I have taken too much "Vitamin-I" over the years, and it finally caught up with me and started causing stomach and esophagus problems. I've wanted to try Celebrex, but it's way too expensive. Have tried Meloxicam and it's much gentler than Ibuprofen, but let's just say it did come with some side effects on my gastrointestinal system.
"Q: Does FDA test drugs?
A: No. It is the responsibility of the company seeking approval to market a drug to conduct laboratory and animal tests on the safety and effectiveness of a proposed new drug and then to submit that information to FDA for review by CDER physicians, statisticians, chemists, pharmacologists, and other scientist."
I'm personally in favor of publicly funding drug research and open sourcing the results, but fat chance that'll happen anytime soon.
We have these regulatory agencies for a reason. The FDA is in fact far stricter about drug testing and approval than the EU is.
Minor correction: pore. Confused me quite a bit because I wasn't sure which of the spellings it was...
You're right that the FDA isn't replicating the study. But the premise of the system is that this replication isn't necessary, assuming that the process for exploring a new drug and testing its' safety and efficacy is well defined and considered.
And public health is what's at stake here, so there should never be enough tests.
Whereas with a drug trial, the company is telling the FDA from the very start "Hey, we have a drug we think might treat diabetes. We want to get this approved and on the market, so here is our plan for how we will conduct the trial." They then conduct the research in a much more open manner than typical lab studies in other fields.
Finally, there is the Institutional Review Board that is charged with ensuring all academic studies do not harm their participants in any way. Lying about your methodology in a medical study would get you expelled from your profession so fast your head will spin.
I would argue that the flipside of this being a public health matter is that people are suffering and dying of a condition that could be helped by a drug that we have to test for years and years. If we can conduct a transparent and rigorous double blind study and determine the safety and efficacy of the drug, we should be doing it.
There's no prescription drug you can take here that is actually tested by the FDA. They work with the manufacturers to ensure the testing is thorough and accurate, but the company's themselves fund and conduct the testing.
There's just simply no opportunity to test out a drug in 100 different studies with 100 different groups of people and cherry pick the study you want to submit to the FDA. The process doesn't work like that.
The FDA is required to approve the study plan, the pharma (or really, the contract research organization (CRO) acting on its behalf) reports back to the FDA. The FDA decides based on the reported study result (reported to the FDA) whether the drug can be marketed and under what constraints.
Why should tax payer pick up the tab on a clinical trial like this? Over the life time of a modern drug, the clinical trials required can easily approach $1B.
One of the key things that tipped me off was that they compared "prescription strength" Ibuprofen to Celebrex once, then didn't mention it again. I get that it is like for like (prescription for prescription), but the vast majority of people taking Ibuprofen are not taking prescription strength dosages.
This should not be "news" it should be given to doctors to consider. We probably need a medical body to review these types of papers to determine whether they are actionable by medical professionals.
The point of the study is to compare long-term, daily use of NSAIDs. It isn't saying that you should take Celebrex for a headache (nor could you as it requires a prescription).
You shouldn't be so quick to dismiss a study that you think is "obviously a commercial" if you aren't familiar with the subject matter at hand.
I'm not saying this study is bad, but studies paid for by corporations for their own gains should be the last we see running through news headlines. But of course, that is partly the effect they'd want from them...
if you don't toe the line with the result of your study, that'll be the last one you do for the entire industry.
If not, there is literally no way to compensate for that level of statistical bias. Stomach/kidney/heart damage is not linear, and there's no mention of when people gave up taking the medications.
