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--- Prominent cardiologist criticizes drug ads
"Herman Rubin" news:cr72k2$2fu4@odds.stat.purdue.edu... > In article > reeder > >On 30 Dec 2004 16:28:34 -0800, "outrider" > >wrote: > > > >>Herman Rubin wrote: > >>> In article <1104426922.180905.180070@z14g2000cwz.googlegroups.com>, > >>> Outrider > > ................. > > >From the web site "VIOXX - the painful story of politics, business and > >statistics errors" > >http://www.interconus.com/products_dynatrack.htm > >A theory that attributes the increased risk to abnormal changes in the > >structure or shape of lipids caused uniquely by Vioxx, may explain why > >LDLs are more susceptible to oxidative damage, and therefore, > >contribute to cardiovascular damage. Such potential damage should be > >monitored and reversed... > > >Question: How do you "reverse" the Vioxx damage? > > First of all, there is a question whether this theory > is correct. It would not surprise me that any drug > might have this side effect, but as stated this is > not verified. > > If you are aware of the mass of literature on oxidative > damage, you could come up with quite a few possibilities. > What is known about the complicated biochemistry involved > is almost zilch, and this research is not the type which > gets the big funding. > The whole problem with medicine is that the biochemistry of the human animal is still mostly unknown, as in, "What causes cancer" and similar questions.
In article <1104452914.381959.29500@c13g2000cwb.googlegroups.com>, outrider >Herman Rubin wrote: >> In article <1104426922.180905.180070@z14g2000cwz.googlegroups.com>, >> Outrider >> >MrPepper11 wrote: >> >> "A new analysis of four-year-old data shows a 'significant' >increase >> >in >> >> heart attack and stroke in patients taking Vioxx after as little >as >> >six >> >> weeks." >> Yes, but it took four years for them to get the increased >> number of heart attacks and strokes. >They knew and suppressed the data which showed a significant problem >"within six weeks". (the origininating post). >> It also has to be compared to the benefits which they got. >If all this is washed away by a flood of mistrust, pharma and FDA have >no one to blame but themselves. Consumers simply do not trust them >anymore to act in the best interests of healthcare, over stockholders >share. .................. >> >> It also contains Topol's response, in which he publishes a new >> >analysis >> >> of four-year-old data that he says shows a "significant" increase >in >> >> heart attack and stroke in patients taking Vioxx after as little >as >> >six >> >> weeks. The data was previously available only in briefing >documents >> >> prepared by staff at the Food and Drug Administration. >> In that case, the FDA bears some of the responsibility. >Yes they most certainly do. Some might say, more responsibility. >Pat Oliphant Dec 20 >http://www.ucomics.com/patoliphant/2004/12/20/ >> >> Before 2000, they say, there was little clinical evidence of a >heart >> >> risk for Vioxx. Based on a theoretical risk alone, the executives >> >> argue, Merck took care to watch for heart attacks and strokes in >its >> >> big clinical trial. The data from both less-reliable observational >> >> studies and clinical trials was conflicting, and Merck began three >> >big >> >> cancer prevention studies that could also assess any risk Vioxx >> >caused >> >> to the heart. One of these studies was the one that resulted in >Vioxx >> >> being pulled from the market. >> >> "The record, in short, is one of careful analysis at every stage, >a >> >> continued commitment to research and prompt and decisive action in >> >> response to clinical-study results," the scientists say. >> >> Merck's defense all along has been that Vioxx looked bad because >> >> naproxen, another pain killer that it was compared to, actually >> >> potected the heart. Naproxen is an older drug sold by Bayer as >> >Aleve. >> >> But in his response, Topol looks at data from a previous study >that >> >> compared 390 patients taking Vioxx to 588 patients taking a >placebo. >> >> The study, called 090, showed that five, or 1.3%, of patients >taking >> >> Vioxx had heart attacks or strokes, compared to one, or 0.2%, in >the >> >> placebo group. Although those numbers are small, they were >> >> statistically significant, according to Topol. >> Do you have any idea what statistical significance means? >> I doubt that Topol does. >No. Like Topol most surely did in this situation, I would hire someone >who does. On this, you are almost certainly wrong. Statistical significance is the mantra of the religious (meaning ritualistic) use of statistics by people in the medical field. >In this case, a one-sided result >> this strong or stronger would occur by chance one time in 25 >> if there was ABSOLUTELY NO difference, which is less than the >> usual significance level, one