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The Popular Over-The-Counter Cold Medicine That Science Says Doesn't Work (forbes.com)

HughPickens.com writes: Back before methamphetamine cooks started buying up non-prescription decongestants to brew crank, all of us were able to buy effective decongestants right off the store shelf without a problem. Now David DiSalvo writes at Forbes that to fill the store-shelf void, drug companies substituted the already-FDA approved ingredient phenylephrine for pseudoephedrine. But the oral decongestant phenylephrine simply doesn't work at the FDA-approved amount found in popular non-prescription brands, and it may not even work at much higher doses. Researchers at the University of Florida are asking the FDA to remove oral phenylephrine from the market. "We think the evidence supports that phenylephrine's status as a safe and effective over-the-counter product should be changed," says Randy Hatton. "We are looking out for the consumer, and he or she needs to know that science says that oral phenylephrine does not work for the majority of people."

In 1976, the FDA deemed a 10 milligram oral dose of phenylephrine safe and effective at relieving congestion, making it possible for companies to use the ingredient without conducting studies. But Leslie Hendeles and Hatton say phenylephrine does not effectively relieve nasal stuffiness at this dose. They say the FDA cited four tests demonstrating efficacy at the 10 milligram dose, two of which were unpublished and sponsored by drug manufacturers. In contrast, the FDA cited six tests demonstrating no significant difference between phenylephrine and placebo. Hendeles said a higher dose may work, but no research has been published regarding safety at higher doses. "They need to do a dose-response study to determine at what higher dose they get both efficacy and safety," says Hendeles adding that until then "consumers should go that extra step and get it (pseudoephedrine) from behind the counter."

25 of 310 comments (clear)

  1. Duh by Anonymous Coward · · Score: 5, Insightful

    Anyone who has taken a product sans pseudoephedrine already knows they don't work.

    1. Re:Duh by MachineShedFred · · Score: 4, Insightful

      Well here's the real problem - pseudoephederine is a short cut to making meth. Meth cooks made meth before they figured out you could use decongestants. Meth cooks still make meth after the so-called restrictions.

      In fact, meth cooks in Mexico make meth using extract from natural ephedera plants that grow like weeds, and then smuggle it across the border the same as anything else.

      In the end, we've just made it harder for legit use, just like practically all other "think of the children" and drug war legislation. Oh, and the pharma companies were able to perpetrate a multi-billion dollar placebo scam for the last 10 years by selling a decongestant that does NOTHING.

      --
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  2. This isn't news by russotto · · Score: 5, Insightful

    Everyone knows PE doesn't work. It's only there so the government can claim they haven't removed all the useful OTC decongestants from the market. Yes, technically you can still buy pseudoephedrine in most states, but doing so puts you on a list which gives them probable cause to bust down your door on suspicion of meth manufacture.

    1. Re:This isn't news by Anonymous Coward · · Score: 5, Informative

      Furthermore, the FBI's own stats show that the ban/restriction on pseudoephedrine has made the problem worse. Before the ban, meth was mostly a mom & pop business. For the next 2 or so years after the ban meth sales dropped, but then the mexican cartels more than filled the gap with wholesale production (like Breaking Bad style industrial manufacturing importing the raw ingredients from China) and now instead of little guys who are mostly dumbasses selling to their neighbors you've got organized crime networks all over the country.

      Meanwhile I don't feel safe buying a sudofed and there are a bunch of stories of people being arrested for having bad allergies. I don't have the link handy, but the very first person arrested for buying too much was buying it for his kid.

    2. Re:This isn't news by alvinrod · · Score: 5, Insightful

      The government would be better off decriminalizing all drugs and producing chemically pure versions and controlling the sale of those substances while investing the revenues in treatment programs. It won't eliminate addiction, but it will go a long way to reducing the amount of organized crime in this and other countries that make their profits off the back of illegal drug sales. That in turn would go a long way towards freeing up law enforcement who wouldn't have to devote nearly as much activity towards dealing with the gangs that run the illegal drug trades.

    3. Re:This isn't news by Anonymous Coward · · Score: 5, Insightful

      Alcohol prohibition proves you wrong. Eliminating it greatly reduced gang crime. History is a great teacher, people are just to fucking stupid to realize it.

    4. Re:This isn't news by Wrath0fb0b · · Score: 5, Insightful

      In the short term, existing gangs will move to other areas of criminality, which are less profitable (or else they would switch now). The reduced cash flow will also intensify competition (read: violence) in those endeavors.

      In the medium term, a few organizations will die out, the remainder will claim their new turf but with less wealth to spread around both for status (read: bling) and patronage (read: cheddar, philanthropy). There won't be much less crime here at this stage, but the organizations will be less able to buy loyalty (kinship).

