Re: Congress to Probe Policies at NIH

[Guest guest]

This one makes me nervous. Is it really a Conflict of Interest probe...or

something else?

They are probing an NIH scientist for COI with pharmaceutical companies -

that is researching fungal infections. Before I would make any conclusions

on this one, I would want to know what the research found. Why are they

challenging him for COI, yet nothing in the article shows that he has a

financial

benefit in the outcome of the research?

Just because one receive pharmaceutical money for research, does not

automatically mean their findings are tainted. In order to establish COI, an

erroneous outcome must also be present. Companies like Clorox fund research

within

this arena all the time. Some great, relevant data have come from the

Clorox research.

What I would want to know on this one is:

What data was collected from this research regarding the effectiveness of

antifungal medications?

What fungi were implicated as causing illness that responded well to the

antifungal treatments of the study?

What were the symptoms of those who took part in the study?

What symptoms with the treatments of antifungals were able to be corrected?

Is this one really a COI probe, or is it a scapegoat to keep the known

illnesses/deaths of Katrina and the known illnesses that will be caused by the

usage of mycoherbicides in Columbia and Afganastan on the QT...not to mention

all the financial stakeholders impacted by fungal induced illnesses from sick

buildings.

This one seems sketchy to me. A possible spin on the subject of COI for the

benefit of industry?

Sharon Kramer

[Guest guest]

WOW and woW again

>

> Congress to Probe Policies at NIH

>

> A bipartisan group asks the health agency for details of a

> researcher's ties to drug companies to assess its conflict-of-

> interest guidelines.

>

> Los Angeles Times - CA

> By Willman, Times Staff Writer

>

> August 10, 2006

>

> http://www.latimes.com/news/nationworld/nation/la-na-

> nih10aug10,0,2010043.story?coll=la-home-headlines

>

> WASHINGTON — A bipartisan group of congressional leaders has asked

> the director of the National Institutes of Health to provide

details

> of a senior researcher's ties to several pharmaceutical companies.

>

> The congressional leaders, including the Republican chairman and

the

> ranking Democrat of the House Energy and Commerce Committee, said

in

> their letter that they wanted the details in order to evaluate

> conflict-of-interest policies at the NIH. They requested a response

> by week's end.

>

>

> " We have received the letter, and NIH will be responding to the

> committee, " NIH spokesman Ralbovsky said Wednesday.

>

> The senior researcher, Dr. J. Walsh of the National Cancer

> Institute, helped lead clinical trials that used the companies'

> drugs to treat suspected fungal infections in patients with

> compromised immune systems. Walsh also appeared alongside company

> representatives at various U.S. Food and Drug Administration

> meetings regarding antifungal products made by the companies.

>

> Two of the companies, Pfizer Inc. and Merck & Co., have

acknowledged

> paying Walsh fees in recent years.

>

> According to the congressional letter, the Energy and Commerce

> Committee " is seeking to determine if there is a sufficient factual

> basis to formally investigate questions about National Institutes

of

> Health policy, the adequacy of NIH oversight or other issues that

> may be raised by the conduct of this NIH scientist. "

>

> The July 28 letter was signed by Rep. Joe L. Barton, R-Texas, the

> committee's chairman; Rep. D. Dingell, D-Mich., the ranking

> Democrat; Rep. Whitfield, R-Ky., the chairman of the panel's

> Oversight and Investigations Subcommittee; and Rep. Bart Stupak, D-

> Mich.

>

> The letter was prompted by articles published July 16 by the Los

> Angeles Times, which reported Walsh's appearances with the

companies

> at the FDA meetings, his acceptance of fees from Merck and Pfizer,

> and his leadership role with the clinical trials.

>

> Walsh's fees were not among the industry payments reported by the

> NIH to the congressional committee two years ago, when the panel

> first examined potential conflicts of interest among agency

> scientists.

>

> The Times also reported that, when results of two of the clinical

> trials were published in 1999 and in 2004, controversy flared as

> other scientists questioned whether dosages of " control " drugs used

> in the studies were adequate. The dosages were set by the

scientists

> who designed and carried out the research in collaboration with the

> sponsoring companies.

>

> U.S. conflict-of-interest law generally prohibits a federal

employee

> from representing an outside party before a government agency.

> Walsh, in earlier comments to the newspaper, said that he appeared

> before the FDA not as a company representative but " as a government

> scientist providing information and/or evaluation " regarding

> clinical trials.

>

> As for the dosages, Walsh and researchers with whom he collaborated

> had said that the studies were properly conducted and followed

> accepted standards of care. Both studies' designs were reviewed and

> approved by the FDA and by boards at the medical sites where

> patients were treated.

>

> In their letter to the NIH director, the four congressional leaders

> requested a wide range of documents, including all internal

> financial-disclosure reports filed by Walsh from 1995 to 2005.

>

> The letter also requested copies of any related policy

that " permits

> [NIH] scientists as part of their official duties to assist drug

> companies with presentations to FDA advisory committees or FDA

> staff. "

>

[Guest guest]

true, wouldn't ya like to be a mouse in someones pocket. well, maybe

not a

mouse.

>

> This one makes me nervous. Is it really a Conflict of Interest

probe...or

> something else?

>

>

> They are probing an NIH scientist for COI with pharmaceutical

companies -

> that is researching fungal infections. Before I would make any

conclusions

> on this one, I would want to know what the research found. Why

are they

> challenging him for COI, yet nothing in the article shows that he

has a financial

> benefit in the outcome of the research?

>

> Just because one receive pharmaceutical money for research, does

not

> automatically mean their findings are tainted. In order to

establish COI, an

> erroneous outcome must also be present. Companies like Clorox

fund research within

> this arena all the time. Some great, relevant data have come from

the

> Clorox research.

>

> What I would want to know on this one is:

>

> What data was collected from this research regarding the

effectiveness of

> antifungal medications?

>

> What fungi were implicated as causing illness that responded well

to the

> antifungal treatments of the study?

>

> What were the symptoms of those who took part in the study?

>

> What symptoms with the treatments of antifungals were able to be

corrected?

>

> Is this one really a COI probe, or is it a scapegoat to keep the

known

> illnesses/deaths of Katrina and the known illnesses that will be

caused by the

> usage of mycoherbicides in Columbia and Afganastan on the QT...not

to mention

> all the financial stakeholders impacted by fungal induced

illnesses from sick

> buildings.

>

> This one seems sketchy to me. A possible spin on the subject of

COI for the

> benefit of industry?

>

> Sharon Kramer

>

>

>

>