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KATHLEEN CEI
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When an
anthrax-laced letter was opened in the Washington office of South
Dakota Sen. Tom Daschle on Oct. 15, 2001, Capitol Hill staff had
good reason to panic. Ten days earlier, Bob Stevens, a 63-year-old
photo editor at the supermarket tabloid the Sun, had died from
complications relating to inhalation anthrax. "Are you afraid?" the
letter taunted. Yes, they were.
Nearly three dozen Capitol Hill staff tested positive for anthrax
exposure. Spores of the deadly bacterium were found in the mailroom
and were feared to have been disseminated throughout the building.
The only prudent thing to do, authorities decided, would be to
administer doses of the powerful antibiotic Cipro to those who were
in proximity to the infected letter.
Daschle's office adjoined that of Montana Sen. Max Baucus. Baucus
staffer John Angell took the drug along with all of his colleagues.
Neither Angell, nor anyone else working at the Capitol, contracted
inhalation anthrax. The drug seemed to work. But now some are
asking, "At what cost?"
Days after starting his cycle of Cipro, Angell began suffering
pain in his joints and tendons. Walking became labored and painful.
He stopped taking Cipro, but his condition did not improve. In fact,
his condition has never improved. Chronic pain forced Angell to
leave his post with Baucus. He now works as a consultant from home
and lays the blame for his disability on Cipro.
And Angell is not alone. The drug that he believes debilitated
him is being blamed by many others for destroying their normal
lives, and now they are taking action. A Philadelphia law firm is
preparing a class action lawsuit against Bayer Pharmaceutical,
Cipro's Germany-based manufacturer, which has its North American
headquarters in West Haven. The suit is being filed on behalf of the
Capitol Hill staff, Washington postal workers, employees of American
Media--publisher of the Sun and National Inquirer--and all those who
claim to have been injured after taking Cipro in the wake of the
anthrax scare. The suit also involves persons who took the drug for
routine medical purposes.
In a separate action, hundreds of postal workers from Washington,
D.C.'s Brentwood mail processing facility are suing the Postal
Service for failing to provide them with sufficient information
about the building's anthrax contamination and their possible
exposure.
John Dirzius, President of the Greater Connectucut Area Local of
the American Postal Workers Union complains that his members were
also misled about the true peril of working in a contaminated
processing plant.
"At the end of November, they said that they found trace amounts
of anthrax at the Walingford processing plant," Dirzius says. "Three
months later, the state epidemiologist said that there were 3
million spores found on one machine. We went on a year and a half
journey from the GAO to Congress to find out the truth."
Last December, Sen. Baucus called on the General Accounting
Office--the investigative arm of Congress--to determine whether
public-health authorities knew enough "about the risks, benefits and
consequences of long-term Cipro use as a preventive measure against
anthrax." A Baucus spokeswoman says the investigation is now in the
hands of the Centers for Disease Control.
Attorney Steve Sheller is leading the Cipro lawsuit. Hundreds of
people, Sheller believes, are suffering severe health problems
related to the drug.
Sheller says Cipro has left his clients with a variety of
debilitating ailments, including severe joint pain, tendinitis and
muscle ache, severe anxiety and panic attacks, insomnia and
depression.
Sheller claims Cipro was often the wrong medicine for dealing
with the anthrax scare and that Bayer knew the drug could cause
complications, particularly if taken in combination with other
drugs, but continued to push its use anyway.
"They were handing Cipro out like candy," Sheller says, and his
clients were not informed about possible adverse effects.
If the Sept. 11 attacks shattered a sense of national
invulnerability, the anthrax case seemed to show that we were not
completely helpless. Cipro had been approved by the U.S. Food and
Drug Administration the previous July specifically to treat
inhalation anthrax.
