Testifying before a U.S. Senate committee looking into the Vioxx-induced heart attacks of an estimated 100,000 or more Americans (and probably as many as 10,000 Canadians), Dr. David Graham said that such “a terrible tragedy” could have been prevented. It wasn’t. Why not? Because the agency assigned to ensure the safety of pharmaceutical drugs—the U.S. Food and Drug Administration (FDA)—is focused almost entirely on assessing the alleged benefits of a drug instead of its potential harm. As now structured and operated, he said, the FDA “is incapable of protecting the country against another Vioxx.”
This was not just the opinion of a family physician. Dr. Graham is not only a specialist in pharmacology and epidemiology, but also serves as associate director for science and medicine in the FDA’s Office of Drug Safety. He knows firsthand about the FDA’s preoccupation with protecting the interests of the big pharmaceutical companies (which it regards as its “clients”) instead of protecting the people who take FDA-approved drugs. [You’ll find excerpts from the courageous Dr. Graham’s testimony on Page 10.]
All of the criticism levelled by Dr. Graham against the FDA can be equally applied to its Canadian counterpart, Health Canada. It’s all detailed in the recent CCPA book by Mike McBane of the Canadian Health Coalition. If you haven’t yet read Ill-Health Canada, I urge you to get a copy because it’s a powerful, disturbing, eye-opening account of how the government department entrusted with protecting our health has instead been virtually taken over by the big food and drug corporations.
Don’t take my word for it, or even Mike McBane’s. Take the word of the Canadian Medical Association Journal, which recently took Health Canada to task in an editorial.
The C.M.A. Journal noted that Vioxx had been approved by both the FDA and Health Canada, even though both “were aware of the increased risk of cardiovascular adverse events long before the drug was withdrawn from the market. There is also evidence that the manufacturer (Merck) tried to play down the risk in its promotional material for doctors.”
The Journal went on to chastise both the FDA and Health Canada for “putting their resources into assessing drug benefits, not harms. . . The built-in bias toward approving drugs without adequate assurance of their safety is a fundamental and (often literally) fatal flaw. . . The current FDA/Health Canada emphasis on partnerships with industry and rapid drug approval conflicts with the public’s expectation that these agencies exist to protect them by restricting approval to drugs that have been thoroughly tested.”
You might think that Health Canada would have learned a lesson from the Vioxx tragedy. You might think it would be heeding the criticism and advice it’s getting from doctors and concerned health-care activists. You’d be wrong. Incredibly, its officials are actually planning to weaken even further the inadequate safety and testing procedures that led to Vioxx and other horrendous tragedies like thalidomide and the thousands of tainted blood deaths in Canada. They want to scrap the Canada Food and Drugs Act and replace it with legislation that will allow the drug approval process to be even further shortened and speeded up. They want to put the onus of proving the drugs unsafe on the doctors and their patients (presumably through the subsequent incidence of serious or even fatal side-effects) instead of on the drug companies or the government.
If “Ill-Health Canada” has its way, and if enough MPs can be swayed, these irresponsible legislative changes will be approved. The big drug companies will be ecstatic.
This is what happens when corporations acquire so much power that they can sweep aside all public-protective mechanisms in the pursuit of profits. When the financial health of their biggest shareholders becomes more important than the physical health of the vast majority of citizens, the CEOs don’t hesitate to press their compliant politicians to put corporate profits first. Always. Every time. Regardless of the consequences.
This dark side of corporate rule can be pandered to politically because it is rarely exposed to public view. Most people never get to know about the ill-effects of corporate-driven laws and policies. Yes, the withdrawal of Vioxx did get mentioned in the press, but not the damning details about the failure to heed the risks exposed in prior tests, or the obscenely fast approval of its marketing. As for the 100,000 Americans and estimated 10,000 Canadians hit by Vioxx-induced heart attacks, where was the media outrage? Four Mounties get shot in the line of duty and the media give vent to an outpouring of grief for weeks. These four deaths were indeed a tragedy, but so were the needless deaths of a far larger number of Vioxx victims. The difference, of course, is that the villain in the Vioxx carnage was a drug company (and its political and bureaucratic “partners” in government), rather than a murderous psychopath. The corporate media know better than to even hint at corporate wrongdoing on such a massive scale.
Dr. Graham put the magnitude of the Vioxx afflictions in terms of a comparable number of deaths and injuries from airline crashes. It would have taken the crashes of two to four passenger jetliners every week for five years to add up to the ghastly toll exacted by Vioxx.
“What would you do about so many plane crashes?” he pointedly challenged the senators.
They didn’t give him an answer, but, in post-9/11 America, they’d probably just put all the blame on terrorists.
And we all know that corporations are not terrorists. Don’t we?
(Ed Finn is the CCPA's Senior Editor. He can be reached at [email protected].)