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High Profits -- At What Cost?
Manufacturer markets unsafe needles in light of epidemic
Reynolds Holding, William Carlsen, Chronicle Staff Writers THE
MARRIOTT HOTEL
Tuesday, April 14, 1998
http://sfgate.com/cgi-bin/article.cgi?f=/chronicle/archive/1998/04/14/MN62035.DTL
THE MARRIOTT HOTEL
NEAR FRANKLIN LAKES, N.J., 1988
Russell Kuhlman felt about an inch high.
Top sales managers for Becton Dickinson and Company, the world's
largest needle maker, had gathered for their quarterly meeting,
and listed on the agenda was a new device that could
dramatically cut into a deadly epidemic of needle sticks among
health care workers.
Kuhlman, the company's 1987 sales champion, couldn't wait to
talk about it.
``I piped up and said, `This is exactly what our customers
need!' ''
Laughter rippled through the room.
``Nobody else in that room seemed to get it -- to see that
health care workers deserved a safer product,'' he recalled.
Three months later, Kuhlman turned down an offer to become one
of Becton Dickinson's national sales trainers and left for a
competitor. He was convinced that Becton Dickinson had no
intention of letting its safer devices undercut sales of
conventional needles -- the lifeblood of the $2 billion
corporation.
Seven years earlier, researchers had warned that conventional
needles were transmitting lethal diseases to the nation's
nurses, doctors, laboratory technicians and hospital workers at
an alarming rate.
Since then, infections from accidental needle sticks had grown
into an epidemic -- and virtually nothing was being done about
it.
But by 1988, the medical industry and the government could no
longer ignore the emergency.
As many as 12,000 medical workers a year were contracting
hepatitis B from needle sticks, according to the Centers for
Disease Control. Two hundred to 300 were dying. And thousands
more were getting hepatitis C, AIDS and other lethal diseases.
Health care workers demanded action -- in court and in
Washington, D.C.
OSHA promised tough new safety regulations. Medical researchers
called on needle manufacturers to replace conventional devices
with new generation safety needles. And manufacturers such as
Becton Dickinson introduced a small number of new designs like
the one unveiled to Kuhlman and his colleagues.
At last, there was hope that the medical establishment and the
government were taking meaningful steps to prevent the epidemic
from needlessly destroying even more lives.
But something would go dreadfully wrong. Just as Kuhlman had
feared, few of the safer needles would reach the hands of
medical workers. And the epidemic would rage on.
UNIVERSITY OF VIRGINIA
CHARLOTTESVILLE, VA.
On Aug. 4, 1988, the New England Journal of Medicine published a
landmark study that for the first time blamed needle sticks on
syringe design rather than the carelessness of medical workers.
Janine Jagger, a professor in the neurosurgery department at the
University of Virginia, had analyzed 326 needle injuries. She
concluded that preventing needle sticks would involve more than
just warning workers not to recap needles, a procedure viewed as
a major cause of injuries.
``The optimal solution is to design devices that allow the
needle to remain covered during and after use,'' Jagger wrote.
The article offered manufacturers the first clear definition of
a safer device: one that requires little or no training to use,
keeps workers' hands behind the needle and has a built-in safety
mechanism.
``In this way, (the safety mechanism) is certain to be available
precisely when and where it is needed,'' Jagger wrote.
``Moreover, the safety feature . . . should be in effect after
disposal, thus protecting the trash handler as well as the
user.''
Jagger, a brain trauma expert who had earlier pushed to have air
bags installed in autos, was optimistic. She said a ``historic
opportunity'' to accelerate the transfer of new needle
technology into the workplace was at hand.
``A timely response,'' she wrote, ``. . . can bring about
substantial and lasting improvements in an area in which
progress is long overdue.''
BECTON DICKINSON HEADQUARTERS
Franklin Lakes, N.J.
For executives at Becton Dickinson, the Jagger study posed a
serious challenge: How to deal with the inevitable demand for
safer needles without jeopardizing the corporation's estimated
70 percent share of the conventional needle market.
Any major shift to safer needles would require significant
engineering, retooling and marketing costs, and the new needles
would compete with standard designs that the company had offered
for decades.
The company seemed determined ``to minimize the capital outlay''
on any safer device, said Robert Stathopulos, an engineer at
Becton Dickinson from 1972 to 1986. ``Why scrap your existing
molds when you can modify them and maybe build an additional
component for a safety syringe?''
