Bobby Grozier was on top of the world before he took the pills. A senior software adviser for a Fortune 500 company based in Manhattan, he earned a great salary and was happily married with a young daughter. That changed when he was prescribed a toxic combination of drugs to treat lingering symptoms of what his doctor thought was prostatitis. Ten years later, he suffers from permanent brain damage, is on disability and has lost more than $3 million in medical costs and income.
Grozier was prescribed a combination of Ciprofloxacin and Vioxx, a nonsteroidal anti-inflammatory drug. Shortly after taking the medicine his ears began to ring. He called Bayer, the company that produces Ciprofloxacin, and reported his symptoms to a pharmacist who told him to keep taking the drug to get the full effect.
Shortly after Grozier stopped taking the prescriptions, he suffered a psychotic episode. He had difficulty breathing, experienced hallucinations, and was barely able to call his mother to ask her to take him to the hospital.
“Things in my ears were resonating like I was in an echo chamber,” Grozier said. “And everything was wavy…it was unbearable. I really thought I had a heart attack and was dying.”
At the hospital, Grozier was given a sedative. The doctor he spoke with blamed the episode on irritable bowel syndrome, wrote him a prescription for Xanax and sent him home. But his symptoms steadily worsened. He experienced numerous petite mal seizures, was unable to bathe himself and suffered from severe anxiety.
“I was praying to God to take my life, let me die,” Grozier said. “It was unbearable.”
After researching his symptoms online, Grozier concluded that he had been poisoned by the medications his doctor prescribed. Ciprofloxacin is a fluoroquinolone, an antibiotic used to treat bacterial infections in many different parts of the body. Fluoroquinolones include Ciprofloxacin, Levofloxacin and Levaquin, as well as many other drugs. Fluoroquinolone poisoning is a little-known reaction to the drug. Symptoms include central nervous system (CNS) toxicity, phototoxicity, cardiotoxicity, arthropathy and tendon rupture. Several fluoroquinolones have been taken off the market due to severe adverse reactions, but these instances are few and often result in long legal battles.
The actual amount of poisonings that occur due to floroquinolones is uncertain. Some consider the occurrence to be rare while others say it is far more common than many realize. The lack of recorded cases is due to several factors. Often people do not realize that they have been poisoned, or their doctors do not credit the symptoms to the medication, partly due to the delayed toxicity. Patients can react to the drugs weeks or months after they are prescribed and patients and doctors do not make a connection between the drugs and the symptoms.
Another reason the condition is often unrecognizable is due to its lack of visible physical symptoms. One victim of the poisoning said it is often referred to as “the invisible illness,” saying, “[people] look at you and think you’re normal because there’s no open wound or cast…on the inside our nerves are damaged, our tendons are damaged, certain receptors in the brain are not functioning properly.”
While stories about floroquinolone poisoning have been published in the Inter Press Service News Agency, the Associated Press and numerous medical journals, the topic is not reported on frequently in the media, and people tend to be skeptical when first learning about it. This lack of knowledge has caused many sufferers to become activists, helping to educate people about the topic. A documentary titled Certain Adverse Events was produced and is available on YouTube. Stephen Fried’s book, Bitter Pills, examines the corruption within the pharmaceutical industry, focusing on his own experiences after his wife was poisoned by an antibiotic.
John Fratti, a former pharmaceutical sales representative, suffered a severe adverse reaction to Levaquin in 2005. He has tried to increase awareness of the poisoning, attempting to share knowledge about the drugs’ effects. Fratti possesses a Freedom of Information report on Levaquin that he requested from the FDA, which shows there have been 1,015 death outcomes and 14,796 individual safety reports resulting from the drug.
After contacting the Office of Special Health Issues and meeting with FDA officials to discuss the dangers of Levaquin, Fratti was hired by the agency, serving part- time as an FDA patient representative for drug safety. Increasing awareness about floroquinolone poisoning is crucial to many patients because doctors are often unaware of the condition and attribute the symptoms to stress, depression or another infection. Many patients communicate with each other online.
