By Jenny Manzer – 2005 Michener-Deacon Fellowship recipient (published December 2006)
People across the country are struggling to cope with effects of an adverse drug reaction, but we – and even they – don’t know it, says Colleen Fuller, a Vancouver-based drug safety advocate.
The Canadian public simply does not realize the extent of the harm being caused by drug side-effects, she says.
“People will say, ‘Oh, these are symptoms of the condition that’s being treated, so it’s not really a symptom, it’s not a side-effect of the drug,” says Fuller. She insists it’s a view encouraged by the drug industry. “And I think that Health Canada doesn’t address these misperceptions in the public adequately enough.”
Fuller, who is a diabetic, experienced severe drug side-effects herself starting in 1995, when the animal-derived insulin she relied on was taken off the market.
Left with no choice, she switched to a newer form of synthetic insulin billed as more closely resembling human insulin. She found the drug affected her ability to detect low blood sugar. Fuller experienced seizures, lost weight and couldn’t concentrate. She feared going to sleep in case she never woke up. She even slipped into comas.
“People lose their ability to detect low blood sugar and so, for example, I would be sitting here talking as my blood sugar is plummeting and in mid-sentence I would be on the floor in a coma,” she says. “And that’s what was happening to me and it happened over and over and over again.”
Fuller lived this way for five years. She was told repeatedly that she was the only one having a bad reaction to the insulin. In fact, thousands were. Eventually Canadian diabetics that couldn’t tolerate the new insulin banded together to regain access to animal-based insulin. The whole experience changed Fuller forever. It also nearly destroyed her marriage.
Patients who suffer serious drug side-effects are often affected emotionally and psychologically, as well as physically, she stresses. Families break up under the strain and people lose their homes when they can’t work anymore.
“When people go through these experiences, it’s like being in an earthquake that never ends. You can’t grab onto anything, because it’s shaking too.”
In 2003 Fuller helped start PharmaWatch, a non-profit consumer group, to promote greater public involvement in drug safety. Fuller, a health policy researcher by trade, steadfastly believes that consumers have been shut out of the drug safety system. While Fuller says there needs to be more consumer involvement and oversight, Canadians can also step up their awareness of how to avoid experiencing drug side-effects in the first place.
One of the key steps is to stop looking for a chemical solution to every problem.
“We live in a culture where the idea of taking drugs is kind of a lifestyle choice. We’ve drifted quite a ways away from the idea of prescription drugs being only necessary in certain circumstances,” says Fuller. “The drug industry likes to promote drugs as something that are fun to do that will improve your life and the public does buy into that to some extent.”
Experts say patients must stop expecting to always get a prescription when they visit their doctor. Always ask what other choices are available, advises James McCormack, a professor with the faculty of pharmaceutical sciences at the University of British Columbia, “You should really be going in and saying ‘What non-drug things should I do?’ The bottom line is: If I don’t do anything, what will happen? And if I do this, what will happen, percentage wise?”
Research has shown repeatedly that the public places far too much faith in medicines, often grossly overestimating their benefits. “Patients are not even in the ballpark. They’re not even playing the same game,” says McCormack. “They laugh when I tell them the benefits. They go, ‘You’ve got to be kidding me.'”
Physicians and patients also need to remember that newer is better in cars and computers, but not necessarily medications. Sticking with the tried and true may be cheaper, but more importantly safer.
Newer drugs are heavily promoted, but older medications are often just as effective and have the benefit of being road-tested for potential side-effects. Older drugs are also cheaper, which saves us all money -whether through the public purse or by our private insurance rates.
Barbara Martinez, who works for a drug benefits consulting firm in Toronto, says patients and physicians must get out of this mindset. “I want the newest car, and the newest VCR, we want the newest thing,” she says. The public also thinks that all drugs are completely safe, just because they’ve been approved by Health Canada. But the real test of the drugs comes in the first few years of use in the real world, says Martinez, who worked in the drug industry for many years. “Just because Health Canada approved it, we don’t know that it’s safe, so stop thinking that.”
“It’s amazing how the pharmaceutical industry has been able to convince us that each new drug is incrementally better,” says Larry Sasich, a consultant with the Washington, D.C.-based consumer group Public Citizen. “There’s nothing in our drug approval standard that requires a new drug to be therapeutically superior to an old drug before it can come on the market.” Sasich adds that we don’t need more drugs – we need better drugs, and the only way to determine which drug is better is to do head-to-head studies.
Martinez says we also have to shake the idea that drugs are free if we have a private plan; we pay for them, one way or another.
A shocking number of patients don’t take their prescriptions – which experts suggest is due to side-effects. Canadian pharmacies accept unused pills one week a year to encourage people to clean out their medicine cabinets. The results are measured in tons, marvels Martinez. “All of those pills were paid for by somebody, probably by an employer.”
Martinez says she sees her clients’ drug costs going up 10% or 20% every year. “And their employees are not getting better. We’re not healthier. We’re just taking more drugs, that’s all.”
