar t ic leshows many of the ways that FDA influence is felt inother countries of the world and should help in widelyreinforcing this message.
One aspect of FDA international work that is notcovered in the article is the continued willingness ofFDA to share its expertise with FAO, WHO and otherinternational agencies. FDA is one of the leadingsources of support and expert advice to the FAO/WHOCodex A l imen ta r i us Commiss ion i n te rna t i ona l f oodstandards program. In addition at FAO, we regularlyboiTow FDA sc ient is ts to serve on b lue-r ibbon FAO/WHO expert panels advising UN agencies and membercountries on the use and safety of food additives,pesticide residues, or on other food control problems.We also use the services of current or retired FDA ex
perts in advising developing countries on ways tostrengthen programs to assure the quality and safety ofdomestic and exported food supplies.
Over the past few years, FDA employees and retireeshave carried out FAO consultancies in Fiji, the People'sRepublic of China, several countries of southeast Asia,the Middle East and Africa, throughout the Caribbean,and in Central and South America. In all these areas ofthe world, EDA remains the best-known name in effective food control, which of course helps us to moreeasily carry out our EAO projects. Our thanks to EDAfor its continued help, which assists in improving foodquality and safety throughout the world.
John R. LupienRichard J . DawsonJ o h n R . W e a t h e r w a x
Food and Agriculture Organization of the United NationsRome, Italy
4 / May 1987 / FDA Consumer
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Mammography is presentlythe best method of detectingbreast cancer at its earlieststages—before the cancerhas spread and often beforethe tumor can be felt.
- - - i! y:, '--f'kI . - . i - A
£ . . . . ydate equipment be used so that the images produced will be of the highestquality. The better the quality of the image, the better the chance of detectingcancer if it is present. High-quality images also help avoid unnecessary levelsof radiation exposure.
Here are some questions for a womanto ask about a facility before getting am a m m o g r a m :1. Do your X-ray technologists and radiologists have specific training inmammography?
Technologists perform the examination, properly positioning the patient, operating the equipment, and developingthe film. Radiologists are medical doctors who interpret the results of the mammogram. Special training is essential forobtaining the best images with the leastpossible radiation and for interpretingthose images properly.2. Do you use "dedicated" mammography equipment?
In technological parlance, "dedicated" means that the equipment is designed specifically for mammography,providing the best mammograms with aslittle radiation as possible.3. How often is your mammographyequipment inspected and calibrated?
The answer should be at least anmialh.A look at what goes on during a mam-
mography examination may also help allay some fears. The patient usuallystands during the procedure, and thetechnologist positions the breast on ahorizontal support above the X-ray film.Compression of the breast by a devicecalled a "paddle" is necessary forproper positioning. The paddle is aboutthe size of this page. With some equipment, the technologist uses the paddlemanually to compress the breast. Thepaddle stays in position while the technologist goes behind an X-ray shield andtakes the exposure. After the exposure,the technologist returns to the patient andreleases the compression. However, withsome newer equipment, the technologistcompresses the breast only partially before going behind the machine wherethere is a button that allows automaticcompletion of the compression. After theX-ray is taken, the compression is immediately released automatically, minimizing the compression time and thediscomfort. The newer compression devices may be more uncomfortable thanthe older-style compression by a balloon-type device, but the newer devicesprovide higher quality images.
Although there may be some discomfort while the breast is compressed, thereshould not be a great deal of pain. Propercompression is crucial to a high-quality
6 / May J 987 / FDA Consumer
Breast Self-Examimtion (BSE)Breast self-examination should be done once a month so
you become familiar with the usual appearance and feel ofyour breasts. Familiarity makes it easier to notice anychanges in the breast from one month to another. Earlydiscovery of a change from what is "normaF' is the mainidea behind BSE. If you menstruate, the best time to doBSE is two or three days after your period ends, when yourbreasts are least likely to be tender or swollen. If you nolonger menstruate, pick a day, such as the first day of themonth, to remind yourself it is time to do BSE.
1. Stand before a mirror. Inspect both breasts for anything unusual, such as any discharge from the nipples,puckering, dimpling, or scaling of the skin.
The next two steps are designed to emphasize any changein the shape or contour of your breast. As you do themyou should be able to feel your chest muscles tighten.
2. Watching closely in the mirror, clasp hands behindyour head and press hands forward.
3. Next, press hands firmly on hips and bow slightlytoward your mirror as you pull your shoulders and elbowsforward.
Some women do the next part of the exam in theshower. Fingers glide over soapy skin, making it easy toc o n c e n t r a t e o n t h e t e x t u r e u n d e r n e a t h .
4. Raise your left arm. Use three or four fingers of yourright hand to explore your left breast firmly, carefully, andthoroughly. Beginning at the outer edge, press the flat partof your fingers in small circles, moving the circles slowlyaround the breast. Gradually work toward the nipple. Besure to cover the entire breast. Pay special attention to thearea between the breast and the armpit, including the armpit itself. Feel for any unusual lump or mass under thes k i n .
5. Gently squeeze the nipple and look for a discharge.Repeat the exam on your right breast.
6. Steps 4 and 5 should be repeated lying down. Lie flaton your back, left arm over your head and a pillow orfolded towel under your left shoulder. This position flattensthe breast and makes it easier to examine. Use the same circular motion described earlier. Repeat on your right breast.
mammogram with the lowest radiationdose possible. Women who experienceincreased tenderness of the breast beforetheir menstrual periods may want toschedule the exam for after their periods.
For women under 50, medical opinionvaries on when mammographic screeningis appropriate. Because it is clearly sobeneficial for women over 50, somemedical experts also recommend thatwomen begin getting mammograms intheir 40's or earlier. The American Cancer Society, the American College of Radiology, and the American MedicalAssociation all recommend a "baseline"mammogram (to which later mammograms can be compared) between ages35 and 40, mammograms yearly or every
other year between ages 40 and 49, andyearly mammograms from age 50 on.But, due to lack of data on benefits ofscreening to women under 50, somemedical groups, such as the NationalCancer Institute, recommend mammographic screening for women under50 only if they are in high-risk groups(generally, these include women whohave themselves had breast cancer orwhose mother or sisters have had it).
A woman should ask her physicianwhich course is best for her, and shouldremember that these recommendationsapply to screening when no abnormalities have been found during a physical examination. (A woman in whom anabnormality has been identified or is sus
pected should follow her physician's advice regarding diagnostic mammographicexamination—the age guidelines do notapply here.)
Women should also examine theirbreasts monthly for any abnormalities.(See diagram.)
Fear or ignorance need not keep awoman from being screened for breastcancer by mammography. With theproper knowledge and caution she canlimit the risks and reap the benefits ofthis relatively painless, quick and safeprocedure that could save her life. ■
Judith Willis is the editor of the FDADrug Bulletin, a publication for healthprofessionals.
FDA Consumer / May 1987 / 7
Travelers' Advisory;Malaria Still ThreatensMuch ofGbbeb\ Evelyn Zami i la
M alaria doesn't make the kind ofheadlines that AIDS does, but the
disease is a far greater problemthroughout the world today. It was at onetime in our own history, too. Out of a total of 600,000 Civil War dead andwounded, malaria was responsible for8,100 deaths in the Union army alone.Probably an equal number of Confederate soldiers died of the disease, thoughno one is sure of the exact toll because
many of the South's medical recordswere destroyed in the burning of Richm o n d .
These figures may surprise manyAmericans who perhaps think of malariaas a Third World disease, and don't realize it existed off and on in many parts ofthe United States for years. Human carriers probably arrived with Columbus orshortly afterward and infected the susceptible mosquito population. The disease eventually made its way as far northas New England and as far west as Cal-i f o m i a .
The use of cinchona bark, a drugknown to the Incas as effective againstmalaria, and quinine, isolated fromcinchona by French chemists in 1822,led to some degree of control over thedisease, so that by 1850 malaria hadbeen eliminated in many parts of thecountry. But malaria hung on longer inthe South than in other areas because theheat and humidity favored survival of allinsect life, including mosquitoes that carried yellow fever and dengue, as well asmalaria. As late as the 1920s, the diseasecaused such severe labor shortages insouthern industr ial towns and mil ls thatthe U.S. Public Health Service wascalled in to destroy mosquito breedingareas and administer drugs to malariav i c t i m s .
Malaria is not endemic (continuouslypresent) tO the United States anymore. It
was eradicated by malaria control programs in the early 1950s. Isolated episodes of introduced malaria are stil l
reported occasionally, however. GIs whoreturned wi th malar ia f rom Vietnamcaused a few of them. The latest and
largest recent outbreak occurred in thesummer of 1986, when 27 cases showedup in San Diego County, California. Presumably the disease was brought in byMexican migrant agricultural workerswho were probably illegal aliens and forthat reason did not seek medical care.
Although such outbreaks have occurredonly 14 times since 1950, they can happen again, because the types of mosquitoes that can play host to the malariaparasite still exist in California and in thes o u t h e a s t e r n s t a t e s .
But local outbreaks don't cause publichealth authorities as much concern as thefact that a million Americans travel each
year to areas where malaria is prevalent.Some come home with it. Many don'trealize how serious malaria can be andhow important it is to be treated. TheU.S. Centers for Disease Control estimates that about a thousand Americanscontract malaria abroad each year, although only a fraction of that number isreported. (CDC, located in Atlanta, is adescendant of the Office of Malar ia Control, which was established during WorldWar II to eradicate malaria around troopcamps in the South.)
Says Dr. Hans Lobel, a malaria expertwi th CDC: "Safar is in East Afr ica are
very popular with travelers. It's nice tosee the animals in the game parks, butnot so nice to get malaria and perhapsdie." Of the 1,941 reported cases of malaria contracted by U.S. civilians duringtravel abroad from 1970 to 1980, 27died. The toll is increasing. In 1985
8 / May 1987 / FDA Consumer
o
Jp-.
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alone, there were 450 reported cases ofmalaria among Americans and 12 deaths.Most of the fatalities are due to the most
dangerous type of malaria (falciparummalaria), which is spreading in Africaand is also present in some parts of Asiaand South America. Falciparum malariacan cause kidney failure and affect thebrain. Malaria may also cause severecomplications, such as anemia, jaundiceand enlarged spleen, that leave its victims debilitated for a long time.
At one time, international health authorities thought malaria could be wipedout completely. After World War 11, aworldwide campaign was launchedagainst malaria using pesticides anddrugs. DDT proved remarkably effectiveat killing the Anopheles mosquito, whichcarries the parasites that cause the disease, while chloroquine—a drug developed during the war—killed malaria
parasites in the body. The campaign wasso successful that the World Health Or
ganization announced 25 years ago thatthe "eradication of malaria has become areality within our reach."
But extinction of both the mosquitoand the disease has eluded all efforts.Nature is an Artful Dodger; Some mosquitoes have become resistant to DDTand other pesticides; and some strains ofthe parasite have become resistant todrugs. Malaria has made an alarming resurgence in parts of the world where itonce appeared to be gone forever. In1963 only 17 cases were reported in SriLanka; five years later the total jumpedto 1 mi l l ion.
Unfortunately, the nations of theworld that have the most malaria havethe least to spend on malaria control. Aresearcher with Worldwatch Institute, anonprofit private research group locatedin Washington, D.C., said: "Protectionagainst malaria in areas where the disease exists costs an estimated $2 per person each year. This sum is greater thantotal per capita health spending for allhealth services of a number of ThirdWorld countries, including India,Pakistan and Ethiopia."
The result is that while malaria hasbeen conquered by the affluent nations ofNorth America and Western Europe,where the disease was also easier toeradicate because it occurred only sporadically, it is still a major health problem in more than half the world'snations. Over most parts of Africa andthroughout the tropics, malaria killsmore people than any other disease.About 6 mil l ion to 11 mil l ion cases ofmalaria are reported each year to theWorld Health Organization, but the realnumber may be 10 times as high. (Datafrom tropical Africa is not included, because of reporting difficulties.) CDC estimates that the actual number of cases isclose to 200 million a year.
Four different parasites are responsiblefor human malaria, and each one acts inits own way in the body. (While mosquitoes are usually the carrier by whichhumans are infected, malaria can also beacquired through a blood transfusionfrom an infected donor, or from sharingcontaminated hypodermic needles, or, invery rare cases, can be passed frommother to fetus.) Depending on whichparasite has caused the infection, the incubation period ranges from nine to 40days. After several days of feeling listless, with loss of appetite, headache,muscle aches, low fever, and other flulike symptoms, the classic symptoms ofmalaria usually appear—teeth-rattlingchills that may last from 20 to 60 minutes, a fever that can reach 107 degreesFahrenheit and last for hours, and, finally, the break in the fever that leavesthe malaria vict im drenched in sweat and
totally exhausted. The paroxysms assume a regular pattern, appearing every36 to 72 hours—again depending on theparasite—and may be accompanied bynausea, diarrhea and vomiting. Betweenparoxysms, the malaria victim may feelwell, except for fatigue.
Without treatment, some types of thedisease can recur, submitting its victimsto a rerun of the original symptomsmonths and even years later. Thoughvictims gradually build up some immunity to the disease within a matter ofweeks, so that subsequent attacks are notas serious as the first, infections can lastfrom one to 20 years.
In most cases the disease can beavoided, but it takes a little forethought.CDC's Dr. Lobe l warns : "There i s a
high risk of being infected with malariain many parts of the world, especially inAfrica. It's essential to take prophylaxis[preventive drugs]. A recent surveyshowed that 50 percent of Americansw h o w e n t t o m a l a r i a l a r e a s w e r e n o t
(Continued on page 11}
FDA Consumer / May 1987 / 9
A StunninglyComplex Disease
Anopheles mosquito
Malaria is transmitted throughthe bite of adult female Anophelesmosquitoes—about 60 out of the400 types of Anopheles carry malaria. The mosquito must be infected by a malaria parasite, orPlasmodium, a one-celled animal.Although there are more than 100species of Plasmodia, only fourprimarily affect man—P. falciparum, P. ovale, P. malariae andP. vivax. The rest of them prey onan imals .
The parasite goes through different, complicated cycles in bothits hosts—a nonsexual cycle in human beings in which it multipliesby dividing, and a sexual cycle in ] Anophelesthe mosquito, in which male and \ —«»» \ X / V g .female ce l ls un i te to form a fer t i l - 1 v ^ f aized egg. The mosquito doesn't O p̂ametocytesl ̂ /appear to be harmed by the parasiteit harbors, though at one time somescientists wondered if mosquitoesgot malaria's chills and fever.They don't.
