Tuesday, February 28, 2012

Do Not Stop Your Statins

As my tween daughter would say, "OMG!"
The media is a buzz with the news that the FDA is changing the warnings on statins.
The New York Times claims "Safety Alerts Cite Cholesterol Drugs’ Side Effects."
According to the Wall Street Journal "FDA Warns on Statin Drugs."
And the text on the bottom of the CNN report states "FDA places warning on statin labels."


Statins, which are cholesterol lowering medications are now one of the most commonly prescribed medications in the US. If I were one of the millions of patients taking a statin, I would be pretty worried based on what I am hearing from the media. 

Fear Not!  There is Nothing to Worry About.  Do Not Stop Your Statins!

Before getting in the details, it is important to note:
1. It is pretty irresponsible of the media to use scary headlines, when the warnings from the FDA weren't really that bad.  In addition, the warnings about liver problems (the one you hear about in all those TV commercials) were actually downgraded. 
2. It is not entirely the media's fault.  The FDA does a very poor job when releasing information.  When they update something, they should make it clear to physicians and patients what the real risk is.  Once again, the FDA failed miserably.
3. Statins are probably some of the safest medications we have. If patients could easily perform and interpret their own blood work, these might even be over the counter.  Some have suggested that this might be a good idea. Moreover, statins reduce heart attacks and strokes (#1 and #4 killer in the US). Though no medication is perfectly safe, I can think of no other long term medication where the risk benefit ratio is so far in favor of the drug. Cardiologist John Mandrola put this best in his post (via KevinMD) "Let's close the chapter on statin safety." 

Ok, now for the details. 
Today the FDA released information that they were updating warning information on statins. Essentially, there are three areas where safety data was updated: liver enzymes, memory impairment and diabetes.

Liver enzymes- This one is actually good news. Earlier statins caused some elevations in liver enzymes which were feared to potentially cause liver damage.  After many years of usage, it doesn't seem this fear is warranted.  Because they can affect the liver, patients with pre-existing liver disease should use statins cautiously. Even though statins can cause liver enzyme elevation, it is usually at the highest doses and usually returns to normal when the statin is stopped of the dosage is lowered. The routine monitoring of liver enzymes that was once recommended is now no longer required. 

Memory Loss- This is the one that makes me the most annoyed. First, because it really isn't true and second because the way the FDA communicated the data is useless at best and harmful at worst, since patients may stop taking statins because they are afraid that they will get Alzheimer's. 
According to the release the
"FDA reviewed the AERS database, the published medical literature (case reports and observational studies),4-13 and randomized clinical trials to evaluate the effect of statins on cognition.14-17"  

The numbers above refer to references of studies they looked at. However, of the 13 studies they analyzed "did not suggest that cognitive changes associated with statin use are common or lead to clinically significant cognitive decline." In fact, most of these studies were looking at use of statins to PREVENT Alzheimer's. Thus, most of the data they used to make this recommendation was from their own AERS database.  It would have been really nice to release this data! However, one of the mentioned publications did look at MedWatch drug surveillance system of the Food and Drug Administration (FDA) from November 1997–February 2002 for reports of statin-associated memory loss.  Of course we don't know the exact number of patients that took a statin during those 5 years, but it was in the millions.  The authors were only able to find 60 reports, of which none was truly confirmed (just patient report) and more than half noted improvement when the statin was stopped. 

I have previously blogged about this issue back in 2008 in my post Lipitor and Memory Loss as well as another post Lipitor: Responding to SpacedocSpacedoc is really Dr. Duane Graveline, MD, MPH, a family physician who became a NASA's scientist, but is better known for his book "Lipitor, Thief of Memory" which he wrote after having two episodes of something called transient global amnesia (TGA) which he states was associated with his use of Lipitor from 1999 - 2000. In fact, I actually became aware of TGA because the mother of a close friend had the exact same thing. 
Bottom Line- There may be some connection between Lipitor and memory loss. However, even if there is, it is extremely rare (you have a better chance of winning the lottery) and even if you get it, it usually goes away if you stop the medication. In other words, there is absolutely no reason to be alarmed, and no reason not to take the drug if you need it to control your cholesterol. 


Diabetes- This is another topic that I have blogged about, and one that seems not to want to go away.  You can see my post "Statins Don't Cause Diabetes" for all the details.  Much of the concern came from a Crestor trial which actually showed Crestor to cut heart attack risk in half in patients that had relatively normal cholesterol.  This study used a particularly high dose of Crestor, and the FDA warnings point to other studies using high dose statins with similar findings.  It is important to note that in the Crestor study, about 40% of the patients were at risk for developing diabetes in the first place, that measures of diabetes in the study were really no different, but the physician reported (i.e. unconfirmed) rates of diabetes were increased.   However, more importantly, if you look at the actual rates of developing diabetes it was 3% in the Crestor group an  2.4% in the placebo group.  In other words, if statins increase your risk of developing diabetes, it increases it only by 6/10 of a percent (not as low a winning the lottery/memory loss, but pretty darn low). However, with millions taking a statin, even a small risk is something to consider.  However, one must also note that diabetes is a disease process more than just an isolated sugar number, and it is unclear what actual risk a statin would cause by turning a pre-diabetic patient into a diabetic one.  In fact, patients who are pre-diabetic have a 4 to 6 times greater risk of heart attacks and strokes, and statins have been used in pre-diabetic patients and shown to reduce their risk of heart attack and strokes.  Conversely, no study has shown that reducing sugar in a diabetic reduces their risk of heart attack and stroke. 


Bottom Line-statins may raise your sugar a tiny bit, and for those patients who are at risk for developing diabetes, taking a high dose statin may "push" that patient into having diabetes sooner than expected.  However, even in that circumstance, the statin is probably still well worth the risk since it is potentially preventing a heart attack or stroke and slightly increasing the sugar probably has no clinical ramifications. 

90 comments:

ShottleBop said...

If, as John Mandrola says, statins' benefits appear to come from their anti-inflammatory effects, rather than from their effect on cholesterol levels (an assessment with which Dr. Graveline agrees, by the way), what effect would you expect statins have to have on absolute risk if (1) you have had arterial blockage (addressed with a stent), (2) your LDL is very high (230), as is your total cholesterol (low 300s), but 90+% of the LDL is the large, fluffy type, HDL is typically 75-84 and triglycerides under 50, and (3) a recent hs-CRP shows very little inflammation (0.57, vs. a lab-reported "normal" range of 1.00-3.00)?

Dr. Matthew Mintz said...

@shottlebop,
There is no scientific way to answer your questions, as I am not aware of a statin trial in high risk patients with elevated LDL and HDL, and normal CRP. You essentially have a few "positive" risk factors (low crp, high HDL, fluffy LDL particles), one big negative risk factor (LDL), and known CV disease. In my opinoin, the fact that an artery had blockage shows that you have atherosclerosis and therefore are at great risk for heart attack and stroke. In addition, despite som many positive risk factors, you still managed to build up plaque. Thus, regardless of you numbers, Framingham risk score, and low CRP; I would probably recommend a potent statin like Crestor or Lipitor with an LDL goal of at least less than 100. Again, since there is no study that I am aware of that looks at patients with circumstances close to yours, this is more of an opinion then fact.

ACD22 said...

Thanks for the timely post. I freaked reading the original stories and went right to your blog to get the real story. Very happy to see that the facts about statins were in your post.

Anonymous said...

Why is the FDA's use of inflammatory language any worse than statin manufacturers ongoing commercials implying nearly everyone should be on statins if only they're cholesterol is too high, even though we know that statins only proven benefit is among people with *existing* CVD? This big pharma fear mongering with cherry picked data designed to prove only what they want proven its more offensive than anything the FDA has done.

Anonymous said...