She says Canadians may not realize that insurance contracts are renegotiated every year, and the cost is not based on all employees insured by the company but by your colleagues. If one employee spends a lot, it will come out of your pool. The end result is that companies start cutting dependents out of plans or transferring costs in premiums or deductibles.
We have to shop more wisely, she argues, so we can afford the important drugs. She recalls one father with brain cancer whose treatment cost around $40,000. The drugs bought him another year. The treatment meant the man’s daughter was seven, instead of six when he died, and during that year he played, talked and shared time with her. “Was that drug worthwhile? You bet it is,” says Martinez. “But we’ve got to quit wasting money on drugs that people really aren’t benefiting from so that we can afford these expensive drugs.”
We can’t afford to keep spending on pricey new drugs that are no better than their older counterparts, she says.
Doctors assume patients want the latest, greatest thing – and we’ve got to start telling them otherwise and asking about other choices, she says. People are often shocked at the idea of asking their doctor why they prescribed a drug. “They’ll say, ‘But I can’t. I’m not allowed to do that, I have to do what the doctor prescribes.'”
As well as avoiding a prescription altogether, it may often be possible to try a lower dose of a medication to reduce risk of side-effects. Dr. Jay Cohen, an adjunct associate professor at University of California, San Diego in family and preventative medicine, writes extensively about medication safety. A drug company’s main goal is to produce a drug that outperforms the competition, which can lead to higher doses – and more side-effects, he says.
“They’re so focused on efficacy. They’re really focused on putting out a drug that really, really is stronger and better than their competitors – and they can say that in their advertising, ‘Ours helps 75% whereas theirs only helps 63%,'” says Dr. Cohen.
“But of course as you go to higher and higher dosages, just as when you drink more alcohol or coffee, you bring more risk, and they don’t talk about that at all. Studies have shown they really downplay the side-effect issue.”
Drug doses aren’t necessarily created with the idea of maximizing safety, but maximizing efficacy, which translates into maximizing sales, he says. Dr. Cohen doesn’t recommend changing doses in acute situations, such as infectious diseases or cancer, but says for conditions such as depression and high cholesterol patients should ask their doctor if they could start a medication at a lower dose. The approach follows the medical profession’s “start low, go slow” mantra of prescription drug use.
Drugs have historically not been tested in the elderly or women, even though these groups are the biggest consumers of medication, he notes. Young, healthy males can tolerate more medication, so when you establish dose in that group, it may be too strong for others, he says.
Dr. Cohen says many of the top-selling drugs that later showed problems, such as the antidepressant Prozac or the painkiller Bextra, were proven in earlier studies during the testing phase to be effective at far lower doses than those later recommended by drug companies – without the same side-effects.
Consumers should also be aware of their sensitivities to medication, and inform their physicians. Dr. Cohen says if people are sensitive to caffeine and alcohol, it may mean they’re more vulnerable to drug side-effects. Doctors often ask about drug allergies, which are rare, but seldom about side-effects, which are very common, he says.
Once they’re on a medication, patients also need to be aware of any new symptoms they might experience.
“It takes a lot of people to really get harmed by these drugs before the medical profession realizes ‘Well, maybe it’s more than we think.’ Imagine how many patients were told ‘It’s not the drug,'” says Dr. Cohen.
One of Public Citizen’s key rules for avoiding harm from drug side-effects is to be alert to any changes after starting medication.
“What we’ve told our readership for years is that if you start a new drug and you develop a new symptom, assume it’s the new drug and not the disease that you’re being treated for that causes the symptom,” says Sasich.
Another good strategy is to ask your doctor if you can stop one of your other medications when you start a new drug. “Too often there is not a physician that has overall responsibility for all of the patient’s drugs and physicians are loathe to discontinue a drug that another physician has prescribed,” says Sasich. “It’s kind of like a snowball with drugs.” The more drugs you take, he adds, the more chance you’ll have some kind of interaction or adverse drug effect.
Consumers should keep a list of all the drugs they’re taking, and make sure that at least one of their doctors knows about all of them. Patients should regularly ask, “Do I still need to be taking this? Can we lower the dose? Can we stop this one or that one?”
Sasich says patients also need good access to information that is regulated by the government about their medication. They should receive this information with every new and refilled prescription so they know the risks of the drug and what steps to take if an adverse effect appears.
Sasich and his wife, a Canadian pharmacist, have studied the information leaflets distributed by pharmacies here and found them lacking information. “Some of these are atrocious, they’re absolutely worthless,” he charges.
Public Citizen keeps a list of “Do Not Use” drugs. It’s up to more than 200. They encourage patients to look at the list before they get a prescription filled and ask if there is an alternative “We’re much more interested in preventing things from happening than patients finding out that we wrote about it.”
Remember, he adds, there’s no such thing as a safe drug. All drugs have risks, so people must take charge of their own drug safety.
For information on Canadian drug advisories and recalls, how to file and adverse drug reaction, or to search the adverse drug reaction database, visit Health Canada’s MedEffect page at:
For Public Citizen’s list of Do Not Use Drugs and other tips visit www.worstpills.org
Adverse drug reactions can be reported to Health Canada by calling (866) 234-2345 or by fax at (866) 678-6789.