Showing posts with label drug safety. Show all posts
Showing posts with label drug safety. Show all posts

Monday, September 29, 2014

A Possible Soution To Health Canada's Willful Impotence



Yesterday I wrote about the fact that Health Canada has 'convinced' (not ordered) Apotex to stop importing drugs from one of its suspect plants in Bangalore, India. The agency's (and Health Minister Rona Ambrose's) ongoing timid relationship with pharmaceuticals at the expense of our health and safety suggests stronger measures are needed

Writing in The Star, Amir Attaran thinks he might have a solution to this sorry state of affairs. The professor in the Faculty of Law and faculty of Medicine at the University of Ottawa asks,
should we reduce, or nearly abolish, Health Canada’s drug regulatory functions? Could we be safer by trusting in the decisions of larger, better-funded, foreign drug regulators instead of little lame Health Canada?
He looks to Europe for a model:
The 28 countries of the European Union, many of them quite small, long ago decided that it is expensive, inefficient and sometimes dangerously ineffective for each country to have its own drug regulator. Nowadays, most of them have delegated large parts of their drug regulatory functions to an EU-wide organization, the European Medicines Agency.
Attaran is not optimistic that Canada will likely follow suit with a similar co-operative venture:
Here, the Harper government’s asphyxiating control of government scientists and almost childish pride in Canadian sovereignty mean that Health Canada minimally co-operates with America’s FDA just next door. This is dumb: the FDA is more transparent, better resourced and scientifically better equipped than Health Canada will ever be.
He goes on to offer a picture of the FDA's ruthless effectiveness in interdicting suspect drugs:
Consider the case of Ranbaxy, a pharmaceutical company from India. Last year, the FDA successfully prosecuted Ranbaxy for manufacturing adulterated drugs and misleading it with false, fictitious and fraudulent drug testing data — crimes for which Ranbaxy paid $500 million (U.S.) in criminal and civil penalties.

Contrast that decisiveness with Health Canada's feckless dealings with the same company:
Even though former Ranbaxy executives say they are “confident there were problems” with drugs sold here, after the criminal conviction Health Canada refused to ban Ranbaxy’s factories, and instead negotiated with the company to voluntarily pull a few of its medicines off the market for testing; Health Canada won’t say which ones.
According to Attaran, the main reason for this gross disparity of response is not legal, but cultural,
namely the indolent, lapdog attitude of ministers like Ambrose and the public servants at Health Canada, who seem to lack any understanding of how governments should regulate.
Because they refuse to learn from the best practices of bodies like the FDA and the European Medicines Agency, he concludes that
we should in part abolish Health Canada and harmonize our drug regulation with those foreign agencies that are more competent than our own government.
While that might strike many as too drastic a solution, it is clear that major changes are needed if we are to be protected from corrupt and venal pharmaceutical companies that place their profits and their shareholders above the health and safety of Canadians.

Friday, April 18, 2014

Slamming Harper Secrecy




The Toronto Star recently revealed the following:

Health Canada is keeping secret the vast majority of the drug reviews it conducts despite a clear promise from the federal minister to publish this critical safety information.

Only 24 of 152 drug reviews completed last year by Health Canada are being considered for public release, the Toronto Star has learned. The drug safety reviews that will be open to the public are those triggered by alarms raised by foreign regulators, medical or scientific literature or Health Canada’s routine monitoring activities.


The main reason? Wholly consistent with the Harper regime's legendary secrecy and the preeminence it accords to all things corporate, is this justification:

The information is classified in part because it was provided “with the understanding that this information is proprietary,” a Health Canada spokeswoman told the Star in an email Wednesday.

In layperson's language, corporate concerns trump citizen safety. Aided and abetted by Health Canada, safety information falls under the rubric of commercial secrets - this despite some well-publicized tragedies that might very well have been avoided had the public had access to vital information about toxicity studies and drug side effects.

As usual, perspicacious Star letter-writers offer their views of this intolerable insult to all who believe that the free flow of information is one of the crucial elements of a healthy democracy:


Ottawa keeps drug reviews under wraps, April 12

The Canadian public is once again being “stonewalled” by the Harper government. The reason that I am calling this the “Harper Government” is the fact that Stephen Harper runs this government like a dictatorship. His ministers are muzzled until Harper approves of what statements they are allowed to make to the media.

He arbitrarily releases information only when he feels like doing so, not when the public has a genuine need to know the details of situations, such as rail safety measures put in place after the disaster in Quebec, and now the federal drug reviews of 151 various medications.
According to Dr. David Juurlink from Sunnybrook Hospital, “These drugs harm people and in some instances they kill people. Frankly, shame on (Ottawa) for even contemplating not publishing them.” The doctor doesn’t realize that in Ottawa there is no shame, only secrecy.

Why all of this secrecy when Ottawa has supposedly made a commitment to being more transparent? This government is as “transparent” as the heavily tinted windows in a motor vehicle.

In 1947, there was a movie starring Danny Kaye, The Secret Life of Walter Mitty. This movie was re-made in 2013 with Ben Stiller as the star. In Canada, it could have been made as The Secret Life of Stephen Harper, starring our Prime Minister.

Also, Harper would have been the perfect guest on the 1950s and 1960s TV show I’ve Got A Secret. He has so many secrets that the panel would never guess to which one he was referring.


Warren Dalton, Scarborough


The reason Ottawa keeps drug reviews under wraps is the same reason Transport Canada keeps under wraps the movement of toxic materials through highly populated areas. The “conservative corporate party” in Ottawa is not about to bite the hand that feeds it. Ask yourself: who is damaged by disclosure?

Nicholas Kostiak, Tottenham


Drugs that have been developed under the sole funding of the private sector may, indeed, legitimize claims to exclusive rights to such information. Where the public has funded the research and development of pharmaceuticals, however, the public has a right to the results of such research.

Canadian taxpayers have contributed billions of dollars, under a multitude of programs, to the development of pharmaceuticals. We seem to have forgotten Harper’s Economic Action Plan and the Canada Foundation for Innovation, which funnelled hundreds of millions of dollars to the research and development of pharmaceuticals in the year 2009 alone. If you follow the money, you’ll discover that the public has just as many proprietary rights to the much-guarded research.

Those who wish to have exclusive rights to research results, data, analyses, outcomes or reports should also ensure their exclusive funding of such research activity rather than looking to the public purse for support. Until then, we have a right to know exactly what our money has produced.

Stella Kargiannakis, Toronto