Drugmakers not following up speedy approval-US study 
Author Message
 Drugmakers not following up speedy approval-US study

Quote:
>>That is all completely beside the point. The drug companies know what

their responsibilities are when they put a drug thru this fast-track
process, and they benefit financially (bilions of dollars) by doing so,

and to not follow up and live up to their responsibility is at best
disengenuous and at worst may be causing more serious problems for the
very people that their {*filter*} are supposed to help.

I cannot believe that you, or anyone else, would want to defend this
greedy and harmful lack of social and fiduciary responsibility. <<

COMMENT:

Have you ever done a clinical study?  The problem with "promising" to
do one in the future is you never know what you might be letting
yourself in for.  The drug you're making might not sell well, and you
may have trouble getting the numbers. The patients may be
uncooperative, and so on. There are all kinds of reasons post clinical
studies can fail or take times which somebody thinks is "too long".
And not all of them are the drug company's fault.

Is everybody to blame for even the possiblity of somebody not
performing on a promise?  Sure, the same way everybody's to blame when
anybody defaults on ANY sale made on credit. The problem with drug
sales "on credit" is that the bank can repo your car, and it can even
evict you from a home on which you missed house payments. That leaves
you and the kids standing out on the cold sidewalk in your slippers,
but at least you're breathing. What happens when a pharm company will
not or cannot perform, is that third parties take a much worse{*filter*}ing
than that, and it's not pretty. Essentially what happens (or what
you're arguing *should* happen) is that anybody taking such a drug gets
a letter.

"Dear Taxpayer. Somehow or other, somebody couldn't come up with enough
money or time or will or something or other to do a proper study on the
drug you're taking, in the time which We decided was enough time. So
therefore, the drug is being withdrawn from the market, and you are
gunna die. We are sorry for any inconvience this may cause Feel free to
write your congressperson. Love, The FDA. Protecting and Serving since
1906."

Needless to say, this doesn't go over very well. The FDA only survives
now because most people who die of some disease which could be cured by
some experimental drug that is stuck in the regulatory pipeline, never
know what they're missing.  So they can't and don't blame the
government. But let them take a few doses of something that works on
their leukemia or HIV, however, and now the camel has its nose in the
tent. Take the stuff away, and they DO tend to write their
congresscritters, as their {*filter*} counts take a dive. So it's a mess.
And that's exactly what has happened.

I am frequently amazed that Classical Liberals, who figure they are the
natural champions of all poor and the dispossessed and the voiceless
and the discriminated against, suddenly seem to suffer some kind of
brain-fog when it comes to health and disease.  Naturally, they want
everybody to have every kind of medical care that exists, and have it
free, and have it now.  But when it comes to kinds of medical care that
are in the process of being developed, Liberals couldn't care less. No
subsidies do they propose. Not only do they not "see" the medical care
of the future, they don't even believe in it. And if told about it,
hold it in deep suspicion. For they have turned over responsiblity for
the invention of it to people they consider essentially bad and
untrustworthy to begin with, so how else indeed can they regard the
eventual product? The fact that nearly all the existing healthcare
which Liberals insist on buying for the poor has come into existance in
this same fashion, seems to make little impression on Liberals.  They
don't like the inventors, they don't like the products--- and they
think that those that exist are all horribly overpriced. :)  It's the
Woody Allen joke all over again: The cooking.net">food is terrible at this resort!
And such small portions! That's Liberalism. Pharmaceuticals are
dangerous and bad in America, and even more shocking is that the poor
have no access to them....

SBH



Mon, 19 Nov 2007 03:47:24 GMT
 Drugmakers not following up speedy approval-US study
Quote:
>>That was a straight forward response as to why drug companies do not do what

they are suppose to do and why the FDA should not rely on them to do
it.
Vioxx was fast tracked in Canada by Canadian drug pharm companies
making
deals with government regulatory agencies.
It didn't help them did it? <<

COMMENT

And why should it?  If you rely on the US/FDA system of drug
development, you end up taking the same risks along with the rewards.
Canada has long forsaken its burden of medical research and R&D costs,
allowing it to be done elsewhere so that Canada can reap the benefits
without having to pay the costs. This is not because Canada is poor--
it has about the same per capita income as the US.  Rather, it's that
Canadians are too cheap. Canadians hold the standard British idea that
healthcare ought to be free, and even though they pay only half as much
for it as Americans do, they still think it's too much.

