KA-CHING FOR EMORY AND NEMEROFF

More stories appearing about disgraced psychiatrist, Dr. Charles Nemeroff, in today's press and blogs.

The Wall Street Journal carries the headline: 'Grassley Blasts Emory over ‘CME-Like’ Defense of Nemeroff' and reports how Sen. Charles Grassley is accusing Emory University of making up a new term in an effort to defend its star psychiatrist from accusations he failed to properly report hundreds of thousands of dollars in payments from drug companies during this decade.

In explaining why psychiatrist Charles Nemeroff failed to report payments from GlaxoSmithKline, Emory said Nemeroff reported to them that some of the payments from Glaxo, maker of antidepressant Paxil, were for talks that weren’t promotional in nature but instead were “CME-like.” Calls to Emory and Nemeroff for comment weren’t returned immediately.

The Wall Street Journal Blog reports on how Nemeroff wrote himself a cheque for $3000 for writing an article on Effexor, an antidepressant.

Meantime, The New York Times goes with a story where psychiatrists are 'revising the book of human troubles'.

If we let these psychiatrists write what I think they are going to write then we are going to have one major problem on our hands. It seems some of the questions being thrown into the pot are, Is compulsive shopping a mental problem? Do children who continually recoil from sights and sounds suffer from sensory problems — or just need extra attention? Should a fetish be considered a mental disorder, as many now are?

The book, the Diagnostic and Statistical Manual of Mental Disorders or [DSM-V] is both a medical guidebook and a cultural institution. It helps doctors make a diagnosis. We are heading into the abyss folks and Pharma will be throwing us one by one into that abyss is this book of absurdity sees the light of day.

It's been said that scientists who accepted the invitation to work on the new manual agreed to limit their income from drug makers and other sources to $10,000 a year for the duration of the job.

Hopefully they may find a cure for Pharmaceutical greed.

Fid

Fid

Read the new book, The Evidence, However, Is Clear...The Seroxat Scandal

ORDER THE PAPERBACK
'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman
SIGNED COPIES HERE OR UNSIGNED FROM CHIPMUNKA PUBLISHING

Mail Order Academics

Simply Genius!

Read the new book, The Evidence, However, Is Clear...The Seroxat Scandal

By Bob Fiddaman

ISBN: 978-1-84991-120-7
CHIPMUNKA PUBLISHING

AVAILABLE FOR DOWNLOAD HERE


PAPERBACK COMING SOON

Glaxo & The Premenstrual Collusion

You may remember a few days ago I wrote about the recent study coming out of Hamilton, Ontario regarding Paxil [Seroxat] and PMT [Pre Menstrual Tension]

The study was conducted by Dr. Meir Steiner with St. Joseph's Healthcare.

Thanks to the wonders of the internet I now have the full paper.

The study was conducted by Steiner M, Ravindran AV, Lemelledo JM, Carter D, Huang JO, Anonychuk AM, Simpson SD.

The declaration of interests [Financial Disclosure] shows what I believe to be a severe conflict of interests in this study.

First and foremost the study was funded by GlaxoSmithKline, Canada.

Financial Disclosure:


Financial disclosure:

Dr. Steiner has served as a consultant to Eli Lilly, Pfizer, GlaxoSmithKline, Lundbeck, Novartis, Wyeth, Ortho- McNeil, AstraZeneca, and Azevan; has served on the speakers bureaus of AstraZeneca, Eli Lilly, Pfizer, GlaxoSmithKline, and Wyeth; has served on the advisory boards of Eli Lilly, Pfizer, GlaxoSmithKline, Lundbeck, Ortho-McNeil, Wyeth, Sherring, Ferring, and Azevan; and has received grant/research support from Wyeth, Pfizer, AllerGen, AstraZeneca, Canadian Institutes of Health Research, Society for Women's Health Research, Ontario Mental Health Foundation, and Physicians Services Inc. Foundation.

Dr. Ravindran has received grant/research support from, served as a consultant for and on the advisory boards of, and participated in continuing medical education programs sponsored by AstraZeneca, Cephalon, Eli Lilly, GlaxoSmithKline, Janssen-Ortho, Pfizer, Roche, Servier, and Wyeth.

