24 replies to this topic

[sUper GeNius]

http://www.cnn.com/2...rugs/index.html

[Mind]

A large study with a significant positive result. I know many people here are on the anti-pharma bandwagon, just wondering what you all think of the study.

I still don't see the need to take statins when inflammation and cholesterol levels can be controlled so easily and effectively through diet and natural supplements.

Healthy men and women with good cholesterol levels could significantly reduce their risk of heart disease by taking cholesterol-lowering drugs, better known as statins, according to a study released Sunday.
Today, only people with high levels of cholesterol are prescribed cholesterol-lowering drugs, known as statins.

Today, only people with high levels of cholesterol are prescribed cholesterol-lowering drugs, known as statins.

Nearly 18,000 people in 26 countries, including 7,000 women and nearly 5,000 minorities, participated in the clinical trial, the results of which were published in The New England Journal of Medicine.

All had very good cholesterol levels, with average LDL -- or "bad" cholesterol -- levels of 108 and average HDL --or "good" cholesterol -- levels of 49.

However, each participant had elevated levels of "high-sensitivity C-reactive protein" or hs-CRP -- a marker that indicates inflammation in the body and can contribute to coronary heart disease, the No. 1 killer of men and women in the United States.

Under the current guidelines set for lowering cholesterol levels, none of the participants would have qualified for taking statins.

In the study, the participants took 20 milligrams of the drug Rosuvastatin -- commercially known as Crestor -- or a placebo pill.

The maker of Crestor, AstraZeneca, funded the study.

According to the lead author, Dr. Paul Ridker of the Brigham and Women's Hospital in Boston, Massachusetts, the pharmaceutical company had no input in the study's design and didn't see the final data analysis until the study was submitted for publication.

Designed to last up to five years, the trial was stopped after less than two because endpoints set by an independent oversight committee were met, the study says.

Researchers found that participants taking Crestor cut their risk of heart attack, stroke and death by nearly half -- 44 percent -- compared with participants taking the placebo.

[david ellis]

A large study with a significant positive result. I know many people here are on the anti-pharma bandwagon, just wondering what you all think of the study.

I still don't see the need to take statins when inflammation and cholesterol levels can be controlled so easily and effectively through diet and natural supplements.

Researchers found that participants taking Crestor cut their risk of heart attack, stroke and death by nearly half -- 44 percent -- compared with participants taking the placebo.

44% sounds like a significant result, but it isn't. The previously advertised 33% reduction was not impressive. It was 3.3 people saved out of 100 people taking statins. Millions spent on stains versus four less heart attacks and strokes. On the face of it, statins don't seem cost effective.

You are right Mind, why don't they focus on inflammation rather than total cholesterol? There are better predictors of CVD. Calcium scores, CRP, Lp(a), oxidized LDL, even an inexpensive Triglycerides/HDL ratio, are much better predictors that total cholesterol. This solves the problem they have faced in the past, 50% of people with heart attacks had normal cholesterol.

But I think pharma has thought this through, they designed a study that used an even lower TC limit for recommending statins. And it came out exactly like they hoped. One more person out of a 100 escaped a CVD event. There is no payoff in identifying the individuals truly at risk. And a huge payoff by broadening the group of persons taking statins, a very sharp increase in sales to offset the loss of markup as statins go generic.

Edited by david ellis, 09 November 2008 - 05:34 PM.

[Ringostarr]

Using Crestor to prevent heart attacks and save lives in apparently healthy people would add nearly $10 billion a year to the nation's medical bill, according to calculations released Monday.

Resveratrol, or other sirtuin activators, will do this for much less.

[niner]

44% sounds like a significant result, but it isn't. The previously advertised 33% reduction was not impressive. It was 3.3 people saved out of 100 people taking statins. Millions spent on stains versus four less heart attacks and strokes. On the face of it, statins don't seem cost effective.

3.3 heart attacks or strokes (especially strokes!) avoided for the cost of 100 people taking statins doesn't sound like that bad of a value. How many person-years of life are we saving per dollar? What would be the cost to care for a stroke victim until they die? Aren't there statins that are off patent, or nearly so? That will change the cost equation dramatically. If this application is only to persons with high hs-CRP, it's not like we'd be treating everyone; where did the $10B figure come from? Seems kind of high if it's only applied to hs-CRP patients.

