Perhaps drugs ought to be primarily consumed in the country of origin, and only that in excess of that country's demand can then be shipped abroad.
U.S. health officials said Wednesday they have found a contaminant in a blood-thinning drug produced by Baxter Healthcare Corp. that has been linked to more than a dozen deaths in the United States.
In early February, the Food and Drug Administration launched an investigation and then a recall of some forms of the product.
The scrutiny began after a spike in reports of health problems associated with heparin, a drug made by Baxter from pig intestines at plants in China and Wisconsin. Uh oh . . . .
Though the cause of the problems has not been determined, FDA investigators found "a heparin-like compound -- that is not heparin -- present in some of the active pharmaceutical ingredients" in both facilities, said Dr. Janet Woodcock, acting director of the FDA's Center for Drug Evaluation and Research. You mean someone went out and actively researched what would fool the quality tests on an important drug? Now who on earth would do something like that? Maybe it was accidental.
The contaminant, which made up 5 percent to 20 percent of each sample tested, "reacts like heparin in some of the conventional tests used for heparin," which explains why it was not picked up, she told reporters in a conference call.
No causal link between the contaminant and the adverse events has been established yet, Woodcock said. She added that it was not clear whether the contaminant was added accidentally, as part of the processing or deliberately.
It also was not clear whether the contaminant was introduced in the company's plant in Wisconsin or the one in China, Woodcock said. Let's see. US authorities have no fuc&ing clue what the contaminant is after consulting plant officials I'll bet. Hmm. That leaves one other option, which involves a country with too many businessman who often have less respect for consequences on human life than the almighty Yuan.
Though she said the exact structure of the contaminant has not been identified, "it is similar to heparin glycans." Glycans are polysaccharides, a complex class of carbohydrate. She added it was unclear whether other heparin products used outside the United States might also contain the product.
Later this week, the agency will release recommendations on how manufacturers and regulators can screen for the contaminant, she said. How 'bout close the China plant. That would screen out lots of stuff.
Last year, pet food made in China was found to be tainted with an ingredient that replaced more expensive protein and that initial tests did not identify as a contaminant. Asked if the heparin contamination could be a similar case, Woodcock said, "It's possible."
Doctors have used the blood-thinner for 60 years with "no history of any problems whatsoever," said the FDA commissioner, Dr. Andrew C. von Eschenbach. Von Eschenbach said it would be "disingenuous" to expect the agency would be able to inspect "every institution in every case." Yeah, but if you use profiling and common sense, it might help cut the problem down to size. If not eliminate it altogether.
I seem to recall that the FDA was created exactly to inspect every institution that handled food or drugs.
Over the last fiscal year, the agency reported having inspected more than 1,000 foreign plants, a record.
Since the agency issued its report that 19 deaths had been linked to the drug since January 1, 2007, it has received word of another 27 deaths, "but many of those do not fit our definition of this type of event," Woodcock said.
In all, the FDA has received 785 heparin-linked reports of adverse events -- including difficulty breathing, nausea, vomiting, excessive sweating and plummeting blood pressure that can lead to life-threatening shock. "They're continuing to come in fairly rapidly because there has been a lot of reporting of this," she said.
In a written statement, Baxter said its tests have suggested "that the root cause may be associated with the crude heparin, sourced from China, or from the subsequent processing of that product before it reaches Baxter."
Meanwhile, Scientific Protein Laboratories LLC, which supplies the company with the active pharmaceutical ingredients, issued a statement saying it is working with the FDA, Baxter and outside experts to identify the cause of the adverse events. "Thus far, no conclusions have been reached about the root cause," it said. "It is premature to conclude that the heparin active pharmaceutical ingredient sourced from China and provided by SPL to Baxter is responsible for these adverse events." No it isn't.
It said that its voluntary recall of suspect product was being made as a precaution. And the alternative to a voluntary recall of this "suspect" product here? Yeah, I thought not.
#1
investigators found "a heparin-like compound -- that is not heparin -- present in some of the active pharmaceutical ingredients" in both facilities,
Posted by: Mike ||
03/06/2008 12:39 Comments ||
Top||
#5
Part of the problem is that there are now plenty of raw materials that are produced only in China. So there are no alternative sources to go to when this kind of issue comes up.
A dozen deaths in the U.S. alone? Over what period of time, I wonder. And how many deaths and health problems occurred due to this that were not reported to the FDA as being associated with heparin.
#6
I recall vaguely that artificial sweetners such as Sacchrin are Polyglycols (so is antifreeze)
So what's the "Contaminant? Antifreeze? it's sweet to the taste.
