article: researchers go unchecked, report says

[Guest guest]

NY Times

January 19, 2008

Researchers Go Unchecked, Report Says

By GARDINER HARRIS

WASHINGTON — The National Institutes of Health do almost nothing to

monitor the financial conflicts of university professors to whom it

provides grants, a government report found, and the huge federal

research agency does not want to start now.

The agency does not know the number of conflicts or the nature of

them, nor does it track how universities and other institutions went

about solving those conflicts, according to a report issued Friday

by the inspector general of the Department of Health and Human

Services.

A top official at the health institutes was unapologetic about its

hands-off approach to overseeing the financial conflicts of grantees.

" For us to try to manage directly the conflict-of-interest of an

N.I.H. investigator would be not only inappropriate but pretty much

impossible, " said Dr. Norka Ruiz Bravo, the institutes' deputy

director for extramural research.

The health institutes awarded more than $23 billion last year

through over 50,000 competitive grants to more than 325,000

researchers at over 3,000 universities. Each grant typically

underwrites only a part of the cost of the research at issue.

Universities are increasingly seeking other sources of income to

support research, and drug and device makers have become an

important resource. But blending these sources of financing can

often present researchers with troubling conflicts of interest, and

managing such conflicts has become dizzyingly complex.

Indeed, academic medicine has become so rife with conflicts of

interests in recent years that the Food and Drug Administration has

complained that it has difficulty finding experts for its advisory

boards who do not have a conflict.

Most universities entirely trust their professors to report

financial conflicts, and efforts to verify professors' filings are

almost unheard of.

But there is growing unease about the myriad financial conflicts

that some researchers and many doctors routinely participate in.

Critics fear that the money may distort research and change the

practice of medicine, leading doctors to prescribe more, and more

expensive, drugs and devices, sometimes to patients' detriment.

Senator E. Grassley, Republican of Iowa, said his

investigators had uncovered instances in which doctors financed by

the health institutes had also taken money from drug makers but did

not report the income to their universities.

" Universities need to take this issue more seriously, " Mr. Grassley

said, " and the N.I.H. should monitor its grants more closely for

this problem. "

The health institutes were the subject of an intense Congressional

investigation in 2004 and 2005 into the financial conflicts of some

of its researchers. As a result, the agency issued one of the

toughest conflict-of-interest policies in the world of medical

research, banning its researchers from consulting for drug and

device makers.

But those rules apply only to researchers who work directly for the

health institutes. Eighty percent of the agency's $29 billion budget

goes to support extramural researchers whose paychecks are largely

paid for by universities.

The agency provides little direct oversight over this sea of

scientists, and it has little interest in doing so.

Still, in an effort to assess the size of the problem, the agency

asked its 27 institutes and centers to send any conflict-of-interest

reports to the Office of Extramural Research, which administers many

of its grants. But many of the institutes failed to follow the

request, which was not a directive, according to the report.

Investigators with the inspector general were able to find just 438

conflict-of-interest reports filed from 2004 through 2006, and 89

percent of them provided no details about the nature of the conflict

being reported or how it was managed.

Dr. Ruiz Bravo said she believed that the system was nonetheless

working well. The health institutes conducted an audit in 2006 of 18

sites and found numerous problems with the way universities handled

conflicts of interest, particularly with how well they took account

of financial conflicts that arose after a grant was awarded.

" I think it is working to the extent that people are being honest, "

Dr. Ruiz Bravo said, " and I think most people are honest. "

Dr. Ruiz Bravo said the health institutes would soon mandate that

the institutes and centers provide her office with a report about

each conflict reported to them by universities. But, she said, these

reports will still lack details about the conflicts and how they are

managed.

Payments generally must exceed $10,000 over a 12-month period before

the health institutes consider them a potential conflict.

[Guest guest]

It's amazing that Gardiner has such sharp perceptions

regarding the COIs and safety-cover-ups of academics involved with

promoting pharmaceutical products-- other than vaccines. He was on

Ira Flatow's " Science (what science?) Friday " last summer bashing the

hell out of Omnibus parents.

