Imagine this scenario:
"The Government has my Baby's DNA! " cried a new mother who just found out her baby's blood has been sampled so the baby can be tested for a series of life-threatening diseases. While she is thankful that her baby has been tested negative, she is still upset that her baby's DNA remains in the hands of the government … Is that really true? If so, what's the big deal ?
In the past few years, newborn screening programs across the world have taken some heat from the public. While the program was originally initiated to protect and to serve families, many advocates have taken a new twist to the population-based screening. General public miscommunication and misinterpretation of the original purpose of newborn screening could possibly shut down one of the most life-saving and cost-effective programs for public health.
Read this link, and compare your thoughts about the Scotland's situation with other countires (such as the US, UK, Asia … etc). Incorporate what you've learned this week's lessons and discuss the 'ethical, legal, and social issues' (ELSI) that have or have not been considered in this current news on newborn screening (NBS). What would be your recommendations?
http://www.phgfoundation.org/news/15345/
OR1. You can share the new, 'surprising' information you learned2. Ask a question that needs additional clarification, 3. Share a news link relevant to the discussion. 4. Reply to another student's comment.
To be honest, I find this entire post to be a rather shocking. Prior to reading this post and article, I knew that newborn screening existed and that Guthrie cards were used to test for disease but I did not even think about what was being done with this data or that this data was being stored. Without parental consent, I do not believe that this data should be able to be stored or used for research. If Guthrie cards are going to be used for medical research, parental consent, broad or narrow, must be granted. In addition, the confidentiality of the data must be maintained in order to protect individuals from discrimination and invasion of privacy. This information is not the government's property and the government should not be allowed to test an individual for a specific gene if consent is not granted. I definitely do believe newborn screening should be continued; however, data previously collected should be disposed of or consent would need to obtained for the data.
ReplyDeleteI think that the testing of newborn DNA for the presence of life-threatening diseases is a good thing in theory. The same way we want and value early detection of disease through cancer screening, etc., so that treatment can also be early and effective, could be applied here. However, the idea that the DNA is retained forever or for some long period of time by someone is unsettling for many. I think that the big deal with this is that some see it as an invasion of privacy, and a violation of their autonomy. Did they consent to a one-time test or did the government agency or physician let the patient know their genetic information or that of their children would be stored and perhaps used for more testing or future research? I think that the individual or the parent has a right to know all that their genetic information will be used for, and that there should also be a right to opt-out either after one test or before any testing as suggested in the PHGfoundation article. There should also be more education of what exactly the procedures are with the genetic information, and also the comparisons of the great benefits of infant screening for public health with the small amounts of benefits.
ReplyDeleteI think the Scotland situation is very similar to some other countries, including the US. Though there is widespread use of newborn screening and genetic information testing in general, there is not widespread knowledge about how and why it is done. There is a lot of room for misinterpretation and overreaction and miscommunication, so it makes sense that many people would be against it at first glance. I think that people are want to think of the worst case scenario when it comes to DNA, so it is important for everyone to be informed. Even if providing informed consent/broad consent is timely and expensive, would it not be in the best interest of the patient to do it?
From an epidemiological standpoint, it is absolutely outrageous people are considering shutting down the newborn screening program. The Guthrie cards (and any other newborn screening programs) are implemented because it can screen newborns for a wide variety of diseases and genetic conditions. Screening tests are not so easily implemented, too. There is a lot of consideration that goes into the tests before implementation. One is that the risk of having the disease must be more dangerous than the risk of taking the screening test. I agree with the countries that have decided to destroy the blood cards. Parents agree to allow testing on their children, but they do not consent to anything afterwards. Once the blood is taken and the tests are processed, there should be no use of the blood cards.
ReplyDeleteI agree with Stefanie that genetic screening is great, we can gain very valuable information from screening, both about the disease and for the patient's prevention and treatment. And not just in theory, genetic screening can be great in practice too, but only if it's done legally and ethically. I was appalled when I read this article, because this seems not only unethical but also illegal. The article doesn't go into much detail, but did the parents consent to this? Even if they consented to the blood tests, this clearly wasn't informed consent if the mother just found out what the blood test was for. This seems very similar to the BNSF Railroad company case we discussed in class, in which the employees weren't told the purpose of the tests. Also there must not have been any certificate of confidentiality if they were able to use the results for criminal cases. If that info was used in America to prosecute a criminal it would be a violation of the fourth amendment of the right against unreasonable search and seizures. I think all the results of the previous genetic tests should be anonymized so they could still be used for medical research, but wouldn't pose a threat to the individual's privacy or rights. All future results should have informed consent and certificates of confidentiality.
ReplyDeleteI think it would be a shame to shut down this newborn screening program in Scotland for a variety of reasons. First, like the article mentions, this program screens for a variety of disorders, including phenylketonuria, congenital hypothyroidism, sickle cell disease, and cystic fibrosis. Though these conditions are rare, screening newborns for them ensures that early treatment will improve their health and maybe even prevent severe disability. Second, screening will also indicate if babies are carriers for some of these diseases. This is useful information in the case of sickle cell disease. Babies that are carriers of sickle cell disease are generally healthy but some will need treatment for anemia because they will be unable to produce enough red blood cells. A third reason this newborn screening program should not be shut down is that it is a method of preserving individual genomes. Guthrie cards preserve genomes and allow doctors to compare an individual's epigenome over the course of time in order to determine how modifications to gene expression are brought about by environmental conditions.
ReplyDeleteI do not think that Scotland should shut down their newborn screening program. This program has tremendous public health benefits, and its preventative nature saves Scotland’s health system a lot of money from potential future illnesses. Advocates against the program have a fair point though; I was very surprised to read that there have been cases where police used the cards to identify criminals. This is an example of a legal implication. I think a potential compromise would be to screen babies, inform parents of the results, and then destroy the sample if parents do not agree to sign forms allowing the government to keep the sample. In this way, the government is obtaining consent, which is an ethical implication, while still maintaining this public health program.
