Caramel apples linked to listeriosis outbreak may have reached Canada

Caramel apples linked to an outbreak of listeria infections in the U.S. may  have been imported into Canada, federal officials say.

There are two cases of listeriosis, one in Ontario and one in Manitoba, with the same genetic fingerprint as seen in the U.S. investigation, the Public Health Agency of Canada (PHAC) said Tuesday.  

As a precaution, Canadians are advised to not eat commercially produced, prepackaged caramel apples imported from the U.S. (Bernard Thomas/The Herald-Sun/Associated Press)

Investigators continue to determine if these individuals ate prepackaged caramel apples imported from the U.S. Their health status is not known.

As a precaution, agency officials advised Canadians to not eat commercially produced, prepackaged caramel apples imported from the U.S. until further notice, although the risk to Canadians is low.

The advice applies to plain caramel apples as well as those containing nuts, sprinkles, chocolate, or other toppings. The products could have a shelf life of one month, the agency said.

In the U.S., the Centers for Disease Control and Prevention said as of Monday, a total of 29 people infected with the outbreak strains have been reported. They were all hospitalized. Five deaths have been reported and the infection contributed to three of the fatalities with one unclear and the fifth unrelated to listeriosis.

Canadian officials recommended if you have a candy apple product and are unsure if it would qualify as a caramel apple, do not consume it.

Instead, put the caramel apple in a plastic bag and throw it out to prevent animals from consuming the product from your garbage. Then wash your hands.

Listeriosis can be treated with antibiotics. Early diagnosis is key, especially for people at high risk, such as pregnant women, older adults and people with weakened immune systems, PHAC said.

Only a few people exposed to listeria will develop listeriosis.  Symptoms include fever, muscle aches, nausea and diarrhea, headache and neck stiffness. Severe symptoms can include convulsions.

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Blood pressure apps 'not quite ready for prime time'

Millions of people could be trying to measure their blood pressure with untested, inaccurate and potentially dangerous smartphone applications, or apps, a new study finds.

Researchers analyzed the top 107 apps for "hypertension" and "high blood pressure" that are available for download on the Google Play store and Apple iTunes and found that nearly three-quarters offered useful tools for tracking medical data.

But they also found seven Android apps that claimed users needed only to press their fingers onto phone screens or cameras to get blood-pressure readings — claims that scientists say are bogus.

A growing number of hypertension patients use mobile health technologies to track and manage their conditions, researchers say.

"This technology is really in its nascent stages, and it's not quite ready for prime time," lead author Dr. Nilay Kumar told Reuters Health.

Kumar, an attending physician at the Cambridge Health Alliance in Cambridge, Massachusetts and a Harvard Medical School instructor, was surprised to learn that apps marketed as turning smartphones into blood pressure measuring devices had been downloaded at least 900,000 times and as many as 2.4 million times.

"That's concerning that such a small number of apps have been downloaded so many times," he said. "We were surprised by the popularity."

He wasn't sure how the technology supposedly works but said the phone camera appears to read a finger pulse.

"It's really in a research-and-development stage. It's not ready for clinical use. For now, we need to be careful that we are not using things that are inaccurate and could be potentially dangerous," he said.

Apps that inaccurately measure blood pressure could lead to false alarms and possibly fatal false assurances, Kumar said.

'The idea that you're going to be able to stick your finger on the camera of your smartphone and get an accurate blood pressure reading is pretty farfetched right now.'- Dr. Karen Margolis

About one in three American adults has high blood pressure, according to the U.S. Centers for Disease Control and Prevention. Also known as hypertension, the condition has been called the silent killer because it often shows no warning symptoms but increases the risk of heart disease and stroke, two leading causes of death.

A growing number of hypertension patients use mobile-health technologies to track and manage their conditions, the authors write in the Journal of the American Society of Hypertension.

The study, conducted earlier this year, in general found good news about blood pressure apps. The majority, or 72 per cent, of the most popular apps allowed consumers to keep track of their medical data. About a quarter could directly export recorded information to physicians' offices. And nearly a quarter included tools to enhance medication adherence.

But healthcare agencies, such as universities, helped develop only a tiny fraction of the apps, 2.8 per cent, the study found.

