Patients, Not Pocketbooks
The conference, called “Human Subject Protection and Financial Conflicts of Interest,” will bring together patient advocates, university academics, clinical researchers, hospital staff, entrepreneurs and government officials to help the agency firm up its policy requirements.
     The key issue will be ensuring that medical researchers are always looking out for the best interests of their patients, not their pocketbooks.
     Of concern: Might some researchers bend the results to get the answer that will give them the million-dollar payoff? Would they cover up any adverse effects when signing on new patients? And should patients always be told of possible investigator bias?
     “Today, we’re living in a world where the primary investigator may own the company [conducting the study] or have stock in it,” says Abbey Meyers, president of the National Organization for Rare Diseases, a patient advocacy group. “It’s in his best interest that if the trial isn’t successful, maybe he won’t release all that information to the public.”

Gelsinger Case Highlighted
The case of Jesse Gelsinger, the 18-year-old Tuscon, Ariz.,-man who died in a gene therapy trial last September, has put this issue in the spotlight.
     After Gelsinger’s death, an FDA investigation revealed he may not have been properly informed of all the risks of the study and that he may not have been a suitable candidate for the study, but was admitted anyway.
     “We’re left wondering: Was the scientist’s financial benefit linked to the fact that this young man was not told the whole truth?” says Meyers, who will be voicing such concerns at the conference. “There should never be that doubt.”
     Of course, experts point out, other motivations have always been at play in the research world: ego, reputation, social agendas, pressure to “publish or perish.”

Money Conflicts Potentially Enormous
But financial conflicts of interest are of immense interest now because academic researchers today are more likely to also be stakeholders or CEOs of companies than ever before.
     Marcia Angell, former editor in chief of the New England Journal of Medicine, wrote in an editorial this spring titled “Is Academic Medicine For Sale?” that the ties between industry and academia have gotten out of hand.
     “So much clinical work today is co-mingled with commercialization,” agrees Sheldon Krimsky, a science policy expert at Tufts University in Medford, Mass.
     And that may affect decision-making. “Any time you’ve invested money into something, it’s going to reinforce any enthusiasm you have,” Krimsky says. “You wonder, ‘Are they holding on to this trial because their kid’s education is in the balance?’ It’s a real issue.”

Lapses Exception, Not Rule
But many researchers say that these high-profile cases of alleged ethical lapses reflect the exception and not the rule. Adequate protections are already in place and just need to be better enforced, they say.
     “If I invent a new drug and build a start-up company and begin to test my invention, I must follow a dizzying set of regulations to assure a valid and honest test of the drug,” says Dr. Patrick Lyden, chief of clinical neurology at the University of California at San Diego. “I believe that further legislation or administrative rule-making is unnecessary.”
     Current policy requires researchers to disclose possible financial conflicts of interest when applying to the Public Health Services, including the National Institutes of Health, for a grant, and when applying for FDA approval. Researchers must then inform their patients of financial conflicts, as well.

Money Interests Not Disclosed
But no one is ensuring that patients are being told.
     At individual hospitals, institutional review boards are given the responsibility of evaluating proposed clinical trials and making sure patients will be protected.
     Subjects of clinical trials are typically required to sign informed consent papers that explain every detail about the experiment’s risks and benefits — but often omit whether the investigator will be profiting from the results.
     At schools like the University of California at Los Angeles and at Johns Hopkins School of Medicine in Baltimore, Md., policy requires that researchers tell patients when they have a financial interest in the product being tested.
     “We are obligated to fully disclose any information that a reasonable person would want to know,” says Steven Peckman, associate director of human subjects research at UCLA. “A potential research subject can make a considered decision whether they want to embark on the project.”