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.
Thursday, October 15, 2009
Wednesday, October 14, 2009
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)
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)
Friday, October 9, 2009
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)
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)
(Submitted by Tara Vaughn)
Thursday, October 8, 2009
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)
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)
Friday, October 2, 2009
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.
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
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
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