Piglet-killing PED virus spreads to second Canada farm

By Rod Nickel

WINNIPEG, Manitoba Mon Jan 27, 2014 3:29pm EST

WINNIPEG, Manitoba (Reuters) – The piglet-killing Porcine Epidemic Diarrhea virus (PEDv) has spread to a second Canadian farm, government officials said on Monday.

A laboratory test confirmed the virus in a barn near Chatham-Kent, Ontario, and another possible case is under investigation in the same area, said Greg Douglas, the Canadian province’s chief veterinary officer.

“We still are under the impression that there are strategies to help mitigate, slow the spread of this virus in Ontario,” he said. “However, the confirmed case, the second case, and the third under suspicion, does change the situation, the reality.”

The two Chatham-Kent farms involve finishing barns handling older pigs that generally get sick and recover from the virus.

Last week, the Ontario government said the virus, which has killed at least 1 million pigs in the United States, was found on a hog farm in southern Ontario’s Middlesex County, marking the first confirmed case of the virus on a Canadian farm.

Virtually all of that farm’s several hundred two- to five-day-old piglets have died, Douglas said.

Ontario is Canada’s second-biggest hog-producing province, after Quebec.

Olymel LP, one of Canada’s biggest pork processors, also detected the virus last week at an unloading dock of its Saint-Esprit slaughter facility northeast of Montreal, Quebec.

PEDv – which causes diarrhea, vomiting and severe dehydration in hogs – has turned up in 23 of the 50 states since its discovery in the United States last April.

The virus, which is already established in Europe and Asia, poses no threat to humans and is not a food safety risk, according to the Canadian Swine Health Board. The virus can spread through contaminated pig feces on pigs, trucks, boots and clothing, and the industry has increasingly demanded trucks be disinfected before they load pigs.

If the virus were to spread across Canada within one year, it would cause an estimated C$45 million ($40.6 million) in damage to the Canadian hog industry, said Amy Cronin, a hog farmer and chairwoman of Ontario Pork.

A drop in the Canadian hog supply would pose a major challenge for Olymel and fellow hog processor Maple Leaf Foods Inc, both of which also raise pigs.

($1=$1.108 Canadian)

(Editing by James Dalgleish)

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Drug critic slams FDA over antibiotic oversight in meat production

By P.J. Huffstutter and Brian Grow

Mon Jan 27, 2014 3:10pm EST

(Reuters) – The Food and Drug Administration allowed 18 animal drugs to stay on the market even after an agency review found the drugs posed a “high risk” of exposing humans to antibiotic-resistant bacteria through the food supply, according to a study released Monday by the Natural Resources Defense Council.

The study by the NRDC, a non-governmental group that criticizes the widespread use of drugs in the meat industry, is the latest salvo in the national debate over the long-standing practice of antibiotic use in meat production. Agribusinesses say animal drugs help increase production and keep prices low for U.S. consumers, while consumer advocates and some scientists raise concerns over antibiotic-resistant bacteria.

The FDA stirred the debate late last year when it unveiled guidelines for drug makers and agricultural companies to voluntarily phase out antibiotic use as a growth enhancer in livestock. The agency said those guidelines were an effort to stem the surge in human resistance to certain antibiotics.

But the NRDC’s study found the FDA took no action to remove 30 antibiotic-based livestock feed products from the market even after federal investigators determined many of those antibiotics fell short of current regulatory standards for protecting human health.

NRDC focused on a review conducted by the FDA from 2001 to 2010 that focused on 30 penicillin and tetracycline-based antibiotic feed additives. The drugs had been approved by regulators to be used specifically for growth promotion of livestock and poultry – essentially to produce more meat to sell.

The FDA did not immediately respond to a request for comment on the report.

Some academics specializing in antibiotic resistance criticized the NRDC’s study, saying that the findings do not reflect current regulatory standards because some of the drugs have been withdrawn from the market.

They also say that the study assessed FDA safety guidelines that have been replaced with more stringent standards.

Dr. Randall Singer, associate professor of epidemiology at the University of Minnesota, told Reuters that drug makers and the U.S. livestock industry are phasing out antibiotics used principally for growth promotion.

