Re: FDA Calls Crestor Ads 'False and Misleading'



D

Daniel Ganek

Guest
TC wrote:
> RobJ wrote:
>
>>New York Times
>>December 23, 2004
>>
>>F.D.A. Calls Ads for Cholesterol Pill Crestor 'False and Misleading'
>>By GARDINER HARRIS
>>
>>WASHINGTON - AstraZeneca's recent full-page newspaper advertisements
>>defending the safety of its cholesterol-lowering pill, Crestor, are
>>"false and misleading," in part because serious concerns remain about
>>the safety of the drug, federal drug regulators said Wednesday.
>>
>>The advertisements stated that "the F.D.A. has confidence in the
>>safety and efficacy of Crestor" and that the agency "as recently as
>>last Friday publicly confirmed that Crestor is safe and effective."
>>Neither is true, said a letter from the Food and Drug Administration
>>to AstraZeneca.
[[ SNIP ]]
>
> Lookee, lookee, the FDA is actually trying to look as if it is doing
> something useful now. Too little too late, eh?
>
> TC
>

I'm neither for nor against the FDA, BUT, wasn't it just a few years
ago we were all *****ing that the FDA took TOO long to approve drugs?

Now, we're all *****ing and moaning that they're not during their job and
letting drugs on the market too soon!

/dan
 
Daniel Ganek wrote:
> TC wrote:
> > RobJ wrote:
> >
> >>New York Times
> >>December 23, 2004
> >>
> >>F.D.A. Calls Ads for Cholesterol Pill Crestor 'False and
Misleading'
> >>By GARDINER HARRIS
> >>
> >>WASHINGTON - AstraZeneca's recent full-page newspaper
advertisements
> >>defending the safety of its cholesterol-lowering pill, Crestor, are
> >>"false and misleading," in part because serious concerns remain
about
> >>the safety of the drug, federal drug regulators said Wednesday.
> >>
> >>The advertisements stated that "the F.D.A. has confidence in the
> >>safety and efficacy of Crestor" and that the agency "as recently as
> >>last Friday publicly confirmed that Crestor is safe and effective."
> >>Neither is true, said a letter from the Food and Drug
Administration
> >>to AstraZeneca.
> [[ SNIP ]]
> >
> > Lookee, lookee, the FDA is actually trying to look as if it is
doing
> > something useful now. Too little too late, eh?
> >
> > TC
> >
>
> I'm neither for nor against the FDA, BUT, wasn't it just a few years
> ago we were all *****ing that the FDA took TOO long to approve drugs?
>
> Now, we're all *****ing and moaning that they're not during their job
and
> letting drugs on the market too soon!
>
> /dan

Were we? I don't think so. Unless by "we" you are talking about the
pharma industry.

TC
 
"TC" <[email protected]> wrote in message
news:[email protected]...
>
> Daniel Ganek wrote:
> > TC wrote:
> > > RobJ wrote:
> > >
> > >>New York Times
> > >>December 23, 2004
> > >>
> > >>F.D.A. Calls Ads for Cholesterol Pill Crestor 'False and
> Misleading'
> > >>By GARDINER HARRIS
> > >>
> > >>WASHINGTON - AstraZeneca's recent full-page newspaper
> advertisements
> > >>defending the safety of its cholesterol-lowering pill, Crestor, are
> > >>"false and misleading," in part because serious concerns remain
> about
> > >>the safety of the drug, federal drug regulators said Wednesday.
> > >>
> > >>The advertisements stated that "the F.D.A. has confidence in the
> > >>safety and efficacy of Crestor" and that the agency "as recently as
> > >>last Friday publicly confirmed that Crestor is safe and effective."
> > >>Neither is true, said a letter from the Food and Drug
> Administration
> > >>to AstraZeneca.
> > [[ SNIP ]]
> > >
> > > Lookee, lookee, the FDA is actually trying to look as if it is
> doing
> > > something useful now. Too little too late, eh?
> > >
> > > TC
> > >
> >
> > I'm neither for nor against the FDA, BUT, wasn't it just a few years
> > ago we were all *****ing that the FDA took TOO long to approve drugs?
> >
> > Now, we're all *****ing and moaning that they're not during their job
> and
> > letting drugs on the market too soon!
> >
> > /dan
>
> Were we? I don't think so. Unless by "we" you are talking about the
> pharma industry.

"We" were. "We" being people who were hearing about treatments in the
development stages for conditions where there was no treatment or no relief.
"We" demanded a shorter process.
 
