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Epidemic of opioids: did the FDA stir up the crisis? – "60 minutes"



We have reported the causes and effects of the opioid epidemic for several years – interviews with government informants, doctors and Americans who have become dependent on powerful pain pills. We did not have a high-level artist from the pharmaceutical industry to sit in front of our cameras, until now. Tonight, Ed Thompson, a drug producer who has managed and produced opiates for decades for Big Pharma, interrupted the ranks to condemn his industry and his federal regulator, the Food and Drug Administration, which, he said, opened the gateways on

Ed Thompson: The main cause of this epidemic is unlawful approval by the FDA of opioids for the treatment of chronic pain.

Bill Whitaker: FDA has lit this opioid crisis? 1

9659002] Ed Thompson: No doubt they start firing.

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<p>  Ed Thompson told us when the first opioids, Oxycontin, were first approved in 1995, it was based on science that only showed it safe and effective when it was used "short-term" . FDA has made a fatal decision and, without having a new science to support it, has expanded the use of Oxycontin to almost everyone with chronic illnesses, such as arthritis and back pain. <strong> </strong> </p><div><script async src=

Ed Thompson:

Bill Whitaker: Wow

The FDA did this by simply changing a few words on the label that no one ever reads for a long insertion. Today, the label says that powerful pain pills are effective for "daily, round-the-clock, long-lasting … treatments." And this small change in the label has made a big difference in how pharmaceutical companies will sell all opioids, allowing them to sell more and more tablets at higher and higher doses.

Ed Thompson: Drug Label is the most important document for this product. It determines if someone can make $ 10 million or $ 1 billion.

Bill Whitaker: How is this?

Ed Thompson: Because it allows you to promote drugs based on labeling.

Ed Thompson owns PMRS, a successful pharmaceutical company in Pennsylvania that manufactures drugs for Big Pharma. It made him a wealthy man. But now he runs the risk of survival. He does what no other drug maker has ever done, he filed a lawsuit with the FDA at the federal court to force him to stick to science and limit the opioid label to short-term use.

"There is no research on the safety or effectiveness of opioids

Thompson calls on the FDA to start with its latest opioid, a Thompson's creative path to sabotaging the system." He can lose money by developing his new drug, but if he succeeds, it will create

Bill Whitaker: The decision in your direction may reduce the multibillion industry.

Ed Thompson: That's right, probably from about $ 7 billion to $ 10 billion. on the p to come out of the market.We decided to stop the sale of snake oil to US citizens in 1962.

Bill Whitaker: Snake oil?

Ed Thompson: Yes sir. You are using high doses, long-term opioids when they have never been There is no evidence that they are effective.It has extraordinary evidence of harm and death when you use them.

Professor Brandeis, Dr. Andrew Kolodny is one of the most recognized drug addicts in the country and is a witness to expert in litigation against Big Pharma, including Purdue, an Oxycontin manufacturer. He has been trying to change the FDA brand since 2011 to make clear opiates not for everyone.

  kolodny.jpg "height =" 349 "width =" 620 "class =" lazyload "data-srcset =" https://cbsnews3.cbsistatic.com/hub/i/r/2019/02/24/c20227a6 -3a60-415d-abbb-6e550e7d6143 / thumbnail / 620x349 / 24b8da333197b280a9035eb689c77c0f / kolodny.jpg 1x, https://cbsnews3.cbsistatic.com/hub/i/r/2019/02/24/c20227a6-3a60-415d-abbb- 2x "srcset =" data: image / svg + xml,% 3Csvg% 20xmlns% 3D "http% 3A% 2F% 2Fwww.w3.org% 2F2000% 2Fsvg & # 39;% 20viewBox% 3D & # 39; 0% 200% 20620% 20349 & # 39;% 2F% 3E & # 39; /> </span><figcaption class= Dr. Andrew Kolodny

Dr. Andrew Kolodny: These are the most important remedies for relieving suffering at the end of life and use If you take them around the clock, you will quickly become tolerant of the painful effect. To continue to receive relief of pain, you need higher and higher doses As doses become higher, treatment becomes more dangerous and the risk of death is increasing.

