First private abortion clinic in Ulster to open

Marie Stopes Northern Ireland will open in the province next week, but the new clinic has already attracted criticism from anti-abortion campaigners.

A private abortion clinic is to open in Northern Ireland for the first time, it has been announced.

Marie Stopes Northern Ireland will launch in Belfast next week, offering a service the clinic says it knows is sought by women in the province.

It will operate within Ulster’s current legal framework, which dictates that a woman can only have an abortion if her life is at immediate risk or if there is a long term or permanent risk to her physical or mental health.

The termination must be carried out within the first nine weeks of the gestation period and must be a “medical abortion” – one in which the woman takes two doses of pills – rather than a surgical one.

The law on abortion in Northern Ireland is different to that governing the rest of the UK, where any woman can undergo a termination up to the 24th week of pregnancy.

The new Ulster clinic has already proved controversial, with an anti-abortion group calling for it to be shut down.

But Marie Stopes hailed the opening as “great news for the people of Northern Ireland.”

Dawn Purvis, programme director at Marie Stopes Northern Ireland, said: “We will be able to meet their family planning and sexual health needs in a way that has not been seen here before.

“We have a new, purpose built, centrally-located specialist centre, our team are highly trained and dedicated health care professionals and our services will be delivered in a confidential, sensitive and non-judgmental way.

“Marie Stopes International is well known for focusing on offering services where they are needed most and a centre like ours has never existed before in Northern Ireland. We know that people here want this kind of world class service.”

As well as offering medical abortion, the centre will offer a range of sexual and reproductive services, including contraception, HIV testing, sexually transmitted infection testing and treatment, and ultrasound scanning.

But Precious Life, an anti-abortion organisation, said the announcement about the Belfast clinic was “a matter for the police and courts”.

Bernadette Smyth, the director of the group, said: “Any attempt to start killing unborn children in Northern Ireland will fail. Anyone who kills an unborn child in Northern Ireland is committing an illegal criminal act.

“We remain confident that anyone who tries to perform abortions in Northern Ireland will be brought to justice.”

She claimed the “pro-abortion movement” was “riding rough-shod over the views of the vast majority of people here.”

The organisation plans to contact the police, public prosecution service, the attorney general and the Department of Health to “ensure the law here is rigorously enforced.”

Marie Stopes International will operate in Belfast from next Thursday.

One in ten babies born under abortion limit survives

More than one in ten babies born before the abortion limit lives to see their first birthday, official figures have revealed.

Out of 750 babies born before 24 weeks in the womb, 92 lived for at least a year, the infant mortality data from the Office of National Statistics show.

The figures from 2010 are sure to reignite the abortion debate following comments by Jeremy Hunt, the new Health Secretary and Maria Miller, the new women's minister that the current 24 week limit should be lower.

David Cameron has ruled out a new Parliamentary debate on the limit.

The figures show that five babies born at less than 22 weeks gestation out of 247 born alive, lived for at least a year, 11 out of 171 born at 22 weeks lived, and 76 out of 332 born at 23 weeks survived.

The survival rate, as shown in the ONS figures, had not changed significantly over the previous four years, hoovering between 11.5 per cent and 13.5 per cent.

Experts said survival of very premature babies has not changed dramatically for twenty years and disability rates remain high in those who live.

Doctors do not usually attempt resusitation and life savings measures in babies born under 22 weeks unless the infant is particularly strong and well.

Overall the figures show that infant mortality has dropped steadily from 4.7 per 1,000 live births in 2007 to 4.1 per cent per 1,000 in 2010.

Women under the age of 20 and over 40 were more likely to have a baby die before a year old, generally because they were more likely to be born prematurely.

Babies born as twins or triplets were five times more likely to die.

Neil Marlow, Professor of Neonatal Medicine at University College London and co-author of the Epicure studies on premature baby survival said: "Survival at 23 weeks has remained very low and in many hospitals there are very few survivors.

"Even in the hospitals that do offer care subject to parents wishes the outcomes are much the same as in 1995.

