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Medical Forum / General / General / January 2005Statins in primary prevention
I'm not sure why, but I never got this on my news server: zwalanga wrote (in a thread about folate supplementation): > As I mentioned in my response to you on sci.med.cardiology where this > message originated, I was not name calling when I referred to spotting > a rat in my dreams. Is that what you assumed? The rat was symbolic of > the disease for which I am now undergoing evaluation. I might have said > when I was out walking today I saw the shadow of the wendigo, and when > I came home I learned my grandfather had been taken ill. > > And it seems to me on this issue of statins toxicity and efficacy > everyone has a different opinion. I am just a consumer, trying to > understand, not only for myself, but for the hundreds of people who > contact me who also have statin injury. > > I post this below not in argument (because I am grateful you would take > the time to answer me) but to show there is difference of opinion. Can > you help me understand how the following is wrong and you are right? > The speaker is an academic physician. As you are too I believe. Zee > > "The best analysis of the outcomes from five major statin studies comes > from > the Therapeutics Initiative newsletter # 48 > > http://www.ti.ubc.ca/pages/letter48.htm > > The absolute risk reduction for heart attack and stroke is around > 1.4%. (yet > when you factor in the other serious adverse events, the benefits > disappear). The '40%' you always hear about is a misleading 'relative' > difference. Such as, in the 4S study of simvastatin for five years 8.5 > percent of patients on placebo died of a heart attack. 5% on the drug > > similarly died. A difference of 3.5% (but '5%' is 42% less than 8.5% > so Merck, in its ads use the wondrous 42% to convince docs why they > need to put their patients on Zocor. (And this study was done in people > with confirmed heart disease)." I have certain specific objections to the discussion in the Therapeutics Initiative newsletter and don't agree with the way the benefits and side effects are equated above, but it's probably not worth going through such issues point by point. I agree with the basic point that looking at relative differences in mortality (or cardiac events) with statins is not terribly helpful in making individual decisions. Beyond that, I agree completely that drug companies and researchers routinely use relative risk reductions to make the benefits of a drug seem much greater than they really are.(I also think a 42% decrease in events is higher than the averages seen in most statin studies.) But statins do seem to decrease the relative risk of serious events and mortality by about 25-35% in nearly every group they have been studied in. It's possible to twist the data in various ways to suggest that statins have not shown quite that benefit in this or that subgroup, but in general this sort of *relative reduction* appears again and again in the studies. So in deciding whether to take a statin, it makes sense to ask whether that degree of relative reduction translates into an *absolute reduction* you would care about. So if reducing your risk of an event from, say, 9% to 6% over the next 10 years doesn't seem worth taking a pill every day and risking side effects, I would completely agree with a decision not to take a statin. Almost no one with a baseline risk of 3% would think it was worth taking a pill every day to drop that risk to 2%, and nearly everyone with a baseline risk of 30% would think it was worth taking a pill every day to drop that risk to 20%. In between, individual patient preferences will lead to individual decisions. There's no one right answer for everyone.  SignatureDavid Rind drind@caregroup.harvard.edu David Rind <drind@caregroup.harvard.edu> wrote in part: >I have certain specific objections to the discussion in the Therapeutics >Initiative newsletter and don't agree with the way the benefits and side [quoted text clipped - 28 lines] >drop that risk to 20%. In between, individual patient preferences will >lead to individual decisions. There's no one right answer for everyone. Yes. Well put. I will add that if either society or an individual thinks that heart disease is a serious problem, then reducing it by 30% or so is important. While I'm sure that the pharmaceutical firms state the benefits of their wares in the most flattering way possible by using a relative measure, it is still the case that a *relative* reduction of 30% or so in a *serious* problem is a good achievement. A 100% relative reduction would mean elimination of the bad outcome altogether. So a relative reduction gives a natural measure of effectiveness of the drug against that outcome. I take a statin to reduce my risk of death (and morbidity) from heart disease. I would not take one in order to reduce my risk of being killed by a meteor even if it had the same relative mortality reduction in each case. -- Jim Chinnis Warrenton, Virginia, USA jchinnis@alum.mit.edu > David Rind <drind@caregroup.harvard.edu> wrote in part: > > >I have certain specific objections to the discussion in the Therapeutics > >Initiative newsletter and don't agree with the way the benefits and side > >effects are equated above, but it's probably not worth going through > >such issues point by point. > > > >I agree with the basic point that looking