The US opioid crisis was largely created by the FDA and pharma companies. The FDA continue to do nothing to stem this terrible social ill; instead, they continue to approve more and more opioids, and more and more powerful ones.
Seeing as they are flagrantly immoral in this area, I would expect the same to hold true in every area of their operations. This criticism is levelled at the management of the FDA, and not at the hundreds of FDA scientists, of whom the majority, I'm sure have both morals and good professional intentions.
The Food and Drug Administration is sacrificing American lives by continuing to approve new high-strength opioid painkillers, and manipulating the process in favor of big pharma, according to the chair of the agency’s own opioid advisory committee.
Dr Raeford Brown told the Guardian there is “a war” within the FDA as officials in charge of opioid policy have “failed to learn the lessons” of the epidemic that has killed hundreds of thousands of people over the past 20 years and continues to claim about 150 lives a day.
Brown accused the agency of putting the interests of narcotics manufacturers ahead of public health, most recently by approving a “terrible drug”, Dsuvia, in a process he alleged was manipulated.
“They should stop considering any new opioid evaluation,” said Brown. “For every day and every week and every month that the FDA don’t do the right thing, people drop dead on the streets. What they do has a direct impact on the mortality rate from opioids in this country.”
Brown, an anesthesiologist who chairs the FDA committee of specialists advising the agency on whether to approve new opioid painkillers, said he no longer had confidence in repeated assurances by the FDA leadership that it was taking the epidemic seriously and prepared to put public health above the commercial interests of drug makers.
“I think that the FDA has learned nothing. The modus operandi of the agency is that they talk a good game and then nothing happens. Working directly with the agency for the last five years, as I sit and listen to them in meetings, all I can think about is the clock ticking and how many people are dying every moment that they’re not doing anything,” he said. “The lack of insight that continues to be exhibited by the agency is in many ways a willful blindness that borders on the criminal.”
Brown’s comments echo criticisms by US senators who have condemned the FDA for what they say is its “complicity” in the epidemic, for approving the powerful painkillers that drove the crisis and then failing to use its powers to protect the public as the death toll escalated.
Four US senators wrote to the head of the FDA, Dr Scott Gottlieb, late last year urging him not to allow Dsuvia, a powerful opioid pill, on to the market because it was “to the detriment of public health”.
Dsuvia is a branded narcotic sufentanil pill, a more potent version of fentanyl, made by Californian pharmaceutical company AcelRx. The signatories included Senator Joe Manchin of West Virginia, whose state has the highest rate of opioid overdose deaths in the country.
“This puzzling and unacceptable course of events is unfortunately reminiscent of previous FDA processes and practices that contributed to the opioid epidemic,” the letter said.
The FDA’s credibility has been badly damaged by the opioid crisis amid accusations that at times it behaved less as a regulator overseeing the pharmaceutical industry than a business partner of drug manufacturers. The agency helped unleash the epidemic two decades ago when it approved the sale of a high strength narcotic pill, OxyContin, as safer and more effective than other painkillers on the say so of the manufacturer, Purdue Pharma, and without requiring clinical trials. Since then the FDA has approved other opioids for wide prescribing even as evidence mounted the drugs were addictive, open to abuse and often not effective for long-term use.
The FDA was also embarrassed by revelations that officials responsible for opioid approvals were taking part in “pay to play” schemes in which manufacturers paid to attend meetings to draw up the criteria for approving prescription narcotics.
Donald Trump’s opioid commission identified the failure of the FDA and other federal institutions to properly regulate opioids and their manufacturers as an important factor in the epidemic.
After Trump appointed Gottlieb, the new FDA chief admitted the agency “didn’t get ahead” of the crisis and promised “dramatic” action. He said he favoured examining not only whether an opioid worked but whether it was needed and whether the risks of it feeding the epidemic outweighed benefits for patients.
But that commitment has been called into question by the slow pace of introducing new practices and regulations – and by the approval of Dsuvia, a potent pill developed with the US defense department.
An advisory committee rejected the drug in 2017 over safety concerns. The senators said that they were “deeply troubled” that when Dsuvia was resubmitted for consideration the following year, the FDA excluded members of the agency’s drug safety committee from the hearing. The senators also said they were concerned because the decision was made when Brown, a strong critic of Dsuvia, was absent at a professional conference in San Francisco.
“There’s no question in my mind right that they did that on purpose,” he said. “The FDA has a lack of transparency. They use the advisory committees as cover.”
The FDA is not required to follow the decisions of its advisory committees but has been wary of going against their decisions since 2012, when the agency created a political storm by overruling a decision to reject Zohydro, an opioid 10 times more powerful than regular painkillers.
Doctors and specialists on the committee questioned the safety of the drug and the need for it given the epidemic. The senior FDA official at the hearing, Dr Bob Rappaport, who was head of the agency’s opioid approval division, angered other members by telling them there had to be “a level playing field for business”, which was widely interpreted as putting the right of pharmaceutical companies to make money ahead of public health.
