Skip to main content

Thank you for visiting nature.com. You are using a browser version with limited support for CSS. To obtain the best experience, we recommend you use a more up to date browser (or turn off compatibility mode in Internet Explorer). In the meantime, to ensure continued support, we are displaying the site without styles and JavaScript.

  • EELS (Ethical Economic Legal and Social) Article
  • Published:

EELS (Ethical, Economic, Legal & Social) Paper

Ethical problems in pharmacogenetic studies of psychiatric disorders

The Pharmacogenomics Journal volume 6, pages 289–295 (2006)Cite this article

The recent explosion of genetic and pharmacogenetic studies increased the available knowledge about heritability and genetic transmission of many diseases, in the fields of oncology, medicine, neurology and they have also contributed to augment the comprehension of some pathophysiological mechanisms of the diseases with a genetic component. In fact, biomedical research is trying to define the molecular mechanisms of pharmacological effects, and to individuate operatively important polymorphisms in genes involved.

Concerning the field of psychiatry, the variation in individual response to psychotropic drugs is a crucial problem in mental health. In fact a large quote of patients continues experiencing significant psychiatric symptoms, even during and after drug treatment, and some of them develop also drug-induced serious adverse events. Noteworthy, psychotropic drug efficacy may not occur until a certain time after initiation of drug treatment and this could result in a delay between the beginning of the treatment and the use of an effective drug. During this period, patients are exposed to a severe worsening of their quality of life.

This is a preview of subscription content, access via your institution

Access options

Buy this article

  • Purchase on Springer Link
  • Instant access to full article PDF
Buy now

Prices may be subject to local taxes which are calculated during checkout

References

  1. Malhotra AK, Murphy Jr GM, Kennedy JL . Pharmacogenetics of psychotropic drug response. Am J Psychiatry 2004; 161: 780–796.

    Article  Google Scholar 

  2. Serretti A, Artioli P . From molecular biology to pharmacogenetics: a review of the literature on antidepressant treatment and suggestions of possible candidate genes. Psychopharmacology 2004; 174: 490–503.

    CAS  PubMed  Google Scholar 

  3. Arranz M, Mancama D, Staddon S, Clark D, Parsons M, Mata I et al. Advances in the pharmacogenetic prediction of response to atypical antipsychotics. Pharmacogenetics, In Psychiatry Meeting 2003, New York: Green tab.

  4. Kawanishi Y, Tachikawa H, Suzuki T . Pharmacogenomics and schizophrenia. Eur J Pharmacol 2000; 410: 227–241.

    Article  CAS  Google Scholar 

  5. Waterwort DM, Bassett AS, Brzustowicz LM . Recent advances in the genetics of schizophrenia. Cell Mol Life Sci 2002; 59: 331–348.

    Article  CAS  Google Scholar 

  6. Anonymous. The nuremberg code. JAMA 1996; 276: 1691.

  7. CavalliSforza L . The History and Geography of Human Genes. Princeton University Press: Princeton, New Jersey, USA, 1994.

    Google Scholar 

  8. American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders, 4th edn, American Psychiatric Association: Washington DC, 1994.

  9. American Psychiatric Association. Practice guideline for the treatment of patients with schizophrenia. American Psychiatric Association. Am J Psychiatry 1997; 154: 1–63.

  10. American Psychiatric Association. Practice guideline for the treatment of patients with major depressive disorder (revision). American Psychiatric Association. Am J Psychiatry 2000; 157: 1–45.

  11. Osborn DP, Fulford KW . Psychiatric research: what ethical concerns do LRECs encounter? A postal survey. Local research ethics committees. J Med Ethics 2003; 29: 55–56.

    Article  CAS  Google Scholar 

  12. Singh D . Ethical issues of pharmacogenetics must be addressed, says Nuffield Council. Bmj 2003; 327: 701.

    Article  Google Scholar 

  13. Appelbaum PS, Andrews L, Zuiker ES, Basu A, Tsapakis E, Aitchison K et al. Ethical issues in psychiatric genetics ethical, legal, and social issues in genetic testing for complex genetic diseases pharmacogenetics and psychiatry using pharmacogenetics and pharmacogenomics in the treatment of psychiatric disorders: some ethical and economic considerations ethical issues in psychiatric genetics research: points to consider. J Psychiatr Pract 2004; 10: 343–351.

    PubMed  Google Scholar 

  14. Andrews L, Zuiker ES, Basu A, Tsapakis E, Aitchison K . Ethical, legal, and social issues in genetic testing for complex genetic diseases Pharmacogenetics and psychiatry. Valparaiso Univ Law Rev 2003; 37: 793–829.

    PubMed  Google Scholar 

  15. Basu A, Tsapakis E, Aitchison K . Pharmacogenetics and psychiatry. Curr Psychiatry Rep 2004; 6: 134–142.

    Article  Google Scholar 

  16. Basu A, Tsapakis E, Aitchison K, Biesecker BB, Peay HL . Pharmacogenetics and psychiatry Ethical issues in psychiatric genetics research: points to consider. Curr Psychiatry Rep 2004; 6: 134–142.

