International Headline Of The Day

"MAN WHO MOONED THE QUEEN FINED FOR HIS CHEEK"

From The Guardian, naturally.

Ex-FDA chief: Bayer Held Back Yasmin Safety Data

FDA reviewers are calling for more research on the safety of newer birth-control pills. The agency's expert panelists are gearing up to weigh evidence at a meeting later this week. Canadian regulators say Bayer will revise the labeling on Yaz and Yasmin to reflect an increased risk of blood clots. Kessler also maintained Bayer held back data before Yasmin won agency approval in 2001--including details about clot risks from an internal study, plus two cases of clots in patients using the pill. And in the middle of all this back-and-forth about Bayer's Yaz and Yasmin contraceptives, some court documents were unsealed, revealing allegations of a Bayer cover-up from ex-FDA Commissioner David Kessler, Bloomberg reports. Expected to testify in upcoming  patient lawsuits, Kessler stated Bayer withheld information and analysis suggesting an increase in blood-clotting risk for those taking Yasmin. "Bayer presented a selective view of the data, and that presentation obscured the potential risks associated with Yasmin," Kessler said in the document (as quoted by Bloomberg). Kessler also maintained Bayer held back data before Yasmin won agency approval in 2001--including details about clot risks from an internal study, plus two cases of clots in patients using the pill. "Had I, or a medical review officer, known these facts prior to approval, further investigation would be warranted before a decision on Yasmin's NDA could be made," he stated. As Bloomberg notes, the court documents were unsealed too late to make the FDA's deadline for materials for this week's advisory committee meeting. The agency wouldn't comment on the documents, the news service reports. Nor would Bayer, whose spokeswoman said the company doesn't comment on outstanding litigation. Read the origial story in Fierce Pharma

And Now, A Word From Your Sponsor: Rehab Reviews

With the launch of TheFix--Maer Roshan's website for recovering addicts--comes a considerable, er, buzz. (Sorry!) Nice story in The New York Times business pages on opening day, some impressive bylines in the mix--Susan Cheever and Mark Ebner, for instance--and the very Radar-like photo feature, Messiest Celebrity Breakdowns, there under the Celebrity Meltdown tab. But the best feature behind the "addiction and recovery, straight up" slogan: The Rehab Reviews, "the inside scoop from former clients." They're complete with a star-rating system, price tag, and notes on accommodation. Here's the four star review of A.R.C. in LA. And here's an extract from the largely positive review of Silver Hill, the Connecticut hideout to which Mariah Carey retreated years ago, suffering from exhaustion:

Recovery at Silver Hill begins as soon as the sun rises: local A.A.-er’s who have been fixtures on the S.H. grounds for years pick up clients for “early bird” 7:30 am meetings every morning. Then it’s back to the residence for meditation, which is followed by breakfast (a breakfast bar with fruit, cereal, pancakes, yogurt or an omelet from the omelet bar). The cafeteria, located in the main house, “was like a country club buffet for every meal,” says one recent resident. “Salad bars, lots of protein and veggie options, and desserts were plentiful.”

In case you're shopping, or just peeping, this is your stop.

"Diabetes Belt" Carves a Swath through U.S. South

More than 18 million people in the U.S. have been diagnosed with diabetes, which costs an estimated $174 billion annually. Typically, local public health agencies carry out the initiatives to manage and prevent this chronic disease, but because prevalence figures are generally given on national and state levels, local workers cannot gain the traction—and funding—to rein in rates in their areas. 

A new study drills down to the county level, revealing wide disparities within states and striking national patterns. "We're extremely excited about the county level," says Lawrence Barker, associate director for science at the U.S. Centers for Disease Control and Prevention (CDC) Division of Diabetes Translation.

Many of the counties with the highest rates of diagnosed diabetes—higher than 11.2 percent of the population compared with the national average of 8.5 percent—are concentrated in 15 states and form an area the study's authors have labeled the "diabetes belt" (after the so-called "stroke belt" that described U.S. Southeast in the 1960s).

"We've known for many years that there was a lot of diabetes in the Southeast," Barker says. But the new analysis, based on data from the self-reported national phone survey called the Behavioral Risk Factor Surveillance System (BRFSS), confirmed that the disease has a distinctive geographical distribution. The map and findings will be published in the April 2011 issue of the American Journal of Preventive Medicine.

Read more at scientificamerican.com

Nuns Ask McDonalds to Come Clean on Kids' Calories

Perhaps when the meek inherit the earth they would like it to be a healthier place. Katherine Hobson of The Wall Street Journal reports that a group of Philadelphia nuns wants McDonald’s to examine its own “policy response” to obesity and other diet-related diseases in kids.

That’s the McNugget unearthed by footnoted.com from the fast food company’s preliminary proxy statement. Proposal No. 11 is offered by the Sisters of St. Francis of Philadelphia, leading a coalition of other orders and Catholic institutions. (The Sisters of St. Francis own at least $2,000 of McDonald’s common stock, according to the proposal.)

The proposed resolution:

“WHEREAS, the contribution of the fast food industry to the global epidemic of childhood obesity and to diet-related diseases, such as diabetes, cancer and cardiovascular disease, have become a major public issue …”

(Then the proposal lists a mess of statistics about childhood obesity and food marketing to children, as well as a list of actions by other groups, including the Happy Meal crackdowns in northern California.)

“RESOLVED: Shareholders ask the Board of Directors to issue a report, at reasonable expense and excluding proprietary information, within six months of the 2011 annual meeting, assessing the company’s policy responses to public concerns regarding linkages of fast food to childhood obesity, diet-related diseases and other impacts on children’s health. Such report should include an assessment of the potential impacts of public concerns and evolving public policy on the company’s finances and operations.”

Footnoted.com says that McDonald’s eventual response will likely include “lots of facts and figures, [and] will also suggest that shareholders vote against the company having to issue such a report.” Look for that in a future filing.