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HICNet Medical News Digest      Mon, 29 Jan 1996        Volume 09 : Issue 07

Today's Topics:

  Treating and Preventing Venomous Bites
  News About Breast Implants
  Interstitial Cysititis: Progress Against Bladder Condx
  Guarding Against Glaucoma

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Date: Wed, 24 Jan 1996 11:26:19 -0700
From: David Dodell <david@dental.stat.com>
To: hicnews
Subject: Treating and Preventing Venomous Bites
Message-Id: <1.5.4b11.16.19960124182619.1e7fe27e@dental.stat.com>

* FDA Consumer Magazine:  Treating and Preventing Venomous Bites

by John Henkel

They fascinate. They repel.

Some pose a danger. Others are harmless.

And whether they are seen as slimy creatures or colorful curiosities,
snakes play important environmental roles in the fragile ecosystems of
the nation's wildlife areas.

People who frequent these wilderness spots, as well as those who camp,
hike, picnic, or live in snake-inhabited areas, should be aware of
potential dangers posed by venomous snakes. Every state but Maine,
Alaska and Hawaii is home to at least one of 20 domestic poisonous
snake species. A bite from one of these, in which the snake may inject
varying degrees of toxic venom, should always be considered a medical
emergency, says the American Red Cross.

About 8,000 people a year receive venomous bites in the United States;
nine to 15 victims die. Some experts say that because victims can't
always positively identify a snake, they should seek prompt care for
any bite, though they may think the snake is nonpoisonous. Even a bite
from a so-called "harmless" snake can cause an infection or allergic
reaction in some people.

Medical professionals sometimes disagree about the best way to manage
poisonous snakebites. Some physicians hold off on immediate treatment,
opting for observation of the patient to gauge a bite's seriousness.
Procedures such as fasciotomy, a surgical treatment of tissue around
the bite, have some supporters. But most often, doctors turn to the
antidote to snake venom--antivenin--as a reliable treatment for serious
snakebites.

Antivenin is derived from antibodies created in a horse's blood serum
when the animal is injected with snake venom. In humans, antivenin is
administered either through the veins or injected into muscle and works
by neutralizing snake venom that has entered the body. Because
antivenin is obtained from horses, snakebite victims sensitive to horse
products must be carefully managed. The danger is that they could
develop an adverse reaction or even a potentially fatal allergic
condition called anaphylactic shock.

The Food and Drug Administration regulates antivenins as part of its
oversight of biological products. The agency requires certain criteria
to be met before these materials are sold, including standards for
purification, packaging and potency. FDA also regulates antivenin
labeling, ensuring that data on potential side effects and other
pertinent information are available. The agency also periodically
inspects antivenin production facilities to ensure compliance with
regulations.

Types of Poisonous Snakes

Two families of venomous snakes are native to the United States. The
vast majority are pit vipers, of the family Crotalidae, which include
rattlesnakes, copperheads and cottonmouths (water moccasins). Pit
vipers get their common name from a small "pit" between the eye and
nostril that allows the snake to sense prey at night. They deliver
venom through two fangs the snake can retract at rest but can spring
into biting position rapidly. About 99 percent of the venomous bites in
this country are from pit vipers. Some--Mojave rattlesnakes or
canebrake rattlesnakes, for example--carry a neurotoxic venom that can
affect the brain or spinal cord. Copperheads, on the other hand, have a
milder and less dangerous venom that sometimes may not require
antivenin treatment.

The other family of domestic poisonous snakes is Elapidae, which
includes two species of coral snakes found chiefly in the Southern
states. Related to the much more dangerous Asian cobras and kraits,
coral snakes have small mouths and short teeth, which give them a less
efficient venom delivery than pit vipers.  People bitten by coral
snakes lack the characteristic fang marks of pit vipers, sometimes
making the bite hard to detect.

Though coral snakebites are rare in the United States--only about 25 a
year by some estimates--the snake's neurotoxic venom can be dangerous.
A 1987 study in the Journal of the American Medical Association
examined 39 victims of coral snakebites. There were no deaths, but
several victims experienced respiratory paralysis, one of the hazards
of neurotoxic venom.

Some nonpoisonous snakes, such as the scarlet king snake, mimic the
bright red, yellow and black coloration of the coral snake. This
potential for confusion underscores the importance of seeking care for
any snakebite (unless positive identification of a nonpoisonous snake
can be made).

The bites of both pit vipers and coral snakes can be effectively
treated with antivenin. But other factors, such as time elapsed since
being bitten and care taken before arriving at the hospital, also are
critical (see accompanying article).

First Aid for Snakebites

Over the years, snakebite victims have been exposed to all kinds of
slicing, freezing and squeezing as stopgap measures before receiving
medical care. Some of these approaches, like cutting into a bite and
attempting to suck out the venom, have largely fallen out of favor.

"In the past five or 10 years, there's been a backing off in first aid
from really invasive things like making incisions," says Arizona
physician David Hardy, M.D., who studies snakebite epidemiology. "This
is because we now know these things can do harm and we don't know if
they really change the outcome."

Many health-care professionals embrace just a few basic first-aid
techniques.  According to the American Red Cross, these steps should be
taken:

   * Wash the bite with soap and water.
   * Immobilize the bitten area and keep it lower than the heart.
   * Get medical help.

"The main thing is to get to a hospital and don't delay," says Hardy.
"Most bites don't occur in real isolated situations, so it is feasible
to get prompt [medical care]." He describes cases in Arizona where
people have caught rattlesnakes for sport and gotten bitten. "They
waited until they couldn't stand the pain anymore and finally went to
the hospital after the venom had been in there a few hours. But by
then, they'd lost an opportunity for [effective treatment]," which
increased the odds of long-term complications.  Some medical
professionals, along with the American Red Cross, cautiously recommend
two other measures:

   * If a victim is unable to reach medical care within 30 minutes, a
     bandage, wrapped two to four inches above the bite, may help slow
     venom.  The bandage should not cut off blood flow from a vein or
     artery. A good rule of thumb is to make the band loose enough that
     a finger can slip under it.

   * A suction device may be placed over the bite to help draw venom
     out of the wound without making cuts. Suction instruments often
     are included in commercial snakebite kits.

Treatment Drawbacks

Antivenins have been in use for decades and are the only effective
treatment for some bites. "Antivenins have a fairly good safety
record," says Don Tankersley, deputy director of FDA's division of
hematology. "There are sometimes reactions to them, even
life-threatening reactions, but then you're treating a life-threatening
situation. It's clearly a case of weighing the risks versus the
benefits."

