Did the FDA ignite the opioid epidemic?

https://www.cbsnews.com/news/opioid-epidemic-did-the-fda-ignite-the-crisis-60-minutes/

We have reported on the causes and effects of the opioid epidemic for several years — interviewing government whistleblowers, doctors, and Americans who’ve grown dependent on the powerful pain pills. We have not had a high-ranking executive from the pharmaceutical industry sit before our cameras, until now. Tonight, Ed Thompson, a drug manufacturer who spent decades managing and producing opioids for Big Pharma, breaks ranks to denounce his industry and its federal regulator, the Food and Drug Administration, which he says opened the floodgates on the crisis with a few little changes to a label.

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.

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Ed Thompson speaks with correspondent Bill Whitaker

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.

“There are no studies on the safety or efficacy of opioids for long-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.

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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.  

Dr. David Kessler: It was a marketing tsunami.  And the agency didn’t catch it.

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.

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If there is one victim who confirmed for Ed Thompson that turning on his industry was the right thing to do, it was Emily Walden, who would become an unlikely ally. Thompson manufactured an opioid oxymorphone. The same drug that took the life of Walden’s son TJ, a private in the Kentucky National Guard.  

Emily Walden: He was getting ready to be deployed to Africa and a few weeks prior to that he went on a camping trip with a group of friends and a police officer knocked on my door the next morning telling me that he had passed away.

Tj had grown addicted to the drug and was easily able to get it without a prescription. Walden went to Washington, D.C. to ask the FDA why her community was being flooded with pain pills. It was there she met Ed Rhompson.  

Bill Whitaker: What did you say to him?

Emily Walden: “You manufactured the drug that killed my son.”

Bill Whitaker: He is now on your side.

Emily Walden: Yes.

Bill Whitaker: That just seems like an odd connection.

Emily Walden: It is. But Ed might be my only hope in getting this fixed. The FDA’s responsibility is public health and the safety of drugs, and they’re not doing their job. They haven’t been doing their job for 20 years.

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.

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Dr. David Kessler

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?

9 Responses

  1. I’m a person in pain. I have had it for years. Since I was 17 I’ve had injuries under treated, told I was malingering, making a bigger deal out of things, until testing got better. MRI, testing for carpal tunnel, nerve conduction, even exokoratory surgery once. All confirming that I has reason to complain! Well, now I have had three whiplash injuries, lumbar arthritis, Fibromyalgia, and ME/Fibromyalgia. Pain medicines has given me a great relief in pain. Made my life more bearable. I am so tired of these people saying it’s not meant for us! Damn it! It helps me! Take them away I will be tortured again! I may be dependent on it.
    Antidepressants are also a medicine people become dependent on. Marijuana causes dependency, was illegal all over the County, note it’s being allowed in many states, Alcohol causes dependency, still legal. Caffeine causes dependency, still legal. Carbohydrates cause dependency, still legal. Try going off carbs! You’ll see how dependent you are on them!
    Look at quality of lif . Just because I can’t work, can’t clean most days, have to wait for energy to take a shower, just because I can go to the store one day and not another due to illnesses, shouldn’t keep me from being able to have one major symptom relieved.
    We euthanize animals for pain! But you plan on letting humans suffer with pain after they’ve exhausted all other treatment that they can afford! Yes, even the cost of pain medicine has quintupled since Obama Care started!!! Ridiculous. Genetic testing can determine if a person would possible OD on theseedicines. Slow metabolizers would have to start on small dosed and increased slowly.
    People like me were started low, kept there for years, still hurting, until pain management drs started taking over long term treatment. They found a dosage that helps me and I’ve been on it for 3 years now and it still works. Opiate tolerant, just keeps my body from itching and vomiting now. Doesn’t mean I need more and more medicine. I needed more medicine for years but wasn’t taking more or given more until pain drs took over my care. Now I’m at a higher dose than 90MME. But for 3 years haven’t needed an increase and still don’t. Comfortable. Yes, there days I still hurt more than I’d like. But the majority of the time I am at A 2 on the pain scarier. Down from a 6 on low doses, Down from a 10 without medicine. Screw all of you. Give it back to the pain drs and let their experience do their jobs! Stop taking their license’s away. Unless they truly are a pill mill. Those can go away. But ones with our records, documenting our progress, get off their cases. CDC needs to stop. Can’t even get a good psychiatrist now. State run addiction medicine is the only thing you get anymore. No to anxiety drugs, no to pain meds, no to antidepressants. You must be an addict if you need those! Ridiculous!

