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“Is the FDA Too Cozy With Drug Companies?” plus 2 more Health – TIME

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“Is the FDA Too Cozy With Drug Companies?” plus 2 more Health – TIME


Is the FDA Too Cozy With Drug Companies?

Posted: 28 Sep 2016 08:47 AM PDT

People who work at the U.S. Food and Drug Administration (FDA) as medical reviewers are responsible for parsing the risks and benefits of a particular drug before it gets the agency’s approval. But a new report from two researchers at the Oregon Health and Science University, published in the journal The BMJ, suggests many of these medical reviewers go on to work for the drug companies they oversaw while working for the government.

Critics have called out this revolving door between the FDA and the pharmaceutical industry, and the study’s authors wanted to see how the numbers matched up to that claim. They looked at the FDA’s list of haematology-oncology drug approvals from 2006 to 2010 and scanned all medical reviews from 2001 to 2010 in the agency’s database, then looked up the subsequent jobs of the people who worked as medical reviewers for those drug approvals.

The researchers found that among 55 people who worked as haematology-oncology medical reviewers from 2001 to 2010, 27 continued in their roles at the FDA, two people worked at the FDA but held other appointments, and 15 left the FDA to work with or consult for the biopharmaceutical industry. The jobs of the rest of the people could not be determined.

“I don’t think there is overt collusion going on, but if you know in the back of your mind that a major career opportunity after the FDA is going to work on the other side of the table, I worry it can make you less likely to put your foot down,” says study author Dr. Vinay Prasad, an assistant professor of medicine at the Oregon Health and Science University. “Regulators may be less willing to be very tough, and I worry that is happening.”

In response to the report, FDA spokesperson Jason Young sent TIME the following statement:

Employees leaving government for industry is a dynamic that is present across government agencies and is not unique to FDA. The FDA has a strong set of rules in place to ensure that our employees are working in the public interest, not to advantage any company, organization or individual. Federal laws and FDA ethics rules cover issues like outside employment, avoiding real and apparent conflicts of interest, recusals, disclosure requirements, protecting confidentiality, a ban on gifts from regulated industry, and avoiding conflicts should a federal employee choose to seek or negotiate outside employment. Furthermore, past federal employees are bound by additional rules protecting the confidentiality of information they worked on while in federal service, a cooling-off requirement for senior employees, and other important rules against switching sides, contacting former employees, and contacting agency leaders.

Study author Prasad says he would like to see more transparency from the FDA on the number of people who go from the agency to the drug industry. He noted that former FDA commissioner Dr. Margaret Hamburg said in a March interview that she won’t consider working for companies that the FDA regulated for a couple years, calling it a “cooling-off period.” Prasad said they were unable to determine in their report how many people went directly from the FDA to the pharmaceutical industry.

Prasad also adds that more needs to be done to recruit and retain the best talent at the FDA. “We need to address why people are leaving the FDA,” he says. “I sympathize for them. These are people doing an important job and … they’re certainly earning less than what they can make in the [pharmaceutical] industry.”

You Asked: Should I Worry About Wi-Fi Radiation?

Posted: 28 Sep 2016 05:00 AM PDT

At home and at work, dozens of wireless networks are streaming invisible radio waves through your space and body. (So are the phones, computers, Bluetooth speakers and other devices that connect to them.) It’s logical to wonder—and worry—about what effect all that wireless energy might have on your health.

But while the volume and ubiquity of wireless devices is a new phenomenon, the kind of radiation they produce has been the subject of scientific scrutiny for decades, says John Moulder, professor emeritus of radiation oncology at the Medical College of Wisconsin.

In 2013, Moulder coauthored a review of the existing health research on Wi-Fi. Like your mobile phone, Wi-Fi routers send and receive information using radio waves, which are a form of electromagnetic radiation, he says.

The research on radio waves and human health goes back at least to the 1950s, when there were concerns about Navy servicemen being exposed to powerful shipboard radar. “We have 50 or 60 years of research into the kind of radiation associated with Wi-Fi,” Moulder says.

All that research has taught us that at high frequencies, electromagnetic radiation can promote tumor growth and cancer. The sun’s ultraviolet rays and their links to skin cancer are one example. Even at lower frequencies, very high levels of electromagnetic radiation exposure can hurt you. “But we’re talking skin burns, not cancer or tumors,” says Kenneth Foster, a professor of bioengineering at the University of Pennsylvania.

Foster was Moulder’s coauthor on that 2013 review of Wi-Fi’s health effects. He says that, based on our current understanding of radio wave strengths and risks, world health authorities have set safety standards for all devices and appliances that emit electromagnetic radiation—from phones and microwaves to your car’s keyless entry fob. “The exposure you get from your Wi-Fi router is orders and orders of magnitude below those safety limits,” he explains.

