Bad News For Statins

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I’ve been working on a software project for the past 13 hours, and I’m too fried to write much of a post.  But a reader brightened my evening by sending me a link to an article in the Los Angeles Times that’s bad news for statin-makers.  When the big newspapers start picking up on this stuff, the pharmaceutical companies have reason to worry.  Here are some quotes and comments:

At the zenith of their profitability, these medications raked in $26.2 billion a year for their manufacturers.  The introduction in recent years of cheaper generic versions may have begun to cut into sales revenues for the brand-name drugs that came first to the market, but better prices have only fueled the medications’ use: In 2009, U.S. patients filled 201.4 million prescriptions for statins, according to IMS Health, which tracks prescription drug trends. That’s nearly double the number of prescriptions written for statins in 2001, four years after they arrived on the American pharmaceutical landscape.

It’s nice to know people can permanently weaken their muscles now without spending too much.  I knew people were popping statins like they’re tic-tacs, but 201 million prescriptions?!  That’s disturbing.  Worse, the statin-makers want doctors to prescribe these poisons to kids. 

But in recent months the drugs’ touted medical reputation has come under tough scrutiny.

Better ten years too late than never.

Statins were initially approved by the Food and Drug Administration for the prevention of repeat heart attacks and strokes in patients with high cholesterol who had already had a heart attack. And used for that purpose – called “secondary prevention” – the drugs are powerful and effective medications, driving down patients’ risk of another heart attack or stroke by lowering their levels of LDL (or “bad”) cholesterol.

AAARRGGHH!!  No, for @#$% sake, lowering cholesterol is just a nasty little side effect.  To the extent that statins do any good, they do it by lowering inflammation.  You can lower inflammation by cutting the garbage out of your diet.

Then physicians came to believe statins could also reduce the risk of a first heart attack in people who have high LDL cholesterol but are nonetheless healthy. This use of statins – called “primary prevention” – has driven the growth in the market for statins over the last decade.

It’s amazing what you can believe when a hot little pharmaceutical rep in a tight skirt gives you a sales pitch.  When we’re giving drugs to people who are “nonetheless healthy,” something is very, very wrong.

Today, a majority of people who use statins are doing so for primary prevention of heart attacks and strokes. It is this use of statins that has come under recent attack.

“There’s a conspiracy of false hope,” says Harvard Medical School’s Dr. John Abramson, who has cowritten several critiques of statins’ rise, including one published in June in the Archives of Internal Medicine. “The public wants an easy way to prevent heart disease, doctors want to reduce their patients’ risk of heart disease and drug companies want to maximize the number of people taking their pills to boost their sales and profits.”

False hope?  But Dr. Abramson, those Lipitor commercials are so convincing.  Every time I see the one where the guy is pleading with his older brother to take statins, it brings a tear to my eye.  (If I ever told my older brother to take statins, it would be to weaken him to the point that I could finally beat him in arm-wrestling.  But I don’t want to win that badly.)

Heart patients and their physicians are not the only ones to pin their hopes on statins. The drug companies that brought statins to the market have explored the medications’ benefits in prevention or treatment of such conditions as Alzheimer’s disease, rheumatoid arthritis, prostate and breast cancer, kidney disease, macular degeneration and diabetic neuropathy. Although clear proof that statins could forestall or treat any of these diseases might bring in millions of new, paying customers, results have largely been mixed, inconclusive or disappointing.

Well, I am just stunned that beating down your liver’s ability to produce cholesterol hasn’t turned out to be a cure for damned near everything.  Perhaps we need to start removing livers completely.  Tonsils at age 5, then livers a year or so later.  We’ll lie to kids and tell them they can rub all the ice cream they want on their bellies afterwards.

In an ideal world, debate over the clinical virtues or vices of a drug would be long settled by the time the medication saw a meteoric rise in use. But in a healthcare system that relies on commercial incentives to spur drug development, prescription medications are a product like any other.

Yeah, that’s bound to be a problem with our current system of direct-to-consumer sales by pharmaceutical companies.  If only we could place some kind of responsible intermediary between them … perhaps someone in a white coat.

Sometimes, by the time the deliberate pace of medical research and debate suggests that a drug is not all it’s been cracked up to be, it’s already become a bestseller.

