Aug 24, 2004

Biocon, clinical deaths and Genetic Engineered drugs

The Biocon case gets curiouser and curiouser.
First newspapers reported that the Central government has admitted before the Supreme Court that some patients died during the clinical trials of genetically engineered (GE) drugs by two pharma companies without prior statutory approval but down played it saying the mortality rate was much lower than accepted norms.
The affidavit of the Ministry filed through advocate Vijay Panjwani said that
the Rs 600 crore Bangalore-based pharma company, Biocon India Ltd, had obtained
the approval of all competent authorities under the applicable rules to
undertake clinical tests of r-human insulin.Therefore, the Environment Ministry
on July 14 condoned the procedural lapse by Biocon India in not seeking approval
of GEAC before proceeding to conduct human trials of the drug.

This was followed by Biocon's denial done none other than by Kiran Mazumdar Shaw the darling of the media.

Biocon Chairman and Managing Director Kiran Mazumdar-Shaw told mediapersons
that the trials were conducted strictly in accordance with protocol based on
internationally accepted standards and with the consent of all volunteers
"We wish to categorically state that no deaths occurred during the
clinical trials conducted in relation to r-human insulin by Biocon," she said.
"Not a single death occurred," Shaw said.

Sify adds

She said the detailed information of the clinical trials for the r-human insulin
were published on the company's website and it intends to do the same for all
future trials.
Biocon had obtained approvals from the Genetic Engineering
Approval Committee (GEAC) for large-scale process optimisation of r-human
insulin for R&D purpose; approval from the Drugs Controller General of India
(DCGI) for conducting the clinical trials and approval from the Review Committee
on Genetic Manipulation (RCGM) for conducting the clinical trials, the company
said in a statement.
On the issue of not obtaining the GEAC approval for
phase III human clinical trials, Shaw said, "as per the protocol which has been
put on the Department of Biotechnology website, we were not required to get GEAC
approval, later on, there was a correction passed, where they said, you need to
take GEAC clearance for Phase III trials".
Shaw said there was some confusion in this regard.
Biocon officials said they did not want to talk about the merit of a public interest litigation in the Supreme Court filed by an NGO - Adar Destitute and Old People Home (ADOPH) - against GEAC, Biocon and Shanta Biotech for conducting human trials of genetically engineering drugs without prior approval, saying it was sub judice. Shaw said the marketing of the r-human insulin, which the company is planning to launch in October would not be affected with this case.

Sure some confusion exists. There is Shantha Biotech also in the scene. Hindu Business Line reports:

THE Genetic Engineering Approval Committee (GEAC) said that there has been a
clear lapse on the part of the Hyderabad-based Shantha Biotechnics Pvt Ltd in
not obtaining clearance before conducting the Phase-III human clinical trials
using Recombinant Streptokinase for treatment of acute myocardial infarction
(heart attack).

So did the deaths occur due to the trials of r-streptokinase or r-dna Human Insulin? And what repercussions does this have for trials of drugs in India? I wonder if the media would have let the companies brush it off so easily if this were in the Western world rather than India...