The U.S. Food and Drug Administration (FDA), which regulates medical devices, has not approved any of the blood pressure apps, the authors write.

The study's findings raise "serious concerns about patient safety" and reveal an "urgent need for greater regulation and oversight in medical app development," the authors say.

Dr. Karen Margolis, an internist and director of clinical research at HealthPartners Institute for Education and Research in Minneapolis, would also like to see more oversight.

"The idea that you're going to be able to stick your finger on the camera of your smartphone and get an accurate blood pressure reading is pretty farfetched right now," she told Reuters Health.

Margolis has studied devices to measure blood pressure but was not involved in the current study.

"There is virtually no information at all about how accurate these apps are," she said. "It doesn't sound to me like it's ready for routine use in any way that medical decisions could be based on."

Regulatory authority over smartphone apps that can be turned into medical devices remains unclear, Kumar said.

Writing earlier this year in The New England Journal of Medicine, a group of three lawyers, led by Nathan G. Cortez of the Southern Methodist University Dedman School of Law in Dallas, Texas, warned that mobile health, or mHealth, poses a challenge for the FDA.

"Many members of Congress and industry believe that regulation will stifle mHealth innovation," the lawyers wrote. "The true challenge, however, is creating a regulatory framework that encourages high-value innovation while also preventing the market from being overcome with products that are ineffective or unsafe."

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Ebola cases in Sierra Leone show signs of slowing

The increase in new cases of Ebola in Sierra Leone seems to be slower, the World Health Organization says, as the country's government restricts travel over the holidays.

As of Dec.  21, the death toll has risen to 7,588 out of 19,497 reported cases in the Ebola outbreak that began a year ago, the United Nations' public health agency said Wednesday.

A Liberian woman washes her hands from a bottle of chlorine water to curb the spread of Ebola. The Ebola death toll has risen to 7,588 out of 19,497 reported cases. (Ahmed Jallanzo/EPA)

"Reported case incidence is fluctuating in Guinea and declining in Liberia," WHO said.

"In Sierra Leone, there are signs that the increase in incidence has slowed, and that incidence may no longer be increasing. The country's west is now experiencing the most intense transmission in the affected countries, and response efforts have been strengthened to curb the spread of disease in the area."

Guinea, Sierra Leone and Liberia have all improved their ability to isolate and treat Ebola patients but there are still shortfalls in some districts because of an uneven distribution of cases and beds, WHO said.

Sierra Leone's capital of Freetown accounts for one-third of the country's 315 new confirmed cases.

Last week, Sierra Leone's government joined UN partners to step up efforts to limit spread of the disease in western parts of the country.

Travel is restricted between districts during the holidays. People may go to church services on Christmas Day but President Ernest Bai Koroma requested they return home immediately after.

Public gatherings at restaurants, nightclubs and beaches are banned and markets have reduced their hours.

Guinea reported its highest weekly case incidence — 156 confirmed cases. The WHO said the number was largely because of a surge of cases in the southeastern district of Kissidougou.

"This emphasizes the need for continuing vigilance in case management, safe burial practices and social mobilization, to prevent outbreaks in areas previously experiencing little or no transmission."

In Liberia, incidence has been declining for a month but transmission remains intense. The country reported 21 cases in the week to Dec. 21. The district of Montserrado, which includes the capital Monrovia, continues to experience the highest activity in the country.

Meanwhile, the UN peacekeeping mission in Liberia says one if its staffers has become infected. It brings the number of UN members who've fallen sick with Ebola to four.

The global toll includes cases imported to Nigeria, Senegal, Mali, Spain and the United States.

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CDC monitoring lab technician for possible Ebola exposure

A laboratory technician for the U.S. Centers for Disease Control and Prevention has been placed under observation for possible exposure to the deadly Ebola virus due to an apparent mix-up in lab specimens, the Atlanta-based agency said on Wednesday.

The technician, who was working on Monday with Ebola specimens that were supposed to have been inactivated but which may instead have contained live virus, will be monitored for signs of infection for 21 days, the disease's incubation period, CDC officials said.

The error follows two high-profile cases of mishandled samples of anthrax and avian influenza at the CDC earlier this year that called into question safety practices at the highly respected research institute and drew criticism from Capitol Hill.

