Pharmacogenomics: DNA Is Not Your Destiny

Mar 1, 2022
Munsch Hardt Legal Health Care Update

One positive trend in healthcare is the increasing use and development of pharmacogenomics, which is the study of how each individual’s genetic makeup impacts their response to medications. Its goal is to allow providers to avoid the “one size fits all” approach to treatment and provide a personalized response. The expectation for the increased use of pharmacogenomics and clinical testing is to reduce the risk of side effects and allow providers to avoid the trial and error that can occur when there are several potential treatments and the doctors are uncertain as to which one(s) will have the desired result. Avoiding this delay is especially important in oncology patients where early detection and treatment are paramount. Additionally, adverse effects from pharmacologic drug reactions cause more than 100,000 deaths per year in the US and contribute to the ever-rising cost of healthcare.

Ethics & Privacy Compliance

Pharmacogenomics brings with it a wide array of ethical issues. For instance, because Medicare and insurance companies are only slowly beginning to reimburse for the testing in certain circumstances, the benefits of the testing are often reserved for those patients who can afford to pay out of pocket. This disparity increases the notion that the haves and have-nots participate in two separate and distinct healthcare systems.

In addition, the labs and clinical research departments performing these tests will obtain significant personal health information on patients, which could be harmful if that information were to fall into the wrong hands. This increases the need for providers to focus on security and privacy compliance and, sadly, this also increases the likelihood that cybercriminals will view healthcare providers as a source of revenue through ransomware attacks.

Prior to performing a genetic test for pharmacogenomics studies, the provider should obtain informed consent from the patient. The patient should receive a full explanation of the purpose and possible results of the test, which will include the main information about the effectiveness of the personalized drug to be synthesized. Patients should be made aware of the ways in which the results may impact their lifestyle. Most notably, the consent should address the approach planned for managing non-pharmacogenomic findings.

Genetic Risk Considerations

The results of pharmacogenomics testing may have serious implications for patients’ family members. For example, a test may show the patient has a genetic variant that puts him or her at significant risk for the development of a preventable condition, including an adverse effect from a specific medication. This may lead one to believe that the patient’s family members would also be at risk for carrying this genetic variant. Some medical ethicists have argued that this situation creates a duty for the physician to inform the family members of the potential risks.

While it is true that physicians are obligated to protect third parties from harm in a number of circumstances (the classic example being the psychiatrist who is told that a third party is in danger), it is not at all clear whether this obligation would apply in the vast majority of genetic risk cases. The duty to protect a third party would likely be trumped by the need to protect the confidential information of the patient. HIPAA prohibits the release of genetic results to family members without the express permission of the patient. Providers performing these tests should consider employing a genetics counselor who has the tools to preemptively discuss the ethical risk of informing family members, or at least letting them know the patient was tested.

Additionally, any duty to warn a family member involves the practical limitations of the healthcare provider or researcher. Providers do not always have enough information about a patient’s family in order to be able to recognize who might be at risk. Just because a patient has a high-risk genetic variant does not mean that her family member will experience an adverse event.

Additional Considerations

As this testing becomes more common, additional issues arise, such as:

  • If a patient experiences adverse side effects from a medication that has genetic warnings but he or she was not tested beforehand, will the failure to test be viewed as negligence? 
  • Would the standard of care differ depending on whether or not the patient’s test would be covered by insurance? This potential variance would effectively create a higher standard of care for those with more comprehensive insurance coverage.
  • If the medication’s labeling contains genetic warnings, is the provider safe from a claim for damages if she informs the patient about the benefits of the test, but the patient declines the test? If so, it will be important to get the informed consent and waiver of treatment in writing.

These issues are currently being debated – but have not yet been legislated or litigated. It would be wise for the medical community to consider these issues, advise providers and draft legislation before the decision is made for them by juries across the country. Stay tuned as the science always seems to stay ahead of the law.

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