People previously treated with antivenin for snakebites probably will
develop a lifelong sensitivity to horse products. To identify these and
other sensitive patients, hospitals typically obtain a record of the
victim's experience with snakebites or horse products. But some people
with no history of such exposures may have become sensitive through
contact with horses, or possibly exposure to horse dander, and not know
they are sensitive. Others may be sensitive without any known or
remembered contact with horses. So hospitals also perform a skin test
that quickly shows any sensitivity. Some hypersensitive patients may
even react severely to the small amount of antivenin used in the skin
test.  Hospitals have procedures for reviving patients with serious
reactions. Some victims with positive skin tests can be desensitized by
gradually administering small amounts of antivenin.

Newer kinds of antivenins derived from sheep are under study now and
show some promise, according to FDA officials. But progress has been
slow due to low demand and the small number of venomous bites a year.

Certain venomous snakebites may be treated without using antivenin.
This is usually a judgment call the doctor makes based on the snake's
size and other factors, which normally involves close monitoring of
patients in a medical facility.

"In some areas, such as desert areas, most rattlesnakes are small and
don't have as potent a venom," says Edward L. Hall, M.D., a
Thomasville, Ga., trauma surgeon who treats snakebites. "You might get
by with those patients in not using antivenin." But with other snakes,
Hall says, antivenin can be a lifesaver. For example, the Eastern
diamondback rattlesnake--found in large quantities in the region of
Georgia where Hall practices medicine and in other Southern states from
the Carolinas to Louisiana--can reach six feet in length and deliver a
potent payload of venom. "It's an enormously dangerous bite that
requires very aggressive treatment [with antivenin] or the patient will
die," Hall says.

Treatment Dilemmas

Because not all snakebites, including those from the same species, are
equally dangerous, doctors sometimes face a dilemma over whether or not
to administer antivenin. Venomous snakes, even dangerous ones like the
Eastern diamondback, don't always release venom when they bite. Other
snakes may release too small an amount to pose a hazard.

Hall says his experience in Georgia bears this out. "Some 20 to 30
percent of patients we see who have been bitten by a snake, who
actually have fang marks, have not received any venom at all." He says
one reason for this may be poor timing by the snake. "Pit vipers have a
very sophisticated mechanism that allows them to deliver venom at the
exact instant the teeth are sunk into the flesh. So it has to be
precise timing. But what we often see is that the [snake's timing is
off and] venom is squirted on the pants leg or released prematurely."

Another complicating factor is the diverse potency of venom. "Venom can
vary within species and even within litter mates--brothers and
sisters," says Arizona physician Hardy. For example, he says, a common
pit viper in the Southwest, the Mojave rattlesnake, may carry a
powerful neurotoxic venom in some areas and a less toxic one in
others.

Hall's work in Georgia and Florida shows that factors such as genetic
differences among snakes, their age, nutritional status, and the time
of year also can affect venom potency. All these variables make it
nearly impossible for doctors to characterize a "typical" venomous
snakebite. That's why there exists what Hall calls "so much
controversy" about snakebite treatment.

The solution, Hall says, lies with the patient. "Truly the only way to
look at snakebites is on an individual basis and on the patient's
actual reaction to the venom." Basic signs like pain, swelling and
bleeding, along with more complicated reactions such as ecchymosis
(purple discoloration), necrosis (tissue dies and turns black), low
blood pressure, and tingling of lips and tongue give medical
professionals clues to the seriousness of bites and what treatment
route they should take.

Some experts emphasize that though antivenin can effectively reverse
the effects of venom and save life and limb, there is no guarantee that
it can reverse damage already done, such as necrosis. Some patients may
later require skin grafts or other treatment. Arizona physician Hardy
says the potential for limiting complications is one compelling reason
to seek medical treatment as soon as possible after a snakebite.

Avoiding Snakebites

Some bites, such as those inflicted when snakes are accidentally
stepped on or encountered in wilderness settings, are nearly impossible
to prevent. But experts say a few precautions can lower the risk of
being bitten:

   * Leave snakes alone. Many people are bitten because they try to
     kill a snake or get a closer look at it.

   * Stay out of tall grass unless you wear thick leather boots, and
     remain on hiking paths as much as possible.

   * Keep hands and feet out of areas you can't see. Don't pick up
     rocks or firewood unless you are out of a snake's striking
     distance. (A snake can strike half its length, Hardy says.)

   * Be cautious and alert when climbing rocks.

What do you do if you encounter a snake when hiking or picnicking? Says
Hardy:  "Just walk around the snake, giving it a little berth--six feet
is plenty. But leave it alone and don't try to catch it."

Though poisonous snakes can be dangerous, snake venom may have a
positive side.  Clinical trials are presently under way to test the
therapeutic value of a venom-derived product called ancrod in treating
stroke. Earlier proposals, using snake venom to treat neuromuscular
disorders such as multiple sclerosis, never reached the clinical trial
stage.

John Henkel is a staff writer for FDA Consumer.

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

                          How NOT to Treat a Snakebite

Though U.S. medical professionals may not agree on every aspect of what
to do for snakebite first aid, they are nearly unanimous in their views
of what not to do. Among their recommendations:

   * No ice or any other type of cooling on the bite. Research has
     shown this to be potentially harmful.

   * No tourniquets. This cuts blood flow completely and may result in
     loss of the affected limb.

   * No electric shock. This method is under study and has yet to be
     proven effective. It could harm the victim.

   * No incisions in the wound. Such measures have not been proven
     useful and may cause further injury.

Arizona physician David Hardy, M.D., says part of the problem when
someone is bitten is the element of surprise. "People often aren't
trained in what to do, and they are in a panic situation." He adds that
preparation--which includes knowing in advance how to get to the
nearest hospital--could greatly reduce anxiety and lead to more
effective care.

-------------------------------------------------------------------------------
FDA Consumer magazine (November 1995)
---
Internet : david@dental.stat.com
Telephone: +1-602-860-1121
FAX      : +1-602-451-1165
Web      : http://www.stat.com/~david


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

Date: Wed, 24 Jan 1996 11:24:05 -0700
From: David Dodell <david@dental.stat.com>
To: hicnews
Subject: News About Breast Implants
Message-Id: <1.5.4b11.16.19960124182405.1e7f7176@dental.stat.com>

* FDA Consumer Magazine:  News About Breast Implants

by Marian Segal

Recently published studies have shown that women with silicone
gel-filled breast implants do not have a greatly increased risk of some
well-defined autoimmune diseases, which were among the serious health
concerns surrounding the devices. These include potentially fatal
connective tissue diseases such as scleroderma and lupus
erythematosus.

Widespread reports of adverse reactions to silicone gel-filled implants
and a lack of evidence supporting their safety led the Food and Drug
Administration to order the devices off the market in April 1992. They
remained available only to women in clinical studies, mostly women
seeking breast reconstruction after breast cancer surgery. (See
"Silicone Breast Implants: Available Under Tight Controls" in the June
1992 FDA Consumer.) Saline-filled implants were allowed to remain on
the market for all uses.

