WASHINGTON — Activists on Friday delivered a parting gift to Scott Gottlieb, the outgoing Food and Drug Administration commissioner, at the entrance of a federal building here: an 800-pound, supersized heroin spoon stamped with the FDA’s logo.

The group urged FDA to stop approving “dangerous” opioids and to instead encourage the development of more drugs to treat addiction. Many protesters decried the November approval of Dsuvia, a mega-potent pain drug, and urged the Trump administration to nominate an FDA commissioner who would take a different tack than Gottlieb on opioid approvals.

The protest comes after a series of demonstrations at museums funded by the Sackler family, the now-infamous founders of Purdue Pharma, the manufacturer of OxyContin. But Friday’s event, which took place just five blocks from the Arthur M. Sackler art gallery on the National Mall, marked a shift in protesters’ focus from the pharmaceutical industry to government.

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The protesters numbered around 100. Though Homeland Security officers kept a watchful eye on the group, no arrests were made, even as protesters staged a lengthy “die-in” near the building’s entrance.

“When you are willing to overrule the objections of your expert advisory committees on opioids and rapidly push them out when you’ve got this climbing death rate, and yet you consistently slow-walk the medications to treat addiction, we have trouble,” said Carol McDaid, a lobbyist whose practice focuses on addiction and recovery issues and who attended the protest.

The protest took place at the HHS headquarters and not at FDA’s campus in Silver Spring, Md., because the space in front of those buildings is not accessible to unauthorized visitors, said Ryan Hampton, an activist and author who helped orchestrate Friday’s protest. In a speech, Hampton credited his recovery from addiction to medication-assisted treatment and said the FDA should work to spur treatments beyond the three currently available medications: naltrexone, buprenorphine, and methadone.

While it was an FDA-centric protest coinciding with Gottlieb’s final day on the job, Esposito said the action had been planned months before, prior to Gottlieb’s announcement he would leave the agency.

Sarah Peddicord, an FDA spokeswoman, said in a statement that the FDA “has been acting forcefully to address the crisis, which is the largest and most complex public health tragedy that our nation has ever faced.” She cited achievements that ranged from ensuring opioids are properly prescribed to prioritizing new forms of MAT to expanding naloxone availability.

Gottlieb made the opioid crisis one of the focuses of his nearly two-year tenure at the FDA, supporting efforts to sell the overdose-reversal drug naloxone over the counter, emphasizing the importance of medication-assisted treatment, and cracking down on illicit drug sales over the internet.

Controversially, he cracked down on the use of kratom, an unregulated herbal supplement that affects the same brain receptors as many opioids. While kratom is often used in nonmedical settings to treat pain or symptoms of opioid withdrawal, Gottlieb said FDA tests found unsafe levels of lead and nickel in numerous kratom samples, and said separate investigations found kratom companies marketing the drug for uses unvetted by medical literature.

The Dsuvia approval appeared to outweigh those accomplishments, however, especially after the head of an FDA advisory committee overseeing the approval process publicly protested the drug’s approval. In a letter, he predicted the drug would instantly lead to diversion and death following its approval. Despite those objections, the committee voted 10-3 to recommend Dsuvia’s approval.

But protesters said his actions were insufficient in the face of Dsuvia’s approval — and the agency’s ruling that Brixadi, a new addiction drug, could not be marketed in the U.S. until the exclusivity period for a similar product expires in late 2020.

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The supersized sculpture of drug paraphernalia, complete with painted liquid heroin and burn marks on its bottom, is protest art manufactured by Domenic Esposito, a Boston-based sculptor whose brother has struggled with addiction. In a previous demonstration, Esposito left a spoon at the Connecticut headquarters of Purdue Pharma, the opioid manufacturer increasingly blamed for exacerbating the crisis.

“They need real investigations,” Esposito said of the FDA, alleging that the agency contributed to poor oversight of drug manufacturers and distributors who allowed rates of opioid prescription and diversion to spike in the past two decades.

Esposito, who drove from Massachusetts to D.C. on Thursday night with the sculpture in tow, said he’s manufactured four spoons to date: each cast from molten metal and emblazoned with a different logo, as appropriate.

He left the first at Purdue’s headquarters, and gifted another to Maura Healy, the Massachusetts attorney general who has aggressively investigated Purdue’s role in accelerating addiction deaths. A third came to Washington for Friday’s protest, and a fourth still is being prepared for a tour along the East Coast during which parents who have lost children to overdose can sign the spoon with their names.

The group’s chant, throughout the event: “Two hundred dead every day — we blame the FDA.”

Gottlieb told the Washington Post on Thursday that he will soon return to the American Enterprise Institute, a conservative think tank, as a resident fellow focused on prescription drug pricing.

Ned Sharpless, the director of the National Cancer Institute, will serve as acting FDA commissioner beginning next week. It is unclear whether President Trump is likely to nominate him to serve in the long term.