Since his poisoning, Bobby Grozier has also reached out to many victims. He has also started the Web site www.fqvictims.org in order to share information about floroquinolone poisoning. Another Web site founded to support victims of floroquinolone poisoning is www.fqresearch.org, founded by David Fuller. It provides documentation and research about floroquinoline poisoning, including legal information about clinical trials.
Fuller took Floxin to treat pneumonia in 1986 and suffered a heart attack and a blow to his Achilles tendon. In the ’90s, he took Ciprofloxacin for a sinus infection and has almost completely lost his vision and developed a kidney stone as well as experiencing serious damage to his joints. He diagnosed himself after reading articles online.
“I’m pretty much blind,” he said. “Prior to this, I didn’t even wear glasses. My hips are going to have to be replaced. My hands are like claws — I can barely bend my fingers. I had to have root canals, and I had teeth break off and fall out of my mouth when I was brushing.”
Furious with the misinformation that had been presented online, Fuller decided to start his own source of information. He launched his Web site in 2002, and the foundation was started in 2007. A toxicity discussion forum was started in January 2008.
“I’ll be at this until they put me in my grave,” he said of his work. “Somebody has to do this — trying to get Congress to take a look at this, trying get elected officials to take a look at this…People are literally dying from this drug as we talk.”
Fuller said direct toxicity and DNA damage are two reasons floroquinolones are harmful to so many people. “These drugs change the blueprint by which the replacement cells are made. Now you’ve got defective cells making more defective cells. If the body can recover from it, you’ll get better, but if the damage is so massive the body can’t recover, you’re permanently disabled.”
Anesthesiologist Todd Plumb was prescribed Levaquin in 2006. His symptoms included skin burning, profound insomnia and agitation, elevated liver enzymes and numerous issues with his gastrointestinal tract as well as severe numbness and burning pain in his extremities. He described the full onset and progression of neuropathy as similar to what cancer patients experience when going through chemotherapy.
Plumb, who had never heard of fluoroquinolone poisoning during his years as an emergency room doctor and anesthesiologist, went to 15 doctors and spent a week in the Mayo Clinic, attempting to find a diagnosis. He also learned about fluoroquinolone poisoning online.
“You’ll see the same story repeated over and over again,” he said. “Joint and tendon pain. Tendon rupture. Severe extremity pain. And no one believes them.”
The disbelief, according to Plumb, is due in part to the structure of the health care system, as doctors are taught to have faith in the medicines they prescribe their patients.
“It’s like losing faith in your religion,” Plumb said. “I was in their camp before it happened to me. I’d had several people complain to me about problems with Cipro. I thought it was a safe medication that worked pretty well. I didn’t want to feel myself that I was doing harm to patients.”
Plumb attributes some of this attitude to studies that are published in medical journals, saying almost every study of a drug shows a beneficial outcome.
“The FDA doesn’t do the research on the drug,” he said. “The research and development and presentation of that is left to the drug companies themselves. And they can alter and change and present the drug in the best way possible.”
He credits this partially to the fact that drug companies purchase advertising in medical journals. “Every reputable medical journal in America is funded by drug company advertising. Journals wouldn’t get out to doctors unless drugs were advertised in journals.
“It’s a culture of drug companies holding all the sway,” Plumb continued. “They pay for everything. Even the way the information is dispersed to physicians. If you look at a journal and count how many pages are drug company advertisements and how many are studies, the drug companies outweigh the studies.”
Processing complaints about drugs and determining the impact of those complaints is a muddled process, according to Plumb, exemplified by the removal of Vioxx from the market and the resulting news that the studies about the drug were ghostwritten. Merck stopped selling Vioxx, a type of non-steroidal anti-inflammatory drug, in 2004 after evidence linked it to heart attacks. After the drug was taken off the market, more than 10,000 lawsuits were filed against Merck by former Vioxx patients or their families. In 2007, the company agreed to a $4.85 billion settlement.
The following year, it was revealed that the studies on Vioxx were ghostwritten. According to a New York Times article from April 2008, Merck & Company conducted research on Vioxx and concealed its role in the studies by paying prominent scientists to lend their names to them.
The total number of deaths that can be credited to Vioxx is unknown, but Dr. David Graham, in testimony before the U.S. Senate, estimated that 88,000 to 139,000 Americans experienced heart attacks as a side effect from the drug, and 30 to 40 percent of those died, resulting in 27,000 to 55,000 deaths due to Vioxx.
