Posted on the Inquirer Tue, Jan. 11, 2005
Research royalties went untold
Government scientists got millions and did
not have to tell those tested. Now, that must change.
By John Solomon
Associated Press
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. The Department of Health and
Human Services promised in May 2000 that scientists' financial stakes
would be disclosed to patients, a pledge that followed an uproar over
conflicts of interest in federal experiments.
The National Institutes of Health says it did not order the
disclosure of royalties until last week, shortly after the Associated
Press filed a Freedom of Information Act request.
"Quite frankly, we should have done it more quickly," NIH spokesman
John Burklow said. "But as soon as Director [Elias] Zerhouni found out
about it, he ordered it done immediately."
The nearly five-year delay means hundreds, perhaps thousands, of
patients in NIH experiments decided to participate in experiments
without full knowledge about the researchers' financial interests.
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 the
AP. In 2004, these researchers collected a total of $8.9 million. Only
a dozen received the legal maximum of $150,000 a year.
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 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 is because NIH told doctors not to report royalties on federal
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 involved in clinical research
involving the inventions for which they are being paid, meaning they
will be affected by the new policy, according to records.
Among them are Anthony Fauci, the director of the National
Institute of Allergy and Infectious Diseases, 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.
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.
Lane keeps his royalties but said he occasionally gave patients
journal articles listing him on the patent for interleukin-2.
"I believe patients should know everything that might influence
their desire to be participants in research," Lane said.
