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Medicine Government United States

FDA Declares Popular Alt-Medicine Kratom an Opioid (nbcnews.com) 230

Posted by BeauHD from the natural-path dept.
An anonymous reader quotes a report from NBC News: The Food and Drug Administration declared the popular herbal product kratom to be an opioid on Tuesday, opening a new front in its battle to get people to stop using it. New research shows kratom acts in the brain just as opioids do, FDA Commissioner Dr. Scott Gottlieb said in a statement. And he said the agency has documented 44 cases in which kratom at least helped kill people -- often otherwise healthy young people.

"Taken in total, the scientific evidence we've evaluated about kratom provides a clear picture of the biologic effect of this substance," Gottlieb wrote. "Kratom should not be used to treat medical conditions, nor should it be used as an alternative to prescription opioids. There is no evidence to indicate that kratom is safe or effective for any medical use." The FDA released detailed accounts of several of the deaths. The victims often had mixed kratom with other substances, including chemicals taken out of inhalers and found in over-the-counter cold and flu drugs.
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FDA Declares Popular Alt-Medicine Kratom an Opioid More

FDA Declares Popular Alt-Medicine Kratom an Opioid

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  • You know, if people want to.... (Score:3, Insightful)

    by cayenne8 ( 626475 ) on Wednesday February 07, 2018 @05:09PM (#56086003) Homepage Journal
    ...voluntarily take themselves OUT of the gene pool, who are we to protect them from themselves?

    Maybe this is just nature at work, and putting some needed chlorine into the gene pool?

    • Re:You know, if people want to.... (Score:4, Informative)

      by bobbied ( 2522392 ) on Wednesday February 07, 2018 @05:27PM (#56086123)

      Where I get your position....I'm not sure I agree.

      It seems to me that the FDA has a purpose and if something being sold openly in stores is killing folks, they might just have the responsibility to respond. I think they see this as a matter of public safety, and I think they have at least some justification for this. They've restricted other products for less, even if those being killed are being stupid and using more than recommended to get high...

      Now calling something an opioid that's not actually derived from similar sources as opium does seem a bit heavy handed, because that puts this substance on a path to be made illegal to posses or use. It may act in similar ways as opium, however it's not actually opium...

      • Yeah I'm with you, screw using kratom, go back to heroin or $randomfentanalog instead. Way safer.

      • Re: (Score:2, Insightful)

        by Archangel Michael ( 180766 )

        FDA has a purpose

        Yes. But probably not the purpose its name implies. When you can't outline PROVABLE facts about FOOD, because only DRUGS (FDA approved) can treat illness and disease. That's why if you get Scurvy, they will PRESCRIBE vitamin C, but if you say Citrus Fruits, strawberry's can kiwis can cure scurvy, you're breaking the law turning food into drugs.

        Once you realize this, then it all makes better sense.

        • Re:You know, if people want to.... (Score:5, Insightful)

          by pr0fessor ( 1940368 ) on Wednesday February 07, 2018 @06:18PM (#56086453)

          If you go to a doctor because you have scurvy he will prescribe vitamin c to get you better fast and recommend you change your diet so you don't have a problem with it again.

          if you go to a doctor and he just happens to find a vitamin deficiency that's not causing an illness he will recommend changing your diet because that promotes long term health and only prescribe a supplement if that fails

          If your doctor is having you follow up constantly prescribing medications that you would need to be on for the rest of your life instead of trying to find a way for you live without medication then you are very sick (maybe diabetes) or you need a second opinion.

        • FDA has a purpose

          Yes. But probably not the purpose its name implies. When you can't outline PROVABLE facts about FOOD, because only DRUGS (FDA approved) can treat illness and disease. That's why if you get Scurvy, they will PRESCRIBE vitamin C, but if you say Citrus Fruits, strawberry's can kiwis can cure scurvy, you're breaking the law turning food into drugs.

          Once you realize this, then it all makes better sense.

          LOL.. I guess you don't like the FDA at all then.. But in this case, we are not dealing with food are we?