After mating, the female mosquito requires a blood meal to develop her eggs. When an infectedmosquito bites a human being,spores of the malaria parasite (orsporozoites—asexual reproductivecells) in the insect's salivary glandsenter the bloodstream and withinhalf an hour migrate to the victim'sliver. The sporozoites hide withinthe liver, growing and dividing,until the infected liver cells rupture, spilling out new forms of theparasite (merozoites). Within 20seconds, these new forms invadered blood cells, again growing anddividing, until the red blood cellsrupture, liberating merozoites thati n v a d e o t h e r r e d b l o o d c e l l s . T h i s
cycle goes on and on until the patient is treated with drugs, or develops enough immunity to controlthe multiplication of the parasites,or dies of complications. The rupturing of the blood cells is believedto be responsible for the characteristic symptoms of chills and fever.
To complicate the matter further, some of the merozoites in the
After an infected mosquito bites a human being, sporozoites from itssalivary glands enter the bloodstream and travel to the liver. Therethey change form into merozoites and re-enter the bloodstream, wherethey invade red blood cells and multiply. Some of the merozoites develop into sexual forms called gametocytes. When a mosquito bitessomeone with malaria, it takes in these male and female gametocytes,and fertilization results. The fertilized egg is called an oocyst.
blood develop into sexual formscalled gametocytes. When theAnopheles mosquito bites someonewho has malaria, it takes in thesemale and female gametocytes, andfer t i l izat ion resul ts . The fer t i l ized
egg, called an oocyst, lodgeswithin the mosquito's stomachwall. The cyst ruptures, releasingsporozoites that enter the insect'ssalivary glands. The mosquito isthen ready to infect the next victim.
The cycle can be interrupted bydestroying the parasite in the human host and the appropriate mosquito in the environment. Though
the problem of pesticide resistanceand drug resistance has made thisdifficult, researchers are trying todevelop better drugs andpesticides. To circumvent resistance completely, scientists areworking on vaccines. This is proving to be no easy matter either, asthe parasite is really three parasitesin one, depending on whether it'sin the sporozoite, merozoite orgametocyte phase. Vaccines mustbe aimed, ideally, at all forms ofthe parasite. Studies in monkeyshave begun for vaccines against thesporozoite and merozoite phases."
10 / May 1987 / FDA Consumer
This day relenting God
Hath placed within my hand
A wondrous thing; and God
Be praised. At His command,
Seeking His secret deeds
With tears and toiling breath,
I find thy cunning seeds,
0 million-murdering death.
1 know this little thing
A myriad men will save,
O Death, where is thy sting?
Thy victory, 0 grave?
Nineteenth century British malaria research pioneerSir Ronald Ross, on the dread disease in his Philosophies
(Continued from page 9)properly protected. Ten percent took noprophylaxis at all, while 40 percent tookthe wrong drugs or didn't take them regularly." Besides Africa, malaria is transmitted in large areas of South andCentral America, the Indian subcontinent, Southeast Asia, and areas ofOceania (Papua New Guinea, Irian Jaya,the Solomon Islands, and Vanuatu).
Travelers planning to visit these areasshould begin drug therapy two weeks before leaving the United States. Early preventive treatment will ensure an adequatelevel of the drug in the blood and will allow any potential side effects to makethemselves known. Drug therapy shouldcontinue during travel and for six weeksthereaf ter.
Even though it's possible to contractmalaria when medication is taken, anyone who doesn't take drugs is temptingfate. The drugs not only help preventmalaria, but suppress and eliminate thedisease in those who have already contracted it.
If travelers experience any flu-likesymptoms upon returning home, theyshould consult a doctor. Malaria symptoms can begin as early as a week or soafter exposure or can show up months later, even with preventive treatment. Theearlier malaria is treated, the better thechances for complete recovery. Delayingtreatment can be fatal. This especiallyapplies to pregnant women, as the disease can result in abortion, stillbirth, andlower-than-normal birth weight. Sincethe parasite is found in the blood, thephysician can confirm whether it's malaria by examining stained blood smearsunder a microscope. Treatment variesdepending on the parasite or parasites,because it's possible to contract morethan one type of malaria at the samet i m e .
For over 300 years, quinine was theonly remedy available for treating malaria. Though an excellent drug, quininecauses many side effects, including deaf
ness, visual disturbances, nausea andvomiting. Today chloroquine is the primary anti-malarial preventive drug because it's safe to take—even for pregnantwomen and ch i ld ren—and e f fec t i ve
against three of the four species of Plasmodia (the malaria-causing parasites)that afflict humans. In Africa, parts of
Southeast Asia, and some South PacificIslands where the falciparum parasite hasdeveloped resistance to chloroquine, acombination drug called Fansidar (generic name: pyrimethamine/sulfadoxine)is sometimes added to the traveler's
regimen. Chloroquine doesn't usuallycause allergic reactions, but some people
FDA Consumer / May 1987 / II
are sensitive to Fansidar, a sulfa drug.Several U.S. travelers have died as a result of severe reactions to Fansidar. Thedrug must be discontinued and a doctornotified if itching, rash, sore throat, orlesions in the mouth or genital areas occur. Quinine and tetracycline can be substituted. In vivax malaria, a type ofmalaria in which relapses are common,primaquine is used to eliminate parasitesthat persist in the liver after drug treatm e n t .
Besides taking drugs, travelers mustprotect themselves from being bitten bymosquitoes. As the Anopheles mosquitoprimarily feeds at night, travelers shouldremain in well-screened locations fromdusk to dawn, especially in rural areas(the risk of infection in most cities ismuch lower). Clothes should cover mostof the body, and mosquito nets should beused around the bed. A good insect repellent (those that are most effective contain N,N diethylmetatoluamide, alsoknown as DEBT) should be used on anyexposed areas of the skin, and living andsleeping areas should be sprayed with aflying-insect spray containing pyrethrum.
Travelers planning trips to areas of theworld where there is a risk of contractingmalaria may want to contact state and local health departments, or CDC at (404)329-2572, for more information. Alsoavailable is the publication "Health Information for International Travel," forsale at $4.75 (stock no. 017-023-00174-4), from the Superintendent of Documents, U.S. Government Printing Office, Washington, D.C. 20402. Thetelephone number is (202) 783-3238."
Evelyn Zamula is a member of FDA'spublic affairs staff.
SEARCHim im Si UMALm urUnraveling the Mystery of Malaria's Cause
Dr. William Osier, perhaps one of the finest physicians in the world in his day, was justly famous as a diagnostician. But in an article in an 1889 Johns HopkinsBulletin, Osier, then physician-in-chief to the newlyopened Johns Hopkins Hospital in Baltimore, tells howhe made the wrong diagnosis and so contributed to thedeath of an aged patient.
An 81-year-old man had been admitted to the hospital with a temperature of 104 degrees Fahrenheit, whichsoon rose to 105 F. The old man told the doctor thatabout two weeks earlier he had had a heat stroke while
picking berries, but had recovered uneventfully, andhad gone about his business until he began to feel sick.When Osier examined him, he noted congestion in thelungs and general weakness, along with the fever. Thediagnosis was pneumonia. Since not much could bedone about pneumonia in those days beyond making thepatient comfortable. Osier let nature take its course.The old man's temperature remained high for a fewdays, but on the fourth day after admission fell to belownormal. He had no chills. On the eighth day he died.Post-mortem examination of his blood and spleen revealed the cause of death as malaria, endemic (continuously present) to the Baltimore area at that time. Dr.Osier was chagrined, because quinine might have savedthe patient's life.
Osier learned his lesson. Thereafter, he made a bloodtest for malaria parasites mandatory for all patients admitted with fever or low temperature. Although thechief symptoms of malaria—chills, fever, sweating, enlarged spleen—are so distinctive that medical historianshave been able to identify the disease from records asfar back as Hippocrates (460-377 B.C.), not every casefollows the same pattern, as Dr. Osier discovered.
The disease displays a wide variety of symptoms; insome cases there is no fever. Osier mentioned in his article that of 24 cases of malaria admitted to the hospitalin its opening months, seven did not have ordinarysymptoms of the disease—it was identified only by theb l o o d t e s t .
Through the ages, the disease has baffled others be-
12 I May 1987 / FDA Consumer
/freas of the world where malaria is most prevalent.
sides Dr. Osier, and in more ways than one. It may becommon knowledge today that certain mosquitoes harbor parasites that can cause the disease, but up until theend of the 19th century, the most popular theory wasthat malaria was caused by bad air. Others thought itwas caused by bacteria or by drinking swamp water.
A surgeon in the French army had the first inklingthat malaria was caused by a parasite, and it happenedmore or less by accident. In 1880 Alphonse Laveranwas examining a glass slide of a malaria patient's bloodunder a microscope when he saw tiny transparentbodies containing red pigment put out whiplike hairsand lash about in the blood, much as an octopus putsout its arms. What he was seeing were male gameto-cytes—a sexual form of the Plasmodium parasite—putting out flagella to find and fertilize female gameto-cytes. Laveran realized they were living creatures, parasites that lived within a red blood cell. In spite of initialwidespread skepticism, within a few years Laveran'sdiscovery was confirmed by others.
Finding the actual parasite that caused the diseasewas a giant step forward, but how did it get into humans? The mosquito was suspected as a malaria carrierat least 1,500 years ago in India, but definitive proofhad to wait for some time. The breakthrough came in1879, when the British physician Dr. Patrick Manson(founder of the field of tropical medicine) found tinyworms in the stomachs of mosquitoes that had fed onthe blood of patients with filariasis, another parasiticaldisease. Manson theorized that a mosquito might alsobe involved in the transmission of malaria, possibly ashost to an intermediate stage in the malaria parasite'sdevelopment.
In 1894 Manson shared this information with Dr.Ronald Ross, a British surgeon in India, where malariawas so prevalent that the British army was routinely issued preventive doses of quinine. Ross set out to proveManson's hypothesis. He began his experiments byraising two types of mosquitoes—the common housemosquito and the yellow fever carrier—and feedingthem on the blood of malaria patients. On dissecting
V
their stomachs—no easy task in those days of primitivelab equipment—he found those same bodies that Laveran had seen putting out flagella. But when healthyvolunteers were exposed to the bites of these mosquitoes, nothing happened.
Looking back over those discouraging days, Rosswrote in his memoirs years later: "I was tired, and whatwas the use? I must have examined the stomachs of athousand mosquitoes by this time. But the Angel ofFate fortunately laid his hand on my head." This happened when Ross spotted a different kind of mosquitoin the hills of Madras one day, a dapple-winged type hehad not noticed before. It occurred to him that maybehe was using the wrong mosquito.
After exposing this type of mosquito to a patient withmalaria, he saw pigmented cysts in the stomach wall ofthe insects. He sent his findings to Manson in London,who cabled back, "You are now on the right track atlast." Since prejudice against experimenting with humans was strong, at Manson's recommendation Rosscontinued his studies on the sparrow, which also contracts malaria, and worked out the complete life cycleof the parasite. He was able to prove that the cyst was afertilized egg that would burst open and release sporesthat traveled to the salivary glands of the mosquito.When the mosquito bit a human being, these sporesquickly entered the bloodstream, causing the disease.
In spite of what seemed positive proof of the waymalaria was transmitted, there were still many doubtersamong the experts. To lay the controversy to rest onceand for all, Manson exposed his own son to infectedmosquitoes. As expected, his son contracted malaria,but recovered with treatment. Three of his pupils alsovolunteered to live in a mosquito-proof hut during malaria season in Italy, and none came down with the disease. The doubters were convinced.
Both Manson and Ross were knighted. Nobel prizesfor medicine went to Ross in 1902 and Laveran in1 9 0 7 . ■
FDA Consumer / May 1987 / 13
TAKING A LOOK AT EYE EXAMS by Egon Week
14 / May 1987 / FDA Consumer
Ask people which of their five senses they value the most,and almost everyone would say their sight. The visual images that dominate our lives are priceless treasures, and wewould sacrifice much to preserve them.
One important way to preserve the precious gift of sight isregular checkups by an eye doctor. (For exactly what is meantby an "eye doctor," see the accompanying article.) In mostcases, of course, people get their eyes checked to see if theyneed glasses, or a change in their prescription if they alreadywear them. But thorough, regularly scheduled eye exams alsocan be vitally important in detecting serious diseases and disorders that affect the eyes. Often, early detection and treatmentcan control or correct problems that otherwise could lead topermanently impaired vision or even blindness.
Another benefit of an eye exam is that, while peering intothe eyes—with the help of sophisticated instruments—a doctorcan discern symptoms of serious diseases, such as high bloodpressure, diabetes and cancer, that affect the entire body. Infact, it's sometimes the eye doctor who is the first to pick upclues to such conditions.
Here's a rundown of what to expect from a good eye exam.
M E D I C A L H I S T O R Y
Eye exams generally start with a medical history. What problems or symptoms are prompting the patient to seek an exam?Is there a family history of eye disorders that may be linked toheredity, such as glaucoma or retinitis pigmentosa (an inheriteddegenerative disease of the retina)? Is the patient taking anymedication? These are some of the questions an eye doctormay ask.
V I S I O N T E S T I N G
Vision testing ordinarily begins with the patient reading lettersof the alphabet from a Snellen chart—the standard used in alle y e e x a m s .
Most people know that normal visual acuity is designated as20/20—meaning that the smallest print on the eye chart thatsomeone can read at 20 feet corresponds to the line for standard "normal" v is ion. Someone who can ' t read the 20/20 l ineis asked to look progressively higher up on the chart to biggerprint until the letters can be read. The designation for that linethen becomes the measure of visual acuity. For example, ifsomeone can begin to distinguish letters from 20 feet only aftermoving to the line that can normally be read at 200 feet, that's2 0 / 2 0 0 v i s i o n .
Three types of problems related to the eye's focusing abilitycan cause poor vision: nearsightedness, farsightedness and astigmatism. Nearsightedness, or myopia, is by far the mostcommon. It arises when the lens of the eye brings images intofocus in front of, rather than precisely on, the back of the eye'sinterior, the layer of light-sensitive cells called the retina. Concave (like two saucers placed back to back) lenses correct myopia.