in 20. This is all it means. >> But in any case, the question has to be asked whether the >> additional 1%, or even 5%, chance of cardiovascular >> problems is worth the benefits of being able to take the >> drug without gastrointestinal problems. >They did not cause less gastrointestinal problems. (Are you reading the >newest literature on this?) If they did not, they never would have made it. At any rate, they do work in a different manner than NSAIDs. >Naproxen has >> fewer such problems than aspirin, but it has them. >Naproxen raised heart attack risk. I'll take buffered aspirin. And if >it still bothers my stomach I'll take it with a meal. And if I still >have problems, I'll use prilosec or something as little problematic as >I can. I may try glucosamine and chondwhatever; I may also investigate >two nutraceuticals which have recently been mentioned on these >newsgroups. I will use ice, heat, postural modification and physical >therapy. Consistently. Not "try" but will. As we say in the diabetic newsgroup, your mileage may vary. BTW, using Naproxen has been shown to reduce the cardiovascular benefits of aspirin if taken together, but it does have benefits. With the present attitude toward side effects, I am surprised that aspirin has not been withdrawn. However, I have never had any stomach problems from aspirin, and what I take is not buffered. I am taking a proton pump inhibitor, and it is doing its job. But it seems that proton pump inhibitors increase the occurrence of bacterial and viral infections; this is because the first line of defense against them is stomach acid. People in a clinical trial, or other double-blind test, are less likely to have non-major problems that unmonitored people have because of the medical care from the trial. >> The data he based his >> >> analysis on has previously been buried in FDA briefing documents. >> >> Merck's Peter Kim has said in interviews that '090' was too small >to >> >be >> >> considered a strong result. Definitely. One problem in using "statistical significance", which I, as a statistician understanding the problem, which is decision making under uncertainty, would never use as such, is that it requires that there be a "balanced random" sample. This is never the case. One can never prove something by statistics, and can only revise the odds. >> >> For those that have been following the underlying scientific fight >> >over >> >> the testing of Vioxx, the letters are an interesting new twist. >But >> >> unfortunately for Merck, at this point the important forum for >these >> >> questions is not in The New England Journal of Medicine, but in >the >> >> courts, where the first Vioxx liability case could go to trial in >> >2005. >> >Every one of the Merck exec should be brought up on charges. People >> >died because of the way they marketed this drug, knowingly spinning >> >clinical trial evidence. It did not have to be that way. They chose >> >that it would. >> If they had not marketed the drug, how many would be >> severely suffering from arthritis, unable to move >> about, or even in pain? >vida supra >ALL drugs have benefits and >> risks, and these should be spelled out to the extent >> known, and the individual make the decision, including >> what is known about individual behavior. >They should be spelled out. Period. The extent known, must be all >discovered. To date it has not. So this *must* change. Too bad it took >a Vioxx to bring this about. But at this time it is not, and I doubt this will get the FDA to change their policy of concealment, which is a necessary part of their withholding drugs from the market. The policy should be to make the information available, and let the user decide. The information available is far less than that, in both directions. -- This address is for information only. I do not claim that these views are those of the Statistics Department or of Purdue University. Herman Rubin, Department of Statistics, Purdue University hrubin@stat.purdue.edu Phone: (765)494-6054 FAX: (765)494-0558
"Herman Rubin" news:cr71ig$5240@odds.stat.purdue.edu... > > Definitely. One problem in using "statistical significance", > which I, as a statistician understanding the problem, which > is decision making under uncertainty, would never use as such, > is that it requires that there be a "balanced random" sample. > This is never the case. One can never prove something by > statistics, and can only revise the odds. > My my Herman. At it again. Knowing the odds is what we need. The biology of the human animal is far, far from known so the odds is what we go on. You know that. Why rant and rave? > But at this time it is not, and I doubt this will get the > FDA to change their policy of concealment, ^^^^^^^^^^^^^^^^^^^^^^^^^^^^^ Herman, I did not know you were paranoid too. I thought you were just thinking that the rabbit and the ant would solve social probems!!!
