(from the ‘why I should run the FDA’ files)
The FDA is priming itself to ban Vicodin and Percocet because statistics have placed these drugs as the leading substances involved in liver failure when taken along side with acetominaphin.
I have chronic back pain. It’s not a mere nuissance; my back injury keeps me up at night…sometimes all night, sometimes several nights in a row. It sucks: laying in bed with no weight on your joints and feeling immense pain no matter what position you lay in. I’ve suffered this condition since I was 19, and I perceive it as an injustice. I’m not even 30, I haven’t even had kids, and I’ve spent 1/3 of my life in debilitating pain. One of the reasons I failed my quals was that I couldn’t bear sitting and studying because of the pain. I even attempted crying myself to sleep. Yeah, it sucks that bad.
I don’t like Vicodin because it is addictive and I find that I need an increasing dosage in order to attain the pain-killing effect. I figured this out when I was prescribed Vicodin to attenuate my back pain. One pill worked wonders the first night, but it took two the second night…then three and a half…and it seemed that my pain required an exponentially increasing dosage of the drug from then on. I decided that it would not be a smart move to continue taking Vicodin. I have a few pills left and I take them only when I’m unable to get to sleep at 4 am and am in unbearable pain. Apart from those specific circumstances – being at the very boundary of my sanity in horrid pain in the middle of the night – I’d rather flush these drugs down the toilet.
So, that’s what I think about Vicodin.
But are drugs like Vicodin and Percocet so severely dangerous that they warrrent regulation by the FDA? I have my doubts.
The FDA appears to be linking these drugs to liver failure. However, it looks to me that incidents of liver failure involving Vicodin and Percocet are nearly always overdoses of the drugs, and/or involving excessive consumption of alchohal, which is something that all prescribing physicians caution against upon giving a prescrption for said drugs.
This stuff really gets my goat. I don’t even like Vicodin! However, the action proposed by the FDA is absurd – just like the banning of ephedra. If you don’t recall, the FDA banned ephedra because a bunch of highschool-aged football players with heart defects were taking the product and died after not following the clearly stated warnings on the label. Unfortunately for many others, ephedra happens to be the only food-based product which is proven to attenuate metabolic syndrome. Yeah. Thanks a lot, you dumb f***ers.
If I were going to commit suicide, I’d probably try to overdose on readily available opiates like Vicodin and Percocet. The combination of these drugs with acetominaphen and alchohal has been proven a danger to the liver, which is why one’s physician is prudent to caution one against taking these drugs in combination with alcoholic beverages when one is being prescribed such treatments.
The fact that the FDA is likely going to impose regulations on these substances because people like to over medicate themselves with them as a means to end their lives, or are unable to follow simple instructions, is pure madness.
My husband suffers from chronic back pain. Sometimes, in between treatments, it becomes disabling. Like most, we are not able to just not work one day…..so, every now and again, he uses percocet (I drive). He understands its use, and his limites. He has regular liver checks. He couldn’t make it through some of the more extreme times without it. And I wouldn’t want him to have to. Have you ever seen someone you love in extreme physical pain? Here’s a thought – let’s pull it off the shelf and make it unavailble to those who need it, to protect those who abuse it?! But hey, let’s sell alcohol and nicotine and other non-medicinal products that injure, maim and kill more people. Has the world gone topsy turvy?
This is so incredibly naive, I don’t even know where to begin. Really, Barb, I expect better from you. I’ll let Vinny take this one.
I’d add that on ephedra, you’re also wrong. “A review of ephedra-related adverse reactions, published in the New England Journal of Medicine in 2000, found a number of cases of sudden cardiac death or severe disability resulting from ephedra use, many of which occurred in young adults using ephedra in the labeled dosages.”
But hey, your dismissive characterization of high school football players too dumb to follow the label just has so much snap!
(And, of course, it doesn’t help that the purveyors of ephedra-based products, mainly Metabolife, knew about thousands upon thousands of adverse reactions but withheld this information from the FDA.)
Think about getting a waterbed? There is absolutely no pressure put on your points. I can sleep all night on my arm and it won’t go numb. Plus it’s heated so that you can get all snuggly when the weather turns cold. Yes, I have one
Actually, I sleep best on hard surfaces. Like my floor. No Joke. Pressure points don’t bother me, but soft surfaces actually stretch my ligaments more, which is the cause of my muscle spasms.
My wife fractured her back skydiving and had some nerve damage from it (L1,L2). She used gabapentin(brand name Neurontin)for a number of years. She says it was the only pain reliever that left her mind clear enough to think. Its a nonnarcotic,see http://en.wikipedia.org/wiki/Gabapentin
T, have you actually read the Haller article, the one which you are referencing, or are you just quoting me something from an op-ed? I’ve read the article, I read it in full when I was researching energy metabolism as an undergrad, and I just read it again, and I hate to break it to you, but you really don’t have a point. I’m sorry that you think my oppinion on ephedra is naive, but I assure you, by the definition of “naive”, it is not.
The article reviewed 140 reports of symptoms from ‘97-’99. Of the 140 reports, 13 resulted in death. 13! That is .0001% of the estimated people taking supplements containing ephedra. Yes, I know, it’s damn obnoxious that people who write things like what you quoted up there coyly leave out the numbers that put it in perspective. Also, I’d suggest looking more carefully at the actual data before slapping quotes around all willy-nilly on a blog which referrences “science” in it’s title. But since I actually enjoy breaking these things down for people, I’m happy to do it right here. This study was a survey study, so the experimenters had no way to control variables from subject to subject, which is why they say the “independentally reviewed cases.”