The new studies do not, however, rule out the possibility that a subset
of women with implants may have a small increased risk of these
conditions, or that some women might develop other immune-related
symptoms that don't conform to "classic" disease descriptions.

Nor did the studies address other important safety questions, including
implant rupture rates and the incidence of capsular contracture
(shrinking of scar tissue around the implant, which can cause painful
hardening of the breast or distort its appearance). Answers to these
and other questions await the results of new or ongoing studies.

Reasons for New Studies

Breast implants had been marketed since the early 1960s--several years
before the first medical device law was enacted in 1976, charging FDA
with regulation of medical devices. Every year, thousands of American
women had had implant surgery for augmentation (to enlarge or reshape
their breasts) or for reconstruction following mastectomy (removal of
the breast) to treat breast cancer. Most of the implants consisted of a
rubber silicone envelope filled with silicone gel; about 10 percent
were filled with saline (salt water).

[Image]  Silicone gel-filled breast implants (a 94K JPEG file) [Image]
Saline-filled breast implants (a 74K JPEG file)

Under the 1976 law, implants and many other devices already in use were
allowed to remain on the market, with the understanding that the agency
would at some time ask manufacturers to submit scientific data showing
these "grandfathered" products were safe and effective.

FDA requested this information for silicone gel-filled implants in
April 1991 in response to a growing number of adverse reaction reports
that raised safety concerns about the devices. The data submitted did
not prove the devices safe, as required by law, so the agency
restricted their use to clinical trials designed to resolve the safety
questions.

Between Jan. 1, 1985, and March 16, 1995, FDA received 91,322 adverse
reaction reports associated with silicone breast implants and 19,296
reports involving the saline implants. These reports included risks
clearly associated with the devices, as well as adverse effects
attributed to the implants, but not proved to be linked to them. (See
accompanying articles, "Known Risks of Breast Implants" and "Possible
Risks of Breast Implants.")

Silicone Implant Studies

Some recent studies comparing the rates of immune-related diseases in
women with implants versus those without implants have provided
reassurance that women with implants are not at a greatly increased
risk of these disorders.

The largest of these retrospective, or "look-back," studies is the
Harvard Nurses' Health Study. The study used data from 87,501 nurses
followed for other research purposes from 1976 through May 31, 1990,
before there was widespread media coverage of the possible association
between breast implants and connective tissue disease. None of the
women had connective tissue disease at the start of the study.

In an article published in the June 22, 1995, New England Journal of
Medicine, the researchers reported that 516 of the nurses had developed
definite connective tissue diseases. Women with breast implants
numbered 1,183. The types of implants included 876 silicone gel-filled,
170 saline-filled, 67 double lumen (silicone gel-filled implants with a
saline-filled outer envelope), 14 polyurethane-coated, and 56 of
unknown type. Only three of the 516 women with definite connective
tissue disease had implants (one silicone-gel filled, one saline, and
one double lumen).

The authors reported they "did not find an association between silicone
breast implants and connective tissue disease, defined according to a
variety of standardized criteria, or signs and symptoms of these
diseases."

Similarly, a 1994 study conducted at the Mayo Clinic found no increased
risk of connective tissue diseases among implant recipients. The
investigators based their conclusion on comparison of the medical
histories of 749 women with breast implants in Olmsted County, Minn.,
with a similar group of women who did not have implants.

"Because of the limitations in the size and type of the studies,
however, the true risk of these diseases is not known," says S. Lori
Brown, Ph.D., a research scientist officer in the epidemiology branch
of the agency's Center for Devices and Radiological Health. "Although
the criteria others may be using to assess those studies show that some
concerns are eliminated," Brown says, "unfortunately, they don't rule
out a small, but significant, increased risk."

An immunology and epidemiology expert, Brown explains that an inherent
problem in the studies is that some connective tissue diseases are
extremely rare. "If you have a disease that has an incidence of 1 in
100,000 in the general population, for example, and you do a study of
750 women with implants, like the Mayo Clinic Study, then you wouldn't
really expect to see even a single case of that disease," she says,
"unless there's an exceedingly high--more than a hundredfold--increase
in risk."

Small studies like these can rule out huge risks, but not smaller, yet
significant risk increases that would only show up in studies that
include several thousand women with implants, Brown says. Nor do the
studies fully examine or answer whether the implants might in some
women lead to symptoms not typical of classical disease
manifestations.

Other Concerns

Brown also stresses that connective tissue diseases are not the only
issue of concern, especially since they may affect a much smaller
proportion of women with implants. The larger issue, she says, is the
local complications that are clearly related to breast implants, such
as rupture and migration of the silicone gel, capsular contracture, and
infection.

"Of the two groups of women who consider getting implants--for breast
reconstruction or for augmentation," Brown says, "the larger group
wants them for cosmetic purposes. These are healthy women who may go
out and get implants without a clear picture of what the possible risks
are. They may end up going back in for surgery time and again and never
be happy with the cosmetic effect."

In testimony before a congressional subcommittee in August 1995, FDA
Commissioner David A. Kessler, M.D., stated that "Published studies to
date suggest a rupture rate between 5 and 51 percent--an enormous
range--and unfortunately, we do not know with any confidence where
within that range the real rupture rate lies." He also cited two
studies that indicate the risk of rupture increases as the implants
age.

Another concern--increased risk of breast cancer--has not been borne
out by studies. "Several studies have indicated there is no increased
risk of breast cancer in women with implants," Brown says. However, she
adds, these women are not yet in the age group that is more prone to
breast cancer, and it remains to be seen whether they will eventually
have a higher incidence of breast cancer than women without implants.
Long-term studies to look at this are under way.

Manufacturers' Studies

The events that led to removal of silicone implants from the market
made it clear that prospective, or forward-looking, studies were also
needed to answer important safety questions. Implant manufacturers
agreed to conduct human trials in three phases: urgent need, adjunct,
and core studies.

"The purpose of the first phase [urgent need] actually was simply to
quickly provide implants to women who were already in the process of
getting them for breast reconstruction or for another medical reason,
and to bridge the time until the adjunct studies were begun," says
Sahar M. Dawisha, M.D., a rheumatologist and medical officer who joined
FDA's division of general and restorative devices in April 1993.

The women did, however, have to sign an informed consent form that
summarized the risks and benefits of the implants. This form had not
previously been required.

"The second phase, or adjunct, studies were intended to follow
reconstruction patients for five years to assess short-term safety
data, including rates of capsular contracture, rupture, and
complications such as infection and hematoma [collection of blood that
may cause swelling, pain and bruising]," Dawisha says. "These studies
are open to all women wanting breast reconstruction with implants
because of mastectomy, traumatic injury to the breast, or a disease or
congenital disorder causing a severe breast abnormality. They do not
include augmentation patients."

