Tuesday, October 27, 1998
For decades, researchers warned that contaminated syringes could transmit deadly viruses with cruel efficiency. But efforts to defuse the crisis were failed, and today, it has become an insidious global epidemic, destroying millions of lives every year.
(First Of Three Parts)
Dr. Ciro de Quadros, chief of the campaign that eradicated polio from the Western Hemisphere, could not believe the numbers. When the esteemed Brazilian and other world health leaders arrived in Switzerland last spring, they expected to discuss the progress of the global vaccination program -- the most successful public health campaign in history.
Instead, they got a medical time bomb.
In de Quadros' hand was a chilling internal report: 10 million people a year were contracting lethal diseases such as hepatitis and AIDS through the reuse of contaminated syringes.
De Quadros rose to his feet and implored his colleagues to keep the findings confidential -- at least until the numbers could be reviewed once more.
``These figures are so incredible,'' he said, ``that if they are released, they will make the front pages of newspapers around the world.''
But an earlier internal WHO study had revealed an even more alarming figure: Every year as many as 1.8 million people infected by contaminated syringes, mostly children, would die -- about one every 20 seconds.
Medical researchers had warned for decades that hypodermic needles could be deadly. But the WHO reports made it painfully clear that world health officials had an international medical crisis on their hands -- and urgent action was needed.
``We want to avoid creating a panic,'' said WHO's Michel Zaffran, who helped prepare the still-unreleased infection numbers. ``But maybe there is a need to create that panic to solve this problem.''
This is a story, based on hundreds of interviews and thousands of documents, about a vast, virtually invisible epidemic, a crisis that could have been defused more than a decade ago.
It is about soaring disease rates in Egypt and plunging life expectancies in Brazil; children combing garbage dumps for syringes to sell in Kenya and India; and ignorance, poverty and corruption driving medical workers in Cambodia and Russia to reuse needles dozens -- sometimes hundreds -- of times.
It is about a promising generation of nonreusable syringes that got lost in a multibillion-dollar corporate battle over the global syringe market.
It is about how the world's leading syringe manufacturers first ignored the problem, then either delayed the new technology or did little to get it into the hands of health workers.
And it is about how top world health officials -- including several with de Quadros in Conference Room A -- downplayed the mounting death toll for years, fearing that publicizing it would jeopardize their immunization programs.
The story began more than half a century ago with the emergence of the hypodermic syringe: an instrument of almost mystical life-saving power, yet one that can spread disease with deadly efficiency.
In 1920, the tropical disease yaws had been striking down villagers for as long as anyone could remember. The microbe invaded the body through broken skin, raising ugly lesions, inflicting excruciating pain and often totally disabling its victims.
Then, medical workers fanned across the countryside with hypodermic syringes containing a chemical called Salvarsan.
``So spectacular were the results,'' a West African medical journal later reported, ``that all types of patients began to clamor for injections, and most of them refused other forms of orthodox treatment.''
In 1923, Salvarsan shots cured hundreds of yaws-infected Samoans. Similar results involving other diseases and medicines were reported from Jamaica, India and Nigeria.
By the 1950s, mass injection campaigns with penicillin all but eradicated yaws. The image of syringes as magic was firmly established in the developing world, with patients often refusing to leave clinics before getting injected.
``Injections and syringes had become the symbol of modern medicine . . . a metaphor for everything fast and efficient,'' two medical anthropologists later wrote.
But the talismanic attraction of the syringe began to fade among health care workers.
Patients in Madagascar, Samoa and the Congo developed paralysis from polio transmitted through injections. Cases of hepatitis spread by syringes surfaced in West Africa.
Even in the United States, studies showed that syringe reuse spread malaria, hepatitis and other serious infections.
The ``Injection Age'' had arrived, but it had come with a price.
Peter Stevens and his colleagues at Roehr Products sat around a corner table in 1954, picking at pasta and wondering how to keep the fledgling medical supply company from going under.
By then, it had become clear that a used syringe could transmit disease. Stevens and his colleagues had an idea: a plastic syringe so cheap that doctors would discard it after a single shot.
``We introduced our needle not because of moral considerations,'' Stevens said, ``but because this is a litigious country, and everybody was afraid of lawsuits.''