          Now if you are one of those people upset with the FDA because they take a dim view of medical claims made by supplement makers, I point out that we didn't have the FDA for a good part of our existence, and during that time literally ANYBODY could create some "medication" that cured everything from baldness and hoof rot to your wife's hair color and sell bottles of turpentine mixed with wood alcohol and

      • Re:You know, if people want to.... (Score:4, Insightful)

        by rogoshen1 ( 2922505 ) on Wednesday February 07, 2018 @06:24PM (#56086501)

        This is probably just a fun way to shoe-horn in banning designer drugs (even those that are yet to have been formulated), without having to actually go through all the trouble of specifically banning anything in specific terms.

        Example: there's a ton of different cannabinoids (natural, and synethetic). A precedent like this would allow for the banning of all similar substances (natural or synthetic) because they 'bind to the same receptors as THC'.

        • Yea, which is why I consider this a bit heavy handed by the FDC, they are side stepping the normal process here. Not that I would support legalization efforts, I don't, I just don't like the way the FDC is taking advantage of the perception of an opioid problem for something that really isn't an opioid derived from the usual sources.

      • Too lazy to look up the specifics but LOTS of drugs bind to opiate receptors. Including most antidepressants. It's an absolutely asinine way to attempt to regulate a drugs. It is fast, handy but it isn't science.

      • The FDA, like many federal agencies, has a long history of corruption and arresting innocent people. As long as these behaviors are intact, the FDA should not be making any decisions to prohibit anything. Since, in fact, these behaviors will never end as long as the FDA exists, it should be disbanded and a new agency created with far less scope and power. Basically, the FDA should do nothing but test for purity and shut down firms that sell adulterated products. Banning and chasing down mind-degrading drugs

      • Now calling something an opioid that's not actually derived from similar sources as opium does seem a bit heavy handed, because that puts this substance on a path to be made illegal to posses or use. It may act in similar ways as opium, however it's not actually opium...

        Opiates are drugs that are derived from opium. Opioids are chemicals which bind to the receptors that opium binds to. All opiates should be opioids but not all opioids are opiates. Fentanyl and methadone are two synthetic chemical opioids which are not derived from opium. If kratom binds to the same receptors as opiates then kratom is an opioid and the FDA is classifying them correctly.

        • Close; opiates are naturally occurring opioids. The endogenous chemicals morphine mimicks, e.g. endorphins and enkephalins, are also opiates. Then opioids are divided into synthetic (fentanyl) and semisynthetic (oxycodone, which is derived from the natural opium alkaloid thebaine).
          This action by the FDA is going farther than just saying 'since this binds to opiate receptors it's an opioid', which was already a universally accepted scientific fact, it's an action designed to bolster the case for scheduling
      • More importantly, in order to bring a medication to market, there is a *lot* of data that is required. You can't just start selling and hope nobody does. The FDA isn't saying this product can't ever be sold just that it has to come to market like any other drug.
        • The FDA and DEA want it placed on Schedule I, which will make it virtually impossible to study. And yeah, it's a plant, you absolutely should just be able to start selling it.
    • are you suggesting Kratom is killing folks, because it's not [youtube.com]. The FDA says that the deaths were caused by mixing Kratom with other substances, but don't really go into details and their own data [huffingtonpost.com] seems to prove otherwise.

      This is more shitting on poor people and another extension of our racist drug policy. The goal is to fill the private prisons (which are now a convenient source of slave labor [theatlantic.com] that _you_ compete with) while allowing roundabout institutionalized racism and segregation [google.com]. There is literally

      • Re:What the devil are you on about? (Score:4, Interesting)

        by ChrisMaple ( 607946 ) on Wednesday February 07, 2018 @09:36PM (#56087289)

        The age of "racist drug policy" is long gone; the urge to ban substances is based on authoritarianism and dogooderism. Accusing people of racism where none exists weakens your case and makes you look like a fool.

        It gets worse. Your tying race to poverty reveals that you have racist beliefs.

        • is what I'm hearing. Your arguments don't hold up to math. Even accounting for all control factors (income, location, family status, etc) blacks are 2-3 times more likely to be arrested for drug violations and get harsher sentences. This is a statistical fact you can prove for yourself with a few minutes on google. If we can't acknowledge facts, even when they make us uncomfortable, well, I don't know what to do. I really don't. But you're not going to see legalized drugs unless we attack the underlining re

        • It gets worse. Your tying race to poverty reveals that you have racist beliefs.