The drug was widely seen as a silver bullet against the fatal
illness, and Bayer vowed to keep the nation armed. The company
churned out more of the drug at its German manufacturing
headquarters and sent it to the company's North American
pharmaceutical headquarters in West Haven. There, during 24-hour
shifts and under heightened security, the drug was processed into
tablets and packaged. By mid-October 2001, the company had cranked
up its production from 20 million to 50 million tablets per month
and said it would continue that pace until the demand subsided.
The Centers for Disease Control estimates that 10,000 persons in
the eastern U.S. were offered a 60-day cycle of Cipro as part of an
unprecedented prevention program. Many more went hunting for the
drug. Dr. John Shanley, director of the infectious disease division
at the University of Connecticut Health Center, received "tons" of
requests for Cipro in the days after the Florida anthrax attacks.
About six weeks later the hysteria subsided. The number of new
cases of anthrax dwindled and then stopped. Five people died from
inhalation anthrax. By the time Ottilie Lundgren, 94, of Oxford,
Conn. --the last victim--succumbed, attention had already turned to
events in Afghanistan, the Middle East and other fronts in the war
on terrorism. The fact that the source of the anthrax attack has
never been discovered has all but been forgotten.
But the looming lawsuit and second anniversary of the anthrax
attacks raise many questions about how officials dealt with the
outbreak, in particular the widespread use of Cipro.
"That is why this is so important," Sheller says. "When you have
an emergency situation like the anthrax attacks, you want to make
sure that people are given important information about what they are
being handed. That did not happen in many instances, and it does not
happen even today in non-emergency situations."
Sheller, a founding partner of the firm Sheller, Ludwig and
Badey--one of the biggest product liability and class action firms
on the East Coast--has been part of many high-profile suits,
including claims for faulty breast and penile implants, the
aggressive marketing of Prozac and endoscope safety.
Sheller claims that Bayer's promotion of Cipro during the anthrax
scare offers only one example of a drug company providing inaccurate
information about its product in order to boost sales. If his
clients had known the dangers of Cipro, particularly when taken in
combination with other drugs, Sheller says, they would never have
taken them.
Even some of those who are skeptical of Sheller's claims of
widespread health problems caused by Cipro see problems in how
authorities dealt with the anthrax scare and have misgivings about
how a similar biological or chemical terror attack would be handled
in the future. The decision to widely use Cipro against the anthrax
attacks, seen as a prudent response at the time, now seems to have
been hasty and made without a full appreciation of the consequences.
"The problem was that the dangers of weaponized anthrax were not
fully appreciated, nor the dangers of side effects from Cipro," says
David Ozonoff, professor of environmental health at Boston
University's School of Public Health, who has studied the response
to the anthrax outbreak.
The CDC, he says, "should have known better about how many spores
it took to infect. They issued a falsely reassuring line that it
took 10,000 spores. ... Secondly, there was additional information
that was almost certainly known to the military about the dangers of
weaponized material that was not shared with public health
authorities, compounding the problem."
While Cipro was the most potent drug, it was not the only one
effective against the strain of anthrax behind the outbreak. In
fact, many common antibiotics, such as penicillin, were just as
effective in killing the bacteria. Such reports went unheeded at the
time, as did warnings about side effects and word that widespread
improper use of the drug could diminish its long-term effectiveness.
Instead, the strongest medicine was sought first.
"I'm not saying that Cipro does not work," Sheller insists. "What
I am saying is that it should not be used to the extent that it is
used."
Bob Grozier, 44, a claimant in Sheller's suit, agrees. His
experience with Cipro began before the anthrax attacks, when he was
diagnosed with a bacterial infection of his prostate in early 2001.
Suffering crippling pain and urinary problems, Grozier was twice
prescribed antibacterial cycles. Twice the problem returned before
he began a 60-day cycle of Cipro and a second anti-inflammatory drug
to ease the pain in his prostate.
The drugs seemed to work. A prostate culture found that Cipro had
knocked out the bacteria. But within days of finishing the cycle,
Grozier began hearing a ringing in his ear and had trouble sleeping.
