tag:blogger.com,1999:blog-36762711.post8288338094645784975..comments2023-11-03T06:14:58.449-04:00Comments on Drug and Device Law: Obama Wins!Rachel B. Weilhttp://www.blogger.com/profile/02251124525069607080noreply@blogger.comBlogger7125tag:blogger.com,1999:blog-36762711.post-56558551938227777312008-10-22T09:13:00.000-04:002008-10-22T09:13:00.000-04:00Here is a copy of an email that was under protecte...Here is a copy of an email that was under protected order until the Ortho Evra plaintiffs got it released. It shows the exact mentality of the drug companies: <BR/><BR/>Email from Paul Soons (Dr Paul Soons, Vice President Clinical Development Johnson & Johnson)<BR/><BR/>“Just got a strange(great??) idea on solving the issue of which product to take as reference product in a possible future (BE) study if we were to reformulate EVRA…why not take an IV comparison in such trial and really confirm what is in the label: “…releases 20 micrograms of EE to the blood stream per 24 hours…and…Css of EE during one week of patch wear is approx. 40-50pg/ml…”<BR/><BR/>So this is how they pharmaceutical companies trick us. They did not tell the women that the estrogen level on the package was for IV administation and not the patch that was worn on the body. And this email is directly from the VP/Dr. of Clincial Development. And you want to trust these folks?Anonymousnoreply@blogger.comtag:blogger.com,1999:blog-36762711.post-4279488613280481802008-10-22T01:49:00.000-04:002008-10-22T01:49:00.000-04:00You're amateurs. Tell us what the market's going t...You're amateurs. Tell us what the market's going to do. (And no fair saying it's going to go up during the next 30 years.)Anonymousnoreply@blogger.comtag:blogger.com,1999:blog-36762711.post-42247950383375069362008-10-21T13:39:00.000-04:002008-10-21T13:39:00.000-04:00Bye bye Billable hours.Bye bye Billable hours.Anonymousnoreply@blogger.comtag:blogger.com,1999:blog-36762711.post-83137247457683937462008-10-21T13:33:00.000-04:002008-10-21T13:33:00.000-04:00A legislative fix would certainly occur given the ...A legislative fix would certainly occur given the importance of trial lawyer contributions to the Democratic party and the trial lawyers have lots of chips to call in. Second, any decision in Levine will likely be narrowly drawn and not field preemption as the Wyeth lawyers have told their client. Isn't amazing how Wyeth continually gets it wrong? You want tea leaves: Watch the HRT litigation bankrupt Wyeth.Anonymousnoreply@blogger.comtag:blogger.com,1999:blog-36762711.post-48210252812480914862008-10-21T11:59:00.000-04:002008-10-21T11:59:00.000-04:00Since we're reading tea leaves, my tea is on the n...Since we're reading tea leaves, my tea is on the notion that FDA will be a higher priority than suggested, mainly because pharma and accountability are on the tea table in a very different way.<BR/><BR/>The attacks on the agency in the <BR/>90s, amounting to calls for its dissolution, came from many of the same folks who support preemption today. Deregulation and preemption are part of a single movement. Dingell, Waxman, et. al. remember it well.Anonymousnoreply@blogger.comtag:blogger.com,1999:blog-36762711.post-25575306821619464542008-10-21T10:03:00.000-04:002008-10-21T10:03:00.000-04:00Does anyone know how popular the Wyeth v. Levine o...Does anyone know how popular the Wyeth v. Levine oral arguments will be on the 3rd? For those who are planning to attend, how early would you go? Thanks.Anonymousnoreply@blogger.comtag:blogger.com,1999:blog-36762711.post-69710090522669471102008-10-21T10:00:00.000-04:002008-10-21T10:00:00.000-04:00Couldn't an all-democratic congress and democratic...Couldn't an all-democratic congress and democratic executive just statutorily overrule Wyeth should it come down in the drug-and-device-law-blog's favor?Anonymousnoreply@blogger.com