“Death by Levaquin” Brain/Body Toxic Drug

Pfizer’s Nigerian Nightmare
Nicole Perlroth 12.08.08, 12:00 AM ET

  What if a drug company experimenting on critically ill children doesn’t get the proper parental consent, 11 of those children die and a whistleblower is fired?

Those are the charges leveled against Pfizer in a legal battle that has dragged on for the past seven years in Manhattan federal court and in Nigeria, where the government is seeking $8.5 billion in restitution and damages–and jail terms for various Pfizer officials, including former chief executive William Steere.

Things may come to a head soon. A federal appeals court is expected to rule on whether the children’s parents can go after Pfizer in New York. Meanwhile, to avoid what’s shaping up to be an ugly court battle, Pfizer is said to have offered to settle with the Nigerian government for $150 million, plus money to modernize and equip a Nigerian infectious disease hospital.

Pfizer says the children died from the disease, not from the drug trial, won’t confirm a possible settlement, and says it’s “proud” of its role during the 1996 epidemic, an ugly trifecta of meningitis, cholera and measles. Twelve thousand Nigerians died from meningitis alone, many of them children.

What really happened at a remote sub-Saharan hospital in Kano, Nigeria may never be known. But interviews with Pfizer employees, parents of some of the victims, Food & Drug Administration officials, court filings and other legal documents provide an unsettling look at the pitfalls of doing hurried drug trials in Third World countries.

That’s happening more often these days. Under pressure to reduce research costs and win fast-track approvals, drug companies do 43% of their clinical trials abroad, up from 14% ten years ago. The Tufts Center for the Study of Drug Development says that number will rise to 65% within three years.

Roll the tape back to the spring of 1996. Outside the cluster of cinder block structures that make up Kano’s Infectious Diseases Hospital, hundreds of sick children are lined up, awaiting treatment from Doctors Without Borders, the nonprofit group, which has set up a tent on hospital grounds.

The doctors are injecting the children with oily chloramphenicol, endorsed by the World Health Organization as the recommended treatment for bacterial meningitis epidemics. The half-century-old drug is rarely used in developed countries because of a sometimes fatal side effect (blood disorders). But it’s readily available in Third World countries because it is economical and effective.

Five thousand miles away in a Pfizer research lab in Groton, Conn., infectious disease specialist Scott Hopkins is surfing the Internet when he spots a story on the epidemic–and sees opportunity. Pfizer was waist-deep in an ambitious test of Trovan, an antibiotic showing promise against a wide variety of infections, from bronchitis to pneumonia. It had potential to be Pfizer’s answer to Bayer’s Cipro, then the leader in the $11 billion anti-infection market.

Pfizer had already enrolled thousands of adults in Trovan clinical trials but had not tested it yet on children, which posed a problem. Trovan belongs to a category of powerful antibiotics called quinolones, which have the ability to penetrate tissues to kill bacteria.

But there can be serious side effects, including liver problems and cartilage and tendon abnormalities. In early stage testing quinolones had caused liver and joint damage in young rats and dogs. In order to gain maximum market share, Pfizer would have to develop an oral form of Trovan that proved safe for pediatric use.

Hopkins put together a group of five researchers and within six weeks had chartered a DC-9 to Kano, Nigeria. Normally, it takes nine months to design a late-stage drug trial. Pfizer says the trip could never have been made so quickly if a global pediatric trial hadn’t already been in the works.

One physician stayed behind. Pfizer had hired Juan Walterspiel, a pediatric infectious disease specialist at Yale Medical School, in 1994 for Trovan’s pediatric clinical development. Pfizer says it doesn’t know why Dr. Walterspiel wasn’t selected to go to Nigeria. But Dr. Walterspiel, who declined to speak with FORBES, would later write to chief executive Steere that the Nigerian study was “in violation of ethical rules for the conduct of medical experiments in humans.”

Once in Nigeria, Dr. Hopkins and his team set up shop near the Doctors Without Borders tent. Over the course of two weeks they picked 200 out of the thousands of children awaiting treatment, between 3 months and 18 years old. Half got a full daily dose of Trovan, orally or by injection, depending on age and/or ability to swallow, for five days. The control group got an injectable dose of Rocephin, a Hoffmann-La Roche drug widely used against meningitis. Those kids got 100mg of Rocephin on the first day but only one-third of that dose each of the next four days.

Why? Pfizer argues that Rocephin injections can be painful. The full dosage takes several seconds to inject. “Kids don’t like needles,” says a spokesman.

Plus, Pfizer says one of its on-site doctors had helped develop Rocephin at Roche and believed the lower dose “more than enough.” But that wasn’t proved until seven years later, when a Doctors Without Borders study showed the lower dose to be effective.

A month later five children in the Trovan group and six in the Rocephin group were dead. Pfizer says those results were “remarkable,” given that the epidemic killed 10% of those infected.

But parents of the dead children in the Trovan group claim they were never shown–or were read–a consent form and weren’t told about Trovan’s risks or that a proved treatment from Doctors Without Borders was just steps away.

Parents of the dead children in the Rocephin group argue their children would have lived had Pfizer given them the full dose. Dozens of others allege that the trial left their children paralyzed, deaf, mute or blind.

Pfizer says it had bilingual nurses on-site who obtained oral consent from all the parents. The company also says it has all the patient charts with “yes” and “oral” boxes checked as to whether and how their consent was obtained. But Pfizer declined to show these consent forms to a reporter.

Are all the plaintiffs in fact the parents of the dead and injured children? Pfizer says that not all the names on the complaint match up with initials of patients listed on the medical charts. (Pfizer says it’s common to record only initials to protect confidentiality.)

