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Medical Forum / Diseases and Disorders / Alzheimer's / September 2006

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Truth about drug companies - follow up

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Tumbleweed - 21 Aug 2006 08:37 GMT
Alan,

here's what happens when you let government decide what drugs can and cant
be used (details below);

Summary

UK government body decides that some drugs arent 'cost effective' and
effectively bans them unless you want to pay for them yourself. In your
proposal, these drugs wouldnt even be allowed to be prescribed at all.
Note 'cost effective' in the Alzheimers case means that carers spend longer
with sufferers in a worse state. But hard(er) times for carers and sufferers
doesn't cost the state anything so that doesn't come into the equation.
Given the choice between a doctor who may be influenced by drug companies
one way or the other, and a government that would ban a drug outright,
removing any vestige of choice, I'd have to take the former every time.

http://news.bbc.co.uk/1/hi/health/5262760.stm

"Charities have criticised a decision not to make two bowel cancer drugs
widely available on the NHS.
The National Institute for Health and Clinical Excellence (Nice) said there
was insufficient evidence to recommend Avastin and Erbium.
But charities say both drugs, used to treat advanced disease, are the best
option for seriously ill patients.
They say the drugs have  been shown to extend life expectancy by four to
five months in some patients."
(TW:I suppose patients living longer would cost the government more, maybe
thats something to do with them not being cost effective?)

http://news.bbc.co.uk/1/hi/programmes/politics_show/5124286.stm
Campaigners, carers, patients and MPs joined protests against a
recommendation by the National Institute for Health and Clinical Excellence
(NICE) to limit, or in some cases ban, treatment with four separate drugs.
NICE say that donepezil, ivastigmine and galantamine should be provided on
the NHS, but only when new patients have reach the "moderate" stage of the
condition.
(TW:obviously, this decision would mean they will reach the moderate stage
quicker
:-(

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Alan Meyer - 26 Aug 2006 22:55 GMT
> Alan,
>
> here's what happens when you let government decide what drugs can and cant be used
> (details below);
> ...

I agree that they problem you raise is a real one.  And I
also agree that when you allow government to regulate an
industry, dangers like the one you point out crop up.
Regulation does have real dangers.

However I also think that failure to regulate has real
dangers.  There was a time in the U.S. when the most
outrageous quack medicines were hawked to the public
and many people had no way to figure out whether they
were good or not.

This problem still exists in some neighboring countries.
My Dad seriously considered taking my Mom to the
Bahamas where some quack had offered to cure her
Alzheimer's for $50,000 using a new drug that had been
"suppressed" by the FDA.  I forget the name of the drug
but it had been discovered by the FDA to cause very
serious liver disease and had no effect on Alzheimer's.

The trick is to find the right balance between government
regulation and _laissez faire_.  It isn't easy.  Errors can be
made on either side.  But it seems to me we have to try.

   Alan
Dana Carpender - 26 Aug 2006 22:58 GMT
>>Alan,
>>
[quoted text clipped - 24 lines]
> regulation and _laissez faire_.  It isn't easy.  Errors can be
> made on either side.  But it seems to me we have to try.

Germany's Commission E has used government money to do extensive
clinical testing on herbal medicines, something that isn't done in the
US because all testing is paid for by the pharma companies, and they
have no reason to do tests on anything they can't patent.  As a result
of Commission E's work, herbal medicines are far more widely used in
Europe than they are here.

Dana
Tumbleweed - 27 Aug 2006 00:49 GMT
>>>Alan,
>>>
[quoted text clipped - 33 lines]
>
> Dana

Actually they are cutting back on herbal medicines in the UK (which would
generally mean the same for the EU), in general because the providers wont
do the tests that show whether they are effective or if they have side
effects. No doubt this is partly because of cost, partly because they will
be shown to be ineffective or have side effects, and partly because for
generic herbs no one company will pay if all will benefit.

There is a whole raft of them that will shortly no longer be available. For
some time they have been available through a loophole, in that they have
been marketed as foods rather than drugs, so no tests were needed. I think
this is shortly to change.

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Alan Meyer - 27 Aug 2006 18:01 GMT
>> ...
>> Germany's Commission E has used government money to do extensive
[quoted text clipped - 14 lines]
> they have been available through a loophole, in that they have been marketed as foods
> rather than drugs, so no tests were needed. I think this is shortly to change.

Testing of supplements is a good example of where government
intervention can be positive.  Clinical trials are very expensive.
As TW points out, the commercial incentives for trials of
supplements are very weak.

There are many things that are in the interests of society, but not
in the interests of individual private companies.  Some of the
simplest and most common examples include:

 National defense
 Universal childhood education
 Public libraries
 Roads and highways
 Public health (the area we are talking about in this discussion)

Capitalism isn't opposed to these things, it's just that no one can
make a profit maintaining the armed forces, educating children
whose families can't pay, loaning books for free, building roads
that don't have tollboths, or taking care of illnesses that don't
generate major drug sales.

So we get together and collectively fund these activities, and
even enlist private companies (by paying them tax dollars) to
help.

   Alan
Dana Carpender - 27 Aug 2006 18:51 GMT
> There are many things that are in the interests of society, but not
> in the interests of individual private companies.  Some of the
[quoted text clipped - 15 lines]
> even enlist private companies (by paying them tax dollars) to
> help.

I can't see enlisting private pharma companies to test supplements or
herbs.  They have too much to lose.  Example:  My doctor wanted to put
me on Cymbalta (antidepressant) a while back.  I was reluctant,
particularly because my pharmacist was nervous about my using any of the
various stuff I use to get to sleep (even OTC stuff) with the Cymbalta,
and I don't care how good an antidepressant the stuff is, if I haven't
slept in 4 days, I'm not going to be a cheerful girl.

Well, I did a little research, and learned that the latest research on
St. John's Wort showed that the reason previous research was equivocal
-- sometimes it seemed to work really well, and sometimes not at all --
was because they'd been standardizing for the wrong constituent.  They'd
discovered another constituent, and when they standardized for *that*,
even the Mayo Clinic was giving the stuff high marks for treating mild
to moderate depression.  Accordingly, I found St. John's standardized
for that newly-identified constituent, and it's worked really well for me.

