LONDON (Reuters) – New imaging technology suggests an experimental drug for Alzheimer’s reduces clumps of plaque in the brain by around 25 percent, lifting hopes for a medicine that disappointed in clinical tests two years ago.

Health

Bapineuzumab — being developed by Pfizer Inc, Irish drugmaker Elan Corp and Johnson & Johnson — is a potential game-changer because it could be the first drug to treat the underlying cause of the degenerative brain disease.

Investor confidence in the antibody medicine, however, took a big hit in July 2008 when it failed to meet its main goal in a mid-stage trial and caused brain swelling at higher doses. The new study, which only involved 28 patients, is modest fillip.

“It demonstrated that the drug has an effect on the pathological hallmark of Alzheimer’s disease,” lead researcher Juha Rinne from Finland’s University of Turku told Reuters.

Rinne and colleagues used a novel imaging substance called carbon-11-labeled Pittsburgh compound B, which sticks to areas of the brain where there is a lot of beta amyloid plaque.

After 78 weeks, they found that patients given bapineuzumab had about a 25 percent reduction in plaque compared with those on placebo. The effect was similar with three different doses of the drug, they reported in the journal Lancet Neurology.

The treatment was generally well tolerated, although two patients on the highest dose had transient brain swelling. The drug’s developers have since dropped the top dose from large ongoing Phase III trials.

Commenting on the results, Sam Gandy from New York’s Mount Sinai School of Medicine said it was too early to say effective disease-modifying drugs were at hand, but the ability to measure plaque in living subjects was “something of a breakthrough.”

Experts are divided on the root cause of Alzheimer’s and hence the best way to tackle it.

Most advanced drugs, like bapineuzumab, have focused on removing clumps of amyloid plaques, which are thought to stop brain cells from functioning properly. But a rival school blames toxic tangles caused by an abnormal build-up of the protein tau.

Rinne’s imaging study was funded by Elan and Wyeth, which is now part of Pfizer.

(Editing by Jon Loades-Carter)

WASHINGTON (Reuters) – Eating meat may be a much more common trigger for anaphylaxis — a severe and potentially deadly allergic reaction — than previously thought, U.S. researchers said on Sunday.

Health

A study of 60 patients who had unexplained severe allergic reactions suggests that a compound in meat known as alpha-galactose may be the culprit, according to research presented at a meeting of the American Academy of Allergy, Asthma & Immunology in New Orleans.

They found immune system proteins called IgE antibodies in 25 out of 60 patients who had unexplained allergic reactions.

“We believe that the presence of IgE antibody to this sugar is wider spread in the human population as a whole than we had initially expected,” Dr. Scott Commins of the University of Virginia, who led the research, said in a telephone interview.

“What we’re finding is that this traditional notion of allergy to meat being very rare may, in fact, not be true,” Commins added.

Alpha-galactose is produced in most mammals but humans and great apes make an antibody to the sugar, Commins said.

“So the problem becomes when people make IgE antibody to this sugar and then they eat meat or dairy products that contain the sugar then they get a delayed reaction,” Commins said.

The anaphylaxis may seem to appear out of the blue because the meat or dairy may have been eaten four to six hours earlier, Commins said.

“The typical scenario has been if you don’t react to food within two hours, then it’s not the food, in this case that doesn’t seem to be true, Commins said.

Typically, anaphylaxis occurs within minutes.

Commins and colleagues screened blood samples from 60 patients, testing for the antibody to alpha-galactose. The people in the study — 22 at the University of Virginia, 20 at the University of Tennessee and 18 at John James Medical Center in Australia, had anaphylaxis and no apparent cause for it, Commins said.

Twenty-five tested positive for alpha-galactose and no other patterns were found that would have otherwise explained the cause of their anaphylaxis, the researchers said.

(Editing by Maggie Fox and Sandra Maler)

NEW YORK (Reuters Health) – Getting students to exercise more might not just address obesity issues but also improve their grades with a U.S. study finding physically fit students tend to score higher in tests than their less fit peers.

Health  |  Lifestyle

Test scores dropped more than one point for each extra minute it took middle and high school students to complete a one mile run/walk fitness test, according to Dr. William J. McCarthy and colleagues at the University of California in Los Angeles.

Schools and parents seeking to optimize their students’ academic performance should take heed, McCarthy noted in an email to Reuters Health.

For optimal brain function “it’s good to be both aerobically fit and to have a healthy body shape.”

McCarthy and colleagues compared physical fitness and body weight measures with scores on California’s standardized math, reading, and language tests among 749 fifth-graders, 761 seventh-graders, and 479 ninth-graders who attended schools in Southern California between 2002 and 2003.

About half of the students were girls, 60 percent were white, 26 percent were of Hispanic ethnicity, and about 7 percent each were African American and Asian/Pacific Islander.

