“Parents who frequently move house put children’s health at risk,” according to the Daily Mail. The newspaper said that research found moving several times can affect children’s health and psychological state, and also increases the likelihood that a child may use illegal drugs.
This Scottish research, which looked at potential links between moving house in childhood and adult health, produced far more mixed results than the Mail implied. However, the press release accompanying the research did not always clearly reflect the findings of the study, which found very few significant links between moving frequently and poor health.
In fact, once the researchers accounted for factors such as social deprivation and moving schools, moving house was only significantly linked to a higher chance of using drugs in later life. Adults who had moved frequently showed no greater risk of being overweight, having high blood pressure, long-term illness, psychological distress, drinking or smoking later in life.
While researchers say the risk of having certain measures of poor health was “elevated” in people who moved house more frequently as a child, the increase in risk was not statistically significant, which means it could have happened by chance.
Where did the story come from?
The study was carried out by researchers from the Medical Research Council, the University of Stirling, Queen’s University and Scotland’s Chief Scientist Office. It was funded by the Chief Scientist Office of the Scottish Government Health Directorate. The study was published in the peer-reviewed Journal of Epidemiology and Community Health.
The study’s findings were overstated by the Daily Mail. The newspaper reported that there were “negative health effects” from frequent moves, whereas the study found that frequent moving was only significantly linked to an increased chance of drug use. This finding on drug use was independent of other variables.
Moving during childhood was not significantly associated with adult measures of physical health, such as weight and blood pressure. The Mail only touched on these elements towards the end of its report.
It’s worth noting that in the press release that accompanied publication of the study, only the penultimate paragraph stated that only illegal drug use was independently associated with frequent moves.
What kind of research was this?
This research was part of a large cohort study from the west of Scotland, which has taken place over 20 years. It compared the health of people who had been “residentially stable” during childhood with those who had moved house, using a range of health measures.
The authors say previous research suggests that frequent childhood moves may be associated with poorer health outcomes and behaviour in adolescence. The researchers say their present study brings together a wider range of health outcomes than has previously been considered, and also looked at the extent to which associations between childhood mobility and health in adolescence last into adulthood.
What did the research involve?
The study was based on a cohort of 1,515 participants who were 15 when it started in 1987 and who were followed up for 20 years. Data from this cohort were collected at five points in time, the final time when the participants were 36. The final sample analysed in the study was 850 participants, so 665 original participants (44% were not included in the final analysis because they had left the study.
Researchers collected their data through face-to-face interviews conducted by nurses. A parental questionnaire was completed at the start of the study.
The researchers got information about moving house from the number of addresses people had lived at between birth and 18 (they excluded recent moves out of the family home . They collected information on a range of health measures including:
- Physical health measures - these were all taken by nurses and included body mass index, waist-to-hip ratio, lung function and blood pressure.
- Overall health - people were asked to report whether they had limiting long-term illness (answering yes or no and to give their own assessment of their general health, as rated on a four-point scale.
- Psychological distress - this was assessed using a standard 12-item questionnaire (with a cut-off score of 3 points taken to indicate psychological distress . Whether people had thought about suicide was also examined, with people asked at certain points whether they had thought about taking a drug overdose or deliberate self-injury. The third measure of psychological distress was anxiety, as measured on a standard scale.
- Health behaviours - the behaviours examined were heavy drinking (defined as exceeding maximum weekly safe limits , illegal drug use and smoking.
Importantly, the researchers also looked at participants’ family and household circumstances based on information provided by the children’s parents at the start. They also looked at other factors such as social deprivation (calculated by postcode and using recognised deprivation categories , housing status (home-owner or not , social class, family structure (intact or not and number of siblings. Also included were data on school mobility, derived from the number of primary and secondary schools attended. The researchers also looked at participants’ social class, education and marital status in adulthood.
The researchers then analysed the relationship between number of house moves in childhood and health at the ages of 18 and 36. They adjusted their findings for possible confounders, such as social class, deprivation and family circumstances.
What were the basic results?
The researchers found that approximately one in five people did not move address throughout childhood. Three in ten moved once or twice, and a further one in five had moved at least three times. They also found that children in single-parent households and those with two or three siblings were significantly more likely to have moved home (while those with at least four siblings were more likely to have stayed put .
After they adjusted their findings for both socioeconomic circumstances and the number of school moves, the researchers found that, when the participants were 18:
- People who had moved at least three times were significantly more likely to have used illegal drugs than those who had never moved ( odds ratio [OR] 2.44, 95% confidence interval [CI] 1.45 to 4.10 .
- Those who moved at least once had a significantly higher chance of scoring 3 or more (indicating distress on the questionnaire for psychological distress than those who had not moved at all (OR 1.62, 95% CI 1.11 to 2.35 .
- The risk of several outcomes (having a long-term illness, having suicidal thoughts for those who had moved at least once, and heavy drinking and smoking for those who had moved at least three times were “elevated” compared to those who had not moved at all, but the increased risks were not significant.
- There was no association between childhood mobility and physical health measures such as blood pressure and weight.
When the participants were aged 36, the researchers found that:
- Frequent moving in childhood was independently associated with illegal drug use (OR 1.92, 95% CI 1.00 to 3.69 .
- The odds of poor health across other measures remained “elevated” but not statistically significant.
- There was no association between moving address during childhood and physical health measures such as blood pressure and weight.
How did the researchers interpret the results?
The researchers concluded that increased residential mobility in childhood is associated with an elevated risk of poor health in adulthood, across a range of measures. This is explained in part, they say, by both social and economic circumstances and the frequency of school moves.
The relationship between childhood residential mobility and poorer health appeared to be stronger in adolescence than adulthood, possibly because people’s own socioeconomic circumstances lessened the effects over time.
Conclusion
This study looked at the effect of multiple address moves during childhood on people’s physical and psychological health at the ages of 18 and 36.
The way the authors interpreted the results of their study is confusing. They say that a higher risk of poor health outcomes is associated with frequent moves of home in childhood. However, the only significantly higher risk, once the results were adjusted for various confounders, was illegal drug use. This is important because it means that the other increases in risk identified are more likely to have occurred by chance.
The study examined an important issue, and one strength is the length of time of it covered. Another is its detailed collection of data, which might help explain why frequent moves of house could have an association with poorer health outcomes. For example, this could be because of frequent school moves, family break-up and deprivation.
However, the study has a number of limitations. Its high drop-out rate (around 43% raises the question of reliability and it is possible that those who dropped out or were lost to follow-up also had the most mobile childhoods. The study’s reliance on the parents to report outcomes, such as overall health, is another limitation as their reports may be subjective or difficult to appraise.
Families move home for a range of different reasons, including improved schooling and employment opportunities, change in financial circumstances or family break-up, and the study did not assess the reasons for the family moves. It seems obvious that children are more likely to be negatively affected when disruption or financial problems cause a family to move, rather than when the motive is to seek better schools or a better job.
