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Monday, December 28, 2009

[diabetes_int] Digest Number 8510

Messages In This Digest (7 Messages)

Messages

1a.

FDA Confirms Benefits of Crestor in Patients without Elevated Choles

Posted by: "rogerhlmn@aol.com" rogerhlmn@aol.com   rogerhlmn

Sun Dec 27, 2009 4:01 am (PST)




From "FDA" via "Diabetes In Control" newsletter ---

Statins are to lower cholesterol, right?
Lowering cholesterol decreases risk of heart attacks, etc, right?
So let's give everyone statins (or at least this statin!), right?
Answers to all the above according to the FDA are a big YES!!!

Statins are already hugely profitable for bigPharma, but how much is enough?
Answer: "There's never enough"!

Whole article at:

http://www.diabetesincontrol.com/index.php?option=com_content&view=article&id=8736&catid=1&Itemid=17

Hope you all had a wonderful holiday.
Now I need more coffee
Roger, T2, etc...
___________________________________________

FDA Confirms Benefits of Crestor in Patients without Elevated Cholesterol

Federal scientists say AstraZeneca's cholesterol pill Crestor lowers the risk of heart attack, death and stroke in patients without a history of heart disease, though some safety concerns remain.

... the Food and Drug Administration cites the findings of AstraZeneca's study released last November. The study showed that patients with lower cholesterol and few heart risks could still benefit from taking Crestor, setting the stage for a dramatic expansion in use of the drug that already exceeds $1 billion in annual sales.
The British drugmaker wants the FDA to broaden Crestor's labeling based on those results ...

... FDA's review also cites several safety concerns, including a higher rate of diabetes in patients taking Crestor.
About 2.8 percent of patients taking Crestor in the 17,000-patient Jupiter study developed diabetes, compared with 2.3 percent of patients taking a dummy pill. The difference was statistically significant, according to the FDA ...

.. "It is this clinical reviewer's opinion that the treatment benefit observed in the Jupiter trial outweighs the risk, but further clinical trials are needed to further define this benefit-risk ratio," ...

... The panel also will discuss 13 deaths due to gastrointestinal disorders seen in Crestor patients, compared with just one in the placebo group. The agency review suggests the higher rate was a "chance finding."
The FDA also will raise questions about 18 Crestor patients who reported a "confusional state," compared with four in the placebo group ...

... AstraZeneca points out that half of all heart problems occur in patients with normal cholesterol levels, who stand to benefit from expanded use of Crestor ...

... the agency's Endocrinologic and Metabolic Drugs Advisory Committee agreed that the benefit of rosuvastatin outweighed the risk, it said that patients should be carefully monitored for diabetes and they admonished the manufacturer to "carefully define the target population in marketing materials." ...

[Non-text portions of this message have been removed]

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1b.

Re: FDA Confirms Benefits of Crestor in Patients without Elevated Ch

Posted by: "christine110965" india910@cs.com   christine110965

Sun Dec 27, 2009 6:06 am (PST)





--- In diabetes_int@yahoogroups.com, rogerhlmn@... wrote:
>
>
> From "FDA" via "Diabetes In Control" newsletter ---
>
> Statins are to lower cholesterol, right?
> Lowering cholesterol decreases risk of heart attacks, etc, right?
> So let's give everyone statins (or at least this statin!), right?

I need to share something; please forgive me if I don't have ALL the facts and details entirely straight, but I think that I have the general underlying story set fairly accurately in my mind.

We have a client at work. Now, our "clients" are generally insurance companies, and by extension, the insured owners and drivers, or supermarket owners, or . . . you get the idea. We had one insured who we represented in two different cases that were almost identical in how the accidents occurred (both rear-end hits; we got out on both); this guy is the owner of a limousine company that is isnured by one of our biggest insurance company clients (probably the biggest client). He developed a very good working relationship with one of my bosses (both young women, both ten-plus years younger than me). One day, he called to speak to her about possibly representing his father on a completely unrelated matter.