Almost 32 percent of the students were overweight and about 28 percent were obese, the researchers report in The Journal of Pediatrics. The researchers estimated students’ aerobic fitness according to their one-mile run/walk time on a flat track. With a 15-minute maximum allowed time to complete the test, the boys averaged slightly less than 10 minutes, while the girls averaged a little less than 11 minutes.

McCarthy’s team found that nearly two thirds of the students (65 percent) fell below the state fitness standard for their age and gender. Compared with these students, students who met or exceeded fitness standards had higher average test scores. Allowing for age, social and economic status, gender, ethnicity, and body size did not significantly alter this association.

Compared with students of desirable weight, overweight and obese students also scored significantly lower on tests, the researchers found.

These findings, McCarthy’s team notes, confirm and extend those of previous investigations. They say further studies are needed to figure out why aerobic fitness may play a role in academic performance.

If future studies confirm a cause-and-effect link between lower fitness and reduced academic performance, “schools will have to reverse their recent disinvestment in physical education ostensibly for the purposes of boosting student achievement,” they concluded.

(Reporting by Joene Hendry of Reuters Health, Editing by Belinda Goldsmith)

LONDON (Reuters) – Does this sound like anyone you know? Darryl is 35, has a steady job, a stable home and good marriage, enjoys a few beers in front of the TV most nights — doesn’t have what most people would call a drink problem.

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In the United States alone there are probably around 36 million Darryls, according to the National Institute on Alcohol Abuse and Alcoholism (NIAAA), which created the character, played by an actor on its website to help train doctors.

He doesn’t exercise as much as maybe he should so he’s a little overweight. At an average of four drinks a day, he is no alcoholic: but some experts now see him as a high-risk drinker and say he could succumb to “alcohol use disorder.”

Millions more people across the developed world — who drink a few glasses of wine every night after work or look forward to three nights of repeated shots with chasers on the weekends — may today be adding up to a major health and social problem.

Could there be a pill to help them?

A reassessment of the nature of addiction, particularly to alcohol, is starting to pique Big Pharma’s interest. For years the industry has been lukewarm, assuming either that finding a cure for alcoholism is impossible, or else that the target market — homeless drop-outs, jobless bums and convicted drink drivers — would not make for great returns.

Now changing western attitudes and cheap supermarket-supplied alcohol have made excessive drinking normal, including among the middle classes. Some experts predict the arrival soon of a new generation of drugs to help everyday drinkers.

“The potential market for medications that can be prescribed for these functional alcoholics is huge,” said Mark Willenbring, an addiction expert and psychiatrist in the United States.

Just as with depression treatment 30 years ago, he says alcoholism research could be approaching a “Prozac moment” when it will become more natural, and more acceptable, for doctors to prescribe a pill to help people through a bad patch.

There are already drugs available to treat alcoholism, but their effects vary widely. As scientists’ understanding of what alcohol does to our brain functions deepens, so, potentially, does the range of possible treatments.

Data from Thomson Pharma, a ThomsonReuters company that monitors the drug industry, show there are 24 drugs in development for alcoholism, including around 10 or more in mid-stage trials.

BIG BOOZERS ATTRACT BIG PHARMA

Drug giants Merck and Eli Lilly are the biggest hitters stepping up to the plate at the moment: each is pursuing two possible drugs through mid-stage human trials for treating alcoholism.

Biotech firm Alkermes is also very active in this area, with three drugs in development — two new compounds, and the third a new format of an existing medicine.

As is often the case when drugmakers show renewed interest in an expanding concern, critics may accuse the firms of seeking to create a “new disease” to generate a market for otherwise unnecessary medicines.

But others argue the outcome could prove a lifeline to millions whose drinking presents a risk to their health, and a big bill to society.

“They don’t need the intensity of treatment that more severe cases do,” said Willenbring. “They don’t need to go to alcoholics anonymous for the rest of their lives, they can respond well to some medication and brief behavioral support.”

Alcohol and its consequences kill 2.3 million people a year around the world, according to the World Health Organization: that amounts to 3.8 percent of all deaths, ranking drink just below unsafe sex and just above malnutrition in the top 10 causes of death.

When it comes to the burden of disease caused by alcohol, the evidence against drink really stacks up.

As well as contributing to traumatic death and injury in car crashes and other accidents, alcohol is associated with chronic liver disease, many cancers, acute alcohol poisoning, fetal alcohol syndrome and heart disease — which is itself the No. 1 killer of men and women in industrialized nations.

“Here in the U.S. we have at least 18 million adults who suffer from alcohol use disorder, and probably twice that many who are high-risk drinkers who don’t have a diagnosis. We also have roughly 7.5 million adolescents who are binge drinkers, and at least a 1.5 million who are alcohol dependent,” said Raye Litten, the NIAAA’s chief of medications development.

