Antipsychotics death risk charted in dementia patients



"Some antipsychotic medication may increase the risk of death in patients with dementia more than others, according to US research.
The drugs have a powerful sedative effect so are often used when dementia patients become aggressive or distressed.
A study, published on the BMJ website, argued that antipsychotics should not be used "in the absence of clear need".
Experts said better alternatives were needed to antipsychotics.
A study in 2009, suggested 180,000 people with dementia were taking antipsychotic medication in the UK and said the drugs resulted in 1,800 additional deaths.
Researchers at Harvard Medical School followed 75,445 people in nursing homes who had dementia and were prescribed antipsychotics.
The researchers said some drugs were associated with more than twice the risk of death than risperidone, another antipsychotic which was used as a benchmark to compare the other drugs.
The study concluded: "The data suggest that the risk of mortality with these drugs is generally increased with higher doses and seems to be highest for haloperidol and least for quetiapine."
However, the way the study was conducted meant it could not say definitively that certain drugs actually caused more deaths, merely that there was a link between the two.
The Department of Health said antipsychotic use was "resulting in as many as 1,800 unnecessary deaths per year. This is simply unacceptable." (...)"
in BBC

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Cancer Drugs Approved by FDA



"  Cancer Drugs were approved by FDA: Federal regulators said Tuesday that they’ve approved new suppliers for two crucial cancer drugs, easing critical shortages — at least for the time being — that have left patients and parents frightened about missing life-saving treatments.
The news brings a light at the end of the tunnel for some patients, but not for thousands of others, given that there are currently 283 separate drugs in short supply or totally unavailable in this country.
On Tuesday, the Food and Drug Administration said it will temporarily allow importation of a replacement drug for Doxil, a drug for ovarian and other cancers that hasn’t been available for new patients for months.
The agency also has approved another supplier for a preservative-free version of methotrexate, a crucial drug for children with a type of leukemia called ALL and for high-dose treatment of bone cancer. The version with preservatives can be toxic or cause paralysis in children and other patients getting the drug either via injections into spinal cord fluid or at very high doses.
The FDA also has approved the release of a batch manufactured by Ben Venue Laboratories Inc., shortly before it closed several factories at its complex in Bedford, Ohio, due to serious quality problems. That closing is what turned the on-again, off-again methotrexate shortage that began in late 2008 into a crisis almost overnight, with fears that patients would begin missing treatments as soon as the end of this month.
“We have made real progress … We believe that (suppliers) will be able to meet the demands of patients in the U.S. market” for the two drugs indefinitely, FDA Dr. Commissioner Margaret A. Hamburg told The Associated Press in an exclusive interview. “It’s a huge relief for us.”
The FDA increasingly has been able to prevent drug shortages, mainly due to a sixfold increase in manufacturers voluntarily notifying the FDA when they anticipate shortages, Hamburg said.
Thanks to such notice, the agency prevented 195 drug shortages in 2011, mostly late in the year after President Obama issued an executive order giving FDA additional powers to address the shortages. Between that order on Oct. 31 and this week, the agency has prevented a total of 114 drug shortages.
Hamburg said that when FDA’s much-expanded drug shortages team is notified about impending shortages and contacts other manufacturers, those companies have been “very responsive” as FDA worked with them on finding ways to boost production.
In the latest case, the FDA said it has temporarily allowed importation of an alternative to Doxil called Lipodox, made by Sun Pharma Global FZE. The Indian drugmaker is already known to the agency, and its factory and the production line for Lipodox have been inspected.
The FDA also has given approval to APP Pharmaceuticals LLC to begin making a preservative-free version of methotrexate in addition to its current drug that includes preservatives. The company had made a preservative-free version years ago, but needed to update paperwork and meet other requirements, which the FDA expedited. It’s expected to start shipping the medication by the middle of March.
Another maker, Hospira Inc., expected today to start shipping about 31,000 vials of preservative-free methotrexate, more than enough to meet a month’s demand, to hundreds of hospitals and treatment centers.
Still, hundreds of other drugs remain in short supply, including many other cancer medicines. (...)"
in Time
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H5N1 Study