That’s why I refer to Dane Cook as the Lipitor of comedy.

And yet, the relationship between cholesterol-lowering and heart disease is not perfectly understood.

Well, there’s an explanation for that.  I’ll use an analogy to clarify:  You could spend dozens of years and millions of dollars trying to understand the relationship between me and Salma Hayek and not get anywhere.  The reason?  We don’t have a relationship … other than the one time we passed each other in a hallway at Disney.

In the first of three studies published in the Archives last month, medical researchers found that, contrary to widely held belief, statins do not drive down death rates among those who take them to prevent a first heart attack.

And yet they lower cholesterol rather dramatically.  Hey, I’m starting to wonder if high cholesterol causes heart disease at all …

A second article cast significant doubt on the influential findings of a 2006 study, called JUPITER, that has driven the expansion of statins’ use by healthy people with elevated blood levels of C-reactive protein, a measure of inflammation. A third article suggested potential ethical, clinical and financial conflicts of interest at work in the execution of the JUPITER study and concluded the widely hailed trial was “flawed” and raises “troubling questions concerning the role of commercial sponsors.”

I’ve read critiques of JUPITER written by skeptical doctors who crunched the data.  Bottom line is that it’s one of worst studies ever.  Here’s just one example:  At one point, the statin-takers showed slightly better results.  Later, the difference between statin-takers and placebo-takers began to shrink to nothing.  So the researchers conveniently chose to place the study’s “end point” at a time when there was still a difference.  Those are the numbers they reported.

As many as three-quarters of patients currently taking statins haven’t yet had a stroke or heart attack; they have diabetes or high LDL cholesterol, conditions widely thought to put them at high risk of having one.

Those patients largely joined the ranks of statin consumers after 2001, when the National Heart, Blood and Lung Institute adopted guidelines on the treatment of patients with high cholesterol. The guidelines, updated again in 2004, suggested that as many as 36 million Americans should take statins – essentially tripling overnight the potential American market for the drugs. Of the nine experts involved in drafting the cholesterol treatment guidelines, the National Institutes of Health later acknowledged that eight had substantial financial ties to statin makers – links that may have predisposed them to view evidence of statins’ benefit in its most positive light.

I think that last sentence pretty much says it all.

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30 thoughts on “Bad News For Statins

  1. TonyNZ

    I find the advertising on certain products amusing at times and saddening at others. When they have “LOWERS CHOLESTEROL” in big letters and “reabsorption” in weenie letters after. A thinking person can extrapolate what this is actually saying. I’m glad this may get a bit of publicity. Keep us posted on the fallout (if any).

    I’d love it if the fallout was a big drop in statin prescriptions.

    Reply
  2. Todd S.

    My father is type 1 diabetic and has been on statins now for many years. He also prefers to keep his sugar up around 200 as it’s just “easier to manage” that way. Of course, he follows ADA guidelines and gets plenty of whole grains and cooks in hearthealthy omega 6 oils. I can’t convince him that what he’s been told is just wrong. We have too many “experts” and not enough dissenting opinions in this country.

    Agreed, but at least those dissenting opinions are starting to show up in the mainstream press.

    Reply
  3. Marc

    Tom.
    you wrote;

    “The reason? We don’t have a relationship … other than the one time we passed each other in a hallway at Disney.”

    You see if I worked for big pharma or the media… I’d say
    You DO have a relationship with Selma…I mean you walked in the same hallway. didn’t you? 😉

    Sadly,this is EXACTLY how big (pharmaceutical) companies and the media justify most of their “evidence”.

    Wonderful post!

    Marc

    They keep looking for the relationship because they’re desperate for it to exist. It would be like if I spent 20 years stalking Salma Hayek and kept insisting, “But she WINKED at me! I swear!”

    Reply
  4. Marc

    Oh and quickly, did you see the opening of the new POPTART store in NYC?
    I did a quick write up on my blog, but would love to read a post by you on that one. 🙂

    Marc

    Poptart sushi?!! I’d rather eat the raw fish and take my chances.