Within a year, Roehr was selling the world's first disposable syringe, a 5-cent plastic model called Monoject.
But there was little demand for Roehr's new product. Most doctors insisted that it was safe -- and much cheaper -- to sterilize and reuse glass syringes. ``We pushed and pushed,'' said Stevens, but ``people in the health care field just didn't want to hear about it.''
Becton Dickinson and Company had heard about the Monoject and realized that plastic disposable syringes were the future.
In the summer of 1957, the nation's leading maker of glass syringes sent a small army of executives, engineers and assembly workers to Columbus, 70 miles west of Omaha.
Their mission was to create an inexpensive plastic syringe, and in the company's thermometer factory on the edge of town, they started work on a disposable version that would be called Plastipak.
At night, the team would gather at Louie's steak house to discuss their progress and belt out a theme song:
A million a week in the springtime
A million a week in the fall
A million a week in the springtime
Or we won't get home at all!
On a late winter day in 1960, Marjorie Atkins visited Dr. Albert Weiner for anxiety treatment. Weiner, an osteopath specializing in psychotherapy, injected her with a sedative.
Within six months, the 53-year-old woman was dead of hepatitis.
Fourteen more of Weiner's patients would die of the disease during the next eight months, and 29 others would fall gravely ill.
Weiner was eventually convicted of 12 manslaughter counts for injecting patients with syringes contaminated by hepatitis.
The case made national headlines and sent doctors around the country scrambling for disposable syringes. It also secured the fortunes of Becton Dickinson and Roehr Products.
Within a year of Weiner's conviction, sterile disposable syringes captured a third of the nation's needle market, and needle manufacturers were producing tens of millions of disposables annually.
The sudden demand for disposables made Roehr Products an attractive takeover target, and in 1961 the company was sold to a firm that would become Sherwood, Davis & Geck, the nation's second-largest syringe company.
But no company profited more from the soaring demand for disposables than Becton Dickinson. With cash raised by its first public stock offering, the company began making millions of the syringes, promoting them as a surefire way to stop the spread of disease.
In just three years, sales revenues quadrupled, and Becton Dickinson was on the road to becoming the most powerful needle manufacturer in the world.
It didn't take long for the nation's doctors to realize that the new disposable syringes presented health hazards of their own.
As more disposables were manufactured, used and discarded, more were picked from the trash by drug addicts, children and others risking deadly infections.
At the American Medical Association's 1967 convention, Resolution No. 26 called on needle manufacturers to ``adopt designs to prevent reuse.''
It was the first public warning that the new disposables could be just as dangerous as the syringes they replaced.
The resolution passed unanimously.
Needle manufacturers ignored it. Years later, Becton Dickinson officials would say they had never heard of it.
On June 27, 1969, more than 200 factory workers lined up for vaccinations against the ``Hong Kong'' flu.
Four days later, one worker died of septic shock. In a few more days, the plant's 51-year-old technical manager, his left upper arm swollen from a massive bacterial infection, was dead.
Medical investigators traced the deaths to streptococci bacteria spread by the vaccinations. Disposable syringes had been used, but to save money, doctors had filled each syringe with 20 doses. Although the needles had been changed between each injection, back pressure from the shots apparently forced infected blood into the syringe barrel, contaminating the vaccine.
It was among the earliest documented cases of lethal infections transmitted through disposable syringes.
In 1974, the World Health Organization launched the most powerful attack in history on deadly diseases: an ambitious campaign to vaccinate every child around the globe.
Inspired by the success of mass immunizations against smallpox, WHO's Expanded Program on Immunization focused on tuberculosis, diphtheria, tetanus, whooping cough, polio and measles.
These diseases had killed tens of millions of people in the early 1970s. But by 1974, only 5 percent of the world's children had been vaccinated.
Reaching more would take training, vaccines -- and millions of clean needles and syringes.
At the time, WHO believed that reusable glass syringes, properly sterilized, were safe enough for the immunization program. They were also the cheapest option, because one syringe could administer dozens of shots, whereas the new disposables were designed to be discarded after a single injection. So the agency hired armies of health experts to train immunization workers around the globe on sterilizing the reusable needles.
From 1974 to 1980, millions of vaccinations were administered and recorded. Children in virtually every community of every country were immunized.