“We have been telling (both of) them for years to be prepared for the elimination of growth promotion and feed efficiency labeling because you cannot make that change overnight,” said Singer, who reviewed the NRDC report for Reuters.

The NRDC, which reviewed more than 3,000 pages of documents through a federal Freedom of Information Act request, said it found evidence to suggest nine of the drugs are still on the market and used by livestock producers. Reuters was not able to independently verify that detail immediately.

One of the drugs still on the market is animal health company Zoetis Inc’s Penicillin G Procaine 50/100, which is fed to poultry in part to aid in weight gain.

The NRDC says the FDA twice laid out its concerns to that drug maker that the product failed to meet safety regulations. The unnamed original sponsor of the drug apparently disputed the regulators’ findings, according to excerpts from a 1997 letter sent to the FDA and included in documents obtained by the NRDC.

A spokeswoman for Zoetis, a unit of Pfizer that owns the drug today, said the company already is working to phase out use of the drug for growth promotion as part of the new FDA guidelines and is planning to relabel the drug for more limited purposes.

Once companies remove farm-production uses of their antibiotics from drug labels, it would become illegal for those drugs to be used for those purposes, Deputy FDA Commissioner Michael Taylor told reporters recently. Although the program is meant to be voluntary, Taylor said the FDA would be able to take regulatory action against companies that fail to comply.

NRDC attorney Avinash Kar, one of the study’s authors, said the group’s findings raise questions about whether regulators will be effective in enforcing the new guidelines

“The FDA’s failure to act on its own findings about the 30 reviewed antibiotic feed additives is part of a larger pattern of delay and inaction in tackling livestock drug use that goes back four decades,” Kar told Reuters.

(Reporting By P.J. Huffstutter in Chicago and Brian Grow in Atlanta; editing by David Greising and Amanda Kwan)

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Britain unveils ban on e-cigarettes for under-18s

LONDON Sun Jan 26, 2014 2:01pm EST

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E-cigarettes are displayed at 'smoke-not-smoke' at Camden in London June 9, 2013. REUTERS/Toby Melville

E-cigarettes are displayed at ‘smoke-not-smoke’ at Camden in London June 9, 2013.

Credit: Reuters/Toby Melville

LONDON (Reuters) – Britain said on Sunday it would ban the sale of electronic cigarettes to children aged under 18, citing possible adverse health effects and outlining a need for further medical research.

E-cigarettes, which are puffed like a regular cigarette but deliver nicotine by vaporizing liquid rather than burning tobacco, have grown in popularity and some analysts predict the market could outpace conventional cigarettes within a decade.

“We do not yet know the harm that e-cigarettes can cause to adults let alone to children, but we do know they are not risk- free,” England’s Chief Medical Officer Sally Davies said in a statement.

She added that e-cigarettes can produce toxic chemicals and that variations in the strength of the nicotine solutions between different products meant they could end up being “extremely damaging” to young people’s health.

The global market for e-cigarettes was estimated at more than $2 billion last year by market consultant Euromonitor.

Under-18s are already banned from buying conventional cigarettes in Britain. Sunday’s announcement included plans to make it illegal for adults to buy regular cigarettes for consumption by under 18s.

The changes will be written into a bill already on its way through parliament and are expected to have cross-party support, although the opposition Labour party criticized the government for not acting more quickly.

The battery-powered metal tubes of e-cigarettes are seen as less harmful than regular cigarettes and a useful way to wean smokers off their habits. Critics, however say they can act as a gateway to nicotine addiction and that more research is needed on the health implications.

Regulators in Europe and the United States have been debating policy towards the industry. The European Union reached an agreement in December to allow e-cigarettes to be sold as consumer products rather than more tightly regulated medical devices.

(Reporting by William James; Editing by Mark Heinrich)

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Analysis: Replay of energetic deal-making seen for drugmakers in 2014

By Deena Beasley and Ransdell Pierson

Sun Jan 26, 2014 12:21pm EST

(Reuters) – The torrid pace of deals in the pharmaceutical and biotechnology sectors through 2013 is not expected to let up this year, thanks to new technologies to address unmet medical needs.

