Ethical Concerns of Home Genetic Tests

Genetic testing is a somewhat controversial issue, especially when it comes to home genetic test kits. There are many ethical and personal consequences you need to consider before you take a home genetic test. This article will explore some of these consequences and considerations.

On May 7, 2010 the national drugstore, Walgreens, had planned on beginning to sell home genetics test kits called the Genetic Health Report, made by Pathway Genomics. However, after the United States Food and Drug Administration (FDA) sent a letter to Pathway Genomics, Walgreens decided to delay the sale of these home genetics test kits. While the Food and Drug Administration and genetic specialists raise concerns about the Genetic Health Report being marketed by the company, Pathway Genomics asserts that their product does not need the FDA's approval as the product falls into an exemption class.

Consumers who purchase these tests send saliva samples to Pathway Genomics. The company asserts it can determine an individual's risk of getting more than 70 different conditions and diseases, such as Huntington's Disease, diabetes, breast cancer, hypertension, heart disease, and lung cancer. However, there are several ethical concerns raised about the Genetic Health Report.

Cost: Cost is one ethical concern I can see with these tests. With the struggling economy, a significant portion of the population who may want to assess their risk for getting a certain disease may not be able to based on how much the kit and assessment cost together. According to CNN, the Genetic Health Report test kit costs $20. The test results, however, cost anywhere from $79-249, depending on what information the customer would like to know.

In addition, if an at home genetics test indicates that you may develop a certain disease, you may want to get further tests to investigate this possibility. Not only are at home genetic tests not covered by your insurance, but further tests to investigate the likelihood that you will develop a certain condition will also probably not be covered by your insurance. Thus, the consumer may spend hundreds or even thousands of dollars on other tests to verify the results of the Genetic Health Report.

Accuracy: To date, there have been no scientific studies supporting the accuracy of home genetic tests, according to the Federal Trade Commission. It is true that home genetic tests may alert you to the possibility of developing a specific condition later in life. This knowledge may help you make lifestyle and dietary changes that may be helpful in preventing the disease. However, it is also possible that these tests may produce false positives or false negatives. False positives occur when a test indicates that you are at risk for developing a disease or passing that condition to your child when there really isn't a genetic predisposition. False negatives occur when a test indicates that you are not at risk for developing a specific disease or passing it on to your child when you really do possess a genetic predisposition to doing so.

Additionally, if home genetics test produce positive or false positive results, an individual may worry or fret over the likelihood that he or she will eventually develop the condition the test indicated he or she is likely to have in later life. This worry, in turn, could produce its own physical health problems.

On the other hand, a false negative result may give an individual a false sense of reassurance that he or she will not develop a condition one fears getting later in life. An individual who is falsely reassured may not pay attention to his or her health or lifestyle. If he or she notices signs and symptoms of a particular condition, one may ignore them, incorrectly thinking that he or she doesn't have it based off the test's results.

Furthermore, there are concerns about how little is known about genetics in general. While genetic specialists know some of the unusual characteristics and mutations on genes that are related to specific diseases, they still do not know all of the possible mutations and unusual characteristics that occur on genes that are related to diseases. Thus, while home genetic tests may look for the most commonly known mutations and characteristics on genes linked to diseases, they may miss others. This may produce a false negative result.

Lack of Interpretation: While at home genetic test kits may provide individuals with information, this information is often not interpreted by the lab where the test was sent. Thus, an individual must then either go and see a genetic specialist in person or call the company the test was done at and speak to a genetic specialist there. Getting your results interpreted by a genetic specialist at the company is often an added expense.

In addition, according to Jeffrey Vance, MD, Ph.D., and chairman of genetics at the University of Miami Miller School of Medicine, while a genetics test may tell an individual that he or she is at risk for a disease, it does not tell that person how much at risk they are. Thus, a person can know that he or she is at increased risk of developing heart disease, but he or she doesn't know if he or she is twice as likely as the average person to develop the condition or ten times as likely. Furthermore, he asserts that someone who has a genetic risk of getting a disease doesn't always develop the condition and individuals who have no genetic risk for diseases sometimes do develop them. This is because genes are only one piece of the puzzle. Genes, lifestyle, environment, and a person's experience all interact in the development of diseases.

If you are considering taking a genetics test at home, please talk to your primary care doctor about the risks and benefits of doing so. Your primary care doctor will also be able to provide you a referral to a genetics specialist who can interpret the results of your test if you decide to take it. Genetic testing has some benefit, risks, and ethical concerns you should consider closely before deciding to test yourself for specific genetic conditions.

Sources:

CNN: Walgreens Postpones Plans to Sell Personal Genetic Tests:
http://www.cnn.com/2010/HEALTH/05/12/genetic.testing.walgreens/index.html

Federal Trade Commission: Facts for Consumers: At-Home Genetic Tests: A Healthy Dose of Skepticism May be the Best Prescription:
http://www.ftc.gov/bcp/edu/pubs/consumer/health/hea02.shtm

Medicine Net: Concerns Raised About Drugstore Genetic Test:
http://www.medicinenet.com/script/main/art.asp?articlekey=116293