CDC spokeswoman Barbara Reynolds told Reuters the technician's risk of exposure to Ebola, even if the virus were active, was believed to be low and that the worker was not being quarantined while under observation.

She said a small number of other CDC employees who entered the lab where the samples in question were handled also "were assessed and none require monitoring."

"There was no possible exposure outside the secure laboratory at CDC and no exposure or risk to the public," the agency said in a statement. Lab scientists discovered on Tuesday what had transpired, and reported it to superiors within an hour, it said.

The problem occurred when active Ebola virus samples were believed to have been mixed up with specimens that had been rendered inactive for further testing in a lower-security lab down the hall, Reynolds said.

When inactivated specimens turned up the next day in storage, lab personnel realized that they apparently had transferred the wrong samples, ones that had contained active virus material, out of the higher-security lab, Reynolds said.

CDC officials could not be certain because the material in question had by then been destroyed and the lower-security lab decontaminated under routine safety procedures, she said.

The technician who handled the samples had worn protective gloves and a gown but not a face mask, she said. Ebola virus is not airborne. In a lab environment, it could be transmitted from a contaminated surface through physical contact that spreads the virus to the eyes, nose or mouth of an individual.

The mishap resembled the anthrax incident, in which researchers mistakenly believed they had transferred an inactivated sample of bacteria to a lower-security lab where workers wear less-protective gear. No illnesses resulted from that breach.

Then as now, the CDC temporarily halted the transfer of samples at its high-security labs while it reviewed its protocols.

In July an agency scientist, Dr. Michael Bell, was appointed to a new role overseeing lab safety and a panel of independent experts was formed to advise the institute on such issues.

Bell has since returned to his previous post, Reynolds told Reuters, though she did not say whether anyone else had assumed the lead role for lab safety.

"I am troubled by this incident in our Ebola research laboratory in Atlanta," the CDC director, Dr. Tom Frieden, said of the latest error. "Thousands of laboratory scientists in more than 150 labs throughout CDC have taken extraordinary steps in recent months to improve safety."

The CDC also was criticized by some for not doing more to prepare the U.S. medical establishment to deal with Ebola when a Liberian man visiting Dallas in October was diagnosed with the disease after initially being turned away from a hospital emergency room there.

Two nurses who treated that patient before he died ended up contracting the virus but survived. They are the only two people known to have been infected on U.S. soil during the current Ebola epidemic, which has killed more than 7,500 people, most of them in West Africa.

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Top job at national microbiology lab filled

Canada's National Microbiology Laboratory has a new leader.

Matthew Gilmour will start his job as scientific director in February, the Public Health Agency of Canada announced Tuesday.

He will be responsible for the National Microbiology Laboratory in Winnipeg and the Laboratory for Foodborne Zoonoses in Guelph, Ont., which examines diseases that can spread between animals and humans.

As the scientific director of National Microbiology Laboratory in Winnipeg, Matthew Gilmour will manage the delivery of laboratory public health and emergency preparedness programs. (Public Health Agency of Canada)

The job involves managing the delivery of laboratory public health and emergency preparedness programs, providing strategic scientific advice to officials and representing the lab nationally and internationally.

In April,  some scientists and public health leaders expressed concerns that the federal government may not be looking for a top-notch scientist, given how the job was posted on a government jobs website without fanfare, with a short deadline, and without an explicit requirement for candidates to be experienced scientists.

World-renowned HIV scientist Frank Plummer was the lab's previous scientific director.

Gilmour is currently a clinical microbiologist with Diagnostic Services of Manitoba and an assistant professor in the Department of Medical Microbiology at the University of Manitoba.

He previously held the positions of Director of Bacteriology and Enteric Diseases and the Chief of Enteric Diseases at the National Microbiology Laboratory, the public health agency said.

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Gay blood donation lifetime ban could ease in U.S.

An FDA advisory committee discussed the effectiveness of new blood supply tests for HIV infections earlier this month.

The U.S. Food and Drug Administration said on Tuesday that it plans to change its blood donor policy recommendation to allow gay men to donate blood one year after their last sexual contact.