This is why I was pissed about the FDA’s decision; there is a lack of controlled scientific evidence, results from studies administering the drug to a controlled population in a controlled environment, where other influences, such as other medications, are taken into account. This is how human studies are done, my friend. Haller et. al. did ok with what they were trying to do, they said they were considering whether adverse events were more likely to do with ephedra rather than another variable, such another medication, but we have a word for this in science: speculation. It’s not an all out disqualifier on the study, but speculation does not translate into evident. It calls for further, more controlled studies, and these were not, and in my oppinion, should’ve been done. The closest they came was looking at individual ephedrine alkaloids. Phenphen was banned, and rightly so it was. The conclusions clearly state that there is a discrepency between previous studies, which controlled for the effect of ephedra on bronchiodilation ( the benficial effect of the supplement in treatment of metabolic syndrome) and controlled the dosage of ephedra at 25-50 mg (higher than the dosages estimated in the cause of adverse effects seen by the Haller group, and what Haller et. al. found. The add that this discrepency – Haller found a higher risk of adverse effects associated with a smaller dosage of ephedra – is most likely due to indivicual differences or additive effects of other substances in the supplement. That’s science-ese for “we were unable to control for the effects of ephedra, alone.”
I’m sorry, but the FDA really should not have banned ephedra. I don’t know what your problem is, T, the fact that highschoolers were taking the drug against what it written on the label, or that their coaches were having them train while wearing “sweat” suits, while taking ephedra, shouldn’t amount to the FDA banning of a proven beneficial substance.
I would like the FDA to undertake a better study of ephedra. Haller states that “ephedrine is rarely prescribed today for medical purposes, because newer drugs have more specific actions and fewer side effects.”
…he’s wrong about that. No newer drugs have effectively reduced metabolic syndome. The best treatment, currently, is gastro-bypass surgery. He goes on:
“The risks of taking ephedra alkaloids as a dietary supplement, however, are difficult to justify because the alkaloids have no demonstrated benefit. Unlike vitamins and minerals, ephedra alkaloid supplements are not essential for proper nutrition.”
…If you had studied nutrional biochemistry, you’d understand what is implied by the wording ‘essential for proper nutrition.’ It’s an elementary concept. Vitamins and minerals must be acquired from food or dietary supplements because they are essential for some body processes and our body doesn’t produce them on our own. Physiological process will run just fine without supplementation from non-essential foods, like ephedra. But the term ‘non-essential” should not be read as “not having an impact.”
“People who take these products to increase their exercise capacity or to lose weight place themselves at risk without a substantial likelihood of benefit.”
…there’s that speculation, again
THese guys didn’t study the benefits, they studied the adverse effects. In fact, I’d speculate that at least 140 people out of the estimated 13 million users were able to reduce metabolic syndromes by use of ephedra. It should’ve been studied better before being banned. THe use of acetominephen in vicodin and percocet should also be studies more. Acetominephen is tylenol. When taken with the other ingredients in narcotic and opiate pain killers, it has evidentally caused harm. THis is certainly important, because acetominephen appears to not play nicely with others. Not shockingly, taking acetominephen – tylenol – along with caffeine, is very harmfull, and caused a lot of adverse effects seen in ephedra users – because ephedra supplements usually contain caffeine. Knowing the FDA, however, I think they’ll simply dash vicodin and percocet, rather than taking appropriate steps that would advance our scientific and medical understanding of how acetominephen works and what happens when it is combined with other drugs.
Your head has been dislodged from your butt, now. You’re welcome.
Of the 140 reports, 13 resulted in death. 13!
Yes, because any adverse effect less severe than death should be dismissively waved away. And I’m the one with my head up my butt?
I don’t know what your problem is, T, the fact that highschoolers were taking the drug against what it written on the label, or that their coaches were having them train while wearing “sweat” suits, while taking ephedra, shouldn’t amount to the FDA banning of a proven beneficial substance.
My problem is that I don’t think that’s a fair generalization of the people who wound up with serious issues as a result of ephedra use. But you’re welcome to prove me wrong on that count. In any case, you don’t exactly give an air of fair-minded judgment when you make claims akin to “everyone who was harmed was a rockhead anyway.”
I would like the FDA to undertake a better study of ephedra.
Your presentation makes it seem as though Ephedra was foolishly and prematurely banned on the basis of one guy’s analysis. JAMA and AIM were also involved, among others. The JAMA report was actually a meta-analysis, which the scientist in you ought to love and respect. How much more study do you want?
But, of course, I suspect that your underlying objection has nothing whatsoever to do with the science. It’s an objection to the Big Bad Government telling Poor Little Pharma Company what they can and cannot do. Or, at a minimum, it’s a belief that any drug or supplement that cannot be conclusively proven to be harmful should be open and avaialble, rather than the prevailing view that the burden of proof ought to be on those asserting the safety and efficacy of a substance.
“But, of course, I suspect that your underlying objection has nothing whatsoever to do with the science. It’s an objection to the Big Bad Government telling Poor Little Pharma Company what they can and cannot do. Or, at a minimum, it’s a belief that any drug or supplement that cannot be conclusively proven to be harmful should be open and avaialble, rather than the prevailing view that the burden of proof ought to be on those asserting the safety and efficacy of a substance.”
