Print edition : December 16, 2005

Interview with Ru Chih C. Huang, Biology Professor of Johns Hopkins University.

Five years after she tested experimental anti-cancer compounds developed at the Biology Department of Johns Hopkins University, Baltimore, United States, on 27 patients at the Regional Cancer Centre in Thiruvananthapuram, Professor Ru Chih C. Huang is more than cautious when she finally breaks her silence on the controversial trials. Excerpts from an e-mail interview she gave R. Krishnakumar:

Why did you choose to do the first human trials of the chemicals in India rather than in the U.S. where the disease is (reported to be) more prevalent?

The RCC is a renowned institution and is the best place to do oral cancer studies, and the incidence of oral cancer in southern India is very high relative to almost all other parts of the world (especially the U.S.).

What is your comment on the Hopkins inquiry finding that "there was no proper IRB approval and no proper safety testing in animals" and the sanctions imposed on you by the university?

No comment.

What was the agreement that you signed on behalf of the JHU with the RCC?

This agreement is a confidential research agreement, and I have no further comment.

What commitment did you make regarding the medical and/or financial benefits to the participants in the M4N and G4N trials and to the RCC that provided you the opportunity to conduct them? Did the RCC doctors involved in the trial stand to gain financially through the agreement?

Funding was provided to cover the basic cost of research. There was no funding provided for personal gain by any of the physicians participating in this research.

What do you have to say on the way the trials were then conducted at the RCC?

The conduct of the studies by the physicians in India in my view was professional and proper.

In one of your interviews you are reported to have said that there was no harm done to patients in India. Since there is no evidence of continuous monitoring of patients for the effects of the chemicals in them, except for some "regular follow-up" on how they were responding to surgery, radiotherapy or chemotherapy, how do you conclude that no harm was done to any of the patients?

I am not clinically involved with the follow-up of these patients. You would need to direct that question to the appropriate physician.

Prior studies had indicated that chaparral (creosote) extracts (from which M4N and G4N were developed) could damage the liver and the kidneys. What exactly were the risks that the patients at the RCC should have been aware of when they signed the consent forms?

M4N is not chaparral or a chaparral extract. There is no evidence in any testing undertaken before or after this study that M4N has any toxicity to the liver or the kidney.

Since the JHU denies it had any role in the RCC trial or had signed cheques for funding it, who was responsible for the trial on the RCC patients? Who funded the trial? Was it an entirely private venture?

The RCC has the record on this and I believe you have this information already.

RCC authorities had stated here that the biopsies of M4N/G4N-injected tumours from 27 patients were sent to you for further research as part of the agreement you had signed. Then there was the controversy and it was never explained what came of the samples or what the results of your study on them showed. Did the results contribute in any way to the ongoing trials using M4N? Where did you conduct further studies using the biopsy samples?

The results from the biopsies are very strongly supportive of further development of EM-1421. These data have directly led to further and more extensive evaluation of M4N as a drug (EM-1421).

Why is it that, even after five years of the "Phase II" trials (as it was wrongly described then) at the RCC, the company that has been established exclusively for developing drugs using chemicals developed by you, has not been able to go beyond Phase I trials in the U.S. (especially in patients with the same type of cancer as in the RCC trials)? Is it because some of the results of the trials in the U.S., as announced by the principal investigators concerned, conflict with the claim of the RCC doctors that "none of the research subjects suffered any adverse events, complications or harm"? Or, because the trials are finding it difficult to get volunteers, as was suggested in some reports from the U.S.?

My understanding is that Erimos has progressed to Phase II studies of EM-1421, and, more importantly, has broadened the research from direct intra-tumoral injection to include intra-venous administration of the drug for all refractory tumours, a very important target. The research by Erimos has been subject to FDA review throughout. From talking with researchers at Erimos, the safety profile for M4N [EM-1421] has been consistently good.

Why were the trials using G4N discontinued after it was tested in some RCC patients?

G4N basic research is continuing in my laboratory, as part of a drug discovery programme to more effectively treat tumours and viral diseases.

If a safe drug is developed out of M4N eventually, what benefit would it bring to the patients on whom the chemicals were tested initially or their relatives or to the RCC?

Development of M4N, if successful, will provide patient benefit worldwide. As per ethics of drug development, there was, and is, no specific benefit agreed with any patient participating in any study of M4N worldwide.

What is your comment on the July 2001 statement by the then RCC Director, Dr. M. Krishnan Nair, that the drug when developed would get a "joint patent", "profits would be shared equally" and "if it is given to a drug company, as is usually done, the RCC would get 50 per cent of the royalty"?

I know of no basis for these comments.

Can you explain who all own BioCure Medical, BioCure Technologies and Erimos Pharmaceuticals - or the company with various names that has undertaken research using M4N and chemicals developed by you at Hopkins. Who funds it and what has been your role in them? How is Johns Hopkins University associated with these companies?

BioCure Medical was a subsidiary of BioCure Technologies, a company created to develop M4N and other drugs in 2000. BioCure changed its name to Erimos. The company is owned by a private investment group from Singapore. Johns Hopkins has a small percentage ownership in Erimos.

What is your reaction to allegations that all you were interested in was the biopsies from the RCC and now that you have got it, you, as well as the JHU that stands to gain from the work done at the RCC, are trying to absolve yourself of all responsibility for the trial?

That's an amazing allegation, and factually incorrect.

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