    Article  Google Scholar 

  17. Appelbaum PS, Grisso T, Frank E, O’Donnell S, Kupfer DJ . Competence of depressed patients for consent to research. Am J Psychiatry 1999; 156: 1380–1384.

    CAS  PubMed  Google Scholar 

  18. Grisso T, Appelbaum PS . Comparison of standards for assessing patients’ capacities to make treatment decisions. Am J Psychiatry 1995; 152: 1033–1037.

    Article  CAS  Google Scholar 

  19. Appelbaum PS, Grisso T . Assessing patients’ capacities to consent to treatment. N Engl J Med 1988; 319: 1635–1638.

    Article  CAS  Google Scholar 

  20. APA. Guidelines for assessing the decision-making capacities of potential research subjects with cognitive impairment. American Psychiatric Association. Am J Psychiatry 1998; 155: 1649–1650.

  21. Sachs GA, Stocking CB, Stern R, Cox DM, Hougham G, Sachs RS . Ethical aspects of dementia research: informed consent and proxy consent. Clin Res 1994; 42: 403–412.

    CAS  PubMed  Google Scholar 

  22. Marson DC, Hawkins L, McInturff B, Harrell LE . Cognitive models that predict physician judgments of capacity to consent in mild Alzheimer's disease. J Am Geriatr Soc 1997; 45: 458–464.

    Article  CAS  Google Scholar 

  23. Marson DC, McInturff B, Hawkins L, Bartolucci A, Harrell LE . Consistency of physician judgments of capacity to consent in mild Alzheimer's disease. J Am Geriatr Soc 1997; 45: 453–457.

    Article  CAS  Google Scholar 

  24. Elliot C . Mentally disabled and mentally ill persons: research issues. In: Reich WT (ed). Encyclopedia of Bioethics. Simon and Shuster: New York, 1995.

    Google Scholar 

  25. Faden RR, Beauchamp TL . A History and Theory of Informed Consent. Oxford University Press: Oxford, 1986.

    Google Scholar 

  26. Appelbaum PS . Rethinking the conduct of psychiatric research. Arch Gen Psychiatry 1997; 54: 117–120.

    Article  CAS  Google Scholar 

  27. Cassel CK, Meier DE, Traines ML . Selected bibliography of recent articles in ethics and geriatrics. J Am Geriatr Soc 1986; 34: 399–409.

    Article  CAS  Google Scholar 

  28. High DM, Doole MM . Ethical and legal issues in conducting research involving elderly subjects. Behav Sci Law 1995; 13: 319–335.

    Article  CAS  Google Scholar 

  29. Savulescu J, Kerridge IH . Competence and consent. Med J Aust 2001; 175: 313–315.

    CAS  PubMed  Google Scholar 

  30. Carpenter Jr WT, Gold JM, Lahti AC, Queern CA, Conley RR, Bartko JJ et al. Decisional capacity for informed consent in schizophrenia research. Arch Gen Psychiatry 2000; 57: 533–538.

    Article  Google Scholar 

  31. Karlawish JH, Casarett D . Addressing the ethical challenges of clinical trials that involve patients with dementia. J Geriatr Psychiatry Neurol 2001; 14: 222–228.

    Article  CAS  Google Scholar 

  32. Kim SY, Cox C, Caine ED . Impaired decision-making ability in subjects with Alzheimer's disease and willingness to participate in research. Am J Psychiatry 2002; 159: 797–802.

    Article  Google Scholar 

  33. Saks ER, Dunn LB, Marshall BJ, Nayak GV, Golshan S, Jeste DV . The California Scale of Appreciation: a new instrument to measure the appreciation component of capacity to consent to research. Am J Geriatr Psychiatry 2002; 10: 166–174.

    Article  Google Scholar 

  34. W.M.A. World Medical Association declaration of Helsinki. Recommendations guiding physicians in biomedical research involving human subjects. JAMA 1997; 277: 925–926.

  35. Shapira A . The rules applying to scientific research. J Int Bioethique 2001; 12: 43–49.

    Article  CAS  Google Scholar 

  36. McEwen JE, Reilly PR . A survey of DNA diagnostic laboratories regarding DNA banking. Am J Hum Genet 1995; 56: 1477–1486.

    CAS  PubMed  PubMed Central  Google Scholar 

  37. McEwen JE, Reilly PR . Stored Guthrie cards as DNA ‘banks’. Am J Hum Genet 1994; 55: 196–200.

    CAS  PubMed  PubMed Central  Google Scholar 

  38. Emilien G, Ponchon M, Caldas C, Isacson O, Maloteaux JM . Impact of genomics on drug discovery and clinical medicine. Qjm 2000; 93: 391–423.