"  H5N1 Study: Experts have delayed a decision on whether controversial research into the H5N1 bird flu virus should be released.
It had been looking at how the work could be released while guarding against its abuse by bioterrorists.
But talks at the World Health Organization in Geneva decided more discussions were needed to see if it could be possible to publish in full.
One of the two journals which want to publish has already agreed to wait for talks to be complete.
H5N1 Study about mutation fears
The controversy is centred on two research papers - one of which was submitted to Science, the other to another leading journal, Nature, last year.
They showed that the H5N1 virus could relatively easily mutate into a form that could spread rapidly among the human population.
The studies prompted the US National Security Advisory Board for Biotechnology (NSABB) to ask both journals last November to redact some sensitive parts of the research, which it believed could be used by terrorists to develop such a virus.
The request caused outcry among some scientists who believed that it was an infringement of academic freedom.
Some pointed out that the scientists had given presentations about their work at conferences and the details were already widely circulated, so redaction would have little purpose.
The scientists who carried out the research, and the journals concerned, have been considering the request and listening to suggestions as to how the research results could be redacted in the scientific journals, but distributed to bona fide researchers who urgently need the information.
The information is vital to develop a vaccine to any human form of bird flu, and it would enable surveillance teams to see if the bird flu virus was mutating into a form that could be transmissible to humans.
But such efforts have been put on hold for four months as governments, scientists and the journals decide what to do.
The Geneva meeting of 22 scientists and journal representatives agreed that publishing only parts of the research would not be helpful, because they would not give the full context of a complete paper.
It agreed to extend a temporary moratorium on research using lab-modified H5N1 viruses, but also recognised that research on naturally occurring virus "must continue".
Dr Keji Fukada, assistant director-general of health security and environment for the WHO, said: "Given the high death rate associated with this virus - 60% of all humans who have been infected have died - all participants at the meeting emphasised the high level of concern with this flu virus in the scientific community and the need to understand it better with additional research.
"The results of this new research have made it clear that H5N1 viruses have the potential to transmit more easily between people underscoring the critical importance for continued surveillance and research with this virus."
Dr Fukada added: "There is a preference from a public health perspective for full disclosure of the information in these two studies. However there are significant public concern surrounding this research that should first be addressed."
Experts will now look at what information is already in the public domain and how that relates to the contents of these research papers.
A further meeting is likely to happen in a couple of months' time.
Nature has said it is happy to wait - if there is a chance it will able to publish in full.
Science's editor Dr Bruce Alberts, had previously said it also wanted to publish full details of the work, unless progress was made on how to circulate details of the findings to scientists."
in BBC

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Cold baths benefits



"Cold baths benefits after exercise can soothe sore muscles but it is unclear whether this is safe, say experts.
Plunging into chilly water can provide a shock to the system and may even be harmful, researchers at the UK Cochrane Centre warn.
After looking at available trial evidence - 17 small studies involving 366 people - they say there is not enough evidence to back the technique.
There may well be other better ways to ease muscular aches, they suggest.
This might include a spot of light jogging or a dip in a warm bath, they say.
The idea of this cold baths benefits sometimes referred to as cryotherapy, is to reduce swelling and the associated stiffness and soreness that comes with working the muscles hard.
The trend started in elite level sport, but it is becoming increasingly popular amongst amateur athletes too.

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Comedian Eddie Izzard, who last year ran 43 marathons in 51 days to raise money for charity, said his daily ice baths were a necessary evil to stop his "legs inflating to twice the size of an elephant".
In the studies that the Cochrane team looked at, participants were asked to get into a bath or container of cold water after running, cycling or resistance training.
In most trials, participants spent between five and 24 minutes in water that was 10-15C, although in some cases much colder temperatures were used or participants were asked to get in and out of the water a number of times.
Lead researcher Dr Chris Bleakley, of the University of Ulster, Northern Ireland, said: "We found some evidence that immersing yourself in cold water after exercise can reduce muscle soreness, but only compared to resting or doing nothing."
But there were too few studies that compared cold baths with other interventions to say that it is the best strategy for sore limbs.
And safety concerns remain unanswered.
Dr Bleakley said: "It is important to consider that cold water immersion induces a degree of shock on the body.
"We need to be sure that people aren't doing anything harmful, especially if they are exposing themselves to very cold water for long periods."
Leonie Dawson, professional adviser to the Chartered Society of Physiotherapy, said: "This isn't advisable for everyone. If someone had an underlying heart condition then the shock could be damaging.
"And for anybody with Raynaud's - a problem of the circulation - it would have a devastating effect on them."
She said it would also be important to ensure that the water was clean for hygiene reasons: "Some rugby clubs have a wheelie bin filled with cold water that the players will use one after the other, even if they have open cuts and injuries from the playing field."
She said, generally, applying something cool on the skin to reduce pain and swelling was safe.
"It makes up part of the PRICE guidelines - Protect, Rest, Ice, Compression and Elevation - for managing soft tissue injury.
"But it is worth remembering that some of those gel ice packs you can get go down to temperatures of minus 20 and if you go to sleep with them on you can get a rather nasty ice burn." "
in BBC
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Heart Disease Inherited

