11-2-18 FDA approves a new opioid 10 times more powerful than fentanyl. The drug is called sufentanil*, which can be in a tablet version of an opioid marketed for intravenous delivery but is administered under the tongue using a specially developed, single-dose applicator. These “unique features” make the medicine well-suited for the military and therefore was a priority for the Pentagon https://www.statnews.com/pharmalot/2018/11/02/fda-dsuvia-fentanyl-approval/
* carfentanil, 100x stronger than fentanyl, is also FDA-approved.
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Laurie Powell, a former medical brand strategist—
Laurie Powell: The thing about the FDA is the FDA, is, is not a full time, a career job. It’s a few years on the FDA and then they’re being courted by the pharmaceutical companies. You’ll have a Merck going in and saying to somebody on the FDA, oh, I’ll give you $600,000 if you’ll come and work on our regulatory committee to go, to go into bat for us with the FDA. And they’ll say, okay, well I’ll think about that. And then there’ll be like a Pfizer will come in and say, well, we’ll give you $800,000 a year to come in and work on our regulatory committee. And so, it becomes like a bidding war like that. So the FDA knows that their next jumping off point to go from a lower paying government job to being a very lucrative Pharma job on the inside, on the manufacturing side. They know that that’s part of their career path, so that I’m sure weighs heavily into their decision making process.
Mike Papantonio: So Ben, it sounds like the loyalty of drug rate regulators ultimately goes to the highest bidder. Break this down. You’ve done such a spectacular job with these videos telling the story that, that corporate media refuses to tell, by the way. So break this down for us just a little bit, if you would.
Ben Swann: Well I think it makes a lot of sense to anybody who even is on the outside of this of how this would work, right? If you are government employee working for the FDA and you are sitting on these committees within the FDA essentially deciding which drugs are approved and which are not. And keep in mind, as you know, Mike it is like a a 10 year to 13 year process to get a drug approved.
It costs millions upon in some cases over $1 billion to get some drugs approved and so when you have that power you are easily and heavily courted by drug companies who come in and say, look, give us an easier time or let this drug through. And when you are done here at the FDA, we’ve got a cush plum spot waiting for you and you’ll be on our regulatory committee. Think about what that means.
You don’t have to design drugs, you don’t have to have any medical background. All you have to do is to help guide us through the process of getting more drugs approved in the future and we’ll pay you six hundred thousand, eight hundred thousand, a million dollars a year to sit on this committee. And what we find is that the FDA has been using their influence in their vast of money to influence regulators at the FDA.
It’s why so many drugs get approved in the first place, but there’s actually a bigger issue than just that. Once a drug is approved by the FDA, it is rarely ever reviewed after the fact and that means that once a drug gets through, there’s almost no one on the FDA side assigned to going back and saying, let’s take a look at drugs that were approved but now have side effects that are harmful and in some cases even deadly.
Mike Papantonio: Ben, I’ve handled about 30 of the biggest pharmaceutical catastrophes in America. I’ve actually tried the cases taking the depositions, gone to trial and tried the case and the pattern that we see is, is evident. It is that you, this belief that the FDA is a regulator is a myth because as you point out, and I gotta tell you something, I know you’ve been a journalist a long time. This is, this is great work you’re doing here because the corporate media won’t tell this story.
And this is the story, that revolving door between corporate drug companies and the FDA has made it so impossible to get an objective view of whether or not a drug will kill you or not. That I tell people don’t even take a drug unless it’s been on the market for 10 years because the FDA has become so dysfunctional. And you’ve, you’ve spoken to physicians and you’ve written, you’ve looked at this, the funding of the FDA.
You’ve looked at all the parts. Is there any question that the FDA at this point has just become completely dysfunctional because the financial chokehold that takes place?
Ben Swann: No, I, I think there’s multiple things that have happened. You’re absolutely right. I mean, the FDA is, is completely dysfunctional in that respect. And it’s also starved in terms of funding. The requirements that have been put on the FDA by Congress in terms of the pressure to get new drugs approved at a faster rate versus the staffing they have. https://trofire.com/2019/06/27/big-pharma-bribing-fda-officials-to-approve-dangerous-medications/
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7-29-19 After serving as Commissioner for the Food and Drug Administration for just under two years, Scott Gottlieb unexpectedly resigned in April to spend more time with his family. He left behind a legacy of unprecedented expansion of the FDA’s regulatory powers, a persistent commitment approving generic drugs and an unclear path for the future of the agency.
Eighty-three days later Gottlieb announced he was joining Pfizer’s advisory board. He will also serve on the company’s science and technology committee as well as its regulatory and compliance committee. https://www.fdareview.org/2019/07/29/worried-about-big-pharma-then-reduce-the-fdas-regulatory-power/
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“It is my observation,” chairman of FDA’s Anesthetic and Analgesics Drug Product Advisory Committee, Raeford E. Brown Jr., MD, a professor of pediatric anesthesia at the University of Kentucky, Lexington, wrote, “that once the FDA approves an opioid compound there are no safeguards as to the population that will be exposed, the postmarketing analysis of prescribing behavior, or the ongoing analysis of the risks of the drug to the general population relative to its benefit to the public health. Briefly stated, for all of the opioids that have been marketed in the last 10 years, there has not been sufficient demonstration of safety, nor has there been postmarketing assessment of who is taking the drug, how often prescribing is inappropriate, and whether there was ever a reason to risk the health of the general population by having one more opioid on the market.” https://www.the-hospitalist.org/hospitalist/article/178955/pain/fda-approval-powerful-opioid-tinged-irony
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