ReplyDeleteThe article “Ethical, Legal, and Social Implications of Genomic Medicine,” that was discussed in class today really surprised me. The case of the Northern Santa Fe Railroad was shocking, not only because the company used the blood samples taken from their employees without telling them the purpose, but because the company thought they would get away with it. I’m curious what the company thought would happen if they had found a mutation responsible for carpal tunnel—how would they have explained how they found this?
ReplyDeleteEven more shocking to me was the case of the women who sued her father’s surgeon for not telling her that she had a 50% risk of having the disorder that caused her father to die from colon cancer. I am confused as to how the intermediate court in New Jersey ruled in the daughter’s favor, claiming that the physician “had a duty to warn her… even over her father’s objections.” From my understanding, the only time a physician can breach doctor-patient confidentiality is in the case of infectious diseases or when a patient threatens violence against another.
In addition, how high does the chance have to be of getting a disease to warrant a physician breaking another patient’s confidentiality to let the person know? In this case, the daughter felt that because she had a 50% risk of developing the disease, the physician should have told her. I am curious what would have happened if there was a 40% risk, or even 30% risk— would the case have still been the same?
I would imagine that this would be a very difficult situation for a physician to be in, debating over whether to break confidentiality to inform a person of their risk of a disease or to remain silent, and it does not make it easier that there are not clear guidelines as to what they must do in such cases. This warrants the creation of stronger legal guidelines for such sticky situations.
I do not think that Scotland should shut down the screening program with the Guthrie cards. This test is crucial in discovering genetic disorders in babies within 48 hours of life and can help get the newborn early treatment to hopefully limit the severity of the illness. Without the screening process, many newborns would grow up to have severe diseases that could have been caught early on. With regards to the use of the DNA though, I think that the government officials should figure out some way to get consent from the parents to use the DNA for further studies. The article mentions that 2.5 million cards are stored in Scotland alone which would be extremely costly and time consuming to contact parents, but that is the most ethical and legal way to go about obtaining consent. I was shocked that there have been government's that have used these DNA cards in criminal cases because that does not seem ethical or legal.
ReplyDeleteThis is a huge issue not just in Scotland but all over the world because many countries use these type of tests on newborns. I do not think that the DNA should be destroyed because if consent is given, the screening tests could be used in important research in the future. But, there should be strict rules about who can use the tests and the purpose before they are used.
I completely agree with Lindsay. This program is vital to ensure that newborns receive the best possible care and is able to prevent unavoidable deaths. This program should not be shut down, however, some changes or guidelines should be imposed. Under no circumstances should the government be able to access this DNA for any tests, other than the original ones for which they obtained consent. As with any other legal consent, the parents consented narrowly, for the purpose of their newborns being released with a clear bill of health. If the government wishes to use any DNA for other research they should absolutely be required to gain additional consent. These DNA cards should not be used for criminal cases unless they follow procedure, as they would if they were subpoenaing any other DNA evidence. As Lindsay said, the DNA should not be destroyed since it has been consented to for these particular tests. It may be a good option for parents to be able to decide if they wish for the DNA to be destroyed following a certain period of time after their newborns are released and healthy. These programs are extremely important across the world and yield very beneficial results, however there absolutely needs to be strict control that follows ethical and legal guidelines.
DeleteI, like many others before me, believe that the Guthrie testing is a critical public health program that must continue to be used in every country. However, I think there should be stricter regulations surrounding the collection and storage of the data. I do not necessarily agree with what Lindsay said above, especially because I do not think that just because consent is given that the tests can be used for future research. Like Lauren mentioned, there is a huge difference between narrow and broad consent, and I think that when approaching a sensitive topic such as newborns, narrow consent is the optimal way to do so. I managed to find a pamphlet for newborn screening currently in place in Western Australia (one of the countries listed in the article) and it states that the newborn's parents should be aware that the bloodspot samples will be stored for up to 2 years before being destroyed. In addition, they discuss the fears surrounding future use of these tests, promising the parents that all identifiable information will be removed before doing so. I think that by addressing how these samples will be used as well as how long they will be kept, Western Australia does a successful job in informing parents prior to receiving consent. This pamphlet is available on the site of the Western Australia Department of Health, so I do think that these protocols are still being followed, but considering that the article above was written in 2014, I do not know if anything has recently changed.
ReplyDeletePamphlet: http://www.health.wa.gov.au/docreg/Education/Prevention/Genetics/HP009372_newborn_screen_test.pdf
I am an advocate for keeping newborn screening (NBS), which is an effective preventative program. I believe there should always be consent to whether the parent wants the data to be stored or destroyed; consent for what the data will be used for, etc. Although the government used it for forensic purposes, which can be beneficial, ethically and legally consent from the parent/ patient should be given first, so that socially- parents/patients may have accepted government use of their data. Although challenging to implement, ideally I recommend keeping NBS, however placing strict regulations to make sure it is ethically and legally sound, as well as socially accepted.
ReplyDeleteNewborn screening is an important tool in preventing severe disability or death by ensuring that babies obtain early treatment. However, there are numerous concerns over the storage and collection of bloodspot samples. There is concern over the legality of storing the samples without consent. In Scotland, they only began obtaining consent in 2003 when the collection began in 1965. Some ethical issues include the collection possibly acting as a de facto DNA database, commercial companies exploiting the collection, collection leading to discrimination, and police using the collection in crime detection and prosecution. A social issue is that all this uproar over the consent concerns could be solved by providing more awareness on the importance of bloodspot storage.
