Shareware Overload Trio 2/Shareware Overload Trio Volume 2 (Chestnut CD-ROM).ISO/dir26/hicn743.zip/HICN743.TXT

Text File | 1994-09-11 | 60KB | 1,163 lines

HICNet Medical News Digest      Sun, 11 Sep 1994        Volume 07 : Issue 43

Today's Topics:

  [MMWR] Outbreak Shigella flexneri on a Cruise Ship
  [MMWR] Uveitis Associated with Rifabutin Therapy
  [FDA] Panel Recommends Studies for Breast Self-Exam Devices
  [FDA] The Doxylamine Dilemma
  [FDA] Electromagnetic Interference with Wheelchairs
  [FDA] The New Food Label: Scouting for Sodium related to Blood Pressure
  [FDA] Approves Test for Prostate Cancer
  [FDA] OTC Options - Help for the Sleepless
  [FDA] Tricks for the Tired
  [FDA] Safeguarding Human Tissue Transplants

             +------------------------------------------------+
             !                                                !
             !              Health Info-Com Network           !
             !                Medical Newsletter              !
             +------------------------------------------------+
                        Editor: David Dodell, D.M.D.
   10250 North 92nd Street, Suite 210, Scottsdale, Arizona 85258-4599 USA
                        Telephone [phone]
                           FAX [phone]
                         Internet: [e-mail]
                           Bitnet: ATW1H@ASUACAD
              Mosaic WWW: http://biomed.nus.sg/MEDNEWS/welcome.html

Compilation Copyright 1994 by David Dodell,  D.M.D.  All  rights  Reserved.
License  is  hereby  granted  to republish on electronic media for which no
fees are charged,  so long as the text of this copyright notice and license
are attached intact to any and all republished portion or portions.

The Health Info-Com Network Newsletter is  distributed  biweekly.  Articles
on  a medical nature are welcomed.  If you have an article,  please contact
the editor for information on how to submit it.  If you are  interested  in
joining the automated distribution system, please contact the editor.

                             Associate Editors:

E. Loren Buhle, Jr. Ph.D. Dept. of Radiation Oncology, Univ of Pennsylvania

       Tom Whalen, M.D., Robert Wood Johnson Medical School at Camden

        Douglas B. Hanson, Ph.D., Forsyth Dental Center, Boston, MA

             Lawrence Lee Miller, B.S. Biological Sciences, UCI

            Dr K C Lun, National University Hospital, Singapore

             W. Scott Erdley, MS, RN, SUNY@UB School of Nursing

      Jack E. Cross, B.S Health Care Admin, 882 Medical Trng Grp, USAF

  Albert Shar, Ph.D. CIO, Associate Prof, Univ of Penn School of Medicine

  Martin I. Herman, M.D., LeBonheur Children's Medical Center, Memphis TN

   Stephen Cristol, M.D., Dept of Ophthalmology, Emory Univ, Atlanta, GA

                  Subscription Requests = [e-mail]
              anonymous ftp = vm1.nodak.edu; directory HICNEWS
               FAX Delivery = Contact Editor for information


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

Date: Sun, 11 Sep 94 08:03:40 MST
From: mednews (HICNet Medical News)
To: hicnews
Subject: [MMWR] Outbreak Shigella flexneri on a Cruise Ship
Message-ID: <[e-mail]>

Outbreak of Shigella flexneri 2a Infections on a Cruise Ship

     During August 29-September 1, 1994, an outbreak of
gastrointestinal illness occurred on the cruise ship Viking
Serenade (Royal Caribbean Cruises, Ltd.) during its roundtrip
voyage from San Pedro, California, to Ensenada, Mexico. A total of
586 (37%) of 1589 passengers and 24 (4%) of 594 crew who completed
a survey questionnaire reported having diarrhea or vomiting during
the cruise. One death occurred in a 78-year-old man who was
hospitalized in Mexico with diarrhea. Shigella flexneri 2a has been
isolated from fecal specimens from at least 12 ill passengers.
Antimicrobial susceptibility testing of representative isolates
indicated resistance to tetracycline and susceptibility to
ampicillin and trimethoprim-sulfamethoxazole. The subsequent two
cruises of the ship were canceled. Investigation of the mode of
transmission is under way.
     Additional information is available from the Vessel Sanitation
Program, Special Programs Group, National Center for Environmental
Health, telephone [phone].

Reported by: Communicable Disease Control, Los Angeles County Dept
of Health Svcs; Div of Communicable Disease Control, California
Dept of Health Svcs. Foodborne and Diarrheal Diseases Br, Div of
Bacterial and Mycotic Diseases, National Center for Infectious
Diseases; Vessel Sanitation Program, Special Programs Group,
National Center for Environmental Health; Div of Field
Epidemiology, Epidemiology Program Office, CDC.

* This recommendation allows slightly higher doses of prilocaine
when body weight is measured in pounds rather than kilograms (8
mg/kg=3.6 mg/lb).



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

Date: Sun, 11 Sep 94 08:04:39 MST
From: mednews (HICNet Medical News)
To: hicnews
Subject: [MMWR] Uveitis Associated with Rifabutin Therapy
Message-ID: <[e-mail]>

        Uveitis Associated with Rifabutin Therapy

     In 1993, the Public Health Service Task Force recommended use
of Mycobutin* (rifabutin) at a daily dose of 300 mg for prophylaxis
for disseminated Mycobacterium avium complex (MAC) infection in
patients with human immunodeficiency virus (HIV) infection and less
than 100 CD4+ T-lymphocytes/uL (1). However, uveitis (an
inflammatory eye condition characterized by pain, redness, and
possible temporary or permanent loss of vision) has been associated
with rifabutin therapy.
     Uveitis has occurred among participants in several trials for
treatment and prophylaxis of MAC in which rifabutin was
administered at daily doses of 300-900 mg per day in combination
with other agents, particularly clarithromycin and/or fluconazole
[2-4; C. Benson, Rush-Presbyterian St. Luke's hospital, Chicago,
personal communication, 1994). Patients who developed uveitis have
had mild to severe symptoms that resolved after treatment with
corticosteroid and/or mydriatic eye drops; in some severe cases,
however, resolution of symptoms occurred after several weeks.
Uveitis occurred an average of 2-4 months after initiation of
treatment for MAC (2).
     Uveitis is rare when rifabutin is used as a single agent at
300 mg/day for prophylaxis of MAC in HIV-infected persons, even
with the concomitant use of fluconazole or macrolide antibiotics.
However, if higher doses of rifabutin are administered in
combination with these agents, clinicians should be alert to the
possibility of uveitis. Patients should be instructed to report
symptoms of uveitis (i.e., pain, redness, and loss of vision) to
their physician.
     For patients with uveitis, temporary discontinuation of
rifabutin and ophthalmologic evaluation are recommended. In most
mild cases, using rifabutin again is acceptable; however, if signs
or symptoms recur, use of rifabutin should be discontinued.
     Physicians are encouraged to report cases of uveitis to the
Food and Drug Administration's MedWatch Program, telephone (800)
332-1088 ([301] 738-7553).