  2. I beg to differ on the miss use of opiates for chronic pain. I have pages of failed “safer options” the side effects have a drastic negitive effect on my ability to function and care for my children, they cause cognitive, emotional psychological issues as well as new pain thats not relieved by anything. They are additionally not at all effective. Believe me I would much rather beable to take those than to sit here in in awful pain day in and day out in agony or on a good day (which are rare) being afraid to do anything to cause increased pain. All because I no longer have have access to my low dose of pain medication daily. Medical marijuana is a great option…….for those who respond well to it. I sadly do not. I don’t want to be high (which i didn’t get on opiates) but thats what i get, and worse no relief from pain. Cbd? Yes i have tried that so hopeful but no several well respected brands several strengths and dosage. No sadly it didn’t work. Additionally frustrating is the cost of all these is they are very expensive for those of us living in poverty so trial and error with these can be the differance of………pay the electric? Buy food? Try yet another non covered option.

    The medical community needs to treat patients as individuals not as all drug seeking addicts. They need to learn more about how and why different meds work for different people. P450 liver enzyme testing for genetic mutations helps but is not full proof and only covers the portion of the med metabolized thru the liver. If partly metabolizes thru another organ that portion isn’t represented.

    I recently started buspar to avoid uping dose of another med. Reading about the med it says its thought to work with serotonin and dopamine receptors…….thought…….they don’t know? Cleveland clinic genetics dept told me the same thing about Voltaire (ineffective, aggregates ibs-d causes black tarry stool) baclofan (causes awful cognitive and psychological side effects in addition to new pain in knees and elbows that would not relent and was not affected by ANY pain relieving method rx topical otc etc)

    I have a right to a decent quality of life. Anti depressant require a wean down and for many cause terrible withdrawl if even an hour or two late. But these are considered safer…….I have never been the same since they had me on those for 7 years.

  3. So what happens to Chronic Pain Patients that are neither addicted or drug seeking, that need strong medicine for their pain when the pain is @ a 7-10? We are being treated like addicts, abusers, and with suspicion when we go to urgent care and etc! We got lumped in the wrong group.

  4. I have been on the Fentanyl Pain Patch since about 2005. I started out at 25 and today (2019) I am at 50 MCG . My choice. I know that Fentanyl was used for Cancer patients but I also know it has given me quality of life as a person dealing with RSD-Fibromyalgia- Venous Insufficiency – Degenerative Disc Disease (which came on yrs ago). I am also Diabetic but I also take care of myself. I get blood work done ever 3 months – My Internist turned me over to a pain mgmt doc and I am glad she did. She felt intimidated by DEA and certainly was not about to lose her license. I am my own advocate. I keep my medical history updated and when I see a new doctor they get a copy of it. I am also ALWAYS up front about being on Fentanyl. The medical community has treated me with kindness and have been wonderful to me especially after reading my diagnosis’. I do get a break through pain med and take it ONLY as needed. I always read the warning labels. I am very much in tune with that. My world as I knew it fell apart in 2004 after diagnosis after diagnosis was made. I had to give up my secretarial business. Burning pain is something I would not wish on anymore. Opioids are needed for people like myself who are dealing with a lot. We just want to be able to do our housework and perhaps a little gardening. I would be on the couch or in bed if not on the patch. Truth! I had one surgery at L5 S1 in 2008 after under going a Discogram. They do not last either. The Spine Centers I feel are the big money makers out there

  5. Obviously the motive is to get wealthy after the suing of pharmaceutical manufacturing.

  6. With no context this ends up as a nice click bait headline for the uninitiated into seeing another reason to be anti-opiods.

  7. What would they then consider for treatment of chronic pain? Seems that this question is never addressed. Are people suffering with chronic pain supposed to just continue to suffer until they die of causes related to the suffering?
    There are millions of people For Whom The Chronic opioid therapy is highly effective for them. Why not ask a number of them about use of opioids and construct a study based on their input. Not all of them could be considered liars. I believe this should be considered a scientific method as well as any other type of study.

    Do other of the so-called Advanced countries have this problem? Are they letting their chronic pain patients suffer and die in agony? Is this opioid crisis that we have in the United States replicated and other countries that have medical procedures such as ours?

  8. These simpletons just have to find simplistic solutions, don’t they? No matter how ludicrous, anti-factual, and utterly insane their ideas get, the media keep solemnly reporting as if they actually make sense. It drives me absolutely barking mad.

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