From today's WSJ:
Cancer Patients Are Investing
In Experimental Drugs
Some Participants in Cancer Trials
Are Buying Stock In Makers
Of Drugs Being Studied
By AMY DOCKSER MARCUS
Staff Reporter of THE WALL STREET JOURNAL September 29, 2004
Cancer-drug researchers are struggling with how to address a growing problem: cancer patients who buy stock in the manufacturers of drugs that they themselves are taking as part of a clinical trial.
Oncologists say they are increasingly hearing from trial participants who had reacted well to an experimental drug and then invested in the drug's maker. The strategy is a byproduct of a surge in the number of clinical trials being conducted today. But many researchers say the practice raises serious ethical questions.
A major concern is that patients who are also stock investors may play down toxic side effects they are experiencing -- or play up the benefits -- if they have a financial interest in the outcome of a trial.
Researchers say that the integrity of the research could be questioned if it became known that a patient had invested in the drug being studied. Some also fear that, because the information learned in clinical trials is not publicly available, patient investors might be subject to insider-trading liability.
Oncologists say they are seeing increased evidence not only of patients investing themselves, but also of patients sharing nonpublic drug-trial information with outsiders, facilitated by the growth in Internet chat rooms, message boards and blogs. On one recent trial at the University of Chicago School of Medicine, investigators saw posted on an stock-investment Web site detailed information about a patient's positive response to a company's drug, just days after the doctors themselves knew about it.
Paul R. Helft, an oncologist on the trial, says he wondered if the patient was the source, and it made him question the accuracy of the patient's previous symptom reports. "You don't want a situation where the doctor fears he can't speak frankly about the drug to a patient" for fear that information will be used for investment purposes, adds Dr. Helft, who is now with the Indiana University School of Medicine.
Cancer researchers say they have no concrete evidence of patients manipulating trials or drug makers'
stocks. And not all researchers see this as a significant problem. But the issue has raised enough concern that the Journal of the National Cancer Institute published an article recently by Dr. Helft and other researchers at the University of Chicago, calling for a survey of major drug-testing programs to examine the practice of patient investing.
Marvin Kuithe, 62 years old, has inoperable kidney cancer. As part of a trial at the Cancer Therapy & Research Center in San Antonio, he was given an experimental drug from Ariad Pharmaceuticals of Cambridge, Mass. When his tumor started shrinking, says Mr. Kuithe, "I got excited about the drug and the company." He talked to other patients who reported feeling better too. Five months ago, he bought 3,400 shares of Ariad, his first investment in that company.
With the stock currently under $7 a share, it is well below the $11-plus Mr. Kuithe says he paid. But he doesn't plan to sell even though he has stopped responding to the medication and had to be taken off the trial. "Just because it stopped working on me doesn't mean it won't help others," he says.
Buying What You Know
Mr. Kuithe doesn't believe that his investing involves the use of any insider information. When he worked for Shell Oil, he says, he invested mainly in oil companies because that's the field he knew best. Now that he has terminal cancer, he follows developments in cancer research. Mr. Kuithe says he has never posted information about his trial experience on the Internet, though he talked to his brother, who also invested in Ariad stock.
At Ariad Pharmaceuticals, Chairman and CEO Harvey Berger says that the practice of patient investing does stir misgivings about the accuracy of reported side effects during a trial. "The integrity of clinical trials is at the top of the list [of considerations], and anything that could compromise this integrity concerns me," he says.
The increase in patient investing is being fueled by an explosion in recent years in the number of drugs being tested. While there were once perhaps only 40 new agents in early-phase trials at any given time, today there are several hundred, reflecting tremendous growth in scientists' understanding of possible targets for cancer drugs. This, in turn, has resulted in more patients than ever joining clinical trials -- particularly early-phase trials, where oncologists say the greatest potential financial conflicts exist.
Early Risk
Whereas many late-stage trials involve a placebo and patients don't know what they are taking, patients in early-phase trials know what drug they've been given and can be more certain that a good reaction is due to the drug. It is also at this early phase -- when researchers are testing mainly safety and dosage -- that patients could have the most negative impact. It is vital that researchers have accurate feedback on side effects when they're judging a drug's safety.
Plus, in the early stages of research, the public has little information about a drug to base investment decisions on, so a trial participant theoretically has an advantage.
Concern about early drug-trial information leaking out is also being driven by wider changes in the cancer community. Patient-advocacy groups have become important sources of information for patients, and many have online chat rooms where patients exchange information on promising new drugs, rumors they hear about how others are faring, and their own experiences.
Some groups are aware that stock analysts may log on to gain an early look at trial results and do try to restrict access to cancer patients only, but that isn't always possible. Even the American Society of Clinical Oncology has grappled with this problem. At the group's annual meeting in June, trial results on promising new drugs weren't given out early to lower the chances someone might trade on it before data were officially released to the public.
A Look at the Rules
Federal guidelines restrict physicians' ability to invest in companies using information from a clinical trial. And the Securities and Exchange Commission has prosecuted physicians for insider trading while running trials. But when it comes to cancer patients, the situation is murkier.
The SEC defines insider trading generally as buying or selling stock based on nonpublic information. And many patients clearly have such information, gleaned from not just their own experience with a drug, but also from conversations with doctors and nurses in the trial, and even from the "informed consent" documents they sign to join the trial. Such documents lay out known toxicities and risks.
Breach of Trust?
But to be considered insider information, it must also be "material" -- which lawyers say essentially means it has the potential to move the stock. And it must involve a breach of fiduciary duty or trust. It's unclear whether patients are breaching a trust by sharing or acting on drug-trial information. The only documents they sign are the informed-consent forms, which do not specifically address confidentiality. And some cancer researchers say that adding confidentiality requirements to such forms could deter patients from signing up for trials at a time when it's already difficult to fill the growing ranks of studies.
Daniel Reinberg, a litigation partner in Chicago's Foley & Lardner law firm, says that a patient's liability for insider trading cannot be ruled out, though, he adds, "It would be a hard case to prove."
John Heine, a spokesman for the SEC says, "We don't comment on hypothetical situations," and notes that he isn't aware of any insider-trading cases involving cancer patients in trials.
In 2002, stock analyst David Risk of Sterling Financial Investment Group was sanctioned by the National Association of Securities Dealers for sending his brother to impersonate him and join an insomnia-drug trial. Mr. Risk then used information his brother gathered to write stock-research reports on the drug's manufacturer. But that situation involved very different breaches of trust than a cancer patient would face.
Objective Evidence
Not everyone in the cancer-research community agrees that patient investing is a problem. "There are a lot of reasons patients minimize symptoms they have during a trial other than a financial interest in a drug,"
says Mace Rothenberg, director of the
early-drug-testing program at the Vanderbilt-Ingram Cancer Center in Nashville.
Patients often fear they will be taken off a potentially life-saving drug if they report adverse side effects. Others, he says, may tell doctors what they think they want to hear. That is why investigators try to rely on objective measurements, such as changes in blood tests or scans, rather than a patient's subjective report, says Dr. Rothenberg.
Anthony W. Tolcher, director of clinical research at the Institute for Drug Development at the Cancer Therapy & Research Center in San Antonio, and Mr.
Kuithe's doctor, says that one patient's experience is unlikely to give that person any particular investment advantage. In many cases, he says, only one patient in an entire study will respond to a new drug. Patients often do not know the larger picture, he says. |
