U.S. regulators have approved a powerful new opioid tablet to be used in hospitals over objections from critics who fear the pill will be abused.

The new drug approved by the U.S. Food and Drug Administration (FDA) on Friday is five to 10 times more potent than pharmaceutical fentanyl and will be used as an alternative to intravenous (IV) painkillers in medical settings.

Approval for the drug, which will be manufactured by a California company called AcelRx and marketed under the name Dsuvia, was supported by the Department of Defense. The Pentagon wants to have a pill that it can give soldiers on the battlefield to relieve pain when using an IV is not possible.

Critics say the pill could be diverted to illicit use and could worsen the country’s opioid crisis.

One of the pill’s critics is the head of an FDA committee tasked with advising regulators about whether drugs should be approved. This month, in a rare dissent with his committee, Raeford Brown urged the FDA to reject the drug and predicted the medicine would be abused inside and outside medical settings.

FDA Commissioner Scott Gottlieb said in a statement Friday that there would be “very tight restrictions” placed on the drug’s distribution and that the medicine was intended only for supervised settings like hospitals. The drug will not be available in retail pharmacies.

Gottlieb also said he would seek more authority for the FDA to consider whether there are too many similar drugs on the market, a move that could limit the number of new opioid drugs approved by the agency in the future.

“We won’t sidestep what I believe is the real underlying source of discontent among the critics of this approval — the question of whether or not America needs another powerful opioid while in the throes of a massive crisis of addiction,” Gottlieb wrote.

Preliminary figures from a report by the U.S. Drug Enforcement Administration released Friday showed more than 49,000 opioid-related deaths in 2017. That was a rise from the reported 42,249 opioid overdose deaths in 2016.

The DEA’s National Drug Threat Assessment report shows that heroin, fentanyl and other opioids continue to pose the highest drug threat in the nation.

Developers of the new opioid pill say the tablet is placed under the tongue and starts reducing pain in 15 to 30 minutes. It contains sufentanil, a chemical cousin of the fentanyl, which is commonly used after surgery and in emergency rooms. Each pill will come in a plastic applicator that looks like a syringe and will sell for $50 to $60.

The FDA says that because of the controls on drugs in medical facilities, medicines rarely get into the hands of general public through hospitals. However, the agency acknowledges that the greatest risk of misuse of such drugs is among medical personnel themselves.

Sidney Wolfe, founder of Public Citizen’s Health Research Group, said in a statement: “It is certain that Dsuvia will worsen the opioid epidemic and kill people needlessly. It will be taken by medical personnel and others for whom it has not been prescribed. And many of those will overdose and die.” 
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Participants at the first ever WHO Global Conference on Air Pollution have adopted a plan for reducing air pollution, which every year prematurely kills an estimated seven million people.  

The World Health Organization (WHO) has called the conference a resounding success, noting 900 people attended, twice as many as expected.  Furthermore, it says more than 70-member states, non-governmental organizations, and other participants have made voluntary commitments to take action to reduce air pollution.

Director of the WHO’s Department of Public Health and Environment Maria Neira said the WHO is taking a leading role in setting forth action to tackle air pollution for a cleaner, healthier world.  

“WHO, as the global health agency, made, as well, very strong commitments, starting by proposing an aspiration target of reducing by two-thirds the mortality caused by air pollution by the year 2030.  And, this is really a big challenge that we will mobilize and, we will call for everyone to contribute to that,” she said.  

Neira said prompt action is needed to reach that goal.  For example, she says people need to stop burning solid waste and agricultural waste.  She said they have to move away from fossil fuels.  She said people in Africa and other areas with populations in great need must be helped to meet the goal.

“We need to liberate those three billion people that today, they are still relying on fossil fuels at the household level to cook or heat or light their house.  We need to make sure that they will have access to clean sources of energy,” said Neira.

The WHO plans to put in place a tracking system to monitor commitments made by the participants.  The system is intended to gauge the progress being made toward achieving better health for all by freeing the world of air pollution.   

 
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Uganda will begin administering the experimental Ebola vaccine to approximately 2,000 health care and front-line workers along its border with the Democratic Republic of Congo on Monday, the Ministry of Health said.

Uganda has no confirmed cases of Ebola, but as the threat worsens in the DRC, the preventive measure is seen as necessary because of heavy border traffic. More than 20,000 people cross from the DRC into Uganda and back every week, the ministry says.   