          No, but saying that implies that you either (a) don't understand Correlation != Causation, or (b) are willing to forget that you know (a) for long enough to make a fallacious racism claim.

        • Re:What the devil are you on about? (Score:5, Informative)

          by drinkypoo ( 153816 ) <drink@hyperlogos.org> on Thursday February 08, 2018 @05:50AM (#56088359) Homepage Journal

          The age of "racist drug policy" is long gone;

          False. [jhu.edu]

          the urge to ban substances is based on authoritarianism and dogooderism.

          And it disproportionately targets blacks and other minorities [aclu.org] (but especially blacks.)

          Accusing people of racism where none exists weakens your case and makes you look like a fool.

          Pretending racism doesn't exist where it totally does exist weakens your case and makes you look like a white supremacist.

        • The first part of this post makes a lot of sense and deserves the +5. The second portion needs a -1. No idea how one would moderate that. Guess it depends on who has points. The prison industrial complex certainly isn't racist. They don't care who is filling a bed as long as they get paid. On the other hand, you only have to look out the window to see that our long history or racism in this country is still having a profound effect.
    • You seem to be under the mistaken impression that if we replace prohibition with education, prevention, and treatment, using regulated commercial products, users would just OD. In reality, the number of addicts in general, and the percentage of addict ODs specifically, would plummet (see Portugal and Heroin Maintenance Programs).

  • Stupidity rules (Score:5, Insightful)

    by nospam007 ( 722110 ) * on Wednesday February 07, 2018 @05:12PM (#56086021)

    "The victims often had mixed kratom with other substances, including chemicals taken out of inhalers and found in over-the-counter cold and flu drugs."

    So flu drugs and inhalers 'contributed' to their deaths as well as the child laxative used to dilute heroin.
    Best to forbid everything.

    People had taken up to _9_ different things and only 44 cases?
    That's not science, that's anecdotes.

    • Re:Stupidity rules (Score:4, Insightful)

      by NettiWelho ( 1147351 ) on Wednesday February 07, 2018 @05:23PM (#56086085)

      That's not science, that's anecdotes.

      It gets even better; the whole war on drugs is completely unconstitutional.

    • Re:Stupidity rules (Score:5, Interesting)

      by Anonymous Coward on Wednesday February 07, 2018 @05:37PM (#56086201)

      I came to inject my personal experience with Kratom a good decade back.

      Due to an injury and a multi-month stay in the hospital for many surgeries, once out and a good way through recovery I found myself physically dependent on actual opioids, becoming unbearably sick whenever I just stopped taking them.

      I found it was easier to lower my dosage by a certain percent every few days, and initially worked with my doctors to do just that.
      About a month in they ended up simply cutting off my prescription while only down to 25mg/day from my original 100mg/day.

      In absolute terror to feel like I did when cold stopping, I turned to a friend who somehow managed to remain prescribed a large quantity prescription that he was basically doing the same thing as I was, tapering down, but he wasn't working with his doctor for it and remained on the same dosage the full time.

      This helped a lot to continue my plan, at least up until he was sent overseas for work for six months.

      Not wanting to either go down the hardcore path, or the withdraw agony, it was suggested I try Kratom pills.

      So here's the thing. They did work to trick the body and brain enough to not experience withdraws, so clearly there is something in the stuff that acts similar to the real thing.
      But it is VERY mild. There is no high, no pain relief, no other effects.

      However to get even the relief from withdraws, I had to take 6-8 giant capsules every 4 or so hours. Basically a $40 bottle a day.
      I can totally see why someone would turn to shooting up instead of that crap.

      These pills are like most "natural herbal" pills you see peddled, huge size "triple zero" gelcaps packed with powder. These are the kind that suck to take even one of, let alone 8 at once.
      They also float, so its a bitch to swallow them with water so you don't gag and choke.
      They also do quite a number on your stomach inducing cramps and all.

      When they were suggested to me, the same person said it needs a larger than usual dose, aka 6-8 pills instead of what it said on the bottle. The funny part was 6 pills WAS what was suggested on the bottle.

      I can't even imagine how many you would need to take at once to get any sort of recreational effects out of the things.
      I'm not even sure I could physically get enough down at a time to get any more effect without throwing up.

      I know people will go to some amazing extremes to get high, but damn!

