[Fwd: [DOEwatch] Fluoride based antibiotic shows crippling effect--- Cipro and Bayer]

[Guest guest]

Source:

http://westchesterweekly.com/gbase/News/content?oid=oid:34987

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Anthrax vs. the Cure

Exposed Workers Blame Cipro for Crippling Effects.

 

by Patrick Rucker - September 25, 2003

Westchester County Weekly, NY

 

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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