[sUper GeNius]

44% sounds like a significant result, but it isn't. The previously advertised 33% reduction was not impressive. It was 3.3 people saved out of 100 people taking statins. Millions spent on stains versus four less heart attacks and strokes. On the face of it, statins don't seem cost effective.

3.3 heart attacks or strokes (especially strokes!) avoided for the cost of 100 people taking statins doesn't sound like that bad of a value. How many person-years of life are we saving per dollar? What would be the cost to care for a stroke victim until they die? Aren't there statins that are off patent, or nearly so? That will change the cost equation dramatically. If this application is only to persons with high hs-CRP, it's not like we'd be treating everyone; where did the $10B figure come from? Seems kind of high if it's only applied to hs-CRP patients.

See:

http://www.usatoday....stor-cost_N.htm

[aikikai]

Statins are good if you want to pee out your muscles and kidneys. My father peed his muscles out because of statins.

Rat poison.

Edited by aikikai, 11 November 2008 - 02:16 PM.

[kismet]

Using Crestor to prevent heart attacks and save lives in apparently healthy people would add nearly $10 billion a year to the nation's medical bill, according to calculations released Monday.

Resveratrol, or other sirtuin activators, will do this for much less.

Or just imagine they'd give the money to the Mfoundation. Much better.

[bgwowk]

You are right Mind, why don't they focus on inflammation rather than total cholesterol? There are better predictors of CVD. Calcium scores, CRP, Lp(a), oxidized LDL, even an inexpensive Triglycerides/HDL ratio, are much better predictors that total cholesterol.

They did focus on inflammation, not cholesterol. The study specifically looked at treating people with normal or low cholesterol, but with high CRP. The statin cut CRP by more than half, with an accompanying huge reduction in heart attacks.

The "$10 billion" cost estimate assumes that all people in the U.S. with elevated CRP would be treated with brand-name Crestor. However you can get a generic statin at Walmart for $4 per month, or even *** $40 A YEAR *** if you buy 90-day supplies. That's less than most supps. It puts the cost of treating the entire U.S. population with elevated CRP in the millions of dollars, rather than billions, even with the $80 a year CRP test.

However I think total population costs are a bad way to do medical economics. Do we really want the medical community to decide efficacy and even access to therapies based on whether insurers and governments could afford to provide them to everyone? Imagine going out to buy computer equipment, and being told that a certain monitor is not recommended because if every household bought one the country could not afford it. People should always be able to individually choose how and how much money they spend on health.

If I had elevated CRP that couldn't be controlled by lifestyle or supplements, I would seriously consider taking a statin.

[david ellis]

44% sounds like a significant result, but it isn't. The previously advertised 33% reduction was not impressive. It was 3.3 people saved out of 100 people taking statins. Millions spent on stains versus four less heart attacks and strokes. On the face of it, statins don't seem cost effective.

3.3 heart attacks or strokes (especially strokes!) avoided for the cost of 100 people taking statins doesn't sound like that bad of a value. How many person-years of life are we saving per dollar? What would be the cost to care for a stroke victim until they die? Aren't there statins that are off patent, or nearly so? That will change the cost equation dramatically. If this application is only to persons with high hs-CRP, it's not like we'd be treating everyone; where did the $10B figure come from? Seems kind of high if it's only applied to hs-CRP patients.

To save 4 persons from a CVD event it is necessary that 100 people take statins for 10 years. $100/mo (for Crestor) times 12 months times 12 years times 100 people is a total cost of $1,200,000. So I get a cost per life saved of about $300,000. Of course this cost doesn't include the cost of people harmed. The costs of mental problems, muscle damage, and other side effects is probably very large.

If you were one of the 100 guys and were thinking what to do with your money, would you bet a stream of money for 20 years that you would be one of the 9 out of 100 people saved?

$1200/year invested over 20 years at 7.7% (7.7% is my portfolio expected rate of return) will be worth $53,000 to you. Your chance of suffering a $50,000 CVD event is 9% (Two 10 year periods preventing 4.4 CVD events) 9% times $50,000 yields an expected average cost of $4500. Would you spend $53,000 to cover an expected average cost of $4500?