Speaking of Vioxx, anybody who believes that pharamaceutical companies
make {*filter*} and guaranteed profits, is invited to put their money
where their mouth is, and invest their retirement nest-egg in the top
10 grossing pharma companies, starting with MRK. Think of it as your
own private little biotech bonanza.  You should make out like a bandit,
right?

In fact, I hope all you Liberals did that LAST year, and bought the
{*filter*}ly profitable Merck at $46 a share and Pfizer at $36.  Figuring
to finance all your wars against the "legal drug cartel" by using their
own *guaranteed* {*filter*} profits against them. Yeah, baby.  Such a
great plan.  Can't fail.  Right?  No?

When you figure out what's wrong with this simple idea, you'll be
smarter.

SBH



Mon, 19 Nov 2007 05:18:36 GMT
 Drugmakers not following up speedy approval-US study

Quote:

>> SBH

> "...die of some disease which could be cured by
> some experimental drug..."

> Could we have a list of {*filter*} on the market today which cure? (Only one
> drug per class please).

Could we have a definition of "cure" please?

m



Mon, 19 Nov 2007 08:56:01 GMT
 Drugmakers not following up speedy approval-US study
"...die of some disease which could be cured by
some experimental drug..."

Could we have a list of {*filter*} on the market today which cure? (Only one

drug per class please).

Zee

COMMENT:

Why the artificial limitation?  Especially since we create the drug
classes themselves partly on the basis of how they work.

As you know, there are dozens of curable cancers and hundreds of
curable infectious diseases.

Thrombolytics are curative in many instances of clots in lung, heart,
brain and other vasculature.  Acne and hypertension can sometimes be
cured with a single course of drug therapy (followed in some cases by a
life style change). Pregnancy can cause hypertension  and high {*filter*}
sugars which requires {*filter*} if the mother is to survive the
pregnancy--but which cease to be needed when it's over. Some autoimmune
problems and bouts of acute asthma can also be treated by a single
course of {*filter*}. Eat a peanut you're allergic to, or get stung by the
wrong bee, and epinephrine may save your life. Ditto for the many, many
antibody antivenins and antitoxins available. And there are {*filter*} for
acute attacks of problems from Wilson's disease to hemochromatosis,
that will get you through the first bout, followed by which a change in
life style constitutes the cure (but without which, you might never get
the chance to change your life). You can put put type II diabetic coma
in here also. acute GI bleeding from ulcer, thyroid storm from
infection, and so on. Antiarrhythmics and antiepileptics can also allow
survival from an otherwise fatal electrical disturbance in heart or
brain, caused by trauma or clot or infection. Following all of which,
need for the drug may cease to exist.

There are many life-threatening cases of trauma, shock, drowning,
asphixia, burn, heatstroke, hypothermia, etc, etc, which require
support with many kinds of intravenous fluids, electrolytes, nutrients,
and oxygen.  Patients who make it though the healing process from these
insults, are often cured. I don't know if analgesics and anxiolytics
are "curative," in the usual sense, but they allow the patient to make
it though a self-limited process which otherwise would be far more
life-threatening.  Certainly this is true for general anesthestics!
You still might be cured without the drug, but you'd make much more
noise.  A cure for a long bout of screaming, then.  This also goes for
acute bouts of psychiatric decompensation. The straightjacket and
padded room isn't a cure, but it can keep you alive until you mind
heals. {*filter*} can do that also, with less leather. Antidepressants and
even neuroleptics aren't necessarily for life.

Tranfusions and organ transplants can be curative for life-threatening
problems. Though not strictly {*filter*}, all of them are supported by
{*filter*}, and would be impossible otherwise. Do you know why the {*filter*}
doesn't clot in the bag, Zee?