"I got complete insomnia where I could not sleep at all," Grozier
says. "Then shortly after that I had a massive, incredibly massive
panic attack. It was so bad that I had to go to the emergency room."
"We took him in there and got him in the door and he laid down on
the floor in the waiting room and started to weep," remembers
Grozier's mother, Shirley, who was there at the time. "He cried and
cried and cried. ... That was the first time I saw my adult son
cry."
Before Grozier's health problems, he was a computer systems
manager at an insurance company in eastern Pennsylvania, earning
$88,000 a year. Now living in his mother's house with his wife and
daughter, Grozier relies on disability insurance and Social
Security.
"I've met several people on the Internet that have been damaged
by Cipro," Grozier says. "It's scary because a couple of them are
three to five years out and still have symptoms."
Bayer insists that its drug is safe. According to Dr. Paul
MacCarthy, vice president of U.S. medical science at Bayer's West
Haven facility, Cipro is a highly effective antibiotic with an over
15-year record of successfully treating a wide range of severe
bacterial infections--urinary tract, prostitis, respiratory tract
and bronchial--with few adverse effects.
The observed side effects, according to Dr. MacCarthy, "were
typically gastrointestinal--nausea, vomiting, diarrhea. ... We're
talking side effects of less than 5 percent."
Cipro has largely proven itself safe and effective, MacCarthy
says. He points out that the Centers for Disease Control conducted a
study of the impact of Cipro on those taking it after the anthrax
outbreak and found that there were few long-term effects. MacCarthy
also points out that the FDA approved a high-dose, once-a-day
version of Cipro last August to treat urinary tract infections and
that other drug companies are now producing their own generic
versions of the drug.
A CDC study released one year after the attacks indeed concluded
that "adverse events associated with antimicrobial prophylaxis
[Cipro is the dominant drug in the study] to prevent anthrax were
commonly reported, but hospitalizations and serious adverse events
as defined by Food and Drug Administration criteria were rare."
"If you are telling me that someone had these effects and they
were persisting, long-term, months to years after treatment, I would
be surprised," Dr. MacCarthy says.
To Colin Isaac, a chemical industry analyst for J.P. Morgan in
London, Sheller's Cipro case sounds opportunistic.
Attorneys may smell blood since Bayer was forced to remove its
anti-cholesterol drug Baycol from the market in August 2001. That
product led to over 10,000 lawsuits, Isaac estimates, and forced
analysts like him to guess the company's exposure. "On the Baycol
thing there were all sorts of calculations you could do looking at
the number of plaintiffs, what sort of amounts of money the were
looking for, whether it was going to be covered by insurance. That
did seem like a pretty serious case."
Isaac is less worried about the firm's exposure in the Cipro
case, he says, because "Cipro is one of the biggest-selling
antibiotics in the world" and has been sold by Bayer for a long
time.
"It is a massive drug that has never before had these side
effects," Isaac says. "I would be surprised, to be honest, if they
get anywhere with this."
Sheller insists that he has a strong case. He predicts it will
follow the arc of his successful suit against GlaxoSmithKlein,
makers of Lymerix, the Lyme disease vaccine that was recently forced
off the market.
The health problems faced by Grozier and others can be directly
traced to Cipro, Sheller maintains, and he looks forward to proving
that point. The frequency and common nature of the complaints
against Cipro indicate that the drug is to blame, he says.
"I never had these problems before," Grozier says. "It's not only
my experience, but [also the experience of] the great number of
people I've met on the Internet. It could not be possible that we
all had normal lives, took this medication and now our lives are
ruined."
Whatever the result of the suit, some say the real lesson of
Cipro's use to treat anthrax will be for the future of a chemical or
biological attack.
"The 'security concerns' about scientific information, which
keeps such information closely guarded, is almost certainly more
dangerous than having it out there," says environmental health prof
Ozonoff. "There are thousands of soft targets to tempt the average
terrorist, and they don't need relatively sophisticated information
to do it. The big danger is that important information will not be
shared with those in the public health community who need to know
it."