(Continued on page 16)
FDA Consumer / May 1987 / 15
For proper eye care, specialists recommend this schedule of visits;• Infants with a family history of visionproblems, particularly genetic eye diseases, should be examined as early aspossible. (Basic eye checks are usuallypart of routine physicals performed bypediatricians.)• Preschoolers should be checked by an
eye-care practitioner for visual acuity,alignment of the eyes, and eye disease.• Thereafter, children of school ageshould be checked once every 18 monthsto 2 years, nearsighted children more frequently.• Adults should have an eye examination periodically (the American Op-tometric Association says once every twoyears is enough).• Impairment of accommodation andother eye changes are part of the aging
process, so eye-care specialists recommend an examination around age 40.Thereafter, more frequent examinationsmay be advisable.
Of course, a health professionalshould be consulted any time there is aninjury, infection, or other disorder affecting the eyes. ■
Who's Who inEye CareA person seeking eye care can easily beconfused by the names of the differentspecialists. Opticians, optometrists andophthalmologists do not have the sametraining, nor can they provide all thesame services. Here's some help in sorting them out.
Ophthalmologist. An ophthalmologisti s an M.D.—a doc to r o f med ic ine—inthe medical and surgical specialty of eyecare. Ophthalmologists are trained totreat the eyes for functional problemsand for diseases. They have completedfour years of undergraduate premed studies, four years of medical school, oneyear of internship, and a three-year residency in ophthalmology. They must thenpass an examination and be licensed by astate medical board to practice medicine.
They can prescribe drugs for diagnosingand treating eye problems and can perform eye surgery.
Ophthalmologists are therefore thebest prepared to treat eye injuries, pain,swelling, inflammation, and other healthconcerns connected with the eyes.
Optometrist. An optometrist is a doctor of optometry—but not a medical doctor. Optometrists complete a four-yearcourse of study at an optometric college.They diagnose and treat functional problems and visual defects such as thosecorrected with glasses, contact lenses, orvisual training. In 48 states and the District of Columbia they are licensed to administer diagnostic drugs, and in 12 ofthese states they may also prescribetherapeutic drugs to treat eye disease.
Many optometrists have an undergraduate college degree even though theprerequisite for admission to schools ofoptometry is two or three years of under
graduate training.In order to be licensed, they must pass
oral, written and practical examinations.If glasses or a new prescription for
glasses or contact lenses is needed, eitheran optometrist or an ophthalmologistmay be consulted.
Optician. Opticians are technicianswho fill prescriptions for eyeglasses.They do not perform eye examinations.Opticians may or may not grind lenses,but they fit them into frames and adjustthe frames so that they fit comfortablyand the lenses are properly positioned tocorrect v is ion defects.
Thirteen states have licensing requirements for opticians. In Virginia, for example, candidates must complete a two-year program of training after highschool or a three-year apprenticeship.The other 37 states have no formal re
quirements. ■
(Continued from page 15)In farsightedness, or hyperopia, images fall into focus
beyond the retina. Convex (curving outward, like the outsideof a ball) lenses are used to correct hyperopia.
Astigmatism is caused by irregularities in the curvature ofthe cornea, the protective covering over the lens of the eye.Astigmatism results in blurred vision, which can be correctedby specially ground lenses.
Another term eye doctors use in discussing vision is ''accommodation." Accommodation is the ability to focus onthings near the eye, and it makes reading possible. Impairedaccommodation results in presbyopia, which is corrected withconcave lenses for reading or with bifocals that have a readingprescription in the lower part of the lens and a prescriptionabove for distant focus.
The doctor has two ways of arriving at a prescription to correct visual defects. With an instrument called a retinoscope,light is focused through the pupil onto the retina. By observingthe movement of the light as it is reflected back through theeye from the retina, the doctor is able to measure optical flaws.
Then, with another instrument called a phoropter, the eyedoctor moves corrective lenses into place in front of the eye.
The effect of the lenses can be checked by shining the retinoscope's light into the eye through the corrective lenses or byhaving the patient read from the Snellen chart. The correctionsare then fine-tuned by asking subjects which lens or lens combination enables them to read best and most comfortably. Finally, color vision is checked by asking the subject to read thenumbers seen in patterns of colored dots on an Ishihara ColorIden t i fica t ion char t .
Following these checks for visual acuity comes the medicalpart of the exam. Because of their training as doctors of medicine and state laws that regulate eye-care practices,ophthalmologists may be best equipped to conduct this part ofthe eve exam.
G L A U C O M A
Glaucoma is an eye disorder caused by excess pressure in theeye. It accounts for 12 percent of the cases of blindness in theUnited States. The incidence of glaucoma is higher in older
16 / May 1987 / FDA Consumer
people, affecting about 2 percent of the population over 40The pressure of eye fluids inside the eyeball is regulated by adelicate circulatory mechanism that is indirectly linked to thecardiovascular system. When this mechanism is impaired byconditions such as structural defects, eye injuries or aging ex-cess pressure may rise.
Too much pressure can damage the optic nerve. Asglaucoma progresses, it increasingly impairs peripheral visionand, if untreated, can cause blindness.
Symptoms of glaucoma can be detected in several ways,such as by measuring the eye's internal pressure and by gauging the extent of peripheral vision.
Internal pressure is measured with an instrument called atonometer. To make measurements with a traditional type,part of the instrument briefly touches the cornea, so eyedropscontaining a local anesthetic are applied to keep the eyelidsfrom flinching. A newer type of tonometer directs a puff of airat the eye, making eyedrops unnecessary. Glaucoma can usually be controlled by drugs, but sometimes corrective surgery isn e c e s s a r v .
form of annoying—and contagious—conjunctivitis is called redor pink eye for the way it discolors the eye.
Although rare in North America, trachoma, another form ofconjunctivitis, is the leading cause of blindness throughout theworld. An astounding 500 million people have, or have hadthis disease, according to Dr. Thomas Chalkey, author of a 'book on eye care titled Your Eyes. It is caused by a microorganism called chlamydia. The infection can cause scarring of thecornea, which can impair or completely destroy vision.
A more detailed examination of the conjunctiva and theOther front parts of the eyes is done with an instrument called aslit-lamp, or biomicroscope. The cornea is inspected for signsof disease and when prescribing contact lenses, which fit overthe cornea.
Other potential indicators of eye problems may also bechecked during a thorough eye exam, such as eye reflexes andmuscle balance (to make sure the eyes are properly aligned).
W I N D O W S I N T O T H E B O D Y
C A T A R A C T S
An eye exam also includes a check for developing cataracts. Acataract is a gradual clouding of the eye's lens. In some cases,the lens finally turns an opaque white, shutting off vision entirely. Cataracts most often occur among the elderly. Germanmeasles in a mother during pregnancy may cause congenitalcataracts in her baby. Eye trauma and glaucoma are other causes.
To treat cataracts, the clouded lens is removed surgically. Itis then either replaced by glasses, contact lenses, or intraocularlenses.
' L A Z Y E Y E ' '
In "lazy eye," which doctors call amblyopia, an individual'sbest vision corrected with glasses is still poorer than normal20/20 vision. In young children with amblyopia, one eye mayappear to be turned away from the line of sight—thus, each eyemay point toward a different visual object. This causes twoconflicting images to be sent to the brain. To compensate, thebrain tends to ignore the image from the lazy eye. As a result,the unused eye doesn't develop normally, and the untreatedcondition may progress to serious vision impairment.
In almost all cases, lazy eye can be corrected. However, ifneglected, by the age of 9 vision in the "lazy" eye may be reduced permanently.
C O N J U N C T I V I T I S
The conjunctiva is a thin, transparent tissue that covers thefront of the eye (except for the lens and iris, which are coveredby the cornea) and the inside of the eyelids. The conjunctiva isinspected for inflammation (conjunctivitis) and other problems.Inflammation may be caused by microorganisms such as bacteria or viruses, allergenic agents, or chemicals. One common
While our eyes serve as our windows on the world, for physicians they can serve as windows on the internal workings ofthe human body. With the help of an ophthalmoscope—an instrument that focuses a thin beam of light on the retina—anophthalmologist can examine the inside of the eye and uncovera variety of diseases that may affect the entire body.
After administering eyedrops that contain a drug to dilate thepupil, the physician can peer through the ophthalmoscope toinspect tiny blood vessels called arterioles and venules. Thosein the eye nourish the retina as others throughout the bodynourish all other parts. But in the living patient, it's possible tosee these tiny blood vessels only on the retina.
Their condition can give clues about high blood pressure, diabetes, stroke, transient ischemic attacks (so-called "mini-strokes"), hardening of the arteries, and blood diseases such asl e u k e m i a .
Microaneurysms, tiny balloon-like swellings of the bloodvessels, may be a sign of diabetes. The doctor also can lookbehind the eye, so to speak, to view the optic nerve (which carries light impulses from the retina to the brain) and examine itsshape and color for signs of neurologic diseases such as braint u m o r s .
Other changes that may be visible include hemorrhages, dis-colorations and tears of the retina. Other health problems thatleave telltale signs include syphilis, sickle cell anemia, collagen diseases such as lupus, lead poisoning, endocarditis (alife-threatening inflammation of the lining of the heart), German measles, and multiple sclerosis.
There's clearly a wealth of medical knowledge to be foundwithin our bodies' "windows"—knowledge important to ouroverall health, and especially to the most precious of our
Egon Week, a free-lance writer, has written extensively onhealth and medical issues.
FDA Consumer / May 1987 / 17
For centuries, athletes have soughtfoods that would give them the winning edge. Charmis of Sparta, victor ofthe Olympic Games in 668 B.C., trainedon a diet of dried figs. About 2,500years later, a number of 19th centuryathletes purged their stomachs of "noxious matter" and then consumed largequantities of red meat and beer.
Nutritionists advise today's athletes toeat a more varied diet. In fact, athletes ofthe 20th century—whether they be milerson the high school track team or middle-aged joggers running for better health—are generally counseled to follow thesame dietary rules suggested for averageA m e r i c a n s .
This means they should eat a well-balanced diet, obtaining most of their calories from complex carbohydrates such ascereals, breads and pasta. They alsoshould get enough fiber and avoid fatty,cholesterol-laden foods and foods high insugar or sodium.
But some health magazines suggestthat, for the physically active, good nutrition involves more than merely eatingthe right foods. These publications implythat a well-balanced diet is inadequate,and that athletes must consume high-potency vitamin pills or protein supplem e n t s .
Such suggestions can bewilder athleteswho are looking for a nutritional edge intheir sport. In pursuit of the promotednutrient of the hour, they may throwaway their money on pills and powdersthey don't even need, and end up with apoorer diet to boot.
"Clearly, it is not possible to changeaverage athletes into champions simplyby altering their diet," says nutritionistVirginia Aronson.
The most important determinant ofathletic prowess, according to the experts, is something over which we exertno control: our genes. Most rank physical training next; good nutrition comes int h i r d .
Dr. J.R. Brotherhood, writing in thejournal Sports Medicine, puts the issuethis way: "There is no magic diet that initself enhances performance." But, henotes, "an incorrect diet will negatemuch hard effort on the training field."
For the athlete, does good nutritionmean consuming more nutrients thannon-athletes? Many athletes need moreof some nutrients, but the same amountof others. Much depends upon the particular sport. Marathon running, competitive swimming, or weight lifting requiremore calories than less demandingsports. Athletes engaged in these vig-
NUTRITIONAND THE
by Doug Henderson
orous activities generally need more ofthe energy-providing nutrients, particularly carbohydrates. Because of increased fluid loss through perspiration,they also need more water andelectrolytes (electrically charged chemicals within the body—See "Electrolytes:The Charge in the Body's Power System" in the July-August 1986 FDAConsumer). Yet, with few exceptions,their vitamin and mineral requirementsare quite similar to those of non-athletes.
Three nutrients—carbohydrates, protein and fat—supply energy, but carbohydrates are the major source ofenergy during exercise. Carbohydratesfurnish the fuel for anaerobic exercise,such as sprinting, where muscles workfaster than the heart and lungs can supplythem with oxygen.
The body bums both carbohydratesand fat during aerobic or enduranceevents (cross-country skiing or running amarathon)—activities in which muscleswork slowly, permitting the heart andlungs to meet immediate demands foroxygen. Initially, carbohydrates supplythe bulk of this fuel, but the body obtainsmore of its energy from fat as aerobic activity continues.
Muscles do not perform at their bestwhen fueled solely by fat; they also require glucose (a form of sugar that circulates in the blood) and glycogen (theform of carbohydrate in which glucose isstored in muscle and the liver). If theglycogen supply runs out, an athlete'sperformance is encumbered.
Because the body stashes limitedquantities of glycogen—an average of1,800 calories worth—athletes must continue to replenish their supplies by eatingcarbohydrates. The body harbors enoughfat, on the other hand, to supply an aver
age of 140,000 calories. But athletesdon't need a high-fat diet to maintaintheir fat reserves; calories in excess ofbody needs for carbohydrates, proteinand fat are all stored as body fat.
Thus, the American Dietetic Association suggests the same diet for athletes asfor the general public—less than 35 percent of calories from fat and at least 55percent of calories from carbohydrates.When caloric needs are high, carbohydrates, preferably starches, should supply most of the extra calories. Overweight athletes should decrease fat, notcarbohydrates, in their diets.
Many athletes believe that they needvery high-protein intakes, including protein supplements. Their coaches oftenthink so, too: A study in the Journal ofthe Amer ican Dietet ic Associat ion revealed that two-thirds of Texas highschool coaches harbored this misconcept ion .
Athletes in the training stages of building muscle may require slightly moreprotein than non-athletes, particularly atthe beginning of training. However,enough protein to meet these needs canbe obtained from an ordinary balanceddiet, especially if enough calories areconsumed to take care of energy needs.
"At least some of this protein shouldbe of high biological quality, that is,from animal sources," says nutritionistMarilyn Stephenson of FDA's Center forFood Safety and Applied Nutrition. Animal sources include meat, eggs and dairyproducts.
Protein supplements are not only unnecessary, they also provide calories thatwill increase body fat if caloric intake isgreater than energy needs. Excessiveamounts of protein also may trigger dehydration, because the body excretes water to dispose of urea, a substanceformed in the breakdown of protein.
Unlike the requirement for protein, anathlete's need for water may greatly exceed that of non-athletes. Most of the energy released during exercise is heat,which, if not disposed of through theevaporation of sweat, could rapidly anddangerously increase body temperature.
While sedentary individuals lose aquart of water daily from sweating, athletes engaged in strenuous activity maylose two to four quarts (four to eightpounds) per hour. As little as 3 percentweight loss from sweating (4.5 poundsfor a 150-pound person) causes fatigueand encumbers performance. Greaterlosses lead to adverse effects, including adecline in blood circulation, low bloodpressure, hallucinations, and heat stroke.
