American Medical System and Vioxx

[Ivor the Engineer]

That has nothing to do with Vioxx. It's a common marketing practice from pharmaceutical companies to create 'educational' organizations in order to form journals which publish research and opinion pieces in support of their products. Then they hand them out or mail them out to physicians. They're called Throwaway Journals, because that's what you do with them when they show up on your desk.

Linda

Are you claiming such publications are ineffective at achieving the goals which motivate their use?

 

[ponderingturtle]

If Cayce is a homeopath, his remedies will not have directly led to anybody's death. Homeopathic remedies are harmless. So are most other alternative meds.

This also supports faith healing so well. That can not have ever killed anyone either as it does nothing. And no quack or faith healer would ever instruct patients not to get the best medical treatment in addition to the quakary they are selling either.

Homeopathy is remarkably effective against malaria after all.

 

[Ivor the Engineer]

Medicine will improve when patients trust physicians less and feel free and able to question physicians' opinions and reasoning without sanction. I'm not sure physicians are particularly keen on this happening anytime soon.

If anything, a physician's desire to believe he or she practices science-based medicine can be seen as a move to increase power and authority of the physician over the patient.

 

[fls]

The detailed account was provided by Kirkpatrick because Cayce was arrested. That was one of only two times that occurred (the other time was for fortune-telling), and so it was a rather big deal. But I'm still trying to figure out how, with all the skeptics who have examined Cayce's medical readings -- both contemporaneously and after the fact -- they can't come up with an instance where his remedy killed, or even caused harm, to one of his clients.

For the same reason that nobody realized that Vioxx was harmful. Despite throwing in a line about examination by sketpics, the kind of information that was necessary to discover that Vioxx was harmful was never available on Cayce's patients. Data on all outcomes on even some patients was not collected, let alone data on all or on a random selection. And no control group was available for comparison, so even if that information had been collected, it wouldn't have been possible to notice a relative increase in harm. The age-specific rate of myocardial infarction in the study populations for those on Vioxx was less than the rate in the general population. Using your reasoning, one would have concluded that Vioxx was beneficial for the prevention of heart disease.

I grant you that, the day after John Q. Public died of a heart attack after taking Vioxx, there was no headline reading "John Q. Public dies of a heart attack after taking Vioxx." However, an investigation found that Vioxx was associated with a significantly increased risk of heart attacks.

The sort of investigation that was unavailable for any of Cayce's patients.

Do you know of evidence that any of Cayce's remedies were associated with an increased risk of heart attacks or other serious medical risks?

Again, you're not making any sense. On the one hand you are saying that the availability of useful information allowed us to discover harm that we otherwise had missed. And on the other hand you are saying that the absence of useful information allows us to assume that there is no harm to be discovered. You can't have it both ways without looking like a fool.

Linda

 

[fls]

Common or not, it sucks.

Totally. And it illustrates why the medical profession should not consider PHARMA a source of medical education.

Linda

 

[fls]

I'm just going to have to concede this one to you. My previous research was apparently insufficient and further review of the available resources only supports your own understanding of the matter.

The larger point remains, however. Had Vioxx not been unnecessarily fast-tracked by the FDA, early cardiovascular data from the VIGOR study, which were already interesting enough to cause the researchers to take notice of by the time the drug was approved, might have delayed or prevented it release so that more conclusive results could have been had. Before a year had even passed from the time pf approval and the VIGOR study concluded, it was known that people were far more likely to suffer an arrest or stroke on Vioxx than naproxin and Merck's considered opinion that it wasn't Vioxx that was dangerous by naproxin that had a protective effect is nothing short of assuming the position that favors your revenue stream.

I'm not saying that one or the other is right, but if the association between MI and Vioxx had turned out to be spurious, then the FDA could also have been criticized for unnecessarily causing death by withholding a much safer drug from the market. As I mentioned earlier, the issue of gastrointestinal complications and death from the use of NSAIDs is not trivial. I think that this illustrates that the gatekeeper role of the FDA is critical to ensuring both safety and effectiveness. And I think the editorial I referenced in my first post, by Topol, outlines how they fell short in that role.

While the desirability of having a dangerous drug on the market is debatable in comparison to what might happen to patients that don't have it, that's nothing I've been disputing. What I've been defending is Rodney's suggestion that drugs are and have been prescribed without doctors or patients being aware of what those risks are, and my future interpretation/elaboration that in the case of Vioxx, that occurred in a manner that was preventable. It took an inordinate amount of time to get proper labeling on the packaging and literature for Vioxx detailing the discovered risks after they were known. Patients, who are not expected to be aware of all the details, were heavily marketed toward and the risks downplayed, not mentioned, or claimed to be an effect of all NSAIDs before any such claim could be verified. Doctors, while fully capable of reading all the papers produced concerning the drug, were still subjected to calls from Merck explaining away objections raised by those studies with arguments and downplaying negative interpretations, even as the company was aware that evidence continued to mount against it's own official line.

And this illustrates the benefit of evidence-based medicine and of following ethical guidelines with respect to physician-industry interactions. If physicians follow these guidelines, then whatever sneaky tricks the pharmaceutical companies want to employ become irrelevant.

However, coming from Rodney, the OP is nonsensical, since he spends his time here defending a system of 'medicine' (supplementary, complementary and alternative medicine (SCAM)) which foregoes evidence-based practices, lacks professional ethics, breaks pretty much every guideline physicians use with respect to the practitioner-industry interactions, and has no gatekeeper. And from all that we are meant to conclude that his system is much safer than that for conventional medicine.