You’re wrong about that. Part of the scientist in me has very strong ties back to research in metabolic disorders, which is what I had planned to study prior to switching over to straight-up chemistry. And I’m still inclined to make my way back to that field. My dislike for the FDA’s course of action in the ephedra case has jack-shit to do with “Big Governement,” and everything to do with what I feel is a lack of scientific evidence which could prove very important in our understanding of various symptoms of metabolic disorders. Where do you get off making that assertion? Nothing I’ve said in this post has anything to do with Big Government vs. Pharma, it has to do with the fact that I don’t think the FDA is run very well – period. I’ve had this oppinion about the ephedra issue since well before I tended towards my current beliefs about the federal government; 0.0001% of a group (that’s all the adverse effects, not just the deaths, over the total number of estimated users) is not a number that supports what these guys claim on enough of a scientific basis to warrant the banning of the substance, leading to a discontinuation in further examinations. Eat me, dude.
Oh, and by the way, being a good scientist means not agreeing with everything the author concludes just because it was published by JAMA or NEJM. It means being a reasonable skeptic, and asking questions, and pointing out where more information is needed. A shitty scientist is one who says, “well, it was published, so we should accept it and never question it.” If we thought like this, the theory of quantum mechanics would’ve been laughed out of town, and we wouldn’t have technology like MRI today. So don’t tell me that I ought love and respect these results as a scientist.
Love and respect != agree with.
Let’s remember what you’re accusing the FDA of doing: you’re accusing them of wrongly (and possibly irresponsible) banning a substance based on scant-to-nonexistent evidence.
Could the research be wrong? It’s always a possibility. But most or all of the peer-reviewed research of the time pointed in the same direction, and that was to a combination of dubious efficacy and a real risk of serious side effects. This wasn’t just one guy’s opinion, or even one group’s opinion, and that’s the way you were painting it. Has subsequent research shown that the FDA overreacted? If so, I’d sure like to see it.
I apologize if the “Big Bad Government” speculation — and I thought the wording made it clear that speculation was all it was, hence “I suspect” — went too far, but the overarching theme to your rant seems to be that the FDA shouldn’t err on the side of caution, and that’s something I just can’t agree with, or even comprehend.
Now, I’m inclined to agree that the FDA hasn’t been run very well over the past decade, but we’re likely to disagree about the reason we think that is. If anything, the FDA has been too lax in its testing, regulation and enforcement.
From what I can tell here, this is how I see it: based on zero first-hand knoweldge of what went into the decision-making process, and a whole host of assumptions about what information they did and didn’t have, you go beyond merely alleging that the FDA is overreaching, and skipped directly to calling them “dumb motherf***rs,” and saying that you ought to be in charge. You frequently get your panties all up in a twist about KTK’s tone, but on this post and comment thread, a serious gander at the lady in the mirror seems to be in order.
(Now, on a quick re-read, I suppose it’s plausible that you were referring to the high school football players as the dumb mofos, and not the FDA, but that’s certainly not how it comes across.)
I’m gonna stand by my oppinion on the FDA – ephedra case. Thank you for pointing out that you agree that the FDA has been too lax in it’s testing. I probably havent made it clear that this is also my oppinion. But, as I’ve said, there needed to be more solid tests done on effects of ephedra. As I said, the data acquired doesn’t do the job of supporting the actions taken, in my oppinion, and they call for further testing. How is this unclear or tone-y?
And I still want to run FDA. I’m quite skilled at statistics and scientific controls, and I think they could benefit from having someone as horribly stringent (when it comes to science-ing) like me saying “need more evidence, go find more studies on x in which the experimenters have controlled for variable z….” and then I should be given a lab and a host of support to conduct the needed experiments in an efficient manner. When I say I want to run the FDA, it’s not an off-the-cuff remark. I do want to get in there and make sure that thorough examinations are conducted.
I said I disagreed with their decision on ephedra based on what I viewed as insufficient data to support their claims. You seem to be interpretting this to mean that I think the FDA should lighten up. I think I was pretty clear in stating that I believed the FDA jumped to conclusions, and that this is what I had a problem with, and I backed up my allegations.
And I don’t think the FDA should have to err on the side of anything; they should collect some more goddamn data! I expect better than under-one-onethousandth of a percent of users. I can think of a whole bunch of experiments that should’ve been conducted, but weren’t. Hence, why the FDA needs me
Also, let me clarify on WHY I made the “Big Bad Government” supposition. You wrote:
But are drugs like Vicodin and Percocet so severely dangerous that they warrrent [sic] regulation by the FDA?
The implication here is that the FDA has no business regulating drugs unless they’re severely dangerous — a common claim among anti-government types. And let’s face it, you’ve got plenty of anti-government tendencies, many of them self-admitted.
But the FDA’s job is to regulate all drugs, not just the really, really dangerous ones. Even the most benign over-the-counter pharmaceuticals require FDA approval, and must conform to FDA regulations. If you believe, as I do, that consumer protection is an important function of government, then there’s nothing at all objectionable about this.
Even if you meant “ban” where you wrote “regulate,” which I now suspect you did, it’s still prudent in my estimation to ban particular drug blends where there are legitimate, serious, evidence-backed concerns about consumer safety. It’s not as if such bans are irreversible, you know.