The drug trial ended in May 1996. Dr. Walterspiel’s letter to Steere, dated Dec. 18, 1997, was not well received. Among the points he made: “Some of the children were in critical condition and most of them malnourished, which made oral absorption even more unpredictable. At least one died after a single oral dose; such a patient … should never have received an experimental antibiotic orally.”

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Responding in a Feb. 26, 1998 letter, a Pfizer lawyer refuted everything in Dr. Walterspiel’s letter: “The company acted appropriately and with complete regard for all legal, ethical, and humanitarian concerns.”

The next day Dr. Walterspiel was fired. Pfizer confirms that, but says it was “completely unrelated” to his complaints. Really? A wrongful termination suit subsequently filed in a Connecticut federal court was later settled. Neither Pfizer nor Dr. Walterspiel would comment on the settlement.

During a 1997 FDA audit Pfizer produced a letter dated a week before the trial began from a Nigerian hospital granting it ethical clearance. But the letter doesn’t really help Pfizer’s case: It was backdated.

Pfizer concedes the backdating is “unfortunate” but now argues there’s no Nigerian law or regulation requiring ethical committee approval before conducting a clinical trial. “Therefore,” Pfizer argues, “there was no need to obtain what the law did not require.”

However the lawsuits turn out, no more patients will be exposed to Trovan. Having initially applied to use it for pediatric meningitis, Pfizer withdrew that use from its application after the FDA audit found dozens of discrepancies in Pfizer’s records. The company says it intended to renew its application following a global pediatric trial already under way.

But it never had the chance. After approving Trovan for 14 other uses in 1997, the FDA advised Pfizer to pull the drug–two years and more than 2.5 million prescriptions later–citing “safety concerns.” The problem: deaths from Trovan-linked liver injuries. 

 

Before the Levaquin poisoning I could sleep a good 8 hours. Not anymore. The first year and a half of this toxicity I probably got about 3 to 4 hours a night. I went many nights with no sleep. 46 hours of no sleep was my record. I talked to a Cipro poisoned guy who went 4 days with no sleep and on the 5th night he got 3 hours of sleep. Last night I went to bed at 1:00 a.m. and fell asleep at around 4:30 a.m. Three and a half hours of lying in bed with my head shaking constantly and my legs burning. I got a prescription for Xyrem which is GHB, the date rape drug. You can’t eat anything for 3 hours prior to taking it or it doesn’t work well. Unfortunately I had some food and thus couldn’t fall asleep. It’s maddening just lying there praying for sleep. I even took Lyrica, and some narcotics and a little Ativan. Didn’t help. My brain is so fried from the Levaquin poisoning. I seem to wake up multiple times for no apparent reason. I don’t think I ever get into a stage 3 or 4 sleep. The doctor who prescribes Xyrem to me said it is one of the safest medications there is. He prescribes it to another quinolone victim.

The GHB makes my tingling a little worse but it does provide some sleep. I wouldn’t even put an asprin in my body 4 years ago. I didn’t want any pharmaceutical drugs in my body. I didn’t need to because I was very healthy. Now I am forced to take a bunch of drugs just to provide relief from Levaquin toxicity ( My living Death )

GHB has been criminalized and demonized by the media. Yet it is one of the safest substances known. It doesn’t even get metabolized by the liver or the kidneys. It used to be sold in health food stores back in the 1980’s for about ten dollars. Now my month’s prescription of Xyrem ( GHB ) costs $1,310 dollars. Over a thousand dollars for a one month supply. My health insurance pays for most of it but I still have a $50.00 copay. The drug companies  that make Ambien and Lunesta and the other sleep medications and antidepressants know it is a great drug so they use the media as their vehicle to demonize this useful substance. It is good for depression, cholesterol, anxiety, panic attacks and many other health problems.  They know GHB could do away with many drugs that are big cash producers today. I am sure there were many natural antibiotic alternatives for the supposed infection I had. But no, I was given Levaquin and the doctor assured me that it was very safe.

For the men and women troubled by Lariam, those dry statistics were very real and sometimes deadly experiences.

“I was a raving, crazy lunatic,” Martin Giannini said in an April telephone interview with UPI from Dublin, where he is trying to rebuild a life he says was shattered by Lariam. He took Lariam from June 1995 through September 1996 as a Peace Corps volunteer while in Togo in West Africa.

He said his mental problems started with nightmares, headaches and dizziness. He said his condition the next two months quickly deteriorated into an enveloping psychosis that required him to be evacuated.

“I just went to pieces,” Giannini said. “I’d been telling (Peace Corps medical personnel) since Day One that I had been having problems with this drug.”

Back in the United States, Giannini suffered from hallucinations. He heard voices. His mental problems climaxed in a three-day high-speed car trip that led him from Oklahoma to Illinois and into Wisconsin, where after a car crash he was found wandering in the woods. He has been hospitalized several times. He said he considered suicide.

“There were times … It was amazing I survived.”

Peace Corps medical officials said reports of mental problems among volunteers are due to the onset of schizophrenia that can show itself in the early 20s, when most volunteers join up, but not because of Lariam.

“We do get people who develop schizophrenia in the Peace Corps, but it is not associated with mefloquine,” said Russell Gerber, chief of the epidemiology unit at the Peace Corps.

Giannini sought back wages from the U.S. government, because the Peace Corps is a federal agency. In March 1998, the U.S. Department of Labor wrote Giannini a letter saying the department agreed to pay his medical expenses and compensate him for lost wages, “for a single, sustained, but acute psychotic reaction to mefloquine use” that lasted a full year.

