TAG of the Week:
Welcome to Walgreens, a place where you can buy snacks, toothpaste, and a genetic DNA test...(let's take a pause)...
With high specificity and sensitivity rate, screening test and diagnostic testing are useful medical tools which can identify diseases, genetic disorders, and health issues. Once a patient is identified with a genetic disorder and with proper course of treatment, the manifestation of the disease can be prevented and even deaths can be avoided. What happens when genetic testing is offered outside the context of the doctor's office, and the choice of getting a genetic test lies directly in the hands of consumers, in the absence of the doctor's referral. In May 2010, the drug store, Walgreens, started to offer genetic testing kits products over the counter. Within a month, these kits were taken down from the store.
Current Event Los Angeles Times News:
http://latimesblogs.latimes.com/booster_shots/2010/05/pathway-genomics-testing-kit-in-walgreens.html
If you were to market genetic testing products, would you have a disclaimer? What would it say?
Or in another scenario, a friend saw one these genetic testing products at CVS and is debating whether or not to purchase on these tests after finding out that her cousin has breast cancer. How would you advise your friend?
If I were to market genetic testing products, I would approach the consumer similar to how pregnancy tests are advertised - by being clear about the test's accuracy and including an advisory statement that consumers should still go to the doctor to confirm results. The disclaimer would give an exact account of how accurate/ reliable the test is and would refer consumers to the appropriate clinical tests for more information. The risk in a product like this is that it can increase the number of unnecessary follow up testing if the screening is that accessible. If I had a friend who was debating taking this test, I would tell him/her to speak to a doctor for positive results, as opposed to potentially wasting time and resources into a screening test that may or may not be entirely accurate.
ReplyDeleteI actually completely agree with Farrah's comment, and if I was a marketing agent I would definitely market this product the same exact way, if not more stringent on the recommendation to seek further medical attention from a genetic counselor. For example, if pregnancy tests come back negative, they say you may still be pregnant, but does not firmly recommend you seek medical attention, only after multiple negative tests in the absence of a period. However, I think these products should include a disclaimer that states their margin for error and proven efficacy in clinical trials. They should never say that they are completely conclusive, or that they are substitute for seeking out the advice of a genetic counselor. Overall, those who purchase the product should understand that the tests may be somewhat accurate, but follow up with a genetic counselor to interpret the results is absolutely essential.
ReplyDeleteHowever, considering the other scenario, I would advise my friend to approach her doctor and discuss what her potential risk is even before taking any tests. For example, if her cousin was the first person to have breast cancer in generations, it is likely that it was the result of an unfortunate mutation in her BRCA 1 or BRCA 2. If a family history was taken and it turns out that more than just her cousin have had a history or breast or ovarian cancer, then I would suggest, as would a genetic counselor, that a more extensive family history be taken and genetic testing be done. However, I do not think buying at-home testing kits would be very useful. With unconfirmed efficacy and safety, these tests have not yet proven to be reliable, and are not cost-effective. Therefore, I would suggest my friend seek out the advice of her PCP and review her family history of breast and ovarian cancer, and then if her PCP confirmed her risk as medium to high risk of developing cancer, she should proceed with testing with a genetic counselor.
This is definitely a dangerous setting for genetic testing---the people that are likely to purchase these tests probably like the appeal of finding it at home and not having to go through a medical professional. If they took the test that the article mentioned about the effectiveness of drugs, they might be inclined to stop taking a drug that is actually doing them more good than harm without consulting their doctors first. Because of people that would take the results at face value, if I were to market genetic testing products, I would definitely have a disclaimer. I completely agree with Farrah and Jane; the disclaimer would have to say that the tests aren't completely reliable and a follow-up with a medical professional is essential. Without proper interpretation and counseling, people might take the results the wrong way and make unnecessary changes.
ReplyDeleteIf my friend wanted to buy this product I would not advise against it; taking a test like this as a screen cannot hurt. However, I would encourage her to be prepared to discuss the test with a professional that could explain the implications of her results.If she is really curious and there is a way for her to estimate her risk, then she should be allowed to do it, as long as she knows to interpret the results with caution. -Becca Adlman
I agree with both Farrah and Jane in that these tests should have a disclaimer saying these tests are only meant to be an advisory statement. The disclaimer would include that if the test is positive then you should NOT rely on the results of this test, but go see a doctor and talk about the results. These tests are pretty generic and won't compare to the "gold-standard" test that can truly detect a disease.
