Patient info in clinical trial not to be shared: CIC

Data about patients participating in clinical trials cannot be shared, the CIC has held while dismissing an RTI plea seeking details of stalled Human Papilloma Virus (HPV) vaccine trials in the country.

Updated: Apr 04, 2011, 21:15 PM IST

New Delhi: Data about patients
participating in clinical trials cannot be shared, the Central
Information Commission has held while dismissing an RTI plea
seeking details of stalled Human Papilloma Virus (HPV) vaccine
trials in the country.

The HPV vaccine clinical trials are being investigated
by a committee of Drug Controller of India as allegations of
ethics violations including on informed consent, safety
protocols and other such issues were raised from several
quarters, the RTI applicants submitted in their plea.

The Government had allowed "Gardasil" (imported by M/s
MSD Pharmaceuticals, Gurgaon) and "Cervarix" (imported by M/s
GSK Pharmaceuticals, Mumbai), to undergo phase-III clinical
trials in India, before granting permission to import and
market authorisation.

The trials were started in Khammam, Andhra Pradesh and
Vadodara in Gujarat in association with a US-based non-profit
organisation PATH. After four deaths of participants in
Gujarat and two deaths in Andhra Pradesh were reported, the
Government had stopped the trials.

"The cause of deaths was determined as viral fever,
drowning, suicide, severe anaemia with malaria and suspected
snake bite. Based on the concerns on these deaths, states have
been advised not to carry out any further vaccinations at
present," Minister of State for Health S Gandhiselvan had
informed Parliament.

The applicants wanted to know details of these trials
including the data generated from the studies which was denied
to them.

In the case, Information Commissioner Annapurna Dixit
had called for comments from parties involved in the clinical
trials including NGO Path, GlaxoSmithKline Pharaceuticals and
MSD Pharmaceuticals besides Director General Health Services.

All the parties were unanimous that patients data
cannot be shared as keeping it private is one of the clauses
of the agreement a company enters with the patient.

"The data contains variety of information regarding
the pharmaceutical company`s laboratory, pre-clinical and
clinical data including product indications, efficacy,
tolerability and safety, pharmaco-kineticks, drug
interactions, side effects, contra-indications, adverse
effects etc. which are data directly related to patients,"
Dixit held.

She said even the Drug and Cosmetics Act says that in
every clinical trials patient related information is to be
held in strict confidentiality by the institutions concerned.

She directed not to reveal information pending
investigations and held that "upon the final outcome of the
inquiry, the DGCI out of the information in its possession
shall provide information...severing all and any patient
related information as also any information which deals with
exclusive intellectual property rights of the pharmaceutical
companies."

PTI