It is all a numbers game. Relative risk is tricky statistics. You would think 44% is dramatic, but it is not really. It is just 4.4 people out of a 100. I am upset that they used the same trick as before to make the universe of people at risk very large. With total cholesterol they moved the reference range from plus 300 to 200 and falling. With CRP they have already moved the reference range from 3 to 2. (Labcorp has a 0-3 reference range).

Why use a shotgun to treat people at risk? That is a lot of waste, over a 10 year period only 4 out of 96 bullets hits the target. Why didn't they use a basket of techniques, calcium score, Trig/HDL ratios, Lp(a), measure oxidized LDL, and on and on. Why isn't there a movement to shrink the population targeted for drugs? Would you be happy with a measles vaccine that only helped 4 people out of a 100?

This is a good illustration of why free market principles don't work for medicine. Pharma is doing what it can to maximize its profits. They are ensuring that their customer base and profits are huge. There is an asymmetry of information. Pharma talks about relative risk, patients don't know the difference between relative risk and absolute risk. Pharma knows about side effects, but do not have to fully divulge what they know. Pharma can keep doing studies until they get a good result. There is no obligation to divulge studies that failed. With asymetrical information, patients will always get the short end of the stick.

Because tactical games like relative risk yield big rewards, research is not focused on a cure that works only for those sick. It is no wonder that our medical costs are heading for the sky twice as fast as the rest of the western world. Thoughtful regulation has to be better than this "wild west" free market. That is one solution I can think of. There are probably more, we should be looking for them.

[david ellis]

The statin cut CRP by more than half, with an accompanying huge reduction in heart attacks.

david-
My experience using fish oil and curcumin. All safe, low cost supplements. Lowered my hsCRP to 15% of its initial value.

Lab-Corp reference range 0-3 mg/L
06/02/05 C-Reactive Protein, Cardiac 3.3 mg/L
08/23/06 C-Reactive Protein, Cardiac 1.3 mg/L
04/19/07 C-Reactive Protein, Cardiac 5.3 mg/L
05/14/07 C-Reactive Protein, Cardiac 0.9 mg/L
05/18/07 C-Reactive Protein, Cardiac 1.7 mg/L
05/07/08 C-Reactive Protein, Cardiac 0.5 mg/L

The high April 07 reading was due to inflammation in my knee - hsCRP is not specific for heart disease.



.

If I had elevated CRP that couldn't be controlled by lifestyle or supplements, I would seriously consider taking a statin.

david-
I would look for other causes of the inflammation before I went to statins. The test is not specific, it measures general inflammation. Why would they use a test that is non-specific and only marginally better than cholesterol in accuracy?

I have heard that up to 30% of the population suffers side-effects from statins. To get Pharma's good statistics, the folks who drop out are not included. If it was 30%, the accuracy score could drop to 3 out of a 100 over 10 years.

I tried statins and they made me feel weak, 30 years older. First and only time in my life I went AMA, Against Medical Advice. It was very quiet in the Doctor's office after the loud discussion finished. A smart move on my part, because despite my very high cholesterol, my carotid arteries are clean as a whistle. And I suffer no noticeable long term affects from taking statins. A sonogram last month proved that my heart is strong, functional and normal.

My wife, who has excellent cholesterol tests, has a few tiny plaques at the bifurcation of the arteries. That is one family's story.

[bgwowk]

My experience using fish oil and curcumin. All safe, low cost supplements. Lowered my hsCRP to 15% of its initial value.

Lab-Corp reference range 0-3 mg/L
06/02/05 C-Reactive Protein, Cardiac 3.3 mg/L
08/23/06 C-Reactive Protein, Cardiac 1.3 mg/L
04/19/07 C-Reactive Protein, Cardiac 5.3 mg/L
05/14/07 C-Reactive Protein, Cardiac 0.9 mg/L
05/18/07 C-Reactive Protein, Cardiac 1.7 mg/L
05/07/08 C-Reactive Protein, Cardiac 0.5 mg/L

That's a very nice result. Of course we have the usual problem that there's no way to prove the utility of supplements for decreasing CRP and heart-disease risk as rigorously as was done for a brand-name statin because unpatented supps are too cheap for anyone to pay for large studies. We now know with greater certainty that cheaper drugs and supplements that lower CRP will probably also reduce heart attack risk only because a company selling an expensive drug had the money to pay for a large study on the effects of lowering CRP.

