Feds Failed to Disclose Financial Interest<\/a>
\nMon Jan 10, 4:17 PM ET
\nBy JOHN SOLOMON, Associated Press Writer<\/p>\nWASHINGTON \u2013 Government scientists have collected millions of dollars in royalties for experimental treatments without having to tell patients testing the treatments that the researchers\u2019 had a financial connection, according to documents and interviews.<\/p>\n
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\u2019 financial stakes would be disclosed to patients, a pledge that followed an uproar over conflicts of interest and mistakes in federal experiments.<\/p>\n
The National Institutes of Health says it didn\u2019t implement a policy to order the disclosure until last week, shortly after The Associated Press filed a Freedom of Information Act request.<\/p>\n
\u201cQuite 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,\u201d NIH spokesman John Burklow said.<\/p>\n
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\u2019 financial interests.<\/p>\n
\u201cIt\u2019s hard for patients to make an informed decision when they don\u2019t have all the information,\u201d said Bill Allison of the Center for Public Integrity, which monitors the ethics of government employees.<\/p>\n
\u201cWhen a doctor says, \u2018Here, try this experiment, it is safe, or it will help,\u2019 and the patient isn\u2019t 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,\u201d Allison said.<\/p>\n
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.<\/p>\n
In 2004, these researchers collected a total of $8.9 million. Only a dozen received the legal maximum.<\/p>\n
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\u2019 take, the government received $55.9 million in royalties for the same inventions and put that money back into research.<\/p>\n
The arrangements can create concerns about conflicts.<\/p>\n
For instance, two top managers in NIH\u2019s 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.<\/p>\n
Such research helps bring the treatment closer to possible commercial use, which could in turn bring the researchers and NIH higher royalties.<\/p>\n
Except for patent records and scientific journals, the patients have had no easy way of learning about the researchers\u2019 financial stakes.<\/p>\n
That\u2019s 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\u2019s policy.<\/p>\n
Fifty-one NIH royalty recipients are currently involved in clinical research involving the inventions for which they are being paid, meaning they\u2019ll be affected by the new policy, according to the information obtained by AP.<\/p>\n
Among them are National Institute of Allergy and Infectious Diseases Director Anthony Fauci and his deputy, H. Clifford Lane.<\/p>\n
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.<\/p>\n
The government has licensed the commercial rights to that treatment to drug maker Chiron Corp., and Fauci\u2019s 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.<\/p>\n
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 \u2013 fully disclose the payments to patients.<\/p>\n
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 profit.<\/p>\n
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.<\/p>\n
\u201cI\u2019m going to give every penny of it to charity \u2026 no matter what the yearly amount is,\u201d he said.<\/p>\n
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.<\/p>\n
Lane keeps his royalties but said he occasionally gave patients scientific journal articles that noted he was listed on the patent for interleukin-2. \u201cI believe patients should know everything that might influence their desire to be participants in research,\u201d Lane said.<\/p>\n
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.<\/p>\n
\u201cWe were reluctant to make a formal policy until the broad policy came down from the department and NIH,\u201d Fauci explained.<\/p>\n
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.<\/p>\n
Then-Health and Human Services Secretary Donna Shalala pledged in May 2000 that the government would develop policies to require \u201cthat any researchers\u2019 financial interest in a clinical trial be disclosed to potential participants.\u201d<\/p>\n
Congress, concerned by reports of conflicts of interest and researchers\u2019 conduct in several high profile experiments, was told the changes would happen. The government first published guidance for the disclosure in January 2001.<\/p>\n
Current HHS Secretary Tommy G. Thompson issued new guidance this May that again clearly cited \u201ccompensation that may be affected by the study outcome\u201d and \u201cproprietary interests in the products, including patents, trademarks, copyrights or licensing arrangements.\u201d<\/p>\n
NIH, however, didn\u2019t order the disclosure until last week\u2019s policy.<\/p>\n
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