But now the points mentioned above are as good as confirmed with a pen and paper. Robert Califf is the new FDA commissioner. If you think that Califf's first detail will be to clean up lobbying, ensure the sanctity of the agency and assure the public that the FDA's primary objective is to protect and serve the public at large, then you are completely wrong. Califf has ties so deep to pharmaceutical companies that it isn't even practical to attempt to hide them. In fact, he's pitching it as a beautiful thing for all of us. He recently told NPR, "Many of us consult with the pharmaceutical industry, which I think is a very good thing. They need ideas, and then the decision about what they do is really up to the person who is funding the study." Have we come to such a futile point in time that our expectations are so incredibly low that we don't even bother to get upset over a statement such as that of Califf's?
Califf was formerly the operator of a clinical research center at Duke University. The multimillion dollar center received more than half of it's funding from pharmaceutical ventures. He's written scientific papers for the pharmaceutical industry. He listed seven pharmaceutical companies as having paid him for consulting them. His compensation was made possible from some very familiar names, including Merck and Novartis. And if you think this is just overstating the reality of a situation, well then consider he's already approved statin drugs from Sanofi and Amgen, two companies he's consulted for in the past.
Califf is a known supporter of Merck's Vioxx, a drug which has led to the heart attacks of up to 140,000 people. Vioxx's marketing on the part of Merck was as scammy as anything we'd ever seen. They even withheld information from the FDA (source). So where were Califf and his unbiased considerations into the matter? In an interview in 2004 with PBS, Califf was asked to comment on Vioxx. You can imagine his circular, self-serving response.
SUSAN DENTZER: Let's talk about, just briefly about some general classes, NSAIDS and the risk that [inaudible] of those and then we will move to the specific situation of Vioxx.
It's not commonly understood, as you said, that all drugs have risks and benefits. It's perhaps not even commonly understood that the entire class of non-steroidal anti-inflammatory drugs have cardiovascular risks. So, let's talk about that. What are the risks of these drugs?
DR. CALIFF: We've known for a long time that non-steroidal anti-inflammatory drugs have a variety of risks, in addition to their benefit. First of all, let's back up and recognize we live in a society where people are living longer and longer. If you just walk the streets of a town like Durham, North Carolina, about half the people that you run into will have had an aching joint some time in the past week. So, we are - or a headache or something like that and are not taking non-steroidal anti-inflammatory drug that would relieve that discomfort.
It is very dramatic and obvious the symptomatic benefit that one gives.
On the risk side, from the very beginning, we've known that these drugs cause [break] in the stomach. And in fact, it's a surprise to a lot of people to learn that thousands of people die from gastrointestinal bleeds [break] here in the United States from non-steroidal anti-inflammatory drugs taken chronically. Also, if you take them in very high doses, there's problem kidney damage if you do it chronically.
So, these are drugs that are now over the counter, because we use them so much. But those are sort of really obvious risks that we've known about.
SUSAN DENTZER: What about the cardiovascular risks?
DR. CALIFF: What wasn't really known until recently was the potential for cardiovascular risk, mostly because we thought of blocked up blood vessels as simply a problem of cholesterol being too high. We now know that inflammation is a key part of coronary-artery disease. So, these are drugs that alter the inflammatory pathways that we have in our bodies that are natural defensive pathways against infections and irritation and all sorts of things that happen to us.
So, when we perturb that inflammatory system, it could be either good or bad. And we don't - it's so complicated, we can't really tell which is which. So, it really has not been known that there might be risks, because the non - that there were risks, but it's been a theoretical possibility.
This FDA positional assignment is blasphemous. The saddest part in it, however, is our own complacency, whether that be from our naivety or our sad ignorance and apathy. For Califf to market himself as a "pharma insider" who will use that for good is insane. But for him to further his point saying that many other FDA members consult with the pharmaceutical industry is beyond ludicrous. The fact is, Califf is a highly paid pharmaceutical shill. Do we actually believe he will suddenly bite the hand which feeds him? Will he cease doing speeches on behalf of the industry whereas he is paid handsomly by pharma? What if the Vioxx situation occurs once again while Califf is at the helm? I think we understand how that will end for all of us.