Industry Self-Regulation - Another Update

Last week I wrote two posts on the Harper regime's ideological decision not to impose mandatory reporting of drug shortages on the pharmaceutical industry. The government instead has placed its market-driven faith on a voluntary system, with results nearly as disastrous as those in Canada's food industry, which also enjoys a high degree of autonomy from government oversight. Hopefully, the debacle of XL Foods has not yet faded from public memory.

Today's Star reports yet another dire consequence of forsaking the protection of public health in favour of fealty to the private sector:

The last time Alena Rossnagel walked on her own, it was following long-awaited kidney surgery in April 2011.

A drug shortage had forced her to use a substitute antibiotic in the final two weeks leading up to her procedure. But the substitute left her legally blind, caused severe inner ear damage and forced her to rely on a walker.

“I was left with this body that couldn’t do anything,” Rossnagel said from Portage la Prairie, Man. “The new ‘normal’ has become the use of a walker, no driving, being cognitively impaired, hearing loss, visual impairment and myriad of other symptoms.”

The drug that she had been taking to treat a persistent infection was Trimethoprim, but in the weeks leading up to her surgery a shortage developed, and she was given Gentamicin, known for its toxic side effects. Probably the most disturbing aspect of this tale is that neither her doctor nor pharmacist had advised her of an impending shortage of her drug of choice. Says Rossnagel:

...if there had been a mandatory system to report drug shortages in April 2011, “I would be a normal person, I wouldn’t be living in this totally bizarre other world.”

As I wrote in my earlier posts, Health Canada had strongly advised against a voluntary, as opposed to mandatory system of drug-shortage reporting. But due to the inertia/incompetence/ideology of the Harper government, people like Rossnagel must pay the consequences.

The final ugly truth is perhaps best summed up by Health Canada spokesman Sean Upton, who said it was the responsibility of the drug maker to make the post online, but that if they don’t, there is no legislation that can punish a drug company if they don’t.

Just one more indication, I suppose, of how the Conservative Government of Canada really feels about the people it 'serves.'

Industry Self-Regulation - An Update

Yesterday I wrote a post about the plight of Ryan Harrington, the young man who, were it not for a drug called Celontin, would suffer upwards of 200 seizures a day. Because the Harper regime opted for a voluntary system instead of a law requiring companies to report drug shortages, Harrington had only a one-week supply of the drug left.

The Toronto Star today reports that his family has been able to secure a one-month supply of the drug from the U.S., no thanks to our government. Says Brigitte Harrington, Ryan's mother:

“It’s a band-aid” ... “We’ve applied another band-aid to the layer. We have not addressed the problem. We have not cleaned up the mess.”

Despite the shortage, Health Canada denied three separate applications from Harrington to acquire the drug from the U.S.

When asked why the first three requests were denied, Health Canada spokesperson Sara Lauer responded, “Initial requests … were not fulfilled because the manufacturer, ERFA, informed Health Canada the product would be on the market until December 2012 and it was working to avoid any potential back-order.”

I would like to think that our political 'leadership' has learned something from this episode, distressing in its wider implications, but experience suggests that in the battle between marketplace ideology, so beloved of the Harper regime, and the public good, we the people are pretty much on our own.

Industry 'Self-Regulation'

In a world rife with the environmental, economic and social consequences of unfettered capitalism, the term 'industry self-regulation' has always struck me as little more than a oxymoron. Examples abound of what happens when government regulatory agencies enter into what turn out to be Faustian bargains with the corporate sector, the sad case of XL Foods perhaps the one most prominent in recent memory.

Today's Star exposes yet another failure of corporate oversight as it reports on the plight of Ryan Harrington, a young man afflicted with a severe form of epilepsy that, without the proper medication, leads to upwards of 200 seizures a day. Unfortunately, he has just a seven-day supply left of the only drug that limits his episodes to three per day, Celontin. The blame for his plight must rest solely on the shoulders of Federal Health Minister Leona Aglukkaq and the ethos that her government embraces

Because she opted for voluntary instead of mandatory reporting of drug shortages by the pharmaceutical industry, Harrington faces his dire situation. This, despite the fact that Health Canada staff warned that a voluntary system would be “susceptible to bad company behaviour.”

Why is this failure to report the drug shortage so crucial in Harrington's situation? Had his family known, they could have applied for special access to the drug, which is still produced in the U.S.

As is so often the case today, it is the journalistic integrity of The Toronto Star that has brought this issue to the public's attention. A followup editorial, which I hope you will take time to read, makes a compelling case for mandatory reporting:

A comprehensive, up-to-date system providing early warning of drug shortages would give hospitals, doctors and provincial health ministries a head start on finding alternatives and developing strategies for coping with what's to come. Forewarned is forearmed. So it doesn't make sense from a public health perspective to give manufacturers a penalty-free choice on whether or not to comply.

Not something those ideologues possessed of 'terminal certitude', to borrow a phrase used by Owen over at Northern Reflections, may want to hear, but nonetheless a necessary measure for the rest of us.