Reported by: Div of Antiviral Drug Products, Center for Drug
Evaluation and Research, Food and Drug Administration, Rockville,
Maryland. Div of HIV/AIDS, National Center for Infectious Diseases,
CDC.

References
1. CDC. Recommendations on prophylaxis and therapy for disseminated
Mycobacterium avium complex for adults and adolescents infected
with human immunodeficiency virus. MMWR 1993;42(no. RR-9):14-20.
2. Shafran S, Deschenes J, Miller M, et al. Uveitis and
pseudojaundice during a regimen of clarithromycin, rifabutin, and
ethambutol. N Engl J Med 1994;330:438-9.
3. Trapnell CB, Narang PK, Li R, et al. Fluconazole increases
rifabutin absorption in HIV positive patients on stable zidovudine
therapy [Abstract no. PO B31-2212]. Vol 1. IX International
Conference on AIDS/HIV STD World Congress, Berlin, 1993.
4. Siegal F, Eilbott D, Burger H, et al. Dose-limiting toxicity of
rifabutin in AIDS-related complex: syndrome of
arthralgia/arthritis. AIDS 1990;4:433-41.



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

Date: Sun, 11 Sep 94 08:09:57 MST
From: mednews (HICNet Medical News)
To: hicnews
Subject: [FDA] Panel Recommends Studies for Breast Self-Exam Devices
Message-ID: <[e-mail]>

      PANEL RECOMMENDS STUDIES FOR BREAST SELF EXAM DEVICES
                     Sept. 1, 1994

     We are receiving inquiries about today's advisory committee
meeting on devices to aid in breast self examination.  The
following can be used to answer questions.
     FDA's Obstetrics and Gynecology Devices Advisory Panel
recommended that such devices be tested before they are allowed on
the market.  The panel, a group of outside experts, recommended
that laboratory and clinical studies be performed to address the
following questions:
     *  Does the device add benefit to a conventional breast self
examination?
     *  After using the device routinely for a long time, will a
woman be more likely or less likely to seek help if she finds an
abnormality?
     *  Could the device "mask"  breast lumps, making them more
difficult to detect?  If this were the case, it could delay a
woman's seeking medical attention.
     *  Could the device lead a woman to believe she has a breast
lump when in fact none exists?  If this were the case, it could
cause needless anxiety and lead to unnecessary testing, including
biopsies.
     The panel also stressed the need for clear labeling of the
device to be sure that women understand its proper use and
limitations.  They also recommended that groups of women be
involved in developing the labeling.



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

Date: Sun, 11 Sep 94 08:11:24 MST
From: mednews (HICNet Medical News)
To: hicnews
Subject: [FDA] The Doxylamine Dilemma
Message-ID: <[e-mail]>

                   The Doxylamine Dilemma

     In 1978, FDA approved a new drug application providing for OTC
marketing of doxylamine succinate for nighttime sleep-aid use.
     Subsequently, the National Cancer Institute found that
methapyrilene, an antihistamine similar to doxylamine, was a potent
cancer-causing agent in rats. As a result, methapyrilene was
removed from the market in 1979. This prompted FDA's National
Center for Toxicological Research to study doxylamine for
carcinogenicity and chronic toxicity.
     The scientists gave mice and rats variable doses of doxylamine
in their feed for two years and then examined their tissues.
     "We got the study results in 1991, and they were
inconclusive," says FDA microbiologist Katharine Freeman. "There
were no significant differences in survival in the treated or
nontreated rats or mice, and it was impossible to say if the
changes seen in some animals--like tumors and liver toxicity--were
species-specific, or if the findings were relevant to human use. We
were left with the problem of how to deal with such nebulous
findings."
     At FDA's request, the Pulmonary-Allergy Drugs Advisory
Committee evaluated the data and concluded doxylamine would not
likely cause cancer in humans. It recommended OTC status, but
suggested the rodent findings be included in the product labeling.
     Concerned about how to present the information in a way that
would be useful to consumers, FDA in 1993 asked its newly formed
Nonprescription Drugs Advisory Committee for recommendations about
doxylamine and its labeling.
     This committee agreed with the pulmonary-allergy panel that
doxylamine is unlikely to cause cancer in humans and is safe for
OTC use. It recommended, however, that there be no statement about
tumors in the labeling, but that FDA present the information in an
agency talk paper and FDA Consumer article. In January 1994, FDA
amended the monograph for OTC antihistamine drug products to
include doxylamine succinate.



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

Date: Sun, 11 Sep 94 08:13:10 MST
From: mednews (HICNet Medical News)
To: hicnews
Subject: [FDA] Electromagnetic Interference with Wheelchairs
Message-ID: <[e-mail]>