“The public high risk of cross-border transmission of Ebola to Uganda was assessed to be very high at national level,” said Jane Ruth Aceng, Uganda’s minister for health. “Hence, the need to protect our health workers with this vaccine. Currently in Uganda, we have 2,100 doses of the vaccine available at the National Medical Stores and preparations are in high gear, including training of the health workers that are to be targeted.”

Many of those crossing the border are from the DRC’s North Kivu province, about 100 kilometers (62 miles) from the Ugandan border, where armed conflict has made fighting the Ebola outbreak a challenge. 

The vaccine, known as rVSV, has been used during recent outbreaks in Congo, Guinea and Sierra Leone, and is currently being dispensed in North Kivu.

Uganda’s Health Ministry says the Ebola vaccine will be given with the consent of Uganda’s health workers, since it is being used outside of clinical trials.

Despite being experimental, the vaccine is absolutely safe, Aceng says.

“The vaccine is a recombinant vaccine genetically developed by getting a particle of the Ebola gene, replacing a particle of the gene with another virus called the vesicular stomatitis virus. The vaccine therefore is a genetically modified organism, that is able to replicate and cause antibody production against the Ebola virus but not cause Ebola virus disease,” she explained. 

The Ebola virus causes a severe and often fatal hemorrhagic fever.

The Democratic Republic of Congo has confirmed 250 cases of Ebola — causing 180 deaths — and another 41 suspected cases.
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A paralyzed man you’re about to meet didn’t have much hope that one day he’d be able to walk again. But thanks to a new medical device, things are looking up for him. VOA’s Mariama Diallo reports.
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Two U.S. government agencies are giving conflicting interpretations of a safety study on cellphone radiation: One says it causes cancer in rats. The other says there’s no reason for people to worry. 

No new research was issued Thursday. Instead, the National Toxicology Program dialed up its concerns about a link to heart and brain cancer from a study of male rats that was made public last winter.

The Food and Drug Administration, which oversees cellphone safety, disagreed with the upgraded warning. And “these findings should not be applied to human cellphone usage,” said Dr. Jeffrey Shuren, FDA’s chief of radiological health.

What’s most important is what happens in humans, not rats, said Dr. Otis Brawley, chief medical officer of the American Cancer Society.

 “The incidence of brain tumors in human beings has been flat for the last 40 years,” Brawley said. “That is the absolute most important scientific fact.”

 The original study

 In a $30 million study, scientists put rats and mice into special chambers and bombarded them with radiofrequency waves, like those emitted by older 2G and 3G phones, for nine hours a day for up to two years, most of their natural lives. 

The levels the rodents experienced were far higher than people are typically exposed to. 

The findings

Last February, the National Toxicology Program said there was a small increase in an unusual type of heart tumor in male rats, but not in mice or female rats. The agency concluded there was “some evidence” of a link. Also, the February report cited “equivocal evidence” of brain tumors in the male rats.

Thursday, the agency upgraded its description of those findings. The heart tumor increase marked “clear evidence” of cancer in male rats, it announced. There is “some evidence” of brain cancer.

The change came after the agency asked outside experts to analyze the findings.

“We believe that the link between radio frequency radiation and tumors in male rats is real, and the external experts agreed,” said John Bucher, the toxicology agency’s senior scientist.

While his agency said the risks to rats don’t directly apply to people, the study raises safety questions.

The disagreement

The FDA immediately disagreed, firing off a press release assuring Americans that “decades of research and hundreds of studies” has made the health agency confident that the current safety limits for cellphone radiation protect the public health.

Plus, FDA pointed out confusing findings from the rodent study — such as that the radiated rats lived longer than comparison rats that weren’t exposed to the rays. The toxicology agency said it appeared that the radio frequency energy helped older rats’ kidneys.

There’s a reason two different government agencies are clashing — they’re asking different questions, said George Washington University public health professor George Gray. 

A former science chief for the Environmental Protection Agency, Gray said the toxicology program examined how cellphone radiation affected animals. By looking at what it means for humans, the FDA “brings in more sources of information and data than just these recent tests in rats and mice,” he said in an email.

So are cellphones safe?

“I’m calling you from my cellphone,” noted the cancer society’s Brawley. 

He pointed out one well-known risk from cellphones: Car crashes when drivers are distracted by them.

As for cancer, if people are concerned, they could use earphones or speakers, he said.

Those who study risk aren’t hanging up.

“My family and I won’t change our mobile phone habits based on this news,” said George Washington’s Gray, co-author of the book “Risk: A Practical Guide for Deciding What’s Really Safe and What’s Really Dangerous in the World Around You.”
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Men with prostate cancer who get surgery or radiation are also more likely start taking antidepressants than their counterparts who don’t get aggressive treatment, a recent study suggests.

