Tucci78 on June 03, 2012, 06:24:02 am
Also, the medical drugs have medical side-effects; it's like there's a tasting comission out there, saying "No, this one is too fun, it can't be medicine : BANNED" 

One of the unintended (but wholly anticipated) consequences of direct-to-patient prescription drug advertisements has been the way in which the FDA's Office of New Drugs (which handles enforcement of 21 CFR 202.1 promotional regulations) requires the verbal recapitulation of those adverse effects most commonly seen in Phase III clinical trials during television and radio commercials. 

It's right and appropriate to do that, but it gives pharmacotherapeutically illiterate clowns to comment about how "the medical drugs have medical side-effects" and by imputation the street drugs don't.

I'm given to consider what an O.N.D.-approved radio commercial for Aspirin (it was originally a Bayer Pharmaceuticals product, and the word started out as a trademarked name) might sound like when the moment came to start listing the adverse events profile....

Ah, well.  21 CFR 202.1 only pertains to prescription drug advertisements. 
"I is a great believer in peaceful settlements," Jik-jik assured him. "Ain't nobody as peaceful as a dead trouble-maker."
-- Keith Laumer, Retief's War (1966)

Andreas on June 03, 2012, 07:44:55 am
I thought you, of all people, would be able to appreciate that the pure herbal extracts that have been noticed by the world's populace to have useful effects, are more often more pleasant to use than the chemically produced compounds made to emulate their effects, minus the fun.

Street drugs are the government's invention

Tucci78 on June 03, 2012, 08:43:16 am
I thought you, of all people, would be able to appreciate that the pure herbal extracts that have been noticed by the world's populace to have useful effects, are more often more pleasant to use than the chemically produced compounds made to emulate their effects, minus the fun.

Street drugs are the government's invention

Me, "of all people"?  Taking issue with "pure herbal extracts" like foxglove tea, essence of deadly nightshade, and what can be gotten out of the castor bean in the way of ricin and Ricinus communis agglutinin?

From a pharmacotherapeutic perspective - meaning, of course, me, "of all people" - predictable bioavailability is a matter of vital importance when you're trying for optimal beneficial effect and minimum possible adverse events related to the administration of a compound in the purposeful management of a medical disorder.

We're not making salad dressing to taste here, bubbie, but undertaking the address of a pathology, hoping to restore homeostasis with a minimum prospect of iatrogenic complications.  Primum non nocere.

(I, of course, use the Italianate pronunciation of that last word, and screw those goddam Brits and their "knock-a-ray" nonsense.)

You go with your "more pleasant to use" happy horsepuckey, and I'll stick with boring old "more predictably safe and effective."

Makes for a bunch fewer people getting themselves "all corpsified."

(Thank you, Mal Reynolds.) 
« Last Edit: June 03, 2012, 09:01:06 am by Tucci78 »
"I is a great believer in peaceful settlements," Jik-jik assured him. "Ain't nobody as peaceful as a dead trouble-maker."
-- Keith Laumer, Retief's War (1966)

myrkul999 on June 03, 2012, 12:27:43 pm
Also, the medical drugs have medical side-effects; it's like there's a tasting comission out there, saying "No, this one is too fun, it can't be medicine : BANNED" 

One of the unintended (but wholly anticipated) consequences of direct-to-patient prescription drug advertisements has been the way in which the FDA's Office of New Drugs (which handles enforcement of 21 CFR 202.1 promotional regulations) requires the verbal recapitulation of those adverse effects most commonly seen in Phase III clinical trials during television and radio commercials. 

It's interesting to note, that the longer the list of side-effects, the more people seem attracted to the advertised drug. Just one of thse "stupid human tricks", I guess.

customdesigned on June 03, 2012, 01:21:11 pm

You go with your "more pleasant to use" happy horsepuckey, and I'll stick with boring old "more predictably safe and effective."


I can illustrate with a personal real life example.  My mother was born with heart arrhythmia.  In her old age, she needs her blood thinned to survive the condition longer.  Being an herbalist (majored in Botany, actually), she wanted to use Vitamin E - which is also a blood thinner.  A little research showed why doctors use rat poison instead of Vitamin E. 

The Vitamin has a decidedly non-linear response curve.  To put it poetically, Vitamin E and Vitamin K arm wrestle for your blood.  As you ramp up the levels of both, any hiccup in either can be catatrophic, as the arms slam down to the table on one side or the other, resulting either in death by the equivalent of rat poison, or massive clotting.

