To read the article in its original form, go here.
19 October 2009 (BioNews 530)
By Antony Blackburn-Starza
Maria Bousada, 69, once the world's oldest mother, died in July this year leaving behind two young children born following IVF only two years earlier. Her death reignited the debate surrounding 'older mothers' - or more specifically, post-menopausal women who require fertility treatment to conceive. In response to media attention surrounding Ms Bousada's death, Professor Sammy Lee, an expert in medical ethics, embryology and biomedical sciences based at University College London (UCL) arranged a conference co-sponsored by the Progress Educational Trust entitled '21st Century Motherhood', with the aim to engage the public and stakeholders in rigorous debate. The event took place at UCL on 18 September. What emerged from the day-long discussion directed by informed presentations from an array of experts from scientific, ethical, social, feminist and other academic backgrounds was the 'problem' is both, of course, important to fertility patients and society at large but, as yet, surprisingly under-explored. Media sensationalism aside, what exactly were the objections to Ms Bousada having children beyond the age of 60 and on what grounds were such objections founded?
The issues
Reproductive autonomy versus the best interests of the child
From an ethical perspective, the issue of 'older mothers' creates tension between the principles of the reproductive autonomy of the mother and the best interests of the child, but also the interests of wider society. It is a classic exposition of the clash between neo-liberal attitudes towards private behaviour, facilitated by the rise of the fertility industry to meet the demands of 'consumers', and paternalistic efforts to protect women from their own possibly ill-founded decisions and also to protect the unborn child.
Naomi Pfeffer raised the point first of all when speaking of the woman's right to choose what to do with her body. Surely this is absolutely central to the whole issue - if a woman believes she is fit and healthy to raise a children then why should be prevented from doing so? The problem is that Maria Bousada thought just this, believing that longevity ran in the family, yet was diagnosed with fatal cancer just months before her children were born. It is a trite point but statistically speaking 'older' mothers are more likely to die sooner after giving birth than younger mothers. Commenting on the issue at the time, Josephine Quintavalle of Comment on Reproductive Ethics, summed up the ethical problem: 'Why would a woman want to become a mother at an age when she knows her children are much more likely to be orphaned when they're young?' she asked.
Yet the rights of the women cannot be ignored. The 'right' to bear children is evidenced in Article 16 of the Universal Declaration of Human Rights: 'Men and women of full age, without any limitation due to race, nationality or religion, have the right to marry and to found a family.' Whether rights discourse covers fertility treatment is unclear but for these purposes assuming that it does, the question arises as to at what point is the state permitted to interfere with a woman's right to bear children? The only true principle, I believe, that justifies such a measure, is the best interests of the children which, in other areas of the law such as consent, operates above the decision-making rights of the parents.
Health and wellbeing of mother and child
Practically, the question of safety both for the mother and the unborn children featured prominently in the discussions. First and foremost, children born to 'older mothers' are arguably placed at risk of physical harm during the pregnancy and birth, but also to psychological harm if their mother dies of 'old age' whilst they are still in their infancy. Anna Smajdor of the University of East Anglia pointed out that pregnancy is inherently risky anyway but mothers choose to assume this risk rather than not having children at all. But this inherent risk of pregnancy increases as the mother becomes older and this cannot be ignored when providing IVF to, say, a woman over 60. It is a question of thresholds and where we must draw the line is when the risks to either to mother or child become excessive to make such a pregnancy unadvisable.
Second, there is the problem of 'fertility tourism', whereby residents who are either denied or cannot access fertility treatment in their own countries travel abroad to countries with more permissive regulations. This issue is always relevant when limits to IVF are considered. Such patients are exposed to exploitation and health risks as fertility services in some countries is not regulated as strictly as they are elsewhere. Further, if, for example, a clinic in the UK denies a 65 year old woman IVF on the basis of risks to her and the child's health, despite the fact that a clinic in, say, India, may be willing to perform the service, the risk to mother and baby remain exactly the same. Fertility tourism does not get around the problem but merely allows women to circumvent protectionist rules.
Social attitudes towards 'older mothers'
The conference also touched upon social attitudes towards older mothers. Here, the discussion moved towards changes in social attitudes over the last few decades. Peter Brinsden, Consultant Medical Director at Bourn Hall Clinic, told the audience that in the 1980s mothers were considered 'old' at the age of 40. Today, many women would contest this view and indeed women between the age of 40-44 have a 65 per cent of conceiving naturally. The lifestyle choices of women have also developed over the years with an increasing number choosing to postpone motherhood to pursue a career. Yet the difference between a women who conceives naturally at 40, or for that matter any age, to a women who requires fertility treatment is the crux of the issue here. Fertility technology allows women as old as 70 to successfully conceive - but should they?
There may be in-built sexism in the way society views older parents. Sammy Lee illustrated how the media portray older mothers as being selfish yet they appear to congratulate older fathers. When approaching the issue we must there be mindful that we are not simply expressing prejudice about the woman's role in bringing up a child - if possible, both parents are in it for equal measure.
Conclusion
The conference provided an opportunity to discuss various perspectives and left those attending with no clear answer. Indeed, none was expected. The conference met its purposes to the engage the public in debate and to delineate the approaches to the issue but there is more that needs to be done. From a regulatory perspective, this concoction of various issues invites the question whether IVF is indeed properly regulated at present and whether there should be greater regulation of the provision of IVF for older mothers, either in guideline or legislative form.
