Hayfever vaccine study raises hopes for new allergy treatment

Researchers are developing a new vaccine for hayfever which could be more effective, less invasive for patients and less expensive than vaccines already available to patients on the NHS.

Scientists at Imperial College London and King's College London have carried out a study that showed a significant reduction in skin sensitivity to grass pollen that was associated with an increase in "blocking antibodies" in the bloodstream. The results are so encouraging that King's has today launched a clinical trial in collaboration with Guy's Hospital, working together as part of King's Health Partners. The trial is funded by the Medical Research Council and National Institute for Health Research via the Efficacy and Mechanism Evaluation programme, and will further investigate the vaccine as a potential new hayfever treatment.

The researchers say the approach defines a completely new concept in treating allergies and in the future could have an impact on treating other conditions such as asthma and food allergies.

Hayfever affects one in four people in the UK. An allergic reaction to grass pollen triggers a blocked or runny nose, sneezing, itchy eyes and in some cases asthma symptoms. For many individuals this can interfere with work or school performance, sleep and social activities. Tablets and sprays may temporarily relieve symptoms, but for severe cases one option is a vaccine to "switch off" the allergy, called immunotherapy.

The vaccines currently used involve high doses of allergen given by injection underneath the skin (subcutaneously) or sometimes as a daily tablet or drops under the tongue. In most cases this involves large numbers of injections in an NHS allergy clinic or daily tablets or drops taken continuously, which can be inconvenient for patients and expensive for the NHS.

Published today in the Journal of Allergy and Clinical Immunology, this new study shows that a series of low dose allergen injections (less than a thousandth of the usual dose) into a higher layer of the skin (intradermally), rather than subcutaneously, led to a 90 per cent reduction in skin reactivity to grass pollen.

Researchers administered the vaccine intradermally to volunteer hayfever sufferers from Royal Brompton and Harefield NHS Foundation Trust. One group of subjects received six injections of grass pollen extract at two-week intervals over 10 weeks. The participants' allergic responses in the skin were then measured. The initial injection provoked an allergic reaction on the arm visible as a lump around 10 cm in diameter lasting 1-2 days. Over time a dramatic 90 per cent reduction was seen in the size of the lump suggesting that the allergic reaction was gradually being switched off with each injection. The size of the lump did not decrease in another group of subjects who received only two injections separated by 10 weeks.

During the study none of the participants reported unwanted side effects and the injections did not trigger hayfever symptoms.

The researchers believe that the method of injecting the vaccine intradermally is a major factor in its success, as the skin is a highly active immunological area - more so than underneath the skin where allergy vaccines are traditionally administered.

Professor Stephen Durham, from the National Heart and Lung Institute at Imperial College London, said: "There is great interest in giving immunotherapy by novel alternative routes to improve uptake by the immune system. The results of this study provide an excellent foundation for going on to test the intradermal vaccine route in clinical trials."

Dr Stephen Till, Senior Lecturer at King's College London said: "The results of our study are hugely exciting. We now want to find out if this process can also switch off grass allergy in the nose and improve hayfever symptoms, so we are today launching the PollenLITE clinical trial to further test our new approach."

Maureen Jenkins, the director of clinical services at the charity Allergy UK, said this was a "very exciting development" which "offers hope for sufferers".

She added: "The proposed vaccine, if successful, is much quicker and more straightforward than current immunotherapy treatment for hay fever, which takes years. It also has the potential to offer cost savings.

"If this series of injections proves effective in combating hay fever, it will be a wonderful step forward in tackling this common, but often underestimated allergy."

A separate vaccine would have to be developed to help people with allergies to tree pollen.

9/11 cancer victims to have treatment funded

(CBS News) Monday's announcement that the government would add about 50 types of cancer to the list of 9/11-related illnesses that's health care costs would be covered has provided relief for what many are calling an overdue decision. But, the announcement also raised concerns over the amount of available funds for suffers and families.

Government to cover cancer health care costs for 9/11 responders and victims
Government will fund care for 50 types of cancers linked to 9/11 under Zadroga Act
60 Minutes: The Dust At Ground Zero

On the eve of the 11th anniversary of the terrorist attacks, the National Institute for Occupational Safety (NIOSH) announced it would cover the cancer care for responders and other victims exposed to the toxic dust at ground zero who developed cancers including lung, breast colon, and leukemia and lymphoma. The program had previously only covered lung diseases, asthma and chronic cough along with mental health illnesses such as post-traumatic stress disorder (PTSD) and depression.