As to your stand on the FDA, you haven’t addressed the point directly, but I’d like you to do so: What should the FDA’s default stance be? Should it be to approve anything where it hasn’t been conclusively proven to do harm? Should it be to deny anything that hasn’t been conclusively proven to be safe? Or should it be to favor the status quo, whichever way that happens to be, unless and until they get conclusive proof that they should change it?
In my judgment, you should err on the side of consumer safety. Based on your arguments here, you seem to disagree.
Also, proposing regulation in 1997 and acting on it in 2004 — seven years later — hardly seems to fit the description of “jumping to conclusions.” And it’s also worth noting that the FDA’s 2004 ban was not a total ban — it was a ban on ephedra in dietary supplements, which IMNSHO there was plenty of evidence to support doing. And, of course, there’s the history: ephedra-based products became popular in the first place as companies cleverly argued that it was food rather than a drug, and thus immune to pre-existing drug regulations governing ephedrine and pseudoephedrine.
I do have plenty of anti-federal gov’t tendencies. However, I dislike the FDA for the reasons I’ve given and I don’t feel I need to justify those reasons again. You had no cause to bring up my libertarian views here, it has nothing to do with why I don’t like the FDA, and I’d appreciate it if you didn’t try to color things non-politically motivated statements I’ve made as such. ANyways, I accept your apology.
I’ve been perfectly clear that my beef with the FDA has to do with their regulation process and the data they base it on. I want to see more stringent testing, and regualtions that also take into account the benefits. This is not an original oppinion of mine, many I worked with felt that the FDA has a tendency to unfairly weigh risks and benefits. What I mean by that is not that risks should be dashed in light of the fact that there are benefits, but that the FDA, in banning some substances, does in fact condemn a lot of people to suffering, and in many cases, it seems, the number of people who would have benefitted from treatment greatly outnumber the number of people who suffered adverse reactions.
Like I said, I don’t want to see them erring on the side of anything, I want to see them collecting more goddamn data before making their decisions.
As far as I’m concerned, you haven’t answered the question. They HAVE to start from somewhere, so where do they start from? What should be the status of a substance for which the FDA has, in your opinion, done insufficient testing?
Interestingly, caffeine is a food, found in coffee, but it is also found in many dietary supplements. Caffeine, taken with acetominephen, is also wildly harmful to one’s liver. So, should the FDA regulate caffeine?
I also fail to see how your libertarian views are irrelevant to a discussion of what you think a government agency should or should not do, nor do I see why bringing up that aspect should have been off limits. It’s not as if you’ve made any secret of those views, so apart from snarky tone — which you led off with in your original post before anyone even commented, by the way — I just don’t see how I crossed any line with respect to that.
Interestingly, caffeine is a food, found in coffee
Being naturally found in a food doesn’t make something “a food.” By that definition, MANY pharmaceuticals are “food,” including cocaine. Should the FDA not regulate cocaine?
So, should the FDA regulate caffeine?
Depends what you mean by “regulate.” In some ways, it already does.
Well, regulate in the same way they are regulating vicodin and percocet, since it has a strikingly similar effect on the liver when taken in combination with tylenol.
Ohhh, the scientist in me wants to do a combinatorial study on drugs that are bad actors with acetominephen now, to see if their metabolic pathways are related….
See, that is another reason why the FDA needs me. An experiment to determine relationships between the molecular structure and breakdown of drugs such as these in the human metabolic pathways would be greatly beneficial to the field drug design; we would have a better idea about what drugs may form harmful byproducts, or how the breakdown of specific structures occur and could lead to damages, and we could take that into consideration when we look for new treatments.
P.S. Say, what does the “F” in FDA stand for?
*I teed up an obvious comeback here, let’s see if she bites.*
Farts.
In my oppinion as a scientist, based on previous studies, some of which are referrenced in the JAMA and NEJM articles, ephedra supplements in the 25-50mg range are effective bronchiodilators. Bronchiodilation is achieved normally through exercise. However, for subjects who may be unable to exercise, due to morbid obesity or diabetes for example, the cannot achieve the bronchiodilation from exercise. Thus, the ability of a supplement to safely induce bronchiodilation should be examined. This would mean not only testing the dosage requirements, but also determining what is needed for this to be done safely. As in, what activities should subjects refrain from when on the medication. It seems to me that they should refrain from intense exercise because of the apparent relationship between bronchiodilation and harmful bp seen when subjects were exercising. I, of course, would like to know what that data looks like. How does bp increase during normal exercise, and how does it increase during exercise when a patient has taken a bronciodilator? How does the amount of bronchiodilations affect bp levels when a subject is not exercising? How do physiological benefits of bronchiodialtion respond to varying dosage of ephedra? All this is very interesting to me, and I was quite disappointed as an undergrad intent on studying cardiovascular therapies that there would be no further tests on ephedra.
The treatment of ephedra as a food vs a drug has also interested me. The FDA rarely bans foods to the extent that it banned ephedra – which is a natural supplement falling under the food category. As a student back at UMass, however, I learned that certain foods, and also certain activities such as exercise (studying exercise as a prescription to obtain distinct medical benefits = the study of kinesiology) had obvious effects on physiological funcitons and health, so it might make more sense to treat a food like ephedra in the same way we would treat drugs, however, in order to do this, the should re-do their examination, start from the beginning, as if it were a new product.