UPI talked to 32 doctors, scientists and other experts, and 27 people who said they suffered adverse side effects from Lariam use. UPI reporters also reviewed dozens of e-mails from around the world — from soldiers, travelers and medical experts in the field — about problems with Lariam, as well as published reports.

Some examples:

– Francis Macleod Matthews, a 37-year-old lawyer who had taken Lariam a year earlier but continued to be troubled by bad dreams, threw himself off the roof of an apartment building in London. The coroner, Paul Knapman, ruled the death a suicide and said, “It is more likely than not that Lariam played some part,” according to the Times of London.

– Irish tourist Malcolm Edge, 27, was found hanging in a hotel room in Ho Chi Minh City, Vietnam, in 2000; he was taking Lariam. Edge had undergone a startling personality change on the trip, according to a traveling companion. The Dublin coroner notified the Irish Medicines Board that “concerns were expressed at the inquest in relation to possible psychotic reactions to Lariam,” but the coroner made no conclusion whether Lariam was a contributing factor in the death.

– In Australia, John O’Callaghan, 29, committed suicide after being treated with Lariam for malaria he contracted on a surfing trip to Indonesia. “Almost immediately,” his mother Jan wrote in an e-mail to the group Lariam Action, “he suffered severe neuropsychological and physical side effects. We did not know he was suffering from mefloquine toxicity. He had no history of these (physical and mental) illnesses. For a couple of years he tried to return to his previous healthy lifestyle. Finally, in September 2000, he took his own life.” He left a note:

“I know God will forgive me. No one could live with how I am feeling now. I know I will never forgive the bastards that gave me Larium. I am now the same as when I first had it — fully spinning can’t even walk properly – the walls are moving. My head feels like someone let a box of ants in it, extreme pain in my head. I am fully losing it. What does the future hold — ‘psyciatric wards’ no way. I know I’ve always been a little bit different even before I had Larium but since it first blew my brains apart and then settled down I have never been the same, always dazed and confused, always physically sick. I never thought this could happen to me. Sorry Mum, Dad”

O’Callaghan’s account of symptoms mirrors those of several others: Charles Perry, who committed suicide in Ohio in 1999, spoke of a relentless pain at the base of his cranium, said his wife, Linda: He would put his head on the table and hold his hand over the base of his skull, saying, “This is where it hurts.” (Linda Perry sued Roche for alleged failure to warn about side effects, including suicide. The lawsuit recently was settled out of court. The terms were not disclosed).

Rosemary Waller of Cincinnati kept a diary of symptoms that developed after she took Lariam in the summer of 1997. Her entry for May 3, 1999, reads: “Scalp burning, gripping intensified into worst-ever headache.” On June 8 she noted “almost continuous scalp sensations of burning, crawling, gripping, hole-boring through in one of several spots on scalp.”

Elisa von Joeden-Forgey, who went to Africa in 1995 as part of her doctoral work at the University of Pennsylvania, described “this horrible burning sensation in the back of my head, in my lower cranium, this burning, constant burning.”

– In a March e-mail from Nairobi, Kenya, psychiatrist Dr. Lorin Mimless wrote of treating seven patients with what he said were clear Lariam reactions.

Among the cases he describes is a 32-year-old man he saw a year ago who he said had no history of psychiatric problems and was on no other medicine. He said the man became paranoid and over a two-day period his problems “developed into a full-blown psychosis requiring hospitalization in Britain. The patient on arrival tried to kill himself by hanging.”

Mimless said he saw the man recently and “he still had significant psychiatric symptoms — depression, occasional paranoid thoughts when anxious, and suicidal thoughts that would come and go not connected to the depression. He could not explain them but they would come once or twice a month, sometimes for a day, sometimes for a few hours. He would attribute them to Lariam, although he always had the fear they would not go away.”

A researcher who formerly reviewed Lariam side-effect reports at Roche said he now believes the company has been too hesitant to alert physicians and consumers to side effects that emerged after a drug had been approved.

“Roche has developed an attitude of not adjusting the information it supplies to physicians and patients about the performance and safety characteristics of their drugs,” said Dr. Donald H. Marks, former associate director of clinical research at Roche. Marks said he left Roche in 1991 to take a promotion to director at another company.

Marks said there is “ample reason” to believe Lariam causes suicide. Marks said Lariam can cause “spontaneous neurological activity” and “irritation of certain sensitive areas inside the brain” that could lead to suicidal behavior long after someone stops taking it.

Roche did not respond to UPI’s written questions about Marks’ comments. Alfaro, the Roche spokesman, said: “Roche takes the issue of safety very seriously and is diligent in monitoring the safety of all its drugs.”

Two statistical studies of FDA data commissioned by UPI showed a far higher incidence of problems that could lead to suicide in people taking Lariam than in those taking doxycycline, an antibiotic recommended by the CDC as another drug to prevent malaria.

The studies’ authors said that because both drugs are recommended by the CDC for prevention of malaria, a comparison of reported mental problems among users of both drugs is valid.

The FDA said in a statement to UPI that suicide rates of patients taking doxycycline and Lariam cannot be validly compared because most people treated with doxycycline receive it for acute bacterial infection — a much shorter therapeutic regime — and not for prevention of malaria.

The FDA also said doxycycline has its own drawbacks: it cannot be used in children, sensitizes people to the sun, has to be taken daily while Lariam is taken weekly, and causes anorexia, nausea and vomiting.