Dr. LeMelledo has received honorarium and performed clinical trials for Roche, AstraZeneca, GlaxoSmithKline, Pfizer, and Merck and has received funding from Canadian Institutes of Health Research, Canadian Psychiatric Research Foundation, and University of Alberta.

Dr. Carter has received grant/research support from Wyeth.

Mss. Huang and Anonychuk and Dr. Simpson are employees of GlaxoSmithKline, Canada.


Thanks to Neil Carlin for pointing me in the right direction to help me find the full paper for this 'study'.

Fid

Read the new book, The Evidence, However, Is Clear...The Seroxat Scandal

By Bob Fiddaman

ISBN: 978-1-84991-120-7
CHIPMUNKA PUBLISHING

AVAILABLE FOR DOWNLOAD HERE


PAPERBACK COMING SOON

What Are We Working For?

I just read Dr Aubrey Blumsohn's message on Scientific Misconduct entitled 'A crooked scientist'

With the current state of affairs going on at Brown University, Aubrey's message was simple:

There was a crooked man,
And he walked a crooked mile.
To confer with his crooked neighbor,
Who wore a crooked smile.
The crooked man's neighbor,
Lived in a crooked nook.
Both being crooked people,
They read a crooked book.
Inside were crooked tales,
Of other crooked men.
'Twas a crooked man's dream,
Shared with a crooked friend.

The following video by Big Country kind of sells the same message.

Read the new book, The Evidence, However, Is Clear...The Seroxat Scandal

By Bob Fiddaman

ISBN: 978-1-84991-120-7
CHIPMUNKA PUBLISHING

AVAILABLE FOR DOWNLOAD HERE


PAPERBACK COMING SOON

Alabama Sues GSK, Novartis for $800 Million in AWP Case

Source FDA News

Alabama Sues GSK, Novartis for $800 Million in AWP Case

The state of Alabama has begun its trial against Novartis and SmithKline Beecham, a subsidiary of GlaxoSmithKline (GSK), for as much as $800 million for allegedly overcharging Medicare, Medicaid and private insurers by inflating the average wholesale price (AWP) of drugs.

Read on

Read the new book, The Evidence, However, Is Clear...The Seroxat Scandal

By Bob Fiddaman

ISBN: 978-1-84991-120-7
CHIPMUNKA PUBLISHING

AVAILABLE FOR DOWNLOAD HERE


PAPERBACK COMING SOON

New study about antidepressants – Big Pharma and medical agency working close together to save profits and careers

The news that antidepressants in actual fact don’t work better than sugar pills and increase the risk for suicide have filled major media the last year. Psychiatrists, Big Pharma and medical agencies, responsible for distorting the facts for many years, are now working hard to save profits and careers.
Sweden 6/25/2008 07:29 PM GMT (TransWorldNews)


Janne Larsson
Reporter – investigating psychiatry

Source: Transworld News

The new study, “A Regulatory Apologia - A review of placebo controlled studies of new-generation antidepressants”, claiming that antidepressants work well for all forms of depression should be seen in that light. It’s another good example of how alleged objective medical agencies work close together with the pharmaceutical industry and its paid psychiatrists to increase sales.

The study was announced in the journal of the Swedish Medical Association (Läkartidningen) April 15, 2008. In the article the longstanding advocate for antidepressant drugs Professor Björn Beerman from the Swedish equivalent to the FDA, the Medical Products Agency (MPA), promoted continued high level use of these drugs. Beerman did not believe in the data presented internationally and said (as many times before) “there is no doubt that the medication has effect and that this is independent of degree of depression”. He further stated that “the effect should be less good in milder depression, that we don’t believe in”.

In the article Beerman with pride announced the new study from the MPA; a study supposed to prove his statements. The study was said to be submitted for publication in the most prestigious medical journal on the planet, the Lancet.

But this part of the story needs to be told:

What Beerman didn’t say (April 15) was that the Lancet already, almost two weeks earlier, (April 4) had rejected the article – it was not to be published. The MPA then made another try, and submitted the data to the British Medical Journal (BMJ) – another journal with high impact. But the response was the same, the BMJ rejected the material.

So the agency – with its for Big Pharma so important “research message” – went directly to the manufacturers, or more correctly to a journal with an editor-in-chief who probably has meant more for the approval and sales of antidepressant drugs internationally than anyone else: The agency submitted its article to European Neuropsychopharmacology, with its editor-in-chief, Dr. Stuart Montgomery. And it was accepted.

