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Dr. Orrange received her BA in Biology at the University of California, San Diego, and a Masters Degree in Health Sciences at the Johns Hopkins University School of Public Health. She received her MD from the USC Keck School of…
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The Jupiter Trial: Should we all be screened for the use of Statins?
Once or twice a year a major clinical trial is stopped early because of positive results and occasionally even changes the way we practice medicine. The Jupiter Trial published in this weeks New England Journal of Medicine, which has been discussed at length in the lay press, may be one of those trials.
In patients with high cholesterol, treatment with statins reduces cardiovascular risk, even in people without a history of cardiovascular disease. What has always been tricky, however, is that nearly half of all first cardiovascular events occur in people whose low-density lipoprotein (LDL) cholesterol levels are below the level where we would consider lipid-lowering therapy. Our struggle in primary care has been to refine our ability to identify people who are at risk and to find interventions capable of reducing that risk.
Why did this study get our attention? 1) In the Justification for the Use of Statins in Primary Prevention: an Intervention Trial Evaluating Rosuvastatin (JUPITER) the authors selected their treatment population according to high-sensitivity C-reactive protein levels and NOT LDL cholesterol. 2) This strategy was based on two observations: high-sensitivity C-reactive protein has been shown to be an independent predictor of cardiovascular events and statins reduce levels of both high-sensitivity C-reactive protein and LDL cholesterol. 3) The subjects in JUPITER were healthy people with LDL cholesterol levels of less than 130 mg but with high-sensitivity C-reactive protein levels of 2.0 mg or more per liter. Participants were assigned to receive either rosuvastatin (Crestor) 20 mg each day, or placebo. 4) The question being asked was this: does Crestor 20 mg once a day in healthy folks with a CRP > 2.0 help prevent nonfatal heart attack, stroke, or death from cardiovascular causes. 5) Here is the DRAMA: The trial was stopped, after a median follow-up period of 1.9 years, by the data and safety monitoring board. Why? The treatment group has significantly lower risks of stroke, heart attack and death from heart disease compared to the placebo group. So, what do we know now? In at least one trial, a statin has been shown to improve outcomes for patients with cholesterol levels that are considered optimal but with elevated levels of C-reactive protein. In a survey done this week by the New England Journal of Medicine 50% of physicians said they would change the way they screen patients AND change who they would suggest treatment to based on this trial. I'm waiting for a couple other trials to be published as I am slightly uncomfortable that the study was sponsored by Astra Zeneca (who makes Crestor). However, if the evidence continues to pile up it will be nice to use this piece of ammunition against our number 1 killer...heart disease. Dr O.
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I share your discomfort about the fact that the drug's manufacturer was the sponsor of the study. As a scientist I constantly battle against situations where personal bias might influence the results. Even though NEJM and Harvard are very respectable organizations the study leader has a lot to benefit from concluding that CRESTOR has a significant beneficial effect. That sure sounds like conflict of interest to me. It is too bad the drug companies can't contribute these kinds of funds to the American Heart Association(or other health organization as appropriate for the drug under study) and then let them determine what studies should be done.
Considering your distance and winter weather conditions, If I were your doctor, I would call in the lab request to the nearest lab for you, then schedule a follow up appointment for when you are not snowed in. Thats called customer service.
I think its time we get rid of the word "patient" and replace it with "customer". Its more fitting.
1) We all know that diet and exercise are hugely important to health and statins will never replace that
2) I have posted blogs on natural remedies for lowering cholesterol and several weight loss posts
3) Having said that: We have to remember MANY people who suffer from heart disease cant be "blamed" for behavior they can modify...many of them have NORMAL cholesterol (as those in this study do), exercise regularly and eat all the right things and genetics have dealt them a bad hand...and this may help them out
Dr O.
God Bless
chip
If we study graphs of heart disease in the united states, you see a rapid rise beginning around 1920 and peaking around 1968. What caused this dramatic increase in death rates from heart disease in that time period?
Also the Australian Aborigines were once strong healthy hunters in the Austarlian bush in the 1930's. But they too succumbed to cancer and heart disease over the next 70 years as they adapted to a modern way of life consuming foods that the Europeans brought to Australia. Today the Australian Aborigines have one of the highest rates of heart disease. BTW, they also have one of the lowest cholesterol levels of anyone in the world.
#15 is right. We are consuming processed junk food that has absolutely no place in our body's chemistry. We lack physical activity too.
