DRUG BUST by Alan Cassels
The people’s briefing note on prescription drugs
• Why is more money going towards drug discovery research than drug safety research? Because that’s what the government of Canada is paying for.
Today’s fortune-tellers, horoscope writers and other modern soothsayers are very compelling figures. They are magnets for attention even though their predictions should be thought of as entertainment and not enlightenment. Yet some predictions do turn out to be right. Julius Caesar was murdered by a conspiring group of senators in Rome, but at least he was warned by his wife and a soothsayer who said the Ides of March – the 15th of the month – could be a very bad day indeed.
This year on the Ides of March, Canada’s federal government chose to announce, with much fanfare, an investment of $150 million over the next five years for pharmaceutical research. The funding seems to be aimed primarily at drug researchers connected to drug companies – because you need matching funds to play in that pool – and at a mere $30 million per year over five years, this doesn’t seem like that much. If, however, we step back from that announcement and gaze into a crystal ball, we can judge with some degree of certainty where the government’s priorities may be taking us. In an era of restraint and worries about the fiscal health of the country, and with the Conservative’s Health Minister Leona Aglukkaq plunking down a big wad of cash to help strengthen “Canada’s position as a preferred location to conduct clinical research,” you tend to pay attention. If you like the idea of Canadians doing clinical research and welcome Canadian patients being the research subjects, you’d welcome such an announcement.
If you have a debilitating disease like MS or Parkinson’s, you might be glad that Canada’s government is prioritizing pharmaceutical research and putting money towards researching products to help our citizens stay healthy. The announcement also noted the new investment will “accelerate the development of new clinical practices and health products, which will have a direct impact on treatment and services provided to patients.”
I know many hardworking researchers who would salivate over even a small portion of the new $150 million, especially the relatively poor lot struggling away doing health services research, investigating drug safety questions or testing different ways to make physicians better aware of adverse drug warnings. But clearly this new funding is not about using the drugs we have more thoughtfully; it’s about developing even more of them. I look into the crystal ball and wonder why it seems important to have drug research done in Canada. Does it matter if a new drug, a new computer program or a new car is designed, tested and built in Mumbai, Melbourne or Montreal? Arguments could be made either way, but the stark reality of globalization is that the global mega-corporations who develop any product nowadays – whether it’s a mobile phone or an osteoporosis drug – are ruled by the laws of the marketplace and will get things done where it is cheapest.
So why would pharmaceutical companies want to develop and test their drugs in Canada if they could do so in Africa, India or China at a fraction of the price? That’s a complex question, but we do know that federal tax incentives and research funding to sweeten the pot will, at least, buy some temporary loyalty. Developing drugs is all about determining effectiveness, learning if a new chemical entity will work in certain diseases and result in improved health outcomes. We absolutely need that kind of research and the drug industry and the Canadian government, including our Health Minister, would argue we need to fund the people and the infrastructure to keep high tech medical research in Canada. All part of the “knowledge economy” they’ll say. Others would argue where a product is developed and tested is irrelevant because the global companies doing the developing will want to sell them wherever they find paying customers. This leads me to conclude that, by necessity, we need more of the kind of research that can only be done here – applied research – which is about taking effective treatments and practices and maximizing their efficient use in a Canadian health system.
Archie Cochrane, a British researcher whose name now brands the internationally esteemed Cochrane Collaboration, one of the best sources of systematic health evidence in the world, wrote a book called Effectiveness and Efficiency: Random Reflections on Health Services. Over 40 years ago, he stressed that governments must actively determine a nation’s research priorities and that “pure” research” can be done and is, in fact, done all over the world.” He said that to improve the effectiveness and efficiency of a health service, governments needed to make considerable investments in applied research.
Applied research asks “real world” questions such as: does health service X or drug Y or diagnostic test Z produce health outcomes in our population that are worth the money we invest in them? And if not, what does produce those desired health outcomes?
One example of applied research could lead to safer and more effective use of pharmaceuticals. We have a Canadian research network called DSEN – the Drug Safety and Effectiveness Network – which was set up a few years ago and funded with $30 million over five years to study the real world safety and effectiveness of drugs. Research to discover rare side effects or adverse effects of drugs already on the market is intensive work that is relatively low-cost, but with potentially high impact. While the DSEN group is studying some vital questions, including the safety of statins (cholesterol-lowering drugs) and antipsychotics (drugs for schizophrenia, but also widely used in the elderly), will it be enough to make much of a dent in the way drugs are used in this country? The crystal ball says no.
Undoubtedly, there are many important drug safety issues that affect millions of Canadians that may never get studied because of insufficient funds and these important research questions might include:
1. Are cholesterol-lowering drugs safe or effective in women and the elderly? (All the data accumulated so far says it’s probably neither.) 2. Should teenagers be prescribed antidepressants, given the known harms of suicide risk? 3. Should pregnant women consume certain prescription drugs when we don’t know their overall risk to the fetus? 4. Should antibiotics be limited to only the most serious, verifiable bacterial infections, which would help stop the deadly onward march of antibiotic resistance? 5. Should the elderly have their blood pressure lowered so vigorously with drugs and could this be contributing to an epidemic of hypotension (low blood pressure) that leads to falls and broken hips? It’s clear the Ides of March announcement of a new $150 million won’t answer important questions like these. The drug companies don’t want to ask questions that might lead to the population taking less of their products.
Will further research in pharmaceutical development make a difference in the lives of Canadians? It might, but that crystal ball is murky. Would it be better to put more money into drug safety and ways to get patients off dangerous drugs to keep people healthier? I can’t read the future, but that’s where I’d invest my money.
A final point: everyone who swallows pills has a golden opportunity to make the world a better place. Have you had an adverse reaction to a drug? Then why not share that experience with others by asking your doctor or pharmacist to file a report with MedEffect Canada, our federal adverse drug reaction reporting system? (Just Google MedEffect Canada.) You could also call the Canada Vigilance hotline at 1-866-234-2345 (toll-free) and file a report with a new website launched in Canada at www.rxrisk.org.
Alan Cassels is a drug policy researcher at the University of Victoria and author of the forthcoming book Seeking Sickness: Medical Screening and the Misguided Hunt for Disease, due out April 2012. Read more of what he’s writing about at www.alancassels.com