Which amounts to a loss for the makers of Cymbalta.  The stuff would
have run me about $125 a month, the St. John's is running me about $30,
and of course that's going to someone else.

I agree we need tax funding for research on supplements, herbs, etc, but
it shouldn't be through any company that stands to lose thereby -- or
gain thereby, either.  And considering the political power of the pharma
industry, I don't see it happening any time soon.

Dana
Tumbleweed - 27 Aug 2006 22:41 GMT
>  Accordingly, I found St. John's standardized for that newly-identified
> constituent, and it's worked really well for me.
[quoted text clipped - 6 lines]
> it shouldn't be through any company that stands to lose thereby -- or gain
> thereby, either.

Don't you mean it _should_ be? That doesn't make any sense otherwise? Why
should companies or people not involved with a particular drug (be it pharma
or heb originated) have to pay for testing?

>  And considering the political power of the pharma industry, I don't see
> it happening any time soon.
>
> Dana

It would be interesting to know the size of the alternative or herb sector.
I'm sure they have also a  massive vested interest in trials _not_ being
done, since the majority are likely harmless to harmful. St Johns Wort is
one of the few that actually comes up as useful. BTW, it is contraindicated
with certain other herbs and drugs, check up on that.

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Dana Carpender - 27 Aug 2006 22:51 GMT
>> Accordingly, I found St. John's standardized for that newly-identified
>>constituent, and it's worked really well for me.
[quoted text clipped - 10 lines]
> should companies or people not involved with a particular drug (be it pharma
> or heb originated) have to pay for testing?

Why would we trust the results from a company that stands to lose or
gain money according to those results?  See Vioxx.

No, I think research needs to be financially disinterested.

Dana
Evelyn Ruut - 28 Aug 2006 01:13 GMT
>>> Accordingly, I found St. John's standardized for that newly-identified
>>> constituent, and it's worked really well for me.
[quoted text clipped - 17 lines]
>
> Dana

Dana honey, in principle I cannot but agree with you.   But is it possible
to find even ONE person who is financially disinterested?   I don't think
so.  Altruism is a very rare attribute.
Signature


Best Regards,

Evelyn
(to reply to me personally, remove 'sox')

Dana Carpender - 28 Aug 2006 17:00 GMT
>>>>Accordingly, I found St. John's standardized for that newly-identified
>>>>constituent, and it's worked really well for me.
[quoted text clipped - 21 lines]
> to find even ONE person who is financially disinterested?   I don't think
> so.  Altruism is a very rare attribute.

Okay, I'll settle for "doesn't stand to gain or lose millions upon
millions of dollars."

Dana
Alan Meyer - 28 Aug 2006 18:52 GMT
> ...
>> ...
[quoted text clipped - 3 lines]
>
> Okay, I'll settle for "doesn't stand to gain or lose millions upon millions of dollars."

I think there are a lot of financially disinterested researchers,
in fact, most of them are.  Most of the scientists at universities
and at drug companies are working for salaries, not profits
from drugs.

Most of the leading research is coming from universities, where
the respect of one's colleagues, together with a deep interest
in the science, and a belief in the value of what they are doing,
are often the biggest motivations for hard work.

I work for an hourly wage as a computer programmer.  But I
care about what I'm doing and try to do the best I can.  If
someone makes big bucks out of a program I worked on, the
best I can hope for is that they'll use my services again.  I'm
okay with that.

It's true that I don't work night and day with no personal life
at all like some entrepreneurs I've met.  But I think I'm still
pretty motivated to do a good job.

   Alan
Deborah - 29 Aug 2006 01:49 GMT
> Most of the leading research is coming from universities, where
> the respect of one's colleagues, together with a deep interest
> in the science, and a belief in the value of what they are doing,
> are often the biggest motivations for hard work.

Who depend on grants from government and drug companies.

I by no means intend to demean the dedication of the dedicated.

I just think they're generally co-opted by Hobson's choices.
Tumbleweed - 29 Aug 2006 07:55 GMT
>> Most of the leading research is coming from universities, where
>> the respect of one's colleagues, together with a deep interest
[quoted text clipped - 6 lines]
>
> I just think they're generally co-opted by Hobson's choices.

if what you imply is true (researchers fake tests to please their drug
overlord masters), every single drug would pass all its tests with flying
colours, and be shown to be better than all other drugs for the same
condition. It aint so.

We live in the real world, not one where limitless amounts of money from
disinterested parties mean that all drugs can be tested by independent third
parties. If there is a problem with faked tests, then its the regulations
that need strengthening, rather than taking money from me (or you but I'm
concerned about me) to test every single possible drug. There simply isnt
enough money, resource or time to implement this utopian testing regime, and
you still wouldnt remove biases.

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Deborah - 30 Aug 2006 02:00 GMT
Tumbleweed, I don't think we're really at cross purposes, here, but I'm
not sure, either.

How much do you know about major drug multinationals? (I know it's a lot,
so start from there, please, if you wish.)
Tumbleweed - 28 Aug 2006 01:53 GMT
>>> Accordingly, I found St. John's standardized for that newly-identified
>>> constituent, and it's worked really well for me.
[quoted text clipped - 13 lines]
> Why would we trust the results from a company that stands to lose or gain
> money according to those results?  See Vioxx.

Not sure exactly what happened there, but "Bad examples do not make good
law" . is this where due to side effects they are being prosecuted, even
though they have been warned about them? Like I said, only seen a few
headlines, not sure of the details, though I do know that in the US you'll
sue anyone even if a warning sign was stapled to your forehead. I did find
this though.....
"Merck successfully defended in Doherty v Merck where a grandmother claimed
that the drug had caused her heart attack. The jury in Atlantic City, New
Jersey found that Vioxx did not contribute to her heart attack, that Merck
acted responsibly in informing the medical community about the benefits and
risks of the drug and that the drug company's marketing efforts did not
mislead consumers.