What is the mathematical basis for your statement that the statin's probability of preventing a heart attack or stroke is greater than the risk of it accelerating the development of diabetes, particularly among people with no evidence of existing coronary artery disease? Is it opinion, or based on statistics from controlled trials?

Dr. Matthew Mintz said...

@anonymous 3/14-
"we know that statins only proven benefit is among people with *existing* CVD." That's not entirely true. There is almost no study that does not show CV benefit for statins in any population, with or without established CVD. The JUPITER study is a prime example in that it showed a 50% reduction in MI's of people not only with no CVD but also relatively normal cholesterol levels. The issue has to do with magnitude of benefit which is greatly increases with increasing risk. Thus, even though statins might cut half the heart attacks in a low risk group, if we are talking the difference of 1/1000 heart attacks vs. 2/1000 heart attacks over 3 years, it might be worth the cost/risk of 1000 patients taking a statin.
The problem with the FDA warnings are they didn't really balance any risk with benefits or discuss the magnitude of the risk. There should have been something that stated "though we decided is was important to include these warnings it should be noted that statins have been shown to prevent heart attacks and stroke. In contrast, all drug ads are required by the FDA to state both risk and benefits, as any person who watches TV is keenly aware of.
@ anonymous 3/14-this is based on statistics from clinically controlled trials. Specifically the JUPITER trial. Worst case scenario, Crestor taken by patients with no known CVS and relatively normal cholesterol (and also -like many Americans- were already at risk for developing diabetes) increased diabetes by about 27% and a 56% reduction in any fatal or non-fatal CV event. Even if it were 50% for both, one could argue that diabetes can be managed effectively with medicine, where having a heart attacks leads to complications and death. Thus, even it were 50% for both, the argument could still be made in favor of the statin.

Anonymous said...

Dr. Mintz, would you care to comment about the importance of cholesterol in the brain, and the process called synapses where nerve cells communicate with each other, aiding in memory and recall.

I'm going to be real upfront with you Dr. Mintz. As I read your comments, your financial relationship with big pharma shines brighter than the Sun on a clear day.

You can elect not to post this if you want. That's your right. But lets see if you have the courage to do so.

Dr. Matthew Mintz said...

@anonymous
My financial disclosures are clearly listed on my blog's home page under "more about Dr. Mintz." I consult and have spoken for the industry, and feel no shame in doing so. I am paid for services rendered, though at a rate far below what other consultants with similar education and expertise would get. I consult because I feel the industry will provide better products to patients with input from actual doctors. I speak because I think information about new medications is better when it comes from actual physicians.
I try to minimize any bias by working with multiple drug companies on multiple diseases, so I am not beholden to any particular product. That being said, I certainly recognize that my work with industry can potentially bias my opinion.
On the issue of statins, I have not consulted for or spoken for a company regarding a lipid lowering therapy in several years.
In regards to what seems to be your question, cholesterol is extremely important to the brain because it protects the lining of nerves. However, infants whom this would be particularly important have ridiculously low levels of cholesterol and their brains develop just fine. There is likely a LDL or total cholesterol level that is too low and has the potential to cause brain problems. However, an LDL between 40-70 (the most aggressive goals of lipid lowering therapy) is very likely a safe range.
Finally, if statins were dangerous to brains or nerves, we would likely see many reports of dementia and Alzheimer's. However, the opposite is true. Though not all studies prove a benefit, some do.
P.S.I have the courage to post my own opinions on my own blog with my own actual name. Posting confrontation comments and challenges under an anonymous name is pretty easy to do.

DAVE TURGEON said...

Dr. Mintz:

If you had been a victim of statin poisoning, as I have been, I can assure you your opinions on the efficacy and risk/benefits would be much different than they presently are. I say "poisoning", because that is exactly what they did to me. I was so sick, in so many ways, I was virtually bed ridden and unable to work. Muscle weakness (neuropathy), debilitating fatigue, mental fog, a clinical level of depression, adverse personality changes, motor neuropathy, increased blood sugar and insulin resistance levels, I could go on but you get the message. And all at a daily dosage of 10mg Lipitor. As is now being recognized, even low dosages of statins taken over a long period can slowly and eventually result in virtual complete incapacitation. All I can say is, I am glad I am not your patient.

Dave Turgeon.

Linden Malki said...

My own experience with Mevacor included noticeable memory loss and brain fog, (I was forgetting customers' orders at work which was very uncharacteristic of me)which did largely clear in about two weeks. However, my memory is simply not as good at it was. A cousin who has been on statins for almost ten years scared me the last time I saw him because he couldn't find places that he had known for years and couldn't find his way onto a freeway he had driven for years. It took him four hours to find someplace 45 minutes from where he started, and never did show up the next day at an event we had planned to attend.
I also had muscle pain and weakness so severe I could not lift my arms above my shoulders, and could not put on a jacket because I could not reach far enough back. It also cleared with the discontinuaiton of the Mevacore, but it took over a year to be able to tie an apron string behind my back.
I also had a cataract that became much worse and then improved to its original level without the Mevacor. My opthamologist said he had seen this often.
I believe that many of the side effects do not find their way into the statistics because doctors do not believe their patients' reports. And I have seen reports of clinical trials that admit that participants who drop out of the study because of side effects are not included in the final result.
I have a degree in mathematics, and have noticed in many of the reports the statistics are distorted and interpreted in a misleading manner.
My own primary physician was at one time one of those who believed statins would be good for everyone--and has changed his mind and understands why I refuse to take them.
Linden Malki

Linden Malki said...

My own experience with Mevacor definitely included memory loss severe enough to make it almost impossible do my job--and it mostly cleared two weeks after I discontinued the medication. However, my memory is still noticeably impaired almost seven years later.
I also had debilitating muscle pain that was so bad I could not lift my arms above my shoulders nor put on a jacket--which was noticably better within a few weeks but took a year to regain the full range of motion.
My opthamologist said that my having a cataract become worse with the medication and then improve without it was something he had seen before in patients. I am convinced from my own experience and many of my friends and family that statin sideeffects are common but often the patient does not recognize what is happening at first, and his doctor does not believe it, so they are not reported.
I have noticed that some studies admit that participants that drop out because of the side effects are not included in the final report. Also, claims of a "50% difference" when the actual difference is between 2% and 3% may be techically correct but very misleading, especially as all-cause mortality is not reported when it is higher in statin users.
My own doctor once believed that statins should be widely prescribed, but now understands my refusal to take them.

Vita-Manny said...

Is it true that many of the problems caused by statins is in direct correlation in the reduction of Coquinine biosynthesis; leading to low serum levels which cause muscles to atrophy as well as the depletion of the cholesterol the brain needs to function properly. Seems many of my clients have had many of the same complaints, all begining with Statins, then they had to be on Aricept, due to memory loss, then Anti-depressants for depression. why wouldnt pharemceutical comapnies add Coquinine to Statins, to help reduce some of the debilitatin side-effects. Or better yet, do you Dr. Mintz suggest to your patients to supplement with CoQ10 or even provide the information that High doses of Vitamin C have been found to inhibit the same the HMG-CoA Reductase enzyme as the statin drugs. The inescapable conclusion is that vitamin C does what statins do - lowers cholesterol -- without side-effects. If the statin drugs were patterned after Vitamin C, they lack many other benefits of the vitamin. For example, vitamin C promotes the production of coenzyme Q10 and lowers lipoprotein. My guess is there is more money in marketing another pill to mask the side-effects of statins than to add this vitamin-like substance becasue there is no way to patent it. I might sound a little like a "conspirocy theorist" by making this statment but it makes "cents".

Dr. Matthew Mintz said...