ReplyDeleteWith the scenario I would advise my friend to see a doctor and look up her family history. If her cousin is the only one with breast cancer then the diagnosis may not affect her as much. If many people in her family have breast cancer then she should go see a doctor. The doctor will be able to order all the necessary and appropriate tests to determine is she really does have breast caner.
I can see how offering screening tests in settings such as Walgreens or CVS might be attractive; it saves a trip to the doctor's office, could be cheaper and the individual can perform it in the privacy of their home. However, I agree with Farrah and Jane that the tests should come with disclaimers and should not replace actual medical consultation.
ReplyDeleteIf the patient were to take the test at face value, as Becca suggested in her post, to make decisions about their health and then test positive, how would they know what they should do next in terms of treatment or prevention? Although it would be possible to include information about "what to do next" with the over-the-counter tests, it would not be able to replace the experience and support of an actual doctor who could better explain the results of the test and recommend what the next steps should be.
Therefore, if a friend of mine was considering taking a CVS tests I would probably advise her against it, informing her about the risks of potential error/questionable accuracy and reliability of the test and that it would be wiser to see a doctor.
I also believe that such genetic testing kits being sold over the counter should definitely include disclaimers that clearly state the purpose and reliability of the tests. With a thorough disclaimer, the consumer would be well-informed that the test is merely a precautionary measure and that there is the potential chance of it being wrong; companies would also not be as liable for the fallout from false results. The consumers would be more aware and, though the tests may instill unnecessary fear and worry if the results are wrong, they may also help to prevent potentially dangerous diseases at earlier stages if the results are correct. The tests would serve as warnings for people to follow up and get screened by their doctors for a definite answer. As long as the products are distributed with a disclaimer, as well as caution and moderation, fully disclosing to the consumers of its accuracy, reliability, and potential risks/benefits, then I personally don't consider it to be very harmful. People have the free will to decide to purchase it or not- just because it's available, it doesn't mean everyone has to buy it. They have the choice to spend their money on it and if they want to do so, knowing that it could be false, then I don't think there is anything really wrong with it. It is definitely the more convenient and slightly cheaper alternative to making an appointment or taking a trip to the hospital. I think it could potentially promote early prevention by urging people who have taken the tests to follow up with their doctors for more positive results, which would lead to an overall healthier community. Everyone should be getting officially tested by their doctors to be safe regardless, but many people decide not to for a number of reasons such as laziness, fear, inconvenience, etc. Though these tests may or may not be accurate, I think it would encourage people to take their health more seriously and seek out the help from more reliable sources, like their doctors or the hospital. And though I would recommend for my friend in the scenario to see a doctor over buying the test, I wouldn't necessarily advise her against buying the test either. I would just tell her to be aware that the results may not be correct and that she should definitely follow up with a doctor afterwards.
ReplyDeleteA thorough and comprehensive disclaimer is a must for genetic testing kits sold over the counter at local stores such as CVS or Walgreens. On the same note, the disclaimer must be understood by any persons who may enter the store and consider the product. Therefore requiring it to have clear explanations and should stress the stringency of seeking further medical attention from a genetic specialist. Even though the price of the test is not that expensive, the necessary follow-up with a specialist may be costly. On a side note, will insurance policies cover the cost of this service or will it be out-of-pocket?
ReplyDeleteLike any other product sold in CVS or similar stores, no one is forced to purchase this test; it's a personal choice. The prices listed in the article where not outrageous, especially considering the possibility to receive preventative care for a positive result prior to needing a variety of treatments and having to pay a large sum of money.
What type of results would you receive though? Would the "average Joe" be able to understand them, as well as the have the opportunity to do anything about it? What about those who are underinsured or not insured and they receive positive results back for a disease. How are they going to be affected, how will they pay for the necessary and further treatments? Will there be tests for other disorders? What will come of this testing and how reliable are the results? This genetic testing also leads to many other difficult moral and ethical questions.
To address my friend - I wouldn't advise against taking the test as long as she is prepared to accept the results and is capable of taking further preventative measures.
I agree with Becca that this is not the best place for genetic testing. Even if there was a disclaimer to clarify that the results may not be entirely accurate, a lot of people might not necessarily read through disclaimers and fine print and take it that seriously. The general population probably doesn't have a lot of information on what the tests mean and how to read the results, and people who are buying these at-home tests are likely doing so to bypass going through a medical setting. This means that they are not getting any counseling on what the results mean and what it means for their associated risks, leading to people acting in ways that may not necessarily be the best for their health.