As to side effects of statins, there would probably be fewer side effects if people taking statins would supplement with CoQ10. Unfortunately that's also hard to prove because CoQ10 is unpatented.

I don't like big pharma either, but they are not intrinsically bad guys. If people want a system where government dictates what medicines can be advertised as efficacious based on large expensive clinical trials, then medicines produced by the system will necessarily be expensive and unnatural so that they can make enough money to pay for the trials. The high cost of health care is not so much a product of greed as it is of a society with no political tolerance for risk in medicine.

Edited by bgwowk, 12 November 2008 - 01:17 AM.

[david ellis]

I don't like big pharma either, but they are not intrinsically bad guys. If people want a system where government dictates what medicines can be advertised as efficacious based on large expensive clinical trials, then medicines produced by the system will necessarily be expensive and unnatural so that they can make enough money to pay for the trials. The high cost of health care is not so much a product of greed as it is of a society with no political tolerance for risk in medicine.

Yes, they are not bad guys, but they are amoral. First thing taught in business schools is maximize profit. No solutions on how to protect the commons are taught. As a result, we get bad science. Cholesterol has never been proven to cause CVD. How can cholesterol be the cause when half the people with CVD have normal cholesterol? It would be like saying 1/2 of the people with mumps don't have swollen faces. And now, more bad science, guessing from the similar effectiveness numbers, I would guess that half the people with CVD have CRP lower than 2mg/L. Bad science pays more profit than searching for a low cost effective solution. Free markets work when there is symmetry in information and power between buyer and seller. Free markets do not work when there is asymmetry in information and power. And Pharma's marketing plans are proof that the asymmetry is exploited to the maximum.

Selling drugs to 96 out of a 100 who do not need them seems like a very profitable business plan, but the commons are devastated because a lot of money has been spent to no result. The problem here is not the FDA's stringent assessment of risk. The problem is the focus is on profit. If a business builds a bridge, there will be huge profits, but no commons. If a government builds a bridge, there is a big improvement in the commons. That's why the biggest improvements in America have been done by government. Government built canals. Government built railroads by providing subsidy in the form of land and mail monopolies. Bridges and highways are built by governments. Basic research for Pharma is done by government subsidy. It is unjust that the people pay high market prices for products whose basic research was paid for by the people. If the common good was the goal rather than profit maximization we could get better health for less money. The problem is that the interest of Pharma is only profit, not the commons represented by the health of citizens. It is a mismatch, and explains why our health costs rise faster, and the health ranking of our citizens falls at the same time.

[bgwowk]

It was government that created the system in which getting permission to sell one new drug takes ten years and almost one billion dollars, and in which it is illegal for even dying patients to try medicines not approved by the FDA. The whole FDA/big-pharma infrastructure is a direct result of laws made by politicians believing they are protecting common interest.

The difference between greedy business vs. government protecting the common interest is the difference between gains in computer performance vs. gains in disease treatment over the past 46 years since the Kefauver Harris Amendment. I prefer the rate of gain achieved by greedy business, thanks.

[stephen_b]

There's an informative (IMO) posting on the heart scan blog on this study.

Stephen

[david ellis]

It was government that created the system in which getting permission to sell one new drug takes ten years and almost one billion dollars, and in which it is illegal for even dying patients to try medicines not approved by the FDA. The whole FDA/big-pharma infrastructure is a direct result of laws made by politicians believing they are protecting common interest.

The difference between greedy business vs. government protecting the common interest is the difference between gains in computer performance vs. gains in disease treatment over the past 46 years since the Kefauver Harris Amendment. I prefer the rate of gain achieved by greedy business, thanks.