Doxycycline is the malaria preventive President Clinton was prescribed when he traveled to India and Pakistan in early 2000.

PharmaGenesis of Bethesda, Md., and Fibonacci Group, a Philadelphia-based consulting group, conducted two separate studies of FDA raw data. Both firms do work with attorneys suing drug companies.

In one study for UPI, PharmaGenesis determined people taking Lariam were five times more likely to have reported mental problems that could lead to suicide than people taking doxycycline. In the other, Fibonacci examined the FDA data and calculated the rate of side effects per prescription. It found a 150 times greater rate of depression and a 40 times greater rate of suicide attempts among Lariam users compared with doxycycline users.

The studies did not find a single successful suicide associated with doxycycline in the past four years, even though doxycycline, an antibiotic, is prescribed 25 times more often than Lariam, which is used only for treatment and prevention of malaria. Lariam is prescribed some 350,000 times a year, doxycycline is prescribed 9 million times a year for a variety of medical reasons, according to data from IMS Health, a healthcare information company.

Experts on drug side effects warned the FDA’s data cannot solely be used to draw conclusions about drug safety, but they agreed analyses from 1997 forward are best because at that point the agency began tracking suicides.

The PharmaGenesis analysis found three reports involving suicide prior to 1997 were “high probability,” based on a review of the psychiatric side effects reported in those patients.

Roche’s documents said seven suicides were reported by the end of 1998 as associated with Lariam use, including one in 1994, two in 1997 and four in 1998.

Roche and Lobel have said mental problems in those taking Lariam might be related to increased stress during travel. Keith Altman of Fibonacci Group said he thinks the 1997-2001 data debunk that assertion — particularly considering the different prescription totals for the two drugs.

“If you’re looking at rates-per-prescription, you’re talking about a 40 times greater rate of suicide attempts in Lariam than in doxycycline,” Altman said. “Look at depression: the rate of depression is 150 times greater in Lariam. I just can’t see a 150-times-greater rate of depression when you consider that a lot of these people are happy they’re going on a trip.”

A clinical study in October 2001 in the peer-reviewed Clinical Infectious Diseases journal showed 29 percent of travelers taking Lariam complained of neuropsychiatric side effects and that 5 percent were so bothered they quit taking the drug altogether. The “randomized controlled trial” was done among 976 travelers in the field.

Another drug company, Glaxo-Wellcome, funded the study and used Lariam as a control pill to gauge the safety of its own anti-malaria drug, Malarone, approved by the FDA in July 2000. FDA data shows two suicides reported among Malarone users.

Croft, the British army lieutenant colonel, said the Glaxo-Wellcome study shows the U.S. government warnings for Lariam “need to be revised urgently now that there is good evidence for the potential harms of mefloquine.”

Roche also makes Accutane, the popular acne drug that has also been associated with reports of suicide mainly among young people. In one high-profile case in Florida, the mother of Charles Bishop filed suit against Roche April 16, alleging Accutane made Bishop, 15, fly a Cessna plane into a Tampa high-rise and kill himself in January.

Roche and some drug experts have both said there is no concrete scientific evidence to link Accutane to suicide. Unlike its approach with Lariam, however, Roche in May 2000 put new language on the Accutane label warning of suicide risks, almost 20 years after the FDA approved the drug in 1982.

An alleged failure by Roche to provide adequate warning of Lariam side effects, including suicide, was at the heart of the lawsuit filed by Linda Perry in federal court in Ohio. The suit recently was settled. Charles Perry, 54 and a father of seven with no history of mental illness, took Lariam in 1998 during an African safari to celebrate his 30th wedding anniversary with his wife, Linda, a nurse.

The suit alleged the information provided by the pharmacy that filled their Lariam prescription warned only of possible “nausea, diarrhea, stomach upset, vomiting, dizziness or vision problems” and to “report difficulty breathing.”

Linda Perry contended that before her husband took the fourth pill, he was hallucinating. She said after returning to Ohio, they followed directions and took another four pills over the next four weeks. But Charles Perry spiraled into psychosis. He was hospitalized in the weeks before he killed himself with a shotgun in January 1999. His psychiatrist filed a report with the FDA blaming the suicide on Lariam.

Roche contended in court that there was nothing to prove Lariam can cause suicide. “The proposition advanced by plaintiff here — that Lariam causes such profound psychotic episodes that suicide is a known or knowable consequence of Lariam use — is simply not supported by competent medical and scientific literature,” Roche lawyers wrote in a court filing in January.

“No well-controlled clinical study supports such a causal relationship. As such, it is not generally accepted in the medical community that Lariam use leads to suicide.”

 

 

But a significant number of people have seen and felt first hand its devastating side effects. Vicki Mabrey reports.

It was supposed to be a dream vacation, a safari to Kenya a year and a half ago for Dr. Robert Daehler and his wife Jane, seen here on home video. What you won’t you see is how, deep in the African bush, she suddenly transformed before his eyes.

“She just became completely psychotic in the van,” says Bob. “(She) started taking her clothes off and she had called people back from the dead. And they had a doctor at this lodge that came into the van. And she looked at Jane and she said, ‘Did she take Lariam?’ She said she had seen this in many Americans.”

So had three other doctors in Africa, who confirmed the diagnosis. Jane Daehler was flown home, strapped to her seat with a bedsheet. At home, she spent a month in a psychiatric hospital, in and out of psychosis, with terrifying hallucinations. At the U.S. hospital, she was diagnosed with Lariam-induced psychosis.

“They were just horrific. I thought that people were trying to kill me all the time. I thought that my family was going to be killed,” says Jane.