The way children’s wellbeing is affected by frequent moving is an important issue, but it is also a complex one which needs to be examined further.
Links To The Headlines
Parents who frequently move house 'put children's health at risk'. Daily Mail, February 9 2012
Links To Science
Brown D, Benzeval M, Gayle V et al. Childhood residential mobility and health in late adolescence and adulthood: findings from the West of Scotland Twenty-07 Study. Journal of Epidemiology and Community Health, 6 February 2012 (published online first
A skin cancer drug can improve Alzheimer-like symptoms in mice engineered to mimic the condition, it has been widely reported.
Many national newspapers have covered the news, which is based on aninal tests involving the drug bexarotene (brand name Targretin , which is currently only used to treat a rare form of skin cancer. This drug was given to mice that had been genetically engineered to develop a condition similar to Alzheimer’s, and in a short space of time the mice showed lowered brain levels of a key protein called beta-amyloid. Beta-amyloid is the substance that forms the protein plaques in the brain that are characteristic of Alzheimer’s. The researchers also observed post-treatment improvements in the brain function of the mice – for example, they were better able to build nests and remember the way through a maze.
Although this research is in animals and there is limited direct application to humans at the current time, these early findings do show some potential for further research. Notably, the drug had a rapid effect on amyloid plaques that are characteristic of Alzheimer’s, and the fact that drug is currently licensed means it will have undergone safety regulations for its current use. That said, there are no guarantees it will prove as safe or effective in people with Alzheimer’s.
At the current time no tests have been carried out in humans with Alzheimer’s, only an animal model of the disease. The research will undoubtedly be of interest to researchers, doctors, and patients and their families, but it is far too early to suggest that this could be a cure for Alzheimer’s.
Where did the story come from?
The study was carried out by researchers from Case Western Reserve University School of Medicine, Cleveland, and other institutions in the US. The study was supported by a number of research funding foundations, including the Blanchette Hooker Rockefeller Foundation, Thome Foundation, and the Roby and Taft Funds for Alzheimer’s.
The study was published in the peer-reviewed journal Sciencexpress.
BBC News gives accurate coverage of this study. The Sun, Daily Mail and The Daily Telegraph featured slightly optimistic headlines, but their articles generally do make it clear that this was a study in mice and give good accounts of the research.
What kind of research was this?
This was animal research aiming to investigate the effects of a drug called bexarotene on a mouse model of Alzheimer’s disease.
Bexarotene activates a receptor on the surface of cells that is known to be involved in triggering the production of a protein called ‘apolipoprotein E’ (ApoE . The ApoE protein is involved in the breakdown of soluble beta-amyloid, a protein that builds up to form the characteristic insoluble plaques seen in the brains of people with Alzheimer’s.
All humans carry a gene containing the code for producing the ApoE protein, but some people carry a particular variant of the ApoE gene known as the ApoE e4 allele. People carrying this variant are known to be at increased risk of developing Alzheimer’s disease, and carrying this variant seems to be associated with the build-up of beta-amyloid plaques in the brain. Therefore the researchers were interested whether a drug that increases production of ApoE could potentially have an effect on the build-up of beta-amyloid in the brain. To explore this possibility they decided to test the drug in mice with Alzheimer’s-like symptoms, looking at whether it could reduce their their beta-amyloid levels and improve their cognitive performance.
What did the research involve?
The researchers used various different genetically engineered mouse models of Alzheimer’s in their experiments. The researchers carried out a number of tests to assess the effects of bexarotene on soluble beta-amyloid in the fluid surrounding the brain, insoluble beta-amyloid plaques in the brain, and cognitive performance of these mice.
The mice were administered oral bexarotene for three, seven, nine, 14, 20 or 90 days. These mice were compared with similar mice that did not receive bexarotene. The researchers looked at mice of three different ages: two months, six months and 11 months in order to look at the effects of the drug when given to mice at different stages of their Alzheimer’s-like condition – the older mice having more beta-amyloid protein build-up.
The mice in models of Alzheimer’s display impairments in their performance in several tasks: navigating a water maze (an indicator of cognition ; nest construction (an indicator of social behaviour ; fear response to placement in a shock chamber; and sense of smell. In a sample of mice the researchers tested performance in these four areas after administering the drug.
After the treatment periods the mice’s brains were examined to look for any changes.
What were the basic results?
The researchers found that administering a single dose of bexarotene gave a rapid reduction in levels of soluble beta-amyloid in the fluid surrounding the mice’s brains. There was a 25% reduction within 24 hours and this reduction was retained for over 70 hours. Up to 84 hours after treatment there was a return to pre-treatment levels of soluble beta-amyloid.
In six-month-old mice treated with bexarotene, insoluble beta-amyloid levels in the brain were reduced by 40% after 72 hours. When bexarotene was given to mice for longer periods of time they found a sustained reduction in beta-amyloid throughout the treatment period. They found comparable effects of the drug when testing in older, 11-month-old mice with greater beta-amyloid build-up.
The drug also improved the cognitive, social and sensory deficits of the mice:
- both six-month and 11-month-old mice treated for seven days showed improvements in fear conditioning; the six-month old mice also showed improvements in fear conditioning with 90 days of treatment
- performance in the water maze improved after 20- and 90-day treatment periods
- nest construction behaviour was restored after 72 hours of treatment
- ability to sense odours was restored by three days of treatment
How did the researchers interpret the results?
The researchers conclude that activation of the receptor involved (the retinoid X receptor through use of bexarotene helps to clear beta-amyloid build-up in mouse models of Alzheimer’s and gives a rapid reversal of the associated cognitive and neurological deficits.
Conclusion
This animal research has demonstrated that bexarotene can have a positive effect in clearing the build-up of the characteristic beta-amyloid protein plaques and improving cognitive impairments in mouse models of Alzheimer’s. Bexarotene (brand name Targretin is an anti-cancer drug that is currently licensed specifically for the treatment of a rare type of skin cancer called advanced cutaneous T-cell lymphoma.
Although this research is in animals, and therefore has a limited direct application to humans at present, these early findings do present some genuine potential that needs further research. There is bound to be great interest in the finding that the drug seemed to have an early effect on the amyloid plaques characteristic of Alzheimer’s, particularly as the study involved a drug that is already licensed for use in a specific, rare type of cancer (advanced cutaneous T cell lymphoma . Given its existing use, there may be the possibility of earlier testing in humans than there would be if this were a completely new chemical in development, which would have completely unknown health and safety effects.Nevertheless, this drug has not yet been tested in humans with Alzheimer’s, and results from such studies will be needed before we know for certain whether it is also helpful in humans.
Better treatments for Alzheimer’s in humans are needed, and research such as this is is an important early step towards achieving this goal. While it is far too early to say whether this drug could be a cure for Alzheimer’s, at least in the context of this early research the drug has marked itself out as a clear candidate for further exploration.