Posted by: Redneck Jim ||
03/06/2008 14:06 Comments ||
Top||
#7
#1: investigators found "a heparin-like compound -- that is not heparin -- present in some of the active pharmaceutical ingredients" in both facilities
I missed that. Does it mean that the US-side is involved as well? It seems impossible to me that they would tinker with the FDA-approved formula. Is it possible that a supplier is messing with the component ingredients? Who is the supplier - China perhaps?
#8
Plastic crap and textiles from China are bad enough but food and drugs? What that tells me is that U.S. businessmen and their pet politicians are just as contemptuous of human life as their Chinese counterparts. At the very least these products should be clearly labeled as being from China. Then consumers could ask their doctors or pharmacists for alternatives.
#4
In her appeal, the defence counsel held up a plate showing the size of the hole and said that she could not squeeze through with her 110-centimetre (44-inch) bust.
Heck she can hardly squeeze into that sports jacket she's wearing in the pic.
#6
FARK.com Posters showed some pics of 40DD-and-neyond babes - D *** NG, and I thought DOLLY and KITTEN NATIVIDAD were "it". You hear stories or rumors about larger female cup sizes, but don't believe until you actually see it.
The above being it, CLEARLY WE MUST SUPPORT THIS OUTSTANDING JAPANESE INSTITUTION AND PRACTICE.
WASHINGTONA crippling idiom shortage that has left millions of Americans struggling to express themselves spread like tugboat hens throughout the U.S. mainland Tuesday in an unparalleled lingual crisis that now has the entire country six winks short of an icicle.
Since beginning two weeks ago, the deficit in these vernacular phrases has affected nearly every English speaker on the continent, making it virtually impossible to communicate symbolic ideas through a series of words that do not individually share the same meaning as the group of words as a whole. In what many are calling a cast-iron piano tune unlike any on record, idiomatic expression has been devastated nationwide.
"This is an absolute oyster carnival," said Harvard University linguistics professor Dr. Howard Albright, who noted that the 2008 idiom shortage has been the country's worst. "I don't know any other way to describe it."
Albright said that citizens in the South and West have been hit by the dearth of idioms like babies bite the bedpost, with people in those colorful expressionheavy regions unable to speak about anything related to rain storms, misers, sensations associated with nervousness, difficult or ironic predicaments, surprise at a younger relative's rapid increase in height, or love. In some areas, what few idioms remain are being bartered or sold at exorbitant prices. And, Albright claims, unless something is done before long to dry out the cinnamon jars, residents of Texas may soon cease speaking altogether. . . . Land o' Goshen! The chances of averting disaster are slim to none, and Slim's leavin' town!
With an emergency measure to release a pepper-stack of backup idioms into everyday speech still being debated in committee, Congress has been criticized for its inability to respond to the crisis. Moreover, a number of Beltway insiders have accused members of both houses of abusing their positions to gain access to hundreds of 1920s-era idioms that have been kept in reserve for decades.
"Well, bully," said Sen. Charles Schumer (D-NY), who claimed that the Capitol was not expecting a shipment of fresh idioms for weeks. "Americans have to collar all their jive, and take us cats at our word: Everything's copacetic, daddy-o, so don't flip your lids." Dig that Senators righteous riff. That was ready, so help me! Hes got his boots on! The cats were fallin out when they heard it!
. . . Authorities said they expect the shortage to subside by April, but in the meantime, they urge citizens to skip shy the rickshaw until such time as the flypaper marigolds have a chance to waterfallwith or without a pole dragon's cottageunless the cork and the bubble-truck tumble from the mountaintop, at which point, of course, old birds could light up every tuba tent and walleyed river king from 44 to the roller coaster.
Posted by: Mike ||
03/06/2008 06:56 ||
Comments ||
Link ||
[11125 views]
Top|| File under:
#1
However, the TLA shortage is a much more immediate problem.
Posted by: Mike ||
03/06/2008 14:35 Comments ||
Top||
#3
What with many idioms not passing the PC test, a lot have fallen out of favor:
Math teacher daughter was helping a student work through an algebra problem; knowing that there may be multiple ways to achieve the correct answer, she said that there was more than one way to skin a cat. that earned her a time out in the principal's office the next day; seems another student was a PETA member.
Anybody out there who has tried this stuff? Has it hit store shelves yet?
Don Egolf remembers what Army chow looked like when he served in Germany in World War II: A tin of scrambled eggs and bacon bits that he pried open with a tiny can opener.