According to its own internal documents, Roche pharmaceuticals, Lariam’s maker, has received over 3,000 reports of psychiatric problems associated with the drug, from nightmares, depression and hallucinations to paranoia, psychosis and aggression.

But could Lariam lead to something worse? That was the question raised last summer when Master Sgt. William Wright and three other Ft. Bragg soldiers were accused of killing their wives, all within a period of just under six weeks. Wright and another soldier were given Lariam, and Wright is considering using that as part of his defense. One of his fellow Green Berets thinks Lariam did play a role. John Lown, now an ordained minister, visits Wright in jail every week.

At first, Lown says, Wright was “very confused, he was very paranoid, and I was like ‘Wow this is not the Bill that I knew.’… About the fifth week after that, he was, he was coherent. He was fine. He even said, ‘Well, I’m thinking a lot better now.’”

What does Lown think caused his change? “I think it was the medication. It took about two months for the stuff to clear out of your system.”

Lown and his unit had names for the days they took Lariam: “Everybody would call it manic Mondays or wild Wednesdays.”

His wife, Debbie, says she’d see an immediate change when he was on Lariam: “He just turned ugly towards me… And when I mentioned that to other wives, they said that’s the way their husbands are as well.”

The other wives told her that while on Lariam, their husbands “were very negative, aggressive. Couple of them even complained how they’d be woke up in the middle of the night, shook, be called names. One running down the street without his clothes on, hollering, screaming.”

How does she know it just wasn’t the stress of the job? “He’s been on other deployments where Lariam was not required and he didn’t have these kind of problems,” says Debbie.

Like her husband, Debbie Lown is convinced Lariam was a factor in some of the Ft. Bragg murders. She had even complained to military authorities as far back as 1996.

“I said, ‘I’m not asking you to stop giving them the Lariam. I’m just asking you to better inform the soldiers of what they’re taking, tell their wives, because they’ll save marriages that way, they’ll save lives that way,’” she recalls.

Jane Daehler agrees that knowing it is the Lariam can make all the difference. “If it wasn’t for (my husband), I honestly think that somebody could have put me in a mental institution and thrown away the key.”

Before the trip, her husband, a physician, says he was careful, since his wife had been treated for depression in the past and was on what he says was a low, preventative dose of Prozac. He checked with a travel clinic, the Centers for Disease Control website, and his physicians drug guide.

The information was written by drug companies for doctors and approved by the Food and Drug Administration. The key part is the warning section, which states: “Lariam should not be prescribed in patients with active depression or with a history of psychosis or convulsions.”

“That’s what I read,” says Bob. “And Jane did not have active depression. She did not, it was 10 years earlier. She did not have psychosis ever. She never had seizures…. Nor did I. There was no reason why either of us couldn’t take this drug.”

But what was not in the warning section, what may have raised a red flag for the Daehlers are these disturbing side effects, depression, hallucinations, psychotic or paranoid reactions, aggression, all listed towards the end.

“They buried the lead. They took the important information that would’ve tipped off a doctor, and stuck it down there in a part that’s not part of the warnings,” says attorney Bernard Fischman, who represents the Daehlers in a lawsuit they’ve filed against Roche. Fischman argues that the company failed to properly warn them.

Can’t Roche argue, that the information is there? “It doesn’t call any attention to the real nature of this problem. There’s no mention of psychiatric problems under the warning section of that package insert,” says lawyer Paul Smith, who is also representing the Daehlers.

“There’s alternatives that can be taken, there’s just no reason that americans should be taking Lariam,” says Bob Daehler.

Doxycycline, a common antibiotic, and malarone, approved two years ago, are both effective in preventing malaria and have fewer psychiatric side effects than Lariam.

Roche, the drug company, claims that Lariam causes serious psychiatric side effects in only one in 10,000 people. But Dr. Paul Clarke, an infectious disease specialist and the medical director of a large network of travel clinics in Great Britain, organized his own study, after he and other British doctors saw problems with much greater frequency.

“It was confusion, it was disorientation, it was anxiety and panic attacks,” says Clarke. “There were episodes in which people were clearly divorced from reality and indeed had unusual symptoms that could be described as psychotic.”

Their research confirmed the hunch. Not one in 10,000, but closer to one in a 140 suffered disabling side effects, defined as substantially disrupting their lives – the same kinds of side effects that Dr. Clarke had seen in his patients.

Why such a huge difference in the numbers? Because of the key difference between the term “disabling” in Dr. Clarke’s study and the term “serious” as used by the drug company. In Roche’s study, serious meant you had to be dead, in the hospital or have a long-term disability to count. It’s an industry standard all drug companies use, but with that narrow definition, Dr. Clarke says, Roche’s study may have failed to identify up to seventy times more patients with troubling side effects.

Based in part on Dr. Clarke’s study, British authorities began to recommend using Lariam less often. Despite his concerns, though, he still says Lariam can be a useful drug.

“It’s very easy to take once a week, it gives you very good protection, you get good compliance. And if you’ve taken it in the past and never had a problem with it I, for one, would be very sorry to see it go, because it’s a good drug,” he says. He only wants people to be better informed.

60 Minutes II asked both the FDA and the CDC about how well the American public is informed of Lariam’s potential dangers. But both government agencies chose not to do an interview. The FDA did send a statement, saying that Lariam’s benefits far outweigh its risks.

Roche also declined a request for an interview, but sent a statement saying, in part, that no prescription drug is free of side effects.

Roche also said there’s no way for a physician to predict every person at risk for psychiatric side effects. Linda Perry considers her husband a perfect example of that.

