A Canadian senior says she is still suffering serious health problems after the prescription medication she had been taking for decades seemed to suddenly stop working, and no one could explain why.
A CBC News investigation found Canadians are being kept in the dark about their prescription medications. The investigation has also raised questions about how much Health Canada knows about the chemical ingredients in pharmaceuticals in this country and where they come from.
Go Public obtained U.S. government documents that suggest a serious lack of testing and standards at some foreign labs making medical ingredients for export to Canada.
Almost two years after Evelyn Mitchell's medication seemed to stop working, she says she is still dealing with the repercussions.
"I can't even cut the grass or tend my flower garden or bake bread. It's very difficult," said Mitchell, who lives half the year in Nova Scotia and the other half on P.E.I.
Mitchell, 82, suffers from hypothyroidism, a condition where her thyroid gland doesn't produce enough of an important hormone. Mitchell says she had been on the same medication since the 1970s with no problems.
But in early 2013, she noticed something was wrong.
"I started getting sicker and sicker and sicker and itchy and fatigued, very fatigued," she said. "Everything that hypothyroidism has, I had again."
Her doctor ran tests that revealed the drug that had worked for years seemed to have stopped working.
"I did a very thorough review of care," Mitchell's physician, Dr. Ajantha Jayabarathan, told Go Public. "And having ruled out all kinds of other reasons why she had the symptoms that she did, and why her [thyroid] levels were so high, I had to come to the conclusion that there was an issue with the [medication] she was taking."
Jayabarathan changed Mitchell's medication and her hormone levels were soon back to normal, although recovery has been slow.
Go Public provided the company that makes the drug with a sample of what Mitchell and her doctor believe was a bad batch of medication. It tested the pills and determined "the claim of lack of potency is not substantiated."
Ingredients made offshore
Mitchell and her doctor started looking for answers as to what might have caused her problems.
They questioned where the drug's ingredients were made after hearing about a U.S. Food and Drug Administration crackdown on problems at foreign labs in India and China that manufacture the drug ingredients known as APIs (active pharmaceutical ingredients) for Canadian and U.S. pharmaceutical companies.
Neither Jayabarathan nor Mitchell could get the answers they were looking for, despite checking with the pharmacy and the company that made the drug in 2013.
"As consumers of health-care products, we have the right to know where something is produced, what kind of tests are in place to ensure the product is safe … this is information that should be freely available," Jayabarathan said.
Health Canada said the manufacturing location of APIs is "confidential business information."
Mitchell learned the APIs in her drug were manufactured in Western Europe, but experts say most of Canada's APIs are manufactured in China and India, where costs are lower.
Through a Freedom of Information request, Go Public obtained dozens of FDA inspection reports that outline numerous and serious infractions at foreign manufacturing labs, mostly in India, used by Canadian and U.S. drug companies. The infractions include:
- Failure to properly test drug batches to ensure quality.
- Improper sterilization of equipment and packing material.
- Ignoring test results that showed problems with APIs, then destroying all the samples and any record of the test results.
- Failure to notify consumers of a potentially contaminated API batches.
Health Canada slow to react
Jillian Kohler, an associate professor at the University of Toronto, says Health Canada has been slow to react to the growing number of foreign companies manufacturing ingredients for Canadian prescriptions. It's now a multi-billion dollar industry.
"Health Canada has to get its act together — really be more proactive instead of reactive — and really start prioritizing where these risky facilities are [and] how to deal with this problem in a smarter way," says Kohler, who specializes in the outsourcing of Canadian drug ingredients and potential problems.
The lack of information and transparency aren't the only issues, according to Kohler. Health Canada doesn't have the resources to travel to foreign countries to inspect even a fraction of the labs to ensure safety standards are met.
Companies do own checks
Instead, it relies on pharmaceutical companies to do their own checks, or on reports from third-party manufacturers in those foreign countries to determine whether the drugs meet Canadian standards.
"The problem is, we're dealing with human lives here … so when we're dealing with pharmaceuticals it's not like getting a faulty computer, but it's about getting a product that can essentially either save a life or lose a life," Kohler says.
Health Canada says it uses "inspections by trusted regulatory partners of facilities abroad" to ensure the safety of imported drugs.
In June, Health Canada announced what it calls "the next phase" of its Regulatory Transparency and Openness Framework Plan, promising, in part, to give Canadians more information when it comes to drug safety and inspections.
Kohler says the transparency plan is a good step, but it's too early to tell whether it will make a difference in providing more information to Canadians about their prescriptions.
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