His father, who is actually our insured *driver* in one of our cases with the limousine company, was given Crestor earlier. At the time a lot less was known about the side-effects and consequences of taking the drug. It has destroyed him. He is unable to continue driving, he has been in almost constant treatment with no improvement in his symptoms, and this started occurring within a WEEK of his starting the drug. It is so frustrating to him; he has lost so much muscle strength that he can barely function now, and this was a strong, independent man. We're now representing him relative to the damage that Crestor caused him -- though we haven't filed a lawsuit and haven't actually contacted the drug manufacturer yet as we're still collecting medical records and information. I certainly couldn't say that everyone and anyone who uses Crestor is going to experience what he has, but what he has been enduring as a result of taking this medication for only a very short period of time (he stoppped it almost immediately after the symptoms appeared; still, there has been no improvement whatsoever). This medication terrifies me. No one warned him of these possible side-effects.

I am in a very bad place with my cholesterol right now, and I fear every time I get blood work done that this is going to be the time that my endo insists that I begin using a statin or other cholesterol med. MY issues with cholesterol, however, are my own fault, and I know EXACTLY what I need to do to get them under control, and it's the simplest thing in the world (another condition I've had for many years that for some reason I simply DO NOT treat with the meds I need to treat it with, despite the fact that for almost 20 years, I was able to do exactly that; now I have this enormous insurmountable mental block and I can't seem to find my way around it). My total cholesterol and my LDL are too high, but my HDL is also quite high and my triglycerides are very low - it's an unmistakable cause and effect situation. I have to get the other condition back under control. My doc, though, recognizes the link and she often doesn't even tell me the full story about my cholesterol because she knows what's doing it, and what I need to do to get it back to a good place.

Christine

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Messages in this topic (7)
1c.

Re: FDA Confirms Benefits of Crestor in Patients without Elevated Ch

Posted by: "rogerhlmn@aol.com" rogerhlmn@aol.com   rogerhlmn

Sun Dec 27, 2009 6:17 am (PST)




Thanks for sharing that story with us Christine.
Roger, T2, etc...

>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>

>>> I need to share something; please forgive me if I don't have ALL the facts and
etails entirely straight, but I think that I have the general underlying story
et fairly accurately in my mind.
We have a client at work. Now, our "clients" are generally insurance companies,
nd by extension, the insured owners and drivers, or supermarket owners, or . .
you get the idea. We had one insured who we represented in two different
ases that were almost identical in how the accidents occurred (both rear-end
its; we got out on both); this guy is the owner of a limousine company that is
snured by one of our biggest insurance company clients (probably the biggest
lient). He developed a very good working relationship with one of my bosses
both young women, both ten-plus years younger than me). One day, he called to
peak to her about possibly representing his father on a completely unrelated
atter.
His father, who is actually our insured *driver* in one of our cases with the
imousine company, was given Crestor earlier. At the time a lot less was known
bout the side-effects and consequences of taking the drug. It has destroyed
im. He is unable to continue driving, he has been in almost constant treatment
ith no improvement in his symptoms, and this started occurring within a WEEK of
is starting the drug. It is so frustrating to him; he has lost so much muscle
trength that he can barely function now, and this was a strong, independent
an. We're now representing him relative to the damage that Crestor caused him
- though we haven't filed a lawsuit and haven't actually contacted the drug
anufacturer yet as we're still collecting medical records and information. I
ertainly couldn't say that everyone and anyone who uses Crestor is going to
xperience what he has, but what he has been enduring as a result of taking this
edication for only a very short period of time (he stoppped it almost
mmediately after the symptoms appeared; still, there has been no improvement
hatsoever). This medication terrifies me. No one warned him of these possible
ide-effects.
I am in a very bad place with my cholesterol right now, and I fear every time I
et blood work done that this is going to be the time that my endo insists that
begin using a statin or other cholesterol med. MY issues with cholesterol,
owever, are my own fault, and I know EXACTLY what I need to do to get them
nder control, and it's the simplest thing in the world (another condition I've
ad for many years that for some reason I simply DO NOT treat with the meds I
eed to treat it with, despite the fact that for almost 20 years, I was able to
o exactly that; now I have this enormous insurmountable mental block and I
an't seem to find my way around it). My total cholesterol and my LDL are too
igh, but my HDL is also quite high and my triglycerides are very low - it's an
nmistakable cause and effect situation. I have to get the other condition back
nder control. My doc, though, recognizes the link and she often doesn't even
ell me the full story about my cholesterol because she knows what's doing it,
nd what I need to do to get it back to a good place.
hristine <<<

[Non-text portions of this message have been removed]

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Messages in this topic (7)
1d.