In 1998, Linda and Chuck Perry left their Midwest ranch and their seven children to go on an African safari for their 30th wedding anniversary. Linda, a registered nurse, checked with her doctor, her pharmacist, and the local health department. For malaria protection, they all recommended Lariam.

“The first warning I ever got was from the safari guide in Africa,” says Linda. “She says to me, ‘Well, why do you take Lariam?’ It’s a hallucinogen very much like LSD.’ And I said, ‘the CDC recommends it.’ And she said, ‘Well, we never take it.’”

After four doses of Lariam, the Perrys were having night sweats and vivid nightmares. But everyone, including the CDC, had stressed taking the full dose of the drug, which meant taking it for four weeks after the trip. That’s when Chuck Perry’s real problems began.

“(He) didn’t know where he was. I mean, he ran out in the yard,” Linda Perry says. “I can remember tackling him in the yard saying, ‘What are you doing? What are you doing?’ you know. (He said) ‘The neighbors are after me, somebody’s after me.’ And it was just bizarre.

Linda Perry says her husband had no prior history of depression or mental illness. Chuck Perry was hospitalized and tested repeatedly. A team of doctors became convinced that Lariam was responsible. Linda says that the doctors didn’t know how to help him. Six months after returning home from Africa, Chuck Perry committed suicide.

“We had no way to know that this drug would be so powerful that it could alter his personality so much and damage him so much that he would, in fact, do that in some type of delusion or hallucination. That’s what we didn’t know,” says Linda Perry.

But Roche did know something about Lariam and suicide. Over the past year, two UPI reporters, Dan Olmsted and Mark Benjamin, unearthed internal documents. They show that by the time Chuck Perry killed himself, the company knew of at least seven suicides, and 13 suicide attempts, by people living outside the United States – all associated with Lariam. But nowhere in its product information was there any mention of the word suicide.

After two years of trying to attribute Chuck Perry’s suicide to other causes, Roche settled a wrongful death suit with Linda Perry last May.

Two months later, Roche dramatically changed its product information. Psychiatric side effects are now in the warning section, including, for the first time, rare cases of suicide.

But Roche says there is no proof linking its drug to suicide, and points out that Chuck Perry is the only reported American suicide of the more than five million who have taken Lariam in the U.S. that doesn’t address the other suicide reports outside the United States, but Roche says those cases are well below the suicide rate in the general population. Roche declined to give current figures, saying that accurate numbers on all reported events are hard to come by.

Says Dr. Paul Clarke: “What is not clear is, how many people may have been permanently damaged, if any, or indeed may have gone as far as a psychotic episode, which might’ve led to some other ghastly accident.”

But could it have led to murder at Ft. Bragg? In early November, the Army released its findings, which said that Lariam, in the army’s words, does not explain the clustering of violent deaths there. As a result, the military probably won’t change its policy on Lariam’s use.

Should it be given to soldiers with guns? Says Clarke: “I would not give it to them. Because we do have alternatives and we do know they’re effective.”

 

 

I never thought that doctors were capable of doing this to me. They
were careless, didn’t even take into account my size and OD’d me on
quinolones.

Past me was a happy, young mom. Always a good girl. Never did any
kinds of drugs. My husband and I rose from poverty and went to
college. Hence, shows how now naive I was in trusting these degree
people and not checking what I was ingesting. I never thought that
there could be such evilness as this legal poison. I certainly didn’t
expect doctors to send me down this road.

I’m a severe case. I don’t know if I will be around to see my husband
and kids. I had so many dreams. My husband and I would have another
baby, raise our kids, travel to exotic places and be financially
independent. This was four months ago before my nightmare started.
No doctor wants to take me now and if they do, they seem to just pass
on the buck without regards to how I feel. I cry myself to sleep and
my kids see me cry and I can’t help it. My skin is attached to my
bones and it’s affected my central nervous system. I can’t sleep at
night and have all sorts of pains. I wake up wanting my mom as if I
were a three year old. I think I’d rather die than go through more
emotional and physical pain. I am God’s child. How could they treat
me like this?

I’m afraid to seek psychiatric help. Medical bills keep piling up. I
probably will end up going to Mexico to run blood tests and exams
since it’s practically impossible to get a doctor to run them here.
And I have very good insurance, ironically.

So this is my American dream. Wow. I think if I’d stayed poor, I
would have tried simple solutions for the UTI’s I had. Please pray
for me if any of you believe. I feel I’m running on empty.

Lydia

This is a story copied off of a quinolone support forum. As you can see these horrific reactions affect everyone in the family, not just the one who takes these pills. The quinolone manufactures need to be held accountable for all the lives they have destroyed. They probably spend more money on covering up this toxicity than they do in researching these antibiotics. Not only are we poisoned, the drug companies leave the innocent people that they have poisoned with no antidote. The leave us for dead. White collar crime needs to be punished for their misdeeds.

Please educate others on the severe and crippling side effects of Levaquin and other quinolone antibiotics so that more families are not ruined like this one.  

I had a phone interview with Nancy Edward’s neice who is a journalist here on the east coast. Nancy Edwards is the movie director in Hollywood that took Levaquin and couldn’t walk. She is finishing up the Quinolone documentary called Floxed. Should be released in late December. Her neice was really nice to talk to on the phone. She and Nancy are just as furious as me about what has happened to tens of thousands of us that are now crippled from these antibiotics. I asked her to put my Levaquin Youtube video in the article. It helps when people can see the suffering first hand. If my health ever improves I will be contacting radio stations, newspapers and other media outlets.