at relative differences in > >mortality (or cardiac events) with statins is not terribly helpful in > >making individual decisions. Beyond that, I agree completely that drug [quoted text clipped - 19 lines] > >Almost no one with a baseline risk of 3% would think it was worth taking > >a pill every day to drop that risk to 2%, and nearly everyone with a > >baseline risk of 30% would think it was worth taking a pill every day to > >drop that risk to 20%. In between, individual patient preferences will [quoted text clipped - 18 lines] > > I take a statin to reduce my risk of death (and morbidity) from heart disease. Faith, not science. > I would not take one in order to reduce my risk of being killed by a meteor > even if it had the same relative mortality reduction in each case. > -- > Jim Chinnis Warrenton, Virginia, USA jchinnis@alum.mit.edu > > David Rind <drind@caregroup.harvard.edu> wrote in part: > > [quoted text clipped - 79 lines] > > Faith, not science. Though I do not believe it was your intent, you just paid Jim a very nice compliment. Blessed are those who have faith. Hope the above information enlightens you. Such is the work being done here for Christ's glory (http://makeashorterlink.com/?U1E13130A). Servant to the humblest person in the universe, Andrew -- Dr. Andrew B. Chung, MD/PhD Board-Certified Cardiologist http://www.heartmdphd.com/ ** Who is the humblest person in the universe? http://makeashorterlink.com/?L26062048 What is all this about? http://makeashorterlink.com/?K6F72510A Is this spam? http://makeashorterlink.com/?D13B21FF9 "zwalanga" <zwalanga@yahoo.com> wrote in part: >> I take a statin to reduce my risk of death (and morbidity) from heart >disease. > >Faith, not science. Bayesian statistics, actually--part of what is called "science." We never know all that we need to know in making a decision, nor can we be certain about many of the considerations that enter into it. But we have to make decisions as best we can. A drug can't be held back until long-term (lifetime?) studies are done. It can't be held back until every rare side-effect is quantified. I can decide to take a statin or not. I have to decide based on how well the many studies pertain to me, what I know about my special circumstances, and what I know about other actions i can take. All that requires *judgment.* Your use of the word, "faith," would apply if I were suspending my judgment and substituting someone else's. I don't accept at face value what pharmaceutical firms say. I have thought long and hard about the data. -- Jim Chinnis Warrenton, Virginia, USA jchinnis@alum.mit.edu > "zwalanga" <zwalanga@yahoo.com> wrote in part: > [quoted text clipped - 4 lines] > > Bayesian statistics, actually--part of what is called "science." Just saying Bayesian does not mean it is correct, as I belive those of your profession who cleve to other stats gods pointed out at one time. > We never know all that we need to know in making a decision, nor can we be > certain about many of the considerations that enter into it. But we have to > make decisions as best we can. We. Well you and the rest of your *we* certainly do not. That has been proven most recently with Vioxx. Bextra and Celebrex coming up? Your we and my we do not know all we need to know because, as has been shown here over the past year, industry and FDA have withheld negatives, clinical trials are designed to favour a positive outcome, trials stop before adverse events really start, FDA allows pharma to say what will go on the product monographs and package inserts, pharma controls medical education, front-line physicians are getting their continuing med info from salespeople and lipid specialists and cardiovascular "experts" are virtually owned by industry. Then, we have the whole mish mash of adverse event reporting. All side effects of statins, including rhabdomyolysis, are called rare. Why? Because they really are rare, or because if we close one eye and rely on only peripheral vision with the other that makes them rare? Stats of after market events are based on adverse event reports which are voluntary, when done by physicians say something nebulous and indirect, do not take into consideration that physicians will not even know the death or event was caused by the statin even *if* they are pre-dispossed to reporting it. Mis-reporting, and under-reporting. We hear repeatedly how fibrates and fibric acid derivatives are responsible for statin adverse events, but even in rhabdomyolysis deaths to 2000 they all taken together were in the minority. And who uses those drugs anymore? What would an analysis of the data from 2000 to 2003 show? Nothing else to blame the rhabdomyolysis deaths on... Even if I was a middle aged man who had high cholesterol, diabetes and other so-called risk factors, I would ask myself: Did I have heart disease or heart attack before I took a statin? If not, what does evidence based medicine say about using statins for prevention? And if I did have a heart attack before I took a statin, how many heart attacks has my statin saved me from since? Faith. > A drug can't be held back until long-term (lifetime?) studies are done. It > can't be held back until every rare side-effect is quantified. I understand there is serious complaint about how trials are designed; that trial particpants are chosen so as to leave out anyone who could risk a positive outcome; that drugs advertising is what most people