Archive for January 30th, 2009

Old Drug, New Tricks

January 30th, 2009 | No Comments | Source: J. Biological Chemistry, TJOLS

For decades it didn’t look like clioquinol was going to qualify for the Pharmaceuticals Hall of Fame.

The hydroxyquinoline antibiotic had been used since World War II to treat amoebic infections and shigella gastroenteritis until being blamed for an enormous outbreak of subacute myelo-optic neuropathy in Japan in the 1960s.

There was little scientific reasoning behind the presumed association, and the drug had been used safely by millions before the epidemic but hey, other antibiotics were available to treat the conditions in question so why take a chance?

So the drug passed quietly into retirement, presumably never to be heard from again.

comebackkids Old Drug, New TricksBut then out of nowhere, recent animal studies have surfaced purporting to show that clioquinol reverses progression of not one but 3 seemingly unrelated neurodegenerative conditions–Alzheimer’s, Huntington’s and Parkinson’s disease, respectively.

That’s got to be the greatest comeback since Cream rocked Madison Square Garden in 2005.

“The drug affects a gene which when inhibited can slow down aging,” Siegfried Hekimi told the Journal of Life Sciences. “The implication is that we can change the rate of aging. This might be why clioquinol is able to work on this diversity of diseases that are all age-dependent.”

Hekimi and colleagues at McGill University recently reported in the Journal of Biological Chemistry that clioquinol inhibits a mitochondrial enzyme known as CLK-1, or simply “clock-1.” 
 
The mechanism by which clioquinol inhibits CLK-1 remains unclear. “One possibility is that metals are involved as clioquinol is a metal chelator,” Hekimi explained.

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Vast Solution in Ruse to Build IEDs

January 30th, 2009 | No Comments | Source: Washington Post

Improvised Explosive Devices cause most US troop casualties in Iraq and kill or maim thousands of civilians every year in that country and Afghanistan.

Once in awhile, US troops recover an unexploded IED and have look inside. To their dismay, they often find circuit boards, GPS devices and timers produced by US companies. 

sophisticatediranianied 300x248 Vast Solution in Ruse to Build IEDsIran it turns out, has become adept at acquiring US-made materials that can be used to make IEDs, assembling them and transferring them to a bunch of nut cases in Iraq and Afghanistan.

“The schemes are so elaborate, even the most scrupulous companies can be deceived,” David Albright told the Washington Post. Albright is president of the Institute for Science and International Security and recently co-authored a report on the matter.

And despite one celebrated US government success in interrupting this deadly flow, Iran is still in business.

In 2004, Iranians operating out of 4 Dubai-based front companies including one with the innocuous moniker Mayrow General Trading began scheming to acquire bomb circuitry, according to Justice Department documents.

The companies all used the same managers and business addresses, yet their requisitions appeared legitimate and to be associated with benign projects. The network secured parts from US firms in several states.

In 2006, the Bush administration busted the operation. The Commerce Department subsequently restricted Mayrow’s ability to trade with US companies. Dubai officials helped uncover the operation and have collaborated with US officials ever since.

But months after the bust, the network reconstituted itself in Malaysia under the name Vast Solution. It was a simple matter of changing a few shipping routes and company names. The new enterprise was headed by an Iranian using the name Majid Seif.

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GAO Slams FDA on Devices

January 30th, 2009 | No Comments | Source: NY Times

In the last few years, the GAO has criticized the FDA for failing to protect our food supply, assure the quality and safety of drugs produced abroad and detect emerging adverse event trends in post-marketing drug surveillance.

thatsgottahurt 300x225 GAO Slams FDA on DevicesSo forgive those who barely batted an eye when the GAO called out the agency once again last week, this time for fumbling its fundamental responsibility to assure the safety and efficacy of medical devices.

That pacemaker your Uncle Harry received last week? Almost certainly, it received nothing more than casual look-see from the agency.

The FDA approval process begins by assigning medical devices to one of 3 classes which in turn drives the degree of regulatory scrutiny they recieve.

Reading glasses, tongue depressors and the like are Class I devices, usually exempt from review. Mercury thermometers are Class II, worth at most a quickie.

Class III devices include the good stuff: pacemakers, MRI machines and heart valves for example.

But according to a Congressionally approved 1976 process, Class III products also receive perfunctory reviews if they are found to be essentially similar to devices already on the market.
 
Or, as Memorial Sloan Kettering physician Peter Bach told the New York Times. “The manufacturer wheels in their new Ferrari and says, ‘Look, it’s just like the Model T,’ ” which is essentially enough to guarantee FDA approval.

 “Then they say to doctors, ‘Why would you drive anything but a Ferrari?’ This drives up the cost of care without (necessarily improving) outcomes,” Bach told the New York Times.

In its report, the GAO emphasized “it is imperative that FDA take immediate steps” to put a more rigorous approval process in place for medical devices.

FDA officials insisted to GAO investigators that updating the rules was a priority. But “when asked for their time frame for doing so, the officials did not provide one,” according to the report.

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