      ELECTROMAGNETIC INTERFERENCE WITH POWERED WHEELCHAIRS
                        August 26, 1994

     FDA is receiving inquiries about reports that electromagnetic
interference (EMI) can cause some power-driven wheelchairs and
scooters to move unexpectedly.  The following can be used to answer
questions.
     The agency has investigated this matter and determined that
EMI  can cause unexpected movement in some power-driven wheelchairs
when they are turned on.  Not all brands and models of power
wheelchairs and scooters have this problem.  Some have greater
immunity levels than others that may protect against EMI.
     Common sources of EMI include cellular phones, CB radios, TV
and radio stations, amateur (HAM) radios and police, fire and
ambulance radios.
     After receiving reports of problems, FDA  tested sample
wheelchairs and scooters in its laboratories and obtained
information from manufacturers and users about possible EMI-related
incidents.  As a result of its review, the agency last May asked
wheelchair manufacturers to take steps to protect powered
wheelchair users from the potential hazards of EMI.
     FDA required all firms to clearly label wheelchairs and
scooters with the immunity level, or else state that the immunity
level is not known.  It also required them to label wheelchairs and
scooters to warn users of the potential hazards of EMI.
     The agency also asked manufacturers to:
     *  Establish  a minimum recommended immunity level of 20 volts
per meter for all new motorized wheelchairs and scooters.  This
would provide a reasonable degree of protection against the more
common sources of EMI.
     *  Undertake an educational campaign to inform  users and
those who care for them about the risks of EMI and ways to avoid
it; and
     *  Solicit reports of possible EMI incidents and continue to
monitor the full scope of the problem.
     FDA  first learned of a possible problem with motorized
wheelchairs from a complaint in June 1992.  As a result, the agency
began testing sample wheelchairs in its laboratories.  Those tests,
on several brands of power-driven wheelchairs and scooters,
revealed that most -- but not all -- of those sampled were
susceptible to interference at various radio frequencies.  In some
tests, the brakes released.  In others, the wheels moved
uncontrollably.  Sometimes both occurred at once.  The extent to
which this happens in actual use is not known.
     In early 1993, FDA began inspecting facilities of all
domestic and foreign motorized wheelchair and scooter manufacturers
to gather information on the problem.  The agency  reviewed
warranty and complaint files and looked at any manufacturing
practices that could contribute to this type of problem.
     The inspections revealed numerous complaints about erratic,
unintentional wheelchair movement, sometimes resulting in injuries.
It is unclear, however,  exactly what caused the chairs to move in
those cases.   In addition to EMI, unexpected movement can be
caused by failure of an electronic component or by user error.
     In May 1993,  FDA sent letters to all U.S. manufacturers
asking them to provide any information they had about possible
problems with radio wave interference, including complaints,
reports of injuries and studies on power-driven wheelchairs.  In
July 1993, the agency alerted consumer groups that represent
wheelchair users about the possible problem and requested similar
information.
     An estimated 10,000 motorized wheelchairs and 50,000 motorized
scooters are sold annually in this country.



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

Date: Sun, 11 Sep 94 08:14:08 MST
From: mednews (HICNet Medical News)
To: hicnews
Subject: [FDA] The New Food Label: Scouting for Sodium related to Blood
Pressure
Message-ID: <[e-mail]>

                      The New Food Label
Scouting for Sodium and Other Nutrients Important to Blood Pressure
                       By Paula Kurtzweil

(This is the second in a series of articles telling how to use the
new food label to meet specific dietary needs.)

     For years, consumers watching their sodium intake have had to
plod through ingredient lists on many food labels like high school
students through a Shakespearean play. They had to read a lot of
unknown words and then do plenty of guessing.
     Aiming to get some idea of a food's sodium content, consumers
knowledgeable about sodium-restricted diets looked for names like
sodium caseinate, monosodium glutamate, trisodium phosphate, sodium
ascorbate, sodium bicarbonate, sodium stearoyl lactylate, and other
sodium-containing ingredients, including salt (sodium chloride).
     It wasn't easy, and it wasn't always accurate. Elizabeth Adams
of Churchton, Md., can vouch for that. She started to limit her
sodium intake 23 years ago. She recalled spending "a long time" in
grocery stores reading ingredient lists and looking for nutrition
information, which then was voluntary and, until recently, appeared
on only about 60 percent of food labels.
     "I got to the point where I didn't buy a food unless it had
only one ingredient or carried nutrition information," she said. "I
had no idea otherwise how much sodium the food had in it."
     Resorting to such measures will no longer be necessary for the
nearly 50 million Americans like Adams who suffer from hypertension
(high blood pressure) and the many others who want to reduce their
risk for it. The food label they depend on to help monitor their
sodium intake--and thus control their blood pressure--now must
state how much sodium a food contains per serving and how the food
fits in with their daily diet.

Label Changes
     These requirements are the result of the Nutrition Labeling
and Education Act of 1990 and regulations from the Food and Drug
Administration and the U.S. Department of Agriculture. Under these
regulations, consumers are seeing:
~    Nutrition information in bigger, more readable type on almost
all packaged foods. It appears in the table headed "Nutrition
Facts," which is usually on the side or back of the package.
Nutrition information also will be available in stores near many
fresh foods, like fruits and vegetables. (See "Nutrition Info
Available for Raw Fruits, Vegetables, and Fish" in the January-
February 1993 FDA Consumer.)
~    "% (percent) Daily Values," which tell consumers at a glance
the levels of important nutrients in a food and how those amounts
fit into a daily diet.
~    Serving sizes that closely reflect the amount people actually
eat.
~    Strictly defined nutrient-content claims, like "low-sodium,"
"salt-free," and "rich in potassium." This means that when
consumers see such claims, they can believe them. (See "A Little
'Lite' Reading" in the June 1993 FDA Consumer.)
 ~   Strict rules for using health claims, such as one that links
low-sodium diets to a reduced risk of high blood pressure. (See
"Starting This Month, Look for 'Legit' Health Claims on Foods" in
the May 1993 FDA Consumer.)

Sodium's Role
     Some of the information--particularly that pertaining to
sodium content--will be of special interest to people with high
blood pressure.
      Sodium has long been a major dietary factor in reducing the
risk of, and controlling, high blood pressure. (For more on
hypertension, see "High Blood Pressure: Controlling the Silent
Killer," in the December 1991 FDA Consumer.) This role was
reiterated as recently as January 1993 in the fifth report of the
Joint National Committee on Detection, Evaluation, and Treatment of
High Blood Pressure. The committee noted that numerous studies have
shown that reducing sodium intake can reduce blood pressure.
     What is a reduced sodium intake? According to Camille Brewer,
a registered dietitian and nutritionist in FDA's Office of Food
Labeling, therapeutic sodium-restricted diets can range from below
1,000 milligrams (mg) to 3,000 mg a day.
     "American adults, on average, eat too much sodium--between 4
to 6 grams (4,000 mg to 6,000 mg) daily," she said. "Most people
would benefit from moderately reducing their sodium intakes."
     Brewer advises people who are considering a sodium-restricted
diet to consult a physician, dietitian or nutritionist first.
     Under FDA's food labeling rules, the Daily Value for sodium is
2,400 mg. (Daily Values are a new label reference tool. See "'Daily
Values' Encourage Healthy Diet" in the May 1993 FDA Consumer.) FDA
established this value because it is consistent with
recommendations and government reports that encourage reduced
sodium intakes.
     Salt and other sodium compounds used in food processing are
the biggest contributors of sodium to most people's diets, Brewer
pointed out. (One teaspoon of salt has about 2,000 mg of sodium.)
These substances are used in food processing for preserving,
flavoring and stabilizing other ingredients, she said.
     "That's why the ingredient lists of canned, frozen, and other
processed foods often contain the names of so many sodium
compounds," she said.
     Also, kosher beef, lamb and chicken have salt added.
     Sodium also is present naturally in some foods, such as milk,
cheese, meat, fish, and some vegetables.

