As a clinical physician I prescribe many different types of medications for patients and recent experiences have made me worried that the generics I prescribe may not work as advertised. I’m not even sure about what is in those drugs. And recent reports about Health Canada failing at one of its most important jobs are only making me more worried. Are we getting the ingredients we expect or are we allowing generics into Canada that have impurities and are less effective than assumed?
Tom Blackwell’s report in the March 14, 2015 edition of National Post discusses how Health Canada’s opinion about generic medication manufacturing in India (20 million doses sent to Canada or ten per cent of yearly consumption) seems to be at odds with what the FDA is finding:poor quality control of imported generic medications. This seems to be congruous with what many physicians’ anecdotal reports about their patient’s varied clinical response is from them.
Granted the reports are anecdotal and conflict with the claims of the generic medication companies and indeed pharmacists that these meds are efficacy-equivalent to their brand-name counterparts. Anecdotal reports do not constitute data or evidence but should act as the basis for posing questions to test the claims and should lead to further evaluation of our patients’ experiences.
Indeed, it has not been a good week for Health Canada, having been completely embarrassed by an excellent CBC Marketplace exposé on how easy it is to get your useless made-up children’s cold medication (Nighton) approved with a Natural Health Product Drug Identification Number (NPN DIN) giving it the veneer of credibility and misleading the public in the process.
Now, according to Blackwell, Health Canada’s opinion about the substandard manufacturing practices of some of the companies in India differs from health protection agencies like the FDA. His report outlines what I and many of my colleagues have observed: sometimes generic medications do not work.
There are several anecdotal examples that happened this past week in my practice. These are not rare events and are harmful to patients from a quality of life perspective.
I had a 19-year-old autistic man under the care of his mother. She is a wonderful lady who takes great care of him and is especially attuned to his mood changes and stresses. He is taking an antidepressant called Cipralex to help combat bouts of anxiety and agitation. It is effective and controls his condition well.
His mom told me that the drug was changed to a generic last month and within several days of the change, his behaviour deteriorated with his agitation making a return. No other changes or new stressors occurred at that time. Her son was unaware of the switch to generic format. She dispenses the medications to him and his autism interferes with his ability to note these changes in medication. When she reverted to the brand-name, his symptoms resolved.
Another patient is taking Nexium for his gastroesophageal reflux disease (GERD). It does provide relief. When it was changed to generic, his symptoms worsened and he experienced more side effects including headache. Switching back to brand-name allowed him to return to his normal baseline.
I want to emphasize that I am not biased in favour of brand-name medication. I want medications that are reliable and effective. Many generics do as purported but these stories should generate more than just the popular refrain that generics are exactly the same as their brand-name counterparts.
This leads back to Blackwell’s report. Why is Health Canada acting after the fact by testing medications only when they arrive in Canada as opposed to insisting that quality control measures be imposed at the site of production? As Blackwell quotes University of Ottawa Law professor and health-policy expert Amir Attaran, ”œEither it has quality or it doesn’t. Merely testing it in Montreal does not imbue it with qualities it never possessed.”
For an agency that is providing a free pass to sell useless natural products with NPN DINs or Homeopathic Medicine DINs (HM DIN) thereby potentially endangering Canadians’ health, one begins to doubt the reassurances that our generic medication supply from India is safe and effective. Blackwell writes, ”œCanadian, Australian and European regulators also gave passing grades to Ranbaxy, despite the company’s guilty plea to seven offences in the U.S., notes Dinkar Saran, a pharmaceutical-industry consultant with PriceWaterhouseCoopers in Boston.”
Once your credibility takes a hit, it is difficult to regain especially with respect to protecting the public’s health. In addition, being a woo-approval agency does not help your image.