A disgrace: Crestor, the drug for people who don't have high cholesterol

[Jmuls]

The FDA and the pharmaceutical industry's agenda in the U.S. is clear and simple, medicate the population and control the people. This is absurd!

FDA Panel Recommends Crestor to Prevent Heart Attacks in Healthy People
Crestor Use in Those Without Heart Disease Shows Some Benefits; Not Without Risk

By PEGGY PECK
MedPage Today

Dec. 16, 2009—


The joke in the world of heart disease is that "they should put statins in the water," but to a U.S. Food and Drug Administration advisory panel that has recommended giving statins to "healthy" people, it's no joke.

The panel voted 12 to four with one abstention to recommend that the potent statin Crestor (rosuvastatin) be approved to prevent heart attacks in people who have no history of heart disease and don't fit the traditional profile of an "at risk" population.

The FDA is not obligated to follow the advisors recommendations, but it often does. If it did so this time, it would mark a first -- a drug normally used to lower dangerously high LDL (bad) cholesterol in people with a history of heart disease or risk factors to develop heart attacks or strokes would be approved for the prevention of heart attacks in healthy people.

The new label as recommended by the advisors would state that the drug should be given to men age 50 or older and women age 60 or older who have LDL cholesterol of less than 130 mg/L and triglycerides of less than 500 mg/L if -- and this too is a first -- the patient also had an elevated blood level of C-reactive protein, a marker for inflammation.

The committee's vote was immediately seized upon by cardiologists who characterized it using terms ranging from "great news" to "courageous."

"If the FDA accepts this recommendation, it will expand the number of Americans eligible for statin therapy by millions," said Dr. Steven Nissen, chair of cardiovascular medicine at the Cleveland Clinic.

Dr. James Stein of the University of Wisconsin School of Medicine and Public Health called the vote "very significant," adding that if approved, "it will also, have the (possibly) unintended consequence of increasing highly sensitive CRP testing in the U.S."

Dr. Cam Patterson, a professor at the University of North Carolina School of Medicine, agreed with Stein. "It's been difficult to find a compelling reason to order CRP levels on patients," Patterson said. "This is some guidance from the FDA about how to take high CRP levels into account, and that is good news."

And Patterson predicts that clinicians will see this as a signal to use other statins for this population as well. Although the panel vote dealt only with the Crestor label, Patterson said pointed out that another popular statin -- Lipitor -- will be available as a generic in 18 months. "It will be tough to justify paying a premium price for Crestor when another high potency statin is available at a much cheaper price."

The basis for the new indication was the JUPITER study of almost 18,000 men and women, average age 66. All patients in the study had no history of heart disease, but did have an elevated level of the marker called CRP.

Patients in the study took 20 mg of Crestor or a sugar pill placebo for 1.9 years. At the end of that time, the patients taking Crestor had an average LDL cholesterol of 55 mg/dL-- down from 109 mg/dL when they started the study.

And compared with patients who took the placebo, the Crestor patients had a 44 percent reduction in heart attacks, stroke, need for surgery or stenting to open clogged arteries, or death from heart disease.

For every 25 people treated with Crestor, a heart attack, stroke, or death was prevented.

Those results, according to Dr. Melvyn Rubenfire of the University of Michigan, were a "home run for JUPITER" but it is not clear if the results would be same with another statin.

Noting that the panel's vote was a "somewhat courageous decision", Rubenfire said the "issue now is how the FDA, physicians, and insurers approach the results. That is, 'are all statins the same?' The robustness of the results are unique to Crestor."

But there were some risks associated with Crestor, including 13 deaths due to gastrointestinal disorders in study subjects taking rosuvastatin, and 18 patients reported a "confused state" while taking the drug.

The most troubling adverse event, however, was an uptick in investigator reported new onset diabetes mellitus in the treatment arm, 2.8 percent versus 2.5 percent, or an increased risk of 27 percent.

Although the 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."

Crestor is marketed by AstraZeneca, which also sponsored the JUPITER trial.