The central question that emerged was when is it legitimate to interfere with the reproductive rights of the woman and on what grounds such an intervention should be justified. Introducing the debate, Professor Lord Robert Winston stressed that the medical profession should not interfere with what is essentially a personal decision for the woman. Analogies to abortion may be drawn here, which remains in the hands of doctors, in theory at least.
Yet I do not feel that the decision to have a child is solely the mother's decision and the best interests of that child should always be paramount. Guidelines make it clear that the primary factor to be considered when providing fertility treatment to older mothers is the wellbeing of the child. This includes both physical and psychological risks and I believe where the is a 'real' risk of either materialising then fertility treatment should not be offered. This is essentially a medical question and when we introduce the notion of safety into the decision-making process then it unavoidably medicalises the issue.
Another approach is to withhold fertility treatment on the basis that is does not take away from the mother - nothing lost, nothing gained. If IVF is viewed as a positive intervention dependant on the will of the medical profession (a woman cannot perform IVF alone) then those offered such services as legitimately permitted to deny treatment - as they are today. This merely infringes reproductive autonomy in an indirect manner. Yet such an approach leads to a negative conclusion that fertility treatment is a 'luxury' rather than akin to other medical interventions.
What is clear, however, is that if further regulatory steps are to be introduced, however, it must be done is a sensitive and measured fashion so not to alienate older fertility patients and to not put pressure on patients to seek treatment abroad. The conference has set the scene for further avenues of debate but what is yet to emerge is a clear normative principle to guide it. I feel this can only be the welfare of the child, a principle that should never be curtailed, but then not everyone would readily agree.
RELATED ARTICLES FROM THE BIONEWS ARCHIVE
The problem with 21st Century Motherhood
17 August 2009 - by Dr Sammy Lee
Did the death of Maria Bousada change public attitudes to the modern phenomenon headlined as 'Oldest Mums'? The world's media certainly made hay and the news reverberated for a few days; and it seems likely that the Channel 4 documentary 'the Worlds Oldest Mums' was rescheduled to screen early to catch the media wave which the death generated. The aftermath, though, of this tsunami seems to have largely been relative indifference....[Read More]
World’s oldest IVF mother dies from cancer two years after giving birth
20 July 2009 - by Antony Blackburn-Starza
The world’s oldest mother has died from cancer aged 69. María Carmen del Bousada de Lara, from Spain, gave birth to twins two years ago through IVF. She received fertility treatment in Los Angeles, California, after misleading doctors about her age and gave birth to two boys in Barcelona at the age of 66. It is reported that Ms Bousada paid around £30,000 for treatment at the Pacific Fertility Centre where she told doctors that she was 55 to avoid the clinic’s age limit for treatment. Her...[Read More]
60 year-old woman gives birth to twins in Canada after fertility treatment abroad
16 February 2009 - by Sarah Guy
A 60 year-old woman has sparked controversy in Canada by travelling to India to receive fertility treatment after years of failed attempts to conceive naturally. Ranjit Hayer, originally from India, has become the oldest woman in Canada to give birth after receiving IVF at Dr Anoop Gupta's Delhi fertility clinic; her twin boys were delivered seven weeks prematurely by Caesarean section at the Foothills hospital in Calgary last week....[Read More]
Friday, October 23, 2009
Wednesday, October 21, 2009
Privacy
When 2+2 Equals a Privacy Question
By NATASHA SINGER
Published: October 17, 2009
TIME to revisit the always compelling — and often disconcerting — debate over digital privacy. So, what might your movie picks and your medical records have in common?
How about a potentially false sense of control over who can see your user history?
While Netflix and some health care concerns say they have been able to offer study data to researchers stripped of specific personal details like your name, phone number and e-mail address, in some cases researchers may be able to re-identify you by correlating anonymous information with the digital trail that you’ve left on blogs, chat rooms and Twitter.
Of course, you may be fine with that. On the other hand, you may not want complete strangers rummaging around in your history of movie selections or medical needs.
For example, contestants in Netflix’s competition to improve its recommendation software received a training data set containing the movie preferences of more than 480,000 customers who had, as they say in the trade, been “de-identified.” But as part of a privacy experiment, a pair of computer scientists at the University of Texas at Austin decided to see if it was possible to re-identify those unnamed movie fans.
By comparing the film preferences of some anonymous Netflix customers with personal profiles on imdb.com, the Internet movie database, the researchers said they easily re-identified some people because they had posted their e-mail addresses or other distinguishing information online.
Vitaly Shmatikov, an associate professor of computer science at the University of Texas at Austin and a co-author of the “de-anonymization” study, says the researchers were able to analyze users’ public postings and connect that to their Netflix preferences — including how a person may have rated films with controversial themes. Those are choices a person may or may not want to make public, Mr. Shmatikov said.
Steve Swasey, a Netflix spokesman, disputed the study’s conclusions, saying the customers were not re-identifiable because Netflix had altered the data set before sending it to contestants.
“There is no way with certainty that anyone could link a Netflix member with the data Netflix has disclosed by linking it with any publicly available data,” he said. “The anonymity of the information is comparable to the strictest federal standards for anonymizing personal health information.”