But soon after the immunization campaign started, WHO officials discovered that many of the needles and syringes used had not been properly sterilized.
They realized that the children were being vaccinated and exposed to lethal diseases at the same time.
In October 1980, a WHO newsletter published a cover story on a radical new device -- a syringe containing a simple mechanism that prevented it from being used more than once.
The story called the device ``the syringe of the future.''
It was the first public notice that world health officials had found a simple technological solution to the problem of syringe reuse. And it suggested that the agency was acutely aware of the underlying social and economic costs of treating victims.
The story warned that ``the use of contaminated syringes, especially when they are used over and over again, can cause infections and even lead to an epidemic. . . . Such `accidents,' which are not uncommon, can be more costly . . . than measures to prevent them.''
The new syringe was ``inexpensive'' and would ``shortly become available,'' the article said.
The syringe was never produced.
In June 1981, skittish staffers at the national Centers for Disease Control and Prevention in Atlanta slipped a disturbing report onto Page 2 of the agency's weekly newsletter. It described unusual cases of Pneumocystis pneumonia among homosexual men. The workers feared provoking panic -- and prejudice -- over a brewing epidemic unlike any they had seen before.
A year later, at a meeting of national health experts in Washington, D.C., the fatal immune-system disorder that could be transmitted by bodily fluids, blood and used needles was given a name: AIDS.
Researchers would discover that AIDS was not just a problem within gay communities in the United States and Europe. It was also rampant among heterosexuals in the Caribbean and Africa.
AIDS did what no other disease before it could: force world health experts to pursue a technological solution for syringe reuse.
``We'd been concerned about needle reuse since the 1970s,'' said Peter Carrasco, a technical adviser on immunization at the Pan American Health Organization. ``But with AIDS in 1982, that's when we really had to start looking at it.''
Since John Lloyd joined WHO's childhood immunization campaign in the late 1970s, his most frustrating task had been to make vaccination workers properly sterilize reusable plastic and glass syringes and needles.
The workers would run out of fuel for portable field sterilizers supplied by WHO. Or they would see people waiting in line and, feeling rushed, fail to boil or steam the syringes long enough. Or experienced operators would move on, leaving the sterilizers in untrained hands.
Often, the workers wouldn't even try to sterilize the syringes and needles.
Then, in the mid-1980s, a number of African countries began using disposable syringes -- a shift that threatened to undermine the sterilization program completely.
The sterilizers could not adequately clean the plastic disposables, which also softened and bent at high temperatures. ``We started getting very worried about the confusion people were experiencing with two types of syringes,'' he said.
Lloyd realized that sterilizers alone would not stop syringes from spreading disease.
In 1984, Lloyd went to visit his old friend Peter Evans.
Four years earlier, as a UNICEF procurement officer, Evans was fiddling with a disposable syringe when he noticed that a few simple changes would make it impossible to use more than once.
``I thought I was on to something,'' Evans recalled.
So he applied for a U.S. patent, but his application was rejected.
``I found there were at least four earlier patents along the same lines going back some 20 years,'' he said.
But Evans' modified syringe caught Lloyd's eye.
``As we were talking,'' Lloyd said, ``I noticed that he had this intriguing gadget on his desk.
``It was like a revelation.''
Michael Free and his colleagues at PATH, a nonprofit developer of health technology for developing countries, were trying to develop a syringe that could be used only once.
In 1985, he enlisted his former student, Richard Jaffe, an anesthesiologist at Stanford University medical school, to help revamp their design.
``It was too easy to defeat (and reuse),'' said Jaffe. So he and a partner made several modifications.
Free also consulted Terence Ellard, a Seattle instrument maker. Ellard said he, too, refined the PATH design, taking it ``from something that was never going to work to something that worked well.''
The new device worked well enough to provoke serious interest from the U.S. Agency for International Development. Over the next few years, the agency would give PATH about $250,000 to develop the device further.
In 1986, health experts from WHO, USAID and other agencies asked inventors and medical manufacturers around the world to submit designs for nonreusable syringes.
The syringes had to automatically destruct after one use, include needles that could not be removed, and contain other features that met the requirements of child immunization programs.