    Article  CAS  Google Scholar 

  39. Fuller BP, Kahn MJ, Barr PA, Biesecker L, Crowley E, Garber J et al. Privacy in genetics research. Science 1999; 285: 1359–1361.

    Article  CAS  Google Scholar 

  40. Botkin JR, McMahon WM, Smith KR, Nash JE . Privacy and confidentiality in the publication of pedigrees: a survey of investigators and biomedical journals. JAMA 1998; 279: 1808–1812.

    Article  CAS  Google Scholar 

  41. Parker LS . Ethical issues in bipolar disorders pedigree research: privacy concerns, informed consent, and grounds for waiver. Bipolar Disord 2002; 4: 1–16.

    Article  Google Scholar 

  42. Parker LS . Bioethics for human geneticists: models for reasoning and methods for teaching. Am J Hum Genet 1994; 54: 137–147.

    CAS  PubMed  PubMed Central  Google Scholar 

  43. Nebert DW, Bingham E . Pharmacogenomics: out of the lab and into the community. Trends Biotechnol 2001; 19: 519–523.

    Article  CAS  Google Scholar 

  44. Anonymous. Proposed model federal policy for protection of human subjects; response to the First Biennial Report of the President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research. Fed Regist 1986; 51: 20204–20217.

  45. Leflar RB . The cautious acceptance of informed consent in Japan. Med Law 1997; 16: 705–720.

    CAS  PubMed  Google Scholar 

  46. Classen DC, Pestotnik SL, Evans RS, Lloyd JF, Burke JP . Adverse drug events in hospitalized patients. Excess length of stay, extra costs, and attributable mortality. JAMA 1997; 277: 301–306.

    Article  CAS  Google Scholar 

  47. Persidis A . The business of pharmacogenomics. Nat Biotechnol 1998; 16: 209–210.

    Article  CAS  Google Scholar 

  48. Kendler KS . ‘A gene for…’: the nature of gene action in psychiatric disorders. Am J Psychiatry 2005; 162: 1243–1252.

    Article  Google Scholar 

  49. Serretti A, Calati R, Mandelli L, De Ronchi D . Serotonin transporter gene variants and behaviour: a comprehensive review. Current Drug Targets, in press.

  50. Schulman KA, Linas BP . Pharmacoeconomics: state of the art in 1997. Annu Rev Public Health 1997; 18: 529–548.

    Article  CAS  Google Scholar 

  51. Ameen M, Smith CH, Barker JN . Pharmacogenetics in clinical dermatology. Br J Dermatol 2002; 146: 2–6.

    Article  CAS  Google Scholar 

  52. Anderson JL, Carlquist JF, Horne BD, Muhlestein JB . Cardiovascular pharmacogenomics: current status, future prospects. J Cardiovasc Pharmacol Ther 2003; 8: 71–83.

    Article  Google Scholar 

  53. Flexner CW . Advances in HIV pharmacology: protein binding, pharmacogenomics, and therapeutic drug monitoring. Top HIV Med 2003; 11: 40–44.

    PubMed  Google Scholar 

  54. Severino G, Chillotti C, Stochino ME, Del Zompo M . Pharmacogenomics: state of the research and perspectives in clinical application. Neurol Sci 2003; 24 (Suppl 2): S146–S148.

    PubMed  Google Scholar 

  55. Serretti A, Artioli P . Predicting response to lithium in mood disorders: role of genetic polymorphisms. Am J Pharmacogenomics 2003; 3: 17–30.

    Article  CAS  Google Scholar 

  56. Phillips KA, Veenstra DL, Oren E, Lee JK, Sadee W . Potential role of pharmacogenomics in reducing adverse drug reactions: a systematic review. JAMA 2001; 286: 2270–2279.

    Article  CAS  Google Scholar 

  57. Forster HP, Emanuel E, Grady C . The 2000 revision of the declaration of Helsinki: a step forward or more confusion? Lancet 2001; 358: 1449–1453.

    Article  CAS  Google Scholar 

  58. Human D . Declaration of Helsinki. Lancet 2001; 357: 236.

    Article  CAS  Google Scholar 

  59. Ramsay S . More developments in developing-world research ethics. Lancet 1999; 354: 1405–1406.

    Article  CAS  Google Scholar 

Download references

Acknowledgements

We acknowledge Charles Weijer for his useful comments to the paper.

Author information

Authors and Affiliations

  1. Institute of Psychiatry, University of Bologna, Bologna, Italy

    A Serretti & P Artioli

Authors
  1. A Serretti
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. P Artioli
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to A Serretti.

Additional information

Duality of interest

None declared.

Rights and permissions

Reprints and permissions

About this article

Cite this article

Serretti, A., Artioli, P. Ethical problems in pharmacogenetic studies of psychiatric disorders. Pharmacogenomics J 6, 289–295 (2006). https://doi.org/10.1038/sj.tpj.6500388

Download citation

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1038/sj.tpj.6500388

This article is cited by

Search

Advanced search

Quick links