Mentor Corporation of Santa Barbara, Calif., began adjunct studies in
1992.  According to Pamela Powell of the company's Clinical Programs
Department, as of July 5, 1995, 12,125 patients were enrolled in the
studies.

The third phase, or core studies, Dawisha says, were intended to
determine the full safety and effectiveness profile of the device,
including rupture rates, quality-of-life benefits, extent of
interference with mammography, and many more safety concerns--including
rheumatologic assessments--that would need a large number of women.
They were also to include augmentation patients. The sponsors, however,
have not initiated these studies.

Saline Implants

Although many of the local complications of gel-filled implants are
also associated with saline implants, the latter were permitted to
remain on the market unrestricted for both reconstruction and
augmentation. FDA considers saline-filled implants less risky, because
although they have the same silicone rubber envelope as gel-filled
implants, leakage or rupture would release only salt water, not
silicone gel, into the body.

Nevertheless, FDA is requiring manufacturers to collect data on the
saline implants as well, because the incidence of known risks (for
example, deflation and capsular contracture) is not well defined. When
the Medical Device Amendments were passed, it was determined that these
devices would also eventually require premarket approval. In January
1993, FDA notified saline implant manufacturers that they would have to
submit safety and effectiveness data for their products. In December
1994, the agency told them what type of safety and effectiveness data
were needed, and delineated objectives and time frames for the trials.
Saline implants will stay on the market while the studies are
conducted, but the companies must report the laboratory, animal and
clinical data in stages, and must provide written information on the
known and possible risks of their products.

"Women considering saline implants should ask their doctor for a copy
of the manufacturer's information sheet, a copy of the product insert
sheet for the specific implant to be used, and a copy of the hospital
informed consent form," says Barbara Stellar, FDA's breast implant
information and outreach coordinator.

Stellar recommends women be given these documents at least a month
before surgery is planned, if possible, so they can thoroughly discuss
benefits and possible risks with surgeons, radiologists, and other
women. These women should also ask their physicians about participating
in the saline breast implant trials.

Brown hopes that further studies will more clearly define risks
associated with all types of implants.

"We need to be able to tell women considering breast implants--whether
for augmentation or reconstruction--the specific risks on which they
can base their decision," she says. "It should be made clear that
implants do not last forever, that they may break, and in what time
period it is thought they might break. Most women have no idea implants
break and there's very little information about rupture rates.

"The same is true for other complications, some of which may require
further surgery or may cause the woman to be displeased with the
cosmetic effect, which, of course, is the reason she got them," Brown
says. "For a product that a person is putting in her body presumably
for 20 years or more, we should have this information."

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

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

                         Known Risks of Breast Implants

Signing a consent form is now part of the procedure for all women
undergoing breast implant surgery. They must also be given information
about the devices' known and possible risks.
Surgical Risks

   * possible complications of general anesthesia, as well as nausea,
     vomiting and fever

   * infection

   * hematoma (collection of blood that may cause swelling, pain and
     bruising, perhaps requiring surgical draining)

   * hemorrhage (abnormal bleeding)

   * thrombosis (abnormal clotting)


   * skin necrosis--skin tissue death resulting from insufficient blood
     flow to the skin. The chance of skin necrosis may be increased by
     radiation treatments, cortisone-like drugs, an implant too large
     for the available space, or smoking.


Implant Risks

   * capsular contracture (hardening of the breast due to scar tissue)

   * leak or rupture--silicone implants may leak or rupture slowly,
     releasing silicone gel into surrounding tissue; saline implants
     may rupture suddenly and deflate, usually requiring immediate
     removal or replacement

   * temporary or permanent change or loss of sensation in the nipple
     or breast tissue

   * formation of calcium deposits in surrounding tissue, possibly
     causing pain and hardening

   * shifting from the original placement, giving the breast an
     unnatural look

   * interference with mammography readings, possibly delaying breast
     cancer detection by "hiding" a suspicious lesion. Also, it may be
     difficult to distinguish calcium deposits formed in the scar
     tissue from a tumor when interpreting the mammogram. When making
     an appointment for a mammogram, the woman should tell the
     scheduler she has implants to make sure qualified personnel are
     on-site. At the time of the mammogram she should also remind the
     technician she has implants before the procedure is done, so the
     technician can use special techniques to obtain the best mammogram
     and to avoid rupturing the implant.

--M.S.

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

                       Possible Risks of Breast Implants

   * Autoimmune-like disorders--signs include joint pain and swelling;
     skin tightness, redness or swelling; swelling of hands and feet;
     rash; swollen glands or lymph nodes; unusual fatigue; general
     aching; greater chance of getting colds, viruses and flu; unusual
     hair loss; memory problems; headaches; muscle weakness or burning;
     nausea or vomiting; and irritable bowel syndrome.

     Recent studies have shown, however, that there is not a large
     increased risk of traditional autoimmune, or connective tissue
     disease, from silicone gel implants.

   * Fibrositis/fibromyalgia-like disorders (pain, tenderness and
     stiffness of muscles, tendons and ligaments).

--M.S.

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

                          Polyurethane-Coated Implants

About 110,000 women have silicone gel-filled implants with a
polyurethane coating, intended to reduce the risk of capsular
contracture. In April 1991, an FDA analysis showed that polyurethane
foam could break down under human body conditions to form a chemical
called TDA, which can cause cancer in animals. As a result, the
manufacturer immediately stopped selling the product.

Recently, however, a study to measure TDA in women with polyurethane
implants found that a woman's risk of cancer from exposure to TDA
released by the implant is negligible--about one in a million over a
lifetime. FDA considers it unlikely that even one woman would develop
cancer from these implants. The study supports the agency's original
recommendation that women who are not having problems should not have
the implants removed solely because of concern about cancer from TDA
exposure.

--M.S.

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

                                Immunology Tests

Several laboratories are offering tests that claim to detect levels of
antibodies to silicone that presumably indicate a leaking or ruptured
implant.

FDA has not cleared or approved these tests for such purposes, and the
agency has sent letters to several companies, warning of future
regulatory action if they continue to promote the devices without a
premarket approval application.

"There are important unresolved issues with these tests," says Peter
Maxim, Ph.D., chief of the Center for Devices and Radiological Health's
immunology branch of the division of clinical laboratory devices. "For
one thing, the very existence of silicone antibodies has not been
proven to the satisfaction of all scientists," he says. "Secondly, if
antibodies are detected, is there in fact a correlation with the
presence or the status of implants, or do they reflect prior
environmental exposure? Silicone is in a myriad of products, including
foods, medicines, and antiperspirants absorbed by the skin, to name a
few."