Rat poison (coumadin), on the other hand, is nice and linear, so you can reliably control the effect via dosage.

We talked her out of the Vitamin E therapy.

Tucci78 on June 03, 2012, 01:39:54 pm
Also, the medical drugs have medical side-effects; it's like there's a tasting comission out there, saying "No, this one is too fun, it can't be medicine : BANNED" 


One of the unintended (but wholly anticipated) consequences of direct-to-patient prescription drug advertisements has been the way in which the FDA's Office of New Drugs (which handles enforcement of 21 CFR 202.1 promotional regulations) requires the verbal recapitulation of those adverse effects most commonly seen in Phase III clinical trials during television and radio commercials. 

It's interesting to note, that the longer the list of side-effects, the more people seem attracted to the advertised drug. Just one of thse "stupid human tricks", I guess.

I don't think that it could even seem that such is so.  It's more likely that the drugs presently advertised are being perceived by people as panaceas aimed at the resolution of damned nasty conditions. 

We've gotten past the "blockbuster drugs" era of the '90s, when the rat-bastard MBA types had taken over the pharmaceuticals industry built up so laboriously by the pharmacologists and the clinicians to exploit the fruits of intensive drug development that had resulted in therapeutic categories like the H2-blockers, the proton pump inhibitors, the atypical neuroleptics, the angiotensin converting enzyme (ACE) inhibitors, the "statin" drugs, the angiotensin receptor blockers (ARBs), the calcium channel blockers, and all those other goodies which were only laboratory dreams when I was in medical school. 

(Kids, I came up into practice when a potassium-sparing diuretic was the best-selling prescription drug in the country, beta blockers were the bee's knees, and antidepressants were introduced in bedtime-only dosing because they put a patient into a dopey haze until the recipient got somewhat habituated to the sedative effects.)

A prescription drug is considered a "blockbuster" if it is used to treat - not cure - the effects of a chronic medical condition widely prevalent in the population and it can be prescribed with little practical concern for either unpredictable adverse events or commonplace drug/drug interactions. 

Once the Big Pharma companies got patent locks on enough "blockbuster" products, they didn't have to know dick about clinical medicine or pharmacology to look like real hot-shuts running multi-billion-dollar pharmaceuticals outfits.  Those friggin' suits just put R&D into "neutral" and coasted through the '90s while those of us wearing the increasingly tattered and stained white coats watched the product development pipelines peter out and dry up. 

The only places where therapeutic targets seemed to be accessible to what little the suits were willing to devote in terms of R&D spend were in therapeutic areas where the patients were in a good bit more trouble than you found when all you were concentrating on was a mild-to-moderate chronic condition highly prevalent in the population, like obesity or essential hypertension or atherosclerosis or Type 2 diabetes mellitus.

Take chronic moderate-to-severe rheumatoid arthritis as an example.  A complex autoimmune disorder that's nowhere near as common as osteoarthritis (which goddam everybody gets eventually).  Consider the small-molecule and monoclonal antibody disease modification anti-rheumatoid drugs (DMARDs) being advertised direct-to-consumers nowadays.  Now, these things scare the snot out of me.  I'm a primary care grunt, and while I've had to treat patients who are being run on such agents by the rheumatologists, I know good and goddam well how troublesome they are in terms of both adverse events profiles and drug/drug interactions.

But for various reasons, the FDA concedes that these things can be advertised directly to patients, and thus we've got persuasive material being put before genuinely sick and miserable folks (along with their friends and family members) making supportable claims about remediation, along with lengthy yammers about "the longer ... list of side-effects" necessarily associated with these DMARD products.

The older blockbuster drugs have for the greatest part either gone off-patent or they're subject to tremendous competition from previous blockbusters that have.  Note that Lipitor (atorvastatin calcium) quit getting advertising support years ago, long before the molecule itself lost patent protection, because once Zocor (simvastatin) "went generic," what kind of idiot doctor bothered to prescribe Lipitor when he could get just about the same effectiveness much more cheaply with generic simvastatin?

