The Thin Edge of a Slippery Wedge

"It is a drug [Leucovorin] we commonly use, so its absence is serious. We are missing an even more important drug in Etoposide for the same reasons and for many months. Last week we learned that another important drug called Vinorelbine is on back order, and a new Canadian producer is being sought."
"It seems to be getting worse. There were some [shortages] a few years ago that were resolved after a few months. I can tell you at the Jewish no patient has been impacted yet, because we're shifting them around where there are other options. Patients are being given other options. But where this is the best drug, we're absolutely giving them the drug."
"It will affect people. I don't know what;s happening in the rest of the province, but everyone is scrambling to try and do their best. It's like a bunch of divers all breathing off of one [oxygen tank]. They have to share. It's crazy."
Dr. Gerald Bastist, director, Segal Cancer Centre, Jewish General Hospital, Montreal

Oncologists say drug shortages are becoming more frequent in Canada. Health Canada told CBC News it 'recognizes the impact that these shortages have on the patients who rely on these important medications and is taking action to address them.' (Gerry Broome/The Associated Press)

"Drug shortages have become a time-consuming and unwelcome part of pharmacists' daily practice, as they spend more and more of their time helping to mitigate the impact on their patients."
Canadian Pharmacists Association

"Health Canada recognizes that drug shortages can have a significant impact on patients and health professionals and is committed to working with all stakeholders -- including provinces and territories and companies to help prevent or minimize their impact on patients and their families."
Anna Maddison, spokesperson, Health Canada

"In order to maintain the highest quality standards, an important manufacturing set-up change was required, thus causing a disruption in the supply of this molecule."
"We are working in collaboration with the manufacturing site and Health Canada to ensure the earliest possible market reintroduction."
Isabelle Troitzky, spokesperson, Sandoz Canada

Three intravenous cancer drugs in particular are in short supply in Ontario, Quebec, Nova Scotia and New Brunswick. (CBC)

A spokesperson for Fresenius Kabi USA explained the shortage of Vinorelbine on "challenges sourcing the active pharmaceutical ingredient". Dr. Batist has little patience for the excuses: "It's a story of corporate irresponsibility ... and then regulatory lack of oversight because no one was able to anticipate these things. And so we're constantly catching up". It is anything but a stable situation when access to vital medications for seriously ill and chronic patients becomes a problem of shortages whatever the cause.

That oncologists across Canada are nothing short of alarmed by a chronic and growing shortage of essential cancer drugs speaks volumes about the vulnerability of their patients. Exemplified by the fact that there is no word on when one of the medications will once again be available for those needing its special properties. These are drugs delivered intravenously; Vinorelbine for non-small lung cancer and metastatic breast cancer; Leucovorin to decrease toxic side effects of two other chemotherapy drugs; and Etoposide for lung cancer, malignant lymphomas and testicular cancer.

All dread cancers. All requiring constant attention and the administering of specific medications in hopes of extending life, and yet one of the drugs is out of circulation with no word when supplies of the medication will once again resume, if ever. Pfizer Canada and Teva Canada Ltd. stopped their production of the drug, Pfizer citing "raw material availability", Teva discontinuing the drug for "business reasons", according to a website, drugshortagescanada.ca, under contract with Health Canada.

Two generic drug makers producing Vinorelbine, are under extreme pressure resulting from the discontinuations, all the more so since both, Fresenius Kabi Canada Ltd, and Generic Medical Partners Inc. are themselves struggling with shortages of their own, citing in part, "demand increase for the drug". All the more reason, since more people are being diagnosed, to be able to depend in the medical community, to access this vital drug since patients' ability to recover, and their future is concerned.

No one can be under any illusions that pharmaceutical companies produce their products for the greater good of humankind. Their purpose in production always has been, continues to be, and will remain so in the future, to make profits, and the more the better. Profits, they intone, enable investment in pharmacological research to produce new and more effective products for a wide range of illnesses. For which they will have patents. And when those patents run out and generic drug manufacturers rush to produce their own versions, the original drug maker loses interest.

After all, their high prices cannot compete with the pricing of generic products, sometimes substantially more affordable than the original. What has been revealed is that Vinorelbine, Leucovorin and Etoposide have gone off-patent and so their profitability has fallen for brand name medications. For the time being, resourceful oncologists have been prescribing equally effective substitutes. Their concern is that this approach has its limits.

And then, the Canadian Pharmacists Association released survey results indicating that drug shortages across the board (not merely involving cancer medications) have increased during the last five years. Name-brand pharmaceutical manufacturers meet a government controlled pricing schedule in Canada. Their operations in the United States -- often where the head offices are located and where the companies originate, operate entirely under the free enterprise system; they set their own prices and do so on the premise that the market will bear high prices.

Except that it's always the most vulnerable who suffer under that kind of regime; people requiring drugs but who have no insurance plan, or have a plan that pays only partial costs, and they are victimized, unable to pay for a full regimen of whatever pharmaceutical they require to maintain their chronic illnesses or to fight off disease. They look longingly at Canada where most drugs approved by Health Canada are priced substantially lower. And if and when they can, attempt to access their drugs in Canada.

This is particularly true with insulin, where a vial comes with a $34 price tag in Canada and $340 for the same vial of insulin in the United States. So, as neighbours we should share our questionable good fortune, of course. However, given short supplies there is an obligation to Canadians to be able to access pharmaceuticals meant for Canadian consumption.

It would hardly be possible for an industry geared to providing medications for a population of some 37-million to plan a ten-fold increase in production to accommodate a population of 330-million when problems arise servicing the needs of even 37-million. It's past time for Americans to demand of their government  that it take its responsibilities relating to health and security of supplies of pharmaceuticals and affordable pricing seriously.

Innovative Medicines Canada, an industry lobby group, has appealed to the Canadian Government:  "Although purchasing agreements with suppliers may contain clauses that would prevent bulk export to the U.S., many Canadian pharmaceutical companies are subsidiaries of U.S. corporations and may become obliged to do so through U.S. legislation."

A pharmacist counts prescription drugs at the CentreTown Pharmacy in Ottawa. Innovative Medicines Canada is urging the federal government to get ahead of a U.S. plan to export Canadian drugs in bulk. (Chris Wattie/Reuters)