Re: FDA Confirms Benefits of Crestor in Patients without Elevated Ch

Posted by: "mlbbb" mb9901@charter.net   mlbbb

Sun Dec 27, 2009 3:13 pm (PST)



From what I remember form reading, it is high HDL & low triglycerides that are important not the rest (unless the cholesterol is extremely high, not just high and the same for the LDL, with some exceptions.) I remember reading (paraphrasing) "That some men that have heart attacks have high LDL and some men do not", i.e. the correlation is not there. (Almost all studies have been done on men.)

There is a correlation between heart attacks and VLDL, but no correlation between VLDL and LDL. There is a correlation betweem VLDL nad triglycerides, high triglycerides implies high VLDL.

But Christine has low triglycerides.

By the way, VLDL can be tested for but it is not easy (and is expensive to test for) unlike LDL. That is why they test for LDL and not VLDL.

--- In diabetes_int@yahoogroups.com, rogerhlmn@... wrote:
>
>
> Thanks for sharing that story with us Christine.
> Roger, T2, etc...
>
> >>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>
>
> >>> I need to share something; please forgive me if I don't have ALL the facts and
> etails entirely straight, but I think that I have the general underlying story
> et fairly accurately in my mind.
> We have a client at work. Now, our "clients" are generally insurance companies,
> nd by extension, the insured owners and drivers, or supermarket owners, or . .
> you get the idea. We had one insured who we represented in two different
> ases that were almost identical in how the accidents occurred (both rear-end
> its; we got out on both); this guy is the owner of a limousine company that is
> snured by one of our biggest insurance company clients (probably the biggest
> lient). He developed a very good working relationship with one of my bosses
> both young women, both ten-plus years younger than me). One day, he called to
> peak to her about possibly representing his father on a completely unrelated
> atter.
> His father, who is actually our insured *driver* in one of our cases with the
> imousine company, was given Crestor earlier. At the time a lot less was known
> bout the side-effects and consequences of taking the drug. It has destroyed
> im. He is unable to continue driving, he has been in almost constant treatment
> ith no improvement in his symptoms, and this started occurring within a WEEK of
> is starting the drug. It is so frustrating to him; he has lost so much muscle
> trength that he can barely function now, and this was a strong, independent
> an. We're now representing him relative to the damage that Crestor caused him
> - though we haven't filed a lawsuit and haven't actually contacted the drug
> anufacturer yet as we're still collecting medical records and information. I
> ertainly couldn't say that everyone and anyone who uses Crestor is going to
> xperience what he has, but what he has been enduring as a result of taking this
> edication for only a very short period of time (he stoppped it almost
> mmediately after the symptoms appeared; still, there has been no improvement
> hatsoever). This medication terrifies me. No one warned him of these possible
> ide-effects.
> I am in a very bad place with my cholesterol right now, and I fear every time I
> et blood work done that this is going to be the time that my endo insists that
> begin using a statin or other cholesterol med. MY issues with cholesterol,
> owever, are my own fault, and I know EXACTLY what I need to do to get them
> nder control, and it's the simplest thing in the world (another condition I've
> ad for many years that for some reason I simply DO NOT treat with the meds I
> eed to treat it with, despite the fact that for almost 20 years, I was able to
> o exactly that; now I have this enormous insurmountable mental block and I
> an't seem to find my way around it). My total cholesterol and my LDL are too
> igh, but my HDL is also quite high and my triglycerides are very low - it's an
> nmistakable cause and effect situation. I have to get the other condition back
> nder control. My doc, though, recognizes the link and she often doesn't even
> ell me the full story about my cholesterol because she knows what's doing it,
> nd what I need to do to get it back to a good place.
> hristine <<<
>
>
>
>
>
>
> [Non-text portions of this message have been removed]
>

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Messages in this topic (7)
1e.