Thalidomide baby problems are much less likely now, and I am happy with the progress made by both business and government working together in the last 46 years. I am not arguing that government doesn't need reform, it obviously does, I am just pointing out another obvious fact that what is good for pharma, is not necessarily good for the country. I am for business, my retirement portfolio depends on business being successful.
Cheers

[edward]

If I had to take a lipid drug I would take a Fibrate, not only do they have postive effects on HDL, LDL and triglycerides they have been shown to positively effect body composition, insulin sensitivity etc. See discussion over at Mind and Muscle.

Edit: This link to a discussion of fibrates works, sorry about that... http://www.mindandmu...showtopic=24351

Edited by edward, 13 November 2008 - 03:26 AM.

[Mind]

The high cost of health care is not so much a product of greed as it is of a society with no political tolerance for risk in medicine.

Excellent point here and a chance to bring up my "universal waiver" idea again. Call me a dreamer, but I wish we had an internationally recognized agreement called a universal waiver that someone could sign if they wanted to take an experimental drug or try an experimental treatment. They would agree to not sue under any circumstances (even if fraud was involved).

[Chad Meadows]

This is a good illustration of why free market principles don't work for medicine. Pharma is doing what it can to maximize its profits. They are ensuring that their customer base and profits are huge. There is an asymmetry of information. Pharma talks about relative risk, patients don't know the difference between relative risk and absolute risk. Pharma knows about side effects, but do not have to fully divulge what they know. Pharma can keep doing studies until they get a good result. There is no obligation to divulge studies that failed. With asymetrical information, patients will always get the short end of the stick.

Is it really a problem of free market? Let's consider this, if fish oil manufacturers could legally advertise on TV just like Pharma that their products reduce risk of heart attack with no side effects I would anticipate we would see a significant free market correction. However, it seems to me more a problem of free speech.

Chad.

[lunarsolarpower]

Put the stuff in gumballs!

Are you serious?

Edited by lunarsolarpower, 13 November 2008 - 05:09 AM.

[niner]

It was government that created the system in which getting permission to sell one new drug takes ten years and almost one billion dollars, and in which it is illegal for even dying patients to try medicines not approved by the FDA. The whole FDA/big-pharma infrastructure is a direct result of laws made by politicians believing they are protecting common interest.

The difference between greedy business vs. government protecting the common interest is the difference between gains in computer performance vs. gains in disease treatment over the past 46 years since the Kefauver Harris Amendment. I prefer the rate of gain achieved by greedy business, thanks.

If creating medicines that are both effective and safe were even remotely as easy a problem as building a faster computer, this comparison might be meaningful. The problem, as you noted, is that our society has little political tolerance for risk. This is a bit more understandable when you consider what that risk looks like up close; a stream of injured and dead people, including such situations as the thalidomide tragedy.

If we want the safety and efficacy that come from clinical trials, but we also want affordable drugs, what would be wrong with the government funding clinical studies of unpatentable supplements? Unfortunately, if such a thing were proposed, the country would be littered with the remnants of Republicans whose heads had exploded. Something about "Socialism"...

[Mixter]

IMHO, we should applaud the results of such studies...

...and then still avoid pharma unless really necessary. I'm already occasionally taking red rice yeast extract (with CoQ10), which naturally contains lovastatin, but without side effects. (As long as you take plenty of CoQ10 with it, as is absolutely necessary with every statin to avoid low CoQ10 in the heart muscle.).

Monasceus purpurus from red rice yeast is where they originally isolated lovastatin from... perhaps it contains many other things that prevent the more serious side effects of designer statins, or maybe altering the chemical structure of something that controls so much gene expression is risky... anyhow the original statin doesn't work a lot worse than the derivatives, but with much less side effects. Put red rice yeast w/ CoQ10 in stevia-sweetened gumballs and sell as supplement? I'd buy a few hundred if they taste OK

In short: I look up to modern medicine, drugs and yes, pharma in general as something absolutely necessary to improve the human condition. But the statin market is a typical example of making dozens of derivates of something old with the same mode of action and efficacy, but higher risks, just to create new patents and approvals. Pharma industry is corrupt but very good and necessary at its core. It's the FDA system that keeps corrupting the pharma industry (just like banks couldn't be evil without forced currency monopoly and the federal reserve system), and the FDA system that urgently needs replacement first. Go to LEF or another anti-FDA organisation and donate, now. http://www.lef.org/m...s-Itself_01.htm