ReplyDeleteI think that consent should have been obtained when the collection began. Unfortunately, the collection began at a time when people were less aware over the implications of consent issues. Although, I’m not sure if destroying the whole collection is the right thing to do. There are numerous benefits to the collection such as the monitoring and improvement of the newborn screening program, the longer-term interests of individuals and their families, research, and identification of missing persons. I think asking if people want to opt out and have their sample destroyed might be the best choice.
From this article, it’s evident that clear and transparent policies on newborn screening storage are important.
I do not think that Scotland should shut down it's newborn screening program. From a public health perspective, the use of Guthrie tests is a very important screening tool that can be useful in detecting diseases and risks at such a young and critical point in the lifespan of a human. The article did bring up several interesting alternatives which are worth considering.
ReplyDeleteMy first thought after reading the article was, what about informed consent? We just learned about informed consent, and what about making narrow consent an option? This would mean that parents would consent for their infant's blood to be used for this one time, which would assure the government could no longer use it if they wanted. However, the author of the article mentioned that this would be an expensive think to make happen and probably isn't the most feasible.
Another thought that the article brought up was destruction of the Guthrie cards after use-- I think this is a fair idea. This would assure that the government/hospital can have no further information after this test is done. I think this method would be better than an opt-out system... because I feel as though many families would choose to opt out based on the fact that policy has made it optional.
Either way, the public needs to have better understanding and awareness of the important of newborn screening, and a public health awareness campaign would be a great start.
My recommendation would be to continue the usage of newborn screening and taking the samples of blood, but with certain legal additions to guidelines for consent. Parents should be able to opt out of giving their child's blood sample if they wish, after being disclosed about the possible benefits and harms of doing so. An even more specific option could let parents choose if they will allow their children's information to be used for research, medicine, or neither.
ReplyDeleteIf the blood sample were to be collected, certain measures should be taken to make sure the information would solely be used for research and medical purposes. For example, if police request a sample from the database, they would need to have reasonable suspicion and a warrant to do so. An act similar to GINA should also be instated in countries without it, to prevent employers and healthcare companies from accessing the data when deciding whether to provide insurance, firing/hiring, and so on.
The information provided by these databases is way too valuable to society for them to be destroyed. The database is useful for children's health and destroying such records would be devastating. I believe the consent/opt-out option is the best choice in terms of ethical, legal, and social implications.
I also learned about the case of Henrietta Lack last semester and playing devil's advocate regarding genome research, I think at that time the benefits of utilizing her cells outweigh the negative implications. Her cells were so unique and lead to many scientific breakthroughs, including the development of the polio vaccine which saved millions of lives.
ReplyDeleteHowever, in today's world, consent from patients and their families is crucial. NBS is important regarding the lives of children, but I just don't understand why programmes are archiving millions of samples? Are they just trying to keep samples in case of future research? To keep a population DNA base to confirm identities of crime suspects? Regardless, I'm surprised that there is a loophole in the system that allow the retention of Guthrie cards without the parent's permission. The samples archived now should be destroyed to avoid any complications and for future NBS, parents should be informed about everything done to their child's sample and consent should be given if samples are to be stored.
Ethical issues: The ethical issues that arise from this is whether or not the DNA collected from the newborn to screen for diseases can be used against them at some point during the future. For example, in the article, it was mentioned that the DNA has been used to identify criminals. Will the DNA be used to harm the newborn in the future somehow? What if it is used to screen for more serious diseases that might cause discrimination in the newborn's future?
ReplyDeleteSocial issues: A social issue is the spread of fear amongst the parents as well as the spread of misinformation about the newborn screenings. The screenings are essential and important to having a healthy newborn. If fear and misinformation spread among the parents, it may cause harm to the successful program.
Legal issues: The legal issue here is whether or not informed consent is obtained from the parents before further testing on the DNA is done beyond the screening for diseases. In addition, informed consent should be obtained if the samples are to be stored. Finally, confidentiality should be maintained for all blood samples stored so that the information cannot be used against the newborn that the sample originally came from.
I believe that the Scottish government should destroy the newborn blood samples that are currently stored in order to regain public trust. Newborn screening is essential within the first 48 hours of a baby's life so it is important to keep the program running. Informed consent should be obtained from the parents in the future to determine whether or not they will be okay with the blood samples being stored. The parents should have a choice in deciding whether or not the blood samples will be stored after screenings are done. In addition, they should decide what experiments can be done on the blood samples and remove any identifiers after screening for diseases is completed. In this way, the parents will feel informed and confidentiality will be maintained.
I agree with what seems like most of the students are saying; that Scotland should not shut down their newborn screening program. It definitely would be a shame considering the huge opportunities such a program holds in disease detection and early intervention.
ReplyDeleteAnd I completely agree with Gina P.'s comment that the real problem people are worried about their DNA being in the hands of the government, is that they do not fully understand or are informed of how the program operates and what exactly they do. This is where the social issues lie in the "Ethical, Legal, and Social Implication of Genomics." People seem to be misunderstanding the purpose of the program and are only thinking of how their DNA or their child's DNA can be "misused." I think they are forgetting the fact such a program exists to save lives by detecting potential diseases at an early stage. If society is able to understand that more and and look at how much the positives outweigh the 'negatives', people will be more willing to keep the program.
However, looking at it from the ethical, legal, social implication standpoint, the parents' should be given consent and given more information on what happens with the DNA afterwards and about the government keeping their genetic information because in the end, it is someone's personal genetic information and they should have the right to give that consent.