Weight Reduction
     Label information about fat, calories and fiber also will be
important for people with high blood pressure who are overweight.
These are the nutrients of most concern to those trying to lose
weight or control it. (See "Making It Easier to Shed Pounds" in the
July~August 1994 FDA Consumer.)
     Body weight, like sodium intake, often closely correlates with
blood pressure: As weight goes up, blood pressure frequently  does,
too. If weight is reduced, blood pressure often goes down.

Other Nutrients
     Hypertensives also may be interested in label information
about potassium, calcium and magnesium. According to the Joint
National Committee's report, evidence suggests that these nutrients
may play a role in reducing the risk of high blood pressure. For
this reason, nutrition experts often encourage people with
hypertension to increase their intakes of these nutrients.
     Information about a food's potassium and magnesium content is
required on the Nutrition Facts panel only if the food contains
added potassium or magnesium as a nutrient or if claims about those
nutrients appear on the label. In all other cases, it is voluntary.
When listed, potassium must appear below sodium on the Nutrition
Facts panel, and magnesium must be shown in the list of vitamins
and minerals.
     The Daily Value for potassium is 3,500 mg. For magnesium, it's
400 mg.
     Information about calcium is mandatory. It, too, appears in
the list of vitamins and minerals. The Daily Value for calcium is
1 gram (g), or 1,000 mg.

%Daily Values
     The place to begin is the "%Daily Value" column under
Nutrition Facts. This column contains numbers that show whether a
food is high or low in the nutrients listed. For people with high
blood pressure, the %Daily Value for sodium is especially
important.
      If the %Daily Value for sodium is 5 or less, the food is
considered low in that nutrient. So, the goal should be to select,
as much as possible, foods that have a %Daily Value for sodium of
5 or less. The goal for the full day's diet should be to select
foods that together add up to no more than 100 percent of the Daily
Value for sodium.
     People with high blood pressure also may want to check the
%Daily Values for fat, fiber, calcium, and, if listed, potassium
and magnesium. The goal for the full day's diet should be to select
foods that together add up to no more than 100 percent of the Daily
Value for fat and at least 100 percent for fiber and calcium.

Serving Size
     Serving size information is important, too. It tells the
amount of the food, stated in both common household and metric
measures, to which all other numbers apply.
     Under the new regulations, serving sizes are designed to
reflect the actual amounts that most people eat, although they are
not necessarily the amounts recommended by various health groups.
     Also, the serving size must be about the same for like
products--for example, different brands of potato chips--and for
similar products within a category of foods--for example, potato
chips, pretzels, and popcorn within the category "snacks." This
makes it easier to compare the nutritional qualities of related
foods.

Other Information
     The Nutrition Facts panel also gives the amount in milligrams
of a food's sodium content. This information can help consumers who
monitor the milligrams of sodium they consume.
     The %Daily Values for other nutrients are helpful, too,
because they can help consumers determine how nutritious a food is
overall. Whether the %Daily Values are for nutrients most people
should limit--for example, saturated fat and cholesterol--or eat
more of--for example, total carbohydrate, fiber, vitamin A, and
calcium--the %Daily Values tell at a glance how the food compares
nutritionally to others.

Food Label Claims
     On some food packages, claims describing the food's
nutritional benefits may appear. Often, they will show up on the
front of the package where shoppers can readily see them.
     Nutrient claims--like "sodium-free," "salt-free," and "very
low sodium"--describe desirable levels of nutrients in the food.
(See "Nutrient Claim Guide.")
     Relative nutrient claims compare a product to the "regular"
version of the food or to a similar food. For example, a "reduced-
sodium" claim on the label of canned spaghetti sauce means the food
has at least 25 percent less sodium than regular canned spaghetti
sauce. A claim of "light in sodium" on canned spaghetti sauce means
the sodium has been reduced by at least 50 percent.
     Other claims simply show that a food is high or low in a
nutrient, without any particular comparisons to other products. For
example, "low-sodium" means the food has 140 mg or less per
serving. "Very low sodium" means it has 35 mg or less per serving.
     Also, health claims may be made about the relationship between
a nutrient or food and a disease or health-related condition. Only
those health claims authorized by FDA may appear because they're
the only ones supported by substantial scientific evidence.
     The claim that diets low in sodium may reduce the risk of high
blood pressure is an authorized claim. This claim can appear only
on products that meet the definition of "low-sodium" and that
provide 20 percent or less of the Daily Value for fat, saturated
fat and cholesterol per serving. FDA incorporated this requirement
so that low-sodium foods would not be counterproductive by being
high in other components that contribute to heart disease.
     Whatever the source--health claims, nutrient claims, or the
Nutrition Facts panel--consumers, especially those restricting
their sodium intake, will find that the new food label puts an end
to the guessing games they may have played before. Instead, they'll
see that the label gives them more complete, accurate information
to help them make more healthful food choices. n

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

Special Report
     In-depth but easy-to-understand information about the new food
label is provided in an FDA Consumer special report, Focus on Food
Labeling. Copies cost $5 each. To order, write to: Superintendent
of Documents, P.O. Box 371954, Pittsburgh, PA 15250-7954. Ask for
stock number S/N 017-012-00360-5.

Nutrient Claim Guide
Sodium
Sodium-free: less than 5 milligrams (mg) per serving
Very low sodium: 35 mg or less per serving or, if the serving is 30
grams (g) or less or 2 tablespoons or less, 35 mg or less per 50 g
of the food
Low-sodium: 140 mg or less per serving or, if the serving is 30 g
or less or 2 tablespoons or less, 140 mg or less per 50 g of the
food
Light in sodium: at least 50 percent less sodium per serving than
average reference amount for same food with no sodium reduction
Lightly salted: at least 50 percent less sodium per serving than
reference amount. (If the food is not "low in sodium," the
statement "not a low-sodium food" must appear on the same panel as
the "Nutrition Facts" panel.)
Reduced or less sodium: at least 25 percent less per serving than
reference food.

