The revelation of these and other scandals led to the National Research Act of 1974, which required institutional review boards to approve and monitor all federally funded research. The Department of Health and Human Services followed up by creating what is now called the Office for Human Research Protection, whose job was supposed to be to oversee the IRBS. But the nature of medical research has changed dramatically in the past few decades. "Back then, research tended to be a single investigator working at an academic institution conducting a small-scale clinical trial," says Dr. Jeremy Sugarman, director of the Center for the Study of Medical Ethics and Humanities at Duke University School of Medicine. "As the medicine changed, however, the review system did not."

Until last year, in fact, when the agency's budget tripled, OHRP had just two full-time investigators to monitor more than 4,000 federally funded research institutions. Since 1980, the agency has audited, on average, just four sites a year. The FDA is somewhat more vigilant, making site visits to about 200 of the approximately 1,900 IRBS that oversee research on FDA-regulated products.

Meanwhile, IRBS, which are supposed to be the first line of defense against unethical or badly designed studies, are often overwhelmed by the job. At some large research universities, a single irb must supervise more than 1,000 clinical trials at once. Indeed, a 1996 report by the General Accounting Office found that some IRBS spend only one to two minutes of review per study. Board members can't possibly be experts in every field; most are in-house researchers whose own studies are likely to come up for review someday. Says George Annas, a critic of current U.S. laws: "Researchers tend to approve research; they know this is how the institution makes its money. They rarely deny anything."

The financial conflicts of interest can extend not only to the institutions but also to the researchers themselves. One of the reasons Jesse Gelsinger's death in the University of Pennsylvania's gene-therapy trial in 1999 seemed especially scandalous was that James Wilson, the principal investigator in the study, held a 30% equity stake in Genovo, which owned the rights to license the drug Wilson was studying; the university owned 3.2% of the company. When Targeted Genetics Corp. acquired Genovo, Wilson reportedly earned $13.5 million and Penn $1.4 million.

This doesn't mean that scientists are pushing bad drugs just to make money. Their interest is in research, and they often need the financial backing of corporate patrons just to get started. After Wilson's financial interests in the Gelsinger case came to light, he insisted that they played no role whatsoever in his decisions, that research was his driving motivation. Yet Marcia Angell, former editor of the New England Journal of Medicine, argues that such a link tends to bias the investigator, even if the bias is unconscious. A recent study by the University of Toronto analyzed 70 studies of a controversial heart drug. The results were telling: 96% of the researchers who were supportive of the drug had ties to companies that manufactured it, and only 37% of those critical of the drug had such ties. As more and more scientists either own stock in or get funding from for-profit companies, the ones who have no industry connections are increasingly rare.

In the Oklahoma case, it may have been a nobler motive that tripped up McGee. "McGee is a good surgeon and a decent man," maintains his whistle-blowing research nurse, Mathias. "But he became a biased investigator. He thought he had found the cure for cancer. He really wasn't interested in running a clinical trial; he wanted to administer his drug"—even if that meant breaking the rules to get there. Although McGee said he had tested his drug properly on animals, he had not; the data he submitted in his original protocol came from animal studies of a different drug. McGee promised the FDA that he would test each lot of the new vaccine on animals for safety before injecting it into humans. The FDA's subsequent investigation found that such testing had not been done adequately.

Then the university review board dropped the ball. Despite federal rules requiring it to conduct "continuing review" of ongoing studies, the board met just once a month, typically for an hour, and then went out to dinner. Among other things, the board approved McGee's consent form, which contained numerous errors. McGee later got permission to add more subjects than the original 25 he had applied for. According to the OHRP investigation, 11 of McGee's first 18 subjects didn't meet eligibility criteria. Like most of the key oversight decisions, this one actually came directly from the irb chair, Daniel Plunket, who often did a one-man "expedited review" without consulting the rest of the board. James Robinson, Plunket's lawyer, insists "there is no evidence" his client "took any action on his own."

Mathias reported substantial protocol violations to Plunket and told Dr. Harold Brooks, dean of the university's College of Medicine in Tulsa, as well. They finally agreed to hire an outside consulting firm to audit the experiment. The finding: deficiencies "so severe that it is beyond the scope of this report to advise corrective actions." This finally persuaded Brooks to put the trial on hold. But according to the investigation, Brooks and Plunket decided not to share the report with the irb; instead, Plunket filed an annual report that stated, "There are no significant safety issues related to the vaccine." That gave cover to McGee's letter lying to patients about why the trial was being halted.

That's when Mathias wrote her whistle-blowing letter. On the basis of its investigation, the OHRP shut down all federally funded human research at the university. The university, meanwhile, did its own digging and came to the same conclusions. It disbanded the Tulsa irb, suspended and later fired McGee, and terminated Plunket and Brooks as well. And on July 7, 2000, it sent a new letter to McGee's subjects. This one admitted that "in fact, the trial was closed because of possible safety concerns."

In the wake of the trial's cancellation, 11 families have sued McGee, Plunket, Brooks, the irb and the university. Says Phyllis Friesner, whose husband died in McGee's trial: "I want the universities and the hospitals to take notice. I want to change the way they do business." Dawanna Robertson, who discovered she was pregnant while on the vaccine, has a more personal reason to be angry. "For the rest of my life," she says, "I will wake up every day and think, 'Is there something wrong with my daughter?'" Robertson says she blames everyone involved, "but I blame myself the most. How could I have been so dumb? I didn't ask enough questions. I heard only what I wanted to hear."

Yet 12 of the 94 patients, even after reading about all the problems with the vaccine, fought to be put back on it after the trial was shut down. Rosie Whisman, now 60, joined McGee's trial in 1999 after finding a knot in the side of her groin. She had Stage IV melanoma, and doctors gave her three to six months to live. She found out about McGee after her daughter saw his ad on television. McGee did the surgery to remove the knot and put her on his vaccine. She has been cancer free ever since.

"I thank God every day for Dr. McGee," she says. She doesn't care, she says, that the drug wasn't properly tested on animals before being given to her. "When you're given three to six months to live and someone offers you something that will allow you to spend more time with your kids and grandkids, you do it. Who cares if they've tested it on animals? It was my only chance to live."

A federal judge has ruled that he has no jurisdiction in the lawsuits against McGee, but attorneys are pursuing the matter in state court. Michael Atkinson, McGee's lawyer, is trying to get the case dismissed there as well. "None of the participants in this trial suffered any real injury," he says. "And any technical issues, they were the University of Oklahoma's fault. They failed to give McGee adequate resources and staffing."

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