Becton Dickinson had another problem: its ability to design new
products. In a 1988 Harvard Business School study about the
company, one Becton Dickinson manager conceded, ``I'm not
impressed with our R&D (research and development)
capabilities.''
So the company went outside for a solution: A syringe with a
simple plastic shield that could slide over a needle. The device
was invented by Norma Sampson, a Fullerton nurse concerned about
needle sticks.
With the help of two relatives and a South Carolina engineer
named Charles Mitchell, Sampson sold the rights to Becton
Dickinson in 1987 for a 4 percent cut of future sales. And in
1988, the company introduced the new Safety-Lok Syringe.
But according to Mitchell, Becton Dickinson priced the syringe
so high that few hospitals would buy it, leading the patent
holders to doubt whether the company really wanted to sell the
device.
``We certainly were disturbed,'' said Mitchell. ``There was a
tremendous HIV scare at the time, and we thought this was the
right product to come to market.''
Market studies conducted for the company in 1988 show that
although customers expressed ``tremendous anxiety and concern''
about needle sticks, they had serious reservations about the new
syringe's ``premium selling price.''
Company memorandums and court documents obtained by The
Chronicle indicate that the device was initially priced as high
as 78 cents -- three to 10 times higher than Becton Dickinson's
conventional syringes.
Yet industry experts say the new product would have cost only
pennies more to make in full production.
The company refused to comment on its manufacturing costs.
``If they had priced it lower, then maybe they would have sold
more early on,'' said Richard Coggins, an executive at
Mitchell's company.
But a low price would not have allowed Becton Dickinson to
maximize profits if, as expected, demand for safer needles
increased.
``If you price a new product at a low point,'' Coggins
explained, ``it's very difficult to raise the price as
competition comes in.''
According to legal documents, the company felt entitled to the
high price because the new device would save hospitals the cost
of testing and treating health care workers for potentially
lethal needle sticks.
And as premium prices dramatically slowed sales of the safer
syringe, they also, in effect, preserved sales of conventional
devices, the core of Becton Dickinson's business.
``Essentially, BD owns the market,'' says Stathopulos. ``So if
they could sell safety syringes to enhance the business, they
would. But the strategy was not to replace conventional syringes
with a safety syringe.''
Becton Dickinson, though, contends that it has made, designed
and patented more safety medical products than any other
manufacturer.
``The company considers safety to be of the utmost importance,''
said Becton Dickinson spokesman Ronald Jasper.
But other manufacturers have reduced the price of safer needles
just to get them into the market.
For example, when Gary Schwallie, vice president of marketing at
International Medication Systems, realized the extent of the
needle stick epidemic, he knew he had to act -- even if it meant
cutting into profits.
So in July 1990, the small Southern California needle
manufacturer slashed the price of its Stick-Gard Safety Needle
from 45 cents to 19 cents per unit.
``Price,'' Schwallie said at the time, ``should not be an
obstacle in protecting health care professionals from
life-threatening risks of the HIV and hepatitis B viruses.''
MOSCONE CENTER
SAN FRANCISCO
Janine Jagger was frustrated as she prepared to address health
care workers at the 6th International Conference on AIDS the
summer of 1990.
As part of her presentation, she was to show slides of several
new safety devices, including Becton Dickinson's self-sheathing
syringes. She had data showing that the devices could eliminate
up to 85 percent of needle sticks.
But Jagger felt helpless. It had been two years since the New
England Journal of Medicine published her article -- and still
there was little progress in controlling the needle stick
epidemic.
She estimated that 64 health care workers would get the AIDS
virus that year from needle injuries, and thousands more would
contract hepatitis.
During her speech, she could barely contain her anger over the
high cost of the new, safer needles. Her wrath was directed not
only at Becton Dickinson, but at all manufacturers asking
premium prices for safer products.
For example, Baxter Healthcare Corp., a major supplier of
intravenous line systems, charged five times more for devices
that replaced needles used to enter the lines -- even though the
blunt plastic devices cost less to produce than the steel
needles did.
``Safety is viewed as an optional market opportunity, of
interest only if potential profits appear higher than those
earned from conventional, hazardous technology,'' Jagger told
the Moscone audience.