Many men with early-stage prostate cancer may not need treatment right away, or ever, because these tumors often don’t grow fast enough to cause symptoms or prove fatal. In the absence of symptoms or tests that suggest tumors are growing quickly, doctors may advise men to put off immediate treatments like surgery or radiation and instead get regular screenings to reassess whether the cancer is dangerous enough to warrant

intervention.

For the current study, researchers examined data on men with early-stage prostate cancer, including 4,952 people who had surgery, 4,994 who got radiation and 2,136 who opted instead for surveillance, or “watchful waiting.” In the year before their cancer diagnosis, 7.7 percent of the men were prescribed antidepressants, and this climbed to 10.5 percent in the first

year after diagnosis.

Compared to a control group of men in the general population without a prostate cancer diagnosis, men with prostate cancer were 49 percent more likely to be taking antidepressants five years after surgery and 33 percent more likely to take antidepressants five years after radiation treatment, the study found.

But watchful waiting wasn’t linked to any increase in the odds of men taking antidepressants.

“Prostate cancer patients often fit the demographic profile (white, older age, and male) of someone at risk for depression,” said senior study author Dr. Robert Nam of Sunnybrook Health Sciences Centre in Toronto.

“Once they receive treatment for prostate cancer, whether that is surgery or radiation, they may experience treatment-related side effects, such as erectile dysfunction, incontinence, and bowel dysfunction, which can significantly

worsen quality of life,” Nam said by email.

Roughly half of men diagnosed with prostate cancer receive treatment known as androgen deprivation therapy, which suppresses production of the male sex hormone testosterone and contributes to mood disorders, Nam added.

Men in the study who received surveillance tended to be older and were more likely to have multiple chronic health problems than the patients who got surgery or radiation.

Limiting factors

The study wasn’t a controlled experiment designed to prove whether or how different approaches to prostate cancer treatment might directly impact mental health. Another limitation is the potential for factors not measured in the study to have influenced both the treatment decisions men made and their mental health, researchers note in European Urology.

A separate study in the same journal, however, looked at trends in management of erectile function after prostate cancer surgery and offered fresh evidence that many men may be missing out on interventions that could improve their sexual health and quality of life.

The study examined data on 2,364 patients who had prostate cancer surgery at one U.S. academic medical center between 2008 and 2015.

Researchers didn’t find any meaningful changes in the proportion of men who had erectile dysfunction up to two years after surgery, despite advances in surgical care and postoperative penile rehabilitation during the study period.

This study also wasn’t a controlled experiment, and it’s possible that results from a single medical center might not reflect outcomes for men who got prostate cancer treatment elsewhere.

The study also didn’t examine how any use of antidepressants might have played a role in men’s sexual health after prostate cancer surgery.

“Sexual dysfunction is a common adverse effect of antidepressants,” Nam said. 

“Identifying the cause of the sexual dysfunction can be complicated as these symptoms are also associated with depression and can be improved once the patient’s depression is treated,” Nam added. “A healthy lifestyle, consisting of a well-balanced diet and exercise, is an important way to promote good sexual function, regardless of underlying medical

conditions.”
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A 10th person died amid a viral outbreak at a pediatric care center while a different strain of the virus was found at another facility in the state, New Jersey health officials said Thursday. 

The state Health Department confirmed in a statement that the “medically fragile child” at the Wanaque Center for Nursing and Rehabilitation had the adenovirus infection. 

There have been 28 cases associated with the respiratory virus at the center, where the affected children had severely compromised immune systems. One of those who died was a young adult. 

“The loss of these young lives is heartbreaking, and our thoughts are with the families who are affected,” Health Commissioner Dr. Shereef Elnahal said in a statement. 

The state also said there were four confirmed adenovirus cases among pediatric patients at Voorhees Pediatric Facility, near Philadelphia, but preliminary tests have ruled out it’s the same strain affecting Wanaque. 

The department said it’s working with the Centers for Disease Control and Prevention to monitor the illness and announced earlier this week that infection control teams were being sent to New Jersey’s four long-term pediatric centers to help with training. 

Officials have said there is not a wider public health concern stemming from the outbreak. 

New patients are not being admitted at Wanaque. 

The department also said Thursday that the illness was last detected on Tuesday. The previous date had been Monday. But, the department said, that’s not a surprise since the disease has a long incubation period of up to two weeks. 

