Under the table
#133090 - 01/19/05 11:14 PM
Two top scientists - Dr. Anthony Fauci, director of the National
Institute of Allergy and Infectious Diseases, and his deputy, H.
Clifford Lane - are among 916 government researchers who have been receiving royalties on experimental drug treatments without disclosing those royalties on their annual ethics forms or on experimental patient consent forms.
The practice is legal, though NIH says it has now drafted a policy to require disclosure.
Health officials say the current and former employees are collecting
royalties on drugs or medical inventions they developed while working
for the government.
The royalties are paid by drugmakers licensed to
produce the drugs. Some $8.9 million in royalties was paid to
government-employed drug inventors in 2004; the average royalty per
inventor was $9,700.
Below is an example of royalties received by Fauci and Lane on the
interleukin-2 AIDS regimen, an experimental treatment for patients with
HIV that they invented. Fauci has said he donates all his royalties to
charity, while Lane has opted to keep his.
Royalties Paid on Interleukin-2 AIDS Regimen Since 1997
1997 $23,606.13 $23,606.13
1998 $3,066.67 $3,066.67
1999 $3,066.67 $3,066.67
2000 $3,066.67 $3,066.67
2001 $3,066.67 $3,066.66
2002 $3,066.67 $3,066.66
2003 $3,066.67 $3,066.66
2004 $3,066.67 $3,066.66
Source: National Institutes of Health
Feds Failed to Disclose Financial Interest
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 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 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
Director (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 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
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
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
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
A panel of peers from the National Cancer Institute was brought in to
approve the Esprit project because Fauci and Lane were in a position to
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
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
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.
ON THE NET
National Institutes of Health: http://www.nih.gov
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