Salt (Sodium Chloride)
Salt-free: sodium-free (see above definition)
Unsalted, without added salt, no salt added:
~    no salt added during processing, and
~    the food it resembles and for which it substitutes is normally
processed with salt
(If the food is not "sodium free," the statement "not a sodium-free
food" or "not for control of sodium in the diet" must appear on the
same panel as the Nutrition Facts panel.)

Potassium
High-potassium: 700 mg or more per serving
Good source of potassium: 350 mg to 665 mg per serving
More or added potassium: at least 350 mg more per serving than
reference food

Calcium
High-calcium: 200 mg or more per serving
Good source of calcium: 100 mg to 190 mg per serving
More or added calcium: at least 100 mg more per serving than
reference food

(For weight-reduction claims, see "Making It Easier to Shed Pounds"
in the July-August 1994 FDA Consumer.)

Alternatives to High-Sodium Foods
     If you find yourself continually eating more than 100 percent of
the Daily Value for sodium each day, consider these lower sodium
alternatives. For labeled items, check the %Daily Value for sodium; try
to select foods that provide 5 percent or less per serving.

Instead of:                        Eat:
smoked, cured, salted, and canned  unsalted fresh or frozen beef,
meat, fish and poultry             lamb, pork, fish, and poultry

regular hard and processed         low-sodium cheese, low-sodium
cheese, regular peanut butter      peanut butter

crackers with salted tops          unsalted crackers

regular canned and dehydrated      low-sodium canned soups,
soups, broths and bouillons        broths and bouillons

regular canned vegetables          fresh and frozen vegetables and
                                   low-sodium canned vegetables

salted snack foods                 unsalted tortilla chips, pretzels,
                                   potato chips, and popcorn




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

Date: Sun, 11 Sep 94 08:15:16 MST
From: mednews (HICNet Medical News)
To: hicnews
Subject: [FDA] Approves Test for Prostate Cancer
Message-ID: <[e-mail]>

              FDA APPROVES TEST FOR PROSTATE CANCER
                        Aug. 29, 1994

     The Food and Drug Administration today approved the first
blood test to help detect prostate cancer in men 50 and older.  The
test, a prostate specific-antigen (PSA) blood test, was approved
for use in conjunction with a digital rectal exam.
     The PSA test was initially approved by FDA in 1986 to aid in
the care of patients who already had been diagnosed with prostate
cancer.  Today's approval expands the use to include helping to
diagnose the disease.
     The PSA test by itself cannot be relied on to determine
whether a man has prostate cancer.  It must be used in conjunction
with other diagnostic procedures, including the digital rectal
exam.  The final diagnosis requires a biopsy.
     "This test--used with other procedures--can help detect those
men at risk for prostate cancer early on when more treatment
options are available," said FDA Commissioner David A. Kessler,
M.D.  "But for the test to help, men must be aware of the
importance of early check ups and get them on a regular basis."
     FDA's approval of the test--the Tandem PSA Assay made by
Hybritech Corp. of San Diego--is based on a review of clinical
studies on safety and effectiveness submitted by the manufacturer
and on the recommendation of FDA's Immunology Devices Panel.  The
tests were done in conjunction with a digital rectal exam.
     The firm's studies of more than 6,300 men showed that PSA
testing when combined with a rectal exam was more effective in
detecting prostate cancer than either a rectal test or PSA test
alone.
     While high levels of PSA may signal prostate cancer, they may
also signal other common, non-cancerous prostate disorders.
Conversely, low PSA levels do not necessarily indicate an absence
of prostate cancer.  Therefore, it is important that the PSA test
be interpreted with results from other established procedures such
as a digital rectal exam.  If either test is positive, confirmatory
testing with transrectal ultrasound and biopsy is needed to
diagnose prostate cancer.
     Prostate cancer is the second most common cancer in men in the
United States, after skin cancer.  The prostate gland, which
produces seminal fluid, is about the size of a walnut and is
located below the bladder and in front of the rectum.
     Most cases of prostate cancer occur in men 65 or older, with
the risk increasing with age.  Approximately 13 percent of American
men will be diagnosed with the disease during their lifetimes, but
most cases never become life threatening.
     Many questions still remain in the medical community about how
best to treat prostate cancer.  To help answer these and other
questions, the National Cancer Institute is currently sponsoring a
long-term screening study of 37,000 men, ages 60 to 74.



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

Date: Sun, 11 Sep 94 08:16:04 MST
From: mednews (HICNet Medical News)
To: hicnews
Subject: [FDA] OTC Options - Help for the Sleepless
Message-ID: <[e-mail]>

            OTC Options - Help for the Sleepless
                     By Marian Segal

     When your head hits the pillow but your body refuses to sleep,
lying in the dark counting sheep just might induce tossing and
turning instead of heavy eyelids.
     Often, simple remedies can solve the problem of an occasional
restless night. For some people, just a few minutes' reading or
television gazing will lull the mind to sleep. Others coax slumber
by taking a warm bath or light snack just before bedtime. Over-the-
counter (OTC) nighttime sleep-aids, regulated by the Food and Drug
Administration, are another option.
     According to a 1993 report to Congress by the National
Commission on Sleep Disorders Research, "frequent or chronic
insomnia, estimated to affect more than 60 million Americans--about
one of every three adults--is a severe problem for approximately
half of those individuals."
     Insomnia lasting just a few days--what the American Sleep
Disorders Association (ASDA) calls "transient insomnia"--is a
common aftermath of stress or excitement. It's not unusual to lose
one or two days' sleep worrying about a spat with a spouse or a
report due at work. Good things sometimes keep people awake, too,
like an exciting sports event or anticipation of the start of a
vacation.
     "Short-term insomnia"--lasting two or three weeks--may result
from ongoing stress. A job setback, illness, or death of a loved
one can upset normal sleep habits for a while. If unresolved,
"chronic insomnia"--defined by the ASDA as "poor sleep every night,
most nights, or several nights a month"--may ensue.
     There are a lot of questions about sleep that scientists can't
answer--why it's necessary, what its purpose is, how it's
regulated, or what the brain does during sleep. But you don't have
to be a scientist to recognize the effects of going without sleep.
Anyone who has slept poorly for a few nights running knows that's
the reason they are tired and irritable, and have trouble
concentrating and staying alert.
     Chronic insomnia can have more serious consequences. In a
March 24, 1993, commentary in the Journal of the American Medical
Association, sleep expert William C. Dement, M.D., Ph.D., notes
that drowsiness is blamed for some 200,000 to 400,000 automobile
accidents a year, accounting for almost half of all accident-
related deaths in the United States.
     The commission's report to Congress links sleep deprivation to
increased psychosocial problems and illness and death, and to
diminished productivity and performance. It names fatigue and
drowsiness as contributors to accidents in hospitals, military
operations, and the nuclear industry, and to major air, rail, road,
and sea transportation disasters. The Challenger space shuttle
explosion, the Exxon Valdez grounding, and the collision of two
Conrail freight trains resulting in four deaths and $6 million
dollars in damages are among several catastrophes cited.
     So, while researchers want to learn more about sleep for  many
reasons, we plain folk who lie awake nights simply want to know how
we can get more of it.