Moving forward, storage of newborn screening tests and use of those tests for medical research should come from informed consent. It is unethical to use their health information without their knowledge. The parents should know where there baby's information is going and how it is going to be used. In these situations, broad consent would seem most appropriate. As long as the Guthrie tests are made unidentifiable, then broad consent would seem ethically and legally sound. The parents should have a broad understanding of how the tests are going to be used in medical research and they should consent to it before the information is used. However, parents should have the option of choosing narrow consent in which they have to sign off on every use of the medical information. Furthermore, there should be a way of not giving consent without losing access to the newborn screening tests.
ReplyDeleteThe article raised the question of potential inappropriate use of the information for law enforcement purposes. I would agree with the article in saying that it is an infringement of civil liberties. There should be protections against this. If the government keeps the cards, then they can only be used for what the consent form says: unidentifiable medical research. However, as stated before, access to these government funded newborn screening tests should not be tied to consent of the storage of and future uses of the tests. They should get the NBS tests regardless of whether or not they consented to the above. Use for medical research should be secondary. In this case, access to government funded health services should not come with lesser legal protections.
If consent was not obtained in the past, then I would not advise the complete destruction of the bloodspot cards, as countries have done, such as Australia, or considered doing, such as Ireland. The solution proposed in the news article seems like the best option - a well-published opt-out system. This system would need to ensure that it is in fact well-published and in such a way as to ensure equal knowledge of the opt-out system across all populations. Without such assurances, disparities could occur among the tests that are either destroyed or kept.
Newborn screening programs and the use of Guthrie cards have had an enormous positive impact on our populations from a public health standpoint. Not only are these screening programs more cost-effective than treatment programs, but they have also saved the lives of millions of children. While I agree that the storage of this genetic information is unethical, I do not think that these screening programs should be discontinued; the positives far outweigh the negatives in this case.
ReplyDeleteThe parents gave narrow consent to the collection of their childrens' genetic informations, not broad consent. Therefore, this information should not have been stored or used for later use. I think that the opt-out program that was discussed in the article is a good idea to cost-effectively respect the rights of those who gave their genetic information, however this still would not respect the rights of the deceased whose genetic information is still on file, and it would be difficult for the opt-out program to be common knowledge to all those affected. I do think that in the future, the genetic information should be destroyed after testing unless parents give explicit consent for its retention.
I do see the value of keeping the Guthrie cards as records from a scientific standpoint. Professor Chan, for example, used old Guthrie cards in her research of TRECs and SCID in newborns. Using the old Guthrie cards was an easy and cost-effective method for getting the data she needed. On the other hand, I also agree with the others before me who have said that the government should not be holding onto genetic information without the parents' consent. I feel that Scotland, the United States, and other countries should be obtaining consent before storing the babies' genetic information. While we do have some protection from the Genetic Information Nondiscrimination Act, it doesn't cover everyone in full. It is much more ethical to ask parents if they consent to having their child's DNA stored. The Government also has the obligation of telling the parents how this information will be used and protected. I feel that as long as parents were aware that their child's DNA was being kept and were told if/how it would be used in the future, it would be beneficial for future researchers to keep those Guthrie cards as records.
ReplyDeleteI am also surprised that the uses for some of the Guthrie cards are being used for non-medical means, such as confirming someone as a criminal. I agree with many of the others above and do not think that this type of use of the Guthrie card is ethical, especially without having obtained the proper consent to do so. However, I do think that Guthrie cards can be useful in obtaining further research on certain diseases and disorders. For example, Professor Chan used them to discover an association with low to zero TRECs in babies with SCID, which was significant and helped us to identify and understand more about SCID. Therefore, I do think that the Guthrie cards are useful in this way but only if physicians have obtained the proper consent. In the situation of Scotland and many other places, the physicians did not obtain the proper consent. They only obtained narrow consent and did not explain that they would be kept and possibly used for future uses nor did they get the consent to use it for future uses. Therefore, future use of the Guthrie cards are only ethical if the parents give fully informed broad consent. This includes complete knowledge and understanding of what is going to be done and can possibly be done with the Guthrie cards and their full acceptance of using the Guthrie cards for these issues. Once having obtained full informed broad consent from the parents, then the Guthrie cards can hopefully be used to obtain further research on certain areas and other beneficial uses.
ReplyDeleteTesting the newborn DNA for diseases is great and a positive action for the well being of the babies. The screening will help the parents and doctors gain information about the likelihood of certain diseases. This helps with early detection in order for early prevention and treatment. I believe this new process is very helpful but there are some legal and ethical issues that we need to understand if we want the screening to continue. The physicians need to inform the parents when they sign the form about where the information of the DNA screening is going to. If it is used for labs and future tests then the physicians need to explain it to the parents. After that, the physicians can use the data only with the permission of the parents. Also if the government wish to keep track of this, it should also have a separate consent form for it as well. Like in the PHG Foundation article, the Guthrie card is used for research by the government only with consent from the patients or their parents or else there will be an outcry from patients complaining that it violates their privacy and their rights. I believe this screening is too valuable and helpful to discontinue due to ethical debates. I believe there will be more good that comes out of it if we continue to do this screening to newborns as long as we answer the ethical and legal issues. The most important thing is to inform the patients and have them sign consent forms for both research use and government use. The government should also be understanding that not every patient wants to give away their information and should not force the patients to do so. This way we can continue to use DNA screening without fear of privacy.