In August 2006, a jury found in favor of Merck in the company's first case
in California, Grossberg v. Merck. The jury found that Merck was not
negligent, that it did not conceal information and that Vioxx did not cause
Grossberg's heart attack.

So, maybe Vioxx is more a case of people suing because someone is always to
blame and people demand a drug with no side effects even though thats not
possible. Betchaa St Johns Wort has side effects but I suppose there is no
one to sue in that case?

I'd rather just firm up the law on testing & publishing results than have
someone take money out of my pocket to test numerous herbs that may or may
not be useful to me, plus have someone else profit from it!

> No, I think research needs to be financially disinterested.
>
> Dana

Nice theory but I dont see how that would work in practice, how much of your
pay would you 'volunteer' given there is essentially an endless requirement
and the money will coem from the taxpayer? I volunteer none of mine, so
they'll have to take twice as much from you :-)

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Deborah - 29 Aug 2006 02:06 GMT
> So, maybe Vioxx is more a case of people suing because someone is
> always to blame and people demand a drug with no side effects even
> though thats not possible. Betchaa St Johns Wort has side effects but I
> suppose there is no one to sue in that case?

I'm ALL for people taking personal responsibility -- or, failing that,
having it rammed down their gullets -- when the consequences of their
actions are freely available and common sensical.

For example, I have NO sympathy AT ALL for people who filed for bankruptcy
because they maxxed out their 20 credit cards buying big screen TVs and
DVDs, I-pods, cable modem, HDTV, luxe vacations and cruises, designer
clothes, Hummers, restaurant meals, cinema tickets, concert tickets,
gasoline to get them where they didn't have to go, etc.

I do see a distinction between the above and people who took meds
authorized for prescription by the FDA, likely the single-most worldwide
obstructionist government agency for legal drug approval on the planet.

Add to that the fact that our current gov. has done gymnastics magic
worthy of Cirque de Soliel in aid of big pharma...

YRMV

Best,
Deborah
Alan Meyer - 29 Aug 2006 05:00 GMT
...
> I do see a distinction between the above and people who took meds
> authorized for prescription by the FDA, likely the single-most worldwide
> obstructionist government agency for legal drug approval on the planet.
...

According to Marcia Angell in _The Truth about Drug Companies_
(from which this thread gets its title), the FDA has gone from being
the slowest to approve agency among the developed countries to
the fastest in the last 10 or so years.

Both patients and drug companies (guess which one has had
the most influence) have put enormous pressure on the government
to speed FDA drug approvals.  The pressure has been very
effective.  Some scientists now argue that the FDA is granting
approvals too quickly to drugs that are not effective.

> Add to that the fact that our current gov. has done gymnastics magic
> worthy of Cirque de Soliel in aid of big pharma...

Indeed.

I think most of this is just outright corruption, no different from
the corruption of doctors by buying them expensive gifts.  But
it's also the case that big pharma's propaganda is quite effective.
Even well meaning congressmen and doctors are still taken
in by the flood of misleading or false data coming from the
drug companies about how much money they invest in research,
how much benefit the produce, how many lives they are saving,
how "educational" their marketing is, and so on.

  Alan
Deborah - 30 Aug 2006 02:58 GMT
> ...
>> I do see a distinction between the above and people who took meds
[quoted text clipped - 28 lines]
>
>    Alan

Alan, do you get as disgusted as I do when you see televison
advertisements for brand-name drugs?

There's no ethical place for direct marketing in pharmaceuticals. Full
stop. Period.

Good points, Alan.

Deborah
Alan Meyer - 31 Aug 2006 03:53 GMT
> ...
> Alan, do you get as disgusted as I do when you see televison
> advertisements for brand-name drugs?
>
> There's no ethical place for direct marketing in pharmaceuticals. Full
> stop. Period.

Absolutely.  The Aricept ad is infuriating.  The others are
no better.  They show healthy, happy, smiling people who
are on expensive drugs with the implication that you too will
be healthy, happy and smiling on those drugs.

I want to puke every time I see the smiling actor say,
"I couldn't remember my grandchildren's names [before Aricept]"
or the smiling actress who says, "I'm ready for chemotherapy."

Anyone who has been in an Alzheimer's home or a cancer
ward or anywhere in the real world has to wonder what planet
the people in those ads came from.

It is my understanding that direct to consumer drug advertising
is banned in every other advanced country - as it used to
be banned in the U.S.

Interestingly, we think of the Republican Party as most
deeply in bed with the drug companies - which it probably
is.  But it was Clinton that allowed the TV ad abomination
to flower.

   Alan
Deborah - 31 Aug 2006 03:54 GMT
> Interestingly, we think of the Republican Party as most
> deeply in bed with the drug companies - which it probably
> is.  But it was Clinton that allowed the TV ad abomination
> to flower.
>
>     Alan

Eh, all our "rulers" are beneath our most humble citizens.

Third party, anyone?

Populist, for a few years/decades?
Tumbleweed - 29 Aug 2006 08:05 GMT
>> So, maybe Vioxx is more a case of people suing because someone is
>> always to blame and people demand a drug with no side effects even
[quoted text clipped - 14 lines]
> authorized for prescription by the FDA, likely the single-most worldwide
> obstructionist government agency for legal drug approval on the planet.

Can you expand upon that because I dodn't know what you are proposing. Are
you proposing the FDA should be 100% correct all the time? That every single
drug trial must be capable of being 100% capable of spotting all side
effects, however obscure?

Lets say that 1 in 100,000 people will suffer a severe side effect. Lets say
that side effect is documented and each person warned about it before taking
the drug. Should those people be compensated for millions of dollars each?
On what basis?

Lets say that side effect isnt documented because it wasnt found in the
trial, and the trial was well run . Again, should those people be
compensated for millions of dollars each? On what basis?

Its only in the third case, side effects deliberately covered up, that the
drug company bears liability.