Daniel Ganek wrote:
> TC wrote:
> > RobJ wrote:
> >
> >>New York Times
> >>December 23, 2004
> >>
> >>F.D.A. Calls Ads for Cholesterol Pill Crestor 'False and
Misleading'
> >>By GARDINER HARRIS
> >>
> >>WASHINGTON - AstraZeneca's recent full-page newspaper
advertisements
> >>defending the safety of its cholesterol-lowering pill, Crestor, are
> >>"false and misleading," in part because serious concerns remain
about
> >>the safety of the drug, federal drug regulators said Wednesday.
> >>
> >>The advertisements stated that "the F.D.A. has confidence in the
> >>safety and efficacy of Crestor" and that the agency "as recently as
> >>last Friday publicly confirmed that Crestor is safe and effective."
> >>Neither is true, said a letter from the Food and Drug
Administration
> >>to AstraZeneca.
> [[ SNIP ]]
> >
> > Lookee, lookee, the FDA is actually trying to look as if it is
doing
> > something useful now. Too little too late, eh?
> >
> > TC
> >
>
> I'm neither for nor against the FDA, BUT, wasn't it just a few years
> ago we were all *****ing that the FDA took TOO long to approve drugs?
>
> Now, we're all *****ing and moaning that they're not during their job
and
> letting drugs on the market too soon!
>
> /dan

There really is no pleasing everybody so it is wiser to simply seek out
God's will.

May God bless those who read the following:

http://makeashorterlink.com/?I24E5151A


May what I have written enlighten you and others.

Such is the work being done here for Christ's glory
(http://makeashorterlink.com/?U1E13130A).


Servant to the humblest person in the universe,

Andrew

--
Dr. Andrew B. Chung, MD/PhD
Board-Certified Cardiologist
http://www.heartmdphd.com/

**
Who is the humblest person in the universe?
http://makeashorterlink.com/?L26062048

What is all this about?
http://makeashorterlink.com/?K6F72510A
Is this spam?
http://makeashorterlink.com/?D13B21FF9
 
Remember Rezulin - the "miracle" diabetes pill on the FDA's fast-track
approval, now cited as a suspect in at least 556 deaths. But heck, it
made $2.1 billion in sales for Warner-Lambert.
The sordid tale is still online at http://www.latimes.com/rezulin
 
"Mark Probert" <Mark [email protected]> wrote in message news:[email protected]...
>
> "TC" <[email protected]> wrote in message
> news:[email protected]...
> >
> > Daniel Ganek wrote:
> > > I'm neither for nor against the FDA, BUT, wasn't it just a few years
> > > ago we were all *****ing that the FDA took TOO long to approve drugs?
> > >
> > > Now, we're all *****ing and moaning that they're not during their job
> > and
> > > letting drugs on the market too soon!
> > >
> > > /dan
> >
> > Were we? I don't think so. Unless by "we" you are talking about the
> > pharma industry.
>
> "We" were. "We" being people who were hearing about treatments in the
> development stages for conditions where there was no treatment or no relief.
> "We" demanded a shorter process.

If you haven't already, read "Against Leviathan: Government
Power and a Free Society" by Robert Higgs. It's a real eye
opener..

The FDA is as corrupt if not more corrupt than any other
government bureacracy, such as the DEA and other domestic
terrorist organizations.
 
"Mark Probert" <Mark [email protected]> wrote in message
news:[email protected]...
>
> "TC" <[email protected]> wrote in message
> news:[email protected]...
>>
>> Daniel Ganek wrote:
>> > TC wrote:
>> > > RobJ wrote:
>> > >
>> > >>New York Times
>> > >>December 23, 2004
>> > >>
>> > >>F.D.A. Calls Ads for Cholesterol Pill Crestor 'False and
>> Misleading'
>> > >>By GARDINER HARRIS
>> > >>
>> > >>WASHINGTON - AstraZeneca's recent full-page newspaper
>> advertisements
>> > >>defending the safety of its cholesterol-lowering pill, Crestor, are
>> > >>"false and misleading," in part because serious concerns remain
>> about
>> > >>the safety of the drug, federal drug regulators said Wednesday.
>> > >>
>> > >>The advertisements stated that "the F.D.A. has confidence in the
>> > >>safety and efficacy of Crestor" and that the agency "as recently as
>> > >>last Friday publicly confirmed that Crestor is safe and effective."
>> > >>Neither is true, said a letter from the Food and Drug
>> Administration
>> > >>to AstraZeneca.
>> > [[ SNIP ]]
>> > >
>> > > Lookee, lookee, the FDA is actually trying to look as if it is
>> doing
>> > > something useful now. Too little too late, eh?
>> > >
>> > > TC
>> > >
>> >
>> > I'm neither for nor against the FDA, BUT, wasn't it just a few years
>> > ago we were all *****ing that the FDA took TOO long to approve drugs?
>> >
>> > Now, we're all *****ing and moaning that they're not during their job
>> and
>> > letting drugs on the market too soon!
>> >
>> > /dan
>>
>> Were we? I don't think so. Unless by "we" you are talking about the
>> pharma industry.
>
> "We" were. "We" being people who were hearing about treatments in the
> development stages for conditions where there was no treatment or no
> relief.
> "We" demanded a shorter process.

