Archive for February 17th, 2009

Clean-up on Aisle Nine

February 17th, 2009 | No Comments | Source: NY Times

grassleydunksoverewing Clean up on Aisle NineRepublican Senator Charles Grassley has been all over the medical device industry for years.  Why just a month ago he called out the University of Wisconsin in the Zdeblick-Medtronic debacle.

“I am concerned that Wisconsin’s reporting requirements do not go far enough to fully capture a physician’s potential conflict of interest,” he said a moment after revealing the surgeon had pocketed $19 million, most of it undisclosed from Medtronic, the nation’s largest spinal device producer.

That was quite a performance, but now Grassley is movin’ in for serious carcass. Last week, he and Herb Kohl, who ironically is a cheesehead, reintroduced legislation that would require device makers and Big Pharma to list all financial ties with physicians on a .gov Web site.

devicemakersgopffffft 300x225 Clean up on Aisle NineThe public is clamoring for transparency,” Kohl said of the Physician Payments Sunshine Act.

And other parts of the government are providing precision support for the senators on multiple fronts. 

In 2007 for example, the Justice Department forced knee and hip makers to accept its oversight as a quid pro quo for not looking further into allegations they bribed physicians to use their stuff.

In fact Justice already requires knee and hip makers to disclose all payments to physicians on corporate Web sites and has capped per-day consulting payouts to physicians at a measly $500.

Even some hospital systems are getting into the act. Kaiser Permanente for example does not permit its physicians to accept income from the private sector and requires that device makers compete for contracts on price, perish the thought.

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Sasha to get Roast Beef on Rye

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

Federal officials said last week that Peanut Corporation of America,  the Georgia firm at ground zero of the salmonella outbreak that has killed 8 and sickened 500 in 43 states and Canada, knowingly distributed  contaminated peanut butter a dozen times in the last 2 years.

According to investigators from the FDA and CDC, company-sponsored tests on outgoing products from the Blakely, Georgia plant were positive for the pathogen 12 times since 2007.

thistastesfunny 200x300 Sasha to get Roast Beef on RyePCA shipped the products anyway, occasionally after receiving a clean report from an independent laboratory.

Food producers don’t have to disclose the results of internal testing, so regulators were clueless until after the pigeons flew the coop, the Washington Post reported.

Until closing the plant and then filing for bankruptcy in the aftermath of the fiasco, PCA sold peanut butter and paste produced at the Blakely plant to companies that make candies, cereal, cookies, crackers, cookies, energy bars, and ice cream.

The FDA and PCA have recalled 2,000 possibly tainted products so far. Peanut butter sold in supermarkets appears to be clean.

Remarkably, until the outbreak the woefully understaffed FDA had never set foot inside the Blakely facility.

State inspectors did visit Blakely last October, right when the tainted products were being made. Alas, they didn’t test for salmonella.

Why, the Post wanted to know?

“We do pull product samples from time to time, but we can only run 4,500 samples in a year, and we have 16,000 food-processing and food-sales stores in the state,” Oscar Garrison, a Georgia consumer protection official answered reassuringly.

Even the Big O was outraged.

“That’s what Sasha eats for lunch,” Obama told Matt Lauer. “Probably 3 times a week. I don’t want to worry about whether she’s going to get sick as a consequence of eating her lunch.”

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Feds Fumble Handoff to Digital TV

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

A decade ago, the US government decided we should switch from analog to digital TV. It was a no-brainer. People would get improved reception and the Feds would rake in $20 billion by selling the analog spectrum to cell phone carriers.

The only problem was wiring 20 million US households that watched the tube the old fashioned way. Many of them rely on TV for news about things like impending floods, severe weather and other life-threatening events.

Low income, elderly and Hispanic viewers were particularly likely to be analog users.

These people needed a converter box which cost $80. Senator Ed Markey reasoned government was going to profit from the transition, so it should pay for the boxes.

He wanted to give consumers two $60 coupons each, which would cost $4 billion. Republicans said what are you crazy and capped the program at $1.5 billion.

Meanwhile, the FCC thought the NTIA was supposed to do consumer education but the NTIA was dead in the water due to laughably frequent leadership changes. It turned out the FCC was supposed to do it.

Now the deadline was approaching and the people wanted their coupons.

Not a problem, the NTIA told Congress in November. “The coupon program has both sufficient funds and system processing capabilities to…distribute…more than 50 million coupons (in time)…and to do so without…a backlog.”

So on January 4 the coupon program ran out of money and millions had no coupons.

And Congress had mandated that the coupons be distributed third class mail which we think involves horses and buggies so it was taking a month to get there anyway.

“Millions of Americans, including those in our most vulnerable communities, would have been left in the dark if the conversion had gone on as planned,” sighed the Big O upon signing a bill postponing implementation for 4 months.

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