DOJ and FDA pop Guidant for failures of three models of its implantable defibrillators

If I haven’t said it before, I’ll say it now. The FDA is awesome. On the occasions when the FDA tag teams with the DOJ? Watch out!

The FDA and the DOJ just popped Guidant LLC for $296 million. Their crime was withholding information about “short-circuiting failures of three models of its implantable cardioverter defibrillators: the Ventak Prizm 2 DR (Model 1861) and the Contak Renewal (Models H135 and H155).”

“The devices, once surgically implanted, constantly monitor the electrical activity in a patient’s heart for deadly electrical rhythms and deliver an electrical shock to the heart in an effort to return the heartbeat to normal. If they fail to operate properly when needed, a person can die within minutes.”

Nice company.

This $296 million fine is also “the largest criminal penalty ever imposed on a device manufacturer for violating the Food Drug and Cosmetic Act”.

Maybe nailing companies with $200 million dollar fines will get them to be a touch more responsive to things like this!

If you know someone that has an implanted defibrillator, have them check with their doctor to see if it happens to be a Ventak Prizm 2 DR (Model 1861) or either of the Contak Renewal Models (H135 and H155). You just might save their lives.

Here’s the link to the FDA/DOJ announcement.

Strange: FDA now requires device manufacturers to include information on pediatric populations

The new FDA requirement that’s described in this press release is a bit odd.

As of now, the FDA requires that “manufacturers now must include a description of any pediatric subpopulations that suffer from the disease or condition that the device is intended to treat, diagnose, or cure. Manufacturers also must include the number of affected pediatric patients.”

Lemme make sure I understood this… the FDA wants to know what diseases and conditions a manufacturer’s product is designed to treat? And a real quantifiable number of how many kids are affected by the disease that their product intends to treat?

Hmmm.

The press release also says… “Very few devices are developed or assessed specifically for use in pediatric patients, those 21 or younger at the time of treatment or diagnosis. This effort will provide a better understanding of which devices developed for use in adults should be assessed or modified for use in pediatric populations. The requirements, contained in the Food and Drug Administration Amendments Act of 2007, will also improve the agency’s ability to track the number of approved devices for which there is a pediatric subpopulation who could benefit and the number of approved devices labeled for use in pediatric patients.”

Anything that tries to fly under the banner “we’re doing it for the kids” is an automatic suspect in my book.

Is there anything wrong with this request? Not that I can see. But is it a strange request? Most definitely.

Here’s the official FDA press release on the new requirement.

News stories the mainstream media missed : 04/03/10

Here are some news stories from this week that I think the mainstream media completely missed out on. All links are from legitimate news sources and not the fringe / wacko sites.

* You’ll never ever see this in the mainstream media… cola lowers a man’s sperm count by 30 percent. As in only 7 out of 10 are still there! Tea and/or coffee are OK, so it’s not caffeine that’s doing it! Just say no to Coke! [PHYSORG]

* The first paragraph of the story says it all. “Using a technique called transcranial magnetic stimulation – in which magnets are used to disrupt neural activity in specific parts of the brain – scientists managed to “turn off” people’s moral centers.” Great. So if someone puts a specially modified hat on someone’s head, they can make them “bad” and forget their own code of morality. This has all kinds of ugly written all over it. The technical story is at [PNAS] and one “in English” is at [IO9]

* In more positive scientific news, “Playing the video game Tetris after a major shock can reduce symptoms of post-traumatic stress disorder, claim Oxford researchers.” OK. What I wanna know is how the hell did they find this correlation? And why do I suddenly hear the Tetris music? [TELEGRAPH.CO.UK]

* Trees are growing faster and bigger throughout the world? Maybe because there’s more CO2 for them to inhale? [NPR]

* Hoarders may have some serious drain bamage. “…hoarders had lower metabolic rates in the anterior cingulate cortex, one region responsible for motivation, focused attention, error detection, and decision making.” So, according to my sitcom science degree, another whack on the head should restore them to normal, right? Or is that only good for amnesia? [DISCOVER]