You should know by now: The ideal FDA needs to approve all effective safe
drugs overnight, and will catch all harmful and ineffective drugs
immediately.

And that little nonsense about a process for distinguishing between the two?
The public's not concerned with that.
 
"James Stein" <[email protected]> wrote in message
news:[email protected]...
>
> "Mark Probert" <Mark [email protected]> wrote in message
> news:[email protected]...
> >
> > "TC" <[email protected]> wrote in message
> > news:[email protected]...
> >>
> >> Daniel Ganek wrote:
> >> > TC wrote:
> >> > > RobJ wrote:
> >> > >
> >> > >>New York Times
> >> > >>December 23, 2004
> >> > >>
> >> > >>F.D.A. Calls Ads for Cholesterol Pill Crestor 'False and
> >> Misleading'
> >> > >>By GARDINER HARRIS
> >> > >>
> >> > >>WASHINGTON - AstraZeneca's recent full-page newspaper
> >> advertisements
> >> > >>defending the safety of its cholesterol-lowering pill, Crestor, are
> >> > >>"false and misleading," in part because serious concerns remain
> >> about
> >> > >>the safety of the drug, federal drug regulators said Wednesday.
> >> > >>
> >> > >>The advertisements stated that "the F.D.A. has confidence in the
> >> > >>safety and efficacy of Crestor" and that the agency "as recently as
> >> > >>last Friday publicly confirmed that Crestor is safe and effective."
> >> > >>Neither is true, said a letter from the Food and Drug
> >> Administration
> >> > >>to AstraZeneca.
> >> > [[ SNIP ]]
> >> > >
> >> > > Lookee, lookee, the FDA is actually trying to look as if it is
> >> doing
> >> > > something useful now. Too little too late, eh?
> >> > >
> >> > > TC
> >> > >
> >> >
> >> > I'm neither for nor against the FDA, BUT, wasn't it just a few years
> >> > ago we were all *****ing that the FDA took TOO long to approve drugs?
> >> >
> >> > Now, we're all *****ing and moaning that they're not during their job
> >> and
> >> > letting drugs on the market too soon!
> >> >
> >> > /dan
> >>
> >> Were we? I don't think so. Unless by "we" you are talking about the
> >> pharma industry.
> >
> > "We" were. "We" being people who were hearing about treatments in the
> > development stages for conditions where there was no treatment or no
> > relief.
> > "We" demanded a shorter process.
>
> You should know by now: The ideal FDA needs to approve all effective safe
> drugs overnight, and will catch all harmful and ineffective drugs
> immediately.
>
> And that little nonsense about a process for distinguishing between the
two?
> The public's not concerned with that.

Agreed. There are those who expect perfection from the FDA and all
humankind.
 