Nevertheless, the Texas researchers say they were indeed able to positively identify Netflix customers, and some privacy advocates say their study raises questions about whether newly strengthened laws governing the security of electronic health records — which contain information on diagnoses and treatments entered by health care providers — may offer incomplete privacy protection. Leaked movie preferences might embarrass or stereotype you, they said. But information extracted from medical records and then linked back to you, they said, has the potential to cause social, professional and financial harm.
“Movie records can be sensitive in some cases; it could be embarrassing for someone to find out I like romantic comedies,” Mr. Shmatikov, the computer scientist, said in a recent phone interview. “But definitely for health records, this is a huge issue.”
And you don’t need records containing a person’s name and address to figure out to whom the records belong, he said, “As our research shows, pretty much any information that distinguishes one person from another can be used to re-identify records.”
The idea of an entirely paperless medical system holds the promise of more efficient and cost-effective care. And, with the incentive of stimulus package money, many companies are rushing to sell clinical information systems to streamline services like patient scheduling, sample tracking, and billing at hospitals and clinics.
In some cases, the same companies that sell data management systems to hospitals and physicians also store that information and then repackage it to make money on other services.
The clinical information systems market in the United States has sales of $8 billion to $10 billion annually, and about 5 percent of that comes from data and analysis, according to estimates by George Hill, an analyst at Leerink Swann, a health care investment bank.
But by 2020, when a vast majority of American health providers are expected to have electronic health systems, the data mining component alone could generate sales of up to $5 billion, Mr. Hill said. Demand for the data is likely to be robust. Policy makers and hospitals will want to dig into it to analyze physician practices and glean information about patient health trends.
Big players like the Cerner Corporation, which maintains electronic health systems for 8,000 clients, including large hospitals and retail clinics, and smaller players like Practice Fusion, which offers its Web-based health record systems free to health care providers, say they make use of patient data collected from their clients.
A spokeswoman for Cerner, whose Web site promotes its “data mining of our vast warehouse of electronic health records,” said the company shares de-identified patient data with researchers or drug companies looking for patients to participate in clinical trials. The patient records are “double scrubbed,” she said, explaining that the company removes personal data like names and addresses before it runs a search using a numbered code for each patient.
Other sensitive information, like mental health records, might be removed before the patient data is sent out, she said.
The Web site of Practice Fusion, meanwhile, quotes Ryan Howard, the chief executive, as saying that the company subsidizes its free record-keeping systems by selling de-identified data to insurance groups, clinical researchers and pharmaceutical companies. In an interview, however, Mr. Howard said Practice Fusion had not yet started selling patient information but that it intended to do so.
NEW regulations require notifying patients if their personally identifiable medical information gets loose, and they prohibit selling protected health records. But privacy advocates said electronic health records remain vulnerable because no federal law now forbids the sale of de-identified health care data.
In 1997, for example, a researcher identified the medical records of William Weld, then the governor of Massachusetts, by correlating birthdays, ZIP codes and gender in voter registration rolls and information published by the state’s government insurance commission.
There are no current federal laws against re-identification, said Dr. Deborah Peel, a psychiatrist who is a director of Patient Privacy Rights, a nonprofit watchdog group in Austin, Tex.
“Once personal health data gets out there, it’s like the Paris Hilton sex tape,” Dr. Peel said. “It is going to be out there forever.”
By NATASHA SINGER
Published: October 17, 2009
TIME to revisit the always compelling — and often disconcerting — debate over digital privacy. So, what might your movie picks and your medical records have in common?
How about a potentially false sense of control over who can see your user history?
While Netflix and some health care concerns say they have been able to offer study data to researchers stripped of specific personal details like your name, phone number and e-mail address, in some cases researchers may be able to re-identify you by correlating anonymous information with the digital trail that you’ve left on blogs, chat rooms and Twitter.
Of course, you may be fine with that. On the other hand, you may not want complete strangers rummaging around in your history of movie selections or medical needs.
For example, contestants in Netflix’s competition to improve its recommendation software received a training data set containing the movie preferences of more than 480,000 customers who had, as they say in the trade, been “de-identified.” But as part of a privacy experiment, a pair of computer scientists at the University of Texas at Austin decided to see if it was possible to re-identify those unnamed movie fans.
By comparing the film preferences of some anonymous Netflix customers with personal profiles on imdb.com, the Internet movie database, the researchers said they easily re-identified some people because they had posted their e-mail addresses or other distinguishing information online.
Vitaly Shmatikov, an associate professor of computer science at the University of Texas at Austin and a co-author of the “de-anonymization” study, says the researchers were able to analyze users’ public postings and connect that to their Netflix preferences — including how a person may have rated films with controversial themes. Those are choices a person may or may not want to make public, Mr. Shmatikov said.
Steve Swasey, a Netflix spokesman, disputed the study’s conclusions, saying the customers were not re-identifiable because Netflix had altered the data set before sending it to contestants.
“There is no way with certainty that anyone could link a Netflix member with the data Netflix has disclosed by linking it with any publicly available data,” he said. “The anonymity of the information is comparable to the strictest federal standards for anonymizing personal health information.”
