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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 They say the FDA cited four tests demonstrating efficacy at the 10 milligram dose, two of which were unpublished and sponsored by drug manufacturers.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."
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 They say the FDA cited four tests demonstrating efficacy at the 10 milligram dose, two of which were unpublished and sponsored by drug manufacturers.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."
Anyone who has taken a product sans pseudoephedrine already knows they don't work.
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.
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.
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.
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.
In many places, the sale of pseudoephedrine is straight up banned. In many other places, the purchasing of pseudoephedrine is severely limited in quantity which is enforced by a pretty widespread database. The last time I purchased some, I got grilled for 10 minutes by an assistant manager because I last purchased some 3 or 4 months ago. They kept apologizing because I was 'near the limit' but that the authorities threatened them with removal of their various pharmacy licenses if someone went over their 'allotment' at their pharmacy. They went so far as to give me a box of 'the other stuff' for free. After I left I was immediately pulled over and grilled by a police officer about 'trying to obtain narcotics.' Yes, the motherfuckers called the police on me after I left.
It doesn't stop there. Trucks to major stores, carrying pseudoephedrine products, have been stopped and searched/delayed only ending when those products were surrendered, for no legal reason. Still the meth epidemic continues mostly unabated as the serious meth cooks just buy their shit from China, filter it through a few people, and have enough supply to cook for a decade. Everyone else suffers. Its literally easier to obtain meth where I live than it is to obtain two boxes of medication containing pseudoephedrine.
In fact, Desoxyn (methamphetamine hydrochloride tablets) is still legal in the USA. It's a prescription drug used to treat obesity and ADHD, in the same Schedule II as Ritalin (methylphenidate hydrochloride) and Adderall (mixed amphetamine salts).
Enough of this, help support http://www.alltrials.net. They demand that all trials are registered and published.
... 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.
Nothing else taken orally works for me. PE also raises my blood pressure temporarily. That's where the warnings should lie. Making it difficult to acquire sufficient amounts to produce meth had the effect of pushing the manufacture over the border and increasing the amount of violent crime involved in smuggling it back into the US. Oh yeah, and puts me on more government lists. They'll probably put me on the no-fly list for being chronically congested.
It's the only thing that is offered because these companies are cheap assholes.
I only buy the good old stuff you have to give blood samples and anal probings to get. Luckily the guy at costco will let me do two transactions to get two 15 pill packs to last for a while.
Do not waste time with any of the alternate crap as it really is 100% ineffective.
Do not look at laser with remaining good eye.
I never take medication when I have a common cold. It just doesn't help. Is your throat sore? Just drink some tea. Is your nose stuck? blow it. It will get better in a day or two. Only if I get a headache I may take some Acetaminophen or Ibuprofen, but that's it.
Spicy feeds clear the sinuses. Hooray for capsaicin!
Clear your nose to the point that you can breathe through both nostrils.
Doesn't work when your nasal membranes are swollen shut. Plus, you could blow out an eardrum if you try to clear your nose too strenuously. I know this personally.
Tiller's Rule: Never use a word in written form that you've only heard and never read. You will end up looking foolish.
"and he or she needs to know that science says that homeopathy does not work for anyone."
That's the study I really want to see!!!
"I don't know, therefore Aliens" Wafflebox1
I tend to agree. I get sinusitis around twice a year, with the changing of seasons. An ENT I spoke to about it says it's just allergic reaction, so not much sympathy there. I generally avoid most drugs, mostly because I don't feel so much better that I would risk the side effects (let alone the costs) - from cold meds and decongestants all the way to antibiotics.
I have started using a neti pot to rinse out the gunk in the nose and lowest sinus cavity with some salt solution. The morning routine seems to be most beneficial since stuff seems not to drain as well when sleeping (horizontal) as opposed to during the day (vertical). Keeping things moist enough so that natural drainage doesn't stop also helps. I still do get the sinus episodes, but they seem to be fairly mild and I haven't taken prescription meds for the last couple. Bed rest for a day or two, some doctor-recommended vitamins/supplements, and off I go again. (Yes, I'm thankful for my GP that is understanding that way and doesn't put some medical gestapo on my case when I ask her if there's an alternative treatment to the antibiotics course she would otherwise prescribe.)
I've tried the OTC nasal decongestants for a few years before giving up. I would just suffer without wasting my money. They never seemed to work for me. The neti pot worked better. I thought it was just me those pills didn't work for. Now science brings me comfort. A pox on the snake oil being sold!!
