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WARNING-Actos-Avandia
Posted by W. Baker


In alt.support.diabetes Al Hardy <a.hardy2@ntlworld.com> wrote:

If I recall correctly, about 5 years ago there were three drugs onthe
market , Actos, Avandia and ? (don't remember the name). They all were
insulin resistance reducers. ? was pulled from the market because of, I
believe it was liver problems, but at any rate, there was too high
incidence of death from a side effect. There has been discussion before
on this group about people getting edema with these drugs and being taken
off them. THis warning is quite specific to a particular group of
individuals, as bigAl has pointed out and certainly is contraindicated if
it results in any edema or unusual weight gain, particularly from water
retention.

Isn't Metformin also supposed to have some insulin reduction effect
without the edema, as well as its primary action of reducing glucagon
release from the liver?

Wendy

Posted by W. Baker


In alt.support.diabetes Al Hardy <a.hardy2@ntlworld.com> wrote:

If I recall correctly, about 5 years ago there were three drugs onthe
market , Actos, Avandia and ? (don't remember the name). They all were
insulin resistance reducers. ? was pulled from the market because of, I
believe it was liver problems, but at any rate, there was too high
incidence of death from a side effect. There has been discussion before
on this group about people getting edema with these drugs and being taken
off them. THis warning is quite specific to a particular group of
individuals, as bigAl has pointed out and certainly is contraindicated if
it results in any edema or unusual weight gain, particularly from water
retention.

Isn't Metformin also supposed to have some insulin reduction effect
without the edema, as well as its primary action of reducing glucagon
release from the liver?

Wendy

Posted by Jenny


Al,

Years ago before the AIDS epidemic when drugs were only marketed to doctors,
not the public, the FDA was more rigorous in testing drugs. Unfortunatley,
in response to the dire need of AIDS patients to try experimental drugs, the
whole process got speeded up and drugs now hit the market with short term
studies done in a couple thousand people which cannot catch any long term
effects.

In addition, the drug companies pretty much run the FDA since they fund it,
and the current administration is not interested in any more regulation of
huge corporate campaign donors.

There's an excellent book called _Bitter Pills: Inside the hazardous world
of legal drugs_ by Stephen Fried which anyone who takes pharmaceuticals
should read. Fried was a mainstream investigative journalist whose wife
suffered irreversible brain damage from a Floxin drug prescribed for a minor
urinary tract infection. He was able to document the way that the
manufacturer had kept the drug on the market despite mounting evidence that
it caused this side effect in a small number of people. His expose of how
the approval and aftermarket process works is must reading!

As a thin T1, Actos or Avandia would not be of use to you. Your problem
isn't insulin resistance (i.e. an inability for cells to respond to insulin)
it's not making insulin, which is something else entirely.

These insulin resistance drugs are prescribed for Type IIs who still make
insulin but who are believed to be insulin resistant (usually without any
actual testing.) The drugs work on PPAR-gamma receptors in muscle tissue to
help those tissues take in blood sugar with the help of the body's own
insulin. According to the endocrinologist I saw, this tends to pack on
weight in these muscle tissues (arms and legs in particular).

A low carb diet would help a young person with Type II diabetes because many
people in the earlier stages of type II diabetes still make enough insulin
to handle a modest load of carbohydrate--12 - 15 grams a meal but not the
200 - 300 grams that old fashioned dieticians and doctors recommend. When
overweight people with type II diabetes go on a low carb diet, their weight
loss can also be very dramatic. I know many people who have lost as much as
100 pounds over a year of low carbing. That kind of weight loss itself
reduces insulin resistance too, which makes blood sugar much easier to
control.

Unfortunately here in the US we are bombarded with TV and magazine ads for
these very expensive drugs which are advertised with all the subtlety (and
logic) of new cars. The message they give is that these drugs take care of
diabetes without the person having to make any changes in their diet. Since
drug manufacturers fund most medical research nowadays, most of the articles
doctors read about diabetes are about how drugs control it.

Sad . . .

