By the time Bill Hamlet dropped out of a clinical trial of Genentech's Raptiva in December 2000, the 58-year-old artist and woodcarver could...
By the time Bill Hamlet dropped out of a clinical trial of Genentech’s Raptiva in December 2000, the 58-year-old artist and woodcarver could barely walk or stand.
Thick red scabs from a severe outbreak of psoriasis covered his legs, back and torso. Blood stained his sheets and clothing. Before entering the study, Hamlet says he was in good health. He took the medication methotrexate to control psoriasis and a mild case of psoriatic arthritis, a condition causing inflammation of the skin and joints.
In his half year in the trial, Hamlet was first given a placebo, a substance with no active medicine, and then an experimental drug. He says that when he consented to join the test, no one told him his psoriatic arthritis could worsen if he got a placebo.
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Hamlet, who lives in Pittsboro, N.C., enrolled in the test, sponsored by Genentech, at his doctor’s suggestion in July 2000. His doctor, Mark Fradin, 45, was the physician running the trial in nearby Chapel Hill.
Hamlet says Fradin, a dermatologist, told him the experimental drug was promising and offered fewer side effects than methotrexate. He says he trusted Fradin and signed a consent form. “I always thought he was my buddy,” Hamlet says.
To begin the Genentech test, Hamlet had to stop taking methotrexate. Within weeks of discontinuing the successful treatment, Hamlet’s skin irritation flared up worse than it ever had, he says.
“You see how horrible it was,” Hamlet says, flipping through a blue binder filled with photographs that chronicle his transformation from a man in robust health to one in constant pain.
Within a week of beginning the test with a placebo and 72 days after stopping methotrexate, Hamlet’s arms, trunk and legs were covered with scabs and “large encrustations,” according to a lawsuit he filed against Genentech, Fradin and Western Institutional Review Board (WIRB), which was hired by Genentech to ensure that risks didn’t exceed benefits.
Genentech and WIRB paid Hamlet an undisclosed amount this year to settle the lawsuit, which was filed in Orange County Superior Court in North Carolina. The defendants neither admitted nor denied wrongdoing. “We reached a confidential settlement, and it’s not our policy to comment on the details of a lawsuit,” Genentech spokeswoman Tara Cooper says.
Fradin said in a deposition in July 2004 that he didn’t know whether Hamlet would be given Raptiva or a placebo during the trial. Fradin said he might have advised Hamlet not to enter the trial if he had known Hamlet might get a placebo.
“If I had known that he would not get any active drug, and if I had known that he would have a significant flare-up, then I might have counseled him not to do it,” Fradin said.
Fradin didn’t return calls seeking comment. His lawyer, William Daniell, says Fradin settled Hamlet’s suit without paying damages. “He feels the care he provided was entirely appropriate,” Daniell says.
Angela Bowen, WIRB president, says she doesn’t think her agency did anything wrong. “Nor do I think the physician did anything wrong with Hamlet,” Bowen says.
Arthur Caplan, director of the Center of Bioethics at the University of Pennsylvania, says such explanations make no sense.
“Its outrageous to take any patient for whom a therapy is working well and, without that person’s full, complete and indisputable knowledge, stick them into a placebo-controlled trial,” he says. “The core principle of medical ethics is, ‘First, do no harm.’ “
Within a month of starting the drug experiment, Hamlet developed symptoms of arthritis, medical records show. By December 2000, his condition was so extreme he needed a cane to walk. During the next six months, Hamlet saw Fradin at least 12 times, according to the suit. Fradin and WIRB never advised him to leave the trial, Hamlet says.
Although Hamlet grew increasingly ill, he didn’t drop out of the trial because he was convinced he would eventually get Raptiva. Hamlet says he suspected he was getting a placebo three weeks into the trial. Because the rules of the trial prohibited clinicians from knowing who got placebos, Hamlet had no way to know if he did.
Hamlet’s suspicion was confirmed when he saw his records more than two years later, after filing the lawsuit. By October 2000, Hamlet was switched to the experimental drug, and the psoriasis slowly improved. His arthritis grew worse, records show.
The FDA approved Raptiva for treatment of plaque psoriasis in October 2003. The medication doesn’t work to control the symptoms that were associated with Hamlet’s psoriatic arthritis, Genentech said in a March 2004 news release.
Greg Koski, a physician and former head of the federal Office for Human Research Protection, which protects people in federally funded clinical trials, says patients who are being successfully treated shouldn’t be taken off medication to try an experimental drug or placebo.
Hamlet’s case should be a lesson to the clinical-trial community, Koski says. “It’s an example of how the system can really fall apart and result in harm to individuals,” he says.
On Dec. 21, 2000, Hamlet received his last injection in the trial. He dropped out a week before the trial ended.
“I felt like a guinea pig,” Hamlet says. “I would say that I got zero medical care during the study. I became the person to observe, not to treat.”