Should Crestor Be Prescribed As A Preventive Med?
25 CommentsBy Ed Silverman // March 31st, 2010 // 6:54 am
AstraZeneca recently received FDA approval to market its Crestor cholesterol fighter as a preventive pill for millions of folks who don’t have high cholesterol - and that prompts some to wonder whether this is a good idea, The New York Times writes. The skeptics point to concern that cholesterol meds may not be as safe as a preventive drug as previously believed for people who are at low risk of heart attacks or strokes. Others suggest the benefits may not outweigh side effects.
One risk - a recent paper indicated that statins could raise the risk of developing Type 2 diabetes by 9 percent, the paper continues. “It’s a good thing to be skeptical about whether there may be long-term harm from healthy people taking a drug like this,” Mark Hlatky, a professor of health research and cardiovascular medicine at the Stanford University medical school, tells the Times.
There is also debate over the blood test used to identify new patients. Instead of looking for bad cholesterol, the test measures the degree of inflammation in the body, but there is no consensus that inflammation directly causes cardiovascular problems.The clinical trial on which the FDA approved the new use looked only at patients who had low cholesterol and an elevated level of inflammation in the body measured by a test called high-sensitivity C-reactive protein, or CRP, the Times writes.
Crestor may be given to apparently healthy people — men 50 and over and women 60 and over — who have one risk factor like smoking or high blood pressure, besides elevated inflammation. However, in the trial, the heart attack rate was 0.37 percent, or 68 patients out of 8,901 given a placebo. Among Crestor patients it was 0.17 percent, or 31 patients. That 55 percent relative difference between groups is 0.2 percentage points in absolute terms — or 2 people out of 1,000, the Times notes, adding that 500 people would need to be treated for a year to avoid one usually survivable heart attack.
Eric Colman, a deputy director of the FDA’s Center for Drug Evaluation, tells the paper that the decision provided an option, not a mandate for docs. However, “the benefit is vanishingly small,” cardiologist Steve Seiden tells the Times. “It just turns a lot of healthy people into patients and commits them to a lifetime of medication.” Hmm… Interesting notion. What do you think?
Is Marketing Crestor As A Preventive A Good Idea?
- No (76%, 141 Votes)
- Yes (24%, 45 Votes)
Total Voters: 186
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Former Pharma Marketing Director
OK, so obviously I am against this. How about change of lifestyle measures first? That sounds like good “preventative medicine”. Why would a doctor want to prescribe something to a patient who is obviously healthy? The last remark, in case some do not figure it out, is me being sarcastic…
Shame on the FDA. Perhaps AstraZeneca had a “file” on someone on the panel?
Dan
One begins to develop coronary plaques in their 20s. Statins address the lipid core within such plaques, thus stabilizing them, and preventing a myocardial infarction.
From a preventative paradigm, Lescol may be a more suitable statin than one such as Crestor, or Lipitor, for that matter.
Lisa Van Syckel
No Thanks,. I’ll pass.
pharmavet
Dan, you’re the man. I worked on Lescol when we at Reliant co-marketed it with Novartis. You’re observations are spot on. The early development of atherosclerosis came from several sources. One was the landmark Bogalusa Heart study in Louisiana, which first called attention the issue in children and adolescents. Even before that it was known from autopsies on soldiers killed in WWII that many of these men in their 20’s and otherwise in perfect health had plaques in their coronary arteries.
Some of the most impressive data comes from the Framingham Heart Study. If you study the frequency distribution curves of serum cholesterol for inddividuals with or without coronary heart disease, the curves strikingly overlap. This means that there is no “cutoff” number for serum cholesterol that predicts whether one will or will not develop CHD.
I won’t go as far as some people who suggest putting statins in the drinking water, but I think that a low dose of a lipophobic statin, like Lescol or Pravachol in normocholesterolemic individuals is an excellent idea, especially if they have other risk factors.
M Helm, MD
Dan and PVet,
AZ is trying to make this about inflammation, NOT cholesterol/coronary plaques. The indication is based on an observation of a correlation with reduction of CRP and CV risk in (relatively) low risk individuals.
Fluva and prava have a relative paucity of prevention data compared to others. Rosuva is not the only one which seems to have anti-inflammatory effects. It will take many years to determine whether or not this is a valid theory for prevention. Read the AP article for the costs to prevent one heart attack, (if the numbers above are not sufficient to create skepitcism) and the motivation for pursuing the indication is pretty obvious.