So, to answer your question, if it were up to me, I would return to testing of ephedra as a drug, starting with the experiments I briefly stated above, so that it might become a potential medical treatment for metabolic syndrome.
Well, regulate in the same way they are regulating vicodin and percocet,
In other words, consider banning pharmaceutical products that combine caffeine with acetaminophen, but continue to allow caffeine and acetaminophen to be sold separately? I don’t see what that would be such a big deal.
So, to answer your question, if it were up to me, I would return to testing of ephedra as a drug, starting with the experiments I briefly stated above, so that it might become a potentional medical treatment for metabolic syndrome.
And what’s the status of ephedra until such time as that testing can be completed? If you’re saying “treat it as a drug,” then whether you realize it or not, you’re effectively backing the FDA’s action. Drugs require approval BEFORE they can be sold for a given purpose, and ephedra has never earned any such approval for weight loss, to my knowledge.
As for no further testing, why not? Did the FDA’s ruling explicitly prohibit all further testing? If some company thinks ephedra is safe and effective, there’s nothing (to my knowledge) stopping them from chartering the studies necessary to prove it.
The massive amounts of red tape in order to get the human-testing committee to agree to let you test an FDA banned substance, I imagine, are a big honking deterrant.
As for the status during testing, I’m not sure I understand what you mean. Also, I’m not backing what the FDA did. They treated ephedra as a drug, in saying that it didn’t measure up to drug standards…but no one had been testing it as a drug, they had been testing it like a food. Essentially, because ephedra – the food supplement – was found to have dangerous risks according to drug standards, they banned it. It doesn’t add up, in my book. I think they should start the whole process over again to see if an ephedra-based drug to treat metabolic disorders would be possible. I believe that ephedra could have benefits as a medical treatment, and can be safely used (I mean, at least 99% of users managed to remain safe), and it should be given more attention.
C’mon. Admitt it. I’d be good for the FDA. You might disagree with my political views, and my oppinions on where the FDA messed up with ephedra, but I’m the most OCD meticulous science-bitch you’ll meet. Those f***ers will get thorough with their experimentation if I ever have a say in it.
As for the status during testing, I’m not sure I understand what you mean.
It’s really not that complicated. While it’s being tested for efficacy and safety, should it be legal to sell, illegal to sell, or somewhere in between? Unless you think the answer to that question is “it should be legal to sell,” it’s hard to find fault with what the FDA did (other than perhaps to criticize them for lack of follow-up, although I’m not sure that such follow-up is the FDA’s job).
[The FDA] treated ephedra as a drug, in saying that it didn’t measure up to drug standards…but no one had been testing it as a drug, they had been testing it like a food.
Don’t you see? This was precisely the problem! The makers and marketers of ephedra-based products were trying to have it both ways, by marketing the product like a drug (claiming that it treats certain conditions), while claiming it’s “food” for regulatory purposes. Are you honestly saying the FDA shouldn’t cry shenanigans in cases like that? Also, ephedra isn’t “like” a drug, it is a drug; it’s just one that happens to occur naturally. (And I’m sorry, but if what you’re selling is a pill, it’s a hell of a lot closer to “a drug” than to “a food,” no matter what you’re calling it.)
And again, it’s important for purposes of this discussion to clarify what the FDA did in 2004 — it didn’t “ban ephedra,” period, full stop. It banned its use in dietary supplements. You can still sell ephedra within the pre-existing guidelines for the sale and use of ephedrine and pseudoephedrine. You just can’t coyly pretend “lalalalala it’s food” and bypass those rules.
As to whether you’d be good for the FDA, I can’t really judge that proposition, because I haven’t been able to get a clear bead on what you think the FDA’s job ought to be.
Side note: If only the OCD applied to your spelling.
I’m the most OCD meticulous science-bitch you’ll meet
Interestingly enough, for all your meticulous OCD science bitchiness, you seem to have missed the entire point of the decision you yourself have been criticizing, as well as what that decision actually does.
statistics have placed these drugs as the leading substances involved in liver failure when taken along side with acetominaphin
Vicodin and Percocet aren’t purely narcotic drugs; they’re a combination of a narcotic with acetaminophen. Taking them with even more acetaminophen greatly increases the dosage of the latter, which is the one that causes liver damage.
Vicodin . . . is addictive and I find that I need an increasing dosage in order to attain the pain-killing effect
That’s the problem. This is true for many people on these drugs, but taking increasing doses of the narcotic means you’re also getting increasing doses of the acetaminophen – plus whatever other Tylenol you’re scarfing on the side to help deal with the pain the prescription drug can’t handle. For many people, long-term use of Vicodin and Percocet is a pathway up through larger and larger doses of acetaminophen – which they don’t realize, because many of them don’t know there’s Tylenol in the preparation they’re taking – until they finally overdose.
The FDA banned only preparations of the combination of the two drugs together. It did not ban any of the narcotics in Percocet or Vicodin (they’re two different ones), and it did not ban acetaminophen. It also didn’t ban taking them simultaneously. You just have to take them in separate pills. (The FDA also recommended reducing the per-pill dosage of OTC acetaminophen, but rejected proposals to limit acetaminophen sales or container sizes.)