ReplyDeleteI would advise my friend to go through a medical setting, to have a better chance of reliable results and help making an informed decision.
First of all I want to say that I do not believe placing genetic tests on the public market is an appropriate way for individuals to seek genetic information because of the many implications associated with biology and hereditary. But if for whatever reason I found myself in the position of saleswoman for genetic testing products I would make sure my product had a disclaimer which not only protected the individual using the item but also protected my business from liability concerns related to misdiagnosis, misuse, information disclosure and confidentiality, among other issues.
ReplyDeleteHowever with such an extensive disclaimer, I feel that it is almost counterproductive in terms of weighing the revenue generated from genetic tests against the liability concerns. This is because there appears to be more risks than benefits involved in putting these tests in a Drug Store like Walgreen’s. Especially since the general population is by no means trained to administer and interpret the test and in addition a genetic testing provides controversial information, which I believe should not just be given to an individual without the proper support of individuals who know how to help rationalize in a tumultuous situation where the recipient of information may not be able to due to the burden this information has on them. I also feel that if genetic tests are offered to the general public then the demand for supplementary items such as treatment options would need to be offered to the general public, because in order for genetic tests to be effective in their goals of early diagnosis and treatment then the individual taking the test would need to have the next step available at their own convenience. It also does not make sense to just provide the buyer with the tools to self-diagnose, but yet they do not have the tools to treat themselves. At this point in time, if an individual walked into the doctor’s office and said I diagnosed myself with Taysach’s what do I do next, the doctor would be put in a tough position as to whether he should take his patient’s word for it and proceed with treatment although he did not either administer the test himself or send his patient to a specialist. Or then again should he retest the patient and what if subsequent test results produce different information? What happens then when the patient who believes she has a disease is actually told otherwise? The possibilities for complications are essentially boundless. Therefore the most appropriate disclaimer would be “not for retail or public sale,” which would restrict the administration of genetic testing to Geneticists and other Specialists.
I would advise the friend to go visit her doctor or even try to schedule an appointment with the doctor who diagnosed her cousin because he or she would have a better sense of the family history of breast cancer. But I would not condone her purchasing a breast cancer test for many of the same reasons I mentioned above in the previous scenario.
I think it gives the person a false sense of knowledge about their future which could cause more harm then good. If this product was to be sold and I was marketing it I would put a disclaimer that made it very clear that the test is not definitive. Although you can test positive for having a particular gene that might put a person at a higher risk for developing diseases there are many other factors that can influence the manifestation of such illness. I would make sure to include that the results of a positive test should encourage the person to take preventative steps and improve their health behaviors to defer the onset of a potential disorder. Additionally, a negative test should still indicate a person to try and alter any health damaging behavior because this result does not mean that the person is completely free from risk.
ReplyDeleteIf my friend was interested in buying an OTC test I would try and convince them otherwise. I think the importance of seeing a trained professional with regards to genetic testing is that they can council you both before and after the test. This way a person is well informed and does not panic or experience any unnecessary stress by not being fully prepared. Although, knowing that your genes predispose you to a certain cancer or illness that might cause you to get screened often and take preventative measures I still feel that taking a genetic test is not the best idea. I think that as of now the test is mostly having negative side effects because some people who take it think their future is set in stone and they only focus on those diseases their genes are telling them they are predisposed for. In my opinion it is better to be kept in the dark and take suggested preventative measures that are suggested to the population like everyone else and stay as healthy as you can. Seeing a doctor regularly and having a healthy lifestyle can prevent many diseases and reduce environmental influences that might interact with genes to cause the disease anyways. To me, we should focus on getting a greater percentage of the population to do just that which would decrease mortality and morbidity instead of taking OTC genetic tests.
I agree with the previous posters that these over-the-counter genetic test kits should have disclaimers about their safety and reliability. Similar to the "Cheating Gene" situation blown up by The Today Show, these tests are being marketed as something they are not. The Pathway Genomics Corporation that was selling these kits in Walgreens admits on their website that their lab testing methods are not regulated by the U.S. Food and Drug Administration. The company also states that the results are "not intended to provide medical advice" nor are they "intended to be used solely by the patient in the diagnosis, cure, mitigation, treatment or prevention of disease." Basically, these tests may give you information about your DNA but according to the company you should not act on that information. So what's the point then?
