By Noble Sprayberry

The question seemed simple. Mark Ratain, MD, asked a patient where they learned about a clinical trial for a new cancer drug. The answer, a printout from a website with forums for stock investors, only brought more questions for Dr. Ratain, a professor of medicine at the Cancer Research Center of the University of Chicago.

He monitored the site, learning that investors sought detailed information on the progress of clinical trials to guide their investment strategies. “It talked about other people I knew and what they were saying,” he says. “One day I noticed non-public information about one of our patients.”

Evidence was anecdotal but sufficient for concern. Should patients in trials use their personal knowledge of a drug’s success or failure to guide their own stock choices? Do patients chatting in online cancer forums unintentionally release information that can affect stock prices?

One of the most disturbing possibilities is also the least likely—a patient falsifying trial results to drive up a company’s stock, Dr. Ratain says. Patients who purchase stock from the drug’s manufacturer may withhold information about side effects.

“It’s theoretically possible you could get biased data because a patient had a position,” he says. “I think the real concern should be for the trial sponsors regarding confidentiality of data and the impact of leaks from patients on the trading behavior of stocks.”

Dr. Ratain says he has seen trial results move financial markets during a phase II trial. A company’s stock, trading at $3 at the beginning of the trial, marked a 10-fold price increase after the first presentation of data. There was no public abstract but lots of information was available on Internet message boards, he says.

Dr. Ratain, two other physicians and a law professor wrote an article printed in the Journal of the National Cancer Institute last year exploring the issue. While no one has conducted a broad study, Dr. Ratain says people were intrigued.
“Patients have access to market-moving information before anybody else in clinical trials,” he says. “There’s no legal or ethical language or constraint that relates to the patients.”

John Hiney, a spokesman for the Securities and Exchange Commission (SEC), says he was unaware of any cases in which the SEC addressed this issue. He would not comment on what would constitute a patient crossing the line into insider trading.

It is possible, though, for patients to violate the law by using their knowledge of a trial to guide investments, says Richard Epstein, a University of Chicago law professor and co-author of the journal article. It’s possible, but not certain, that a research subject who trades on non-public information violates insider trading laws, he wrote in the article.

One possible solution is to ask patients to meet the same standards as physicians, Epstein tells CURE. Physicians must already disclose any financial conflicts of interest. Requiring patients to follow similar guidelines, including an emphasis on keeping information confidential, could address many of the issues, Epstein says. “When you’re running trials, you don’t want people to publish in any fashion.”

A contract expressing the limits of a trial participant’s ability to share information might suffice, says Epstein, who agrees there’s not yet a serious problem.

John Robertson, a bioethicist and University of Texas law professor, says such a contract would limit speech as a condition of participation without violating the First Amendment since the First Amendment applies only to state action, not private companies. “If the group running the trial, say a pharmaceutical company, would like to set a condition of participation, they could certainly ask patients to agree to such a condition.”

Currently, there are many online forums where patients trade information about their treatments and the development of new drugs, creating a fertile resource that could be misused by a stock trader, says Dr. Ratain.

Leonardo Faoro, MD, completing his residency in internal medicine at the Mayo Clinic in Rochester, Minnesota, started the Cancer Forums (www.cancerforums.net) eight months ago. It’s grown to more than 20 forums, with participants sharing their hopes, worries and knowledge. One breast cancer patient involved in a trial wrote about her experience, but the focus was more on how she was treated and the overall experience than on the success of the drug, says Dr. Faoro.

“Investors may be hungry for any information they can gather, but I don’t think it would give them a big advantage,” he says. “It would be just one or two patients out of a trial with hundreds.”

For now, participants in clinical trials face no limits on how they share information. “Patients certainly don’t feel any constraints about sharing information about either themselves or what they’ve heard from their physician or what they’ve heard in the waiting room,” says Dr. Ratain.

Now, he says, the medical community must decide the boundaries it’s willing to accept.