The big pharma companies call themselves “research based” and push to get their “cures” and “breakthrough” drugs on the market faster. Less than 5% of drugs introduced in Canada are considered to be breakthrough or substantial improvements over existing therapies. In 2006 only one drug out of the 89 approved would fit that category.
The truth is that Health Canada already prioritizes drugs identified as breakthroughs and assigns reviewers accordingly, having shortened the time for approvals by 2002 to 215 days. There is no justification for lowering the safety bar for the other 95% with conditional or fast-tracked approvals.
The recommendation proposed is that conditional drug approvals should never lead to faster approvals where benefits will not outweigh the risks by the evidence. Drug reviewers are like the air traffic controllers of drug safety. No one tells air traffic controllers to get those jets in faster.
Clinical drug trials are biased in many ways, the most common being burying those that show the drugs don't work. In January an entire class of drugs that three million Canadians take, SSRI antidepressants like Paxil and Effexor, was shown not to work for the vast majority of patients who take them. The drug companies had convinced our doctors that they do work for this large group by making sure that 88% of their clinical trials that showed the drugs didn't work were never published. Doctors believe that the drugs are 11% to 69% more effective than they are. Since 1988, SSRIs have caused thousands of excess Canadian suicides.
The recommendation is that we support the proposal for compulsory registration of every clinical trial at its start, and we add that it must include complete transparency. All data and results are to be published on the Internet, even if the trial is not completed. We recommend that the new legislation include an offence of “misleading the regulator”.
The precautionary principle. Risk management is the industry standard for conducting business responsibly. What it means in reality is that they're managing their risk of being sued successfully when their drugs harm patients. It is a practice that puts human lives on the same continuum as money, a key reason prescription drugs are the fourth leading cause of death. We are concerned that the paper's proposal for monitoring corporate risk management plans could be construed as Health Canada adopting corporate risk management.
The precautionary principle does not appear anywhere in Health Canada's documents. In its essence, the precautionary principle means better safe than sorry. It recognizes that in a complex system it's impossible to fully predict outcomes. It assumes that errors occur, and the higher the magnitude of the error, the greater the level of precaution required. It shifts the burden of proof to those who are favouring a risky course of action. With big pharma's dismal safety record, it is crucial to insist they provide evidence that their products are safe and effective before the products get into the bloodstreams and organs of our loved ones. The best way to do this is using the precautionary principle.
The Canadian Environmental Protection Act states that under the constitutional laws of Canada, the government must apply the precautionary principle where there are threats of serious or irreversible damage. Surely we must set the same high standard of managing risk to our loved ones as we do for waterways in our new legislation using the precautionary principle.
One final recommendation. “Cause and effect” is an extremely high standard. In fact, it's an inappropriate standard for regulating prescription drugs. Deadly adverse drug reactions are almost impossible to prove—for example, the hundreds of heart deaths after people took Viagra—because our regulators and courts often buy into the industry standard of proof, which is a higher standard than any court in the world. By cause and effect, cigarettes do not cause lung cancer.
We recommend that new legislation should authorize the whole range of regulatory activity to be triggered by the association of an adverse drug reaction with a drug based on worldwide epidemiological evidence. This will save hundreds and thousands of lives.
I have two additional recommendations, Chair, but I want to give the rest of the time to my colleague.