Genetic Testing: Remarkable Resource or Invasion of Privacy?

The Genetic Information NondiscriminationAct of 2007 hasbeen introduced in Congress andis purportedly intended to modify severalfederal laws to prohibit employers andinsurers from misusing a patient's geneticinformation. Similar legislation hasbeen introduced annually for more than10 years but has never passed.Soothsayers now say, however, that thislegislation has a high likelihood of passage.

The growth in this segment of scienceis remarkable and exciting. Genetic testsare currently available for well over 1000diseases, including several for relativelycommon conditions such as heart diseaseand colon cancer. The implicationsfor health care organizationsand providers are many,including the cost of care,protecting patients'privacy,and ethics-related issues.

Genetic testing and personalizedtreatment based onresults will likely increase thecost of care. Pharmacists willneed to strengthen relationshipswith hospital laboratories(or those entities whichare performing the tests) andcollaborate on recording resultsand treatment strategieswith multiple disciplines.Pharmacy departments willneed to budget for these personalizedtherapies, usingstatistics for the incidence ofthe condition and in collaboration withprescribers. It will be interesting (andessential) to monitor reimbursement bypublic and private insurers for these therapiesand to determine an institutionalpolicy on treatment options that are uninsuredor otherwise notcovered. I also wonderwhether the growingtrend toward "limited distributionsystems"will beused by drug companiesfor these personalizedtherapies. If not, do pharmacydepartments currentlyhave the appropriateresources, such asstaff, dedicated compoundingfacilities, expertise,etc, to support theirown personalized therapyservices?

The public debate largelysurrounds protectingpatients'privacy fromemployers and insurers toavoid discriminatory practices, not onlyrelating to themselves but also to theirbiological families, whose insuranceavailability could be challenged if geneticpredisposition were known. Given thatcompliance with the Health InsurancePortability and Accountability Actremains a challenge, I would suggest thatpharmacists, as patient advocates,become involved as organizations developpolicies on medical record documentationof genetic testing results whileprotecting patient privacy.

Finally, I suspect that a number of ethicalissues will arise related to genetictesting and treatment beyond a patient'sability to pay. For example, if a patient'sgenetic test indicates that he or she doesnot have the appropriate test response,but the desperate patient argues fortreatment with the drug, will we, or canwe, deny treatment based on populationstatistics?

It seems as if we have much to ponderas this issue continues to evolve. Are wetalking to all the right people?

Mr. McAllister is director of pharmacyat University of North Carolina (UNC)Hospitals and Clinics and associatedean for clinical affairs at UNCSchool of Pharmacy, Chapel Hill.