      Granted this is just my own experience, and I had a lot going on with my body at the time, but I find it a bit hard to believe that the Kratom itself is what caused these deaths.

      Your comment about mixing it with other chemicals seems to me to be spot on.

      • Did you try Loperamide (Brand name Imodium)... it's an opioid that does not cross the blood-brain barrier (the only reason it is OTC). Off-label use for sure, but some people cut off from prescriptions have had success with it ("poor man's methodone").

        • You have to be careful with loperamide. 100mg then tapering lower for a week or two is fine and will stop withdrawal 90% or better; but taking 800mg at once or 200+mg/day long-term (some people have taken up to 1200mg/day--- yes, 600 pills-- for months) is associated with heart rhythm abnormalities that have resulted in a number of fatalities.

      • A trick I was recently introduced to for swallowing pills more easily: Tilt your head down to look at the floor as you swallow. Sounded ridiculous, but worked wonderfully.

        I suppose if you think about it, that's how we evolved to drink - out of a river or pond. Your tongue automatically does all the work to force water up and into your throat, and anything else gets carried along for the ride. And floating pills would end up being first down the gullet, I would think.

  • Learning (Score:5, Informative)

    by markdavis ( 642305 ) on Wednesday February 07, 2018 @05:23PM (#56086087)

    Learn something new every day. Never even heard of "kratom" until today.

    https://en.wikipedia.org/wiki/... [wikipedia.org]

    "is a tropical evergreen tree in the coffee family (Rubiaceae) native to Southeast Asia in the Indochina and Malaysia phytochoria (botanical regions). M. speciosa is indigenous to Thailand, Indonesia, Malaysia, Myanmar, and Papua New Guinea, where it has been used in traditional medicine since at least the 19th century. Kratom has some opioid- and stimulant-like properties."

  • Government For Sale (Score:5, Interesting)

    by CanHasDIY ( 1672858 ) on Wednesday February 07, 2018 @05:28PM (#56086129) Homepage Journal

    I'm just going to leave this here...

    http://www.pogo.org/our-work/r... [pogo.org]

  • The Republicans have taken a hard-line stance on any drug with mind altering affects, even vary mild ones. If it's not tobacco or booze they've been against it. The corporate Dems (Chuck Schumer, Joe Manchin, Feinstein, etc) are the same. Mostly bought off by big Pharma & private prison industries. Here's hoping somebody at least primaries Feinstein.

  • Not Helping Further Public Health (Score:5, Insightful)

    by LeftCoastThinker ( 4697521 ) on Wednesday February 07, 2018 @05:38PM (#56086205)

    The first part of the finding, that Kratom acts similarly to an opioid, is a reasonable, scientific discovery. The next step, stating that it is not useful in treating any medical conditions, is complete bullshit. From WebMD: "Advocates say the herb kratom offers relief from pain, depression, and anxiety. Scientists say it may hold the key to treating chronic pain and may even be a tool to combat addiction to opioid medications." https://www.webmd.com/mental-h... [webmd.com]

    The FDA has no damn clue if Kratom is medicinally useful. If the FDA were reasonably interested in promoting the general health and welfare of the population, the next step would be to temporarily ban Kratom while THEY perform historic investigation, investigate anecdotal accounts of medicinal properties, and then if warranted perform voluntary double blind clinical trials to validate or refute the historical and anecdotal evidence. I have never heard of this herb, let alone taken it, but many naturally occurring plant components have medicinal properties.

    All drugs have side effects, all drugs can be dangerous. To pull a medicinal herb without any plans to properly study it while giving blanket statements condemning its use is dishonest and fuels the antivaxers and alternative medicine movements that have been steadily growing in the US.

    • Drugs that directly make you feel good are always classified as "not useful in treating any medical conditions"

    • Re: (Score:2)

      by sl3xd ( 111641 )

      The FDA has no damn clue if Kratom is medicinally useful.

      That's exactly the problem. The FDA was given power to ban claims without proof of therapeutic effect.

      , the next step would be to temporarily ban Kratom while THEY perform historic investigation

      The FDA tried to enact a temporary ban. People complained, petitioned congress, etc.

      The FDA is not authorized to spend a dime of taxpayer money to prove a drug is safe or effective; their duty is to prevent potentially dangerous or addictive substances from being sold until proven safe. The prospective seller is the one who has to foot the bill to prove it's safe and effective.

      many naturally occurring plant components have medicinal properties.