    Reply
  5. Brooks

    Great to see mainstream media even raising the issue, though they still don’t really question the entire premise, i.e. the lipid hypothesis. After seeing Fat Head I decided to start reading Good Calories Bad Calories and it’s really the most upsetting book I’ve ever read. The way cholesterol has been vilified and chronic high blood sugar ignored is just about enough to make me believe it’s a conspiracy and not just cognitive dissonance. I want to break into my relatives’ houses in the middle of the night and replace their Lipitor with Tic Tacs.

    I was alternately fascinated and outraged while reading Good Calories, Bad Calories.

    Reply
  6. Rebecca

    What will doctors do with the new found information on statins?

    Nothing.

    My mother’s doc will continue to refill the Rx, driving home that her cholesterol needs to be “just a little lower” until my mother is too weak to walk into the office. At which point, the doc will say “the side effects are too great!” and switch her to another cholesterol lowering prescription.

    Round and round the mulberry bush…

    That’s what happened with my mom, until I managed to convince her cholesterol isn’t the issue.

    Reply
  7. 1956okie

    Thanks, Tom, for sharing articles like these. They give me at least a glimmer of hope.

    And I feel your pain, Rebecca. As my mom got weaker and weaker, nearly crippled from statin after statin, the doctor just kept saying, “But you HAVE to take these or you could have a stroke–OR WORSE!!” Of course, it scared the living daylights out of her! It’s taken years to get her to stand up to him and get off the stupid things. Even so, she still clings to her Weight Watchers ways (which have never worked), fills her fridge with fat-free mayo, dressing, cheese, skinless chicken,etc. I suppose you can’t expect to win ALL the battles, but every little bit helps!

    You won a major battle getting her off statins.

    Reply
  8. A different Marc

    The poster above stole my name so I will use this pseudonym.

    “That’s why I refer to Dane Cook as the Lipitor of comedy.”
    Freaking Hilarious! (not Dane Cook, your joke).

    I never got the Dane Cook thing. I tried to watch of his cable specials and turned it off. I thought maybe it was an age thing, but my 29-year-old son doesn’t think he’s funny either.

    Reply
  9. Nick

    Unfortunately statins are big business (as you mentioned in your post). On our site Drugs.com we track pharmaceutical sales and Lipitor has been #1 since we started tracking (2003).

    http://www.drugs.com/top200.html

    Crestor also features highly in sales. Just Lipitor and Crestor made up $7,671,331,000 worth of sales in 2009 alone. There are other statins but we don’t have complete data for them.

    I guess we’re in the wrong business.

    Reply
  10. The Dude

    I recently had a VAP test (after eating Paleo for 6 months) and my doctor said

    Doc: “All your LDL is pattern A, which is excellent! But your LDL is too high, so we need to lower it.”
    Me: “So I have too much excellent cholesterol? Why would I want less?”
    Doc: “Because it’s too high… have you thought about Statins?”
    Me: “Good-bye.”

    Is talking about statins part of the Hippocratic oath now? Like Kurt Harris argued – “Is it really plausible that our bodies evolved to simultaneously create two substances that are like some perverse yin and yang, with good HDL trying to save us from the LDL that is furiously trying to clog our arteries with cholesterol?”

    Geez, that’s awful. All patten A, and he’s suggesting statins. Sheesh.

    Reply
  11. Kate

    I’m 35. Dane Cook is not funny. I’ve seen a few movies in which he was supposed to be funny, but somehow never managed to be. He’s “funny” because he’s hot, not because of his acting or what comes out of his mouth.

    Rats. I should’ve been born hot.

    Reply
  12. Walter Norris

    “pattern A” – I think I get it, but could you elaborate?

    Pattern A is the large, fluffy LDL. It doesn’t penetrate the walls of the coronary arteries — it’s too big. If anything, type A LDL may have anti-inflammatory properties and help prevent infections.

    Type B is small and dense. It can penetrate the walls of arteries, where it may become oxidized and lead to plaque buildup.

    For years, the medical establishment has been worrying about high LDL without distinguishing between types. If you have high LDL but it’s all or nearly all type A, it’s not a concern and certainly no reason to take a statin.

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  13. Jo

    Good grief you don’t look old enough to have a 29 year old son!!