“We gave up on the FDA,” Fuller said. “They’re useless. They went from being the finest regulatory agency in the world to the worst.”
The FDA maintains the system MedWatch, which is used to report adverse effects to drugs. Manufacturers are required to file a report with MedWatch if a patient reports any reactions to a medication. According to Fuller, the system is severely flawed.
“The FDA throws away 75 percent of those reports, and the rest go into a database that people can’t access except the FDA,” he said. “In 1996 they changed over to a different database and everything that happened prior to 1996 you can’t get access to. They pretty much wiped out a history of adverse reactions and gave drug companies a clean slate.”
In 2008, Johnson & Johnson’s drug Levaquin went on trial for causing tendon damage. Schedin v. Johnson & Johnson was held in federal court in Minneapolis. John Schedin, 82, filed the suit, claiming he ruptured the Achilles tendons in both feet after taking Levaquin. He claims Johnson & Johnson and its Ortho-McNeil-Janssen Pharmaceuticals unit did not warn doctors and patients of the drug’s association with tendon damage. Schedin won the case and was awarded damages of $700,000.
This case is the first trial of more than 2,600 claims in U.S. courts alleging that Levaquin causes tendon damage. In 2008, the FDA required an upgraded warning on tendon damage posed by Levaquin and similar drugs. The black box warning was required for all fluoroquinolones in July 2008.
The warning is a result of the efforts of Public Citizen, a non-profit, consumer rights advocacy group, which filed a lawsuit requiring the warning on the drugs’ packaging and requiring pharmacists to give patients FDA-approved medication guides that also carry the warning.
“There were letters sent out in 2008, telling doctors that these drugs can blow a man’s tendon,” Fuller said. “They only came out after a 12-year battle. Public Citizen started fighting this in 1996. We had to sue the FDA in federal court to get them to review these petitions that we filed.”
Following the issue of the black box warnings, Fuller said the FDA downplayed the effect. Renata Albrecht, the head of the FDA’s Division of Special Pathogen and Transplant Products, estimated that spontaneous ruptures were occurring in approximately one in 100,000 people. The FDA said taking the drugs appears to triple or quadruple the risk, bringing a total of four out of 100,000 people who are at risk.
The study, “Increased Risk of Achilles Tendon Rupture With Quinolone Antibacterial Use, Especially in Elderly Patients Taking Oral Corticosteroids” presents a total of anywhere from four to 28 out of 100 patients instead of four out of 100,000 patients, the total presented by the FDA.
Confusing or inaccurate statistics concerning medical research are not unusual. The process of approving a drug for use is fraught with conflict of interest, according to Plumb. In 2007, the FDA issued guidelines barring advisers with more than $50,000 invested in an FDA-regulated drug or medical device company unless they receive a waiver from the agency. People with financial interests of less than $50,000 can participate on the panel but are unable to vote without a waiver from the agency.
“There were no laws against drug company officials physically being on the committee up until a few years ago,” Plumb said. “The Levaquin lawsuit is the tip of the iceberg. It’s a convenient way to mask the other problems it can cause that are more prevalent.”
According to Plumb, the culture of prescriptions in American heath care is in need of examination and possible revision.
“It’s the lesser of two evils,” Plumb said. “Doctors are making decisions over and over. Medications can cause problems, but they save lives. They take that argument and extend it to say medications don’t usually cause problems, so I’ll give it and hope it doesn’t cause problems. We’re a cultured society that believes that antibiotics in particular are lifesaving and we really need them. Heaven forbid that they are actually causing problems in patients.”
In order to increase awareness about fluoroquinolones, Plumb said many aspects of the system are in need of change, including the education received in medical schools. He said very few continuing education courses have much to do with the pharmacy, and if they do, a doctor presents pharmaceutical research in a positive light.
The presentation of research is also a problem in the sale of pharmaceuticals, according to Fratti. Having once worked as a sales representative, he experienced firsthand the culture of pharmaceutical sales and the influence representatives had on doctors.