What the public isn't being told is, CRP levels can easily be controlled through the supplementation of fish oil and getting 25-Hydroxyvitamin D levels up to par, in accordance with the Vitamin D Council (which will normally require supplementation with vitamin D, as you just can't rely on diet and sun exposure alone to get the job done). Decrease and ultimately eliminate processed, refined sugars and carbohyrates, and the CRP levels plummet even lower. But instead, the powers to be want to throw everyone on a statin that will induce a whole slew of side effects, dramatically effecting health and quality of life.

If you care to, please discuss.

 

[Ashop]

Weird I read this. I have a friend who was prescribed this drug..but cholesterol was near perfect,,,just recently.

 

[longhorn814]

then they can sell them more drugs to counter the sides of crestor!!

 

[jalsmiley]

The FDA and the pharmaceutical industry's agenda in the U.S. is clear and simple, medicate the population and control the people. This is absurd!



What the public isn't being told is, CRP levels can easily be controlled through the supplementation of fish oil and getting 25-Hydroxyvitamin D levels up to par, in accordance with the Vitamin D Council (which will normally require supplementation with vitamin D, as you just can't rely on diet and sun exposure alone to get the job done). Decrease and ultimately eliminate processed, refined sugars and carbohyrates, and the CRP levels plummet even lower. But instead, the powers to be want to throw everyone on a statin that will induce a whole slew of side effects, dramatically effecting health and quality of life.

If you care to, please discuss.

the public is told this you can control some of the factors with fish oil etc...thats almost common knowledge of anyone who has two seconds plus a computer or a doctor that has half a brain. i reply to this thread because a good friend of my family is a doctor who does lot of this type research, also teaches at umdnj and is type to of guy to be first to tell you lot of drs dont know shxt or when fda says something bs etc...and he has been reccommending same thing for years now. he has nothing to gain from us as we dont pay for his services...he has my father who was very high cholesterol on script fish oil and crestor....his cholesterol is now perfect and has been since following the advice...just may be that for some fish oil and other vitamins alone are not enough

also remember it is up to the patient to talk to dr about what sides they experience and whether the benefits outweigh the sides...my father has had zero sides and it been few years minimum he is on this, probably longer

 

[Pumped1]

then they can sell them more drugs to counter the sides of crestor!!

thats the whole idea.... what a fucking joke

 

[machola]

What the public isn't being told is, CRP levels can easily be controlled through the supplementation of fish oil and getting 25-Hydroxyvitamin D levels up to par, in accordance with the Vitamin D Council (which will normally require supplementation with vitamin D, as you just can't rely on diet and sun exposure alone to get the job done). Decrease and ultimately eliminate processed, refined sugars and carbohyrates, and the CRP levels plummet even lower. But instead, the powers to be want to throw everyone on a statin that will induce a whole slew of side effects, dramatically effecting health and quality of life.

If you care to, please discuss.

I don't understand the problem. Why do you think this not a good thing?

study of almost 18,000 men and women, average age 66...For every 25 people treated with Crestor, a heart attack, stroke, or death was prevented....And compared with patients who took the placebo, the Crestor patients had a 44 percent reduction in heart attacks, stroke, need for surgery or stenting to open clogged arteries, or death from heart disease.

Doctors do educate patients on benefits of a good diet and exercise program all the time. Some advocate fish oil. But this study looks very good for Crestor. I'm glad it was approved for this use.

 

[jalsmiley]

I don't understand the problem. Why do you think this not a good thing? Doctors do educate patients on benefits of a good diet and exercise program all the time. Some advocate fish oil. But this study looks very good for Crestor. I'm glad it was approved for this use.

i agree...those who are chastising this decision, do you do your own research and have a doctor you can trust or are you like the rest of the population that just listen to every commercial and falls prey to everything you see on tv...do some of your own research and weigh the risk/benfit ratio for yourself and make an educated decision...its just like mcdonalds advertising how great the bigmac is..because of that are you gonna run and eat ten of them and then chastise them.

 

[Kaladryn]

All they are really saying is that CRP levels are significant for predicting heart disease.