ReplyDeleteThis is way too much! I certainly do not agree with selling genetic testing products over the counter, but if I were to market the product I would definitely have a disclaimer. As many of my peers have said throughout this blog, the disclaimer will state the level of reliability and validity of the test. Moreover, the test could lead to misdiagnosis and for further assistance they would need to see a physician. Honestly, there are many people out there who do not know to properly read a label. This will lead to confusion and misuse—it could lead to many false positives and/or false negatives. The disclaimer will also state that the company will not be liable for misdiagnose, misuse, or any other related issues.
ReplyDeleteI would tell my friend to make an appointment with her primary care physician, in order to determine her risk of developing breast cancer. In the meantime, he/she could also do her/his family history diagram and gather as much information as he/she can to make the best out of the visit. If my friend still wants to buy one, I would say that the test is not 100% accurate and it could potentially give a misdiagnosis. In the end, he/she will have to see a doctor.
I can't believe that the idea to sell genetic testing kits at walgreen's was actually approved. This irresponsible utilization of genetic technology is a perfect example of rushing in to thins too quickly. Genetics is still a fairly new field. Discoveries are still being made, while theories are being rapidly proven, disproven, or modified. Although findings are often displayed in the news, the general public is still largely unaware of what it means in the context of their lives. This is exactly why genetic pretest counseling is now a normal practice to determine whether a genetic test is truly in an individual's best interest. When walgreen's sells these self-test kits, they do not sell the counseling sessions with qualified professionals; rather, they leave the consumer to make an uninformed, snap decision that may alter their lives in ways they hadn't imagined for the bargain price of two hundred dollars or less. Then, after the test is taken, consumers may be presented with the problem of understanding the results. This means comprehending what the results mean in terms of their own everyday lives. This means learning what are the next steps, if any, to take. Or in the case of Alzheimer's disease, what risk do they face on an individual level. There are so many questions that consumers may want to ask or do not know to ask, but still cannot ask a piece of paper. This brings to mind the assigned article, "Genetic Testing for Cancer Susceptibility: The Promise and Pitfalls" by Lerman and Shields. The mention of related ethical and social issues, specifically genetic and racial discrimination seems like a point that should not be forgotten in this situation. Consumers may not realize all that they are actually receiving from this walgreen's test. Lerman and Shiled's note the alarming statistic that, "13% [of Americans]...reported that they or a family member had been fired or denied a job because of a genetic condition in the family" (Lerman &Shields, 2004). It may be argued that there are protection laws in place to counteract this employer practice, yet the mention that, "only 31 states have passed laws that ban the misuse of genetic information by employers" (Lerman &Shileds, 2004), does not provide much support to that claim. The consumer should be fully aware of all consequences to a genetic test, a state of comprehension that can only be reached after appropriate counseling. I would advise my friend to speak to her doctor and receive a referral, if that is still her wish.
ReplyDeleteI think genetic testing should be available to the public with a disclaimer. In this day and age if we have the technology to answer life changing questions why not go for them? I'm sure when the take-home pregnancy test came out it caused an uproar because of the social acceptable ties attached to them regarding a women having the right to sex, get pregnant out of wedlock and terminate if she wanted.
ReplyDeleteIf anything affordable available genetic testing should be viewed as a good thing because it promotes preventative health measures. For example, if someone took the gentic test and found out they were more likely to develop breast cancer then they could take that information and be more aware to check for breast lumps and ultimately catch the the cancer faster. This in turn would be beneficial to the patient and doctor to nip the cancer in the bud before it became too late.
As a disclaimer I would write the accuracy of the test and just warn people of the pros and cons of DNA testing.
Pros: you know and be proactive about knowing
Cons: you know and you stress out in a bad way
I find it very interesting that such a big named company such as Walgreens would sell such a controversial product. Then again, Walgreens has been in the hot seat for exploiting workers, underpaying them, and not providing adequate health insurance to its workers in the past.
ReplyDeleteThe idea behind a self-genetic testing kit is kind of mind boggling. On one hand, the consumer can find out their potential genetic flaws that can directly or indirectly affect themselves and their loved ones. However, on the other hand, are they really getting the true facts? The article brings up the point of whether a licensed professional would be able to help one diagnose the results. If not, emotional and physical pains may ensue due to false information.
I don't think I would ever want to sell a genetic testing kit in the first place. But if I were in that situation, I'd but a disclaimer stating that this product is not completely accurate and to seek professional insight prior to purchasing said kit. If my friend wanted to purchase one of these kits because she was confronted with the potential of getting breast cancer, I'd tell her to leave the kit alone and check with her doctor. With all the extensive medical innovations out there, it's much safer to get a professional's insight on such situations rather than self-diagnoses. Bad things can only come out of it.