      You're not wrong. The problem

      • I agree with what you are saying here, but there is a big gap in the current system. When a potentially useful drug is patented by a pharma company, that company has an incentive to do the drug trials. When a potentially useful drug is for some reason not patentable (as in this case) there is nobody to pay for trials. Stage I and stage II trials can probably get done on academic grants, but it would be hard to fund a stage III trial like that.

        I am not a pharmaceutical researcher or funder, I am happy to acc

        • I agree with what you are saying here, but there is a big gap in the current system.

          The "big gap" comes in the form of NIH. Other countries do perform these kind of studies, but we won't accept the results of any study not performed in the USA because we're better than everyone else in the world and none of them have anything to say that we would be interested in. At least, that's how the FDA operates.

          • That should change, at least to be updated with a list of countries whom we have found to be rigorous and accurate with their trials (probably most of Western Europe, Australia, etc.) and there should be an automatic investigation triggered in the US if ANY study found medicinal value in a naturally occurring substance. This is actually what people want their tax dollars funding...

      • The root problem though is this is not a drug, this is a plant. Phara companies arent interested in plants because they can't patent naturally occurring compounds. This plant could turn out to be a 100% safe and effective cure for opoid addiction, but without someone to do the research, the FDA has just shafted thousands of addicts.

        This is obviously speculation, but it is a real problem with the FDA and why growing numbers of Americans are ready to see the agency gutted and totally re-organized with a man

    • Re: (Score:3)

      by MobyDisk ( 75490 )

      You are misunderstanding what the FDA is saying.

      The FDA has no damn clue if Kratom is medicinally useful.

      Agreed. And the FDA seems to be saying that too. Read on...

      The next step, stating that it is not useful in treating any medical conditions, is complete bullshit.

      They did not say that.

      They said:

      Kratom should not be used to treat medical conditions, nor should it be used as an alternative to prescription opioids. There is no evidence to indicate that kratom is safe or effective for any medical use.

      So they are merely saying that thereis no proof yet that this drug is safe or effective.

      the next step would be to temporarily ban Kratom while THEY perform historic investigation...

      This is a common misconception. The FDA does not do such investigations. The FDA reviews claims and evidence provided by others and make decisions based on it.

      To pull a medicinal herb without any plans to properly study it

      The FDA did not "pull" the herb. They merely stated two scientifically-backed statements: That it acts like an opioid, an

      • Except the best disease it seems to be useful for is opiod addiction. The thing everyone in politics claims to want to address without actually addressing. And which is caused by the FDA in the first place. Prescription pain pills are cut off while people are addicted, and the cheapest / easiest thing to get their hands on is fucking Heroin, because getting Oxy / Vicodin on the black market is more expensive. Why were they on those opiods in the first place? Because Acetaminophen, Asprin, Ibuprofen are

        • Re: (Score:2)

          by MobyDisk ( 75490 )

          Except the best disease it seems to be useful for is opiod addiction

          Read the article. The entire point of the FDA statement is because there is no evidence that it is useful for opioid addiction. They just linked to a bunch of studies showing that. There are better alternatives, and they are often free.

          they find this Kratom which might help, and now that's banned too/quote>
          The FDA did not ban Kratom.

      • You are misunderstanding what the FDA is saying.

        He is not.

        The next step, stating that it is not useful in treating any medical conditions, is complete bullshit.

        They did not say that.
        They said:
        Kratom should not be used to treat medical conditions, nor should it be used as an alternative to prescription opioids. There is no evidence to indicate that kratom is safe or effective for any medical use.

        When you boil the two statements down, the same thing is left in the bottom of the kettle. Also, their statement is an outright lie. There is evidence that kratom is effective for medical use. Meanwhile, many prescription medications approved by the FDA aren't safe. The side effects are worse than the illness they "cure".

        the next step would be to temporarily ban Kratom while THEY perform historic investigation...

        This is a common misconception. The FDA does not do such investigations. The FDA reviews claims and evidence provided by others and make decisions based on it.

        And that's why the FDA is shit. It's only negative. It doesn't do anything positive.

