- Rebecca Walberg, Manitoba Columnist, Troy Media Corporation
While a study released last month by the Canadian Centre for Policy Alternatives (CCPA) correctly identifies a number of administrative problems involved in drug monitoring, arguing that Canada allows new drugs onto the market too soon, its emphasis on the hazards associated with innovative drugs leads it to advocate for an unduly restrictive approach to pharmaceuticals.
CCPA's conclusions are wrong because it forgot to include two stakeholders in their analysis: patients and their doctors. Both safety and good medical outcomes are maximized if patients and their doctors have as many treatments options as possible, as well as comprehensive information about the risks and benefits of all indicated drugs.
Drug companies, of course, are not disinterested actors in pharmaceutical policy, since their income depends upon consumption of their product. But governments are equally biased, since every province subsidizes out-patient prescriptions for those in need, and pays directly for drugs prescribed and administered in hospital.
The stakeholders least biased and best positioned to make informed and appropriate decisions about when to use drugs and which ones to use are patients together with their doctors. Needless to say, it is patients who stand to lose or gain the most when choosing a course of treatment. Patients are not well served by an adversarial relationship between those who develop and sell drugs and those who regulate them.
When a new drug is submitted to Health Canada for approval, its manufacturer must satisfy the government that the drug is safe and effective. The interval between submission and approval is, on average, almost two years long in Canada. In the US, UK and Sweden, it takes slightly over one year to accomplish the same thing. When investigators take longer to authorize the use of a drug, the possibility that dangerous side effects will be discovered before the drug hits the market increases. Too often, however, the downside of lengthy delays between the development of a drug and its use in Canada is left out of the equation.
The longer it takes for a new medication to be approved for use the more patients who might be helped by the drug must go without, even when people with identical conditions in other countries are being prescribed the drug and benefiting from it. Health Canada, recognizing this, is working on meeting a goal of approving or barring a drug within 300 days of its submission, or 180 days if the drug is considered a high priority. Advocating for patient safety, a number of critics, including the CCPA, believe that faster approval will increase the number of patients who have serious reactions to new drugs, resulting in injury or death.
But by stressing the number of fatal adverse drug reactions, the criticism misses the wider issue. What too many critics of the pharmaceutical industry neglect to address is that patients taking experimental or newly released drugs are usually suffering from diseases that greatly hamper their quality of life and can be fatal. All medications carry some risk, however small. They are prescribed because they also confer great benefits. Whether the risks for a particular patient outweigh the benefits is a difficult judgment that is different in every case. It is precisely because this decision is so personal that it should be left to patients and their doctors.
In order to make the right decision, though, doctors must be equipped with up-to-date and accurate information about the side effects associated with any drug, and they must share this information with their patients. In this respect, the CCPA paper is exactly right.
One way to mitigate the risk is to follow the US example of imposing penalties – through litigation - on manufacturers who don't disclose the risks of their products. This dynamic is largely absent in Canada.
The solution is not to ask the government to play a heavy-handed role and decide on behalf of patients and doctors what treatments should be available to Canadians. Nobody has as much on the line when choosing a treatment plan as patients themselves. The best way to ensure good outcomes combined with access to drugs is to make available as many options as possible, coupled with current and comprehensive information about the risks, known and unknown, of each treatment.
It is time to change Health Canada's focus from delaying access to drugs to boosting access to information to help Canadians, with their doctors, make the best choices possible about their medical care.