Between 2011 and 2016, patents in developed markets will expire on brand-name drugs that would otherwise have generated sales of $127 billion, according to data firm IMS Health. To replace some of the lost revenue, larger drugmakers are looking to bring in new products, often in areas of significant scientific advancement such as treatments for cancer, rare diseases and drugs designed to turn off the activity of rogue genes. Much of the breakthrough science is coming from biotechnology, meaning drugs derived from living cells.

There were 10 major M&A deals involving publicly traded biotech companies last year, led by Amgen Inc’s $10 billion buyout of Onyx Pharmaceuticals. That was up from nine the previous year and six in 2011, according to JP Morgan.

“I think deal making this year will be even better because there was a lot of validation last year,” said Joseph Gulfo, chief executive officer at Breakthrough Medical Innovations LLC, a consulting company to drug and medical device companies. “The new discoveries and data have sparked a tremendous amount of interest from the bigger companies.”

Rather than the mega-mergers typically done to achieve big cost savings through layoffs and factory closings, most drugmakers are aiming for deals that increase sales. Many of them detailed their strategies this month at the annual JP Morgan Healthcare Conferenceare.

Those strategies included acquisitions of smaller companies as well as risk-sharing through product licensing and drug development partnerships.

AbbVie Inc, maker of top-selling arthritis drug Humira, is interested in a “gradual buildup” of its pipeline of experimental drugs, having forged a dozen collaborations with other drugmakers in the past three years, most involving drugs in mid-stage trials, said Chief Financial Officer Bill Chase.

“We don’t have the need to go out and do a big deal. Large synergy deals are not overly attractive,” he said.


With the 65 percent run-up in the Nasdaq Biotechnology Index last year, valuations of companies have gotten so high that licensing and partnership deals are becoming a more popular way to share financial risk.

“Biotech companies realize that developing a drug these days is economically and mathematically different than 20 years ago,” said James Sabry, global head of partnering at Roche unit Genentech. “Most don’t have that level of sophistication. Partnering with a pharma company is the only way to create long-term value.”

Companies like Amgen and Roche performed well last year and don’t really need to acquire new assets, beyond companion diagnostics to complement their products, said Anne O’Riordan, global managing director of Accenture Life Sciences.

According to Accenture’s analysis, drugmakers that rank in the mid-tier in terms of growth prospects from new drugs and geographic expansion would include GlaxoSmithKline, Novartis and Sanofi.

A third clump of companies have relatively weak late-stage drug development pipelines and are still in the midst of dealing with expiring patents on top-selling drugs.

But most still have high profit margins and generate robust cash flows. “A lot of them can afford to buy something,” O’Riordan said.

AstraZeneca, which recently paid $4 billion to buy Bristol-Myers Squibb’s share of the two companies’ diabetes joint venture, probably falls into that third camp, O’Riordan said.

Israel-based drugmaker Teva Pharmaceutical Industries, recently named turnaround specialist Erez Vigodman as its CEO and agreed to buy NuPathe Inc to expand its portfolio of medicines to treat conditions affecting the central nervous system.

Israel Makov, chairman of Biolight Israeli Life Sciences Investments Ltd, and a former CEO of Teva, said he believes deal flow among healthcare companies will be just as robust in 2014 as last year: “Why? Because there is a lot of money in the system and few places to invest it.”

He predicted “more and more Big Pharma buying biotech because the problem with Big Pharma is the pipeline, and biotech can provide them the pipeline. Its even more expensive to develop a drug on your own and fail.”

Companies like Teva, Merck & Co, Eli Lilly and Pfizer are avidly on the lookout for deals to supplement the flow of drugs from their own laboratories.

Eli Lilly CEO John Lechleiter said his company is “very active in the animal health space; we’re gonna be buyers not sellers there.”

He also said Lilly will look for ways to bolster its existing strengths in therapeutic areas such as neuroscience, diabetes, oncology, autoimmune diseases, or to widen its geographic presence.

“Growth is a challenge … we have to take risk,” Merck CEO Kenneth Frazier said in comments at the conference, while noting that the company still needs to build shareholder value and protect its capital.