I got an email from a lady named Jackie in Florida a while ago. She has been crippled from just a half of one Floxin pill. She has been suffering for many years. She told me she called up a TV station in Florida and they came out and did a story on her in the local news. I think that is great. I applaud her for her efforts. A few days ago I hobbled into my local pharmacy to get my pain medication and the local news station was doing a story on cough cold medications for the upcoming winter season. When I saw this I shuffled out to my car and came back in with a bunch of quinolone literature that I keep in my trunk. Hopefully they will do a story on this toxicity. Glenn Beck was doing a book signing today close to where I live but I was in too much pain from too much walking. Had to prop my legs up and elevate them to minimize the burning.  Glenn Beck would have been a good person to get this toxicity out there since he has a big audience. 

Please educate others on the severe crippling effects of quinolone antibiotics.

Been to a couple of hospitals now posting the Levaquin / Cipro  ”Black Box”  warning on the walls. Nobody seems to question me. The guy at Staples printed a bunch up for me for free since he feels sorry for me when I shuffle in to the store.  As I said many times before every person should have the right to informed consent before taking these antibiotics. That is why I am posting these. Patients have to sign a consent form with their doctor before they take Accutane, a drug used to treat severe cases of acne. Accutane has a history of causing severe neurological damage just like quinolones. There are some other drugs that have this status as well. I think quinolones more than any other class of medication warrants this level of informed consent.  

I campaigned for the Attorney General in Pennsylvania. Sent him a financial donation along with putting signs up for him. I wasn’t strong enough to push the signs in the ground because of my Levaquin poisoning so my parents basically did the work for me. My 80 year old parents are stronger than I am. Hard to believe. I am hopefully going to be meeting with the Attorney General’s staff to try and get some stricter warning labels on quinolones. A member of the Attorney General’s staff was poisoned by Avelox so this helps our case. There is an association of Attorney Generals that wield some influence. The Illinois AG has petitioned the FDA concerning quinolones. Hopefully, the Pennsylvania one will join them. If a few AG’s join togather that can wield some positive influence.  

Exposed Workers Blame Cipro for Crippling Effects

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.”

 

 

