MEDICAL RESEARCH

'Complying with established policy'

In this e-mail interview to R. Krishnakumar on November 15, Johns Hopkins University's press spokesman and Executive Director, Communications and Public Affairs, Dennis O'Shea answers questions on the missing elements in the university's statement about the Hopkins inquiry into the controversial drug trial:

The university has still not named Dr. Ru Chih C. Huang as the scientist involved, even after saying that action is being taken against the scientist. Why is this so?

The investigation was conducted and the report written under the faculty disciplinary policy of the School of Arts and Sciences, which includes provisions for confidentiality. The university is complying with its established procedure and policy. Nothing I say in this message either confirms or denies your assertion as to the identity of the researcher.

In an earlier response to Frontline you had said that the "source of the funding of the trial remains a focus of the investigation." Can you explain what the investigation has found out on this? What exactly is the nature of involvement of the "start-up company Biocure, Minnesota" and the role of the "Singapore businessman Ang Tiong Lee" in the drug trial?

As you and I may have discussed before, Biocure and Mr. Lee had no involvement in this trial at the RCC, none whatsoever. Biocure was created as a company well after the trial was over. Also, Mr. Lee first met with university officials long after the RCC trial was over. The investigation found that the trial was not sponsored by the National Institutes of Health or any federal agency. The report was inconclusive as to whether any federal funds were used, but did find that - if there were any federal funds involved - it was a very small amount, in the low hundreds of dollars.

What will be the status of the private funding and the patent that Hopkins holds on the M4N "drug", and who will be the real financial beneficiaries, if indeed the university is to continue the research?

There is at this time no approved protocol at Johns Hopkins for any additional human subjects research involving M4N or G4N. Will there ever be? That was not a matter addressed in the investigation and it has not been addressed in any other forum at this time.

What role or benefit will the RCC have in any such future research?

My answer is the same as to the above.

The committee report says it found no evidence that any patient had been harmed or treatment was delayed. Did the Hopkins investigative committee also inquire into what exactly happened at the RCC here to come to such a conclusion?

The information available to the committee on this point included the September 15 statement of the Government of India and the report, posted on the Internet, of the Indian Medical Association, Kerala Branch.

One of the findings is that Dr. Huang signed "several versions of a document" committing the university to collaboration with the RCC. Which exactly is the document you are referring to here? What will be the status of the university's collaboration with the RCC from now on?

The document was an agreement to conduct collaborative research. The faculty member did not have any authority to sign this document on behalf of the university.

The post-inquiry statement makes it clear that Dr. Huang will be able to continue her "promising" work further, even though she may not have the title of "principal investigator". Dr. Huang has already said she and her colleagues plan to conduct a series of experiments with the "cancer drug". Does this not mean that the university's investigation and its authorities have failed to address the serious ethical issues involved in the trials conducted ("without adequate preliminary tests in animals") on unsuspecting patients at the RCC? Please comment.

I completely reject the premise of your question. It is not at all clear, either from the university's statement or from anything else, that the research that led to this investigation will continue. If the faculty member in question ever, while at Johns Hopkins, seeks to be involved again in any form of human subjects research, that faculty member will be under very strict supervision of a senior faculty member with experience in clinical trials. In addition, the research will have to be thoroughly vetted by an institutional review board, as the RCC study should have been. The university is absolutely determined to ensure that, if this researcher is involved in any future human studies of any kind, those studies will be performed in a manner consistent with the standards of Johns Hopkins University.

What is the university's comment on the role of the RCC and its authorities in the drug trial?

I have no comment on this point.

Dr. Ru Chih Huang has said in a report in The Baltimore Sun (November 12) that the university was "partially responsible" for this, that "it did not tell her she had to get IRB approval", that "it is wrong for the university to say it didn't know about it", that "they knew about it since 1999" and "they wired the money to pay for it." What is the university's reaction to this?

It is and always has been the responsibility of the researcher to ensure that all applicable requirements, including IRB approval, are adhered to before conducting a study. The fact that some people may have known the researcher was pursuing a project does not mean that they knew that the researcher had failed to comply with the rules about seeking IRB approval.

Was an international contract research organisation also involved in finding patients for the Hopkins study at the RCC? If so, please give details.

I have no knowledge of anything like what you describe here.

Does the university have anything to say on why the U.S federal agencies involved in human research protection failed to look into the Hopkins-RCC drug trial as closely as they did the Hopkins asthma study?

The university notified the FDA (the U.S. Food and Drug Administration), ORI (the Office of Research Integrity of the National Institutes of Health) and OHRP (the Office of the Human Research Protections of the U.S. Department of Health and Human Services) as soon as it launched the investigation. The university has also provided those agencies with the results of the investigation. Of course, it is not for me to speak for the agencies about what, if anything, they plan to do now that they have received the report. That is for them to say.