Dr. Joel Lexchin is professor emeritus at York University and an emergency physician with the University Health Network in Toronto. He recently presented the Harry Crowe Foundation’s Olivieri Lectureship on Medical Ethics, where he spoke of the relationship between the pharmaceutical industry, the medical profession and government.
You believe that the relationship among these three large players significantly impacts how we regulate drugs in Canada, affecting cost, safety and prescribing patterns. How serious are the implications?
Very serious. When it comes to drug regulation and federal policies affecting how much we pay for drugs, it seems that the interests of the industry are being placed above that of the public. The fallout is that drugs come on the market with unknown safety issues, and in some cases where their benefits have not been established, it takes a decade or longer until it becomes known if the drugs are doing what they claim they’re going to do. We pay more on a per capita basis than any other country in the world, outside of the US, for prescription drugs.
Why is this happening?
We aren’t alone, but the problems seem particularly acute in Canada. The root can partly be traced back to “user fees” introduced in the mid-90s, which the federal government began collecting from industry to help run the drug regulatory system. Prior to this, Health Canada (HC) was solely funded from tax dollars with a primary responsibility to the citizenry. Now it’s getting about half of the cost of running the drug regulatory system from the industry. So now it has two masters and there’s evidence that the introduction of user fees along with other initiatives to reduce regulation has biased the way HC operates in favour of drug companies.
What solutions could you propose?
Restore full funding for the drug regulatory system from public money. Also, HC must become much more transparent in the information it releases. We need to see what kind of information the drug companies give to HC when they try to get drugs on the market, how HC evaluates that information, and for HC to become much more aggressive in monitoring safety issues. I advocate that Canada should pick and choose among the best practices internationally.
But don’t intellectual property rights protect the information drug companies share with HC?
A lot of the data is deemed confidential business information, and as such won’t be released by HC unless the companies agree to it. But other countries seem to make it work. New Zealand has the best model on pricing. It’s very aggressive about how it deals with companies, and its citizens pay considerably less than Canadians. The European Medicines Agency is currently doing the best job on transparency. They proactively release large volumes of material to their public website. In the US, the FDA certainly has problems, but is also much more public in what it discloses.
Doctors and pharmaceutical companies interact as well. What are the issues you see in their relationship?
That relationship really solidified back in the 50s and early 60s when they faced a common enemy in the federal government. The profession was very worried about the introduction of Medicare and bitterly opposed it, and drug companies worried that patents would be stripped. Although that relationship has weakened over the years, it still exists. The Ontario government has just announced plans to make drug companies disclose payments to doctors and health care institutions. Over $500 million annually is spent by industry marketing products to doctors, who, despite what they think, are vulnerable regarding the information they get from industry, leading to problems with the way they prescribe.
A problem very much in the public eye is the looming failure of many antibiotics. Why is this happening?
Drug companies behave like any rational economic actor and want the best return on their money. Antibiotics fail on a number of fronts. They’re only used short-term. Drug companies want products that are used for a lifetime because that’s where the money is. New antibiotics, if they are used rationally, will only be used very occasionally, and kept in reserve for when other medications don’t work. All of these things inhibit drug companies from being interested in developing new antibiotics.
Is there a role for government here?
Government already finances the bulk of the basic research which companies translate into new medications, and should be looking at directly getting into the development of new drugs, possibly through crown corporations, and especially in areas with high medical need but relatively low commercial value to industry. Canada can’t do this on its own, but could champion a coordinated international initiative.
You’ve spent decades investigating these issues. Why?
What’s driven my interest is a desire for social justice. Also, as part of the profession I think that we’ve been given a privilege to be able to help people, and so have to be free of conflict of interest.