Nevertheless, the Texas researchers say they were indeed able to positively identify Netflix customers, and some privacy advocates say their study raises questions about whether newly strengthened laws governing the security of electronic health records — which contain information on diagnoses and treatments entered by health care providers — may offer incomplete privacy protection. Leaked movie preferences might embarrass or stereotype you, they said. But information extracted from medical records and then linked back to you, they said, has the potential to cause social, professional and financial harm.
“Movie records can be sensitive in some cases; it could be embarrassing for someone to find out I like romantic comedies,” Mr. Shmatikov, the computer scientist, said in a recent phone interview. “But definitely for health records, this is a huge issue.”
And you don’t need records containing a person’s name and address to figure out to whom the records belong, he said, “As our research shows, pretty much any information that distinguishes one person from another can be used to re-identify records.”
The idea of an entirely paperless medical system holds the promise of more efficient and cost-effective care. And, with the incentive of stimulus package money, many companies are rushing to sell clinical information systems to streamline services like patient scheduling, sample tracking, and billing at hospitals and clinics.
In some cases, the same companies that sell data management systems to hospitals and physicians also store that information and then repackage it to make money on other services.
The clinical information systems market in the United States has sales of $8 billion to $10 billion annually, and about 5 percent of that comes from data and analysis, according to estimates by George Hill, an analyst at Leerink Swann, a health care investment bank.
But by 2020, when a vast majority of American health providers are expected to have electronic health systems, the data mining component alone could generate sales of up to $5 billion, Mr. Hill said. Demand for the data is likely to be robust. Policy makers and hospitals will want to dig into it to analyze physician practices and glean information about patient health trends.
Big players like the Cerner Corporation, which maintains electronic health systems for 8,000 clients, including large hospitals and retail clinics, and smaller players like Practice Fusion, which offers its Web-based health record systems free to health care providers, say they make use of patient data collected from their clients.
A spokeswoman for Cerner, whose Web site promotes its “data mining of our vast warehouse of electronic health records,” said the company shares de-identified patient data with researchers or drug companies looking for patients to participate in clinical trials. The patient records are “double scrubbed,” she said, explaining that the company removes personal data like names and addresses before it runs a search using a numbered code for each patient.
Other sensitive information, like mental health records, might be removed before the patient data is sent out, she said.
The Web site of Practice Fusion, meanwhile, quotes Ryan Howard, the chief executive, as saying that the company subsidizes its free record-keeping systems by selling de-identified data to insurance groups, clinical researchers and pharmaceutical companies. In an interview, however, Mr. Howard said Practice Fusion had not yet started selling patient information but that it intended to do so.
NEW regulations require notifying patients if their personally identifiable medical information gets loose, and they prohibit selling protected health records. But privacy advocates said electronic health records remain vulnerable because no federal law now forbids the sale of de-identified health care data.
In 1997, for example, a researcher identified the medical records of William Weld, then the governor of Massachusetts, by correlating birthdays, ZIP codes and gender in voter registration rolls and information published by the state’s government insurance commission.
There are no current federal laws against re-identification, said Dr. Deborah Peel, a psychiatrist who is a director of Patient Privacy Rights, a nonprofit watchdog group in Austin, Tex.
“Once personal health data gets out there, it’s like the Paris Hilton sex tape,” Dr. Peel said. “It is going to be out there forever.”
Sunday, October 18, 2009
NIH Human Participant Protection Training
Here is the link to the NIH Human Participant Protection Training. We will talk about this assignment in class on Thursday, October 15. Please be prepared to write a 2-page analysis/critique of the program by early next week (probably Tuesday, October 27). You can find the training program here. You will need to register before you can take the training session.
The guidelines for your brief critique (critical analysis) of the training are:
- Keep the length to no more than 1 typed page.
1. make a claim about training and explain what this issue is and why it is important.
2. what are the implications for researchers given your claim?
3. what are the implications for human subjects given your claim?
4. what are the implications for research in general and its benefit to the public?
5. add a conclusion- short- that reinforces or at least summarizes your point.
The guidelines for your brief critique (critical analysis) of the training are:
- Keep the length to no more than 1 typed page.
1. make a claim about training and explain what this issue is and why it is important.
2. what are the implications for researchers given your claim?
3. what are the implications for human subjects given your claim?
4. what are the implications for research in general and its benefit to the public?
5. add a conclusion- short- that reinforces or at least summarizes your point.
Friday, October 16, 2009
Biobanking Newborn Screens
Please feel free to comment on the following two issues:
A lack of standardized consent policies, for example, is a concern for researchers seeking to use genetic information from these samples in genome-wide association studies and other research.
There also is no universal definition of specimen ownership once the screening process is complete, and there is a lack of public awareness about newborn screening,
HHS to Weigh Blood Spot Screening Storage Issues
August 26, 2009
By Matt Jones
NEW YORK (GenomeWeb News) – The Department of Health and Human Services plans to review the practices and policies surrounding the use and storage of dried newborn blood spots after screenings in biobanks, and a new white paper will frame the issues that HHS will consider.
The new paper, commissioned by the Advisory Committee on Heritable Disorders in Newborns and Children, will recommend that the federal government provide funding and administrative support for several aspects of dried blood spot storage and screening. It also will recommend that parent or patient consent should be obtained for certain uses, and it advises their accessibility and their dispersion should be controlled.