@Vita Many
Don't think it is a conspiracy, but because vitamins and supplments are regulated by the FDA like food is regulated, manufacturers of such products aren't required to do the same kind of rigorous research that the pharmaceutical industry is required to provide. Because of this, there is very little data on supplements. There are a few published studies on CoQ10, with mixed results. For my patients that (due to high cardiovascular risk) must be on a statin but still have some muscle side effects, I do recommend CoQ10, which has seemed to work for some patients. I am not aware of strong research regarding Vitamin C lowering cholesterol, or more importantly preventing heart attacks and strokes.

Anonymous said...

You don't seem to be aware of much. That a doctor in 2012 could still be minimizing and trivializing the side effects, particularly the cognitive negative effects is just plain astounding. I think you must be getting a huge whack of graft from phama for this.

Read Therapeutics Initiatives, Statin Effect Study and Cochran Collaboration for the truth. Then go to the survivors group Stopped Our Statins, and Space Doc. See Dr. M. Kendricks YouTubes on Statins.

The reason the FDA warning is muted is because FDA, Health Canada and TGA take money from pharma for each drug licensed. Do you think they're going to bit the hand that feeds?

Doctors refuse to report. It's been documented. They just won't report, making all kinds of excuses. The doctor who runs Healthy Skepticism says it takes too much time. Guess what? If only about 10 out of 100 possible side effect reports are made, it's RARE.

I daily work to save people from doctors like you Mintz, who play a game of fast and loose with your patients, for your profit. We can all read. It's all here with substantive evidence, available to everyone, but you apparently.
Stain Survivor

Dr. Matthew Mintz said...

@statin survivor
It's not that statins don't cause any side effects. They do.
However, more than any other medication available, statins have proven benefit in preventing heart attacks and strokes (the leading causes of death in the US). Everything in medicine is about risks and benefits. Based on substantial exisiting data, in general, for patients at risk for heart attack and stroke this risks of the statins are far outweighed by the huge benefit they can provide.
I don not make any money from prescribing vs. not prescribing statins.
Lipitor is now available as generic atorvastatin.

Donna Hubbard said...

I was put on crestor i now have diabetes i will never take statins again. Lipitor gave me muscle pain. I will research any meds given me from now on.

Anonymous said...

Quote: "Statins have proven benefit in preventing heart attacks and strokes."

Dr. Mintz, I hate to burst your bubble but it simply not possible to prove taking a statin averted a would-be heart attack. Or worded another way, its impossible to prove in any individual they would have suffered an event had they not been taking a statin.

Dr. Mintz, patients want to be able to look up to thier physicians, but when we see this kind of gullibility among doctors its discouraging to say the least. We need a professional mind for a doctor, not a "Hank Kimbal" mindset from the TV show Green Acres.

I think you should voluntarily give up your license to practice medicine.

Lets see if you have the courage to post this.



Dr. Matthew Mintz said...

@anonymous 4/11. I have the courage to post your comment.
Do you have the courage to post your name? Pretty easy to belittle a physician under the veil of anonymity.
Technically, you are correct that there is only one being that is omnipotent and can predict the future. Thus, no physician can say if you take a certain medication it will prevent a heart attack in you individually. However, that's not the point. Study after study have shown that seatbelts save lives, yet there is no way I can no for sure if wearing a seatbelt will save your individual life. However, just as would be irresponsible to tell people not to worry about wearing seatbelts because there is no way to know if it would protect them specifically, it would be irresponsible to tell people not to use statins because study after study has shown that in patients taking statins compared to patients not taking statins risk of heart attacks are reduce. Most of these studies (unlike seatbelt studies) are randomized controlled trials, considered by the scientific community as the highest level of evidence. There is almost no medication studied with more randomized controlled trials than statins. Now, you can argue that benefit of statins is greatest in those at highest risk or that the risk/benefit ratio is not strong enough to recommend statins for most people. However, you can not argue with the fact that statins reduce heart attacks and strokes. This is a scientific fact.

Anonymous said...

No Mr. Mintz, I can and do argue statins are 100% worthless and place the public's health at serious risk.



Anonymous said...

Your comparison of statins to seat belts is very poor. With seat belts we have clear cut accidents where occupants of vehicles are restrained rather then being thrown through the windshield, subsequently surviving what would most likely be fatal otherwise.

With seatbelts we have excellent physical evidence of a benefit.

With statins we have marketing triumph over medical science.

In my opinion, statins are snake oil.

Dr. Matthew Mintz said...

The comparison is accurate.
We have randomized trials in which patients who take statins have fewer heart attacks and strokes. This is scientific evidence at the highest level. If you refuse to acknowledge science that I suppose that is your right.

Dr. Matthew Mintz said...

"I can and do argue statins are 100% worthless."

Please provide your evidence.
My evidence is that many randomized clinical controlled trials have proven statins beneficial. Can you provide evidence (not just opinion) that they are not beneficial?

Anonymous said...

It is impossible to prove someone would have suffered a heart attack had they NOT been taking a statin. Its that simple. The effectiveness of statins in outcomes is immeasurable.

All we have are are industry sponsored studies proclaiming the glory of their own product. And that is all we have. Nothing more.

There is no way to prove statins saved or extended anyone's life, even in a group setting.

To prove a statin saved someones life, you must prove they would have otherwise died had they not been taking the statin. Tell me Matthew, how are you going to do that?

More disturbing is the claim that "statins have saved millions of lives" based upon the decline in heart disease related deaths since statins came onto the market. Statin proponents credit the decline to the drug. BUT they fail to disclose that heart disease was in decline for two decades before statins came around. This is called a half truth, or lying by omission.

Until someone can provide solid evidence statins prevent heart attacks and save lives, there is no proof statins provide a benefit.

Its slick gimmick marketing.

Dr. Matthew Mintz said...

Since there is only one who is omnipotent, there is not way to know if a patient would have died with or without a statin. By that logic, one can not prove anything.
The gold standard in science for proof is the randomized controlled trial. Multiple randomized controlled trials, some sponsored by industry and some not, show that statins prevent heart attacks, strokes and save lives.
If you do not accept scientific the scientific method then we can not have an intelligent discussion.

Anonymous said...

I fully accept a legitimate scientific method. What I don't accept is marketing hype.

Dr. Matthew Mintz said...

Your initial comment was
"Dr. Mintz, I hate to burst your bubble but it simply not possible to prove taking a statin averted a would-be heart attack."
I am stating that the scientific method uses randomized controlled trials that prove statins prevent heart attacks. Thus, if you "fully accept a legitimate scientific method," you will accept the fact that statins do prevent heart attacks, retract your original statement, and consider an apology for your request for me to surrender my license. Now, if you want to make the arguement that statins are over-hyped and heavily marketed to patients by the companies that make them, that is at least a legitmate arguement to make. However, if you accept science you will accpt the fact that they do work and benefit some patients and are not simply "snake oil."

Anonymous said...

I'm standing my ground, agreeing with the drug company's original disclaimer:

"Has not been shown to prevent heart attacks, strokes, or heart disease."

They got that right.

Dr. Matthew Mintz said...

Please send a link to where the manufacturer states:
"Has not been shown to prevent heart attacks, strokes, or heart disease."
Google has zero hits for that direct quote.

Anonymous said...

For many many years, drug companies had the disclaimer on their brand statin drug websites, "Has not been shown to prevent heart disease, heart attacks or strokes."

About 2 or 3 years ago the disclaimers came down. But they were present the majority of the time.

Anonymous said...

...and I remember the disclaimer on TV commercials, but ya have to be quick or you will miss the words at the bottom of the screen.

Dr. Matthew Mintz said...

That's because now we have sufficient evidence to prove this claim is true.
Ironically, this is evidence against your argument that statins have been falsely marketed by the drug companies. In fact,despite initial evidence that statins worked, companies used a disclaimer (likely required by the FDA) that statins had not been proven to prevent heart attacks. Now that there is evidence that they do prevent heart attacks, that disclaimer has come down.

Anonymous said...