The outbreak won’t be considered over until four weeks without a new illness goes by. 

Little risk, usually

Adenovirus usually poses little risk for healthy people. It can cause mild cold or flu symptoms, and some strains also cause diarrhea and pink eye. 

The strain found in the Wanaque rehab center outbreak is called type 7 and is among the more potent types. It sometimes causes more serious respiratory illness, especially among those with weak immune systems. 

Elnahal had earlier said all the cases of the outbreak occurred in a respiratory, or ventilator, unit. The department has since said one staff member became ill but has recovered. 

The identities of those who died and the affected patients have not been disclosed. 

Over the past decade, severe illness and death from type 7 adenovirus have been reported in the United States, according to the CDC, but it’s unclear how many have died from it. 

The CDC cited a 2001 scientific paper that reported a 1998 outbreak of type 7 at a facility in Chicago that left eight patients dead. The paper said civilian outbreaks were not frequently reported because of a lack of lab resources. 
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A new report recently published in the journal Nature suggests the Earth’s oceans are absorbing more of the planet’s excess heat than previously thought.

Scientists have known for some time that oceans store excess heat energy, and this helps keep the planet in its balmy, just-right temperature for supporting the explosion of life on Earth.

Knowing how hot the ocean is getting, and how fast that temperature is rising, helps scientists understand more about human-impacted climate change. It helps them know how much excess energy is being produced, and it helps them predict how much heat the ocean is capable of absorbing and how much warming will be felt on the Earth’s surface.

Up until the report was issued this week, the Intergovernmental Panel on Climate Change (IPCC) thought it had a pretty good handle on how much excess energy the oceans were absorbing. Using those numbers, the panel set targets for the amount of carbon reduction necessary to slow, and ultimately reverse, potentially devastating planetary warming.

But these new numbers suggest those targets may have to be revised upward by 25 percent. Research by the study’s lead author, Princeton professor Laure Resplandy, indicates our oceans are absorbing about 60 percent more heat energy than previously estimated.

According to Resplandy, the world’s oceans have taken up more than 13 zettajoules of energy every year between 1991 and 2016. A joule is the standard unit of energy; a zettajoule is one joule, followed by 21 zeroes.

“Imagine if the ocean was only 30 feet deep,” Resplandy said. “Our data show that it would have warmed by 6.5 degrees Celsius every decade since 1991. In comparison, the estimate of the last IPCC assessment report would correspond to a warming of only 4 degrees Celsius every decade.”

How they got the new numbers

It’s not that the old numbers were wrong; it’s that the new numbers relied on new techniques and new ways to measure ocean warming. The old techniques used spot measurements of ocean temperature. But Resplandy and her team measured the amount of oxygen and carbon in the air, a number they call “Atmospheric Oxygen Potential (APO).” As oceans warm, they release oxygen and carbon into the atmosphere, which increases APO.

Another factor that raises APO is the burning of fossil fuels. Resplandy and her team compared the expected rise in APO due to the burning of fossil fuels, and compared it to the actual APO they were seeing. By looking at the difference, the team was able to predict how much carbon and oxygen were being released by the oceans and, therefore, how warm the world’s oceans were getting.

Why the new numbers matter

A host of countries, including the U.S. and China, signed the Paris Climate Accord in 2015, which aims to keep average global temperatures from rising more than 2 degrees Celsius above pre-industrial levels. Many climate scientists predict that if temperatures go above that mark, humans will be faced with devastating long-term global affects. Keeping those temperatures down requires cutting the amount of greenhouse gases pumped into the atmosphere.

The U.S. has since pulled out of that climate agreement, but most of the rest of the world remains focused on limiting the rise of the world’s average temperatures.

This new research suggests that accomplishing that goal requires countries to pull 25 percent more carbon out of the atmosphere than they’ve already committed to cleaning up.
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An investigation has found that a failed Russian rocket launch three weeks ago that aborted after just two minutes was caused by a sensor that was damaged during assembly, a top Russian official said on Thursday.

The Soyuz-FG rocket carrying NASA astronaut Nick Hague and Roscosmos’ Alexei Ovchinin failed shortly into the October 11 flight, sending their emergency capsule into a sharp fall back to Earth. The two men landed on a steppe in Kazakhstan safely in the accident, the first of its kind for Russia’s manned program in over three decades.

The head of the Russian space agency earlier blamed the failure on a malfunction of a sensor, but didn’t explain why it didn’t work.