Links To The Headlines
Alzheimer's brain plaques 'rapidly cleared' in mice. BBC News, February 10 2012
Skin cancer drug 'reverses Alzheimer's'. The Daily Telegraph, February 10 2012
Skin cancer drug 'clears Alzheimer's protein from the brain'. Daily Mail, February 10 2012
Does skin cancer drug offer Alzheimer's hope? Channel 4 News, February 10 2012
Links To Science
Cramer PE, Cirrito JR, Wesson DW, et al. ApoE-Directed Therapeutics Rapidly Clear ?-Amyloid and Reverse Deficits in AD Mouse Models Science. Published online February 9 2012
Watch Video |
Listen to the Audio
JEFFREY BROWN: President Obama backtracked some today on a birth control insurance mandate. His new plan sought to satisfy critics of the plan, while maintaining support from women's health advocates.
The president entered the White House Briefing Room bent on calming a political storm.
PRESIDENT BARACK OBAMA: Religious liberty will be protected, and a law that requires free preventive care will not discriminate against women.
JEFFREY BROWN: Just three weeks ago, the administration announced that religiously affiliated schools, hospitals and other institutions had to cover birth control free of cost. Roman Catholic officials, in particular, charged the mandate would force them to violate their own teachings.
Today, the president said the revised plan would address that objection.
BARACK OBAMA: Under the rule women will still have access to free, preventive care that includes contraceptive services no matter where they work. So that core principle remains.
But if a woman's employer is a charity or a hospital that has a religious objection to providing contraceptive services as part of their health plan, the insurance company -- not the hospital, not the charity -- will be required to reach out and offer the woman contraceptive care free of charge without co-pays and without hassles.
JEFFREY BROWN: The president of the Catholic Health Association, representing Catholic hospitals, welcomed the decision.
Sister Carol Keehan said in a statement, "The framework developed has responded to the issues we identified that needed to be fixed."
The head of the U.S. Conference of Catholic Bishops was more restrained. Archbishop of New York Timothy Dolan said, "Today's decision to revise how individuals obtain services that are morally objectionable to religious entities and people of faith is a first step in the right direction."
Groups that supported the birth control mandate, from Planned Parenthood to the National Organization for Women, backed the compromise.
Louise Melling is deputy legal director for the American Civil Liberties Union.
LOUISE MELLING, American Civil Liberties Union: We were pleased that, today, the Obama administration made perfectly clear its longstanding commitment to contraceptive coverage, that it made clear, again, and reaffirmed its commitment to ensure that women across the country, no matter where they work, will be able to have coverage for contraception.
JEFFREY BROWN: For their part, Republican presidential candidates kept up their criticism of the original mandate.
Former House Speaker Newt Gingrich spoke at a gathering of conservative activists in Washington.
NEWT GINGRICH (R : Our core document says we are endowed by our creator with certain unalienable rights. And Barack Obama seeks to cut across those.
And I, frankly, don't care what deal he tries to cut, this is a man who is deeply committed -- if he wins reelection, he will wage war on the Catholic Church the morning after he's reelected. We cannot trust him, we should -- we know who he really is, and we should make sure the country knows who he really is.
(APPLAUSE
JEFFREY BROWN: At that same conference, former Pennsylvania Sen. Rick Santorum accused the administration of overreach. He spoke shortly before the president's remarks.
RICK SANTORUM (R : This is the kind of coercion that we can expect. It's not about contraception. It's about economic liberty. It's about freedom of speech. It's about freedom of religion. It's about government control of your lives. And it's got to stop.
(CHEERING AND APPLAUSE
JEFFREY BROWN: Mitt Romney didn't directly respond to the Obama announcement, but he vowed that his would be a pro-life presidency.
MITT ROMNEY (R : And I will reverse every single Obama regulation that attacks our religious liberty and threatens innocent life in this country.
JEFFREY BROWN: The president today suggested the political uproar should die down now that the policy has changed.
BARACK OBAMA: I understand some folks in Washington may want to treat this as another political wedge issue, but it shouldn't be. I certainly never saw it that way.
This is an issue where people of good will on both sides of the debate have been sorting through some very complicated questions to find a solution that works for everyone. With today's announcement, we've done that.
JEFFREY BROWN: With the president hoping to put the birth control furor behind him, aides will be watching to see if Republicans in Congress push ahead with emergency legislation on the issue.
RAY SUAREZ: This afternoon, I spoke about the president's decision with Kathleen Sebelius, the secretary of health and human services. She spoke from the front lawn of the White House, where construction has been under way for more than a year, work that resumed during our interview.
Secretary Sebelius, welcome back to the NewsHour.
HEALTH AND HUMAN SERVICES SECRETARY KATHLEEN SEBELIUS: Thank you. Nice to be with you, Ray.
RAY SUAREZ: Could the administration have avoided a damaging fight over contraception coverage by announcing this policy in the first place?
KATHLEEN SEBELIUS: Well, I think what people missed is that the announcement that I made two weeks ago suggested that we were moving ahead with the exemption that had been originally drafted, but, also, we would spend time reaching out to stakeholders, to religious employers who objected to offering this coverage, and we would spend a year finding arrangements that both respected their religious liberty, but made sure at the end of the day that women employees of these institutions, whether she was a university professor or a nurse or a janitor, could make their own determination about very important preventive health care.
RAY SUAREZ: Did you have any idea what was coming? Were you warned by administration colleagues about possible backlash?
KATHLEEN SEBELIUS: Well, there were certainly people who felt we should broaden the exemption greatly.
I think the president from the outset determined that he was not willing to have millions of American women bear the financial burden of their employer deciding they should not access contraception, a drug that is the most frequently used prescription drug of women 14 to 40, and that often has a serious financial cost, up to $600 if a woman is paying out of pocket for it.
So, on one hand, we wanted to make sure that the preventive health benefits, no co-pays, no co-insurance applied to the whole range of IOM recommendations, so keep the exemption narrow, for churches and church affiliates, but also use the time to look at the 28 states which have mandatory contraceptive coverage, see what arrangements were satisfactory to the various Catholic institutions who right now offer that coverage, universities and hospitals, and deem that to be effective going forward.
When the firestorm broke out, the president basically said, we have got to speed up this process. Let's find a solution respecting religious liberty and guaranteeing that millions of women in America, and really all women in America now, have insurance policies that will have a range of health services needed by them and their families without co-pays and co-insurance to make sure they can access them.
RAY SUAREZ: So, you mentioned the administration spoke to religious institutions beforehand. Have you spoken to them about this latest adjustment, this latest change of policy?
It's reported that President Obama has already spoken to Archbishop Timothy Dolan of New York, one of the senior leaders of the Catholic Church.
KATHLEEN SEBELIUS: Well, I don't -- I know he has reached out to Archbishop Dolan. I know he has spoken to Sister Carol Keehan from the Catholic Health Association, who has issued a statement very supportive of this rule that we're going to publish in the federal register today.