I agree with my classmates and think that this form of test would definitely need a disclaimer. And not just a disclaimer but an mini course on genetics, genetic testing and analyzing test results. Something no company could offer I found a quote I found interesting by Dr. Robert Marion chief of genetics and development medicine and director of the Center for Congenital Disorder at Montefire Medical Center in New York City that said “The technology is running way ahead of the ethical, legal and social implications of doing the testing, and we need to sort all this out before we can start to offer these tests on a mass scale,"http://www.businessweek.com/lifestyle/content
ReplyDelete/healthday/639079.html . And I think its true I think it would be socially, legally and ethically irresponsible to put this kind of personal medical testing on the shelves. I found it interesting that Walgreen’s ended up not putting this item on the shelf and looked into why and found a few articles that said that the FDA got involved saying that this was not legal because it was not approved by the FDA, and that they needed to be approved to continue. I’m glad the FDA got involved because the general public is not ready for this kind of information, I think this information is still hard to understand when you have all the resources including health professionals and genetic counselors helping you walk through it.
I believe that making genetic tests readily available to society is not the way to go. Genetic tests are just one of the many factors in determining whether a person is going to get a disease or condition. For instance, if one of my friends just found out that her cousin has breast cancer and was debating whether or not to purchase a genetic test, I would advice her against purchasing one. I would recommend that she talk to her parents and see what they have to say and then go talk to a genetic counselor. Then she is not doing this just as a spur of the moment thing. I would tell her to do this because we are not a very knowledgeable society when it comes to the medical field, especially in genetics. People may only know about genetics from what they hear and see in the media. She needs to be informed in all possible areas on the subject before she can really decide on getting a genetic test or not. And if she does decide to obtain one then she will have the right support to guide her and talk about what the results mean and how they may or may not affect her life. Thus, I would not market genetic testing products as an over the counter product. People really need to be informed before, during, and after the genetic test process and placing them on the self is not going to provide people with enough information.
ReplyDeleteThe real danger with this product is that the likelihood of misinformation will prevent some people from seeking their physicians because they believe the results of the test to be final. However, it’s important to realize that consumers who utilize Walgreen’s product would have to seek real genetic counseling because there is information beyond the genetics that need to be considered. For example, the emotional and social repercussions of a positive test result need to be sufficiently understood in order to help patients make reliable decisions. As we saw in the film “In the Family,” the choices some women have to make when they are positive for breast cancer are heart-wrenching. To be able to weight the pros and cons of the options available, namely a mastectomy or an oophorectomy, involve decisions that make these potential cures nearly as daunting as the ominous disease.
ReplyDeleteTherefore, the disclaimer I would include on the product would reflect the fact that results are not 100% accurate (likely due to fault specificity and sensitivity measures) and therefore further genetic counseling and/or risk assessment counseling must be sought. Additionally, who will protect the genetic data that may be discovered through these tests? To take a real genetic test, an informed consent is endorsed before the testing takes place, I am sure this part is not included in Walgreen’s, but in terms of confidentially and general rights, it’s obviously important. Also, this product clearly does not provide the information or support to the patient which is critical to their future.
In response to J. Daniel’s question regarding if insurance policies would cover the cost of this service or if it will be out-of-pocket, I think it’s interesting to think about the subgroups or the specific populations that would be more likely to purchase the product. For instance, it has been shown in studies that African American women are less likely to obtain genetic testing for BRCA due to disparities in wealth, health care, and a feeling of skepticism towards physicians. Therefore, although I believe the test is generally inefficient, there is a chance that it will be helpful for some people who decline, or cannot seek medical care, since they can obtain this genetic product out of pocket and entirely eliminates the physician-interaction aspect. Thus, it could raise more awareness in this population and possibly cause them to become more medically orientated, which is a good consequence.
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ReplyDeleteAs is mentioned in the blog genetic testing for different types of diseases is an incredibly powerful tool. However a medically uniformed person who attempts to screen himself or herself or a loved one can potentially create for themselves more harm than good. These tests are not like a simple pregnancy test where there are a limited number of results. The results of a pregnancy test or a test to decide if your child has strep throat are easy to understand without any medical knowledge. However, even these tests can result in a misdiagnosis. Genetic testing and some of the diseases that can be tested for are complex. The results are not always clear cut and a knowledgeable medical provider should be the one to both administer the tests and interpret them.