Mark Probert wrote:
>
> "James Stein" <[email protected]> wrote in message
> news:[email protected]...
> >
> > "Mark Probert" <Mark [email protected]> wrote in message
> > news:[email protected]...
> > >
> > > "TC" <[email protected]> wrote in message
> > > news:[email protected]...
> > >>
> > >> Daniel Ganek wrote:
> > >> > TC wrote:
> > >> > > RobJ wrote:
> > >> > >
> > >> > >>New York Times
> > >> > >>December 23, 2004
> > >> > >>
> > >> > >>F.D.A. Calls Ads for Cholesterol Pill Crestor 'False and
> > >> Misleading'
> > >> > >>By GARDINER HARRIS
> > >> > >>
> > >> > >>WASHINGTON - AstraZeneca's recent full-page newspaper
> > >> advertisements
> > >> > >>defending the safety of its cholesterol-lowering pill, Crestor, are
> > >> > >>"false and misleading," in part because serious concerns remain
> > >> about
> > >> > >>the safety of the drug, federal drug regulators said Wednesday.
> > >> > >>
> > >> > >>The advertisements stated that "the F.D.A. has confidence in the
> > >> > >>safety and efficacy of Crestor" and that the agency "as recently as
> > >> > >>last Friday publicly confirmed that Crestor is safe and effective."
> > >> > >>Neither is true, said a letter from the Food and Drug
> > >> Administration
> > >> > >>to AstraZeneca.
> > >> > [[ SNIP ]]
> > >> > >
> > >> > > Lookee, lookee, the FDA is actually trying to look as if it is
> > >> doing
> > >> > > something useful now. Too little too late, eh?
> > >> > >
> > >> > > TC
> > >> > >
> > >> >
> > >> > I'm neither for nor against the FDA, BUT, wasn't it just a few years
> > >> > ago we were all *****ing that the FDA took TOO long to approve drugs?
> > >> >
> > >> > Now, we're all *****ing and moaning that they're not during their job
> > >> and
> > >> > letting drugs on the market too soon!
> > >> >
> > >> > /dan
> > >>
> > >> Were we? I don't think so. Unless by "we" you are talking about the
> > >> pharma industry.
> > >
> > > "We" were. "We" being people who were hearing about treatments in the
> > > development stages for conditions where there was no treatment or no
> > > relief.
> > > "We" demanded a shorter process.
> >
> > You should know by now: The ideal FDA needs to approve all effective safe
> > drugs overnight, and will catch all harmful and ineffective drugs
> > immediately.
> >
> > And that little nonsense about a process for distinguishing between the
> two?
> > The public's not concerned with that.
>
> Agreed. There are those who expect perfection from the FDA and all
> humankind.


Enter Christ Jesus :)


May God bless those who read the following:

http://makeashorterlink.com/?I24E5151A


May what I have written enlighten you and others.

Such is the work being done here for Christ's glory
(http://makeashorterlink.com/?U1E13130A).


Servant to the humblest person in the universe,

Andrew

--
Dr. Andrew B. Chung, MD/PhD
Board-Certified Cardiologist
http://www.heartmdphd.com/

**
Who is the humblest person in the universe?
http://makeashorterlink.com/?L26062048

What is all this about?
http://makeashorterlink.com/?K6F72510A

Is this spam?
http://makeashorterlink.com/?D13B21FF9
 
James Stein wrote:
>
> "Mark Probert" <Mark [email protected]> wrote in message
> news:[email protected]...
> >
> > "TC" <[email protected]> wrote in message
> > news:[email protected]...
> >>
> >> Daniel Ganek wrote:
> >> > TC wrote:
> >> > > RobJ wrote:
> >> > >
> >> > >>New York Times
> >> > >>December 23, 2004
> >> > >>
> >> > >>F.D.A. Calls Ads for Cholesterol Pill Crestor 'False and
> >> Misleading'
> >> > >>By GARDINER HARRIS
> >> > >>
> >> > >>WASHINGTON - AstraZeneca's recent full-page newspaper
> >> advertisements
> >> > >>defending the safety of its cholesterol-lowering pill, Crestor, are
> >> > >>"false and misleading," in part because serious concerns remain
> >> about
> >> > >>the safety of the drug, federal drug regulators said Wednesday.
> >> > >>
> >> > >>The advertisements stated that "the F.D.A. has confidence in the
> >> > >>safety and efficacy of Crestor" and that the agency "as recently as
> >> > >>last Friday publicly confirmed that Crestor is safe and effective."
> >> > >>Neither is true, said a letter from the Food and Drug
> >> Administration
> >> > >>to AstraZeneca.
> >> > [[ SNIP ]]
> >> > >
> >> > > Lookee, lookee, the FDA is actually trying to look as if it is
> >> doing
> >> > > something useful now. Too little too late, eh?
> >> > >
> >> > > TC
> >> > >
> >> >
> >> > I'm neither for nor against the FDA, BUT, wasn't it just a few years
> >> > ago we were all *****ing that the FDA took TOO long to approve drugs?
> >> >
> >> > Now, we're all *****ing and moaning that they're not during their job
> >> and
> >> > letting drugs on the market too soon!
> >> >
> >> > /dan
> >>
> >> Were we? I don't think so. Unless by "we" you are talking about the
> >> pharma industry.
> >
> > "We" were. "We" being people who were hearing about treatments in the
> > development stages for conditions where there was no treatment or no
> > relief.
> > "We" demanded a shorter process.
>
> You should know by now: The ideal FDA needs to approve all effective safe
> drugs overnight, and will catch all harmful and ineffective drugs
> immediately.
>
> And that little nonsense about a process for distinguishing between the two?
> The public's not concerned with that.