I know he has spoken to Cecile Richards from Planned Parenthood, who was also very supportive of the rules we put out today. We are going to be -- again, as we develop the specifics around this regulation, work with insurance companies, work with institutions.
But I think this does exactly what the president asked us to do, which is make sure that millions of women, regardless of who their employer is, can make their own health decisions, have access to this full range of very important preventive health services, as recommended by the Institute of Medicine, and at the same time respect the religious liberty of their employers who may object to either paying for or directly offering this coverage.
RAY SUAREZ: Secretary, can we talk about mechanics? If you've just taken a new job at a religiously based hospital or university, your employee paperwork is silent on reproductive health care, what happens next?
KATHLEEN SEBELIUS: Well, typically, if you are a new employee and in an insured plan, the insurance company or the variety of insurance companies are the ones who actually publish the benefit package.
So, in this case, again, the insurance company would be reaching out to employees, making it clear that it is their choice whether to access contraceptive benefits. And what we know, Ray, is that actually this is a no-cost benefit, that the National Business Council on Health, that our actuaries, a variety of people in group plans say having contraception as part of a group insurance plan actually lowers the overall cost, doesn't increase it, because, on balance, preventive services around family planning, avoiding what may be unhealthy pregnancies, avoiding the health consequences of that actually is a cost reducer.
So we have a situation where the insurance companies directly offer this benefit to the women employees, and the religious employer doesn't pay for it, doesn't refer to it, and doesn't have to offer it.
RAY SUAREZ: You say money from the religious institutions doesn't pay for this, but isn't money fungible?
If a Catholic nonprofit is paying for your insurance coverage, isn't it paying for contraception if you are getting the coverage through that same insurer?
KATHLEEN SEBELIUS: Well, again, Ray, in this case, actuaries have looked at this benefit.
The federal employees health plan, when contraception was added to federal employees' benefit, which is the largest employee group in the country, costed this as no cost, free, no cost, because adding contraception and having some employees take advantage of that coverage lowers the overall cost of the health plan.
So we have that in place around the country. We have actuaries that have inserted that, and so we're not -- this isn't a shell game of passing the costs along. This is a real no-cost option that is, according to the National Business Council on Health, could reduce an insurance plan by about 15 percent. We're not counting on that.
But I think we can say very safely that this doesn't add to the cost of either the employer's plan -- and we know that women, if they have to purchase this coverage outside of a health plan, could spend up to $600, which is a substantial financial barrier to access a very important health benefit and a benefit used by 99 percent of women across this country at some point in their lives.
RAY SUAREZ: Well, you've transferred the administrative burden to insurance companies. Are insurers ready to pay? Have they signed on?
KATHLEEN SEBELIUS: We will be doing just that.
But as part of the Affordable Care Act, our department will define the rules under which we offer these benefits. And we're confident that this works and that insurers are prepared to step up and do this. Again, this is in place in many states in the country right now, where there is an insurance company providing benefits to employees, and the employer not directly offering those benefits.
RAY SUAREZ: Health and Human Services Secretary Kathleen Sebelius, Madam Secretary, thanks for joining us.
KATHLEEN SEBELIUS: Great to be with you, Ray.
“Children born to women undergoing cancer drug treatment show normal results in physical and mental development tests” The Guardian has reported.
The news is based on research that examined the health of 70 children who were exposed to chemotherapy in the womb during the final two-thirds of pregnancy. Between the ages of 18 months and 18 years of age the children were given examinations of their general health, brain and heart function and hearing. Their cognitive function, hearing, heart function, growth and development were all comparable with the general population. However, being born prematurely was associated with lower cognitive scores, leading the researchers to recommend against doctors inducing early delivery in women requiring chemotherapy. The researchers also say their results do not support delaying chemotherapy in pregnant women.
During pregnancy treatment decisions have to be made that are in the best interest of the mother’s health, while trying to avoid the risk of harm to the fetus. Unfortunately though, this relatively small dataset cannot provide conclusive proof that chemotherapy poses no risk at all to the unborn child. The researchers say that their study is currently gathering longer-term data on wider numbers of children to help explore the issue further.
Where did the story come from?
The study was carried out by researchers from Leuven Cancer Institute and Katholieke Universiteit Leuven in Belgium, and other institutions in Czech Republic, the Netherlands and Canada. The study was funded by a number of European medical research and technology funds and the Belgian Ministry of Health. The study was published in the peer-reviewed medical journal The Lancet.
In general the news provided balanced coverage of this study. The Daily Mail’s headline declared that pregnant women with breast cancer can have chemotherapy and surgery and “still give birth safely”. However, this is slightly confusing as the focus of this study was not women with breast cancer, and the study looked at children’s long-term development rather than the safety of their delivery. The researchers’ main finding was actually that premaurity was associated with lower IQ scores, meaning that planned premature delivery may not be the best option.
What kind of research was this?
This was a cohort study looking at how foetal exposure to maternal cancer and treatment, including chemotherapy, affected the physical and cognitive development of child at various points through their childhood.
While it is known that exposure to chemotherapy during the first 12 weeks of pregnancy can increase the risk of congenital defects in the baby, there is uncertainty over whether exposure during later stages of pregnancy can also affect heart and brain development. The researchers say that up until now, limited data has been available on the longer-term outcomes of children exposed to chemotherapy in the uterus. With this in mind they intended to record the general health, cardiac function, and brain development in children who were exposed to chemotherapy in the uterus.
Cohort studies such as this are the best way of assessing harms from chemotherapy in pregnancy, as it is generally believed to be potentially harmful to the baby, but is sometimes unavoidable in clinical practice. Setting up a trial randomising pregnant women with cancer to receive cancer treatment or not in order to assess developmental effects on the offspring would be unethical, both for the mother (who may be denied the treatment she needs and baby (who may put at unnecessary risk of harm . Therefore a cohort study is likely to be the most appropriate way of exploring the issue.
What did the research involve?
From 2005 onwards researchers began gathering study subjects from cancer referral centres in Belgium, the Netherlands and the Czech Republic. This included both pregnant women receiving chemotherapy at the time, and children and mothers who had been exposed to chemotherapy several years prior to the study. Dependent on the age of the child the researchers carried out assessments at ages of 18 months, 5–6 years, 8–9 years, 11–12 years, 14–15 years, or 18 years. The study is ongoing, and in time these children will be given further examinations.
The researchers carried out neurological examinations, tests of cognitive function (using recognised child development tests or IQ tests , heart examinations (electrocardiography and echocardiography , and administered a questionnaire on general health and development. Children who were over five years of age also received hearing tests in addition the Child Behavior Checklist, a questionnaire that screens for behavioural and emotional problems.
The researchers compared their findings with available norms such as national data for height, weight, head circumference, as well as national and international reference data for neurodevelopmental tests, and heart examination tests.
What were the basic results?