You can still take exactly the same drug regimen you’ve already been taking (and it will probably be cheaper). You can still take any combination of the ingredients of the drug you’ve been taking (and you’ll have more control over those combinations). The new regulation just forces people to be consciously cognizant that they’re taking two different drugs, and decouples increasing dosages of the one that makes you rob liquor stores from increasing dosages of the one that destroys your liver and kills you in a matter of hours.
In other words the regulation prohibits nothing at all that was already permitted, but creates a default whereby the unrecognized-dosage-increase phenomenon – which is what kills people – is avoided; it allows people to have any dosage of either drug they choose, but forces them to make a conscious, positive choice to do so. It’s a good example of Thaler and Sunstein’s concept of “libertarian paternalism” – “nudging” people to make better choices by making them more aware, and protecting them by setting the default to a safe outcome rather than a potentially deadly one.
It’s hard to see how this is possibly worse than before. The only possible argument against it is that the convenience of taking both drugs in one pill instead of two, for people who need exactly that combination of dosages every time, is important enough to kill several hundred people a year for whom those are the wrong dosages. Which does strike me as perfectly in keeping with the general libertarian mindset, but that’s hardly an endorsement.
No, sadly, my OCD is apparenty strictly limitted to my laboratory practices.
“…because many of them don’t know there’s Tylenol in the preparation they’re taking – until they finally overdose.”
Well, they would be aware of this if they read the warning label on the pill bottle.
I’ll admit that it’s not that bad, and it will have very little negative effect. It’s not nearly as bad as the ephedra issue. However, you still have a better chance of getting struck by lightening than you do of overdosing on acetominephen. That, to me, is hardly a case for changing the administration of these drugs. Way to go on being useless, FDA (there’s my libertarian sentiment for you, guys).
Well, they would be aware of this if they read the warning label on the pill bottle.
This is precisely the sort of idiocy that pervades a ton of libertarian thought. The information is available, if people make an effort to look for it, therefore we can claim we’ve done enough. Never mind whether or not people actually will make the effort to look at it, much less understand it when they do.
But it’s good to see you’ve slid from “absurd” to “not that bad” in less than 24 hours. Even if you still haven’t made anything close to a coherent defense of your stance on the ephedra issue.
Sooo, you’re saying that the FDA’s action was needed because people aren’t able to follow simple written instructions? Gotcha.
It’s not the outcome that I found so offensive about the FDA’s action on the matter of acetominephen regulation, but that such a highly improbable occurance warrants a regualatory change.
And I think I’ve clarified and justified my stance quite well on ephedra. I don’t think 0.0001% of users is a sound basis for a change in regulation, and it certainly shouldn’t have lead to the banning of this substance in light of the potential long term benefits to a greater number of people.
So, what is it that you’re not clear on, again? Did I lose you when I started talking science?
I’m the most OCD meticulous science-bitch you’ll meet … However, you still have a better chance of getting struck by lightening than you do of overdosing on acetominephen.
So much for being OCD about verifiable scientific claims. Lightning deaths in the US: 82 per year, on average. Deaths from acetaminophen overdose in the US: 458 per year. You’re more than 5.5 times more likely to die from an acetaminophen overdose than from a lightning strike. But hey, 450+ preventable deaths per year is statistically insignificant, so why bother, right?
Sooo, you’re saying that the FDA’s action was needed because people aren’t able to follow simple written instructions?
Not “aren’t able,” but “don’t” or “won’t.” (Come on, I defy you to tell me with a straight face that you truly believe even 10% of the people who get prescription drugs fully read and understand that three-page warning booklet that comes with the pills — never mind over-the-counter stuff.) I know the good little libertarian response to that is “fk ‘em, let ‘em die if they don’t read and understand every detail of every warning label they ever come across,” but the growns-ups in society generally try to plan for what we expect people to do, not for what we think they ought to do.
Perhaps analysis paralysis is your preferred state of being on issues of public safety. I’m glad the FDA doesn’t share that disdain for public health. But gee, now that I learn more about it this sure sounds like a panicked, over-the-top knee-jerk response!
So, what is it that you’re not clear on, again?
Well, when you argue that they should treat it like a drug rather than like food, but because it’s food they can’t, that’s confusing. And when you throw out numbers like “0.0001% of users died” as if that informs the debate (and completely ignore the number of serious reactions that didn’t result in death), that makes it even harder to grasp what your angle actually is. I’m trying to give you the benefit of the doubt and not assume what logically follows from what you wrote, which is that anything less than death is nothing to be concerned about. I sure hope that’s not your point. (By the way, 0.00001% of Americans were killed on 9/11 — guess we shouldn’t have done anything about that, either.)
Did I lose you when I started talking science?
No, you lost me when you started talking ideological non-interventionist BS.
Must correct my own error. I wrote:
That’s off by two orders of magnitude. The correct figure is 0.00001 of all Americans, or 0.001%. Stupid unit conversions!
The national lightning safety institute (wtf?) reported 1000 strikes on people per year, which is where I got my number. I’m sorry that I sound dismissive in talking about the deaths of 450 people from accidental drug overdose, but 1.4 x 10-6 % of a population doesn’t surmount to requiring regulatory changes by the FDA, in my oppinion.
“Come on, I defy you to tell me with a straight face that you truly believe even 10% of the people who get prescription drugs fully read and understand that three-page warning booklet that comes with the pills — never mind over-the-counter stuff.”
