Medical Forum / General / General / December 2004
JAMA on FDA & PHARMA: Lack of vigilance, lack of trust
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outrider - 22 Nov 2004 18:48 GMT Incidence of Hospitalized Rhabdomyolysis in Patients Treated With Lipid-Lowering Drugs
http://jama.ama-assn.org/cgi/content/full/292.21.2585v1
Potential for Conflict of Interest in the Evaluation of Suspected Adverse Drug Reactions Use of Cerivastatin and Risk of Rhabdomyolysis
http://jama.ama-assn.org/cgi/content/full/292.21.2622v1
Potential for Conflict of Interest in the Evaluation of Suspected Adverse Drug Reactions A Counterpoint
http://jama.ama-assn.org/cgi/content/full/292.21.2643v1
Postmarketing Surveillance-Lack of Vigilance, Lack of Trust http://jama.ama-assn.org/cgi/content/full/292.21.2647v1
Ed Mathes - 22 Nov 2004 23:52 GMT Don't you have more important things to do with your time? Like work? Earn a living? If you already do that, great...then, instead, find some hobby or something to divert you to more productive things than the crap you put on this newsgroup.....
Maybe fix you up with John.....or Gastaldo over on sci.med.
> Incidence of Hospitalized Rhabdomyolysis in Patients Treated With > Lipid-Lowering Drugs [quoted text clipped - 13 lines] > Postmarketing Surveillance-Lack of Vigilance, Lack of Trust > http://jama.ama-assn.org/cgi/content/full/292.21.2647v1 outrider - 23 Nov 2004 00:33 GMT > Don't you have more important things to do with your time? Like work? Earn > a living? If you already do that, great...then, instead, find some hobby or > something to divert you to more productive things than the crap you put on > this newsgroup..... > > Maybe fix you up with John.....or Gastaldo over on sci.med. What statin and what dose are you using, again, Eddie me boyo?
STATINS AND NON-CARDIAC ENDPOINTS Authors:
GOLOMB BA
Author Address: BGOLOMB@UCSD.EDU, UCSD SCHOOL OF MEDICINE, 9500 GILMAN DRIVE, 0995, LA JOLLA, CA 92093-0995
Source: Crisp Data Base National Institutes of Health
Abstract:
DESCRIPTION (adapted from investigator's abstract): A relation of lowered cholesterol to increased aggressive behaviors (including suicide) and impaired cognition has been variably demonstrated and remains to be established or excluded with confidence. HMG-CoA reductase inhibitors ("statins") are the most widely used agents and their effects are of special interest. Purpose: To examine the effect of statins on aggressive responding, cognition, and serotonin in individuals with moderate LDL and no identified cardiovascular disease (CVD). Hypothesis: Statin therapy will increase aggressive responding on the PSAP (Point Subtraction Aggression paradigm, a standardized aggression measure that correlates with both violent behavior and serotonin); will reduce measures of cognition (including psychomotor speed and attention); and will change serotonin (gauged by whole blood serotonin), which may be a mediator of effects on behavior and perhaps cognition. Secondarily, it is hypothesized that simvastatin (lipophilic) will exert more potent effects on cognition (and perhaps aggression) than pravastatin (hydrophilic); that serotonin (5HT) changes will related to changes in aggressive responding and perhaps cognition; and that a "susceptible subset" may be defined by baseline characteristics including biochemistry, mood, personality, and extremes of cardiovascular reactivity.
Keywords:
serotonin
hydropathy
blood chemistry
antihypercholesterolemic agent
clinical trial
drug adverse effect
oxidoreductase inhibitor
human subject
HMG coA reductase
aggression
cognition
psychomotor function
human therapy evaluation
violence
clinical research
behavioral /social science research tag
Language: English
Publication Types:
Research
Supporting Agency: U.S. DEPT. OF HEALTH AND HUMAN SERVICES; PUBLIC HEALTH SERVICE; NATIONAL INSTITUTES OF HEALTH, NATIONAL HEART, LUNG, AND BLOOD INSTITUTE
Country or State: CALIFORNIA
Entry Month: June, 2003
Zip Code: 92093-0995
Year of Publication: 2002
Secondary Source ID: CRISP/2002/HL63055-04
Award Type: G
Document Number: CRISP/2002/HL63055-04
> > Incidence of Hospitalized Rhabdomyolysis in Patients Treated With > > Lipid-Lowering Drugs [quoted text clipped - 13 lines] > > Postmarketing Surveillance-Lack of Vigilance, Lack of Trust > > http://jama.ama-assn.org/cgi/content/full/292.21.2647v1 Ed Mathes - 23 Nov 2004 02:03 GMT And, again...DIDN'T ANSWER THE QUESTION(s)!!
I use Vytorin 20/10, thank you very much.
> > Don't you have more important things to do with your time? Like > work? Earn [quoted text clipped - 118 lines] > > > Postmarketing Surveillance-Lack of Vigilance, Lack of Trust > > > http://jama.ama-assn.org/cgi/content/full/292.21.2647v1 outrider - 23 Nov 2004 02:17 GMT > And, again...DIDN'T ANSWER THE QUESTION(s)!! But I notice you did. Good boy. Down!
Zee
> I use Vytorin 20/10, thank you very much. It shows. Unless you were always uber-hysterical.
Zee
> > > Don't you have more important things to do with your time? Like > > work? Earn [quoted text clipped - 118 lines] > > > > Postmarketing Surveillance-Lack of Vigilance, Lack of Trust > > > > http://jama.ama-assn.org/cgi/content/full/292.21.2647v1 Ed Mathes - 23 Nov 2004 02:32 GMT I have said this before....
Obfuscation
Don't answer the question
Insult, Insult, Insult some more
Name call
And don't answer the question
And the worst thing is...people actually listen to and believe her...
> > And, again...DIDN'T ANSWER THE QUESTION(s)!! > [quoted text clipped - 148 lines] > > > > > Postmarketing Surveillance-Lack of Vigilance, Lack of Trust > > > > > http://jama.ama-assn.org/cgi/content/full/292.21.2647v1 outrider - 23 Nov 2004 03:11 GMT As have I. I'll play the way I'm being played. Zee
> I have said this before.... > [quoted text clipped - 162 lines] > > > > > > Postmarketing Surveillance-Lack of Vigilance, Lack of Trust > > > > > > http://jama.ama-assn.org/cgi/content/full/292.21.2647v1 listener - 23 Nov 2004 04:03 GMT Ed,
You're not the first person to react to Zee (Outrider) this way, and I'm sure you won't be the last...and it always plays out the same: eventually you're simply labeled a statin-induced aggressor! It's an easy way for her to rationalize her insulting behavior and reinforce her notion that she's in the right.
L.
"Ed Mathes" <emathes@rochester.rr.com> wrote in news:_ixod.11560$AL5.300 @twister.nyroc.rr.com:
> I have said this before.... > [quoted text clipped - 162 lines] >> > > > > Postmarketing Surveillance-Lack of Vigilance, Lack of Trust >> > > > > http://jama.ama-assn.org/cgi/content/full/292.21.2647v1 outrider - 23 Nov 2004 10:36 GMT > Ed, > [quoted text clipped - 5 lines] > > L. ~~~~~~~~~~~~~~~~~~~~~~~~~~~
Newsgroups: sci.med.cardiology Subject: Re: Heart Drugs May Target AIDS Virus, Study Shows From: listener <liste...@nospam.net> Date: 17 Aug 2004 12:34:24 GMT References: <Xns9547B891FC6A0some1outthere@38.144.126.79> <abf8de5b.0408162016.4bd65370@posting.google.com> Message-ID: <Xns954857EBE348Asome1outthere@38.144.126.103> User-Agent: Xnews/5.04.25 X-Trace: romeo.newsreader.com CYyz3J9ccs3mr=_txh9yiCfzxN39.l7w_t=zWR9fM.v6.gaU_ Lines: 99
C'mon, fresh~horseshit, just respond to the topic not me. This isn't personal.