Professional or Self-Help?
     People with chronic insomnia should see a doctor for
treatment, which may include short-term use of prescription
sleeping pills. Poor sleep for extended periods may be a symptom of
an underlying disorder, such as depression, sleep apnea (repeated
interruptions of breathing during sleep), pain from arthritis or
other illness, or a neurological disease.
     But if all that's needed is a little help to overcome a
restless night or two, a do-it-yourself approach is sensible.
Experts have come up with many useful tips to help people fall
asleep and develop and maintain good sleeping habits (see "Tricks
for the Tired").
     Used appropriately, OTC and prescription sleep-aids also can
help provide sounder sleep, the ASDA advises. The association
cautions, however, that for some types of insomnia, such as that
caused by breathing disorders, the products may be dangerous.
     "Before taking any OTC drug product, you should read the label
for directions on how and when to use it, and whether you should
check with a doctor before taking it," says FDA regulatory review
pharmacist Michael Benson. "Antihistamines are the ingredients in
OTC nighttime sleep-aids that make you nod off, and some contain
other ingredients, like an analgesic for pain," he says.
     FDA allows three antihistamines--diphenhydramine hydrochloride
(HCl), diphenhydramine citrate, and doxylamine succinate--to be
used as the active ingredient in OTC nighttime sleep-aids.
     In the early 1970s, FDA began a review of OTC drug products.
Manufacturers were requested to submit data on the safety and
effectiveness of the active ingredients for their intended uses.
Expert panels on various classes of drug products were convened to
review the data and make recommendations to the agency.
     In 1978, FDA approved a new drug application providing for OTC
marketing of doxylamine succinate for nighttime sleep-aid use. In
1982, the agency authorized the initial marketing of
diphenhydramine HCl and diphenhydramine citrate for this use. These
two drugs were the only ones included in the agency's final
monograph on OTC nighttime sleep-aids, issued in 1989. After the
monograph's publication, products containing active ingredients
other than doxylamine succinate, diphenhydramine HCl, or
diphenhydramine citrate had to be reformulated or taken off the
market.

Read the Label
     Consumers can find out what ingredients are in an OTC drug
product by reading the label. Unisom contains doxylamine succinate,
for example, while Nytol contains diphenhydramine HCl. Some
products, such as Sominex Pain Relief Formula and Bufferin AF Nite
Time contain an analgesic for pain relief as well as an
antihistamine. You may find that one works better for you than
another. Because of the different product ingredients, the label
warnings and directions for use vary.
     Most OTC sleep-aid product labels caution patients with
certain conditions to check with a doctor before taking the
product. Such conditions include shortness of breath, asthma,
emphysema, chronic pulmonary disease, glaucoma, and difficulty
urinating due to enlarged prostate gland. The labels also warn
against taking the product along with alcohol or other central
nervous system depressants, such as sedatives or tranquilizers,
because they heighten the depressant effect.
     (Recently approved revisions in wording will appear on all
labels by April 11, 1995: The words "breathing problems" will be
used to describe shortness of breath and difficulty breathing
related to obstructive pulmonary disease; "chronic bronchitis" will
replace "chronic pulmonary disease"; and the word "asthma" will be
removed. These changes will help consumers recognize respiratory
distress symptoms more readily.)
     Sleep-aids that contain aspirin must carry a warning to
consult a doctor about Reye syndrome before giving the product to
children and teenagers who have chickenpox or flu symptoms. Reye
syndrome is a rare but serious disease that has been associated
with use of aspirin in children with these conditions. This warning
may also appear on products containing other salicylates. These
drugs should not be given to children under 12, and they should not
be used for more than two weeks unless under a doctor's direction.
Pregnant and nursing women should check with a doctor before taking
these products.
     OTC nighttime sleep-aids can provide welcome relief from a
night of wide-eyed wakefulness. OTC status does not, however,
guarantee the product is hazard-free. Just like prescription drugs,
OTC drug products must be used with care.
     "The bottom line for all OTC drug products," says FDA's
Benson, "is to read the label and follow the instructions."
     (For more on insomnia, see "Why Aren't You Asleep Yet? A
Bedtime Story" in the October 1989 FDA Consumer. Also, write to the
American Sleep Disorders Association, 1610 14th St., N.W.,
Rochester, MN 55901.)



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

Date: Sun, 11 Sep 94 08:17:10 MST
From: mednews (HICNet Medical News)
To: hicnews
Subject: [FDA] Tricks for the Tired
Message-ID: <[e-mail]>

                   Tricks for the Tired

     If you're having trouble sleeping, you may want to try
modifying some behaviors that might be keeping you awake. The
American Sleep Disorders Association suggests one or more of the
following practices might help:
~    Get up about the same time every day, regardless of when you
go to bed.
~    Go to bed only when sleepy.
~    Establish relaxing pre-sleep rituals, such as a warm bath,
light bedtime snack, reading, or watching television.
~    Exercise regularly. Get vigorous exercise--such as jogging or
squash--in the late afternoon, and mild exercise--such as simple
stretching or walking--two or three hours before bedtime.
~    Don't eat or drink caffeine-containing products within six
hours of bedtime. It's better not to smoke at all, but if you do,
avoid smoking at bedtime. Caffeine and nicotine are both
stimulants. Even if they don't interfere with falling asleep, they
may trigger awakenings later.
~    Don't drink alcoholic beverages at bedtime. A nightcap may
induce sleep, but it can interfere with sound sleep through the
night.
~    Don't nap, unless you find that naps don't interfere with
sleep later on.
~    If you often worry at bedtime, reserve another time of day for
working on problems.
~    If you can't sleep, get out of bed and go to another room to
read or watch television.
     You may want to try sleep restriction. This strategy is based
on the finding that many insomniacs spend excessive time in bed,
hoping to make up for lost sleep.
     Go to bed later than usual, and get up at the same time each
morning. Stay in bed only as long as you actually sleep, even if
it's only a few hours. When you sleep at least 90 percent of your
allotted time in bed for five days in a row, go to bed 15 minutes
earlier. After a week or two you should be sleeping better and,
after a few months, as long as you want.
     While you can try this on a do-it-yourself basis, ASDA says,
it is generally more easily done under the supervision of a sleep
specialist.