[Benae]

One of my concerns with the Jupiter study is that it was supposed to go on for 4 years, but was stopped at 1.9 years.
"Randomized trials stopped early for benefit are becoming more common, often fail to adequately report relevant information about the decision to stop early, and show implausibly large treatment effects, particularly when the number of events is small. These findings suggest clinicians should view the results of such trails with skepticism."
JAMA. 2005;294:2203-2209

Other cautions worth noting:
http://www.fda.gov/c...ory/crestor.htm (June 2004)
U.S. FDA is alerting physicians to the need to carefully read the Crestor product label and follow the recommendations for starting doses, dose adjustments, and maximum daily doses to minimize the risk of myopathy in individual patients.
http://www.fda.gov/c...stor_3_2005.htm
http://www.fda.gov/c...vastatinHCP.htm

I'm afraid the message mass millions of people will take from this study as advertised by the media is: "normal healthy people should take statins". Go ahead, overdosed America, take another pill. I would be questioning why the study was halted so early as generally a greater risk is identified. Also, at the time the study was terminated, "75% of the participants were taking their study pills which means that 25% weren’t taking their study pills. And we don’t really know how many of the deaths in the study group came from the 75% taking their meds or the 25% who weren’t because the data was evaluated using an intention-to-treat analysis". (http://www.proteinpo...r-disease/1853/). Additionally, there is no long term safety data on very low LDL levels as reportedly achieved in this trial.

Dr. William Davis, author "Track Your Plaque": http://heartscanblog.blogspot.com/
"Crestor 20 mg per day, contrary to the study and to many statin studies, will not be tolerated for long by the majority. Muscles aches are not common--they are inevitable, sometimes incapacitating. While JUPITER showed 15% of both treatment and placebo groups experienced muscle effects--no different--this is wildly contrary to real life. My interpretation of these data in a practical sense is that Crestor 20 mg per day as sole therapy is useful in a disinterested, non-compliant patient who is unwilling to make substantial changes in lifestyle and nutrition. Helpful? Yes, but hardly an invitation for the world to take Crestor."

[Alistair]

I would just like to factor something else in here that hasn't been mentioned so far regardless of whether or not taking Crestor/rosuvastatin is a good idea for people like us or whether you view the pharma industry or the studies it funds with suspicion or not.

Currently, legislation does not support drugs that promote longevity, only ones that cure diseases and aging is not classified as a disease. Look at what Sirtris/GSK have had to do with resveratrol derivatives - test them against diabetes but in the expectation that any drug being approved would get used off label for longevity.

This legislative barrier will need to be removed before we get any significant progress in longevity medicine.
Astrazeneca have just funded a study that brings this issue into focus - concrete evidence that a drug may prevent cardiovascular disease and keep healthy people healthier longer. I would say that if anyone has a chance of getting the necessary changes in legislation, it is likely to be the drug companies.

Personally, I see this study as a significant step towards compiling a body of evidence to lobby for a change in legislation and therefore a significant step towards longevity medicine becoming a reality and I think we should welcome and support it.

Best Regards,

Alistair

[david ellis]

I would just like to factor something else in here that hasn't been mentioned so far regardless of whether or not taking Crestor/rosuvastatin is a good idea for people like us or whether you view the pharma industry or the studies it funds with suspicion or not.

Currently, legislation does not support drugs that promote longevity, only ones that cure diseases and aging is not classified as a disease. Look at what Sirtris/GSK have had to do with resveratrol derivatives - test them against diabetes but in the expectation that any drug being approved would get used off label for longevity.

This legislative barrier will need to be removed before we get any significant progress in longevity medicine.
Astrazeneca have just funded a study that brings this issue into focus - concrete evidence that a drug may prevent cardiovascular disease and keep healthy people healthier longer. I would say that if anyone has a chance of getting the necessary changes in legislation, it is likely to be the drug companies.

Personally, I see this study as a significant step towards compiling a body of evidence to lobby for a change in legislation and therefore a significant step towards longevity medicine becoming a reality and I think we should welcome and support it.

Best Regards,

Alistair

And wouldn't it be great if a new version of an old drug had to beat the old drug, rather than the placebo. Then we could be assured there really is progress.