Roger Perlmutter, head of research at Merck, said there are no longer many undervalued late-stage pharmaceutical product candidates. “There are earlier-stage products and we intend to exploit that opportunity,” he said.

(Reporting by Deena Beasley and Ransdell Pierson; Editing by David Gregorio)

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Health and 'hookups' correlated in first-year college women

Sexual experimentation outside of committed romantic relationships, or “hooking up,” is typically portrayed by the media as unhealthy, especially for young women. These portrayals, however, are largely conjecture.

Researchers from Syracuse and Brown Universities set out to examine the relationship between young women’s health and hooking up more closely; their findings, in “Sexual Hookups and Adverse Health Outcomes: A Longitudinal Study of First-Year College Women,” are now available in The Journal of Sex Research, the official publication of the Society for the Scientific Study of Sexuality and a publication from Routledge.

The study examined the associations between sexual hookup behavior and depression, sexual victimization, and sexually transmitted infections. 483 first-year female undergraduate students completed 13 monthly surveys assessing hookup versus romantic sexual behaviors in relation to depression, sexual victimization, as well as self-reported and biologically-confirmed STIs.

Researchers found that early college hookup behavior was associated with sexual victimization and depression, but did not predict future depression. Hookup sex and romantic sex were both associated with STIs, and pre-college hookup behavior predicted early college experiences of sexual victimization. Overall, the potential negative outcomes associated with hooking up in female college students suggest a need for proactive educational efforts and further research into the nature of these associations.

Story Source:

The above story is based on materials provided by Taylor & Francis.Note: Materials may be edited for content and length.

Taylor & Francis. “Health and ‘hookups’ correlated in first-year college women.” ScienceDaily. ScienceDaily, 14 January 2014. <www.sciencedaily.com//releases/2014/01/140114114159.htm>.

Taylor & Francis. (2014, January 14). Health and ‘hookups’ correlated in first-year college women. ScienceDaily. Retrieved January 23, 2014 from www.sciencedaily.com//releases/2014/01/140114114159.htm

Taylor & Francis. “Health and ‘hookups’ correlated in first-year college women.” ScienceDaily. www.sciencedaily.com//releases/2014/01/140114114159.htm (accessed January 23, 2014).

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HPV test awareness, knowledge still low

By Shereen Jegtvig

NEW YORK Fri Jan 24, 2014 2:21pm EST

NEW YORK (Reuters Health) – Americans are more aware that there is a test for the human papilloma virus (HPV) than counterparts in the UK and Australia, according to a new study, but few people knew much more than that.

“Awareness of HPV has tended to be low but has been rising since the introduction of testing and vaccination,” said Jo Waller, the study’s senior author.

People seem to be more aware of HPV vaccination than testing, however, which is not surprising given the publicity around the vaccine, added Waller, a public health researcher at University College London.

The Pap test, used to look for abnormal cell changes in the cervix, is much older and generally familiar to most people, but the newer HPV test looks for the virus that causes those changes, Waller said.

The HPV test was only introduced in the 1990s and it’s used a little differently in each of the countries that were included in the new study, Waller pointed out.

In the U.S., HPV testing is used as a screening tool in women over the age of 30. In both the U.S. and the UK, HPV testing is also used along with the Pap test to determine the next steps in treatment – for instance, biopsy.

In the UK and Australia, the HPV test is also used to monitor treatment results.

Waller said that many studies have attempted to assess the public’s knowledge about HPV and HPV testing, but they all used different methods and asked questions in different ways, so it’s hard to compare the findings.

“We wanted to use the same questionnaire to look at knowledge across three countries where HPV testing is used in different ways,” she told Reuters Health in an email.

The researchers used an online survey to find out if participants in the U.S., UK and Australia were aware of HPV testing and HPV in general.

The first question asked was ‘Before today, had you ever heard of HPV?’ Participants who responded ‘yes’ were then directed to 15 general questions about HPV.

Participants were then asked ‘Have you ever heard of HPV testing?’ Those who responded ‘yes’ were asked six more questions about the test.