In July 1987, the health experts gathered to review the submissions.
There was one from Johns Hopkins University medical researchers, another from a small Spanish manufacturer and several from designers in England, Denmark and Switzerland.
A millionaire French inventor proposed an idea he conceived after contracting hepatitis from a hospital needle -- the same design touted in the WHO newsletter seven years before.
No designs were submitted by Becton Dickinson, Sherwood or any other major syringe manufacturer.
Still, the group of experts adjourned with 35 different prototypes.
On Nov. 16, 1987, the group reconvened in the nation's capital to discuss the most promising prototypes.
Two stood out, Lloyd recalled, both developed by PATH. One included a thumbnail-size plastic bubble that could be squeezed flat to administer a shot. The other was the syringe that Jaffe and Ellard helped refine.
The need for safer syringes was becoming more urgent. Sterilization programs were failing. Disposable needles were creating new problems. And a series of reports from around the world suggested that the dangers of reusing syringes were out of control.
In 1984, hepatitis was found in more than 15 percent of syringes discarded in Florence, Italy. In 1986, researchers reported from Zaire that syringes transmitted monkey pox and that people who received more injections had higher rates of HIV infection.
In 1987, the CDC reported that of nine African countries surveyed, not one sterilized syringes before vaccinations.
Still, Lloyd and the other health experts were confident. They believed a powerful, though tragic, force was on their side.
``We all hoped very much,'' Lloyd said, ``that the AIDS crisis would provoke manufacturers to pick up the idea of the autodestruct and that the crisis would help them project it into the market.
``I can recall a great deal of optimism as I looked around the table that day. People were very intrigued and hopeful that we could achieve safety with a device.''
They thought they had reached a new era of safe injections -- and naively believed they would continue to immunize children without inflicting deadly disease.
In April, The Chronicle published ``Deadly Needles,'' a three-part series about accidental needle injuries. Today, we begin a new series about deadly viruses transmitted through syringe reuse -- an epidemic destroying millions of lives every year. .
-- TODAY: (1920-1987) Researchers warn of an emerging epidemic.
-- TOMORROW: (1988-1994) Prototypes of nonreusable syringes promise safer injections.
-- THURSDAY: (1995-1998) After miscalculations by health officials and resistance by needle makers, turmoil fuels the epidemic.
For more about ``Deadly Needles'' watch NewsCenter 4 at 6 p.m. tonight. Or, log onto www.sfgate.com. for this week's series, as well as The Chronicle's three-part series on accidental needle sticks published in April.
The statistics and other figures used in this series came from a number of sources:
The estimated number of worldwide infections and deaths caused by reuse of contaminated syringes -- 10 million infections and 1.8 million deaths per year -- came from internal reports of the World Health Organization. These reports are still under scientific review and have not been published, but WHO officials say the draft figures are conservative estimates.
The estimates of the global prevalance of the diseases that are most likely to be spread through syringe reuse -- HIV, hepatitis B and hepatitis C -- came from data compiled by WHO, the U.S. Centers for Disease Control and Prevention (CDC) and United Nations AIDS.
Figures on the number of nonreusable or ``autodestruct'' syringes produced and distributed were compiled from syringe manufacturers, United Nations Children's Fund (UNICEF), WHO and a group of immunization experts called Technical Network for Logistics in Health (Technet).
The funding figures for development of several nonreusables syringes were supplied by the U.S. Agency for International Development (USAID) and Program for Appropriate Technology in Health (PATH). Pricing data for the syringes came from UNICEF and individual manufacturers.
U.S. and global estimates of accidental needle sticks came from the International Health Care Worker Safety Center, CDC, WHO and from studies in Thailand, Pakistan and Tanzania.
INVISIBLE EPIDEMIC 1920-87
. FIRST SYRINGE 1897: Becton Dickinson and Co. opens for business and begins selling its first syringe -- made of glass -- for $2.50.
1920s-'30s: In tropical countries, injections soar in popularity after shots cure the disfiguring disease called yaws.
1930: Researchers note an increase in polio following hypodermic injections in Madagascar.
1933: A medical journal reports that a rare occurrence of malaria in Omaha, Neb., is the result of a syringe shared by two drug users.