I don't know if your website accepts links to video, but I'll give it a try anyway.

This is a Crestor TV commercial. It displays the disclaimer "Has not been shown to prevent heart disease or heart attacks".

http://www.youtube.com/watch?v=IcfcdhRxLdc

Anonymous said...

Well, you asked me to post a link where the manufacturer states "Has not been shown to prevent heart disease or heart attacks". and I posted a link for you.

Dr. Matthew Mintz said...

This is an older commercial for Crestor, which is why they have a disclaimer. Now that Crestor, the newest statin, has evidence that it prevents heart attacks (in Crestor's case in relatively low risk patients without high cholesterol), there is no disclaimer. If you go to Crestor.com you will not find that language.
I am not sure what you motive is for being so passionately anti-statin. Maybe you are concerned about the high cost of health care and the role that expensive drugs play? Maybe you or a loved one experienced side effects from a statin? If you are of the opinion that statins are overly marketed leading to their overuse, then state this opinion and support it with evidence. If you are of the opinion that the risks of statins don't outweigh their benefits, then state this opinion and support it with evidence. While I don't share this opinion, there are arguments that can be made and we can have a rationale debate. However, you can not say that statins don't prevent heart attacks because that is simply not the case. There is scientific proof that statins prevent heart attacks. It would be equivalent of stating the earth is flat.

Anonymous said...

I will make my motive clear.

I am disgusted by the damage these drugs have inflicted on innocent people. Statins have hurt more people than the recent bombings in Boston. More people than 9-11. Statins may not have the drama of those events, but people get injured just the same.

Statins will eventually collapse under their own fraud. But until that happens, countless others will suffer the consequences of taking them.

Dr. Matthew Mintz said...

At least this is a position we can debate. I am guessing that you or a loved one(s) has experienced adverse events from statins. For that, I am sorry and hope you are healing well.
Everything in medicine is a risk benefit analysis. There is no drug that works perfectly in every patient and has no side effects. Tylenol can be a very dangerous drug, even if used as currently instructed.
As a physician, I must weigh the risks and benefits of each medication I recommend. For statins, there is overwhelming evidence that in high risk patients (diabetes, multiple risk factors for heart disease) that these drugs reduce the risk of heart attack and stroke by at least 30%. Thus, if your risk for heart attack and stroke is 20%, taking a statin would cut this risk to about 14%. The most common side effects from statins are muscle aches. These occur at about 3%, are usually mild and usually go away. More serious side effects range from about 0.01% to 0.0001%. Thus, if it's a choice of decreasing your heart attack risk by about 6% vs. serious side effects of 0.01%, the risk benefit ration usually works out in a statin's favor. However, in patients with lower risk for heart attacks or those more susceptible to side effects (elderly, for example) the risk benefit ration may not work out as well.
Overall, in the right patients, I believe these drugs are quite effective and do much more good than harm. Unfortunately, some are harmed. Hopefully, in the future, we will have better ways of predicting who will benefit and who will not or worse, be harmed.

Anonymous said...

You are certainly entitled to your opinion. I myself do not believe inducing a deficiency of the mevalonate pathway does anything to prevent heart disease or heart attacks.

Dr. Matthew Mintz said...

Again, my opinion is that the benefits of the statins usually outweigh the risks. However, it is fact that statins prevent heart attacks.

Anonymous said...

There is no way to prove that Matthew.

Dr. Matthew Mintz said...

The scientific community believes that the gold standard of proof is the randomized controlled trial. Multiple randomized controlled trials show statins prevent heart attacks. Therefore, there is scientific proof that statins reduce heart attacks. If you choose to not accept science, that is your prerogative. The value or risk of statins can be argued, but statins preventing heart attacks is a scientific fact.

Anonymous said...

The controlled trials simply show a difference between the two groups, but do NOT prove statins prevent heart attacks.

To state statins prevent heart attacks is an assumption.

I can further explain my position with an imaginary trial. I will call this trial the ASSUME trial.

We have 20,000 participants. 10,000 in each group. This trial will run for a total of 5 years.

But here is the twist. I am going to give both groups a placebo.

At the end of five years the odds of both groups experiencing identical event rates is one in a zillion. By pure chance alone, one group will experience fewer events.
Guaranteed!

In the end either placebo A or placebo B will win. If the placebo B group experienced fewer events, is it fair to say placebo B prevents heart attacks?

Of course not. it would be ludicrous. All we have shown is a difference in event rates between the two groups, but we have not proven placebo B prevents heart attacks.

True medical science is not based upon assumptions. Now you know why I called it the ASSUME trial. Hopefully I don't need to remind everyone what the letters in the word ASSUME is an acronym for.

Have a good day.

Dr. Matthew Mintz said...

Yes, but that's were statistics come into play. Studies must be designed to be large enough to show statistically significant differences for even small events. In your ASSUME study, even if there was a difference between A and B, it would not be considered statistically signifcantly different and therefore not proof. Randomized trials that show a statistically significant difference and have appropriate power constitute scientific proof.
Since you obviously don't believe or trust me, I emplore you to talk to any scientist or doctor you know to discuss how randomized clinical controlled trials are proof of efficacy.

Anonymous said...

"In your ASSUME study, even if there was a difference between A and B, it would not be considered significantly different and therefore not proof."

You just assumed any difference would not be statistically significant, but you don't know that Matthew. The ASSUME study could show a 40% Relative Risk Reduction in heart attacks for placebo B. Its mathematically possible.

Dr. Matthew Mintz said...

"You just assumed any difference would not be statistically significant, but you don't know that Matthew."
Not true, anonymous.
You stated both groups would experience identical event rates of one in a zillion, and by pure chance alone, one group would experience fewer events. If this is the case, then these results would not be considered statistically significant and thus not proof, even if the relative risk was 100%. By definition, statistically significant means "did not occur by chance."

Anonymous said...

"you stated both groups would experience identical event rates of one in a zillion"

No sir. Go back and re- read my posting. I said the ODDS of both groups experiencing the same event rate is one in a zillion.

Matthew there will be a difference. it could be small, or it could be large.

All I need is 3 heart attacks in placebo A group, and 2 heart attacks in placebo B group, and I can now say placebo B has a 33% reduction in heart attacks.

Dr. Matthew Mintz said...

If there are 3 heart attacks in one group and 2 in the other group, those results would not be statistically significant in a population of 20,000. In cases where results are not statistically significant, neither absolute or relative risk matters.
Again, if you want to argue that the absolute risk of statins preventing heart attacks is small and given their side effects, use in many patients taking is not warranted, that would be an opinion that you could have (though I don't agree with it) that could be backed up by evidence. However, the fact remains that statins have shown a statistically significant and clinically significant (not 2 patients vs 3 patients) reduction in heart attacks.

Anonymous said...

Its mathatically possible the ASSUME study could also come up with 300 heart attacks in Placebo group A, and 200 Heart attacks in placebo group B. Should we then say Placebo B reduces heart attacks by 1/3?

What scientific proof do we have placebo B was responsible for the 33% reduction in heart attacks?

In science we can prove penicillin eradicates infection.

We can prove dropping a mento into diet coke causes a violent reaction.

But nobody on planet earth knows who is destined to have a heart attack, and who isn't. Therefore its impossible to prove taking a pill, any pill, prevented a heart attack.

Dr. Matthew Mintz said...