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

Date: Sun, 11 Sep 94 08:18:05 MST
From: mednews (HICNet Medical News)
To: hicnews
Subject: [FDA] Safeguarding Human Tissue Transplants
Message-ID: <[e-mail]>

              Safeguarding Human Tissue Transplants
                        by John Henkel

     For millions of Americans, human tissue transplants represent
a modern miracle.
     These bits of donated eye, skeleton, skin, muscle, sperm, and
other reusable body tissues can restore sight or repair injured
knees and ankles. They can help mend a burn victim or renew a
cancer patient's lost bone. They can even replace a failing heart
valve or allow an infertile couple to have children.
     But like blood and other body fluids, these living materials
also can transmit disease--including HIV (the virus that causes
AIDS) and two types of viral hepatitis. Concern over this potential
is fueling increased FDA oversight of the human tissue industry,
which provides products for an estimated 300,000 transplants a year
in the United States.
     FDA and industry experts say the chance of actually passing
disease through transplants appears small. They emphasize that
patients should not decline a needed transplant for fear of
acquiring a disease. Industry organizations, they say, have made
notable efforts to oversee tissue bank products.

Industry Checks Itself
     For years, without extensive federal controls, large segments
of the domestic human-tissue industry have self-regulated the
quality and commerce of products through voluntary compliance with
industry standards. For example, trade groups such as the American
Association of Tissue Banks (AATB) and the Eye Bank Association of
America (EBAA) sponsor voluntary accreditation programs requiring
periodic inspections and adherence to standards.
     FDA estimates that more than 100 of the 150 to 200 U.S. tissue
banks are accredited by AATB or are undergoing accreditation. Of
EBAA's member banks, which are responsible for providing tens of
thousands of corneas annually, 95 percent are accredited. The
American Fertility Society accredits some reproductive tissue
banks. The American Red Cross, a major supplier of human tissue,
uses AATB guidelines. In addition, five states--California,
Florida, Georgia, Maryland, and New York--require licensing of
tissue bank facilities.
     In May, the national Centers for Disease Control and
Prevention published new guidelines for preventing HIV transmission
in tissue and organ transplants. CDC~s guidance now includes
detailed instructions concerning issues such as donor screening and
testing, donor exclusion criteria, inactivation of infectious
organisms, and recall of tissues found to be contaminated.
     Since 1985, U.S. doctors have performed 1 million tissue
transplant operations, according to CDC estimates. In all these
cases, only two tissue donors are known to have transmitted AIDS to
recipients. (Other diseases, such as hepatitis and rabies, have
been transmitted through transplants, though the incidence is
extremely low.)
     Both AIDS transmission cases occurred in the mid-1980s, during
the early days of the AIDS epidemic, when tests for the virus were
less sophisticated.
     One incident involved transfer of a small amount of bone
tissue from an HIV-positive donor, which infected a recipient. The
other  episode came to light three years ago. A reputable Virginia
tissue bank, LifeNet Transplant Services, had stored 61 organs and
tissue grafts taken from a man in 1985 after he died of gunshot
wounds. Before removing organs and tissue, the bank twice analyzed
the donor's blood for infectious disease. In both instances the
blood tested negative. But in 1991, through retrospective analysis
using more refined methods, the tissue bank discovered that the
donor's blood tested positive for HIV.
     The bank immediately set out to find and test recipients. Due
to poor record keeping by hospitals and practitioners, LifeNet
could locate only 34 of more than 40 patients who received the
infected organs or tissue. Seven of these persons are known to have
contracted the AIDS virus, and three have died.

FDA Tightens Controls
     Concerns that disease transmission, though rare, can occur,
coupled with new information gleaned from an FDA investigation into
imported human tissue, have prompted FDA to impose controls on
tissue banking and has set the stage for possible congressional
action. In December 1993, FDA imposed interim rules that make most
banked human tissue--including bone, ligaments, tendons, fascia
(muscle-enclosure tissue), cartilage, corneas, and skin--subject to
some of the same kinds of scrutiny for infectious agents now
applied to the nation's blood supply.
     The rules do not cover transplants of organs such as the heart
and liver, which are managed under separate programs in the federal
Health Care Financing Administration and Health Resources and
Services Administration. Other tissue products fall under existing
regulations and are exempt from the new rules. For example, bone
marrow transplants are managed by the National Institutes of
Health. Dura mater (brain membrane material), heart valve
allografts, and corneal lenticules are regulated by FDA under the
Medical Device Amendments of 1976.

Sperm and Ova
     Reproductive tissues, primarily sperm and ova, are presently
not regulated by the federal government and are exempt from FDA's
interim rules. Though this industry has some degree of self
regulation and state monitoring, it is not without its problems.
     Last October, Congress heard testimony from New York state
officials explaining that until the state tightened standards in
1989, many of New York's sperm banks had been based in physician's
offices and often used fresh semen from untested donors. The
officials identified other problems, such as employees' lack of
technical expertise in infectious disease testing and inadequate
screening of donors who designate a semen recipient. The state had
also found a case in which two semen bank operators were using only
themselves as donors but leading recipients to believe that the
bank had stored semen from more than a dozen donors.
     While emphasizing the potential of passing infectious disease
through reproductive tissue, FDA officials also point out the
possibility of transmitting inherited diseases. Based on these
concerns, Congress is now considering legislation that would give
FDA regulatory oversight of sperm and ova banks and make these
facilities accountable to rigid standards. Meanwhile, FDA cautions
persons who intend to use donated reproductive tissue to discuss
with their doctors the screening and testing standards under which
the tissue was collected and insist on documentation.

