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Westchester County Weekly, NY
Exposed Workers Blame Cipro for Crippling Effects
by Patrick Rucker - September 25, 2003
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.
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
antibacterials, 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 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."
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