Iris Gorfinkel is a General Practitioner, and Founder and Principal Investigator at PrimeHealth Clinical Research in Toronto, Ontario.
On July 10, 2018 Health Canada issued a recall of several products containing the blood pressure lowering drug, valsartan. This came in response to a disclosure from its Chinese manufacturer that the drug had been contaminated with a known carcinogen. A massive effort to contact patients to stop the affected drug lots, and to replace it with an alternative, ensued. Few clinicians had been even remotely aware that valsartan is mostly manufactured in China.
Valsartan is far from unique in this regard. China has become the world’s dominant supplier of essential ingredients needed to make most of the world’s other medicines as well.
When I purchase a head of lettuce in Canada, I can see a clear disclosure of its origin. Most other consumer items are held to the same standard. However, when it comes to vital medicines such disclosure rules do not apply. Instead, trust is placed primarily in Health Canada’s oversight. The quality of a drug’s manufacturing process rarely makes the radar when clinicians assess unexpected adverse events. The ongoing failure to disclose where drugs are made reduces the vital consideration of potential quality issues in drug manufacturing.
How is it that most of the active pharmaceutical ingredients (APIs) in Canadian drugs originate in China? In the 1980s the U.S., Europe and Japan had been the world’s manufacturer of most APIs. This changed in 1984 when the U.S. mandated the birth of generic drugs. This new demand for cheaper drugs pushed demand for cheaper ingredients. In 2000 the U.S. effectively removed tariffs on goods, including those on pharmaceuticals imported from China.
Soon thereafter, China was able to out-compete American manufacturers by flooding the market with cheap drugs. One example of this is penicillin. The over abundance of penicillin coming from China exported to the U.S. made manufacturing penicillin in the U.S. uncompetitive. The last penicillin manufacturer in the U.S. stopped producing the drug by 2004. China has since repeated this practice with most other drugs, too, and has thereby successfully out-competed most of its global competitors in manufacturing APIs.
To compound this effect, goods manufactured abroad remained subject to tariffs when importing to China. Such tariffs compounded the impact of higher costs of manufacturing APIs outside of China, further stifling competition. China’s domination in the manufacturing of APIs was thereby ensured. Once China had a stronghold on a particular API, what generally followed was a price increase of that API.
Most clinicians are unaware that 80% of the world’s pharmaceuticals’ active ingredients are currently manufactured in China.
Such heavy reliance on any one country is concerning. Improving the transparency of where drugs are made may help in reversing this dependency.
While simple in concept, the real-life application of such transparency is surprisingly complex. While most APIs originate in China, pharmaceutical companies often purchase and package the final product elsewhere utilizing components from other countries. This confounds a simplistic definition of “where a drug is made”. Still, at a minimum, Canadians need to be informed of the origin of the API.
The introduction of such transparency in Canada would carry with it far-reaching implications. In addition to an increased awareness among Canadian physicians that APIs have mostly been outsourced to China, physicians might consider more carefully the quality of manufacturing when assessing unexpected adverse events.
What the introduction of such transparency is not likely to do is to significantly impact the quality of APIs manufactured in China. This is because Canada’s purchasing power amounts to only 2% of the world’s pharmaceutics, even though we pay very high prices for drugs compared to most other countries.
Nor could such transparency be expected to improve Health Canada’s true level of oversight in foreign drug manufacturing. Health Canada lacks sufficient resources to travel to foreign countries to inspect even a fraction of the numerous outsourced manufacturers. Financial constraints force Health Canada to rely on pharmaceutical companies themselves to ensure that Canadian standards are met.
Ultimately, foreign drug manufacturers are under no direct obligation to adhere to Canadian standards. The check and balance in the commerce of pharmaceuticals rests with the drug manufacturers’ willingness to comply with our standards in order to optimize their sales. Manufacturing standards in China have improved substantially as western drug companies continue pouring billions of dollars into research facilities in China in the ongoing quest to manufacture cheaper drugs. Yet, our dependency on one country manufacturing the majority of our drugs raises serious concerns.