>

> NY Times

>

> January 19, 2008

> Researchers Go Unchecked, Report Says

> By GARDINER HARRIS

>

> WASHINGTON — The National Institutes of Health do almost nothing to

> monitor the financial conflicts of university professors to whom it

> provides grants, a government report found, and the huge federal

> research agency does not want to start now.

>

> The agency does not know the number of conflicts or the nature of

> them, nor does it track how universities and other institutions

went

> about solving those conflicts, according to a report issued Friday

> by the inspector general of the Department of Health and Human

> Services.

>

> A top official at the health institutes was unapologetic about its

> hands-off approach to overseeing the financial conflicts of

grantees.

>

> " For us to try to manage directly the conflict-of-interest of an

> N.I.H. investigator would be not only inappropriate but pretty much

> impossible, " said Dr. Norka Ruiz Bravo, the institutes' deputy

> director for extramural research.

>

> The health institutes awarded more than $23 billion last year

> through over 50,000 competitive grants to more than 325,000

> researchers at over 3,000 universities. Each grant typically

> underwrites only a part of the cost of the research at issue.

>

> Universities are increasingly seeking other sources of income to

> support research, and drug and device makers have become an

> important resource. But blending these sources of financing can

> often present researchers with troubling conflicts of interest, and

> managing such conflicts has become dizzyingly complex.

>

> Indeed, academic medicine has become so rife with conflicts of

> interests in recent years that the Food and Drug Administration has

> complained that it has difficulty finding experts for its advisory

> boards who do not have a conflict.

>

> Most universities entirely trust their professors to report

> financial conflicts, and efforts to verify professors' filings are

> almost unheard of.

>

> But there is growing unease about the myriad financial conflicts

> that some researchers and many doctors routinely participate in.

> Critics fear that the money may distort research and change the

> practice of medicine, leading doctors to prescribe more, and more

> expensive, drugs and devices, sometimes to patients' detriment.

>

> Senator E. Grassley, Republican of Iowa, said his

> investigators had uncovered instances in which doctors financed by

> the health institutes had also taken money from drug makers but did

> not report the income to their universities.

>

> " Universities need to take this issue more seriously, " Mr. Grassley

> said, " and the N.I.H. should monitor its grants more closely for

> this problem. "

>

> The health institutes were the subject of an intense Congressional

> investigation in 2004 and 2005 into the financial conflicts of some

> of its researchers. As a result, the agency issued one of the

> toughest conflict-of-interest policies in the world of medical

> research, banning its researchers from consulting for drug and

> device makers.

>

> But those rules apply only to researchers who work directly for the

> health institutes. Eighty percent of the agency's $29 billion

budget

> goes to support extramural researchers whose paychecks are largely

> paid for by universities.

>

> The agency provides little direct oversight over this sea of

> scientists, and it has little interest in doing so.

>

> Still, in an effort to assess the size of the problem, the agency

> asked its 27 institutes and centers to send any conflict-of-

interest

> reports to the Office of Extramural Research, which administers

many

> of its grants. But many of the institutes failed to follow the

> request, which was not a directive, according to the report.

>

> Investigators with the inspector general were able to find just 438

> conflict-of-interest reports filed from 2004 through 2006, and 89

> percent of them provided no details about the nature of the

conflict

> being reported or how it was managed.

>

> Dr. Ruiz Bravo said she believed that the system was nonetheless

> working well. The health institutes conducted an audit in 2006 of

18

> sites and found numerous problems with the way universities handled

> conflicts of interest, particularly with how well they took account

> of financial conflicts that arose after a grant was awarded.

>

> " I think it is working to the extent that people are being honest, "

> Dr. Ruiz Bravo said, " and I think most people are honest. "

>

> Dr. Ruiz Bravo said the health institutes would soon mandate that

> the institutes and centers provide her office with a report about

> each conflict reported to them by universities. But, she said,

these

> reports will still lack details about the conflicts and how they

are

> managed.

>

> Payments generally must exceed $10,000 over a 12-month period

before

> the health institutes consider them a potential conflict.

>