"This doesn't mean that we do not see successful outcomes at 23 weeks, simply that they remain very rare. "Gestational age assessment is relatively imprecise and it may be that some of these children are in fact more mature.

" This is in contrast to the improving outlook at 24 and 25 weeks, where we have seen significant improvements in survival and in survival without impairment between 1995 and 2006, which we hope to publish details of very soon."

Anthony Ozimic, communications manager of the Society for the Protection of Unborn Children (SPUC), said: ”Anyone who has experienced the trauma of a premature birth will warmly welcome scientific advances in saving prematurely-born babies, but the viability of unborn children should not be used as a guide for reforming the law on abortion.

"Viability is a criterion which varies from place to place in the country and from place to place in the world.

"Viability has nothing to do with the humanity of the child in the womb; it has everything to do with technological progress and the excellence and dedication of medical staff.

"A child's capacity to survive is not what makes him or her a human being. When a premature baby, after receiving expert treatment, sadly dies, doctors are not criticised for treating a non-person.
"They have tried to save a baby, but sadly failed. Passing legislation on such an arbitrary basis leads to legislatures making equally arbitrary exceptions – as the UK Parliament did in 1990, making abortion lawful up till birth for disabled babies and on certain other grounds.”

Anne Scanlan, of the pro-life group Life, said: "The survival rates for pre-term babies, released by ONS, is just further proof of the humanity of the unborn child. Thanks to the free availability of 4D ultrasound images we now have a window on the womb and we can no longer ignore the fact that abortion ends the life of an unborn child.

"As the general public become increasingly aware of foetal development, they feel more and more uncomfortable with the reality of abortion, and with late term abortions in particular.
"We are delighted that the need for change is finally being recognised, and that politicians are at last beginning to question our current abortion laws."

A spokesman for BPAS, the British Pregnancy Advisory Service, which carries out most abortions on behalf of the NHS, said:“Survival rates for extremely premature infants are sadly extremely poor, as this data shows.

"There is certainly no new scientific evidence to warrant a reduction in the abortion time limit, as certain ministers have suggested in recent days.

"But the science will only ever be one component of the discussion around abortion – the reality and needs of women’s lives are just as important. A very small number of women will continue to need abortion after 20 weeks for very good reasons.”

Natika Halil, Director of Information Services at the Family Planning Association, said: “FPA’s support of the abortion time limit of 24 weeks is guided by the latest medical evidence and clinical guidance."

Bad news stories 'alter women's stress response'

Bad news stories, such as those about murder, seem to alter the way women respond to stressful situations, according to a small study.

Women produced more stress hormones in tests if they had read negative newspaper stories.

The study on 60 people, published in the journal PLoS One, showed there was no equivalent effect in men.

Experts said the findings showed "fascinating" differences between the sexes.

Researchers in Canada compiled newspaper clippings of negative stories, including accidents and murders, as well as neutral stories such as film premieres.

Men and women read either negative or neutral stories and then did a scientific stress test. Levels of the stress hormone, cortisol, were measured throughout the study.

One of the researchers, Marie-France Marin, from the University of Montreal, said: "Although the news stories alone did not increase stress levels, they did make the women more reactive, affecting their physiological responses to later stressful situations."

Men's cortisol levels were not affected.

She added: "It's difficult to avoid the news, considering the multitude of news sources out there.

"And what if all that news was bad for us? It certainly looks like that could be the case."

'Gender puzzle'

 
The scientists suggested that women may be naturally better at identifying threats to their children, which affects the way they respond to stress.

Professor Terrie Moffitt, from the institute of psychiatry at King's College London, said: "According to self-report studies, women say they are more 'stress reactive' on average than men.

"This study adds fascinating new evidence of change in a stress hormone after an experimental... challenge.

"Stress researchers confront a real gender puzzle: As a group, women seem more reactive to stressors, but then they go on to outlive men by quite a few years.

"How do women manage to neutralise the effects of stress on their cardiovascular systems? An answer to that question would improve health for all of us."

