H1N1 Vaccine Safety

Read this article and watch this youtube video, and then respond to the following prompt:

Considering the widespread reach and severity of the H1N1 pandemic, vaccinations have been rushed through the manufacturing process to the public by the government. The first round of people are about to receive vaccines right now, and it should be available to the general public by the end of this month. Considering that the potential side effects are unknown in scope and severity, is it best for the government to act deontologically and release an untested vaccination? Or is it in the best for the government to act from the standpoint of utilitarianism and not side-step all health and safety precautions pertaining to this vaccine?

(Submitted by Nikhil Shah)

Clinical Studies and Doctors

After participating in and critiquing the NIH training, this article is an interesting one.

After reading, do you think it is morally right or wrong for doctors to bend the rules of clinical studies in order to help their patients? Why or why not?

(Submitted by Caren Steinway)

Direct to Consumer Fertility Tests

Warning on self-test fertility kits

20 October 2009
By Rebecca Robey
Appeared in BioNews 531

Women have been warned against relying on 'over-the-counter' home fertility tests to gauge whether they can afford to delay starting a family. Scientists and doctors cautioned that such tests may provide false hope, encouraging women that they have several years of fertility left without looking at all the important factors.

Women are born with their complete supply of eggs for their lifetime contained within their ovaries. Over time this supply steadily diminishes, eventually leading to the menopause when the supply is exhausted. Home fertility tests, or 'ovarian reserve' tests, cost as little as £25 to £180 and use a blood or urine sample to estimate the number of eggs a woman has left by measuring her levels of a hormone called follicle-stimulating hormone (FSH). As the number of eggs falls, the level of FSH in the woman's blood rises, and so the information can be used to predict how many child-bearing years a woman might have left.

However, fertility experts are concerned as they feel these tests do not offer a complete picture. Such tests do not give any information about the quality of the eggs or other factors that may be crucial for fertility. Stuart Lavery, a consultant gynaecologist at the IVF (in vitro fertilisation) unit at Hammersmith hospital, London, explained: 'The concern with over-the-counter tests is that although they are helpful, because they focus the mind on fertility, they can also give false reassurance. If the fallopian tubes are blocked or the partner doesn't have fabulous sperm, it may be giving you false hope'.

These concerns were raised after research presented at the American Society for Reproductive Medicine's annual meeting in Atlanta, Georgia, US, provided evidence that the same tests may be useful indicators of the likelihood of successful IVF when used in a clinical setting. A study at the Advanced Fertility Centre of Chicago used FSH tests in conjunction with ultrasound examinations that also estimate the size of a woman's egg reserve to predict the fertility of 1,380 women under the age of 35 who were undergoing IVF. IVF was successful in 59 per cent of women with normal results in both tests compared to 35 per cent of women with abnormal FSH levels and just 9 per cent of women who had abnormal results in both tests.

Ovarian reserve tests are routinely used in women over 35 years old considering IVF in the UK, and the new study indicates it may also be useful for younger women to help them decide whether to pursue the often costly procedure. Dr Todd Deutch, managing director of the Advanced Fertility Centre of Chicago, emphasised that this did not mean the tests were good indicators for women trying to conceive naturally. He said: 'I think relying on these tests to gauge fertility generally... is not a good extrapolation of this data. These tests don't tell the whole story'.

RELATED ARTICLES FROM THE BIONEWS ARCHIVE

Increase in UK women over 40 seeking fertility treatment
11 June 2007 - by Danielle Hamm
Recent figures released by the UK fertility regulator, the Human Fertilisation and Embryology Authority (HFEA), show a tenfold plus increase in women over 40 seeking fertility treatment using their own eggs. The number of women over 40 seeking fertility treatment using donated eggs is not know, but...[Read More]
Over-the-counter fertility test to go on sale
05 January 2006 - by BioNews
Scientists at the UK's Birmingham University have developed a fertility test kit that can be bought over-the-counter at chemists and used by couples at home. The Fertell test, which will cost about £80, takes less than an hour to work and is said to give accurate results in nearly all...[Read More]
DIY fertility test
09 July 2001 - by BioNews
Doctors and scientists from the University of Birmingham and Genosis, a medical devices company in the UK, have developed a 'fertility test kit' that can be used - both by men and women - at home. The kit is called 'Fertell' and is designed to measure fertility levels in couples trying to...[Read More]
Test measures ticking biological clock
12 July 1999 - by BioNews
A fertility test that measures the viability of eggs in a woman's ovaries may soon give women the ability to tell the time on the proverbial biological clock. The test is the result of six years of work by Oxford scientists who discovered that levels of the hormone, inhibin B...[Read More]
SOURCES & REFERENCES
Doctors warn against over-the-counter fertility tests for family planning
The Guardian | 20 October 2009
High Street fertility tests could give wrong results, experts warn
The Daily Telegraph | 20 October 2009
Home tests on biological clock 'could give women false hope'
The Times | 20 October 2009
Why home fertility tests fail to deliver
The Daily Mail | 20 October 2009

choosing who should survive in a swine flu pandemic

Worst Case: Choosing Who Survives in a Flu Epidemic
James Estrin/The New York Times
Published: October 24, 2009