``Health care workers cannot wait for industry to decide that it
is profitable to eliminate unnecessary workplace risks. Until
safety becomes mandatory by aggressive regulation, legislation
and litigation, health care workers will continue to contract
preventable disease while safer technology collects dust on
corporate shelves.''
JOHN PETER SMITH HOSPITAL
FORT WORTH, TEXAS
When Patricia Wetzel was growing up on a Minnesota farm, a
career in medicine was far from her mind. She was a musician, a
flutist so talented that she earned a place at the prestigious
Julliard School in New York City.
But Wetzel soon realized that she would be ``less than the best
in the world,'' as she put it, so she quit. And to her parents'
disappointment, she chose to become a doctor, one with a
save-the-world attitude that would lead her to an AIDS ward in
Fort Worth.
By her third year as a resident at John Peter Smith Hospital,
Wetzel was known around the hospital as ``the AIDS doctor,'' one
of the only physicians who would go near patients with the fatal
disease.
``They were treated horribly,'' she recalled, ``and it just
pissed me off. I couldn't make anyone understand that these were
the neediest of the needy.''
One AIDS patient in particular -- a construction worker who had
gone home to die -- concerned Wetzel because nurses refused to
draw blood at his house.
So on a Saturday morning in September 1991, rather than have an
ambulance bring him to the hospital for $600, Wetzel went to the
patient's home for blood samples. She completed the procedure
and, finding no safe disposal container there, recapped the
blood-drawing needle.
Upon returning to the hospital, Wetzel reached for the
collection tubes -- and felt a sharp jab.
The cap had fallen off.
She jerked back her hand, shocked to see the blood-drawing
needle dangling from her finger.
``You think crazy things,'' she recalls, ``like, `I should cut
off my finger -- if I could just get rid of this finger.' ''
A little more than three months later, she tested positive for
HIV.
Wetzel sued Becton Dickinson, claiming the unshielded needle
that had stuck her was unreasonably dangerous and that the
company was negligent in continuing to sell a blood-drawing
product it knew could be made to be safer.
In fact, Becton Dickinson had been selling a safer version since
1989. Like its Safety-Lok Syringe, the company priced the new
blood-drawing device at a premium: more than double the cost of
licensing, developing and manufacturing it, according to court
documents.
As a result, many hospitals -- including John Peter Smith --
refused to buy it.
OSHA OFFICE
WASHINGTON, D.C.
When OSHA officials promised tough new safety rules to protect
health care workers, there was optimism that the government was
at last paying attention to the needle stick epidemic.
The optimism wouldn't last long.
Within a year of the agency's 1987 announcement, Susan Harwood
was having a tough time coping. As director of the agency's risk
management office, Harwood was worried that progress on the
regulations was going much too slowly.
``What keeps me up at night is knowing that people are dying
unnecessarily because OSHA has delayed or failed to get out a
standard,'' she told Congress in April 1988.
Finally, in 1989, OSHA issued its proposed regulations and
called for comment. With safe needle technology still in its
infancy, the proposal focused on gloves, masks, protective
gowns, puncture-resistant disposal boxes and the three-shot
hepatitis B vaccine.
In January 1989, Secretary of Labor Ann McLaughlin vowed that
OSHA's final regulations would be released by the end of the
year.
But it would take two additional years before they were
published.
CALIFORNIA HOSPITAL ASSOCIATION
SACRAMENTO
Officers of the California Hospital Association thought little
of OSHA's needle stick rules when the agency released them for
comment.
The influential association, which represents 467 of the state's
hospitals, called the proposals ``too expensive, a waste of
resources and overkill.''
The hospital association was not alone in its reaction to OSHA's
draft regulation.
Individual hospitals across the nation downplayed the needle
stick crisis. Doctors' groups complained that the new rules
would put them out of business. And dentists mounted a
nationwide letter-writing campaign demanding that their
representatives and senators block any regulation.
Collectively they sent a clear message to OSHA: Back off and let
us handle the problem.
SURGERY DEPARTMENT
SAN FRANCISCO GENERAL
Concern about needle sticks at San Francisco General Hospital
reached the boiling point on March 29, 1991, when a medical
student was stuck with a contaminated catheter needle while
helping prepare a patient for surgery. The patient later tested
positive for HIV.
