This year's Nobel Prize for medicine and physiology was awarded to a trio of researchers who, over the course of many years, discovered two drugs that have been used to treat millions of people worldwide: ivermectin and artemisinin.
It will come as a shock to many Canadians, then, to learn that these life-saving anti-parasitic drugs are almost unavailable in this country, a twisted reality that speaks volumes about our drug regulatory system.
Let's start with ivermectin, a novel therapy for roundworm developed by William Campbell of the United States and Satoshi Omura of Japan. The medicine has nearly eradicated onchocerciasis (river blindness) and helped to sharply reduce the incidence of elephantiasis.
These tropical diseases are exceedingly rare in Canada – only one or two cases a year of river blindness appear in travellers. In those cases, tropical-disease specialists can make a special access request to Health Canada and the drug's maker, Merck, will provide it free. (The company has been giving the drug away in the developing world since 1987, an initiative that challenges the "greedy Big Pharma" narrative a bit.)
But ivermectin can also be used to treat a broad range of parasitic infections, including strongyloidiasis, Norwegian scabies and lice. Yet, ivermectin cannot be prescribed; access has to be approved on a case-by-case basis, and it is usually granted if the situation is considered life-threatening.
This can be problematic, particularly in a multicultural country such as Canada with a good number of immigrants and refugees. Worldwide, hundreds of millions of people – most in Southeast Asia and Africa – are infected with the parasitic intestinal worm Strongyloides stercoralis. The parasite is transmitted through bug bites and most people never know they are infected. But if they become immune-compromised – because of cancer, rheumatoid arthritis, HTLV-1 infection (a retrovirus similar to HIV) or a host of other conditions – the parasite can multiply exponentially and quickly become lethal.
Now, let's look at artemisinin, a life-saving treatment for falciparum malaria developed by Chinese researcher Tu Youyou, for which she was awarded a share of the Nobel Prize.
It is also a special-access drug, but stocked in the 13 Canadian hospitals designated as malaria treatment centres. While malaria is rare in Canada – a couple of dozen cases are imported annually – it is deadly and can kill quickly.
Artemisinin, however, can also be used to treat schistosomiasis (also known as snail fever), another parasitic infection that afflicts hundreds of millions worldwide. While it is not deadly, the disease can damage internal organs and cause brain damage in children. Again, artemisinin is not readily available to treat cases in Canada.
So why are ivermectin and artemisinin, drugs that are on the World Health Organization's list of essential medicines, not readily available in Canada – at least for humans? (Ivermectin is widely prescribed by veterinarians to treat parasitic worms in pets and farm animals. Some savvy consumers even use their dogs' medicine to treat their kids' head lice.)
The simple – and absurd – reason is that it is not worth the drug maker's time, effort and expense to have these world-beating drugs approved for sale in a market as small as Canada.
What these examples tell us is that the drug regulator, Health Canada, needs to be more flexible and less bureaucratic. There is no reason that these drugs, which have been approved by the U.S. Food and Drug Administration and have been used safely on millions of people, cannot be rubber-stamped and made available to Canadian patients in need.
These neglected, Nobel-winning drugs also remind us that Canada doesn't have a coherent policy on how to approve and fund so-called orphan drugs (those used for rare conditions, and for which there is a desperate need but no profitable market). The federal government unveiled an Orphan Drug Framework in 2012, but still hasn't implemented it.
Finally, that we actually need ivermectin and artemisinin in Canadian health practices is a sobering reminder that the world is getting smaller, and that tropical diseases are not just in the tropics.
The Nobel Prize, which highlighted a China-Japan-U.S. triumvirate of excellence in research, reminds us that, in science, there is no longer an "us" and "them." There shouldn't be in our drug-approval system either.
André Picard