The American public seems to 'want to have its cake and eat it'. Drugs are
being withdrawn, even if the overall benefit is higher, because of the cost
of the legal side (damages and legal costs) even for well known and
publicised side effects. The attitude seems to be, "its always someone's
fault".

Sometimes, it isnt.

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Deborah - 30 Aug 2006 02:39 GMT
Apologies to all, but I felt it was necessary to intersperse my replies to
maintain context.

>>> So, maybe Vioxx is more a case of people suing because someone is
>>> always to blame and people demand a drug with no side effects even
[quoted text clipped - 19 lines]
> Can you expand upon that because I dodn't know what you are proposing.
> Are you proposing the FDA should be 100% correct all the time?

Of course I am not.

That
> every single drug trial must be capable of being 100% capable of
> spotting all side effects, however obscure?

Certainly not.

> Lets say that 1 in 100,000 people will suffer a severe side effect.
> Lets say that side effect is documented and each person warned about it
> before taking the drug. Should those people be compensated for millions
> of dollars each? On what basis?

It gets a bit murkier, here. How do we know the documentation is reliable?
Have we not seen multiple warnings, in our admittedly long lifetimes,
Tumbleweed, when the warnings were insufficient, for whatever reason?
Thalidomide? I'll bet you recall that one. (I presume you're as much, or
nearly so, a dinosaur as I am. I'm coming up, rapidly, on 55.) A worthy
drug, in some cases. But, beyond doubt, truly terrible in other
applications.

> Lets say that side effect isnt documented because it wasnt found in the
> trial, and the trial was well run .

I suppose that's where we part company, in essence. I suspect the trials
are seldom well run, and, when they are, I suspect the results are
manipulated to the benefit of big pharma. Yes, T, I am a cynic; one who
desperately wishes for solutions to my demented LOs condition, and is
willing to make allowances and take personally responsible risks.

Again, should those people be
> compensated for millions of dollars each? On what basis?

Sometimes, yes, they should be compensated for millions, if a jury can be
convinced that the proscecution proved the manufacturers willfully hid,
falsified, obfusticated test data relating to severe side effects.

You see, I'm a (cough, cough, it's really hard for me, as a native of
Georgia/South Carolina, USA, to apply the word to myself,) Yank, and we
were lately accustomed to the legal principle of somewhat limited
responsibility on the part of corporations. (We're learning otherwise,
quite rapidly, so don't worry too much about us...) You are not a Yank,
and that's no insult. I lived in Suffolk for several years, in the last
millenia, and absolutely adored every minute of it. Fact is, Brits don't
have the historical right to sue we do. (And that goes against us "Yanks",
as often as it aids us, IMO. Abuse, you know...)

> Its only in the third case, side effects deliberately covered up, that
> the drug company bears liability.

Well, *hello*! Do you really think that multinational drug companies
really care about patients above profits? If you do, I would like to ask
for your hand in marriage. (Not really; I'm done with that.)

> The American public seems to 'want to have its cake and eat it'.

Yes, well, that's what the corporate media would like you believe.

> Drugs are being withdrawn, even if the overall benefit is higher,
because of
> the cost of the legal side (damages and legal costs) even for well
> known and publicised side effects. The attitude seems to be, "its
> always someone's fault".

This is a reasonable sounding argument, which is why it's got so much wear
out of the tread. It ain't factually so.

Really.

I'll show you links another night. I'm knackered from working my 11 hr.
day.

> Sometimes, it isnt.

And, I cannot argue with that. Sometimes, it isn't. There will always be
numbnuts.

Best to you, T,
Deborah
Dennis P. Harris - 30 Aug 2006 03:26 GMT
On Wed, 30 Aug 2006 01:39:46 +0000 (UTC) in
alt.support.alzheimers, Deborah
<celiej@yaspamisnotwelcomedhoo.com> wrote:

> Apologies to all, but I felt it was necessary to intersperse my replies to
> maintain context.

no need for apology;  that IS proper netiquette.  it's even
better netiquette to quote only the part of the past to which you
are replying.

too bad everyone else copies the entire posts and bottom posts,
or top posts, or posts without quoting so there's no context.
Tumbleweed - 30 Aug 2006 19:34 GMT
> Apologies to all, but I felt it was necessary to intersperse my replies to
> maintain context.
[quoted text clipped - 43 lines]
> drug, in some cases. But, beyond doubt, truly terrible in other
> applications.

thats true, but what your point? BTW, thalidomide is now being used against
cancer, apparently its very effective. Is that a good idea? I'm not sure.
SHould someone be unable to get what will bea very good drug because there
sia chnace it might get taken by a pregnant woman later? Its a tough one.
Who is responsible if this happens? The drug manufacturer? The person who
let it get out? the person who took it?

>> Lets say that side effect isnt documented because it wasnt found in the
>> trial, and the trial was well run .
[quoted text clipped - 4 lines]
> desperately wishes for solutions to my demented LOs condition, and is
> willing to make allowances and take personally responsible risks.

What evidence do you have for that? Many drugs are withdrawn because they
dont make it through various phases of trials. If what you say is true,
they'd pretty much all get through and to market, wouldnt they?

> Again, should those people be
>> compensated for millions of dollars each? On what basis?
>
> Sometimes, yes, they should be compensated for millions, if a jury can be
> convinced that the proscecution proved the manufacturers willfully hid,
> falsified, obfusticated test data relating to severe side effects.

Thats not what I said though. I said, >>if the trial was well run<<. No one
would argue with the latter, but its cheating to answer that question!! The
former is the difficult case, and you didnt answer that :-)

> You see, I'm a (cough, cough, it's really hard for me, as a native of
> Georgia/South Carolina, USA, to apply the word to myself,) Yank, and we
[quoted text clipped - 12 lines]
> really care about patients above profits? If you do, I would like to ask
> for your hand in marriage. (Not really; I'm done with that.)

You are answering a different question to the one I asked!! Please try and
pay attention in class :-)

>> The American public seems to 'want to have its cake and eat it'.
>
> Yes, well, that's what the corporate media would like you believe.