        To pull a medicinal herb without any plans to properly study it

        The FDA did not "pull" the herb. They merely stated two scientifically-backed statements: That it acts like an opioid, and that there is not yet evidence it cures any disease. If someone wants to sell this, then they need to do that research and submit it to the FDA.

        Only one of those statements is scientifically backed. The FDA says precisely the same thing ab

      • Their statement "There is no evidence to indicate that kratom is safe or effective for any medical use." is 100% a lie.

        The actual true statement would be: "There is no FDA backed/approved studies to indicate that kratom is safe or effective for any medical use." Two very different things, as the FDA does not have exclusive rights to objective reality.

    • Re: (Score:2)

      by e3m4n ( 947977 )

      I find it interesting they say 'works similar to opiods'.... by that do they mean it triggers a dopamine reaction? If so why the hell is sugar and HFCS still legal? They also do it. In fact this known sugar high is exactly why the fucking straws at mcdonalds are so large you could almost suck a marble through them. They want to speed up the absorbtion of sugar in the sodas so you associate this sugar high with their stores.

      • Probably "binds to opioid receptors". Of course, binding to them doesn't necessarily translate to "activates them in the normal manner". Lots of pharmaceutical drugs work precisely by binding to different chemical receptors while failing to activate them.

  • And yet you can still buy and grow opium poppy. (Score:4, Interesting)

    by hey! ( 33014 ) on Wednesday February 07, 2018 @06:28PM (#56086521) Homepage Journal

    The exact same plant our military is attempting to eradicate in Afghanistan. It's just technically illegal to harvest and store "opium poppy straw", but if you harvest and milk seed pods for opium tea nobody is going to stop you; the DEA literally doesn't want to know because then it's got to crack down on gardeners. Or if you don't have a garden you can buy the dried seed pods at the florist for flower arrangements, and when you're done with them make your opium tea from them.

    I'm not saying there's nothing to be done on the supply end, but even if you stopped all the heroin coming into the country and outlawed the "garden" poppy, addicts would just turn to synthetic opioids, some of which can be synthesized from innocuous precursors. The primary fight has to be prevention and treatment of addiction.

    • The exact same plant our military is attempting to eradicate in Afghanistan.

      Actually they're guarding the fields and helping the warlords traffic it. "Economic stability".

      But, yeah, they should ban poppy seeds if they're thinking about banning kratom.

  • ...how much time our government spends worrying about plants that haven't killed anything other than corporate profits, and how very little time they spend worrying about an opioid epidemic which was largely created by pharmaceutical companies.

  • when will the FDA protect us against those drugs?

  • Many are people that toxicology reports stated had multiple drugs within their bloodstream. The cases in sweden were laced with a synthetic opiate too. In one case, one person died of a fucking gun shot wound but somehow ended up on their report until they redacted it!

    But hey, let's just take their word for it.....

  • Yes, this means that the FDA has officially announced that kratom has similar therapeutic effects to other opioids. Anyone looking to reduce their prescription charges or kick an oxycodone or hydrocodone habit (apparently it's less addictive) now knows that this is a medically legitimate option rather than some pseudo-science scam.

  • No thank you (Score:3)

    by PopeRatzo ( 965947 ) on Wednesday February 07, 2018 @11:46PM (#56087679) Journal

    If three fingers of bourbon and a quarter ounce of weed can't take me there, I ain't going.

      [This message has been brought to you by the Association of California Marijuana Dispensaries. Please smoke and drive sensibly, and wait until you're twenty-one. If you're pregnant, ask your doctor before scarfing down that bag of edibles you dumb cow. That's how you got knocked up in the first place.]

  • The pathway that opioids take in the pleasure centers is the same as alcohol. This was discovered in the 1960s. Different drugs (and experiences, etc.) take different pleasure pathways. Alcohol and opioids take the same path, and has to do with at least 4 important chemicals in the brain (serotonin, GABA, etc.). There are lots of different paths, but booze and opioids take the same one.

    Why would this thingy be classified that way just because it affects the brain the same as opioids? Alcohol does. So alcoho

  • Fuck the Trump administration. This decision is what will kill many, as kratom helps legions of people get off truly dangerous opiates. Kratom is not at all dangerous. Cheeseburgers are more dangerous than kratom. I thought it was impossible for me to hate the Trump administration any more than I already do, but now I hate them even more. How is it we keep electing the most awful people in the country?

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