Re: FDA Confirms Benefits of Crestor in Patients without Elevated Ch

Posted by: "Dora Smith" tiggernut24@yahoo.com   tiggernut24

Sun Dec 27, 2009 3:51 pm (PST)



I've had my VLDL tested. That's how I know they were high. But I do believe that at the time I had medical insurance. It may not have been a cheap test. I think it was ordered by my endocrinologist.

Yours,
Dora Smith
Austin, TX
tiggernut24@yahoo.com

----- Original Message -----
From: mlbbb
To: diabetes_int@yahoogroups.com
Sent: Sunday, December 27, 2009 5:13 PM
Subject: [diabetes_int] Re: FDA Confirms Benefits of Crestor in Patients without Elevated Cholesterol

From what I remember form reading, it is high HDL & low triglycerides that are important not the rest (unless the cholesterol is extremely high, not just high and the same for the LDL, with some exceptions.) I remember reading (paraphrasing) "That some men that have heart attacks have high LDL and some men do not", i.e. the correlation is not there. (Almost all studies have been done on men.)

There is a correlation between heart attacks and VLDL, but no correlation between VLDL and LDL. There is a correlation betweem VLDL nad triglycerides, high triglycerides implies high VLDL.

But Christine has low triglycerides.

By the way, VLDL can be tested for but it is not easy (and is expensive to test for) unlike LDL. That is why they test for LDL and not VLDL.

--- In diabetes_int@yahoogroups.com, rogerhlmn@... wrote:
>
>
> Thanks for sharing that story with us Christine.
> Roger, T2, etc...
>
> >>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>
>
> >>> I need to share something; please forgive me if I don't have ALL the facts and
> etails entirely straight, but I think that I have the general underlying story
> et fairly accurately in my mind.
> We have a client at work. Now, our "clients" are generally insurance companies,
> nd by extension, the insured owners and drivers, or supermarket owners, or . .
> you get the idea. We had one insured who we represented in two different
> ases that were almost identical in how the accidents occurred (both rear-end
> its; we got out on both); this guy is the owner of a limousine company that is
> snured by one of our biggest insurance company clients (probably the biggest
> lient). He developed a very good working relationship with one of my bosses
> both young women, both ten-plus years younger than me). One day, he called to
> peak to her about possibly representing his father on a completely unrelated
> atter.
> His father, who is actually our insured *driver* in one of our cases with the
> imousine company, was given Crestor earlier. At the time a lot less was known
> bout the side-effects and consequences of taking the drug. It has destroyed
> im. He is unable to continue driving, he has been in almost constant treatment
> ith no improvement in his symptoms, and this started occurring within a WEEK of
> is starting the drug. It is so frustrating to him; he has lost so much muscle
> trength that he can barely function now, and this was a strong, independent
> an. We're now representing him relative to the damage that Crestor caused him
> - though we haven't filed a lawsuit and haven't actually contacted the drug
> anufacturer yet as we're still collecting medical records and information. I
> ertainly couldn't say that everyone and anyone who uses Crestor is going to
> xperience what he has, but what he has been enduring as a result of taking this
> edication for only a very short period of time (he stoppped it almost
> mmediately after the symptoms appeared; still, there has been no improvement
> hatsoever). This medication terrifies me. No one warned him of these possible
> ide-effects.
> I am in a very bad place with my cholesterol right now, and I fear every time I
> et blood work done that this is going to be the time that my endo insists that
> begin using a statin or other cholesterol med. MY issues with cholesterol,
> owever, are my own fault, and I know EXACTLY what I need to do to get them
> nder control, and it's the simplest thing in the world (another condition I've
> ad for many years that for some reason I simply DO NOT treat with the meds I
> eed to treat it with, despite the fact that for almost 20 years, I was able to
> o exactly that; now I have this enormous insurmountable mental block and I
> an't seem to find my way around it). My total cholesterol and my LDL are too
> igh, but my HDL is also quite high and my triglycerides are very low - it's an
> nmistakable cause and effect situation. I have to get the other condition back
> nder control. My doc, though, recognizes the link and she often doesn't even
> ell me the full story about my cholesterol because she knows what's doing it,
> nd what I need to do to get it back to a good place.
> hristine <<<
>
>
>
>
>
>
> [Non-text portions of this message have been removed]
>

[Non-text portions of this message have been removed]

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Messages in this topic (7)
1f.