Child in car without seatbelt. Car crashes due to drivers fault. Car rolls
over several times, door opens and child is thrown out. Parents sue car
manufacturer for having door that flies open when car is rolled over. have
cake, eat it. There are probably a billion other examples, and I am not
including the famous hot coffee/mcdonalds case.

>> Drugs are being withdrawn, even if the overall benefit is higher,
> because of
[quoted text clipped - 9 lines]
> I'll show you links another night. I'm knackered from working my 11 hr.
> day.

OK. But even if it aint so, the legal costs simply get added onto the price
of all drugs.

>> Sometimes, it isnt.
>
[quoted text clipped - 3 lines]
> Best to you, T,
> Deborah

And you.

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Deborah - 31 Aug 2006 03:45 GMT
Once I finish up laughing, I'll reply, Tumbleweed. Please allow me a day
or two, if not more. "Ernesto" approaches.

I always look for, and savor, the humo(u)r first, though it's not a funny
subject we're talking about.
Alan Meyer - 31 Aug 2006 04:17 GMT
The big problem with drug companies is the quantity
of money they make.

In 2002, the top 10 American drug companies made more
profit than all 490 of the rest of Fortune 500 companies
PUT TOGETHER!

As Everett Dirksen used to say, "A billion here, a billion
there, pretty soon you're talking real money!"  The drug
companies are making REAL money.  They're making
so much money, with higher profit margins than virtually
every other industry, that both the pressure and the
opportunity to distort our medical care and corrupt our
doctors, and to distort our laws and corrupt our legislators
and regulators, is enormous.

It doesn't require terrible people in the drug companies
for this corruption to develop.  It is an inevitable consequence
of the economic situation.  If one drug company fails to
corrupt doctors and lawmakers, the other companies will
eat its lunch.  If one salesman fails to corrupt his doctors
and another does, he'll lose out on the sales.  Free market
competition works that way.

The subject of clinical trials came up.

Not too many years ago, clinical trials were mainly financed
by NIH and perfomed by hospital staff under the direction
of medical school professors.  Results were published in
the literature, as the professors wrote them.

Today, most of the funding comes from the drug companies.
The companies sign contracts with the medical schools.
The contracts specify that the professors will conduct the
research, but the company will have the right to review and
intercede in the procedures, and most importantly, the right
to approve or block any publication before it can be published.

The school doesn't have to agree to this.  They can say no.
If they do, the company goes to another school and offers
them the millions of dollars to conduct the trial.  Research
money doesn't grow on trees.  Medical schools need it
badly.  They cave in.

The clinical trials process really is being corrupted and the
quality of the research, and especially the published results,
really is being compromised.  For example, serious negative
results might cause a company to hold off submitting a
drug for approval.  But those results will NOT be published,
as they would have been in the past.

One of the few checks left is the tort system that allows
smart but sleazy lawyers to sue the pants off the drug
companies (their very favorite, because very richest, targets).
So the companies have to police themselves to some
degree.

The tort system is itself a horrible, corrupt, abomination.
Everything that Bush and the Republicans say about it
seems to me to be true.  But I worry about what will happen
in the drug development world if "tort reform" takes away
that last check on drug company license, and if we have
not made new government regulations to check the
drug company corruption.

   Alan
Deborah - 31 Aug 2006 04:55 GMT
> The big problem with drug companies is the quantity
> of money they make.
[quoted text clipped - 62 lines]
>
>     Alan

Alan, you had me on board until the last paragraph. Surely, there are
those who will extort our once vaunted system. That doesn't make Bush and
the Republicans right, or correct, or remotely Constitutional. Here's the
thing that really, *really* gets me -- this isn't partisan, it's about the
ultimate survival of our nation. I have grandchildren. This is Big, for
me:

If we, the American people, cave in and allow mythical, non-human
Corporations, and *not THE People*, under our lawful Constitution, to
prevail, we have ceded our heriditary human rights. At that point, RIP,
USA, and much/many more.

I wish I had more faith in The People. Seems too many of us are interested
only in American Idol and a whole lot more that I don't follow. (I've
never seen a single episode of either American Idol or The Sopranos. Not
that I'd watch The Sopranos if could, even if I had that cable
tier...which I don't. I, personally, loathe gangster/gangsta
"entertainment.")

(Please prove me wrong!)

Deborah
Alan Meyer - 31 Aug 2006 16:01 GMT
> ...
> > The tort system is itself a horrible, corrupt, abomination.
[quoted text clipped - 18 lines]
> prevail, we have ceded our heriditary human rights. At that point, RIP,
> USA, and much/many more.

I'm not sure whether you're arguing against tort reform here.

We've gotten far afield from Alzheimer's Disease, but I will say
that I believe that it is true that many blameless companies and
private citizens are ripped off or even destroyed every year by
unjustified but skillfully pursued lawsuits.

Tort reform seems desirable to me, but only if we can put
new safeguards in place that enable us to rein in big company
malfeasance without these predatory lawsuits.

> I wish I had more faith in The People. Seems too many of us are interested
> only in American Idol and a whole lot more that I don't follow. (I've
> never seen a single episode of either American Idol or The Sopranos. Not
> that I'd watch The Sopranos if could, even if I had that cable
> tier...which I don't. I, personally, loathe gangster/gangsta
> "entertainment.")

Ah yes, "The People", "the Great Unwashed", the great cross
that we of the liberal elite must bear.

What can I say?

> (Please prove me wrong!)

In order to do that, do I have to prove myself right?

I think I better give up now.

   Alan
Deborah - 31 Aug 2006 20:01 GMT
>> ...

<snip>

>> (Please prove me wrong!)
>
[quoted text clipped - 3 lines]
>
>     Alan

No, no.

You may be interested, or enraged, by the links I sent Tumbleweed.
Discussion is good.

Best,
Unwashed Liberal Elite ;)
Deborah - 31 Aug 2006 19:59 GMT
>> Apologies to all, but I felt it was necessary to intersperse my
>> replies to maintain context.