Of the 2,409 men and women who answered the survey, about 61 percent had heard of HPV, Waller’s team reports in the journal Sexually Transmitted Infections.

Among those who had heard of the virus, only half were aware of the HPV test. Awareness of the HPV test was higher in the U.S. than in the UK and Australia.

The participants who had heard of HPV testing, on average, answered less than half of questions about details of testing correctly. Overall, women knew more than men.

Most of the survey participants did know, for example, that the HPV test can be done at the same time as the Pap test, and that a positive HPV test doesn’t mean a woman will definitely get cervical cancer.

But they didn’t know a negative HPV test indicates a low risk of cervical cancer. Few also knew that the HPV test is not an indicator of whether the HPV vaccine is needed.

“It’s also important for people to understand that although the HPV vaccine protects against HPV, it’s still really important for women to have screening, to check for (virus) types not covered by the vaccine,” Waller said.

Women who are screened and found not to have the HPV virus should be reassured that their risk of developing cervical cancer over the next five years is extremely low, Waller added.

SOURCE: bit.ly/1aLPRNE Sexually Transmitted Infections, Online January 9, 2014.

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New criteria may reduce autism diagnoses

By Shereen Jegtvig

NEW YORK Thu Jan 23, 2014 3:33pm EST

NEW YORK (Reuters Health) – The number of U.S. kids diagnosed with autism has been on the rise, but that trend could turn around with new diagnostic criteria coming into effect, researchers say.

By applying the new symptom checklist to 6,577 children who already met the old definitions for autism and related disorders, the study team found about 19 percent of the kids would not get an autism diagnosis today.

“Parents have no reason to be concerned about the findings of this study which is not about re-diagnosing people or taking away their diagnoses,” Dr. Brian King told Reuters Health in an email.

King is director at the Seattle Children’s Autism Center and director of child and adolescent psychiatry at the University of Washington and Seattle Children’s Hospital. He was not involved in the new study, but he was involved in drafting the new diagnosis requirements.

The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) contains the symptom checklist for every psychiatric disorder recognized by the U.S. healthcare system.

Experts have suggested that it sets a higher threshold for diagnosing Autism Spectrum Disorder than the previous version, DSM-4-TR. Small studies attempting to test that theory have not been conclusive, however.

For the new report, the researchers looked at a larger national sample of kids, led by Matthew Maenner of the National Center on Birth Defects and Developmental Disabilities at the Centers for Disease Control and Prevention in Atlanta.

“This is a population-based study that’s really looking at how children are being evaluated and what symptoms are being described in everyday community settings,” Maenner told Reuters Health.

The new DSM-5 doesn’t separate the so-called autism spectrum into separate conditions such as autistic disorder and Asperger disorder. The previous subtypes are simply classified as Autism Spectrum Disorder (ASD).

The new manual uses seven diagnostic criteria rather than 12 in the previous edition to define ASD. In addition, the new version takes historical behavior into consideration along with current behavior.

Maenner and colleagues applied the new criteria to 6,577 eight-year old children who were diagnosed with autism and related disorders from 2006 to 2008.

About 81 percent of those children would still meet the criteria for having ASD. This translates to a rate in the population of about 10 per 1,000 people having ASD instead of 11.3 per 1,000 as is currently estimated.

The results were published in JAMA Psychiatry.

Maenner said that children who had been given a special education classification of autism were more likely to meet the new criteria.

“Children that had an intellectual disability were slightly more likely to meet the new criteria than children without intellectual disability; and children with a history of developmental regression, which is either a loss or plateau of skills, were also more likely to meet the new criteria,” Maenner said.

He noted that many of the kids who would not be diagnosed under the DSM-5 only missed by one criterion.

Parents may be concerned about how the new diagnostic changes might affect their kids, but Maenner says that from a parent’s perspective, the evaluation for ASD isn’t necessarily going to change, at least in terms of the signs that will be looked for in developmental screening.

“The things that would indicate early developmental delays are going to be the same, and you’d want to follow up if there are any concerns,” Maenner said.

He acknowledged that looking at kids diagnosed by one set of rules in the past doesn’t give a perfect picture of what will happen going forward.

