Archive for March 17th, 2009

Oxidative Stress

March 17th, 2009 | 2 Comments | Source: BurrillReport, PLoS Medicine

For decades, scientists theorized that aging was caused by oxidative stress, a phenomenon in which cellular damage is caused by free radicals and nasty oxygen-based molecules that build up over time as byproducts of normal biological processes.

freeradicalAccording to the theory, the cellular defense against the culprits-which are enzymes known as superoxide dismutases-gets overwhelmed by the accumulating bad guys and the next thing you know, cells are looking like Methuselah.

From the theory sprung an entire industry hawking antioxidant therapies from Vitamin A to Coenzyme Q which supposedly boosted the body’s ability to water-cannon the free radicals.

Alas clinical trials have never shown them to work and now McGill University scientists are raising doubts about the validity of the oxidative stress theory itself.

Siegfried Hekimi and colleagues disabled one-by-one, 5 genes coding for superoxide dismutases in a worm that goes by the unassuming name C. elegans.

The successive gene deletions did not shorten the worms’ lifespan; in fact in one instance, the altered critters outlived the wild-types.

The report is in PloS Genetics.

bagtheCoenzymeQ?Come to think of it, the evidence supporting the oxidative stress theory is circumstantial, Hekimi told BurrillReport.

And oxidative stress could be the result of aging rather than its cause.

“It is true that the more an organism appears aged, whether in terms of disease, or appearance or anything you care to measure, the more it seems to be suffering from oxidative stress. (But) people think correlation is causation,” he told BurrillReport.
 
Hekimi’s not saying oxidative stress is actually a good thing. It clearly interferes with normal cellular functioning. But it’s a stretch, he says, to say that oxidative stress causes aging.

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Big O’s e-Team in the Stone Age

March 17th, 2009 | No Comments | Source: Washington Post

When Barack Obama’s economic Hail Mary cleared Congress, his e-team posted the legislation on whitehouse.gov with an open invitation to post comments. The bill was 1,071 pages long but responses were limited to 500 characters.

next2ovaloffice“Absurd,” cried Ellen Miller of the Washington-based Sunlight Foundation, who spoke for many.

A day later the e-team managed to bump the count to 5,000 while removing egg from its eye and chewing gum at the same time, but that was an inauspicious beginning for the geekocrats who had been canonized just months earlier for running the most tech savvy presidential campaign in history.

The Big O had hired Macon Phillips to be the White House director of new media, and immediately kinged him to special assistant with direct access to The Man and The Blackberry.

He envisioned whitehouse.gov to be his major communication platform, a digital Cape Canaveral from which he could launch gold nuggets that would rain down on supporters.

But the site, it turns out, doesn’t permit email blasts.

And the Presidential Records Act mandates that all White House written communications be preserved so Web pages on the site must be archived every time they’re modified, which gums up site refreshing.

“This is uncharted territory,” said Phillips, which we take to mean that no one tried to chart the territory before the Big O unpacked his gym bags on January 20.

But Phillips can point to progress. WhiteHouse.gov now has a blog, a YouTube channel, and a jobs link for example.

The first post on that blog announced that that all non-emergency legislation will be posted there for 5 days, giving the public a chance to review and comment before the president signed off.

That promise lasted until Congress passed the SCHIP extension and the Big O signed it 3 nanoseconds later.

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Ranbaxy Faked Drug Trial Results

March 17th, 2009 | No Comments | Source: Washington Post

FDA officials say Ranbaxy knowingly submitted misleading lab information about the safety and efficacy of drugs it produced and planned to distribute in the US.

theyllneverfindoutAnd given the sordid history between the US regulatory agency and the gigantic India-based generic drug producer, the FDA has decided to forego all work on Ranbaxy drug applications until the company gets its act together.

The transgressions occurred at the company’s Paonta Sahib facility which produces 25 drugs that have already been approved by the FDA.

However the agency refused to provide a list of affected drugs because it has “no concern about the safety or efficacy of Ranbaxy’s drugs on the US market.”

That’s according to Deborah Autor, the FDA’s director of compliance.

In one instance, Ranbaxy employees refrigerated drug samples that were supposed to be tested at room temperature or higher for shelf life.

Other tests to assure drugs maintained potency over time were carried out on the same day or just days apart, according to the Washington Post.

actualranbaxyrubberstampAnd records show that lab results were validated by employees who weren’t on the premises the day the tests were run.

“These…findings indicate a pattern and practice of submitting untrue statements of material fact and other wrongful conduct,” the FDA hissed in a letter to Ranbaxy.

Ranbaxy had to know this was coming. It had been warned twice in 2006 by the FDA that its inspectors had found numerous deviations from safe, proper manufacturing practices.

Then last September, the FDA banned imports of 28 Ranbaxy-produced drugs after discovering ineffective sterilization procedures, inadequate protections against contamination from allergy-causing ingredients, and incomplete records at Paonta Sahib and elsewhere.

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