Scientists Question Cancer Gene Trials At Duke University

UPDATE: Duke tells Shots that it is suspending the enrollment of new patients in the clinical trials until a full review of the underlying data and science can be completed.

Résumé padding. It's not just for politicos.

Duke University has suspended a cancer researcher for allegedly lying on his résumé, and now, independent scientists want to halt clinical trials based on his work until it can be properly reviewed.

The Cancer Letter recently reported that Anil Potti had falsely claimed to have won a prestigious Rhodes Scholarship in 1995. Over the years, scientists have also had a lot of questions about Potti's research -- including how he handled data in a potential new cancer screening technique.

It all began with a 2006 paper in which Potti claimed to have achieved a breakthrough in gene screening for cancer treatment. The idea was to look at the genetic code of cancerous cells, which is differs from that of healthy cells. Potti said he was able to use genetics to tell which cells would respond to which chemotherapy.

As anyone who's had cancer or a relative with cancer will know, this would be huge.

Chemotherapy can be highly effective against cancer, but it doesn’t always work. Patients often have to try a few rounds with a few different drugs before they find something that their specific cancer will respond to. Pre-screening cancer treatments based on genetics tests could mean cheaper, faster, and more effective cancer treatments. And it would mean less pain for cancer sufferers.

Cancer researchers at the MD Anderson Cancer Center in Houston saw Potti’s work and got really excited. They asked Keith Baggerly and Kevin Coombes, both involved with biostatistics at MD Anderson, to check into Potti’s work.

It’s not an easy experiment to check under the best of circumstances. Like most geneticists these days, Potti tested thousands of genes in hundreds of samples. He used computer codes to find several correlations that he claimed could be used to predict the response to chemotherapy.

But try as they might, Coombes and Baggerly could not reproduce the results. Even worse, they found serious errors in Potti’s work. Columns of data had been shifted and sample labels switched. When Coombes and Baggerly corrected the problems, the correlations vanished. In other words, patients who used the gene screening to choose a chemotherapy were essentially flipping a coin, Kevin Coombes told Shots.

Potti and his co-authors were forced to issue a series of embarrassing corrections. Nevertheless, they stood by the work and went forward.

Three clinical trials are now actively recruiting participants in the Durham, N.C. area to test their screening techniques.

“I think those clinical trials should be stopped and the science behind them should be investigated,” Coombes says.

Many other geneticists we contacted agreed.

While the trials will not harm any of the patients -- the chemos being used are all accepted treatments for the cancers involved -- researchers fear the work is a waste of time and money.

But not everyone agrees with them. Patients enrolled in the trial should finish their treatment, says Otis Brawley, an oncologist and chief medical officer of the American Cancer Society.

“The absolute worst thing you can do for them is stop treating them now,” he says. Nevertheless, Brawley says he would like an explanation from Duke about Potti’s latest transgression: The Cancer Society awarded him a $750,000 grant for research, and they may want their money back, he says.

Duke has placed Potti on administrative leave, but Douglas Stokke, a spokesman for the University, would not say whether his clinical trial would be allowed to continue.

Potti did not respond to e-mails or phone calls.