Feds Failed to Disclose Financial Interest

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Tue, 11 Jan 2005 02:46:49 -0500

 

 

[sSRI-Research] Feds Failed to Disclose Financial Interest

 

 

 

 

Feds Failed to Disclose Financial Interest

 

http://news./news?tmpl=story & cid=542 & u=/ap/20050110/ap_on_go_ca_st_pe/r\

esearch_royalties_4 & printer=1

 

Mon Jan 10, 4:17 PM ET

 

By JOHN SOLOMON, Associated Press Writer

 

WASHINGTON - Government scientists have collected millions of dollars in

royalties for experimental treatments without having to tell patients

testing the treatments that the researchers' had a financial connection,

according to documents and interviews.

 

The personal royalties are legal, though the researchers developed the

treatments at government expense. But the Health and Human Services

(news -

web sites) Department promised in May 2000 that scientists' financial

stakes

would be disclosed to patients, a pledge that followed an uproar over

conflicts of interest and mistakes in federal experiments.

 

The National Institutes of Health (news - web sites) says it didn't

implement a policy to order the disclosure until last week, shortly after

The Associated Press filed a Freedom of Information Act request.

 

" Quite frankly, we should have done it more quickly. But as soon as

(Elias A.) Zerhouni found out about it, he ordered it done

immediately, " NIH

spokesman John Burklow said.

 

The nearly five-year delay means hundreds, perhaps thousands, of

patients in

NIH experiments made decisions to participate in experiments that often

carry risks without full knowledge about the researchers' financial

interests.

" It's hard for patients to make an informed decision when they don't have

all the information, " said Bill Allison of the Center for Public

Integrity,

which monitors the ethics of government employees.

 

" When a doctor says, 'Here, try this experiment, it is safe, or it will

help,' and the patient isn't aware he has a financial interest in the

outcome of that treatment, it in essence is taking advantage of someone by

not letting them have all the information, " Allison said.

 

In all, 916 current and former NIH researchers are receiving royalty

payments for drugs and other inventions they developed while working

for the

government, according to information obtained by AP. They can collect

up to

$150,000 each a year, but the average is about $9,700, officials said.

 

In 2004, these researchers collected a total of $8.9 million. Only a dozen

received the legal maximum.

 

The government owns the patents and the scientists are listed as inventors

so they can share in licensing deals struck with private manufacturers. In

addition to the inventors' take, the government received $55.9 million in

royalties for the same inventions and put that money back into research.

 

The arrangements can create concerns about conflicts.

 

For instance, two top managers in NIH's infectious disease division have

received tens of thousands of dollars in royalties for an experimental

AIDS

(news - web sites) treatment they invented. At the same time, their office

has spent millions in tax dollars to test the treatment on patients across

the globe, the records show.

 

Such research helps bring the treatment closer to possible commercial use,

which could in turn bring the researchers and NIH higher royalties.

 

Except for patent records and scientific journals, the patients have

had no

easy way of learning about the researchers' financial stakes.

 

That's because NIH told doctors not to report royalties on their

government

ethics disclosure forms and did not require the royalties listed on

patient

consent forms until last week's policy.

 

Fifty-one NIH royalty recipients are currently involved in clinical

research

involving the inventions for which they are being paid, meaning they'll be

affected by the new policy, according to the information obtained by AP.

 

Among them are National Institute of Allergy and Infectious Diseases

(news -

web sites) Director Anthony Fauci and his deputy, H. Clifford Lane.

 

The two managers have received $45,072.82 each in royalties since 1997 for

an experimental AIDS treatment known as interleukin-2 that they invented

with a third NIH doctor, Joseph Kovacs, the records show.

 

The government has licensed the commercial rights to that treatment to

drug

maker Chiron Corp., and Fauci's division subsequently has spent $36

million

in taxpayer money testing the treatment on patients in one experiment

alone.

Known as the Esprit experiment, it is one of the largest AIDS research

projects in NIH history, testing interleukin-2 on patients at more

than 200

sites in 18 countries over the last five years.

 

Both doctors said they were extremely sensitive about the possibility

of an

appearance of a conflict of interest and took steps on their own to

address

it even as they waited for their agency to do what they believed

should have

been done all along - fully disclose the payments to patients.

 

A panel of peers from the National Cancer Institute (news - web sites) was

brought in to approve the Esprit project because Fauci and Lane were in a

position to profit.

 

Fauci, an internationally known expert on illnesses from the flu to AIDS,

said he originally refused to take the royalties but was told he

legally had

to accept them. So he has donated all the money to charity.

 

" I'm going to give every penny of it to charity ... no matter what the

yearly amount is, " he said.

 

Fauci also said he once tried to report his payments on his federal

financial disclosure report, which is available to the public, but was

told

to remove them because NIH considers the money federal compensation, not

outside income.

 

Lane keeps his royalties but said he occasionally gave patients scientific

journal articles that noted he was listed on the patent for interleukin-2.

" I believe patients should know everything that might influence their

desire

to be participants in research, " Lane said.

 

Both acknowledged they were unwilling to tell interleukin-2 patients about

the royalties on consent forms until NIH developed its policy. Both

will do

so from now on.

 

" We were reluctant to make a formal policy until the broad policy came

down

from the department and NIH, " Fauci explained.

 

Their case illustrates the gulf between what the government promised

nearly

five years ago in the midst of controversy and what actually has been

done.

 

Then-Health and Human Services Secretary Donna Shalala pledged in May 2000

that the government would develop policies to require " that any

researchers'

financial interest in a clinical trial be disclosed to potential

participants. "

 

Congress, concerned by reports of conflicts of interest and researchers'

conduct in several high profile experiments, was told the changes would

happen. The government first published guidance for the disclosure in

January 2001.

 

Current HHS Secretary Tommy G. Thompson issued new guidance this May that

again clearly cited " compensation that may be affected by the study

outcome "

and " proprietary interests in the products, including patents, trademarks,

copyrights or licensing arrangements. "

 

NIH, however, didn't order the disclosure until last week's policy.

___

 

 

 

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