The next problem, Maxim says, is that there are claims that extremely
high antibody levels may indicate a leaking or ruptured implant. This,
then, raises the question of what medical intervention, if any, should
be taken.

Sahar M. Dawisha, M.D., a rheumatologist in FDA's division of general
and restorative devices, adds that no one really knows what the
clinical significance of an antibody to silicone means or at what level
it is harmful.

"Furthermore," she says, "in autoimmune or connective tissue
disease--where antibody tests are generally used--the presence of
antibodies doesn't define the disease. A disease is defined by clinical
signs and symptoms, and antibodies are used as supporting evidence."

Finally, John Nagle, consumer safety officer in the Center for Devices
and Radiological Health's diagnostic devices branch, says, "The tests
themselves may be harmless, but they sure are expensive, somewhere
between $500 and $1,000," adding that "a lot of them are being done for
litigation purposes rather than to help the patient medically."

--M.S.

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

                               Information Packet

To obtain a comprehensive packet of information on breast implant
issues, request FDA's publication, "Breast Implants, An Information
Update," by calling the agency's breast implant information line at
(1-800) 532-4440.


FDA Consumer magazine (November 1995)
---
Internet : david@dental.stat.com
Telephone: +1-602-860-1121
FAX      : +1-602-451-1165
Web      : http://www.stat.com/~david


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

Date: Wed, 24 Jan 1996 11:05:28 -0700
From: David Dodell <david@dental.stat.com>
To: hicnews
Subject: Interstitial Cysititis: Progress Against Bladder Condx
Message-Id: <1.5.4b11.16.19960124180528.1baf3386@dental.stat.com>

* FDA Consumer Magazine:  Interstitial Cystitis
                          Progress Against Disabling Bladder Condition

by Evelyn Zamula

The woman knew she was going to be fired from her job. Since her 20s,
this insurance firm middle manager has suffered from interstitial
cystitis (IC), an inflammatory disease of the bladder wall.

The chief symptoms Marsha (not her real name) has are a smaller than
normal bladder capacity, urgent and frequent urination, feelings of
pressure and pain around the bladder and in the pelvic area, and
painful sexual intercourse. Now 46 years old, she has coped with these
symptoms fairly well until recently, when they have worsened. On some
days, Marsha is in such agony that she can barely walk.

Though sympathetic at first, Marsha's supervisor became impatient with
her frequent bouts of pain and trips to the bathroom, as well as time
lost from sick days and doctor's appointments, even though she's made
up every minute.  When she started to miss policy meetings, Marsha
began to get indications that she would be fired. Her boss would
comment that she couldn't know what was going on because, "You aren't
always here."

Finally, when Marsha needed to urinate every 20 minutes at work and 10
times during the night, leaving her exhausted and depressed in the
morning, she became so fearful of being asked to leave that she decided
to retire on disability instead. She hopes to return to her job when
she feels better, but so far it hasn't been possible.

Marsha counts herself among the more fortunate of IC sufferers because
she receives long-term disability benefits and has both Medicare and
private medical insurance. Also, unlike many other women, whose
marriages and relationships are put under severe stress by IC, Marsha
is lucky to have a supportive husband.

Cause Elusive

No one knows what causes IC. It wasn't recognized as a disorder until
about 20 years ago. In 1978, the Food and Drug Administration approved
Rimso-50, a purified form of the industrial solvent dimethyl sulfoxide
(DMSO), for symptomatic relief of IC. Before that, many patients were
neither diagnosed nor treated.

Because physicians could find no organic cause, the prevailing medical
opinion was that IC was a "hysterical female condition," even though at
least 10 percent of cases are in men. Even Campbell's Urology, the
definitive text of urologic diseases, stated as late as 1986 that IC
was "daunting in its evasion of being understood. [It] may represent
the end stage of a bladder that has been made irritable by emotional
disturbance." The book further states that interstitial cystitis may be
a pathway for the discharge of unconscious hatreds.

People with IC have had to put up with this type of disbelief for a
long time.  Kristene E. Whitmore, M.D., chairwoman of the Department of
Urology, Philadelphia Graduate Hospital, Philadelphia, Pa., says, "The
average number of doctors seen before diagnosis is five, and it takes
three to five years to get that diagnosis."

When the columnist Ann Landers wrote about IC in 1987, she received
10,000 letters from patients or their families, relieved that the
condition was finally being recognized. A 1987 study conducted by the
Urban Institute in Washington, D.C., found that IC makes people so
miserable that they contemplate suicide four times more often than the
general population and that they rate their quality of life lower than
those who undergo kidney dialysis. Nearly 30 percent of IC patients
can't work full-time, according to the study.

Although no bacteria or fungi or viruses are found in patients' urine,
many researchers believe it's possible that IC is caused by an
infectious agent that hasn't yet been identified.

Researchers have also suggested it may be an autoimmune disorder of the
bladder's connective tissue, in which the body's defense mechanisms
against invading bacteria turn suddenly against healthy tissue. In some
patients, special white blood cells called mast cells, which are
associated with inflammation, are found within the bladder's mucous
lining. Or, some scientists theorize that the disorder may be an
allergic reaction, because many patients have a history of allergies.

Some women go into remission during pregnancy, while others get worse,
suggesting that in some patients hormones may be involved. Complicating
the picture, many women with IC also suffer from a variety of other
conditions, such as irritable bowel syndrome, migraine headaches,
fibromyalgia (chronic aching of the muscles, joints, and connective
tissues), low back pain, and similar disorders.

One theory in favor at present holds that the inner lining of the
bladder (the glycosaminoglycan or GAG layer) that protects the bladder
wall from toxic effects of urine may be "leaky," allowing substances in
the urine to penetrate the bladder wall and trigger IC symptoms. A
California study found that 70 percent of IC patients they examined had
a "leaky" bladder lining.

More likely, any or all of these factors may exist, leading many
researchers to conclude that IC is a syndrome, or a collection of signs
and symptoms, rather than a specific disease. Others, such as Whitmore,
believe it's more than one disease and is different in every person.

Making a Diagnosis

Although there is no test that identifies IC, urologists rely on
several criteria to make a diagnosis:

   * Frequent and urgent urination, and pelvic or bladder pain,
   especially as the bladder is filling.

   * Pinpoint hemorrhages that can often be seen on the bladder wall
   during cystoscopy (an examination of the bladder's interior with a
   long, lighted tube, performed under anesthesia). This is called
   nonulcerative IC, seen in about 95 percent of patients.


   * Cracks, scars, and star-shaped sores called Hunner's ulcers that
   are found in the bladder wall in ulcerative IC. Bladder capacity is
   decreased because the usually elastic bladder walls become stiff and
   don't expand normally.