The FDA's proposed policy would replace its current stance, which backs indefinite deferral for this group as part of its policies aimed at protecting blood supplies. It said the move puts the policy in line with that of other men and women who are at increased risk for HIV infection.

The FDA said it will issue draft guidance on the policy, hopefully early in 2015. It would then review the comments and issue final guidance "as quickly as possible," Peter Marks, deputy director of the FDA's Center for Biologics Evaluation and Research, said during a press briefing.

An FDA advisory committee met earlier this month to discuss the issue around changing its policy for donations from men who have sex with men. Those discussions highlighted the effectiveness of new blood supply tests for HIV infections. In November, an advisory committee to the U.S. Department of Health and Human Services had recommended replacing the ban with the one-year deferral that the FDA is now proposing.

Marks said during the briefing that scientific evidence for a ban shorter than a year was not "compelling."

In 2013, Health Canada announced it will allow men to donate blood if they haven't had sex with a man in the last five years. Previously, men who said they had sex with a man, even once, since 1977, were not eligible to donate blood in Canada.

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Caramel apples linked to listeriosis outbreak may have reached Canada

Caramel apples linked to an outbreak of listeria infections in the U.S. may  have been imported into Canada, federal officials say.

There are two cases of listeriosis, one in Ontario and one in Manitoba, with the same genetic fingerprint as seen in the U.S. investigation, the Public Health Agency of Canada (PHAC) said Tuesday.  

As a precaution, Canadians are advised to not eat commercially produced, prepackaged caramel apples imported from the U.S. (Bernard Thomas/The Herald-Sun/Associated Press)

Investigators continue to determine if these individuals ate prepackaged caramel apples imported from the U.S. Their health status is not known.

As a precaution, agency officials advised Canadians to not eat commercially produced, prepackaged caramel apples imported from the U.S. until further notice, although the risk to Canadians is low.

The advice applies to plain caramel apples as well as those containing nuts, sprinkles, chocolate, or other toppings. The products could have a shelf life of one month, the agency said.

In the U.S., the Centers for Disease Control and Prevention said as of Monday, a total of 29 people infected with the outbreak strains have been reported. They were all hospitalized. Five deaths have been reported and the infection contributed to three of the fatalities with one unclear and the fifth unrelated to listeriosis.

Canadian officials recommended if you have a candy apple product and are unsure if it would qualify as a caramel apple, do not consume it.

Instead, put the caramel apple in a plastic bag and throw it out to prevent animals from consuming the product from your garbage. Then wash your hands.

Listeriosis can be treated with antibiotics. Early diagnosis is key, especially for people at high risk, such as pregnant women, older adults and people with weakened immune systems, PHAC said.

Only a few people exposed to listeria will develop listeriosis.  Symptoms include fever, muscle aches, nausea and diarrhea, headache and neck stiffness. Severe symptoms can include convulsions.

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Blood pressure apps 'not quite ready for prime time'

Millions of people could be trying to measure their blood pressure with untested, inaccurate and potentially dangerous smartphone applications, or apps, a new study finds.

Researchers analyzed the top 107 apps for "hypertension" and "high blood pressure" that are available for download on the Google Play store and Apple iTunes and found that nearly three-quarters offered useful tools for tracking medical data.

But they also found seven Android apps that claimed users needed only to press their fingers onto phone screens or cameras to get blood-pressure readings — claims that scientists say are bogus.

A growing number of hypertension patients use mobile health technologies to track and manage their conditions, researchers say.

"This technology is really in its nascent stages, and it's not quite ready for prime time," lead author Dr. Nilay Kumar told Reuters Health.

Kumar, an attending physician at the Cambridge Health Alliance in Cambridge, Massachusetts and a Harvard Medical School instructor, was surprised to learn that apps marketed as turning smartphones into blood pressure measuring devices had been downloaded at least 900,000 times and as many as 2.4 million times.

"That's concerning that such a small number of apps have been downloaded so many times," he said. "We were surprised by the popularity."

He wasn't sure how the technology supposedly works but said the phone camera appears to read a finger pulse.

"It's really in a research-and-development stage. It's not ready for clinical use. For now, we need to be careful that we are not using things that are inaccurate and could be potentially dangerous," he said.