--Jenny

Cut the carbs to respond to my new email address!
New photo: http://www.geocities.com/jenny_the_bean/jennypics.htm
Weight: 168.5/137
Diabetes Type II diagnosed 8/1998 -
HBa1c 5.2 10/03
Low Carb 9/1998 - 8/2001 and 11/10/02 - Now

http://www.geocities.com/jenny_the_bean
How to calculate your need for protein * How much people really lose each
month * Water Weight Gain & Loss * The "Two Gram Cure" for Hunger Cravings
* Characteristics of Successful Dieters * Indispensible Low Carb Treats *
Should You Count that Low Impact Carb? * Curing Ketobreath * Exercise
Starting from Zero * Do Starch Blockers Work? * NEW! Why the Low Carb Diet
is Great for Diabetes * NEW! Low Carb Strategies for People with Diabetes


"Al Hardy" <a.hardy2@ntlworld.com> wrote in message
news:brpt6f$5nmv2$1@ID-191168.news.uni-berlin.de...


Posted by Jenny


Al,

Years ago before the AIDS epidemic when drugs were only marketed to doctors,
not the public, the FDA was more rigorous in testing drugs. Unfortunatley,
in response to the dire need of AIDS patients to try experimental drugs, the
whole process got speeded up and drugs now hit the market with short term
studies done in a couple thousand people which cannot catch any long term
effects.

In addition, the drug companies pretty much run the FDA since they fund it,
and the current administration is not interested in any more regulation of
huge corporate campaign donors.

There's an excellent book called _Bitter Pills: Inside the hazardous world
of legal drugs_ by Stephen Fried which anyone who takes pharmaceuticals
should read. Fried was a mainstream investigative journalist whose wife
suffered irreversible brain damage from a Floxin drug prescribed for a minor
urinary tract infection. He was able to document the way that the
manufacturer had kept the drug on the market despite mounting evidence that
it caused this side effect in a small number of people. His expose of how
the approval and aftermarket process works is must reading!

As a thin T1, Actos or Avandia would not be of use to you. Your problem
isn't insulin resistance (i.e. an inability for cells to respond to insulin)
it's not making insulin, which is something else entirely.

These insulin resistance drugs are prescribed for Type IIs who still make
insulin but who are believed to be insulin resistant (usually without any
actual testing.) The drugs work on PPAR-gamma receptors in muscle tissue to
help those tissues take in blood sugar with the help of the body's own
insulin. According to the endocrinologist I saw, this tends to pack on
weight in these muscle tissues (arms and legs in particular).

A low carb diet would help a young person with Type II diabetes because many
people in the earlier stages of type II diabetes still make enough insulin
to handle a modest load of carbohydrate--12 - 15 grams a meal but not the
200 - 300 grams that old fashioned dieticians and doctors recommend. When
overweight people with type II diabetes go on a low carb diet, their weight
loss can also be very dramatic. I know many people who have lost as much as
100 pounds over a year of low carbing. That kind of weight loss itself
reduces insulin resistance too, which makes blood sugar much easier to
control.

Unfortunately here in the US we are bombarded with TV and magazine ads for
these very expensive drugs which are advertised with all the subtlety (and
logic) of new cars. The message they give is that these drugs take care of
diabetes without the person having to make any changes in their diet. Since
drug manufacturers fund most medical research nowadays, most of the articles
doctors read about diabetes are about how drugs control it.

Sad . . .

--Jenny

Cut the carbs to respond to my new email address!
New photo: http://www.geocities.com/jenny_the_bean/jennypics.htm
Weight: 168.5/137
Diabetes Type II diagnosed 8/1998 -
HBa1c 5.2 10/03
Low Carb 9/1998 - 8/2001 and 11/10/02 - Now

http://www.geocities.com/jenny_the_bean
How to calculate your need for protein * How much people really lose each
month * Water Weight Gain & Loss * The "Two Gram Cure" for Hunger Cravings
* Characteristics of Successful Dieters * Indispensible Low Carb Treats *
Should You Count that Low Impact Carb? * Curing Ketobreath * Exercise
Starting from Zero * Do Starch Blockers Work? * NEW! Why the Low Carb Diet
is Great for Diabetes * NEW! Low Carb Strategies for People with Diabetes


"Al Hardy" <a.hardy2@ntlworld.com> wrote in message
news:brpt6f$5nmv2$1@ID-191168.news.uni-berlin.de...


