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August 17, 2005

A newspaper’s investigation is focusing new attention on the way some university researchers take money to share early opinions about clinical drug trials they are conducting.

This month, The Seattle Times published articles that detailed the way investment firms tap into medical professors and other doctors involved in drug trials to get advance work on how the trials are going. The article prompted Sen. Chuck Grassley, an Iowa Republican who is chairman of the Senate Committee on Finance to write a letter to the Securities and Exchange Commission and the Department of Justice requesting an investigation.

The researchers, who have signed confidentiality agreements with drug companies, are not supposed to talk about the trial results before they are complete and public. But investment firms, looking for early information that could point to the future success or failure of a drug, offer doctors hundreds or thousands of dollars an hour to give information that is passed on to select investors. The practice produces potential conflicts of interests, and allows investors chosen for inside information to profit at the expense of other investors. Many of the cooperating doctors, expert and the Seattle article said, work at universities.

“It probably involves more academics than anything else,” said Scott Pendergast, a doctor in private practice who said he gets faxes, e-mails, or calls weekly from firms looking for information. Pendergast, several years ago, was a lead researcher for the drug Macugen, which treats macular degeneration, an eye disease that can cause blindness. According to The Seattle Times article, Citigroup Smith Barney spoke with doctors who had researched Macugen and went on to research Lucentis, a drug that promised better results than Macugen. Based on their interviews, Smith Barney put out a report that forecast the unreleased results of Lucentis trials. The report, which was issued to select investors, was accurate in saying that Lucentis appeared more effective than Macugen. Eyetech, the company that made Macugen, saw its stock value cut in half in a single day based on report, the Times reported.

Pendergast said he has “never talked to any investor, and never will,” but he knows that many researchers do. In the Seattle article, one firm employee said he only spoke with researchers who did not have confidentiality agreements. But Pendergast said all the doctors involved in clinical drug trials have confidentiality agreements. “They should know better,” he said. The article noted that some researchers said they were just giving their impressions, and had not divulged trial results early. “That can be even more valuable than data,” Pendergast said.

Universities should consider adopting a blanket rule saying that researchers should not speak with investors, reporters, or anybody else about the trial, except to publicize that it is ongoing, until it is over, Pendergast said.

Arthur Caplan, director of the Center for Bioethics at the University of Pennsylvania, was not sure such a rule would work. “Screening wouldn’t work,” he said. “Too many conversations go on over the phone, and with outside people. That might just push the practice underground.” Caplan said sharing confidential information with investors is particularly egregious when it comes from researchers sitting on the data-safety-monitoring board, a panel that looks out for the safety of test subjects.

“There’s a potential conflict of interest for keeping people in a study there,” Caplan said. “Maybe they should have to disclose, ‘I’d like you to be in this study, and I’ll be making money depending on the results.’” Caplan added that many researchers are supposed to disclose outside sources of income to their universities. He said universities should redouble their efforts to examine those income sources.

David Miller, who runs the newsletter Biotech Monthly,  said he never pays for information, and he hopes universities don’t decide to levy blanket restrictions on researchers talking about drugs they’ve worked with. “It’s important for doctors to be able to talk to other doctors,” he said. He added that there are plenty of legitimate reasons to talk to research doctors after results have been published. “I’ll talk to them about how patients reacted to taking the drug. Does it take a long time to administer? Do nurses hate preparing it? All that is important for how it will play in the marketplace.”

In an analysis of  the Seattle article, Miller urged the SEC to enforce insider trading regulations, but called on ethics boards not to silence doctors completely.

The SEC has already launched an investigation of Robert Figlin, a kidney cancer specialist at the University of California at Los Angeles who was named in the Times article. UCLA is launching its own internal investigation, and Figlin has promised full cooperation. In the Times article and in an interview with UCLA’s Daily Bruin, Figlin has maintained that he only provided public information, and appropriate expert consultation during a paid conference call. The Times article said he made predictions about the success of a cancer drug, which he denies. In the Daily Bruin article, Figlin said: “It was my hope that there would be a survival benefit, because I'm a cancer doctor. I in no way said that I knew that there was a survival benefit.”

Caplan thinks an SEC lawsuit could be the best medicine for medical researchers who are too chummy with investors. “I think one SEC suit will control this,” he said.

Still, experts do not expect the Wall Street invitations to cease. “If you are a top author, or a top person at a university medical center, you have a price on your head,” Miller said. “My guess is nearly all of the top people have done this.”

 

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