~~~~~~~~~~~~~~~~~~~~~~~~~~~
NNTP-Posting-Date: Sat, 06 Dec 2003 19:23:42 -0600 From: liste...@nospam.net Newsgroups: alt.america,alt.current-events.usa,alt.impeach.bush,alt.politics.bush,alt.politics.gw-bush,alt.politics.usa,alt.politics.usa.republican Subject: Re: Bu$h Even Lied About Iraq Trip! Why!? Date: Sat, 06 Dec 2003 20:24:34 -0500 Message-ID: <1lv4tvkeh4fvnh0qa262oj0mar48vmh9m6@4ax.com> References: <OBK944723E0725150001138@r2-dv8.anarchy.gov> <68a5f8dc.0312050416.52611216@posting.google.com> <vt14et42mvvu8b@corp.supernews.com> <3fd14034$1_2@mk-nntp-2.news.uk.tiscali.com> <aNGdnaByX_X3Q0yiRVn-sA@comcast.com> <9hp3tvgv28m2hjofpr8ofu7f7she52f1tu@4ax.com> <ibCdneZJ-8SnvE-iRVn-sQ@comcast.com> <e3e4tvct1lr027qcovi3fhlrrjuui11c5m@4ax.com> <4-2dnTPYzaynoE-iRVn-uw@comcast.com> <rok4tvga1p6pjph4fk2hu64o83rvb7eqk1@4ax.com> <mY-dnWgGktaU9E-iRVn-iw@comcast.com> X-Newsreader: Forte Free Agent 1.93/32.576 English (American) MIME-Version: 1.0 Content-Type: text/plain; charset=us-ascii Content-Transfer-Encoding: 7bit Lines: 52 NNTP-Posting-Host: 68.46.75.74 X-Trace: sv3-fhtsa8mQhz7gbsjlPUugzQje35RNedVL5zYEHDRhwErSCQOczoSxbeE1dBYpej2FG7SYETQNkd1YTAq!1B8G+pXr6tYOPnlldSxrqgGHkbCkodUIml4dMIRoUT7ilWnGCuH4sCl2M0oO/z4VO1mjqA== X-Complaints-To: a...@comcast.net X-DMCA-Complaints-To: d...@comcast.net X-Abuse-and-DMCA-Info: Please be sure to forward a copy of ALL headers X-Abuse-and-DMCA-Info: Otherwise we will be unable to process your complaint properly X-Postfilter: 1.1
If you went to that web site I cited you would hear President Bush himself utter those statements, fuckhead. They are taken verbatim from his utterances. Too bad for you, you pussy. f.ck you and your "I request proof". What bullshit! Oh, I forgot...you're afraid of the big, bad website...it might give you some disease or virus. Jesus, what is your problem? Your not only a complete dumb sh.t, but your a paranoid dumb sh.t too!
George Bush himself uttered those statements, word for word - and many many more. They were and still are LIES and young men and women and civilians have lost their LIVES because of those LIES and the man should be thrown out of office for LYING.
God, you are truly a worthless piece of sh.t, you right-wing wacko. If it weren't for the internet you would surely be in a psycho ward. End of discussion. Buh-buy.
beachhouse - 23 Nov 2004 14:29 GMT > And, again...DIDN'T ANSWER THE QUESTION(s)!! > > I use Vytorin 20/10, thank you very much. since this is among the newest agents, i'm just curious as to why this would be your preferred therapy for patients with hyperlipidemia... and how you became aware of it. is this detailing?
Ed Mathes - 24 Nov 2004 00:01 GMT There is a lot of misconception about "detailing".
"Detailing" is the term applied to what happens when a pharmaceutical salesman ("drug rep") gives us his or her sales pitch.
Most of us realize it as just that, a sales pitch. Use my product because.....My product is better because.....This and That study show.....
They are trying to convince me that their product is the best choice there is. That is their job. They get bonused (or not) by their ability to increase "market share".
The misconception is (1) the only source of information we look at is provided by the reps, and (2) I make more money prescribing branded medications (I wish!!)...My brother thinks I'm paid for every prescription I write. Were that true, I would not be worrying abut how to pay for my daughter's college education!. In fact, financially, it is better for me to write for generics in certain categories....I would get a higher return of my "withhold". Most HMOs grade us by how much we stray from their guidelines, their clinical pathways, use of their "preferred products", etc.
The drug reps are a source of information, period. They provide information that I might not glean elsewhere. It may alert me to innovative and/or advances in therapy. It is incumbent upon me to then verify the information they provide, read the studies and formulate my own conclusions, and decide if study conclusions can translate into something clinically applicable. I weigh other options that are available...other therapies, other medications, what is "allowed" or "approved" by the patient's insurance plan, what is affordable, and yes, how efficacious and safe these products are. I then may try the product on selected patients to get some clinical experience OR wait until others report their experience OR wait and see what the specialists do OR do nothing to change my current "habits".
Anyone who depends solely on reps for information is either stupid or lazy.
But reps are a source of things valuable and should be used...be it information, be it education, be it free samples, be it patient education material, etc.
Vytorin: I personally use Vytorin. I have used both Zocor and Zetia as single agents in the past and decided on the convenience and less expensive single pill. Zocor has hard endpoint data and lots of other data to support it's use (also IMHO). Zetia is an interesting medication. Studies/trials/etc have shown it to be effective, side effects similar to placebo, and well tolerated.
I believe, based on available scientific data and my own clinical experience, the experience of others in my office, and the recommendations by other providers who's opinions I respect, that Vytorin is effective and safe.
I was aware of Zetia before it came on the market because "pre-launch" data published and I read it. Yes, I was detailed, still am! But I was also given a lot of useful information by the reps.
Ed
> > And, again...DIDN'T ANSWER THE QUESTION(s)!! > > [quoted text clipped - 3 lines] > be your preferred therapy for patients with hyperlipidemia... and how you > became aware of it. is this detailing? beachhouse - 24 Nov 2004 13:53 GMT > The drug reps are a source of information, period. They provide > information > that I might not glean elsewhere. They are sales representatives. They are not pharmacists/pharmacologists/scientists -- their focus is to sell their company's drug and convince you not to prescribe a competitor's products. I find them extremely poor sources of information, actually. On a personal level, many are very friendly, interesting folks and I respect the job that they do -- as I would any salesperson. But it is ridiculous the way drugs are marketed to physicians and to patients by drug companies. Drugs are not like toothpaste and shouldn't have to be sold with lunches, shiny pens and pads, and golf tournaments. This has got to end.
> Anyone who depends solely on reps for information is either stupid or > lazy. > > But reps are a source of things valuable and should be used...be it > information, be it education, be it free samples, be it patient education > material, etc. Why do we need samples? Samples are typically for the newest and most expensive drugs -- when was the last time you got samples of an ace inhibitor or beta blocker? All you're likely to get are the newest ARB's or calcium channel blockers. Patients should not be maintained on samples of medications --- instead, the drug rep should assist with enrolling them in a reduced cost/free drug program with a particular company or assisted with medicaid/other charity care plan.
> Vytorin: I personally use Vytorin. I have used both Zocor and Zetia as > single agents in the past and decided on the convenience and less [quoted text clipped - 4 lines] > Studies/trials/etc have shown it to be effective, side effects similar to > placebo, and well tolerated. There is simply no reason for every patient with hyperlipidemia to be prescribed a combination agent as a first-line drug. None. Now, I could see for those not achieving target LDL, it's a good option. I"m happy it's out there. But whether you realize it or not, you've been detailed by your specialist colleagues (who may be member's of that drug company's speaker's bureau) and by the reps.
>> > And, again...DIDN'T ANSWER THE QUESTION(s)!! >> > [quoted text clipped - 4 lines] >> be your preferred therapy for patients with hyperlipidemia... and how you >> became aware of it. is this detailing? David Rind - 24 Nov 2004 20:04 GMT > There is simply no reason for every patient with hyperlipidemia to be > prescribed a combination agent as a first-line drug. None. > Now, I could see for those not achieving target LDL, it's a good option. > I"m happy it's out there. But whether you realize it or not, you've been > detailed by your specialist colleagues (who may be member's of that drug > company's speaker's bureau) and by the reps. Actually, I think you could go further than that. There's no published evidence that ezitimibe, one part of the combination being discussed, has any clinical benefits either alone or in combination with other drugs for cholesterol. It has been shown to reduce LDL levels, but that is not the same as showing that it has a favorable effect on clinical outcomes. (There are no trials showing it doesn't have clinical benefits either. No clinical endpoint trials have been published.)
