Cipro Made Us Sick
Hundreds to sue West Haven-based Bayer over a drug they took to fight anthraxSep 25, 2003 | Hartford Advocate
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 related to inhalation of 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 bacteria were found in the mailroom and were feared to have been disseminated throughout the the building.
The only prudent thing to do, authorities decided, would be to administer doses of the powerful antibiotic Ciprofloxacin Hydrochloride or 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 left him debilitated 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 aafflicted gainst Bayer Pharmaceutical, Cipro's Germany-based manufacturer that 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 says his members have been made aware of the suit and some may join. The Wallingford mail processing plant tested positive for antrax spores in November 2001. A Connecticut woman died of anthrax exposure from a letter traced to the Wallingford site.
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 said the investigation was now in the hands of the Centers for Disease Control and Prevention.
Attorney Steve Sheller is leading the Cipro lawsuit. Hundreds of people, Sheller believes, are suffering severe health problems related to the drug. Sheller claims Cipro was often the wrong medicine for dealing with the anthrax outbreak and that Bayer knew the drug could cause complications, particularly if taken in combination with other drugs. But Bayer continued to push its use nevertheless.
"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 FDA 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, 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.
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 attacks 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 liability 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 to encourage wide use 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. 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 used in the attacks. In fact, many common antibiotics, such as penicillin, were just as effective in killing anthrax. Such reports went unheeded at the time, as did warnings about side effects. 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 cycles of antibiotics and 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. 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."
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 from 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 off 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 they were looking for, whether it was going to be covered by insurance. That did seem like a pretty serious case."
Isaac is less concerned about the firm's exposure in the Cipro case, he says, because "Cipro is one of the biggest-selling antibiotics in the world" that has been sold by Bayer for a long time and has recently had certain dosages go off patent.
"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. The health problems faced by Grozier and others can be directly traced to Cipro, Shiller 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."