ReplyDeleteIf I were to market a genetic testing product, a disclaimer, would have to be included. Patient’s need to know detailed, yet understandable background information about what they are testing. Also information about sensitivity and specificity of tests need to be added in order for the customer to know that results are never 100% proof. Even if one receives results that are abnormal, it isn’t fair to automatically assume disease and rush to conclusions without medical knowledge from a professional.
If my friend was debating on performing a home genetic test, I would tell her not to do it. I would explain the risk of incorrect results and the damage that could do to her. Also, the fact that the individual is doing the test on his or her own doesn’t sit well with me. The instructions may be clear, but I would feel much more comfortable if my doctor were to perform the test, in his office (a sterile professional environment).
If I were to market a genetic testing kit I would make completely sure that I tell customers that these are not always accurate. As a customer I don't think I would trust these over the counter tests because I just wouldn't see them as 100% accurate. Instead of wasting my money on buying 2-3 of these tests to make sure the results come back consistent, I would just save up more money and get the real test done if I really needed to know my genetic diagnosis. As a customer I would be very afraid that even though they claim they are highly specific, sensitive, and accurate; to get the wrong result and live with a life of worry until I get proper high technology clear diagnosis about what this over the counter kit is telling me. I think they went off the market only a few months after they were put out there exactly for that reason. People did not trust the product, didn't see it as being completely accurate or maybe so many people tried it and were unhappy with the results that no one bought it anymore. Even though a take home kit for genetic testing is a good idea, I feel like most people would be very hesitant to to try these when it comes to such a serious and important topic such as genetic testing.
ReplyDeleteAlthough at first glance it seems that the ability to purchase a genetic testing kit at a local pharmacy would be a convenient option to determine if one is at risk for various genetic diseases, a visit to a doctor would be a more efficient and reliable way to obtain this information. Using a genetic testing kit at home poses a few potential problems. The first is that the test results may not be accurate, leaving users with either false feelings of content, or an unnecessary sense of worry. For example, in a study conducted by the United States Government Accountability Office regarding direct-to-consumer genetic tests, the investigators found that consumers received test results that were misleading and of little or no practical use. Also, the donors received DNA-based disease predictions that conflicted with their actual medical conditions. These results show major flaws in the home genetic testing kits. An additional negative aspect of home genetic testing is that once the consumer receives the results, he or she may be unaware of how to react to the information, or what proper action to take next. It is imperative that a genetic counselor interprets these results to adequately inform the patient of their condition. These tests may be a good starting point for people to be aware of the possibility of genetic testing, however, it should be left to the professionals.
ReplyDelete(Direct-to-Consumer Genetic Tests. Misleading Test Results are Further Complicated by Deceptive Marketing and Other Questionable Practices. United States Government Accountability Office. July 22, 2010.)
Selling genetic screening tests at Walgreen's just does not seem like a good idea to me. There is a reason that people go to see genetic counselors when they get these sorts of tests done; there should be a professional around to help people interpret their results AND to help them cope with potentially bad news. The idea that someone might just get a letter or email that says, "You're a carrier for Tay-Sachs! Sorry about that" is ridiculous.
ReplyDeleteThat being said, if I were to package genetic testing products, I would definitely have a disclaimer recommending that consumers contact a genetic counselor, especially if they want to test themselves for something potentially serious. Also, I would be sure to emphasize that they should take their results with a grain of salt when they use some of these tests and that not all genetic tests can supply answers that are black and white.
I agree with Rachel C that genetic counselors and other medical professionals are important in the genetic testing process. I also agree with Rachel C's comment about genetic tests not being so black and white. A genetic test shouldn't be on the same level as purchasing a pregnancy test from the drug store. Before a consumer purchases such a product, they should think about the implications of this knowledge that will affect them and their family. Also, there is no way of knowing if these results are accurate, which is why professionals should be involved.
ReplyDeleteAlso, these kits don't seem very safe regarding the disclosure of genetic information. How would these scientific companies know that the person sending in the kit is using their own saliva? This tool could be dangerous in the sense that it seems easy for people to misrepresent themselves, which leads to many ethical issues.
I hate to sound like a broken record but I too agree with the post before me. On average, the general population does not know the background information about genetic testing or may not even care to read the disclaimer presented on the test. I can honestly say that when I download a computer program I do not read the 40 or some pages of disclaimer that come with it and just click that I agree to the term and conditions. There are many conditions that go along with genetic testing such that there could be confusion about reading the tests, knowing that even if you are positive that does not guarantee getting the disease, or some of the psychological stress that may come with the results. Genetic counselors have been trained to deal with these situations but I feel that most people who use the test will just go to relatives or friends who may not know what to say or be able to give the proper referrals. In addition, what will have that by some small chance the company mixes up the results of two people and someone gets someone else’s positive test? That could cause major psychological stress. I do not thinking genetic testing over the counter is necessary or even plausible.