Posted by Jenny


Wendy,

The earlier drug was Rezulin. One of the things that came out before it
was pulled off the market was that even though the manufacturers included a
"black box warning" i.e. the most strongly worded warning about fatal side
effects, doctors continued to prescribe it to people in the group at risk
for fatal reactions and did not do the periodic liver testing that the drug
companies recommended.

There is some evidence that these new drugs also cause occasional liver
failure (i.e. death!) but they'll have to kill a lot more people before they
get pulled off the market. Unfortunately, if a drug only kills 30 or 40
people a year, it will continue to be marketed. This is only a problem, of
course, if you are one of the forty!

-- Jenny

Cut the carbs to respond to my new email address!
New photo: http://www.geocities.com/jenny_the_bean/jennypics.htm
Weight: 168.5/137
Diabetes Type II diagnosed 8/1998 -
HBa1c 5.2 10/03
Low Carb 9/1998 - 8/2001 and 11/10/02 - Now

http://www.geocities.com/jenny_the_bean
How to calculate your need for protein * How much people really lose each
month * Water Weight Gain & Loss * The "Two Gram Cure" for Hunger Cravings
* Characteristics of Successful Dieters * Indispensible Low Carb Treats *
Should You Count that Low Impact Carb? * Curing Ketobreath * Exercise
Starting from Zero * Do Starch Blockers Work? * NEW! Why the Low Carb Diet
is Great for Diabetes * NEW! Low Carb Strategies for People with Diabetes


"W. Baker" <wbaker@panix.com> wrote in message
news:brqkg1$dgp$1@reader2.panix.com...


Posted by Jenny


Wendy,

The earlier drug was Rezulin. One of the things that came out before it
was pulled off the market was that even though the manufacturers included a
"black box warning" i.e. the most strongly worded warning about fatal side
effects, doctors continued to prescribe it to people in the group at risk
for fatal reactions and did not do the periodic liver testing that the drug
companies recommended.

There is some evidence that these new drugs also cause occasional liver
failure (i.e. death!) but they'll have to kill a lot more people before they
get pulled off the market. Unfortunately, if a drug only kills 30 or 40
people a year, it will continue to be marketed. This is only a problem, of
course, if you are one of the forty!

-- Jenny

Cut the carbs to respond to my new email address!
New photo: http://www.geocities.com/jenny_the_bean/jennypics.htm
Weight: 168.5/137
Diabetes Type II diagnosed 8/1998 -
HBa1c 5.2 10/03
Low Carb 9/1998 - 8/2001 and 11/10/02 - Now

http://www.geocities.com/jenny_the_bean
How to calculate your need for protein * How much people really lose each
month * Water Weight Gain & Loss * The "Two Gram Cure" for Hunger Cravings
* Characteristics of Successful Dieters * Indispensible Low Carb Treats *
Should You Count that Low Impact Carb? * Curing Ketobreath * Exercise
Starting from Zero * Do Starch Blockers Work? * NEW! Why the Low Carb Diet
is Great for Diabetes * NEW! Low Carb Strategies for People with Diabetes


"W. Baker" <wbaker@panix.com> wrote in message
news:brqkg1$dgp$1@reader2.panix.com...


Posted by Al Hardy


Jenny wrote:
drugs are not marketed to doctors or piblic, only advertised, and not even
supplied by the doctor, but the pharmacist. But there is possibly a
linguisic difference between my undestanding of the word *marketing* and
yours.

totally autonomous in every other way.



load? I eat 85gm to 95gm per day, but then I wish to put on another 7lbs or
slightly more.


Al.



Posted by Al Hardy


Jenny wrote:
drugs are not marketed to doctors or piblic, only advertised, and not even
supplied by the doctor, but the pharmacist. But there is possibly a
linguisic difference between my undestanding of the word *marketing* and
yours.

totally autonomous in every other way.



load? I eat 85gm to 95gm per day, but then I wish to put on another 7lbs or
slightly more.


Al.



Posted by Herman Rubin


In article <brqkg1$dgp$1@reader2.panix.com>, W. Baker <wbaker@panix.com> wrote:
The other drug was Rezulin.

They all were
The incidence of death from liver problems was NOT that
high; about 1 in 50,000, and this was without carrying out
liver tests. It would not have been withdrawn if Actos and
Avandia, slightly different drugs believed not to have the
liver problem, were not already going through the approval
process.