 

[DShaw]

You'd think those pill pushing bastards would come up with something to counter the negative health effects of the flouride & chlorine added to tap water...

(can you tell I'm madly in love with Big Pharma? I mean, I know medicine is necessary, but there's a place for natural health too.)

 

[Jmuls]

the public is told this you can control some of the factors with fish oil etc...thats almost common knowledge of anyone who has two seconds plus a computer or a doctor that has half a brain. i reply to this thread because a good friend of my family is a doctor who does lot of this type research, also teaches at umdnj and is type to of guy to be first to tell you lot of drs dont know shxt or when fda says something bs etc...and he has been reccommending same thing for years now. he has nothing to gain from us as we dont pay for his services...he has my father who was very high cholesterol on script fish oil and crestor....his cholesterol is now perfect and has been since following the advice...just may be that for some fish oil and other vitamins alone are not enough

also remember it is up to the patient to talk to dr about what sides they experience and whether the benefits outweigh the sides...my father has had zero sides and it been few years minimum he is on this, probably longer

For some, statins are a must, because this population just doesn't respond to anything else. But my issue has to do with the fact that they want to push a statin like Crestor on to individuals who have no lipid issues what so ever. This isn't right. You don't medicate unless there's a need for it. Plain and simple. And even before you medicate, you should have exhausted all other methods to correct the issue.

As for your father, that's great that he's had zero sides on Crestor. I have read Crestor tends to be more tolerable than other meds like Simvistatin and Lipitor. Does your father supplement with CoQ10 due to the drug depleating plasma levels?

I don't understand the problem. Why do you think this not a good thing? Doctors do educate patients on benefits of a good diet and exercise program all the time. Some advocate fish oil. But this study looks very good for Crestor. I'm glad it was approved for this use.

You think it's a good idea to be put on a medication when you have no condition that warrants its use? That's what the idea here is. Throw you on a statin for the hell of it. Just because. You can't possibly see that as an acceptable course of action.

Doctors eduacte on the drugs only. They don't educate on the powers of fish oil and vitamin D nearly as much as they should. I interact with dozens of MDs on a daily basis, and I've never crossed paths with 1 that educates on the importance of many of these supplements. My very own specialist told me he saw no need in supplementing with vitamin D. Food would take care of the job. This is impossible! It will never happen. You will never achieve a 25-Hydroxyvitamin D level north of 40ng/ml unless you supplement.

I work for a very large, highly reputable cardiology department at a large scale teaching hospital. The patients I deal with daily supplement with no more than 2-4 fish oil caps a day. That's supplying no more than 600-1200mg of EPA & DHA. That's nothing! And that's what their doctor is recommending to them to take for a dose. The whole point of supplementing with fish oil is to help correct the incredibly scewed ratio of omega3:6 that most Americans have.

Let me state again though, there are individuals who must be prescribed statins to combat their dangerously high LDLs. These people just don't respond to other corrective measures.

 

[Jmuls]

Another point I wanted to touch upon that I didn't mention above was diet. The large majority of docs do absolutely no coaching on correct nutritional advice. They advocate a low fat, high fiber diet rich in whole grains. This is pretty much what the AHA recommends as well. This is the exact diet that will continue the problems along and keep the patient in the diseased state. A diet rich in whole grains will typically feature many wheat based items. Wheat is one of the main culprits. It dramatically increases CRP levels as well as triglycerides, which in turn raise LDLs. It's essentially promoting inflamation, which many agree is the main factor behind the high incidence of heart disease in the U.S. These dietary recommendations are doing nothing more than continuing the vicious cycle instead of stopping in dead in it's tracks.

 

[machola]

You think it's a good idea to be put on a medication when you have no condition that warrants its use? That's what the idea here is. Throw you on a statin for the hell of it. Just because. You can't possibly see that as an acceptable course of action.

Doctors eduacte on the drugs only. They don't educate on the powers of fish oil and vitamin D nearly as much as they should. I interact with dozens of MDs on a daily basis, and I've never crossed paths with 1 that educates on the importance of many of these supplements. My very own specialist told me he saw no need in supplementing with vitamin D. Food would take care of the job. This is impossible! It will never happen. You will never achieve a 25-Hydroxyvitamin D level north of 40ng/ml unless you supplement.