IOW, folks want Lord Jesus Christ to take over the FDA :)

May God bless those who read the following:

http://makeashorterlink.com/?I24E5151A


May what I have written enlighten you and others.

Such is the work being done here for Christ's glory
(http://makeashorterlink.com/?U1E13130A).


Servant to the humblest person in the universe,

Andrew

--
Dr. Andrew B. Chung, MD/PhD
Board-Certified Cardiologist
http://www.heartmdphd.com/

**
Who is the humblest person in the universe?
http://makeashorterlink.com/?L26062048

What is all this about?
http://makeashorterlink.com/?K6F72510A

Is this spam?
http://makeashorterlink.com/?D13B21FF9
 
>
> There really is no pleasing everybody so it is wiser to simply seek out
> God's will.

Well, there's clearly no point looking in that so-called
'good book' for it:
http://www.skepticsannotatedbible.com/howto.html


> May what I have written enlighten you and others.
>
> Such is the work being done here for Christ's glory


And here too:
http://www.jesusneverexisted.com/


> Servant to the humblest person in the universe,

How nice! And yet somehow we don't see you 'giving
away all that you have'. Why is that, I wonder...?

Philippic
 
On Thu, 23 Dec 2004 17:09:55 -0500, "Mark Probert" <Mark
[email protected]> wrote:

>
>Agreed. There are those who expect perfection from the FDA and all
>humankind.


There is a HUMONGOUS continuum between "perfection" and the
performance of the FDA, Marla.
 
"Ilena Rose" <[email protected]> wrote in message
news:[email protected]...
> On Thu, 23 Dec 2004 17:09:55 -0500, "Mark Probert" <Mark
> [email protected]> wrote:
>
>>
>>Agreed. There are those who expect perfection from the FDA and all
>>humankind.
>
>
> There is a HUMONGOUS continuum between "perfection" and the
> performance of the FDA, Marla.


Actually, what we refer to is the fact that people decry how long it takes
the FDA to get a drug certified. And when those times are shortened, they
complain that the screening process is not rigorous enough. Those two
qualities are mutually exclusive, yet people desire both.

The FDA is *just* an organization. The fact that an ideal exists does not
mean we can achieve it.
 
In article <1103860526.3078be9dad2522507ddd97ea17a227dc@teranews>,
"Dr. Andrew B. Chung, MD/PhD" <[email protected]> wrote:

> For those who are filled with the Holy Spirit, the Holy Bible teaches
> how to seek out God's will in what is going on in the world.

What does it teach for those not so filled?
 
Philippic wrote:
>
> >
> > There really is no pleasing everybody so it is wiser to simply seek out
> > God's will.
>
> Well, there's clearly no point looking in that so-called
> 'good book' for it:
> http://www.skepticsannotatedbible.com/howto.html

For those who are filled with the Holy Spirit, the Holy Bible teaches
how to seek out God's will in what is going on in the world. For those
who are close-minded, the Holy Bible shows only the flaws and
imperfections of man. God is not the God of dead but of the living.
(Luke 20:38).

> > May what I have written enlighten you and others.
> >
> > Such is the work being done here for Christ's glory
>
> And here too:
> http://www.jesusneverexisted.com/

Not really in comparison to this:

http://makeashorterlink.com/?X1C62661A

> > Servant to the humblest person in the universe,
>
> How nice! And yet somehow we don't see you 'giving
> away all that you have'. Why is that, I wonder...?

I do not have anything that does not belong to God.

May God bless those who read the following:

http://makeashorterlink.com/?I24E5151A


May what I have written enlighten you and others.

Such is the work being done here for Christ's glory
(http://makeashorterlink.com/?U1E13130A).


Servant to the humblest person in the universe,

Andrew

--
Dr. Andrew B. Chung, MD/PhD
Board-Certified Cardiologist
http://www.heartmdphd.com/

**
Who is the humblest person in the universe?
http://makeashorterlink.com/?L26062048

What is all this about?
http://makeashorterlink.com/?K6F72510A

Is this spam?
http://makeashorterlink.com/?D13B21FF9
 
In article <1103861288.a95e5fe8e6c4743814b1d285a2b9d0fe@teranews>,
"Dr. Andrew B. Chung, MD/PhD" <[email protected]> wrote:

> [email protected]lid wrote:
> >
> > In article <1103860526.3078be9dad2522507ddd97ea17a227dc@teranews>,
> > "Dr. Andrew B. Chung, MD/PhD" <[email protected]> wrote:
> >
> > > For those who are filled with the Holy Spirit, the Holy Bible teaches
> > > how to seek out God's will in what is going on in the world.
> >
> > What does it teach for those not so filled?
>
>
> That man (including the skeptical reader) is flawed, fallible, and
> judgmental.