There has been discussion before
Apparently the problem with edema was not caught during
drug testing. There are NO "safe effective drugs".

Slight. Metformin also has its risks, including liver
problems and lactic acidosis, I believe.


--
This address is for information only. I do not claim that these views
are those of the Statistics Department or of Purdue University.
Herman Rubin, Department of Statistics, Purdue University
hrubin@stat.purdue.edu Phone: (765)494-6054 FAX: (765)494-0558

Posted by Herman Rubin


In article <brqkg1$dgp$1@reader2.panix.com>, W. Baker <wbaker@panix.com> wrote:
The other drug was Rezulin.

They all were
The incidence of death from liver problems was NOT that
high; about 1 in 50,000, and this was without carrying out
liver tests. It would not have been withdrawn if Actos and
Avandia, slightly different drugs believed not to have the
liver problem, were not already going through the approval
process.

There has been discussion before
Apparently the problem with edema was not caught during
drug testing. There are NO "safe effective drugs".

Slight. Metformin also has its risks, including liver
problems and lactic acidosis, I believe.


--
This address is for information only. I do not claim that these views
are those of the Statistics Department or of Purdue University.
Herman Rubin, Department of Statistics, Purdue University
hrubin@stat.purdue.edu Phone: (765)494-6054 FAX: (765)494-0558

Posted by Julie Bove






"W. Baker" <wbaker@panix.com> wrote in message
news:brqkg1$dgp$1@reader2.panix.com...
Rezulin was the drug that was pulled.
I think so.

--
Type 2
http://users.bestweb.net/~jbove/



Posted by Julie Bove






"W. Baker" <wbaker@panix.com> wrote in message
news:brqkg1$dgp$1@reader2.panix.com...
Rezulin was the drug that was pulled.
I think so.

--
Type 2
http://users.bestweb.net/~jbove/



Posted by Jenny


Al,

In the US drug companies run prime time TV ads targetted to the most
simpleminded viewers which typically end up with a voiceover telling you
something like "Ask your doctor about how Happinex can solve all your
earlthy problems!" You need the prescription from the doctor to buy them at
a pharmacy but doctors fear if they don't give that prescription to you when
you ask, you'll change doctors, so they mostly do. The advertised drugs cost
20 times what generics cost that do the same job, and are the main reason
why my monthly health insurance payment is higher than what my rent used to
be.

Magazines are filled with ads for these products too. On the back page in
tiny letters they have all the warnings and side effects listed, but no one
but me appears to read them.

There are still far too many dieticians and doctors telling patients to eat
a low fat, high carb diet for diabetes. I know. It's idiotic! But the
cousins have one of those doctors, and of cours they've been seeing him all
their lives so telling them he's an idiot is a complete waste of time.

Plus, a wierd phenomenon I've noted is this. Since I have my blood sugar
under control and have lost all this weight, most of the local people who I
know who have diabetes seem to think I don't REALLY have diabetes like they
do! They sit there eating their doctor-prescribed pasta and whole wheat
bread, and finishing it off with the no-sugar-added low fat ice cream (which
has more carbs than real ice cream) and explain that it might be okay for me
to eat all that dreadful fat I eat and all that protein, but since they're
diabetic, they can't! <sigh>

-- Jenny

Cut the carbs to respond to my new email address!
New photo: http://www.geocities.com/jenny_the_bean/jennypics.htm
Weight: 168.5/137
Diabetes Type II diagnosed 8/1998 -
HBa1c 5.2 10/03
Low Carb 9/1998 - 8/2001 and 11/10/02 - Now

http://www.geocities.com/jenny_the_bean
How to calculate your need for protein * How much people really lose each
month * Water Weight Gain & Loss * The "Two Gram Cure" for Hunger Cravings
* Characteristics of Successful Dieters * Indispensible Low Carb Treats *
Should You Count that Low Impact Carb? * Curing Ketobreath * Exercise
Starting from Zero * Do Starch Blockers Work? * NEW! Why the Low Carb Diet
is Great for Diabetes * NEW! Low Carb Strategies for People with Diabetes


"Al Hardy" <a.hardy2@ntlworld.com> wrote in message
news:brqs1u$4ik9j$1@ID-191168.news.uni-berlin.de...