Brown described a breakdown in confidence and trust between his advisory committee and FDA officials responsible for opioid approvals. He characterized them as out of touch with the consequences of the epidemic and locked into a view promoted by drugmakers that those who become hooked are to blame for their addiction not the pills or prescribing practices.
Brown blamed the problem in part on “cozy, cozy relationships between the pharmaceutical industry and various parts of the FDA”. Since a change to the FDA’s funding in the 1990s, the agency division responsible for opioid approvals relies on the drug industry for 75% of its budget. The agency denies the money buys influence.
The FDA declined to respond to Brown’s specific criticisms.
Gottlieb has previously defended Dsuvia by saying it is required for use in circumstances where other drugs cannot be administered, such as a battlefield. The FDA chief promised “very tight restrictions” on its distribution to stop the drug appearing on the illicit market. He insisted the FDA had “learned much from the harmful impact” that prescription opioids have had.
But Brown remains skeptical.
“Nothing is fundamentally being done to effect change in the regulation of opioids. If the FDA continues to encourage the pharmaceutical industry to turn out opioid after opioid after opioid, and the regulation of those opioids is no better than it was in 1995, then we’ll be cleaning this up for a long time,” said Brown.
Ed Thompson: The root cause of this epidemic is the FDA's illegal approval of opioids for the treatment of chronic pain.
Bill Whitaker: The FDA ignited this opioid crisis?
Ed Thompson: Without question, they start the fire.
Ed Thompson told us when the top selling opioid, Oxycontin, was first approved in 1995, it was based on science that only showed it safe and effective when used "short-term." But in 2001, pressured by Big Pharma and pain sufferers, the FDA made a fateful decision and, with no new science to back it up, expanded the use of Oxycontin to just about anyone with chronic ailments like arthritis and back pain.
Ed Thompson: So this is what a package insert looks like.
Bill Whitaker: Wow
The FDA did it by simply changing a few words on the label, that lengthy insert no one ever reads. Today the label says the powerful pain pills are effective for "daily, around-the-clock, long-term… treatment." And that small label change made a big change in the way drug companies would market all opioids, allowing them to sell more and more pills at higher and higher doses.
Ed Thompson: A drug's label is the single most important document for that product. It determines whether somebody can make $10 million or a billion dollars.
Bill Whitaker: How so?
Ed Thompson: Because it allows you to then promote the drug based on the labeling.
Ed Thompson owns PMRS, a successful Pennsylvania pharmaceutical company that manufactures drugs for Big Pharma. It's made him a rich man. But now he's putting his livelihood at risk. He's doing what no other drug maker has ever done, he's suing the FDA in federal court to force it to follow the science and limit the opioid label to short term use.
Thompson is challenging the FDA to start with his newest opioid. It's Thompson's creative way to sabotage the system. He may lose money rolling out his new drug, but if he is successful, it would set a precedent. Other manufacturers would be forced to change their labels and limit their marketing.
Bill Whitaker: A decision going in your direction could pull down a multi-billion-dollar industry.
Ed Thompson: Correct. Probably somewhere between $7 and $10 billion a year would come off the market. We made a decision to stop selling snake oil to U.S. citizens in 1962.
Bill Whitaker: Snake oil?
Ed Thompson: Yes, sir. You're using high-dose, long-duration opioids when they've never been designed to do that. There's no evidence that they're effective. There's extreme evidence of harms and deaths when you use them.
Brandeis professor Dr. Andrew Kolodny is one of the country's most-recognized addiction specialists and has been an expert witness in litigation against Big Pharma, including Purdue, the maker of Oxycontin. He has been trying to get the FDA label changed since 2011 to make clear opioids are not for everyone. kolodny.jpg Dr. Andrew Kolodny
Dr. Andrew Kolodny: These are essential medicines for easing suffering at the end of life and when used for a couple of days after major surgery or a serious accident. If you're taking them around the clock every day, quickly, you become tolerant to the pain-relieving effect. In order to continue getting pain relief, you'll need higher and higher doses. As the doses get higher, the treatment becomes more dangerous and the risk of death goes up.
Bill Whitaker: That sounds exactly like heroin addiction.
Dr. Andrew Kolodny: It's essentially the same drug.
To understand how this began we traveled to this small courthouse in Welch, West Virginia, where we uncovered the minutes of secret meetings in 2001 between Purdue Pharma and the FDA. The files were part of the state's lawsuit against Purdue for deceitful marketing.
60 Minutes got a court order to obtain these documents. They reveal it was at those secret meetings the FDA bowed to Purdue Pharma's demands to ignore the lack of scientific data, and changed the label to, "around the clock…for an extended period of time.''
Ed Thompson: I can't think of anything more harmful taking place that took place then. It opened the floodgates. It was the decision of no return for the FDA.
Purdue told us Oxycontin always was approved for long-term use. But an internal document shows the company was jubilant about the labeling change. Quote: "The action by the FDA…has created enormous opportunities" to expand the market. The drug company's ads soon extolled the virtues of Oxycontin's effectiveness and sales tripled.