Bill Whitaker: It sounds the same as heroin addiction.

dr. Andrew Kolodny: It's essentially the same drug.

To understand how this began, we went to this small court building in Welch, West Virginia, where we discovered the protocols of secret meetings in 2001 between Purdue Pharma and the FDA. The files were part of a lawsuit against Purdue against fraudulent marketing.

60 minutes have received a court order to receive these documents. They find that, at these secret meetings, the FDA worshiped Perd's Pharma to ignore the lack of scientific data and changed the label to "round the clock … over a long period of time."

Ed Thompson: It was not a decision that there was no return for the FDA.

Purdue told us that Oxycontin has always been approved for long-term use. Quotation: "FDA action … has created tremendous opportunities" to expand the market, and advertisers' announcements soon expressed the benefits of Oxycontin's performance and sales tripled

Doctor. David Kessler: It was a marketing tsunami, and the agency did not get on it.

60 minutes have repeatedly addressed the former FDA Commissioner David Kessler on issues related to the safety of drugs. was first approved, but he left before changing the marking. Today he was detained by cities and counties who sued Great Farm in the opioid crisis. After reviewing our documents and self-checking, he says that changing the label for long-term use was a mistake.

Dr. David Kessler: There are no studies on the safety or efficacy of opioids for prolonged use

Bill Whitaker: But there is a law that says that a drug can not be raised as safe and effective if it is not safe and effective. . Yet, with the FDA sanction, these opioids are used in a way that you think has not been proven.

Dr. David Kessler: That's right. There is no rigorous scientific evidence that the agency should rely on.

The change of the label was an empty check – one industrial industry received billions and billions of dollars. Big Pharma now has a green light to push opioids to tens of millions of new pain patients all over the country.

Bill Whitaker: Let me remind you of some of the words you used to describe the pharmaceutical industry in your industry.

Ed Thompson: So?

Bill Whitaker: Corrupt.

Ed Thompson: Yes.

Bill Whitaker: Amorphous?

Ed Thompson: Yes.

Bill Whitaker: Broken? ] Ed Thompson: Yes. They are suitable for the behavior that has taken place.

Bill Whitaker: You are a drug executor. You are producing drugs.

Ed Thompson: Many drugs.

Bill Whitaker: Are you in some way guilty of this epidemic?

Ed Thompson: I would like to be smart enough to see this epidemic before. before I got three or four years old. Absolutely. But as soon as you find out that this is not right, you have to do the right thing. Is there something more important?

Emily Walden: My son wanted to fight for his country. His country failed.

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If there is one victim who confirmed to Ed Thompson that the inclusion of his industry was correct, that was Emily Walden, who became Thompson who made opioid oxymorphone – the same drug that took the life of Walden's son TJ, a private at the National Guard Kentucky

Emily Walden: He was preparing for Africa and a few weeks before that he went on a trip with a group of friends and field. The next morning, the officer knocked at my door, telling me he was dead.

Tj got used to drugs and easily got it without a prescription. Walden went to Washington, DC, to ask the FDA why her community was flooded with pain pills. It was there that she met Ed Rompson.

Bill Whitaker: What did you say to him?

Emily Walden: "You made a drug that killed my son."

Bill Whitaker: Now he's on your side.

Emily Walden: Yes.

Bill Whitaker: It just seems like a weird affair.

Emily Walden: That's right. But Ed may be my only hope for this. The responsibility of the FDA is public health and drug safety, and they do not do their job. They did not do their job for 20 years. Andriy Kolodny agrees. A passion expert Brandeis began his own investigation of why the FDA would endorse the continued use of opioids when there was no credible science to support it.