<snip>

>>> Lets say that 1 in 100,000 people will suffer a severe side
>>> effect. Lets say that side effect is documented and each
[quoted text clipped - 18 lines]
> responsible if this happens? The drug manufacturer? The person
> who let it get out? the person who took it?

As to who is responsible, the answer I give is "all of the above."

>>> Lets say that side effect isnt documented because it wasnt
>>> found in the trial, and the trial was well run .
[quoted text clipped - 10 lines]
> what you say is true, they'd pretty much all get through and to
> market, wouldnt they?

I don't believe they'd all get to market, no.

Have a look here:

http://observer.guardian.co.uk/business/story/0,,1312765,00.html

Here are the final two paragraphs:

<begin quote> Bit by bit, health activists in Britain and America
have uncovered the core of pharma might: a sinister mesh of hidden
influences in the regulation and practice of medicine that is
painstakingly dissected in Medicines Out of Control? by Charles
Medawar and Anita Hardon.

In both countries, clinical drug tests are paid for by the pharmas,
who tweak the trials' design for the best possible results. Until
recently, only the most favourable findings got published in the
20,000-odd biomedical journals, many of them dependent on pharmas
for funding. The drugs are approved for marketing by regulators,
whose salaries are mostly financed by the subjects of their
evaluations - since pharmas pay to have their products vetted. The
medicines are then prescribed by doctors routinely courted with
pharma gifts - from free pens to family skiing holidays - meant to
persuade them to change their prescribing habits. <end quote>

>> Again, should those people be
>>> compensated for millions of dollars each? On what basis?
[quoted text clipped - 8 lines]
> answer that question!! The former is the difficult case, and you
> didnt answer that :-)

Got me there, T, so I'll try to do a bit better. I don't believe
every patient harmed by unforeseen side-effects in a carefully
researched med should get millions. Maybe only thousands. <g> Maybe
nothing. There's no one correct answer. So, you see, your original
question was rigged. :-)

<snip>

>> Well, *hello*! Do you really think that multinational drug
>> companies really care about patients above profits? If you do,
[quoted text clipped - 3 lines]
> You are answering a different question to the one I asked!!
> Please try and pay attention in class :-)

This is where I lost it laughing, last night.

>>> The American public seems to 'want to have its cake and eat
>>> it'.
[quoted text clipped - 8 lines]
> probably a billion other examples, and I am not including the
> famous hot coffee/mcdonalds case.

Of course there are many examples of ludicrous lawsuits. Hey, we've
got volumes of them. But, that's a red herring. We were talking of
actions taken by reasonable people.

>>> Drugs are being withdrawn, even if the overall benefit is
>>> higher,
[quoted text clipped - 13 lines]
> OK. But even if it aint so, the legal costs simply get added
> onto the price of all drugs.

These links don't specifically address big pharma, but they do
dovetail into the statement you make above. I expect you'll have
reservations about some of these sources, and so you should. It's
never good policy to take on faith everything you read or hear, is
it? Some of these, *I* find slightly absurd.

http://www.press.uchicago.edu/Misc/Chicago/036480.html

<http://www.centerforajustsociety.org/press/article_ideasinaction.a
sp?pr=1117>

http://www.citizen.org/congress/civjus/tort/articles.cfm?ID=785

http://www.aarp.org/bulletin/yourhealth/righting_wrongs.html

http://www.washingtonmonthly.com/features/2004/0410.mencimer.html

PS - Which industry has, far and away, the highest profits in the
world?

Going for the oars, now. It's about to get unpleasant, here.

Best,
Deborah
Deborah - 31 Aug 2006 22:22 GMT
> Going for the oars, now. It's about to get unpleasant, here.
>
> Best,
> Deborah

Usenet post sinning, by responding to myself. This last was a reference to
the weather where I live. It could be worse, so far.

Best regards,
Deborah
Evelyn Ruut - 31 Aug 2006 23:06 GMT
>> Going for the oars, now. It's about to get unpleasant, here.
>>
[quoted text clipped - 6 lines]
> Best regards,
> Deborah

Deborah, I hope you are not getting any of those tropical storms in your
area!

Hope all is well with all of those who live in the path of these storms!

Signature

Best Regards,

Evelyn
(to reply to me personally, remove 'sox')

Deborah - 01 Sep 2006 00:00 GMT
>>> Going for the oars, now. It's about to get unpleasant, here.
>>>
[quoted text clipped - 12 lines]
> Hope all is well with all of those who live in the path of these
> storms!

Thank you, so much, Evelyn.

Please send your best thoughts to the folks along the far-northwestern
SC/far-northwestern NC shores, and those inland who will certainly be
affected along the Eastern US seaboard. There's a lot of rain in this
system, not so much wind. Flooding is what worries me.

I'm not expecting much beyond heavy rain and high winds, at this point. At
some point, the bullet will not be dodged on my section of the SC coast.
<nervous lol>

Hoping you and Peter and family are well,
Deborah
ladylove77 - 01 Sep 2006 00:10 GMT
Deborah, where do you live in SC.  My daughter lives in Beaufort.
Gwen

>>>> Going for the oars, now. It's about to get unpleasant, here.
>>>>
[quoted text clipped - 26 lines]
> Hoping you and Peter and family are well,
> Deborah
Deborah - 01 Sep 2006 00:49 GMT
> Deborah, where do you live in SC.  My daughter lives in Beaufort.
> Gwen

Murrells Inlet.

Glad to know your daughter is in the clear.