Because it's easier to define IC by what it isn't than by what it is, a
diagnosis must rule out bacterial cystitis--the most common urinary
tract infection--whose symptoms it most closely resembles. Bladder
cancer, kidney stones, vaginitis, endometriosis, sexually transmitted
diseases, and tuberculous and radiation cystitis, as well as prostate
infections in men, are some other conditions that must be considered.
Thus, interstitial cystitis becomes a diagnosis of exclusion.

Although about 10 times more women than men get IC, it's possible that
men have been underdiagnosed. "We haven't been real sensitive in
screening our prostatitis patients, so maybe more men have IC than we
think," says Whitmore.

Symptoms usually begin between 20 and 50 years of age, but the average
age of onset is 40. Some cases have been diagnosed in children. About
450,000 people in the United States are believed to have IC, but true
numbers are hard to come by, because many cases are either undiagnosed
or misdiagnosed. Although occasionally more than one member of a family
has IC, the disorder is not believed to have a genetic component.

Treating the Condition

There is no cure for IC. All doctors can do is try to relieve the
symptoms, a challenging task, because they vary from person to person.
People may have flare-ups and remissions, and different patients
respond to different treatments. A particular type of therapy may work
for a while and then lose its effectiveness. Sometimes, stress or a
change of diet triggers symptoms.  Occasionally, IC goes into remission
spontaneously.

Paradoxically, the cystoscopy used to diagnose IC also seems to make
some people feel better. To enable the doctor to look inside the
bladder with the cystoscope, the bladder is filled with water. This
bladder distention helps about 30 percent of patients, at least for the
short term, probably because the bladder is stretched and capacity is
increased. It's also possible that the procedure may interfere with the
transmission of pain signals by nerves in the bladder. The fact that IC
can only be diagnosed by cystoscopy under anesthesia explains why many
cases are overlooked even by urologists.

In a similar procedure, Rimso-50 is instilled directly into the bladder
by a catheter. The solution is retained in the bladder for about 15
minutes before being expelled by spontaneous voiding. This treatment is
given every two weeks until maximum symptomatic relief is obtained,
then repeated as needed.

For some patients, Rimso-50 treatments become less effective over time.
About 50 percent of patients experience significant pain relief for an
average of about 10 months. The drug works by penetrating the bladder
wall to reduce inflammation and acts as a muscle relaxant by preventing
muscle contractions that cause pain, frequency and urgency.

Disadvantages of Rimso-50 include a garlic-like odor on the skin and
breath that may last up to 72 hours. Some patients may develop a
chemical cystitis after use of the drug that goes away within one or
two days. Patients taking Rimso-50 also require a blood test every six
months to make sure the blood count and liver and kidney function are
normal. Periodic ophthalmologic examinations are also recommended.

"You have to customize therapy for the person," says Whitmore, who
advocates a number of untraditional therapies, many of which have not
been reviewed by FDA for this purpose. They include acid-restricted
diets, alkalization of urine, bladder holding and retraining (delaying
voiding for increasingly longer intervals), biofeedback and electric
stimulation, acupuncture, muscle relaxants, antidepressants,
anti-inflammatories, antihistamines and analgesics, and an experimental
bladder "wash" consisting of an anesthetic, an antibiotic, an
anticoagulant, and hydrocortisone.

From 40 to 60 percent of IC patients may benefit from low doses of the
tricyclic antidepressant amitriptyline (Elavil and others), according
to Vicki Ratner, M.D., and colleagues in the Journal of Women's Health,
Vol. 1, No. 1, 1992. Physicians prescribe it not only to treat the
depression that is common in IC patients, but to take advantage of its
bladder-relaxing, allergy-fighting, pain-blocking, and sedating
properties.

When pain is severe, some people may benefit from transcutaneous
electrical nerve stimulation (TENS). Mild electrical impulses delivered
to the body through wires placed on the lower back or abdomen or
through devices implanted in the body may alter nerve transmissions to
the bladder and help trigger release of pain-blocking hormones.

A bland diet helps some IC people. Doctors recommend avoiding high-acid
foods, such as citrus fruits, that may irritate the bladder, or spicy
foods that may cause the release of histamine. Restricting alcoholic
beverages, carbonated sodas, coffee and other caffeinated products, and
beverages and foods with artificial sweeteners appears to reduce
symptoms in some people.

Surgery is an option when all else fails. Some urologists may remove
the diseased portion of the bladder and attach a piece of the patient's
bowel to the remaining healthy tissue to make a larger bladder. In
other cases, the bladder is completely removed and urine is rerouted to
a bag outside the body or a pouch inside the abdomen. However, about
half of patients don't get pain relief from this procedure.

"I don't take the bladder out unless I've used all the tricks up my
sleeve," says Whitmore. "When patients have bladders the size of a
walnut or smaller, or when they have intractable pain, then they're
candidates for cystectomy [bladder removal]. The operation has allowed
some people to get out of the house and have a life."

Whitmore tells her patients that, as with all disorders of chronic
pain, there is going to be a certain amount of anger, anxiety and
depression. "I say to them, 'I have an 85 percent chance or greater to
make you better, but I can't teach you how to cope with your illness,
so you've got to get some help.' I encourage them to go for
self-hypnosis, self-relaxation, and other coping techniques, or to seek
therapy with psychologists or psychiatrists. I tell them, 'if you can't
cope, you're not going to get better.'"

Researchers funded by the federal government, drug companies, and the
Interstitial Cystitis Association have stepped up their efforts to find
out more about the disorder. Philip Hanno, M.D., chairman, Department
of Urology, Temple University School of Medicine, Philadelphia, Pa.,
expects that in the next decade, treatment for IC will be more
beneficial than the therapy available now. He believes that ultimately
there will be a cure for most cases of this painful and disabling
condition.

Evelyn Zamula is a freelance writer in Potomac, Md.

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

                                  IC Symptoms

The symptoms of interstitial cystitis are similar to those of a urinary
tract infection. Most people have some of the following symptoms:

   * urgent need for frequent urination both day and night

   * reduced bladder capacity

   * feelings of pressure, pain and tenderness around the bladder,
   pelvis and genital area, which may increase as the bladder fills and
   decrease as it empties.

   * painful sexual intercourse

   * in men, discomfort or pain in the prostatic area.

--E.Z.

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

                                 For More Info

More information about interstitial cystitis is available from:

Interstitial Cystitis Association
P.O. Box 1553
Madison Square Station
New York, NY 10159
(1-800) 422-1626

American Foundation for Urologic Disease, Inc.
300 West Pratt St.
Suite 401
Baltimore, MD 21201
(1-800) 242-2383
---
Internet : david@dental.stat.com
Telephone: +1-602-860-1121
FAX      : +1-602-451-1165
Web      : http://www.stat.com/~david


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

Date: Wed, 24 Jan 1996 11:06:26 -0700
From: David Dodell <david@dental.stat.com>
To: hicnews
Subject: Guarding Against Glaucoma
Message-Id: <1.5.4b11.16.19960124180626.1bafd844@dental.stat.com>

* FDA Consumer Magazine:  Guarding Against Glaucoma

by S.J. Ackerman

An outstanding scholar still in his 30s, John felt his "sight getting
weak and dull"--occupational eyestrain, he supposed. Soon his left eye
dimmed, starting from the left side. Then his right eye failed,
"perceptibly and gradually over three years." By age 43, he was totally
blind.

