Given relevant history, it still seems extremely unlikely to me that FDA/DOJ would itself take legal action for any of this.

However, FDA preemption has not yet been upheld, and it seems conceivable that a state-level damages case could include some of this material. Again, the defense would be that only FDA can rule about its own defrauding, based on the Buckman case. But in Kent v. Warner-Lambert the SC was tied 4-4 (Roberts recused himself because of stock-holdings), a case that turned, in part, on Buckman and its relevance.

Thus, while a very long long-shot, it now does seem to me that there _may_ be material here that, at some level, could be used in relevant legal action.

Either way, the airing of the story via Grassley’s committee will - one hopes - provide one more cautionary tale about how things sometimes happen.

I’ll also ask what I often do: Assuming there were such “coding maneuvers,” how do industry folks view this? Is this the kind of thing that hardly ever happens? The kind of thing relatively easy to make happen? The kind of thing that happens more than it used to?

Thank you.

“The obfuscation of the risks via creative coding undermines the FDA approval. Unless the FDA was explicitly aware that the data being presented as emotional liability was, in fact, a mix of suicidality/suicidal ideation and emotional lability, the data presented in the tables, figures and listings is an example of intentionally misleading reviewers and undermining the federal regulatory process. In such a situation, wouldn’t there be a possibility of an extremely strong case in the federal courts?

If the FDA was aware and did not ensure accurate representation of the data, correct labeling and prescribing information, would it be possible to appeal the federal pre-emption ruling with an argument that the FDA failed to fulfill its obligations?”

One would assume, based on reasonable notions of justice, there would be grounds for such a case, there would almost certainly not be under preemption.

The reason is that, in the first scenario, FDA would have itself to conclude that it was defrauded (if it so believed) and successfully prosecute for felony fraud. Given the history of such cases, the odds of that happening are virtually zero. It’s Office of Criminal Investigation simply do not pursue these kinds of cases. This would apply to either civil or criminal penalties under the first scenario that OC presents.

Re: the second - that the FDA, in effect, collaborated in what some would view as fraud - again, the odds of action are slim to none. Based on relevant precedents, if the FDA does not agree that it was defrauded, I do not believe there is an arena in which that judgment (or that of any similar federal agency) could be challenged.

Probably, the only grounds for action would be if an FDA-insider/whistleblower was able to bring forth evidence that agency officials knowingly colluded with what they knew was non-compliant action by GSK. But, even then, you’d virtually have to have evidence of behavior on the level of bribe-taking or unambiguously damning memos for this to go anywhere. Again, a whistleblower would be needed to produce such stuff.

Sam

There were also 1,308 reports of Suicidal Depression / Suicidal Ideation attributed to Paxil, 119 instances of Homicidal Ideation and 158 reports of Mania.

Taking another view, 1,277 Individual Safety Reports were submitted to the FDA between 2004 and 2007 where the Adverse Reactions were experienced by a pregnant or new mother taking Paxil or her unborn or newborn child being exposed to the drug via the placenta or breast milk. These reports include 65 miscarriages among 112 Deaths: http://www.psychdrugdangers.com/MothersAct.html

The majority of MedWatch (AERS) reports are submitted to the FDA by the Manufactuer after learning of an Adverse Reaction to its product.

These miscarriages and other severe congenital defects (such a Transposition of the Great Vessels wherein the position of the aorta and pulmonary artery are reversed, or Anencephaly where most of the brain and spinal chord are missing at birth) were not caused by a sugar pill.

Sam

I wonder why Mary Anne Rhyne failed to respond to the mags request for numerical proof that Glenmullens conclusion was incorrect? …
Could it be because his interpretation of the Paxil data was NOT incorrect ?

Mary Anne Rhyne has been sprouting corporate bull about Paxil for Years..
Never once has she publically apologised about Study 329, Paxil’s damage to children, or the hundreds of thousands of people who were lied to about Paxil side effects and withdrawals..
Is she a spokesperson or just a paid propagandaist?
Either way…I’m sure Joeseph Goebells would be proud..

If the FDA was aware and did not ensure accurate representation of the data, correct labeling and prescribing information, would it be possible to appeal the federal pre-emption ruling with an argument that the FDA failed to fulfill its obligations?

Regardless, I think this is a situation in which individual personnel directly involved in this fraud (including, but not limited to executives) could and should being held criminally responsible.

Did you notice the similarities between GSK’s words, and the words that are written in the Antidepressant Medication Guide!!!!!!!

Paxil has never been FDA approved for the use in children and Adolescents, and it carries a Black Box Warning for increased violence and suicide.

You can read some of GSK’s internal Documents here:
http://www.paxilharmschildren.com

GSK shouldn’t have bragged about winning Preemption in a case involving a dead child

Adults are 18 and 65
Geriatrics > 65

Pediatrics <18
- Adolescents (a sub-set of pediatrics) are 12-17
- they tend to block younger pediatric age groups for subset analysis in studies of those ages