Oleg Skorobogatov, who led the probe into the accident, told reporters on Thursday that the investigation found that the sensor was damaged during the final assembly at the launch pad in Kazakhstan.

Russian rockets are manufactured in Russia and then transported by rail to the Russia-leased Baikonur cosmodrome.

The last time Russia saw an aborted manned launch was in 1983, when two Soviet cosmonauts jettisoned and landed safely after a launch pad explosion. More recently, Russia’s space program has been dogged by a string of failed satellite launches involving unmanned vehicles.

Skorobogatov said officials are now taking steps, including putting all assembly staff through competence tests and additional training, to make sure such incidents will not happen again

The rocket producer will also take apart two other rockets which have been recently assembled and are due to launch in the coming weeks and then re-assemble them, Skorogobatov said.

Russian space officials plan to conduct two other unmanned Soyuz launches before launching a crew to the space station. The current space station crew — NASA’s Serena Aunon-Chancellor, Russian Sergei Prokopyev and German Alexander Gerst — was scheduled to return to Earth in December after a six-month mission but will have to stay there for at least an extra week or two to ensure a smooth carry-over before the new crew arrives in early December.

The Russian Soyuz spacecraft is currently the only vehicle for ferrying crews to the International Space Station after the U.S. space shuttle fleet retired. Russia stands to lose that monopoly with the arrival of SpaceX’s Dragon and Boeing’s Starliner crew capsules.
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The 2017 flu season was particularly bad in the Northern Hemisphere. Nearly 80,000 people died in the U.S., including 180 children. Already this year, the virus has claimed the life of a child in Florida. 

A Florida hospital has surveyed parents throughout the U.S. to find out why some don’t get their children immunized even though it could put them in danger.

WATCH: Some Parents Don’t Understand the Flu Shot

Why get the shot?

Kids are very effective spreaders of disease. Just ask Ehren McMichael, mom of three.

“My husband and I just assume if one kids gets it, it’s do the best you can and then hope for the best because more than likely, someone else in the house will come down with it as well,” she said.

Even though kids don’t like getting a shot, McMichael’s kids, including her daughter Hannah, know why they get one.

“It helps protect you from the flu, and so when you go to school, your friends don’t catch it,” Hannah said.

The same is true for her son Brayden.

“It’s better to get a shot than get sick,” he said.

Flu shot myths busted

Orlando Health Arnold Palmer Hospital for Children in Florida surveyed parents and found a significant number of them are misinformed about the vaccine. The survey found that more than half the parents questioned think children can get the flu from the shot, a third don’t think the vaccine works, and almost that many think the flu vaccine causes autism.

Dr. Jean Moorjani, at Orlando Health, tries to help parents understand why their kids should get vaccinated against the flu.

“Doctors recommend the flu vaccine because we know, based on science and research and facts, that it is the best way to protect yourself and your family against the flu,” she said.

“You cannot get autism from the flu vaccine. It is not a conspiracy for doctors to recommend the flu vaccine. The parts of the virus that are used are completely dead, so you cannot get the flu from the flu shot,” she added.

Get your shot early

Scientists try to figure out what strains of flu are likely to circulate in a given year, but even if they guess wrong, Moorjani said, the vaccine still offers some protection.

“When your body receives the flu vaccine, your body starts to think, ‘OK, I’ve got to start making antibodies to help protect against the flu virus.’ So even if it’s not a perfect match, getting the flu vaccine will still give your body some protection,” she said.

Infectious disease experts recommend getting vaccinated before the flu season begins. This goes for adults, as well. It helps protect those who are vaccinated as well as babies who are too young to be vaccinated.
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Most people associate the flu with coldlike symptoms. They don’t realize the flu can lead to life-threatening complications. Last year was a particularly bad flu season in the Northern Hemisphere: Nearly 80,000 people died in the U.S., including 180 children. Already this year, a child in Florida died from the flu. A hospital there did some research and found a significant number of parents are concerned about the safety and effectiveness of the flu vaccine. VOA’s Carol Pearson has details.
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Scientists are putting a robotic Mars rover to the test in Spain’s rocky Tabernas Desert. The European Space Agency and Russia’s Roscosmos space agency plan to land a rover on the Red Planet in 2021, to search for microscopic signs of life. Faith Lapidus reports.
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Somalia hosted its first technology and innovation conference this month, with much talk about the industry’s potential. Somalia’s security threats and poor governance make attracting investment a huge challenge. But as Mohamed Sheikh Nor reports from Mogadishu, a company has set up the capital city’s first co-working space to help foster Somalia’s digital economy.
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