Health Canada blocks dying patients from access to drug

Two lung disease specialists are accusing Health Canada of shortening some patients' lives, by denying them access to an inexpensive, relatively harmless drug not sold in Canada.

"I am appalled and angry that a federal agency that we fund through our taxes would deny Canadian citizens who are dying of a treatable, infectious disease potentially life-saving medication," said Dr. David Forrest, of Nanaimo, B.C.

In previous years, Health Canada granted several patients special access to the drug, called clofazimine. The doctors said that approachhas suddenlychanged, for no good reason.

"We had a process in place that was working, for 20 years or so, and now all of a sudden were running up against a brick wall," said Dr. Stephen Field, from Calgary.

Drug is last option

The patients have a bacterial lung infection called Mycobacterium avium complex, known as MAC, but are multi-drug resistant.

"Its a very uncomfortable way to slowly pass away," said Field.

One of Forrests patients, Dean Robertson, has been treated with several drugs since 2010, but none worked. Forrest wants to give him clofaziminewhich has been widely used for leprosyto treat his lung disease.

"If I dont get this drug I am going to possibly die from this infection," said Robertson, who was forced to stop working because of his illness.

Clofazimine is widely available in developing countries, but is not approved for sale in the U.S. or Canada, because the drug company Novartis hasnt applied for approval.

Forrest said clofazimine has worked very well for one of hisother patients with MAC, who was given special approval to get the drug by Health Canada earlier.

Robertson said it's his last option. "Im 57 but I feel like I am 90. Its just I cant walk or stand very long. The fatigue is unbelievable."

He said another drug he tried caused him to lose his sight, temporarily, which forced him to stop taking it.

"I went blind. I woke up one morning and my vision was gone."

Few side-effects

By contrast, the physicians and literature indicate the worst possible side-effect from clofazimine is a change in skin pigmentation.

"The worst thing they have to deal with is their friends asking them whether theyve been travelling down south because of their nice suntans," said Field.

"There are a number of lung specialists across the country that would like to have access to this drug and have confidence in it and have patients that could benefit from it."

"How can Health Canada justify to Canadians that [Robertson and others] should not be provided access to a potentially life-saving drug which is cheap, non-toxic and has demonstrated efficacy in the treatment of MAC infection?" asked Forrest.

Health Canada has been telling them for several months that the drug needs more study.

"Periodically, the program's medical and scientific staff evaluate whether ongoing access to the drug is appropriate," said a statement from the agency.

"When Health Canada reviewed the effectiveness of clofazimine in the treatment of MAC, the department found that current literature does not support this usea number of drugs, including clofazimine, were shown to have limited or no evidence of clinical efficacy."

The doctors insist they have seen it work, more than once. In addition, they said the lack of efficacy the agency refers to was on MAC patients also infected with HIV/AIDS.

"The argument theyve made is in a different population in patients with a different condition that they didnt benefit from the drug," said Field. "I personally think this is irrelevant."

Most importantly, the doctors pointed out, patients with drug-resistant MAC have nothing to lose.

"They can be very sick and slowly deteriorate," said Field. "While on the medication, they often improve and can get on and live their life as well as they can."

No money for study

Forrest estimates about 1,200 people are diagnosed with MAC each year in Canada, but only a fraction dont respond to other available drugs.

Field said he tried to start a clinical trial for clofazimine, but drumming up funding was impossible.

"Its really unrealistic to think that well be able to do a proper study given the current funding environment for research in Canada," he said.

He suspects the drug manufacturer Novartis is also not interested in studying or marketing the drug in Canada, because there are few patients who need it and many of them are elderly.

"To get drugs approved requires big support from the pharmaceutical companies and they will only do it if there is a realistic possibility of them making profit," said Field.

Novartis sent Go Public a statement, which did not directly address the doctors' request for access to the drug.

"The issue of access to medicines is complex, involving factors including development and health policies, health-system infrastructure and best practices, pricing, rational medicine use and adequate funding," said a statement from the company.

Robertson said he doesnt understand how drug companies and governments work. He just wants another chance to get better.

"Can I please try this? I meanno harm done. Can I at least try? Cause its my last option," said Robertson. "When some people can get it and I cantand Im at the end of my treatment?"

Forrest did not mince words in expressing how he will feel if the government doesnt respond to that plea.

"Responsibility for his death is going to lie squarely with Health Canada," said the physician. "The blood of these people is on their hands."

Submit your story ideas to Kathy Tomlinson at Go Public

Follow @CBCGoPublic on Twitter

Documents

• Letter from Dr. David Forrest to Health Canada.
• Health Canada's reply to letter.
• Health Canada's response to CBC.
• Drug company's statement.