Bill Whitaker: What did you find? Andrew Kolodny: We learned that a group of experts and the FDA and pharmaceutical companies held private meetings at these meetings, changing the rules by which opioids get approval.

He filed a request for a Freedom of Information Act. In an email after an email between the FDA, Big Pharma and consultants, he learned about the closed doors at luxury hotels like Four Seasons in Washington, DC, where for 35,000 dollars, drug dealers paid to consultants: a table with the FDA, "hobnobbing with regulators". Emails indicate that one of the participants is worried that it can be viewed as a "pay-to-play".

dr. Andriy Kolodnyy: They had drugs, they worked on drugs that they wanted to approve. And through these meetings they managed to get these products on the market.

Bill Whitaker: It sounds unethical. Andrew Kolodny: It's unethical.

Bill Whitaker: If Not Unlawful

Doctor. Andrew Kolodny: If it is not illegal, it should be illegal.

No less suspicious, but legitimate, a large number of key FDA regulators who went through the back door to workplace drug addicts. Two healthcare workers, initially approved by Oxycontin, Curtis Wright and Douglas Kramer, shortly after leaving the FDA, went to work with the Purdue Pharma opioid manufacturer.

Doctor. Andrew Kolodny: Culture at the FDA continues to be too cozy with the industry, which it should regulate.

The agency charges medical companies more than $ 800 million a year and depends on this money to pay salaries to workers who not only changed the opioid label, but also reviewed new drugs such as Dsuvia, the most powerful opioid tablet. approved

  kessler.jpg height = "349" width = "620" class = "lazyload" date-srcset = "https://cbsnews1.cbsistatic.com/hub/i/r/2019/02/25/88a141a8 -64d9-49b4-9d26-fc6f92d5cbe0 / thumbnail / 620x349 / 6780e908176e3189a9aa19d49af33433 / kessler.jpg 2x6 "srcset =" data: image / svg + xml,% 3Csvg% 20xmlns% 3D & # 39; http% 3A% 2F% 2Fwww.w3. org% 2F2000% 2Fsvg & # 39;% 20viewBox% 3D & # 39; 0% 200% 20620% 20349 & # 39;% 2F% 3E & # 39; /> </span><figcaption class= Dr. David Kessler

Bill Whitaker: Only a few weeks ago, the FDA approved a new opioid that is 1000 times more powerful than morphine. And is this in the middle of this opioid epidemic, how is it possible?

Dr. David Kessler: I do not understand, I understand your question, I do not get the agency's actions.

Bill Whitaker: Should not the FDA be our watchdogs to protect us?

Dr. David Kessler: How many people, in your opinion, worked in the division?

Bill Whitaker: I have no idea.

Dr. David Kessler: right.

Bill Whitaker: When I look at a slaughterhouse in American cities and towns, this just does not seem to me to be a good excuse.

dr. David Kessler: This is not an excuse. This is a reality. You have a system of pharmaceutical advancement, which has changed the way of medicine, and no one, okay, stopped him.

The current FDA Commissioner, Dr. Scott Gotlib, has refused our request for an interview, but the statement says: he made aggressive steps to confront the crisis, "but he admitted" a lot of mistakes were made in this way … Although the agency has adhered to the law on the approval and regulation of opioids, we in the FDA include ourselves among those who had to act before. "

Bill Whitaker: You say that they have to do things to fix the label. I'm not a scientist, but it's not like it's hard to do. David Kessler: And it needs to be done.

Ed Thompson: We have here with Truth Problem.

Ed Thompson does not wait. Now he has joined the growing movement of physicians, lawyers and patients who want Big Farm to make their passion for the profit of opioids, which is why he decided to take over the industry and the FDA. 19659002] Bill Whitaker: If you succeed, you will be able to beat the multibillion industry.

Ed Thompson: And if I fail, then you will have more and more deaths every day. This is a good decision, is not it?

Producers Ira Rosen and Sam Hornblower


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