are basing their informed choice on (emotion), and that even FDA physicians do not believe they are gettin unbiased information. Middle aged men at high risk are probably the only group to which even those rigged clincial outcome stats might apply. But stay tuned, because the "high risk" keep changing as statin pharma run to squeeze every dollar out of the drugs bfore more and better informed people say "no". As it stands the stats for drop out are about 65 percent after one or two years. Did you have heart disease before you took a statin? How many heart attacks has your statin saved you from since you started taking them? Faith. You're rolling the dice and hoping you are going to be one of those what was it 3 percent? > I can decide to take a statin or not. I have to decide based on how well the > many studies pertain to me, what I know about my special circumstances, and [quoted text clipped - 4 lines] > -- > Jim Chinnis Warrenton, Virginia, USA jchinnis@alum.mit.edu "zwalanga" <zwalanga@yahoo.com> wrote in part: >> "zwalanga" <zwalanga@yahoo.com> wrote in part: >> [quoted text clipped - 8 lines] >Just saying Bayesian does not mean it is correct, as I belive those of >your profession who cleve to other stats gods pointed out at one time. We are both using our best abilities to decide what to do. Neither of us is employing "faith." -- Jim Chinnis Warrenton, Virginia, USA > "zwalanga" <zwalanga@yahoo.com> wrote in part: > [quoted text clipped - 13 lines] > We are both using our best abilities to decide what to do. Neither of us is > employing "faith." In truth, you are both employing faith in yourselves. Hope the above information enlightens you. Such is the work being done here for Christ's glory (http://makeashorterlink.com/?U1E13130A). Servant to the humblest person in the universe, Andrew -- Dr. Andrew B. Chung, MD/PhD Board-Certified Cardiologist http://www.heartmdphd.com/ ** Who is the humblest person in the universe? http://makeashorterlink.com/?L26062048 What is all this about? http://makeashorterlink.com/?K6F72510A Is this spam? http://makeashorterlink.com/?D13B21FF9 > "zwalanga" <zwalanga@yahoo.com> wrote in part: > [quoted text clipped - 15 lines] > -- > Jim Chinnis Warrenton, Virginia, USA "We are both using our best abilities to decide what to do." In this I completely agree Jim, and respect your right to your decision (however ill informed it may be..snicker). Recommend a movie for me to rent. I have access to a tv for a few weeks. Zee Zee, Starsky & Hutch is a good pick.... I love Owen Wilson. And Shrek 2 is supposed to be good too. I would like to add one item to all the above. When studies are published, the results are referenced in future articles. And people doing research, rely on these articles to make informed decisions. I've found a few instances where future articles continue to quote a study, when revised findings were published after the conclusion of the study. This really alters the results. when a person makes a decision to take a drug based on advertized results, and those results are incorrect..... this is what I would call... LYING. And this is flatly WRONG. Adults make decisions based on the facts and if the facts are slim, well, they can choose that path knowingly. The public at large is being duped into taking expensive drugs that can be life threatening because drugs companies are lying, when convenient to do so. A very scarey question many statin users ask when the pain seems too much to take..... Is it safe to stop taking statins? One example of incorrect results: Is It Risky to Stop Statins? http://www.healthandage.com/Home/gid2=1769 I've grabbed the sentence that most people focus on: QUOTE: "Those who stopped statin therapy were about 3 times more likely to die or have a heart attack than those who continued on statins." OUCH.... If you search on "stop statins", you will find many article like the one above.... QUOTE: "1,616 patients in the study. 47 died and 65 had heart attacks within 30 days after hospitalization." OUCH again.... The source at the bottom of these credible articles indicate: "Withdrawal of statins increases event rates in patients with acute coronary syndromes." C. Heeschen, CW. Hamm, U. Laufs, et al., Circulation, 2002, vol. 105, pp. 1446--1452 Most people stop there..... I dug a little deeper... I found an "updated" article titled, "Withdrawal of Statins in Patients With Acute Coronary Syndromes", http://circ.ahajournals.org/cgi/reprint/107/3/e27 Same article name, with the credits to the same people, stating that previous findings were incorrect: INCORRECT..... how could that be? QUOTE: "In reevaluating our data, we discovered that approximately one-third of the study population had missing data for troponin T at baseline and were excluded from the multivariate model we used to adjust for possible confounding factors." What, did these folks go out for coffee and some one forgot to count them..... how do you forget to mention 1/3 of the test subjects? QUOTE: "Although the direction of the trend is maintained in this reanalysis, there is insufficient evidence to support the original conclusions." BUT the lie gets carried on. I was scared out of my whits trying to balance the decision to have my husband stop taking statins. He's been in pain for 8 years, but when pain turned into memory loss, confusion, visual disturbances, and the doctors denied that statins could be the cause..... I went