In his final days at FDA, Gottlieb sought to highlight much of the work the agency had done to curb the crisis, tweeting a letter from former FDA Commissioner Margaret Hamburg about a man whose son died from suicide after being able to obtain treatment for opioid addiction. FDA commissioners have passed pictures of the son, Michael, from one to the next since Hamburg’s tenure in 2015.

“Today,” Gottlieb wrote Tuesday on Twitter, “I gave it to Ned Sharpless.”

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  • Illegal drugs are the problem. Tramadol by itself unless you take like half the bottle is not going to get you high.i take them everyday and drive and function fine but nerve pills and muscle relaxers make me sleep all day.with kids I csnt live like that.i have scoliosis and a slipt disc on my spine.without meds I cant walk and laying down hurts too. If these people knew what the pain was like they would not be blaming drs for overprescribing.how can people think they know better than drs.this keeps up were going to see a huge decline in drs. Why be one if government controls what they do. If my meds are taken away I don’t want to live anymore in this pain.sad people care more about people that abuse the drugs than those that are killing themselves from the pain.people know illegal drugs kill so its their own fault for taking them.they will keep taking no matter the laws it’s illegal now and it’s still a problem.why go after the legal opioids that are needed.if these people felt half the pain I feel they would be begging for meds.

  • I am a chronic pain patient. I have tried everything under the sun, but my pain turned into Centralized pain from Fibromyalgia. I always worked through my pain, I used to be a plumber (besides steel errection it is the hardest job to do in the OSHA handbook). At 32 I felt my first day of Centralized pain, it went away and I have Poland Syndrome, which means my Pectoral Muscle is missing. My back is constantly trying to rip itself apart. I was put through a year of therapy by a Chiropractor, measured on a machine for strength in my limbs and I was told I could come to him everyday the rest of my life and never be better. At 42, I needed pain management the twisting of my spine and lower back injuries kept slowing me down. It gave me the ability to move again. Now I am 52 and my medications have been cut and I am on the highest doseage according to the MME chart. I have stopped taking my meds on a few occasions, I changed to Methadone to get away from Oxy yet I still have 4 instants for breakthrough pain per day. I can say this, the people taking scripts need to know that if you are high you are taking too much medication. Pain should be in the background waiting for you, twinge here and there, you will never be pain free. But it is for allowing for Mobility and lessening of your pain. Not to be HIGH. No one with a REAL pain managment doctor should be high except perhaps those being administered in a hospital setting for Cancer, Kidney Stones and other accute pain issues. Many people need EDUCATION. FENTANYL CAN KILL. HERION CAN KILL. Prescriptions dont kill unless you do not use the medication as your doctor says. Addiction kills as well but that is not part of prescriptions or caused by them. Prescriptions are tools, abuse the tools that is the person’s taking them fault. Willpower to say no helps keep you out of harms way. Deciding you need to abuse them, drink with them, take other meds without checking, that is your fault, so is illicit drugs. People who are addicted to substances will sometime in their life come across them. And they will abuse anything, gold paint, gasoline, transmission fluid, meth, heroin, oxy, Lyrica, video games, sex. It is a fact of life and sometimes of death. Quit blaming Drug makers and Doctors unless they are moving product outside legal channels. I have seen the FEDS raid doctors on very skimpy evidence, saying they are pill mills and I can say this if it is a regular doctor I understand. If it is a pain management doctor, how dare you. I find it repugnant. The 90MME chart is flawed and was spoken about by many pain managmement specialists. 2200 MME is the highest anyone living has been on in pain. So tell me how 90 is sufficient in all cases?

  • This is very personal to me and i know I’m not the only one that was lied to i was prescribed hydrocodone 13 yrs ago it made me sick and unable to function so my friend explained to me that drug was a opiate and i immediately went to the doc and asked him to put me on something that was non controlled substance and he handed me a package of 50 mlgs of ultram and it helped my neck pain and for two yrs i took it only as needed and i ended up inbemergency room on a wknd because i never asked for a refil and as it turned out i was experiencing withdrawls and that medicine is now a controlled substance in the state of Florida as of 4yrs ago and i have felt very betrayed by big pharma the fda they really need to b held accountable and my advice is to really do ur own research on any medicine if at all possible try to go to all natrual if at all possible stay safe and keep healthy out there to everyone that truly suffers from pain

  • Y cant the fda and everystate offer free medication that helps people who r sufforing from addiction and stop making them suffer more it’s very aparent we live in a corrupt system if they really want to solve this epidemic they created make them pay for the right meds to help the suffering we know y they just want to make more billions from the amaricans that just want to live normal lives

  • Tragically the country has an addiction problem that can’t be stopped unless draconian control of drugs from all sources, legal or not, are implemented. Can’t put all blame on pharma,FDA or any administration, gotta go back decades on this. You can always make a case for blame on companies and govt but where is people taking responsibility for own actions. Addiction is tragic no matter the reason but like alcohol and cigarettes someone chooses to keep using even though we all know the potential for disaster is well known.If we keep abusing stuff Human physiology will take over eventually ,then yer hooked. Stop drugs at the border, Drs overprescribing, illegal drug trade, people willingly and selfishly doing drugs, politicians doing nothing for decades! I suppose not much will change but people have to want to change before the bad stuff happens, it’s too late after! Beware, humans involved! Don’t hold your breath

  • How about being responsible for your own actions. It’s like suing a grocery store because I struggle with my weight. No, I should make better choices while I’m there.