That was in 1652. John Milton triumphed over blindness, still serving
the British foreign office and writing literary classics like "Paradise
Lost." Yet he never ceased lamenting "how my light is spent/Ere half my
days, in this dark world and wide."

What relegated him to seeing "a universal blank" was probably
open-angle glaucoma, which today needlessly blinds 80,000 Americans
each year. It causes another 900,000 to lose some vision. Yet now we
have means Milton lacked to thwart "the sneak thief of sight" with a
number of treatments approved by the Food and Drug Administration.

Glaucomas are a group of diseases sharing certain features, commonly
including high intraocular pressure (IOP), damaged optic nerves, and
loss of peripheral vision. Early detection can contain two glaucomas:
chronic (sometimes called common) and acute.

Primary open-angle glaucoma (chronic glaucoma) affects mostly adults
over age 35. This most prevalent glaucoma is the sneak-thief disease
without noticeable symptoms. By the time it's detected, it has started
doing damage.

The uncommon primary angle-closure glaucoma (acute glaucoma) may seem
the opposite of common glaucoma, erupting in a sudden, violent attack.
It's also possible to get both common and acute ("combined-mechanism")
glaucoma together.  The unusual low-pressure glaucoma is another
variant. Regular eye examinations can help protect against the onset of
open-angle and closed-angle glaucomas.

The cornea is the clear outer covering of the eye. Separating it from
the iris (the colored part) is the anterior chamber, a space filled and
inflated by aqueous humor. This fluid (unrelated to the tears which
bathe the outside surface of the cornea) originates in the ciliary body
just behind the iris. It circulates in the anterior chamber, nourishing
the eye's delicate tissue and keeping it from collapsing, at a pressure
usually measuring between 10 and 20 millimeters of mercury. To maintain
equilibrium, the aqueous humor drains through a porous tissue in the
angle in front of the iris, where it meets the cornea, called the
trabecular meshwork.

If the aqueous humor cannot drain properly, either because the drainage
canals become clogged (as in chronic glaucoma) or because the iris is
pushing against the cornea (as in angle-closure glaucoma), it backs up,
exerting pressure on the gel in the vitreous cavity at the center of
the eye. Eventually the building pressure affects the delicate optic
nerve at the rear. Since the optic nerve transmits visual images to the
brain, damage to parts of it correspondingly reduces vision.

Pressure over 21 millimeters may prompt concern, while pressure over 24
mm can indicate glaucoma level--but not always. These measures are not
absolute. Some individuals tolerate higher pressures than others. Half
the people with undiagnosed glaucoma have pressures below 22 mm, while
others with higher pressures never develop glaucoma, with optic nerve
damage causing loss of vision. Low-pressure glaucoma can be especially
elusive. Moreover, tonometry (the measurement of eye pressure) can be
affected by many factors, even by the time of day (IOP measuring
highest in the morning).

Tonometry measures the force necessary to indent the eye. One method is
to anesthetize the eye, then press a tonometer onto it. Another is to
measure the force needed for a puff of air to indent the cornea.

While widespread eye-puff testing at health fairs detects pressure
levels, a more thorough examination calls for an ophthalmoscopic test
enabling doctors to see into your eye to examine the optic nerve for
damage or a high ratio of its central cup to the surrounding disc. (See
accompanying article.) They must also take personal characteristics
into account in evaluating an individual's risk of glaucoma.

Chronic (Primary Open-Angle) Glaucoma

Physicians do not like to begin therapy prematurely in individuals
identified as at risk for chronic glaucoma. Patients considered
"pre-glaucoma" should have their eyes examined as often as their
doctors think necessary.

Increasingly frequent dosages of medications may be needed as the eye
develops tolerance to the medicine. Drug therapy can effectively thwart
the progress of glaucoma, but it can mean taking an escalating variety
of eye drops and pills, with various side effects, for life.

Topical medications for glaucoma are serious medicine, not to be
confused with over-the-counter eye drops for easing common eye
irritations. The most popular maintenance eye drop, Timoptic (timolol
maleate), may have side effects on the nerves, digestion, vision, skin,
respiration, and heart of some individuals.  Timoptic is a beta-blocker
eye drop. Taken usually twice daily, beta blockers decrease production
of aqueous humor. Side effects may include lowered pulse rate and blood
pressure, exacerbated asthma, and fatigue. In June 1995, British
researchers reported that drops in this class may be related to
breathing impairment in elderly people with previously unrecognized
respiratory problems.

Timoptic's century-old predecessor, pilocarpine, requires more frequent
use to do its job, increasing drainage of aqueous fluid in both open-
and closed-angle glaucomas. Pilocarpine is a miotic, designed to
increase aqueous fluid drainage. Because miotics work by making the
pupil smaller, they can result in dim vision and may increase the risk
of cataracts.

Another class of medications, adrenergic agonists, such as epinephrine,
also increases aqueous humor drainage, with possible side effects of
allergic reactions, blurred vision, headache, and increased heart rate.
Alpha adrenergic agonists decrease aqueous humor production after
surgery or aid patients taking maximum dosages of other medications.
Side effects include red eyes, allergic reactions, and dry mouth.

Diamox carbonic anhydrase inhibitor tablets, like beta blockers,
decrease production of aqueous fluid, but these drugs seem to provoke
more prominent side effects in some people, including mental
depression, kidney stones, tingling in the hands and feet, and
sometimes anemia.

FDA's May 1995 approval of a Carbonic Anhydrase Inhibitor in eye drop
form as Trusopt (dorzolamide) provides a medication that may have fewer
and reduced incidence of these severe side effects.

Since reactions to medications vary so much from person to person, a
drug that causes one individual problems may be easily tolerated by
another. An appropriate drug regimen, therefore, needs to be worked out
carefully between patient and health professional.

Glaucoma medications are potent drugs. Those who take them should
consult a pharmacist to be certain that they won't interact adversely
with any other prescriptions or over-the-counter drugs being taken. For
example, some over-the-counter products, including decongestants, may
not be suited for people at risk of glaucoma.