It seems a fair expectation to me. The last time I was prescribed vicodin, I was clearly advised (verbally) not to drink or take tylenol while taking the medication, and there were written warnings on the pills that stated the same thing. If roughly 450 people die from overdose on acetominephine, I don’t think that number supports your claim that unwillingness to read or ignorance of warnings is a signifigant problem, either.
450 deaths per year *is* statistically insignificant, according to, well, statistics. When talking about what the FDA should do, it doesn’t make sense to discuss this in total ignorance of these statistics. It also makes your accusations of being an ideological non-interventionist with disdain for public health pretty hollow statements.
In view of the reasons why people are overdosing, it would seem that the problem isn’t how acetominephen is regulated, but that people are unaware or willingly ignorant of the risks. People will still self-treat with OTC medications, and the idea that OTC medications are safe will still result in people taking too much. You still have to read the damn bottle, you still aren’t supposed to take acetominephine over a long period of time. It’s why the bottle says “if symptons don’t go away after X many days, stop taking this drug and seek the advice of a physician.”
At least all this media coverage should increase people’s awareness, and hopefully many more will read those bottles.
Once again, you’re acting as though DEATH is the only thing that should spur action. I couldn’t find the stats on number of lightning strikes per year, which is why I did the death comparison. But since you kindly provided that statistic, I’ll assume it’s accurate. According to my link above, acetaminophen overdose leads to over 100,000 calls to poison control centers per year (over 100x as many as lightning strikes), and over 56,000 emergency room visits per year. Interestingly, the death rate is virtually identical — 0.820% of lightning strike victims die, whereas 0.818% of acetaminophen overdose victims die. In any case, I think I’ve made my point on that matter.
It seems a fair expectation to me.
You sooo need to read Predictably Irrational.
Regarding the number of deaths and illnesses, statistical significance is not the be-all and end-all. The important questions are whether the deaths and illnesses are preventable, and if so, at what cost? In this case, the answers are “yes,” and “very little,” respectively. If you could prevent five deaths per year with a simple change that costs next to nothing and has very little downside, you’d do it, wouldn’t you?
Let’s loop back around to Vinny’s example, shall we? Should we stop inspecting food products for things like salmonella, because the people who die from that is “statistically insignificant?” Maybe you only prevent a handful of illnesses and deaths per year, but the cost of doing so isn’t very high, and preventing illnesses and deaths is worth doing when you can reasonably do so.
That, to me, is the key here. The changes being proposed are actually quite minor, quite easy to implement, and have broad support among the people whose job it is to look at that sort of thing. So where’s the beef?
I could totally see your reaction if they were talking about an outright ban on acetaminophen, or the stupid sign-up-for-the-stuff-behind-the-counter bullshit that we have to go through to get pseudoephedrine these days, but that’s not what we’re talking about here. We’re talking about not being able to get extra-strength Tylenol over the counter any more, but still being able to get regular strength Tylenol. Big whoop. We’re talking about some subset of the population being prescribed two pills rather than one. Again, big whoop.
More succinctly, here’s why I initially reacted so strongly to this post. To me, it read as “taking simple precautions = stupid.” In the case of ephedra, it read as “putting the brakes on a potentially dangerous scam = stupid.” Erring on the side of caution and protecting consumers from a potentially harmful fraud are not “stupid” where I come from.
See your place for a lesson on stats. I want to clarify what I mean when I say statistically insignificant. It hasn’t anything to do with a disdain for public health, bud. So, yeah, it’s in your comment thread.
Also, like many of our conversations, we get down to where we differ actually, and I think we’re getting there. Namely, what you said:
““taking simple precautions = stupid.” In the case of ephedra, it read as “putting the brakes on a potentially dangerous scam = stupid.””
I don’t think that taking simple precautions is stupid. I think we already have adequate precautions, but the fact that people don’t follow them is stupid and is not going to be solved by making them more simplistic. I will eat my hat if this later proves false, and I’ll do a little happy dance if less people die if making precautions more simplistic ends up working, but time will tell on that.
I also don’t share your oppinion that the ephedra ban is a good thing because it protects us from a potentially dangerous scam. For the same numbers-related reasons as the acetominephen emergencies, I don’t believe we are correct in our portrayal that a statistically significant number of people were falling prey to said scam.
Again, see your thread for the definition of “statistically insignificant.”
I’m gonna have to say “ta for now”. I’m going to bed.
Respectfully, SB
My beef with your use of “statistically insignificant” was not with the definition thereof, but of its relevance to this discussion. To that end, context matters. As you admitted at my place, 400 deaths is 400 deaths (and 56K injuries is 56K injuries); I take it a step further and say that preventing those is generally a good thing, whether or not the actual numbers technically work out to a statistically significant portion of the population.
I think we already have adequate precautions
A whole lot of experts in the medical policy field (with a whole lot more subject matter expertise than you) disagree, and you cavalierly called them “stupid.” That’s my problem.
I don’t believe we are correct in our portrayal that a statistically significant number of people were falling prey to said scam.
There’s a time when it’s possible to be too sciencey, and fail to see the forest for the trees. In public policy, “significant” and “statistically significant” aren’t always interchangeable. Tens of thousands of reported issues are nothing to sneeze at, even if they are a relatively tiny portion of overall usage. Especially where there’s reason to believe that over time, left unchecked, the share reporting problems would grow.
hmmm…yeah, we’re definately gettin’ there.