      In the long term, the reduced status and patronage will mean fewer recruits and ultimately an equilibrium with less crime. But you are right, gangsters don't go into accounting. The difference comes from convincing kids to go into accounting instead of criminality, and to do that you've got to reduce the total revenue of the criminal organizations.

    5. Re:This isn't news by Ol+Olsoc · · Score: 5, Insightful

      it will go a long way to reducing the amount of organized crime in this and other countries that make their profits off the back of illegal drug sales

      These crime gangs will just look for some other large profit activity. If drugs were legalised, do you think they'd all re-train as accountants?

      Sorry, the accountant cartel has that one already sewn up. But seriously, much of all of this goes back to good old ethanol. When the puritans decided we couldn't have it it just opened up the floodgates for funding criminal based business, as people aren't going to stop getting their buzz on, and those who will provide can make a lot of money for their risk.

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

      Other high water marks for OC were the Harrison act in 1914 and the Marijuana Tax act in 1937.

      But when old Dick Nixon declared "War on Drugs" in 1971. The money really started pouring in for the bad guys, and the military tactics we used got them into military tactics of their own.

      There will always be bad guys. There will always be vice. What you do, is remove the profit from it. When there is no profit, you are probably as close to controlling it as you can ever get.

      One thing is for certain - The staunchest anti-drug strong law crusaders are on the same page with the most ruthless drug cartels in wanting strict anti-drug laws.

      --
      The shepherds did so well protecting the flock that the sheep no longer believed that wolves existed.
    6. Re:This isn't news by pla · · Score: 4, Insightful

      If drugs were legalised, do you think they'd all re-train as accountants?

      FDR appointed Joe Kennedy as the first chairman of the SEC for a reason.

    7. Re:This isn't news by alvinrod · · Score: 4, Insightful

      Outside of drugs, the next biggest criminal enterprise is probably prostitution, which is yet another vice crime that shouldn't be illegal. As Carlin said, "Selling's legal. Fucking's legal. Why isn't selling fucking legal?"

      Once you eliminate those you're down to much lower profit margins and can't support the kind of massive gangs that trouble law enforcement so much. Even if they try to stick with the illegal drug business who would want to buy from them when you can get a better product from a legal source?

      Also, you still need someone to work at the store that's selling the drugs. Seems like there are probably some out of work drug dealers that could handle a counter job and be tax paying citizens. If taxes are used to fund other organizations to help people get over their addictions, etc. that's additional jobs that are being created rather than having the revenues end up in the coffers of criminal enterprises while still leaving society with the cost of cleaning up the consequences.

    8. Re:This isn't news by reboot246 · · Score: 3, Informative

      The SEC is the Southeastern Conference. Joey Kennedy used to write for the Birmingham News. Don't know who the FDR character was, maybe he was in some comic book.

      Just kidding, AC. You seriously need to learn a little bit of history. That single sentence you scoffed at had more insight and knowledge than a hundred regular posts here.

      I wish I had some mod points, but I can't seem to get any nowadays. It's been weeks since I had any.

  3. Already knew this by aldousd666 · · Score: 4, Funny

    I remind the pharmacist every time I have to sign my life away to buy the real stuff that the PE doesn't work. They always wink and laugh like 'sure it doesn't, we know you're cooking very small amounts of Meth with this at home, no need for the cover story.'

    --
    Speak for yourself.
    1. Re:Already knew this by aldousd666 · · Score: 3, Interesting

      Did you ever read the waiver you sign? $100,000 fine and imprisonment, not for making meth, but for buying too much Sudafed.

      --
      Speak for yourself.
  4. Thanks to the War on Drugs by XxtraLarGe · · Score: 4, Interesting

    I used to take Sudafed for my allergies, but then they had to change because METH. Now I take Claritin D, and if I want more than a 2 week supply, I have to get a prescription. This requires me to go see my doctor every so often, because she isn't keen to give prescriptions without checkups. All of this mess because somebody might use a drug as an ingredient for a drug that used to be legal.

    --
    Taking guns away from the 99% gives the 1% 100% of the power.
    1. Re:Thanks to the War on Drugs by dfenstrate · · Score: 5, Interesting

      I have ridiculous allergies, and take a number of antihistamines to keep them in check (but hey, the asthma is enough in check that I can run, so I'm happy.)

      Try eating a tablespoon a day of locally produced honey, unfiltered, for a month or so. The beekeeper should be the closest one to your home you can find, though even 100 miles out still ought to work.

      Sending the local pollen through your digestive tract gives your immune system another shot at getting used to pollen without causing respiratory problems. I used to have terrible allergies that could barely be controlled by double doses of claritin. I still have allergies, but they're much milder and much more controllable by medication.

