Archive for February 18th, 2009

Get the Lead Out

February 18th, 2009 | No Comments | Source: Environmental Science & Tech., Washington Post

In 2001, an additive placed in Washington DC’s water had the unintended effect of leaching lead out of the pipes and into the water supply. The plume didn’t resolve until 2005 and District residents have worried ever since what effect it had on their children.

wheresjoewhenweneedhim Get the Lead OutTo address the matter, Dana Best and colleagues from Children’s National Medical Center reviewed 28,000 lead level test results performed at their facility.

They found that among children younger than 16 months of age and hence most vulnerable to lead’s deleterious effects, the percent of tests that exceeded the official threshold for concern (10 micrograms) jumped from 0.5 to 4.8 by the peak of the crisis in late 2001.

By 2004, that fraction had dropped to 1.8%.

Best’s group used that and other data to estimate that in 2003-2004, an incremental 900 children developed dangerously high lead levels as a result of the tainted water supply.

dontdrinkthewater 200x300 Get the Lead OutA few extrapolations later, the scientists ventured to guess that these kids lost 2-3 IQ points on average and sustained a slightly increased risk of behavioral problems as a consequence.

The study is in Environmental Science & Technology.

The investigators warn however, that there is no legitimately “safe” level when it comes to lead exposure. Even at levels below 10 micrograms scientists have detected similar reductions in IQ.

That’s why Bruce Lanphear, a lead-poisoning expert at Simon Fraser University told the Washington Post, “we suspect that there are thousands, possibly tens of thousands, of children who have experienced harm as a result of increased lead exposure” in the District.

So is 2-3 IQ points a lot?

Best was optimistic. “With enrichment, with a good school environment, it is likely that the loss will not affect your child in a significant way,” she told the Post (leaving open the question as to whether these things were available to all kids in the District).

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The Party’s over for Plavix

February 18th, 2009 | No Comments | Source: MedPageToday, Wall Street Journal

Last week the FDA’s Cardiovascular and Renal Drugs Advisory Committee unanimously agreed that Eli Lilly’s clot-buster Effient should be approved for the prevention of thrombosis in several acute coronary syndromes.

The FDA normally follows its panel recommendations, and if so Lilly will at long last have an answer to Plavix, the world’s second leading drug by sales with 2007 revenues in excess of $7 billion.

nicewhileitlasted 300x199 The Partys over for PlavixPlavix is co-marketed by Sanofi-Aventis and Bristol Meyers Squibb. Its patent expires in 2011.

The Committee green-lighted Effient for unstable angina and acute myocardial infarction. It was supposed to vote as well on whether to approve the drug for stent thrombosis prophylaxis, but maybe they had planes to catch. 

The Committee’s decision was driven by results from the TRITON-TIMI study, a head-to-head smackdown between Effient and Plavix in which the former proved superior when it came to reducing death from myocardial infarction.

It was saddled with an annoying tendency to kill people via bleeding complications, though.

To deal with the risk-benefit trade-offs, the Committee members recommended that Effient’s go-live should include label warnings regarding the risk of bleeding, especially in those with a history of stroke or who are scheduled for coronary bypass.

There was also a bit of haggling over the excess cancer cases and deaths observed in Effient-treated patients during TRITON-TIMI, but ultimately the committee decided that was a fluke. 

plavix The Partys over for PlavixIn TRITON-TIMI, 33 people who received Effient died of cancer whereas only 21 died in the Plavix group.

But “the trial was not designed to answer questions about cancer. The cancers diagnosed in TRITON are probably coincidental,” William Macias, Lilly’s medical director told MedPageToday.

And the committee tended to agree. “I wouldn’t have a problem giving this drug to a family member, said James Udelson, a Committee member and the chief of cardiology at Tufts.

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Auto Parts Guys Need a Bailout, too

February 18th, 2009 | No Comments | Source: Wall Street Journal

Now that the Big O’s nixed the idea of a car czar and tasked Tim Geithner and Larry Summers to deal with the Big 3 who are asking for boatloads more money as we speak, let’s hope those economic titans understand the entire auto parts industry is about to go pfffft unless it gets bailed out, too. 

endoftheroad 300x199 Auto Parts Guys Need a Bailout, tooThe parts suppliers requested federal aid 10 days ago. $25.5 billion was the opening bid made by the Motor & Equipment Manufacturers Association, a trade group representing 400 companies in the sector.

It’s probably just coincidence that the amount is nearly identical to the handouts already received by GM, Chrysler and their flailing finance divisions…so far.

“Without immediate assistance to suppliers, the country will face massive job losses and the eventual breakdown of the entire automotive sector in the United States,” according to an 11-page request from the Association that was obtained by the Wall Street Journal.

Last week GM and Chrysler reported breathtaking declines in domestic vehicle sales for January: GM dropped 49% and Chrysler was off 55%.

In 2008, 40 auto parts suppliers filed for bankruptcy protection. That number is likely to be surpassed this year almost no matter what.

The suppliers propose that $7 billion be used to fund a “quick pay program” allowing the beleaguered auto makers to pay suppliers 10 days after receipt of goods. That’s substantially less than the 45 days or more that has become their norm.

They also want $10.5 billion to guarantee receivables and $8 billion in federal loans.

Failure of key parts suppliers could cripple the industry faster than a rabbit on skates because the Big 3 use just-in-time supplier management systems meaning they have essentially no inventory on hand to feed the assembly line.

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