For those not familiar with the work of Dr. Montgomery it can be said that he played a major role in helping Big Pharma to get new antidepressant drugs approved in the beginning of the 90-ties (despite that the actual data already at that time showed the drugs gave an increased risk of suicide). He was also responsible for the famous concealment of Seroxat/Paxil severe withdrawal symptoms. Instead of accepting the clear withdrawal symptoms so that patients and doctors could be warned Dr. Montgomery and colleagues misclassified these symptoms as signs of recurring depression – needing more drug treatment.

So a study with the PR-message that antidepressants work well for all forms of depression would most likely be very welcome in the European Neuropsychopharmacology. And it was. One of the reviewers of the article made the point very clear, saying: “This meta-analysis is very timely in the situation when the recent meta-analysis of Kirsch et al. (2008) induced a lot of uncertainty about the efficacy of antidepressants, both in the psychiatric community as well as in public opinion.” It was recommended that the article should be published “without any delay, given the situation mentioned above [“uncertainty … in the psychiatric community as well as in public opinion”].”

The MPA and its counterpart FDA have done almost nothing to use the wealth of data in its files to show the actual suicide risks with antidepressants, and to warn doctors and the public. (See the newly unsealed extensive analysis by Dr. Joseph Glenmullen of GlaxoSmithKline’s hiding of Seroxat/Paxil suicide data, as an example of how the pharmaceutical industry can act, and how ineffective and silent a regulatory agency can be in questioning the data in the drug applications http://finance.senate.gov/press/Gpress/2008/prg061208a.pdf , 4MB.) The lack of positive drug effects has always been denied by the MPA. The ineffective system for postmarketing surveillance of adverse drug effects is putting the public at severe risk – yet it is allowed unchanged year after year. The often horrible withdrawal symptoms of antidepressant drugs have been explained away as signs of recurring depression – and thus transformed to evidence of positive drug effects; and this manipulation has been accepted by the regulatory agencies. The MPA and the FDA, supposed to protect the public, are agencies out of control, and see the pharmaceutical industry as their real clients.

It’s first in a situation, where independent analyses of data submitted to the FDA show no positive effect of antidepressant drugs compared to placebo, that the Swedish MPA puts all its “research resources” in action to prove the opposite. The eagerness for collaborating with Big Pharma in getting out a PR-message, to handle the “uncertainty about the efficacy of antidepressants, both in the psychiatric community as well as in public opinion”, is yet another example of betrayal of the real clients – the public.


Janne Larsson
Reporter – investigating psychiatry

janne.olov.larsson@telia.com


Read the new book, The Evidence, However, Is Clear...The Seroxat Scandal

By Bob Fiddaman

ISBN: 978-1-84991-120-7
CHIPMUNKA PUBLISHING

AVAILABLE FOR DOWNLOAD HERE


PAPERBACK COMING SOON

The Parallels of Scientific Misconduct

Dr Aubrey Blumsohn over at Scientific Misconduct has a rather interesting set of posts recently added to his blog.

Although not Seroxat related there are some parallels to the recent investigation of GlaxoSmithKline by the MHRA.

They key to Aubreys posts is basically 'accountability' where he focuses on an individual named Professor Eastell.

Eastell is the Head of the Academic Unit of Bone Metabolism at the University of Sheffield and Honorary Consultant in the Metabolic Bone Centre at Sheffield Teaching Hospital´s NHS Trust.

This from Jennifer Washburn at slate.com (Dec. 22, 2005)

Did a British university sell out to Procter & Gamble?

Earlier this month, Sheffield University in Britain offered $252,000 to one of its senior medical professors, Aubrey Blumsohn. According to a copy of a proposed settlement released by Blumsohn, the university promised to pay him if he would agree to leave his post and not make "any detrimental or derogatory statements" about Sheffield or its employees.

...In the summer of 2002, Blumsohn, a senior lecturer and bone metabolism specialist, and Dr. Richard Eastell, Sheffield's research dean, signed a $250,000 research contract with Procter & Gamble. Blumsohn and Eastell were to evaluate the effectiveness of P&G's osteoporosis drug, Actonel. The goal was not to win FDA approval; Actonel was already being widely prescribed. Instead, the Sheffield study would shed further light on how Actonel affects women's bones and their susceptibility to fractures. According to Blumsohn, Eastell had already reviewed blood and urine samples from two previous P&G clinical trials of Actonel. Now Blumsohn was supposed to evaluate a third trial, with the aim of providing a final analysis of all three.