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ReplyDeleteIf I had to market genetic testing products, I would be certain to be very explicit about what the test does. Although it may be nice to e certain of whether you are predisposed to a certain disease or not, if the physician of your family members or yourself has not offered you this test (based on looking at your family history, etc) then you probably do not need it. Moreover, often times people may consider this test to be something trivial and not something to worry about, but if you or a family member gets a positive result, it would certainly cause a lot of worrying and stress. When taking genetic tests, I would make sure to explain to the consumer that they must be prepared for both positive and negative results. Unlike a pregnancy, this is not something that can be terminated or altered once you find out about whether or not you are positive for the disease.
ReplyDeleteWith regards to the friend with a cousin who has breast cancer, I would strongly urge her to go see a genetic counselor before she makes such a decision because once you find out your results, there is no going back. I would tell my friend that she should explore all her options before taking this CVS test. Moreover, this test may not be accurate and may give false positive results or even false negative results and it really would be better to just do see a doctor and ask his/her opinion (again, based on family history, etc)
Just like any other marketed health product, if I were to market genetic testing products they would definitely include a disclaimer. Medical appliances rarely have guaranteed accuracy. Therefore, a disclaimer stating this and recommending a second opinion on positive or inconclusive results is definitely necessary. The disclaimer I would include would state: “this product is NOT for the purpose of replacing medical opinions from trained professionals, but rather to serve as a guide, or recommendation for follow up care.” If placed in the above scenario I would first recommend that my friend go directly to a professional geneticist. However, if due to financial or additional setbacks this is not an option, I would suggest the next best thing, which would be to purchase the genetic test. However, personally I see no purpose in purchasing the product if when the results are interpreted no follow-up is performed. Therefore, I would mention that if the results are in anyway positive or inconclusive a follow-up ought to be made to confirm these details. I am in no way against the use of over the counter genetic testing, however only to serve as a source of screening that is complimented with the opinion of a trained professional, as well as a regime of preventative care (if available).
ReplyDeleteIf I had a friend who saw a genetics testing kit on sale at CVS I would definitely advise her not to purchase the test, and if she did purchase it I would tell her to take the results into considerations, but not as a definite. If her cousin recently was diagnosed with breast cancer, the friend would probably feel more at risk of contracting the disease herself because it has afflicted someone so close to her genetically. There is always the possibility that her cousin's breast cancer was genetically linked, therefore possibly putting my friend at a greater risk. However, I think the only way to have this question properly answered would be to go to a doctor and have, first, a consultation with the doctor, and if advised then seek genetic testing. The doctor should professionally administer the genetic testing; a CVS over the counter test product should not be trusted.
ReplyDeleteHaving someone not educated in the field and with no practice in doing genetic testing should not be able to test themselves. The risk of false negatives and false positives would increase, which could provoke certain reactions. If someone gets a false positive, they could change their outlook on life or fall into depression for no reason. They also may not know how to handle the information, whereas a doctor could suggest genetic counseling or other means of coping. On the other hand, a false negative would make the person relieved and they probably would not seek further testing, which could allow the cancer to develop unnoticed for a longer time. For these reasons I think that only professionals should be able to administer genetic testing.
Having genetic tests available for anyone to purchase could potentially create a risky scenario where individuals rely on the results of the test and do not seek professional help from genetic counselors. Therefore, in order to prevent this from occurring, disclaimers on the product should indicate the exact accuracy of the test. Not only should consumers know about the accuracy of the genetic test, but should also be advised to seek professional help from a genetic counselor. If this product is available to consumers, then this information must be included on the package, yet I still firmly believe that it shouldn’t be available to consumers in the first place. I feel that a lot of individuals do not know what they are getting into by simply buying a genetic test, and the trauma that can occur after knowing the results can be very detrimental. Because of this reason, I feel that all individuals interested in knowing their genetic results should undoubtedly speak to a professional counselor.
ReplyDeleteI 100% agree with T.burks. I do not believe that genetic tests should ever be allowed on the market. If individuals were able to deal with the implications revealed by genetic test results there would not be an entire profession and extensive counselling process required both before AND after genetic testing. If tests were to become available over the counter, I think the psychological and emotional damage experienced by many less knowledgable individuals would occur.