For someone who actually wants to read the study, here's the link: http://www.nejm.org/doi/full/10.1056/NEJMoa1611593#t=article
tl;dr - they admit that taking more than 200mg of celecoxib does some damage, and 800mg doses (they apparently were limited by regulations to 200mg/day) showed the same heart damage they expected to see. Time magazine is a horrible source
I would have guessed similar to the article - Naproxen was the softest on my stomach for as long as I could take it, but over the years I both built a tolerance for it and it wasn't strong enough so I switched to meloxicam (the gentlest on my stomach and the strongest pain reliever of the group, but only available by prescription) and was on it for nearly a decade. I'd go back on it too if I were able - it was definitely the best thing I've ever taken for my pain. Celecoxib was just more expensive ($20 copay vs $4 generic) and didn't work as well. I'm very sad that NSAIDs are no longer an option for me, as they both reduced the pain and treated it, but unsurprisingly 20 years of taking NSAIDs daily caught up with me... medicine still hasn't come up with a better solution for long term pain management, despite the desperate need.
I react well to both of them. Since ibuprofen is cheaper, I am more likely to use it. Though honestly, for my worst recurring pain, I take both ibuprofen and paracet (Tylenol), on advice from the doctor. The same seems to help my spouse with dental pain.
Have you looked into prolotherapy before? (sugar water injections)
The idea is that it acts as an irritant which increases blood flow and other healing responses to that area. Tendons in particular are thought to heal slowly because they don't have great blood flow. This strikes me as similar to the ideas of dry-needling and platelet-rich plasma injections.
> "I don't want the public to think that if you take an occasional ibuprofen or naproxen that you're going to have kidney failure or you're going to die," Nissen says. "We didn't study that. We studied daily doses in arthritis patients [taking] ... high doses of these drugs."
The headline doesn't reflect this, but it probably wouldn't get as many clicks if it said "daily use of prescription-level ibuprofen may not be as safe as was thought".
"Just saw this study come out a few days ago and it kind of is no news. The harm of nsaids has been known and the warnings are out there. I tell patients everyday not to take advil/naproxen if they are older than 40/50 because of the heart and stomach issues.
Will be interesting once they release celebrex as over the counter, this latest study will definitely catapult that process exponentially.
In the mean time, only take nsaids if u really need to, with food and i tell patients to eat frequently and not too much salt to combat the water retention which causes the heart issues."
Aspirin is prescribed for some specific conditions due to its antiplatelet effect. From what I understand, for normal healthy people, there isn't much benefit of daily aspirin. And, there is potential for some side effects -- in addition to the same stomach problems / heartburn issues that plague other NSAIDS also has some bleeding type issues due to the antiplatelet effect.
Well, Bayer runs (or ran) ads encouraging just that behavior.
Such a thing would never fly in Europe. They'd get laughed out of the room and sued.
I'm not sure how that compares with other treatments or the average but offhand it seems pretty high to the point of asking whether it's worth it.
For patients with existing heart disease or prior strokes, the NNT is between 50 and 333 depending on the outcome you're considering. Source:
For prevention of a first heart attack or stroke, the NNT is between 1667 and 3000 depending on the outcome. Notable is that no deaths were prevented by the therapy. Source:
> In almost every measure, ibuprofen looks worse, naproxen is intermediate and celecoxib is the best.
> the heart concerns led the FDA to require its maker, Pfizer, to pay for additional studies to ensure that celecoxib did not put people at increased risk of heart trouble
And afaik Celecoxib is the only one marketed solely by Pfizer, at prices 5 times higher than the other 2.
Am I being paranoid thinking this at least deserves more study, not conducted or paid for by pharma?
Do their rivals have an incentive to check Pfizer's work? If they're publishing bogus studies to get through regulatory checks, it could delay the new drug from being released.
Further, if they're publishing bogus studies, it seems like the FDA would be partially responsible. So one might expect the FDA to possibly run trials of their own on a random sample of drugs, and compare with what the drug companies published.
Also, Trump has mentioned speeding drugs through the FDA process. There might be less incentive to cheat the results if they don't need to do it to release their drug.
It's generic now.
If there is a version on the market with only 60% bioavailability, somebody screwed up (the FDA).
At moderate doses, celecoxib was found to be noninferior to ibuprofen or naproxen with regard to cardiovascular safety. (Funded by Pfizer; ClinicalTrials.gov number, NCT00346216.)