Surgery of all kinds is supported by {*filter*}, and would not (and was not)
much fun without them. Many surgeries would be flatly impossible
without drug support. From absessed teeth to diseased gallbladders to a
need for a pacemaker or a repleacment for a worn-out joint, surgery can
be curative.

That's not exhaustive, and is of the top of my head. And it does not
even get to "management" of chonic disease with drug therapy, which may
well be worthwhile even if not curative. Imagine if we'd had any of our
modern antihypertensives for Woodrow Wilson or FDR.  

SBH



Mon, 19 Nov 2007 09:46:23 GMT
 Drugmakers not following up speedy approval-US study

Quote:
>"...die of some disease which could be cured by
>some experimental drug..."

>Could we have a list of {*filter*} on the market today which cure? (Only one
>drug per class please).

There are beginning to be some candidate cancer {*filter*}. And
antibiotics, of course.

I suppose vaccines don't count. You have to get sick first?

By "cure" do you mean that you take the drug once and never need
anything again for the illness? Twice? Indefinitely?

I have a friend with carpal tunnel syndrome. She had a steroid
injection and never has needed any further treatment. Is she
cured?

Just seeking some clarification.
--
Jim Chinnis   Warrenton, {*filter*}ia, USA



Mon, 19 Nov 2007 10:11:22 GMT
 Drugmakers not following up speedy approval-US study

Quote:
> I suppose vaccines don't count. You have to get sick first?
>>That's right. And even Smallpox has returned. We didn't cure. We

postponed.

Nonsense. Smallpox was eradicated from the wild in 1980 and has never
returned. If it still exists, it's in a dewar somewhere as a germ
warfare agent, and would be used by terrorists. So far, it hasn't been.
It's a WMD. You know, the ones we keep looking for, and not finding?
Right now it's a Boogeyman.

If it ever does get out, it will be some work to isolate and vaccinate
around the cases, but it's doable (it was done in Africa under far
worse conditions than we'll ever have in the US). There's enough
vaccine on hand at the CDC to vaccinate everybody. But they won't need
to. Smallpox is only mildly contageous. It's not transmitted by people
who aren't already very ill, and one can vaccinate all contacts of ill
people for several days after contact, and prevent it. Too bad we can't
do that with the flu-- but the flu doesn't behave like smallpox, and is
a much harder disease to contain, than smallpox would be.

SBH



Mon, 19 Nov 2007 11:41:39 GMT
 Drugmakers not following up speedy approval-US study

Quote:
> As you know, there are dozens of curable cancers and hundreds of
> curable infectious diseases.
>No I don't know. Curable cancers? Just more spin on the actuality of

it. It's just so much marketing and shining the patient on when you
tell them they are cured if their cancer doesn't reappear within five
years. When it reappears two years after the 'cure' what do you call it

then? <<

COMMENT:

You have to pick some time frame for "cure" to be operative. If cancer
appears 19 years later, what do you call it THEN?  Do you think having
once had cancer, that makes you immune to cancer, even the same kind of
cancer, for the rest of your life? Nobody promises that. Cancer's a
common disease.

Various kinds of cancers have various kinds of survival curves. Some
change more than others from 5 years to 20 years. Others change very
little, and for those cancers, 5 years is a good estimate. If you got
some generic cancer 20 years ago, you'd have 63% chance of being alive
relative to your peers without cancer, at 5 years. If all cancers that
*could* be cured *were* cured by then, that number would not change at
10 years. In fact, it drops to 57%.  Then 53% at 15 years and 51% at 20
years. So some people are dying of the initial cancer or the same kind
of cancer as they first had, even between 15 and 20 years later. But
not many.  In fact, 2% over-all. Most of these are {*filter*} cancer, with
some lymphomas. For the latter, it's hard to tell if it's the original
disease or a new one. For the {*filter*} cancer, it's probably the same
disease. For {*filter*} cancer the relative survival figures at 5, 10, 15,
and 20 years are 86, 78, 71, 65%. Still going down at 20 years with new
{*filter*} cancer deaths. But for a disease like ovarian cancer, the
figures are 55%, 49%, 50%, 50% Basically you can see the curve flattens
out by 10 years, and if you haven't died of it by 10 years, you
probably won't by 20 years.

