Comments on: Pfizer Manipulated Neurontin Studies: Experts

By: suzanne miller

suzanne miller — Sat, 14 Nov 2009 03:55:09 +0000

it help my pain so I say its a keeper

By: Virginia Lee

Virginia Lee — Fri, 17 Oct 2008 14:24:39 +0000

After reading all of these articles and comments I want to thank Justice in MI for all your thoughtful comments. I agree with Just A Thought. Thanks to for the FDA and Ex pharms folks too. All this supports my descision to not use products of the strength to harm me that Pfizer and others like them have developed. It seems the more of them you use the more you need to kill the side effects the first one caused. Is there a problem with treating the disease in this country? Maybe it is all about money; which will doom us all.

By: Justice in MI

Justice in MI — Thu, 09 Oct 2008 15:58:01 +0000

As I understand it (not that well), the major journals are now requiring more along the lines of what you write.

But I’m not sure how they “police” it. And, if violated, I still doubt it is within the purview of FDA.

So the core of my point: Here is a way to commit hard-core fraud, with serious consequences, yet be fully protected if preemption becomes law - even though this is an arena FDA doesn’t even regulate!

Talk about a power grab….

By: Former pharma Marketing Exec

Former pharma Marketing Exec — Thu, 09 Oct 2008 01:44:55 +0000

Shouldn’t the FDA request that any published studies on any drug be written by the PI’s tmeselves and only after the PI’s can firmly attest to having seen all the raw data?

We know that Pharma does not always provide all the raw data back to the PI’s and we know that very often these studies are written by either people in the medical department of the drug in question or ghost writers hired by pharma.

If the PI realizes that action can be brought against them for not reviewing all the raw data, well this should certainly help to curtail these malicious activities.

You know, the line between snake oil sellers and pharma is getting thinner and thinner, or has it already disappeared?

By: Justice in MI

Justice in MI — Wed, 08 Oct 2008 22:48:37 +0000

To Just a Thought - I have had the same thoughts.. In some respects, not all bad. If a likely anti-preemption Congresss is elected, and one assumes the Supreme Court does not live in a political vacuum, a more narrow ruling in Levine becomes more probable.

By: Justice in MI

Justice in MI — Wed, 08 Oct 2008 22:41:34 +0000

FDA Reviewer wrote: “I have seen numerous examples where even after the company has been told no to what they claim they still go ahead and publish the same claims even after FDA has rejected them.”

This was precisely the case with the CLASS study as published in JAMA. FDA did nothing, of course. beyond an untypically quoteable expression of exasperation from Bob Temple.

To Dan - What is “newsworthy” in the current story is that this is independent of the off-label scam of 2004. If true, this is fraud on docs and pts for _approved_ uses of Neurontin.

By: Dan A.

Dan A. — Wed, 08 Oct 2008 21:38:20 +0000

This was known by the DOJ years ago about these issues with Neurontin via David Franklin, a Harvard PhD CSL who pushed off- label with Neurotonin using constructed Parke- Davis (Pfizer bought this company’s parent, Warner Lambert, about a decade ago)studies to physician targets by coercion of his employer. They settled in 2004, as a result of reporting this activity to the US Attorneys and others in 1996. He only worked for them for a few months. You can read about the case on the DOJ or TAF websites, or via a search engine.

By: An FDA reviewer

An FDA reviewer — Wed, 08 Oct 2008 20:53:49 +0000

Re: Justice’s comments. I’m not aware of any regulatory authority FDA has over publications.

No matter what the data says a company may make whatever claims they want about what it means when they submit it. It’s the FDA’s job to separate wheat from chaff. I have seen numerous examples where even after the company has been told no to what they claim they still go ahead and publish the same claims even after FDA has rejected them.

I’ve even seen where companies have been told no to advertising claims multiple times and still go ahead and then even when the FDA advertising division is aware of it the FDA does absolutely nothing.

By: Chris

Chris — Wed, 08 Oct 2008 19:27:13 +0000

Meanwhile, we still have the FDA proposing allowing the distribution of off-label journal articles by pharma companies.

By: Just A Thought

Just A Thought — Wed, 08 Oct 2008 18:57:49 +0000

I am not seedy enough for this world.

FYI, JiM, a friend wrote me regarding a story he saw on MSNBC which mentioned the Levine case. He thought it was to be heard sometime in the last couple of days and was not aware of the FDA preemption movement. I was confused because I knew it was to be in November. Ed explained to me that the MSNBC report was the Supreme Court discussing the things coming up for their new session. So word has gotten out to some tiny extent. Of course it is also being over-shadowed by Wall Street and the election season. Is it any wonder that the case will be heard in November when our votes will be cast. I have become cynical enough to think that is by design. Ruling possibly depending on who wins?

For those who think the FDA is careful and that this industry is an example of morality:
I’d like to set you up with a low adjustable rate mortgage so you can buy the mansion of your dreams.