American Medical System and Vioxx

[Cynic]

If it seems absurd that someone would merely be pointing out that the sky is blue, then why should our first instinct be to assume that's what he's saying? Sometimes it seems as if people go out of their way to misunderstand others. I don't know Rodney, but it seems a more charitable interpretation would be that he feels not enough effort is being put into assessing and communicating those risks at multiple levels. From there, the conversation could go any number of directions, but it hasn't gone in most of them.

The practicable application of quality control and assurance (as applies to UncaYimmy's peanut butter example) is a different thing altogether. No one is saying that drugs aren't made per spec. As I see it, the problem is systemic and mostly human. It wasn't too long ago that physician practices were forbidden to accept gifts and advertising paraphernalia (pads, pens, etc) from pharmaceutical companies for precisely these reasons. The more compensation of any sort doctors got related to a particular medication, the more likely they were to prescribe it. Tendencies like that can only mean that appropriateness, risk assessment, and informed decisions aren't the only factors involved -- but they should be. Drugs aren't just prescribed, they are marketed. Even under the best of conditions, doctors are only able to perform their duty as well as the information they're able -- or willing -- to access. The FDA itself, whose role it is to protect people, receives much of its funding based on the success of the very products it oversees. Not much of an incentive to shut some of the blockbuster drugs down, or smite the their manufacturers for withholding critical negative information.

That's what color the sky is, but it doesn't have to be that color forever. More can be done to ensure that patients and doctors are aware of both the potential risks and benefits of the medications and treatments they're prescribed. I'm not calling the industry bad here -- I'm saying there's opportunity for improvement.

 

[Uncayimmy]

If it seems absurd that someone would merely be pointing out that the sky is blue, then why should our first instinct be to assume that's what he's saying? Sometimes it seems as if people go out of their way to misunderstand others. I don't know Rodney, but it seems a more charitable interpretation would be that he feels not enough effort is being put into assessing and communicating those risks at multiple levels. From there, the conversation could go any number of directions, but it hasn't gone in most of them.

I quoted exactly what Rodney said was the point of his post. Here it is again:

The main point is that drugs are often-times prescribed without knowing all of the ramifications of their use, and sometimes those ramifications prove extremely deleterious, if not fatal.

Who doesn't know that? But to delve further, some of us do know Rodney from past experience, so seeing this is not a surprise.

The practicable application of quality control and assurance (as applies to UncaYimmy's peanut butter example) is a different thing altogether.

Actually, it's not. Look at Rodney's quote again with additions:

The main point is that peanut butter often-times sold without knowing all of the ramifications of its use, and sometimes those ramifications prove extremely deleterious, if not fatal.

Or remove peanut butter and substitute any food you want. If I decide to market a lentil, red pepper, beef and chocolate pie, there is no requirement that I do any testing to make sure there are no cross-reactions. The ingredients are generally regarded as safe. For all we know, that combination could cause a cross-reaction with aspirin and cause bleeding ulcers.

No one is saying that drugs aren't made per spec.

That's correct, so why are you bringing it up?

As I see it, the problem is systemic and mostly human. It wasn't too long ago that physician practices were forbidden to accept gifts and advertising paraphernalia (pads, pens, etc) from pharmaceutical companies for precisely these reasons. The more compensation of any sort doctors got related to a particular medication, the more likely they were to prescribe it. Tendencies like that can only mean that appropriateness, risk assessment, and informed decisions aren't the only factors involved -- but they should be. Drugs aren't just prescribed, they are marketed. Even under the best of conditions, doctors are only able to perform their duty as well as the information they're able -- or willing -- to access. The FDA itself, whose role it is to protect people, receives much of its funding based on the success of the very products it oversees. Not much of an incentive to shut some of the blockbuster drugs down, or smite the their manufacturers for withholding critical negative information.

And these are good points to make. Rodney could have made those points without posting old news about Vioxx.

That's what color the sky is, but it doesn't have to be that color forever. More can be done to ensure that patients and doctors are aware of both the potential risks and benefits of the medications and treatments they're prescribed. I'm not calling the industry bad here -- I'm saying there's opportunity for improvement.

That's fine. What are you specific suggestions?

In my perfect world I'd like to see a Big Huge Database o' Medical Records. Every time I visit the doc, I'd want all my vitals entered along with the other stuff the doc noted. All of my prescriptions would be tracked along with my testimony about how faithful I am about taking them. I'm betting the medical experts could sift through this data and see areas that might merit further research. As it is, we can't even get doctors and hospitals to report things like measles at a consistent and sufficient level.

Of course, this brings up all sorts of issues about privacy and cost. And considering how some "researchers" don't understand how to properly analyze a bunch of raw data gathered without a test in mind, we'll have issues in that regard. But overall I think the notion has some merit.

 

[Mojo]

The main point is that drugs are often-times prescribed without knowing all of the ramifications of their use, and sometimes those ramifications prove extremely deleterious, if not fatal.

You mean like prescribing large doses of belladonna to small children?

 

[fls]

If it seems absurd that someone would merely be pointing out that the sky is blue, then why should our first instinct be to assume that's what he's saying?

I think that's why several of us asked what his point was, which he still hasn't answered.

I don't know Rodney...

I do.

Linda

 

[Rodney]

To point out that medicines present risks is as useful as pointing out that the sky is blue.

If the risks are clearly identified, I don't have a problem with a medicine being marketed. That was not the case with Vioxx, and thousands died unnecessarily.

