GLOBAL PUSH FOR SAFE NEEDLES

The World Health Organization, UNICEF and other international health
agencies have begun an aggressive new campaign to halt a global epidemic of
lethal diseases spread by contaminated needles.

Setting a deadline just three years away, the plan calls for phasing out
the use of all standard disposable and sterilizable syringes in developing
countries' immunization programs and replacing them with a new genera tion
of syringes that can be used only once. The new self-disabling -- or
``auto-disable'' -- syringe program is part of an even broader initiative
by a coalition of world health agencies, including WHO, UNICEF and the
federal Centers for Disease Control and Prevention designed to curb the
transmission of potentially deadly viruses through unsterile needle use in
therapeutic injections as well as in vaccinations.

Last year, 1.2 billion immunization shots were given in developing nations.
More than 10 billion therapeutic needle punctures and injections are
administered annually in those countries.

In October, WHO reported that as many as 21 million people a year contract
hepatitis, HIV and other deadly viruses from unsafe injection practices --
more than twice the agency's earlier estimates.

The next month, on November 8, the new syringe policy was announced and
signed by the leaders of WHO, UNICEF, the International Red Cross and the
Red Crescent Societies.

The sweeping safe injection campaign follows a series of Chronicle articles
last year reporting that the practice of reusing syringes in developing
countries has been spreading blood-borne viruses at an alarming rate.

Internal 1998 WHO reports obtained by The Chronicle estimated that the
reuse of contaminated syringes was causing as many as 10 million new
infections each year and resulting in more than 1 million deaths

- --nearly one every 20 seconds.

The articles also reported that auto-disable syringes were developed more
than a decade ago, but profit concerns by needle manufacturers and
reluctance by health officials to pay the extra cost of the new syringes
delayed their widespread use in developing nations.

This year, WHO updated its preliminary estimates based on more complete
field data. The agency published its findings in a series of articles on
injection safety in the October issue of the Bulletin of the World Health
Organization.

The report estimates that between 10.4 million and 20.9 million people are
being infected each year with viruses transmitted through the reuse of
contaminated syringes. The report's authors also warn that even the new
higher estimates are the result of conservative calculations.

``As we review the successes and failures of global health at the end of
the 20th century,'' said an editorial accompanying the articles, ``an
alarming pattern emerges suggesting that the `first do no harm' principle
may be being violated on a grand scale as a result of unsafe injection
practices.

``Injection overuse and unsafe practices combine to account for a
substantial proportion of the new infections with hepatitis B, hepatitis C
and the HIV virus.''

GLOBAL CRISIS

Medical authorities have understood the risks of blood-borne infections
from contaminated syringes and needles for more than 50 years. The United
States and other industrialized nations have largely solved the problem
through the use of cheap, disposable plastic syringes that are used once
and discarded.

But most developing countries lack the money, the political will and the
medical standards to make a wholesale change. Instead, they have relied
upon sterilizing reusable syringes or reusing inexpensive disposable syringes.

But sterilization programs in those countries often failed because of
ineffective training and supervision and, in some cases, the lack of fuel
to run the sterilizers. Disposable syringes, which cannot be sterilized for
reuse, flooded developing countries in recent years and have compounded the
problem because supplies are inadequate and the syringes are used multiple
times, sometimes after being recycled from medical waste.

WHO officials determined by the mid-1990s that in most developing nations,
up to 30 percent of injections in immunization programs -- affecting
millions of vulnerable children -- were not sterile, and 50 percent of
therapeutic injections were unsafe.

These unsafe practices have led to the spread of particularly virulent
diseases such as hepatitis, which is caused by several virus strains that
attack the liver and are most often fatal when contracted during childhood.

In its recent journal articles, WHO officials estimate that 20 to 80
percent of all hepatitis B infections in China, India and Romania are now
caused by reused syringes.

SINGLE-USE SYRINGES

Health officials increasingly have turned to auto-disable syringes as a way
to halt the spread of infectious diseases.

Developed at WHO's prompting and with U.S. funding in the late 1980s, most
auto-disable syringes resemble standard syringes -- with one key
difference: They include tiny alterations that automatically lock down a
syringe's plunger after an injection.