* Scientists have also just proven that “the presence of an attractive woman elevates testosterone and physical risk taking in young men.” This needed scientific proof? Seriously? [DISCOVER MAGAZINE]

* In more serious and infuriating news, some U.S. Bishops have very quietly started to allow priests accused of pedophilia back into the church [NPR] AND the head of the Catholic League said all that all this alleged abuse really wasn’t pedophilia because the boys were ‘post-pubescent’, saying “the age at which children become “post-pubescent” is around 12 or 13.” [RAWSTORY] Oh, so it wasn’t 11 year old boys being molested, it was 12 year old boys. And this makes it OK then? Somebody in the upper echelon of the Catholic church needs to clean house with a vengeance. Justified wrath of God, excommunication, “and you will know my name is the Lord when I lay my vengeance upon thee” kind of cleaning house.

* In another bit of infuriating news, the father of a Marine whose funeral was picketed by the Westboro Baptist Church has to pay the Westboro Baptist Church more than $16,000 for their legal fees and for their protest of his son’s funeral. [CNN] But the cavalry arrives from… Bill O’Reilly?!? Bill O’Reilly said he will pay every cent of that $16,000 legal fee for the father, saying “That is an outrage. I will pay Mr. Snyder’s obligation. I am not going to let this injustice stand.” Wow. I’m actually impressed and surprised. [NEWSMAX]

* If you notice the roads you travel on start to suck in a few years, it’s because gravel roads are making a comeback. Asphalt is $400 a ton and gravel is $20 a ton. That ads up quick! Michigan and Minnesota are starting it off. [KIPLINGER]

* The states are now getting in deep trouble financially in other areas too. Nothing to see here people! Move along! [NYTIMES]

*… aaaaand Greenspan says the economy is going to get worse, too. His early warning prediction was just validated. Keep moving! Nothing to see! [BLOOMBERG]

* …aaaand A giant sell-off in treasuries is being viewed as “a warning to Washington that it can no longer borrow with impunity.” Nothing to see at all! That’s why it’s only being covered in England! Move along now! [TELEGRAPH.CO.UK]

* What kind of man repos private jets from drug lords? Or from corrupt governments? Or steals them out of the heart of Russia? Helloooooo Hollywood? I got another summer blockbuster for you people! Contact me for a script! [AIRSPACE MAG]

* Speaking of summer blockbusters, Independence Day 2 and 3 are in the works, with Will Smith supposedly onboard for both. Yes, Independence Day is a movie with a major plot hole every five minutes, but it was fun to watch. Maybe this time they will send something aside from fighter jets with air-to-air missiles after the motherships. A sequel demands fuel-air bombs and other assorted thermobaric carpet-bomb runs from the stratosphere! I’ll pay to see that! [IO9]

* In technical news, an HDMI cable is an HDMI cable. There is NO DIFFERENCE between a $150 HDMI monster cable and a generic $10 HDMI cable to connect stuff to your High Definition TV. I have three generic $7 HDMI cables, and everything connected to them gives a perfect picture on my HDTV. Here’s the proof… [MINT.COM]

* In other technical news, how about a counter-surveillance camera that “spots other cameras, scopes, binoculars and human eyeballs gawking at it.” You can see who is spying on you or has you in their sights in real time? I’ll take two please. [GIZMODO] and the actual product is available at [JET-PROTECT]

* Want a secret lift to park your car directly in the living room? Not a problem, Mr, Wayne. Will you and Mr. Grayson be dining in tonight? [TODAYANDTOMORROW] with blueprints at [WHATWEDOISSECRET.ORG]

New Sprint “Satisfaction Guaranteed or Money-Back” offer sounds very impressive

Sprint just announced a new “Satisfaction Guaranteed or Money-Back” offer.

“Beginning tomorrow, the Sprint Free Guarantee gives any customer opening a new line of service the chance to try Sprint for 30 days. If a customer isn’t completely satisfied, they can get reimbursed for the device purchase and activation fee, get the early termination fee waived, get a full refund for service plan monthly recurring charges incurred and get all associated taxes and Sprint surcharges associated with these charges waived. In addition, Sprint will waive the restocking fee for new customer exchanges as part of this policy.”