Still, there will be some prescribers who will faithfully follow the marketing line, and sincerely believe they are doing their patients a favor. There will be many paid witnesses to testify on behalf of the “benefit” of this approach. The jury won’t be back for another 20 years, if ever and by then AZ will have supported many quarters of earnings statements with this proposal.
Justice in MI
All I can say here is…stay tuned. There will be more on this issue shortly.
For the moment, FDA has approved “an option” (which docs had anyway). Beyond that, I’ll predict here that the data will not support this option for the great majority of pts, to the degree data actually means anything. Whatever else one says about the NNT numbers, they themselves will shift. And the NNT risk numbers are also in evolution.
To quote Lilly on Zyprexa, this is a great example of “changing the paradigm” in the interest of expanding market share. Beyond that, there is, in my view, squat.
patrons99
This is just further proof, as if we really needed more, that FDA has long ago stopped advocating for the public’s safety. FDA is just another utterly shameless shill for pharma. I don’t know if FDA has bottomed-out yet, but they’ve got to be getting very close to rock bottom. We have discussed statin efficacy and safety concerns extensively, in recent posts, so I’d simply refer to the arguments already presented.
pharmavet
I agree that some prescribers will follow the marketing line, and Rx based on CRP. I also believe it is age-dependent. When I took Clinical Laboratory Medicine in 1971, we were taught not to bother ordering CRP and sed rates because they were such non-specific markers of inflammation. By analogy, the ordering of CK in suspected MI patients was not routinely ordered until the MB cardiac subfraction was determined to highly correlate with myocardial necrosis. Now it is as standard as ordering an EKG.
If I were to predict, I would say that physicians who trained in my generation and earlier will be slow adapters of CRP until a test comes along like CK isoenzymes that will have greater specificty. Even younger doctors in training might be skeptical for different reasons. Due to the high cost of medical care, med students are now educated about laboratory test sensitivity and specificity in regards to prioritizing laboratory tests. Thus, given the low specificity of the current CRP test, then strictly speaking they should be taught against ordering it.
If this assay is to be used as a “screening” procedure, I have my doubts about insurance coverage. About 10 years ago I was part of a large population study on the incidence of subclinical hypothyroids (elevated TSH). When our data sowed that about 10% of the population has an asymptomatic elevated TSH we felt for sure that insurance companies would pay for thyroid screening. To date this has not become a reality, even though subclinical hypothyroidism is an approved indication.
M Helm, MD
I predict television commercials in 3-4 months (if not sooner). Most likely on on network evening news programs and other programing which skews to the correct demographic (50+ caucasian female primarily).
patrons99
Watch out mandated statin rx. This is preventive healthcare at its worst.
“A pill or poke (jab) for every ailment…even potential ailments”.
vince
Sure give it to ever one based on Jupiter a study stopped at 1.9 years ; a skeptic might say before the benefit became less apparent with a dropout rate of 15% a year and explosion of diabetes rates. If it doesn’t work out of well….
riv
* permanent vision damage
* muscle atrophy, pain and weakness
* degradation of muscle causing measurable loss of bone in hip
* persistent instability, weakness, and falling, causing further injury to the hip, knee and back muscles
* gastrointestinal tract problems, including gall bladder disease, pancreatitis, helicobactor pylori ulcer, lesions on liver and lung.
* memory loss, loss of language, confusion over grammar and syntax (I’m an honours English major and journalist up until Lipitor and Baycol put me out of work).
* episodes of transient global amnesia, and loss of knowledge of how to do things I’ve done for my lifetime.
*
* difficulty breathing and persistent coughing
* loss of income while the same doctors who prescribed this unnecessary class of drugs to me refused to help me recover, refused to acknowledge my injury, did not ever apologize, became verbally abusive and invaded my life and family members lives and privacy after I finally, eight years later, complained about their lack of response to my need, which was all I asked for. (I believe it’s called the physician’s protection association’s “scorched earth” response to any complaint or request for intervention.
To those who back this new prescribing policy, I say do a search on the COI of each of the doctors involved, follow the money.
Take Crestor yourselves, and if you can remember how to do that, call your doctor to report your negative effects. There will be…negative effects, that are life-altering, disabling, and long-term. Because statins damage is mitochondrial it will not stop immediately when you stop the drug, and maybe not at all depending on how long you took it, and what dose, and whether or not you are Asian, elderly, female, small of stature, have any other chronic illness–like heart disease.
I was a triathlete. I can barely walk 2 k a day now, haltingly, slowly, with several sit downs along the way. This is six and one-half years after stopping. When you take statins, you will injure joints and muscles that take a long time to repair and recover.
There has been progress, but in the meantime, I’ve lost my livelihood, savings, and faith in the medical profession.