with my gut feeling and we made a mutual decision to stop statins. I read until the wee hours of the morning day after day, trying to make sure I choose the right supplements to get him through the withdrawl of statins and to ensure his stickey platelets stay unstickey..... We are still working our way though statins side effects months after stopping, as do many..... Those who take statins and think statins are not doing any harm to their bodies..... well, you might wake up one day and discover that damage was done silently, while your LDL, HDL and trig's looked great on your test result history. It's like anything where the saying applies.... "If it seems too good to be true, well it probably is." Frankie I forgot to add one thing.... Note: Dr. Christopher Heeschen of the University of Frankfurt is the main reference for these articles. The study was funded by the University of Frankfurt. Heeschen has received lecture fees from Merck, Roche Diagnostics and Abbott Laboratories. Frankie > I forgot to add one thing.... > [quoted text clipped - 5 lines] > > Frankie That about says it all Frankie. Great work. Running out for coffee now...let me know if I miss anything. Zee > Recommend a movie for me to rent. I have access to a tv for a few > weeks. > > Zee Whale Rider Bill SignatureZone 5 S Jersey USA Shade Serious Vision Problems like Starghart?s ? --> http://www.ocutech.com/ In article <No1SpamStill__B2wagner-F6CCE4.05020220122004@news.snip.net>, > > Recommend a movie for me to rent. I have access to a tv for a few > > weeks. [quoted text clipped - 4 lines] > > Bill ?Virgin Suicides?and ?Lost in Translation? are worth a view along with ?Insignificance?. Bill SignatureZone 5 S Jersey USA Shade Serious Vision Problems like Starghart?s ? --> http://www.ocutech.com/ My news reader still seems to be missing a lot of these posts. My apologies if this appears oddly "threaded". Zwalanga wrote: > These studies are industry studies, with just about everyone weeded out > who might scew it to industry disadvantage, using relative rather than [quoted text clipped - 4 lines] > will in the event that any or all statins are proven to be like Vioxx > will suddenly have known it all along. If you take the position that all favorable information about medications published by drug companies is of no value, but that negative information is true, then you will, of course, conclude that the only believable "evidence" about medications is that they are harmful. Not really worth discussing the issue further at that point. While I believe the drug companies often behave badly, in general I think it is possible to evaluate most drugs and studies reasonably objectively. Still, drug companies do seem to come up with deceptive practices that had not occurred to me (like running three identical trials and only publishing the one with positive results), so perhaps in the end they will turn out to be so clever that my interpretations of trials is wrong. That said, given current evidence, I think the evidence is overwhelming that statins are beneficial for people with coronary heart disease. If you want to call this an issue of "faith" we apparently have different definitions of faith. As for Vioxx, I can't claim to have known it all along. But since I am generally skeptical of new medications, I've advised people for years to stick with the older NSAIDs unless they had a clear indication for a COX2. This had nothing to do with any suspicion that Vioxx was causing cardiac events, however. SignatureDavid Rind drind@caregroup.harvard.edu > My news reader still seems to be missing a lot of these posts. My > apologies if this appears oddly "threaded". I post right onto google. They are rebuilding and my posts are often lost. Possibly not as often as some would wish. > Zwalanga wrote: > > These studies are industry studies, with just about everyone weeded out [quoted text clipped - 9 lines] > medications published by drug companies is of no value, but that > negative information is true, then you will, of course, conclude that > the only believable "evidence" about medications is that they are > harmful. Not really worth discussing the issue further at that point. <LOL> Is this a debating tactic they teach at Harvard; put me on the defensive right up front? Lost on me. I am not part of that milieu. Never learned the politic response. > While I believe the drug companies often behave badly, in general I > think it is possible to evaluate most drugs and studies reasonably > objectively. I am sure it is possible. But I am also sure the possible is not being practiced. Just to use the most recent example; neither are the physicians employed by the FDA. Still, drug companies do seem to come up with deceptive > practices that had not occurred to me (like running three identical > trials and only publishing the one with positive results), so perhaps in > the end they will turn out to be so clever that my interpretations of > trials is wrong. That said, given current evidence, I think the evidence > is overwhelming that statins are beneficial for people with coronary > heart disease. I think there may be a role for statins there. But that is a very small real application, and nothing compared to the role pharma marketing departments have created. If you want to call this an issue of "faith" we > apparently have different definitions of faith. It is faith when people buy anything, drugs or cars, based on