Best,
Deborah
Evelyn Ruut - 01 Sep 2006 00:58 GMT
>>>> Going for the oars, now. It's about to get unpleasant, here.
>>>>
[quoted text clipped - 26 lines]
> Hoping you and Peter and family are well,
> Deborah

Deborah, I just got off the phone with my uncle who lives in New Bern NC.
He's battening down the hatches for this one.   Hope you and everyone in
that area is OK.   We are supposed to get rather a lot of rain on Saturday,
but that's all.   We get snow and ice, and have occasional torrential rains
and a couple of years ago there was a small tornado here in upstate NY, but
not too much in the way of high winds.  I guess every area of the country
gets it share of some sort of icky weather :-(

Signature

Best Regards,

Evelyn
(to reply to me personally, remove 'sox')

Tumbleweed - 31 Aug 2006 22:54 GMT
>>> Apologies to all, but I felt it was necessary to intersperse my
>>> replies to maintain context.
[quoted text clipped - 144 lines]
>
> http://www.citizen.org/congress/civjus/tort/articles.cfm?ID=785

Thats why I didnt include that one :-)

> http://www.aarp.org/bulletin/yourhealth/righting_wrongs.html
>
> http://www.washingtonmonthly.com/features/2004/0410.mencimer.html

Thanks, there is some very thought provoking stuff in there. I had heard the
story about the lawnmower/hedgetrimmer (from an American) and didnt realise
(as neither did he) that it was an urban myth.

Of course, some 'facts' are repeated to make companies sound bad when
actually there is just a dull explanation behind them*, but as I say there
is a lot of good stuff there as well.

> PS - Which industry has, far and away, the highest profits in the
> world?

Dont see the relevance of how much money they make. Seriously.
Either what they are doing is right or wrong, either the trials are fake or
not, etc,but whether they make money or not, and how much, shoudnt be an
issue in deciding that.

*for example, 'trials that fail aren't written up in prestigious journals (I
abbreviate)'. Well no, they wouldnt be, first because why report that the
drug you were testing, that you now wont be launching, is no good? What
would be the point? Who would want to read that? Second, because its a
general scientific practice (which probably isnt good, but it happens) to
mostly write up successful experiments, by which I mean experiments that
proved what you set out to prove (unless the results are startling in a
different way). A report that read 'experiments that determined that a
perpetual motion machine didnt work' dont get many people excited. Or 'My 2
year series of tests on mice that will not lead to a cure for cancer.

In one of your references, this is cited as if its part of an evil plot. I
dont think so. However, I do think there is a lot more there that bears
furtherreading. Thanks, no flame proof suit needed!

Signature

Tumbleweed

email replies not necessary but to contact use;
tumbleweednews at hotmail dot com

Deborah - 01 Sep 2006 00:22 GMT
> Dont see the relevance of how much money they make. Seriously.
> Either what they are doing is right or wrong, either the trials are
> fake or not, etc,but whether they make money or not, and how much,
> shoudnt be an issue in deciding that.

It's not so simple, is it?

Regarding how much money they make...

I'm very happy for the manufacturers of medications to be rewarded 2x as
much as the next highest profitable industry. Who can plausibly argue the
fact that 99.9999 percent, or more, of the posters in this group have
benefited, both directly and indirectly, from the products of the pharma
industry? The percentage is either non-existent, or perishingly minescule,
surely.

I'm of the admittedly "Liberal Elite" crowd who probably naively holds
this core belief:

"To whom much is given, much is expected..."

Luke 12:48

And, this may possibly be the only time you'll see me quote the Bible. No
promises about that. There's some good stuff in there.

Best,
Deborah
Dennis P. Harris - 01 Sep 2006 02:23 GMT
> Of course, some 'facts' are repeated to make companies sound bad when
> actually there is just a dull explanation behind them*, but as I say there
[quoted text clipped - 7 lines]
> not, etc,but whether they make money or not, and how much, shoudnt be an
> issue in deciding that.

how much they make from a defective drug should indeed be a
factor in determining ***punitive*** (rather than actual)
damages.  the purpose of punitive damages is to punish the
defendant for negligent or wrongful acts in order to deter them
from continuing the behavior that caused damage to the
plaintiff(s).  IMHO punitive damages should indeed cause pain to
the defendant, in the case of a corporation its officers and
shareholders.
Deborah - 01 Sep 2006 02:42 GMT
>> Of course, some 'facts' are repeated to make companies sound bad when
>> actually there is just a dull explanation behind them*, but as I say
[quoted text clipped - 16 lines]
> the defendant, in the case of a corporation its officers and
> shareholders.

I love this, if for no other reason than to be able to say, there's more
than one way to skin a cat.

(It's a figure of speech. Really. Google it, if you doubt.)

Thanks, Dennis.
Alan Meyer - 01 Sep 2006 02:50 GMT
...
> Dont see the relevance of how much money they make. Seriously.
> Either what they are doing is right or wrong, either the trials are fake or
> not, etc,but whether they make money or not, and how much, shoudnt be an
> issue in deciding that.
...
Well ... maybe.

Making money is not in itself a crime, and shouldn't be.  But I do
think that understanding that this has been the richest industry
in the U.S. is important in understanding what happens inside and
what needs to be done.

Normally, we imagine that competition holds down prices.  But
for reasons that have yet to be explained, that doesn't seem to
work in the drug industry.  There are 7 or more major cholesterol
drugs, 3 major impotence drugs, and numbers of blood pressure
drugs, anti-depressants, and other categories.  And yet the prices
don't fall on any of them until they go off patent, at which time the
prices plummet.  The very same drugs also sell in Canada, Europe
and in other countries at significantly lower prices even though the
U.S. companies that make the drugs aren't forced to sell there.
They could say, screw the price controls - we're not selling.  But
they don't.  So they must be making reasonable profits at the
lower prices too.

Something is wrong with this picture.  There is a compelling
public interest in reasonable pricing for drugs.  There are huge
numbers of people in the United States who literally can't
afford the drugs they need to stay alive.  If movie prices or
restaurant prices or prices of any other luxuries go through
the roof - people don't have to buy.  But with drugs, it's often
your money or your life.

In that situation I believe it is just _wrong_ to allow prices that
generate obscene profits while people suffer or die.

> *for example, 'trials that fail aren't written up in prestigious journals (I
> abbreviate)'. Well no, they wouldnt be, first because why report that the
[quoted text clipped - 6 lines]
> perpetual motion machine didnt work' dont get many people excited. Or 'My 2
> year series of tests on mice that will not lead to a cure for cancer.