New York state health officials recently laid out this wrenching scenario for a small group of medical professionals from New York-Presbyterian Hospital: A 32-year-old man with cystic fibrosis is rushed to the hospital with appendicitis in the midst of a worsening pandemic caused by the H1N1 flu virus, which has mutated into a more deadly form. The man is awaiting a lung transplant and brought with him the mechanical ventilator that helps him breathe.

New York’s governor has declared a state of emergency and hospitals are following the state’s pandemic ventilator allocation plan — actual guidelines drafted in 2007 that are now being revisited. The plan aims to direct ventilators to those with the best chances of survival in a severe, 1918-like flu pandemic where tens of thousands develop life-threatening pneumonia.

Because the man’s end-stage lung disease caused by his cystic fibrosis is among a list of medical conditions associated with high mortality, the guidelines would bar the man from using a ventilator in a hospital, even though he is, unlike many with his illness, stable, in good condition, and not close to death. If the hospital admits him, the guidelines call for the machine that keeps him alive to be given to someone else.

Would doctors and nurses follow such rules? Should they?

In recent years, officials in a host of states and localities, as well as the federal Veterans Health Administration, have been quietly addressing one of medicine’s most troubling questions: Who should get a chance to survive when the number of severely ill people far exceeds the resources needed to treat them all?

The draft plans vary. In some states, patients with Do Not Resuscitate orders, the elderly, those requiring dialysis, or those with severe neurological impairment would be refused ventilators, or admission to hospitals. Utah divides epidemics into phases. Initially, hospitals would apply triage rules to residents of mental institutions, nursing homes, prisons and facilities for the “handicapped.” If an epidemic worsened, the rules would apply to the general population.

Federal officials say the possibility that America’s already crowded intensive care units would be overwhelmed in the coming weeks by flu patients is small but they remain vigilant.

The triage plans have attracted little publicity. New York, for example, released its draft guidelines in 2007, offered a 45-day comment period, and has made no changes since. The Health Department made 90 pages of public comments public this week only after receiving a request under the state’s public records laws.

Mary Buckley-Davis, a respiratory therapist with 30 years experience, wrote to officials in 2007 that “there will be rioting in the streets” if hospitals begin disconnecting ventilators. “There won’t be enough public relations spin or appropriate media coverage in the world” to calm the family of a patient “terminally weaned” from a ventilator, she said.

State and federal officials defend formal rationing as the last in a series of steps that would be taken to stretch scarce resources and provide the best outcome for the public. They say it is better to plan for such decisions than leave them to besieged health workers battling a crisis.

“You change your perspective from thinking about the individual patient to thinking about the community of patients,” said Rear Adm. Ann Knebel of the Department of Health and Human Services.

But some health professionals question whether the draft guidelines are fair, effective, ethical, and even remotely feasible.

Most existing triage plans were designed for handling mass casualties. They sort injured victims into priority categories based on the urgency of their medical needs and their potential for survival given available resources. Much of the controversy over the state plans focuses on two additional features.

These are “exclusion criteria,” which bar certain categories of patients from standard hospital treatments in a severe health disaster, and “minimum qualifications for survival,” which limit the resources used for each patient. Once that limit is reached, patients who are not improving would be removed from essential treatment in favor of those with better chances.

A version of these concepts was outlined in a post-9/11 medical journal article that suggested ways to handle victims of a large-scale bioterrorist event. The author, Dr. Frederick Burkle Jr., said he based his ideas in part on his experiences as a triage officer in Vietnam and the gulf war and on a cold war-era British plan for coping with a nuclear strike. Dr. Burkle said that during the gulf war he once instructed surgeons to halt an operation and work on another patient who was more likely to survive. Surgeons later returned to the first patient.

Dr. Burkle’s ideas were key aspects of guidelines Ontario authorities drew up after SARS to plan for avian flu and other pandemics. This approach and one by a team of Minnesota doctors were modified by groups developing similar guidelines in the United States.

There were important distinctions. Dr. Burkle’s original paper did not anticipate withdrawing care from patients and stressed the need to reassess the level of supplies “sometimes on a daily or hourly basis” in a fluid effort to provide the best possible care.