"The publication of this final rule marks an important step in the effort to provide needed treatment and care to 9/11 responders and survivors through the WTC Health Program," NIOSH director Dr. John Howard said in a statement to the Associated Press.

In June, officials at NIOSH had said in a filing that it favored a major expansion of the program, known as the Zadroga Act, to include people with the different cancer types that span 14 broad categories of the disease. The decision followed a March recommendation by an advisory committee made up of doctors, union officials and community health advocates, who recommended that cancer be added to the program. While a definitive link between the toxic exposure causing these cancers hasn't been definitely shown, the NIOSH committee said the dust contained about 70 known and possible carcinogens.

Firefighter Ray Pfeiffer, who had been saying for years that the hundreds of hours he worked at ground zero had something to do with his advanced kidney cancer, told the CBS Evening News that he welcomed the announcement.

"It's like a vindication saying 'hey listen, you know, we're recognized that we were down there that we did get sick from down there,'" Pfeiffer explained. "It's a little bit of a relief."

The compensation has been held up by a dispute over whether there was evidence of a direct link between the World Trade Center tragedy and cancer.

'Stem cell hope' for deaf people

Stem cell therapy may one day enable deaf people to hear again.

In a new test by UK scientists found that deaf gerbils recover their hearing after human stem cells were injected into their ears.

Hearing partially improved when nerves in the ear, which pass sounds into the brain, were rebuilt in gerbils - a UK study in the journal Nature reports.

Getting the same improvement in people would be a shift from being unable to hear traffic to hearing a conversation.

However, treating humans is still a distant prospect.

The aim of researchers at the University of Sheffield was to replace those baton-dropping nerve cells, called spiral ganglion neurons, with new ones. They used stem cells from a human embryo, which are capable of becoming any other type of cell in the human body from nerve to skin, muscle to kidney.

A chemical soup was added to the stem cells that converted them into cells similar to the spiral ganglion neurons. These were then delicately injected into the inner ears of 18 deaf gerbils.

Over 10 weeks the gerbils' hearing improved. On average 45% of their hearing range was restored by the end of the study.

When these neurons get damaged or die they can't be replaced. This results in a form of deafness called auditory neuropathy, which affects about a tenth of deaf people, according to Rivolta.

Cochlear implants can correct the main form of deafness, which occurs when the cochlea loses hair cells that register sound by bending. But neurons can't be substituted except through an expensive, risky and invasive procedure to implant an electrode directly into the brain.

Now, Rivolta and his colleagues hope to develop much simpler treatments based on the so-called otic neural progenitor stem cells developed in the lab from human embryonic stem cells, the cells in embryos that can turn into all types of bodily tissues.

They injected about 50,000 of the otic neural progenitor cells into single ears of 18 gerbils. The animals' spiral ganglion neurons had been deliberately destroyed with a drug called ouabain, leaving them completely deaf. The stem cells were injected into the cochlea through a tiny, drilled hole.

Post mortems showed that the stem cells turned into specialised spiral ganglion neurons in the ear.

Within 10 weeks, about two-thirds of the animals had recovered some hearing. On average, the animals recovered about 46 per cent of their hearing, as measured by their ability to respond to sounds of varying volume.

"In people, this would mean going from only being able to hear a loud truck on the street to being able to hold a conversation," said Rivolta.

But it will be years before it can be tested in people as Rivolta has said that more work in animals is needed to refine the procedure.

Prof Dave Moore, the director of the Medical Research Council's Institute of Hearing Research in Nottingham, told the BBC: "It is a big moment, it really is a major development."

However, he cautioned that there will still be difficulties repeating the feat in people.

"The biggest issue is actually getting into the part of the inner ear where they'll do some good. It's extremely tiny and very difficult to get to and that will be a really formidable undertaking," he said.

Dr Ralph Holme, head of biomedical research for the charity Action on Hearing Loss, said: "The research is tremendously encouraging and gives us real hope that it will be possible to fix the actual cause of some types of hearing loss in the future.

"For the millions of people for whom hearing loss is eroding their quality of life, this can't come soon enough."

Eating Less Red Meat Could Benefit Health And Environment

reducing down the amount of red meat we eat not only affects our health, but also the health of the environment, study from the United Kingdom suggests.

Researchers from the University of Cambridge found that cutting back on red meat consumption could decrease the number of cases of chronic disease by 3 to 12 percent, and make the carbon footprint nearly 28 million tons smaller per year by decreasing greenhouse gas emissions.

