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Chief science and health correspondent
NBC News
Not long ago, statins were jokingly promoted by some doctors with a “put them in the drinking water” argument. Physicians and drug company experts suggested that the ubiquitous cholesterol-lowering drugs -- including Lipitor, Mevacor, Crestor and Zocor -- should be sold over the counter like cold medications, or offered to everyone above a certain age. The medications appeared so beneficial to health and seemed so free of side effects.
But on Tuesday, the Food and Drug Administration issued a new health alert requiring the drugs carry labels warning about confusion and memory loss, elevated blood sugar leading to Type 2 diabetes, and muscle weakness.
“These warnings should put an end to the all the silliness about giving the drugs to everyone,” says Dr. Garret FitzGerald, chairman of pharmacology at the University of Pennsylvania.
Warnings for diabetes, memory loss added to statins
There is no question that statins -- the most profitable and among the most prescribed drugs ever -- have saved or prolonged millions of lives and will continue to do so. Most people at elevated risk for heart disease should be taking statins. The big issue now will center on determining whose risk is low to moderate and may not need medication.
The not-so-well-kept secret is that a daily dose of statin allows millions to eat whatever fatty food they like without worrying how it affects their cholesterol levels. That’s a tempting proposition. At the same time, drug companies find nothing more appealing than a pill that healthy people take daily for the rest of their lives. These two motivations combine to get million on statins who may not need them -- not much of a problem if there are no risks. But now we have evidence there is.
The FDA approved the first statin, Merck’s lovastatin, in 1987. Other companies produced their own versions over the last two decades as evidence of the drugs’ effectiveness continued to accumulate, adding to their popularity. But, early on, plenty of side effects warnings popped up.
Every time NBC News reported on statins I would receive many communications from viewers who had suffered the muscle-weakening condition, known as rhabdomyolysis, after taking the medication. When they stopped the drug, their muscles usually returned to normal. Doctors who frequently prescribe statins report that a certain percentage -- the best guess is about ½ to 1 percent -- suffer the muscle problems. That’s a rare occurrence as side effects go, but when many millions are taking the drugs, the numbers add up.
As for elevated blood sugar and memory problems, both conditions have been reported for years, but it is harder to guess how widespread the complications are. In fact, last month, a survey of 150,000 participants in the Women’s Health Initiative -- the government’s gigantic study that ended most hormone replacement -- found that older women taking statins were 48 percent more likely to develop diabetes. (The researchers tried to control for obesity and other risk factors.)
Because most people who take statins tend to be older, they’re already more likely to develop diabetes or memory problems. The only test to accurately measure the risk from statins would be a long, controlled trial of thousands of people at low risk for heart disease where half get the drug and half get a placebo. No drug company will pay for it.
Astra Zeneca’s Crestor remains the only statin still under patent protection, and it would be foolish for that company to go looking for harmful side effects. The government’s resources for big expensive studies grow ever more scarce. We may never know the true danger, but at least now the drugs have labels telling patients and doctors to be aware of them
Why did the FDA chose to label the drugs now when the danger signs have been around for years? There is no official answer, but the officials in charge of the FDA now have shown far more willingness to be honest about public health risks than many of their recent predecessors.
As for whether you or a loved one should be taking a statin drug: This is certainly not an automatic decision, but definitely a subject for a discussion with your physician. Because of the FDA’s labeling actions that decision should now be far better informed.
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Damn the drug companies. Once again, screw the people, just give us your money, you'll be fine...BS. I like the line in the report
"The only test to accurately measure the risk from statins would be a long, controlled trial of thousands of people at low risk for heart disease where half get the drug and half get a placebo. No drug company will pay for it"
My question...shouldn't this type of testing have been done before the FDA approved the drug? Once again policiticians in bed with big Pharma; what a surprise. I think the drug companies should HAVE to pay for the testing as well as pay damages to all the families that have been effected by this aloof attitude that has killed many.
Just my opinion...
Interesting that all this is coming out right after Pfizer's patent just expired.
You hit it on the head RoadWarrior-- and I thought I had dementia -- no one told me!
ebnv
They have other drugs for dementia that will kill you also. Now, make sure you take the right one.
Go to spacedoc.com and there you will see several Cardiologist who have come clean about the use of statins and the cholesterol hype.