      It's a pretty low-cost, low-risk home remedy. I stumbled across it when I was doing an internet search for "Is it safe to take double doses of Claritin?", and I figured 'What the hell, it's not like honey is expensive or dangerous.'

      --
      Alcohol, Tobacco and Firearms should be the name of a store, not a government agency.
  5. I'm all Afrin now by tepples · · Score: 4, Informative

    After CMEA, I switched to oxymetazoline nasal spray, which works better than oral pseudoephedrine ever did. People say Afrin can be addictive, but I reduce risk of rebound congestion by using it in one nostril in the morning and the other at night.

    1. Re:I'm all Afrin now by Anonymous Coward · · Score: 5, Informative

      Yeah but pseudoephedrine relieves all congestion, not just nasal.

    2. Re:I'm all Afrin now by Anonymous Coward · · Score: 4, Informative

      ^^^ THIS ^^^

      Usually when I get a bad head cold, it's my ears that get plugged up to the point that I become almost deaf. Then I head to the pharmacy, get the "you dirty meth head!" look, try my best to interact with them verbally (maybe I should learn sign language), get more "you druggie!" looks, sign the "I'm a COW! Mooo!" form, take 2, and in 15 minutes my ears completely unplug.

    3. Re:I'm all Afrin now by thoromyr · · Score: 5, Interesting

      Afrin is pure, unadulterated evil. It is, far and away, the best decongestant on the market, bar none. It is also over the counter.

      It is wrong, IMO, to describe it as addictive due to the connotations of that word. There are no cravings that result from Afrin use. No one is going to feel a compulsion that they "just gotta have it". No junkie related crime. What *does* happen is that your body starts to rely on Afrin to keep the airways clear. Without it, you are stopped up and cannot breath. Even worse, after prolonged use the efficacy of Afrin is decreased. So eventually you will be using it three shots each nostril several times a day and still not be able to breathe.

      Thankfully, you *can* wean yourself off of Afrin. It is miserable, however, and not likely something you want to go through. The sooner you start the better. Although I've never had the misfortune to abuse Afrin like that I've known multiple people who have. At the beginning they talk about how wonderful it is (and it doesn't hurt that it is "just over the counter" so "it must be safe"), then they have to recover from it. I have significant long term breathing issues and at least twice a year I have to use Afrin for a few days in a row. Even at that I eventually noticed a diminishment of effect.

      The fact that something so debilitating, so damaging to the user's health, is sold over the counter while other less harmful drugs are strictly regulated says a lot about the true functioning of the FDA.

  6. The good news... by w3woody · · Score: 5, Funny

    ... is that crystal meth is relatively easy to obtain, and it can be converted to Sudafed. Now all we need is for researchers to simplify the process and provide a practical process for the layman.

  7. The point of stopping the little guy by rsilvergun · · Score: 3, Insightful

    Was never to save people from meth, it was to contain the damage to the poor communities. One of the byproducts of our drug war is that the poors keep their misery to themselves. If they start spilling over we toss then in jail. Meth broke that. You had desperate folks cooking it in middle class neighborhoods. Making it otc restored the balance and put the drug way back where it belonged: in poor neighborhoods

    --
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  8. While they are at it... by MrVictor · · Score: 5, Insightful

    While the FDA is at it, can they please tackle all the other snake-oil products at the drug stores? All the homeopathic crap, Airborne Head On, magnet bullshit, diet pills, etc. They are all 100% bullshit placebos.

  9. Accounting for illegal businesses by sjbe · · Score: 3, Insightful

    If drugs were legalised, do you think they'd all re-train as accountants?

    I have news for you. A lot of them ARE de-facto or even actual trained accountants. If you want to do something illegal on a big scale and not go to jail for it, you had better have a more than passing familiarity with accounting. All that money has to be accounted for same as with any other business and it has to be moved around and used to pay bills, buy materials and stored somewhere. Who do you think does all that? The tooth fairy?

  10. Re:Don't bother by MachineShedFred · · Score: 4, Insightful

    As an allergy sufferer, and a nerd, it matters to me. And go fuck yourself besides. Your comment adds nothing.

    If you don't like the submissions here, then find better stuff for them to post. Don't just bitch about it, do something.

    --
    Slashdot still doesnâ(TM)t support Unicode after it was added to the HTML standard in 1997.
  11. My Approach by kackle · · Score: 4, Interesting

    I have learned to use Afrin to get all the way through a bad cold, but then when I'm feeling better, I use pills to recover from the Afrin dependency, which is usually brief.

    PS - I have dramatically reduced my nasal issues in life once I started taking very good care of my teeth. It never dawned on me that germs have 8 hours every night to travel a short, wet, warm path to my sinuses.