Other experts warned that the study was small so the reported effect

Lawsuit: Pharmacy provided tainted meds in 2002

11:32AM EST October 11. 2012 - Long before the current rash of fungal meningitis, the compounding pharmacy suspected in the outbreak settled a lawsuit alleging it produced a tainted shot that caused a man's death in 2004.

Earlier this summer, a separate pharmaceutical firm with common owners was accused of failing to separate sterile and non-sterile supplies. That pharmaceutical company was shut down Wednesday for inspections, the latest example of fallout from the growing outbreak.

Officials have identified Framingham, Mass., based-New England Compounding Center as the source of steroid shots suspected in the outbreak of rare fungal meningitis that has killed at least 12 people and made more than 130 others sick in 10 states.

Allegations that a shot tainted with bacteria caused a man to contract a different form of meningitis were at the heart of a lawsuit filed against the company over the 2004 death. An 83-year-old man died about a year and a half after receiving a shot produced by the company.

Another drug company that has some of the same owners, Ameridose LLC, agreed to temporarily stop its compounding and manufacturing operations as a precaution while regulators inspect its facilities, but the measure is being done as a precaution, not because of evidence of contamination, officials said Wednesday. Ameridose, based in Westborough, Mass., was accused by a business customer this year of failing to separate sterile and non-sterile products in its warehouse.

Andrew Paven, a spokesman for both companies, said: "Ameridose is a separate entity from New England Compounding Center, with distinct operational management."

"We have separate production facilities, separate processes and operate at separate locations in different cities. Although there is common ownership, the two companies operate under separate registrations and different licensure," the statement from Paven said.

On Wednesday, Massachusetts Gov. Deval Patrick said the New England Compounding Center may have misled regulators and done work beyond the scope of its state license. The company was licensed to fill specific prescriptions for specific patients but exceeded that, he said.

"What they were doing instead is making big batches and selling them out of state as a manufacturer would, and that is certainly outside of their state license," he said.

A company spokesman declined to comment on Patrick's assertion beyond a statement that company officials are focused on cooperating with the investigation. The company has shut down operations and recalled the fungus-contaminated steroid.

A 2004 lawsuit filed in upstate New York's Monroe County claimed New England Compounding Center produced a tainted shot that caused William Koch to contract bacterial meningitis at Rochester General Hospital on July 17, 2002. Koch died Feb. 28, 2004, at the age of 83.

The lawsuit said the shot was the source of Koch's meningitis, but did not explain how that determination was made.

Bacterial meningitis is contagious and much more common than the fungal meningitis involved in the current outbreak. Fungal meningitis is more difficult to catch, according to the Centers for Disease Control and Prevention.

The compounding pharmacy reached a settlement with Koch's widow in 2007 before the case went to trial, according to her lawyer Mark S. Nunn. He declined to elaborate Wednesday because the terms were confidential.

"Really all I can say is that the case settled prior to trial," Nunn said.

Two of the people who founded New England Compounding Pharmacy Inc. in 1998 — Gregory Conigliaro and Barry Cadden — formed Ameridose in 2006, according to documents filed with the Massachusetts Secretary of State's office. The company's website says it provides hospitals around the country with products including intravenous solutions and prefilled oral syringes of painkillers and other medications.

This summer, an organization that represents hospitals in purchasing deals with drug suppliers canceled a contract with Ameridose over allegations that it had poor quality control practices that "rose to a level of concern for patient safety," according to a lawsuit that Ameridose filed in August.

Ameridose denies those allegations and filed a defamation and slander lawsuit in U.S. District Court in Massachusetts on Aug. 8, saying Novation LLC hurt its reputation by making allegations including that there was "no separation between sterile and non-sterile products" in an Ameridose warehouse.
The lawsuit doesn't say what the products were or elaborate on how they were stored. Novation declined to release a copy of its report.

Novation, which leverages hospitals' combined buying power to get better prices on medical goods, sent two employees to audit Ameridose on July 15 and terminated its contract, the lawsuit said.
"Novation has determined that Ameridose does not meet the quality systems requirements needed to maintain a Novation agreement," Novation told its members in an Aug. 2 newsletter, according to the lawsuit.