The current analysis of this ongoing study looked at the participating children’s development until March 2011. The researchers assessed 70 children (27 born between 1991 and 2004, and 43 born after 2004 from 68 pregnancies (two of the women had given birth to twins . All women had received chemotherapy; some were also given radiotherapy, surgery or both. Across the group, 19 different chemotherapy regimens had been given, in which 236 cycles of chemotherapy were administered.
On average the babies were born at a pregnancy duration of 35.7 weeks (i.e. most were premature ; only 23 babies (33% of the cohort were born at full term (37 weeks or over . The average period of follow-up for each child was 22.3 months.
The children’s behavior, general health, hearing, growth, and heart function were comparable to the general population. Most children were recorded as having normal cognitive development, with most children with scores below the normal range having been born prematurely. After the researchers adjusted for age, sex, and country, they found an 11.6 point increase in IQ score for each additional month of pregnancy that the baby was carried for. The researchers found that both members of one of the twin pregnancies had severe neurodevelopmental delay, and could not be assessed with the complete set of cognitive tests.
How did the researchers interpret the results?
The researchers conclude that children exposed to chemotherapy in the uterus do not have increased likelihood of neurological, cardiac, hearing or general health and growth impairments compared with the general population.
However, prematurity was common and was associated with impaired cognitive development; therefore, planned premature delivery should be avoided where possible.
Conclusion
During pregnancy difficult treatment decisions have to be made bearing in mind the best interests of both a mother and her unborn child. This valuable cohort study provides follow-up data on children who were exposed to chemotherapy while in the uterus, from young childhood through to adolescence and beyond.
Its findings are reassuring and suggest that a child’s exposure to chemotherapy during later stage pregnancy (beyond the first 12 weeks is not associated with brain, heart or other developmental complications in the child. As the researchers note, their findings do not support the practice of delaying chemotherapy or performing planned premature delivery in order to administer chemotherapy to the mother after birth (the study suggests that premature birth may carry greater risk of adverse cognitive outcome than chemotherapy exposure itself .
However, though it does provide some reassurance, unfortunately this relatively small dataset cannot provide conclusive proof that chemotherapy poses no risk at all to the unborn child:
- As the researchers acknowledge, two children born to a twin pregnancy had important neurodevelopmental delay and they cannot exclude the possibility that exposure to chemotherapy during a critical time of brain development was the cause. However, the researchers considered that the broad nature of the problems in one of the twins suggested that chemotherapy was less likely to be the cause.
- Also, though the general neurodevelopmental assessments for the cohort were within the normal range expected among the general population, the researchers noted that a sample of children had some discrepancy between verbal performance and IQ values on intelligence tests, while a sample of others had raised problem scores on a child behavior checklist. The researchers say that these findings show that it is possible that chemotherapy has more subtle effects on neurodevelopment.
- Additionally, other longer-term effects that this study has not looked at need to be assessed, including risks of cancer in the offspring themselves or fertility effects.
- It is important to note that all chemotherapy in this study was given after the first 12 weeks of pregnancy: chemotherapy in the first trimester is associated with increased risk of congenital malformations, and this study does not assess or refute this.
- The study lacked a direct comparison group of children not exposed to chemotherapy in the uterus. Though the researchers did compare to national averages, the ideal comparison method would have been performing the same range of tests in children who were born at the same pregnancy gestation but who had not been exposed to chemotherapy.
- The researchers say that their Cancer in Pregnancy initiative will need to continue to gather longer-term follow-up on much wider numbers of children exposed to chemotherapy in pregnancy.
Links To The Headlines
Chemo in pregnancy does not necessarily harm baby, says study. The Guardian, February 10 2012
Pregnant women with breast cancer can have chemotherapy and surgery and still give birth safely. Daily Mail, February 10 2012
Chemotherapy is 'safe during pregnancy'. The Independent, February 10 2012
Pregnant women can be treated for cancer 'without harming baby'. Daily Telegraph, February 10 2012
I wanted to live but I also wanted to keep my baby: mother Caroline Swain. The Daily Telegraph, February 10 2012
Links To Science
Amant F, Van Calsteren F, Halaska MJ et al. Long-term cognitive and cardiac outcomes after prenatal exposure to chemotherapy in children aged 18 months or older: an observational study. The Lancet Oncology, Published Online February 10 2012
The US Food and Drug Administration is getting ready to review generic biotech drugs for the first time.
In advance of this, it released on 10 February 2012 guidelines under which the review process will be carried out. For consumers, the move represents the chance to obtain these hi-tech drugs - which presently command high prices - much more cheaply as so-called ‘biosimilars'.
The 2010 Patient Protection and Affordable Care Act featured one section calling for a biosimilar drug approval channel to open up but stated the FDA should be responsible for its content.
Draft Biotech Drug Guidelines
The draft biotech drug approval guidelines now release represent the administration's response to this call and they cover several areas. These include ‘Scientific Considerations', which supplies information to help generic biotech drug manufacturers prove that their products resemble those on which they're based. Also focused on are ‘Quality Considerations in Demonstrating Biosimilarity to a Reference Protein Product'.
"When it comes to getting new biosimilar products on the market, FDA has taken an innovative approach to supporting their development at every step of the process", Janet Woodcock from the administration's Center for Drug Evaluation and Research explained in a statement. She added: "These draft documents are designed to help industry develop biosimilar versions of currently approved biological products, which can enhance competition and may lead to better patient access and lower cost to consumers."
Generic Biotech Drug Approval
Responding to the news of these generic biotech drug approval guidelines' release, manufacturers expressed content and a statement issued by GPhA - the Generic Pharmaceutical Association sums up their feelings.
"GPhA is pleased that the FDA has issued draft guidance today on the development of a regulatory pathway for generic biologic drugs, or biosimilars, as it is an important step in getting these affordable, lifesaving medicines into the hands of doctors and patients", the organisation said.
According to IMS Health, the worldwide biosimilars market has the potential to reach $25bn in value by 2020, thereby occupying a 10 per cent share of the overall biotech drugs market.
From here, the FDA's guidelines will be open for 60 days consultation, then firmed-up before being re-released in final form.
See also:
Companies supplying
Biotechnology
The Food and Drug Administration approved
Pradaxa use in October 2010. Shortly after, the agency received a number of reports that the drug causes adverse side effects which are both serious and often fatal.
Pradaxa (dabigatran is a medication designed to treat patients diagnosed with non-valvular atrial fibrillation. It is included in a class of drugs referred to as direct thrombin inhibitors that work by preventing an enzyme which causes blood to clot. When not treated, blood clots have the tendency to travel through the body to the brain and cause stroke which can in most cases lead to death.
Increased concerns associated with Pradaxa use caused the FDA to issue a safety communication in December 2011, warning the public and medical community about the risk of injury and other complications associated with Pradaxa.
Reported side effects of Pradaxa include internal bleeding, caused by the drug hindering kidney function leading to an excess of the drug spreading through the system, brain hemorrhaging, kidney bleeding, heart attack, and sometimes death. Of these, internal bleeding is the most serious. Symptoms of internal bleeding are listed on the
Pradaxa internal bleeding website.
