 |  |
 |  |  | |||||||
|
--- Merck Withdraws Arthritis Drug Vioxx
"Dr. Andrew B. Chung, MD/PhD" news:41614361.53A1@heartmdphd.com... > Louise wrote: >> >> In article >> ruben@mrbrklyn.com says... >> > On Fri, 01 Oct 2004 00:18:22 +0000, BilZ0r wrote: >> > >> > > I'm a bit confused. I was SURE I heard on PBS, that there was -some- >> > > early data that indicated an increased risk, and it wasn't until the >> > > colon cancer trial came out that they were sure. I can't find >> > > anything >> > > to back this up now, but it does seem odd, that if the RR was ~100% >> > > higher in the rofecoxib group, that initial phase II-IV trials didn't >> > > spot it. >> > >> > >> > There are many results which simply don't show up until you reach huge >> > numbers of trials. In the case of VIOXX the reduction of adverse >> > affects >> > as compared to tradition NSAID was so large, that any risk was >> > acceptable, >> > and now with newer agents and harder evidence, they are say it is not. >> > >> > The drug is not unsafe and unmarketable. It is not ***AS*** safe as >> > newer >> > agents so they pulled the drug. >> > >> > Ruben >> > >> Problem is: if you are allergic to sulfa, as I am, then Celebrex and >> Bextra are not viable alternatives. Is there something else to try that >> would be as safe and, a "newer agent"? I had trouble with the old >> NSAIDs due to stomach and GERD issues. > > Would suggest you ask your doctor about flavocoxids. > > Example: > > http://www.mcramerican.com/limbrel.htm > > Very good suggestion for this persons problem and there are millions of people just like her. If they find down the road that this has a serious side effect for some people,,,,, it will be pulled also and the lawyers will get involved and we will read here its all about commercialism and bad old drug companies. So it goes. Harv
On Mon, 04 Oct 2004 08:34:41 -0400, Dr. Andrew B. Chung, MD/PhD wrote: > Would suggest you ask your doctor about flavocoxids. > > Example: > > http://www.mcramerican.com/limbrel.htm That doesn't look like it is on the market yet, and I don't have any information yet on it on the on line database. Will need tosearch Index Medicus. Ruben Safir RPh
Louise news:MPG.1bca9833b69c728c98973d@news-server.nyc.rr.com: > Problem is: if you are allergic to sulfa, as I am, then Celebrex and > Bextra are not viable alternatives. Is there something else to try > that would be as safe and, a "newer agent"? I had trouble with the > old NSAIDs due to stomach and GERD issues. > > TIA > > Louise My mother is seriously allergic to sulphonamides, but she's found celebrex the most side-effect free drug she has ever taken.
In article Louise >In article >ruben@mrbrklyn.com says... >> On Fri, 01 Oct 2004 00:18:22 +0000, BilZ0r wrote: >> > I'm a bit confused. I was SURE I heard on PBS, that there was -some- >> > early data that indicated an increased risk, and it wasn't until the >> > colon cancer trial came out that they were sure. I can't find anything >> > to back this up now, but it does seem odd, that if the RR was ~100% >> > higher in the rofecoxib group, that initial phase II-IV trials didn't >> > spot it. >> There are many results which simply don't show up until you reach huge >> numbers of trials. In the case of VIOXX the reduction of adverse affects >> as compared to tradition NSAID was so large, that any risk was acceptable, >> and now with newer agents and harder evidence, they are say it is not. The problem with detecting RR is that the "effective sample size", assuming equal numbers in the treatment and control groups, is essentially the total number found to be at risk. The thousands of others give VERY little information. >> The drug is not unsafe and unmarketable. It is not ***AS*** safe as newer >> agents so they pulled the drug. >Problem is: if you are allergic to sulfa, as I am, then Celebrex and >Bextra are not viable alternatives. Is there something else to try that >would be as safe and, a "newer agent"? I had trouble with the old >NSAIDs due to stomach and GERD issues. This agrees with what I stated in an earlier posting. It should be up to the individual to decide if this increased risk is present or important, and to compare it with the benefits. -- 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
In article BilZ0r >"M*a*r*k P*r*o*b*e*r*t-September 30, 2004" >09-30-04@lambercartel.com> wrote in >news:jwY6d.14308$kq6.7872091@news4.srv.hcvlny.cv.net: >> That is not the marketing standard. A pharmaceutical must be proven >> safe and effective prior to marketing. Testing, which is VERY >> expensive sometimes does not show a problem until the cohort is very >> large. In the Vioxx case, it was a post marketing follow-up that found >> the problem. >I'm a bit confused. I was SURE I heard on PBS, that there was -some- >early data that indicated an increased risk, and it wasn't until the >colon cancer trial came out that they were sure. I can't find anything >to back this up now, but it does seem odd, that if the RR was ~100% >higher in the rofecoxib group, that initial phase II-IV trials didn't >spot it. >But then again, according to forbes.com, there were 5 deaths in the >placebo group, and 10 in the rofecoxib group. so I'd like to see some >actual data on the confidence interval that would fit around that data. Assuming that the sample sizes were equal (if not, some changes need to be made in the calculations), the classical test of significance would give a p-value of about .1509, not usually being accepted as significant. Bayesian calculations would give the "standard" posterior odds as a function of the risk ratio, with 1.0 meaning no difference in effect, as risk ratio odds ratio 1.0 1.0 1.5 2.03 2.0 2.34 2.5 2.16 3.0 1.80 3.5 1.44 4.0 1.13 Remember that large risk ratios have smaller priors, and the scale is more distorted than one would think. If this is the actual data, with 15 total deaths, and the sample sizes were equal, the risk should be made public, and the drug still available. If there were far more in the placebo group, the evidence would be greater, and if there were more in the test group, the evidence would be less. -- 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 « Previous 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 Next » Related Discussion: NATURAL CURE FOR UROLOGY DISFUNCTIONS (2 posts) Re: PROPOSAL: ALT.THYROID (1 posts) Optimal Health (1 posts) Program Links Diabetic Kids With Doctors (1 posts) Top Discussions From Our Archives Fading social life may signal trouble in diabetes Food, Culture, and Diabetes in the United States [Fwd: LYCOPENE AND HEART DISEASE] Other Discussion Categories Diabetes Symptoms Health Care Policy Health Care Providers HMO Arthritis Symptoms Oops!!! Unexpected Error While Reading the Feed
|
| ||||||||
 |  |
