Of Patients and Profits
How a cancer trial ended in betrayal
With millions at stake, research universities become partners in commerce - and medicine pays a price.
Duped: Bob Lange tried an experimental drug for his rare skin cancer. Researchers said he was cured, but it was a lie. Eventually, he went back to standard treatment - phototherapy drugs and ultraviolet light. (Sun photo by Kenneth K. Lam / June 24, 2001)
- The changing creed of Hopkins science
- Standing up to industry
About this seriesOf Patients and Profits
Sunday: How greed corrupted a cancer drug study.
Monday: Once disdainful of industry, Hopkins now embraces business opportunities.
Tuesday: Industry influence and scientists' fight for independence.
- Medical Research
- Trials and Arbitration
- Colleges and Universities
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BIRMINGHAM, Ala. - After Bob Lange spent eight weeks rubbing an experimental cream on the fiery patches on his body, researchers at the University of Alabama at Birmingham told him the drug was defeating the killer inside him. He felt grateful. "I believed it," he recalls. "I actually thought I might be cured."
But it was a lie. The drug had no effect on Lange's rare and potentially fatal skin cancer. And the two key people testing the drug knew it. Lange and 21 other patients were victims of fraud - a scheme made possible by the close ties between the university and the state's most prominent biotech company.
Though promoted as a cure for an incurable disease, the drug in the end produced only disgrace. Two people were convicted last year of defrauding the U.S. Food and Drug Administration. A university physician, one of the nation's leading dermatologists, was banned from testing drugs for the FDA. Investors lost an estimated $34 million in the company, BioCryst Pharmaceuticals Inc., after the bogus data were discovered. The National Institutes of Health accused the university of poor oversight and suspended enrollment of patients in 550 studies.
Lange, a 55-year-old factory manager, worries that the judgment of those in charge was clouded by their financial stake in the outcome.
"If you can't trust the medical profession or the people creating these things to benefit humanity - if they're going to sell out for profits, who is there left to trust?" he asks.
Today, Lange's question echoes in the halls of Congress, in the pages of top medical journals and in university laboratories across the nation.
The public relies on America's medical research centers, subsidized by tax dollars, to serve as independent authorities on drugs and therapies. Like the Birmingham school, many institutions have become business partners in recent years with pharmaceutical and biotech companies, forming what critics call the "academic-industrial complex."
For patients, these alliances can speed development of lifesaving treatments. For schools hungry for research money, the payoff can be enormous: Stanford University and the University of California, San Francisco split $270 million in income from one genetics invention, while Michigan State University earned more than $160 million from sales of two anti-cancer drugs. The Johns Hopkins University realized how much money is at stake after it passed up a chance to patent a DNA-testing method and then watched a Bethesda company turn it into a $100 million product.
But moving into the marketplace is radically changing American medical centers. Increasingly, they're committed both to advancing science and making money. This dual mission can threaten the integrity of medical research and the safety of patients, even at elite institutions.
Doctors at the Fred Hutchinson Cancer Research Center let a blood-cancer experiment drag on for years, even though patients were dying at a higher rate than with standard therapy. At least 20 patients died from causes directly attributable to the treatment, the Seattle Times reported this year. The center and some of its physicians had a financial stake in the treatment.
At the University of Pennsylvania, doctors ignored danger signals in a 1999 gene therapy trial that caused the death of an 18-year-old study volunteer from Tucson, Ariz. Both the physician overseeing the trial and the university held stock worth millions in a company trying to develop the therapy.
A University of Pittsburgh scientist whose research was funded by several drug companies has been accused in a lawsuit of manipulating a study of children's ear infections - contributing to the dangerous overuse of antibiotics.
And the FDA reprimanded a Tufts University researcher for improperly treating a cancer patient with a gene therapy that may have caused his tumor to double in size. Both the scientist and a Boston medical center held a large stake in the company developing the treatment.
"The market obviously is corrupting," says Dr. Steven Piantadosi, a professor at the Johns Hopkins School of Medicine. "It's corrupting at every level."
Experimenting with people is always risky and sometimes tragic. This month, a healthy young woman died after participating in an asthma experiment at Hopkins. There is no evidence, though, that the school or physicians involved had any financial interest in the study.
But the BioCryst fraud shows how research can be skewed when scientists and schools have a major stake in the outcome. It raises the question of whether the current haphazard collection of federal rules governing such conflicts of interest is sufficient to protect patients. And it demonstrates how the cozy relationship between money and academic medicine can threaten public health. If a conspirator hadn't blundered, federal officials say, a worthless cancer treatment could have slipped onto the market.
Like Lange, Marcia Houchens was told that her cancer was getting better when it wasn't. She says she was told that the experimental drug was her only hope, though there were proven alternatives. When she complained to university officials, she was told that her protests were being sent to the university president. Soon after, Houchens learned that he had resigned to become president of BioCryst.
She trusted her life to the researchers, the company and the Birmingham school, but she says all three violated that trust.