 

[Rodney]

You mean like prescribing large doses of belladonna to small children?

If that is necessary to save a life, absolutely.

 

[fls]

If that is necessary to save a life, absolutely.

Vioxx was prescribed to save lives - specifically to avoid the complications, including death, from the use of nsaids.

Linda

 

[Rodney]

I do.

But only on-line. In person, I'm a sensitive, caring human being, and those rumors about dozens of bodies being buried underneath my back porch are, for the most part, false.

 

[Rodney]

Vioxx was prescribed to save lives - specifically to avoid the complications, including death, from the use of nsaids.

Fine, but was there a warning about the significantly increased risk of heart attacks?

 

[fls]

Fine, but was there a warning about the significantly increased risk of heart attacks?

More data was needed to discover that risk. The information from the initial trials wasn't enough, let alone the information from a single use.

Linda

 

[macdoc]

Vioxx was prescribed to save lives - specifically to avoid the complications, including death, from the use of nsaids.

Linda

That's apologia of the highest order..it was marketed as a go out and dance again drug just as Celebrex is.

For a very few indeed it was a valuable alternative to nSAID issues but also a risky one.

For the profits it was a feel good drug for those with aches and pains and various levels of arthritis and other such ailments.

 

[fls]

That's apologia of the highest order..it was marketed as a go out and dance again drug just as Celebrex is.

For a very few indeed it was a valuable alternative to nSAID issues but also a risky one.

For the profits it was a feel good drug for those with aches and pains and various levels of arthritis and other such ailments.

I don't understand your point. Those were/are also the indications for nsaids.

Linda

 

[Cynic]

More data was needed to discover that risk. The information from the initial trials wasn't enough, let alone the information from a single use.

Merck had data that suggested those additional risks prior to its release and the FDA knew it before they approved it. Despite that, it was released anyway with no warnings to the doctors prescribing it or the patients it was marketed to. Merck actually paid academic researchers to stamp their names on papers written by their own in-house researchers and Elsevier was kind enough to make up entire journals to help them out. That's just indefensible.

 

[fls]

Merck had data that suggested those additional risks prior to its release and the FDA knew it before they approved it.

It is not unusual for two groups in a study to differ on measures other than the outcome of interest. For example, some early trials of cholesterol-lowering agents showed a substantial increase in death from suicides, homicides and accidents in the treated group, and Geminis and Libras did not benefit from aspirin in the ISIS study. Subgroup analysis is notoriously unreliable. We can laugh it off when there is no obvious connection, but when it is not so obvious, it may need further investigation. Yes, Merck and the FDA were aware of a sub-group difference, but the information was inadequate to determine whether or not it was a spurious finding.

Despite that, it was released anyway with no warnings to the doctors prescribing it or the patients it was marketed to.

Well, if they were trying to hide it, they didn't do a very good job, because my colleagues and I knew about the possible connection and none of us had inside information. Merck marketing isn't the only source of information for physicians.

Linda

 

[Mojo]

If that is necessary to save a life, absolutely.

Did Cayce know "all of the ramifications" of the treatments he advocated? What tests had he carried out?

 

[Rodney]

Did Cayce know "all of the ramifications" of the treatments he advocated?

His batting average seemed to be very high in that regard. Do you know of a case in which his treatment was followed and there was an adverse reaction to it?

What tests had he carried out?

Evidently he didn't need to carry any out because he had intuitive knowledge.

 

[Mojo]

His batting average seemed to be very high in that regard. Do you know of a case in which his treatment was followed and there was an adverse reaction to it?

No, but the comparatively small numbers he treated, the lack of any systematic follow-up or reporting scheme for such effects, and the fact that all we have is anecdotes, would make any adverse reactions virtually impossible to detect, and even more difficult to prove.

Evidently he didn't need to carry any out because he had intuitive knowledge.

Unlike all these arrogant doctors and tools of Big Pharma...

 

[MRC_Hans]

The main point is that drugs are often-times prescribed without knowing all of the ramifications of their use, and sometimes those ramifications prove extremely deleterious, if not fatal.

That is screamingly ironic coming from a proponent of alternative meds. Alternative meds are ALWAYS 'prescribed' without knowing ANY ramifications of their use, and without ANY follow-up procedures to make anybody aware of any deleterious, even fatal, consequences.

The use of alternative meds is based on superstition, hearsay, and quesswork, and practitioners are not required to maintant ANY form of registration, or feed-back.

Add to this that alternative practitioners need no formal education what so ever.

The only reason this does not often go horribly wrong, is that most alternative meds have little or no effect at all.

Hans

 

[fls]

His batting average seemed to be very high in that regard. Do you know of a case in which his treatment was followed and there was an adverse reaction to it?

How would you know? You seem to think that failing to look for problems means that the problems are not there. Yet, if we applied that same sort of thinking to medical treatments, then there would be no problem with the use of Vioxx. You started this thread with an example of why we need to actively go looking for problems, because otherwise we will not find them. And then you follow it up with a case of not looking for problems. You're not making any sense here.

Linda

 

[ponderingturtle]

What does Benny Hinn have to do with Edgar Cayce?

It shows how quacks can get rather remarkable loyalty and you don't hear about the damage they do.

Since Cayce wasn't a faith healer, what's your point?

Again why should we not think he had a typical dynamic shown in alt med in general and well demonstrated by faith healers?