The syringes are manufactured by several firms, including Becton Dickinson,
the world's largest syringe maker, and until recently they cost more than
twice as much as standard disposable syringes.

But John Lloyd, a WHO injection expert, said the price of auto-disable
syringes already has dropped from more than 10 cents to a little more than
7 cents apiece, and is set to fall again in the spring. That is only
slightly more costly than conventional syringes, which range in price from
4 1/2 cents to 7 cents each.

World health officials, using the most conservative figure of 10.4 million
annual infections, estimate that the direct medical costs of treating
diseases transmitted through syringe reuse now total $535 million annually
- -- more that three times what it would cost to supply auto-disable syringes
to the developing world.

UNICEF has been supplying only auto-disable syringes for emergency and mass
immunization campaigns for several years.

In July, for example, the agency sent thousands of the auto-disable
syringes to East Timor when violence there was suspended during a special
truce so that 30,000 children could be immunized against six major
childhood diseases.

And government officials in India asked the agency for 1.5 million of the
syringes for vaccinations to prevent an outbreak of measles after a killer
cyclone ravaged that nation's east coast last month.

But emergency campaigns represent only a fraction of the total immunization
programs in the developing world.

In March, African immunization managers called on WHO to require the use of
auto-disable syringes for all vaccinations, including routine shots that
make up the bulk of immunizations worldwide.

After meeting in July, WHO and UNICEF officials in November set the year
2003 as the deadline for the shift to auto-disable models.

Some field managers, however, argued that such a schedule is unrealistic.
They said supplies of the auto-disable syringes are limited, and they
objected to the phase-out of sterilizable syringes, insisting that in many
regions of the world, sterilization programs are working and are extremely
cost-effective because a single syringe can be used as many as 200 times.

But WHO, UNICEF, Red Cross and Red Crescent leaders were unswayed. Their
new policy states that the agencies no longer will buy or provide funds for
standard disposable needles as of Jan. 1, 2001.

``By the end of 2001, all countries should use only auto-disable and
sterilizable syringes,'' the agencies said. All sterilizable syringes will
be phased out by the end of 2003.

The agencies also urged all global donors and other partner organizations
involved in immunization programs to finance only auto-disable syringes.

To avoid exposing health care workers and communities to accidental needle
sticks, the agencies urged that all new auto-disable syringes be
distributed ``bundled'' with the vaccine in safe disposal boxes, which are
to be burned and buried when they are filled with the used syringes.

Experts estimate that fewer than 100 million auto-disable syringes are
being produced annually, and manufacturers will need to increase production
by as much as 10 times that amount to meet the new goals.

The syringe companies, however, say they can supply enough auto- disable
needles to meet the dates set by WHO and UNICEF.

``We'll have no problem,'' said Joel Schoenfeld, head of UNIVEC, a New York
needle manufacturer that specializes in auto-disable syringes. ``We have
the ability to produce half a billion syringes a year. All we need is the
order.''

Becton Dickinson has invested heavily in overseas syringe manufacturing,
with plants in India, China, Singapore and Spain that are primarily
producing disposable needles. Dr. Zeil Rosenberg, a medical director with
the company, said the manufacturer can shift production to meet the demand
for auto-disables.

``I think this is very doable,'' he said of the new deadlines set by WHO
and UNICEF. ``We are completely supportive of this new aggressive policy.''

Rosenberg said Becton Dickinson also is designing auto-disable syringes
that will use various lengths and gauges of needles to meet the expected
demand for them in therapeutic injections.

Meanwhile, the global campaign to solve the much larger problem of unsafe
therapeutic injections is just getting started.

In February, a strategic plan commissioned by the U.S. Agency for
International Development was circulated among officials from WHO, UNICEF,
the federal Centers for Disease Control and Prevention and other interested
groups.

The proposal called for a separate network of public health professionals
to organize and carry out the global campaign. In July, Dr. Yvan Hutin, an
infection control expert from the Centers for Disease Control in Atlanta,
joined WHO at its Geneva headquarters to head the initiative.

In October, the first meeting of the Safety Injection Global Network, or
SIGN, was held in Geneva, drawing 50 participants. The publication of the
WHO journal articles was timed to coincide with the gathering.