    I posted a while ago about my dad, who is back on the statins now. I hadn’t realised that when he watched your movie he took away from it that he can eat saturated fat and his cholesterol will go down. Now, I haven’t actually seen the movie, but I suspect that is not what you say. So now both he and his doctor are working hard to drive down his cholesterol to its previous level. His wife gets it, but he doesn’t.

    One thing occurred to me. Yes I am aware that there is no decent research showing that statins are effective, but I would imagine the sort of faith that both my dad and his doc have would be enough to have some beneficial effect on life expectancy even if his brain cells are being fried (he suffers really bad memory loss). That would be quite shocking if it were true, because even with faith they can’t get the data to show statins saves lives.

    Thank you, I’ll turn 52 in November, but I don’t feel it … except on some mornings when my knee likes to remind me about the ligaments I tore as a kid.

    I’m afraid your father misinterpreted. My cholesterol went down when I ate lots of saturated fat — but also virtually no sugar or starch. The really important change was a rise in HDL. The film also explains that it’s not the LDL number that matters; it’s whether your body is making small LDL or large LDL. Your father needs to get a VAP test or a particle-size test. If he’s making mostly large LDL, it’s worthless to beat it down with a statin.

    If you’re able to get ahold of the numbers, divide his triglycerides by his HDL. That ratio, more than any single cholesterol number, seems to be a reasonably accurate predictor of future heart disease. The ratio should be below 2.0.

    Reply
  14. Brendan

    Thanks for sharing this link. Great to see these kind of news appearing in major newspapers. After months of arguing and trying to convince my parents to get off statins, they had recently accepted that taking statins is not a very good preventif measure and stopped taking them.(That’s after sending them countless articles by Dr Eades, Barry Groves…..etc)

    It was very hard to convince them cause they put their whole trust on the bad advices from their higly “qualified” and “experienced” doctors and cardiologists. Like everyone else, they extolled to my parents the virtues of statins and a low fat diet, like it is the true way to salvation from heart diseases. Makes me angry thinking how many million people are fooled by these “qualified” and “experienced” doctors who know very little on diet and cholesterol. (on LDL type/pattern A for example)

    Keep up the good work!

    Glad you finally convinced them. Statins have to be the most over-prescribed drugs in all of medical history, and at the absolute best they might help 1 of 100 taking them.

    Reply
  15. Stanley Fishman

    I think doctors kill more people than disease does. I had a 40 year old friend who was given statins because his cholesterol was “a little too high.” After a few months, he started to lose his memory. When I told him it was the statins, he raised the issue with his doctor. The doctor took him off the statin he was taking, and put him on another statin. His memory continued to deteriorate. He got mad at me for questioning his doctor, and our friendship ended.

    A few years later, I ran into someone we both knew, who told me that my ex friend told her that I saved his life. Turns out the memory problems got so bad he could not work and decided to see a psychiatrist. Nothing helped. My friend finally remembered that I had urged him to check out Dr. Duane Gravelines website. The Psychiatrist looked at the site, and told my friend he had to get off statins. He did. End of memory problems, after a couple of weeks.

    The brain needs cholesterol, period.

    I hope your friend sends a thank-you card and a nice gift. You deserve it.

    Reply
  16. Judy B

    All of these stories sound very familiar! I gave my father (retired MD) quite a few articles from prominent medical journals on the lack of benefits for the elderly. He didn’t read them but asked his doctor about any dangers of statins. Of course, that doc pooh-poohed any dangers and waxed poetic about the so-called “benefits.” I finally gave up as it was clear that he didn’t want to hear anything. He continues getting weaker and weaker and has significant cognitive decline but his doctors continue to say there is no evidence of side effects, just aging!!!

    That’s always what they say.

    Reply
  17. Dan

    There is even more bad news. Check out this article.

    http://www.jstage.jst.go.jp/article/jln/19/1/65/_pdf

    Recent cholesterol trials, with the exception of the flawed JUPITER trial, have been negative. New regulations on clincal trials came into effect after the Vioxx fiasco and under the new regulations, the statins aren’t faring so well. The authors point out this calls into question the “rosey” results of previous statin trials.

    “The next question would be whether it is not time for a full reappraisal of the theory according to which cholesterol-lowering results in a significant protection against cardiovascular morbidity and mortality.”

    That reappraisal is long overdue.

