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FDA Head Acknowledges Suffering Caused by Opioid Crackdown

Scott Gottlieb announces a public meeting focused on the concerns of chronic pain patients.

FDAFDAYesterday Scott Gottlieb, head of the Food and Drug Administration, acknowledged that the crackdown on pain pills, aimed at preventing nonmedical use, is hurting legitimate patients, some of whom have contacted his agency. He announced a July 9 public meeting focusing on the concerns of people who use opioids to relieve chronic pain. The FDA is accepting public comments on the subject through September 10.

"The feedback we received affirmed for us that as we address this crisis, we wouldn't lose sight of the needs of Americans living with chronic pain or coping with pain at the end of life," Gottlieb writes on the FDA's blog. "We've heard the concerns expressed by these individuals about having continued access to necessary pain medication, the fear of being stigmatized as an addict, challenges in finding health care professionals willing to work with or even prescribe opioids, and sadly, for some patients, increased thoughts of or actual suicide because crushing pain was resulting in a loss of quality of life."

Gottlieb said the FDA is "focused on striking the right balance between reducing the rate of new addiction while providing appropriate access to those who need these medicines." He conceded that "opioids are the only drugs that work for some patients," including "patients with metastatic cancer or severe adhesive arachnoiditis."

That may sound like little more than bureaucratic boilerplate, but Gottlieb's comments are notably more compassionate than Attorney General Jeff Sessions' advice to pain patients, who he thinks should "take some aspirin" and "tough it out." Gottlieb's blog post is also consistent with the position he took in 2012, when he argued in The Wall Street Journal that the Drug Enforcement Administration's heavy-handed attempts to prevent diversion of pain pills were "burdening a lot of innocent patients, including those with legitimate prescriptions who may be profiled at the pharmacy counter and turned away." He noted that "others have in effect lost access to care, because their doctors became too wary to prescribe what their patients need."

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    FDA Head Acknowledges Suffering Caused by Opioid Crackdown

    Let me know when he acknowledges suffering caused by Sudafed crackdown.

  • BestUsedCarSales||

    Or when he acknowledges the role of this crackdown in the actual opioid crisis at large.

  • Zeb||

    You mean people don't actually want to be taking mystery Chinese opioids that might kill them?

  • DaveSs||

    Loperamide too

  • Telcontar the Wanderer||

    Is there a list somewhere of every precursor drug that's been proscribed by these twats? I suspect it is not short.

  • fafalone||

    Nothing official on that yet. But Amazon did its own crackdown. Suddenly every single seller had prices changed from $10-15 for a bottle of 200 to $99.99. Wal-mart continued selling it for $8, but limited online orders first to 2 per order, then 1. Doubt it's restricted in-store tho; in-store they still sell the big bottles, as does CVS et al. but there's definitely increasing pressure.

    The danger has been *vastly* overstated. Every single death has come from people recklessly trying to get high on it. The vast majority of use, to almost completely stop withdrawal only requires at most 100mg, tapered down over a week (which is no problem since there's no high in play). Maybe 2-3 weeks.
    The deaths? One was a guy taking over 2,000mg/day for over 8 months (yup, 1000 pills). Nobody has died from less than 800mg (400 pills) daily taken over months (the level build with daily dosing due to long half life-11h). Or from acute dosing above 1200mg with additional drugs to aid in BBB crossing.

    Overall, maybe a dozen or so deaths from people who were extraordinarily irresponsible. But that's gotta be weighed against all the people for whom it's helped them quit, even for a little while. It's saved orders of magnitude more lives. Restricting access is particularly sadistic even for drug warriors.

  • DaveSs||

    Ya, it was a memo to retailers. "Do this or we are going to do this X 2"

    Costco seems to have removed their 2x200 count bottles of it
    My local Wal-Mart seems to have removed their 200count bottles also

  • DaveSs||

    Ya, it was a memo to retailers. "Do this or we are going to do this X 2"

    Costco seems to have removed their 2x200 count bottles of it
    My local Wal-Mart seems to have removed their 200count bottles also

  • Zeb||

    So far fewer deaths than aspirin. But it has something to do with getting high (even if it's often trying to stop getting high), so it must be fucked with.

  • MichaelL||

    But...but...but...You expect them to work on information and not ignorance!

  • ThomasD||

    The FDA has about zilch to do with the pseudoephedrine restrictions.

  • Telcontar the Wanderer||

    or severe adhesive arachnoiditis

    "Just take some RAID and tough it out."

  • BestUsedCarSales||

    Some of us like some nice, sticky, arachnoid tits. Thank you.