Some cancers are have high relative survival rates at 20 years. Thyroid
and testicular cancers have over 90% relative survival at 20 years.
It's probably safe to say that that's a 90% cure, if the word has any
meaning. There's over 80% relative survival at 20 years for melanoma
and prostate cancer. For thyroid cancers the survivals at 5, 10, 15 and
20 years are 96, 96, 94, 95%. The variation means we're within the
error of the data. But no new deaths means no thyroid tissue left for
cancer to start in again. For colon cancer, by contrast, it's 62, 55,
54, 52%.  There's a drop from 5 to 10 years, but still a small drop
after that. Some of these are surely from another colon cancer, which
you have to expect people who've had once, are at higher risk to get
again, if they still have colon left. But nobody who's had ovarian
cancer once, gets a new ovarian cancer again, because there's no place
for it to start. And you can see that in the survival curve there.

SBH



Mon, 19 Nov 2007 12:40:51 GMT
 Drugmakers not following up speedy approval-US study
Quote:
>>WHO says these children were ill. If they weren't ill with Smallpox

what were they ill with; Dewarpox?
http://www.***.com/ ;<

Vaccinia pox. They got the pox virus used in the vaccine. It wasn't
variola, which is smallpox.  All pox virii are not the same. Some kill
you, some don't. That's what makes the vaccine possible, don't you
know.

Quote:
>>But there's a difference between curing any individual of a disease and

eradicating a disease. I know the difference; and I know by and large,
neither of these goals have been achieved. You can finesse it all you
want. Some of what you have listed is just plain embarrassing for a
medical profession of the 21st century. <<

Smallpox has been eradicated. It will not be back unless from some
cryogenic war virus supply in Russia.  The fact that some danger still
exists is not for the embarrassment of doctors, but rather the
respective departments of defense in the first and second worlds.

Polio would also have long been gone from the wild, if it weren't for
religious zealots who refuse to vaccinate, and some paranoid nuts in
Africa.

Quote:
>>Some of what you have listed is just plain embarrassing for a

medical profession of the 21st century<<

Maybe to people raised watching Star Trek. I myself think what has been
accomplished is quite amazing.

Quote:
>>And yes. I know why the {*filter*} in the bag doesn't clot. Are you going to

tell me it's been cured of clotting? <<

No, just temporarily relieved of the power. It can be added back, if
needed, with calcium.

SBH



Mon, 19 Nov 2007 12:53:41 GMT
 Drugmakers not following up speedy approval-US study
They don't share my way of thinking at all. In most cases I would let
the patient decide what constitutes a disease, and I would also let the
patient pay for the drug, unless completely destitute. That cuts down
on complaining by everybody. If you don't think you're getting your
money's worth out of a drug, don't buy it. There you are. If you don't
like what your doctor charges, don't go back. Very simple.

If you let society define diseases for you, you get democratic
solutions to them. And since democracy has certain inherent problems
(money buys votes) then you get those problems in healthcare.  Stop
complaining. Everybody understands what happens when a bunch of people
have lunch and split the bill-- some ass always wants steak and
{*filter*}, and somebody always only wants a salad and water, and feels
screwed. Well, that's healthcare, too. So long as you insist on doing
it that way, that's what's going to happen. Not my fault.

SBH



Mon, 19 Nov 2007 13:33:10 GMT
 Drugmakers not following up speedy approval-US study
Quote:
>>I'm killin' mesef laffing here SlasherBoi. Keeps me warn du Nord. What

is you smoke toke or pack in your nose before you start posting these I

HATE CANUCKS screeds? Gawd I luv it... do carry on... <<

I don't see you disputing my numbers. Canadian biomed research should
be about 10 or 11% of that of the US, in line with the population
ratio. In fact, it's what, 3%?  Less.  You can smoke it all you like.
Those are facts.

We like your post-docs, though. Send more. Might as well, since they
have nothing much to do up there.

SBH



Mon, 19 Nov 2007 14:01:03 GMT
 Drugmakers not following up speedy approval-US study


So tell us what and where we go to get a real cure?
To your house for milk and cookies?



