I don't agree with the conclusions in this article at all. Also consider that Celebrex (same drug family) is still on the market. If these drugs were truly a grim reaper, I don't think Celebrex would still be around.
If anything, this should be seen as a reason to not allow the pervasive advertising of prescription drugs and aggressive peddling of drug swag - Vioxx was peddled in the most ostentatious way -- my doctor STILL has Vioxx clipboards and other junk in his office. I'm sure that this constant brand awareness and patient nagging helped drive sales (ie. encourage potentially unnecessary or inappropriate scripts).
The other thing to consider is quality of life. I began suffering by a sudden onset of what was eventually diagnosed as a degenerated disc in my back -- at age 25. I went through some intensive physical therapy to try to avoid surgery (ultimately an unsuccessful effort), and Vioxx was the only thing that allowed me to function without narcotic pain relief (which I refused to take for more than a week at a time). It was that good at reducing chronic inflammation.
If I were a 75 year old man with severe, debilitating arthritis having difficulty walking or living a decent life, I'd happily volunteer to take a drug like Vioxx to improve the quality of my remaining time here, even knowing that I was at a higher risk of a heart attack.
Your argument seems to be one of simple personal disbelief, that one drug "in a family" can have effects that others don't? That doesn't seem to be borne out by history or logic... Even your own anecdote seems to argue against it: Vioxx worked for you pain, but Celebrex doesn't.
I never tried Celebrex, as I had surgery in early 2004 that eliminated the need for any medication.
I'm not a pharmacist, but the story regarding this drug is more nuanced. Doctors prescribed the two drugs differently, as folks with other drug sensitivities were not good celebrex candidates, and the risk factors associated with vioxx were not known. Vioxx was the more heavily marketed, "safe" choice.
I've heard this from countless other people as well (including many doctors). Apparently, it was a fantastic pain drug for many people.
Should Merck have disclosed the increased risk of heart attack and stroke? Absolutely.
But, part of the problem is the incentives fostered by a bureaucracy like the FDA. If you know that your new wonderfully effective pain medication increases the risk of heart attacks from 4% to 6% (or whatever the numbers were), are you going to disclose that to the FDA, knowing it essentially spells doom for the billion dollars plus you spent on development?
Wouldn't it be nice if pharmacies could just publish all these finding and let people decide what to put in our own bodies. I know they argue that we aren't doctors and therefore shouldn't be forced to make those decisions, but with the aid of a doctor and true transparent facts I'm pretty sure I would have no problem going, okay this drug is twice as good at helping with my terrible pain, and the side effect is that I'm more likely to die of a heart attack. I'd go, well maybe I don't want to take that risk since I'm at risk already for a heart attack, or I could go oh I'm young and have no family history of heart failure, I should be alright the risk is worth the gain.
I can't for the life of me figure out why we can't just do that. Anyone around care to enlighten me?
The majority of patients have ZERO ability to evaluate the risks and benefits with pharmaceutical intervention. The best example I can provide is patient compliance (do they take their drug as prescribed?). You'd be hard pressed to find a rate higher than 50% for any disease (other than the immediately life-threatening ones).
I don't see how the example you list is relevant to my argument that with proper disclosure and warning of risks people won't be able to decide if the risks out-way the gains.
Example I listed: That with full disclosure I can make an educated choice as to what goes into my body.
Example you listed: That over 50% of people that get prescribed something decide to take that something the wrong way as opposed to as directed.
They don't seem to be the same. (for one, using a drug in a matter different then what you've been told to is just gross negligence.)
My argument is this: If you can't count on people to take a drug that will drastically reduce their likelihood of dying, how can you trust them to accurately determine the trade-off between efficacy and safety?
Most patients don't display the ability to figure out risks and trade-offs now (and relatively simple trade-offs at that). Do you think they'll be able to figure out what "45% increase in the risk of heart-attacks (41.2 - 48.8%, 95% confidence interval) in populations who have had a transient ischemic attack in the last 180 days, excluding those who have diagnosed atherosclerosis" means to them?
I think the real problem is that many doctors also lack the capacity to translate statistical data into a rational evaluation of risk.
Consider the infamous 'mammogram statistics problem' as an example. So what do you do then, when nobody in the decision-making chain can be trusted to understand the data?
Especially if the alternative is denying other people loads of relief (not only in the form of proven effective drugs that are taken off market, like Vioxx, but all the drugs that aren't even investigated because they fit in a class of drugs with known negative side effects).
