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--- Prominent cardiologist criticizes drug ads
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." > > http://www.forbes.com/technology/2004/12/30/cx_mh_1230vioxx.html > > Vioxx: More Debate, More Data > Matthew Herper, 12.30.04 > > As doctors struggle to come to grips with what the withdrawal of Vioxx > means for drug safety, the letters pages of the normally sedate New > England Journal of Medicine have turned into a battleground. > > Today's issue contains a letter from Merck, defending itself against > charges from Dr. Eric Topol, the Cleveland Clinic's top cardiologist, > who has said repeatedly that the company should have known far earlier > that Vioxx increased the risk of heart attack. > > 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. > > The fight is more than just academic. The dueling letters are one of > the few times that Merck's scientists have publicly defended their > approach to the drug since the company pulled it off the market. And > Topol's analysis seems to show that even if Merck wasn't aware of the > possible risks to the heart posed by Vioxx, perhaps it should have > been. > > In their letter, Peter Kim, Merck's research chief, and Alise Reicin, > who headed up much of the development of Vioxx, defend their company's > handling of the matter. "Merck has been proactive and conscientious in > evaluating the cardiovascular profile of rofecoxib (Vioxx)," they > write. "Dr. Topol's remarks to the contrary in his Perspective article > (Oct. 21 issue) are false." > > 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 > protected 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. 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. > > 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. http://content.nejm.org/cgi/content/full/351/27/2875 "We indeed acknowledged that naproxen may have a cardioprotective effect,5 but the magnitude of the effect would be unlikely to exceed that of aspirin, at a 25 percent reduction of heart attacks. Instead, in the VIGOR trial, there was a 500 percent increase in heart attacks. This makes any "naproxen hypothesis" of cardioprotection mathematically indefensible." Eric J. Topol, M.D. Cleveland Clinic Foundation Cleveland, OH 44195
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. It also has to be compared to the benefits which they got. .................. >> 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. ................... >> 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 >> protected 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. 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. Naproxen has fewer such problems than aspirin, but it has them. 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. >> 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? 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. >http://content.nejm.org/cgi/content/full/351/27/2875 >"We indeed acknowledged that naproxen may have a cardioprotective >effect,5 but the magnitude of the effect would be unlikely to exceed >that of aspirin, at a 25 percent reduction of heart attacks. Instead, >in the VIGOR trial, there was a 500 percent increase in heart attacks. >This makes any "naproxen hypothesis" of cardioprotection mathematically >indefensible." >Eric J. Topol, M.D. >Cleveland Clinic Foundation >Cleveland, OH 44195 As the blood-thinning properties of aspirin make it the drug of choice in preventing cardiovascular problems, this is almost a ridiculous statement. But we still have the problem of providing pain relief without doing too much other damage, and one reason why acetomenaphen (sp?) is used so much is that it does not have the stomach acidity reaction of aspirin; naproxen is in between, and the Cox-2 inhibitors work in a different manner. -- 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
hrubin@odds.stat.purdue.edu (Herman Rubin) wrote: >Do you have any idea what statistical significance means? >I doubt that Topol does. 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. I suspect very few folks have any understanding of the statistics involved. It'll be interesting to see if Merck's attorneys are able to explain this stuff to juries. The case against Merck is not nearly as clear cut as people think, and the results of a trial could be a big surprise (which would doubtless have everyone talking about those "dumb jurors")
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. 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?) 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. > > 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. > > >> 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. > > >http://content.nejm.org/cgi/content/full/351/27/2875 > > >"We indeed acknowledged that naproxen may have a cardioprotective > >effect,5 but the magnitude of the effect would be unlikely to exceed > >that of aspirin, at a 25 percent reduction of heart attacks. Instead, > >in the VIGOR trial, there was a 500 percent increase in heart attacks. > >This makes any "naproxen hypothesis" of cardioprotection mathematically > >indefensible." > >Eric J. Topol, M.D. > >Cleveland Clinic Foundation > >Cleveland, OH 44195 > > As the blood-thinning properties of aspirin make it the > drug of choice in preventing cardiovascular problems, this > is almost a ridiculous statement. Really? If statins act not by lowering cholesterol but by temporing inflammation in the way aspirin does, why then do people not just take the less problematic and cheaper aspirin? Because, I would say, a couple billion has not been spent telling us we are beautiful people leaping around in the surf and aspirin got us there. But we still have the > problem of providing pain relief I contend many do not do what they could and should before they take painkillers. In rheumatoiod arthritis, this is different. But that is not the majority of those using these drugs for what I think is often frivolous reasons. without doing too much > other damage, and one reason why acetomenaphen (sp?) is > used so much is that it does not have the stomach acidity > reaction of aspirin; naproxen is in between, and the > Cox-2 inhibitors work in a different manner. > > > -- > 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
On 30 Dec 2004 16:28:34 -0800, "outrider" wrote: > >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). 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? 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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