Duke turning to National Academy of Sciences. What did Dzau mean by "broader" investigation?

Monday morning update / August 2, 2010

✔EXTERNAL INVESTIGATION involving the science of Associate Professor Anil Potti and his mentor, Dr. Joseph Nevins, Levine Professor of Breast Cancer Genomics and Director of the Center for Applied Genomics and Technology.

The Cancer Letter and its lead reporter Paul Goldberg, Trinity ’81, who has done Duke University and the public a great service in unearthing this scandal, report that Chancellor Dzau is in negotiation to bring a division of the National Academy of Sciences in to investigate.

If this comes to fruition, Dzau will have fulfilled very well indeed his promise to enlist people with unimpeachable credentials and sterling reputations.

The specific division: The Institute of Medicine National Cancer Policy Forum.

The Chancellor reportedly has been in consultation with Dr. Harold Varmus, the new director of the National Cancer Institute, the federal government's principal agency for cancer research, a division of the National Institutes of Health.

The Cancer Letter says all this "shows that at the highest policy levels, the Duke scandal is viewed as a potential threat to the discipline of genomics rather than as an isolated act of a rogue researcher."

More on Dzau -- and new issues arising from his e-mail to the medical faculty last Thursday -- in a moment.

✔INTERNAL INVESTIGATION. Provost Lange took his first step in the probe into whether Potti faked his Rhodes Scholarship and other credentials -- and promptly stubbed his toe.

The Chronicle asked Lange if he were going to investigate alone or if he'd have a panel. Lange wouldn't say.

Noting that Dzau has said that unlike the external science probe, which will take considerable time, the credentials investigation is almost over, the Chronicle asked Lange how he'll keep everyone informed. Lange wouldn't say, but he did note Potti's rights in a personnel matter -- even if it involved deliberate falsehood -- may prevail over the public's need to know.

Yes, this is the same Lange who has pledged "transparency." Imagine what it would be like if we were going forward with the usual administrative secrecy!!

Lange did allow that his boss Mr. Brodhead -- whose only public comment that Fact Checker can find is a cursory e-mail response to a Chronicle question -- is fully engaged.

Lange owes us -- all of us, every stakeholder and every patient, the family and survivors of every patient, every taxpayer funding the Potti-Nevins research work, everyone who has ever contributed to the American Cancer Society -- a full exposition of his internal procedures right now:

A) who is involved in this investigation? Who will sit in judgment?

B) what the standard for their judgment will be? For example, is one infraction, faking a Rhodes scholarship, enough for termination?

C) If there is a panel, will it require a majority, a super majority or unanimity to terminate Potti?

D) If there is a panel, is it just making a recommendation? Does final judgment rest with an administrator? Who?

Moreover, Lange also owes us a full explanation of how Duke vets all professional resumes -- or for that matter how Duke vets the applications of prospective freshmen.

✔One theory that has emerged: Duke may have breached its own standards in its rush to repopulate its genome enterprise after the departure of Dr. Margaret Pericak-Vance and Dr. Jeffrey Vance. She was director, he was associate director of the Duke Center for Human Genetics.

When the Vance's left for the University of Miami, more than 50 Duke scientists they worked with and $34 million a research grants went with them. In one swoop -- a loss never reported to the Duke community by Duke PR or anyone else to this day. One more reason you need Fact Checker, who has reported on this twice.

Pericak-Vance made her reasons unequivocally clear:

"We met Donna Shalala (the president of Miami) and saw she had the vision and the energy to get things done, which is what Jeff and I are all about. We're interested not only in finding genetic answers, but in translating that to health care, and there's everything here at Miami to do that."

Small wonder that Duke PR is silent.

✔And now back to Chancellor Dzau and issues surrounding the EXTERNAL investigation.

A) As Loyal Readers now know, there has been growing concern about the Potti-Nevins studies for several years. Last fall Duke stopped new patients from entering and did its own investigation. We will call that investigation #1.

Duke cleared Potti-Nevins and re-instated the studies in January.

Investigation #1 is now under attack and Duke has drawn a circle of secrecy around it -- even refusing to say who did the investigating! So much for the promise of "transparency."

It's in this context that Dzau admits need for a "broader" investigation.

Fact Checker doesn't want to parse words, but "broader" is not enough. Dr. Victor, do you mean a total, top to bottom, comprehensive review, following every thread to the end?

If so, Fact Checker applauds. If not, you are giving me lots of ammunition.

The thread includes everyone who has worked in Potti's lab and co-authored articles he has published.

Didn't they suspect something? Could they be held to a professional standard that would expect them to have suspected something? What did they know? When did they know it? Did they participate in the crime of obtaining research grants under false pretenses?

That list of suspects is long. Long. Fact Checker is still developing it. Already have 26 names. Many with MD.

✔ Moreover, Dzau's email said investigation #2 embraces the Potti-Nevins "science." Fact Checker sincerely hopes that the Chancellor is not excluding administrative actions.

As Goldberg, the Cancer Letter reporter, put it:

"It could have been the problem of a rogue researcher based on silence—now it's the problem of the rogue researcher and the administrators that protected him... This is a question of the administration. They are taking a problem that they could have solved, and turning it into a problem that is structural to the institution."

Providing no details, Dzau said Duke would divest itself of investments designed to allow it to profit from discoveries. That has to be fleshed out and its impact explained. We have to know if this pertains to Potti-Nevins alone, or to all Duke research.

Loyal Readers can expect Fact Checker to ask plenty of questions about Duke’s Office of Licensing & Venture$.

✔My fellow Dukies, this is a scandal that is going to metastasize. Today Fact Checker has not discussed the 107 or 109 patients who are still receiving treatment as determined by Potti-Nevins, patients who many doctors say might be better off with other therapies. Dr. Dzau's brief assurance on them, after being pushed to answer, is not enough.

We need to know if Duke has fully informed the 107 of the questions surrounding Potti-Nevins and what options they may have left. Decency requires it.

We have not discussed yet how other cancer patients seeking to enroll in these "studies" contributed tissue for DNA RNA analysis -- not a simple process nor one that is without deadly risk. Was this done because of fraud?

There is going to be litigation over this. Patients suing for malpractice. Their survivors suing. Perhaps the Cancer Society suing to get its money back.

Stakeholders in this university must be assured that no Duke funds will be paid for lawyers to defend anyone who deliberately gave us bum science. Not in civil suits. And for heaven sake, not in criminal prosecution.

✔Thank you for reading Fact Checker.

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