The behind the counter stuff works great but makes me feel 'speedy' and stimulated until it climaxes in a creepy anxious state. Feeling the effects of pseudoephedrine makes this chill person have extra compassion for people with anxiety. I never really understood it until using 'the good stuff'. Now I just suffer without it as well.
f49
--- rapper/producer/bachelorette party stripper
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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No sir. You're not gonna trick me a second time.
You are welcome on my lawn.
Meh. There are plenty of BS "remedies" for all sorts of aliments. All citing "clinical studies" usually of some unknown origin or bought and paid for by themselves. I think ColdFX is one of those. It is far from alone. There is a reason that "Snake Oil Salesman" has its origins in the medical industry's past. One that has never completely gone away. You can walk into any pharmacy anywhere, and probably point to literally hundreds of things that dubiously do anything, don't have any research pointing to that they do, or are marketed in such a way as to not require it.
I don't think any government agency FDA included really does enough about consumer protection in this regard. It is like homeopathy, a government agency will go so far as to say that it is "safe" (of course it is, it is basically nothing), but that is as far as they go, providing no consumer protection against marketing and ripping off consumers thinking they are buying a useful product.
You should try this stuff I found a few years ago, Alkalol. It's an old remedy and you can buy it at CVS and most Walgreens and it's on Amazon. It comes with a little neti-pot type thing and it works great. I find it a lot more effective than just the neti pot with saline solution.
http://www.alkalolcompany.com/
You are welcome on my lawn.
It's supposed to assure us that the medications we take are both safe and effective. In practice, we have seen approvals of compounds that later turn out to be dangerous (Vioxx) or ineffective, as in this case. Meanwhile, the glacial pace of the FDA approval process makes every drug we buy more expensive than it should be.
Time to make FDA ratings advisory, rather than mandatory. Let patients, doctors and insurance companies decide whether they want to stay with the gold standard of FDA-approved, or take a risk on something new and still in the pipeline, or use one of the many medications that are approved in Europe or Japan, but have not yet passed the FDA.
And no, there wouldn't be the explosion of quackery you fear. "Alternative medicines" are already exempt from FDA scrutiny as 'supplements', so that whole area would see no change.
How I can buy 50,000 bullets and high capacity magazines, no questions asked, but if I try and buy 30 boxes of decongestant, cops show up at my door?
If telephones are outlawed, then only outlaws will have telephones.
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.
I've been calling Sudafed PE "Sudafed Placebo Edition" for years.
--- Generation X: The first generation to have SIG lines inferior to their parents... ---
The allergies are so bad where I live meth dealers have been turning meth back into pseudoephedrine.
"A person is smart. People are dumb, panicky dangerous animals and you know it." - K
Pseudoephedrine is still readily available in Canada in many forms, and we don't have huge problems with meth manufacture and addiction. Making it illegal won't solve the social problems which cause people to seek it out in the first place. If you stop people from obtaining pseudoephedrine, they'll just move on to some other drug.
Anthropic principle: We see the universe the way it is because if it were different we would not be here to see it.
Crushed garlic. Eat it raw.
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?
Ephedrine from Ephedra plant (or Ma Huang, if you're Chinese) is exactly as effective as pseudoephedrine, and anybody can grow it in their own garden... why is there a market for the chemically synthesized version in the first place? IIRC, the only difference between ephedrine and pseudoephedrine is that one is a right-handed and the other is left-handed molecule, meaning both good be used for manufacturing meth... makes me wonder when Walter White is going to take up gardening...
I've abandoned my search for truth; now I'm just looking for some useful delusions.
They can't just move into running guns, as there are already criminals that do that, but their main buyers (drug pushers) are not buying, so it doesn't work.
So then there is human trafficking, black markets, illegal gambling, theft, counterfeiting, and extortion.
I don't think there is much growth potential in most of these fields.
And with police relieved from most of the interdiction work, there are more resources left enforce the other problems.
I have yet to find a non-prescription cough medicine that works, yet plenty are available for purchase.
Oh, and how about all those homeopathic choices on the shelves?
You might just as well keep yourself woozy with brandy.
To have a right to do a thing is not at all the same as to be right in doing it
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.
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Go out and get zinc gluconate lozenges or tabs. Ignore CVS's idiot marketdroids calling it "homeopathic", because it's *not*. When I was first introduced to it, 15 years ago, the packaging had about five citations from legitimate medical journals - JAMA, NEJM, with studies that *PROVED*, clinically, that it works - catch the cold in time, and it stops it in its tracks; after it's gotten into you, it'll cut the time it lasts by *half*.
mark
Anybody else confused by TFS?