On Wednesday at the Pentagon the 102nd Infantry Division vet pocketed one of those irksome little openers, the P-38, as a souvenir. Then he dug into the latest in combat cuisine, a plate of blackened catfish, teriyaki chicken, little french toast squares and pumpkin cake -- no opener needed.
The Army offered up samples of the food as it rolled out its newest innovation -- special packets of easy-to-eat, high-nutrition, high-calorie foods designed for mobile forces. The chow, mostly bagged finger-type foods that soldiers can just tear open and eat on the run, will be available in the field next month.
That's not the way it was in his day, Egolf noted. "When we did get to eat, we got K-rations," Egolf recalled, referring to the meals of dried biscuit, canned meat and eggs plus cigarettes that soldiers were issued during the early wars.
The new food "is delicious. This food is seasoned," said Egolf, who now lives at the U.S. Soldiers' and Airmen's Home in Washington.
Spread out on tables along the Pentagon's third floor Wednesday at lunch time, containers of garlic mashed potatoes, barbecue pork, beef and black beans, and Mediterranean chicken simmered as long lines of soldiers waited for a taste. Those new offerings will be available to troops in MREs (meals ready to eat) over the next three years.
Other soldiers snatched up sample packages of jalapeno cashews, chocolate-covered coffee beans and the always popular beef jerky.
Fueling the Army's fighting forces long has been a subject of much research, as the military works to make the food more nutritious, easier to carry and better tasting. The Army knows that food and mail delivery have the biggest impact on soldiers' morale, so the Natick Soldier Research Development and Engineering Center conducts continued testing on new and improved ways to feed the force.
"When you're eating the same things, three times a day, taste and variety is a big thing," said Sgt. 1st Class James Laverty, who has served in Iraq and Afghanistan multiple times with the 160th Special Operations Aviation Regiment. He said the food has changed even since his first tour in Afghanistan when the war began. "It's the taste," he said. "Hands down, that is the number one thing I was impressed with."
Army leaders are calling the new high-calorie Natick offering the First Strike Ration, and it would serve troops like Laverty, who head into combat first and are on the move. The packet is good for three meals, and includes about 3,000 calories -- designed for soldiers moving hard and fast, carrying heavy packs and equipment.
Inside are easy-to-eat, high-protein, high-carbohydrate foods that soldiers can stuff in their rucksacks and chomp on the run, including a pepperoni pocket sandwich, bacon cheddar pocket, tuna, beef jerky, wheat bread, cheese spread, applesauce, several power bars and even a pack of caffeine gum.
"The last thing you want to do is give them something heavy to carry," said Jeremy Whitsitt, outreach coordinator for the Pentagon's combat feeding program. "They can eat these when they're on patrol or while they're marching down the road."
The larger MREs, meanwhile, come with individual flameless heaters and are more elaborate.
The southwest beef and black beans got the nod from Army Secretary Pete Geren, who sampled some of the fare. Using the well-worn adage, he said: "The Army travels on its stomach."
#3
yes, but are the meals halal? We wouldn't want to offend the people we are hunting.
Posted by: Rambler in California ||
03/06/2008 11:41 Comments ||
Top||
#4
grim smile
Mr. Lotp and I bought some of the current MREs from the commissary last year as part of our emergency supply cache. (retiree shopping privileges) Not home cooking, but not bad. Lots of of calories per meal of course, but that just means that we could split one meal among two of us just fine in most circumstances.
Being careful with money means we'll eat those things one way or the other before the expire ....
#5
Way back when, 66-69 I was Navy, one day they replaced all the old "C" (WW2 vintage) rations in the lifeboats with entirely new grub, and gave the old "C" rations to anyone who wanted them, I got a case,(Mainly to sample) and that food was still good, the only thing I couldn't eat was some bread baked in a can (Grease had turned rancid) I kept one of those P-38's (Old style, very small) on my keyring for many years, it finaly wore through the metal and was lost. Very handy little tool. The newer p-38's are several inches long, the old style about one inch overall.
Posted by: Redneck Jim ||
03/06/2008 14:19 Comments ||
Top||
#6
Still got a P-38 or 2 in my "I remember that" drawer in the filing cabinet. And one on my keychain.
One place C's were superior to MRE (and probably the only place) was that you could reheat them in the can on the manifold of a generator, or a deuce and a half. Metal cans > plastic wrapper in that instance.