Dear Verizon: Wow. The gauntlet has been thrown. Any response?

Dear AT&T : You suck. Don’t bother pulling out some father’s brother’s newphew’s cousin’s former roommate of a celebrity for some lame commercials to pretend you can keep up with this.

For complete information about the Sprint Free Guarantee visit, www.sprint.com/guarantee beginning tomorrow.

Tea Party Leader Dick Armey previously lobbied for a terrorist organization

File this under “amazingly good to know”.

Apparently the leader of the “Tea Party”, Dick Armey, was a pretty busy guy! Before leading the “Tea Party”, Armey spent “years spent lobbying for a group recognized by the State Department as being a terrorist organization.”

D’oh!

The article goes on to say… “from 2005 to 2009, Armey promoted the People’s Mojahedin Organization of Iran, otherwise known as Mujahedeen-e-Khalq (MEK), which the State Department has branded a terrorist group. Armey lobbied his former colleagues on behalf of legislation that would have provided taxpayer support to the MEK.”

And as an extra special bonus, from 2005 to 2008, “two Iranian-American businessmen: Akbar Nikooie and Saied Ghaemi… paid out $910,000 to DLA Piper for the service of Armey, his former staffer Jean Campbell, and a handful of other lobbyists to bring issues relating to Iranian “foreign relations” and “human rights” to the attention of Congress, the Department of Defense, the State Department, the White House, the National Security Council and the Department of the Treasury.””

Of course, none of this is on his bio page or on the Tea Party website.

Hmmmm……

You can read about his little past indiscretions here.

UPDATE: The “full” webpage with comments is here.

UPDATE II: The “comments” on the news website are hilarious. “Why the focus on the personalities rather than the idea?” Ah, hypocritical much? Reason #546,781 I don’t trust the left or the right “movements”.

News stories the mainstream media missed : 03/27/10***

Here are some news stories from this week that I think the mainstream media completely missed out on. All links are from legitimate news sources and not the fringe / wacko sites.

* The headline says “Astronomers Find 90% More Universe!” OK, how can you find more infinity? Isn’t that like the divide by zero thing? [UNIVERSE TODAY]

* The Environmental Protection Agency is gonna require EPA certification for contractors working on homes built before 1978. So now I’m gonna have to get a haz-mat suit to fix Aunt Petunia’s windows on her home? [REASON] and [REMODELING]

* You ‘member those commercials “When EF hutton talks, everybody listens?” It’s like that with T Boone Pickens. He may be a little squirrely, but when he moves on something, pay attention. “In Pickens’ eyes, water is going to have a lot of value going forward”. [FT]

* James Harrison, 74, has an antibody in his plasma that stops babies dying from Rhesus disease. His blood and 984 donations has saved 2 million babies’ lives. Pure awesomeness. If I ever win the lottery, I’ll team up with other millionaires and start the “quiet hero” annual award. Capt. Chesley “Sully” Sullenberger would have won it in ’09. James Harrison would have taken it last year. [DAILYMAIL]

* Neuroscientists “created fearful memories in people and then erased them” supposedly to learn how to “treat traumatic memories in people.” Maybe it’s just me, but I think this has the potential to be extraordinarily bad. If the government is still saying waterboarding isn’t torture, imagine what they will do with this? Now I need to add “centered memory retention meditation” to my to do list. [SCIENTIFIC AMERICAN]

* Nanoparticles have successfully killed cancer cells! Repeatedly! And without harming the host cells! The first trial on humans has been a success, with no side-effects at all! Boo yah!!! The future is going to be all kinds of nuts! The story is at [CALTECH], but a friendlier “in english” explanation is at [GIZMODO]

* Scientists think they have a proof of something pulling the entire universe at 2 million miles per hour. It’s pretty mind blowing that we’re all actually moving so fast and don’t notice. [NATIONAL GEOGRAPHIC]

* “High Fructose Corn Syrup Is Linked to Liver Scarring”. That’s some very important stuff that I’m sure will be paid off and buried in the mainstream media, never to be heard from again! [SCIENCE DAILY]