ReplyDeleteIf a friend were to consider using one of these tests I would tell her not to. I would tell her to think about what her reaction would be if the test was positive. I would tell her that seeking out a genetic testing center where counselors and educated doctors could help her through the process is very importat. I would also point out the fact that should it be positive, 1. she wouldn't be able to fully understand what a positive reading implied about her future health and 2. she would need to see a doctor anyway to figure out her next steps towards prevention.
All in all, to cut out counsellors and doctors from the genetic testing process is irresponsible and unsafe. I do not think this should ever be approved.
I understand that with knowledge of a genetic disorder, that people can have a better chance of treating and preventing the disorder more efficiently but I do not support such a product being sold in local stores. I agree with devynw21 when she says that cutting out counsellors and doctors from genetic testing is unsafe. Also, who is to say that someone would not purchase this product and run these tests on other people? This would be a huge confidentiality breech. Would then new laws have to be enforced specifically pertaining to such genetic testing kits? People would probably want to test their prospecting wives or husbands and if the person did not agree to be tested, what would stop these people from finding a DNA sample and doing it themselves without permission. I think this is would be a dangerous implementation.
ReplyDeleteI don't think these tests would be able to provide the proper information on the possible outcomes. If someone were to use the kit and find out they have a genetic disorder, they may not entirely understand it without the consultation with an educated doctor. Reading a pamphlet or something online could give them incorrect information or information that they may not fully understand. This could lead to many more problems.
The way that I look at this scenario of offering an over the counter genetic test kit is by analyzing the positives and negative consequences. The benefits of having this available to the public is that it saves them both time and money of not needing to go to the doctor and get a more costly test done. Many insurance companies don't cover genetic testing and so the costs for it are out of pocket. Insurance companies are not attracted to patients who could be possibly at high risk for a genetic disorder. I think that the downfalls of having genetic tests be over to the counter are far worse and more extreme. Even if these tests have a disclaimer stating the specificity and sensitivity, this could mean nothing to the customer who is buying it. These epidemiological terms are not commonly used in the general public, and so someone who is not involved in the health professional field will probably not know what the statistics on the genetic tests stand for. Another negative thing that can occur is that people who are using the tests on themselves may not know how to properly interpret the results. This is why health professionals and genetic counselors are in charge of administrating these tests. They have lots of knowledge in this field and can help these patients the right way. Furthermore, if someone does take the test and gets a positive result of having a genetic mutation it may not always lead them to see a doctor. It is problematic if this type of patient fails to follow-up and get treatment. This is one of the roles of the genetic counselors; they are able to provide alternative options to assist those with a genetic disorder. There is also risk for misdiagnosis since nothing can be 100% accurate. In the end, I agree with the action that was taken to remove genetic test kits from being over the counter. There are far too many negative consequences that can potentially occur if this product is easily available to the public.
ReplyDeleteI think offering over-the-counter genetics tests is a progressive idea, making these tests that are high in specificity and sensitivity available without a referral by a physician or seeking out a geneticist specialist. This would reduce costs to our healthcare system in terms of health insurance reimbursement for such tests, with the costs (most likely) falling solely in the hands of the consumer.
ReplyDeleteThat being said, I do not believe the vast majority of the population concerned about their genetic makeup will have the knowledge or understanding about what their tests results mean. The field of genetics itself is still very new and constantly changing, therefore, it is imperative that any genetic test performed not under the supervision of a healthcare professional should include a very specific disclaimer for two reasons. One reason is to protect the manufacturer from any potential lawsuits from faulty equipment or results, and also to ensure that the person follows up with their physician to discuss the results of the test.
Additionally, I can’t help but be suspicious of the accuracy of these self-administered tests. Especially in the context of determining ones genetic information, I would much prefer to leave such tests in the hands of trained medical professionals, and not my own.
I agree with Matt that the availability of these genetic tests in Walgreens or other pharmacies would reduce the cost strains of genetic testing when you see a doctor.
ReplyDeleteHowever a doctor knows how to interpret the information and knows how to assess your risk and include other additional factors that may be influencing your risk. I don't think that right now, an accessible genetic test is a good idea for any sort of serious diseases, because as my fellow classmates have already stated, the accuracy of the tests is in question, and the panic that might be generated is of concern.
That being said, if there was a way to increase accuracy of the tests and also let physicians have a hand in their sales it could be a great way to reduce costs in the healthcare system. For example, if the tests were available as a prescription from the doctor AFTER some genetic counseling, etc, the idea may have more hold and could be more beneficial since the patient would already have background information and be informed.