Which Lawyer Group is Handling The Class action lawsuits ?
I had a complete Physical Jan 23, 2004 No sugar problems But high cholesterol. On Feb 1, 2004 I had a Heart attack .
I was told to take plavix ,
April 1, 2004 I am told I am a Type 2 Diabetic .
But told to continue the plavix .
My sugar level will not Go below 200
I quit taking plavix and my sugar goes to 80
Feb 10th My Cardiologist Says to Start taking Zocor.
Today My Sugar level is 225 .
how do you know your sugars were fine?
Plavix is not associated with diabetes
"Why did the FDA chose to label the drugs now when the danger signs have been around for years?". The possible side affects of statins were explained by my doctor and my pharmacist many, many years ago. They are also clearly delineated in the prescription information given by the pharmacy and again are included with the information sheet that the drug company provides in the package. So yes, why now, why is this worthy of a national headlines and why are "news" outlets reporting it? Hmmm, could it be...let's see, statins are the number one drug prescription for pharmacies, this is a fact. This is Huge business for the national chains like Walgreens and CVS. You don't suppose that they would want statins sold everywhere off the shelf, why it would cost them billions. So what did they do? Lobby. For their best interests, not yours. As any insider knows, the FDA is currupt and especially cradles to the Republicans and their big Pharma lobbyists. Any insider know this to be plain a fact. Vote Republican, screw yourself.
The greed for the dollar is not confined to a single political party.
I'm sure there are bad apples on both side of the aisle as well as independents.
Generalizations won't help the issues at hand.
The FDA is useless. If it wasn't, I wouldn't see a hundred commercials for 1-800-bad-drug...
Memory loss?? I don't recall that.
You just couldn't pass it up, cud ya?/
The war on drugs is being fought in the wrong place...try congress next...EPA is a joke.
Once again part of the governments lies to us.
What a shock. Check out how many members of Congress get "donations" from Big Pharma. and they get medicines approved.
The 2010-2012 Congress is bought & paid for. And these idiots wonder why Congress is rated so badly.
They need much more than just removed from their seats, they need to pay for their atrocities.
I'll believe in Corporate Personhood the moment I see one hanged...
Make no mistake... the FDA is there to protect the profits of the drug companies first - not the health of the public.
I was one of the 1/2 to 1% with rhabdomyolysis. It started two days after my first dose of Crestor and became so bad I literally could not move my hand to my mouth, much less get out of a chair.
Symptoms went away within two days of stopping the Crestor.
JV, my doctor didn't explain the side effects of Crestor and I foolishly (my fault) didn't read the warning packet.
Everyone in my family are on statins except me. I have long fought against it. My siblings tell me I am an idiot for not going along. Now I read the symptoms in this article and I see the same symptoms in my brothers. Memory loss and muscle coordination problems, not to mention damage to liver. I am so glad I am the dumb one :)
Good for you! :)
Watch the commercials very carefully. They even admit JUST having high cholesterol is not a reason to take statins. You are suppose to have one of the other risk factors such as high blood pressure... but then again the doctors keep lowering the point they consider high.
billooo,
you clearly have no medical training. Risk for heart disease is based on many factors, cholesterol being one of them. ITs not as simple as "cholesterol plus one"
One of the best defenses against heart disease always has been and continues to be statins
Eric - do you know what "cholesterol" IS? It is a substance, produced in your liver, that is cycled through the body to use for celllular repair. Do you know that unless you are given what is called a VAP test, that cholesterol is NOT a risk factor? The VAP test measures the particle size of you LDL (Low density lipoprotein) cholestrol that is on it's way back to the liver for recycling. If you have a large particle size, it "bounces" back through the bloodstream to be recycled by your liver. If you don't get enough in your diet, then your liver makes what you need. If you have a small particle size, it can stick in your arteries and cause inflammation,a primary factor for heart disease. Standard testing does NOT provide this measurement - thus, your "number" you are given is simply a measure of cholesterol activity in your body at any given time. Did you also know that for WOMEN, based upon the Framingham Nurses Study, that women with "elevated" cholesterol had better longevity than those with low cholesterol, and that low cholesterol is associated with a higher incidence of ischemic stroke? We have been sold a bill of goods here with some terrible side effects. Billooo - you are taking a brave stance against a completely arbitrary "200 or below" number that has no clinical data to back it up - bravo for you!!!!