/8 / May 1987 / FDA Consumer
Because of the tension of athletic performance and the excessive fluid losssome athletes experience, thirst may notreliably signal the need for water. Therefore, athletes in endurance competitionwould do well to follow these guidelinesfrom the American Dietetic Association;• Two hours before an event, drinkthree cups of water. Cold water (41 degrees Fahrenheit) is best; it leaves thestomach and enters the system morerapidly than warm water.• Ten to 15 minutes before the event,drink two more cups of water.• Drink small amounts of water—one-half to one cup—at 10- to 15-minute intervals throughout the competition.• After competition or training, continueto drink water periodically until weighthas been regained.
To determine water needs, athletesshould weigh themselves before and aftertraining and monitor their water intakeduring the training period. For each
(Continued on page 20)
(Continued from page 19)pound lost, they should drink an extrapint of water.
Runners should avoid large amountsof sugary drinks during races, states theAmerican College of Sports Medicine.These beverages actually decrease thespeed at which water leaves the stomach.Athletes also should not drink alcoholicbeverages to replace fluid. Alcohol actually increases fluid loss by stimulatingurine production.
When profuse sweating occurs, thebody loses sodium and potassium; theseare electrolytes that help maintain fluidbalance, metabolize carbohydrates andprotein, transmit nerve impulses, andcontract muscles. While athletes whoperspire profusely may need more sodium and potassium, they seldom requirespecial supplements or beverages to getit. Many foods contain sodium and potassium. Moreover, a well-trained bodyconserves these minerals. During exercise-induced sweating the kidneys release less sodium; athletes acclimated tohot weather excrete less sodium in theirsweat. Extra potassium is released intothe blood when the body breaks downglycogen to produce energy.
In extreme cases, athletes who sweatprofusely, or are not acclimated to intense heat, or have low sodium intakesmay suffer heat exhaustion due to sodium depletion, notes Ann C. Grand-jean, nutrition consultant to theUniversity of Nebraska Athletic Department. 'This can easily be prevented ortreated by consuming foods high in sodium (salted snack foods, ham, pizza) orby adding salt to food at meals." Fruitssuch as apricots, dates, bananas, orangesand raisins will replace lost potassium.
If athletes lose more than four quartsof water as sweat (eight pounds duringperformance), they may need to replacesodium and potassium during the competition. This should be done under the
guidance of the team physician.Some athletes take large doses of vi
tamin supplements in the belief thatdoing so will improve performance. According to nutritionist Aronson, performance-enhancing properties havebeen falsely ascribed to almost every nutrient, particularly vitamins C and E andthe B complex vitamins. Large doses ofany vitamin can help performance only ifnutrient deficiencies exist, says Aronson.
Wheat germ, lecithin, honey, gelatin,phosphates, bee pollen and kelp alsohave been marketed to improve performance, but the performance-enhancingvalue of these substances has not been
scientifically established.
Computing CaloriesNutritionists suggest that athletesconsume no more than 30 percentto 35 percent of their calories asfat, at least 55 percent as carbohydrates, and the remainder as protein. What do the percentagesmean? How can athletes determinethe composition of their diets?
Often, the food label lists theprotein, carbohydrate and fat content in a serving of the product.For example, the nutrition label forone slice of whole-wheat breadmay read:
Protein 2 gramsCarbohydrate 14 gramsFat 1 gram
Carbohydrates and proteinprovide 4 calories per gram and fat
The Wrong EatingB-ackMany athletes grab onto the latestdietary fad or go to counterproductive extremes in search of a nutritional edge in their competition.Here are the real-life experiencesof two athletes and how they wereput on the right dietary track withthe help of a professional nutrition-
Joe, a 225-pound weight lifter,was eating a diet high in fat, cholesterol and protein, and low incarbohydrates. He also was spending almost $40 a month on high-potency vitamins and protein supplements.
Nutritionist Nancy Clark, a registered dietitian and author of TheAthlete's Kitchen, advised him toincrease his carbohydrate intake,especially from starchy foods; decrease his fat, cholesterol and protein intake; and discontinue thesupplements.
Convincing Joe to reduce hisprotein intake was especially difficult, Clark admitted, becausecoaches and friends told him thatmore protein meant more strength."By teaching Joe a 'mini-course'in muscle physiology, I helped himunderstand that a very high proteinintake is unnecessary for him to attain his strength goals," Clark said.
provides 9 calories per gram.Therefore, one slice of this breadprovides about 73 calories—8 fromprotein, 56 from carbohydrates,and 9 from fat. That means about11 percent of calories come fromprotein, 77 percent from carbohydrates, and 12 percent from fat.
For foods without nutrition labels, nutrient information can beobtained from a food consumptiontable found in many introductorynutrition books or from "NutritiveValue of Foods," Home andGarden Bulletin No. 72, publishedby the U.S. Department of Agriculture. It is available for $2.75from the Superintendent of Documents, U.S. Government PrintingOffice, Washington, D.C.2 0 4 0 2 . ■
Jean, a 15-year-old figureskater, had problems similar tothose of many female athletes. Shetried, but failed, to lose 10 poundsin two weeks by consuming only700 calories a day. Ravenouslyhungry, she eventually hinged onfoods high in fat and sugar, such asice cream and cookies. Her estimated binge intake approached3,000 calories. Because she consumed few healthful foods, her dietwas deficient in a number of nu
trients, including vitamin A,riboflavin, calcium, iron and folicac id .
Clark suggested that Jean doubleher daily calorie intake to 1,400calories, allowing her to lose twopounds per week—a more realisticweight-loss goal than 10 pounds intwo weeks.
Clark told her to get more calcium—with little fat—by having adaily glass of low-fat milk, a cupof low-calorie yogurt, and a serving of pizza with low-fatmozzarella cheese. She also counseled Jean to eat high-carbohydratefoods such as potatoes, bread,pasta and crackers.
By following Clark's advice,Jean lost weight at a moderate—and mainta inable—rate. She a lsofound that she was more energetic,skated more strongly, and stayedmore alert in school. ■
20 / May 1987 / FDA Consumer
Caffeine, too, has been suggested as aperformance enhancer, but its effects arestill being studied. Thus far, the indications are that it may be helpful in endurance events. But before usingcaffeine, athletes should remember that ittriggers increased urine excretion, so toomuch caffeine will contribute to dehydrat ion .
Another technique popular among athletes looking for extra energy is carbohydrate loading. Here's the theory behindthis regimen;
Fatigue occurs, many experts believe,when glycogen supplies are exhausted.Carbohydrate loading enhances endurance by packing muscles with higherthan normal levels of glycogen. A regimen is followed that includes exercising to exhaustion one week before anevent to deplete muscles of glycogen,then reducing carbohydrate intake andexercising moderately for three days, andfinally "loading up" on carbohydratesand exercising only lightly for four daysbefore the event to replenish glycogen.
Strict adherence to such a plan, nutritionists warn, is potentially dangerous.Endurance athletes ordinarily exhausttheir glycogen during training anyway.Reducing carbohydrate intake as recommended may trigger nausea, weaknessand depression. Moreover, persistentcarbohydrate loading may cause chestpain and passage of muscle protein inurine. The regimen can be harmful toany athlete, but in particular adolescents,heart patients, diabetics, and people withhigh blood lipids should never carbohydrate load.
The Amer ican D ie te t i c Assoc ia t ion
suggests a modified version in which,one week before an event, athletes reduce exercise and increase their intake of
complex carbohydrates, but not total calor ies.
Considering the intense training athletes undergo to improve performance,can it be assumed that they also practicegood nutritional habits? According to Dr.Brotherhood, no. "There is no evidencethat participants in sports generally selecthealthier diets than less active people,"he states.
In fact, researchers find that athletesgenerally experience the same nutritionalproblems as non-athletes. Here is a sample of those findings, as reported in several nutrition and sports medicinejournals:
Nutrient inadequacies. Many femaleathletes, like other women, don't getenough calcium, iron and protein. Athletes of both sexes may not get enough
vitamin B5 and folic acid (as is the casefor many Americans). To remedy thesedeficiencies, athletes should look todairy products as a good source of calcium; meat, fish, legumes (peas andbeans), and spinach for iron; red meat,poultry, potatoes, lentils, broccoli, andbananas for vitamin B^; such fruits andvegetables as spinach, beets, romainelettuce, and oranges for folic acid; andmeat, eggs and dairy products for protein.
Empty calories. Adult male endurancerunners in one study consumed 20 percent of their calories as alcoholic bev
erages. Those "empty calories," likethose in sugary sweets, have little nutritional value. (For more about empty calories, see the November 1986 FDAConsumer.)
Inappropriate vitamin supplementuse. Ballet dancers in one study tooklarge doses of the B vitamins and vitamins A and C, when no deficiency actually existed. Some of these vitaminscan be toxic in high doses. Vitamin A,for example, can produce anemia, jointand muscle pain, and other adverseeffects with as little as five times theRecommended Daily Allowance.
Too much saturated fat and cholesterol. Several football players in afour-year study at Syracuse Universityconsumed 10 t imes more cholesterol thani s r e c o m m e n d e d . S e v e r a l h a d d i e t s i n
which fat provided over 50 percent oftheir energy, and some ate 20 pats ofbutter in one sitting at the training table.Butter is high in saturated fats and cholesterol, substances linked to heart dise a s e .
Eating disorders. The January 1986issue of The Physician and Sports Medicine reported that 14 percent of collegiate female athletes in one study madethemselves vomit to control their weight,and 16 percent took laxatives for thes a m e r e a s o n .
Among male athletes, wrestlers oftenuse unsafe methods to control their
weight. In the Syracuse Universitystudy, one wrestler consumed only 78calories the day before a weigh-in, then11, 100 calories on the following day.Others used laxatives and diuretics ormade themselves vomit to keep withinthe limits of their weight class. Suchpractices can be extremely dangerous.(See "Eating Disorders: When ThinnessBecomes an Obsession" in the May1986 FDA Consumer.)
The advice for feeding athletes haschanged a lot since the time of Charmisof Sparta. We know that no single foodor supplement provides a "magic bullet"for an athlete's body. Thus, for the vastmajority of athletes—from high schoolquarterbacks to middle-aged joggers, themodern day advice is the same as that forthe general public: Eat a well-balanceddiet from a wide variety of foods in sufficient amounts to meet energy needs.When followed throughout life, such ameal plan will provide benefits long afteran athlete's competitive peak hasw a n e d . ■
Doug Henderson is a free-lance writer,runner, and tennis player in AustinT e x a s .
FDA Consumer / May 1987 111
Know the Right to Me Your Medicinesby Annabel Hecht
4 4 Q wallow capsules whole" ..." D o n ' t c h e w t a b l e t s " . . . " D r i n k
plenty of fluids" ... "Take on an emptys t o m a c h " . . . " D o n ' t m i s s a d o s e " . . .
There are so many things to rememberwhen it comes to taking medication, it'snot surprising that many people—up tohalf the population, in fact—don't taketheir medicines properly. Are these admonitions just a way of harassing thehapless patient who is already confusedand upset by illness? Does it really matter if a tablet isn't taken at precisely theright time? Or are these rules the kindthat were made to be ignored?
The truth is that directions for takingmedications are important. They're specially crafted for each drug to help ensure that it does its job effectively. Basicinformation on how the drug should betaken is on the label of the container. Butif there are any questions about these instructions, the patient, or some familymember, should always ask the doctor orpharmacist to clarify them. The doctoralso should know what other medications—both prescription and nonprescription—the patient is taking toavoid drug interactions.
There are few conditions for whichonly a single dose of a drug is prescribed. Usually medication is taken fora specified period of time (seven to 10days for an antibiotic, for instance), orperhaps for a lifetime if the patient has achronic illness (such as high blood pressure). Medicines may also have to betaken at specific intervals during the day.This is necessary to keep the rightamount of the drug in the bloodstream allthe time. Too much of the drug in thecirculation may cause an adverse reaction; too little won't be completely effect ive.
If the number of doses per day is four,the drug will usually be taken four times
during the waking hours, usually once ateach meal and once at bedtime. In somecases, however, the precise interval is soimportant that the patient might have tobe awakened during the night to take adose. The patient should discuss themedicat ion schedule with the doctor tomake it as convenient as possible.
Some medications are taken only oncea day. If the drug is a diuretic—one thatincreases urination—it's best to take it inthe morning after breakfast. However,when the schedule calls for several dosesof the diuretic during the day, the lastone should be taken no later than 6 p.m.,unless the doctor says otherwise, so thattrips to the bathroom won't interfere withsleep.
Similarly, once-a-day drugs that mightmake the patient nervous or anxiousshould be taken in the morning to allowuninterrupted sleep at night.
Getting the right amount of a drugsometimes can be tricky if the drug isgoing in through the nose instead of themouth. According to the Handbook ofNonprescription Drugs, many asthmapatients don't use their inhalers properly,triggering the spray after inhaling. Whenusing an inhaler, patients should breatheout slowly, then activate the inhalerwhile inhaling slowly and deeply, andhold the breath for at least 10 seconds.Gargling after each use can preventthroat irritation. To prevent clogging, themouthpiece of the inhaler should bewashed daily with warm water.
Topical decongestants—both spraysand drops—can also be tricky. Spraysshould be administered while standing orsitting. The patient should spray onceinto each nostril and blow the nose threeto five minutes later to remove mucus.
Drops, on the other hand, require the patient to lie down either on the back orside—with the head below the shoulders.
The drops should be placed deep in eachnostril without touching the nasal surfacewith the dropper (to avoid spreadinggerms from one user to another. Betterstill, don't share the drops). Then the patient should remain reclining and breathethrough the mouth for about five minutes.
What happens if you miss a dose? It'sa good idea to ask the doctor or pharmacist what to do if that happens beforestarting on a new medication schedule.Sometimes the patient is advised not totake the missed dose, to simply wait until the next dose is due. With some other
drugs, the missed dose should be takenas soon as the patient remembers it.
Often a prescription will read "takeone hour before or two hours aftermeals." The reason is that food in thestomach slows down the absorption ofthe drug, making it less effective. Mostantibiotics are among those drugs that dotheir job better when taken on an emptystomach. But the reverse is true of oneantibiotic, griseofulvin, which is besttaken with meals, especially meals withlots of fat. This helps the body absorbthis particular medicine better.