    Absolutely. I’d like to be a fly on the wall in corporate meetings at Pfizer right now. I bet those are some interesting conversations.

    Reply
  18. k_the_c

    Pfizer is probably making sure the War on Drugs continue. All the pharms would probably go out of business if we could medicate ourselves cheaply and naturally.

    They’d certainly lose some big profits. All my friends are one prescription drug or another.

    Reply
  19. Zoe Harcombe

    Another brilliant and funny blog. I’m loving these. I’ve told the guys at thincs.org (the international network of cholesterol sceptics) that you are deffo one of us! You may know them already…

    Please do you know how I can get your DVD in the UK? I was just about to get it on Amazon and the warning about it being a USA version came up. I could do with a good laugh now that Friends is no more!

    Uffe Ravnskov made me an honorary member of THINCS after I sent him a copy of Fat Head. I get the group emails, which are a great resource.

    Our international distributor has been a huge disappointment. They’ve yet to get the DVD into any foreign countries. Someone told me the DVD plays in a computer DVD drive no matter what the region, but I couldn’t say for sure.

    Reply
  20. Paul451

    By the time I was 40 (eating the SAD all my life, with some totally ineffective low-fat diets every now and then) I was on 4 blood pressure medications and by 42 I was also put on Lipitor. The Lipitor went bye-bye 2 years ago when I started getting severe muscle cramps. Last year I started eating LC, dropped 20+ pounds and lost all but one BP medicine. So now, at age 50, I’m on fewer meds and in better condition (better lipid panel, lower BP, lower weight) than I was when I was 40-something! So much for “Modern Medicine”.

    Modern medicine is good at creating loyal customers. Nothing like selling a drug that leads to other drugs.

    Reply
  21. Monty

    Stephan at Whole Health Source has a new post about the McStatins.

    Maybe this is just me, but after reading the Guardian article I think the editorial authors were being ridiculous on purpose. They are forcing other cardiologistst to come out and say that statins are not a magic bullet and that there are possible side-effects.

    (sorry if this is sent twice – I got an error the first time)

    That would be a relief … but I’m not seeing an indication they were kidding.

    Reply
  22. Liz

    @ Zoe and anyone else in UK who wants to buy the DVD.
    I got my copy from Amazon – it is a USA DVD but it plays back fine in my DVD player.
    You just need to google “region free dvd player”. There are helpful guides to make your player region free. You usually just enter a code using the remote control. You may even find that your player is already “region free”.
    A good guide here . . .

    http://www.moneysavingexpert.com/shopping/dvd-unlock

    Thanks for the tips. All right, you UK fans, get ordering!

    Reply
  23. WordVixen

    You want to hear a brilliant thing? My husband’s doctor prescribed him a statin- get this- because he DIDN’T have high cholesterol! I’m serious, it was “preventative”. Hubs didn’t want to buck the system, but eventually the side effects got so bad that he just went off them cold turkey. Amazingly, almost all of his symptoms have cleared up! (He is on other prescriptions though, which accounts for what’s left).

    My mother, an LPN, goes into rant mode about every 3 weeks because apparently the drug companies are promoting statins as cure-alls, not just cholesterol any longer. Thankfully, dad is now off prescribed statins, but now we’re working on getting him off the red yeast rice supplements as well (same effect as statins, but same side effects as well).

    Good lord, that’s horrible! So we’re drugging people as “prevention” now?

    Reply
  24. DrDon

    Actually high LDL is good just like high HDL. When you compare the average LDL numbers for adults arriving in the ER with heart complaints to the average LDL for the adult population, you find those with low LDL three times more likely to show up in the ER. Similarly, those with above average LDL are three times less likely to show up. So above average LDL is about 10 times better than below average LDL. This might just mean having low LDL indicates your LDL particles are so small (and dangerous) they do not amount to much volume when measured; and similarly high LDL indicates large fluffy protective particles.

    So never forget you want high cholesterol numbers for heart health! Note, the protective effects of high cholesterol can still be overcome by eating too much sugar/fructose/HFCS, “healthy” PUFA vegetables oils high in omega-6 such as soybean oil, and foods made with seed grains/especially wheat. Stick more to saturated fats (mono-saturated fats seem to be okay too?)

    Don

    Reply

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