  • Telcontar the Wanderer||

    Aaaand now Sessions wants to mandate comprehensive treatment.

  • BestUsedCarSales||

    Will there ever be peace between Keebler Elves and Spiders?

  • Telcontar the Wanderer||

    Only if the latter agree to stop having sex except for vaginal coitus without birth control through a bed-sheet between married individuals of the same gender and species.

  • MichaeI Hihn||

    Kids and their kinks these days.

  • BestUsedCarSales||

    It's a non-starter anyway since spiders don't have vaginas. Also, Spiders are extremely homophobic, so the same gender thing also kills it.

  • Telcontar the Wanderer||

    All I was doing was pointing out that Sessions is a closeted homosexual with a deep hatred of breeders who wants to impose his gayness on others through elven-arachnid peace treaties.

    That was clearly what I meant, and any assertion that the phrase "same gender" was in any way unintentional or the result of temporary brain death is invalid, unsubstantiated and, indeed, heterophobic.

  • MichaelL||

    It is truely not a funny thing! If one suffers with it, it is a lifelong battle to have any type of quality of life. People who make treatment decisons, for patients that they have not evaluated, are the ones who should be getting negligence suits. They would prefer for us to just die! Thank you, America!

  • Palin's Buttplug||

    North Korea warns US it could pull out of planned summit with Trump

    North Korea on Tuesday said a planned summit next month between President Trump and Kim Jong Un is at risk because of joint military exercises between the U.S. and South Korea.

    North Korea said it was ending talks with South Korea, and a confusing statement from the country's state news agency strongly suggested that the drills threatened the fate of the historic summit. (The Hill)

    The Dotard is dealing with one of his own kind now.

  • Libertymike||

    Why do you think Kim Jong Un has made the recent peace overtures?

  • Zeb||

    I hope Trump succeeds with NK. First because it would be good if anyone did. But it would be great and amusing if we find out that what the situation really needed all along was another ridiculous jackass to deal with the ridiculous jackass Kim.

  • John C. Randolph||

    What are the chances of this asshole ever admitting that there's no constitutional authority for the DEA to exist in the first place?

    -jcr

  • Rich||

    Now *there* is a statement that hasn't been evaluated by the FDA!

  • Robert||

    He's a MD, not a lawyer. He's not paid for his legal advice, & he's no asshole. He's doing his part for pain control w/in the parameters Congress has left for him.

  • ThomasD||

    The DEA, as a system of interstate licensing and taxation, has at least some Constitutionality.

    The FDA is on much weaker ground.

  • Jerryskids||

    Will there be aspirin handed out at this meeting?

  • MichaeI Hihn||

    Gottlieb said the FDA is "focused on striking the right balance between reducing the rate of new addiction while providing appropriate access to those who need these medicines."

    They'll get a handle on centrally-planned medical care any second now. Barring kulaks and wreckers, and other things over which they have no control, of course.

  • Telcontar the Wanderer||

    In fairness, they are very good at striking right balances. Good and hard.

  • MichaeI Hihn||

    "Hold still! *BAM* Stop wiggling! *BAM* We're helping! *BAM BAM BAM*"

  • BestUsedCarSales||

    This also could be a script from The Flintstones where Barney tries to change his kids diaper.

  • Robert||

    Congress has mandated both as desiderata. If the balance he strikes is more on the freedom side than the avg. reading of Congress would leave one w, he's doing good.

  • MichaeI Hihn||

    To be sure. My line of thinking was more down the path of Congress being free to mandate in one hand and piss in the other. They can win the battle, by furious strokes of redefinition, and yet the war will end predictably. Gottlieb's in a position which I don't envy.

  • Eidde||

    "striking the right balance...providing appropriate access"

    It's sad that this counts as enlightened and forward-looking.

    How about the federal government disclaim any authority to regulate the practice of medicine, based on the 10th Amendment?

  • Robert||

    Well, see, in terms of the federal (even the state) food & drug laws, they always claim that indeed they are not regulating the practice of medicine, & have no power to do so...only the power to regulate commerce in commercial articles such as drugs, including their labeling.

  • Eidde||

    Then why do they reserve the power to send doctors to prison as alleged pill-mill vendors? Wouldn't that be a matter for state medical authorities?

    Wait, let me rub some magic Interstate Commerce fairy dust over this...there, now I see the federal regulatory authority.

  • BestUsedCarSales||

    That was just cocaine.