ReplyDeleteI understand why Scotland would destroy their old Guthrie cards and old records; however, I think it is a mistake to scrap the entirety of the project. Guthrie cards and newborn DNA is an invaluable resource for future research. In my past internships, I have worked on recruiting for newborn studies. Given that newborns are very fragile, many parents are unwilling to sign up their children out of fear of harm for the child or inconvenience. Consenting the parents at the time of DNA collection eliminates both the fear of harm, as the DNA will be tested anyway, and is extremely convenient for both researchers and parents. I think that everyone else has more than adequately addressed the importance of further newborn screening research, so I'd like to address the efficiency and practicality of consenting parents for the collection and future use of their child's DNA. If a study requires only mass blood samples, it could spend excess amounts of its budget recruiting and sticking subjects. Collecting DNA of newborns is not only good for future research purposes, but also for cost effectiveness of research. It allows for the saving of time and funds from recruitment such that those savings could be given to other studies that might have otherwise not been possible because of lack of funds.
ReplyDeleteI believe that Scotland and other nations should not destroy Guthrie cards because so much information can be learned with them. With the help of Guthrie cards, research can be advanced. It will help researchers develop effective screening tests, discover genetic mutations, etc. I don't see the wrong in storing Guthrie cards for future research purposes. I believe it is moral, as long as researchers respect patient privacy and don't publish or reveal identifying information. However, I learned in class that in the US when mother's sign and consent to newborn screening they are consenting to be enrolled in future studies. Unfortunately, mothers may not read the fine print therefore, physicians should properly let their patients know what they are signing. Scotland should not shut down the NBS program because research shows that NBS is cost effective and saves lives. NBS allows for early detection and early treatment which is beneficial.
ReplyDeleteI think it would be terrible if Scotland discontinued the standard newborn screening. If newborns are screened for a number of diseases and something is detected early, the babies could possibly live a much healthier life than they would if the disease was not detected at such an early stage. For example, in class we talked about the origin of newborn screening and how that child could have been prevented from having a disability if his PKU disorder was detected at birth, because he could have been given an alternative to breast milk. I think that example alone is enough evidence to support newborn screening, and I'm sure there are many, many examples like that.
ReplyDeleteHowever, I do think that parents should be made aware and informed if their child's Guthrie card is to be kept and possibly used for future studies. Although the parents may have signed for the screening, it is not exactly informed consent if that is only in the fine print. I think that physicians should educate the parents on what will happen with the Guthrie cards and why it will be so beneficial to science and future studies, so that the Guthrie cards don't have to be destroyed, but it would also be more ethical.
My recommendation is to continue with the Guthrie cards and newborn screenings until some legislature contemplates the issue further because their benefits seem to far outweight any ethical wrong-doing in my eyes. To me, it does not seem like a pertinent risk to my privacy or wellbeing to have a hospital store my genetic information. We cannot order the discontinence of this testing because of speculation about the government possibly infringing our civil liberties; that’s an assumption and it does us no good to assume the worst. I agree with Tess that Scotland would fare well to initiate a protocol where families are asked for consent before their newborns are tested and accompanying the test is a required information briefing. This should be done with a doctor who explains the possible benefits, risks and other relevant information a parent should expect to help them make an informed decision.
ReplyDeleteIs it true that once blood samples are collected they are in the hands of the government? I don’t see the big deal—We are who we are and though our genome can be altered by epigenomic factors, our DNA largely defines who we are by effecting our general functioning and health throughout our lifespan; there’s no lying or hiding about whether our DNA truly belongs to us or not. The S in ELSI represents the social concerns, which I feel is the biggest issue with this scenario. If the government breaks no laws, and say they use the DNA of your child for research that will eventually help million upon millions of people, it seems to me like the social idea of lying comes into play. The social dilemma could be having researchers as well as friends and family find out about a genetic condition that you may have necessarily wanted to keep a secret about. The cultural perceptions of disease in America could be a huge road block in the expansion of this field and the continuation of life-saving testing.
I believe that the Guthrie cards are a valuable tool for future research and should not be destroyed. Though I understand the concern with government archival of genetic material from newborns through these cards, I think that a system could be constructed by which to remove identifiers and/or obtain consent for future samples. In this way, identities could be protected and/or permission could be obtained to ensure approval for future use. This could help solve the ethical aspect of this issue, as removing identifiers could potentially allow for the use of samples in the future when it is not possible to obtain permission; and new samples could be obtained and used in the future if parents provide consent. The real challenge will be to tackle the social side of this issue, as many people still hold a negative stigma when it comes to genetic testing and the storage of genetic material for future use. I believe that with time, people could really see the benefit of genetic testing and how useful it is to have genetic samples that are stored for future research, as more clinical solutions are reached through research. However, we are still not at the point where genetic research has been fully integrated into a clinical setting, therefore, the general public holds anxieties over such intimate information and the unknown that surrounds its research.
ReplyDeleteThe origin and use of Guthrie cards are very important in decreasing both infant mortality and genetic disorders that would otherwise plague unsuspecting newborns. Guthrie card screening is vital for the detection of disease. The use of Guthrie cards should be used solely for diagnostic purposes. Instead of destroying the cards after they have been screened, the government should de-identify them, as a way of preventing any unethical use of a person's genetic information.
ReplyDeleteNewborn screening provides a host of ethical legal and social issues. From the day a child is born, the government seemingly has a hold of their DNA. But, this is better then the alternative of the child suffering from a curable disease.
My suggestion would be to keep the Guthrie cards in a system that only allows certain people access to the actual patient name. After screening, the cards can be used for further research, but not tied to the infant from whom the sample was taken. Police authorities should not be allowed access to the identifiers. The only reason the patient names would be kept on file would be as a record in case something is later discovered to be unusual with the sample, and the patient ought to be notified.
While reading the article about Scotland, there were two main points that came to mind. First off, Guthrie cards have been extremely successful in achieving early diagnosis for many children and in turn saving their lives. One of the ways that we were able to confirm tests was through using stored Guthrie cards. For example, in the midst of developing a SCIDS test, reverting to Guthrie cards of 18 infants who died help confirm a successful test. Looking at TREC levels gives an indication of whether or not infants are developing T cells. Looking back to those children s cards and observing that they all have a TREC count of 0 confirmed this life saving treatment which can now continue to save lives as time goes by.