At the time, the hospital was already using a safety catheter --
made by Critikon, a division of Johnson & Johnson -- in its
emergency room. But administrators had rejected repeated
requests to make it available in other departments.
At that point, at least two other workers at the hospital had
contracted the AIDS virus from needle sticks.
Employees filed a union grievance petition, quoting a study
stating that 36 percent of the medical staff at nearby UC San
Francisco Medical Center had reported needle sticks when dealing
with patients at high risk for being HIV-positive.
``The annual risk of acquiring HIV for medical interns at UCSF
has been estimated to be four to ten times as high as the annual
risk of occupational mortality for California police officers
and firefighters respectively,'' wrote Dr. Peter Lurie, arguing
for use of the Critikon needle in every department at San
Francisco General.
Hospital managers said they did not buy more Critikons because
the self-sheathing catheter cost too much and had not been
proven effective -- the same arguments hospitals throughout the
country were using to reject safety needles.
But Lurie had done his homework. He cited studies praising the
Critikon for its effectiveness in reducing needle sticks. He
also estimated the added cost at $86,572 per year -- or .027
percent of San Francisco General's budget.
``These costs do not account for the savings produced by the
potential prevention of needle sticks,'' he said, noting that
testing and treatment of injured workers would cost the hospital
tens of thousands of dollars every year.
Three weeks later, the hospital agreed to make the Critikon
available to all departments.
But it was an isolated victory.
OSHA OFFICE
WASHINGTON, D.C.
It was AIDS Awareness Day -- Dec. 2, 1991.
More than five years after health care worker unions petitioned
OSHA for emergency regulations forcing hospitals to provide
stronger protections for employees, the agency finally issued
its ``Bloodborne Pathogen Standard.''
Meanwhile, tens of thousands of medical workers had contracted
hepatitis, and an additional 250 had been infected with HIV
through needle sticks.
Under the OSHA regulation, starting in 1992, hospitals and
employers would have to give workers free hepatitis B vaccines
and supply disposal boxes, protective clothing, gloves and
masks.
Buried in the standard, which covered dozens of pages, was the
requirement that employers use ``engineering controls'' to
prevent needle sticks. Self-sheathing needles were cited as an
example of such controls.
The American Health Care Association, the Home Health Services
Association and the American Dental Association immediately
filed suit in federal court to block the regulation.
Despite the long delay, the unions praised the new standard. But
they worried about how OSHA would enforce it.
Testifying before Congress in February 1992, Bob Moore, a union
official from Washington, D.C., called for ``clear compliance
guidelines'' to force OSHA to follow through on the new
regulation.
The same day, needle-safety expert Janine Jagger reminded
congressional committee members of the stakes involved:
``Today alone, on February 7th,'' she said, ``2,400 health care
workers will have sustained preventable needle sticks, and 50 of
them will plunge needlessly into crisis and uncertainty as they
begin their wait for HIV test results.''
Tomorrow: Broken Promises
-- Health care workers infected while OSHA rules were being
developed: Approximately 60,000 -- Health care workers to die
while OSHA rules were being developed: Approximately 250 --
Daily needle stick victims: 2,400 -- Diseases transmitted by
needle sticks: More than 20
THE SERIES
``Deadly Needles'' is a three-part series about how the medical
industry and government let deadly needle stick injuries run
rampant among health care workers. Today's installment covers
1978 to 1987, when the needle stick epidemic becomes apparent to
the medical establishment.
DAY 1 (1978-1987): A needle stick epidemic ravages health care
workers -- but could have been prevented.
DAY 2 (1987-1992): Health care workers demanding action find a
medical establishment in disarray.
DAY 3 (1992-1998): The medical industry and government do very
little as thousands die.
THE DEVELOPMENT OF SAFER NEEDLE DESIGNS
By the 1980s, manufacturers knew that their medical needles
could spread deadly diseases to health care workers. At the end
of the decade, they began selling safer alternatives, but they
continued to market the conventional needles in massive
quantities.
Health care workers currently use 6 billion needles each year in
the United States. The vast majority are conventional needles
without safety mechanisms.
STANDARD HYPODERMIC SYRINGE
This device revolutionized the practice of medicine 150 years
ago. Uses a plunger and hollow-bore steel needle to inject
medications or withdraw blood and other fluids. Once the needle
is contaminated with infected blood, however, it can be a
dangerous, even lethal, instrument.