If the Assume trial is powered to show a clinically significan difference (i.e. 15% reduction) between placebo A and B, and there are 300 heart attacks in A and 200 heart attacks in B, the study was a randomized, controlled trial and the results are statistically significantly different (can not have occured by change), then yes we can say that placebo B reduced heart attacks.
You simply refuse to accept the scientific method and the randomized controlled trial.
I can not argue this point any more. You either accept the ramdomized controlled trial as scientific proof or you do not. Regardless of what you choose to beleive, RCT's establish proof according to science. You can accept the earth is round, that dinosaurs roamed the earth, or that RCT's establish proof. Or you can choose not to. Regardless of what you choose to believe, these are all facts.
If you wish to discuss the risks and benefits of statins, I am happy to entertain this conversation. However, continuing this discussion is pointless because you continue to discount facts.
Your intial response to this post was incredibly rude which you dared me to post. At the end of the day, you believe statins are evil and fail to accept scientific proof that they in fact that they prevent heart attacks. If the basis of your request for me to surrender my lisence is that I believe that a randomized control trial proves that statins reduce heart attacks, then you should ask all doctors to do the same thing and stop seeing patient because they all believe the same thing.

Anonymous said...

What you perceive as "rude" is my firm stance against harming Americans with a gimmick drug.

You have been bought matthew.

Dr. Matthew Mintz said...

You can state your opinion firmly without calling me unprofessional or asking me to voluntarily give up my license to practice medicine.
There is scientific proof that statins prevent heart attacks. If it is your position that the harms of statins (you claim they have done more harm then 9/11), substantially outweigh any benefits, then support your position with evidence. Calling me names and not accepting science is not likely to get anyone else reading this dialogue to take your side.

Anonymous said...

By the way, whats this "calling me names" claim? I have referred to as Matthew because that's the name you gave.

Dr. Matthew Mintz said...

While my name is indeed Matthew, your use of could be perceived as having a condescending tone.
"Calling me names" refers to your initial post"
"We need a professional mind for a doctor, not a "Hank Kimbal" mindset from the TV show Green Acres."

"I think you should voluntarily give up your license to practice medicine."

You are basically saying that I am a horrible physician (though we have never met and I have never treated you) because I use statins to treat patients.

Anonymous said...

Your Blog reminded me of Hank Kimbal because I thought it was mindless.

Red flags appear all over your blog starting with the title. Every physician knows prescription drugs carry risks. Your minimizing risks, or in some cases flat out denying the risks, I find to be outright irresponsible.

Strange statements such as your response to me about "all doctors believe the same thing" No they don't! Medical opinions vary considerably, and while the vast majority of physicians do believe in statins. Not all of them do.

I think the underlying problem is those payments to you from statin makers bought your loyalty for life.

Dr. Matthew Mintz said...

We are simply not going to agree here.
You are certainly entitled to discredit my opinion based on work I have done with the pharmaceutical industry. I haven't received any payments from a statin company in several years, but that doesn't necessarily prevent me from any bias.
I started this blog many years ago for several reasons. One of them had to do with the increased reporting of medical information in the media and the sensationalism that surrounded it. The media tend to go with headlines that may sell adverstising, but often unnecessary scare patients in the process. You many question the title of the post, but purpose of the post was for patients who had been prescribed a statin by their physician not to be scared. You probably disagree with this position, but again, you are entitled to your opinion. My assumption was that patients on statins discussed the risk and benefit profiles of these medications and agreed to start treatment. There were many scary headlines about the FDA making changes to statins labels, but the bottom line was that nothing was really new here. The one thing that was new was that the FDA finally said that statins really don't cause liver problems. However, you wouldn't know that from the headlines.
Please re-read the original post.
Please look at the data I have cited.
Statins are powerful drugs, and do prevent heart attacks. However, as I have said before, there is no drug that works perfectly and has no side effects. In general, in the right patient population, the benefits of statins outweight their risks. This post was responding to a lot of negative media attention that was unwarranted because nothing the FDA found changes that equation (if anything, benefits statins).
If you have been harmed by statins, I am sorry for this. However, we simply don't have perfect medications. As a physician, my job is to recommend the most appropriate treatments to patients where the benefits of these treatments greatly outweight the risks. There is no way to completely eliminate risks.

Anonymous said...

"There is no way to completely eliminate the risks"

Actually there is one way to eliminate the risks. Don't take statins. If a person elects to never take a statin, the risk of being harmed by them falls to 0%.

Dr. Matthew Mintz said...

Yes, but if a person elects not to take a statin, they get none of the benefits. You have yet to concede the fact that there evidence (quite a bit in fact) that shows that statins prevent heart attacks and strokes. The degree to which that benefit exists relates to how high your risk is, with the higher the risk yielding the greatest benefits.
For example, if one has diabetes they have at least a 1/5 chance of having a heart attack or stroke in the next 10 years, which is reduced by at least 30% with statins. They have about a 3% chance of getting a minor side effect (mild muscle pain that usually goes away) and a 0.01 to 0.0001% chance of getting a very serious, life threating side effect. Given the high risk of disease, large beneft of statins in reducing that risk and low risk of serious complications, for this particular population, statins are beneficial. This is why virtually every medical group recommends statins for diabetics.
Yes, you can completely eliminate risk of statin side effects by not taking them. However, you are not considering the risks of not taking the statins, which is increased risk for heart attacks and strokes.

Anonymous said...

In sales, perception is everything.

Anonymous said...

Matthew, I am going to jump over to the other side of the fence, and play the role of Big Pharma. However there is a twist. I'm going to be painfully honest with you. I'm going to tell you exactly what I am doing and why.

BIG PHARMA: Just between you and me Matthew, the real risk of not taking statins is my profits will drop, and I can't have that. I have enough troubles right now with patents expiring and generics eating into my market share.

I am extremely dependent upon public perception that not buying my product puts them at greater risk for heart attack and stroke. I have spent billions of dollars on this. I need this fear factor to sell my product.

I don't care if statins really prevent heart attacks or not in the real world. As long as I can convince physicians worldwide and give the general public the perception these drugs work.

But I need you Matthew. My product is available only by prescription. You are my front line sales. I will do whatever it takes to get you on board with me.

Remember all those studies I showed you to win you over? All those studies from the 80's, 90's and early 2000's? We did that. Back then I only showed you what I wanted you to see. I withheld the data that didn't support the use of my product.

So I showed you the studies which demonstrated an association of using my product with lower risk for heart attacks and strokes.

Remember in medical school when you learned that association doesn't prove cause? I want you to forget that Matthew. I want you to look at the association I present, then I want you and the public to assume the results that statins prevent heart attacks.

Ever watch a talented magician? An Illusionist like David Copperfield? They are very good at what they do, and they do it by only showing you what they want you to see.

That is how my statin business works Matthew. I only show you what I want you to see, and allow you to assume the rest.

In sales, perception is everything.

Dr. Matthew Mintz said...

Your position that big evil Pharma is trying to pull the wool over physicians eyes and put profits over patients is certainly a reasonable one to take. In fact, there are a few examples where this is somewhat true. Statins are not the case. To flaws in your argument.
1. You are correct that association is not the same thing a causation. The way to prove causation (a method that is accepted by scientist worldwide) is the randomized controlled trial. Multiple, large, well done RCT's have proven that statins reduce heart attacks and strokes. This is a fact that you seem unwilling to accept. We can disagree on the risk/benefit ration, but there is no arguing that statins prevent heart attacks and strokes. This is scientific fact.
2. Not all of the studies come from Pharma. The reality is that most drug studies come from the drug companies that make the drugs. While this is truly a problem, it is also a double edged sword, because if you want more independent studies, someone's going to have to pay for them, and that usually means the goverment, which means higher taxes. While I would certainly welcome more independent studies, and even be willing to pay a bit more in taxes for them, I doubt most Americans would agree to this, especially when Pharma is footing the bill. That said, one of the major clinical trials proving statins prevent heart attacks and strokes was funded not by a drug company but by the NIH. http://www.nhlbi.nih.gov/health/allhat/
In fact the recommendations to use statins also come not from the drug companies, but from the government. The cholesterol guidelines (link below) are from the NIH.
http://www.nhlbi.nih.gov/guidelines/cholesterol/atp3upd04.pdf

Anonymous said...

