Re: JAMA on FDA & PHARMA: Lack of vigilance, lack of trust
Ed Mathes
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.
"outrider" <outr...@despammed.com> wrote in message
news:1101149330.3...@c13g2000cwb.googlegroups.com...
> 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
I use Vytorin 20/10, thank you very much.
"outrider" <outr...@despammed.com> wrote in message
news:1101169984.9...@z14g2000cwz.googlegroups.com...
>
> Ed Mathes wrote:
> > 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: BGO...@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
Ed Mathes
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...
"outrider" <outr...@despammed.com> wrote in message
news:1101176262.5...@f14g2000cwb.googlegroups.com...
>
> Ed Mathes wrote:
> > 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
listener
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" <ema...@rochester.rr.com> wrote in news:_ixod.11560$AL5.300
@twister.nyroc.rr.com:
beachhouse
"Ed Mathes" <ema...@rochester.rr.com> wrote in message
news:OTwod.11552$AL5....@twister.nyroc.rr.com...
> 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
"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
"beachhouse" <sendn...@please.com> wrote in message
news:cnvhfl$k7m$1...@spnode25.nerdc.ufl.edu...
beachhouse
>
> 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
> 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.
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.
David Rind
> 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.)
--
David Rind
dr...@caregroup.harvard.edu
Ed Mathes
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".
> > 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.
> 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
> > 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.
>
> 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
Ed Mathes
<outr...@despammed.com> wrote in message
news:1101343786.5...@f14g2000cwb.googlegroups.com...
>>
> 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?
William Wagner
outr...@despammed.com wrote:
> 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
And where can we find coenzyme q10 supplementation that is validated?
Looks like a deep pit to me!
Bill
--
Zone 5 S Jersey USA Shade
Serious Vision Problems? --> http://www.ocutech.com/
David Rind
> 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.
--
David Rind
dr...@caregroup.harvard.edu
listener
@twister.nyroc.rr.com:
Zee's (outrider's) cholesterol level is over 500 (or at least it was
earlier this year...).
L.
Steve Marcus
"outrider" <outr...@despammed.com> wrote in message
news:1101348814....@z14g2000cwz.googlegroups.com...
> 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
--
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
Probert@lumbercartel.com Mark Probert
> Why do we need samples?
many patients rely on samples because they have no other way to buy
medications.
Kurt Ullman
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
Probert@lumbercartel.com Mark Probert
> include "free" samples, direct to consumer advertising, marketing and
> promotion.
Free samples predated the rise in direct to consumer advertising, marketing
and promotion.
Ed Mathes
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.
>
>
Herman Rubin
Mark Probert <Mark Pro...@lumbercartel.com> wrote:
Doctors frequently give samples to patients who they
can expect to give them information to send to the
manufacturer about effectiveness or dangers.
--
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
hru...@stat.purdue.edu Phone: (765)494-6054 FAX: (765)494-0558
Ed Mathes
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 @ $79.00/month Vs Paxil CR 25mg @83.00/month.
Everyone is bitching but no one is offering anything in the way of a
"solution".....other than close down the pharmaceutical companies and
practice homeopathy (which will never happen).
Ed
"Mark Probert" <Mark Pro...@lumbercartel.com> wrote in message
news:iNIpd.146$vP4...@fe08.lga...
Ed Mathes
"Herman Rubin" <hru...@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
Ed Mathes
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
>
Ed Mathes
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.
"outrider" <outr...@despammed.com> wrote in message
news:1101496820....@z14g2000cwz.googlegroups.com...
>
>
> 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
>
Probert@lumbercartel.com Mark Probert
> 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.
You got off cheap. My son's orthotics and braces (leg) have cost up to
$1900.00.
Steve Harris sbharris@ROMAN9.netcom.com
> 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
> 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.
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
"David Rind" <dr...@caregroup.harvard.edu> wrote in message
news:co2pg9$q99$1...@reader1.panix.com...
> beachhouse wrote:
>> There is simply no reason for every patient with hyperlipidemia to be
>> prescribed a combination agent as a first-line drug. None.
>> Now, I could see for those not achieving target LDL, it's a good option.
>> I"m happy it's out there. But whether you realize it or not, you've been
>> detailed by your specialist colleagues (who may be member's of that drug
>> company's speaker's bureau) and by the reps.
>
> Actually, I think you could go further than that. There's no published
> evidence that ezitimibe, one part of the combination being discussed, has
> any clinical benefits either alone or in combination with other drugs for
> cholesterol. It has been shown to reduce LDL levels, but that is not the
> same as showing that it has a favorable effect on clinical outcomes.
> (There are no trials showing it doesn't have clinical benefits either. No
> clinical endpoint trials have been published.)
>
> --
> David Rind
> dr...@caregroup.harvard.edu
>
Have you seen the idiotic way the combination simvastatin/ezitimibe product
t is being marketed to patients on T.V.?
"it works on *both* kind of cholesterol.... you get cholesterol from your
parents and from your food..."
implication being that you need 2 drugs by necessity to achieve meaningful
lipid lowering.
what crap.
beachhouse
"Kurt Ullman" <kurtu...@yahoo.com> wrote in message
news:wDHpd.922$u81...@newsread3.news.pas.earthlink.net...
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)
beachhouse
"Steve Harris sbha...@ROMAN9.netcom.com" <sbha...@ix.netcom.com> wrote in
message news:79cf0a8.04112...@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
> 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
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.
David Rind
> 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.
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.
--
David Rind
dr...@caregroup.harvard.edu
Frankie
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
beachhouse
should too...
"David Rind" <dr...@caregroup.harvard.edu> wrote in message
news:cogbg6$3qn$2...@reader1.panix.com...
Herman Rubin
Frankie <bir...@gmail.com> wrote:
>> 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.
Steve Harris sbharris@ROMAN9.netcom.com
> 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.
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]
outr...@despammed.com
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
Steve Harris sbharris@ROMAN9.netcom.com
> 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
Frankie
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