Transparency about drug ingredients’ origins is at least as important as transparency of ingredients in foods and other goods. Knowing where drugs come from empowers Canadians and their clinicians to question manufacturing practices when a drug stops working or when faced with an unexplained adverse event. The manufacturing process of drugs is highly complex. Errors that are naturally inherent to this process need to be considered as part of the differential diagnosis when faced with a drug failure. It also needs to be reported when suspected.
I think the direction is simple; if doctor’s are threatened by the question, “Are these drugs cruelty-free, local, fair-trade, and organic…” The Hippocratic Oath truly seems symbolic and hypocritical. A real debatable amount of hums and haws around even entertaining a patient’s need-to-know-basis. It should have been, “let thy food be thy medicine, and let thy chemicals be as well-sourced and labelled as thy food.” A exemplary doctor would take the journey with us; take it as a hag-turned-Athena “golden goose” moment and I’ll enthuse when patient’s need more information at our offices, not less when it comes to pill prescription. Critical thinking doesn’t skip all of us huddled yearning masses.
Suffice it so say, in allopathic context, SO REFRESHED to read a professional and experienced voice lending weight to patient advocacy when the pill’s get tough, and in hindsight, medical staff nevermind the contras FOR YOU. Deep reverence for the effort.
I have been doing research on inferior drugs from China for many years. My compilation of research, complete with published references, is available in the form of a publication entitled Health Care Roulette,, at DrugsFromChina.com
The way Covid-19 is ‘popping up’ in care homes merits investigating whether it initially went ariund globally on one of the APIs. …Then the media “reports it” as if care home workers are getting coronavirus from the residents!
Wow – this is serious especially in light of China’s recent implication that they could suspend pharmaceuticals to the US (and presumably us)! See https://www.foxnews.com/world/chinese-deny-americans-coronavirus-drugs.
Trudeau only cares about one thing and that is himself and his personal agenda’s . Sad that the PM of Canada has deceived the country and supports foreign countries instead of his own. Now we are face with the Corona Virus and Trudeau is travelling the world trying to secure a seat at the UN. He doesn’t close the boarders or take direct measures to protect the citizen’s instead he makes Christine Freeland the VP who knows nothing about this virus. It is sad to see where Canada has come. We need a PM to stand up for Canada, bring manufacturing of Pharmaceutical here in Canada.
I am appalled that we now depend on China for most of our drugs. How can our government allow this to happen when their major responsibility is to protect it’s citizens. Medicines/drugs are vital to our well being. To outsource this to this large extent, is a conflict of interest trading the safety of our citizens for greater profits for the pharmaceutical industry. Shame on our political leaders for letting this happen.
I totally agree. I am a pharmacist and we need to be able to know/trace where the drugs we dispense or consume are fabricated. We know where our t-shirts are made on the tag and not our drugs!! Pressure needs to be made on Health Canada so that every bottle/package carry this info
How can our government allow this to happen when their major responsibility is to protect it’s citizens. Medicines/drugs are vital to our well being. To outsource this to this large extent, is a conflict of interest trading the safety of our citizens for greater profits for the pharmaceutical industry
Please tell me about any differences in standards between Health Canada’s guidelines for prescription drugs versus those used by the Federal Food and Drug Administration in the U.S. The recent book Bottle of Lies” (recommended!) was quite an eye-opener for me, but its focus was on the American situation. Is there a comparable story regarding the Canadian system?
Is the quality of prescription drugs A-one here? Why are there such frequent shortages of such drugs now?
Any information along these lines would be appreciated.
It’s almost impossible to file with the FDA in the US due to the amount of detail and paperwork required beyond drug information written on the bottle (lot numbers etc). You need to also have a doctor fill out forms as well, which typically puts an end to that quest. And then what happens after filing is a mystery since the FDA is overloaded with more important tasks. I just tried to buy a brand name antidepressant but cost $750 so I have buy generic and reduce startup dose and delay therapeutic effects for a month. I had a bad generic before and became suicidal within days, then realized it was the generic and switched immediately.
For me , this was an eye-opener.
One can only wonder, is our major dependence on one country for APIs also behind the disturbing increase in shortages here in Canada of so many frequently prescribed medications?