No recall has yet been issued in the United States on the Pradaxa medication, however, the U.S., Japan, and Australian health officials have issued safety warnings on the drug.
The FDA is also in the process of reviewing a number of claims that
Pradaxa causes internal bleeding. In the meantime, Pradaxa lawyers have to represent victims injured by this potentially dangerous drug and are reviewing cases to file against Boehringer Ingelheim, manufacturer of Pradaxa.
Atrial fibrillation is a condition in which part of the heart does not beat the way it should. If not treated properly, blood cells may not circulate properly and tend to clot causing stroke and other complications.
Xigris® (drotrecogin alfa , a synthetic version of protein C, which is a natural protein found in the body, was introduced in 2001. It was prescribed to treat patients that were diagnosed with severe cases of Sepsis and is used to reduce inflammation, decrease blood clotting, and break down current blood clots.
Sepsis, or blood poisoning, is a life threatening condition. This illness causes inflammation of blood vessels, blood clots, and may also lead to organ failure in severe cases.
Reports state that
federal health regulators are pleading with health care professionals to stop prescribing Xigris to patients that have been diagnosed with Sepsis. Researchers believe that the drug actually increases the risk of bleeding to death rather than reducing the risk.
In 2009, the Food and Drug Administration (FDA launched a review of Xigris due to a study which linked use of Xigris to a high rate of bleeding deaths. About 73 patients were reviewed, 20 of those patients were identified as having a risk of bleeding death, 7 suffered severe bleeding after taking Xigris, and 13 ultimately died. Since then, the FDA has advised doctors not to prescribe any new patients with the drug. The FDA also recommends that doctors ask patients that are currently using the drug to stop use immediately.
On Tuesday, October 25th, a
Xigris recall was announced due to the conclusion from a clinical trial which proved that the drug provides no benefits. Results showed that about 2% of patients prescribed Xigris survive septic shock compared to patients prescribed sugar pills. This trial studied 1,696 patients, half of which were treated with placebo. The FDA noted from this study that Xigris provides no significant benefits. The FDA has also suggested that all consumers that have purchased Xigris return the product back to its suppliers.
Researchers at Duke University Medical Center used new tools they developed to analyze knees and hips and discovered that osteoarthritic knee joints are in a constant state of repair, while hip joints are not.
"This suggests the knee has capacity for repair we didn't know about and the main treatment strategy probably would need to focus on turning off the breakdown of knee tissue," said
Virginia Kraus, MD, PhD, professor of
Rheumatology and Immunology at Duke. "I was hugely surprised to find this."
This suggests that knee and hip osteoarthritis may need different treatment approaches, Kraus said.
Perhaps the natural repair response would be sufficient to lead to a reversal or halting of the disease process in the knee if the joint breakdown could be halted, Kraus said.
"At least with the knee you've got an ongoing repair response that we didn't appreciate until now," Kraus said. "If you could capitalize on that and turn off the degradative (breakdown processing you might have some good effects."
The findings, published in the
Journal of Biological Chemistry on Friday, Feb. 10, suggest that for hips, however, halting the degenerative process might not be enough. The hips would need a treatment to both stop degeneration as well as stimulate factors that could help to begin repair.
The knee is very accessible for injections, so it would make sense to inject the knee with agents that could turn off the degradative processes, and these could be delivered periodically with close monitoring, Kraus said. "That seems like a very viable strategy."
A number of treatment strategies are being tested in clinical trials to switch off the joint breakdown processes, and Kraus is hopeful that this approach will lead to treatment breakthroughs for osteoarthritis.
A cocktail of drugs might be needed for the hip, however, both to halt the degradation and to stimulate the right type of reparative elements.
"I am speculating that a single agent would work for the knee," Kraus said.
The findings about the knee were shocking to her, because the literature for years had compared the knee and ankle. Scientists knew the ankle was resistant to osteoarthritis, but the knee was very susceptible.
The thinking was that the ankle joint bones fit together well, like a ball in a socket, so the joint cartilage is less likely to degrade, while the knee joint bones fit less well together and require tissue, like the meniscus, to create a better fit -- so knee cartilage is more likely to degrade.
"What we found is startling, because the hip joint also has a ball-in-socket structure yet it degrades and fails to mount a strong repair response," Kraus said. "We think this means that joint congruency alone cannot explain the difference in the repair response of joints, so there is more to learn."
Kraus and her team discovered a biomarker that is a measure of an altered (deaminated protein, called D-COMP. In the circulation it signals hip degeneration and in cartilage it provides insight into the repair response of joint tissues. Kraus said this is the first biomarker specific to a particular joint site, and may be developed into a monitoring tool for hip-joint breakdown.
The next step is to understand the reasons for the difference between knees and hips and also to use the new tools to analyze the ankle for its level of repair response.
"Why is the ankle less susceptible than the knee to osteoarthritis?" Kraus asked. "Can we develop other tools to be specific indicators of joint health for other joints in the body?"
Other authors include Duke University Medical Center researchers Jonathan B. Catterall, Ming F. Hsueh, Thomas V. Stabler, Christopher R. McCudden, Michael Bolognesi, Robert Zura, and Sheng Feng. Joanne M. Jordan and Jordan B. Renner are from the University of North Carolina at Chapel Hill.
This work was supported by grants from the National Institutes of Health, National Institute on Aging, National Institute of Arthritis and Musculoskeletal and Skin Diseases, and by the Centers for Disease Control and Prevention/Association of Schools of Public Health.
By Todd Neale, Senior Staff Writer, MedPage Today Published: February 08, 2012
Many of the adverse event reports involved patients who were elderly, had underlying medical conditions, or were taking broad spectrum antibiotics. All of those factors could have contributed to the greater risk of C. difficile-associated diarrhea, but the use of PPIs could not be excluded.
PPIs have been associated with other adverse events in the past, including
resistance to clopidogrel (Plavix ,
low magnesium levels resulting in a greater risk of leg spasms, arrhythmias, and seizures, greater risk of
osteoporotic fractures from chronic use, and
cardiac birth defectswhen used during pregnancy.
The FDA is also reviewing the possible risk of in C. difficile-associated diarrhea in users of another class of acid suppressing medications, the histamine H2 receptor blockers.
Controversial plans to build a US-style mega farm pose serious health risks to those living and working nearby, campaigners say
Controversial plans to build a US-style mega pig-farm in South Derbyshire close to a prison and residential housing pose serious health risks to those living and working there and could breach their legal rights to protection of their private and family life, the local council is being warned.
In the light of fresh legal advice, the organic farmers' group, the Soil Association and Friends of the Earth have joined forces with local group Foston Community Forum and
Pig Business, film-makers and campaigners, to urge Derbyshire county council to refuse planning permission for the proposed development at Foston.