Some states’ triage guidelines are rigid, with a single set of criteria intended to apply throughout the severe phase of a pandemic. That disturbs Dr. Burkle. “I have said to my wife, I think I developed a monster here,” he said.

Recent research highlights the problem of a one-size-fits-all approach to triage. Many state pandemic plans call for hospitals to remove patients from ventilators if they are not improving after two to five days. Studies show that people severely ill with H1N1 flu generally need a week to two weeks on ventilators to recover.

There is also controversy over what values and ethical principles should guide triage decisions, how to engage the public, and whether withdrawing life support in the hospital and withholding it at the hospital door are distinct.

Normally, removing viable patients from life support against their or their families’ will would be considered murder. The New York-Presbyterian Hospital employees who participated in the recent exercise said they would not comply unless given legal protection.

They also never figured out what to do with that hypothetical patient who had his own ventilator, said Dr. Kenneth Prager, a pulmonologist and ethicist. “The issue of removing patients from ventilators,” he said, “was so overwhelming that it precluded discussion of further case scenarios.”

Oldest Woman to Give Birth Dies

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]

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.”

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.

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.

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.”

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)

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)

Swine FLU for Prisoners : First?

State To Give Prisoners H1N1 Shots First
Sheriff Says Jails Perfect 'Breeding Grounds'

BOSTON -- Massachusetts health officials have decided to give swine flu vaccinations to state prisoners before the rest of the population.

Prison officials warn that inmates could quickly spread the flu if not inoculated -- particularly those in high-risk groups such as AIDS patients.

Middlesex Sheriff James DiPaola told the Boston Herald that prisons were the perfect flu "breeding ground." DiPaola dealt with riots in a Cambridge jail when rumors of swine flu spread there.

But state Sen. Mark Montigny said several groups are more vulnerable than prisoners. The New Bedford Democrat said the inoculations should be given to the public immediately.
The vaccines, which are voluntary, will be sent to correctional facilities the second week of November. They are set to be available to the general public by Nov. 27.

AIDS Vaccine

t is an emotional cycle familiar to most AIDS-vaccine researchers: the high of finally making measurable headway against HIV, followed by the crushing low of discovering that the virus has once again found a way to elude them.
It happened again on Saturday when researchers learned that the first ever successful AIDS vaccine turned out not to be the triumph they had originally hoped. In September, scientists from the National Institutes of Health (NIH) and the U.S. Army announced the results of an AIDS-vaccine study in Thailand involving more than 16,000 volunteers. The data showed that the new vaccine had protected 31% of inoculated participants from becoming infected with HIV. But a closer look at a subset of the study's volunteers now reveals that the vaccine in fact protected only 26% of the people who received it. (See pictures of Africa's AIDS crisis.)

The difference is small but critical because the new success rate of 26% falls below the threshold for statistical significance. That means that the odds of being protected from infection by the AIDS vaccine may be no better than chance.

At issue is a matter of head count. If the entire group of volunteers who were enrolled in the study were included in the data, then the results would suggest a 31% effectiveness rate, with 51 in the vaccine arm and 74 in the control group becoming infected with HIV. These are the results that were announced in September. But because this particular vaccine was given in six doses over a six-month period — in what is referred to as a prime and boost regimen, in which the early shots prime the immune system to fend off HIV and the follow-up shots boost the body's immunity — some volunteers became infected with HIV before receiving all six shots, rendering them ineligible to complete the study. Since researchers are aiming to study how well the complete set of inoculations protects against infection, the final data should exclude the one-third of participants who became infected before the study concluded. (Watch an audio slideshow about aging AIDS patients.)

The resulting tally, then, includes a much smaller pool of participants, which automatically lessens the significance of whatever effect, if any, the vaccine appeared to have, says Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases. "When you lose statistical power, something that would have been significant in the [original, larger] population, could now fall below significance merely by the lower numbers. That's what happened with this trial," Fauci says.

According to statisticians, however, scientists generally include all data from the complete, original population, since these numbers more accurately reflect what might happen in the real world. In other words, it's a more rigorous analysis of how effective a vaccine might be in a population of people who, realistically, could be exposed to HIV before they finish the full six doses of a vaccine.

As for why investigators did not reveal both sets of data in their initial announcement, the Army researchers posted this update on the website of the U.S. Military HIV Research Program: "Explaining the differences between them is complex and the appropriate venue for this technical discussion of statistics is at an open scientific conference and in the scientific publication now under review at a major journal." (See the most common hospital mishaps.)

