Sunday, June 10, 2007

Dear Avandia patients...

We were availing ourselves of the news by picking up copies daily of The Boston Globe. That is, during our time away on holiday, in the U.S. Boston being the closest large city, and The Boston Globe representing the most reputable news-gathering and distributing agency in the area, we knew we could reliably update ourselves during our time away from home, and our own Canadian newspapers. What most struck us, in viewing American television, reading U.S. news, is the preponderance and ubiquity of in-your-face pharmaceutical advertising.

Don't Americans get kind of sick of this kind of thing? I suppose if you see something often enough it has a ring of truth and reliability about it; the mind subscribes to what it thinks it knows, giving legitimacy to an argument that just shouldn't exist. We do, after all, visit our family doctor to describe untoward physical symptoms, and allow him/her to diagnose our condition - in transit or there for the duration - with appropriate medications.

The pharmaceutical companies, it would appear, utilize the consuming public - consumers of newspapers and by default, of advertising - to be their good-will ambassadors, selling the efficacy of their products by reputation to the medical community. How quaint.

Each and every issue of The Boston Globe, for example, held at least one and a half full page advertisements which GlaxoSmithKline addressed to "Dear
Avandia patients". That being the drug widely sold to manage the symptoms of type 2 diabetes (also formerly known as adult-onset diabetes, generally a result of genetic predisposition, of age, overweight and lack of adequate physical exercise of the human body). That very same drug which was high in the news in the weeks before our departure, warning that the use of said drug might be inimical to the health of its users.

But here's GlaxoSmithKline and their avuncular assurance via the newspaper to their clients:
"We at GlaxoSmithKline are proud to be the makers of Avandia. As leaders in diabetes, we understand that managing your type 2 diabetes is not easy. We also understand the confusion and concern you may have experienced following recent press coverage about the safety of Avandia. GlaxoSmithKline stands firmly behind Avandia."
One trusts they are more reliable as drug manufacturers than they are adept at using the English language. Having read the above, I must confess I have been left confused and concerned myself. "Leaders in diabetes"? Whatever can they mean by that? That, mayhap, they too are afflicted with the unfortunate life-style disease? That, perhaps, they have been responsible in effecting diabetes onset for all the people whom their drug purports to assist?

But I digress. The advertisement goes on to state that the drug in question is the "most widely studied medicine for type 2 diabetes...GSK has conducted an unprecedented number of clinical trials in order to continuously evaluate the safety of
Avandia, including its impact on the cardiovascular system, and that the 'response to this commitment from well-informed experts and researchers has been encouraging'".

How reassuring. Why then, has it been reported by a cardiologist, reporting in the New England Journal of Medicine that patients in trials who took the medicine had a 43% higher risk of suffering heart attacks compared with those who took other drugs for diabetes management, or even placebos? Better yet, why did a high-placed executive with GlaxoSmithKline bully an independent researcher (now incoming president of medicine and science for the American Diabetes Association's board) who reached similar conclusions, into withholding his findings?

Dr. John B. Buse spoke before the House Committee on Oversight and Government Reform that he had raised concerns about the drug's connection to heart problems away back in 1999, the very year the U.S. Food and Drug Administration approved it for sale to the public. Dr. Buse, department chair at the University of North Carolina testified that, threat aside, he advised The GSK executive that he could no longer submit "under this kind of heat", to withholding his concerns.

Public safety and full disclosure appears not to be in the best interests of giant pharmaceutical companies whose bottom line is severely affected when bad news surfaces about the efficacy and more - the safety - of its drugs.
Avandia has generated more than $3 billion in revenue last year alone, having been prescribed as the drug of choice for over one million Americans with diabetes. Yet, although GlaxoSmithKline was aware of the problems with this drug, they sat on their hands for almost a year before informing federal regulators about clinical trial results linking the drug to substantially increased heart risks.

The fact was GlaxoSmithKline's own analysis of approximately forty-eight studies discovered
similar heart risks, as did a statistical analysis that the Food and Drug Administration conducted themselves. But everything is all right, folks. The people at GlaxoSmithKline have the best interests of diabetes sufferers uppermost in mind. They know the dreadful fall-out that can occur as a result of long-term diabetes mis-management; increased risk of stroke and heart attack, neuropathy, limb amputation, kidney failure, blindness. They're on your side. The vast sums of money they're spending to reassure their drug users of this fact cannot be denied.

So, all you vulnerable people with type-2 diabetes, look after yourselves; your lives depend upon it. And GlaxoSmithKline sends you this message: it's not the money - they're not, after all, interested in saving the reputation of an impugned medicament that has rendered their bottom line so nicely flush in research pay-back. They care about you, they really do.

The message they send to you is, thank you for your patience, your understanding, your loyalty. Above all, thank you for your invaluable trust.

And buy our drugs.

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