From: sbharris@ix.netcom.com (Steve Harris  sbharris@ROMAN9.netcom.com)
Newsgroups: sci.med.cardiology,talk.politics.medicine,sci.med
Subject: Re: JAMA on FDA & PHARMA: Lack of vigilance, lack of trust
Date: 30 Nov 2004 17:38:50 -0800
Message-ID: <79cf0a8.0411301738.372d718@posting.google.com>

"beachhouse" <sendnomail@please.com> wrote in message
news:<cofb01$rk0$1@spnode25.nerdc.ufl.edu>...

> 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 weird 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

From: Steve Harris <sbharris@ix.netcom.com>
Newsgroups: sci.med.cardiology
Subject: Re: Coreg side effect?
Date: 3 Sep 2005 19:08:42 -0700
Message-ID: <1125799721.977522.161010@g47g2000cwa.googlegroups.com>

tedkord@excite.com wrote:
> Hi, all - a question for anyone who may know.
>
> I've had hypertension for a few years, and for
> some time I was on Lisinopril, HCTZ and Atenolol.
> Just about a month ago, my doctor changed me from
> Atenolol to Coreg (25mg/1X-day)
>
> Within a week, I had a fever and extremely sore skin.
> The sore skin started as patches, and soon spread to
> my whole body. It's a pain like when you have a fever,
> and your clothes scratch, but more intense. I went to
> my doc (who was on vacation, so I saw another one there)
> and he put it down to a reaction to nomex (which I wear
> at work). I tried to explain to him that I've been
> wearing nomex for years, and that the problem started
> on my days off, but this guy won't let his diagnosis go.
>
> Anyway, I suddenly start thinking that I've recently
> started this new med, and maybe it's a reaction. I stop
> taking it, and within two days, it's gone. I talk to the
> doctor about it, he poo-poohs the idea, so I restart it.
>
> Again, I've got fever and sore skin, but I also have a
> real infection (ear infection, something respiratory).
> I stopped the Coreg again, and the doctor put me on
> Biaxin XL. The biaxin started clearing up the ear
> infection and chest/head infection, so once again I've
> started the Coreg again.
>
> Now, all the symptoms have cleared up except I have
> intermittent fever and sore skin again. Also some
> pretty extreme fatigue. (I've been on the Biaxin 5
> days now)
>
> I can't find anything about Coreg causing this pain in
> anyone's skin before. Anyone heard of it?


COMMENT:

Something like 0.1% of Coreg users reported an "exfoliative dermatitis"
which would be expected to produce skin pain, redness, and scaliness.

Really, it's not worth it. Not all side effects of all drugs will be in
the PDR. You might want to consider going back on atenolol until all
all symptoms are completely gone. Then try the Coreg ONE MORE TIME. If
the skin problem comes back, or start coming back, see if you your
doctor will help you file a drug side effect report to the FDA.  And
don't ever take the stuff again. Treat it as a drug intolerance or
"allergy".

SBH

From: Steve Harris <sbharris@ix.netcom.com>
Newsgroups: sci.med.cardiology
Subject: Re: Coreg side effect?
Date: 4 Sep 2005 17:41:06 -0700
Message-ID: <1125880866.142715.46450@g44g2000cwa.googlegroups.com>

tedkord@excite.com wrote:
> > COMMENT:
> >
> > Something like 0.1% of Coreg users reported an "exfoliative dermatitis"
> > which would be expected to produce skin pain, redness, and scaliness.
> >
> > Really, it's not worth it. Not all side effects of all drugs will be in
> > the PDR. You might want to consider going back on atenolol until all
> > all symptoms are completely gone. Then try the Coreg ONE MORE TIME. If
> > the skin problem comes back, or start coming back, see if you your
> > doctor will help you file a drug side effect report to the FDA.  And
> > don't ever take the stuff again. Treat it as a drug intolerance or
> > "allergy".
> >
> > SBH
>
>
> Thanks for the reply. I should have stated earlier that the soreness
> of the skin doesn't come with any rash, scaliness, redness, or
> swelling. Ibuprofen/Tylenol do dull it a bit. And, it seems to start
> and be most intense at joints - wrists, armpits, behind the knees.
>
> I stopped the Coreg again today (first full day off it. If it stays
> true to form, I should shake the soreness in another day or two.)
>
> Thanks again.


Good. But really you should be on atenolol to replace it. Beta blockers
in general shouldn't just be stopped all at once. Best to replace them
with another beta blocker, or taper off slowly. Oviously you can't do
the last, so do the first.

S.

From: Steve Harris <sbharris@ix.netcom.com>
Newsgroups: sci.med.cardiology
Subject: Re: Coreg side effect?
Date: 5 Sep 2005 18:59:03 -0700
Message-ID: <1125971943.421697.52240@g43g2000cwa.googlegroups.com>

tedkord@excite.com wrote:
> I'm going back to see my doctor tomorrow, and ask to
> go back on atenolol.
>
> However, Coreg may not be the culprit. I've been off
> it 2 full days now, and my skin is still on fire.
> Even alternating advil/tylenol every 3 hours only
> dulls it. Now, however, it's mainly across my whole
> back and chest. (Still nothing visible) And, the fatigue
> has lessened quite a bit, but I do in general feel blah.
>
> In general, how long would it take for the effects of
> the drug to leave my system? I'm totally unknowledgeable
> about these sort of things.
>
> And again, thanks for all the prompt and informative
> replies.


COMMENT:

Half life is up to 11 hours, so at 4 halflives you still have 6% of the
drug in your system. If it's an allergy, it can take quite a while.
Another day and it's still 1.6%. Give it a week.