BIG PHARMA: We were elated back during the Reagan Administration when it became legal for us to conduct our own studies of our own products. It was like we inherited the world!

Yeah, some studies are still conducted by the gov't. But we make huge political donations so hopefully lawmakers will be on our side.

I must admit, the new trial laws passed in 2007 make it harder to hide unfavorable data. Its not like the good old days when we could just report what we wanted.

As a result there have been a recent string of failures in Cholesterol medicine studies.

But we are thankful to you Matthew for your loyalty and writing this blog about not stopping statins. Looks like our little financial arrangement is still working. This blog is exactly what we want. Keep up the good work.

By the way. Enjoy the following video of some professional illusionists. They only show the audience what they want them to see, and hide behind a curtain momentarily what they don't want them to see. Just my style and why I love this!

http://www.youtube.com/watch?v=f0qC88bvb3o

Dr. Matthew Mintz said...

"As a result there have been a recent string of failures in Cholesterol medicine studies"
Please provide references.

You can be as tongue and cheek as you want, but the data (whether provided by the government or the drug companies)is the data. And it is pretty robust. As a physician, I am obligated to treat my patients based on the best evidence that is available.
When you can provide me solid evidence that the risks of statins outweigh the benefits of statins, then I will reconsider my position.
The video is cute, but you fail to provide evidence of an illusion. They way to prove the magician is not really "magical" is by showing a camera angle from behind the curtain to reveal how he does his trick. Please provide the evidence and prove that all the studies published in thousands of patients (in both US and worldwide) is all a hoax perpretrated by the drug companies and the government folks on their payroll.
All you have done is call things into question by inuendo, but you have yet to provide any evidence to the contrary.

Anonymous said...

BIG PHARMA: Its been a rough few years in clinical trials for cholesterol drugs. This is why we need folks like you Matthew to downplay the risks, and magnify the benefits. Good job.

We depend on a villain image of cholesterol and the lower the better mentality. Target based treatments = target based income, so when the ENHANCE trial failed it was a minor setback in the LDL theory. But the vast majority of our market didn't even take note.

The AIM-HIGH trial was another failure. The improved lipid panels didn't result in better outcomes. Kinda put a blemish on the HDL lipid hypothesis.

Then the HPS2-THRIVE study was as big a failure, producing higher risk for improved lipid panels, again hurting the HDL lipid hypothesis.

Meanwhile the new HDL raising drugs bit the dust.

You know Matthew how important it is to us for the public to associate cholesterol levels with risk for heart attacks. Without that public perception, we wouldn't have a market.






Anonymous said...

I wouldn't use the word "hoax" to describe it. I would say "Business opportunity appealing to the market's desire to lower cholesterol"

I simply do not accept blocking the mevalonate pathway and all its downstream products prevents heart disease or heart attacks, because it doesn't make physiological sense.

Inducing a deficiency of this critical metabolic pathway can only lead to the problems we see coming out of all this.

Dr. Matthew Mintz said...

There is no question that there is a business opportunity. Lipitor was the number one selling drug for several years before going generic. Statins have made the drug companies billions of dollars. If you want to argue that profit motivations have led to over-prescription of statins in populations where the risk benefit ratio is not in a patient's favor, this is a legitimate conversation to have.
You can even question the mechanism. Some have suggested LDL lowering is merely a marker of statin effect and doesn't do much physiologically.
However, you simply not accepting that statins don't prevent heart attacks does not change the truth. Statins prevent heart attacks, regardless of how they work.
You have plenty of arguable points and your arguments would carry much more weight if:
1. You backed them up by some evidence (which you have yet to do).
2. You accepted the scientific truth (based on numerous, large, randomized controlled trials), that statins decrease risk of heart attack and stroke, at least in patients with some level of risk for heart attack and stroke.

Dr. Matthew Mintz said...

AIM-HIGH, ENHANCE and THRIVE were all failures, but they did not look at statins. Niacin (a "safe" drug not really promoted by the drug companies by the way) is a big bust. Never believed in it, never really used it.
ENHANCE is a PERFECT example of what you are talking about. Merck convinced a lot of docs (not be by the way- ask any Merck drug rep in my area) that getting the LDL down with their drug would show the same benefit without some of the risks. Turns out that 1) risks were about the same and 2) no real proof they did anything.
However, statins are different. Whether the prevent heart attacks and strokes by lowering the LDL or by some mechanism we don't even understand, there is clear and consistent proof that statins prevent heart attacks and strokes.
I am aware of only one trial of a statin that wasn't positive (The A to Z trial) and it tried to show that statins immediately after a heart attack (ACS to be exact) were better at preventing a second heart attack, than starting statins a month later. Not exactly the same thing as failing to prevent heart attacks. However there are many, many large randomized trials US/non-US, pharma sponsored/non-pharma sponsored to show that statins prevent heart attacks and strokes.

Anonymous said...

While some subscribe to statins as providing a small benefit to at risk patients based on those trials, I view those trials as nothing more than marketing triumph over medical science.

All I have to do is turn on the TV, open a magazine, or be on the internet and the DTC prescription drug marketing is enough to make me sick.

Its this Market Medicine environment that has led us into this mess. Remember when medicine was medicine, and not commercial marketing antics?

We don't even know the underlying mechanism behind atherosclerosis, yet they have a pill to sell us for it. Whats wrong with that picture?

The statins are wildly profitable. But what if we take the profits out of the equation? Now how anxious are they to put people on statins?

After all if statins save lives, we should put people on them even if there is a financial loss.

In the real world, if there were no money to be made, NOBODY and I mean nobody would be pushing these drugs.







Anonymous said...

Again, its impossible to prove a heart attack would have otherwise occurred, had the individual not been taking a statin.

All we can show is a difference between the two groups, thereby showing an association of fewer heart attacks in the statin group.

This does not prove the statin prevented a heart attack.

If association proved cause, then we could say living near Pine trees causes heart disease, and be right 90% of the time.

Dr. Matthew Mintz said...

"All we can show is a difference between the two groups, thereby showing an association of fewer heart attacks in the statin group."
No, you are simply incorrect.
Please research causation or causality. Causation is established by many factors, but the key factor is changing the cause changes the effect. This is the difference between association (high cholesterol is associated with increased heart attacks) and causality (statins prevent heart attack). A randomized controlled trial is an experiment designed to prove causation.
"Remember when medicine was medicine, and not commercial marketing antics?"
Medicine was never made by the government and provided to people for free. Drug companies made medications. Currently, 85% of all medications prescribed are generics. However, they were all once branded medications. I hope you never get sick, but if you do and need a medicine, it was made availble to you because some drug company was able to discover it, prove it was safe and effective and get it to patients. If drug companies didn't make a profit, then we wouldn't have any drugs. Now, you can argue that drug companies are too profitable, especially given that drug costs are so high. You can also argue that prescription medications are over-marketed (i.e. TV ads) to patients. However, a non-profit drug company making useful medications is simply fantasy. The key is to balance the profit that the drug industry make so that it is profitable to continue to make innovative medications and cost that people have to pay for medications so that they can afford the medicines the drug companies make.
Finally, until you accept that randomized controlled trials are proof of causality (as any scientist will tell you) there is nothing more to discuss.

Anonymous said...

The trials work great when proving a medication can eradicate a disease. Its a great tool for that purpose.

But when we apply that tool to heart attacks, all we can show is a difference in events between the two groups. There is no proof the intervention prevented a heart attack in any one of the participants.

I can't be any more clear than that.

Good bye.


Dr. Matthew Mintz said...

Modern science accepts that a randomized controlled trial proves causation, i.e. if people are randomized to statin vs. placebo, and (assuming the trial was designed and conducted correctly) there was a statistically significant decrease in heart attacks in patients that took statins vs. patients taking placebo, that this indeed proves that statins reduce heart attacks. I am not out on a limb here. This is an accepted fact whether you believe it or not.
I can't be any more clear than that.