Apps that inaccurately measure blood pressure could lead to false alarms and possibly fatal false assurances, Kumar said.

'The idea that you're going to be able to stick your finger on the camera of your smartphone and get an accurate blood pressure reading is pretty farfetched right now.'- Dr. Karen Margolis

About one in three American adults has high blood pressure, according to the U.S. Centers for Disease Control and Prevention. Also known as hypertension, the condition has been called the silent killer because it often shows no warning symptoms but increases the risk of heart disease and stroke, two leading causes of death.

A growing number of hypertension patients use mobile-health technologies to track and manage their conditions, the authors write in the Journal of the American Society of Hypertension.

The study, conducted earlier this year, in general found good news about blood pressure apps. The majority, or 72 per cent, of the most popular apps allowed consumers to keep track of their medical data. About a quarter could directly export recorded information to physicians' offices. And nearly a quarter included tools to enhance medication adherence.

But healthcare agencies, such as universities, helped develop only a tiny fraction of the apps, 2.8 per cent, the study found.

The U.S. Food and Drug Administration (FDA), which regulates medical devices, has not approved any of the blood pressure apps, the authors write.

The study's findings raise "serious concerns about patient safety" and reveal an "urgent need for greater regulation and oversight in medical app development," the authors say.

Dr. Karen Margolis, an internist and director of clinical research at HealthPartners Institute for Education and Research in Minneapolis, would also like to see more oversight.

"The idea that you're going to be able to stick your finger on the camera of your smartphone and get an accurate blood pressure reading is pretty farfetched right now," she told Reuters Health.

Margolis has studied devices to measure blood pressure but was not involved in the current study.

"There is virtually no information at all about how accurate these apps are," she said. "It doesn't sound to me like it's ready for routine use in any way that medical decisions could be based on."

Regulatory authority over smartphone apps that can be turned into medical devices remains unclear, Kumar said.

Writing earlier this year in The New England Journal of Medicine, a group of three lawyers, led by Nathan G. Cortez of the Southern Methodist University Dedman School of Law in Dallas, Texas, warned that mobile health, or mHealth, poses a challenge for the FDA.

"Many members of Congress and industry believe that regulation will stifle mHealth innovation," the lawyers wrote. "The true challenge, however, is creating a regulatory framework that encourages high-value innovation while also preventing the market from being overcome with products that are ineffective or unsafe."

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Wearable opportunities lie in chronic diseases

Wearable technologies such as smart watches that offer fitness information at a glance are part of a growing industry, but health technology experts say innovators should focus on where the need is greatest.

Activity monitors such as FitBit and Jawbone Up range in price from $50 to $200 and are marketed to those interested in getting more physically fit.

The global market for wearable medical devices, from heart rate and pulse monitors to glucose management, was valued at $2 billion U.S. in 2012 and is expected to reach $5.8 billion in 2019, Transparency Market Research estimates.

"One challenge is what some people call the top drawer syndrome," said Jayson Parker, a medical biotechnology analyst at University of Toronto Mississauga. "You buy the health technology, you use it for a while, and then it ends up in your top drawer, never to be retrieved again."

Fitness wearables offer great insights into activity levels, but the market for those devices is already crowded, said engineer Joseph Cafazzo, who leads the Centre for Global eHealth Innovation at Toronto's University Health Network.

Cafazzo says it is early days for the industry. He sees potential in apps to combine different types of data to help people who have chronic illnesses.

"What we're trying to do is combine the things that you should be doing to manage with your diabetes with your markers. What you're eating, maybe your activity levels through a Fitbit or Jawbone Up so people can understand the relationship between what they're eating, their activity levels and their blood sugar levels."

He's also working to develop a device that captures ECG data and streams the heart rate variability data to a smartphone.

These more complex wearables, such as contact lenses to monitor glucose levels in tears of people with diabetes, are classified as medical devices by Health Canada and the U.S. Food and Drug Administration. The regulators need to approve the products for sale.

Manufacturers may see the regulations on medical devices for people with chronic diseases as a disincentive. For Parker, that's because many don't appreciate the opportunities that lie along the whole continuum between fitness wearables and medical devices.