What many people don't realize is that excessive carbohydrate diets, cereal for breakfast, two slices of bread for a sandwich for lunch - with a sugar drink, dinner with a roll, rice, and sugary desert - can lead to higher cholesterol levels in the blood due to its affect on insulin. A "normal" American diet is extremely high in sugar, we should be consuming half of what is "normal".
Want to lower your cholesterol levels naturally? Cut out the carbs! And don't be afraid of FATS. Fats help to stabilize blood sugar, which stabilizes insulin, which will lower cholesterol.
Low fat diets raise cholesterol. Do your own research on the link between carbohydrates and cholesterol. It will change the way you look at a bowl of cereal.
wasnt me:
yes, I know what cholesterol is. I also know, have ordered, and have recieved a VAP test. It is true particle size is important as you claim. But to say LDL numbers are meaningless is plain wrong. It has been shown time and time again to correlate with worse outcomes (courage, framingham, ascot(?) i might be wrong on the abbreviation of the last one--was a european study)
There is no such thing as the framingham nurses study that Im aware of. I think you are mistakingly linking the nurses health study with framingham. Also, your conclusion is false. Please provide a citation. There was an observation that women with elevated cholesterol did not seem to have a higher risk of heart disease; this was likely due to not differentiating between LDL and total cholesterol. In fact, a recent meta-analysis recently put this myth to bed for educated people.
I just wonder about my own diabetes 2 - I am 64, have taken pravachol for about 10 years - started more as a preventive measure. I was diagnosed with diabetes 2 only 2 years ago with no family history and only slightly overweight - lived on a pretty low carb diet. Now I wonder if taking the statin was worth it!!
There is absolutely no evidence that statins have saved many lives, nor that they continue to do so. The whole concept of statins is that cholesterol has anything to do with heart disease. It doesn't. Cholesterol may be an indication of inflammation, which may be an indication of heart disease. IF (and only IF) those two assumptions are correct - which doctors typically don't bother to check - then statins might help. High cholesterol does not even figure in the top risks of death from heart attack.
There is no denying that there are people with off-the-charts cholesterol where medication is indicated. The vast majority with "elevated" cholesterol are being taken for an expensive and unhealthy ride.
I'm just curious and trying to get the best information available.
Are you a biologist, chemist, or pharmacist or in the medical field in some other capacity?
Any chance of some documentation to back up these statements?
Watch the disclaimers at the end of the tv commercials. They outright say it has not been proven to reduce the number of heart attacks. They also say you need to have a second risk factor like high blood pressure.
wrong
MOST people who have heart attacks have "normal" cholesterol. This is something you never hear, but it's easy to find the stats for yourself.
wasn't me;
It is true that many people with heart attacks have "normal cholesterol". I have two points of rebuttal
1) No one ever said cholesterol was the only risk factor for heart disease. If you told me you had a 85 year old man who smokes 2 packs a day since age 12, is diabetic, and eats fried chicken daily and he had a heart attack with normal cholesterol I don't think anyone would bat an ey
2) What is "normal"? Is it the level that kids have (<100)? Could it be that our population's average cholesterol, like our average weight, is too high and not really "normal"? Please don't confuse average with normal. NOt the same thing
I took Lipitor for a week. After 3 days I felt ill. Then I just crawled into bed for several days. I hurt all over, couldn't think, generally felt out of it. Three days after stopping the drug, I was back to normal. When I reported this to my health care provider, she just wanted to change the dosage. I refused. I have no doubt that I would have been totally incapacitated if I had continued on this drug.
Your reaction is an allergy. The same thing happens to me when I eat certain foods.
What would be the basis for this assumption? I was showing the exact side effects we are being warned about. There is no indication that this is an allergy.
For every Yin there is a Yang
Don't you mean for every Lin there is a Yao?
Jeremy Lin is a 6'3" guard born and raised in Palo Alto, CA who is having a great sophmore year and I wish the Warriors had seen his potential last year and kept him on the roster.
Yao Ming is a 7'6" center who played 8 years in the NBA and is a product of Shanghai, China. I wish his foot injury (very common in centers) had not cut his career short.