The BMJ Open study included data from the National Diet and Nutrition Survey of British Adults in 2000-2001. Researchers looked at the amount of meat the people in the study consumed, as well as how many green gas emissions were emitted that are linked to 45 different kinds of food.

After adjusting for proportions, the researchers found that people who regularly ate red or processed meat in the study also just generally consumed more food than people who didn't regularly eat red or processed meat. So, they calculated that if people who ate the most red and processed meat in the study change their eating habits so they ate like the people who consumed the least red and processed meat in the study, that would decrease health risks (such as risk of diabetes, colorectal cancer and heart disease) anywhere from 3 to 12 percent.

Specifically, the Telegraph reported that if men with an average meat consumption of 91 grams per day cut it down to 53 grams per day, it would translate to a 12 percent decrease in colorectal cancer and Type 2 diabetes risks.

Plus, the decreased greenhouse gas emissions linked with food and beverages would decrease each year by about 0.45 tons per person, the researchers calculated.

Even though the data is from 2000 and 2001, the researchers noted that red meat consumption hasn't changed significantly over the last 10 years.

"This indicates that our estimates remain relevant and may even be conservative and highlights the need for action to prevent further increases in intake in the UK population," the researchers wrote in the study.

Previous research has shown a possible link between processed meat consumption and cancer risk, with an extra 50 grams a day of processed meat being linked with a 19 percent increased risk of pancreatic cancer, according to a British Journal of Cancer study.

And even more recently, a group of water scientists has predicted that the whole world is going to be vegetarian anyhow by 2050, in order to accommodate growing population growth.

"There will not be enough water available on current croplands to produce food for the expected 9 billion population in 2050 if we follow current trends and changes towards diets common in western nations," according to the report by Malik Falkenmark and other scientists at the Stockholm International Water Institute noted, as reported by The Guardian.

4-in-1 HIV combination pill approved

The Food and Drug Administration on Monday approved a new anti-HIV pill that combines four medicines to fight the virus that causes AIDS.

The agency approved Gilead Sciences' Stribild as a once-a-day treatment to control HIV in adults who have not still been treated for infection.

The pill contains two previously approved antiviral drugs, emtricitabine and tenofovir disoproxil fumarate, currently sold as the combination pill Truvada. Those drugs are combined with two new drugs: elvitegravir and cobicistat. Elvitegravir interferes with one of the enzymes that HIV needs to multiply. Cobicistat helps prolong the effect of elvitegravir.

Company studies showed that 88 to 90 percent of patients taking Stribild had an undetectable level of HIV in their blood after 48 weeks, compared with 87 percent for patients taking Atripla, another HIV drug that contains Truvada and one other drug.

An estimated 1.2 million Americans have HIV, which develops into AIDS unless treated with antiviral drugs. AIDS causes the body's immune system to break down, leading to infections which are eventually fatal.

Patients can live healthy, normal lives when treated with antiviral cocktails.

Like most other HIV drugs, Stribild will carry a boxed warning about potentially dangerous side effects, including severe liver problems and the buildup of lactic acid. More common side effects include nausea and diarrhea.

Earlier this year, Gilead received FDA approval to market Truvada as the first preventive medicine for healthy people who are at high risk of acquiring HIV. Truvada was first approved in 2004 for patients already infected with the virus.

UK healthy life expectancy rises to nearly 64 for men

Men in the UK expect to live in good health until almost 64 – two years more than they did half a decade ago, official figures show.

The Office for National Statistics found that in the UK healthy life expectancy – a measure of how long people thought they would live free from the debilitating effects of chronic disease or disability – had risen for men from 61.4 years in the years 2005-7 to 63.5 years in 2008-10. For women the rise was more dramatic – three and a half years more.

The figures came on the day that the ONS also revealed that older workers were retiring early – in effect dropping out of the workforce.

There appeared to be significant national differences with men reporting expectations of a healthy life until 64.4 years in England and 63.0 years in Wales, up from 61.6 years and 59.2 years respectively.

However in Scotland and Northern Ireland men's healthy life expectancy declined from 61.2 years to 59.8 years and from 60.7 years to 59.2 years. The ONS said that some of this could be explained by the "UK labour market, where the percentage of older workers is greater in England and Wales than in Scotland and Northern Ireland".

Experts emphasised that there were "real lifestyle differences between the nations".

Alan Maryon-Davis, professor of public health at King's College London, said there were "markedly more smoking, bad diets and drinking in Scotland and Northern Ireland … that will affect how much healthcare people need. But also we have to note that in terms of workforce it will affect who can work longer. We want people to live lives where they can be economically useful, have better relationships and contribute to society."

