INFORMED CONSENT: Grey Line Between Experiment, Innovation
Federal officials are taking a look at several Thomas Jefferson University neurosurgeons who are the subject of a lawsuit filed on behalf of an incapacitated patient whose wife contends he was subjected to "experimental treatment without his knowledge and without proper oversight," the Philadelphia Inquirer reports. The U.S. Office of Protection from Research Risks is eyeing the case to determine whether George Phillips was "fully informed of the nature of the research" involved in his 1994 medical procedure. After finding a "tangle of blood vessels" in the 31 year-old man's brain that seemed symptomatic of an arteriovenous malformation (AVM), Philips' doctors originally recommended a single radiation session to shrink the tumor, then changed the recommendation to multiple sessions. The move took the shape of a policy shift towards treating certain AVM patients with fractioned doses, said Dr. Walter Curran, Jefferson's chair of radiation oncology.
The Philipses were "speechless" when they learned that Mr. Philips was a "medical pioneer." Under their lawsuit -- the Philadelphia Common Pleas Court recently took the "unusual step" of allowing the couple to amend "their malpractice complaint to include allegations of civil conspiracy, fraud and punitive damages" -- the couple contends the "procedure entered the realm of the experimental when the doctors decided to fractionate it." Tom Kiline, the Philipses' attorney, said, "George Philips was treated under a human experiment research protocol which was not made known to the patient and not made known to the university." The surgeons, however, argue that the surgery was "not a radical departure from the standard treatment for his condition." Dr. David Andrews said that only after treating several more patients with cases similar to Mr. Philips did they decide to seek experimental status, saying, "It was a therapy which I subsequently submitted simply to formalize a protocol and a policy that we have set forth." As a result, the physicians did not submit their proposals to the institutional review board until nearly one year after Mr. Philips started his "experimental research." Dr. Stephen Tatter, an AVM expert at Wake Forest University Baptist medical Center, said, "We do things that are, in essence, experimental without having a formal experimental protocol. We do it on a compassionate basis. We don't have anything else to offer the patient" (Uhlman/Vedantam, 8/16).