If a drug upsets the stomach, it may betaken with milk or small amounts ofsolid food, such as crackers. Don't usean antacid as a buffer without firstchecking with your doctor. Some over-the-counter antacids can interfere withthe effectiveness of prescription drugs.FDA has recently proposed that the labeling of antacids be changed to call thisto consumers' attention. (See "MixingAntacids and Rx Drugs Can SpellT-R-O-U-B-L-E" in the October 1986FDA Consumer.)
Whether they are taken with meals oron an empty stomach, it's a good idea totake capsules and tablets with a liquid.That means more than just a sip. With alldue respect to Mary Poppins, it's a cup-
FDA Consumer / May 1987 / 23
Food can hinder the absorption of some drugs, but canhelp the body absorb others.Capsules and tablets shouldbe taken with liquid, preferably water.
ful of fluid, not a spoonful of sugar, thathelps the medicine go down. Also, aswallow of liquid before taking the tabletor capsule lubricates the esophagus andeases the passage of the medicine to thestomach. It's also advisable to stand orsit erect when swallowing a medicine,allowing gravity to help.
Water is generally the best liquid touse, unless the medicine tastes bad. Inthat case, ask a pharmacist what otherliquid can be taken with that particularmedicine. Milk, fruit juice, or soda popmay mask the bad taste, but may alsohamper the effectiveness of the drug.
Once you put the medicine in yourmouth, don't hesitate. Some coated tablets or capsules get sticky when theycome in contact with saliva. Unless youtake plenty of fluid, the medicine maystick to the esophagus and not completeits journey to the stomach. Choking, difficulty in swallowing, and blockage ofthe esophagus may result. The MayoClinic Health Letter (June 1986) recommends eating a banana if you think a tablet or capsule is stuck in your esophagus.The banana, partially dissolved in saliva,will provide a smooth coating that willcarry the stuck tablet with it as you swall o w .
Adequate liquids are also needed toprevent some drugs, such as aspirin andpotassium chloride tablets or capsules.
from irritating the delicate lining of theesophagus and stomach. Liquids dilutethese drugs as they dissolve, decreasingthe chance of irr i tat ion.
It is extremely important to drink a lotof water—as much as eight or moreglasses a day—when taking drugs suchas sulfas and lithium. Otherwise, a concentration of these potent substancescould cause kidney or bladder damage.
A lot of liquid is also essential whentaking bulk-forming laxatives. Thesedrugs won't work at all if there is no liquid to make them expand.
Liquids are also essential if the medication is a powder or a tablet that mustbe dissolved before it is taken. Nevertake a powder in its dry form. Be surethe powder is completely dissolved before drinking the liquid. After emptyingthe glass, swish a little extra water or liquid in it and take one last swallow to getall the medicine.
Certain long-acting or time-releasecapsules and tablets—designed to dotheir job over a long period—should always be swallowed whole. If they arecrushed or opened, they will release theactive ingredients all at once, possiblycausing adverse effects from overdose.
On the other hand, chewable tabletsneed to be thoroughly chewed beforebeing swallowed to help the drug dissolve and enter the bloodstream.
Some drugs work best if they are notswallowed. For example, nitroglycerin,taken for certain heart conditions, is usually administered as a sublingual tablet tobe placed under the tongue to dissolveslowly. Because it is absorbed by the lining of the mouth, the medication getsinto the bloodstream more quickly than ifit were swallowed. The patient taking anunder-the-tongue drug should try not toswallow saliva until the tablet is dissolved completely.
Nitroglycerin, as well as a few otherdrugs, can also be administered througha transdermal patch—a patch applied tothe skin that allows the medicine to beabsorbed slowly. Transdermal patchesmust be applied to clean, dry, hairlessskin. Areas of extensive scarring, calluses or irritation should be avoided.When patches must be applied regularly,the application site should be varied toavoid causing skin irritation. Also, patients should not try to alter the dosagethemselves by cutting or trimming thepatches. If the dosage is wrong, the patient should consult with the doctor.
One final word of advice—keep allmedicines, whether they are prescriptionor over-the-counter, out of the reach ofc h i l d r e n . ■
Annabel Hecht recently retired fromFDA's public affairs staff.
24 / May 1987 / FDA Consumer
Warming to the Idea:Heat Research May Help Hearts,Kidneys, and Man's Best Friend by Bill Grigg
Medical research can start small, andthen build and grow. It can be likea trickle of water from a small springthat joins other streams to create a broadw a t e r f a l l .
That's how it's happening for FDA researcher Paul Ruggera. His work begansimply enough: trying to solve a smalltechnical problem with some medical research equipment. Now the results arebeing applied to improve cancer therapyand to help dogs—and possibly even infants—safely recover from open-heartsurgery. And before it's over, there maybe benefits for transplanting kidneys andother organs and for treating victims ofhypothermia.
Ruggera, a lean and compact engineer, born and raised in Wyoming,didn't set out to do all this. As part ofthe requirements of a five-year agreement between the National Cancer Institute and FDA, he started out in 1981on a relatively narrow, if important,project: The Cancer Institute was studying the effectiveness of using heating devices as a treatment for cancerous tumors
deep within the body. While it has beenproven that heat treatment is effectiveagainst some cancers at or just beneaththe skin, using the procedure for deep-seated cancer—in which the tumorswould be subjected to temperatures up to44 degrees Celsius (111 degrees Fahrenheit)—is still experimental. The CancerInstitute wanted a way to test how evenlyand deeply various devices could heat anarm, leg or the entire body.
Working at FDA's medical device labsin Rockville, Md., Ruggera began testing a "phantom" arm, thigh and trunkdesigned by his colleagues at FDA. Thephantoms were made of plastic and ep-oxy, some of it remarkably like SillyPutty, so that it would have the heattransmission qualities of human bone, fatand muscle. The phantoms were thenplaced within the warming devices, andthe heat that reached the phantoms wasm e a s u r e d .
Producing the results from the phan
tom tests was supposed to be the end ofRuggera's job for NCI, but it proved tobe just the start. Soon Ruggera was designing a heating device himself—onethat wouldn't bum and injure surfacetissue but would carry the heat deep intothe body.
It happened like this: While developing the phantom arm, Ruggera hadlooked at past work in an area called coilfield heating. He found that coils ofvarious lengths of wire had been used toproduce heat, but in a primitive manner.One coil, for example, was simply a cable wrapped directly around the part of
the body to be heated. It provided surface heating.
Other heating devices that the CancerInstitute was interested in, besides thecoils, were wire bands and rings. Reading, studying, considering, Ruggera became intrigued by what he did not find:
While some experimenters had reported using coils to produce radiowaves and thus generate heat, the wiremaking up the coil generally measuredless than one-fourth of the wavelengthbeing used. Ruggera found no experiments showing the effects of using a coilmade of a wire of the exact same length
Dr. James C. Keith Jr., a veterinarian with the Virginia-Maryland Regional College of Veterinary Medicine, prepares to perform a biopsy on an anesthetizeddog as part of a test of a heating coil designed by FDA engineer Paul Ruggera.The coil is being tested to re-warm dogs whose bodies had been cooled foropen-heart surgery. The tests have found that the dogs recover from the re-warming with no adverse effects.
FDA Consumer / May 1987 / 25
The heating coil has the potential to lower the mortalityrate in human infants whomust undergo open-hearts u r g e r y .
FDA engineer Paul Ruggera with the heating coil he developed for cancer research. Ruggera is placing a temperatureprobe into a human thigh phantom (the hollow cylinderthat looks like a drainpipe). The wires that transmit theheat surround the phantom, which is designed to simulatehuman tissue in the way it absorbs heat.
as the radio wave being produced.Although there were no theoretical in
dications it would produce anything,Ruggera and Gideon Kantor, an FDAphysicist who has been involved inradar, radiowave and microwave research, decided to build the new coil.The result was a palpable, patentables u c c e s s .
Ruggera and Kantor made their warming device by coiling a wire of 11 meters(about 36 feet). Flooking a ham radiotransmitter to the coil, they produced radio waves at a frequency of 27 megahertz—a frequency that produces a waveof 11 meters, the same length as the wirein the coil. They found that the coilbroadcast to itself, holding the wavewithin the coil. They also found that thecoil used in this way evenly heated anything placed within it. Deep warmingwas accomplished without hot spots orexcessive heating. The heating alsoproved more intense at the middle of thecoil's length—a benefit in treating specific tumor sites without overexposingadjacent normal tissue. By changing thelength of wire used in winding the coil,the operating frequency can be changed,and by changing the diameter of the coil,devices can be made big enough forarms, legs or the trunk of an adult body.
As a result of its even, deep heat,Ruggera's coil may have distinct advantages for hyperthermia, as the experimental heat therapy for deep-seatedcancers is called.
To make the coil easier for the patientto climb into and use, as well as lessclaustrophobic, Ruggera spent sixmonths developing and testing a designwith an oval opening of 24 inches by 17inches and a mere 20 inches long.
NCI is now sponsoring human clinicaltrials of this design—and the initial results indicate it may be useful in thetreatment of some deep-seated tumors.
End of the story? No.Looking to test the heat coil in other
ways, Ruggera, through Kantor's professional associations, made contact with
26 / May 1987 / FDA Consumer
Drs. Joe Gainer and Milton April ofFDA's Center for Veterinary Medicine,and Dr. James C. Keith Jr. of the Vir
ginia-Maryland Regional College of Veterinary Medicine at Blacksburg, Va.Keith is an expert in the heart and bloodvessels of animals.
Veterinary medicine has made manyof the same leaps forward as humanmedicine in recent years; it is no longerunusual for veterinary surgeons to perform open-heart surgery on dogs andother animals. But because dogs havesmall blood vessels, they can't behooked up to a heart-lung machine to bekept alive during surgery. Instead, theanimal's body is cooled to slow its metabo l i sm.
Whereas the heart-lung machinewould keep the body and brain suppliedwith sufficient oxygen to prevent damagewhile the heart is stopped, the cold reduces the need for oxygen. Dr. Keith explains, "When you chill the body down,you drop the metabolic rate so the braindoesn't need as much oxygen or nut r i e n t s .
"Under the hypothermic, or chill,conditions, instead of irreversible braindamage occurring in three to five minutes, it takes 60 to 90 minutes. So whatwe're providing the surgeon is time,"Keith said.
But reheating a body by the conventional method, heating pads, creates itsown problems. Blood pressure problemsarise, for example, because the unevenwarming dilates surface blood vesselsbefore they can be properly filled by theslowed heart. This and other complications have produced a 50-percent mortality rate for dogs after open-hearts u r g e r y .
Together, the five-man team chilled afrisky beagle with packs of ice to slowits bodily activities—a process approaching suspended animation. They then attempted to revive the dog in the Ruggeracoil. The process was successful. Thedog was soon the same playful animal asbefore, apparently no worse for wear.
Dr. Keith, with the others" help, repeated the process nine more times,lowering the dogs' temperatures to about28 degrees Celsius (about 82 degreesFahrenheit), then warming the animals totheir normal 38 degrees Celsius (100 F).They reported complete recovery of thetest animals each time. Actual heart sur
gery was not performed, but the amountof time required for surgery was incorporated after the cooling. Tests showedwhat the dogs themselves knew—theywere fully recovered.
Dr. Keith believes the coil may drastically improve the success rate of open-heart surgery on dogs. He says the helical coil creates an electromagnetic fieldthat heats the body evenly—and morequickly. Instead of the three to fourhours of rewarming required by heatingpads, the coil restores the body's temperature in 30 minutes.
He believes the coil may also stabilizethe heart's electrical activity, preventingsome of the dangerously erratic heartbeatthat often develops after heart surgery.
The studies have now moved to a second phase. While the first dogs were justchilled, placed in the coil, and warmed,three dogs have now been successfullyoperated upon—chilled with ice packs,their chests opened and hearts stoppedfor half an hour, and their bodies re-warmed with the coil. All three operations were successful, with the dogs backto normal a half hour after they wereplaced in the warming field of the coil.
Dr. Keith thinks the coil may be usedsoon in actual operations on young dogswith congenital heart defects.
Like dogs, human infants have bloodvessels too small to attach to a heart-lungmachine. So their bodies, too, must becooled down to allow open-heart surgery. And because of this, the mortalityrate is high—between 15 percent and 20percent. The heating coil has the potential to lower the rate if it is proven safeand effective. At this point, no studieshave yet been done in humans.
And before commercial use in human
infants is possible, the coil also will haveto be approved by FDA's Center for Devices and Radiological Health, whereRuggera works.
Ruggera is hopeful that the coil maybe put to even more uses. It might provean asset in treating victims of hypothermia, a condition in which exposure tocold drives the body temperature downto potentially fatal levels. (For more onhypothermia, see page 34 of the February 1987 FDA Consumer.) But here, too,studies remain to be done to prove thecoil's safety and effectiveness.
Ruggera also is working with theAmerican Red Cross to see if a variationof the coil could be used to thaw donor
kidneys after they have beencryogenically frozen at extremely lowtemperatures. Currently, when a kidneyis removed from a donor, it is chilledand rushed to the transplant site for immediate use before it is irreparablydamaged. If kidneys could be frozencryogenically and then safely rethawedany time there was a need for a transplant, large numbers of the organs couldbe stored indefinitely, vastly increasingtbeir availability and making far moretransplants possible. The catch is to finda way to thaw the frozen kidneys veryquickly; slow thawing damages the organbeyond use. The coil may solve thequick-thaw problem, but work is onlybeginning on this possibility, Ruggerasays. If it proves successful, it could beused not only in transplanting kidneys,but other critical organs as well.
The promise is great: greater availability of organ transplants, help for hypothermia victims, improved surgicalsurvival for animals and for human infants needing open-heart surgery, as wellas a better experimental way to treat cancer. Along the way, conventional coilheating theory, which wouldn't have predicted the coil's rewarming advantages,is being rewritten. ■
Bill Grigg is the director of FDA's PressRelations Staff.
I-'DA Consumer / l^ay 1987 / 27
W e N o t e b o o k
The Notebook: a potpourri of items of interest gatheredfrom FDA news releases, other news sources, and theFederal Register (designated PR, with date of publication). The Federal Register is available in many largepublic libraries.
■ USDA has filed a petition with FDA requesting permission to use ionizing radiation on poultry to reduce
the number of microorganisms, such as Salmonella, Yersinia and Campylobacter, that cause food poisoning [FRFeb. 20).
■ FDA has available $3.5 million for grants to supportclinical research for development of "orphan" products that show promise in treating diseases but lack commercial support because they show little promise ofprofits. For information about the funds and the application procedure, contact the FDA Office of Orphan Products Development (HF-35), 5600 Fishers Lane,Rockville, Md. 20857.