“That’s quite a market — and it is intriguing to large pharmaceutical companies.”

In Britain and other parts of Europe, the need may even be greater. Almost a quarter of Britons — 33 percent of men and 16 percent of women — are hazardous drinkers, and binge-drinking and its consequences are daily fare for newspaper headline writers and the politicians who must respond to them.

“The toll of alcohol-abuse-fueled aberrant behaviors, from interfamilial violence to slaughter on the highways, wreaks havoc in a scope and intensity that is leagues ahead of all illegal drugs put together,” wrote Harry Tracy, a psychologist and publisher of NeuroInvestment, a monthly publication specializing in central nervous system disorders, in a recent report.

DRUGS — THE OLD AND THE NEW

The race to find more effective drugs is among the hottest areas in alcoholism research, according to the NIAAA’s Litten. Of those available so far, none comes close to being a “magic pill” for drunks, or even high-risk drinkers.

Naltrexone, which cuts the desire to drink by blocking the brain’s opioid receptors, has been around for years. Disulphiram works on the enzymes that metabolise alcohol to make users feel awful if they drink, while acamprosate is thought to ease withdrawal symptoms such as anxiety and insomnia.

The problem is that one drug can work well in some people, yet have virtually no effect on others. Some make people feel so bad they stop taking them and go back to the bottle.

Of the potential new drugs tracked by Thomson Pharma, many are in very early experimental stages, and given the slow and uncertain pace of drug development it could be a decade or more before something — if anything — comes of them.

Those in clinical trials have a 30 percent likelihood of approval rating on BioMedTracker, an analysis tool from Sagient Research, which also works in partnership with Thomson Pharma. That’s average for a drug at that stage.

Yet addiction experts are encouraged — not least by progress in what scientists know about alcohol what it does to the brain.

“In the alcohol field over the past 10 years, what we’ve found is that it’s not just one neurotransmitter system, it’s multiple neurotransmitter systems that are involved in alcohol-seeking and drinking behavior,” said Litten.

“Because of that, researchers are looking at a variety of sites in the brain and coming up with new types of medications to be tested.”

Eli Lilly’s OpRA II drug targets the brain’s opioid receptors, as does Naltrexone, but neither Lilly nor Merck has disclosed the targets for their other experimental drugs. Alkermes’s three projects are all aimed at opioid receptors.

A couple of firms, AstraZeneca and Transcept Pharma, are looking at compounds that hit dopamine receptors — the “reward” pathway in the brain.

Another possibility showing early promise is topiramate, a medicine which hits multiple sites in the brain and is used in epilepsy and migraine treatment. It has shown some ability to cut alcohol intake in heavy drinkers in a small clinical trial.

And other scientists, like Colin Drummond at the National Addiction Center and Britain’s Institute of Psychiatry in London, are focusing on the brain’s stress pathways.

He is about to start a small experiment with mifepristone, which researchers hope may be able to reduce the extreme levels of the stress hormone cortisol released in the brain when alcoholics quit drinking.

“We’re going to start a trial where we will give it to alcoholic patients who come in for detox, with a view to reducing the brain effects of withdrawal,” he told Reuters.

LONDON (Reuters) – Women who get pregnant through in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI) have a higher risk of stillbirth, scientists have found, although the overall risk is still low.

Health

Researchers from Aarhus University Hospital in Denmark studied 20,000 single pregnancies and found a four-fold increased risk of stillbirths for women who had IVF or ICSI compared with women who conceived naturally.

“The results from our study emphasize the need for continuous follow-up of the outcome of fertility treatments so that the information given to infertile couples seeking treatment can be differentiated to their individual circumstances,” Kirsten Wisborg, who led the study, wrote in the Human Reproduction journal Wednesday.

She added, however, that the risk of stillbirth was still very low for IVF and ICSI pregnancies. The rate of stillbirth after IVF/ICSI was 16.2 per thousand, compared to 3.7 per thousand in fertile couples who conceived without medical help.

The researchers said it was not yet clear whether the increased risk was due to the fertility treatment itself or because of unknown factors specific to couples who IVF or ICSI.

IVF is the fertilization of an egg by sperm in a laboratory dish. In ICSI, an egg is fertilized by injecting a single sperm into it.

Doctors previously thought the greater risk of bad outcomes like stillbirths in assisted reproduction might be something to do with the underlying infertility of couples who have it.

But Wisborg and colleagues found that fertile couples who conceived within a year of trying, and so-called “sub-fertile” couples who took longer to conceive, had a similar risk to each other.

“This may indicate that the increased risk of stillbirth is not explained by infertility and may be due to other, as yet unexplained factors, such as the technology involved in IVF and ICSI or some physiological difference in the couples that require (it),” Wisborg wrote.

(Editing by Andrew Roche)