The paper draws no conclusions about the relative safety of ibuprofen. The only claim is that celecoxib is not inferior to the other two NSAIDs.
Note that this research study was funded by Pfizer, the company that markets Celebrex.
Did you think they should've mentioned celecoxib? That's much less known drug. Mentioning ibuprofen means it's more likely to reach the audience that should care about the study.
FYI, celecoxib is the generic name for Celebrex.
Then I noticed that they changed the warning labels to point out the increased risk of heart attack from regular use of Ibuprofen.
Then I had a heart attack.
And all of my doctors (GP, cardiologist, etc.) suggested I quit taking Ibuprofen.
Hrrmmm... to be fair, in the case of any individual, they can never really say exactly why you had an MI when and where you did. And I was a little overweight at the time, but I had very few other risk factors. I never smoked, had no family history of early heart attacks, and I was only 41.
So did Ibuprofen play a role? We'll never know, but I'm following my doctor's advice and not taking it anymore. I'd recommend anyone who uses Ibuprofen frequently consider having a chat with their doctor and think hard about the various risk factors involved.
Even if you open it in a new tab and are still viewing the current one (middle click on my computer).
But they aren't really dangerous per se. Certain population groups shouldn't take them, some can't tolerate them, and there are consequences to taking them over a long-course (which is what this was comparing). But for most with everyday aches, pains, colds, and so on, they aren't that dangerous.
You know, use responsibly and stuff.
Edit: Ulcer, not hernia.
I say this mostly because it is common (though not recommended) to take them on an empty stomach and it seems her reaction to the single pill does was extreme.
However, even when changed to an ulcer, it is the kind of anecdotal evidence that keeps urban legends alive. Long term use of ibuprofen is known to cause ulcers. Rare use, on an empty stomach or not, does not instantly cause bleeding and ulcers. It is much more likely that Broken_Hippo is right or that she indeed has been chronically using ibuprofen.
this is the gist: "There is a new drug that acts similarly to ibuprofen, but appears to be less aggressive towards kidneys. Equally as bad for the heart."
However 70% of the participants failed to complete the study, so its not long term. No percentage risks are quoted. It also doesn't compare how effective celecoxib is compared to the much cheaper and well understood(interaction wise) ibuprofen.
It also notes that high doses were not tested: "600mg ibuprofen three times a day"
That my friend is a fucking large dose, as in three weeks and you have an ulcer dose.
The normal tablest in the US are 200mg: Lots of folks take 2 a few times a day: 400mg 3 times a day, as recommended on most of the packaging.
Prescription ibuprofen is 800mg tablets (most times). This is a fairly common dosage, 3-4 times a day.
600mg four times a day is inline with the BNF daily limit of 2.4g: http://www.evidence.nhs.uk/formulary/bnf/current/10-musculos...
Seriously the BNF is a brilliant resource, it has this to say about celecoxib: http://www.evidence.nhs.uk/formulary/bnf/current/10-musculos...
But I know a lot of folks will take ibuprofen for 7-10 days at those rates. It is pretty common, and just as common for people to regularly take naproxen a few times a day for chronic pain.
Taking pain killers regularly sounds absurd to you because you don't have that sort of chronic pain. And pain is a funny thing: My mother openly admitted that she would get to a point with migraines where the pain was so bad, the side effects didn't quite seem to matter (She learned to go to the hospital or doctor before then).
More often, however, these pain killers are the very things that makes every day life bearable. Some people it means they can be more active but others it just means they can open doors and grab toilet paper with less pain.
Your method is great for people that have occasional pain or needs: After all, it seems a bit silly to take it for no actual reason. And as far as the folks you know, well, if you are young that is more likely. And if not, it is just something the people you know don't talk about.
In acute cases paracetamol can have an 8 gram daily limit. long term you're going to see problems.
When you have something like arthritis, or and old joint injury, you'll be needing long term anti inflammatories