I work for a very large, highly reputable cardiology department at a large scale teaching hospital. The patients I deal with daily supplement with no more than 2-4 fish oil caps a day. That's supplying no more than 600-1200mg of EPA & DHA. That's nothing! And that's what their doctor is recommending to them to take for a dose. The whole point of supplementing with fish oil is to help correct the incredibly scewed ratio of omega3:6 that most Americans have.

I also interact with doctors daily. I guess we have different experiences with them. I'm not sure what exactly your job is on the cardiac unit but anyone who has been educated in medicine can clearly see the benefits to healthy elderly people with elevated CRP levels taking Crestor after reading this article. Its in black and white. Read the text I quoted from the article in my last post. And understand, no one is forcing anyone to take Crestor. Its still ultimately the patient's choice. They just have a new intervention available now.

This is what is called preventative medicine. It is when there is medical intervention before an issue arises. Its possible you take Vit D and fish oil as a preventative measure. I take vit D and fish oil too. I have no medical reason to take them now. Its so I don't have problems later on down the road.

Post menopausal, small-framed, especially Caucasian women frequently are advised to take calcium, vitamin D, possibly even Fosamax or another bone reabsorption inhibitor to avoid getting osteoporosis. Even though they don't have an issue at the time they are at risk. So the treatment is preventative.

In this case, we are dealing with elderly people with increased CRP levels, a group very much at risk of having a serious cardiovascular problem. They don't have a cardiovascular problem now but they are a risk group. This article talks about a study in which they medicated some people in this group with Crestor and compared their results to others in the same risk group who didn't medicate with Crestor. Crestor prevented a large number of serious health issues like stroke, MI, death.

If i had a family member in this risk group I would recommend he take Crestor.

 

[maldorf]

I also interact with doctors daily. I guess we have different experiences with them. I'm not sure what exactly your job is on the cardiac unit but anyone who has been educated in medicine can clearly see the benefits to healthy elderly people with elevated CRP levels taking Crestor after reading this article. Its in black and white. Read the text I quoted from the article in my last post. And understand, no one is forcing anyone to take Crestor. Its still ultimately the patient's choice. They just have a new intervention available now.

This is what is called preventative medicine. It is when there is medical intervention before an issue arises. Its possible you take Vit D and fish oil as a preventative measure. I take vit D and fish oil too. I have no medical reason to take them now. Its so I don't have problems later on down the road.

Post menopausal, small-framed, especially Caucasian women frequently are advised to take calcium, vitamin D, possibly even Fosamax or another bone reabsorption inhibitor to avoid getting osteoporosis. Even though they don't have an issue at the time they are at risk. So the treatment is preventative.

In this case, we are dealing with elderly people with increased CRP levels, a group very much at risk of having a serious cardiovascular problem. They don't have a cardiovascular problem now but they are a risk group. This article talks about a study in which they medicated some people in this group with Crestor and compared their results to others in the same risk group who didn't medicate with Crestor. Crestor prevented a large number of serious health issues like stroke, MI, death.

If i had a family member in this risk group I would recommend he take Crestor.

Wont the other pharm companies want a piece of this action? I would think the other statin manufacturers would be all over this soon. I dont see what makes crestor that much different than the others since they are all statins. I do know though that crestor can slightly raise HDLs and the others dont seem to. I have read that, my doc prescribed it for that, and it has worked for me.

 

[BigMatt]

Another point I wanted to touch upon that I didn't mention above was diet. The large majority of docs do absolutely no coaching on correct nutritional advice. They advocate a low fat, high fiber diet rich in whole grains. This is pretty much what the AHA recommends as well. This is the exact diet that will continue the problems along and keep the patient in the diseased state. A diet rich in whole grains will typically feature many wheat based items. Wheat is one of the main culprits. It dramatically increases CRP levels as well as triglycerides, which in turn raise LDLs. It's essentially promoting inflamation, which many agree is the main factor behind the high incidence of heart disease in the U.S. These dietary recommendations are doing nothing more than continuing the vicious cycle instead of stopping in dead in it's tracks.

