News and Events - 21 Feb 2012

New Diet Pill Side-Effects Under Scrutiny By FDA Regulators

2012-02-20 09:36:10

A weight-loss drug currently under a second review from the Food and Drug Administration (FDA is causing concerns that it may be responsible for birth defects and heart problems, according to documents released by the agency on Friday. The drug, developed by Vivus, was rejected by the agency in 2010, largely because of those risks. A committee of outside advisers to the FDA will meet this week to reconsider whether the drug, called Qnexa, should move forward in the approval process, reports Andrew Pollack for the NY Times. Obesity specialists and patient advocates agree there is a huge need for obesity drugs to bridge a treatment gap between diet and exercise, which do not work for many people, and bariatric surgery, which is expensive and not suitable for those with specialized medical conditions. The FDA, however, has been cautious with approving diet drugs, in part because with two-thirds of American adults overweight or obese, such drugs might be used for a long time by millions of people. There is an FDA Advisory Panel meeting this month that is tasked with combing through 2-years’ worth of clinical data. When Qnexa was last reviewed, the Agency only had 1-year’s worth to examine. The Advisory Panel will have to discuss and vote on whether to recommend supporting or declining the obesity drug after carrying out an overall benefit-risk assessment, reports Christian Nordqvist for Medical News Today. The FDA can choose to accept or reject the non-binding decision but this hardly ever happens. Therefore, Qnexa’s future, at least this time around, depends on what happens this week. When the FDA previously turned Qnexa down, it asked Vivus for more clinical data on the medication’s potential impact on major adverse cardiovascular events and birth defects. One question the advisory committee will be asked to consider is whether Vivus should be required to conduct a large new clinical trial before the final approval is given to assess whether the drug increases the risk of heart attack. Facing more delays, possibly by several years, Vivus has proposed doing the study after approval. Studies also show that the use of topiramate during pregnancy increases the risk of oral clefts, such as cleft lip, by a factor of two to five, according to the FDA staff review released last week. That is a concern, the reviewers said, because “the major consumers of weight-loss drugs are women of childbearing potential,” leading to “the potential for large numbers of pregnancy exposures.”

Qnexa was picked as the most suitable weight loss drug because of the high level of weight loss reported in company studies, with an average of more than 10 percent total body mass reduced among participants of the study, USA Today is reporting. Reviewers for the FDA were still guarded in their approval. “Overall, the long-term clinical impact of the observed modest improvements in comorbidity outcomes is uncertain, particularly in a population with higher risk of CV adverse events,” the FDA wrote, referring to cardiovascular events such as heart attacks. The main cardiovascular concern is that Qnexa increases heart rate. Still, the reviewers did say that the effect of the drug in lowering blood pressure was “somewhat reassuring.” --- On the Net:

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APNewsBreak: FDA to review inhalable caffeine (AP

20.02.2012 18:25:00

AP - U.S. Food and Drug Administration officials plan to investigate whether inhalable caffeine sold in lipstick-sized canisters is safe for consumers and if its manufacturer was right to brand it as a dietary supplement.

Health Highlights: Feb. 20, 2012

20.02.2012 16:38:07

Here are some of the latest health and medical news developments, compiled by the editors of HealthDay: Inhalable Caffeine Product to be Reviewed by FDA The safety of an inhalable caffeine product called AeroShot will be reviewed by the U.S. Food...

Recent counterfeit drug warnings in US (AP

17.02.2012 1:48:20

AP - The Food and Drug Administration is investigating fake vials of the cancer drug Avastin that may have been sold to doctors in three states. In recent years the agency has warned the public about several pharmaceutical counterfeiting cases:

Newt Gingrich threatens to sue over ad he says lies about his record on Chinese 'one-child' policy

rss@dailykos.com (Meteor Blades

18.02.2012 1:47:04

For once, just once, Newt Gingrich may have caught somebody
else
in a lie. No surprise then that he's
shifted his high-dudgeon gear into overdrive. He says that if television stations in Georgia don't stop running an ad about him that his lawyers call “fundamentally NOT TRUE, or as PolitiFACT.org put it—a 'Pants on Fire' lie," he'll sue.

Relying on PolitiFACT to make the case for what's ablaze is always risky. Statements called false there today could be on the honor roll before the weekend is half over. In this case, however, the group probably got it right.

At issue is an ad by the SuperPAC Restore Our Future saying Gingrich “co-sponsored a bill with Nancy Pelosi that would have given $60 million a year to a U.N. program supporting China’s brutal one-child policy.” Various fact-checkers found that the 1989 legislation specifically excluded any funding for involuntary sterilizations, abortions or programs that forced anyone to accept family planning. Any station that runs the ad risks a defamation suit, Gingrich's lawyers state.

Upon hearing the news of the threatened lawsuit, hubris must have stepped off stage to give way to Gingrich with whom it can no longer compete. If a lawsuit were brought against the Newt every time he lied, it would tie up the civil judiciary east of the Mississippi for a decade.

After all, this is the guy who claimed 800 babies were tossed into dumpsters in Washington, D.C. (It was four. Who said only people who made more than a million dollars a year were subject to the income tax when it was initiated. (The rate was 1 percent for earners up to $20,000. Who claimed people could spend their food stamps to go to Hawai'i. (No, they can't. Who said it's illegal to pray in school. (No, it's not. Who said up to 25 percent of the White House staff under Clinton were drug users. (Example #231,309 proving that 87.4 percent of statistics are made up on the spot. Who claimed the United States spend less in 2010 on national defense than at any time since Dec. 6, 1941. (In inflation-adjusted dollars it was higher when than at any time since 1971 . Who said his first wife wanted their divorce. (Court documents say he did. Who said Freddie Mac paid him $1.6 million for "history lessons." (I am not even going to bother with that one. Who claimed he had never supported a mandated health-care coverage. (He had. Who claimed he took a vacation to Greece with Callista to shake up his campaign staff and see the Greek financial crisis up close. (Hahahahaha.

Lying is
second
first nature to Newt Gingrich. Whether it's revising American history or his personal history, he thrives on lies. Couldn't exist without them. If PolitiFACT were on the ball, the guy would have to wear asbestos underwear to get through the day.

 

FDA to probe safety of inhalable caffeine

19.02.2012 18:54:01

U.S. Food and Drug Administration officials plan to investigate whether inhalable caffeine sold in lipstick-sized canisters is safe for consumers and if its manufacturer was right to brand it as a dietary supplement.