On 30 Dec 2004 16:00:24 -0500, hrubin@odds.stat.purdue.edu (Herman Rubin) wrote: > >Do you have any idea what statistical significance means? > >I doubt that Topol does. I'm sure Dr. Topol must have taken Statistics 101 in college: Dr. Eric J. Topol is Chief Academic Officer of The Cleveland Clinic Foundation and Provost of the Cleveland Clinic Lerner College of Medicine of Case Western Reserve University. He is also Chairman of the Department of Cardiovascular Medicine and Professor of Medicine and Genetics. He is Program Director for the NIH supported Specialized Center of Clinically Oriented Research (SCCOR) on the molecular basis of coronary artery disease. He is certified as a Diplomate by the National Board of Medical Examiners, and as a Diplomate by the American Board of Internal Medicine in cardiovascular disease and internal medicine. Dr. Topol has been elected to the American Association of Physicians, the American Society of Clinical Investigation, and the Johns Hopkins Society of Scholars. He is a Fellow of the American College of Cardiology, the American College of Physicians, and the European Society of Cardiology. He has been recognized by the Institute of Scientific Information (ISI) to be in the top 10 (#8) of cited biomedical researchers in medicine (1993-2003), and he is ranked 1st by Science Watch among authors of high impact papers in cardiovascular research (1993-2003). His work on the genomics of coronary disease led to the discovery of the first mutation (MEF2A deletion) inducing coronary disease and heart attack (Science, 2003), and received recognition as a top 10 research advance by the American Heart Association, garnering Dr. Topol the Clinical Research Innovator Award of the Doris Duke Charitable Foundation in 2001. The cardiology program he directs in Cleveland has been ranked Number 1 in the United States by U.S. News & World Report for the past 10 years. Dr. Topol has served as chairman and principal investigator for more than 15 international multi-center randomized clinical trials, including the 5 GUSTO trials, the largest heart attack studies ever conducted, and many others, with cumulatively more than 200,000 patients enrolled. He was the first physician ever to administer recombinant t-PA, 2 different platelet glycoprotein IIb/IIIa inhibitors (abciximab and eptifibatide), and a novel anticoagulant (bivalirudin) to patients with coronary artery disease. The results of these large-scale trials, involving 40 countries around the world, have substantially changed our approach to patients with acute MI, percutaneous coronary interventions, and unstable angina. Currently he serves on the editorial board for over 20 peer-reviewed medical publications including Circulation, Circulation Research, Journal of the American College of Cardiology, American Journal of Cardiology, Heart and the European Heart Journal. He has over 900 original publications and has edited 18 books, including the Textbook of Interventional Cardiology (1s through 4th editions) and the Textbook of Cardiovascular Medicine, the third edition now in preparation. http://www.clevelandclinic.org/
reeder >>Do you have any idea what statistical significance means? >> >>I doubt that Topol does. > >I'm sure Dr. Topol must have taken Statistics 101 in college: Not necessarily. Doctors are notoriously bad at statistics. As a result, they consistently misinterpret and mis-communicate the results of tests. Start « Previous 1 2 3 4 5 6 Next » Related Discussion: XanGo (1 posts) these girls use this service for free - they just want phonesex from real guys 61 (1 posts) Eating Fish Protects Against Stroke (1 posts) Prevention of type 2 diabetes mellitus through inhibition of the Renin-Angiotensin system. (1 posts) Top Discussions From Our Archives Energy. Resilience. Vitality. Want some? Do you do website promotion with no success? Diabetes Spotted at an Earlier Age Other Discussion Categories Diabetes Symptoms Health Care Policy Health Care Providers HMO
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