Harry’s Story

Seven years ago On Dec 13, 1997, when I was 35 years old and in excellent health, I went to the doctor for minor urinary tract discomfort that started to occur after making love with my wife, so I made an appointment with a doctor. I went to the doctor expecting him to perform testing to see if I had an infection, but instead he said “we don’t test in these circumstances anymore, we just prescribe a broad-spectrum antibiotic that kills a wide variety of pathogens.” After 10 minutes in his office, I was whisked out the door and on my way to the pharmacy. After starting the antibiotic he prescribed called Cipro I began feeling anxious and edgy. After a few days on the drug I began to experiencing hallucinations and a higher rate of anxiety where I was euphoric one minute and then crying the next. I called my doctor and he assured me it was the infection causing my symptoms and to keep taking the antibiotic. Then I started experiencing muscle pain in my legs, lower back and pelvis region along with a massive headache. Plus I still had the anxiety which started turning into panic attacks that left me feeling like I was having a stroke. I called both my doc and my pharmacist and they all told me to keep taking the antibiotic because the drug would not cause my symptoms. So I listened to them and kept taking the drug. I then remembered the 1/3 page computer printout I received at the pharmacy when I had the Cipro prescription filled that listed two minor side effects that could occur. They were upset stomach and diarrhea. It also said not to take antacids or zinc and magnesium containing foods within 2 hours before or after taking the antibiotic. That is all it said. Nothing about any other side effects or reactions were written anywhere on the page. Scared and not knowing what to do, I stopped the antibiotic and then went back to the doctor. The doc pointed out how I shouldn’t have stopped the antibiotic half-way thru the course. He said he would prescribe a different antibiotic after I questioned if the drugs could be causing my symptoms. He prescribed another antibiotic called Floxin. After taking it I was still experiencing the panic attacks and severe unbearable chronic pain in my muscles and joints. Because I was on a so-called “different” antibiotic, I figured it wasn’t the antibiotics causing my symptoms because the doc had put me on a different antibiotic and the symptoms where still present so it must be from an infection. I did not know at the time that Floxin was in the same class as Cipro, only it was a stronger version. By now I was in constant severe chronic pain and still having anxiety reactions and panic attacks. I had blood in my urine, my sugar was out of whack and my blood pressure was very low. On numerous occasions I passed out from low blood sugar where after going to the ER was given orange juice and sent home. Continually, I kept either passing out or felt like I was going to pass out. I didn’t know if it was from the panic attacks or the hypoglycemia. It took almost 2 years of going back and forth to emergency rooms and doctor offices before finally figuring out it was my heart that was damaged and I that I needed to have a pacemaker installed. I was rushed in and out of the emergency room too many times to count.I have been admitted into ICU, CCU and 2 mental institutions because of the diagnosis of it being “all in my head”. Then because I was taking narcotic pain relievers for severe chronic pain I was diagnosed as a “drug addict” and someone just trying to get narcotics. As a result, I was sent to a detox center twice, each time for a month, despite the fact that I never had a positive tox screen for any illegal drugs during all those ER visits prior to being admitted to the detox centers. Both times in the detox centers it became obvious that I suffered with severe chronic pain as I attempted to go completely off of the pain medication. The pain was so bad I could not sit still, lie down or do anything. I looked like a fish out of water, squirming in pain and rolling back and forth on the floor in agony. It was quite obvious to the doctors I suffered from chronic pain and so I was released into pain management. I progressively got worse and for over two years I could not even get out of bed except to go to a doctor visit or hospital. Because the doctors didn’t believe my symptoms were from an antibiotic during those first few years (now they do), they referred me to a psychiatrist. My family also assumed the same thing as the doctors, that I was crazy. In addition, from all that was going on in my life, I found myself now going thru a divorce. I then attempted suicide. That was about my lowest point. I thank God everyday now that I survived. Now, the doctors do believe that the antibiotics, called fluoroquinolones (FQ) caused my injuries, however, there are no cures available as of yet. I have been diagnosed with irreversible nerve damage, muscle damage, heart damage requiring the installation of a pacemaker as well as fatigue and muscle weakness and severe, never-ending chronic pain in my legs, arms, back and neck. The anxiety reactions and panic attacks that I suffered during the first four years of the reaction were actually diagnosed as tiny seizures but they have resolved after I started an alternative therapy which I believe helped cure my anxiety. I have other secondary problems as a result of the nerve damage I won’t mention here. I cannot stand up for more than 15 minutes. Just prior to my adverse drug reaction to Cipro and Floxin, I was taking over the family business. My wife had finished her doctorate degree and joined a medical practice and I had a B.S. degree in Environmental Science and then completed the Master Plumber’s program and received my Master Plumber’s License. For the first time in our lives, we both started making good money and we were in the process of buying our first house. We were living the American Dream until those tiny pills turned that dream into an American nightmare. Since that day I lost everything. I am now divorced, have lost my business, my house, trucks, equipment and everything else I owned and loved. I have lost the ability to work and support myself and most of all will probably never have a family at this point. A cannot live any kind of normal life other than being confined to my parents house in a 12 x 8 room where most of the time I lay in bed. I have been living with my parents for 3 years now. They want to sell their house and move to Florida and they do not want me coming with them. Because I am financially ruined with lawyers constantly trying to collect money from me and take me to court for bills I cannot pay, I may end up on the street, homeless. I had to liquidate my 401 k to pay for medical treatments that didn’t work. All I have now is an income of $700 a month from SSI of which roughly $400 goes to medical expenses where I am left with $300 a month to pay for rent, food, utilities, transportation and all the rest of my expenses. Although I live in severe chronic pain everyday and my financial situation is dire, I believe God will protect me and I believe that I will somehow get thru this and things will be all right. What keeps me going is the belief that I have a job to do warning others about the crippling dangers associated with these drugs and stopping this nightmare from happening to others. There is something very wrong with this class of drugs and also with the fact that nothing has been done about this by the FDA or the pharmaceutical companies. There is no reason why these drugs should be used as first-line agents when other much safer, cheaper and just as effective non-fluoroquinolone antibiotics are available and warranted. These FQ drugs were originally used as last-line of defense antibiotics to be used only when nothing else was available but have been being used as first line agents because of the huge profit margins that “patented” drugs bring in as opposed to the generic versions of other older antibiotics. These FQ’s were always banned in the use of children and no one under the age of 18 was to be prescribed an FQ except on a compassionate use basis available only to certain kids with cystic fibrosis or one of the few other indications where FQ use was warranted. However, this past year, FDA approved the use of Cipro to be used in all ages from newborn on up for various indications and other FQ drugs are also being approved for pediatric use. These FQ’s will most-likely be used in children on a first-line basis. There has never been a Dear Doctor letter sent to physicians warning them of any of the serious, crippling and permanently disabling reactions that can occur with FQ use at doses as low as one pill, despite a petition by Public Citizen for FDA to do so as well as citizen complaints, letters and phone calls. The bottom line is that Physicians are still not being warned of the irreversible, crippling ADR’s associated with the use of Fluoroquinolone drugs and new victims are turning up everyday.

Went to the Urologist for a checkup. I now have some sort of hard pea sized lump on my testicle. Urologist didn’t know what it was. Said it could be a cyst. Had an ultrasound done and the Urologist said it looks like a precancerous condition. He said I should have an ultrasound done every 3 months now. He mentioned there are vertical ridges on the ultrasound report. I’m sure it’s Levaquin poisoning doing its work. Probably like the ridges on my thumb nails. My thumb nails look like they have aged 50 years with deep groove like ridges on them.  Just like on T. Boomer’s flox report.  Talked to another quinolone victim who told me quinolones can cause cancer. There is no history of any type of cancer in my family either. There aren’t too many adverse health conditions left that Levaquin hasn’t caused me.

In between patients I heard the Urologist call a script in for Levaquin for a patient. During my appointment I pulled out a sheet I printed up from Injuryboard.com  that had Levaquin and Cipro along with a big bold face Black Box warning. I asked him if he knew about the Black Box warning. He said yeah but that is mostly older people. I told him that Dr. Cohen says it is mostly the young, healthy, and active people that are crippled from this. I could tell he didn’t believe me. I still can’t believe he would prescribe this after I told him I have brain damage and damage to my tendons and nerves for over 3 years now. It was like he didn’t even really care. I really felt offended by his lack of empathy. After I left, I taped the black box warning on a wall outside his office in the medical building. I then hobbled over to Kinko’s and photocopied a bunch more of the black box warnings for Levaquin and Cipro and the information sheet from Antibiotics.org. I taped another black box warning photocopy and Antibiotics.org photocopy in that same medical center and shuffled over to another medical complex and taped up the black box warnings for patients to read. If doctors aren’t going to give their patients informed consent on these poisons then I feel I need to take some sort of action. I wonder how long it will take before these are torn down.  I think I am going to try hitting more medical complexes, hospitals and offices with these warnings.