So does this mean the vaccine was not effective? That depends on whom you ask. Some experts argue that the vaccine's effect, if it exists, is so tiny that it's not worth pursuing in a significant way. "Would I invest in it? The answer is no," says Dr. David Ho, director of the Aaron Diamond AIDS Research Center in New York City. "There are other things that are more likely to work, that are better, easier and more straightforward than this vaccine."

(Submitted by Anne Aldrich)

Ethics and Malpractice

General medical insurance is not the only issue causing problems for our health care system. Costs are also being driven up by doctors practicing defensive medicine and ordering large numbers of unnecessary tests to protect themselves from lawsuits. Even when doctors perform all necessary tests, patients are still able to sue for damages if something goes awry.

For example, a close family friend of ours is a general practitioner. Four years ago he saw a patient who was at high risk for a stroke, and he recommended the patient stay in the hospital overnight for observation. The patient politely declined, and returned home. The next day the patient returned to the hospital in an ambulance, mid-stroke. The patient was admitted into the hospital, treated, and eventually returned home perfectly fine. He did not have any long-term damage from the stroke, and was immediately put on blood thinners and modified his diet and exercise regimen. Not long after the patient returned home, our friend was summoned to court for a malpractice suit. The patient claimed that the stroke was the physician's fault, and that he should have forced him to remain in the hospital overnight. Again, the patient had no long-term damage, no Palsy, nothing except a slight scare and a large medical bill. Initially, the case was thrown out for being frivolous. Our friend believed that the suit was over, and he would be fine minus some legal bills. Four years later the patient again summoned him to court, with new lawyers and before a new judge. The judge accepted the case, and warned our friend to get a good lawyer. Our friend was forced to take a week off from work (thus reducing his usual paycheck by 1/4), hire a lawyer, and begin the process of defending himself for something that was completely ridiculous. The former patient was demanding $500,000 in damages, to compensate him for medical costs, his lawyers, and any emotional damage he may have suffered. Recently, the court again stated that the case was frivolous and threw it out, but our friend still had to incur legal bills for four years, an increase in his malpractice insurance premiums, and the loss of a full week of work (about 80 hours).

Given this example, how can doctors act beneficently when their fear of what may happen if something goes wrong overrides their concern for a patient? Should there be restrictions within the legal system on what is an appropriate malpractice suit?

(Submitted by Leslie Baggeson)

Information Exchange and Ethics

This article about the French government addresses the common debate of who is responsible for the exchange of information that protects an individual. Is it the responsibility of the individual to obtain all the information relevant to his/her health or the responsibility of the company to willingly dispense this information at the expense of their business? What is the ethical solution? (This may remind you of the uninformed consumer debate regarding the mortgage system.)

(Submitted by Tara Vaughn)

Ethical Issues with a Walmart Employee

There was a story on AOL news about a couple from Arizona who was accused of sexual abuse of their three daughters. The couple went to a local Walmart to have over 140 family vacation photos developed, and 6 or 7 of the photos happened to be harmless "bath time" photos of the very young girls either wrapped in towels or in towels smiling next to their father etc. The Walmart associate who developed those photos considered the photos to be pornographic, and reported them. The daughters were taken away from their parents for a month (ages 18 months, 4, and 5) and the parents were taken to court. The judge ruled the pictures harmless, as thousands of people do take photos of their children growing up and especially cute bath time photos. However, the damage has clearly been done because the daughters were taken from their parents and the parents had to register as sex offenders, and were ostracized from their work environments etc. Now that the family is reunited, the couple is suing Walmart for the traumatic ordeal. I thought this story was a good real life example of how two conflicting ethical theories of Consequentialism and Deontology make it difficult to assign blame or forgiveness to either side of the stories. The employee’s actions were nonmaleficent, he or she acted to prevent further harm to the children, but the outcome was maleficent because the family was put through such hardships for the employee’s mistakes. Was the employee acting by the theories of Deontology, and did not think of the possible consequences of his or her actions? Is there more to the story that we do not know?

So the debate at hand over this Walmart situation is whether or not we should punish the associate for the damage that was done to this family by a costly mistake, or commend him or her for acting benevolently for the community and the sake of the daughters whom he or she presumed was in danger? What are we missing from this story that might make the right decision clearer? What does this tell us about two conflicting ethical principles?

(Submitted by Alexandra Pitkin)

Genomics and Universal Health Care

Genomics and Universal Healthcare
October 01, 2009


If the US enters the genomics-based medicine age without universal healthcare, Jeremy Grushcow at The Cross-Border Biotech Blog says that "it will exacerbate existing inequalities and create new ones we haven't even imagined." As an example, Grushcow draws on new guidance from the UK's General Medical Council that says if a patient is found to have a genetic disease, then doctors must inform relatives of their risk. Grushcow says that such notification is only possible with universal coverage. "People with genetic diseases can be informed of their risk because they won't lose their insurance or be forced into a high-risk high-cost pool as a result," he writes.