An executive summary is now available outlining the paper's recommendations.
The white paper was drafted by Bradford Therrell, who is director of the National Newborn Screening and Genetics Resource Center (NNSGRC) and a professor of pediatrics at the University of Texas Health Science Center at San Antonio, and Harry Hannon, who is emeritus branch chief of the Newborn Screening Branch at the Division of Laboratory Sciences, US Centers for Disease Control and Prevention.
In a summary of the white paper, which Therrell and Hannon presented in a conference call today that was hosted by Genetic Alliance, the authors outlined seven recommendations they will deliver to ACHDNC, which will then develop policy recommendations for HHS Secretary Kathleen Sebelius.
Therrell today said that how HHS should propose dealing with the increase in genetic testing on newborns and the potential for genome scans being conducted on newborns "will be good questions" for ACHDNC to answer as it develops specific policies. Hannon agreed, adding that "privacy and confidentiality are going to be big points" that the committee is expected to discuss.
Newborn spot samples "have the potential to generate population-based knowledge that can improve the health of children, support families, and provide information critical to understanding the antecedents of adult diseases," the authors noted. But, they argued, residual storage of these specimens must be done in a way that will assure that the confidentiality and privacy of families is respected and that the specimens are protected.
"Policies are needed in each state to promote public trust, emphasize transparency of administrative practices, and create supporting information that encourages informed public participation," they wrote. Current state laws, while enabling local control and accountability, have created an environment of wide practical variation across the country, according to the authors.
A lack of standardized consent policies, for example, is a concern for researchers seeking to use genetic information from these samples in genome-wide association studies and other research.
There also is no universal definition of specimen ownership once the screening process is complete, and there is a lack of public awareness about newborn screening, the authors intend to tell the committee.
The American College of Medical Genetics, which has advised that all newborns in the US be screened for 29 conditions, recently released a statement that aimed to assuage concerns about the manner in which residual spots are stored and highlighted their importance.
"Residual dried blood spots are vital to effective newborn screening across the United States," Michael S. Watson, executive director of the American College of Medical Genetics, said in a statement issued in May.
"There has been some debate recently whether the residual dried blood spots should be destroyed after screening," ACMG noted. But the group said that these samples are "a valuable national resource that can contribute significantly to the health of our children," and that they "are stored with rigorous control and respect for privacy and confidentiality to protect the public."
Therrell and Hannon plan to provide ACHDNC with seven recommendations:
• All state newborn screening programs should have a legally reviewed and accepted policy addressing the disposition of dried blood specimens remaining after newborn screening testing is completed and the screening results have been validated.
• These screening programs also should have legally reviewed and accepted policies about who may access and use dried blood specimens once they arrive at the state-designated newborn screening lab, including further access after newborn tests are completed.
• All state newborn screening programs should maintain and distribute educationally and culturally appropriate information that includes basic information about how to use these specimens.
• All state newborn screening programs should work to ensure that all women receiving prenatal care are educated about newborn screening.
• If residual blood specimens are to be used for any processes outside of the legally required newborn screening process for which they were obtained, an indication of the parents' awareness and willingness to participate should exist in compliance with federal research requirements.
• Newborn screening programs should assess the utility of any additional consent/dissent process implemented in order to better address issues of storage and use of residual dried blood specimens. The authors argue that the federal government is encouraged to fund such utility projects over the next five years.
• The federal government should provide both funding and administrative support for models of consent and dissent processes on the use of residual specimens in newborn screening; model educational programs for the general public on the importance of newborn screening and the most potential uses of residual specimens to generate population-based knowledge about health and disease; national data on the utility of any additional consent/dissent processes implemented relative to potential research uses of residual newborn screening specimens; and educational materials with facts about potential uses of residual newborn screening specimens for both consumers and prenatal healthcare providers.
A lack of standardized consent policies, for example, is a concern for researchers seeking to use genetic information from these samples in genome-wide association studies and other research.
There also is no universal definition of specimen ownership once the screening process is complete, and there is a lack of public awareness about newborn screening,
HHS to Weigh Blood Spot Screening Storage Issues
August 26, 2009
By Matt Jones
NEW YORK (GenomeWeb News) – The Department of Health and Human Services plans to review the practices and policies surrounding the use and storage of dried newborn blood spots after screenings in biobanks, and a new white paper will frame the issues that HHS will consider.
The new paper, commissioned by the Advisory Committee on Heritable Disorders in Newborns and Children, will recommend that the federal government provide funding and administrative support for several aspects of dried blood spot storage and screening. It also will recommend that parent or patient consent should be obtained for certain uses, and it advises their accessibility and their dispersion should be controlled.
An executive summary is now available outlining the paper's recommendations.
The white paper was drafted by Bradford Therrell, who is director of the National Newborn Screening and Genetics Resource Center (NNSGRC) and a professor of pediatrics at the University of Texas Health Science Center at San Antonio, and Harry Hannon, who is emeritus branch chief of the Newborn Screening Branch at the Division of Laboratory Sciences, US Centers for Disease Control and Prevention.