A report documents that hepatitis can be transmitted by syringe reuse. The study says the virus is almost impossible to remove from a needle through accepted disinfection methods.
A study shows that changing needles is not enough to prevent contamination because blood can back up into the syringe barrel.
A hepatitis outbreak is reported among U.S. soldiers after they receive multiple-dose tetanus shots from reused syringes.
Becton Dickinson introduces the Multifit, its first glass syringe with interchangeable needles.
TUBERCULOSIS A study shows that tuberculosis can be transmitted by syringe reuse.
FIRST DISPOSABLE Roehr Products introduces the first plastic disposable hypodermic syringe, called the Monoject. The company is soon sold to a firm that will become Sherwood, Davis & Geck, the nation's second-largest syringe company.
DEATH LINK Outbreak of hepatitis is traced to a New Jersey doctor who used contaminated reusable syringes. Fifteen deaths result, propelling national sales of disposable syringes.
PLASTIPAK Becton Dickinson introduces its first plastic disposable syringe, called the Plastipak. The company goes public the following year and sells its shares on the stock market.
DOCTORS' PLEA American Medical Association unanimously adopts resolution asking manufacturers to market syringe designs that would prevent reuse. Manufacturers ignore the request.
ROYALTIES WAIVED Wyeth Laboratories, a subsidiary of American Home Products, waives patent royalties to its special smallpox needle, used to deliver 200 million vaccinations a year worldwide.
FLU SHOTS Two factory workers die in Australia from bacterial infection traced to flu shots. The shots were given with the same disposable syringe, but with new sterile needles after each injection.
GLOBAL VACCINATIONS World Health Organization launches Expanded Program on Immunization to vaccinate all children worldwide against diphtheria, tetanus, whooping cough, polio, measles and tuberculosis.
EBOLA OUTBREAK In Zaire, the Ebola virus kills 280 people, most of whom were infected by reused syringes and needles.
SINGAPORE OUTBREAK Outbreak of fatal hepatitis B cases in Singapore traced to contaminated syringes.
SMALLPOX Smallpox eradicated globally making the disease the first victim of worldwide immunization programs.
FIRST AUTODESTRUCT NEEDLE Prototype of one of the first nonreusable or autodestruct syringes, called the ``syringe of the future,'' is described in a World Health Organization newsletter.
STERILIZERS World Health Organization orders hundreds of thousands of portable steam sterilizers for developing countries to prevent cross-infection from reused syringes.
AIDS Virus that causes AIDS is isolated in U.S. and French laboratories. U.S. Agency for International Development agrees to fund development of an autodestruct syringe with nonprofit Seattle group called PATH.
RECOMMENDATIONS WHO and UNICEF issue policy statement requiring use of a sterile needle and syringe for each vaccination and recommend steam sterilization.
Studies of children in Zaire and Haiti show those who receive more injections have higher rates of HIV.
USAID sponsors meetings in Geneva and Washington D.C., with WHO, UNICEF, PATH and a panel of experts to review 35 designs for autodestruct syringes. Among the most promising is a laminated blister model and a syringe with a metal clip that renders it nonreusable, both developed by PATH.
-- In 1974, only 5 percent of the world's children were immunized against the most serious childhood diseases. World Health Organization
Developed in the late 1950s for one-time use, the plastic disposable syringe is still often reused in poor countries.
-- Conventional syringe Includes a plunger and hollow needle for injecting or drawing fluids. Can be used multiple times.
Costs about 5 cents each.
-- UniJect single-use syringe.
Prefilled plastic bubble attached to a needle with a one-way valve. Can give only one injection. Not yet available, but expected to cost relief agencies about 10 cents each. Contaminated barrel can spread disease even when needle is sterile .
Hepatitis B virus
-- Hepatitis B infection can cause cirrhosis and is the leading cause of liver cancer in the world. The virus is extremely infectious and can stay alive in dried blood for up to a year. Only 10 percent of infected adults become chronic carriers, but 60 percent to 90 percent of infected children under 1 year old end up with a chronic condition. One-fourth of chronic carriers eventually die of liver cancer or cirrhosis. A three-shot vaccine has been available since 1982, but it is still too costly for widespread use in many countries.