But in the past, it seemed, P&G had not allowed Eastell to perform his own data analysis. In an e-mail that Eastell wrote to P&G and copied Blumsohn on, he confessed that while presenting a paper at the International Osteoporosis Foundation, he had been unable to respond to questions about his own research posed by a fellow academic. "I think that to avoid criticism in the future it would be good if we could say that we had done the analyses independently," Eastell wrote in the e-mail. He suggested that Blumsohn be entrusted with the independent analysis, so he could vouch for results that would be published under both their names.

Blumsohn and his staff reviewed thousands of blood and urine samples from women with osteoporosis. At this stage, they were "blinded" from knowing which patients had taken Actonel and which had taken a placebo. This helped to ensure objectivity. But when he finished examining the samples in December 2002, Blumsohn says he asked P&G to release the codes for the raw data so he could independently interpret the results.

Blumsohn requested the data access codes for 18 months, as numerous e-mails and other records document (here's one). P&G officials wrote back refusing to permit independent access to the data. However, in a written statement, the company denied that it withheld necessary data. "We have appropriately shared our clinical data with both investigators and regulatory authorities, and have conducted our business with the highest of standards."

...the company denied that it withheld necessary data. "We have appropriately shared our clinical data with both investigators and regulatory authorities, and have conducted our business with the highest of standards."

Ring any bells?

The MHRA involvement seems like a state of Déjà vu considering recent events regarding the hidden data of the Seroxat by GSK.

Dr Blumsohn, like myself, has been banging the drum loudly about a prescribed drug, in this case Actonel. Like me, Blumsohn has merely been trying to raise awareness. Actonel Media Case Reports can be read here and the MHRA's 'investigation' can be downloaded in pdf form here.

It reads:

The Sheffield dispute was discussed inthe UK Parliament in December 2005, and was transmitted by the Health Minister to the UK drugs regulator (the Medicine and Healthcare Products Regulatory Agency, MHRA) for “investigation.” The MHRAis itself accused of failing to examine or to secure raw data in drug licensing applications, simply accepting the word of industry with blind faith (6, 14). Since this was precisely the problem in Sheffield, its disinclination to investigate was hardly surprising.

No investigation (or at least anythingfitting that definition) took place. TheMHRA failed to produce any report, declined to accept any documentary evidence (17, MHRA response to FOIrequest #06/115), stated that the matter was of “low priority” (17), and that the agency does not have any procedure for investigating research misconduct (17,MHRA response to FOI #06/188). Further, it claimed that the drug regulator has no remit, nor any necessary obligation to be interested in the integrity of the scientific literature about drugs (17, MHRA FOI#06/188) unless related to licensing (and collected using documentation appropriate for licensing). It even argued that it is“illegal” for a scientist to have data pertaining to information written in his name without the consent of the company“owning” that data (17, MHRA FOI#06/115).

It refused to compare data itwas sent from Sheffield with the original data it should have received and examined as part of the licensing process forActonel. Initially, this refusal was on the basis that it would be “too much work”(17, MHRA FOI #06/059). Later, it admitted that it had not in fact seen or retained raw data prior to approving the drug (17, MHRA FOI #05/404). With governments setting the standard for scientific conduct, it is hardly surprising that independent science has encountered such difficulties.

For some time now Aubrey has voiced his opinion regarding pharma giants Procter and Gamble and the drug Actonel including, and here I quote, "... the serious implications of the failed but rather sad attempts at coverup and delay by "regulators".

That line in itself prompted me to post about this matter on here. Its parallels are plainly obvious.

Fid

Related Links

Actonel Case Media Reports
Did a British university sell out to Procter & Gamble?
Money and accountability (Procter and Gamble)
The Scientific Misconduct Wiki (Procter and Gamble)

Read the new book, The Evidence, However, Is Clear...The Seroxat Scandal

By Bob Fiddaman

ISBN: 978-1-84991-120-7
CHIPMUNKA PUBLISHING

AVAILABLE FOR DOWNLOAD HERE


PAPERBACK COMING SOON