Ethical Pharmacogenetics in CT

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Dear members,

Ethical issues in

patients' consent to pharmacogenomic trials

1)

Blood

samples are collected from patients participating in clinical drug trials, to

be used for pharmacogenomics research. Collection of blood samples for use in

public genetic databases is done, but there are no reports of the formation of such databases by

or on behalf of the pharmaceutical industry.

2)

In

pharmacogenomics studies, patients are asked to consent to three

separate aspects of

research:

i) The main clinical drug trial,

ii) Research involving a specific genetic test

related to a drug effect,

iii) Unspecified genetic

tests to be used in future pharmacogenetics

research.

They give the

sponsoring pharmaceutical company permission

to link genetic

research on their blood sample to personal medical

information, such as

details of their medical condition and family

history.

It is found that the

limits of consent for pharmacogenomics

studies are being

overreached. Given evidence of the inability of

patients who have

decided to take part in clinical trials to comprehend

information about

trial procedures or to recall information about

potential risks, it

is possible that patients entering into pharmacogenomics

related trials may

not have given careful consideration to all potential

risks and benefits of

this additional research. Patients who already

feel overburdened

with information and anxiety, and in a weakened

position to make

independent decisions, may be exploited in this

situation.

3) Although in conventional clinical drug trials patients are

subjected to additional risks

over and above conventional therapy, patients have at least the possibility of

benefiting either from the comparative drug being tested or from the trial

drug. By contrast, there is no direct benefit to the patient in the pharmacogenomics study and thus compromises in the consent process

cannot be offset against potential therapeutic benefit. As against this, it

could be argued that the risks are much

smaller than those accepted in conventional therapeutic trials.

4)

Issues

of property rights are increasingly being raised in relation to tissue samples.

5)

Blood

samples that are donated for genetic testing during the pharmacogenomics part

of a clinical trial may potentially be extremely valuable commodities for

genetic-based drug development. In addition to their consent to take part in

the research, patients are required to agree in writing that they have no

property rights over the sample or any data generated from it.

6)

Should patients be financially rewarded for

their involvement, as is the case for healthy subjects in Phase I trials and

for the physicians who recruit, conduct and oversee clinical trials? Or should

the fact that patients in the main trial are likely to receive benefit in the

form of therapy be sufficient reward for taking part in additional

pharmacogenetics research? Is it right that participants be excluded from

taking a financial interest in products that have been developed using their

blood or tissue? And to what extent should altruistic reasons on the part of

patients be taken into consideration?

RegardsDr Sanjay Yallappa ChoudhariJR2,Dept of PharmacologyGMC, Nagpur

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