Good bye.

Anonymous said...

Dr. Mintz-

You are a tool for the pharmaceutical industry, and nothing more. My father has suffered severe memory loss since he began taking statins about ten years ago. As soon as I insisted that he stop taking them, well- lo and behold- the fog started to lift for him. But, too late-- my mother has had a nervous breakdown, cracking under the stress of caring for him. Your miracle drug has decimated our family.

I hope you sleep well.

Anonymous said...

As soon as I took my mother off of her lipitor she stopped her mental decline (diagnosis Alzheimer's) and actually showed measurable improvement in her mental capabilities.

Anonymous said...

Your bio says "I am board certified in internal medicine .. I am also an Associate Professor of Medicine at an academic medical center on the East Coast. My time is split between teaching medical students and residents, and caring for my patients."

For such a busy and important guy, you weirdly spend a lot of time on this blog defending statin drugs. I can't imagine even my lowly GP having time to engage in debate so much. Hmmmm...what's in it for you?

Dr. Matthew Mintz said...

"Hmmmm...what's in it for you?"
Nothing of monetary gain (if that's what you are implying)
Statins are some of the most well studied medications in any class that, in addition, have proven benefit in preventing heart attack and stroke. There is not question that decrease deaths from heart attacks and strokes is in part due to statins. In other words, statins save lives, and as a PCP that what I want to do: find preventative ways to save my patients lives.
The problem is that many patients who are excellent candidates from statins (benefit is great and risk is minimal) won't take them because they are affraid. They are affraid of what they read on the internet. They are affraid because the media makes the drugs companies look like they are out to profit while making patients sicker and not better. They are affraid because lawyers place ads on TV about bad drugs like Avandia (which, looks like is actuall safe after all).
There is simply no perfect medicine. Every medicine has benefits and risk. The job for the physician and the patient is to figure out whehter the benefits are worth the risks. However, all the misinformation that is out there makes this an incredibly difficult job for patients and physicians. That is why I started this blog in the first place. My goal is to interpret some of the confusing information that is out there in the media.
Go back and read the original post. It was in response to media headline regarding an FDA announcement. The headlines were pretty scary, but the actual information was not that bad at all, and much of the information was already known. Yet, if people just read the headlines, the take away message is that statins are dangerous.
If one patient who is an excellent candidate for a statin but affraid to take them, then reads my blog and changes their mind, that's all the reward I need.

Jim said...

Dr. Mintz, you seem like an honest man. Can you possibly post some links to statin trials? So far I have been able to find the following, and have noted either positive, negative, or neutral after the study. Positive means statins showed more benefits than harm, neutral = neutral, negative shows more harm than benefit.:

http://www.ncbi.nlm.nih.gov/pubmed/23440795 (Positive)

http://www.mdanderson.org/newsroom/news-releases/2012/ut-md-anderson-study-finds-link-between-statins-and-improved-survival-in-inflammatory-breast-cancer.html
(Positive)

http://www.cancer.org/cancer/news/statin-use-linked-to-reduced-cancer-deaths
(positive)

http://www.forbes.com/sites/matthewherper/2012/03/04/top-cardiologist-argues-we-should-dial-back-on-statins-because-of-diabetes-risk/ (neutral-says statins are good but cut back on them due to diabetes risk)

http://archneur.jamanetwork.com/article.aspx?articleid=1107907 (positive may prevent alzheimer's)

http://my.clevelandclinic.org/heart/prevention/jupiter_trial_summary.aspx (positive)

I didn't include links that say "studies show statins worthless" because they don't show the studies. When I encounter such sites, I want to load my printer up with toilet paper and print out the site.

Dr. Matthew Mintz said...

@ Jima
Thanks for the post.
First, the best way to look at the data is not to look at a bunch of trials but to look for a scientific review of the data. I will post two links that may help.
The first is the articple that is a 2004 update to the cholesterol guidelines (called ATP3) from the NIH. APT4 promises to be out sometime soon, so this stands are the most current recommendations.
http://www.nhlbi.nih.gov/guidelines/cholesterol/atp3upd04.pdf
The second link is from the Cochrane collaborative. Rather than just a summar (like the previous link) they look at all the trials together in a systematic way. The link below is their review of primary prevention, i.e. given statins to people at risk for heart attack and stroke, but who haven't had one yet. http://onlinelibrary.wiley.com/doi/10.1002/14651858.CD004816.pub5/full
After reviewing these two documents, you will see why my stance is that despite some very real side effects, in general, for patients at risk for heart attack and stroke, the risk/benefit ratio for statins very much favors patients using them.
Finally, of all the links you posted, there was only one that you cited as "negative" and this was not a study per se, but the opinion of Dr. Topol on some of the data. Essentially, we know that high dose statins like Lipitor and Crestor increase sugar. For patients who already have high sugar (pre-diabetes), sometime starting them on a statin will "bump" there sugar to the diabetes range. One can argue whether or not this is causing diabetes or just having patients meet the criteria for diagnosis a bit earlier. According to Topol's statement, the Crestor study cause 1 case of diabetes for every 200 patients treated, but only prevented 2 hearts attacks for every 200 patients treated. What he doesn't say in that statement was that the majority of patients in that particular study had a pre-diabetic condition and that compared to people who didn't take a statin, rates of hearts attacks were reduced by about 50%. Furthermore, we know that people who have pre-diabetes have a 4 to 6 fold risk of heart attack or stroke, and very likely benefit more from being on the statin (even if it increases their sugar) to not being on the statin.

Anonymous said...

Dr. Mintz as I read through your postings I notice a pattern that repeats itself. You minimize statin side effects and exaggerate the benefits. This is NOT in the best interests of patients.

Dr. Matthew Mintz said...

I disagree. The health benefits of statins are substantial in certain patient populations. Reducing heart attack and stroke by 30%-50% is substantial. This is not an exaggeration but a summary of tremendous amounts of data. Statins are not without side effects. They are not appropriate for every patient. However, even their most common side effect (muscle pain) only occurs in about 3-5% of patients who take it, is usually mild, and usually goes away. The more serious side effects of statins occur in 1/10,000 to 1/10,000,000 patients. So, if you knew, for example, that your risk for having a heart attack and stroke in the next ten years was 15%, and taking a stating would reduce that risk to under 10% but their was a 0.01% chance you might get a serious side effect, it would seem clear that taking a statin would be in your best interest. Unfortunately, the media, ambulance chasing lawyers and folks on the internet seem to over emphasize the side effects of statins. This is what I believe is not in the best interest of patients.

Anonymous said...

You just did it again. You minimized the risks, and inflated the benefits.

Dr. Matthew Mintz said...

Per Webster's
Minimize

1: to reduce or keep to a minimum
2: to underestimate intentionally : play down, soft-pedal
3: to replace (a window) on a computer display with a small button or icon which will restore the window when selected

I am not underestimating intentionally. I am telling you actual hard data that have been replicated in clinical trials.
If there is a 90% chance of rain, and I say, "oh, don't worry, it's not going to rain" or "it's only going to be a little sprinkle" then I am minimizing the risk of rain.
By stating that the risk of serious side effects is 1/10,000 to 1/1,000,000 I am not minimizing the risk but pointing out that the chance of getting a serious side effect from a statin is minimal.

Similarly, I am not inflating the benefits. It is scientific fact that when statins are taken by patients at risk for heart attack or stroke, that risk is decreased by 30-50% depending on the risk of the patient (greater the risk, the greater the benefit).
Now, it may be your opinion that even though the risk of serious side effects is 1/10,000 to 1/1,000,000 and the reducition in heart attack and stroke is 30-50%, you still wouldn't take/recommend taking statins. You certainly have a right to that opinion.
However, as a physician who sees patients needlessly die of heart attacks (like actor James Gandolfini), I recommend statins for patients at risk for cardiovascular disease.

