[PAA-Discuss] Fwd: Pharmalot - NIH Requires Emory To Disclose All Conflicts

[rebelljb at aol.com]

-----Original Message-----
From: vince <vince_19805 at yahoo.com>
To: undisclosed-recipients:;
Sent: Tue, 14 Oct 2008 5:30 pm
Subject: Pharmalot - NIH Requires Emory To Disclose All Conflicts


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Well.  It's happening. These policies will not be confined to Emory. No 
longer will the NIH put up with the old wink and a nod routine where 
disclosure is concerned.  All other research oriented institutions will 
follow suit.

Running scared?  You bet. Transparency has become the order of the day.

At risk are the billions of taxpayer dollars the universities get that 
is the life blood of their research programs. Hopefully this 
information will be posted online in some readily accessible fashion.  
I'm not holding my breath until this happens.  Up to this point such 
information has been carefully hidden from public scrutiny. 

A clear winner here is the American public. Undisclosed drug company 
money taints the product of these efforts in unimaginable and 
catastrophic wa
ys. If you don't believe this, please see me privately 
after class because I have horrible news about your dear little friend 
who leaves money under your pillow when you lose a tooth. The 
psychoactive drug industry is certainly at the head of the list where 
this is happening, but your moms heart meds are also at risk.

In the best of worlds studies tainted by fraud and corruption would be 
repudiated and expunged.  This will not be the case here. We have seen 
actual fraud in the past few years where researchers have been exposed 
and prosecuted for fabricating studies, but the studies they presented 
are still on the books and presented as valid. 

Vince







NIH Requires Emory To Disclose All Conflicts


In the wake of the investigation by the US Senate Finance Committee 
into Emory University psychiatry professor Charles Nemeroff, the 
National Institutes of Health is now imposing new conditions before 
agreeing to award grants to the university, according to an October 10 
memo sent to faculty.
An NIH regulation requires researchers to report to their universities 
any “significant financial interests” they hold in research financed by 
the agency - defined as income or equity interest of $10,000 from a 
company or 5-percent ownership of its stock. The universities are 
required to tell the NIH whether they were able to manage or eliminate 
the conflicts in order to avoid=2
0bias in the research findings.

The committee is investigating Nemeroff’s alleged failure to fully 
disclose payments from Glaxo while simultaneously conducting research 
into Glaxo drugs, and Emory’s failure to take any action even after 
conducting an internal inquiry (back story).

And so last week, David Wynes, Emory’s vp for research administration, 
wrote that the NIH won’t send any funds unless full disclosure is now 
made by all professors. You can click to see the actual memo or read it 
right here…


From: All Emory University Faculty [All-Faculty at emory.edu]
On Behalf Of Johnson, Julie [JRAE at emory.edu]
Sent: Friday, October 10, 2008 3:10 PM
To: All-Faculty at emory.edu
Subject: FCOI Letter to Research Community

Sent on behalf of David Wynes, Vice President of Research 
Administration. The text of the letter is included below in the event 
you are unable to open the pdf format.

October 10, 2008

Members of the Emory Research Community:



As you may know, the University has been under scrutiny in connection 
with our business practices for the management of research financial 
conflict of interest. I am writing to you to notify you that as of 
October 8, 2008 the NIH has imposed special award conditions on all 
awards made to Emory University. The special award conditions will 
affect both the submission of proposals to the NIH as well as the 
receipt of funding.

In acc
ordance with the October 8, 2008, letter, Emory must submit to 
the NIH an institutional assurance of compliance for each pending 
competing or noncompeting award. Every institutional assurance must 
provide the following information:


1. A list identifying every Investigator participating in the research 
project, including, if Emory is carrying out the research through 
subgrantees, contractors, or collaborators, those Investigators working 
for such entities;

2. An assurance that OSP has on file for each identified Investigator 
on each project an Investigator Report of Financial Interests in 
Research; and/or

3. If a financial interest related to the project has been identified 
for any listed Investigator, a description of the financial interest 
and the actions taken by Emory to manage, reduce or eliminate any 
actual or perceived conflict of interest.


The NIH Institute or Center from whom funding has been sought will not 
issue an award until the institutional assurance and relevant 
information has been received. As used in these requirements, 
“Investigator” means any individual named in the grant budget, and/or 
any person whose biographical sketch is included in the application.

The Investigator Report of Financial Interests in Research form can be 
found on the OSP web page at:
http://www.osp.emory.edu/shared_web/forms.cfm.

It is important to note that, in the future, OSP will non submit any 
NIH grant application 
until disclosures have been received for every 
Investigator participating in the study. Under federal regulations, 
submission of the grant application constitutes an assurance from the 
University to NIH that all disclosures have been made in advance. All 
certifications must include the original signature of the investigator.

Any questions regarding the submission process may be directed to Sarah 
White in the Office of Sponsored Programs at 404-712-3027.

We appreciate your cooperation as we work to ensure that we work to 
demonstrate Emory’s commitment to compliance with NIH regulations and 
requirements.

Sincerely,
David L. Wynes, Ph.D.
Vice President for Research Administration

cc: Earl Lewis, Provost
Fred Sanfilippo, EVP for Health Sciences






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The information herein shall not be considered an endorsement of anyone 
discontinuing psychiatric drugs. If you are stopping taking medication  


IT IS ADVISABLE TO REDUCE DOSES GRADUALLY WITH EXTREME CAUTION, as it 
is difficult to predict who will have problems withdrawing. It is worth 
getting as much information and support as you can, and involving your 
doctor wherever possible. You will find withdrawal information here:   
                                                                  
http://www.mind.org.uk/Information/Booklets/Making+sense/Making+sense+of+coming+off+psychiatric+drugs.htm



FOR MORE INFORMATION ON WITHDRAWAL:: Get Peter Lehmann's book, Coming 
off Psychiatric Drugs: Successful Withdrawal from Neuroleptics, 
Antidepressants, Lithium, Carbamazepine and Tranquilizers.  This 
valuable resource comes in US, UK, Greek. and German editions.