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[Music] Anyone who's taken a prescription drug knows they come with side effects. It's a matter of weighing the risks versus the benefits and trusting your doctor's advice. But some people claim a class of antibiotics called fluoroquinolones has left them suffering from unusual and debilitating health problems. What's more, they say they were never properly warned. Sha O'Shay uncovered that has been a bitter pill to swallow.
In 1928, Alexander Fleming changed the face of medicine almost by accident. Mold from a discarded experiment turned out to be just what he'd been looking for: a treatment that could kill harmful bacteria without killing people along with it. That discovery became known as the miracle of the 20th century: penicillin. Ever since, drug companies like Bayer have been moving pharmaceutical science forward with new, helpful drugs. And that's exactly the caring image videos like these promote to the public. But not everyone is buying it.
Mark Gerard's world is very small these days, and he blames the side effects of Levaquin, part of a family of antibiotics called fluoroquinolones. "There's two chapters to my life: before I took Levaquin and since I took Levaquin, and uh, it's been terrible." The first chapter was a larger-than-life epic. Mark was literally on top of the world. "I lived in the top of the Colorado Rockies, worked at ski resorts." But then he broke his ankle and had to have surgery. When the surgical wound got infected, doctors administered Levaquin.
From there, the problems snowballed. "Within weeks of taking the Levaquin, the swelling began and the and the pain began." Eventually, Mark had to have another surgery to repair the torn tendons. "This scar here is where my peroneus brevis tendons ruptured." On his other leg, a network of inflamed veins reads like a road map, leading to yet another in a series of surgeries. But it wasn't until last year that he finally learned his health problems could be due to Levaquin. Mark says that information came from the internet, not from the manufacturer or a doctor. "There was no warning, no discussion of any possible side effects whatsoever."
Since then, chapter two of Mark's story has turned into a tale of woe. "I've got one problem after another after another after another, and it doesn't look like they're going to end. And I'm broke, and I've lost everything, and I live at my sister's house because she helps me. I'm depressed. I I think about suicide every day." He places the blame squarely on the drug makers. "It's not something they're just finding out now. These people are criminals. They're they belong in prison for the rest of their lives."
Mark's story is not a surprise to Terrence Young. "Their whole range of adverse effects from that group of drugs, and that's why they shouldn't be prescribed as a first-line defense against those conditions. They should be an antibiotic that you use after you've tried other antibiotics." The MP from Oakville, Ontario, learned in the most tragic way possible how a lack of timely warnings about the risks of prescription drugs can destroy lives. It all goes back to when we lost Vanessa in 2000. Young's world was turned upside down when his 15-year-old daughter's heart suddenly stopped beating after taking medication for a stomach problem, a medication that has since been discontinued. "The emergency crew got her to hospital, uh, but it was too late. She died the next day, March 19th."
From then on, Young focused all his grief into finding out how this could have happened. And what he says he learned was disturbing. "I found more and more corrupt practices that prevented doctors and patients learning what the true risks of prescription drugs were. And the reason that's happening is the incredible marketing power of the pharmaceutical industry. These are the wealthiest companies in the world, in many cases, and so they have billions of dollars for marketing, billions of dollars." Young eventually wrote a book about his daughter's death and the powerful forces he believes were behind it.
Millions of injuries and about 200,000 deaths in North America every year. The numbers are staggering. Pharmaceutical giant Bayer rang up about a billion dollars in sales from its two brand-name fluoroquinolones in 2010: Avelox and Cipro. Janssen Ortho markets Levaquin in Canada. In the same year, its parent company, Johnson & Johnson, sold more than $1.3 billion dollars. Those impressive sales figures are in spite of equally stunning numbers of reported adverse reactions and deaths associated with fluoroquinolones. The drug companies claim fewer than 1% of clinical trial subjects suffered serious reactions. Still, Health Canada's database contains about 2,000 reports classified as serious and about 100 deaths linked to fluoroquinolones since 1985. Freedom of Information documents obtained from the U.S. FDA show more than 50,000 adverse reactions and 3,000 deaths where fluoroquinolones are suspected. And Young says it may be much worse. "Multiply that figure times 100 because most doctors never report an adverse drug reaction, and most patients never report one. So the actual adverse drug reaction reports they get represent around 1% of the reality."
"The drug industry is now gone off on a very bad tack. It's a very profit-oriented industry." Tony Merchant has launched Canadian class-action lawsuits against the makers of the three brand-name fluoroquinolones approved by Health Canada: Avelox, Cipro, and Levaquin. He says there were adverse reactions being reported in Europe as far back as the 1980s. "They knew or ought to have known about the problems, and they didn't disclose the problems. So they didn't give to doctors the real opportunity to select another drug instead of these drugs and put their patients at risk in the result."
But despite lawsuits like his, Merchant says drug companies don't appear to be changing their ways. "They still wait to be told. They still wait to be caught. With this drug, they were told in Europe first, then they were told in the United States. The drug companies continue to market, market drugs even when they know that there are problems because they have a huge investment in the drug." The drug companies have yet to file a response to his allegations.