Asked for specifics, Foster says it helps to understand how Wi-Fi works. While most people assume their wireless router is constantly sending and receiving information, Foster says these devices actually transmit just 0.1% of the time. “Maybe that goes up somewhat if you’re streaming video,” he says, “but most of the time your router is just sitting idly waiting for something to happen.”

Also, every inch you put between yourself and your Wi-Fi router significantly lowers the strength of the radiation your body encounters. “Put it this way,” Foster says. “During a call, your mobile phone is transmitting steadily at a strength maybe 100 times more powerful than Wi-Fi, and you’re holding the phone right against your head, and we still don’t find any health issues with that level of exposure.” (The World Health Organization and the International Agency for Research on Cancer have classified mobile phones as a “possible carcinogen,” which means there’s currently not enough research to say cell phones cannot possibly cause cancer. “To date, no adverse health effects have been established as being caused by mobile phone use,” the WHO says.)

That’s not to say there’s no evidence linking phones or wireless technologies to theoretical health concerns. Earlier this year, a rodent study found heavy exposures to cell phone radiation increased rats’ risks for some brain and heart tumors. More rodent research has tied high levels of Wi-Fi and cell exposure to hormonal shifts and oxidative stress—the kind of shifts that could promote cancer or brain diseases.

But many of these animal studies are “all over the place” in terms of their design quality, Foster says. Animal research often does not translate to humans. Also, many of the most worrying experiments involved rodents that had been exposed to levels of radiation far greater than what people encounter when using mobile phones or wireless networks.

Better to look at real people whose occupations expose them to high levels of electromagnetic radiation—including those Navy servicemen back in the 50s. Those kinds of real-world test cases have yet to reveal health risks, Moulder says. “If mobile phones were causing brain tumors, we would have seen higher rates of brain cancer by now, and we haven’t,” he adds.

When it comes to Wi-Fi, he reiterates that there’s nothing different or unique about the kind of radiation this technology spits out. “There’s simply no biological basis to think that Wi-Fi is different than the other forms of radio waves that have been studied for decades,” he says.

Fortunately, those decades of research suggest we can all relax and stop worrying about our wireless networks.

The Americas Are Now Officially Free of Measles

Posted: 27 Sep 2016 10:29 AM PDT

North, South and Central America are the first region in the world to be declared measles-free, after 22 years of work to banish the highly contagious infection that can result in pneumonia, blindness and death.

For an area to gain a measles-free status, at least three years need to pass without any case of endemic transmission (in other words, the infection did not come in from abroad), and a follow-up has to take place year after year.

Thanks to scientific advances, health experts can find out where exactly the virus has come from when a measles case is reported. For example, it was determined that a significant outbreak of measles linked to a case at Disneyland in California in 2014 had come into the U.S. from another country, and therefore was not an endemic.

The main reasons the Americas are now measles-free is due to a strict vaccination program. “Take the example of the country I come from,” said Bahamas-based Dr. Merceline Dahl-Regis, Chair of the International Expert Committee for Elimination in the Americas. “You have 400,000 people [living there] and six million people who come and visit the country – and we don’t have measles because of high immunization coverage.”

“That’s the simple answer. Poor, male, female, whatever the social class, everyone needs to be immunized; high coverage is how you prevent the reintroduction of measles.”

The Pan American Health Organization (PAHO) will continue to work towards freeing the region of polio and other diseases. Years ago, steps were taken towards declaring the region free of neonatal tetanus (a form of tetanus that occurs in newborns) and, if the PAHO is successful in Haiti, that goal may be reached this year. The PAHO has also made progress in the elimination of Hepatitus B, by vaccinating newborns.

But, as Dr Cuauhtemoc Ruiz-Matus, chief of PAHO/WHO’s Comprehensive Family Immunization Program, made clear, freeing regions of disease is no easy feat. “It’s very hard,” he said. “In some countries, the difficulty was that you had so many migrants… they did not have cars and you couldn’t access them.”

He added that ill-defined borders and conflict in the Americas provided further challenges. “In some of the territories… there’s movement back and forth; that was a particular challenge. Then there were issues relating to countries that are still in conflict – we could not get through to some areas because of the domestic fighting that goes on.”

Various countries in the region invested heavily in interrupting the transmission of the infection. “Ecuador, Colombia, Venezuela and Brazil really deserve a significant mention,” Dr Ruiz-Matus said. “They came through and did an excellent job. And we have all learned so much through these experiences.”

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