Their challenge – the first against the scheme under the Human Rights Act – is
set out in a joint letter to the county council, stating that "planning authorities … have an obligation under the Human Rights Act 1998 to consider the effects of their decision on the human rights of affected third parties. The right to private and family life prevents not just physical incursions into the home or residence, but also interference from things such as noise, smell, emissions."
It goes on to say that the prison staff cannot avoid working close to the proposed development unless they resign from the jobs. The inmates of Foston Hall prison are not living in the area by choice, and clearly do not have the option of moving away if the development goes ahead. They will not be able to escape the risk to their health posed by the development, and the letter warns that allowing the pig factory to go ahead could also breach the inmates' right to be protected from inhumane treatment.
Midland Pig Producers (MPP has applied for permission to build the farm – which could house up to 25,000 animals – on a greenfield site west of the historic village of Foston and adjoining a women's closed prison which houses up to 290 prisoners. If approved, it would become the third largest factory farm in the UK, sending more than 1,000 pigs to slaughter every week.
The legal letter also cites new research which shows that intensive pig factories of this kind can adversely affect the health of nearby residents. This has been confirmed by the government's
Health Protection Agency (HPA , which says that those living within 150 metres of intensive pig farms "could be exposed to mutli-drug resistant organisms". The proposed development will be built within 150m of HMP Foston Hall - as well as within 75m of the nearest properties being planned for workers at the development site.
In November last year the project
was dealt a major blow when Derbyshire district council refused to back it. The final decision – already delayed – will be taken at county council level although no date has yet been set for a meeting.
After an application for a mega-dairy in Lincolnshire by Nocton Dairies,
which was later shelved, Foston has become the focus of a fierce fight over opposing visions for British farming. The Soil Association's concerns have been mainly about disease, antibiotic resistance and animal welfare in large pig herds.
But at an early stage the Foston battle took an unprecented twist involving libel law, when the Soil Assocation
received a threatening letter from solicitors Carter-Ruck - acting for MPP – saying its objection was defamatory and should be withdrawn.
Peter Melchett, policy director of the Soil Association, said: "The objections to the pig factory at Foston are mounting all the time, because of the growing weight of new scientific evidence of real risks to the health of local people, and to the staff and inmates of the prison right next door to the proposed site. Now it seems that the legal rights of local people may also be infringed by the proposed development."
Victoria Martindale, representative of the Foston community forum, said: "As a medical professional I am concerned about the health risks that this proposal will bring to local residents. Those living in the closest vicinity to the proposed site include the most susceptible and at risk groups such as children, the elderly and individuals already with known respiratory and other diseases. It is not fair to expect the residents of Foston to go about their everyday lives while being forced to continuously breathe in air that will put their and their families' health at risk."
A Derbyshire county council spokesperson said: "We have had thousands of views during the consultation and have had to look at and consider them. Following this, we have sent out for additional information from some agencies and are awaiting that. When this comes in we shall have to consider this and ensure we have all the information we need before compiling the report for the committee to consider."
MPP was contacted by the Guardian but has not issued a response to the letter.
Terms & Conditions |
More Feeds
In light of the recent anti-aging breakthroughs (namely scientists working tirelessly towards halting the aging process and a pill to prevent gray hair , it begs the question: is “aging” the new medical condition to fear? Perhaps an over-the-top question, but most women I know (and plenty of men talk about aging as if it’s a major illness. Honestly, the way some of my girlfriends talk about wrinkles you’d think they had a degenerative disease of some sort.
These days, people are flocking to plastic surgeons like moths to a flame – all in hopes they’ll stop the proverbial clock. In fact, in 2010, 9.5 million people had cosmetic surgery. That's up 9% from 2009, with breast augmentation and liposuction topping the list of procedures. Our fixation with youth is rampant, as the thought of age (such an ugly word has become a stigma. It’s left me questioning my thoughts and character on the matter and, despite my best efforts, my virtues don’t seem to fall into the “grow old gracefully” bucket…
Is Aging Gracefully For Sissies?
After much thought and soul searching, I’ve concluded that I’m on the fence when it comes to this topic. While my moral character tells me I should consider my smile lines a badge of a happy life and my crows’ feet a brand of years of laughter, my vanity gets the best of me as I scrutinize my wrinkles in the mirror. (I’ll spare you my rants on the toll gravity has taken on areas
below
my the neck. But instead of fretting over signs of aging, shouldn’t we be grateful we’re healthy and able? Not an easy task with titles like crows’ feet, turkey neck, old lady hands, cellulite, and age spots. It’s all too easy to get sucked into the frenzy.
Related:
The Anti-Aging WORKOUT
Eternal Youth?
So, will scientists soon find a way to halt the aging process? It certainly sounds promising. In a study reported in the journal of
Nature
, scientists gave mice a drug that “flushed out” the retired cells (that accumulate naturally with age . Post treatment, the mice suffered from less fat loss under the skin (which keeps skin youthful , had fewer eye cataracts, and less muscle loss. While the research is still in early stages (read: you might be a senior citizen by the time it’s on the market , scientists are confident they’ll create a successful anti-aging cure. And if that’s not enough to lift your anti-aging spirits, this will be: they’re also working on a pill to prevent gray hair. After all, if science will soon allow us to stop the aging process, then we most certainly couldn’t have gray hair giving away our real age, now could we? L’Oreal says it is hard at work creating
this cosmetic breakthrough, and expects it to be on the market by 2015. In short, this magical pill will stop “oxidative stress” (fancy words for the process by which follicles turn hair gray . The downer? If you’ve already got salt n’ pepper hair, you’re SOL.
So, what’s your take? Should aging be considered a disease? Or are we misguided in our unwavering quest for eternal youth? And if we do achieve the cure for aging, what will Mother Nature do for a living? (Starbucks barista? Wal-mart greeter?
I’ll be the first to admit (through gritted teeth I have definitely been “bitten” by the fear of aging (insert self-reproach here . Well then, bring on the snake oils…
More from GalTime:
An ongoing legal case between GlaxoSmithKline and courts in Argentina has drawn attention to possible procedural problems in trials done in developing nations. Natalia Fuertes reports.
After GlaxoSmithKline (GSK was fined US$92 000 by Argentinian courts for administrative irregularities in a vaccine trial, observers have questioned whether trials are done under the same strict principles all over the world.
On Dec 28, 2011, Marcelo Aguinsky, a judge in the province of Mendoza, found GSK guilty of irregularities in obtaining informed consent in a trial assessing the efficacy and safety of Synflorix—a vaccine against Streptococcus pneumoniae and acute otitis media caused by non-typeable Haemophilus influenzae. Aguinsky fined the drug company and the two main investigators, Miguel Tregnaghi and Hector Abate, a total of AR$1 million. GSK is currently appealing the decision. “GSK conducts clinical trials to the same high standards, irrespective of where in the world they are run”, the company said in a statement.