In 2008, the U.S. FDA produced this video explaining its decision to put the strongest possible warning on fluoroquinolones about the risk of tendon injuries. The product information literature also contains a variety of other warnings about heart complications, gastrointestinal, and central nervous system problems. It may be too late for for Mark Gerard, but you'd think the danger to patients would be over. Not according to this woman. "This will never go away, and this, I think, will be forever. It's been over a year now."
Next on 16x9: Drug companies come clean about the risks. So why don't all patients know about them? "Misinformation is it's fatal, basically. It sealed my fate."
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[Music] This is Marsha Crossley Cohen, a professional ballet dancer from Ontario, and this is Gee Bair, an IT worker from Quebec. Both took fluoroquinolone antibiotics in the last year. The manufacturers were ordered to add strong warnings about the risk of tendon injuries in 2008, but four years later, we're still hearing horror stories. "It's unbearably devastating to think I'm going to have to stop what I love more than anything." "It felt like everything, uh, from head to toe was hurting. It was just like this almost throbbing pain everywhere in my body." Mara still tries to pass on her lifelong love of dance to others, but now she has to deal with extreme pain in her Achilles tendon and a condition called tendonitis. A constant ringing in her ears. "I'm I'm heartbroken because, uh, dancing is my life, teaching is my life, and I am very worried that I I'm not able to do that now." Gee is now on disability. The pain making him a prisoner in his own home. "I hardly ever leave the house. It's very hard to think about the future right now since there's not much I can actually do. It's very depressing." Both were prescribed fluoroquinolones for relatively mild sinus infections, and both say they would have refused the drugs had they only been told about the risks. "Had the doctor told you that if you take this particular drug, this might happen, would you have had the prescription filled?" "100% not. This is my life. Misinformation is, um, it's it's fatal, basically. It sealed my fate."
But how could that be? Since 2008, the information that goes out to doctors for all fluoroquinolones has included a much stronger warning about potential risks like tendon injuries, seizures, and accelerated heart rate. "The warning system is almost completely inadequate." Alan Castles is a drug policy researcher at the University of Victoria. He says all the people who should be communicating the risks of prescription drugs are failing miserably. "There's lots of blame to go around. You have physicians who prescribe drugs for, uh, patients who possibly don't need them. You've got the far, the the power of the pharmaceutical industry that continues to market very aggressively, the newest, the latest, the highest-powered treatments, and those get used widely in the community when they shouldn't be. It seems to me that Health Canada certainly doesn't go out of their way to warn physicians in a serious way."
This is the warning doctors see for Levaquin: a 68-page product monograph that does list the potential serious side effects, but not until page five, and it's not given to patients either. Toronto-based Janssen Ortho markets Levaquin in Canada, one of three brand-name fluoroquinolones approved by Health Canada. They declined our request for an on-camera interview and sent a statement reiterating the risks but adding Levaquin has been proven to be a safe and effective medication when used according to the product labeling. "Janssen works closely with Health Canada to ensure our product labeling provides physicians with the information they need to make the most informed decisions for the treatment of their patients." Bayer markets the other two approved brand-name fluoroquinolones, Avelox and Cipro. The company told 16x9, "Bayer's highest priority is patient safety, and we work closely with Health Canada and health authorities on the labeling for our products. Information provided to healthcare practitioners is in accordance with that contained in the product label, and Bayer adheres to strict industry codes."
MP Terrence Young says those industry codes are not nearly strict enough to protect patients. "Even though a simple change could make a big difference, patients should get in their hand a patient information leaflet that is plainly worded, that is it's written in plain language, and the most important safety information is right up at the top in bold print."
"Eleven years you've been working on this. Has anything changed?" "I think it's even worse now. More Canadians now are dying and suffering adverse reactions from prescription drugs than ever." Just last November, Canada's interim auditor general, John Wou, released a scathing report blasting Health Canada for not acting quickly enough. "In some cases, it can take actually up to two years to, uh, to review the safety issue and to communicate, uh, the results, uh, to Canadians, and we think that's that's too long." Health Minister Leona Aglukkaq promised her agency would clean up its act. "Our government agrees with the auditor general's findings, and work is already on the way to address those recommendations."
Young hopes those changes will help, but both he and Alan Castles believe what Canada really needs is an independent drug safety agency. "You can't have the same agency approving drugs and then several years later saying, 'No, we're going to take the drug off the market.' Uh, it just, it doesn't work very well that way." "I watched our group would bite Health Canada in the ass on this one, uh, on on many drug issues." But so far, there are no signs that will happen anytime soon. And for patients like Mark, Marsha, Gee, and many others, after all their suffering, that is still a bitter pill to swallow.
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Next on 16x9: Canadians covet a crown. It really is a big deal in the Chinese community on the other side of the world.
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