Mon, 19 Nov 2007 14:16:17 GMT
 Drugmakers not following up speedy approval-US study


Quote:
> You've seen this? They share your way of thinking: pharma develops a
> drug, creates a disease for it, then decides what defines cure.

And the Canadian government wants to provide it for everyone for free.
Did I get it right?


Mon, 19 Nov 2007 14:18:59 GMT
 Drugmakers not following up speedy approval-US study


Quote:
> I'm killin' mesef laffing here SlasherBoi. Keeps me warn du Nord. What
> is you smoke toke or pack in your nose before you start posting these I
> HATE CANUCKS screeds? Gawd I luv it... do carry on...

> Zee

Why do Canadians hate health care workers? Keep them coming south. We love
Canadian doctors and nurses crossing the border.
We love Canadians being forced to come south for treatment.
Quote:


> > >>That was a straight forward response as to why drug companies do not
do what
> > they are suppose to do and why the FDA should not rely on them to do
> > it.
> > Vioxx was fast tracked in Canada by Canadian drug pharm companies
> > making
> > deals with government regulatory agencies.
> > It didn't help them did it? <<

> > COMMENT

> > And why should it?  If you rely on the US/FDA system of drug
> > development, you end up taking the same risks along with the rewards.
> > Canada has long forsaken its burden of medical research and R&D costs,
> > allowing it to be done elsewhere so that Canada can reap the benefits
> > without having to pay the costs. This is not because Canada is poor--
> > it has about the same per capita income as the US.  Rather, it's that
> > Canadians are too cheap. Canadians hold the standard British idea that
> > healthcare ought to be free, and even though they pay only half as much
> > for it as Americans do, they still think it's too much.

> > Speaking of Vioxx, anybody who believes that pharamaceutical companies
> > make {*filter*} and guaranteed profits, is invited to put their money
> > where their mouth is, and invest their retirement nest-egg in the top
> > 10 grossing pharma companies, starting with MRK. Think of it as your
> > own private little biotech bonanza.  You should make out like a bandit,
> > right?

> > In fact, I hope all you Liberals did that LAST year, and bought the
> > {*filter*}ly profitable Merck at $46 a share and Pfizer at $36.  Figuring
> > to finance all your wars against the "legal drug cartel" by using their
> > own *guaranteed* {*filter*} profits against them. Yeah, baby.  Such a
> > great plan.  Can't fail.  Right?  No?

> > When you figure out what's wrong with this simple idea, you'll be
> > smarter.

> > SBH



Mon, 19 Nov 2007 14:25:46 GMT
 Drugmakers not following up speedy approval-US study

Quote:


>> "...die of some disease which could be cured by
>> some experimental drug..."

>> Could we have a list of {*filter*} on the market today which cure? (Only one

>> drug per class please).
>> COMMENT:

>> Why the artificial limitation?  Especially since we create the drug
>> classes themselves partly on the basis of how they work.

>> As you know, there are dozens of curable cancers and hundreds of
>> curable infectious diseases.

> No I don't know. Curable cancers? Just more spin on the actuality of
> it. It's just so much marketing and shining the patient on when you
> tell them they are cured if their cancer doesn't reappear within five
> years. When it reappears two years after the 'cure' what do you call it
> then?

Define "cure".  The respondent did in his reply.

m



Mon, 19 Nov 2007 15:43:13 GMT
 Drugmakers not following up speedy approval-US study

Quote:

>> I suppose vaccines don't count. You have to get sick first?

> That's right. And even Smallpox has returned. We didn't cure. We
> postponed.

Liar or idiot.  Pick one.  Smallpox has been eradicated.

Quote:

>> By "cure" do you mean that you take the drug once and never need
>> anything again for the illness? Twice? Indefinitely?

> Well. Cure. Gone. I dont' have it anymore. Too bad about you.

Define "cure".

You can't do it.  You can't tell us what the JFC you mean by "cure".  It's a
buzzword for your hatred of all things evidenced-based medicine.  The world
cares not about your obsession.  Give up.

moo



Mon, 19 Nov 2007 15:49:04 GMT
 
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