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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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