ReplyDeleteSomething that I would like to look more into would be the current genetic laws in Scotland. Is there something equivalent to GINA there? I think bringing in the law addresses a subject I hadn't quite thought about before. I think that if the people of Scotland are more worried about those cards being used for forensic use, perhaps public health officials should recommend a law that protects those cards from being used without consent or for uses other than gaining genetic knowledge. It is crucial to keep those cards so as time goes on, if any new tests need confirmation, they can quickly look back to those children and efficiently find what they are looking for.
Therefore, I think it is in Scotland's best interest to continue newborn screening as well as storing the old samples. However, there are many steps they need to take before they will have the full support of the public. Introducing laws such as GINA and others more specific to use of stored newborn screening cards will help the public realize that the intent of public health officials is truly in saving their children and looking forward to create and better current screens. The community needs to be educated on the actual uses for them to understand and support this change. Therefore, instead of stopping these efforts to appease the public, they should defend themselves, explain the main purposes and reasons for what they're doing, and ask the public for their help and support with newborn screening.
I believe the existence of newborn screening for various genetic conditions is something people should be grateful for. This technology is a powerful tool for diagnosing and understanding disease. Without them, screening for diseases at such an early stage in life would not be possible. The use of Guthrie Cards has the potential to become a concern when they are used for other purposes, such as research, without parental consent. An article from back in August of 2012, titled “Archived blood spots could be epigenetic jackpot”, states that in Minnesota this issue has already been taken to the Supreme Court. The final ruling was the genetic information cannot be used for research or stored without consent from the parents. I think this is the best way to protect privacy and should be adopted across all states. As with any other research study, consent is required and I don’t think this situation is any different. I recommend that there should be universal guidelines for the storage and possible later use of the cards. Perhaps samples could be stored for a certain amount of time, allowing for the possibility to be used in research and then later destroyed to protect patient privacy. However, I do believe that parents should have the option to deny researchers to use their newborn’s screening results for research purposes if they so wish.
ReplyDeleteSource: http://www.nature.com/news/archived-blood-spots-could-be-epigenetic-jackpot-1.11258
While I am not shocked that people are concerned with the government having certain knowledge about their genes, I am shocked that the concern has been taken to such extreme measures - as far as having the government destroy all records. A Guthrie card is only a screening measure to detect for any diseases in newborns. Society only benefits from Guthrie cards. I think that if there were some sort of law or an understanding that these results would not be used against the person later in life. I think people are concerned that something taken from them without their own consent (since they were infants) will be used later on in life to deny them healthcare, prevent them from getting jobs, etc. The government should clearly state their intentions with the Guthrie cards once the infants know which diseases they do and do not have. This would ease the nerves of the public and we would not need to get rid of the records. I think these records will prove useful in the future, perhaps the distant future for reasons we don't yet know about, and it would be tragic to destroy all of these records now.
ReplyDeleteAfter reading the article about newborn screening in Scotland, what I immediately took away was there appears to be a lack of education and understanding for both the public and the government. Consideration and application of ELSI (ethical, legal, social implications) would be greatly beneficial in coming to a decision on what to do with these millions of Guthrie cards. From an ethical standpoint, the public and government need to make clear that no discrimination or moral hazard would be present if these Guthrie cards were to be used in the future. However, there is the legal issue of consent on future use of the Guthrie cards, since this was not collected from the parents. In my opinion, using very old cards do not seem to impose any sort of discrimination or moral hazards. From an both of these considerations, if these cards are saved, I believe it would be alright to use them in later research once these cards have reached a certain age. Social implications, how people perceive this genetic information from Guthrie cards will be used, need to be changed and put in a different light. These people need to see how many great things could come from the future use of these Guthrie cards, as shown through SCID and the newborn screening that has been developed from research with Guthrie cards. If the people of Scotland set laws and limitations and change social perception, putting future use of Guthrie cards in a positive light, then maybe the cards can be saved. However, if this isn't done, not only will the public not want to save these Guthrie cards, but also maybe they shouldn't since proper laws, limitations, and protection isn't in place.
ReplyDeleteThe situation in Scotland and other countries creates quite a dilemma. I don't think that the government should keep identifiers on cards that parents did not give permission to keep. However, I don't think that all that information should be destroyed because it could be so helpful in the future. I think it should definitely be illegal for the government to use your genetic information against you (even if you have committed a crime) if you have not given them permission to do so. The best situation I think would be to de-identify all the records before 2003 when Scotland began asking for informed consent so that those records will not be tied back to someone who did not give them permission to do so.
ReplyDeleteI completely understand people's worry, I think it is odd that the government only so recently began asking for consent to use or keep the cards. I think the fact that the cards had not required informed consent before hand poses a huge ethical issue and creates social problems like mistrust in the government and the use of the cards.
I do not think that a blood sample taken as a baby should not be used later in life to be used as evidence against you to prove you committed a crime if your parents had not given permission for that sample to be used in the future. Genetic information is often very hyped up by the media but eve without that hype, I think that information should be treated with extreme care and not be used without permission.
I hope that Scotland and other countries are not forced into destroying all the previous important genetic information that can be studied but I think if countries have not de-identified the cards they definitely should so that people's rights are protected. Hopefully a better understanding of genetic information and the use of those cards among the general public will be possible so that the public does not worry unnecessarily if the right precautions to protect people's identities are in place.