If you study populations with healthy elderly people, some living over 100 years and still active into their 90's, you will find some interesting common denominators. Things like Hard physical labor in the Garden. Consuming a Natural Organic diet free from processing and pesticides, Plenty of sunshine, Close family relationships. These people do not take statins, and they are healthier than us.
We are not deficient in statins. There is no magic pill for heart disease. Instead we should walk, bike to work, ditch all processed foods and eat as natural of a diet as possible.
I personnaly view Statin sales in the same light as the snake oil salesman depicted in the old western movies. He would travel from town to town by covered wagon selling his potion that promised to cure just about everything under the sun.(this should be sounding familiar by now) By the time the towns people had figured out they had been taken, it was too late. The Salesman had skipped town during the night with all their money.
Just my opinion.
"...A national survey of doctors published in the April 2007 New England Journal of Medicine found that 94% of physicians in the six specialties studied reported some type of relationship with pharmaceutical companies’ representatives. Most (83%) received food in their workplace, or accepted drug samples (78%) proffered by visiting representatives. Thirty-five percent reported that drug companies had reimbursed them for the cost of attending professional meetings or company-sponsored sessions that satisfied a physician’s “continuing medical education” requirement. And 28% received payments for consulting with a drug company, giving lectures or enrolling patients in trials..."
http://articles.latimes.com/2007/au...
Similar info as to the extent of "freebies" (food reportedly 83% of the time) can be found in the NEJM, JAMA, etc.
These drugs can be devastating to people's lives. And for what? Someone's silly wild guess that serum cholesterol causes heart disease? What I see is slick marketing disguised as medical science, and alot of people suffering the consequences.
We still don't know what causes heart disease. Yet we have a pill to treat it? Excuse me! ???
Few people have a degree in human biology. Thats why its so easy for the drug companies to pull the wool over the eyes of the general public and sell a cholesterol treatment at $1,000 per year per person. Then they sweep under the rug the suffering of those who have been severely injured.
But I tell you the truth; If every person in the world had a clear understanding on what cholesterol is, how it functions in the body, the horrible NNT scores of statins and a vivid understanding of the risks,
not one pill would sell, and the walls of the Statin Regime would collapse in upon itself.
Remember the Golden Rule, "He who has Gold makes the Rules." In this case it is the drug companies. With JUPITER they rewrote the rules and now YOU WILL be prescribed a statin.
Welcome to the United States of Pfizer.
That said, the article was informative none the less and will help some people as I know several who have gotten good results from statins.
Thanks Doc.
Dusty
Gee, USCSD seems to think there is, as do their Sorry, but that just doesn't get it any more. We really don't know the long term side effects because no one has studied them except the pharmaceuticals; and that's like the fox watching the hen house! As long as the greedy pharmaceuticals pay for and have their fingers in the studies, then I don't believe a word of them. When I went back to college and had to take a required stats class, one of the text books was "How to Lie with Statistics." Basically it said anyone can manipulate statistics in any way they want. And as far as I'm concerned, if the pharms are that confident of their drugs, then why do they advertise them????????? Why do they have to bribe dr's w/not only free samples, but also free meals, free trips, free golf clubs, etc.? My neighbor works in a dr's office & they are fed at least one meal just about every day compliments of one pharm co or another. That money could be used to research side effects!!!
So I guess because most people don't have (known) side effects, the class action lawsuits against phizer are just a way for greedy consumers to make a quick buck, right? I'm sorry, but my quality of life was ruined by lipitor and the negligent drs who prescribed it and didn't monitor me properly and blew off my complaints of increasing fatigue (a now known side effect). Guess where I found out about that side effect? From my dr??? Nope...from a newspaper article. Did a bit of research on lipitor's website and found some very interesting info buried in link after link after link, much of which is gone now.
So I now I will only pay attention to studies that are NOT funded by pharms.
I just wonder why UCSD felt the need to gather evidence of lipitor's devastating side effects.
Maybe, just maybe because it affects more than just a few people. I just did a search trying to find out how many people are on statins and the results were either about statin warnings or other uses for statins. Among the first page results was this link.
According to a Feb 2008 ABC report ( http://abcnews.go.com/Health/HeartD... ), 18 million people take lipitor. That's JUST lipitor!!! Of course this report only focuses on memory loss as a side effect. But it's pretty clear that the studies done that PROVE there's no link between lipitor and memory loss were done by phizer.... need I say more????