  • Gottlieb goes crawling back from the rock he crawled out from under. He had nothing to add to the so called opiate epidemic, except for marketing a few more pharma products, and misinforming the public. It was probably the American Enterprise Institute that created and perpetrated Perdues marketing campaign anyway. In order to continue their false narrative the facts have to be avoided, and corporate interests need to be promoted.

    They took a serious public health issue and turned it into a corporate marketing scheme. America is in an epidemic of despair, and Gottlieb and his cronies are cashing in. They created a world of alternate facts, where beliefs are more important than facts. Why not turn a serious social problem into a marketing campaign, for more pharma products. The AEI did a really good job, demonizing sick people in order to present healthcare as a choice. Americans die every day because they did not have health insurance, or access to care. In the US even people with insurance are dying early, going bankrupt or unable to see a doctor. Up to half of the people dying from opiates are sick or have underlying health problems. The AEI undermined the ACA in order to protect industry profits, so a few dead people with addiction issues, are not a problem for them. They helped create this!

  • Dsuvia was approved when, 6 months ago? Despite the head of the advisory committee famously declaring diversion would be immediate, have there been any documented cases of diversion, misuse or overdose with it?
    The committee voted 10-3 for approval. While there may be other cases where they “overrule the objections of your expert advisory committees on opioids” this isn’t one of them.
    We have swung so far that after demonizing Rx opioids, we now even demonize the patients who need them to survive. There are more and more stories of patients managing severe pain long term with opioids committing suicide when their prescriber decides they won’t Rx anymore, and they are unable to find anyone who will.
    This isn’t to say we don’t still have a major public health crisis, or that Rx opioids weren’t a major contributor, but if you check CDC data from the last couple of years, I believe you’ll see overdose from illegal opioids have surged past ones from Rx opioids. It’s time to find equilibrium.

  • There needs to a be an answer to the drug abuse problems that does not harm chronic pain patients.
    I agree this is a mess but I blame the drug crisis on boredom and unsupervised young people, not people who got prescription opiates for perfectly valid reasons.
    There is no need to make a group of mostly older, disabled and suffering people do without the pain medication they desperately need. There is no need to force surgical patients to scream in agony for want of proper pain control. That is what is happening. This is hysteria of the worse kind. Until there is a better answer to pain control, opiates still have a place in our society.
    Do not forget people are personally responsible for what they do. Addiction does not just sneak up on you one day. Addiction is an illness but also is a choice. One chooses what to put in their bodies. I have been in surgery 28 times, was on powerful opiates for over a year. I did not become an addict, not once. Every time, I merely tapered as I didn’t need pain meds and never had a problem getting off them. Some people do, but it’s still is a choice.
    Now there are millions of people out there suffering, contemplating suicide because they are being force tapered, or stripped of the only medication that will make their lives bearable. It is horrible.
    I hope and pray the new FDA commissioner will look into both problems. Life has gotten very scary.

    • I understand. I had three failed neck sugerys in 94 95 96 and now have bone on bone Dr on t4 to s1 I was on 4 different opiates at the same time also anxiety meds and sezophenia for 10 + Years and was able to work. Then I got saciatia two DAMANGED NERVES IN LOWER back and two DAMANGED nerves in neck , raidoaprhy I cut myself off of all two years ago down to Percocet 10 mg. April 1 I quit pain management and Percocet now I do edibles with thc it kills my pain and all my mental problems
      My point is people are suffering from Dr scared to write scripts. I now can barley walk only get out of house to Dr appt or grocery shopping no family outings nothing
      Instead of making drugs to help JUNKIES make some new pain meds without opiates that’s not addictive and really work
      I have said to much
      Later
      Mike

    • Exactly,
      Addiction is a choice. Punishing 99% of patients who use their medications responsibly for the 1% who do not use them responsibly is careless. And the CDC admitting their algorithms were incorrect and deaths are counted twice when multiple drugs are involved. Come on. Also cdc report on “millions committing suicide have chronic pain”. Do you not see what is happening? Also, cancer is exempt, but in all your “numbers”, how many people taking opioids have a cancer diagnosis? Are you excluding them?
      Guess what? Cancer patients can’t even get opioids right now. Chronic pain patients can’t get opioids, patients in the hospital after MAJOR surgery can’t get opioids.
      Do you realize what is happening?
      I hope all of you need medicine at some point, and can’t get it.
      Then maybe, you will see what you have done to all of us.
      It is scary. I’m scared for my children.
      I’m scared to to go the hospital.
      I hope and pray I don’t get in a car accident, or need surgery.
      God bless us all.
      We are all screwed.
      All because addicts chose to abuse drugs, now we ( legitimate patients) pay the price.
      It’s like suing McDonald’s for making America fat, or the NRA for mass shootings, or big tobacco for all cancers.

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