The bottom line in all of this, however, is the fact that the reason there are labels and literature associated with drugs is to facilitate the education of doctors and their patients as to the risks and benefits of the drugs they're taking and the literature and labeling of Vioxx for a very long time did not reflect the dangers that were known, regardless of interpretation.

Yup, I agree.

Linda

 

[fls]

Are you claiming such publications are ineffective at achieving the goals which motivate their use?

I doubt that's the case. Pharmaceutical companies put a lot of effort into looking for effective marketing practices, so if they do it, there is probably some indication that it has an effect.

Linda

 

[MRC_Hans]

This also supports faith healing so well. That can not have ever killed anyone either as it does nothing. And no quack or faith healer would ever instruct patients not to get the best medical treatment in addition to the quakary they are selling either.

Homeopathy is remarkably effective against malaria after all.

This was the reason I carefully wrote 'direct' damage. The indirect damage from foregoing efficient treatment is always present, but often hard to link to any specific alternative practice.

Hans

 

[ponderingturtle]

This was the reason I carefully wrote 'direct' damage. The indirect damage from foregoing efficient treatment is always present, but often hard to link to any specific alternative practice.

Hans

So the dirrect harm of homeopaths telling their patients not to use effective medicine is an indirrect effect?

 

[Ivor the Engineer]

I doubt that's the case. Pharmaceutical companies put a lot of effort into looking for effective marketing practices, so if they do it, there is probably some indication that it has an effect.

Linda

Science-based marketing vs. science-based medicine.

 

[MRC_Hans]

So the dirrect harm of homeopaths telling their patients not to use effective medicine is an indirrect effect?

It is not a direct harm from the remedy, which was what we were talking about.

- Actually, it is a statement I have become rather fond of. You see, homeopaths tend to hate it when I heartily agree that their remedies are completely harmless.


Hans

 

[Rodney]

I don't suppose it has dawned on you that you likely don't know all the risks you will face when you get out of bed each day?

That's not the relevant issue. Merck presented Vioxx as superior to naproxen because it caused fewer stomach problems, and that's the way the choice between the two drugs was presented to many consumers. However, those consumers had no clue that Vioxx was more likely to cause a heart attack. Had consumers been told that, they could have made an informed choice, but they never were given that opportunity.

 

[Rodney]

If Cayce is a homeopath, his remedies will not have directly led to anybody's death. Homeopathic remedies are harmless. So are most other alternative meds.

This is another clinch: Proponents of alternative meds love to push the dangers of conventional medicines and compare them with the generally harmless alternative meds. Folks, this is because alternative meds in general, and homeopathic remedies in particular, are without ANY EFFECT at all.

This is like comparing real, sharp knives with plastic toy knives. Sure, nobody is ever cut or killed by a plastic toy knife.

- The numerous stories as you call it, is what we call anecdotes.

Hans

Yes, but Cayce was not a homeopath, even though he sometimes recommended homeopaths, who were much more prevalent in the U.S. during Cayce's era than they are now. But the uncomfortable fact that skeptics have to confront is that Cayce occasionally recommended seemingly dangerous treatments, but they had an uncanny knack of working.

 

[paximperium]

Yes, but Cayce was not a homeopath, even though he sometimes recommended homeopaths, who were much more prevalent in the U.S. during Cayce's era than they are now. But the uncomfortable fact that skeptics have to confront is that Cayce occasionally recommended seemingly dangerous treatments, but they are claimed to had an uncanny knack of working.

Bolded correction.

 

[paximperium]

That's not the relevant issue. Merck presented Vioxx as superior to naproxen because it caused fewer stomach problems, and that's the way the choice between the two drugs was presented to many consumers. However, those consumers had no clue that Vioxx was more likely to cause a heart attack. Had consumers been told that, they could have made an informed choice, but they never were given that opportunity.

Supersuper statement. Who are you arguing with again?

And this is opposed to listening to some random person who prescribes a "dangerous" treatment that you take on faith alone?

 

[Rodney]

However, coming from Rodney, the OP is nonsensical, since he spends his time here defending a system of 'medicine' (supplementary, complementary and alternative medicine (SCAM)) which foregoes evidence-based practices, lacks professional ethics, breaks pretty much every guideline physicians use with respect to the practitioner-industry interactions, and has no gatekeeper. And from all that we are meant to conclude that his system is much safer than that for conventional medicine.

In what post did I say that supplementary, complementary, and alternative medicine is much safer than conventional medicine?

 

[Rodney]

Supersuper statement. Who are you arguing with again?

Skeptic Ginger, to name one.

And this is opposed to listening to some random person who prescribes a "dangerous" treatment that you take on faith alone?

Cayce was a random person?

 

[Mojo]

Yes, but Cayce was not a homeopath, even though he sometimes recommended homeopaths, who were much more prevalent in the U.S. during Cayce's era than they are now. But the uncomfortable fact that skeptics have to confront is that Cayce occasionally recommended seemingly dangerous treatments, but they had an uncanny knack of working.^{citation needed}

 

[Mojo]

Cayce was a random person?

Nope, he was a charlatan recommending whatever came into his head.

 

[MRC_Hans]

But the uncomfortable fact that skeptics have to confront is that Cayce occasionally recommended seemingly dangerous treatments, but they had an uncanny knack of working.

1) I am sure you can document the claim that his treatments worked? No?

2) Why would that be uncomfortable? If the treatment was seemingly dangerous, at least it would have some effect. Lots of 'alternative' treatments have some effect, even beneficial. It's just that they are poorly documented, and their possible side effects generally undocumented. - Remember, we were actually talking about side effects?

Hans