Lin is not Ming and Ming is not Lin
I have high cholesterol , am not overweight, sonograms show only low to moderate plaque buildup and no history of heart disease in my family
I go in for my welcome to Medicare exam soon. If my doctor suggests statins knowing the above, I may just ask fora new doctor
moderate plaque buildup is a bad thing...you sweep it away like its nothing but that's not normal at all
There is no doubt in my mind you should be on a statin.
Eric - do yo work for Pfizer? Or Astra-Zeneca?
wasn't me:
No. Neither, or any pharm company
Dont ASSume, because well....i really just spelled it out for you to make it easy for even someone like you to understand
My doctor just reccomended that I begin taking a statin drug, and I declined. He did not explain any of the risks or even mention that statin drugs deplete CoQ10 from the body. I have heard for years from friends and family members taking statin drugs about muscle pain. I think the % is much higher than the 1/2 to 1% they say. I'm not willing to take the risk - after all the heart is a muscle and this is to prevent a heart attack? Now the risks for diabetes and memory loss are at increased risk too? Big pharma has been pushing these drugs for years. Finally the FDA will admit that there are dangers. They are not for everyone, yet most insurers would rather have you go on these dangerous drugs and won't pay for the tests to determine inflamation and other markers to see if you actually are at risk from cholesterol.
what is your evidence of the clinical effect of coq10 depletion by statins?
its not higher than the quoted percentage; please post evidence to the contrary if you have it
Fine. Then take the risk of heart attack. You don't get something for nothing. By the way, skeletal muscle is different than cardiac muscle. A second year med student could tell you that
Inflammation is a risk for heart disease, but its not nearly as established as cholesterol
I immediately stopped taking Lipitor after after many years after reading this article.
I too now have type 2 diabetes and my Son has been complaining about my bad memory for well over a year now. I'm hoping my health now improves.
Single Dad....you really should taper off Lipitor gradually, as abruptly stopping may increase your chances of a stroke.
Go to spacedoc.com for a real eye opener & advice about winding down on statins. I recently quit Lipitor after taking it for two months. I'm no psychic but had this profound intuitive feeling that Lipitor/statins was bad news and was lucky to find this website.
azomite,
not true at all. You don't have to taper off statins.
your website is a crock by the way
Eric,
Please share with us why you think the Cardiologists, Thoracic Surgeon (preformed over 5,000 coronary bypasses) and other MDs & scientist on spacedoc.com would qualify being a "crock".
They have the expertise, experience and supporting data for their claims.
They admit statins have been helpful but mainly for its anti-inflammatory properties.
Do you think all the Doctors on this website are just serving up the "crock" to sell books & supplements?
Please share with us your insight and qualifications for being so dismissive with all the Doctors who have contributed to the web site. This is extermely important as SO many people are taking statins.
Thanks
My qualifications are board certified in internal medicine and adult cardiology. I have seen and treated more patients, have rread more and have more practical knowledge than you have by looking at one website and fancying yourself an expert
What now?
Dr Eric, I know how much you hate internet information but this one is from the American Heart Association. It appears the AHA has a contrary opinion from you about the risk of abruptly stopping statins for some patients. I am surprised with your level of expertise that you are not aware of this.
By the way I never fancied myself an expert on this but do feel compelled to do a little reading on my own since there are some Doctors, such as yourself, who don't.
please post it then...id be interested to see it...
before you take such a superior tone, you should at least have SOME evidence...
you are probably misinterpreting the article. some of this is hard for laypeople to understand. Once you post the source, im sure I'll be able to clear up your misunderstanding
I KNEW IT WAS THE LIPITOR! I was prescribed Lipitor 2 years ago, Since then I have had pain in both knees (not at same time) that were unexplained. Also memory problems where I could not remember nouns, and had troubles remembering what was said to me earlier, dates, places and times of events. I thought I was suffering from early dementia. Doctors told me that was not the case, but could not diagnose my problem. I also had higher blood sugars than normal. Now I am on diabetic meds which barely control the sugars. IT IS THE STATIN!!!! When I lowered my dosage from 80 to 40 mg a day, the pain in my knee disappeared in 2 days. When the pain occured in my other knee after another year, I stopped the Lipitor altogether. Pain was gone in two days. Now they say the blood sugar levels and the memory problems are due to the drug all along. Damn the Drug Companies and Damn the FDA for not releasing this info sooner. They have had people walking around hobbled, confused, taking more diabetic meds and thinking it is all their fault!!! Another case of where the cure is worse than what ails you. I was switched to Crestor last month. I am off of it as of today! The side effects are not worth it!