But, try as I might, I cannot be one of those old timers that says they are Meals Rejected by Ethiopians. The first bunches of these with the dehydrated meat was pretty sucky (but the dehydrated strawberries were great to eat straight up). But just about every set since those has been good. I actually like MREs, and have lived off them for a few weeks. As long as you have a bit of variety they are pretty good.
They weren't bad, but eating the same 12 meals 45 days in a row was too much. More variety is very much needed. However, since they are very rich in calories, you won't poop for the first two weeks. Then ... well... you don't dig a hole. You dig a trench.
#11
Meh - its gonna take a while yet for me to get used to these newfangled MRE's.
"More VARIETY is very much needed" > VARIETY is good when your country is absolutely winning a major war, or in the altern is in no danger of losing a major war even iff it suffers de facto battlefield defeats now and then.
Compare wid STARS-N-STRIPES > ARMY TO CALL UP 10,000 IRR MEMBERS. Read - REAR-ECHELON professionals, technical/trade specialists, bureaucrats, etc.
COLLECTIVELY, BOTH SHOW THAT THE USA IS WINNING AND INTENDS TO STAY IN THE ME - HOWEVER, ALSO INDIR REFLECTS THAT RADICAL ISLAM IS LOSING AND MAY RESORT TO MORE VIOLENT, MUTUALLY DESTRUCTIVE TERROR SCHEMAS, e.g. "AMER HIROSHIMA(S)", + GREAT POWERS CONFRONTATIONISM, TO SAVE ITS JIHAD + OWG AGENDA.
#12
I travelled coast to coast on a diet of mostly coffee, soup and bagels (with different types of meat, etc). You find that you change your diet, when faced with 2500 miles on the road.
#1
Mr Howard criticised the Australian media for concentrating on bad news from Iraq, rather than highlighting advances, and took aim at the Rudd government for regarding Afghanistan as the central front in the war on terrorism.
"While it may be politically convenient, this view is profoundly naive and dangerous," he said.
"One only has to look at al-Qaeda's own words and actions to know that Iraq is every bit as much a major front in the war against terror as is Afghanistan. We simply cannot afford to lose in either."
#3
Genetically-cracked corn, and I don't care,
Genetically-cracked corn, and I don't care,
Genetically-cracked corn, and I don't care,
My master's gone a-way.
Nah. Doesn't work. Too many syllables.
Posted by: Mike ||
03/06/2008 6:16 Comments ||
Top||
#4
Mike, try: Gimmie Gen'-cracked corn - I don't care...
Sri Lankas chief justice on Tuesday suggested corporal punishment for teachers who called in sick this week in the midst of a wage dispute, court officials said Wednesday. Supreme Court Chief Sarath Silva said that if any of the teachers came before, the punishment would be sharp and swift. Teachers taking leave on the pretext of being sick should be given six lashes, he said at the opening of a new court house here Tuesday. If any of these teachers come before me, I know what to do. I will give them six cuts. Teachers say there are several salary anomalies that must be corrected by the government and they staged the strike in a bid to make Colombo act quicker. Unions said the action was a success, but schools reported normal attendance. There are some 210,000 teachers in state-run schools and their average daily absenteeism is reportedly around 20 percent.
Posted by: Fred ||
03/06/2008 00:00 ||
Comments ||
Link ||
[11132 views]
Top|| File under:
#1
Why should they when SCOTUS supported a twenty year suspension of the 14th Amendment equality clause? [and don't try to argue that was nothing short of 'making it up' and a proper reading of the Constitution.]
#3
Britain is turning itself into a third world country with immigrants from Pakistan just like the U.S. is with immigrants from Mexico. Americans workers will find themselves accepting lower wages and a lower standard of living as the country continues to import poverty in the name of globalisation. I guess the plutocracy think they can keep themselves isolated from it in their little enclaves but I wouldn't feel so comfortable if I were them.
#4
They even try to run the Channel tunnels. Frankly, the best workers - Hindus, Philipinos, Brazilians, Chileans, South Africans - are the most likely to immigrate through legal channels.
A multi-volume chronology and reference guide set detailing three years of the Mexican Drug War between 2010 and 2012.
Rantburg.com and borderlandbeat.com correspondent and author Chris Covert presents his first non-fiction work detailing
the drug and gang related violence in Mexico.
Chris gives us Mexican press dispatches of drug and gang war violence
over three years, presented in a multi volume set intended to chronicle the death, violence and mayhem which has
dominated Mexico for six years.
Rantburg was assembled from recycled algorithms in the United States of America. No
trees were destroyed in the production of this weblog. We did hurt some, though. Sorry.