The ONS says that by the time men reach 65 in the UK they have 10 years of healthy life left on average but 18 years of total life expectancy. For women the comparable figures are almost 12 years of healthy life but 20 years of life expectancy.

In a paper accompanying the statistical release the ONS said the life expectancy gap between men and women was narrowing due to changes in lifestyle and employment – with less of the male workforce employed in heavy industry.

"Life expectancy for males has increased at a slightly higher rate than for females in recent years, causing an overall narrowing of the gender gap. In part this may be due to changes in lifestyle, such as more rapid declines in rates of alcohol consumption and smoking among males compared with females. There may also be reductions in the health risks associated with occupations traditionally undertaken by males such as the coal and steel industries."

Earlier this year the Church Urban Fund showed a significant north-south divide – with life expectancy for people living in England's most deprived areas up to 20 years lower than for those in affluent districts.

Groups representing older people said that increasing life expectancy was "great news" but posed challenges. Ros Altmann, director general of Saga, said: "The latest figures showing that more of us are staying healthy into later life these days are really something to celebrate. Medical advances have brought such success in helping people live longer. That does also mean re-evaluating our lives too.

"Working longer, keeping active – and saving more if you can – are vital ingredients of managing the ageing population. We need to help older people look after themselves where possible and help younger people appreciate the value of elders."

Testosterone marketing frenzy draws skepticism‎

"Are you falling asleep after dinner?" "Do you have a decrease in libido?" "Have you noticed a recent deterioration in your ability to play sports?" "It could be Low-T."

Welcome to the latest marketing push by the nation's drug companies.

In this case, it's a blog for Abbott Laboratories' Androgel, a billion-dollar selling testosterone gel used by millions of American men struggling with the symptoms of growing older that are associated with low testosterone, such as poor sex drive, weight gain and fatigue.

Androgel is one of a growing number of prescription gels, patches and injections aimed at boosting the male hormone that begins to decline after about age 40. Drugmakers and some doctors claim testosterone therapy can reverse some of the signs of aging -- even though the safety and effectiveness of such treatments is not clear.

Low testosterone is the latest example of a once-natural part of getting old that has become a target for medical treatment. Bladder problems, brittle bones and hot flashes have followed a similar path: from inconvenient facts of life, to ailments that can be treated with drugs. The rise of such therapies is being fueled by both demographics and industry marketing.

Baby boomers are living longer and looking for ways to deal with the infirmities of old age: Life expectancy in the U.S. today is 78 years, up from 69 years a half-century ago. And companies have stepped up their marketing to the older crowd: Spending on print and television ads promoting testosterone by firms like Abbott and Eli Lilly has risen more than 170% in the last three years to more than $14 million in 2011, according to advertising tracker Kantar Media.

Doctors say that's led to an increase in men seeking treatment for low testosterone. Prescriptions for the hormone have increased nearly 90% the past five years, according to IMS Health. Last year, global sales reached $1.9 billion.

"People are living longer and want to be more active," says Dr. Spyros Mezitis, a hormone specialist at Lenox Hill Hospital in New York. "They no longer consider that because they're older they shouldn't have sexual intercourse."

Former marathon runner Damon Lease, 50, had been complaining of low energy and depression, for which his doctor prescribed a combination of four psychiatric drugs. But since he started taking twice-a-week testosterone injections in May, he says he's been able to stop taking two of the medications and hopes to eliminate them completely. He says he has more energy, improved mood and concentration.

"I spent 27 years running long distances, I like biking, I like hiking, and I guess every guy wants to have an active sex life ... I want to keep doing those things as long as I can," says Lease, who works as a software company executive. "I feel 20 years younger."

MASS-MARKET HORMONE

Despite its rising popularity, testosterone therapy is not completely new. Testosterone injections were long used for men with hypogonadism, a disorder defined by low testosterone caused by injury or infection to the reproductive or hormonal organs.

But the latest marketing push by drugmakers is for easy-to-use gels and patches that are aimed at a much broader population of otherwise healthy older men with low testosterone, or androgen deficiency. The condition is associated with a broad range of unpleasant symptoms ranging from insomnia to depression to erectile dysfunction. Drug companies peg this group at about 15 million American men, though federal scientists do not use such estimates.

Watson Pharmaceuticals now markets its Androderm patch, which slowly releases testosterone into the bloodstream. Abbott has its gel that can be applied to the shoulders and arms. And Eli Lilly's Axiron is an underarm gel that rolls on like deodorant. Androderm, launched last year, had $87 million in sales, and Axiron, which was launched in 2010, had sales of $48 million last year.

