Comments on: Drug Lawsuits Made These States Judicial Hellholes

By: patrons99

patrons99 — Thu, 17 Dec 2009 22:00:59 +0000

Pharmavet, I strongly disagree. CDC might even be worse than FDA at managing drug safety. The WHO, CDC, EMEA, and FDA are all marching to the beat of the same drummer (pharma $$$). Their interests are all conflicted. I certainly do not consider the CDC to be independent of pharma.

By: pharmavet

pharmavet — Thu, 17 Dec 2009 21:16:18 +0000

Patrons99 is correct as far as accurate safety information from FDA. Believe it or not, a few years ago I had to actually had to submit FOIA request on behalf of a pharmaceutical company to access safety data from the AERS database that was more than a few years old. The data were needed for a citizen’s petition, which was submitted way overdue because of the FOIA delay. When we finally received the data, it looked as if had been cut and pasted from several of the FDA’s ancient computer systems. Therefore maybe an independent group is one way to go. The CDC does a pretty good job with their databases. Maybe we should give the job to them.

By: patrons99

patrons99 — Thu, 17 Dec 2009 19:18:42 +0000

pharmavet,

I agree that doctors must shoulder at least part of the blame for under-reporting of AE’s. However, the current system of drug and biologic safety monitoring is broken. Drug (drug, biologic, and device) safety must be completely independent of both FDA and pharma. Anything less is certain to fail. FDA became a client (shill) of pharma in 1992, with the initial enactment of the PDUFA. The public deserves an independent worldwide drug safety database, where both data entry and analysis are independent of pharma’s influence. You cannot let a wolf (FDA and pharma) watch over a hen house. No one should really be surprised at the current drug safety crisis.

By: pharmavet

pharmavet — Thu, 17 Dec 2009 17:03:52 +0000

Patrons99 I think stated on another thread that you are a physician, but even if you’re not, here’s a question for all physicians: How many of you have compulsively filled out an online Medwatch Form each and every time whenever one of your patients has a potentially drug-related adverse event. Answer is very few of you take the 10-15 minutes or so to complete the forms. Most doctors have never even takenn the time tom learn about Medwatch. Therefore, if there is any under-reporting of AE’s, doctors must shoulder at least part of the blame.

By: Doc

Doc — Thu, 17 Dec 2009 10:51:03 +0000

Batman,
Ditto.

By: Batman

Batman — Wed, 16 Dec 2009 23:47:38 +0000

The truth is that these drug companies withhold important information about potential AEs (Adverse Events) for PROFIT. I remember speaking with a Prempro rep who had tons of material that was not appropriate and the company sent it to the reps according to this person. This drug is now a major issue in the courts.

Who is responsible? Likely those above the rep level as they decide who is in the know about threatening issues with the drug. Info is held back for the sake of great sales.

Its one of many. The Hell Holes exist due to the greed and the “profit at any cost mentality”. Unless they hold executives to the fire things won’t change. I mean high up executives too.

Don’t forget the doctors that took the money and eagerly looked away from the obvious issues with their patients taking Vioxx either. The paid consultants were too busy cashing their checks to do no harm.

Batman

By: patrons99

patrons99 — Wed, 16 Dec 2009 17:11:29 +0000

Great post Ed!

As a non-attorney, I am gaining an appreciation of how product liability claims are a major means of redressing personal injuries to the public caused by the myriad of dangerous drugs in the marketplace.

Every pharma should be compelled to disclose how much they pay the preemption lobby in each state on a year-by-year basis. It’s sad to see more states moving in the direction taken by Michigan.

By: Justice in MI

Justice in MI — Wed, 16 Dec 2009 16:47:30 +0000

Ah, some of my favorite reading. The Hellholes report is written in the style of someone who has had 33 too many cups of coffee and is probably off his, well, Zyprexa, for example. Lurid stuff! Great to keep by toilet.

But here is the more serious part. As a result of losing so definitively in Wyeth v. Levine, the preemption lobby–led by ATRA–has escalated its state-by-state strategy. The goal is to get other states to pass statutes similar to ours in Michigan, which provides, in practice, a full shield for drug companies against any liability suits.

The preemption lobby has had some success. And while it is unlikely that states like NJ, NY, CT, or MA will pass such bills–where most of the pharma headquarters are–Texas already has one that is close, and a number of other southern and western states will feel the press of initatives over the next few years (as GA will again).

So, if you don’t want to live in a _real_ judicial hellhole, keep your eyes peeled.