 Signature David Rind drind@caregroup.harvard.edu
beachhouse - 29 Nov 2004 14:19 GMT >> There is simply no reason for every patient with hyperlipidemia to be >> prescribed a combination agent as a first-line drug. None. [quoted text clipped - 10 lines] > (There are no trials showing it doesn't have clinical benefits either. No > clinical endpoint trials have been published.) Have you seen the idiotic way the combination simvastatin/ezitimibe product t is being marketed to patients on T.V.? "it works on *both* kind of cholesterol.... you get cholesterol from your parents and from your food..." implication being that you need 2 drugs by necessity to achieve meaningful lipid lowering. what crap.
David Rind - 29 Nov 2004 23:31 GMT > Have you seen the idiotic way the combination simvastatin/ezitimibe product > t is being marketed to patients on T.V.? [quoted text clipped - 3 lines] > lipid lowering. > what crap. Yes, although for stupid drug company ads, I'm not sure any quite compares to whichever antihistamine is busy promoting itself as having been proven to work for allergies that occur both inside and outdoors.
 Signature David Rind drind@caregroup.harvard.edu
beachhouse - 30 Nov 2004 13:21 GMT ... and since Della Reese uses Avandia I guess that means all her fans should too...
>> Have you seen the idiotic way the combination simvastatin/ezitimibe >> product t is being marketed to patients on T.V.? [quoted text clipped - 7 lines] > to whichever antihistamine is busy promoting itself as having been proven > to work for allergies that occur both inside and outdoors. Steve Harris sbharris@ROMAN9.netcom.com - 30 Nov 2004 22:56 GMT "beachhouse" <sendnomail@please.com> wrote in message news:<cofb5f$1c10
> Have you seen the idiotic way the combination simvastatin/ezitimibe product > t is being marketed to patients on T.V.? [quoted text clipped - 3 lines] > lipid lowering. > what crap. COMMENT:
Yes, the another ironic twist added inasmuch as probably THE main mechanism of ezetimibe/Zetia cholesterol lowering is much like that of bile acid binders: it prevents reabsorption of your own *hepatically excreted* biliary cholesterol, too, as well as the cholesterol you eat. Which means it also (and probably mainly) affects the cholesterol you make, a.k.a. the cholesterol you "get from your parents'[cholesterol control genes]".
The effect of Zetia is just too large to be affecting only the cholesterol you absorb from your diet. I WISH you could lower LDL 25% in anybody by merely removing most of the cholesterol from their diet. But you can't, unless you really cut their calories and saturated fat intake, too.
Zetia would presumably work reasonably well even in vegans (who by definition eat no dietary cholesterol), though I can't find that this interesting experiment has ever been tried.
That said, I agree that the jury's out on whether or not Zetia's or Zetia combos are going to do anything clinically, anymore than bile acid binding resins like cholestyramine/Questran did.
Note that the abstract below says it's not known how ezetimibe works, but it's been recently found to bind to the aminopepdidase N (CD13) receptor. That's an important viral endocytosis receptor. Maybe the stuff will end up as a useful antiviral adjunct therapy, if it doesn't help heart disease.
SBH
Can J Clin Pharmacol. 2003 Winter;10 Suppl A:13A-20A.
The pharmacokinetics of ezetimibe.
Simard C, Turgeon J.
Universite de Montreal, Quebec.
Ezetimibe is the first member of a new class of selective cholesterol absorption inhibitors. The drug and its active glucuronide metabolite impair the intestinal reabsorption of both dietary and hepatically excreted biliary cholesterol through inhibition of a membrane transporter yet to be identified. Absorption of ezetimibe is rapid and not altered by food content following oral administration. The drug is not metabolized by the cytochrome P450 system but extensive glucuronidation takes place in the intestine. Consequently, plasma concentrations of ezetimibe represent approximately 10% of total ezetimibe in plasma. Enterohepatic recirculation observed for ezetimibe and its glucuronimide significantly increases the residence time of these compounds in the intestine, at their site of action. Elimination of ezetimibe glucuronimide appears impaired in elderly patients and patients with renal insufficiency with plasma concentrations increased 1.5- to 2-fold. So far, no drug interaction study has been associated with major changes in either the pharmokinetics of ezetimibe or coadministered drugs.
Publication Types: Review Review, Tutorial
PMID: 14571304 [PubMed - indexed for MEDLINE]
outrider@despammed.com - 01 Dec 2004 01:01 GMT > "beachhouse" <sendnomail@please.com> wrote in message news:<cofb5f$1c10 > > Have you seen the idiotic way the combination simvastatin/ezitimibe product [quoted text clipped - 36 lines] > > SBH Right. Back to square one. Cholestyramine and/or psyllium; oranges (including the peel) oat bran, okra, apples, pectin, almonds, berries, soy (in moderation and probably the whole bean) brown rice, whole grain levain raised breads, fish and salmon oil.
Enjoy!
Zee
> Can J Clin Pharmacol. 2003 Winter;10 Suppl A:13A-20A. > [quoted text clipped - 30 lines] > > PMID: 14571304 [PubMed - indexed for MEDLINE] Ed Mathes - 24 Nov 2004 23:58 GMT I so love selective snips........... I stated in my original post:
""Detailing" is the term applied to what happens when a pharmaceutical salesman ("drug rep") gives us his or her sales pitch. Most of us realize it as just that, a sales pitch. Use my product because.....My product is better because.....This and That study show..... They are trying to convince me that their product is the best choice there is. That is their job. They get bonused (or not) by their ability to increase "market share".
You quoted: From: "beachhouse"
> >"Ed Mathes" <emathes@rochester.rr.com > > The drug reps are a source of information, period. >They provide > > information that I might not glean elsewhere. Beach:
> They are sales representatives. They are not > pharmacists/pharmacologists/scientists -- their focus is to sell their [quoted text clipped - 5 lines] > like toothpaste and shouldn't have to be sold with lunches, shiny pens and > pads, and golf tournaments. This has got to end. Golf Tournament? Haven't been to one of those in a few years. Love the pens though...especially the Levitra pen that automatically unfolds when you hit a button. And the Lipitor "penis" pen. Also like the pens that have the PDA stylus built into it.
And the lunches are good....usually not a healthy lunch....but good.
And this is no different than any other industry...just more highly regulated (Pharma rules).
Do I think drugs should be marketed? Yes and no. Right now there is no better alternative.
> Why do we need samples? Samples are typically for the newest and most > expensive drugs -- when was the last time you got samples of an ace [quoted text clipped - 3 lines] > reduced cost/free drug program with a particular company or assisted with > medicaid/other charity care plan. Why do we need samples? You're kidding, right?
Yes, they are the "newest most expensive drugs".....sometimes there is no "suitable generic alternative". Sometimes patients (at least mine) can't afford to pay even a generic co-pay, let alone full price out of pocket for said generic. So they benefit from my sample closet.
Consider this...there are 10 courses of samples given out for every prescription written.
Chilling stat? I though so. Why not stop sampling and reduce the prices accordingly? That makes more sense to me. But I dare say it won't happen. Not in our capitalistic society.
> > Vytorin: I personally use Vytorin. I have used both Zocor and Zetia as > > single agents in the past and decided on the convenience and less [quoted text clipped - 11 lines] > detailed by your specialist colleagues (who may be member's of that drug > company's speaker's bureau) and by the reps Where in the world did I say I prescribe Vytorin as an initial agent? The above is what I personally use...the pill that passes my own lips every day. After being on Lipitor (bad muscle pain at 10mg), Zocor alone (pain at 40mg), Pravachol(inadequate lowering at 80mg), I am pain free on Vytorin 20/10 with a TChol 169, LDL 69, HDL 53. This level was achieved by a combination of diet(no red meat, lots of fish, veggies, salads), exercise(4.5 hours/wk) and medication. Strong heart history in my family and I have a LBBB from a viral cardiomyopathy last year (EF was 20%, now 55%).
I wrote Vytorin as an initial agent for a patient once: TChol 310, LDL 190, HDL 40. Repeat panel 4 weeks later: TChol 210, LDL 104, HDL 45. Could I have done that with Lipitor? Probably. Zocor alone? Maybe. Crestor? Sure, but I am not convinced Crestor is yet "safe".
My primary Vytorin use to date (probably 5-8 prescriptions) is "conversions" from two separate agents to one pill.
David: Regarding Zetia. EASE demonstrated an additional 23% reduction in LDL when ezitimibe is added to a statin. True, there is no hard endpoint data yet available.
