More Duke research challenged: 57 people deliberately infected with a pallet of viruses

Search terms Duke University Anil Potti

✔✔✔✔✔ FC here. Welcome to a new semester.

As the Institute of Medicine (IOM) arrives on campus to begin its investigation of the Potti Mess....

a respected Canadian researcher is charging more Duke genome science is flawed...

and the university was medically and morally wrong to let one doctor go forward with clinical trials -- that is, with experiments on human beings -- that included deliberately infecting 57 people with a pallet of viruses.

The Canadian, Dr. Steven McKinney, is at the British Columbia Cancer Research Centre in Vancouver. He is a statistician with its Molecular Oncology and Breast Cancer Program.

He has filed a complaint with the Institute, an august body of 2,000 U.S. scientists that agreed last fall to undertake an "unfettered" investigation of Dr. Anil Potti starting now. This is expected to take 18 months and include a broad view of ethical questions in genome research. The IOM has already raised $687,000 for the project.

But unlike the Potti case, which involves a faked Rhodes Scholarship, other lies on his resume and possible fraud in laboratory work, the new charges embrace science only.

FC has learned Dr. McKinney's allegations are being taken seriously by Duke's administration, burned for its initial response to questions about Potti. Apart from the IOM, the university itself is said to be ready to promptly launch its own probe.

Each of the 57 patients who got the live viruses underwent genetic testing that predicted what virus he or she might be susceptible to.

The experiment was designed to compare expectations of what might happen with actual illnesses -- colds and flu -- that developed. The long-range goal of the study was to develop guidelines and testing that might be useful in a pandemic.

McKinney says Duke is using a computer program that guarantees the results researchers want -- so they think they see a pattern that arises from a patient's genes when in fact they are only viewing normal frequency of occurrence by chance.

The letter to IOM specifically mentions Dr. Geoffrey Ginsburg for his role with the 57 patients. After stints at Harvard where he was Director of Preventive Cardiology and led a laboratory in applied genetics of cardiovascular disease, and in private industry, Ginsburg came to Duke in 2004. He wears several hats, including Co-Director, Duke Translational Medicine Institute, the initiative designed to speed laboratory findings into patient care.

FC repeats: Ginsburg is not being charged with any personal misconduct.

Duke's Institutional Review Board and review boards at four other institutions that also allowed the human experiments approved Ginsburg's going forward.

In a lengthy interview with a Deputy Fact Checker Tuesday night, McKinney said unequivocally the researchers should not have been allowed to conduct clinical trials. The reason for this is that their hypothesis was "unproven."

McKinney indicated the Duke computer program has been in use since 2001 (with updates) and that other research may be faulty too -- or at least unproved. In addition to Ginsburg, he mentioned other names which FC is withholding since no formal allegations have been filed.

In one case, McKinney said the researcher is "cherry picking" results from his data, a serious allegation.

✔FC continues research on a Potti Mess bombshell. We initially were going to post last weekend, but delayed for several reasons. Stay tuned.

Thank you for reading Fact Checker, and please remember when you read these posts about stumbles, that many miracles occur in Duke Medicine every day.