US toughens online privacy rules for children

WASHINGTON DC — US regulators unveiled new rules Wednesday aimed at strengthening online privacy protection for children, to reflect the growing use of mobile apps and social networks.

The Federal Trade Commission said its updated rules require online services to get consent from parents if they are aimed at children under 13 or know that they are collecting personal information from young children.

But FTC chairman Jon Leibowitz said the Children’s Online Privacy Protection Act would not include stricter proposals which would have made companies liable for “plug-ins” such as the Facebook “like” button or Twitter’s “tweet” button.

“The Commission takes seriously its mandate to protect children’s online privacy in this ever-changing technological landscape,” said Leibowitz.

“I am confident that the amendments to the COPPA Rule strike the right balance between protecting innovation that will provide rich and engaging content for children, and ensuring that parents are informed and involved in their children’s online activities.”

Leibowitz told reporters that websites will still be able to direct ads to children, and that “the only limit we place is on behavioral advertising,” which is based on a person’s browsing activity.

“Until you get parental consent, you may not build massive profiles of children to deliver advertising,” the regulator said.

The rules close some loopholes on online operators who can be liable for violations of the law, which was passed by Congress in 1998.

But the regulations note that, in light of comments received on a draft, the FTC decided the rules should not encompass platforms such as Google Play or the App Store, that offer access to “someone else’s child-directed content.”

Third-party plug-ins will be responsible only where they have “actual knowledge that they are collecting personal information from users of a child-directed site.”

Leibowitz said the FTC “struggled with this” issue and sought to avoid rules which clamped down on operators to force them to create a “sanitized” Internet for older children and adults.

“We think where we ended up was both balanced and very very strong,” he said. “We did two rounds of comments because we wanted to get it right and we wanted to listen to everybody.”

The proposal drew hundreds of comments, including some who feared Facebook could be held liable if it allowed young children to hit the “like” button without getting parental consent.

Senator Jay Rockefeller, who joined the news conference unveiling the updated rules, said they were as strong as the law allowed.

“The FTC really went as far as they could,” Rockefeller said.

“There will be groups that will complain about it and so will I. But we can’t do anything about it because the FTC is governed by law.”

Jeff Chester, executive director of the Center for Digital Democracy, which lobbies for greater privacy protections, called the FTC move “a major step forward” but warned that it may not be effective.

“We are concerned about possible loopholes that could undermine the intent of the rules,” he said, adding that his group would maintain “file complaints against any company that violates the new rules.”

source: interaksyon.com

US approves first obesity drug in 13 years

WASHINGTON DC - US regulators on Wednesday approved the first drug to treat obesity in 13 years, a drug called lorcaserin, marketed as Belviq and made by Arena Pharmaceuticals.

The drug works to control the appetite through receptors in the brain and was approved as additional therapy for certain overweight and obese patients, combined with diet and exercise.

Trials showed the drug helped people lose an average of three to 3.7 percent of their body weight after a year when compared to a placebo, the US Food and Drug Administration said.

It is approved for use in obese adults with a body mass index of 30 or greater, or overweight adults with a BMI of 27 or greater who have at least one other condition such as high blood pressure, type 2 diabetes, or high cholesterol.

Arena's stock opened the day at $9 per share and jumped as high as 47 percent on news of the US approval. The company said it is also seeking approval on the European market, but has no timeline yet for a decision.

Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research, described obesity as "a major public health concern," and said the new drug offers a treatment option when used "responsibly in combination with a healthy diet and lifestyle."

However, the FDA warned that Belviq is not for women who are pregnant or nursing, and called for further long-term postmarketing studies on the drug's potential risks.

The label will also recommend that Belviq be discontinued in patients who fail to lose five percent of their body weight after 12 weeks of treatment.

"These patients are unlikely to achieve clinically meaningful weight loss with continued treatment," said the FDA statement.

Belviq activates the serotonin 2C receptor in the brain, and may cause serious side effects if taken in combination with certain medications for depression and migraine that increase serotonin levels or activate serotonin receptors.

"Belviq may also cause disturbances in attention or memory," said the FDA.

Common side-effects in patients without diabetes include headache, dizziness, fatigue, nausea, dry mouth, and constipation.

In diabetic patients, side effects may include low blood sugar, headache, back pain, cough, and fatigue.

Lorcaserin was rejected in 2010 by the Endocrinologic and Metabolic Drugs Advisory Committee, which advises the FDA, over concerns that it formed breast tumors in rats.

But those effects did not appear in trials on overweight and obese humans.

An independent advisory committee to the FDA recommended the drug be approved in May after three randomized, placebo-controlled trials of nearly 8,000 patients spanning one to two years.

"All participants received lifestyle modification that consisted of a reduced calorie diet and exercise counseling," the FDA said.

"Compared with placebo, treatment with Belviq for up to one year was associated with average weight loss ranging from three percent to 3.7 percent."

Some patients with type 2 diabetes experienced higher levels of weight loss, with 38 percent of these patients achieving at least five percent loss of their body weight compared to 16 percent who did the same on a placebo.

The pills will be manufactured at Arena's facility in Zofingen, Switzerland, and will be distributed in the US by Eisai Pharmaceuticals.

Arena is headquartered in San Diego, California.

According to Michael Aziz, internist at Lenox Hill Hospital in New York City, the biggest apparent drawback to the drug is the tiny amount of weight loss that patients experience while taking it.

"The only problem with this drug is the weight loss is so, so very low," Aziz told AFP, remarking that a 200 pound (91 kilogram) person might lose just six pounds (2.7 kg) in a year, based on the study data.

"That is so insignificant," he said. "I think people should also implement lifestyle changes because the fact is, people can lose one pound a week and that is perfectly healthy."

The last anti-obesity drug approved in the United States was Xenical (Orlistat) by Roche in 1999.

Sold over the counter as Alli by GlaxoSmithKline, it works by preventing the body from absorbing fat, though its tendency to cause gastrointestinal side effects such as oily, loose stools have curbed its popularity among patients.

article source: interaksyon.com