In a summary of the white paper, which Therrell and Hannon presented in a conference call today that was hosted by Genetic Alliance, the authors outlined seven recommendations they will deliver to ACHDNC, which will then develop policy recommendations for HHS Secretary Kathleen Sebelius.
Therrell today said that how HHS should propose dealing with the increase in genetic testing on newborns and the potential for genome scans being conducted on newborns "will be good questions" for ACHDNC to answer as it develops specific policies. Hannon agreed, adding that "privacy and confidentiality are going to be big points" that the committee is expected to discuss.
Newborn spot samples "have the potential to generate population-based knowledge that can improve the health of children, support families, and provide information critical to understanding the antecedents of adult diseases," the authors noted. But, they argued, residual storage of these specimens must be done in a way that will assure that the confidentiality and privacy of families is respected and that the specimens are protected.
"Policies are needed in each state to promote public trust, emphasize transparency of administrative practices, and create supporting information that encourages informed public participation," they wrote. Current state laws, while enabling local control and accountability, have created an environment of wide practical variation across the country, according to the authors.
A lack of standardized consent policies, for example, is a concern for researchers seeking to use genetic information from these samples in genome-wide association studies and other research.
There also is no universal definition of specimen ownership once the screening process is complete, and there is a lack of public awareness about newborn screening, the authors intend to tell the committee.
The American College of Medical Genetics, which has advised that all newborns in the US be screened for 29 conditions, recently released a statement that aimed to assuage concerns about the manner in which residual spots are stored and highlighted their importance.
"Residual dried blood spots are vital to effective newborn screening across the United States," Michael S. Watson, executive director of the American College of Medical Genetics, said in a statement issued in May.
"There has been some debate recently whether the residual dried blood spots should be destroyed after screening," ACMG noted. But the group said that these samples are "a valuable national resource that can contribute significantly to the health of our children," and that they "are stored with rigorous control and respect for privacy and confidentiality to protect the public."
Therrell and Hannon plan to provide ACHDNC with seven recommendations:
• All state newborn screening programs should have a legally reviewed and accepted policy addressing the disposition of dried blood specimens remaining after newborn screening testing is completed and the screening results have been validated.
• These screening programs also should have legally reviewed and accepted policies about who may access and use dried blood specimens once they arrive at the state-designated newborn screening lab, including further access after newborn tests are completed.
• All state newborn screening programs should maintain and distribute educationally and culturally appropriate information that includes basic information about how to use these specimens.
• All state newborn screening programs should work to ensure that all women receiving prenatal care are educated about newborn screening.
• If residual blood specimens are to be used for any processes outside of the legally required newborn screening process for which they were obtained, an indication of the parents' awareness and willingness to participate should exist in compliance with federal research requirements.
• Newborn screening programs should assess the utility of any additional consent/dissent process implemented in order to better address issues of storage and use of residual dried blood specimens. The authors argue that the federal government is encouraged to fund such utility projects over the next five years.
• The federal government should provide both funding and administrative support for models of consent and dissent processes on the use of residual specimens in newborn screening; model educational programs for the general public on the importance of newborn screening and the most potential uses of residual specimens to generate population-based knowledge about health and disease; national data on the utility of any additional consent/dissent processes implemented relative to potential research uses of residual newborn screening specimens; and educational materials with facts about potential uses of residual newborn screening specimens for both consumers and prenatal healthcare providers.
More Swine Flu Debate: Parents Refusing to Vaccinate their Children
Swine Flu Shots Revive a Debate About Vaccines
By JENNIFER STEINHAUER
Published: October 15, 2009
People who do not believe in vaccinating children have never had much sway over Leslie Wygant Arndt. She has studied the vaccine debate, she said, and came out in favor of having her 10-month-old daughter inoculated against childhood diseases. But there is something different about the vaccine for the H1N1 flu, she said.
Leslie Wygant Arndt of Portland, Ore., has mixed feelings about having her daughter, Beatrice, get the H1N1 vaccine. “I have looked at the people who are against it, and I find myself taking their side,” said Ms. Wygant Arndt, who lives in Portland, Ore. “But then again I go back and forth on this every day. It’s an emotional topic.”
Anti-vaccinators, as they are often referred to by scientists and doctors, have toiled for years on the margins of medicine. But an assemblage of factors around the swine flu vaccine — including confusion over how it was made, widespread speculation about whether it might be more dangerous than the virus itself, and complaints among some health care workers in New York about a requirement that they be vaccinated — is giving the anti-vaccine movement a fresh airing, according to health experts.
“Nationally right now there is a tremendous amount of attention on this vaccine,” said Dr. Thomas Farley, the New York City health commissioner. That focus has given vaccine opponents “an opportunity to speak out publicly and get their message amplified that they didn’t have at other times,” he said.
Barbara Loe Fisher, president of the National Vaccine Information Center, an advocacy group that questions the safety of vaccines, said the swine flu has “breathed new life” into the cause. “People who have never asked questions before about vaccines are looking at this one,” Ms. Fisher said.
The increased interest is frustrating to health officials, who are struggling to persuade an already wary public to line up for shots and prevent the spread of the pandemic. According to a CBS News poll conducted last week, only 46 percent said they were likely to get the vaccine. The nationwide poll, which has a margin of sampling error of plus or minus three percentage points, found that while 6 in 10 parents were likely to have their children vaccinated, less than half said they were “very likely to.”