“We were trained how to downplay or trivialize doctors’ concerns,” he said. “We had role-playing sessions, videotaped and graded on how skillful we were able to do that. Pharmaceutical sales are not about educating a doctor. It’s about marketing a doctor and selling the doctor to make sure the doctor sells your drug.”
Fratti also mentioned the gifts that were exchanged between sales representatives and doctors. He gave away $100 gift certificates, free dinners and golf trips. Additionally, a New York Times article from June 2004 cited doctors receiving checks for $10,000 in exchange for prescribing drugs from certain companies. Conflicts within the sales industry are also documented in Gwen Olsen’s book, Confessions of an Rx Drug Pusher.
Doctors’ offices are not the only place where money presents a conflict of interest, according to Plum. He said drug companies provide a large portion of the operating expenses for the FDA in order to have their drugs evaluated.
Sidney Wolfe, M.D., director of Public Citizen’s Health Research Group, was quoted in Ivanhoe Medical Breakthroughs as saying user fees, which drug companies pay to the FDA to approve their products, are a key problem in the process of approving drugs. User fees paid for more than half the drug reviews in 2009 and totaled more than $600 million of the FDA’s budget.
Fratti has attempted to increase awareness within drug companies, going as far as buying stock in Johnson & Johnson and attending a shareholder convention. During the Q&A session, Fratti spoke to the CEO, board of directors and shareholders, telling them what had happened to him as well as other people who had been injured by Levaquin and asking that a warning be put on the package or the leaflet given out by pharmacists. He also requested that further medical research be done by Johnson & Johnson to help people who have been injured and disabled to regain their health.
Fratti is not the first victim of poisoning to buy stock and speak at the convention. Another man who had been poisoned more than 10 years ago also spoke and was given a standing ovation by the shareholders.
“Many of us have contacted Johnson & Johnson and they’re well aware of this, but despite this, they continue to aggressively promote Levaquin,” Fratti said.
The effects of fluoroquinolone poisoning can be short-term, lasting about two years, or lifelong. Grozier and Fratti are both on disability, while Plumb has been able to return to work, but still suffers from the effects of the poisoning.
Fluoroquinolone poisoning has caused financial devastation for most of the patients. Grozier knows many other people who have suffered from poisoning and have depleted their savings, lost their homes and are no longer covered by health insurance.
The emotional impact is also difficult to endure. For many patients, there is no external physical evidence of their illness and many people are skeptical, refusing to believe that antibiotics can poison people.
Fratti’s experience has been reported in several media outlets, including ABC news, Harrisburg Patriot News and the documentary Certain Adverse Events. Grozier has also attempted to reach out to the media, sending a packet of information about his experience to numerous media outlets, including Dateline, Oprah, 60 Minutes, Montel Williams and 20/20. His attempts did not result in any coverage.
The knowledge that drug companies possess and the lack of action resulting from this knowledge can be credited to the lack of accountability in the drug corporations, Fratti said. The lawsuits are considered the cost of doing business, because paying a fine is less costly than removing the drug from the market.
“There’s no criminal liability for executives,” Fratti said. “They’re using shareholder’s money to pay for fines. Executives are not going to jail. They’re not facing any personal liability…Personal responsibility and accountability needs to take place. What’s happening here with these injuries is a cost of doing business. Because they’re incorporated, the executives have limited liability. Nothing really happens to them as an individual. The company may be fined, but in terms of anything happening to the key executives individually, they’re pretty much immune from any fine or jail term.”
Along with accountability in corporations, a concerted effort from the government is necessary, according to Fuller, who thinks Congress should examine what is happening at the FDA.
“This is a massive cover-up going on in the FDA,” Fuller said. “It’s gross incompetence…The only logical explanation is they care more about the drug companies’ profits than they do about the users of the drug.”
Until changes are put into place at the FDA, people can make an effort to ensure their own safety by researching medications on their own.
“A lot of people think the FDA is out there doing their own rigorous studies on the safety and efficacy of drugs and that’s not the case. They rely on the information supplied to them by pharmaceutical companies,” Fratti said. “Doctors are fed a lot of propaganda from drug reps, and they are influenced in a way that may not be best for the patients. Patients should not blindly put their trust in doctors. I think patients need to be their own health advocates today and do their own research.”