  • Trigger Warning||

    Look, Dr. Jeff Sessions, MD, graduated from Harvard College Yale. He knows how much things should hurt. Comminuted distal radius fracture = Tylenol. Maybe even IV Tylenol! And ketamine without amnesiacs; it scares the pain away! Osteosarcoma pain is to be managed aggressively with deep breathing, prayer, and apple pie eaten under a large American flag while watching the Mets play on a hot summer day.

    Alternatively, the patient can man up and stop being such a whining coward. Two aspirin with a whiskey chaser is all a man needs.

  • Robert||

    What makes you think he thinks any of those things?

  • Agammamon||

    You've seen his personal stance on medical marijuana. That's not new. He's been a massive supporter of locking people up for marijuana use for any reason for his whole public career.

  • Robert||

    You're mixing him up w someone else.

  • Trigger Warning||

    Sessions is a law-and-order drug warrior of the Reefer Madness bent. He always has been.

  • Trigger Warning||

    The words that have come out if his mouth.

  • MichaelL||

    Hear! Hear!

  • gaoxiaen||

    Demerol sure helped before I got a hip replacement. Just sayin'.

  • MichaelL||

    Any doctor, who treats post operative pain with inadequate therapy, is not following the oath he gave to the rest of us! Refusing treatment is nuts! But, I did have a lot of success usingToradol IV and oral Toradol for five days after surgery. (Strangely, it works great for me, as well!) But, if it did not help the pain, they were switched to something that did! Demerol was as helpful for acute pain. But, used for chronic pain, the patients could develop seizures! Happened to my wife! She also got them from Wellbutrin!

  • Echospinner||

    The FDA is not the biggest problem. The major restrictions on prescribing are coming from the state Medical Boards.

    The newest attack is on the non narcotic gabapentin which a lot of docs are using as an alternative. I guess if you take enough of it you get a buzz or something and we can't have that.

  • AlmightyJB||

    God is the only buzz you need. All other forms of pleasure are from Satan and should therefore be illegal.

  • fafalone||

    And the state boards are restricting based on DEA-written prescribing guidelines. The CDC was their mouthpiece; the guidelines were identical to those recommended by the DEA.

    There's even propaganda posing as scientific studies now to reinforce things. Remember that study bandied about in the news about how in the ER opiates were no more effective than Tylenol? That's because the highest dosage in the study was 5mg of hydrocodone or oxycodone! That's a very small dose for pain bad enough to bring someone to the ER. You can see the strategy, limit dosage so much that NSAIDs are just as good, then ban opiates entirely because they're "not effective" and people are dying from them, nevermind that even more die from NSAIDs each year.

  • MichaelL||

    Without that, I will definitely suffer! It might be time to check out! Who cares, anyway?! But, since there are many forms of drugs that the people might put into their bodies, the medical boards want to convict us of "over-prescribing" It is sad the the ignorant are ruining the people that are trained in it! It is like the asylum being run by the inmates! Taken in high enough doses, the gabapenbtin might be considered one. But, in all honesty, being made sleepy by a drug, is no longer what defines the class. They are into "control", are they not?! Fifteen years ago, they were still doing the same thing that they are now!

  • Hackmaschine Mutter||

    Across the US in clinics & hospitals great and small there is a large addicted patient population. We see them every M-Fing day. The Feds created the Frankenstein years ago by telling patients they had a RIGHT to be pain free. And then 0-10 painscale came along. And it was mandated to be asked at every fucking patient contact. And oh, they were in 11/10 pain. And they got shit. So, the Feds giveth & they taketh away. But yeah, most of the patients with cancers are not affected by this. Just chronic pain substance use disorders.

  • Agammamon||

    1. People do have the right to be pain free.

    2. Even cancer patients are affected by this.

  • fafalone||

    Yeah, fuck those junkies who commit suicide just because they were forced to go from a normal life to being bedridden! Making sure the OD rate goes up by making people switch to random street powders is definitely more important than allowing doctors to not torture their patients by denying pain relief.

  • Trigger Warning||

    Hacks, you know the difference between addiction and dependence.

    Also, I get really tired of hearing ER staff casually assume everybody in pain is a drug seeker. You guys sound like cops when they assume everybody is a criminal.

    I agree that the current laws regarding right to treatment in an ER are stupid. If it's not life or limb, if it's an otherwise walking and talking person demanding the D for fibromyalgia, then I agree. But you see a lot of that because of what an ER has become in the US: a really shitty primary care clinic that loses a shitload of money.