■ Residues of daminozide (trade name Alar), a plantgrowth regulator sprayed mainly on apples, were eithernonexistent or much lower than the tolerances established
by the Environmental Protection Agency on 66 samplesof fresh and processed fruit analyzed by FDA during1986. Daminozide, which studies indicate could causecancer in laboratory animals, makes apples firmer, enhances their color, and extends storage life.
■ FDA's Center for Devices and Radiological Health hasproduced a videotape that describes the agency's Problem Reporting Program for medical devices and labo
ratory products. It is available for showing to healthprofessionals from the U.S. Pharmacopeial Convention,12601 Twinbrook Parkway, Rockville, Md. 20852,8 0 0 - 6 3 8 - 6 7 2 5 .
■ FDA has establ ished new and revised action levels forresidues of the pesticide benzene hexacbloride in foodand feed. Although the use of this pesticide was bannedby the Environmental Protection Agency, these levels arenecessary to cover unavoidable residues (FR Feb. 11).
FDA also has set new and revised action levels for thebanned pesticides dieldrin, aldrin, chlordane andD D T .
■ Data on an amino acid combination used in over-the-counter drugs to treat benign enlargement of the prostate gland (benign prostatic hypertrophy) are insufficientto classify it as safe and effective, according to an FDAproposal (FR Feb. 20).
■ A new antibiotic, injectable aztreonam, and a newdosage form of the antibiotic nystatin, nystatin pastilles,have been approved by FDA. (Pastilles are tablets inwhich the active ingredient is incorporated in a mass ofsweetened gum, glycerin and gelatin.) (FR Feb. 13.)
■ Single copies of "Anesthesia Apparatus CheckoutRecommendations," prepared by FDA's Center for Devices and Radiological Health, are available from PeterB. Carstensen, CDRH (HFZ-240), Food and Drug Administration, 5600 Fishers Lane, Rockville, Md. 20857.
■ The "Interim Scientific Report on an EpidemiologicStudy of Certain Dietary Characteristics and CancerMortality," prepared for FDA by the Federation ofAmerican Societies for Experimental Biology, is available for $10 from FASEB, Special Publication Office,9650 Rockville Pike, Bethesda, Md. 20814.
■ Ads for the Today Contraceptive Sponge claimedthat "No reversible method other than the Pill or lUD ismore effective." A competitor gave the National Advertising Division (NAD) of the Council of Better BusinessBureaus clinical studies that indicated that the diaphragmwith spermicidal gel was more effective than the sponge.The sponge manufacturer discontinued the advertising inquestion and assured NAD that future claims will bebased on accurate medical information.
■ After a health fraud notice in FDA's Enforcement Report identified as "gross deception" claims such as reducing fatigue and fighting "winter blues," made by theDuro-Test Corp. for its Vita-Lite fluorescent lamp,Duro-Test submitted new labeling that conforms to FDArequirements for medical devices.
28 / May 1987 / FDA Consumer
DangerousDiet Drugs jfromSouth of theBorderby Richard C. Thompson
Many desperately overweight Americans—an estimated 100,000 a year—have been traveling to the Mexicanborder cities of Ciudad Juarez and NuevoLaredo to obtain what they believe is amiraculous diet drug, Redotex. Officialson the U.S. side have been generallypermissive, since the Redotex capsulesand the pills that are part of the diet regimen are intended for personal use, andpersons bringing them across have prescriptions signed by Mexican doctors.
But FDA and Texas state health officials have become increasingly alarmedat reports of addiction, psychosis, hypertension and even death among users ofRedotex. On Feb. 6, FDA issued an import alert that should halt this over-the-border traffic, since it prohibits anyonefrom bringing any amount of the druginto the United States for any reasonwhatsoever.
Redotex is a mixture of five powerfuldrugs that have no business being offeredin that combination. The principal ingredient is d-norpseudoephedrine, approvedfor use in the United States for colds andallergies and for nasal and throat congestion. It has a stimulant side effect and isalso an appetite suppressant, but in the30-milligram dose in cold remedies thatis no real problem. However, the dosagein Redotex is almost twice that of thecold remedies, which greatly increasesthe risk, especially of aggravating highblood pressure, a condition common inoverweight persons.
Other Redotex ingredients are a thyroid hormone that increases metabolism;a stimulant that increases respiration andblood circulation; a strong laxative (aloe);and the tranquilizer diazepam, intendedto calm the effects of the stimulants.
Medical experts in FDA's Center forDrugs and Biologies recognized this as
an irrational combination of potent drugsthat could cause serious and perhaps fatalreactions; a loss of body electrolytes, increased heart rate, either lower or higherblood pressure, an altered rate of metabolism, and mental confusion and hallucina t i ons .
The ban against Redotex became national news, since people had been coming from several states and drivinghundreds of miles to get to these Mexican clinics, some supposedly arriving inchartered buses as though they were onv a c a t i o n .
Explaining FDA's action, the directorof the regional office in Dallas said in interviews that—as numerous reports ofthese adverse reactions began to appear—the agency could no longer permitRedotex to be brought in, even for personal use. The Texas state health department, which had been monitoring the useof the drug before the ban was imposed,is checking into at least four deaths tosee if Redotex was a factor.
According to those who had been tothe Mexican clinics, patients pay about$20 to the doctors for writing the prescription and then another $10 or so for a
month's supply of medication. If the patient wanted more than that, the doctorswould write additional prescriptions inthe names of the patient's friends.
On occasion, Medix, the Mexicanfirm that manufactured Redotex, wouldprovide a sort of home delivery, with adoctor flying into Laredo from MexicoCity to distribute Redotex to patientswaiting in an office there. They wouldbe given a cursory examination, and thenthe drugs would be handed out, according to a Laredo resident who had been onthe diet regimen.
Although attention was focused on theNuevo Laredo clinics, the operations atCiudad Juarez were apparently much thesame, though traffic there was lighter.
In addi t ion to the Redotex formulat ionmade by Medix, the clinics were dispensing other drugs, particularly diuretics, that are supposedly effective inweight loss. Patients using these in combinat ion with Redotex were at even
greater risk.Dr. Reynaldo Godines, former presi
dent of the Laredo Medical Society ofTexas, noted that these across-the-borderclinics had been operating in a wholesale
FDA Consumer / May 1987 / 29
fashion, prescribing Redotex and theother drugs to as many as 300 people aday, seven days a week. He was particularly critical of the willingness of theclinics to put patients on drugs that areknown to be addict ive.
FDA's import alert calls for the automatic detention of Redotex and other dietpills from Mexico on the basis that theyare unapproved and misbranded newdrugs. FDA has asked U.S. Customs officials to "detain" the drugs when theyare found during routine examination ofpersonal luggage, meaning that travelerscan reclaim them when they return toMexico. But since the purpose of goingto Mexico was to bring them out, it isnot likely that many will be asking fortheir pills back.
Dr. Mario Lieberman, an official of
the Health Secretariat of Mexico, appeared on Mexican national televisionwhen the U.S. ban was announced tocaution against such haphazard use ofthese potent weight-reducing drugs. Hesaid that stricter controls are being imposed on prescribing and dispensingthese drugs by Mexican clinics. He alsosaid that Redotex will be reformulatedand the ingredients changed to make theproduct less dangerous. FDA Commissioner Frank E. Young, M.D., praisedthese actions by the Mexican government, saying he is certain this contributes to public understanding of thehazards and should deter others fromseeking this kind of treatment.
Richard C. Thompson is a member ofFDA's public affairs staff.
M o t h - P r o o f
FDA's inspection of Asia TradingCompany in St. Louis last Aug. 5 beganas purely routine. But when the case wasfinally closed on the Oriental foodwholesaler, some 25,000 pounds of riceand noodles had been destroyed and theFDA inspector was recuperating from aheart attack suffered during the inspect ion .
It was the first FDA inspection of thefirm, which specializes in handling Oriental food for restaurants. The foodswere stored in two basement rooms ofthe firm's headquarters on Olive Streetand in the basement of the Gospel MusicCenter next door.
Problems' began when an investigatorwith FDA's St. Louis office discoveredmassive contamination of the food by rodents and insects, including a flutteringsquadron of moths. It took a turn for thedramatic when the investigator beganhaving chest pains and had to discontinue the inspection. He returned to theoffice to deliver the government car andhis field notes and camera and then wentto the hospital. When it was confirmedthat he was having a heart attack, he washospitalized and ended up having doublecoronary bypass surgery. It was severalmonths before he could return to the offi c e .
While he was hospitalized, his coworkers picked up the case. They reviewed the notes and photos he had leftbehind; they provided ample evidencethat there was much amiss at Asia Trading.
Investigators provided evidence ofbags of rice gnawed by rodents, as wellas dead and decaying rodents and nestingmaterial. Animal urine was found insome bags of rice, and two types of bee
tles were observed in large numbers. Themost predominant pests, however, weremoths, observed throughout the warehouse both in adult and larval forms. Themoths had infested five lots of rice andrice flour and could be seen flutteringfrom walls to food containers. The firm'sowner said he didn't think insects in ricewere really a problem because theywould be washed away during cooking.He also said that since the bugs were onthe outside of the bags, not inside, therewas no problem.
At FDA's request, the Missouri StateHealth Department embargoed the foodsthat were contaminated, about 24,000pounds. On Oct. 30, a U.S. marshalseized the embargoed food plus an additional 1,000 pounds that might be contaminated. The seized food, worth about$8,000, was destroyed in a landfill.
B l o o d B a n k E r r o r s
Companies that run blood donor centers can pretty much count on a visitfrom FDA after a change of owners.FDA regulates those firms to protect thehealth of both donors and recipients ofblood and plasma, the liquid part ofblood. Practices uncovered during onesuch inspection at the Augusta PlasmaCenter, Inc., in Augusta, Ga., led theagency to suspend the new owner's lic e n s e .
FDA's inspections of blood donor centers focus on whether the firm is following the proper practices and proceduresspelled out in the agency's regulations.At the Augusta center last June, the in-
30 / May 1987 / FDA Consumer
vestigator from FDA's Atlanta officequickly saw that this firm's operationswere quite improper. For instance, oneperson being screened didn't seem to understand the examining physician—several people tried to explain what wasbeing asked—but no notation of this wasmade on the person's record. The importance of screening out unsuitable donorsmakes positive identification of prospective donors vital, yet workers didn't askfor proper identification. And though it'scommon for plasma centers to photograph donors so that each record includesa picture, such photos were not on file atthe Augusta Plasma Center—its camerawas broken and the firm didn't bother toget it fixed. The problems were pointedout to the owner, who promised to correct the situation.
However, another FDA visit the nextmonth turned up more violations.Employees who did the screening wereuntrained, inexperienced, and inadequately supervised. Files for identifyingsuitable and unsuitable donors were inaccurate, out-of-date, and often misfiled.Some donors were assigned two donornumbers and, so, had actually donatedunder two separate donor record files. Atleast four of the donors with two fileshad been previously deferred from donating because of a positive test for hepatitisor for HTLV-Ill antibodies. (The presence of HTLV-lII antibodies indicates
that the donor has been exposed to thevirus that causes AIDS, acquired immunodeficiency syndrome.) Accepting a donor who is temporarily or permanentlydeferred because of contaminated blood
jeopardizes the future recipient's health.Accepting a donor who is deferred because of a recent loss of blood or an abnormal protein level in the blood—ofwhich the firm also was guilty—jeopardizes the donor's health. Because of thepotential health threat posed by thoseviolations, FDA's Atlanta office sentAugusta Plasma Center a letter last Aug.24, telling the firm to bring its practicesinto compliance with the law or face possible sanctions, including suspension ofits license.
The Atlanta investigator made a follow-up inspection in November and,again, found major defects with the waythe firm kept records and screened donors. FDA suspended Augusta PlasmaCenter's license on Dec. 2, stopped thefirm from collecting and shippingplasma, required the firm to tell its distributors and sales agents about the suspension, and ordered an inventory ofstored products and the complete recordsof deliveries during the 60 days beforethe suspension. Fortunately, the company shipped products to only one firm,which routinely screens all incomingunits, so no contaminated plasma unitswere used to make additional products.
Augusta Plasma Center is now out ofthe blood bank business, permanently.
J a i l e d
A key figure in a nationwide networkdistributing illegal steroids and other prescription drugs was given a lengthyprison sentence and received a heavyfine after a Florida jury found him guiltyon 21 of 23 felony counts.
James Bradshaw of Dania, Fla., wassentenced to 42 years in prison and fined$210,000 by Judge James Paine of theU.S. District Court for the Southern District of Florida. Paine then suspended 36years of the sentence, leaving Bradshawto serve six years in prison. He alsoplaced Bradshaw on probation for threeyears, meaning that the full sentence willbe imposed if he violates probation.
Bradshaw was known to be a majorsteroid dealer, and when his apartment inDania was searched, FDA investigatorsand other federal agents found eight cartons of illegal drugs, along with $5,000in cash and records that detailed hissources and suppliers. Bradshaw was indicted in May 1986 on charges of illegally distributing prescription drugs,tried and found guilty by a jury in October, and sentenced two months later.
Steroids are prescription drugs with legitimate medical uses that are muchsought by certain athletes—sometimesencouraged by their coaches—for thebody strength and muscle mass they
provide. However, using them withoutmedical supervision carries considerablerisk of organ damage and even death.(See "Anabolic Steroids: Pumping Trouble" in the September 1984 FDA Consumer and "Coming Down on SteroidPushers" in the November 1986 FDAConsumer.)
Some steroids are imported by thedealers; others are legally obtained fromdrug firms in this country (sometimes bya physician or pharmacist), then directedinto illegal channels. A few are out-and-out counterfeits, not at all what theyclaim to be, and could be even moredangerous.
FDA has primary authority when prescription drugs—real or counterfeit—arebeing illegally distributed, since this violates the Federal Food, Drug, and Cosmetic Act. About two years ago FDA,the FBI, and the U.S. Customs andPostal Services combined forces to breakup this illegal traffic and close down thenetworks of dealers and suppliers, looking especially for key players in theseoperations. That effort is still under way,and a number have been fined and sentenced, many to terms as severe asB r a d s h a w ' s .
—This small sample of reports from thefield was prepared by Carol Ballentine,Dixie Farley, Carolyn Hommel, CarolMontalvo, and Richard Thompson.
