Tuesday, September 23, 2014

Canadian shortage of vital bladder cancer drug prompts rationing

Canada is experiencing a serious shortage of an essential drug for the treatment of bladder cancer.
The shortfall, which is due to manufacturing problems at plants operated by two different pharmaceutical companies, could have major consequences for patients.
Without the drug – bacillus Calmette-GuĂ©rin strain tice (BCG) – to control their symptoms, some patients might require surgery to remove their bladders.
We’re struggling with how to ration our stock,” Neil Fleshner, head of urology at University Health Network in Toronto, said in an interview.
“This shortage could last weeks or months and if we run out it will be a travesty.”
To ensure all patients get treatment despite dwindling stocks, Dr. Fleshner said they could be treated temporarily with one-third of the regular dose.
“There is some literature about this so getting one-third of a dose would be a minor compromise – at least in the short-term.
“But going without BCG altogether would be an oncologic disaster,” he said.
The principal supplier of BCG for bladder cancer treatment is Merck Canada Inc., which sells it under the brand name OncoTICE.
Ani Armenian, a spokesperson for the company, said the shortage is due to manufacturing problems at a company plant in Durham, N.C., that are not directly related to the drug.
“Merck has been working to increase supply of this important medicine and is committed to resolving this issue as quickly as possible,” she said.
A second manufacturer, Sanofi Pasteur, makes a product called ImmuCyst, but it has not been available since 2012, when production was suspended due to problem at its plant outside Toronto. The drug will not be available again until mid-2015.
BCG is actually a form of cow tuberculosis. It is also used as a TB vaccine. In Canada, only Nunavut routinely vaccinates against TB and, because of domestic shortages, they now purchase the product from a manufacturer in Japan.
It is not entirely clear how BCG works in bladder cancer patients, but it is believed it stimulates the immune system and keeps the cancer cells from spreading.
Some, but not all forms of bladder cancer can be treated with BCG. Patients get an initial treatment of six doses then maintenance doses every three months for up to three years.
In cases where the drug does not work – or is unavailable – patients usually require removal of the bladder. That, in turn, can result in incontinence, impotence and infertility, as well as reconstructive surgery.
About 8,000 Canadians will be diagnosed with bladder cancer in 2014, according to the Canadian Cancer Society. About 75 per cent of them are men.
About 2,200 people a year die of bladder cancer. It is one of the most treatable forms of cancer, thanks largely to drugs like BCG.
Drug shortages have been a growing problem in Canada (and worldwide) in recent years. The reasons include a scarcity of raw ingredients, changing regulatory regimes and consolidation in the pharmaceutical industry.
The principal response in Canada has been to establish a database to list drug shortages that allows pharmacists, physicians and hospitals to get a sense of which drugs are in short supply so they can look for alternatives.

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