“I wonder if the people disseminating this false information about this vaccine realize that what they are doing could result in some people losing their lives,” said Dr. Jonathan E. Fielding, the director of the Department of Public Health for Los Angeles County. The comments of vaccine dissenters, which he said “politically come from the left and the right,” were frequently “not just counterproductive,” he said, “but downright disgraceful.”
Web sites, Twitter feeds, talk radio and even elevator chatter are awash with skeptics criticizing the vaccine, largely with no factual or scientific basis. The most common complaint is that the vaccine has been newly formed and quickly distributed without the benefit of clinical trials; in fact, the swine flu vaccine was made using the same techniques as seasonal flu shots over the last two decades, and a small number of clinical trials were conducted this year to determine the adequate dose.
There are also claims that the vaccine contains adjuvants — sometimes added to make vaccines more effective — although they have not been used in this one. In addition, there is fear that the vaccine could lead to Guillain-Barré syndrome, as was suspected the last time a swine flu vaccine was distributed, in 1976; flu vaccines are now much purer than they were, minimizing the risk, and Guillain-Barré is far rarer.
In measuring the risk of the vaccine, there is general consensus among doctors that serious adverse reactions are rare and that pregnant women and young people, in particular, are better off with the vaccine than without it. While most people who get H1N1 experience mild symptoms, a recent New England Journal of Medicine study showed that among Americans hospitalized with swine flu last spring, one in four ended up in intensive care and 7 percent of them died.
The illness, unlike other flu strains, has been particularly tough on children and young adults and appears to have a disproportionately high fatality rate in pregnant women.
Health care officials are concerned that some groups, especially pregnant women, are potentially swayed by the large-scale efforts of vaccine opponents.
“One of the things they are focusing on now is immunization and pregnancy,” said Saad B. Omer, assistant professor of global health at Rollins School of Public Health at Emory University, “and their perceptions of the vaccine in use of pregnant women. It is not a benign perception in this case, and could have serious impacts, because pregnant women have high risk of complication if they get the swine flu.”
The anti-vaccine movement, largely comprising activists and a handful of doctors and researchers who connect a variety of health problems — particularly autism spectrum disorders — to vaccines, has failed to find large-scale traction in the United States, where more than 90 percent of children are vaccinated.
But at a conference this month of National Vaccine Information Center, Ms. Fisher said, there were 675 people, more than double the number at the group’s last conference, and half said they were there to discuss swine flu. Unlike most people associated with the center, who have longstanding objections to vaccines or have a connection to the issue because of an autistic child, the newcomers were not traditional skeptics, Ms. Fisher said. “They came not knowing much,” she said, “and left galvanized.”
Further, vitamin vendors — who in some cases operate blogs, with postings by people who claim to be doctors finding fault with vaccines — are reporting an increase in sales related to swine flu. Michael Angelo, chief research and information officer for eVitamins.com, said sales in September for flu-related products had tripled from last September. The company, he said, has sold 17,565 vitamins that it says protects against the H1N1 virus.
Some anti-vaccine groups are also highly organized and quick to respond to openings to promote their message. For instance, this week, an 8-year-old boy from Long Island died roughly a week after receiving a swine flu vaccine, though officials from the New York State Department of Health denied a connection.
Almost instantly, on a memorial page on Newsday’s Web site for the boy, Sean Weisse, a message from an anti-vaccine advocacy group appeared: “We are so sorry to hear about Sean. My understanding, and forgive me if I’m wrong, is that this was a vaccine-related injury. If so, we would like to help you. Best regards, Stan Kurtz, Generation Rescue, Jim Carrey and Jenny McCarthy’s Organization.”
By JENNIFER STEINHAUER
Published: October 15, 2009
People who do not believe in vaccinating children have never had much sway over Leslie Wygant Arndt. She has studied the vaccine debate, she said, and came out in favor of having her 10-month-old daughter inoculated against childhood diseases. But there is something different about the vaccine for the H1N1 flu, she said.
Leslie Wygant Arndt of Portland, Ore., has mixed feelings about having her daughter, Beatrice, get the H1N1 vaccine. “I have looked at the people who are against it, and I find myself taking their side,” said Ms. Wygant Arndt, who lives in Portland, Ore. “But then again I go back and forth on this every day. It’s an emotional topic.”
Anti-vaccinators, as they are often referred to by scientists and doctors, have toiled for years on the margins of medicine. But an assemblage of factors around the swine flu vaccine — including confusion over how it was made, widespread speculation about whether it might be more dangerous than the virus itself, and complaints among some health care workers in New York about a requirement that they be vaccinated — is giving the anti-vaccine movement a fresh airing, according to health experts.
“Nationally right now there is a tremendous amount of attention on this vaccine,” said Dr. Thomas Farley, the New York City health commissioner. That focus has given vaccine opponents “an opportunity to speak out publicly and get their message amplified that they didn’t have at other times,” he said.
Barbara Loe Fisher, president of the National Vaccine Information Center, an advocacy group that questions the safety of vaccines, said the swine flu has “breathed new life” into the cause. “People who have never asked questions before about vaccines are looking at this one,” Ms. Fisher said.
