Patients as guinea pigs

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Contributed by Dr Anant Bhan.Copied as fair use from IEC Exchange.

Vijay

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http://timesofindia.indiatimes.com/city/hyderabad/Arogyasri-patients-turn-guinea\

-pigs/articleshow/7464993.cms

Arogyasri patients turn guinea pigs

Roli Srivastava & Bushra Baseerat, TNN, Feb 10, 2011, 05.57am IST

HYDERABAD: The poor literacy level of Arogyasri beneficiaries has given a

lucrative but worrisome spin to healthcare business in the state- city hospitals

are now hardselling their patient numbers to bag clinical trial projects from

international pharma firms.

Whether big or small, public or private, most hospitals in the state now have a

dedicated clinical research unit to carry out trials. Doctors note there is a

surge in the number of companies headed to the state and also the number of

trials being carried out, " because there are a lot of guinea pigs here " .

Being tested on people are drugs for diabetes, cancer apart from drugs for

cardiac, gastro and liver conditions. Certain drugs for hormonal problems as

well as rheumatic disorders are also being tested currently in city hospitals.

The trials are on even in district hospitals, both private and public and

doctors involved in clinical trials agree that most of their volunteers are

'uneducated and poor'.

There is reliable information on poor patients even being 'supplied' to

hospitals under Arogyasri for the trials. " Getting a signature on the consent

form is not difficult. If it takes a year to get 10 patients to volunteer for a

trial in the US, here the same number can be arranged in no time, " said a

researcher.

Dr M Prakasamma of Academy of Nursing Studies who has been a member of various

ethical committees on medical research in the past says there are huge concerns

on patient awareness on what is being tried on them. And that the clinical trial

business is big is evident from the fact that now institutes for training

manpower to carry out trials have sprung up to meet the growing demand for

personnel in these research units.

Industry sources note that most clinical trials are taking place in government

hospitals, because " recruiting volunteers'' is easy. However, private hospitals

over the last couple of years have emerged as competitors with the state health

insurance scheme giving them the much-needed numbers to bag trials. " If earlier

we could recruit one patient from 10, we now have larger base and can recruit 10

from 100,'' said a senior industry source dabbling in clinical trials.

Predictably, trials have turned into a concrete revenue generation model for

hospitals with some estimates indicating that trials account for 3 per cent of

the hospital's total revenue. " The sector is bullish currently and we expect the

revenue to multiply manifold over the next couple of years, " an industry player

said. Hospitals make anywhere between a couple of lakhs to a few crores for each

trial, the revenue dependent on the nature of the trial, the drug being tried

and the number of patients recruited for the trial.

Hospitals are mostly being offered packages by pharma companies, which includes

the hospital charges as well as the doctor's fee. " Many doctors are now

interested in these trials because they make a neat sum over and above their

salaries, " says a hospital administrator, adding that the trials are coming in

handy for hospitals to lure doctors with jobs offering fat salaries and perks

such as opportunity to travel abroad on the pharma firm's expense to participate

in discussions/conferences on the trials. " At least 60 doctors from government

hospitals alone have gone abroad in the last one year alone, " said a senior

official attached to a government hospital.

So last month, when hospital major Apollo tied up with global clinical trial

provider Quintiles to set up a research unit at its Jubillee Hills facility,

industry players said the announcement was only a formal acknowledgment of an

arrangement that many city hospitals already have. While Apollo publicly

announced its 86-bed unit to carry out 'simple studies on healthy volunteers',

other hospitals such as the Nizam's Institute of Medical Sciences (NIMS) have

over 100 trials going on at any given time.