This doesn't quite fit into the four blog criteria for credit but nonetheless, it was something I wanted to discuss. I was thinking about the first Wilson & Jungner criteria that we had discussed in class "the condition is an important health problem". In class, we broadly defined a disease eligible for screening as important if it had high incidence in the population. Still, I think that the definition can be expanded. Of course, incidence is very important because if many individuals have it, the disease has developed into a pressing issue in society. However, I think our definition should expanded to not only include penetrance but heritability or "a potential to spread through society".
ReplyDeleteMy logic based on “why” individuals are screened for Huntington’s Disease. As some of you may know, Huntington’s Disease is a neurodegenerative disease that is caused by a dominant allele and almost fully penetrant in individuals who possess that particular diseased allele. The clinical onset of disease occurs later in life( between 40 and 50 years) meaning individuals are ignorant of the potential of passing on a debilitating disease to their offspring and thus, spreading it throughout the population. Thus, genetic screening has become available to so that those who have the potential to pass on Huntington’s into the population may make informed decisions on whether or not they should have children. If screening was not readily available for the disease, then it could very well spread to more of the population generation after generation. In my opinion, that makes the disease “important” enough to provide testing and that our description of importance should be modified to encompass the potential spread of diseases such as Huntington’s Disease.
Being born in Vietnam, I was not familiar with Guthrie cards and their usage. Newborn screening is considered a costly procedure. Unlike Scotland, the concern lies more on the financial side than ethical, legal, and social issues. Furthermore, the current conditions of medical facilities in Vietnam cannot accommodate for this technology.
ReplyDeleteWhat really struck me about this article was how ethical, legal, and social issues outweighed the benefits of archived newborn screening blood samples. In my opinion, the program should not be completely shut down but rather regulated more strictly to assure that these blood samples are only used for research purposes. Additionally, there must always be broad informed consent from the parents before any blood sample is taken from their babies.
After reading this article, I can see that Scotland, much like Vietnam, is underestimating the possibilities that newborn screening programs can yield regarding treatment for metabolic and genetic diseases.
That's really interest! In Vietnam do they do newborn screening at all? Or is it up to parents whether or not they want their children to be screened? I wonder what the affect of survival rates/disease prevalence are comparatively. It would be really interesting to discuss in class the differences in country policy and the health outcome!
DeleteI agree with many of the posts above saying that genetic screening for newborns definitely has it's benefits. By shutting down the newborn screening program in Scotland, I believe that there would be a variety of negative impacts as a result. I think that it is very important to get have your newborn be screened for a variety of diseases, despite the fact that they may be rare, it provides a sense of relief to their parents that their child will be born healthy and disease free. If Scotland were to abolish this program, I believe that a lot of paranoia would arise which could potentially take away from the wonderful experience of parenthood. Newborn screening also provides parents and physicians with information regarding whether said newborn may be a carrier of any of the diseases that they have been screened for. This knowledge can not only benefit the future of that individual newborn, but can also be extended to other individuals within the community. I think newborn screening provides parents and physicians with too much useful information that if it were to be taken away, there would be a lot of negative consequences as a result.
ReplyDeleteIt is rather unfortunate that Scotland is actually considering the destruction of these newborn screening records. To do so like Western Australia would be taking a step back in the progress of public health. When these blood samples are taken in the first place, they are taken with good intentions -to prevent or alleviate as soon as possible any congenital diseases or disorders. Thus, these Guthrie cards were never meant to be used to incriminate or discriminate against the people. Nonetheless, the people who are protesting against newborn screening do have a case as seen with the following implications.
ReplyDeleteAs far as ethical issues go, the retention of the cards beg the question of what is the true purpose of keeping these cards? If I was already screened at birth and deemed to be free of the diseases screened for, then why should these health institutions still be allowed to store my information?
Legally-speaking, it is seen that the process for consenting of the retention of the cards was only instituted in 2003, therefore implying that those participants before never agreed to the indefinite storage of their children's bio-information. Thus, the NBS program in Scotland is lacking the technical rights to this information considering that that permission was never granted from those before 2003.
Finally, the social implications are that the general public is at a lack of trust for this program. In Western Australia, the records were obliterated because local police authorities sought the use of these records to assist them in their criminal investigations. The people of Scotland are uneasy with the concerns of not knowing exactly what these cards can and will be used for in the future.
I would recommend that the first priority of business be to earn back the public trust. The only way to do this is to inform participants of the exact clauses and extents to which their information will be used. Once this assurance is granted, Scotland can then establish an opt-out clause for those who still do not want to have their samples stored any longer. To minimize the opting out, Scottish Health Officials can remind the public of the true purpose of retention and the many benefits that go along with the Newborn Screening Program and maintaining health data.
I found it extremely shocking that the Minnesota Department of Health was even considering the option of destroying stored newborn bloodspot samples, and I do not think it to be in the best interest of Scotland to follow this. The samples from the Guthrie cards are used to screen for extremely serious diseases in newborn babies, both congenital and later-onset illnesses. Without this knowledge there would be limited ways of knowing when to start early prevention programs for certain life-threatening diseases. This could possibly be from the lack of education on what Guthrie cards actually are in these areas and how they help to screen for the risk of very serious illnesses and diseases. I believe that a good action step to take going forward would be to implement parental consent for retention of these samples and to provide explicit information on how Guthrie cards will positively affect the lives of their children.
ReplyDeleteI think it would be unwise of Scotland to destroy the bloodspot cards prior to the time informed consent was introduced, even if other major countries like Australia have. The benefits of screening via Guthrie cards are too important for the whole system to be abandoned. However for the future, the government should aim to get true informed consent from parents. Parents should be able to choose narrow or broad consent and have a true understanding of the implications that it could have for their child.
