No early link between all-metal hip implants and cancer

No early link between all-metal hip implants and cancer: study

(Reuters) - All-metal hip implants, which have been shown to have high failure rates and cause a host of other health problems, were not linked to cancer seven years after implantation, new data show.

Concerns have grown in the medical community that the so-called metal-on-metal hip implants shed metal particles through wear on their ball-and-socket structure. Many patients who have received the devices have had elevated levels of cobalt and chromium particles detected in the bloodstream, leading some doctors to worry about their risk of developing cancer.

Johnson & Johnson and Stryker Corp have recalled several models of all-metal implants because of high failure rates -- meaning the patient needed another surgery to fix a problem, such as dislocation -- and set aside billions of dollars to cover patient claims. Neither company was immediately available to comment. Since the recalls, the use of all-metal implants, which were sold as being more durable, has declined sharply.

"Some basic science and some epidemiological studies have suggested that metal-on-metal hip replacements may be associated with an increased risk of developing cancer after total hip replacement and specifically with an increase in malignant melanoma and haematological, prostate, and renal tract cancers," the UK National Joint Registry (NJR) said in its annual report, which was released this week at the British Orthopaedic Association meeting in Manchester, UK.

The NJR, which collects data on joint replacement surgery and monitors the performance of the implants, said it used UK National Health Service Hospital Statistics data to test whether metal-on-metal hip implants are associated with an increased risk of cancer in the early years after hip replacement, compared with other surfaces, such as metal-on-polyethelene.

The NJR said it found no association seven years after implantation but that the devices should continue to be tracked as many cancers can take longer to manifest themselves.

"Due to the age of the NJR we could only assess the risk for the first seven years after hip replacement and are happy to report that we could not identify an increased risk of developing cancer," the NJR said.

"We must, however, point out that many cancers have prolonged latency after initial exposure to carcinogens and thus long-term follow up is needed to provide a definitive answer," it added.

NO U.S. TRACKING MECHANISM

Hundreds of thousands of people have all-metal hip implants. Since the recall, J&J faces thousands of lawsuits over the failure of its ASR model, which was pulled from the market, and more lawsuits tied to its Pinnacle all-metal device, which is still being used.

The United States has no independent registry tracking the performance of medical devices over time, and health regulators are still discussing how manufacturers should follow up on complaints over the all-metal implants.

The U.S. Food and Drug Administration has been monitoring problems with all-metal hip implants and convened a panel of outside advisers earlier this year to discuss their safety. The panel concluded there was little reason for surgeons to use these devices given the risks.

Last year, the FDA ordered implant manufacturers to conduct follow-up studies in cases in which an implant's failure could have serious consequences. Companies were ordered to take blood samples from patients to measure metal ion levels. That analysis has not been completed.

The NJR said its latest analysis continues to support conclusions it drew last year showing markedly higher failure rate with metal-on-metal implants.

In addition to J&J and Stryker, makers of all-metal hip implants include Smith & Nephew, Zimmer Holdings, Wright Medical and Biomet Inc. (Reporting by Debra Sherman in Chicago; Editing by Michele Gershberg, Carol Bishopric and Steve Orlofsky)

Diet drink consumption increasing

The percentage of men and women consuming diet drinks increased over the past 10 years.

Diet drink consumption has increased over the past decade, a trend that reinforces other research showing intake of calories from sugar in regular soda has decreased, government statistics out today show.

"The data suggest that diet drinks may have replaced sugar drinks during this time," says the study's lead author Tala Fakhouri, an epidemiologist with the Centers for Disease Control and Prevention.

The new diet drink analysis shows that the change in diet drink consumption occurred for both women (up from 18% in 2000 to 21% in 2010) and men (up from 14% to 19% in the same period).

Still, only about 20% of people in the USA consume diet drinks on any given day with the majority (80%) not drinking them, the report finds. Diet drinks included calorie-free and low-calorie versions of soda, fruit drinks, energy drinks, sports drinks and carbonated water. Diet drinks did not include unsweetened teas or coffees or 100% fruit juice.

Meanwhile, the consumption of sugar found in regular soda has dropped from roughly 150 calories a day in 2000 to 91 calories a day in 2008.

But when it comes to calories from all sugary drinks, including sodas, fruit drinks, energy drinks, sports drinks and sweetened bottled waters, males consume an average of 178 calories a day; females consume 103 calories, according to other government data.

Overall, about half of the population, ages 2 and older, consume sugary drinks on any given day. Among boys 2 to 19, 70% consume these types of drinks while 40% of adult women consume them.

The statistics from the CDC's National Center for Health Statistics are based on interviews with thousands of people in the National Health and Nutrition Examination Survey. Food and beverage intake is based on in-person interviews about dietary habits.

Among the findings:

-- Diet drink consumption was similar for females and males in 2010, except among adolescents, ages 12 to 19, with 17% girls consuming them on a given day compared with only 9.5% of boys the same age.

-- 28% of white adults consume diet drinks compared with 10% of black adults and 14% of Hispanic adults.

"We know that Americans, mainly white Americans, are increasing significantly the consumption of low-calorie diet beverages," says Barry Popkin, a nutrition professor at the University of North Carolina-Chapel Hill and one of the nation's top experts on beverage consumption. Research suggests that an increased intake of these diet beverages in replacement of sugary beverages reduces weight, he says.

Kelly Brownell, director of Yale University's Rudd Center for Food Policy and Obesity, says, "Diet products are controversial because it is unclear whether they are safe and help people control weight.
"We do not recommend diet drinks, particularly for children, but one can make a case for them if they do in fact displace caloric beverages and do no harm."

Sugary drinks have been in the spotlight for years, and most recently because of news that they may magnify genetic risk of obesity, according to one study. Other research showed that heavy teens who cut soft drink consumption slow weight gain.

New York City is putting a 16-ounce cap on sweetened bottled drinks and fountain beverages sold at city restaurants, delis, movie theaters, sports venues and street carts. The beverage ban, which goes into effect March 12, applies to drinks that have more than 25 calories per 8 ounces. It does not include 100% juice drinks or beverages with more than 50% milk.

Meningitis outbreak toll rises, now 137 cases, 12 deaths

The meningitis outbreak in several states has now claimed 12 lives, with the latest victim dying in Florida, the Centers for Disease Control and Prevention announced Wednesday.

The number of people affected by the deadly outbreak has gone up to 137, officials said.

Victims have died in five states: six in Tennessee, three in Michigan, and one each in Florida, Maryland and Virginia.

Other states involved include Indiana, Minnesota, North Carolina, New Jersey and Ohio.

Officials have tied the outbreak of rare fungal meningitis to steroid shots for back pain. The steroid was custom-made by New England Compounding Center, a specialty pharmacy in Framingham, Mass. The steroid was recalled Sept. 26.

At least one contaminated vial was found at the company, which later recalled every product it makes.
The government has identified about 75 facilities in 23 states that received the recalled doses. It is not clear exactly how many people could get sick, though the fungus is not transmitted from person to person.

The CDC has said clinicians should contact patients who received potentially contaminated injections starting May 21. Once identified, patients with infections should be put on appropriate anti-fungal therapy.

Meningitis is an inflammation of the lining of the brain and spinal cord. Infected patients have developed a variety of symptoms, which have set in one to four weeks after their injections. These include fever, a new or worsening headache, nausea and problems similar to those seen in a stroke.

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."

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