FDA Consumer / May 1987 / 31
Summaries of Court Actions are given pursuant to section 705of the Federal Food, Drug, and Cosmetic Act. Summaries of CourtActions report cases involving seizure proceedings, criminal proceedings, and injunction proceedings. Seizure proceedings are civilactions taken against goods alleged to be in violation, and criminaland injunction proceedings are against finns or individuals chargedto be responsible for violations. The cases generally involve foods,drugs, devices or cosmetics which were alleged to be adulteratedor misbranded or otherwise violative of the law when introducedinto and while in interstate commerce, or while held for sale aftershipment in interstate commerce.
Summaries of Court Actions are prepared by Food and DrugDivision, Office of the General Counsel, HHS.
Published by direction of the Secretary of Health and HumanServices.
S E I Z U R E A C T I O N S
FoodslPoisonous and Deleterious Substances
PRODUCT: Peanuts, Tex Goober, 2 seizure actions, atPrescott and Hope, W. Dist. Ark.; Civil Nos. 86-4021 and 86-4 0 2 2 .CHARGED 2-26-86: When shipped by J.C. Tray lor Farms,Inc., Naples, Texas, the articles contained the added poisonousor deleterious substance aflatoxin—402(a)(1).DISPOSITION: Consent—ordered destroyed. (F.D.C. No.64851/2; S. Nos. 86-313-918 et al. and 86-314-294; S.J.No. 1)
FoodsiContamination, Spoilage, Insanitary HandlingPRODUCT: Spaghettini, macaroni products, crackers, andother food stocks, at Houston, S. Dist. Texas; Civil No. H-86-3504.CHARGED 9-11-86: While held by Antone's Foods, Inc.,Houston, Texas, the articles had been held under insanitary conditions—402(a)(4).DISPOSITION: Consent—authorized release to the dealer forsalvaging. (F.D.C. No. 65025; S. No. 86-453-832 et al.; S.J.No. 2)
FoodslEconomic and Labeling Violations
PRODUCT: Cereal products, canned and boxed, at FallRiver, Dist. Mass.; Civil No. 86-2006-S.CHARGED 7-7-86: When imported from Portugal, the articles(boxes labeled "Nestum flocos de cereals MEL instantaneoPeso liquido 300g ... Fabricado em Portugal por NESTLE'PRODUTOS ALIMENTARES, S.A.R.L. ... Lisboa" and canslabeled "Cerelac farinha lactea ... instantanea [or "multifrutosinstantanea") ... Fabricado em Portugal por NESTLE' PRODUTOS ALIMENTARES, S.A.R.L. ... Lisboa") failed tohave required label information prominently placed and in suchterms as to render the information likely to be understood by theordinary individual under customary conditions of purchase anduse, since such information was not present in the English language—403(f).DISPOSITION: Default—ordered constructively destroyed bydonation to a charitable or governmental organization. (F.D.C.No. 64919; S. Nos. 86-296-112/4; S.J. No. 3)
PRODUCT: Chocolate candy bottles filled with liquor, atLincolnwood, N. Dist. III.; Civil No. 85-C—4360.CHARGED 5-2-85; When shipped by Winters of Florida,Longwood, Fla., the article (labeled "Winters Original Chocolate Liquor bottles ... Liquor 5% By Volume! ... ManufacturedBy Winters Candy Company, Inc., Manteno, Illinois ... Emerson, New Jersey ... Sale of this product to Persons Under theLegal Age for Purchasing Alcoholic Beverages Is Unlawful Inthe State of New Jersey") was a confectionery and contained alcohol other than alcohol not in excess of one-half of I percent byvolume derived solely from use of flavoring extracts—402(d)(2).DISPOSITION: The article was claimed by Winters ChocolateLiquor Bottles, Inc., Manteno, III., who denied the charge andstated that the article was not in violation because it had beentransported in interstate commerce for the purpose of export.The government served requests for admissions upon the claimant. When the claimant failed to answer the requests within 30days, the government moved for summary judgment.
The claimant contended as follows: that, when the article hadbeen shipped to Florida, the article was intended for export, although the claimant had inadvertently failed to label the shipping package with the legend "for export only"; that the articlehad been reshipped to Illinois after the export consignee had
32 / May 1987 / FDA Consumer
canceled his order; and that returning the article to Illinoismerely returned the situation to the ''status quo:' Ultimately, aconsent decree (for settlement purposes only) condemned the article and ordered the destruction of the article. (F.D.C. No.64606; S. No. 85-33^229 et al.; S.J. No. 4)
PRODUCT: Chocolate candy bottles filled with liquor, twolots at New York, S. Dist. N.Y.; Civil No. 86-Civ-501 (JMW).CHARGED 1-15-86: While held for sale, the article was a confectionery and contained alcohol other than alcohol not in excessof one-half of 1 percent by volume derived solely from use offlavoring extracts—402(d)(2).DISPOSITION: The article (both lots) was claimed by WintersChocolate Liquor Bottles, Inc., Emerson, N.J., who denied thecharge. Subsequently, a consent decree recognized that the shelflife of the article had expired and rendered the article useless;and, accordingly, the decree ordered the article destroyed.(F.D.C. Nos. 64798 and 64799; S. No. 86-424-310 et al.; S.JNo. 5)
PRODUCT: Shrimp, peeled and cleaned, frozen, at Jamaica,E. Dist. N.Y.; Civil No. 85-3^96.CHARGED 9-19-85: When shipped by Great Ocean EnterpriseCo., Ltd., Kaohsiung, Taiwan, the article (labeled "Queen ofthe Ocean Brand Frozen Peeled and Cleaned Shrimp . . .Treated with Sodium Bisulfite ... Product of Taiwan") had hada substance (excess water) added to the article so as to increaseits bulk and weight--402(b)(4); the article's label lacked an accurate business address of the distributor and lacked an accuratequantity of contents statement—403(e)(l and 2).DISPOSITION: Consent—authorized release to Ocean WideFood Industries, Inc., Jamaica, N.Y., for bringing into compliance. (F.D.C. No. 64703; S. No.85-360-159 et al.; S.J.No. 6)
Drugs!Human UsePRODUCT: Cefaclor capsules, at Chelsea, Dist. Mass.; CivilN o . 8 5 ^ 6 5 I T .CHARGED 12-16-85: When shipped by Ronidaz InternationalCorp., Geneva, Switzerland, and Galaxy International,Kowloon, Hong Kong, the articles were counterfeit Ceclorbrand of cefaclor capsules, and the articles and their labeling,without authorization, bore the trademark, trade name, andother identifying marks of a drug manufacturer other than theperson who manufactured the article—201(g)(2); and the articles, for the purposes of coloring, contained the nonconformingcolor additive Patent Blue V—501(a)(4)(A).DISPOSITION: The articles were claimed by Rx WholesaleSuppliers, Inc., Miami, Fla. Upon consent of the parties, the action was transferred to the Southern District of Florida for consolidation with a similar action. Ultimately, upon consent of theparties, the articles (except for one full case and part of anothercase of reexported Ceclor capsules) were ordered constructivelydestroyed by being delivered to FDA. (F.D.C. No. 65796; S.No. 574162 et al.; S.J. No. 7)
PRODUCT*. Sulfonamide-type decongestant suspension, atHato Rey, Dist. Puerto Rico; Civil No. 86-0922.CHARGED 6-16-86: When shipped by Propharma, Inc.,Miami, Fla., the article (labeled "Sulfadrin ... Nasal Suspension ... Phenylephrine ... sulfathiazole ... Distributed by
Kramer Pharmacol .. . Miami, Fla. . . . Manufactured by:Mikart, Inc., Atlanta, Ga.") was a new drug without an effective approved New Drug Application—505(a).DISPOSITION: Default—ordered destroyed. (F.D.C. No.64897; S. No. 86-512-082; S.J. No. 8)
Drugs iVeterinaryPRODUCT: Chloramphenicol powder for goldfish, at Mer-cersburg, M. Dist. Pa.; Civil No. 86-1041.CHARGED 7-30-86: When shipped by Argent Chemical Laboratories, Inc., Redmond, Wash., the article was a new animaldrug, and no approval of a New Animal Drug Application wasin effect with respect to its use and intended use—501(a)(5).DISPOSITION: Default—ordered destroyed. (F.D.C. No.64914; S. No. 86-418-176; S.J. No. 9)
PRODUCT: Dichlorvos anthelmintic for dogs, and other veterinary prescription legend drugs, at Claremore, N. Dist.Okla.; Civil No. 86-C-254-E.CHARGED 3-20-86: While held by Willman's Inc., Clare-more, Okla., the labeling of the articles lacked adequate directions for use, and the articles were not exempted because theywere not being sold only to or on the prescription of a licensedveterinarian—502(f)( 1).DISPOSITION: Default—ordered destroyed. (F.D.C. No.64867; S. No. 86 492-818; S.J. No. 10)
C I V I L P E N A L T Y A C T I O N S
DEFENDANTS: Suntana Equipment, Inc., and Randall S.Brown, president. Traverse City, W. Dist. Mich.; Civil No.G 8 5 - 1 7 4 - C A - 7 .CHARGED 3-5-85 in a complaint for injunction and civilpenalties: That the defendants manufactured, labeled and distributed sunlamp products in the form of suntanning beds; that anumber of such beds failed to comply with applicable performance standards in a number of the following respects: a) the sun-tanning beds had been modified with a token box timer whichcaused the maximum timer setting to exceed the recommendedmaximum exposure time; b) the suntanning beds lacked a manual means for the user to terminate radiation emission; c) theprovided protective eyewear was solid plastic without lenses,and prevented the wearer from seeing clearly enough to read labels; d) the bed labels lacked: required certification, requireddanger statement, required ultraviolet-lamp type, required recommended use distances, required protective eyewear warning,required recommended maximum exposure time, required recommendations for sequential exposures, and required statementfor time for expected results; and e) the beds lacked any user information; that FDA had repeatedly informed the defendantsconcerning the failures; that the defendants had failed to repair,replace or refund the purchase price of the violative suntanningbeds—42 U.S.C. 363j(a)(2); that the defendants had failed tocertify such suntanning beds—42 U.S.C. 263j(a)(5); and thatthe defendants should be enjoined from such violations andshould each pay $8,000 in civil penalties for specified violat i o n s .
DISPOSITION: A consent decree of permanent injunction enjoined the individual from any of the complained-of violations,and imposed $500 in civil penalties. A default decree was entered against the corporation enjoining the complained-of viola-
FDA Consumer / May 1987 / 33
tions. (Inj. No. 1100; S.J. No. 11)
C R I M I N A L A C T I O N S
DEFENDANTS: Leo D. Vermedahl, a manager of feediots atDalhart and Lamar, N. Dist. Texas; Criminal No. CR-2-84-0 0 1 7 .