Ameridose strongly objected to the allegations and said in its defamation lawsuit that the Novation auditors were unqualified and made false and misleading statements. Ameridose also said it had been audited in recent years by several other organizations that determined its quality control system "meets or exceeds their high quality standards." Ameridose is regulated by the U.S. Food and Drug Administration.

The lawsuit ended in a confidential settlement Sept. 24.

Paven, the Ameridose and New England Compounding Center spokesman, said Wednesday in his email that the "suit involved contractual commercial issues between the companies that have since been resolved."

A statement from Novation said that while it "vigorously disputed each and every claim made in the lawsuit, the parties ultimately agreed to settle the lawsuit."

Copyright 2012 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.

Scientists trial Botox as hayfever treatment

Never mind wrinkles - a blob of Botox on your nose could banish hay fever, too

• Gel is applied to the nose and will penetrate the skin
• It's hoped the toxin will block chemicals released by the body that cause annoying symptoms

Interference: Botox may block some of the symptom-causing chemicals released by nerve endings in the nose

It has been used to treat a host of ailments from migraines to incontinence - and that's on top of it being the world's most famous wrinkle-buster.

Now Australian scientists are to trial Botox to treat hay fever after early tests showed promising results.

Under the trial, a Botox gel will be applied to the nose to hopefully give hay fever sufferers relief from sneezing, itchy eyes and runny noses for up to three months.

It's hoped that the botulinum toxin will affect the nerves in the nose and potentially block some of the chemicals released by the nerve endings which play a large role in causing hay fever symptoms.

To try and treat the allergy, the Botox molecule has been re-engineered to be able to penetrate through the skin but also through the lining of the nose.

Philip Bardin, a professor at the Monash Medical Centre, said Botox was already widely used in medicine to reduce spasms in muscles following strokes and in treating cerebral palsy.

'This is very new way to use an old medication,' he said

Botox, which makes muscles relax, is a purified form of a nerve poison.

It is produced by a bacteria that causes a disease which paralyses muscles.

Seventy people will be recruited for the new study following a preliminary trial that suggested the drug provided relief.

Last month it was announced that hay fever relief may also come in the form of a jab.
A new vaccine that promises lasting relief for sufferers is being developed, amid fears that the pollen season could go on six weeks longer in future due to global warming.
British scientists behind the project say it could help control symptoms of grass-pollen hay fever with several injections over the course of just a few months.

An existing vaccine requires a course of injections lasting several years and benefits only 1,000 people a year.

Both vaccines are based on similar technology, but immunologists have now discovered that injecting closer to the skin’s surface is far more effective than the current method.

Dr Stephen Till from King’s College London emphasised that it was early days, but said: ‘This new vaccine is potentially applicable to far larger numbers than the existing one.’

Typhoid fever vaccination recalled

Typhoid fever vaccine recalled

The Health Protection Agency (HPA) is aware the Medicines and Healthcare products Regulatory Agency (MHRA) has issued a drug alert to healthcare professionals advising them that the manufacturer Sanofi Pasteur MSD has recalled 16 batches of their typhoid vaccine, Typhim Vi.
This recall is due to concerns about the effectiveness of the vaccine in some syringes distributed from 7 January 2011 following filling problems in the manufacturing process. Therefore some people who have been vaccinated with Typhim Vi may not be fully protected against the disease.

A spokesperson for the HPA, said: “Over the past five years, around 250-300 laboratory confirmed cases of typhoid were reported annually in the UK. Typhoid is almost exclusively acquired abroad through the ingestion of heavily contaminated food and water. Deaths from typhoid are extremely rare in the UK due to availability of effective antibiotic treatment – none were reported between 2007-2011.
“Provisional data from 2011 to September 2012 do not suggest that there has been an increase in cases of typhoid since January 2011, the date from which affected vaccine was distributed.

“Typhoid vaccination is 50-80 per cent effective and travellers are advised to practise strict food, water and personal hygiene precautions even if vaccinated.