I had no cardiovascular disease then, or now.
My total cholesterol level is around 12. My HDL is at or over 2. Not ONE of the physicians, internists, cardiologists, or epidemiolgists paid the slightest attention to that latter number.
All I heard as I was emotionally and verbally abused to take and stay on statins, and try Ezibimibe and Vytorin, was about my TC, and the fact that my father died of a heart attack (but we know nothing about his cholesterol level. (He was a busman and hunter and died portaging a canoe).
Not one of them paid attention to the fact that my mother is alive still, at nearly 100.
You couldn’t measure the depth of my contempt for a profession that has, in my opinion, well and truly buggered First Do Not Harm. I speak for thousands.
riv
“bushman and hunter”
vince
‘First do no harm ” left the medical profession long ago . Its now risk benefit … you take the risk they get the benefit. A companion article On women and statins http://www.time.com/time/magazine/article/0,9171,1973295,00.html You will notice the only expert speaking against statins is the one who does not have a conflict of interest
JaT
This is the very type of thing that has so many people distrusting FDA and drug makers as opportunists at any cost.
You begin to wonder what more can be done to cause people to no longer want a doctor/patient relationship at all.
patrons99
With the FDA looking out for our safety and well-being and full implementation of Codex Alimentarius, our future is guaranteed. We can now look forward to growing old gracefully. NOT!!!
http://www.infowars.com/billions-of-people-expected-to-die-under-current-codex-alimentarius-guidelines/
http://www.infowars.com/mccains-dietary-supplement-bill-an-attempt-to-implement-codex-alimentarius/
http://www.disinfo.com/2009/10/codex-alimentarius-the-plan-to-outlaw-free-trade-of-all-vitamins-minerals-herbs-and-supplements/
http://broadbandforum.in/politics/47014-codex-alimentarius-plan-kill-3-billion-people/
riv
Not epidemiologist. A, what do you call, it, the other e word for the guys who look after metablolism.
Oh I forgot my favourite part of my story.
As I was leaving the doctor’s office with a package of Baycol about three months before recall, a really happy lookin’ guy crossing the parking lot hailed me:
“Hey. That’s a great looking package of product you’ve got there”. (I shit you not. They talk like that).
“Mind if I ask who you got that from?”.
I say. He responds:
“I’ll have to thank her.”
Phil
Endocrinologist
JaT
I have hesitated to post this as it is not exactly palatable. It is valuable though- in this new world of DNA, electronic records, preventative medicine, and the potential for DNA laced SS cards- in an attempt to not allow history to repeat. I am sincerely sorry if anyone finds it offensive. That is not my intent. Just to remember where we have been and what man is capable of:
http://video.google.com/videoplay?docid=9014940408212321489#
Justice in MI
JaT–The history of eugenics in the U.S. is important, but I honestly miss the connection. How are you seeing it?
Lilly K
The influence of the Pharmaceuticalas must be stopped. Prescribing medications just to create to create profits is corrupt and criminal!! WhAT ARE OUR ELECTED AND APPOINTED OFFICALS DOING? wHAT GOOD IS UNIVERSAL HEALTH CARE IF THE PUBLIC IS NOT ASSDURED OF ETHUICAL QUALITY HEALTH CARE?????/ SHME ON THE THE MEDIUCAL PROFESSION, THE HEALTHCARE INSUSTRIES AND ALL CONCERNED WITH HEALTHCARE!!!!@!!@!
JaT
There is no where to go but to know that science and technology can easily become our enemies in the wrong hands. That’s all. I just warn to be cautious- which is Edwin Black’s message.
I don’t know that it is really off topic here considering the known dangers of statins. I am not saying that we will repeat the thinking of eugenicists- just that there is a reckless train of though that everyone needs to be medicated somehow. How many people die from pharmaceuticals each year? We need to be more careful in our research- which Mr. Black touches on as well. Add a little philanthropy and lobbying we can get into big trouble- as that drove the movement.
JimK
If I recall from earlier stories on the “Jupiter” study the lead researcher for the project had a patent pending for the development of a new CRP test. if the “Jupiter” study was adopted as an accepted fact, (done) this researcher would stand to reap a financial windfall.
Correct me if I am wrong.
pharmavet
Jim, I’m not sure how much of a windfall. I went to college with someone who ultimately developed a more specific PSA test, but I don’t think that he became rich off of it.
Dan
Wall Street “too big” to fail almost brought down the world economy with financial instruments designed by Nobel Prize laureats and their students.
Big Pharma will bring down the whole civilization when it forced its worthless patented drugs to the public.