  • MichaelL||

    You got that right. Having been on all sides of th conflict, I now worry that I will have to end my life, prematurely, because the sickness will be too much to bare! And, I can guarantee you that Hacks does not know the difference. But, the ER nurses were great at telling patients they were addicts, too! Or, telling them fbromyalgia does not exist!

  • AlmightyJB||

    I shouldn't need a prescription nor a tax stamp to buy anything I want.

  • RonBPalmer||

    Some people are allergenic to aspirin and everything like aspirin. This leaves Tylenol and opioids. I cannot afford to be addicted to relief that is so hard to come by. I am forced to hoard hydrocodone to deal with serious pain such as migraines. I would never waste one and quite frankly cannot understand how anybody could get addicted to them. They do nothing for me other than relieve pain.

    I suffered from chronic knee pain for 20 years before finding a cure. Anybody who wants to take opioids away from us should first experience that degree of debilitating pain for that period of time.

    It is pure evil to take these away.

  • Hackmaschine Mutter||

    I am sorry to hear that you suffer from pain. It's beyond debilitating and just sucks sometimes. Every single person should be able to decide what is best for them without interference.

  • Trigger Warning||

    I am 100% on patients's side regarding pain relief, but opiates are an eminently shitty choice for migraines, and most kinds of chronic pain. They are the best choice for acute pain to include pain from surgery, intractable pain secondary to serious illness, actual relief of bronchospasm, and palliative care. I cannot see a modern provider prescribing opioids for long-term relief of migraines unless literally every other class of meds (such as antispasmodics, mood stabilizers, ergotamines, SNRIs, etc) had been tried without success.

    I hate that you have such terrible pain. Wish I could help.

  • Zeb||

    I can quite understand how people get addicted to them. But that should have no bearing on whether or not they are available for people who need them to manage pain.

  • gphx||

    All it took for Americans to develop a sudden opiate problem was American soldiers taking control of the Afghan poppy fields.

  • Trigger Warning||

    Thanks. I needed to read something stupid today.

  • Agammamon||

    wat?

  • Zeb||

    Good for him, I guess.

    In related news, I heard someone from the DEA on NPR yesterday claiming that their restrictions and quotas on raw materials have nothing to do with shortages of injectable opioids in hospitals.

  • ThomasD||

    An empty gesture for the most part.

    Most of the heat and pressure has come from the DEA, or state licensing agencies, even if the FDA wanted to change their behavior all they could do is make polite suggestions.

    So, I wouldn't hold your breath.

  • Juliefab65||

    I have luved with chronuc pain for 18 yrs. I lived on my couch unable to sleep in my own bed for 6 yrs before I received medical help by a very knowledgeable and compassionate Doctor. I was prescribed.different pain meds until I found the ones that worked for me which were Methadone 10mg 4 times per day and for breakthru pain, Norco 10mg 3-4 times per day if needed. I became a functioning mom and wife again. I was able to sleep in my own bed for a change which made me cry I was so relieved. My Dr. moved and I alsi mived. I have a new Dr. Who was going to wean me off my pain meds until I saw a pain mngmnt. Dr. Im all for seeing a pain specialist but my Dr
    . Stopped prescribing me my meds instead of weaning me off because i had a negative urine test. I t[ok a)l my meds so something is fushy. Im beyond upset. How can they hurt us like this? I think its a crime. Im suffering and back on my couch

  • Mildred||

    In chronic pain daily from a TKR done in 2011. B.Braun implant AESCULAP manufacturer did not tell doctors that there was a problem with the implant 2011 they insisted The FDA approve it to put it on to the market. The last 7 years I have been complaining about pain from the TKR.
    I have OA in every major joint. I have spinal stenosis in my lumbar. I have Siactic & tailbone pain. I can't have any more cortizone injection because it mixes with my blood chemistry in which it causes inflammation in my Esophagus. I have Barretts Esophagus Diease.
    Radio frequency abbraion don't help. Why because I have a failed tkp causing inflammation in my TKR. I can't have any kind of Nsaids because of the ROUY EN GASTRIC BYPASS. I also have Malabsirption Dr's don't know my Malabsirotion % to even give the correct dosage of any medication. I can't get any pain meds. I have done nothing wrong. I take my medication as prescribed from my Dr's. Please don't punished people like me who need our pain meds to function like a normal person.
    People who need pain medication dont go out to sell their medication. Why because they depend upd them to live a normal life. Go after the people in bars who like to get drunk & high from abusing their medication & shoot up on Herion. It's not the Gun, It's not the Drugs. It's the person who don't have self Control that can not follow orders from their Dr's. They don't care who they hurt! They even end up in prisons.

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