“We looked backwards in time, from the most recent data we have, but the diagnostic practices could change, so the impact on service eligibility might actually be smaller than what we’re reporting in terms of the impact on prevalence,” Maenner said.

When physicians and health professionals adapt to the new criteria, Maenner added, they might be looking for the symptoms that would substantiate a diagnosis – they might pay more attention to symptoms that receive greater emphasis in the DSM-5.

King also said that looking backward at old records could be a problem when you’re interested in new criteria.

For example, some of the kids who would not be diagnosed with ASD under the new DSM-5 might have met the new criteria, but the symptoms weren’t recorded. After the threshold for diagnosis has been met, there’s no reason for a clinician to “over-report” still more symptoms, he explained.

In addition, finding that the numbers are different with a second look (any second look) is to be expected to some degree, he said.

In that light, “finding that the boundaries around the overall spectrum are within 10 to 20 percent with this particular method could actually be viewed as pretty good,” King said.

SOURCE: JAMA Psychiatry, online January 22, 2014.

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Keeping out drafts could mean more radon risk at home

By Kathryn Doyle

NEW YORK Thu Jan 23, 2014 11:57am EST

NEW YORK (Reuters Health) – Sealing up houses to improve energy efficiency also traps more radon inside and may lead to a higher risk of lung cancer, according to a new study based on modeling.

Guidelines suggest people install ventilation systems when they try to reduce heat loss from their homes.

Many energy efficiency measures, like putting draft strips along doorframes, reduce air exchange, study author Paul Wilkinson said.

“Moreover, even where trickle vents (small vents in windows or bricks) are fitted, a proportion will not be used or will be left closed,” said Wilkinson, from the London School of Hygiene and Tropical Medicine.

Radon, a gas produced from naturally occurring uranium in soil and water, is known to increase the risk of lung cancer. It is present in many homes in varying amounts.

The U.S. Environmental Protection Agency (EPA) estimates radon contributes to about 21,000 lung cancer deaths each year, mostly among people who smoke.

Using physics models, Wilkinson and his coauthors calculated what would happen if homes in England used available methods to become more airtight and reduced air leakiness by about one half.

Increasing air tightness without taking any other measures would increase indoor radon levels by an average of more than 50 percent, according to their model, described in the British medical journal BMJ. That would mean the number of homes above the radon action level would increase from 0.6 percent to 2 percent – corresponding to an extra 750,000 people in those homes.

If the homes also installed purposeful ventilation methods that worked most of the time, radon levels would still increase, but to a lesser extent, the researchers found.

Mechanical ventilation and heat recovery systems would also do a great deal to mitigate radon risks, unless the systems failed.

The authors estimated current levels of radon account for about 1,000 deaths per year in England. In their worst-case scenario – more air tightness without extra ventilation measures – they predicted an additional 278 radon-related deaths per year.

“Regardless of type of home construction or perceived air tightness of a home, the first step is to test the home, or other structure, for radon,” R. William Field said. He studies the health effects of radon at the University of Iowa College of Public Health in Iowa City but wasn’t involved in the new study.

“Do it yourself test kits are inexpensive. If a home tests high for radon, increasing ventilation rates and/or installing a radon mitigation system will lower radon concentrations substantially,” Field told Reuters Health in an email.

In the U.S. there is little awareness of the dangers of radon, he said, and only about 30 percent of homes have been tested.

According to an EPA map, states in the Midwest and New England tend to have the highest radon levels.

For most people, the increased risk of radon with more air tightness would likely be small, Wilkinson said.

“These small risks add up to an appreciable burden at (the) population level, however, if a high proportion of the housing stock is retrofitted,” he said.

Installing better insulation fabric in walls can increase efficiency without necessarily increasing radon levels, he noted.

Homeowners should check radon levels before and after installing energy-efficiency retrofits, according to Wilkinson.

He suggested remediation measures like fitting extraction pumps under the floor for homes with high radon levels. When building a home, there are special membranes impermeable to radon that can be built into floors, he added.

SOURCE: bit.ly/1jnvQC4 BMJ, online January 10, 2014.

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