I disagree with this too.  Negative results have very serious and
significant scientific implications.  If a selective serotonin
re-uptake inhibitor appears to cause young people to commit
suicide, that's a fact that needs to be known.  There are a half
dozen of those drugs on the market, and more in development.
Knowing that one trial ran into problems can clue in investigators
that there are dangers here and many more people are at risk.

If a COX-2 inhibitor seems to cause a higher rate of heart attacks,
that needs to be published.  It's not enough to just quietly kill
the research and not bring out the drug.  There are other COX-2
inhibitors and other anti-inflammatory drugs that have similar
mechanisms of action.

If a blood pressure drug turns out to be less effective than a
diuretic in reducing blood pressure, we need to know that.
The law allows the drug company to sell the new blood
pressure drug as long as it is safe and effective (doesn't
kill the patient and does lower blood pressure.)  But if
doctors knew that the drug was less effective than other
drugs, they wouldn't prescribe it, and they certainly wouldn't
shift their patients from diuretics to the new medicines - as
in fact so many have.  How many patients have died because
of blood pressure related diseases who might have been
saved if they had used a more effective drug?

All three of the above are, in fact, real-life examples.  I'm
not making them up.

> In one of your references, this is cited as if its part of an evil plot. I
> dont think so. However, I do think there is a lot more there that bears
> furtherreading. Thanks, no flame proof suit needed!

As I've said before, I think most of the people in the scientific
sections of the drug companies are dedicated people who
are trying to save the world as well as make a decent income
for themselves.  I have great respect and appreciation for
what they do.

But the people in the lobbying and marketing sides of the
business are a totally different story.  They do indeed engage
in what can only be characterized as "evil plots."

What can you call it when drug salesmen buy expensive gifts
for doctors or congressmen other than evil corruption?

It's true that the doctors and congressmen who accept these
bribes are evil too.  But two wrongs don't make a right.

> --
> Tumbleweed
>
> email replies not necessary but to contact use;
> tumbleweednews at hotmail dot com
Deborah - 02 Sep 2006 00:52 GMT
> ...
>> Dont see the relevance of how much money they make. Seriously.
[quoted text clipped - 99 lines]
>> email replies not necessary but to contact use; tumbleweednews at
>> hotmail dot com

I wish I knew enough to reason as much/as well as this. Alan, you've
obviously performed critical thinking on this subject, in the past as well
as in the present.

I'd like to reach this level, or better, (though better isn't all that
likely at my corporeal state,) eventually. I'm working on it, but it's
hard work, hard work. (LOL) It takes most of my "free" time to make a
living, not that it's a credible excuse.

And, no offense meant to Tumbleweed, by any means. I can hear gears
clicking all the way from here. ;)

Best,
D
Alan Meyer - 03 Sep 2006 01:46 GMT
> ...
> I wish I knew enough to reason as much/as well as this. Alan, you've
[quoted text clipped - 5 lines]
> hard work, hard work. (LOL) It takes most of my "free" time to make a
> living, not that it's a credible excuse.

Thanks.  However the real credit belongs to Marcia Angell, the
author of _The Truth About the Drug Companies_.  It's that
book that taught me most of what I know about this subject.

> And, no offense meant to Tumbleweed, by any means. I can hear gears
> clicking all the way from here. ;)

Indeed.  I have disagreed with TW's arguments, but I have
great respect for his or her intelligence and thoughtfulness.

   Alan
Dennis P. Harris - 30 Aug 2006 03:24 GMT
> Its only in the third case, side effects deliberately covered up, that the
> drug company bears liability.

which is EXACTLY the case with vioxx.  and fen-fen.  and a bunch
of others that were pushed hurriedly through the FDA for approval
when repugnicans were in the white house.
Tumbleweed - 30 Aug 2006 19:40 GMT
>> Its only in the third case, side effects deliberately covered up, that
>> the
[quoted text clipped - 3 lines]
> of others that were pushed hurriedly through the FDA for approval
> when repugnicans were in the white house.

...and the public also push the FDA to approve things quickly. Again. cake
and eating it, you cant have it both ways. The balance is a difficult
one.From my quick scan of vioxx, I'm getting the impression thats not a
clear cut case either, with early verdicts being overturned. AFAICS there is
a tendency in the US courts for juries to find in favour of 'the little
guy', and hand out big awards, because of the perception that it wont matter
to a large corporation (irrespective of the rights and wrongs of the case)

Signature

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email replies not necessary but to contact use;
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Dennis P. Harris - 31 Aug 2006 03:25 GMT
> From my quick scan of vioxx, I'm getting the impression thats not a
> clear cut case either, with early verdicts being overturned.

the verdicts being overturned have a lot more to do with the drug
companies throwing an infinite number of lawyers and expert
witnesses at the plaintiffs, rather than the merits of the case.

if they happened in states with elected judges, then i'd suspect
bribery or some other form of monetary influence like so called
"campaign donations".  it's why texas courts are so corrupt, for
example.
Evelyn Ruut - 28 Aug 2006 01:11 GMT
>>  Accordingly, I found St. John's standardized for that newly-identified
>> constituent, and it's worked really well for me.
[quoted text clipped - 21 lines]
> Wort is one of the few that actually comes up as useful. BTW, it is
> contraindicated with certain other herbs and drugs, check up on that.

Another very useful herb is a close relative of the St. Johns Wort.... it is
called Motherwort.   The absolute best cure for hot flashes ever.
Fortunately I no longer need it, but back in the day, Motherwort was the one
very thing that helped.

Signature

Best Regards,

Evelyn
(to reply to me personally, remove 'sox')

Dennis P. Harris - 28 Aug 2006 08:20 GMT
> Why
> should companies or people not involved with a particular drug (be it pharma
> or heb originated) have to pay for testing?

so that both the funder and the tester conducting the research
have no interest in the outcome.
Tumbleweed - 28 Aug 2006 09:37 GMT
>> Why
>> should companies or people not involved with a particular drug (be it
[quoted text clipped - 3 lines]
> so that both the funder and the tester conducting the research
> have no interest in the outcome.

Good intentions, you and dana can start with the first payments.

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