ReplyDeleteAs for the Scottish bloodspots that are from a time before informed consent was introduced I think the easiest solution would be to burn them, BUT I don't think this is the right decision. With 50 years worth of bloodspots scientists can draw from a lot of evidence and perform research that will surely show strong correlations. If researchers are limited to a smaller sample of cards (those with consent), their conclusions are weaker. There are many benefits to keeping the cards. The best solution for Scotland is to assume that all bloodspots before the implementation of informed consent have given narrow consent (for the use of screening for disease in the first week of life), unless informed otherwise. This ensures that the bloodspots won't be used in any way not approved by the parents. If an agency is interested in the sample they must contact the parents. This way the Scottish government won't have to seek consent themselves for all the older samples; however they should monitor that the researchers or police who are interested in certain samples receive informed consent before they can use the bloodspots.
I believe newborn screenings are essential. Because of this process, the lives of millions of children have been spared from diseases and genetic conditions that could affect them later on life for the very worse. A bias definitely exists in this situation because the majority of the population don't realize that these systems and tests, such as Guthrie cards, have more benefits than do more harm. These people have been lead to believe that the government is trying to take control of everything personal, such as the DNA of a person, but don't realize that in this case, it is for the people's benefit. However, I disagree that Scottish government did not inform parents that they were keeping records and samples of the DNA. Although the government means well, they do not have the right to keep something without their permission. I understand that in the long-run that the keeping of the samples will be beneficial for future research purposes that may indeed one day lead to a cure or solution for an existing disease that the people of today are trying to combat, but again, they did not receive the consent from the parents. Destroying all 2.5 million cards in Scotland is not the way to go however. The government should strive to reach out to the parents (and children now since many of them have become adults) and still ask for their permission and still go for an opt-out system.
ReplyDeleteI believe that newborn genetic screening is something that should be a part of a newborn’s checkup routine. Like many of my classmates, I see that genetic testing is a breakthrough in medicine and could be used to benefit a child’s life. Although many of the diseases that the genetic tests are screening for are rare, it could potentially be life changing to know if the child is positive or not. I think the problem in Scotland and with parents in genera; is that they don’t fully understand the reasons for genetic testing. I personally don’t have a problem with knowing that the government has a newborns genetic info. If the parents were signing broad consent forms that state that all of the information will be confidential and not linked to the patients name or the family, then I would just see that as the government using genetic information for medical advances.
ReplyDeleteTo reply to Patrick’s very interesting article, the Newborn Screening Saves Lives Reauthorization Act is something that will help parents better understand the use of genetic screenings. This article gives an example of how genetic screenings need to be improved and can be so incredibly helpful for a newborn. This may be something that Scotland considers because if their program is shut down, they may not be able to help kids like in this article. The most important lesson we learn from this is that the general public and more importantly, parents, should be well educated about the impotents of genetic testing.
Many people have expressed the same sentiments I feel about this issue. While the screening program in Scotland has been highly effective, it has also violated informed consent. I believe that the Guthrie cards should continue to be stored if they've already been stored. If the cards are going to be used for purposes other than screening for disease, then informed consent should be obtained from the parent of the child.
ReplyDeleteAs Petra mentioned in her comment, while other countries such as Australia have burned their Guthrie cards, this is not the best idea, as it is a large database of information that could be used for the benefit of society. She suggests that a good solution is to assume narrow consent and then obtain broad consent for future research. I agree with this, but I think it is also key to write laws specifying what Guthrie cards can be sued for, in order to avoid situations such as law enforcement using bloodspot cards as forensic evidence.
Although improvements can be made to specifying the use of Guthrie cards if they are stored, I think that Scotland is on a good path. As the article mentions, in 2003 Scotland has been requesting informed consent for Guthrie card screening. Informed consent is key to ensuring that ethical standards are met.
During this week's discussion of newborn screening, I found it somewhat alarming that as a public health initiative in identifying diseases, still not many states have states screen for the PKU disorder. It's also somewhat suspect that screening tests vary state to state. It is understandable that obviously some states have higher incidence rates, but I think they should all be more standardized. In all aspects of health care, screening tests are not only likely indicators of disease, but they are by far the most cost effective and (possibly) life saving form of secondary prevention. In this sense, screening newborns for diseases certainly be more cost effective than the cost of care that infants may require for the duration of their lives. I never really considered how amazing this topic was!
ReplyDeleteI found thais article from the "Gene Watch Page" which is very relevant to our discussions on this blogpost:
ReplyDeletehttp://www.councilforresponsiblegenetics.org/genewatch/GeneWatchPage.aspx?pageId=322&archive=yes
I tried to post it last Tuesday but I can't seem to find my comment in the above!
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ReplyDeleteBoth of these articles give me great insight on obesity and the causes of it. The United State is one of the leading nation in obesity in all age groups and it is important to look at this in a different angle because the number of people who are obese are increasing each year.
ReplyDeleteI agree with the article “Obesity Is Found to Gain Its Hold in Earliest Years” that it is important to start from the kindergarteners. Kids these days rarely play outside anymore now that they have cell phones, Ipads, and the internet. It seems like children spend most of their time indoors using those devices. The kindergarten children should have more time spent doing outdoor activities and promote their interest in sports or just the initiative of going outside. This way they will want to play outside more and not want to spend all day inside. Also, another outlook is that school lunch in schools are not the healthiest. Perhaps the school and the board of education and can provide a much healthier alternative for all grade levels.
Although early action from young age can help prevent obesity, I think that the parents, especially the mother, have the largest factor in preventing obesity in children. We do know that genes can cause obesity and especially while the mother is pregnant, what she eats and her lifestyle can greatly affect the baby. Therefore, it is necessary to spread the word to pregnant women and everyone to let them be aware of what they eat. This way it can prevent more people from being obese genetically. Once they are born, it is also up to the parents to teach them to continue on a healthy lifestyle.