I guess use depends on whether you think LDL reduction alone is enough OR in the school that needs (demands?) hard endpoint data. This could be said about some of the statins also. NCEP recommends an LDL <100, but how do we get there? Will any statin do ("class effect")? Or do you want something with hard data? Or a combination of both. Will we still get the hard endpoint data achieved in Heart Protection Study or will the Zetia confound the data?
What are you willing to ask your patients to risk? Plus, direct to consumer advertising comes into play. Patients are demanding medication to get their cholesterol to goal. If you don't get there, what then?....Lawyer "But doctor, why didn't you add Zetia to get to goal?".
And, as most of you should know, most patients aren't motivated enough in the long run to do the lifestyle changes necessary to lead a long, healthy life. Just doesn't happen.
I've typed too much.....
Ed
outrider@despammed.com - 25 Nov 2004 00:49 GMT > I so love selective snips........... > I stated in my original post: > > ""Detailing" is the term applied to what happens when a pharmaceutical salesman ("drug rep") gives us his or her sales pitch. > Most of us realize it as just that, a sales pitch. Use my product because.....My product is better because.....This and That study show.....
> They are trying to convince me that their product is the best choice there is. That is their job. They get bonused (or not) by their ability to increase "market share".
> You quoted: > From: "beachhouse" > > >"Ed Mathes" <emathes@rochester.rr.com > > > The drug reps are a source of information, period. >They provide
> > > information that I might not glean elsewhere. > > [quoted text clipped - 21 lines] > > Why do we need samples? Samples are typically for the newest and most > > expensive drugs -- when was the last time you got samples of an ace
> > inhibitor or beta blocker? All you're likely to get are the newest ARB's or > > calcium channel blockers. Patients should not be maintained on samples of [quoted text clipped - 6 lines] > Yes, they are the "newest most expensive drugs".....sometimes there is no "suitable generic alternative". > Sometimes patients (at least mine) can't afford to pay even a generic co-pay, let alone full price out of pocket for said generic. So they benefit from my sample closet.
> Consider this...there are 10 courses of samples given out for every prescription written. > > Chilling stat? I though so. Why not stop sampling and reduce the prices accordingly? That makes more sense to me. But I dare say it won't happen. Not in our capitalistic society.
> > > Vytorin: I personally use Vytorin. I have used both Zocor and Zetia as > > > single agents in the past and decided on the convenience and less
> > > expensive > > > single pill. Zocor has hard endpoint data and lots of other data to [quoted text clipped - 11 lines] > > Where in the world did I say I prescribe Vytorin as an initial agent? The above is what I personally use...the pill that passes my own lips every day. After being on Lipitor (bad muscle pain at 10mg), Zocor alone (pain at 40mg), Pravachol(inadequate lowering at 80mg), I am pain free on Vytorin 20/10 with a TChol 169, LDL 69, HDL 53. This level was achieved by a combination of diet(no red meat, lots of fish, veggies, salads), exercise(4.5 hours/wk) and medication. Strong heart history in my family and I have a LBBB from a viral cardiomyopathy last year (EF was 20%, now 55%).
> I wrote Vytorin as an initial agent for a patient once: TChol 310, LDL 190, HDL 40. Repeat panel 4 weeks later: TChol 210, LDL 104, HDL 45.
> Could I have done that with Lipitor? Probably. Zocor alone? Maybe. Crestor? Sure, but I am not convinced Crestor is yet "safe". > [quoted text clipped - 5 lines] > I guess use depends on whether you think LDL reduction alone is enough OR in the school that needs (demands?) hard endpoint data. > This could be said about some of the statins also. NCEP recommends an LDL <100, but how do we get there? Will any statin do ("class effect")? Or do you want something with hard data? Or a combination of both. Will we still get the hard endpoint data achieved in Heart Protection Study or will the Zetia confound the data?
> What are you willing to ask your patients to risk? Plus, direct to consumer advertising comes into play. Patients are demanding medication to get their cholesterol to goal. If you don't get there, what then?....Lawyer "But doctor, why didn't you add Zetia to get to goal?".
> And, as most of you should know, most patients aren't motivated enough in the long run to do the lifestyle changes necessary to lead a long, healthy life. Just doesn't happen.
> I've typed too much..... > > Ed "And, as most of you should know, most patients aren't motivated enough
in the long run to do the lifestyle changes necessary to lead a long, healthy life. Just doesn't happen."
And do you include yourself in this view?
If you can control to a reasonable measure by diet and exericise, why are you so eager to be a test market for Vytorin?
Please note other readers: Statins have been shown to cause a type of cardiomyopathy probably owing to coenzyme q10 depletion. The heart is a muscle.
And, one of the primary researchers in statin induced myopathy will not recommend for coenzyme q10 supplementation. He says the evidence isn't there and he will not recommend something he does not 'know'.
Zee
Ed Mathes - 25 Nov 2004 01:14 GMT > And do you include yourself in this view? I said:
> This level was achieved by a combination of diet(no red meat, lots of fish, veggies,
> salads), exercise(4.5 hours/wk) and medication. Strong heart history > in my family and I have a LBBB from a viral cardiomyopathy last year > (EF was 20%, now 55%). You said:
> If you can control to a reasonable measure by diet and exericise, why > are you so eager to be a test market for Vytorin? Without the Vytorin, my TChol was 220, LDL 120 HDL 40
What is "reasonable level" to you?
outrider - 25 Nov 2004 02:13 GMT Over half of those with heart attacks have normal cholesterol levels. So lowering cholesterol to levels determined reasonable by a panel iof experts in conflict of interest to pharma may can be said to be dubious at best.
Your uncorrected levels sound reasonable to me if we are only talking about cholesterol levels, excepting yes, your HDL is low, But likely the more you lower your total with drugs, the more your HDL will drop too.
And if we speak of females and the elderly, apparently reasonable is something else again.
Zee
Steve Marcus - 25 Nov 2004 14:21 GMT > Over half of those with heart attacks have normal cholesterol levels. > So lowering cholesterol to levels determined reasonable by a panel iof > experts in conflict of interest to pharma may can be said to be dubious > at best. But what percentage of those having such heart attacks survive, versus the percentage of those who have heart attacks and high cholesterol levels?
What you neglect is the concept that due to considerations such as the presence or absence of internal damage to coronary arteries (lesions and the like), factors such as blood clotting, and perhaps a plethora of other things, one person having a "normal" cholesterol level may never have cardiac problems along the lines of CAD, while another person may encounter CAD problems. You then further ignore that the guidelines on cholesterol levels specifically indicate much lower LDL and TC levels for those known to have CAD problems than for those who haven't had such problems.
> Your uncorrected levels sound reasonable to me if we are only talking > about cholesterol levels, excepting yes, your HDL is low, But likely > the more you lower your total with drugs, the more your HDL will drop > too. Wrong, because it's the ratios that count. One can lower TC and raise HDL in the sense of increasing the effectiveness of HDL (see http://www.americanheart.org/presenter.jhtml?identifier=180 for the current take on what HDL and LDL do), because one can obtain lower LDL and VLDL. See also with respect to what VLDL does:
http://www.nlm.nih.gov/medlineplus/ency/article/003494.htm#Definition
> And if we speak of females and the elderly, apparently reasonable is > something else again. And, per you, it's impossible that there's a good reason for that?
> Zee Steve
 Signature The above posting is neither a legal opinion nor legal advice, because we do not have an attorney-client relationship, and should not be construed as either. This posting does not represent the opinion of my employer, but is merely my personal view. To reply, delete _spamout_ and replace with the numeral 3
listener - 25 Nov 2004 02:55 GMT "Ed Mathes" <emathes@rochester.rr.com> wrote in news:wlapd.12526$Uf.4155 @twister.nyroc.rr.com:
>> And do you include yourself in this view? > [quoted text clipped - 12 lines] > > What is "reasonable level" to you? Zee's (outrider's) cholesterol level is over 500 (or at least it was earlier this year...).
L.
William Wagner - 25 Nov 2004 01:54 GMT > Please note other readers: Statins have been shown to cause a type of > cardiomyopathy probably owing to coenzyme q10 depletion. The heart is a [quoted text clipped - 5 lines] > > Zee And where can we find coenzyme q10 supplementation that is validated?