What kind of Fat do you think should be a part of the optimun Diet?

Im currently taking Olive oil, Fish oil(15G) , and Saturated Fat from Grass fed Bison and Horse.

I average about 40G of Fat per day from those sources.

Do you think Eating whole eggs is part of a healthy Diet and you would leave them out ?

 

[Jmuls]

I also interact with doctors daily. I guess we have different experiences with them. I'm not sure what exactly your job is on the cardiac unit but anyone who has been educated in medicine can clearly see the benefits to healthy elderly people with elevated CRP levels taking Crestor after reading this article. Its in black and white. Read the text I quoted from the article in my last post. And understand, no one is forcing anyone to take Crestor. Its still ultimately the patient's choice. They just have a new intervention available now..

If a person over the age of 65 has elevated CRP levels, I'm going to assume they also have hyperlipidemia. How often does a patient this age present with an HDL of 60, LDL of 82, triglyceride of 48, and total Chol of 142, yet have a CRP of 3.9mg/L. I highly doubt it exists, and if it does, there's got to be something else causing the elevated CRP, such as infections, autoimmune diseases, or cancer.

Your right though, it is ultimately the patient's choice at the end of the day, so at least we still have freedom of choice to fall back on.

This is what is called preventative medicine. It is when there is medical intervention before an issue arises. Its possible you take Vit D and fish oil as a preventative measure. I take vit D and fish oil too. I have no medical reason to take them now. Its so I don't have problems later on down the road.

I'm quite aware of preventative medicine and I think it's essentially conditional in today's day and age. Yet I whole heartedly believe a huge component of that prevention needs to come through by way of diet and lifestyle modification. It shouldn't be prescribing a 38 year old smoker, with no other risk factors, a statin just because of what may come down the road 10, 12, 14 years from then. Rather, it should be the physician working with the patient to quit the habit. The fact of the matter is, medicine in this country often turns out to be nothing more than slapping a bandaid on a problem, not correcting the problem at it's root.

I take vit D and fish oil as well, and I do it cause I wouldn't otherwise have a healthy omega-3:6 ratio and healthy serum vitamin D level over 40ng/ml. And I can say with much certainty, especially if you're American, that without these supplements, you yourself would have a serum vitamin D deficiency and much higher omega-6:3 ratio, thus giving you a medical reason to take them!

Post menopausal, small-framed, especially Caucasian women frequently are advised to take calcium, vitamin D, possibly even Fosamax or another bone reabsorption inhibitor to avoid getting osteoporosis. Even though they don't have an issue at the time they are at risk. So the treatment is preventative.

In this case, we are dealing with elderly people with increased CRP levels, a group very much at risk of having a serious cardiovascular problem. They don't have a cardiovascular problem now but they are a risk group. This article talks about a study in which they medicated some people in this group with Crestor and compared their results to others in the same risk group who didn't medicate with Crestor. Crestor prevented a large number of serious health issues like stroke, MI, death.

If i had a family member in this risk group I would recommend he take Crestor.

My issue isn't with this group of people being prescribed Crestor. This group already has disease. If they have high CRP, they more than likely have hypercholesterolemia and hyperlipidemia. They're more or less going to go hand in hand with one another. The disease now must be treated. So they're prescribed a cocktail of drugs. It is what it is.

My issue lies with younger people, in their 30s, 40s, even early 50s, who don't have a lipid related issue, yet they're urged and lectured to go on a statin like Crestor as a preventative measure. "Your CRP could increase down the road. Your lipids could increase in a decade." I think this is wrong. Lots of health related things could happen down the road, which means people need to take notice when they're young, to correct and modify their dietary choices and lifestyle practices. This should be the first step for everyone! Coupled with dietary choices is supplementing with certain vitamins and minerals to make up for where whole food falls short. In the end, everything is covered and the internal environment within the body is set for optimal health. And if issues should arise here after, then that issue may have to be addressed with the addition of a medication. Though at least diet and lifestyle was in check first, and this wasn't just an issue that could have otherwise been corrected through those very factors. That's all I could hope for in this country. That people would address and correct certain problems that they actually have control over first, and see how that changes or doesn't change things.