* Real “raise the shields” tech is coming? OK, maybe it’s more like “polarize the hull plating”, but it’s a step forward! Captain Archer, Commander T’Pol, report to the bridge. [TELEGRAPH.CO.UK]

* Bill Gates is making a nuclear reactor that will work for 100 years without refueling. It must be nice to be so rich and politically connected you can do those kinds of things! [INDIANA EXPRESS]

* An alligator was found 20 miles out to sea… swimming with whales. I think the animal kingdom likes to mess with our heads like this on purpose. [MNN]

* Binyamin Netanyahu was “deeply humiliated” after Barack Obama “dumped him for dinner”. Looks like Netanyahu finally met the new sherrif in town! Tl;DR for Netanyahu : Stop building. Make peace. [TIMESONLINE]

* Mr. US finance, Ben Bernanke, says the “U.S. Fiscal Outlook is ‘Somewhat Dark’”. Hopefully just because he’s wearing shades. [BLOOMBERG] And if Bernanke feeling a tremor in the force wasn’t enough, Greenspan feels it too. [BLOOMBERG]

* Dear Republicans, This is what you need to do to make a comeback and have everyone take you seriously again. That is all. [TALKINGPOINTS MEMO]

* So when a conservative think tank proposes a healthcare plan, it’s all good. But when Obama successfully passes the identical thing, it’s socialism? Wait, what? [NY TIMES]

* Mother nature has a sequel to peak oil in the works! We’re running out of phosphate rock! It’s a major component of fertilizer, and current estimates say we will be out in 50 to 100 years. “Worse, phosphorus production could peak in just two decades, according to new research from Australia and Sweden. That’s when demand could outstrip supply, playing out a familiar scenario of scarcity, price shocks, riots, starvation and war.” So I’m guessing phosphorus grenades and tracer ammo are going to be even more expensive, too. Has someone given the military a heads up about this? [ALTERNET]

* The French torture a man to death as part of a gameshow. Fortunately, the man was an actor and everything was based on the Stanley Milgram experiment from 1960, but “only 16 of the 80 participants stopped before the ultimate, potentially lethal shock.” Lesson: Idiots blindly obey authority. Especially if they’re French. [BBC]

* It is officially the end of an era. Iggy Pop dove off a stage – and nobody caught him. [MATADORNIGHTS]

*** You know you’re having a great weekend when 8 PM Friday turns into 11 PM Sunday!

Kill the fatman? A philosophy experiment.

I found a website that gives you a quick philosophy/morality quiz. I thought it was entertaining enough to post here.

Should You Kill The Fat Man? will take about 10 minutes. You answer a few questions, all anonymously, and it rates your views on morality with your consistency in acting on them.

For the record, I got a 100%.

“Your moral consistency score is 100% (higher is better)  Well done. This score suggests that you are admirably consistent in the way you view morality. In fact, none of the people who have completed this activity demonstrate greater moral consistency in their responses than you manage. But don’t feel too pleased with yourself. Most people don’t think about morality very clearly!”

Here’s the link again to Should You Kill The Fatman?

Table of annual fines for not participating in healthcare plan

If you’re thinking of not joining the healthcare plan that was just signed, Bloomberg just detailed what the annual fines for 2015-2016 would be.

“Individuals who don’t purchase insurance would be subject to a fine of $325 in 2015 and $695 in 2016. Individuals may be subject to a charge equal to as much as 2.5 percent of their income in 2016, if the total is greater than the flat payment.”