As are his publications. This is news? Further responses limited to
misc.consumers as I hate crossposting.
 
[email protected]lid wrote:
>
> In article <1103860526.3078be9dad2522507ddd97ea17a227dc@teranews>,
> "Dr. Andrew B. Chung, MD/PhD" <[email protected]> wrote:
>
> > For those who are filled with the Holy Spirit, the Holy Bible teaches
> > how to seek out God's will in what is going on in the world.
>
> What does it teach for those not so filled?


That man (including the skeptical reader) is flawed, fallible, and
judgmental.


May God bless those who read the following:

http://makeashorterlink.com/?I24E5151A


May what I have written enlighten you and others.

Such is the work being done here for Christ's glory
(http://makeashorterlink.com/?U1E13130A).


Servant to the humblest person in the universe,

Andrew

--
Dr. Andrew B. Chung, MD/PhD
Board-Certified Cardiologist
http://www.heartmdphd.com/

**
Who is the humblest person in the universe?
http://makeashorterlink.com/?L26062048

What is all this about?
http://makeashorterlink.com/?K6F72510A

Is this spam?
http://makeashorterlink.com/?D13B21FF9
 
[email protected]lid wrote:
>
> In article <1103861288.a95e5fe8e6c4743814b1d285a2b9d0fe@teranews>,
> "Dr. Andrew B. Chung, MD/PhD" <[email protected]> wrote:
>
> > [email protected]lid wrote:
> > >
> > > In article <1103860526.3078be9dad2522507ddd97ea17a227dc@teranews>,
> > > "Dr. Andrew B. Chung, MD/PhD" <[email protected]> wrote:
> > >
> > > > For those who are filled with the Holy Spirit, the Holy Bible teaches
> > > > how to seek out God's will in what is going on in the world.
> > >
> > > What does it teach for those not so filled?
> >
> >
> > That man (including the skeptical reader) is flawed, fallible, and
> > judgmental.
>
> As are his publications. This is news?

No. This is my answer to your question.

> Further responses limited to
> misc.consumers as I hate crossposting.

Your choice.


May God bless those who read the following:

http://makeashorterlink.com/?I24E5151A


May what I have written enlighten you and others.

Such is the work being done here for Christ's glory
(http://makeashorterlink.com/?U1E13130A).


Servant to the humblest person in the universe,

Andrew

--
Dr. Andrew B. Chung, MD/PhD
Board-Certified Cardiologist
http://www.heartmdphd.com/

**
Who is the humblest person in the universe?
http://makeashorterlink.com/?L26062048

What is all this about?
http://makeashorterlink.com/?K6F72510A

Is this spam?
http://makeashorterlink.com/?D13B21FF9
 
On Thu, 23 Dec 2004 10:23:27 -0500, Daniel Ganek <[email protected]>
wrote:

snip....>
>I'm neither for nor against the FDA, BUT, wasn't it just a few years
>ago we were all *****ing that the FDA took TOO long to approve drugs?
>
>Now, we're all *****ing and moaning that they're not during their job and
>letting drugs on the market too soon!

Ah--there's a number of issues here.

Drugs for life-threatening conditions such as AIDS and some cancers
NEED faster approval to help people obtain access. Such accelerated
approval is predicated on the companies doing larger Phase IV
follow-up studies to evaluate toxicities that may not be picked up in
smaller studies.

Companies usually renege.

Meantime, Pharma spends inordinate resources on products for chronic
but not necessarily imminently life threatening conditions such as
arthritis pain and cholesterol. These require life long use of drugs
and are MUCH more profitable. But studies are usually 6 months or a
year and do not take into account polypharmacy (use of many drugs) and
long duration. Thus, they'll miss the longer term toxicities.

Which suits them fine as long as they can assure multi-billion dollar
per year profits on overcharging drastically for these medications.

They answer only to the parasites of Wall Street, not to the mission
of people's health and what will best serve individuals facing chronic
or acute conditions.

George M. Carter
 
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