Right now - courtesy of some slick "legal graft" applied in the Congress during the Medicare Part D negotiations - some of the DMARD products have really extended patent protections, and the equivalent of "generic" competition ain't gonna hit them for a long, long time.  Push the multi-megabuck TV advertising budget there, Don Draper.  Cha-ching! 
"I is a great believer in peaceful settlements," Jik-jik assured him. "Ain't nobody as peaceful as a dead trouble-maker."
-- Keith Laumer, Retief's War (1966)

Tucci78 on June 03, 2012, 02:26:02 pm
Vitamin [E] has a decidedly non-linear response curve.  To put it poetically, Vitamin E and Vitamin K arm wrestle for your blood.  As you ramp up the levels of both, any hiccup in either can be catatrophic, as the arms slam down to the table on one side or the other, resulting either in death by the equivalent of rat poison, or massive clotting.

[Therapeutic response to] Rat poison ([warfarin]), on the other hand, is nice and linear, so you can reliably control the effect via dosage.

We talked her out of the Vitamin E therapy.

Yeah, that's actually a pretty common phenomenon observed in complex multivariant systems where nonlinear responses to inputs are unavoidable.

Like the global climate.  Nobody should wonder much that medical doctors and physiologists and suchlike folks looked at the anthropogenic global warming (AGW) conjecture back in the late '70s and early '80s, murmured "All of that is supposed to happen just because of man-made atmospheric carbon dioxide?" and commented: "No way, no how.  This is bullshit."

As for warfarin (Coumadin), the problem is getting a therapeutic response without unacceptably raising the risks of therapeutic misadventure.  With a satisfactorily predictable amount of Vitamin E being taken at the same time every day, a cardiologist might be perfectly happy to have small-dose alpha-tocopherol (say 400 International Units) ingested daily while warfarin treatment was ongoing, efficacy and safety measured by INR testing. 

Pradaxa (dabigatran etexilate mesylate) hit the market in 2010 with pharmacokinetic and pharmacodynamic characteristics a bunch more predictable than those of warfarin, with a helluva lot broader therapeutic window (meaning nowhere near as much dosage finagling). 

The thing that slows me down is that I can swamp a Coumadin over-effect by administering Synkavite (menadione), but there's no such recourse if I have to suddenly reverse the anticoagulant effects of dabigatran.

Then again, I don't have to worry about Pradaxa patients going on salad binges and knocking their anticoagulant effect down to nil.

Hrm. I guess this why CMS pays us the big bucks.

Oh. They don't?
"I is a great believer in peaceful settlements," Jik-jik assured him. "Ain't nobody as peaceful as a dead trouble-maker."
-- Keith Laumer, Retief's War (1966)

Oneil on June 27, 2012, 02:32:47 am
Did you ever notice that the posts by the Forum's trolls get more frequent, longer and more inflammatory toward the end of the month? My guess is that they are on medical welfare and have run out of government meds intended to calm them down.  ;D

Personal experience suggests it's more a middle class Health Care problem.  Accursed tight wad HMO / Managed Health Organization forces you to use a scheduled "Mail order once a month Pharmacy."  That combination with the US Postal Service leads me to imagine a lot of Soccer Mom's missing their Proxac as late as the second week of the month.

Beware of those mini vans!  ;D
« Last Edit: June 27, 2012, 05:21:40 pm by Oneil »

Apollo-Soyuz on June 27, 2012, 07:42:59 pm
and antidepressants were introduced in bedtime-only dosing because they put a patient into a dopey haze until the recipient got somewhat habituated to the sedative effects.

Been there, got the tee shirt.

Of course, I was prescribed both amitriptyline and cyclobenzaprine (at different times, and for different reasons) for their side effects, and not for anti-depression.

Both of them knocked me for a complete loop, and I had to check Dr. Google to find out their original purposes.

I predict with Obamacare and universal government stored medical records, in a few years the cop that pulls you over will know (for officer safety of course) that you're got both a carry license and you are on a drug prescribed to "crazy people" (but details will be "private enough" that he won't know it's because you have issues with your back muscles.)

Andreas on June 28, 2012, 07:02:41 am
Just enough information to be dangerous  :D

Apollo-Soyuz on July 06, 2012, 08:35:38 pm

The thing that slows me down is that I can swamp a Coumadin over-effect by administering Synkavite (menadione), but there's no such recourse if I have to suddenly reverse the anticoagulant effects of dabigatran.


The doc said there's an emergency "cure" for rivaroxaban, although I don't know the details. It does not look like the insurance plan wants to pay for it and I can't seem to find anyone around that publishes a cash price.

It sure would be nice to be able to weigh price of Xarelto vs the inconvenience and cost of weekly testing while taking the rat poison.