"[...] all of us were able to buy effective decongestants right off the store shelf without a problem."
"[...] drug companies substituted the already-FDA approved ingredient phenylephrine for pseudoephedrine."
"[...] 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."
So, they removed products from the shelf that had an ineffective ingredient, replaced it with one that has an effective ingredient, and that is a bad thing?
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.
Breaking Good
Which drug culture would that be? The one that's allowed by the government because they get big payoffs from big pharma, or the one that is declared illegal, because they won't grease the right palms?
Drugs are drugs. Some are illegal and some are not. And as far as I can tell, it's completely arbitrary.
For example, Oxycontin is one of the most addictive and deadly drugs there is, yet it is legal with a "prescription". Meanwhile cannibis is mildly addictive, with few side effects, and is generally safe compared to most, but is illegal in most states of the USA.
So, "drugs" being good or bad has nothing to do with their relative danger, it has to do with politics, and politics ONLY.
If telephones are outlawed, then only outlaws will have telephones.
always will use pseudoephedrine.
'nuff said.
Doesn't it stand for Placebo Effect?
Quack therapies and activities abound. F'rinstance:
1) Chiropractors
2) Homeopaths
3) Aromatherapists
4) Psychoanalysts
5) Congress
6) Quantitative Easing
7) Astrology
8) Classical economics
9) Trickle down economics
And the list goes on and on and on....
Please do not read this sig. Thank you.
It works just as well as a sugar pill, which is better than nothing...
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Read this interesting paper on combining Fluticasone with Oxymetazoline (Diflam) to reduce eliminate the rebound effect.
http://www.ncbi.nlm.nih.gov/pu...
I get blocked eustachian tubes when flying which for me can result chronic pain an middle ear bleeding. I take Fluticasone then Oxymetazoline when flying to try prevent the rebound effect. This combo seems more reliable than pseudo.
46137
Hypothetical outline:
Crush crack rocks, dissolve in water, discard whatever dissolves (mostly baking soda).
Take insoluble remnants (largely cocaine freebase), dissolve in excess of Et2O.
Bubble HCl gas through solution to precipitate Cocaine as the hydrochloride salt. Filter from solution, and recrystallize as needed.
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Also effectively banned, thanks to paranoia over its use in illegal drug manufacture, are most Iodine-containing preparations.
I found this out just after Fukishima. While the fallout was on its way to California I tried to get some potassium iodide pills to load our systems with NON-radioactive iodine before it arrived. And I discovered:
- No iodine suplements. (It's not that they were sold out - non of the chain stores OR health-food stores carried them anymore.)
- No iodine-based water purification tablets at the camping stores. (They'd gone to other chemicals and/or methods.)
- No tincture-of-iodine antiseptic for cuts.
- Not even iodine-based disclosing tablets for toothbrushing.
The local compounding pharmacy offered to special-make some potassium-iodide pills (at a hefty price). But they didn't have the material in stock and would have had to order it from the manufacturer - with a delay of about a month. It would have arrived long after the fallout.
I found out from one of the stores what the problem was: Though the Federal Government hadn't actually BANNED iodine preparations, they'd put so much paperwork and inspection in place that it was no longer profitable to sell them. So all the retail outlets had switched to other alternatives or just quit carrying it.
Bantam Dominique roosters crow a four-note song. Once you've heard it as "Happy BIRTHday" you can't NOT hear it that way
Although hearing that they want to remove it from the market as useless crap is heartwarming.
My gripe with the pseudoephedrine restrictions is that it makes it IMPOSSIBLE for someone with minor chuildren to buy enough to treat the houseful of kids. I just
I didn't think I had allergies. I just thought I had small, easily plugged nasal passages. After I became psychotic from lack of sleep due to the continuous feeling of suffocating my doctor proscribed Fluticasone propionate. After suffering for years, I can breath.
Sudafed has 120mg of PE HCI. That seems to be more than 10mg in the study?
Anyway, decongestants with PE are the only ones that work for me. I really don't know why so many people here are saying it doesn't do anything. And no, it's not the placebo effect for me.
Reactions to drugs vary widely. Morphine doesn't work for everybody, but it works for most. PE doesn't work everybody, but it also doesn't seem to work for many.
When a drug has no effect for most people, people are allowed to say "drug does not work" rather than "drug does not work for most people, except for a few ACs on slashdot who say it works for them"
SWM seeks new sig for a brief fling
Uh, what comment?? Yours is the first post.
It is not.
Click the handy "Parent" link on my post.
Slashdot still doesnâ(TM)t support Unicode after it was added to the HTML standard in 1997.