Comments on: Merck & Schering-Plough Battle Skepticism

By: zetia news | Info trend it

zetia news | Info trend it — Tue, 15 Jan 2008 02:30:49 +0000

[...] Merck &amp Schering-Plough Battle Skepticism [...]

By: Lilli

Lilli — Sat, 12 Jan 2008 20:00:15 +0000

Zocor and all the other Statin medications have toxic ingredients that doctors are not watching or reporting the serious harmful side effects that leads to premature death. Hospitals, medical industries, ddoctors and Congress and the the courts to be influenced by the power of the Pharmceutical Companies.
My husband died because doctors would not admit his problem was from Zocor. Pharamceuticals are causing death from medications. Labels on medications mean nothing if doctors do not monitor or report the problems with the medications.
If Americans want honest medical healcare they must contact Congress. Instead of saying, “We Can Not fight City Hall,Keep calling .” Over the counter prescription for cholesterol must be stopped and Congress must pass a honest truthful medication reporting system.

By: FDAAA - Results Database

FDAAA - Results Database — Wed, 21 Nov 2007 13:21:38 +0000

Under the Title VIII of the FDA Amendments Act of 2007 (Public Law 110-85, Sec. 801(a)), the ENHANCE trial (http://clinicaltrials.gov/ct2/show/NCT00552097) summary data of the results would be posted on the “results database” at ClinicalTrials.gov, to be operational by Sept 2008. The required basic results data — including demographic and baseline characteristics; primary and secondary outcome; and serious and frequency adverse events — are required to be submitted within 1 year of study completion for approved drugs, with a delay up to 2 years for trials for “new uses.”

Regarding trial registration, PL 110-85 Sec. 801 also expands the ClinicalTrials.gov registry to require registration of trials for all diseases and conditions, not just those that are “serious or life-threatening” under the previous law, no later than 21 days after enrolling the first patient (http://prsinfo.clinicaltrials.gov/fdaaa.html).

The result should be increased transparency in clinical research, including timely disclosure about ongoing trials and their results.

By: CV MD

CV MD — Tue, 20 Nov 2007 23:54:37 +0000

Hey Merck Schering-Plough,

I’ve got some oceanfront land in Arizona. Are you interested? Why not? You expect people to buy your latest “spinning of the truth.”

CV MD

By: MDMD

MDMD — Tue, 20 Nov 2007 22:27:59 +0000

I hope they get audited by the FDA! They’ll get to the bottom of this fiasco!

By: Concerned CV MD

Concerned CV MD — Tue, 20 Nov 2007 20:34:04 +0000

Who is going to believe any of this? Merck and Schering-Plough are trying to protect their $4 billion franchise of Zetia and Vytorin. This smacks of a failed trial. Whoever heard of changing the primary endpoint 15 months after the clinical trial is done? They haven’t peeked at the data? ENHANCE is now worthless for anything.

By: Dusgusted

Dusgusted — Tue, 20 Nov 2007 19:47:14 +0000

Dear Ed,

Forbes and the WSJ are right on target! Fifteen months after the clinical portion of the study is finished, they’re going to change the primary endpoint? They haven’t looked at the data? An Advisory Board that includes the lead investigator has advised to change the endpoint? No conflict of interest there! The integrity of the study has been destroyed and the regulatory authorities should render it worthless!

Just ask Steven Nissen or the FDA for their opinion. 10 to 1 they would agree. Merck and Schering-plough are just trying to protect their $4+ billion flagship products (Zetia and Vytorin). It’s very bad for them if they don’t do the same thing as Lipitor and Crestor have been shown to do. The FDA needs to audit them!

Disgusted