At Your Own Risk

Some patients join clinical trials out of desperation, others to help medicine advance. Who is to blame if they get sick--or even die?

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By the time Cherlynn Mathias was ready to blow the whistle on Dr. Michael McGee two years ago, it had been clear for quite a while that something fishy was going on. For one thing, there were the hokey infomercials touting his experimental vaccine for malignant melanoma, a particularly nasty form of cancer, as if it were a Veg-O-Matic. Thanks to the vaccine, a patient declared onscreen, my cancer is in total remission. Then there was the sales pitch McGee delivered in person. When she and the doctor met with a prospective patient, says Mathias, who worked as his research nurse, he would come on like a used-car salesman: "'We have the best vaccine out there,'" she remembers his saying. "'Two-thirds of my patients have responded to the treatment.'" He was even giving the drug to his father-in-law, he would tell people; that's how good it was.

But what they got, once they joined McGee's clinical trial, many patients say, was a different story. According to Mathias, more than a third developed severe side effects, including uncontrollable nausea, fevers, rashes, swelling and terrible headaches. Some thought the doctor's behavior was odd. While on the vaccine, one patient, Dawanna Robertson, discovered she was pregnant; she panicked when she recalled the warning on the consent form she had signed: "The potential effects of these drugs on the growing fetus...may include serious birth defects." Yet when she voiced her fears, Robertson says, McGee assured her that the vaccine couldn't pass through the placenta. She received another injection that day.

Still, Mathias says, most of McGee's patients believed that this vaccine was their best chance for recovery from what is usually a fatal disease. That's why they were so shocked when McGee sent them a letter that read, in part, "Patients have enrolled in this study more rapidly than originally expected...Due to this interest, the sponsor has exceeded its capacity to supply the experimental Melanoma Vaccine and is unable to provide material for further injections at this time."

The letter was devastating enough, but Mathias knew it was a lie. The truth was that the trial had been suspended out of a growing concern among McGee's supervisors that it may have been doing more harm than good. So after agonizing for days about what to do, she wrote a long, detailed letter to what is now called the federal Office for Human Research Protections (OHRP), describing McGee's multiple lapses. Her letter reported that McGee had, among other things, stored the vaccine improperly, exposing it to potential contamination; failed to maintain adequate records and track its consistency from batch to batch; mislabeled vials of the stuff; and, worst of all, kept most of the data on adverse side effects secret. An investigation by the Food and Drug Administration confirmed her suspicions and ultimately revealed more than 20 separate deficiencies. "We were doing nothing right," says Mathias. "It was a perfect lesson in how not to run a clinical trial."

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