CHARGED 10-4-84 by grand jury: That, when shipped toTucumcari, N. M. (Count 1), with intent to defraud and mislead, 10 head of cattle (which had been implanted with di-ethylstilbestrol) contained the new animal drug diethylstilbestrolthat could not be safely used in food-producing animals—402(a)(2)(D); that, while cattle (whose edible tissue was a food)were being held for sale, the defendant, with intent to defraudand mislead, in Dalhart, Texas (Counts 2, 3, 4 and 5), andLamar, Texas (Counts 6 and 7), caused a specified number ofhead of cattle to be implanted with diethylstilbestrol—402(a)(2)(D).DISPOSITION: Pursuant to an agreement of the parties, therewas a rearraignment upon Counts 2 through 7 without the allegations of intent to defraud and mislead and without Count 1.Guilty plea to the revised Counts 2 through 7; probation for twoyears.(F.D.C.No.63746; S.No.80-233-914 et al.; S.J. No.l2)
I N J U N C T I O N A C T I O N S
DEFENDANTS: Central New York Livestock Sales, Inc. (t/aDiNitto Farms and Clinton Farm), and Rocco A. DiNitto,owner, and Anthony R. DiNitto, manager, Marcy and Clinton,N. Dist. N.Y.; Civil No. 84-CV-1281.CHARGED 9-17-84 in a complaint for injunction: That the defendants at their dairy farms (E)iNitto Farms, Marcy, N.Y., andat Clinton Farm, Clinton, N.Y.) were engaged in the productionof milk and the sale of calves and dairy cattle for slaughter; thatthe meat and milk from the defendants' farms were ultimatelysold to customers outside the state of New York; that the defendants held quantities of interstate chloramphenicol for use intreating veal calves and dairy cows; that such chloramphenicolwas not approved for use in dairy cattle or any other food-producing animal and was unsafe; that the meat and milk from thedefendants' calves and dairy cattle were adulterated with chloramphenicol and were unsafe when shipped in interstate commerce because persons sensitive to chloramphenicol could sufferserious adverse reactions (including aplastic anemia) when suchmeat or milk was consumed; that FDA inspection of the ClintonFarm disclosed three partially filled bottles of chloramphenicolin a dairy barn; and that a sample of muscle tissue collected atrandom by USDA from a calf sent to slaughter by DiNitto Farmswas analyzed and found to contain approximately 3 parts permillion chloramphenicol; and that the defendants were warnedon a number of occasions that their use of chloramphenicol wasillegal—501(a)(5), 402(a)(2)(D).DISPOSITION: A consent decree of permanent injunction perpetually enjoined the defendants from the complained-of violations. The consent decree also enjoined specified acts involvingthe interstate shipment of milk and the offering for sale of anyanimal, unless and until specified conditions had been met, including the following: the certification by the defendants thatthey no longer possessed any chloramphenicol except under spe
cifically limited circumstances; the testing of the defendants'dairy cows and their milk being found free of chloramphenicolor milk containing illegal drug residues being destroyed. In addition, in the case of animals offered for sale, the defendantswill notify FDA so sampling by USDA can be made at the timeof slaughter and the carcasses, edible organs, and offal ofsampled animals can, if necessary, be quarantined until analytical results are available, and any carcasses, edible organs,and offal containing illegal drug residues are condemned and destroyed. (Inj. No. 1087; S. No 84-369-911 et al.; S.J. No. 13)
DEFENDANTS: Empire Seed Co., and Norman L. Eilert,president, Othello, E. Dist. Wash.; Civil No. 85^15-RJM.CHARGED 6-3-85 in complaint for injunction: that the defendants, at Othello, Washington, operated a food warehouse and abean and pea processing facility; that the defendants routinelyshipped beans and peas in interstate commerce; that, whenshipped, such beans were, in part, decomposed, moldy, insectdamaged, and contained animal, rodent and insect filth—402(a)(3); that, when shipped, such peas and beans had beenheld under insanitary conditions—402(a)(4); that FDA inspections had disclosed a number of specified insanitary conditions;and that the defendants had continued to ship adulterated foodsin interstate commerce.DISPOSITION: Consent decree of permanent injunction enjoined the complained-of violations and enjoined any interstatefood shipments unless and until a number of specified conditionswere met including eliminating all rodents, insects and othervermin from the food storage warehouses, the warehouses werecleaned and renovated, and the defendants reported to FDAwhat actions they had taken to ensure that food at their warehouses was not adulterated. (Inj. No. 1114; S. No. 85-463-819et al.; S.J. No. 14)
DEFENDANTS: Marshall Pharmaca! Corp., Gustave A.Godinez, president, and Rose Marie Godinez, secretary-treasurer, South Hackensack, Dist. N.J.; Civil No. 85-1984.CHARGED 4-25-85 in a complaint for injunction: That the defendants, at their plant at South Hackensack, N.J., manufactured, processed, packed, labeled, stored, distributed in interstate commerce, and held for sale after interstate shipment ofdrug components various drug products; that the circumstancesused for the manufacture, processing, packing and holding ofsuch drugs failed to conform with current good manufacturingpractice—501(a)(2)(B); that FDA had in the past brought othercourt actions against the firm and its president; and that, in viewof the nature, extent and duration of the defendant's failure tocomply with current good manufacturing practice requirements,the government believed that violations would continue unlessthe defendants were enjoined as requested.DISPOSITION: The corporation was dissolved and a consentdecree of permanent injunction was entered into by the individual defendants. The decree specifically enjoined the individualwho had been the firm's president from manufacturing orprocessing any prescription or over-the-counter drug unless eachactivity was carried out under the direct supervision of aqualified individual. (Inj. No. 1081; S. No. 83-345^93 et al.;S.J. No. 15)
DEFENDANTS: Washington Chocolate Co., t/a Carahee
34 / May 1987 / FDA Consumer
Foods, and Michael C. Kelly, president, Kent, W. Dist.,Wash.; Civil No. € 85-1928.CHARGED 9-26-85 in a complaint for injunction; That the defendants prepared, packed, held for sale after interstate shipmentof major components, and shipped in interstate commerce candyproducts (e.g., fruits and nuts coated with carob, yogurt or chocolate) which had been prepared, packed and held under insanitary conditions; that FDA inspections over a number of yearshad revealed insects and insect filth on and near processingequipment and similar insanitary conditions and evidence of insect infestations—402(a)(4).DEPOSITION: A consent decree of permanent injunction enjoined the complained-of violations, unless and until a numberof specified conditions were met, including the cleaning andrenovation of the defendants' facility and the destruction or otherwise bringing into compliance of all contaminated food onhand at the defendants' facility. (Inj. No. 1122; S. No 85^63-405 et al.; S.J. No. 16)
M I S C E L L A N E O U S A C T I O N S
SUBJECT: Gentamicin sulfate injectable antibiotics (for day-old chicks), and their sale without an effective approved NewAnimal Drug Application; Washington, Dist. Columbia; CivilNo. 84-3368.CHARGED 11-5-84 by Sobering Corp., Kenilworth, N.J.,against HHS Secretary Margaret M. Heckler and the FDA, in acomplaint for declaratory judgment and injunctive relief: ThatSobering Corp. had researched, developed, manufactured andsold Garasol (the pioneer gentamicin sulfate injectable antibioticto prevent early mortality of day-old chicks); that SoberingCorp. had engaged in extensive and costly testing to establishthe safety and effectiveness of Garasol and to establish thatGarasol would not create any dangerous drug residue in food-producing animals; that Sobering Corp. had prepared and submitted a New Animal Drug Application for Garasol; that FDAhad approved that application; that Tri-Bio Laboratories, StateCollege, Fa., had subsequently begun manufacturing and sellingGentaject, an injectable gentamicin sulfate antibiotic to preventearly mortality in day-old chicks; that Tri-Bio Laboratories hadnever received FDA approval of a New Animal Drug Application for Gentaject, although it had attempted (without success)to secure approval of a "generic new animal drug application";that subsequently there was a government seizure action againsta quantity of Gentaject and a declaratory judgment suit by Tri-Bio Laboratories against FDA; that the later declaratory judgment suit was concluded with a stipulation of voluntary dismissal in which Tri-Bio agreed to petition FDA for a declarationthat Gentaject was not a new animal drug and FDA agreed not toinitiate enforcement litigation over Tri-Bio for 18 months, or 30days after any denial of such a petition; that, accordingly, Tri-Bio continued its sale of Gentaject despite the absence of anyvalid approval, and FDA's stipulation approving such sales wasin excess of FDA's authority and therefore unlawful and invalid;that FDA's stipulation was an unlawful de facto approval ofGentaject, which approval was arbitrary, capricious, and anabuse of discretion; that Sobering believed it likely that otherfirms would also begin selling a gentamicin sulfate antibiotic(relying on FDA's stipulation as to Gentaject); and that the courtshould declare the stipulation of voluntary dismissal to be in
valid, and declare that FDA could not approve an animal drugfor sale for day-old chicks until a New Animal Drug Applicationhad been approved or an alternative procedure had been properlyestab l ished.DISPOSITION: The parties litigated the action; Schering movedfor a preliminary injunction, and the government moved for dismissal of the complaint. In addition, Tri-Bio Laboratories waspermitted to intervene as a defendant. The court dismissed theaction on ripeness grounds beeause FDA's position was not finaland was likely to be reconsidered. Schering's motion for reconsideration was subsequently denied.
Schering appealed the judgment of the District Court. Uponappeal, the Court of Appeals affirmed the judgment of the District Court, saying that the FDA action in this case fell squarelywithin the confines of the case of Heckler v. Chaney (105 S.Ct.1649) and that FDA's action here was simply an exercise of itscomplete discretion to decide how and when to enforce theFood, Drug, and Cosmetic Act. (Misc. No. 768; S.J. No. 17)
PRODUCT: Glutamic acid hydrochloride (Aciduiin) capsules, and labeling for replacement therapy in gastric HCldeficiency, Indianapolis, S. Dist. Ind.;Civil No.IP 71-C-433.CHARGED 8-17-71 in a complaint for declaratory judgmentand injunction by Fli Lilly & Co., Indianapolis, Ind., and HEWSecretary Elliot L. Richardson and FDA Commissioner CharlesC. Edwards: That the plaintiff, the manufacturer of Aciduiin,marketed Aciduiin and other drugs in interstate commerce; thatsince 1927 the plaintiff had manufactured and sold Aciduiin forthe treatment of hundreds of thousands of patients; that, although Aciduiin was not restricted to sale on prescription, thevast majority of Aciduiin was dispensed to patients pursuant to aprescription: that there was no approved effective New DrugApplication for Aciduiin and no application had been submittedfor the following reasons: (a) the drug was generally recognizedas safe and effective, (b) its labeling before 1938 contained thesame representations concerning use as were contained in itspresent labeling, and (c) Aciduiin was grandfathered; that thegovernment had taken the position that Aciduiin was a newdrug; that FDA had concluded there was a lack of substantial evidence that two other drugs containing glutamic acid hydrochloride were effective for their labeled uses; that FDA had written the plaintiff that FDA regarded the plaintiff's drug to be anew drug without an effective approved New Drug Application;that FDA's authority to classify and regulate drugs was limitedby section 502(a) because Acidulin's labeling was not false ormisleading and the FDA's threat to institute proceedings was ultra vires, exceeded statutory authority, and was unlawful, illegal, arbitrary and not sustained by sufficient evidence; that theplaintiff prayed for declaratory judgment that Aciduiin was not anew drug and its labeling was not false and misleading; and thatthe plaintiff also prayed for an injunction against the taking ofany action against the plaintiff or Aciduiin on grounds that Aciduiin was either a new drug or was misbranded.DISPOSITION: The government denied the plaintiff's charges,asserted that there was a difference of opinion among well-qualified people whether Aciduiin had an appropriate place indrug therapy and that FDA had no objection to Aciduiin beingoffered under prescription labeling. The parties served writteninterrogatories on each other. The plaintiff served a request forthe production of documents.
FDA Consumer / May 1987 / 35
The government moved for summary judgment, and theplaintiff, after having been granted a delay in responding, opposed the government's motion. The government filed a reply tothe plaintiff's opposition to the government's motion for summary judgment. The plaintiff filed a supplementary memorandum asserting that the government had advanced a new theory,not foreshadowed in its original memorandum, as to why it wasentitled to summary judgment on the issue of the status of Acid-ulin under the 1962 grandfather clause of the Federal Food,Drug, and Cosmetic Act.
Subsequently, the plaintiff recommended that the court deferany action in the suit until FDA completed its review of glutamicacid hydrochloride through FDA's Over-the-Counter (OTC)Miscellaneous Internal Drug Products Panel. After a number ofyears, the OTC Miscellaneous Internal Drug Products Panelplaced stomach acidifier products in Category II. In 1982, theplaintiff requested that further proceedings in this action be further deferred while FDA considered comments on panel reportsconcerning OTC digestive aid products.
In 1985, FDA issued a notice of proposed rule-making againststomach acidifier products. Subsequently, the action was dismissed without prejudice pursuant to a stipulation. The stipulation reserved the plaintiff's right to challenge FDA's determination about the plaintiff's stomach acidifier product, andmaintained the status quo until all administrative proceedingswere final. However, the stipulation did not preclude FDA action based on adulteration or any significant new safety information. (Misc. No. 176; S.J. No. 18)
SUBJECT: Starch blocker tablets, and their status as a drugor a food; Deerfield/Barrington, N. Dist. 111.; two related cases;Civil Nos. 82-C^155 and 82-C^156.CHARGED 7-2-82 by Bio-Tech Laboratories, Inc., Batesville,Ark., Vita-Lite Laboratories, Inc., Elkhart, Ind., Dynavest(apartnership), Batesville, Ark., J. John Marshal, Ph.D., Elkhart,Ind., J. Robert Lemon, R.Ph., Batesville, Ark., Ronald F.Frantz, Barrington, 111., against HHS Secretary Richard S.Schweiker and FDA Commissioner Arthur Hull Hayes Jr. in acomplaint for declaratory judgment; That Bio-Tech Laboratories, Inc., distributed Carbo-Lite protein concentrate; that Vita-Lite Laboratories, Inc., distributed Colorex protein concentrate;that Dynavest manufactured for private-label customers proteinconcentrates known as "Alpha-Plex, Seirolac, Reducal and Pre-vacal"; that J. John Marshall, Ph.D., was the discoverer of theprotein contained in such products; that J. Robert Lemon,R.Ph., was the acting president of Bio-Tech Laboratories, Inc.,Vita-Lite Laboratories, Inc., and Dynavest; that Ronald F.Frantz was a product distributor; that the protein in these products "nutritionally" assisted the body inhibiting the digestion ofstarch food; that such protein was prevalent in beans and grainsand was primarily extracted from kidney beans; that FDA hadadvised that the products had been classified as "drugs," andFDA had demanded that the plaintiffs cease marketing the article; that plaintiffs only claimed that the product was a food protein for special dietary application in the inhibition of starch digestion; that the FDA action in classifying the product as a drugwas in excess of its authority and was arbitrary, capricious andan abuse; and that, accordingly, the court should grant a declaratory judgment declaring that FDA's classification action was of
no effect.CHARGED 7-2-82 and amended on or about 7-15-82 by Nu-trilab. Inc., Deerfield, 111., Naturalife-Ecovite Laboratories,Inc. (t/a Paragon Laboratories), Torrance, Calif., Jean PierreProducts, Inc., Torrance, Calif., and Natural Research (a partnership), Los Angeles, Calif., against HHS Secretary RichardS. Schweiker and FDA Commissioner Arthur Hull Hayes Jr. ina complaint for declaratory judgment; That the plaintiffs weresimilarly involved with the production and distribution of starchblocker tablets and similarly objected to FDA's action.DISPOSITION; The two cases were found to be related andwere litigated together. The government denied the charges andcountered that the plaintiffs violated the law by shipping such violative products—505(a)—and that an injunction should issueenjoining the interstate shipment of such drugs. The actionswere consolidated, and the government moved for a preliminaryinjunction.
After a three-day trial, the court ruled that the products inquestion were new drugs in violation of the law and granted thegovernment's request for permanent injunctions. The courtfound that the intent in the marketing of the product was thatstarch blockers be used as a drug for the treatment of overweightconditions. In light of testimony from physicians and scientiststhat starch blockers could have serious side effects, such possibility of harm required the court to classify the product in theinterest of public safety, and classification as a drug would bestserve such purposes. The court also ordered the destruction ofall alpha-amylase inhibitor drugs(i .e., starch blockers),althoughthis portion of the court's order was stayed pending appeal.
Upon motion of the government, the District Court's finalorder was amended to modify a footnote and to add an additionalfinding of violations concerning the drugs while held for sale after interstate shipment, in that such unapproved new drugs' labeling could not bear "adequate directions for use" as was required, because there was no approved use. The proponents ofstarch blockers appealed the adverse decision and order of injunction. The only issue on appeal was whether starch blockerswere foods or drugs.
In affirming the decision of the District Court, the Court ofAppeals found that it was well-established that the definitions offood and drug were normally not mutually exclusive and that anarticle which happens to be a food intended to treat disease stillfits in the statute's definition of a drug. There was a double useof the word "food" in Section 321(f) that made it difficult to interpret the parenthetical "other than food" exclusion in the Section 321(g)(1)(C) drug definition. By that exclusion. Congressmeant a drug to be something "other than food," but was"food" to be interpreted in 321(g)(1)(C) as a term of art in thestatutory sense or in the ordinary sense? In these consolidatedactions, starch blockers are not "food" in either sense. Thestarch blocker tablets are not consumed for taste, aroma, or nutritive value, but are taken for their ability to block the digestionof food and aid in weight loss. To qualify as a drug under Section 321(g)(1)(C), starch blocker tablets must not only be articles "other than food," but must also be intended to affect thestructure or function of the body of man. Starch blockers satisfythe latter requirement because they are intended to affect digestion in the people who take them and are therefore drugs underSection 321(g)(1)(C). (Misc. Nos. 689 and 690; S.J. No. 19)
36 / May 1987 / FDA Consumer ☆ U.S. GOVERNMENT PRINTING OFFICE 1987-181-341/60026
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