DURHAM — Researchers have stopped three clinical trials that rely on the work of a Duke University scientist who may have falsely claimed to be a Rhodes scholar on applications he submitted for federal grant funding.
The three trials are testing the genetic findings reported by cancer researcher Dr. Anil Potti and his colleagues. Last week, Duke placed Potti on administrative leave after allegations arose that on grant applications he embellished his résumé with the prestigious Rhodes scholarship.
Enrollment in the trials was halted Sunday at Duke and elsewhere. The next day, a letter signed by 31 researchers at universities across the nation sharply criticized the work conducted by Potti and Dr. Joseph Nevins, another Duke cancer researcher, noting "serious errors" in their science.
Efforts to reach Potti and Nevins were unsuccessful.
"In this new light, the investigators of three clinical trials ... elected to suspend enrollment of new study subjects ... until a full review of the underlying data and a re-review of the science can be completed," Duke spokesman Douglas Stokke said in a written statement.
The studies were relatively small trials, said Dr. Michael Cuffe, Duke's vice president for medical affairs. One was set to enroll about 270 breast cancer patients at Duke and other centers in the region; another aimed to enlist 117 lung cancer patients; a third sought 150 lung cancer patients. In all, about 109 patients in the Triangle and elsewhere had signed up.
Those participants will continue on the study's prescribed drug regimens, which in most cases were common therapies. Some of the lung cancer patients, however, were testing a drug that has not been approved to treat that form of cancer.
Cuffe said patients who have already enlisted in the trials are not in danger.
"Each of the trials consists of approved, widely used treatments," Cuffe said. "Therefore, we have confidence in the safety of the trials. With these new allegations being raised, we acted out of an abundance of caution ... and went ahead and closed the trials."
Potti's research involved a genetic test that he claimed could predict who might respond well to certain cancer drugs; the trials were testing that approach.
Potti's genetic analysis has been questioned since he first published his results in 2006. According to the letter from the other researchers, scientists could not recreate Potti's discovery, leading them to question whether it was true.
In science, the ability to reproduce results in other labs is crucial for the field to advance, because researchers use one another's work to build and expand on breakthroughs. As a result, poorly documented methods - or false results - hamper progress.
Of particular concern to the outside scientists was the prospect that patients were put at risk by their participation in the clinical trials using Potti's work. They said the unproven genetic analysis could result in patients being prescribed an improper treatment.
"It is absolutely premature to use these prediction models to influence the therapeutic options open to cancer patients," states the letter, which was sent to the head of the National Cancer Institute, Dr. Harold Varmus.
The letter was dated July 19. A spokesman for the cancer institute, Rich Folkers, said the agency received the letter Tuesday but could not comment on its allegations.
It's the second time in a year that the cancer trials involving Potti's findings have been suspended. Duke shut down enrollment late last year when scientists first raised concerns that patients might be at risk. After an outside review, the trials were restarted this year.
As a result of the résumé allegations, Stokke said the university is investigating all of the concerns surrounding Potti and his work.
Questions about Potti's credentials emerged last week in The Cancer Letter, a newsletter that covers cancer issues.
According to The Cancer Letter report, Potti wrote on various applications to the National Institutes of Health and the American Cancer Society that he won a Rhodes scholarship in Australia. On one application, the report said, Potti said he won the Rhodes in 1995. On another, it was 1996, according to the report.
On later bios, he dropped the Rhodes claim, it stated.
The Rhodes Trust does fund 11 scholarships each year for Australian students to study at Oxford University in England. But Potti's name is not on the list of Rhodes winners on the trust's website.
According to The Cancer Letter report, Potti responded to the newsletter's questions with an e-mail message in which he said he was a Rhodes nominee. He did not respond to subsequent questions, the newsletter stated. It also reported other discrepancies in Potti's background.
If he did pad his biography, Potti may have committed a crime. The federal False Claims Act prohibits, among other things, falsifying applications to receive grant funding.
Potti, who came to Duke in 2003 from the University of North Dakota, has brought federal funding to Duke from a variety of sources, but some of that money is now in question. After hearing about The Cancer Letter report, the American Cancer Society late last week froze payments to a $729,000 research project it was funding in Potti's lab.
The controversy is emerging not only as a blemish for Duke, but as a blow to scientific integrity. In recent years, public skepticism has emerged over the existence or seriousness of global warming, the safety of vaccines, and the seriousness of a pandemic flu outbreak.
"It's one of the real dilemmas in maintaining public confidence," said Mark Hall, a medical ethicist and professor at Wake Forest University. "The scientific community needs to police itself and get rid of bad apples. But at the same time it demonstrates it's able to police itself, it's calling attention to dirty laundry."
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