Tissue Brokers
     FDA put its new regulatory controls (see accompanying article)
into action last February when it ordered an El Paso, Texas,
tissue-processing firm to retain or destroy stored tissue and
recall previously distributed tissue from about 180 donors. The
agency determined that the firm, AlloTech, which imported tissue
from Eastern Europe, lacked adequate documentation of medical
history screening and disease testing for the tissue. There was no
evidence that AlloTech's donors carried any of the target diseases,
but FDA saw the firm's shortcomings as a potential hazard.
     AlloTech had dealt with "tissue brokers" marketing donor
cadavers from former Soviet bloc countries. FDA's concern was that
certain brokers could not produce original records of donor
screening or donor consent.
     In a 1993 investigation of imported tissue brokers, FDA found
no proof of disease transmission from any of these products.
Further, the agency points out that some tissue banks may import
human tissue legitimately with the proper documentation.
     In its investigation, FDA collected revealing evidence about
the credibility of some tissue brokers. FDA investigators placed an
order for cadavers after contacting two brokers representing
interests in former Soviet bloc countries. One broker, claiming the
bodies tested disease-free, gave investigators four vials of blood
taken from the cadavers. FDA analyzed the samples and found that
one tested positive for the hepatitis B virus.
     At the time, no federal regulatory provisions existed that
would allow FDA to take direct action. Now, under the agency's
interim rules, FDA can crack down on noncompliant brokers. An
"import alert," put in place last December, requires any tissue
importer to notify FDA before bringing foreign tissue into the
country.
     Acknowledging that importing potentially tainted tissue is
"something that has happened," Jim Weixel, spokesman for the AATB,
says, "it's not really a big problem in this country. The amount of
tissue that comes in from overseas, as far as we know, is very
small compared with that recovered domestically." He adds, however,
that because reporting was never required, "nobody really has
accurate statistics" on tissue importation.

Legislation Introduced
     Over the last several years, Sen. Paul Simon (D-Ill.) and Rep.
Ron Wyden (D-Ore.) have examined safe and effective use of human
tissue transplants. Wyden, key sponsor of a tissue-regulation bill
in the House of Representatives, has spoken out about other
problems with tissue banking besides disease transfer and imported
products. In congressional testimony last October, he called for a
halt to "practices that damage tissue and render it useless."
     For example, he cited "over-freezing for preservation" and
"zapping them with too many gamma rays to irradiate disease" as
tissue-banking "practices that must be stopped." Also, he said,
"there must be further scrutiny of sterilization methods currently
in use which leave cancer-causing residues."
     Further, he pointed out disparities in training levels of
persons who collect, process and store tissues. He called for
uniform training standards that would be required of all banks. On
Nov. 19, 1993, both Wyden and Simon introduced similar tissue-
banking legislation. At press time, both bills still were pending.
     FDA's interim rules are designed as a "temporary measure"
until FDA "can complete its evaluation of whether additional
regulations are necessary," says Steven Falter, director of FDA's
division of bioresearch monitoring and regulation. FDA has provided
technical advice to congressional officials on bills introduced by
Wyden and Simon. Among other things, Falter says, legislation would
require tissue banks to register with FDA. This would put to rest
lingering questions about just how many U.S. tissue banks exist.
With no previous federal oversight of tissue facilities and only
sporadic state supervision of tissue banks, such numbers have been
impossible to produce accurately.
     Other provisions in the bills involve labeling all banked
tissue and requiring that strict written procedures be followed in
tissue recovery, processing, storage, and distribution. A law
regulating tissue products has widespread support in the tissue-
banking industry. AATB assisted Wyden and Simon in formulating
their bills, each of which contained elements already part of
AATB's standards and accreditation program. Likewise, EBAA
advocates "well-drafted legislation." In congressional testimony,
Ellen Heck of the eye-bank trade group said, "The legislation must
take care to seek out and not delay in applying regulation to those
[tissue banks] most likely to linger undetected and, therefore,
unregulated and noncompliant." The American Red Cross agreed that
enforceable federal standards are needed.

Who Will Pay the Bills?
     FDA, Congress and industry agree on one critical aspect about
pending legislation: Regulating human tissues requires resources.
As Kathryn Zoon, Ph.D., director of FDA's Center for Biologics
Evaluation and Research, says, "It will do little good to enact a
statute or launch a [tissue-regulation] program without the
resources to establish the program and sustain the program over
time."
     Where will these funds come from? Key players in the
legislation are brainstorming possibilities. One is to levy user
fees on the tissue-banking industry. Such a program, says Zoon,
"would provide real value to the tissue-banking community in terms
of public credibility and a level playing field, and it is fair to
ask that community to bear the cost." But she warns that user-fee
costs would likely be passed on to consumers. Legislation, she
says, should be "thoroughly examined" for its impact on health-care
reform.
     Industry sources express mixed feelings about user fees. The
AATB, says spokesman Weixel, would likely support such fees,
provided they were fair and "dedicated to accomplishing regulation,
not to underwriting budget difficulties." He says user fees
probably could not fund an entire regulation program, only parts
such as tissue-bank registration and some inspections. Other
resources, such as federal seed money or a value-added tax on
transplants, might be needed to finance compliance, research, and
other critical elements, Weixel adds.
     Though officials are wrestling with how to fund legislation,
many express confidence that the issue will be resolved. "As a
society," says FDA's Zoon, "we must balance the benefits that would
clearly accrue from allocating resources to tissue regulation
against using the resources to address other issues."
     Until further measures take shape, FDA is relying on the
interim rule to safeguard tissue transplants. For the moment, says
FDA Commissioner David A. Kessler, M.D., the rule "will ensure that
the public is protected, and protected well." n

John Henkel is a staff writer for FDA Consumer.

FDA's Interim Rules
     Tissue banks covered under FDA's interim rules now must test
blood specimens from all donors using laboratories regulated under
the Clinical Laboratories Improvement Act of 1988. Blood samples
must test negative for antibodies to HIV (types 1 and 2), hepatitis
B surface antigen, and antibodies to hepatitis C virus.
     Some of the other interim rule conditions provide for:
~    Screening--Tissue banks are required to obtain a medical
history for each donor to help rule out risk factors.
~    Record keeping--Banks must keep written or electronic records
for 10 years that document donor testing and screening. All banked
tissue must be either quarantined or accompanied by proper records.
~    Inspections--FDA can inspect tissue-banking facilities to
ensure compliance with the new rules.
~    Recall--FDA may order the recall or destruction of any tissue
not meeting interim-rule requirements.



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

End of HICNet Medical News Digest V07 Issue #43
***********************************************


---
Editor, HICNet Medical Newsletter
Internet: [e-mail]                 FAX: [phone]
Bitnet  : ATW1H@ASUACAD