“The main early symptoms and signs of typhoid fever are fever, headache, general aches and pains, cough and constipation. Later symptoms include diarrhoea, stomach discomfort, lack of appetite and nausea. If typhoid is untreated it can spread to other family members and contacts in the UK.
“Anyone displaying symptoms of typhoid fever, either while abroad or when back in the UK, should seek urgent medical attention”.
Ends

Notes to editors:

Typhoid, sometimes known as enteric fever, is a disease caused by salmonella bacteria.
Typhoid occurs worldwide, but most cases in the UK are in travellers returning from Pakistan, Bangladesh or India. Even people who have lived in Pakistan, Bangladesh or India are still at risk of getting typhoid when visiting these countries.
Typhoid can be prevented through a typhoid vaccine, which can be obtained free from your GP before travel, and good hygiene practice while abroad.
Booster Typhoid vaccination doses are required after 3 years.
An alternative oral typhoid vaccine is available for travellers from six years of age, and a combined hepatitis A and typhoid vaccine can be used for those aged 16 years or older if hepatitis A vaccination is also required. Travellers should discuss their travel plans with their GP, practice nurse or private travel clinic to ascertain whether these vaccines are appropriate for their trip. For children under six years of age, healthcare professionals should seek specialist vaccination advice from the National Travel Health Network and Centre (NaTHNaC) www.nathnac.org [external link].

How to avoid getting typhoid when you travel:

• Only eat food that is freshly prepared, cooked and served piping hot, or fruit that you have peeled yourself, such as banana and mango
• Only drink bottled or cooled boiled water, or pasteurised milk. When drinking bottled water ensure the seal is unbroken or choose sparkling water to ensure the bottle has not been refilled
• Wash your hands frequently using soap and water
• Wash your hands before preparing food, eating or drinking, and after using the toilet
• Use bottled or boiled water to brush your teeth. Do not use tap water

You should avoid:

• Uncooked food such as salads
• Raw or uncooked shellfish
• Buffets (if you have to eat at a buffet, choose steaming hot dishes)
• Unpasteurised milk and cheese
• Ice-cubes (to keep drinks cold put the container or glass on ice, do not put ice in your drinks)
• Tap water
• Ice-cream products
• Cold desserts in restaurants
• Leftovers

More information on Typhoid from the HPA website.
HPA factsheets on Typhoid have been translated into Bengali, Gujarati, Punjabi and Urdu.
Information about the Medicines Recall is available from the MHRA website [external link].
 

New 3-D mammograms have benefits, risks

This is the second installment in USA TODAY's four-week series on breast cancer. The series looks at screening, treatment and support via social media.

McLean, VA (written by Liz Szabo/USA Today) -- Women are used to making complex choices about mammograms. Should they start at age 40 or 50? Should they be screened annually or every other year? Digital or traditional film?

Now, a growing number of hospitals and radiology centers are asking women to consider yet another mammography option: Regular or 3-D?

USA TODAY's Liz Szabo asked screening experts to talk about the risks, limitations and potential benefits of this new method of early cancer detection.

Q. What is a 3-D mammogram?

A. The technology, called tomosynthesis, provides three-dimensional images of the breast by using a technology similar to CT scans, or computed tomography, says Carol Lee, a radiologist at New York's Memorial Sloan-Kettering Cancer Center and chair of the American College of Radiology's breast imaging commission. The imaging machine moves around the breast in an arc, taking multiple X-rays that a computer forms into a 3-D image. The Food and Drug Administration approved tomosynthesis last year and it's now used in 46 states, according to Hologic, which manufactures the machines.

Q. Why would someone want a 3-D image of the breast?

A. Researchers hope that it will reduce the number of false alarms, in which radiologists call women back for additional mammograms because of uncertainty about their findings, says Constance Lehman, director of imaging at the Seattle Cancer Care Alliance, who is leading a clinical trial on 3-D mammography. About 10% of the 40 million women who get screening mammograms every year receive a "call back," leading to anxiety and sometimes additional types of tests, such as ultrasounds, says Peter Soltani, Hologic's senior vice president of breast health. Lehman notes, however, that this benefit has not yet been definitively proven in a rigorously designed study.