Looks like a deep pit to me!
Bill
 Signature Zone 5 S Jersey USA Shade Serious Vision Problems? --> http://www.ocutech.com/
David Rind - 25 Nov 2004 02:47 GMT > David: Regarding Zetia. EASE demonstrated an additional 23% reduction > in LDL when ezitimibe is added to a statin. > True, there is no hard endpoint data yet available. There are several trials showing additional LDL lowering when ezitimibe is added to a statin. The problem is that we don't know that that means that ezitimibe does anything useful or is even safe. No one feels better just because their LDL is lower. Remember that niacin and the fibrates appeared to increase total mortality when given for primary prevention, despite favorable effects on lipids.
I'm not raising this just to make debating points. I think people should be very hesitant to prescribe anything other than a statin for primary prevention until we have some studies showing clinical benefits. If you tell me you're caring for a 45 yo male smoker with hypertension who had three brothers die of MIs at age 47, and you can't get his LDL below 170 with 80 mg of atorvastatin, I'd probably say roll the dice and add ezitimibe. But that's the sort of clinical scenario it would take to get me to prescribe a non-statin for primary prevention in the absence of clinical endpoint studies. And I'd do it knowing that I had essentially no evidence to support my decision -- that I was just making a guess that it might be helpful in a person at sky high risk for having a bad cardiovascular event.
 Signature David Rind drind@caregroup.harvard.edu
Mark Probert - 26 Nov 2004 14:55 GMT > Why do we need samples? many patients rely on samples because they have no other way to buy medications.
Kurt Ullman - 26 Nov 2004 15:06 GMT >> Why do we need samples? > >many patients rely on samples because they have no other way to buy >medications. Even those with insurance (and the insurance company) may benefit in man instances. For example, I went through four allergy medicines before I found one that had maximum effect with minimal side effects. Got a couple weeks of samples so I did not get a month's supply and then had to throw some away.
-------------------------------------------------------- "Writers even write the silences" -J. Michael Straczynski
beachhouse - 29 Nov 2004 14:17 GMT >>> Why do we need samples? >> [quoted text clipped - 9 lines] > -------------------------------------------------------- > "Writers even write the silences" -J. Michael Straczynski
As I stated in my original post, patients should NOT be maintained on sample medications. I'm speaking about medications for serious *chronic* illnesses with potential for mortality/morbidity if suboptimally treated -- not those for mild, temporary problems (like allergic rhinitis)
outrider - 26 Nov 2004 15:54 GMT > > Why do we need samples? > > many patients rely on samples because they have no other way to buy > medications. Many people would be able to afford medications if the cost didn't include "free" samples, direct to consumer advertising, marketing and promotion.
Zee
Mark Probert - 26 Nov 2004 16:21 GMT > > > Why do we need samples? > > [quoted text clipped - 4 lines] > include "free" samples, direct to consumer advertising, marketing and > promotion. Free samples predated the rise in direct to consumer advertising, marketing and promotion.
outrider - 26 Nov 2004 16:53 GMT It's a spectrum which includes "free" samples. And you can add astro turf to that list I previously posted.
Zee
Ed Mathes - 26 Nov 2004 19:05 GMT But, back before Pharma, I could get concert & show tickets(movie, theater), go golfing, go to the amusement park, include my family in "events", etc.
Now, I get lunch a couple times a week, an invitation to an occasional dinner with a speaker..maybe once or twice a month, pens & pads of paper.
And let's not forget the extremely lovely female reps who call on my office(which, no matter how hard I try, I don't get...even when I sign for them ;-) ).
I am not sure where the money spent on detailing before Pharma went after Pharma....certainly not to reducing medication cost. Probably to direct to consumer advertising.
A marketing budget is a marketing budget I guess.
Another minor factoid....in 1995 there were about 20,000 reps. The last number I heard, for 2002 I believe, was 60,000 reps.
Also, everyone forgets About the "deals" HMOs make with the manufacturers...carry a product as "preferred", get it at a discount. Bundle products together (say Lipitor and Norvasc as preferred), get a bigger discount.
In my small part of the world, people with insurance have a "tiered" system...Tier One are generics and the lowest co-pay ($5-10), Tier 2 are the preferred agents ($15-25), and Tier 3 are non-preferred ($30 up to 1/2 the price...average co-pay is probably $60.00). But, like everything else in health care, the "out-of-pocket" people end up paying full price.
You should also know that not everyone is willing to pay for branded medications. Even a second-tier copay is too much for people.
Look, I agree medications, especially branded meds, are expensive.
I think meds should be the same whether they are sold in Canada, Germany, Belgium or the U.S. I think the "patent period" should be shortened, allowing generic manufacturer's quicker access to branded medications, although Claritin and Augmentin, as generics, aren't much less expensive than their brand-name counterparts. Generic Lovestatin 40mg still costs $65.00/month ...and if you take 80mg, double that. Or, buy Branded Lescol XL 80mg for $67.00/month. Generic Paroxitine 20mg = $71.00/month Vs Brand name Paxil 20mg @ $79.00/month Vs Paxil CR 25mg @83.00/month.
Everyone is bitching but no one is offering anything in the way of a "solution".....other than close down the pharmaceutical companies and practice homeopathy (which will never happen).
Ed
> > > > Why do we need samples? > > > [quoted text clipped - 7 lines] > Free samples predated the rise in direct to consumer advertising, marketing > and promotion. outrider - 26 Nov 2004 19:14 GMT No one is offering anything in the way of solution? Did you not say recently you hadn't posted here for six years? You've got some catch up reading to do boyo.
Zee
Steve Harris sbharris@ROMAN9.netcom.com - 27 Nov 2004 01:50 GMT > I think meds should be the same whether they are sold in Canada, Germany, > Belgium or the U.S. I'll go for that, and we could easily make it happen.
> I think the "patent period" should be shortened, allowing generic > manufacturer's quicker access to branded medications, although Claritin and [quoted text clipped - 3 lines] > $67.00/month. Generic Paroxitine 20mg = $71.00/month Vs Brand name Paxil > 20mg @ $79.00/month Vs Paxil CR 25mg @83.00/month. COMMENT
I think the patent period should be lengthened, actually. As a matter of fairness; why should authors and composers have a longer period of time to profit from the fruit of their intellectual labor than scientists and technolgists? What do we really value in this society-- drugs that save our lives, or movies that entertain us this weekend? Well, you get what you protect, and what you pay for.
Also, a longer tech patent would help as a matter of amortizing/discounting the unavoidably high cost of R&D and regulatory burden over longer time. Shorten the patent period enough and you'll get *no* R&D (in India for more than 30 years they tried lowering it to zero by stealing other counties' drugs, and their R&D dropped to 5% of what it was-- all devoted to reverse engineering). A drug patent period of 50 years would probably significantly lower the difference between brand and generic costs.
That said, some of the high cost of generics is due to the increasingly high cost of entry into the generic market. The FDA is starting to charge developers for its services. I recently had to look at the cost for application for licence for new formulation of a generic I've developed for animals. Application fee alone to the FDA is $119,000, and no guarantees you won't be told to turn around and do all your animal testing again. The problem with animals is only chickenfeed of the problem when it comes to drugs for people.
> Everyone is bitching but no one is offering anything in the way of a > "solution".....other than close down the pharmaceutical companies and > practice homeopathy (which will never happen). > > Ed COMMENT
Since only 10% of the total US $1.5 trillion health care cost goes for drugs, drug companies aren't the source of our problems. I would suggest we look instead to why we pay so much more than anybody else for health care overall. Again, it's not the drugs. We pay nearly 15% of our GDP for healthcare, and Canada runs about 10% and UK around 7%. The higher cost we pay for drugs can't possibly account for more than a tiny fraction of that. If we paid half as much as we do for drugs (comparable to Canada), we'd go down to 95% of our present spending, which would be 14.25% of GDP. Big deal. Not the problem.
The big problem in the US, is we have a terrifically *inefficient* health care system, which doesn't cover preventive care, so a lot of people go without it. That's penny-wise and pound-foolish. It then costs us, as a society, plenty when they do need it, because of course they don't pay for it, and of course we can't just let them die when they get really ill. So it comes out of taxes.
We also, unlike just about every other Western country, really suck at database collection of health care data, which results in endless duplication of services. That's not only expensive but also dangerous.