In case anyone was interested in it, this talk on Crestor is the result of the JUPITER Study. You can read more about it through the following links:

- http://www.medscape.com/viewarticle/583269
- Reduction in C-reactive protein and LDL cholestero... [Lancet. 2009] - PubMed result

Also, let me just add, that a couple years back, through reading DC's and MassiveG's posts, I was introduced to Dr. William Davis, a cardiologist out of Milwaukee, WI, and author of the book "Track Your Plaque," and his incredible blog, The Heart Scan Blog. His writings have opened my eyes to many things. I highly recommend his blog to anyone who has any interest in optimizing heart health. Here's the link: **broken link removed**

Here are a couple of his posts regarding the JUPITER study:

- **broken link removed**
- **broken link removed**
- **broken link removed**

 

[jalsmiley]

For some, statins are a must, because this population just doesn't respond to anything else. But my issue has to do with the fact that they want to push a statin like Crestor on to individuals who have no lipid issues what so ever. This isn't right. You don't medicate unless there's a need for it. Plain and simple. And even before you medicate, you should have exhausted all other methods to correct the issue.

As for your father, that's great that he's had zero sides on Crestor. I have read Crestor tends to be more tolerable than other meds like Simvistatin and Lipitor. Does your father supplement with CoQ10 due to the drug depleating plasma levels?



You think it's a good idea to be put on a medication when you have no condition that warrants its use? That's what the idea here is. Throw you on a statin for the hell of it. Just because. You can't possibly see that as an acceptable course of action.

Doctors eduacte on the drugs only. They don't educate on the powers of fish oil and vitamin D nearly as much as they should. I interact with dozens of MDs on a daily basis, and I've never crossed paths with 1 that educates on the importance of many of these supplements. My very own specialist told me he saw no need in supplementing with vitamin D. Food would take care of the job. This is impossible! It will never happen. You will never achieve a 25-Hydroxyvitamin D level north of 40ng/ml unless you supplement.

I work for a very large, highly reputable cardiology department at a large scale teaching hospital. The patients I deal with daily supplement with no more than 2-4 fish oil caps a day. That's supplying no more than 600-1200mg of EPA & DHA. That's nothing! And that's what their doctor is recommending to them to take for a dose. The whole point of supplementing with fish oil is to help correct the incredibly scewed ratio of omega3:6 that most Americans have.

Let me state again though, there are individuals who must be prescribed statins to combat their dangerously high LDLs. These people just don't respond to other corrective measures.

yes, he supps with coq10... the docs thought is same as what the other guy is saying...preventative and longer life expectancy almost def for certain healthy people and especially people who are healthy but have family history or heart dis. its sort of like excercise...if you do other things for prevention why cant meds be used...my personal opinion for myself is that i dont like taking what i dont need but if it works and people do the necessary research and find it works or may work for them then great....there are going to be meds out there that are wonderful things.

 

[gambit100]

C'mon guys this is the wave of the future

What better way to make money than to put everyone on preventative drugs. Seeing as noone has to take personal responsibility for their health what better way to help most Americans.

Look around you, all day long you see people smoking, Filling their fat obese faces with every sugary treat they can find. The one and only thing most people have the power to change (themselves), The majority look like they have given up. Hell my doctor is about 300 lbs and smokes like a chimney but has the balls to tell me at 6' 235 lbs I am technically obese. When I asked about his health he quietly said he is working on his problems

I read Charles Poliquin's latest rant on obesity and maybe he has a point.

 

[wostok]

Listen to this speech by dr john rengen virapen, he talks about how fucked the pharma industry is.

First some guy talks in german but soon Dr John comes in and speak english.

Watch it, everyone should

YouTube - Dr John Rengen Virapen (1/4) Big Pharma Whistleblower Speaks Out at the AZK in Germany (Full Edit)