Anonymous said...

Seeing patients die of cardiovascular disease does not mean they would have been saved had they been taking a statin.

Dr. Matthew Mintz said...

Just me seeing patients die of cardiovascular disease does not mean it would have been prevented by a statin. However, that's what we have randomized trials for. In a trial, you have two groups, in this case one with a statin and one group without a statin. Thus,you can scientifically determine whether taking a statin would have prevented death. Randomizing patients allows you to determine it was that statin, nothing else that prevented the death.

Anonymous said...

100% Hogwash.

Anonymous said...

You state that memory loss is not true, then you say later that evidence supports it but it returns when you stop taking the drug and odds are like hitting the lottery. I must tell you, I am a relatively healthy 46 year old man, I am a bit heavy and my GP recommended I see a cardiologist because of my family history. I have never had excessively high cholesterol and yet after a routine check and having running many tests I was indeed found healthy but heavy. I was prescribed a statin as "a precautionary measure, because heart patients are routinely lowered into the 70's" as my doctor put it. I have never had issues, my cholesterol was fine and certainly had no heart issues thus far, I was simply fat. Now I have gone through tremendous joint pain, muscle weakness and indeed recognizable memory loss. All significant enough that my GP took me off them after doing some simple strength as well as recall tests in his office. I was on the drugs for two years and my symptoms were dismissed by my GP when I had concerns the first time. (By the way, I had not heard the Statin hysteria until after I was told to stop) After the second year I was visiting for my annual check and I brought up my conditions after some great hesitancy due to previously being dismissed. He was a bit short but decided to do some tests, I came back a few weeks later and tested again and was immediately taken off the drugs. With a sincere apology and a call to gge cardiologist. After taking the dugs for two years, it has taken almost another year to get to a point that my mind "feels" right again. Be very careful to quickly dismiss what you may not understand. I know that Statins are needed and surely save lives. Each case should be looked at much more individually, doctors are quick to prescribe in a standard fashion. And, please be willing to listen, because in your opinion it doesn't happen... does not mean it is not happening.

Dr. Matthew Mintz said...

@ anonymous 9/2
I am not advocating that statins are 100% safe and should be given to everyone. First, statins should be given to patients with known cardiovascular disease or very high risk. If you were not in either of the categories, you should not have been prescribed a statin. Second, statins do have side effects. However, the preponderance of the evidence is that for most patients, the benefits far outweigh the risks. Any patient can experience any side effect from any medication. While the vast majority of the evidence indicates that statins do not affect memory except for extremely rare instances of something called transient global amnesia, it is very possible that it affected you in this way.

Anonymous said...

I appreciate your response. We have found that the cardiologist was prescribing to most of his patience as precautionary and was getting significant "favor" with drug companies. He is currently "in review" which is basically means he will get a slap on the wrists and continue when focus is off of him according to research I have done in the last year. Many doctors are given "incentives by companies to show favor in prescribing their drugs, you are all but denying that there is financial gain for you and those in your profession. There is money in it for you sir, maybe you have not taken it from statin peddlers, but it is there. Not just for drugs, but medical device manufacturers are lining MD's pockets as well. I have learned one thing through all this and the courts. The oath you and others took to first do no harm seems to have a price with many of your colleagues. The problem is that most of those professionals do not get caught because the general public is not smart enough or aware enough to ask questions. The harm is never seen because much of the evidence is covered up... by 6 feet of dirt. My statin memory loss was also just one part. The muscle weakness caused bladder and urinary problems. My cardiologist also told me the benefit out weighed the side affects. No sir, you are defending a drug that I believe we have not seen the last word on yet. Many drugs have been common for years before their try detriment was fully revealed

Anonymous said...

Chasing cholesterol levels for better cardiovascular outcomes is like a dog chasing his tail.

Robin Willcourt said...

The problem about all the studies is this: once you follow the money, the funding ultimately comes back to the food and drug companies.

Governments, or independent organizations are NOT funding most studies. Look who sits on the food advisory and drug boards, or committees that decide public policy in these areas-- almost all of them have been paid by industry somewhere, or they are, blatantly, actually working for these companies.

From all the research done by such fantastic people as Zoe Harcombe and Dr Malcolm Kendrick, among others who have taken the (incredible) time to drill down deeply, you will find that there is pretty much NO independence.

As for the the studies, when all results are totalled up, they do NOT show any significant difference between the treated and placebo groups. The 1 to 3% positive differences of some studies are negated by results in other studies but the latter are clearly not quoted in a study proving a glowing outcome for statins. On top of that, all positive results are all stated as relative risk, hence the 36% reduction in CV events proclaimed by Pfizer about Lipitor is a massive exaggeration.

But even Pfizer had to put in small print in its ads, after loudly proclaiming a 36% reduction in cardiac eventsm, that the absolute reduction was only a paltry 1%. So much for facts!

Managing the production of perhaps the most important substance in the body by controlled poisoning is absolutely astonishing. I can't wait for the class action law suits to come. They'll be monumental. And one can only hope that those people who advocated their use get clobbered as well.

Meanwhile, watch out for the results from studies on intermittent fasting; it is turning out to be a rapid and effective way to manage lipids (even though they are not the primary problem) and a reduction in fructose and other CHOs is proving to be far more effective and infinitely safer than mycotoxic statins. Those studies are in evolution but surprise surprise, it looks as if going back to basics has Man responding to his genetic blueprint far more effectively than jamming a toxic substance into a vital metabolic pathway.

Of course we shall soon be clobbered with an amazing new class of cholesterol lowering drugs with far greater toxicity but with mind-boggling short term profits for the drug companies. And so it goes!

Dr. Matthew Mintz said...

@Robin Willcourt,
I agree that independent research would be much preferred to industry sponsored research. The reality is that this is simply not going to happen. The amount industry spends on pharmaceutical research trumps the entire NIH budget, which focuses mostly on bench science (causes of cancer) and not the effects of drugs on the market. In order to get the independent research you and I would prefer, we would probably need to quadruple the NIH budget. Unfortunately, funds to NIH have been cut due to the sequester. While I am hopeful they can be restored, I have no hope that they will be substantially increased. Thus, we need to rely on industry sponsored studies, with their potential biases, and trust that regulation by the FDA and other bodies will keep them honest.
That said, there are some unbiased studies that show the benefit of statins. In addition, while you correctly point out that relative risks are usually discussed, even small absolute risks are important.
The Heart Protection Study was a non-industry sponsored study that showed:
All-cause mortality was significantly reduced (1328 [12·9%] deaths among 10 269 allocated simvastatin versus 1507 [14·7%] among 10 267 allocated placebo; p=0·0003), due to a highly significant 18% (SE 5) proportional reduction in the coronary death rate (587 [5·7%] vs 707 [6·9%]; p=0·0005), a marginally significant reduction in other vascular deaths (194 [1·9%] vs 230 [2·2%]; p=0·07), and a non-significant reduction in non-vascular deaths (547 [5·3%] vs 570 [5·6%]; p=0·4). There were highly significant reductions of about one-quarter in the first event rate for nonfatal myocardial infarction or coronary death (898 [8·7%] vs 1212 [11·8%]; p<0·0001), for non-fatal or fatal stroke (444 [4·3%] vs 585 [5·7%]; p<0·0001), and for coronary or noncoronary revascularisation (939 [9·1%] vs 1205 [11·7%]; p<0·0001).
So, to your point, a 1.8% mortality benefit may not sound all that great, but it was a big deal for the 179 lives that were saved.

Anonymous said...

50 years ago we were having this same discussion concerning the safety of cigarettes.