I'm tired of hearing that people aren't "covered" by insurance in the US. Everybody's covered, 100%. The *problem* is that they're only covered at the top end, from the point that they need a hospital (or sometimes only from the time they collapse in the ED waiting room). So the obese hypertensives who don't get treated for hypertension, are covered only from the time they need dialysis for the rest of their lives. And the obese smokers get their ventolators when they get pneumonia, and they get their coronary bypass when they have chest pain. But before that, they get nada. But the ICUs and ventilators and bypasses and so forth are very expensive. They are a lot of that extra half-trillion bucks we could be saving.
Of course, there are structural problems. People wait for non-emergent operations in Canada, and for MRIs (big deal-- most MRIs in the US are a total waste of money). In the UK it's a little worse, as you have a pretty hard time getting dialysis past the age of 60, and they won't bypass you unless they can't do anything else and you can't get out of bed. In the US, by contrast, you can see demented 80-year-olds get dialyzed. And if you have insurance and walk into any hospital complaining of pain from your neck to your gain, you've eventually going to get a cardiac cath.
What do we do about all this? Single-party payor presents itself as an option. I hear screams about socialized medicine, and I've made some of them myself. But face reality: we're half-way to socialized medicine already. Literally. We only spend NOW just 20% of our health care dollars out-of-pocket, and 30% more, as private insurance. The rest-- that other 50%-- is paid by tax anyway. How much would it be worth it to us to cut our total bill for all that by 30% or more, by going to a system that costs us only 10% of GDP? The only thing that would happen if we did that, is the out of pocket part, or maybe the insurance part, if you like, would simply go away. All other costs would stay the same. So the horrid socialized medicine simply makes ALL your out-of-pocket costs disappear. In return for that you get Canada.
Well, maybe not quite that good. As noted, Canada benefits by having half the % obese people the US does, and a lot less illegal immigration from their South. But we can't fix either of these problems by denying the people involved preventive care, unless we're really prepared to let them die in the gutter when they get really ill. Libertarians take note. Meanwhile, we either have to build a high wall between us and Mexico, or else change our system. We can't really go on the way we're going.
And debates about the high cost of prescription drugs are just diverting us from these issues. Drugs, however expensive, are mostly preventives to more expensive stuff if you can't get them (we can sort out which drugs that's NOT true for, and not cover them, very much as the HMOs do). If the rest of the drugs were 98% covered for all (a tiny co-pay to keep people from waste), and the government as single buyor negociated directly with manufacturers in all counties for the wholesale price for those medications, I will guess that we'd save net money in the health care system, over all.
SBH
beachhouse - 29 Nov 2004 14:16 GMT "Steve Harris sbharris@ROMAN9.netcom.com" <sbharris@ix.netcom.com> wrote in message news:79cf0a8.0411261750.2d379544@posting.google.com...
<snippage>
> We also, unlike just about every other Western country, really suck at > database collection of health care data, which results in endless > duplication of services. That's not only expensive but also dangerous. <snippage>
Amen. It can't just be a passive database -- it must include software (google is more advanced than most medical record systems) that allows the physician to *search* (what a novel concept) an ever-increasing number of electronic reports/clinic notes, etc.
Quality of care also suffers from endless, pointless "me too" duplication of H-2 blockers, PPI's, cox-2 inhibitors, and ARB's --- all designed to make competing drug companies profitable, rather than really advancing medical care.
<snippage>
> And debates about the high cost of prescription drugs are just > diverting us from these issues. Drugs, however expensive, are mostly [quoted text clipped - 7 lines] > > SBH but *which* drugs should be covered "for all" -- every conceivable prescription drug that's manufactured? There *has* to be some kind of formulary that excludes some of the me-too crap that is flooding the marketplace.
outrider@despammed.com - 29 Nov 2004 23:40 GMT > "Steve Harris sbharris@ROMAN9.netcom.com" <sbharris@ix.netcom.com> wrote in > message news:79cf0a8.0411261750.2d379544@posting.google.com... [quoted text clipped - 10 lines] > (google is more advanced than most medical record systems) that allows the > physician to *search* And the patient. Because, see, the patient has already learned how to use google, and likely surprised his/her physician with a coupla tidbits. Or 12.
Zee
(what a novel concept) an ever-increasing number of
> electronic reports/clinic notes, etc. > [quoted text clipped - 21 lines] > There *has* to be some kind of formulary that excludes some of the me-too > crap that is flooding the marketplace. Steve Harris sbharris@ROMAN9.netcom.com - 01 Dec 2004 01:38 GMT > Quality of care also suffers from endless, pointless "me too" duplication of > H-2 blockers, PPI's, cox-2 inhibitors, and ARB's --- all designed to make > competing drug companies profitable, rather than really advancing medical > care.
> but *which* drugs should be covered "for all" -- every conceivable > prescription drug that's manufactured? > There *has* to be some kind of formulary that excludes some of the me-too > crap that is flooding the marketplace. COMMENT:
Of course. And it's happening in hospitals, HMOs, and every other plan that has a prescription benefit. Though (as I've said here before) I have a slightly different take on this, especially when it comes to preventive drugs, due to my habit of trying medications on myself to see what they feel like. I get a lot of samples, and I've tried dozens of different drug in each of all kinds of classes, from cholesterol meds to antihypertensives to antidiabetic meds to antibiotics, etc. I have a mild case of metabolic syndrome (X) and I do a lot of labwork on myself in the course of testing some of my own nutritional supplements, so I also experiment on myself quite a bit. I don't recommend this for anybody but a pro. But I've learned a lot, at least about my own body.
Boy, you have no idea what wierd side effects some of these things can have! Some of them you won't even find in the package insert. And many of them totally idiosyncratic. I can't tolerate one H2 blocker due to an awful metallic taste in the mouth. Others are fine. One causes GI upset every time. Some NSAIDS hurt my stomach; others don't. It seems to have no relationship to COX selectivity, so long as I suppress acid. Beta blockers give me nightmares. I'm allergic to thiazides, but don't break out-- I just itch where my clothing's tight. I cough with every single ACE inhibitor, but ATBs work okay. Except I metabolize them rapidly and get wild BP swings. I finally found I could use b.i.d. olmesartan (Benicar) to get a really smooth and consistent BP response, go figure. It's supposed to be once-a-day. But THAT drug, expensive as it is, turned out to be the perfect drug for ME. I cut 40 mg tabs into approximate eighths, which takes some dexterity (since they try as hard as possible not to make them even easily quarterable). At 5 mg b.i.d. it's about 40 cents a day. Not expensive. But try getting your HMO or your HMO doc to go through all of that. Or to go FOR all of that. Hell, you have to be a doctor treating yourself (which is what I am) to get it sorted out even that well.
Here's another tale out of dozens I could tell. I have a particular diabetic patient who doesn't get nearly the LDL response he needs from max (80 mg) doses of pravastatin or atorvastatin. But gets a fantastic response, with no LFT hike, with just 40 mg simvastatin. This was not understandable until I found out he's grapefruit juice fiend. Take him off his juice and simvastatin's no better than the others; I did the labs. The catch: his local Blue-Cross plan won't pay for simvastatin (Zocor). They send you, as the doc, a little chart with % LDL lowering per dollar per day per patient, and Zocor is in the wrong quadrant. Lipitor and Pravachol are covered. I sent the chart back to them with a letter and the suggestion that they put in an entry for Zocor and grapefruit juice. Bureaucracy!
But that's not the only problem with these things. You and I know that Zocor and Mevacor and Pravachol have been around long enough to have accumulated some good long term data. All this makes these older statins vulnerable to the newer me-too statins and the HMO wonk with the spread-sheet looking at some artificial endpoint like LDL-lowering per buck. The Lipitors and Baycols and Lescols and Crestors slide through. THEY can low-ball their price, because they didn't ever have to pay for the long-term clinical studies. But you get what you pay for-- we don't know quite how safe they are. I wouldn't take any of the later drugs on a bet, until we know them better. I never prescribed Baycol; I'm conservative about preventives, even secondary preventives.
So I'm all for formularies for covered pharmaceuticals, but if they are national formularies they will need to be really intelligently designed in terms of cost/benefit, and they will need to have lots of mechanisms for individual leeway and exceptions, because people vary hugely in response to various drugs (some of this is psychological, and modern medicine needs a good way of giving people blinded drugs if they're going to be claiming them as insurance-covered agents). That's what we (should be) paying good internists to do-- monitor this stuff and try to separate out the psych stuff from the number-fixing stuff from the really justifiable therapeutics.