Key insight to one of the things wrong in America today:
"... Astra Zeneca’s Crestor remains the only statin still under patent protection, and it would be foolish for that company to go looking for harmful side effects ..."
Really? The only reason it would be foolish is if they are the hook for the deaths they cause. It's time to start associating the number of people that are killed with bad "legal" bad drugs with the politicians that let them into market.
Clearly, there is no accountability in the Executive, Judicial, and Legislative branches of govt today. It doesn't matter what party holds office. Let's make Wash. DC its own country and move them ...well, how about to one of those planets that may have water. We'll worry about how they get there and whether it has water later. Cuz that's how they treat the problems that the American public faces today.
Amen, Bonzeye
Thanks FDA but no thanks. I'll keep taking zocor and enjoy my red meat and cholesterol below 100.
I knew once the patents expired and the cash cow dried up that the truth on statins would start to come out of the woodwork. They did a number on my muscles and my doctor finally switched me to niacin which worked so far.
Guess what statin drugs were derived from? Mushrooms, and they won't kill you. The FDA won't promote them either.
The health care industry is a joke when it is easier to prescribe drugs than prescribe healthy living. It is going to be hard to justify giving all the poor people statins because of the health care bill on the tax payers dime with this coming out.
Notice that a few of the OTC cholesterol meds have had their prices kept at the prescription level by the manufacturer? Sort of like cars. We will never know how much it costs to make the product so we can’t complain about prices. How many hundreds of millions does it take to pay for research investments?
Go to spacedoc.com and there you will see several Cardiologist who have come clean about the use of statins and the cholesterol hype.
great and enlightening website. thanks.
Doctors get massive kickbacks on pushing big pharma, of course they're going to promote meds, the more the better (for their pockets) regardless of patient complaints & knowing the cause behind side-effects, just give me easy money. Holistic is bad, because doctors don't get a kickback... debunk holistic, remind your patients that they're not FDA approved.. as we can all trust the FDA...
Hey, and if you come to them with more problems for them to "treat" from big pharma fallout, that just means even more money in their pockets... You can't sue a doctor and win anymore, so why not? We all know there's nothing more important than greed and golf courses - afterall, they deserve it.
what a crock. Do you have a single shred of evidence that many doctors are recieving kickbacks? This is the kind of outright lying and fear-mongering that makes me wish the internet was never invented
it's written...it must be so
Statins are perhaps the most important medical advancement of the past 50 years. The vast number of lives that they have significantly prolonged, and the extended quality of life they offer for many, cannot be refuted. Diet and exercise are the best medicine, but many americans choose not to, or have issues that prevent their living that way. Doctors can't make a person run 5 times a week, but take a pill once a day... that's doable. What's more, there have been several studies in the last 5 years that have indicated that stains may decrease the incidence rate of over a dozen types of cancers and other types of diseases and aging factors. The side effects reported here have been well known and reported for years; prescription drugs don't require a warning label on the bottle for these types uncommon, mild, and reversible issues as it is the job of MDs and PharmDs to educate patients; that's why they require a prescription!. However, I'm in favor of more transparent info all the time. In particular, the increased 'risk' of diabetes has yet to be shown as a direct effect of the statins, and may be entirely do to bad diet habits after the statins have lowered the heart-disease risk, the 'invincablity' effect. Please don't jump to conclusions of conspiracy and terrible people in "Big Pharma'. They aren't perfect, but they help millions of people, and most of their scientists are honorable men and women with a passion for helping others, as are most of the MDs who sacrifice their own youth and family life working their tails off so that they can treat those in need, eventually all of us.
Plane and simple: statins are our best weapon against the #1 killer in america, heart disease. Make an informed decision that is right for you, but make sure you truly know that risk/benefit ratio, and aren't making judgments out of incomplete knowledge and/or fear.
God bless,
Joe
Finally some common sense. Joe- you are the man!
agreed, great post
Please cite your long term clinical data (not observational data) tha support your hypothesis. It would be helpful if people could read the data.
I cited you a few studies in a previous post. Look at them and get back to me.