For more information on how genetic testing can play out in our health care system, please see these stories: New York Times editorial from October 4th and NPR story on Lewiston Maine.

Genetic disease patients may lose privacy rights to protect families

Genetic disease patients may lose privacy rights to protect families
David Rose Health Correspondent

The actress Christina Applegate had a double mastectomy last year after testing positive for the BRCA1breast cancer gene.

New guidance for Britain’s 150,000 practising doctors could remove the right to confidentiality from patients with inherited diseases.

When a patient is found to have a genetic disease, such as certain forms of cancer, doctors will be obliged to inform relatives about potential risks to their health, the General Medical Council (GMC) says.

Updated guidance on confidentiality, seen by The Times before publication on Monday, suggests that most patients will readily share information about their health with their children and close relatives.

However, in circumstances where family relationships have broken down, where children have been adopted — or patients refuse consent to disclosure — doctors should still share information with others who might be at risk if they remain ignorant of a potentially life-threatening condition.
Related Links

* 'New guidance will not erode patient rights'

* Genetic screening can predict prostate risk

* GPs may be given chance to check their own DNA

Genetics is predicted to become an increasingly important branch of medicine as the underlying causes of more and more diseases are linked to an individual’s family history.

When a patient is found to have a disease caused by an inherited mutation, his or her children, siblings and even parents may also be at risk.

Knowledge of someone’s condition could lead to other family members having mutations or risks diagnosed early, giving them a better chance of prevention or survival.

Despite calls from some campaigners for a change in the law, adopted children do not have a legal right to learn details of their biological relatives’ health records, even if such details are relevant to their own future health.

The GMC’s guidance says that practitioners should balance their duty to keep sensitive medical information private against the duty to help to protect others from serious harm.

“A patient might refuse to consent to the disclosure of information that would benefit others,” the guidance states. “In these circumstances, disclosure might still be justified in the public interest.”

Henrietta Campbell, the former Chief Medical Officer for Northern Ireland, who chaired the working group that drew up the guidance, said that it “makes clear that, in the first instance, doctors should explain to a patient if their family might be at risk of inheriting a condition.

“In those circumstances, most will readily share information about their health. However, if a person refuses, it is the responsibility of the doctor to protect those who may be at risk.”

Frances Flinter, a consultant in clinical genetics at Guy’s and St Thomas’ Hospital, South London, whose service covers four million patients in the South East, said that doctors could trace any affected relatives through the NHS if given a name and date of birth.

They could then get in touch with them indirectly, if necessary without revealing specific identities, by way of a relative’s local GP. This was especially important if patients were nearing the end of their lives or were not able to pass on the information themselves, she said.

“Doctors should only think of passing on information without someone’s consent, if at all, if it has direct health benefits. This is an increasingly important topic as it’s far more common to have families scattered all over the country now, and a GP is unlikely to know the extended family personally,” she said.

“We do see cases, maybe once or twice a year, where people cannot, or do not want to, share their information. In that case, we don’t need to reveal who in the family has been diagnosed. It may be a distant relative or someone the patient has never met,” she said. “Some relatives also don’t want to be screened or find out more, but at least by being contacted, patients can make that choice.”

After pressure from the Government, police and hospital emergency services, the guidance also advises doctors to inform police whenever they treat patients who have been attacked with a knife. Police are already informed about gunshot wounds.

It also provides advice for reporting concerns about patients to the Driver and Vehicle Licensing Agency (DVLA), when, due to ill health, a patient might be unfit to drive.

Statistics behind the need to know

Huntington’s disease Fatal and incurable neurodegenerative disease caused by a dominant mutation that invariably causes disease. Anyone with a parent or sibling with condition has a 50-50 chance of having inherited the gene

Cystic fibrosis Severe and incurable lung condition. Caused by a recessive mutation, so two copies must be inherited, one from each parent, for it to develop. Siblings of CF patients have high chance of beingcarriers

Haemophilia Blood-clotting disorder caused by a mutation on the X chromosome, so usually inherited by boys. Brothers of boys with X-linked conditions have a 50-50 risk of the disease

Breast cancer Some cases caused by mutations in the BRCA1 and BRCA2 genes, which each raise lifetime risk to 60-80 per cent. Women with an affected mother or sister have a 50-50 chance of having inherited the mutation. Some carriers opt for a mastectomy