And also, somebody needs to do some complicated cost-benefit analyses of what the effect of newer and longer-acting drugs on compliance is. And the same goes for classes of drugs. For example, I doubt the statins will ever do for mortality and long-term morbidity what the antihypertensives manifestly do, but the guy who only takes his b.i.d. antihypertensive on average every other day, when he remembers, or doesn't take it at all when he plans to have sex that weekend, is not saving the system any money because they don't let him have the once-a-day pill. The medical and rehab sequelae from one stroke pays for a heck of a lot of Benicar or whatever the newest drug is, vs. Cheapozin or Cheapolol. So there are places (antihypertensives and diabetes drugs go here) where the payers for the me-too drug can afford to be REALLY liberal, because being liberal actually saves net money. A really rational system with limited resources might, for example, pay for even cadillac antihypertensives, and any antidiabetic drug the patient likes. But cover NO statins, except in diabetics and people with proven coronary disease. And maybe no fibrates at all, except possibly in people allergic to fish, and who have pancreatitis from really high triglyceride levels. Or some-such algorithm, subject to review at several levels. That might save maximum lives per buck. I haven't done the math, but somebody needs to.
And, of course, there are articles about all this on medline, done by M.P.H. guys who really get the idea, so it's not like I'm just thinking of this on my own.
The problem for the US, is that until you get everybody covered by the SAME payor for most of their lives (ie, a single payer/payor national public health system) there's no real incentive to do all the above cost-benefit analysis on prevention, really well and really rationally. People still don't stay WITHIN any given HMOs or any given insurance plan long enough for any *preventive* money spent, to fully pay off (except for the patient). So nobody pays attention to much of it. The patient *should* pay attention, in theory, but patients, as individuals, don't take risks rationally. You see that on the freeway. You see that in our country's spending on defense vs. hospitalization vs. research and prevention. The efficient health-care system has the change to at least partly correct for deep deficiencies in the human brain when it comes to risk-taking behavior.
And I'm enough of a libertarian to figure you should have to have the maximally efficient health care system, if you don't want it. But expect to pay the difference, in that case! Beggars can't be choosers.
Libertarians have suggested a voucher system for public education. Well, we can do the same thing for public health. With lots of caveats to prevent 100% voucher-covered Plans from offering free Viagra, then covering the extra expense by refusing to offer renal transplants or dialysis or chemo for leukemia. That would be fine to a pure libertarian, except that in the real world, people who luck out and need dialysis or cancer treatment don't tend to just die with a stiff-uppper lip, figuring they lost the wager. We've seen all that in the medical insurance wars. It's very much the same issue as seatbelts and motorcycle helmets-- the people who lost the bet and broke their necks NEVER paid their own expensese, so now we don't let them even bet on breaking their necks, at all. A shame. And paternalistic, too. But there you are.
Nothing I've said above is TOO radical, except for the tweeks. In Utah, if you're poor enough to need Medicaid, the state merely gives you a card which gives you "free" (ie, tax-payer funded) full coverage by the state-designated private HMO. And then you're fully covered for everything, including your prescriptions. But of course there's a formulary. And so on.
SBH
Ed Mathes - 26 Nov 2004 18:30 GMT Don't you live in Canada where the price is set by the government?
> Many people would be able to afford medications if the cost didn't > include "free" samples, direct to consumer advertising, marketing and > promotion. > > Zee outrider - 26 Nov 2004 19:12 GMT > Don't you live in Canada where the price is set by the government? > > [quoted text clipped - 3 lines] > > > > Zee And that changes what I have said how? Governments still have to buy the drugs, pharma is still charging whatever it can to cover the cost of "research and development" <cough> and the provincial formularies which decree availability and price differ from province to province.
Basic healthcare, paid for by our taxes, differs from province to province with my province one of three now charging an annual fee ($528). For that annual fee I am covered for emergency and surgery, physician visits and meds while in hospital, but not meds outside of hospital. I have no work health subsidy so I would have to pay the market rate for Lipitor, for example. I also paid the full rate for orthotics and wrist splints recently, to correct problems caused by statins.
Lipitor 20 mg. 30 day supply one per day......$ 79.25
Rehab hospital orthotics......................$425.00 Rehab hospital wrist splints..................$ 68.00
Zee
Ed Mathes - 26 Nov 2004 19:31 GMT Buy Lipitor 40mg and cut it in half.... Or Generic lovestatin. Price out Red Rice Yeast...Nature's Bounty will run you $25.00 USD for #120 600mg tablets.
And the Othotics/wrist splints are not made by pharmaceutical companies.....
Cheaper wrist splints...but the one people who roller blade wear.....what, $20.00? Not quite a fashion statement, but functional.
I have orthotics that cost paid a bit over $600.00 U.S. .... I was responsible for half that. I don't have Dental insurance, nor is it covered by my health insurance
Lipitor 40mg (www.drugstore.com) costs roughly $95.00 U.S. Your $70.25 is Canadian dollars? = $67.39 U.S. Still cheaper.
>Basic healthcare, paid for by our taxes, differs from province to >province with my province one of three now charging an annual fee >($528). Annually?? That's $44.00/month Canadian (37.41 USD)
My family HMO health insurance costs about $700.00/month........and that's the group rate. My cost is $100.00/month with my employer picking up the rest.
If I lose my job, I might, MIGHT qualify for Healthy NY ...... Family of 4 coverage is $350.00/month with no drug benefit.
So boo-hoo poor Zee.
> Lipitor 20 mg. 30 day supply one per day......$ 79.25 > > Rehab hospital orthotics......................$425.00 > Rehab hospital wrist splints..................$ 68.00 > > Zee Mark Probert - 26 Nov 2004 19:41 GMT > Buy Lipitor 40mg and cut it in half.... Or Generic lovestatin. > Price out Red Rice Yeast...Nature's Bounty will run you $25.00 USD for #120 [quoted text clipped - 7 lines] > I have orthotics that cost paid a bit over $600.00 U.S. .... I was > responsible for half that. You got off cheap. My son's orthotics and braces (leg) have cost up to $1900.00.
> I don't have Dental insurance, nor is it covered by my health insurance > [quoted text clipped - 23 lines] > > > > Zee outrider - 26 Nov 2004 20:24 GMT My problems are perhaps not as serious as your son's. Here, it is not possible to buy around, one must go to rehab medicine.clincs associated with medical schools. I know carpal tunnel/extensor tenosynovitis splints and simple corrective orthotics are the least of what they do. However, $425 is what I was charged for what I needed, and the govenment, out of healthcare, pays some top up. Then, someone getting what your son had may be charged a lot more because more is being done, and they may charge that all back to work-related health insurance. It differs for each province too.
Zee
outrider - 26 Nov 2004 20:12 GMT > Buy Lipitor 40mg and cut it in half.... Or Generic lovestatin. > Price out Red Rice Yeast...Nature's Bounty will run you $25.00 USD for #120 [quoted text clipped - 34 lines] > > > > Zee I know you have it rough Eddie. That's why I vote for the government that would continue to subsidize Americans healthcare.
Eddie. Boychick. I notice you kissing butt in your posting exchanges with Beachhouse, Harris and Rind. 'Sup with the sass here? Oh. I'm just a patient.
Zee
outrider@despammed.com - 27 Nov 2004 00:29 GMT > Buy Lipitor 40mg and cut it in half.... Or Generic lovestatin. > Price out Red Rice Yeast...Nature's Bounty will run you $25.00 USD for #120 > 600mg tablets. Whether someone would choose any one of these options is of course up to him/her and the physician. But for your information, and to the best of my knowledge, Red Yeast Rice is not available here, nor is the brand Nature's Bounty. `
> And the Othotics/wrist splints are not made by pharmaceutical companies..... We weren't discussing what was made by pharmaceutical companies alone, but what government paid for and didn't, and healthcare costs in Canada, paid privately, by insurance, or government.
> Cheaper wrist splints...but the one people who roller blade wear.....what, > $20.00? Not quite a fashion statement, but functional. A functional wrist splint cannot be purchased over the counter. This is a medical device and must be made by prescription for each person according to the conditon and or illness being treated, size of the person's arm, wrist, hand etc. and the functional needs which must be met while wearing it. Ie) will it be worn only while sleeping, or while keyboarding, or while operating machinery? Will it enclose the thumb, or not?