"This Heart Disease is inherited since men can inherit heart disease from their father say scientists who have tracked the condition to the Y chromosome that dads pass to sons.
By studying the DNA of over 3,000 men they found a particular version of the sex chromosome increases the risk of coronary artery disease by 50%.
As many as one in five British men carry this version of Y.
And the risk of this heart disease inherited confers is in addition to other heart risk factors like cholesterol, The Lancet reports.
Experts already know that men develop heart disease a decade earlier than women, on average. By the age of 40, the lifetime risk of heart disease is one in two for men and one in three for women.
Lifestyle factors like smoking and blood pressure are important contributors. This latest work suggests the male Y chromosome can also play a role in coronary artery disease - a common form of heart disease that kills thousands each year in the UK.
Dr Maciej Tomaszewski, from the University of Leicester, and colleagues studied 3,233 biologically unrelated British men who were already enrolled in other medical studies investigating heart disease risk.
When they carried out genetic tests on the men they found that 90% possessed one of two common versions of Y chromosome - named haplogroup I and haplogroup R1b1b2.
And the risk of coronary artery disease among the men carrying the haplogroup I version was 50% higher than in other men.
The scientists say they now need to pinpoint precisely which genes on the Y chromosome are responsible.
But they believe they already know how they exert their effect - by upsetting a man's immune system.
Dr Maciej Tomaszewski, a clinical senior lecturer at the University's Department of Cardiovascular Sciences, said: "We are very excited about these findings as they put the Y chromosome on the map of genetic susceptibility to coronary artery disease.
"Doctors usually associated the Y chromosome with maleness and fertility but this shows it is also implicated in heart disease."
He said, ultimately, the discovery could lead to new ways to treat and prevent heart disease in men, as well as a genetic test to spot those greatest risk.
In the meantime, he said men should focus on risk factors that they already have the power to modify themselves, such as getting enough exercise and eating a healthy diet to keep their blood pressure and cholesterol down."
in BBC
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NHS claims breast implants



" NHS claims about breast implants about 1,000 private patients with them have contacted the NHS in England.
The figure was given by Professor Sir Bruce Keogh, NHS Medical Director, in evidence to the Commons Health Select Committee receive all NHS claims many more to come. 
Last month the NHS in England said it would remove breast implants from private patients but would not replace them. So NHS claims started.
It is thought around 40,000 women in Britain have breast implants, the vast majority of surgery being for breast augmentation performed in the private sector.
Professor Keogh said 745 NHS patients with breast implants had so far been identified but this figure may rise. Most of this surgery was reconstructive following breast cancer. (...)"

in BBC
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Birth Defects



" Birth defects risks increases four-fold if the pregnant mother has diabetes, researchers say.
The study, published in the journal Diabetologia, analysed data from more than 400,000 pregnancies in the north-east of England.
The risk of birth defects such as congenital heart disease and spina bifida were increased.
National guidelines already recommend having good control over blood sugar levels before trying to conceive.
Both Type 1 diabetes, which tends to appear in childhood, and Type 2 diabetes, largely as a result of diet, lead to problems controlling the amount of sugar in the blood.
This is known to cause problems in pregnancy, such as birth defects and miscarriage, and the baby being overweight due to too much sugar.
There is concern that rising levels of diabetes, particularly Type 2, could make the issue worse.
Researchers at Newcastle University analysed data from 401,149 pregnancies between 1996 and 2008 - 1,677 women had diabetes.
The risk of birth defects went from 19 in every 1,000 births for women without pre-existing diabetes to 72 in every 1,000 births for women with diabetes.
Their report said that sugar levels in the run-up to conception were the "most important" risk factor which could be controlled.
The lead researcher, Dr Ruth Bell from Newcastle University, told the BBC: "Many of these anomalies happen in the first four to six weeks."
She said the number of pregnancies with poor sugar control were "more than we would like".
"It is a problem when the pregnancy is not intended or when people are not aware they need to talk to their doctors before pregnancy," she said.
Guidelines from the National Institute of Health and Clinical Excellence say women should reduce their blood sugar levels to below 6.1% before trying to have a baby. (...)"

in BBC
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Birth Control recalled in US



"Birth Control. Around one million packets of birth control tablets are being recalled in the US, as they might not prevent pregnancy.
The pharmaceutical company Pfizer said a "packaging error" meant the doses were not correct.
It said the tablets did not pose any health dangers, but there was a risk of "unintended pregnancy".
Pfizer is advising women affected to use non-hormonal forms of contraception immediately.
Fourteen lots of Lo/Ovral-28 tablets and 14 lots of Norgestrel and ethinyl estradiol tablets have been recalled. The lot numbers have been published on the company's website.
Throughout the month women would take 21 tablets containing active ingredients and seven which were inert.
The correct dose is essential for preventing pregnancy, however, the drug maker said: "The daily regimen for these oral contraceptives may be incorrect and could leave women without adequate contraception, and at risk for unintended pregnancy."
Women affected have been advised to tell their doctor and return the tablets to their pharmacy."
in BBC
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