So going with the 2.5 percent of income as the basis of the tax / fine, and looking at salaries right as the $695 minimum kicks in, this is what you will have to pay if you choose not to participate in the healthcare plan and have no insurance at all…

INCOME FINE REMAINING
$25,000.00 $625.00 $24,375.00
$30,000.00 $750.00 $29,250.00
$35,000.00 $875.00 $34,125.00
$40,000.00 $1,000.00 $39,000.00
$45,000.00 $1,125.00 $43,875.00
$50,000.00 $1,250.00 $48,750.00
$55,000.00 $1,375.00 $53,625.00
$60,000.00 $1,500.00 $58,500.00
$65,000.00 $1,625.00 $63,375.00
$70,000.00 $1,750.00 $68,250.00
$75,000.00 $1,875.00 $73,125.00
$80,000.00 $2,000.00 $78,000.00
$85,000.00 $2,125.00 $82,875.00
$90,000.00 $2,250.00 $87,750.00
$95,000.00 $2,375.00 $92,625.00
$100,000.00 $2,500.00 $97,500.00
$105,000.00 $2,625.00 $102,375.00
$110,000.00 $2,750.00 $107,250.00
$115,000.00 $2,875.00 $112,125.00
$120,000.00 $3,000.00 $117,000.00
$125,000.00 $3,125.00 $121,875.00
$130,000.00 $3,250.00 $126,750.00
$135,000.00 $3,375.00 $131,625.00
$140,000.00 $3,500.00 $136,500.00
$145,000.00 $3,625.00 $141,375.00
$150,000.00 $3,750.00 $146,250.00
$155,000.00 $3,875.00 $151,125.00
$160,000.00 $4,000.00 $156,000.00
$165,000.00 $4,125.00 $160,875.00
$170,000.00 $4,250.00 $165,750.00
$175,000.00 $4,375.00 $170,625.00
$180,000.00 $4,500.00 $175,500.00
$185,000.00 $4,625.00 $180,375.00
$190,000.00 $4,750.00 $185,250.00
$195,000.00 $4,875.00 $190,125.00
$200,000.00 $5,000.00 $195,000.00
$205,000.00 $5,125.00 $199,875.00
$210,000.00 $5,250.00 $204,750.00
$215,000.00 $5,375.00 $209,625.00
$220,000.00 $5,500.00 $214,500.00
$225,000.00 $5,625.00 $219,375.00
$230,000.00 $5,750.00 $224,250.00
$235,000.00 $5,875.00 $229,125.00
$240,000.00 $6,000.00 $234,000.00
$245,000.00 $6,125.00 $238,875.00
$250,000.00 $6,250.00 $243,750.00

Ouch.

Here’s the link to the Bloomberg article.

Virginia and 10 other states plan to file lawsuit after Obama signs healthcare bill

Here’s the kickoff for the second quarter….

According to an article on REUTERS, “Virginia’s attorney general said he plans to sue the federal government over the healthcare reform legislation, saying Congress lacks authority to force people to buy health insurance.”

Over at CNN, they report 10 other states plan to sue as well. (Florida, Alabama, Nebraska, North Dakota, Pennsylvania, South Carolina, South Dakota, Texas, Utah and Washington.)

The gist of the state’s lawsuits is that the federal government can not force people to buy health insurance and this federal mandate conflicts with some of their pre-existing state laws as well.

Bill McCollum, the Republican attorney general of Florida, said in the CNN article “There’s no way we can do what’s required in this bill and still provide for education, for foster care, for the incarceration of prisoners, all the other things that are in this bill.”

In the same CNN article, White House Press Secretary Robert Gibbs said “the Obama administration expected to win any lawsuits filed against the health care bill.”

Maybe the feds will throw Gonzales v. Raich up as their defense, but they can also just drop the “mandatory” insurance part and tax everyone flat out to sidestep this lawsuit.

I’ll be at the concession stand.

The Reuters story about Virginia is here and the CNN story about the additional states is here.

Want to co-sign the healthcare bill?

Just saw this in my inbox…

“President Obama will soon sign comprehensive health care reform into law. Supporters now have a chance to add our names as “Co-signers” of this historic legislation — adding our names next to President Obama’s to show our pride in helping bring about this great achievement. Organizing for America will establish a permanent archive with all the signatures, so that generations to come will have a record of those who stood together in this moment and won this fight for our future.”

The email was sent by “Organizing for America”, which is a project of the Democratic National Committee.

If you like, head over to http://my.barackobama.com/Cosign to sign up. The site will ask you for your first and last name, email address and zip code.

I’m waiting for the “Hey, that’s not what I wanted” site to go up!