60 Minutes has called on former FDA commissioner David Kessler many times for his expertise on drug safety issues. He ran the FDA in the 1990s when Oxycontin was first approved, but he left before the labeling change. Today, he's been retained by cities and counties suing Big Pharma for the opioid crisis. After reviewing the documents we obtained, and checking on his own, he says changing the label to long-term use was a mistake.
Dr. David Kessler: There are no studies on the safety or efficacy of opioids for long-term use.
Bill Whitaker: But there's a law that says that a drug cannot be promoted as safe and effective unless it's proven to be safe and effective. But yet, with FDA sanction, these opioids are being used in that way that you say have not been proven.
Dr. David Kessler: That's correct. The rigorous kind of scientific evidence that the agency should be relying on is not there.
The label change was a blank check – one the drug industry cashed in for billions and billions of dollars. Now, Big Pharma had a green light to push opioids to tens of millions of new pain patients nationwide.
Bill Whitaker: Let me remind you of some of the words that you have used to describe the pharmaceutical industry, your industry.
Ed Thompson: Yeah?
Bill Whitaker: Corrupt.
Ed Thompson: Yeah.
Bill Whitaker: Immoral?
Ed Thompson: Yes.
Bill Whitaker: Depraved?
Ed Thompson: Yes. They're appropriate for the behavior that's taken place.
Bill Whitaker: You are a drug executive. You manufacture drugs.
Ed Thompson: Many drugs.
Bill Whitaker: Are you at fault in this epidemic in any way?
Ed Thompson: I wish I was smart enough to have seen this epidemic before-- before I got three or four years into it. Absolutely. But once you find out that it's not correct, you have to do the right thing. Is there anything more important?
Emily Walden: My son wanted to fight for his country. His country failed him.
Dr. Andrew Kolodny agrees. The Brandeis addiction specialist began his own investigation into why the FDA would approve the long-term use of opioids when there was no credible science to back it up.
Bill Whitaker: What did you find?
Dr. Andrew Kolodny: We found out that a group of experts and FDA and pharmaceutical companies were having private meetings and at these meetings, changing the rules for how opioids get approved.
He filed Freedom of Information Act Requests. In email after email between the FDA, Big Pharma and consultants, he learned of closed-door meetings at luxury hotels, like this Four Seasons in Washington, DC, where for $35,000 a piece, drug makers paid consultants to, "sit at a small table with the FDA," "hobnobbing with the regulators." Emails show one participant worrying it might be seen as "pay to play."
Dr. Andrew Kolodny: They had drugs in their pipeline, pain medicines that they wanted approved. And through these meetings, they were able to get those products on the market.
Bill Whitaker: That sounds unethical.
Dr. Andrew Kolodny: It is unethical.
Bill Whitaker: If not illegal
Dr. Andrew Kolodny: If it's not illegal, it should be illegal.
Equally suspicious but legal, the large number of key FDA regulators who went through the revolving door to jobs with drug manufacturers. The two medical officers, who originally approved Oxycontin, Curtis Wright and Douglas Kramer, went to work for the opioid maker, Purdue Pharma, not long after leaving the FDA.
Dr. Andrew Kolodny: The culture at FDA continues to be much too cozy with the industry it's supposed to be regulating.
The agency bills drug companies more than $800 million a year in fees and depends on that industry money to pay the salaries of staffers who not only changed the opioid label, but also review new drugs like Dsuvia, the most powerful opioid pill ever approved.
Bill Whitaker: Just a few weeks ago the FDA approved a new opioid that is 1,000 times more powerful than morphine. And this is in the middle of this opioid epidemic. How is that possible?
Dr. David Kessler: I don't get it. I get your question; I don't get the agency's action.
Bill Whitaker: Isn't the FDA supposed to be our watchdogs to protect us?
Dr. David Kessler: How many people do you think were working in a division that oversaw promotion or when this epidemic started to occur?
Bill Whitaker: I have no idea.
Dr. David Kessler: Five.
Bill Whitaker: When I'm looking at the carnage in American towns and cities, that just doesn't seem like a good excuse to me.
Dr. David Kessler: It's not an excuse. It's the reality. You have a system of pharmaceutical promotion that changed the way medicine practiced and no one, all right, stopped it.
Current FDA commissioner Dr. Scott Gottlieb declined our request for an interview but, in a statement said, "the FDA has taken aggressive steps to confront the crisis," but he admitted "many mistakes were made along the way... While the agency followed the law in approving and regulating opioids, we at the FDA include ourselves among those who should have acted sooner."
Bill Whitaker: You say they have to do things to fix the label. The label has been in place since 2001. I-- I'm not a scientist, but that doesn't seem like that's that hard to do.
Dr. David Kessler: And it needs to be done.
Ed Thompson: We got a real problem here.
Ed Thompson isn't waiting. He has now joined a growing movement of doctors, lawyers, and patient activists who want Big Pharma to kick its addiction to opioid profits. That's why he made the decision to take on his industry and the FDA.
Bill Whitaker: If you succeed, you could pull down a multibillion-dollar industry.
Ed Thompson: And if I fail, you're gonna have ever-increasing deaths every day as well. It's a pretty good decision, isn't it?
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