The COMPAS trial was done between 2007 and 2008 in rural areas of three provinces in the east and north of Argentina—Mendoza, Santiago del Estero, and San Juan. It involved around 400 health professionals and was originally intended to recruit 17 000 children.
Problems in the GSK trial first came to light in 2007, when paediatrician Ana Marchese reported possible irregularities to FeSProSa (Syndicate Federation of Argentinian Health Professionals after speaking to the trial participants' families. FeSProSa investigated the accusations and filed a report to the National Administration of Drugs, Food and Medical Technology (ANMAT in December, 2007, declaring problems surrounding informed consent. GSK stated that it was the company that had identified the irregularities through self-monitoring and reported them straight to ANMAT.
ANMAT undertook an inspection of the procedures and consent forms and found that in some of them, there was reason to believe that the parents of the participants did not fully understand what they were signing and the witnesses were not impartial. Due to these irregularities, the recruitment process was stopped in August, 2008. Roberto Lede, director of Planning and Institutional Relationships of ANMAT, states that “the intervention of the ANMAT was very opportune. The recruitment was stopped in the way it was being carried out and resumed with intensive control. It should be noted that the irregularities only affected less than 1% of the subjects.”
14 infants who were taking part in the COMPAS trial died during it. However, because they were in the placebo group, GSK and ANMAT agreed that the trial could continue. COMPAS ended successfully in 2008, with only 18% fewer subjects than originally intended, and Synflorix was approved by ANMAT.
However, as the problem regarding invalidity of some of the consent forms remained, ANMAT issued a fine to GSK and the local doctors in charge. While GSK are appealing the fine in Mendoza, in Santiago del Estero, their appeal to the Supreme Court was successful, and the ruling was dismissed. In San Juan, the local courts have yet to rule.
The ruling of the Argentinian courts marks a pivotal moment in the regulations of trials by local authorities. Luis Petri, a member of the Lower House in Mendoza presented a bill in early January, 2012, to ban clinical trials in the province. “Children of Mendoza must not be used as guinea pigs by pharmaceutical companies to try their drugs or vaccines, regardless of the consent of their parents”, he stated. The bill is still under consideration.
In 2007, about 200 trials were done in Argentina, but not all of them were officially registered. After the irregularities in the COMPAS trial were disclosed, the government decided to create a National Register of Trials. In November, 2008, ANMAT ordered drug companies throughout the country to include a warning sign in red capital letters on every consent form, clearly stating the experimental nature of the trial. However, ANMAT's Lede said that “there was no need to introduce any modifications to the law; the problem was not the law but the compliance with it”.
Brian Angus, director of the Wellcome Trust UK Centre for Clinical Tropical Medicine in Oxford, UK, states that “protection of volunteers for clinical trials is crucial. Especially overseas, where people sometimes do not have the level of education to understand the implications of a clinical trial, there is even greater need for the doctors to act in the patient's best interests. It is ultimately the doctor's responsibility. What would you do if somebody agrees to be part of a clinical trial but you do not think they really understand what it means? The answer is clear, you do not recruit them.”
GSK's fine is the largest Argentina has issued against a drug company. And while the case has led to legal changes in the country, it has also drawn attention to the need to improve ethical and procedural standards of trials done in developing regions of the world.
Vancouver Sun. Using cannabis within three hours of driving causes accidents at nearly twice the rate as those who are not under the influence of drugs or alcohol claims the paper’s authors, from Dalhousie University. Lead author Mark Asbridge, an associate professor in the department of community health and epidemiology at Dalhousie told Kirkey: “Surveys of young drivers have also shown rates of driving under the influence of cannabis have surpassed rates of drinking and driving in some jurisdictions.” “Not only is cannabis relatively easy to obtain, many young people really don’t believe cannabis impairs.” Previous studies into cannabis and automobile accidents have had mixed results. Some showed an increased risk of an automobile collision after using marijuana, others have found either no association whatsoever, or even a lower risk. For this study, researchers reviewed nine studies with a total sample of 49,411 subjects from Australia, New Zealand, the US, France and the Netherlands to determine the driving risks. The studies tested for tetrahydrocannabinol (THC , the active chemical in cannabis, by analyzing blood samples or using direct reports of cannabis use from those involved. Most studies used any amount greater than zero as the cut-off for a positive test result. Duncan Vernon, a road safety manager at the Royal Society for the Prevention of Accidents (RoSPA , told
BBC News that previous studies in controlled lab conditions had shown that cannabis does impair a driver’s ability drive safely and responsibly. “This new research strengthens the evidence that driving under the influence of cannabis increases the likelihood of being seriously injured or killed in a collision,” Vernon explained. “This adds to the argument that a system needs to be put in place to monitor the number of serious and fatal accidents where impairment from illegal drugs was a contributory factor, so that appropriate action can be taken to prevent them.” The study concluded with the suggestion that the consumption of cannabis indeed impairs safe motoring ability and increases the chance of collisions. --- On the Net:
Super continents come and go. And when they come, geologists reason the individual pieces either keep flying apart until they collide and form a new super continent on the other side of the world, or they fall back together and form near the same spot the old one started out at. Researches now say the former is likely over the next 50 million to 200 million years, which would place Pangea II on the north pole. If you measure using creationist years, better firm up those dream
vacation plans!
First to disappear will be the US Gulf Coast as the north shore of South America slides into the US, squeezing the Caribbean out of existence. Then Eurasia skids east and compresses the Atlantic out of being, as both the American and Eurasian super-mass slide toward a super continental polar rendezvous.
- Via
Lindsey Beyerstein, the reason we rely on government regulation to address important issues is because making something a law works:
The amount of trans fat in the American bloodstream fell by more than half after the Food and Drug Administration required food manufacturers to label how much of the unhealthful ingredient is in their products, according to a new study.
- A drug used to treat skin cancer in humans has
unexpectedly eliminated the beta-amyloid plaque associated with Alzheimer's—in as little as 72 hours—in tests on mice. Given the stakes human trials could start very soon.
- Check out this
gorgeous picture of sand dunes on Mars. Will conspiracy theorists pushing the giant Face of Mars to get ahold of it and announce the giant hand that goes with the face has been found? Maybe there's body parts scattered all over the Red Planet ...
- We have added a new
rising science-y star to the deep bench at
FreeThoughtBlogs.
Biodork is a biotech researcher who writes about "pro-choice and GLBT issues, science, politics, religious-based asshattery, separation of church and state stories, health and medicine," just to name a few!
Category: Health News
Created: 2/8/2012 6:06:00 PM
Last Editorial Review: 2/9/2012
Category: Health News
Created: 2/9/2012 4:06:00 PM
Last Editorial Review: 2/10/2012
Category: Health News
Created: 2/9/2012 4:06:00 PM
Last Editorial Review: 2/10/2012
Category: Health News
Created: 2/9/2012 2:06:00 PM
Last Editorial Review: 2/10/2012
No comments:
Post a Comment