desire or "need" created by clever marketing. > As for Vioxx, I can't claim to have known it all along. But since I am > generally skeptical of new medications, I've advised people for years to > stickwith the older NSAIDs unless they had a clear indication for a > COX2. This had nothing to do with any suspicion that Vioxx was causing > cardiac events, however. Zee David Rind <drind@caregroup.harvard.edu> wrote in news:cq7s1k$n3a$1 @reader2.panix.com: > My news reader still seems to be missing a lot of these posts. My > apologies if this appears oddly "threaded". [quoted text clipped - 8 lines] >> will in the event that any or all statins are proven to be like Vioxx >> will suddenly have known it all along. > If you take the position that all favorable information about > medications published by drug companies is of no value, but that > negative information is true, then you will, of course, conclude that > the only believable "evidence" about medications is that they are > harmful. Not really worth discussing the issue further at that point. Well put and right on the nose. L. >David Rind <drind@caregroup.harvard.edu> wrote in news:cq7s1k$n3a$1 >@reader2.panix.com: [quoted text clipped - 21 lines] > >L. Statins are going to go the same way Cox-2 inhibitors are going, just a matter of time. IMHO at wrote: > >David Rind <drind@caregroup.harvard.edu> wrote in news:cq7s1k$n3a$1 > >@reader2.panix.com: [quoted text clipped - 25 lines] > matter of time. > IMHO Why do you say that? (Not that I don't have my own opinion, just want to hear yours.) Zee >>David Rind <drind@caregroup.harvard.edu> wrote in news:cq7s1k$n3a$1 >>@reader2.panix.com: [quoted text clipped - 26 lines] > a matter of time. > IMHO Unlikely, with millions of people safely taking statins. It's more possible that as cardiovascular research improves and specific mechanisms are better understood statins will be replaced by even more effective, better targeted medications. L. >>>David Rind <drind@caregroup.harvard.edu> wrote in news:cq7s1k$n3a$1 >>>@reader2.panix.com: [quoted text clipped - 33 lines] > >L. Guess we shall see........ >>David Rind <drind@caregroup.harvard.edu> wrote in news:cq7s1k$n3a$1 >>@reader2.panix.com: [quoted text clipped - 25 lines] >matter of time. >IMHO (Oh, for the same basic reasons, sorry I wasn't clear.) Read Ravnskov's: The Cholesterol Myths, for some good information on the actual relation of cholesterol to ASCVD. Chuck, agn just IMHO, what do I know????? > I'm not sure why, but I never got this on my news server: > [quoted text clipped - 42 lines] > I agree with the basic point that looking at relative differences in > mortality (or cardiac events) with statins is not terribly helpful in > making individual decisions. Beyond that, I agree completely that drug > companies and researchers routinely use relative risk reductions to make > the benefits of a drug seem much greater than they really are.(I also > think a 42% decrease in events is higher than the averages seen in most > statin studies.) [quoted text clipped - 9 lines] > that degree of relative reduction translates into an *absolute > reduction* you would care about. So if reducing your risk of an event > from, say, 9% to 6% over the next 10 years doesn't seem worth taking a > pill every day and risking side effects, I would completely agree with a [quoted text clipped - 9 lines] > David Rind > drind@caregroup.harvard.edu These studies are industry studies, with just about everyone weeded out who might scew it to industry disadvantage, using relative rather than absolute numbers and ending the trials before major side effects show up. Wright requested *all* negative information for the statins in secondary use for example, and has yet to receive it. Why? I have every confidence that those who so adamantly stand on faith here will in the event that any or all statins are proven to be like Vioxx will suddenly have known it all along. Zee And David, just in case I have not made that clear; I do not blame any one entity for this situation. My government is responsible, the drug regulatory bodies (FDA and Health Canada) are responsible, the pharmaceutical companies are responsible, and finally yes, the physician on the front line is responsible but mostly; me. I am responsible for this problem. And I am responsible for cleaning it up. Zee > I'm not sure why, but I never got this on my news server: > [quoted text clipped - 42 lines] > I agree with the basic point that looking at relative differences in > mortality (or cardiac events) with statins is not terribly helpful in > making individual decisions. Beyond that, I agree completely that drug > companies and researchers routinely use relative risk reductions to make > the benefits of a drug seem much greater than they really are.(I also > think a 42% decrease in events is higher than the averages seen in most > statin studies.) [quoted text clipped - 9 lines] > that degree of relative reduction translates into an *absolute > reduction* you would care about. So if reducing your risk of an event > from, say, 9% to 6% over the next 10 years doesn't seem worth taking a > pill every day and risking side effects, I would completely agree with a [quoted text clipped - 5 lines] > drop that risk to 20%. In between, individual patient preferences will > lead to individual decisions. There's no one right answer for everyone. |
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