Acute (Closed-Angle) Glaucoma

A century after Milton gradually lost his sight, composer Johann
Sebastian Bach went blind in a violent flash, probably from acute
(closed-angle) glaucoma.  Bach thought he aggravated his weak vision by
a lifetime of copying music in the dim light of church organ lofts; his
portrait shows a characteristic squint. Though a surgeon claimed to
have operated successfully on Bach's eyes, the composer's vision failed
again in a few days. He died a few months later, after a futile--and
possibly harmful--second operation.

Acute glaucoma may seem the opposite of open-angle because it erupts in
violent attacks and intense pain, rather than emerging subtly. Yet
patients may not notice minor preliminary episodes, which pave the way
for serious seizures.  People beset by a major seizure must get to an
ophthalmologist, or at least a hospital emergency room, promptly to
save their vision.

Monitoring can protect people prone to acute glaucoma from major
attacks.

Acute glaucoma attacks are emergencies because aqueous fluid gets
trapped in the angle of the eye suddenly. Having nowhere to go, its
abrupt backup can damage the optic nerves, eventually squashing them
irreparably.

Regular, thorough eye checkups can detect the risk of acute glaucoma.
High IOP, family history, and other indicators resemble those for
common glaucoma, but very farsighted people and those of Asian descent
are most vulnerable to angle-closure glaucoma. Once a major
angle-closure attack seems imminent, preventive laser surgery is
advisable, since an attack can damage the eye quickly.

Regular monitoring of people diagnosed with narrow-angle conditions
looks for increased IOP or tissue damage. Telltale symptoms of an
attack include blurred vision, halos around lights, and eye pain sharp
enough to induce vomiting. The eye becomes reddened, feeling as if it
could burst (though it can't). Persons experiencing such attacks should
go immediately to an ophthalmologist or an emergency room, ideally
calling in advance to ready staff to receive a case of closed-angle,
acute glaucoma.

Emergency procedures use eye drops and clinical eye massage to reduce
IOP and prevent the eye from hardening. Once stabilized, the patient
may have laser surgery to create an artificial opening for aqueous
fluid to drain. Acute glaucoma usually attacks one eye before the
other, so laser surgery on the unaffected eye may be recommended at the
time to forestall a second attack there.

Laser Surgery

Some patients may require traditional scalpel surgery, but in recent
years laser operations have come into favor. Laser surgery can't repair
existing damage, but it usually stops glaucoma, both in acute
emergencies and open-angle cases. It may involve minor side effects,
including restrictions on wearing contact lenses, but its risks are
quite low. Sometimes it must be repeated if its drainage openings begin
to close.

Light amplification by stimulated emission of radiation--LASER--sends a
uniform, focused beam of light to pinpoint applications. In glaucoma
surgery for angle closure, the laser creates a minute hole in the iris,
just large enough to allow aqueous fluid to flow freely.

Despite its high-tech wizardry, most laser surgery for glaucoma seems
quite undramatic to the patient undergoing it. (See "Light for Sight,"
FDA Consumer, July-August 1990.) An acute glaucoma patient peers into
the eyepiece on one side of a boxy device while a surgeon manipulating
controls peers into an eyepiece opposite. There's little or no
additional pain, often not even unpleasant sensation, as the surgeon
beams an intense beam of light to "burn" an escape channel for aqueous
fluid, usually in the upper edge of the iris.

The Nd:YAG (neodymium:yttrium aluminum garnet crystal) laser has
emerged with several advantages over the earlier argon laser, including
lower energy requirement, fewer pulses, reduced obstruction, and a
lower rate of subsequent closure of incisions. Its portability allows
the YAG laser to serve even remote Inuit villages in Alaska previously
inaccessible for sophisticated optical surgery.

No wonder that laser surgery in just 25 years has largely displaced
traditional scalpel surgery, which involves hospital stays and higher
risks. Its low risk allows use earlier in the course of the disease,
when its potential benefit is greater.

On the Horizon

Diligence in countering early the subtle onset of glaucoma is the best
protection. Research is making such diligence easier.

Ongoing research aims to simplify dosage demands while reducing side
effects.  For instance, the nuisance of taking preventive eye
medications several times a day discourages some people from protecting
themselves fully. Work is under way to perfect a once-a-week eye
preparation and one-a-day eye drops to ease the use of topical eye
medications. Already, dispenser tips that measure more consistent doses
of eye drops are improving their use.

Even the standard course of escalating treatment for common glaucoma is
being reconsidered. The practice more common in Europe suggests that
reversing this order by starting with surgery may be promising. In
August 1993, the National Eye Institute announced the Collaborative
Initial Glaucoma Treatment Study to compare the long-term effect of
treating newly diagnosed primary open-angle glaucoma with standard
treatment versus immediate laser surgery.

S.J. Ackerman is a writer in Washington, D.C.

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

                              Risks and Responses

Elevated eye pressure and detectable damage to the optic nerves are
significant risk indicators for glaucoma. To prevent needless blindness
from undetected, untreated glaucoma, the American Academy of
Ophthalmology offers additional guidelines for assessing risk.

The academy's guidelines include comparing the diameter of the eye's
cup to that of its disc to obtain a physical gauge of the likelihood of
glaucoma.  Estimates are made vertically along an imaginary line drawn
through the center of the disc from the 12 o'clock to the 6 o'clock
position. The normal optic nerve illustrated with a small cup has a
cup-to-disc ratio of less than 0.5, indicating a low probability of
glaucoma. Moderately advanced cupping, with a cup-to-disc ratio of 0.6
to 0.8 and a neural rim starting to thin, increases the suspicion of
glaucoma. Almost total cup-to-disc ratio of 0.9, exhibiting a very thin
neural rim, creates a high level of glaucoma suspicion.

Personal history factors also enter the assessment; these are shown in
both table format and in chart form (for browsers that do not support
tables). Other variables in risk assessment include extreme
nearsightedness or farsightedness, high blood pressure, and steroid
use.

People at risk of glaucoma should faithfully have eye checkups at the
intervals recommended by their ophthalmologists. Everyone over 40
should have a full eye examination every two years, regardless of risk
factors; African Americans should be vigilant after age 30. Adult
relatives of persons diagnosed with glaucoma should have regular eye
checkups. Glaucoma seems to be hereditary, and even cousins may be at
risk if you are.

Glaucoma treatment decisions are personalized. Even eye color may
affect the rate at which a person absorbs eye medications.

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

                              For More Information

For more information about glaucoma, contact:

   * your doctor

   * American Academy of Ophthalmology's Glaucoma 2001 Campaign (for chronic
     open-angle glaucoma): (l-800) 39l-EYES

   * Foundation for Glaucoma Research: (1-800) 826-6693 or (415) 986-3162

   * National Eye Institute: (301) 496-5248
---
Internet : david@dental.stat.com
Telephone: +1-602-860-1121
FAX      : +1-602-451-1165
Web      : http://www.stat.com/~david


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

End of HICNet Medical News Digest V09 Issue #07
***********************************************