First Introduced
1845
Major manufacturers
Becton Dickinson, Sherwood/Davis & Geck, Smith & Nephew, and
Terumo.
Approximate price
5 cents to 7 cents
SYRINGE WITH PROTECTIVE SHIELD
The earliest safety syringe, it provides some protection from
needle sticks but has been criticized because two hands are
required to push the shield forward and wet hands may slip,
exposing the health care worker to injury.
First Introduced
Late 1980s
Major manufacturers
Becton Dickinson and Sherwood/Davis & Geck
Approximate price
26 cents to 35 cents
SYRINGE WITH RETRACTABLE NEEDLE
The latest design for a safety syringe, it requires only one
hand to operate and cannot be reused after the needle retracts
into the syringe barrel. But the device is not widely available
and costs almost twice as much as syringes with protective
shields.
First Introduced
1997
Major manufacturers
Retractable Technologies, Inc.
Approximate price
50 cents
BLUNT-TIP BLOOD-DRAWING NEEDLE
Blood-drawing needles are more likely than other needles to
transmit infections because they contain large amounts of blood
after use. A Centers for Disease Control study published last
year found that this device reduced needle sticks by 76 percent
-- the highest figure for any blood-drawing device tested.
First Introduced
1991
Major manufacturers
Bio-Plexus
Approximate price
35 cents
WINGED NEEDLE WITH PROTECTIVE SHIELD
Also known as a butterfly, this blood-drawing device is flanked
by two plastic wings that serve as handles for inserting and
removing the needle. After use, the wings can be pushed forward
to slide a protective shield over the needle. The device is also
available without the protective shield.
First Introduced
1994
Major manufacturers
Becton Dickinson
Approximate price
87 cents
Sources: Health Devices magazine, industry advertising and
Chronicle research
STEVE KEARSLEY / THE CHRONICLE
THE DEVELOPMENT OF SAFER NEEDLE DESIGNS
By the 1980s, manufacturers knew that their medical needles
could spread deadly diseases to health care workers. At the end
of the decade, they began selling safer alternatives, but they
continued to market the conventional needles in massive
quantities.
Health care workers currently use 6 billion needles each year in
the United States. The vast majority are conventional needles
without safety mechanisms.
STANDARD HYPODERMIC SYRINGE
This device revolutionized the practice of medicine 150 years
ago. Uses a plunger and hollow-bore steel needle to inject
medications or withdraw blood and other fluids. Once the needle
is contaminated with infected blood, however, it can be a
dangerous, even lethal, instrument.
First Introduced
1845
Major manufacturers
Becton Dickinson, Sherwood/Davis & Geck, Smith & Nephew, and
Terumo.
Approximate price
5 cents to 7 cents
SYRINGE WITH PROTECTIVE SHIELD
The earliest safety syringe, it provides some protection from
needle sticks but has been criticized because two hands are
required to push the shield forward and wet hands may slip,
exposing the health care worker to injury.
First Introduced
Late 1980s
Major manufacturers
Becton Dickinson and Sherwood/Davis & Geck
Approximate price
26 cents to 35 cents
SYRINGE WITH RETRACTABLE NEEDLE
The latest design for a safety syringe, it requires only one
hand to operate and cannot be reused after the needle retracts
into the syringe barrel. But the device is not widely available
and costs almost twice as much as syringes with protective
shields.
First Introduced
1997
Major manufacturers
Retractable Technologies, Inc.
Approximate price
50 cents
BLUNT-TIP BLOOD-DRAWING NEEDLE
Blood-drawing needles are more likely than other needles to
transmit infections because they contain large amounts of blood
after use. A Centers for Disease Control study published last
year found that this device reduced needle sticks by 76 percent
-- the highest figure for any blood-drawing device tested.
First Introduced
1991
Major manufacturers
Bio-Plexus
Approximate price
35 cents
WINGED NEEDLE WITH PROTECTIVE SHIELD
Also known as a butterfly, this blood-drawing device is flanked
by two plastic wings that serve as handles for inserting and
removing the needle. After use, the wings can be pushed forward
to slide a protective shield over the needle. The device is also
available without the protective shield.
First Introduced
1994
Major manufacturers
Becton Dickinson
Approximate price
87 cents
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