-- Chance of getting hepatitis B from a syringe infected with the hepatitis B virus: 30%
Hepatitis C virus
-- The hepatitis C virus also attacks the liver. More than 80 percent of those infected become chronic carriers, and one-fifth of those will develop cirrhosis within 10 to 40 years. A smaller percentage develop liver cancer. The first test for the virus became available in 1989, so much is still unknown about the disease. There is no vaccine. Treatment with interferon is expensive, limited to adults and effective in less than 20 percent of cases.
-- Chance of getting hepatitis C from a syringe infected with the hepatitis C virus: 3%-5%
HIV, also known as the AIDS virus
-- The AIDS virus attacks the immune system, allowing other diseases to develop. AIDS was considered fatal until a recent combination of new drugs led to a dramatic drop in the death rate in the United States. But few people in developing regions can afford the new drugs. HIV is transmitted primarily through sexual contact. Transmission risk from a needle is low. But because the underlying prevalence of the disease is increasing at a rapid rate, particularly in Africa, where unsterile injections are common, the overall risk is rising rapidly.
More than 20 other infections can be transmitted through contaminated needles, including: -- Syphilis, malaria, tuberculosis, streptococcal and staphylococcal sepsis, Dengue fever, Rocky Mountain spotted fever, herpes, hepatitis D and G, babesiosis, brucellosis, leptospirosis, arboviral infections, relapsing fever, Creutzfeldt-Jakob disease and viral fevers caused by Ebola. -- Chance of getting HIV from a syringe infected
with the HIV virus 0.3%
Deadly viruses like hepatitis B, hepatitis C and HIV have spread rapidly over the past few decades and experts say contaminated syringes play a major role in their transmission.
Estimated total annual infections from syringe reuse:
Hepatitis B: 8.3 mil.
Hepatitis C: 1.3 mil.
HIV: 31,000
Estimated annual death rate:
1.4 mil. to 1.8 mil.
-- Sub-Saharan Africa Kenya: Rural doctors are supplied with limited numbers of syringes, forcing them to decide between not providing medical care or reusing the few syringes that they have.
Infections from syringe reuse:
Hepatitis B: 1.25 mil.
Hepatitis C: 204,000
HIV: 16,400
-- Middle Eastern crescent Egypt: Mass injections to treat a water-borne disease in the 1960s and 1970s have resulted in the world's highest incidence of hepatitis C. Investigators say syringe reuse was the cause.
Infections from syringe reuse:
Hepatitis B: 693,700
Hepatitis C: 94,400
HIV: 100
-- Latin America and the Caribbean Brazil: Prompted by a soaring number of AIDS cases, Brazil passed a law in 1996 mandating the use of non-reusable syringes. But the law has never been implemented.
Infections from syringe reuse:
Hepatitis B: 24,700
Hepatitis C: 89,600
HIV: 900
-- Former Soviet Union and Eastern bloc countries Russia: In 1988 and 1989, 246 children in six southern Russian towns are infected with HIV from reused needles and syringes.
Infections from syringe reuse:
Hepatitis B: 446,500
Hepatitis C: 60,800
HIV: 7,300
-- China
A study of 294 village doctors indicates widespread inadequacy of sterilization of syringes and acupuncture needles.
Infections from syringe reuse:
Hepatitis B: 2.51 mil.
Hepatitis C: 339,800
HIV: 100
Other Asian/Pacific Island
Cambodia: More than half of the government's outlay for public health care is swallowed up by graft, resulting in limited availability of syringes and rampant reuse.
Infections from syringe reuse:
Hepatitis B: 1.51 mil.
Hepatitis C: 246,200
HIV: 4,600
World prevalence of the hepatitis B virus More than 350 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 170 million people.
World prevalence of the HIV HIV infections from syringe reuse track the worldwide prevalence of the virus, which now infects more than 30 million people.
Source: World Health Organization and Chronicle research
Chronicle foreign correspondents Sandy Barron in Cambodia, Jack Epstein in Brazil, Steve Fennessy in Egypt, Brian Humphreys in Russia and Andrea Useem in Kenya contributed to this report.
http://sfgate.com/cgi-bin/article.cgi?f=/c/a/1998/10/27/MN52NEE.DTL
This article appeared on page A - 1 of the San Francisco Chronicle