Concerns mount as worldwide shortage of bladder cancer treatment drags on

Doctors in Alberta, and across the country, are doing what they can to shield patients from a worldwide shortage of a key bladder cancer drug, but there are concerns patients could suffer as the shortage drags on.

BCG, or bacillus Calmette-Guérin, is an immunotherapy that involves injecting bacteria into the bladder through a catheter, triggering the immune system to attack the cancer. It is considered the best defence against the most common form of bladder cancer (non-invasive bladder cancer) and in many cases it can eliminate the disease altogether.

Canada's only supplier, Merck, says the shortage, caused by increasing global demand for BCG, could last until the end of October. 

"We are concerned about this," said Dr. Eric Hyndman, a Calgary urologist working at the Rockyview General Hospital's prostate cancer centre.

"It's a very effective treatment for bladder cancer."

100 patients receiving 1/3 normal dose

About 100 Albertans are currently being treated with the drug. In an effort to conserve supply, doctors have cut the amount of BCG they're using in treatments by two-thirds. Some patients who aren't quite as sick are being moved to chemotherapy. 

Alberta Health Services (AHS) says it was notified by Merck in the fall of 2018 that a worldwide shortage was coming, so it began taking steps to conserve the drug then.

The strategy — outlined by the medical advisory board of the advocacy group Bladder Cancer Canada — was used during a previous worldwide shortage in 2015.

"We don't really know the impact that it's going to have. If it does continue on for many months, then it has a real possibility of impacting patient care," said Hyndman.

He added he hasn't seen any negative impacts on patients yet.

If it does continue on for many months, then it has a real possibility of impacting patient care.- Dr. Eric Hyndman

But, according to Hyndman, bladder cancer can come back. He said it's unclear whether reducing the dose of BCG that patients receive now will increase the likelihood of the disease returning months or years down the road.

Dr. Nimira Alimohamed, medical oncologist at the Tom Baker Cancer Centre, is also worried about patients who aren't receiving full doses of a medication that can ultimately cure bladder cancer.

"What we're trying to do is prevent patients from getting more advanced disease. So without this treatment, without enough of it, or without enough of it on time, the worry is that patients could develop more advanced stages of the disease that we can no longer cure," she said.

Low Supply

AHS says it has 75 per cent of its normal supply of BCG. It is monitoring hospital stock levels on a weekly basis and can can shift resources to different parts of the province as needed. 

In a statement emailed to CBC News, a spokesperson said officials are doing "everything possible" to minimize the impact on patients.

"AHS is committed to ensuring no patients go without the medication they require to treat bladder cancer due to the shortage of this medication," the statement said.​

According to AHS, the decision to reduce the dose of BCG is supported by the medical advisory board of Bladder Cancer Canada and the Canadian Urological Association.

Shortage blamed on increasing demand

The pharmaceutical giant Merck is blaming increasing global demand for its shortage. As the primary world supplier of BCG, the company says it has bumped up manufacturing by more than 100 per cent but it is still struggling. It anticipates back orders could continue until the end of October 2019.

In a statement emailed to CBC News, a company spokesperson said BCG "is a very complex medicine to make." According to Merck, each batch takes at least three months to produce and that process involves growing a bacterial strain in a test tube.

Merck says it has put an allocation plan in place and expects to fulfil 75-100 per cent of normal demand.

Calls for alternative supply

Bladder Cancer Canada, which has played a central role in developing the strategy for physicians across the country, is now calling on the federal government to step in.

In a position statement released Thursday, the advocacy group expressed concerns about the shortage dragging on.

"Bladder Cancer Canada is deeply concerned about the current BCG shortage and its effects on the treatment of bladder cancer patients. We are urging Health Canada to bring a second supplier of BCG to Canada," the release said.

For its part, Health Canada won't say whether or not it is looking for ways to bring in other forms of BCG. A spokesperson told CBC News that Health Canada is monitoring the shortage and working with the company to limit the impact on patients.

There needs to be some thought into how we hold industry accountable.- Dr. Nimira Alimohamed

In a statement emailed to CBC News, the spokesperson said that when critical national shortages occur, the agency works to "identify mitigation strategies, which may include regulatory measures and exploring access to alternative products available in other jurisdictions. Factors such as whether the shortage is national in scope, whether alternative supplies are available, and whether the product is considered medically necessary are all considered in determining the potential impact and any necessary actions by Health Canada."

As an oncologist, Alimohamed says this isn't the first cancer drug shortage she's had to deal with and it's an issue she wants to see addressed.

"There needs to be some thought into how we hold industry accountable and how we can ensure that there's processes in place and laws and regulations in place so that this doesn't happen."