Not under estimating the burden of heart disease, but you can find as many opinions out there that say statins don't save enough lives to warrant the expense. Oh, but if it saves one life then it's worth it, right??? If you agree with that logic, then why is ok that even one person's life is ruined by the same drug?????
Why aren't we being proactive by making sure schools serve healthy lunches and remove all the soda & junk food machines? Why do so many hospitals serve the most unhealthy food of all? It's because we are a nation who reacts instead of proacts. We have been turned into pill poppers (remember the Stones song Mother's little helper?) Here take this for your heart and take this for your depression, etc.. Sorry but I think the medical community in general takes too much of what the pharms feed them (literally and figuratively) for granted and instead of doing their own, independent research, and depends on the pharms to do the research.
And now they want us to believe that a statin is a one drug cures all? (re: DS article: Statin use linked to drop in PSA level! http://dailystrength.org/blog/323-s... Oh puh-leeze!
I think you can get access to the whole article (NEJM Nov 20th issue) but briefly: men > 50 and women> 60 with LDL < 130 and CRP > 2.0 were included. Exclusion criteria included: poorly controlled high blood pressure, elevated liver function tests and muscle enzymes, uncontrolled hypothyroidism among others...you can read it online.
Whenever I write a blog about statins many jump in which i like...but remember MOST PEOPLE including many thousands on DS (you can see in our treatment sections how many use statins) have NO problems on the statin drugs. Its important for us to continue to read the published studies and form our own opinions so Ill keep writing them. Also lets not underestimate the burden of heart disease...
Dr O.
I also took estrogen for years after menopause and Rx'd them, as did many other RNPS and MDs.
No medication has a 100% risk free rate. There is always some trade off and it may take years for that trade off to show up after hundreds of thousands of people have taken it. Sometimes the trade off is worth the risk and sometimes not.
I am fortunate that I have a great genetic background for good health as did my mother, but she has I think suffered her strokes in result of the Vioxx she took for years for her arthritic pain.
I take only coated asa for mine and it works fine. I try to stick to the KIS method (keep it simple, stupid) as much as possible.
Unfortunately too many people are taking so many drugs that there is no way to know which drug is causing which side effect. Poly-pharmacy seems to be the rule, not the exception, for the elderly. My consulting physician and I tried to cut these unnecessary drugs down as much as possible and treat as much as we could with life style changes, especially diabetes type II. A pound of prevention is always worth ten pounds of "cure."
I also am suspicious of the drug company's trials---follow the money---because of the huge amount of money involved and the failure of both drug companies and the FDA to ferret out some horrible side effects of drugs. My mother also has horrible, irreversable side effects from Reglan that she was put on by an internest. I was unaware that she was taking them unitl I noticed the side effects and started digging to find out what was going on. Another physician put her on Klonipin 1 mg 3 x a day to try to control the side effects, and this dose made her so unsteady on her feet that she fell and broke a hip, and did nothing for the side effects from the Reglan, besides the effect that it made her so confused she didn't know her own name.
Though I am more than a bit out of date (I am retired) on the newest and the latest therapies, none the less, I try to keep a good eye on what I am doing to my own health with life style and medication and try to steer clear of medication if there is no clear benefit vs risk ratio.
I like Dr. O because she observes that half of cardiac events happen to people with low cholesterol numbers. It doesn't take a rocket scientist to do the math on this one.
So what do we have to gain by shifting our risk from one 50% group that has heart atacks, to the other 50% group that has just as many heart attacks? Absolutely nothing!
But the one shift that really counts here is the $1,000 per month on behalf of the patient into the pockets of the drug company.
Lets look at the REAL numbers here on statins. If you look at a graph of death rates from heart disease in the united states, and overlay a graph of statin prescriptions, you will see a rapid curve upward from statin presciption rates, but you will not see a corresponding downward curve in death rates from heart disease. Instead Heart disease holds a steady course oblivious to statin drugs.
We have been treating patients with statins for 20 years now and it has failed to eradicate cardivascular disease. I think 20 years is long enough.
The only purpose behind the Jupiter trial was to increase market share and line their pockets with money. All other trials failed to show any mortality benefits to statins, so they had to come up with something.
Testing studies gather up groups that are statiscally advantageous. It is not an accurate representation of the population at large. Studies like these are the ones that allow drugs to reach the population and be prescribed to people for whom they destroy health and life.
I am personally sick of hearing about cholesterol. As a Mathematician I know that statistics can be worked to show advantages where ever they are of the best use to the seller. WHat use is a drug if even one person is harmed by the drug?