There is no data to prove that tomosynthesis finds more cancer or saves lives, says Fran Visco, president of the National Breast Cancer Coalition. "3-D is a new technology that should not be used outside of a clinical trial," Visco says.

Q. Who could benefit most from 3-D mammograms?

A. Younger women with dense breasts could potentially benefit the most, Lee says. That's because radiologists have a harder time picking out cancers in dense breasts, because both cancers and dense tissue appear as white on a mammogram. "It's like writing a word on a blackboard and then covering it in scribbles," Lee says. "By subtracting the scribbles, you can see the word better." So far, however, studies haven't proven that 3-D mammograms find significantly more cancers than traditional mammograms, Lee says. "I personally have yet to be convinced that it's substantially better," Lee says. "And it doesn't replace a regular mammogram."

Q. What are the risks and limitations of 3-D mammograms?

A. Because the tests are new, insurance companies may not cover them and may require patients to pay out of pocket.

More importantly, the procedures give women twice as much radiation as a standard mammogram, notes surgeon Susan Love, author of Dr. Susan Love's Breast Book. That's because women who get 3-D imaging still undergo traditional 2-D mammography, as well.

Radiation is a known cause of breast cancer. Researchers in recent years have become concerned about radiation exposure from medical imaging, particularly CT scans. A 2009 analysis estimated that CT scans cause about 29,000 cancers and 14,500 deaths a year. Soltani says the total radiation dose from 3-D mammography is still relatively low, in spite of this increase - from 0.5 millisieverts to 1.0 millisieverts. In comparison, a CT scan of the head has a radiation dose of about 2.0 millisieverts.

But Lehman says a woman's total radiation dose may not necessarily increase if she undergoes a 3-D mammogram. That's because the exam may help her avoid the radiation from repeat scans.

Love says she's skeptical about the technology, which she compares to "a new toy," noting that the most essential questions about its benefits are likely to remain unanswered. The most important question about a new type of screening, Love says, is not simply how well it finds cancer, but whether it saves lives. She says she doubts the makers of tomosynthesis are going to perform that sort of large, expensive, long-term study.

Lee asks, "Is it worth radiating everyone to avoid a few false positives?"

Questions consumers should ask

Consumers often have to make quick decisions about health care, such whether or not to undergo a new type of test -- often with little to no time for research, and sometimes even while wearing little to no clothing.

But making decisions about health care is far more complicated than picking a new shampoo, no matter what a glossy brochure may suggest, says Steven Woloshin, co-director of the Center for Medicine and the Media at the Dartmouth Institute for Health Policy and Clinical Practice.

Woloshin and other outcomes researchers offer these tips to consider when making medical decisions:
-- There's no free lunch. Woloshin recommends that patients have a "healthy skepticism," asking both about the risks, as well as potential benefits, of medical interventions.
 Health care providers may not mention the side effects, complications or potential downsides to an intervention, Woloshin says. Questions to ask include: "What is this test supposed to do? What am I trying to avoid?"

-- Newer isn't always better. When shopping for a new tech toy, such as an iPhone, new can mean more faster, cooler, slicker. In health care, "new can mean unproven," Woloshin says. "New can be dangerous."
 Sometimes, rare side effects of a new drug don't become apparent until it's been used by tens of thousands of people. Other times, a new, brand-name drug is simply more expensive, but no more effective, than older, cheaper therapies, Woloshin says.

-- More isn't always better. Even painless tests, such as X-rays and CT scans, have risks, because they expose patients to radiation, says Fran Visco, president of the National Breast Cancer Coalition. Other screenings can lead to worry and a cascade of follow-up tests, which can be far more invasive and painful than the original test.

Consumers "overestimate what tests can do," Visco says. "Yet we constantly send out these messages that more is better and more often is better, although that's rarely the case."

The American College of Radiology now advises patients to ask questions before undergoing scans, such as, "How will this exam improve my care?" and "Are there alternatives that don't involve radiation?"