Edit: misread your post. Yes, I do trust people to make decisions on efficacy v. risk. This would be even easier if we had a system that promoted the discussion of this information rather than one that effectively prohibited it. Merck should be able to openly say, "Hey guys, we have this great drug that is really effective at managing pain, plus it's non-narcotic. The only downside is, it increases your risk of heart attack by 50%. Talk to your doctor about it."
"Do you think they'll be able to figure out what "45% increase in the risk of heart-attacks (41.2 - 48.8%, 95% confidence interval) in populations who have had a transient ischemic attack in the last 180 days, excluding those who have diagnosed atherosclerosis" means to them?"
That's why I stated earlier that your doctor is and should explain to you what those words and statistics mean in laymen. Your example is full of the exact opposite of what I was saying.
People are typically very poor judges of risk, even while they think they're good at it. If I take this pill I'll lose ten pounds for my class reunion, but I'll probably need a new liver? Sounds good, sign me up!
People are more than sufficiently educated about the risks of drunk driving, but it's still a problem, because bad outcomes only happen to other people.
"If you know that your new wonderfully effective pain medication increases the risk of heart attacks from 4% to 6% (or whatever the numbers were), are you going to disclose that to the FDA, knowing it essentially spells doom for the billion dollars plus you spent on development?"
Did Merck not disclose something? http://en.wikipedia.org/wiki/Vioxx seems to indicate they did disclose the increased risk over naproxen, but tried to explain it away without further investigation.
Both tylenol and marijuana are in the same family of drugs (CB2 agonists), but tylenol kills hundreds of Americans per year whereas marijuana doesn't. The fact that they are vaguely in the same family doesn't mean they have comparable risk profiles.
Tylenol is usually fine if you stick to the recommended doses. Usually when someone has serious problems with it, they've been taking handfuls at a time (which will completely destroy your liver).
IIRC Tylenol (ie Acetaminophen/Paracetamol) is the leading cause of deaths due to drugs.
Both accidental, because the fatal dose is relatively low compared to the therapeutic dose and because deliberate overdoses are far more likely to be fatal than say sleeping tablets.
Is an increased risk of heart attack preferable to narcotics? To my understanding, something simple like morphine has few side effects, beyond the obvious risk for addiction/abuse.
Narcotics don't have negative health side effects, but there are still the issues of:
- Do they actually work to relieve pain?
- Are people able to function normally on them, or are they stuck in bed all day while unable to walk, with severe brain fog, profusely sweating, and nauseous.
- Is it easy to accidentally OD even if you're taking the prescribed dose? (Which is the case with fentanyl patches... accidentally role over in bed or step into a hot shower without remembering to take it off first and there's a good chance you're dead.)
Narcotics also aren't an anti-inflammatory so they're not actually fixing the problem at all, they're just covering up the pain, and often not even very well. That's why medical marijuana is so much better for back problems, because it's a strong anti-inflammatory, and also because the analgesic dose is much lower than the psychoactive dose so you can get relief from your pain without being left unable to function. Especially since you can now get high-CBD marijuana, which is basically non-psychoactive to begin with, but with even stronger anti-inflammatory properties than regular marijuana.
From my personal experience with prescribed narcotics for things like wisdom tooth extraction, kidney stones, etc., is that they don't do much in terms of pain management.
That is interesting about marijuana being anti-inflammatory...I did not know that.
If anything, this should be seen as a reason to not allow the pervasive advertising of prescription drugs and aggressive peddling of drug swag - Vioxx was peddled in the most ostentatious way -- my doctor STILL has Vioxx clipboards and other junk in his office. I'm sure that this constant brand awareness and patient nagging helped drive sales (ie. encourage potentially unnecessary or inappropriate scripts).
The other thing to consider is quality of life. I began suffering by a sudden onset of what was eventually diagnosed as a degenerated disc in my back -- at age 25. I went through some intensive physical therapy to try to avoid surgery (ultimately an unsuccessful effort), and Vioxx was the only thing that allowed me to function without narcotic pain relief (which I refused to take for more than a week at a time). It was that good at reducing chronic inflammation.
If I were a 75 year old man with severe, debilitating arthritis having difficulty walking or living a decent life, I'd happily volunteer to take a drug like Vioxx to improve the quality of my remaining time here, even knowing that I was at a higher risk of a heart attack.