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Health Canada backtracks on citronella bug spray ban

The end of 2014 was supposed to mark the end of citronella-based bug sprays for sale in Canada.

But CBC news has learned Health Canada is now backtracking on its ban due to public pressure. After receiving feedback about the move, the agency has decided to re-examine its regulations around personal insect repellents containing plant-based essential oils, including citronella. Until the review's conclusion, sometime in 2016, currently registered citronella repellents can continue to be sold.

Bug sprays — including plant-based ones — are considered pesticides so they must meet strict safety regulations. After being available to consumers for years, Health Canada proposed phasing out citronella repellents in 2004 due to the "the absence of adequate safety data."

'It is a fantastic victory for the freedom of choosing natural preparations against mosquitoes'- Druide owner Alain Renaud

But, shortly before the last of the repellents were to be pulled from store shelves, the agency changed its position. In a statement, Health Canada told CBC, with the deadline approaching, it had received input from citronella repellent producers and consumers. It then reasoned, "based on the scientific information currently available … it would be in the best interest" to review its regulations.

It added, "The review will examine how to meet the requirements of the Pest Control Products Act while exploring alternative ways to assess [plant-based essential oil insect repellents.]" 

Media attention

Toxicologist Sam Kacew believes the public outcry was sparked by recent news coverage about the ban. The flood of media attention began with a CBC News report back in August.

"There was a lot of negative publicity regarding the steps that [Health Canada] took," said Kacew. He believes the agency may have concluded it made a mistake "and they have to re-look at what they're doing. So I think it's good news from my perspective."

In 2005, Kacew sat on an independent scientific panel to review Health Canada's position on the repellent. He told CBC News back in August that he disagreed with the ban because the panel concluded citronella oil was generally safe as long as it didn't contain the contaminant, methyl eugenol.

"The panel recommendation was that the products that were out on the market were not producing any adverse effects on the consumer," said the University of Ottawa professor.

Health Canada's new review will include another scientific panel. So far, Kacew has not been invited to join it.

Citronella's second chance

Montreal natural products company, Druide, had been making government-approved citronella-based bug repellents since 1995. But it ceased production this year because Health Canada had told the company it could no longer sell the product in 2015.

Now the company has the green light to once again ramp up production. "It is a fantastic victory for the freedom of choosing natural preparations against mosquitoes," said Druide owner Alain Renaud.

Citronella repellents were a bestseller for the company, attracting consumers who prefer plant-based bug sprays over ones with the synthetic chemical, DEET that dominate the marketplace.

While he welcomes the review, Renaud said because his company has already phased out the repellent, it will be a struggle to re-establish it: "Druide has already lost major distribution channels in the pharmacy industry."

Yann Daigneault, Druide's sales manager, said the company also has a public relations hurdle because of Health Canada's original decision. "It's kind of confusing when people call us and say, is your product dangerous? And we have to explain to them, no, it's safe," he said.

PETA pleased

People for the Ethical Treatment of Animals (PETA), which opposes animal testing, also welcomes the Health Canada review. Originally, manufacturers like Druide could have circumvented the ban if they had been able to afford expensive animal trials to prove citronella oil's safety.

When news broke about the ban, several concerned Canadian PETA members contacted its U.S. affiliate. "We were all pretty surprised. It came out of left field," said Jessica Sandler, senior director of PETA U.S.'s regulatory testing department. That's because the United States considers citronella-based bug sprays safe.

PETA U.S. then fired off two letters to Health Canada, protesting the need for animal testing and emphasizing the approval of the product south of the border. CBC News obtained copies of Health Canada's responses. In its first reply, dated Oct. 29, the agency defended its original position. Then in a second letter, dated Dec. 11, Health Canada told PETA that it was re-examining its regulations of insect repellents containing essential oils.

"One of [PETA's] goals is to facilitate this kind of discussion so that the use of animals in any experiments is not the default," Sandler said.

Back to business

Druide plans to reboot production in the new year so it can replenish store shelves by mosquito season this summer. The company hopes that, following its review, Health Canada will allow its citronella-based bug sprays to remain permanently on the market.  

"It's been around already for 20 years, so there's no reason why it shouldn't be around for another 20 years at least," Druide's Daigneault said.

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