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Ever since Johns Hopkins University announced for the first time on July 27, 2001, that the `Hopkins-RCC drug trial study' was conducted without its authorisation, Frontline had been tracking the university's efforts to distance itself from responsibility for the trial conducted on 27 cancer patients in India by one of its scientists. In an e-mail interview, conducted in two parts, to R. Krishnakumar, Hopkins spokesman Dennis O'Shea says the university "acted in accordance with its responsibilities" and is committed to acting "ethically, morally and legally".
Is Hopkins University involved in the M4N clinical trials now under way at many centres in the United States?
No, Johns Hopkins has no direct involvement in the clinical trials.
Certain reports mention that the M4N trials conducted by "Erimos Pharmaceuticals" are "under licence from the Hopkins University". How is Hopkins University or Dr. Ru Chih C. Huang involved in the trials being conducted by it?
Professor Huang is not involved in any clinical research with the drug, nor is Johns Hopkins. Erimos supports laboratory research by Professor Huang and lists her as a scientific adviser.
Where are the Erimos trials taking place? Are they being conducted at Hopkins University too?
No, the Erimos trials are not taking place at Johns Hopkins.
The JHU had said soon after the inquiry in 2001 that any future participation by Dr. Huang in human studies should be under supervision by a senior Hopkins faculty member with expertise in clinical research. If Dr. Huang is involved in the ongoing trials, are they being supervised by Hopkins faculty members?
Professor Huang is not involved in human studies.
Has M4N, developed at the Hopkins Biology laboratory, obtained approval from the U.S. Food and Drug Administration for clinical use?
I am told that the FDA has granted Erimos permission for investigational human clinical use of M4N against particular types of tumours. In other words, Erimos has permission to use the drug in clinical trials.
Are M4N trials being conducted under licence from Hopkins now in countries other than the U.S.?
That is a question best directed to Erimos, as Johns Hopkins has no involvement with the conduct of any M4N trials.
How will Hopkins benefit from drugs developed out of M4N by Erimos?
Johns Hopkins has granted Erimos a licence for development of the drug and has a small ownership stake in the parent company of Erimos. If the drug proves in clinical studies to be effective and safe, and is eventually adopted for use, it is possible that Johns Hopkins could receive some royalties.
If indeed M4N proves to be a safe and effective drug eventually, will Hopkins be under any obligation to the patients in India on whom it was tested initially or to the RCC where the trials took place in 1999-2000?
The potential benefit of any clinical trial that is properly carried out, with properly obtained patient consent, is that there may, in the end, be an approved drug that offers patients a better chance than existing drugs at recovery or survival. Beyond that, it is not clear to me what you mean by "obligation", nor is it clear to me in what sense you suggest that the eventual results of this research could impact that "obligation".
Now that the first ever human trials of M4N and G4N on 27 RCC patients is known to have contributed substantially to the research for a safe and effective drug, what is Hopkins' stand on the issue of "joint patent", "sharing of profits" and "royalty" (with the RCC as was claimed by former RCC Director Dr. Krishnan Nair in 2001)?
Johns Hopkins University has issued a licence to Erimos Pharmaceuticals but has concluded no agreements with any other entity with respect to the commercialisation of this technology.
Is it not a bit strange for Hopkins to argue that: no, neither the university nor Dr Huang is involved in any clinical research with the drug; but, yes, Erimos supports laboratory research by Dr. Huang and lists her as a scientific adviser; yes, Johns Hopkins has granted Erimos a licence for development of the drug and has a small ownership stake in the parent company of Erimos; and yes, if the drug proves in clinical studies to be effective and safe, and is eventually adopted for use, Johns Hopkins could receive a royalty? Is the university then saying that it needs only to be correct legally, perhaps, but not ethically and morally?
I reject your premise that I am making an argument at all. I made factual statements. You asked factual questions: Is Professor Huang or anyone at Johns Hopkins involved in the clinical trials of M4N? The factual answer to that factual question is "No". No one at Johns Hopkins, including Professor Huang, is participating in any clinical trials of M4N. The other statements I made were also factual statements in response to your other factual questions. I have no idea what you are trying to get at with the last sentence of your question. I did not say anything of the kind. Moreover, you have not provided any information that indicates that anything questionable - from a legal, ethical or moral viewpoint - is currently happening. To be clear: As our actions in 2001 regarding the 1999-2000 trials show, Johns Hopkins is committed to acting ethically, morally and legally.
Will it then be correct to assume that, while the university is trying to protect itself and its scientist, it is absolving itself of all responsibility for what the Hopkins scientist and indeed her Indian collaborators did when they used human specimens ("without adequate safety testing in animals", "without proper IRB approval", according to your inquiry report) to study the effects of the chemicals that are now being developed under licence from Hopkins and which would eventually bring royalties to the university and to the scientist?
No. As your question itself indicates: Johns Hopkins investigated this case when it came to the university's attention. The university imposed sanctions on the scientist involved. Those sanctions remain in effect. Far from absolving itself, the university has acted in accordance with its responsibilities
What exactly is Hopkins University's position on the usefulness of the M4N/G4N-injected biopsies that the Hopkins Biology laboratory/or its scientists on its behalf received during 1999-2000 from RCC to the ongoing and possibly lucrative development of a cancer drug (under licence from Hopkins and by a company in which Hopkins has an ownership stake)?
This question reveals some misunderstandings on your part on how these things work. Let me explain. First, neither Johns Hopkins nor any other research university would, as an institution, take a position on a scientific question. Scientific questions are settled among scientists; they conduct experiments, publish results, challenge each other's conclusions and eventually come to a consensus. Universities do not exist to take institutional positions on scientific questions, but rather to provide arenas in which scientific endeavours take place and scientific debates occur - among scientists. Thus, Johns Hopkins has no institutional position on the scientific usefulness of the 1999-2000 results. We did, after our investigation, take an institutional position as to the way in which the 1999-2000 trial was conducted and we announced that position, including the sanctions that were imposed. Second, there is no "Johns Hopkins Biology laboratory" as a collective entity. At research universities, individual faculty members operate their own laboratories.
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