"All of a sudden you've got these big players with a lot of money using consumer directed marketing to change the landscape," said Dr. Natan Bar-Chama, a male reproductive specialist at Mount Sinai Hospital in New York. "They see the potential, they see the market growth annually and it's very impressive."

But government researchers worry that medical treatments have gotten ahead of the science.

Male testosterone is mainly produced in the testes and affects muscle mass, sperm production and various sexual characteristics. The hormone can easily be checked with a blood test, but doctors can't agree on what constitutes a low reading in older men. Typical testosterone levels for younger men range between 300 and 1,000 nanograms per deciliter, but once levels begin dropping there is little consensus on what makes a "normal number."

Some doctors believe testosterone levels below 300 lead to sexual dysfunction in older men, but the rule does not cover all cases. A 2010 study by researchers at the University of Manchester and other European institutions found that 25% of men with testosterone levels above that threshold had the same sexual problems used to diagnose low testosterone. Adding to the ambiguity is that testosterone levels change by the hour, so a man who takes a blood test for testosterone in the morning may get a completely different reading when tested in the afternoon.

SAFETY CONCERNS

Adding to the confusion over what defines "low testosterone," there's not much understanding of whether testosterone replacement therapy actually improves men's symptoms. Evidence of the benefits of testosterone is mixed, and the potential health risks are serious. The largest study conducted to date, a 2008 trial involving 230 patients in the Netherlands, found no improvement in muscle strength, cognitive thinking, bone density or overall quality of life among men taking testosterone. Muscle mass increased 1.2%, but not enough to improve physical mobility.

The National Institute on Aging is currently conducting an 800-man trial to definitively answer whether testosterone therapy improves walking ability, sexual function, energy, memory and blood cell count in men 65 years and older. But those results aren't expected until 2014.

In addition to concerns about testosterone's effectiveness, the long-term side effects of the hormone are not entirely understood because most trials to date have only followed patients for a few months. But the most serious risks include heart problems and prostate cancer.

In 2010, researchers at Boston University's school of medicine halted a large study of testosterone in senior men because patients taking the hormone were five times more likely to suffer a serious heart event, including congestive heart failure, than those taking placebo. A review of 19 testosterone trials in 2006 found that prostate cancer was significantly higher among men taking testosterone. All testosterone drugs carry a warning that the hormone should not be given to men who have a personal or family history of prostate cancer.

Also in 2006, the Endocrine Society published the first physician guidelines for prescribing testosterone for men with androgen deficiency. All six of the co-authors had received consulting fees or research funding from drugmakers that market testosterone. Despite those ties, the authors took a cautious tone, stressing the difficulty of accurately diagnosing low testosterone and acknowledging that they were unable to reach an agreement about when doctors should begin therapy. They also recommend doctors have an "explicit discussion of the uncertainty about the risks and benefits of testosterone therapy."

History has shown that hormone replacement therapy can be dangerous. That hit home for women in 2002 when a landmark study shook up the conventional wisdom about the benefits of estrogen replacement therapy for menopause, the period when women stop producing eggs and estrogen. The federal study found that women taking hormone pills were more likely to suffer heart attacks, breast cancer and strokes. Doctors now generally recommend hormones only to relieve severe menopause symptoms â?? in the lowest possible dose and for the shortest possible time.

In the case of testosterone, Abbott Laboratories says Androgel and other drugs like it are an important treatment option for men with low levels of the hormone. But the company acknowledges that more study is needed.

"Abbott believes that the long-term effects of testosterone replacement therapy should be studied, which is why we continually fund and support additional clinical trials, such as the National Institute of Aging's testosterone trial," the company states.

Doctors who prescribe testosterone say more men should be talking to their doctors about the hormone. "If an older man feels excessively tired or his erectile dysfunction has worsened he should be asking 'is there something wrong with my testosterone?'" says Mezitis of Lenox Hill Hospital. "The awareness should be much broader than it is at this point."

And even critics of the testosterone craze acknowledge that the interest in anti-aging products may be inevitable as life expectancy increases. But they say doctors can do more to help seniors by focusing on lifestyle adjustments that keep them connected to their friends and family, rather than prescribing drugs.

"We really medicalize seniors so much that they think the secret always has to be scientific," says Dr. Nortin Hadler of the University of North Carolina at Chapel Hill, who has written four books on excessive medical care. "We need another perspective to understand the secrets to healthy aging, which by and large are not pills."