Hutin said he is drafting briefing documents to send to health ministers of
developing nations. The goal is to raise awareness about the magnitude of
the reuse problem, in the medical as well as immunization sectors, and to
raise medical standards through international groups of health professionals.

A RIGHT TO SAFE INJECTIONS

``The issue is much broader than simply using auto-disable syringes for
immunizations,'' said Hutin. ``We also have to decrease the overuse of
injections and achieve a behavioral change before we can begin to make a
difference.''

The Safety Injection Global Network is also planning pilot projects for
five countries that will identify strategies to use in developing a
large-scale initiative.

The network also intends to work for the passage of a ``right to safe
injection'' resolution in 2001 by the World Health Assembly, which serves
as a global parliament of health ministers.

``Things are moving,'' said Hutin. ``We are seeing more and more commitment
from governments and partners by the minute. I'm encouraged.''

Despite its extraordinary magnitude, the epidemic of infection and death
caused by unsafe injections so far has received little media attention.

Health officials purposely have avoided publicizing the crisis, fearing
that mass media attention could undermine the success of immunization
programs.

Their concern was spelled out in February's global strategic plan, which
was drawn up by Porter Novelli, a social marketing firm, at the request of
WHO and the U.S. Agency for International Development.

``In particular,'' the proposal said, ``there should be no efforts to
communicate with the media until there are programs in place to assure safe
injections. There is too much potential to create a panic in the service of
informing the public.''

The report said that monitoring the media for news about injection safety
issues is also crucial. Citing The Chronicle series, the authors said that
``there is a very real risk that similar coverage could gain momentum and
this issue could come under a more harsh media spotlight.''

Once health programs have been established, the proposal said, officials
should ``place'' stories in media outlets like CNN, the New York Times, the
British Broadcasting Corp., newsmagazines and wire services.

THE DEVELOPMENT OF SINGLE-USE SYRINGES

The spread of serious infections provoked development of single-use -- or
auto-disable -- syringes in the late 1980s. The devices are sold primarily
to developing countries through relief agencies, but only a tiny fraction
of the 12 billion injections given each year are administered with
auto-disable syringes.

Glass syringes -- can be reused -- but spread deadly disease when not
properly sterilized. Beginning in the early 1960s, many were replaced by
disposable plastic syringes designed to be used once and discarded.

Standard Disposable Syringe

Includes a plunger and hollow-bore needle for injecting medications or
drawing blood and other fluids. Once used, it cannot be properly
sterilized, making it a dangerous even lethal instrument when contaminated
with infected blood.

UNIVEC

A slim and simple autodestruct syringe made by a startup company in New
York. It was designed to meet WHO standards for immunization programs and
loosely resembles a standard syringe.

Sources - Industry advertising and Chronicle research:

- --World prevalence of the Hepatitis B virus

More than 372 million people are now chronic carriers of the hepatitis B
virus. Recent estimates of infections from syringe reuse generally track
the prevalence of the disease globally.

- --World prevalence of the Hepatitis C virus

Hepatitis C infections from syringe reuse follow the global prevalence of
the virus, now carried by more than 177 million people.

- --World prevalence of HIV

HIV infections from syringe reuse track the worldwide prevalence of the
virus, which now infects more than 334 million people.

Source - World Health Organization and Chronicle research

ESTIMATED TOTAL ANNUAL INFECTIONS FROM SYRINGE REUSE:

Hepatitis B: Up to 16 mil.

Hepatitis C: Up to 4.7 mil.

HIV: Up to 161,000

Annual death rate: 1.3 mil.

Sub-Saharan Africa

Hepatitis B: 1.56 mil.

Hepatitis C: 509,900

HIV: 102,400

Middle Eastern crescent

Hepatitis B: 1.04 mil.

Hepatitis C: 141,600

HIV: 240

Latin America and the Caribbean

Infection totals not available

Former Soviet Union and Eastern bloc countries

Hepatitis B: 892,600

Hepatitis C: 121,500

HIV: 23,800

China Hepatitis B: 4.16 mil.

Hepatitis C: 2.27 mil.

HIV: 570

India Hepatitis B: 6.26 mil.

Hepatitis C: 810,900

HIV: 8,600

Other Asian/ Pacific Island

Hepatitis B: 2.51 mil.

Hepatitis C: 820,400 HIV: 25,700