Posted by Jenny


Al,

In the US drug companies run prime time TV ads targetted to the most
simpleminded viewers which typically end up with a voiceover telling you
something like "Ask your doctor about how Happinex can solve all your
earlthy problems!" You need the prescription from the doctor to buy them at
a pharmacy but doctors fear if they don't give that prescription to you when
you ask, you'll change doctors, so they mostly do. The advertised drugs cost
20 times what generics cost that do the same job, and are the main reason
why my monthly health insurance payment is higher than what my rent used to
be.

Magazines are filled with ads for these products too. On the back page in
tiny letters they have all the warnings and side effects listed, but no one
but me appears to read them.

There are still far too many dieticians and doctors telling patients to eat
a low fat, high carb diet for diabetes. I know. It's idiotic! But the
cousins have one of those doctors, and of cours they've been seeing him all
their lives so telling them he's an idiot is a complete waste of time.

Plus, a wierd phenomenon I've noted is this. Since I have my blood sugar
under control and have lost all this weight, most of the local people who I
know who have diabetes seem to think I don't REALLY have diabetes like they
do! They sit there eating their doctor-prescribed pasta and whole wheat
bread, and finishing it off with the no-sugar-added low fat ice cream (which
has more carbs than real ice cream) and explain that it might be okay for me
to eat all that dreadful fat I eat and all that protein, but since they're
diabetic, they can't! <sigh>

-- Jenny

Cut the carbs to respond to my new email address!
New photo: http://www.geocities.com/jenny_the_bean/jennypics.htm
Weight: 168.5/137
Diabetes Type II diagnosed 8/1998 -
HBa1c 5.2 10/03
Low Carb 9/1998 - 8/2001 and 11/10/02 - Now

http://www.geocities.com/jenny_the_bean
How to calculate your need for protein * How much people really lose each
month * Water Weight Gain & Loss * The "Two Gram Cure" for Hunger Cravings
* Characteristics of Successful Dieters * Indispensible Low Carb Treats *
Should You Count that Low Impact Carb? * Curing Ketobreath * Exercise
Starting from Zero * Do Starch Blockers Work? * NEW! Why the Low Carb Diet
is Great for Diabetes * NEW! Low Carb Strategies for People with Diabetes


"Al Hardy" <a.hardy2@ntlworld.com> wrote in message
news:brqs1u$4ik9j$1@ID-191168.news.uni-berlin.de...


Posted by Al Hardy


Jenny wrote:
prescription without the doctor explaining possible unwanted effects, but
then I got a very good doctor.

been told that because I am thin I can`t be diabetic, and insulin has
nothing to do with it! I also got told that only diabetics need insulin,
cause non-diabetics can digest food without insulin, and digested food is
not turned into blood glucose, and the cells don`t need it.

In the face of that, it is not really surprising that possibly damaging
drugs like Actos/Avandia are occasionally the only course of treatment
available.

Al.



Posted by Al Hardy


Jenny wrote:
prescription without the doctor explaining possible unwanted effects, but
then I got a very good doctor.

been told that because I am thin I can`t be diabetic, and insulin has
nothing to do with it! I also got told that only diabetics need insulin,
cause non-diabetics can digest food without insulin, and digested food is
not turned into blood glucose, and the cells don`t need it.

In the face of that, it is not really surprising that possibly damaging
drugs like Actos/Avandia are occasionally the only course of treatment
available.

Al.



Posted by oldal4865



W. Baker wrote in message ...
Three points:

1. I think Rezulin had the market to itself for most of its short product
lifetime. Actos and Avandia came out just as they were removing Rezulin
(I was taking it at the time)

2. Rezulin was an interesting risk-benefit med:

a. The product had life-saving benefits for many
b. The product had life-threatening side effects for a small few

Fortunately, if your doc was alert, he/she checked regularly for the
"easily observed" side effects and pulled you off the med if they showed up.
I have an extremely conservative doc who nevertheless prescribed Rezulin for
me during the liver damage-death publicity period.

At this time, he refuses to allow me to take statins because he can't
differentiate between my arthritis joint pain and the joint pain due to the
statin myopathy side effect. He won't run the liver tests, the joint pain
is enough for him even though my general level of arthritis is quite
significant, i.e. this guy is ***conservative***.