> Lipitor 40mg (www.drugstore.com) costs roughly $95.00 U.S. > Your $70.25 is Canadian dollars? Yes. Canada has its own currency.
= $67.39 U.S.
> Still cheaper. Yes cheaper. We have universal health care and even if that does not include the cost of medication wholly, the provincial health authorities buy bulk bringing cost to consumer down. Even to the American consumer crossing the border...
> >Basic healthcare, paid for by our taxes, differs from province to > >province with my province one of three now charging an annual fee > >($528). > > Annually?? That's $44.00/month Canadian (37.41 USD) Yes, that's for basic, and for one adult, and in my province. Most people have other insurance (privately or work related) on top of that, because this basic is very limited. When I say it covers surgery for example, that's not all surgery or all appliances. If I broke my leg I would get the old fashioned plaster cast covered. If I wanted the more effective newer casts which give better recovery, I would have to pay for it.
> My family HMO health insurance costs about $700.00/month........and that's > the group rate. [quoted text clipped - 4 lines] > > So boo-hoo poor Zee. No boo hoo here Ed. I was responding to your statement re goverment and health care coverage with examples. Not having documents here which set it out chapter and verse, I used me as example.
Zee
> > Lipitor 20 mg. 30 day supply one per day......$ 79.25 > > > > Rehab hospital orthotics......................$425.00 > > Rehab hospital wrist splints..................$ 68.00 > > > > Zee Herman Rubin - 26 Nov 2004 18:51 GMT >> Why do we need samples?
>many patients rely on samples because they have no other way to buy >medications. Doctors frequently give samples to patients who they can expect to give them information to send to the manufacturer about effectiveness or dangers.
 Signature This address is for information only. I do not claim that these views are those of the Statistics Department or of Purdue University. Herman Rubin, Department of Statistics, Purdue University hrubin@stat.purdue.edu Phone: (765)494-6054 FAX: (765)494-0558
Ed Mathes - 26 Nov 2004 19:12 GMT "Herman Rubin" <hrubin@odds.stat.purdue.edu> wrote > Doctors frequently give samples to patients who they
> can expect to give them information to send to the > manufacturer about effectiveness or dangers. And where did you glean this knowledge??
We are obligated to report any significant adverse event attributable to medication regardless of the medication....post-release surveillance.
Typically, medication safety and is part of the trials that were done to get FDA approval.
Do you have nay concept of the malpractice implications inherent in your comment? Give a medication to a patient just so I can report side effects? Get real.
I see your a statistician.....Who said "Lies, Damn Lies, and Statistics"?
Ed
outrider - 26 Nov 2004 19:20 GMT Have you read the post I made regarding the offer Montreal cardiologist Colin Rose received last year from pharma for Ezetimibe? $6000 per patient he enrolled on Zetia. Do you think he's the only one?
As for reporting adverse events--that is voluntary in Canada. Is it not also in the U.S.? I can gar.an.damn.tee none of my phsicians have reported what happened. to me.
If there was any such thing as "post release surveillance" FDA whistleblower Graham wouldn't now be standing with his back to the wall.
Zee
Ed Mathes - 26 Nov 2004 19:38 GMT In 25 years I have never been offered money to start patients on a given medication.
I would think it would be unethical to accept something like that, and would certainly be a violation of the PHARMA agreement here.....
As for reporting.....yes, it is voluntary. I said we are obligated to report......
And, just for you Zee.....I had several bad reactions to a popular medication (which I will not name) over a short period of time 3 years ago. I filed 5 adverse event reports and stopped writing for it... I continue to report "significant" events as they happen....which isn't very often.
> Have you read the post I made regarding the offer Montreal cardiologist > Colin Rose received last year from pharma for Ezetimibe? $6000 per [quoted text clipped - 9 lines] > > Zee outrider@despammed.com - 27 Nov 2004 00:03 GMT Of course it's unethical.
$6000, a pen, lunch, a computer or perfume for your wife: we aren't discussing how much you got, but what we call it. (Apologies to Sir Winston Churchill estate).
".....I had several bad reactions to a popular medication (which I will not name...)"
Learned estimates of adverse event reports put them at less than !0 percent of actual events.
But I am very sorry to hear of your adverse reaction. Lucky for you your clinician is conscientious.
Zee
Frankie - 29 Nov 2004 07:09 GMT > As for reporting adverse events--that is voluntary in Canada. > Is it not also in the U.S.? Zee,
In the USA, yes it is. MedWatch is the FDA's Safety Information and Adverse Event Reporting Program. http://www.fda.gov/medwatch/ However, I think adverse reactions are seriously under-reported.
Example: Mother-in-Law had adverse reactions to Zocor, Lipitor and Zetia. Her son has the same problem, but worse. When M-I-L was switched from one drug to another, does this get reported to the FDA by her doctor? Are we to assume that her doctor raced back to his office to transmit an online form to the FDA? Or send a list at the end of the day? or week? If the answer is NO, that is a serious problem and a HUGE loophole. Frankie
Herman Rubin - 30 Nov 2004 21:39 GMT >> As for reporting adverse events--that is voluntary in Canada. >> Is it not also in the U.S.?
>Zee,
>In the USA, yes it is. >MedWatch is the FDA's Safety Information and Adverse Event Reporting >Program. >http://www.fda.gov/medwatch/ >However, I think adverse reactions are seriously under-reported. <Example: Mother-in-Law had adverse reactions to Zocor, Lipitor and <Zetia. <Her son has the same problem, but worse. <When M-I-L was switched from one drug to another, <does this get reported to the FDA by her doctor? <Are we to assume that her doctor raced back to his office to transmit <an online form to the FDA? Or send a list at the end of the day? or <week? <If the answer is NO, that is a serious problem and a HUGE loophole. <Frankie
As I understand it, the doctor is in violation of the requirements to report.
 Signature This address is for information only. I do not claim that these views are those of the Statistics Department or of Purdue University. Herman Rubin, Department of Statistics, Purdue University hrubin@stat.purdue.edu Phone: (765)494-6054 FAX: (765)494-0558
outrider - 30 Nov 2004 21:54 GMT As I understand it, Herman, there is no "requirement" to report.
Zee
Frankie - 02 Dec 2004 04:08 GMT Herman,
What is the your understanding of the "requirement to report"? What is the vehicle used to report? Is there a "tally sheet" that the doctor carries around all day to note when a patient has a serious reaction to a drug? As busy as doctors are today, I can't envision that they have the time or resources to keep up with the number of statin side effects reports.
>From all the people I correspond with that have experienced side effects from statins, most Dr's would be on the phone with the FDA all day. I still think that statins side effects are seriously under-reported, both by doctors and patients.
Frankie
Frankie - 29 Nov 2004 07:33 GMT As for reporting adverse events--that is voluntary in Canada. Is it not also in the U.S.?
MedWatch is the FDA's Safety Information and Adverse Event Drug Reporting Program. http://www.fda.gov/medwatch/
However, I think drug side effects are seriously under-reported.
Example: Mother in law had side effects from Zocor, Lipitor & Zetia. Her son has the same problem, but worse. When her doctor changed her from one drug to the next, did this get reported somewhere? Are we to assume her doctor raced back to his office and transmitted an adverse event form to the FDA? Or does the doctor fill out a weekly or monthly report and submit it to the FDA? If the answer in NO, then there is a serious problem and a HUGE loophole to drug side effect reporting.
Frankie - 30 Nov 2004 04:24 GMT Re: As for reporting adverse events--that is voluntary in Canada. Is it not also in the U.S.?
Zee,
MedWatch is the FDA's Safety Information and Adverse Event Reporting Program. http://www.fda.gov/medwatch/
You download a form and transmit the form directly to the FDA.
BUT...... I do not have much faith that doctor's are using this form to inform the FDA of the adverse side effects their patients are experiencing from statins.
Example: If someone has side effects from say, Zocor and the patient is switched to Lipitor. Does this get reported? And if this patient has a more serious reaction to Lipitor and is switched to Zetia, does this get reported?
This is a very BIG [potential] loophole as to why the FDA may not have the full story on statin side effects.
Frankie
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