Pharmacogenomics&its

ethical  issues

Pharmacology(the science of drugs)

Genomics(the study of genes& their functions)

Pharmacogenomics

“Pharmacogenomics is the study of how genes affect a person’s response to drugs.”

Source: http://www.admerahealth.com/

“an  appreciably  harmful  or unpleasant  reaction,  resulting from  an  intervention  related  to the  use  of  a  medicinal  product, which predicts hazard from future administration  and  warrants prevention  or  specific  treatment, or  alteration  of  the  dosage regimen,  or  withdrawal  of  the product.”

ADR is an injury caused by taking a medication.

Cause of ADR....

.... motivation for PGx

Source: http://www.bazhua.org/

Source: http://www.ranchcreekrecovery.com/

Ethical issues of PGx

Designer drugs & Economic equity

● New discoveries in genetics may make it possible to tailor-make drugs for individual genotypes.

● Tailor-making drugs will push up the cost.

● All sections of the society may not be able to afford it.

Premedication genetic testing

● Most ADR are due to genetics.

● “Slow metabolizers” more susceptible to ADR; but ultrafast metabolizers may have no clinical response to the usual dose of a drug.

● Early identification of both groups, through a test for DNA variants of cytochrome P450 2D6, could prevent much misery.

● Such testing could have many benefits, both for individuals and drug companies.

● Identify people who are susceptible to ADR, and also those who are unlikely to benefit from a particular drug.

● Make possible the resurrection of some older drugs that are safe and effective for most people, but have been taken off the market because a few people had serious reactions.

● Clinical trials of newer drugs would become more efficient.

Premedication genetic testing

● Insurance companies may charge different premiums for different individuals depending on their response to drugs or may even reject to cover individuals.

● Fear of losing health insurance may be cause of refusal of genetic testing and may lead some people to refuse tests for potential reactions to drugs.

Premedication genetic testing

● Premedication genetic testing, when developed, will be so important to care that it must be part of the medical record; keeping the so-called ‘shadow charts’ to prevent insurers from seeing the information would be highly unethical.

● The problem is best addressed through laws mandating coverage for those who require unusual or expensive drugs, whether for genetic reasons or otherwise.

● When developed, such a one-time test, given early in life, should be part of routine medical care & not require a special informed consent or privacy protection beyond that accorded to usual medical tests.

Premedication genetic testing

Duties to warn

● SNP profiling may affect drug labelling, so as to restrict prescriptions only to individuals with the suitable genetic profile.

● For drugs already approved by the regulatory agencies, subsequent discoveries that people with particular genetic profiles may have adverse reactions would require addition of this information to the label and a warning that genetic screening is necessary.

Duties to warn

● PGx may lead to legal requirements for direct disclosure to the public about genetic risks from drugs.

● In the past, pharmaceutical companies were only required to warn the physician, who acted as a ‘learned intermediary’ in interpreting risks to the patient.

● Genetic testing may remove some of the uncertainties and make the information more comprehensible to the public.

● Therefore, in the future, courts may require disclosure of risks associated with certain genetic profiles to patients and also to the public if a drug is marketed directly.

Benefit sharing

● Sometimes community, family or even individual genotypes may make essential contributions to drug development.

● The drug itself may not benefit the community or individual.

● The basic principle of participation in research, which should be a desire to help others.

● Yet justice requires that communities or families receive some benefits, not necessarily monetary.

● Arrangements for benefit-sharing are best agreed upon between researchers and the group participating before the initiation of the research.

Genomepatri™  assesses  your  inherited  and  acquired genetic  health  risks  for  100+  conditions.  The  results provide  valuable  insight  into  YOUR  genetic predisposition  to  several  health  conditions,  traits, lifestyle tendencies, drug efficacy, and more, helping you  pre­empt  a  majority  of  diseases.  In  combination with  genetic  counseling,  this  will  become  YOUR  master plan to better health, lifelong.

‘Prakriti concept in ayurveda similar to pharmacogenomics’

References:● DC Wertz, Ethical, social and legal issues in pharmacogenomics; The Pharmacogenomics Journal (2003) 3, 194–196

● Edwards IR, Aronson JK, Adverse drug reactions: definitions, diagnosis, and management; Lancet. 2000 Oct 7;356(9237):1255-9.

● http://slideplayer.com/slide/6840467/

● https://ghr.nlm.nih.gov/primer/genomicresearch/pharmacogenomics

● Alan E. Guttmacher, Francis S. Collins, Ethical, Legal, and Social Implications of Genomic Medicine; N Engl J Med 2003;349:562-9.

THANK YOU