3. Metformin has two known, major diabetic benefits. In tests at
Baylor med, the docs found that It reduces liver release of glucose by
about 30%, and it reduces Insulin Resistance by about 35%. Those
numbers are too crude to differentiate though a simple comparison would
suggest that reducing Insulin Resistance actually is its major effect.

(IMO, that Insulin Resistance effect is the reason behind its anti-heart
attack effect)

Note that metformin reduces Insulin Resistance by switching on a mechanism
(AMP-kinase system) which in effect convinces the muscles that they have
just exercised vigorously. Actos, Avandia and XXXX (the 3rd one in
clinical trials) reduce Insulin Resistance by some mechanism involving
fatty acids. Thus, they are complementary; they affect Insulin
Resistance in different ways.

The endo that mentioned the XXXX TZD in a lecture said that it also promotes
edema.

Regards
Old Al








Posted by oldal4865



W. Baker wrote in message ...
Three points:

1. I think Rezulin had the market to itself for most of its short product
lifetime. Actos and Avandia came out just as they were removing Rezulin
(I was taking it at the time)

2. Rezulin was an interesting risk-benefit med:

a. The product had life-saving benefits for many
b. The product had life-threatening side effects for a small few

Fortunately, if your doc was alert, he/she checked regularly for the
"easily observed" side effects and pulled you off the med if they showed up.
I have an extremely conservative doc who nevertheless prescribed Rezulin for
me during the liver damage-death publicity period.

At this time, he refuses to allow me to take statins because he can't
differentiate between my arthritis joint pain and the joint pain due to the
statin myopathy side effect. He won't run the liver tests, the joint pain
is enough for him even though my general level of arthritis is quite
significant, i.e. this guy is ***conservative***.

3. Metformin has two known, major diabetic benefits. In tests at
Baylor med, the docs found that It reduces liver release of glucose by
about 30%, and it reduces Insulin Resistance by about 35%. Those
numbers are too crude to differentiate though a simple comparison would
suggest that reducing Insulin Resistance actually is its major effect.

(IMO, that Insulin Resistance effect is the reason behind its anti-heart
attack effect)

Note that metformin reduces Insulin Resistance by switching on a mechanism
(AMP-kinase system) which in effect convinces the muscles that they have
just exercised vigorously. Actos, Avandia and XXXX (the 3rd one in
clinical trials) reduce Insulin Resistance by some mechanism involving
fatty acids. Thus, they are complementary; they affect Insulin
Resistance in different ways.

The endo that mentioned the XXXX TZD in a lecture said that it also promotes
edema.

Regards
Old Al








Posted by Rose


From another discussion:
When people refer to carbs like the above exchange, are they referring
to total carbs or net carbs (w/ fiber subtracted)?

For example, so far this month, my average daily total carb intake is
105 grams, but 29 of that is fiber. So the average net carbs is about
76 grams/day. If I talk about carb intake in this group, which figure
would I use?

Thanks,
Rose
Type II

P. S. Thank you to everyone who answered my previous question about
being hungry all the time. It was related to carb intake. I threw
away the 11-starch-serving prescribed diet and started eating to my
meter. I cut out half my Amaryl (4 mg in morning now) and I am no
longer bothered by hunger - now hubby has to remind me to eat. My
average FBS has come down to 117 and only four days w/ spikes (160+)
so far this month. Not ideal numbers, I know, but much improved and
going to get better. Thanks again.

Posted by Rose


From another discussion:
When people refer to carbs like the above exchange, are they referring
to total carbs or net carbs (w/ fiber subtracted)?

For example, so far this month, my average daily total carb intake is
105 grams, but 29 of that is fiber. So the average net carbs is about
76 grams/day. If I talk about carb intake in this group, which figure
would I use?

Thanks,
Rose
Type II

P. S. Thank you to everyone who answered my previous question about
being hungry all the time. It was related to carb intake. I threw
away the 11-starch-serving prescribed diet and started eating to my
meter. I cut out half my Amaryl (4 mg in morning now) and I am no
longer bothered by hunger - now hubby has to remind me to eat. My
average FBS has come down to 117 and only four days w/ spikes (160+)
so far this month. Not ideal numbers, I know, but much improved and
going to get better. Thanks again.


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