So, I see that we are not seeing eye to eye on what I’m alluding to when I say “statistical insignificance.” You’re right: statistically insignificant is not interchangeable with insignificant. But I haven’t been using it in that way, as in “insignificant” in terms of not being important. My placement of “statistically” in front of “insignificant” is specifically intentional.
Yes, it is possible to be too sciency, to the point of not seeing the forest for the trees. However, when determining if something like 56K medical emergencies is enough to signify a problem on the level of the forest, which I believe is the scope one needs to consider when we ask if the FDA needs to take action (being federal and all), you have to look at the bigger picture and account for such statistics. On the order of outliers does not support the claim that there is a significant problem with the usage of acetominephin, as I said over at your place, most recently.
Let’s move on. I wouldn’t say I was cavalier about calling the medical experts stupid. I said I though the FDA’s course of action was absurd. Your problem is that your twisting that statement to mean that I think the medical experts are stupid. It seems to me the concensus is not that the precautions are inadequate, in of themselves, but that people are not able to follow them, for a slew of reasons. Whatever the reasons may be, the end result is that people end up taking too much acetominephen for a lack of ability to judge what the proper amount may be. One of the main issues that has been pointed out is the usage of OTC acetominephen. When a person self-treats with OTC acetominephen, they tend to take the maximum dosage anyways. The fact that it is an OTC medication, I believe, to some extent causes the user to believe it is innoccuous and that it is not prudent to follow the instructions.
So, what should the solution be? Let’s both play in your court, for the sake of transitioning from the former debate to a this shade, and say that preventing overdose regardless of statistical significance is the aim.
I wouldn’t say I was cavalier about calling the medical experts stupid. I said I though the FDA’s course of action was absurd.
Say, what’s the title of this post?
But here’s the important note: the recommendations were made by a panel of medical experts. The FDA actually hasn’t done anything yet. So in complaining about Teh St00pid, you’re either disparaging the opinions* of the medical experts who made the recommendations, or failing to understand what has actually happened thus far. You choose.
* – Or perhaps the methods, but that would imply that you know what those methods were.
It seems to me the concensus is not that the precautions are inadequate, in of themselves, but that people are not able to follow them, for a slew of reasons.
It’s actually a little of both. On over-the-counter acetaminophen, the belief is that a lower dose would still be effective in the overwhelming majority of cases, and would reduce risk. As I understand it, the big problem with over-the-counter isn’t so much people taking a really big dose here and there, but rather the cumulative effect of people taking close to the maximum recommended daily dose over a very long period of time.
The larger issue is vicodin and percocet, and the concern there involves when the prescribed dose is ineffective. People, even doctors sometimes, take the easy way out and just up the dosage, which is a bad move because of the acetaminophen. By separating out the other active ingredient (hydrocodone or oxycodone, respectively), you allow doctors to up the dosage of the narcotic without simultaneously upping the dosage of the analgesic. They can still be prescribed together, but now you’ve got better control over the relative doses of the two.
Wow, the spambots have found your ass in a big f’n way!
I know, right?
I know I’m late to the party but…
When I hear that they might take Vicodin (acetaminophen and hydrocodone) off the market, I assume that they would replace these drugs with just a pill of hydrocodone, and not take the drug off the market altogether.
AFAIK, the whole reason to have the acetaminophen in the formula is to be a deterrent to abuse. What really happens is that the hard core drug users google “cold water extraction” and hit “I’m felling lucky”. Too many ordinary people, however, ramp up the dosage themselves (like you were doing) and end up needing further expensive care when they take too much acetaminophen.
This is actually a good move, IMHO, and the only way the gubb’mint can screw this up is to allow big pharma to have patent protection on the new formula. They’ve done this before. You can google “extended release guaifenesin unapproved” and read how the FDA forced other makers of generic prescription off the market when Mucinex was approved. Never mind that guaifenesin is a granfathered drug that pre-dates the FDA itself. Never mind that everyone agreed that the older formulas were safe, even if they never had to prove that they released themselves slowly. The cost went way up too.
Oh, and if tgirsch is still listening… There’s a lot of talk on this thread about ephedra and absolutely nothing about meth.
Look, it’s really this simple. The ban on Ephedra is because you can use it to make methamphetamine.
Oh and the Phenylpropanolamine is no longer sold without a prescription due to a theorized increased risk of stroke in younger women,(either that or the fact that it’s a precurser to amphetamine).
Everyone knows that Psudoephedrine (Sudifed) can be used to make meth, and that’s the reason why you have to show ID, but did you know that you could only buy it in push-through-foil packaging because of another regulation tried earlier? They thought that meth-heads would not bother to push all those pills through the foil. They guessed wrong.
One more thing, there’s a link between sassafrass extract and cancer. The rest of the story is that the safrole that is thought to be the chemical of interest in the cancer studies also happens to be handy in MDMA (ecstasy) synthesis. It’s now banned.
Again, if tgirsch is still listening, this crap is what I generally refer to as “gutter science”.
I’m listening, but I didn’t see anything in particular that demands a response.
Good, we’ll refer back to this “gutter science” stuff when we pick up again on those crazy “sunspot existence deniers”
You’ve got a point there, I’m _sure_ of it!
Girls, don’t fight, you’re both pretty.