With this decision, a "safety approval" by the FDA has now become meaningless. If the agency can put its stamp of public safety approval on a drug that has killed tens of thousands of Americans and that was removed from the market by its own manufacturer following the revelation of studies showing alarming increases in heart attack risk, then what, pray tell, could possibly be the FDA's definition of a dangerous drug?
For the FDA to consider a drug dangerous, it apparently has to kill more than 60,000 Americans. I'm curious what threshold must be reached before the FDA actually does its job and seeks to protect the U.S. public. Do 250,000 people have to die before the FDA calls a drug unsafe? 500,000 people? How about a million people?
There can no longer be any doubt whatsoever about the FDA's true purpose. Regardless of what the agency publicly states, when it comes time to make key decisions about the safety of U.S. consumers, the FDA will side with drug companies every time. We've seen it time and time again: with the FDA's reluctance to pull obviously dangerous drugs off the market in a timely fashion (Rezulin, for example), with the FDA's attempts to silence its own drug safety scientists (censorship of Dr. David Graham, for example), and with the FDA's collusion with drug companies in suppressing clinical trials and other forms of evidence that raise safety questions about prescription drugs. Corruption runs deep at the FDA, it seems.
This decision with Vioxx and other COX-2 inhibitors was a defining moment for the U.S. Fraud and Drug Administration. It was a moment where the agency could have sided with public safety and held fast to a position of responsibility and ethics. Instead, it chose to favor drug company profits and put its stamp of approval on a class of drugs that is arguably the most deadly drugs ever to hit the open market.
A sane, ethical FDA would have not only banned COX-2 inhibitors outright, it would have put an end to direct-to-consumer advertising that ultimately led to the over-hyping and over-prescribing of these painkillers in the first place. Most people taking COX-2 inhibitors don't even need them. They would be better off with simple over-the-counter painkillers or, better yet, natural health treatments like nutrition, herbal remedies and supplements that work far better than prescription drugs for stopping arthritis pain (and without all the negative side effects). Astaxanthin supplements, for one, greatly ease arthritis pain. So do whole food concentrates made from cherries, blackberries and other fruits. There are dozens of other natural health strategies that ease pain as well.
To pull off this public charade of a serious meeting about COX-2 inhibitors, meeting organizers paraded a line of pain victims in front of FDA panelists and got them to beg for the availability of COX-2 inhibitors. The implied message was, "If we can't have Vioxx, we'll suffer!" What this faulty argument fails to mention is the whole universe of alternative treatments, healing foods and natural health therapies that end arthritis pain at least as well as prescription drugs. Nowhere was there a discussion of other choices these patients might make to treat their pain. Instead, it was a fool's choice: Vioxx or nothing.
And thus the whole FDA panel meeting was a sham. It was contrived from the start and designed to do one thing: to give the panel justification to reinstate Vioxx and avoid banning COX-2 inhibitors as a class of drugs. This, in turn, would dramatically boost stock prices of drug companies and keep the drug profit machine churning away for years to come. (I wouldn't be surprised if the vast majority of the people on the FDA advisory panel, by the way, own stock in the very drug companies impacted by this decision.)
It was brilliant theater, but bad medicine. And with this decision, whatever credibility the FDA thought it had remaining has now evaporated. The agency is suddenly the laughing stock of the world. It has taken what many consider to be the most dangerous class of prescription drugs ever introduced and rubber stamped the whole class with the label of "FDA approved."
The very label of "FDA approved" is now synonymous with "Poison." It sort of makes you wonder about all the other drugs the agency has approved, doesn't it? The agency sure has a funny way of defining "safe."
And if you, like many Americans, were holding out in the hopes that the FDA would, for once, do the right thing and protect the American public, you now realize that the agency is so blatantly corrupt that only radical, wholesale reform will ever restore any sense of credibility.
There is an abundance of evidence available right now, published in peer-reviewed medical journals like the British Medical Journal, showing COX-2 inhibitors to be deadly drugs. That's not to mention the internal drug company memos and emails leaked to the press that directly acknowledge the dangers of these drugs. No reasonable person can argue that these drugs are not dangerous. Yet the FDA will no doubt claim there's not enough evidence to show COX-2 inhibitors are dangerous enough to ban them.
I find this fascinating. When the FDA is attacking herbs and nutritional supplements, they will claim there's not enough evidence to prove they are safe. But when it comes to prescription drugs, the agency says there's not enough evidence to prove they're dangerous. All drugs approved by the FDA, it seems, are deemed safe until proven deadly. And even when proven deadly, they apparently aren't deadly enough to warrant banning them.
The FDA is now so clearly the regulatory puppet of Big Pharma that it has proven itself unable to reform from within. It's time for the U.S. public and its legislative representatives to revoke the power of authority over drug safety that has been granted to the FDA in monopoly fashion. It's time to put the power of drug safety into the hands of people who actually care about safety, not those who benefit from drug sales. And it's time to end the oppressive, Dark Ages reign of the U.S. Fraud and Drug Administration which is not only complicit in the deaths of literally hundreds of thousands of Americans, but which seems determined to continue its campaign of power and corruption, no matter what the cost in the American lives.
Dr. Sidney Wolfe (PublicCitizen.org) was right all along. I say we team Dr. Wolfe with Dr. Graham and let them run the FDA. They can start by firing all the bureaucrats that landed us in this drug safety mess in the first place.