The increased interest is frustrating to health officials, who are struggling to persuade an already wary public to line up for shots and prevent the spread of the pandemic. According to a CBS News poll conducted last week, only 46 percent said they were likely to get the vaccine. The nationwide poll, which has a margin of sampling error of plus or minus three percentage points, found that while 6 in 10 parents were likely to have their children vaccinated, less than half said they were “very likely to.”
“I wonder if the people disseminating this false information about this vaccine realize that what they are doing could result in some people losing their lives,” said Dr. Jonathan E. Fielding, the director of the Department of Public Health for Los Angeles County. The comments of vaccine dissenters, which he said “politically come from the left and the right,” were frequently “not just counterproductive,” he said, “but downright disgraceful.”
Web sites, Twitter feeds, talk radio and even elevator chatter are awash with skeptics criticizing the vaccine, largely with no factual or scientific basis. The most common complaint is that the vaccine has been newly formed and quickly distributed without the benefit of clinical trials; in fact, the swine flu vaccine was made using the same techniques as seasonal flu shots over the last two decades, and a small number of clinical trials were conducted this year to determine the adequate dose.
There are also claims that the vaccine contains adjuvants — sometimes added to make vaccines more effective — although they have not been used in this one. In addition, there is fear that the vaccine could lead to Guillain-Barré syndrome, as was suspected the last time a swine flu vaccine was distributed, in 1976; flu vaccines are now much purer than they were, minimizing the risk, and Guillain-Barré is far rarer.
In measuring the risk of the vaccine, there is general consensus among doctors that serious adverse reactions are rare and that pregnant women and young people, in particular, are better off with the vaccine than without it. While most people who get H1N1 experience mild symptoms, a recent New England Journal of Medicine study showed that among Americans hospitalized with swine flu last spring, one in four ended up in intensive care and 7 percent of them died.
The illness, unlike other flu strains, has been particularly tough on children and young adults and appears to have a disproportionately high fatality rate in pregnant women.
Health care officials are concerned that some groups, especially pregnant women, are potentially swayed by the large-scale efforts of vaccine opponents.
“One of the things they are focusing on now is immunization and pregnancy,” said Saad B. Omer, assistant professor of global health at Rollins School of Public Health at Emory University, “and their perceptions of the vaccine in use of pregnant women. It is not a benign perception in this case, and could have serious impacts, because pregnant women have high risk of complication if they get the swine flu.”
The anti-vaccine movement, largely comprising activists and a handful of doctors and researchers who connect a variety of health problems — particularly autism spectrum disorders — to vaccines, has failed to find large-scale traction in the United States, where more than 90 percent of children are vaccinated.
But at a conference this month of National Vaccine Information Center, Ms. Fisher said, there were 675 people, more than double the number at the group’s last conference, and half said they were there to discuss swine flu. Unlike most people associated with the center, who have longstanding objections to vaccines or have a connection to the issue because of an autistic child, the newcomers were not traditional skeptics, Ms. Fisher said. “They came not knowing much,” she said, “and left galvanized.”
Further, vitamin vendors — who in some cases operate blogs, with postings by people who claim to be doctors finding fault with vaccines — are reporting an increase in sales related to swine flu. Michael Angelo, chief research and information officer for eVitamins.com, said sales in September for flu-related products had tripled from last September. The company, he said, has sold 17,565 vitamins that it says protects against the H1N1 virus.
Some anti-vaccine groups are also highly organized and quick to respond to openings to promote their message. For instance, this week, an 8-year-old boy from Long Island died roughly a week after receiving a swine flu vaccine, though officials from the New York State Department of Health denied a connection.
Almost instantly, on a memorial page on Newsday’s Web site for the boy, Sean Weisse, a message from an anti-vaccine advocacy group appeared: “We are so sorry to hear about Sean. My understanding, and forgive me if I’m wrong, is that this was a vaccine-related injury. If so, we would like to help you. Best regards, Stan Kurtz, Generation Rescue, Jim Carrey and Jenny McCarthy’s Organization.”
Thursday, October 15, 2009
Overtesting, Insurance, and Genomics
This article is connected to a discussion about whether it is ethical to run tests of questionable necessity on patients simply because they have the insurance to handle it (not the rarest of actions taken by many hospital administrators).
Additionally, how might this relate to the commercialization of genomics? At present we are limited by technology's ability to manipulate the human genome, but should it advance quickly, this may be the slippery slope that creates an ethical basis for in vitro commercialized manipulation of children.
Read the article here.
(Submitted by Chris Wagner)
Additionally, how might this relate to the commercialization of genomics? At present we are limited by technology's ability to manipulate the human genome, but should it advance quickly, this may be the slippery slope that creates an ethical basis for in vitro commercialized manipulation of children.
Read the article here.
(Submitted by Chris Wagner)
Overtreatment and Dementia
This article discusses overtreatment of patients with terminal dementia and the tendency for less-informed family members to order overly aggressive treatments on the patient's behalf that have no chance of affecting the patient's outcome. This sets the stage for an interesting exchange about how involved a physician should be in family decisions, especially when the patient has lost his/her mental facilities and is no longer competent to make treatment choices. Resource management, cost, emotional distress, and autonomy all factor into this discussion. See the article here.
(Submitted by Chris Wagner)
(Submitted by Chris Wagner)
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