The American Society of Plastic Surgeons (ASPS) released  the detailed figures on cosmetic surgery in 2014, and Euronews outlined seven surprising trends from the US. Among them:

Men and boys having their ‘breasts’ reduced

The number of male teenagers in the US going under the knife for breast reduction in 2014 rose to 6,694, up 14 percent compared with the previous year.

The proportion of obese US teenagers (aged 12-19) has ballooned from 5 percent in 1980 to 21 percent in 2012, according to the Centers for Disease Control and Prevention.

There was an identical trend with adult males: 26,175 underwent surgery to have their ‘breasts’ reduced in 2014, up 14 percent compared with 2013.

Teenagers going under the knife

The number of US teenagers putting themselves forward for cosmetic procedures is on the rise – 224,000 13-19 year olds had work done on them in 2014, a jump of 2 percent on the previous year.

The most popular jobs were nose reshaping, male breast reduction (see above), ear surgery, laser hair removal and laser skin resurfacing.

ASPS says parental consent is required for operations on teenagers under 18.

Diana Zuckerman, president of the National Center for Health Research, said: “There is no question that reconstructive surgeries can benefit children and youth. Surgical procedures to correct cleft lips and palates, for example, are not controversial. Plastic surgery to correct unattractive facial features that can attract ridicule, such as prominent noses and ears, are generally accepted in the United States.

“However, cultural phenomena such as surgical makeovers on numerous television programs and unrelenting pressures on teens to conform to beauty standards make it increasingly difficult to agree on what constitutes a “normal” appearance and when the desire to improve one’s appearance is questionable or even crosses the line to psychopathology.”

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By Sabrina Tavernise, New York Times
April 30, 2015

WASHINGTON — Legislation that would have accelerated the pace of federal drug approvals in a way that critics said threatened to erode patient safety was formally released this week, in a scaled-back version with many of the most controversial provisions left out.

The draft bill presented at a hearing in the House on Thursday represents a less aggressive streamlining of the drug approval process, critics of the earlier draft said, and seems to have secured strong bipartisan support.

The legislation, called 21st Century Cures, has been in the works for months. Its lead sponsor, Fred Upton, Republican of Michigan, said it would speed the pace of drug cures by removing unnecessary hurdles from the regulatory process.

Critics, including top officials at the Food and Drug Administration, had expressed concern that the changes would risk patient safety — for example, by potentially permitting shorter clinical trials and letting drug companies use alternative measures of health as evidence of a drug’s effectiveness and safety.

The bill’s supporters said it was a work in progress that had been assembled in one of the most collaborative, transparent processes Congress has seen in years. The sponsors held eight hearings and more than a dozen round-table meetings in districts across the country to gather comment.

“We have a chance to do something big, and this is our time,” Mr. Upton said.

His co-sponsor, Diana DeGette, Democrat of Colorado, said the lawmakers had made “tremendous progress,” recalling “that hokey video” that she and Mr. Upton made to promote the effort last year.

The draft — at about 200 pages it is half its former size — seemed to allay fears among some experts that it would fundamentally rewire the way drugs are approved. Earlier proposals to give drug companies broad powers to promote their products for uses other than the approved ones and to market brand-name drugs for a longer time without generic competition were not included.

The F.D.A. has defended its record for drug approval speed, saying that in 2014, it approved the most new drugs in almost 20 years, and that it moves faster than its counterparts in other wealthy countries. Experts note that pathways exist for expedited approval, and that the F.D.A. is held to relatively strict timelines under other rules set by Congress. Instead, they say, the bottleneck for new drugs is often a matter of the years of research it takes to find them.

Diana Zuckerman, the president of the National Center for Health Research, said earlier versions of the legislation had “considerable micromanaging of the F.D.A. and enormous power given to industry.”

She added, “Most of that is gone.”

But she cautioned that the bill still held numerous provisions she believed put people at risk, including ones she described as lowering standards for the approval of medical devices and antibiotics. The bill would increase the work the F.D.A. must perform, but not the money it receives, and Dr. Janet Woodcock, an agency official who testified Thursday, said that was a concern.

“We are very stretched in our resources,” she said.

One point that is likely to concern the F.D.A. is a provision that would reduce its authority to regulate some software associated with medical devices.

An earlier version of the bill would have let drugmakers use quicker measures for a drug’s effectiveness during testing — for example, changes in blood sugar level instead of a more final outcome, like development of diabetes. The new draft instead suggests ways the F.D.A. could use those alternative measures, called biomarkers.

The F.D.A. says it already uses them in a substantial share of drug approvals, and Dr. Woodcock told the lawmakers Thursday that the agency did not need additional authority on this count. Progress has been slow in adopting more biomarkers, she said, because they often did not produce enough evidence to allow scientists to draw firm conclusions.

“You have to know those biomarkers are reliable before you can take a chance on a human life,” she said.

See the original article here.

By Michael Williamson, Bloomberg BNA

April 10, 2015

The FDA April 8 released two final guidance documents that will help provide timely patient access to high-quality, safe and effective medical devices for unmet medical needs, Jeffrey Shuren, the director of the agency’s Center for Devices and Radiological Health, said in a blog posting.

Reaction to the two documents is mixed – pitting industry against some patient advocates.

One guidance document describes the FDA’s Expedited Access Program (EAP), which should “speed qualifying devices to patients with life-threatening or irreversibly debilitating conditions” without compromising the agency’s high standards for safety and effectiveness, Shuren’s blog posting said. The other guidance document outlines the agency’s current policy on balancing premarket and postmarket data collection during FDA review of premarket approval (PMA) applications. In addition, the document addresses whether or not the circumstances when postmarket data collection is appropriate for PMAs meet the criteria for the EAP.

Two stakeholders seemed pleased with the EAP document. The Advanced Medical Technology Association (AdvaMed), “commends the agency for its efforts to explore supplementary review pathways to provide more timely patient access to new technologies for life-threatening or irreversibly debilitating diseases or conditions that addresses an unmet medical need,” Janet Trunzo, the association’s senior executive vice president for technology and regulatory affairs, told me in a April 9 e-mail.

In addition, Ben Moscovitch, officer with the medical device project of the Pew Charitable Trusts, a nonproft policy organization, told me April 9 many of the recommendations his group made on the draft version of the EAP document were included in the final document. For example, he told me that the EAP final guidance document reflects a Pew suggestion from 2014 that the FDA should require the initiation of postmarket trials and completion of those studies within a certain timeframe.

Not everyone is pleased with the guidance, however. The EAP final guidance “is part of a larger problem where the FDA is bowing to pressure from Congress to weaken safeguards that are intended to protect patients from unsafe medical products,” Diana Zuckerman, president of the National Center for Health Research, told me in an April 9 e-mail. She is also president of the Cancer Prevention and Treatment Fund.

See the original article here.