Re: FDA Confirms Benefits of Crestor in Patients without Elevated Ch

Posted by: "christine110965" india910@cs.com   christine110965

Sun Dec 27, 2009 4:03 pm (PST)





--- In diabetes_int@yahoogroups.com, "mlbbb" <mb9901@...> wrote:
>
<< From what I remember form reading, it is high HDL & low triglycerides that are important not the rest (unless the cholesterol is extremely high, not just high and the same for the LDL, with some exceptions.) >>

Which is exactly what I'm dealing with. I spent a bit of today searching for the results of my most recnet blood work (early November) so that i could share the exact numbers with you all, but I couldn't find the fax from my doctor. However, I do remember that my HDL was close to 80 and my triglycerides were hovering around 48 or so. My total cholesterol was high, but not obscenely high (~210-ish); same for my LDL (~110). However, as I said, my doctor is often less concerned with attacking the cholesterol as an issue on its own because she KNOWS why it's elevated -- and so do I. Thyroid and cholesterol are intimately linked. For the last almost two years, I have been SO unbelievably lax about taking my thyroid medication -- I have been hypothyroid for 20 years, and for the first 18 years, I took that medication religiously, EVERY morning, and though I had times when I was sluggish and was exhibiting symptoms of being sluggish, I have NEVER been THIS lax about it. I go for weeks at a time when I take nothing, then I scramble and "catch up," taking three times the dose in a single day. It does't work. My last TSH clocked in at 120. With a reading like that, it's a wonder that I'm even able to function at all. Much earlier this year, in February, I was hospitalized for five days. They were aware of my existing medical issues when the blood work was done, and I had THREE doctors INDEPENDENTLY seek me out during my stay to tell me that my TSH was at 150. Natually, my cholesterol was elevated. The two are undeniably linked. I see it myself; my TSH is hovering near normal, and my cholesterol and LDL are near normal. FWIW, TSH is supposed to run somewhere between .5 and 5.0 -- though even that is debatable and some labs have a lower "normal" in place. So yeah, you can see that I'm not just elevated, I'm obscenely elevated. And all it would take is remembeting to take a tiny pill once a day.

Christine

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1g.

Re: Trusting the FDA again?

Posted by: "Joseph Navarro" demokratia@cox.net   demokratia2003

Sun Dec 27, 2009 11:32 pm (PST)



At 7:00 AM -0500 12/27/09, rogerhlmn@aol.com wrote:

>From "FDA" via "Diabetes In Control" newsletter ---
>
>Statins are to lower cholesterol, right?
>Lowering cholesterol decreases risk of heart attacks, etc, right?
>So let's give everyone statins (or at least this statin!), right?
>Answers to all the above according to the FDA are a big YES!!!

The FDA was inspired by guys like Upton Sinclair and Teddy Roosevelt.
The deregulation of Friedman economics emasculated the FDA and the
USDA during the reign of Bush Jr. Companies approved their own meds
and the politicians made sure the FDA was not funded so that harmful
meds would be approved and big bucks rolled in to the drug company
coffers. The USDA has not checked for dangerous bugs or poisons in
meat because again the politicians deballed these agencies so that
toxic meat could be sold at the market. One lady has become a
crusader to restore the USDA to its former days when it did its job.
This lady's son died from infected meat from the market. But if this
kind of arrogance is not enough, the Bush machine appointed lobbyists
to head the USDA escalating their arrogance to exponential levels.
This betrayal of the public trust is on its way to being reversed.
Margaret Hamburg is Obama's commissioner now running the FDA and from
this report it seems we don't have to expect the low levels of
corruption it sunk for 8 years under Bush.

http://abcnews.go.com/Health/story?id=7059201&page=1

http://eco-chick.com/2008/11/1663/under-president-obama-will-the-fda-finally-do-its-job/

http://abcnews.go.com/Health/Politics/story?id=7084460&page=1

Joe

[Non-text portions of this message have been removed]

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