The health care products giant Johnson & Johnson continued to market an artificial hip in Europe and elsewhere overseas after the Food and Drug Administration rejected its sale in the United States based on a review of company safety studies.
During that period, the company also continued to sell in this country a related model, which earlier went on the market using a regulatory loophole that did not require a similar safety review.
It is not known how many people overseas received the replacement hip after the agency decided in 2009 not to approve it, nor the number who received the closely linked implant sold in this country. During some eight years on the market, the two implants were used in about 93,000 patients worldwide, about one-third of them in the United States. Both models were based on the same component, an all-metal hip socket cup that experts say was faulty in design.
The DePuy orthopedic division of Johnson & Johnson, citing declining sales, began phasing out both models of the device — formally known as an articular surface replacement device, which DePuy marketed under the name ASR — in November 2009 and formally recalled them in August 2010 amid reports in databases of orthopedic patients abroad showing they were failing prematurely at high rates.
But in a confidential letter, the F.D.A. told Johnson & Johnson in August 2009 that company studies and clinical data submitted to gain approval in the United States to sell the model available overseas were inadequate to determine the implant’s safety and effectiveness, according to a summary of the letter reviewed by The New York Times.
UPDATE: The Heartland Institute insists the information is fake, and is asking people to remove it. But since this is the same climate-denial group that published stolen scientist emails, I say “Fuck you.”
I was talking to a friend who lives in another state about how allergies are really, really bad this winter. I told him my eyes were burning and watering, and my nose runs all the time, too. We were kidding around: “Gee, wonder why that’s happening?” It was 52 degrees today in Philadelphia and the plants and flowers are starting to bud and bloom. More importantly, the leaf mold from the fall never got killed off, because we never got a sustained frost.
So of course I’m really happy to see that the Koch brothers are gearing up for an all-out propaganda effort to turn children into climate-change deniers:
Internal documents acquired by ThinkProgress Green reveal that the Heartland Institute, a right-wing think tank funded by the Koch brothers, Microsoft, and other top corporations, is planning to develop a “global warming curriculum” for elementary schoolchildren that presents climate science as “a major scientific controversy.” This effort, at a cost of $100,000 a year, will be developed by Dr. David E. Wojick, a coal-industry consultant.
“Principals and teachers are heavily biased toward the alarmist perspective,” Heartland’s confidential 2012 fundraising document bemoans. The group believes that Wojick’s project has “potential for great success,” because he has “contacts at virtually all the national organizations involved in producing, certifying, and promoting scientific curricula.” The document explains that Wojick will produce “modules” that promote the conspiratorial claim that climate change is “controversial”:
Dr. Wojick proposes to begin work on “modules” for grades 10-12 on climate change (“whether humans are changing the climate is a major scientific controversy“), climate models (“models are used to explore various hypotheses about how climate works. Their reliability is controversial”), and air pollution (“whether CO2 is a pollutant is controversial. It is the global food supply and natural emissions are 20 times higher than human emissions”).Wojick would produce modules for Grades 7-9 on environmental impact (“environmental impact is often difficult to determine. For example there is amajor controversy over whether or not humans are changing the weather“), for Grade 6 on water resources and weather systems, and so on.
Wojick will receive $5,000 per module, with twenty modules produced a year. Wojick, who manages the Climate Change Debate listserv, is not a climate scientist. His doctorate is in epistomology.
Remember, that’s almost four months of additional unemployment benefits that people who really need it won’t get. If only we had a Democrat in the White House… oh, wait.
A song that’s sort of my personal love anthem. Steve Earle:
Marshall Crenshaw has written some wonderful love songs:
I’d rather have a song like this than a box of chocolates. Big Star:
9pm EST tonight. My guests are David Dayen and Stuart Zechman. Listen here!
Call 646-200-3440 with questions or comments.