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Last Updated: May 5, 2009 - 12:58:27 PM |
"We Don't Like The FDA," chant ten thousand demonstrators in candlelight vigils, some dressed as cows.
"Mad Cow, You Eat It!"
"Send Mad Cow To The Presidential Office!"
A scene from the National Mall? San Francisco?
No the nightly rallies are in Seoul and 22 other South Korean cities to protest ratification of the pending US/South Korea free trade agreement, KORUS FTA.
The agreement, drafted a year ago but not yet signed, would boost two-way trade between the nations to $98 billion a year from $78 under the condition that South Korea lift almost all restrictions on US beef, including the age of butchered cattle.
KORUS FTA is considered the most significant event in South Korea-US relations since the 1953 military accord and was punctuated by a visit last month from newly elected South Korean President Lee Myung-Bak to Camp David where no South Korean president has been invited. Lee is a pro-American conservative, unlike his predecessor Roh Moo-hyun who was elected on an anti-American platform.
While the FTA delivers on Lee's pledge to double South Korea's wealth if elected and lets the US rebuild its Asian beef trade obliterated by a mad cow scare five years ago--especially exports to China and Japan--many in South Korea are saying, "You want us to import WHAT"?
Because South Korean cuisine, "includes cow bones and intestines that are believed to have a higher concentration of prions," writes Cho Jin-seo in South Korea Times, South Koreans feel they are at greater risk for Creutzfeldt-Jakob Disease (vCJD) if the beef is infected with mad cow disease.
They interpret the agreement's prohibition of, "the use of the entire carcass of cattle not inspected and passed for human consumption, unless the cattle are less than 30 months of age, or the brains and spinal cords have been removed," to mean meat from cattle under 30 months old or stripped of the high-risk materials will be uninspected.
Gruesome TV programs featuring cows being slaughtered and a report by a professor of medicine at Hallym University on MBC that South Koreans are genetically more vulnerable to vCJD--which other scientists refuted--have fanned the flames. So have Internet based rumors that cosmetics, diapers, sanitary napkins and noodles contain cow tissue and are contaminated.
Until the discovery of mad cow disease in the US in 2003, South Korea was the third largest importer of US beef, spending $850 million year. It eased the ban in 2006 only to find backbones, a banned substance, lurking in the beef and reban it (see: Charlie Brown; football) impounding 5,300 tons. Now the meat, which has been in storage, is rumored to soon be released. Will it be billed as fresh?
Of course there are other dangerous meats in the South Korean diet. No hygiene regulations govern the millions of dogs slaughtered for food each year says the Herald Sun, because they are not considered livestock.
But that doesn’t mean worries about US beef are unfounded.
Seven people have died from probable Creutzfeldt-Jakob Disease in the US in the last nine months including Connie Albert of Lincoln IL and Roger Leon Dalton of Willis, VA in Aug. 2007; Roland Lacey and Ray Norris--who lived within three miles of each other near Stanton, DE--and a 79-year-old woman in Milwaukee, WI all in Dec. 2007; a 53-year-old man in Colby, KS in Jan. 2008, a former meat worker, and Aretha Vinson of Portsmouth, VA in April.
While public health officials are quick to rule CJD "sporadic," not meat-caused--even before brain biopsies or when it's in clusters (hello)--to forestall panic about food and hospital safety, Aretha Vinson presented a perfect storm for US trade officials:
Not only was she young at 22 and her family outspoken--"She has not traveled overseas. She's not even been to the Midwest," said her mother, adding she "wasn't the only one who ate this food,"--the news broke in the middle of the Bush/Lee summit.
Dr. Richard Raymond, USDA Undersecretary For Food Safety, himself was forced to assure the South Korean and American publics that it wasn't what everyone thought, citing the same we-don't-really-know-but-it-sounds-good "epidemiologic characteristics" and "preliminary results" other dissembling public health officials use, in a May 4 statement.
"An official release once all testing is completed and confirmed is expected soon," he added, no doubt hoping it comes after the South Koreans sign.
Nor does the provision in the beef agreement at the heart of the foment--that South Korea can't halt beef imports if mad cow breaks out in the US (unless the Paris-based World Organization for Animal Health downgrades the US safety rating)--instill much faith.
Do trade officials know something we don't know?
Especially since in May the Bush administration urged a federal appeals court to reverse a lower court ruling that allowed Arkansas City, KS-based Creekstone Farms Premium Beef to conduct advanced mad cow testing on its animals--presumably because it would raise consumer questions and make other packers look bad. (viz. BST-free milk labels)
"This is the government telling the consumers, 'You're not entitled to this information,'" protested Creekstone attorney Russell Frye, according to the AP, a charge also heard in March when USDA refused to name companies selling 143 million pounds of recalled Westland/Hallmark beef because the information was "proprietary."
Meat from 200,000 dairy cows was impounded followed a Humane Society of the United States undercover video depicting slaughter of downer cattle <http://www.hsus.org/farm/news/ournews/undercover_investigation.html >--a violation of US mad cow regulations.
The video may even have reached South Korea. END
FDA Rejects New Merck Drug and Imposes Restrictions on Marketing
Even as Merck seeks closure on its Vioxx nightmare by paying $4.85 billion to tens of thousands of plaintiffs who took the painkiller--not that it did anything wrong--the bad ink continues.
Articles about Vioxx, withdrawn from the market in 2004 for doubling stroke and heart attack risk, in the April 16, 2008 JAMA charge Merck disguised mortality data it submitted from Vioxx trials to the FDA and wrote the scientific papers itself it claimed were penned by doctors.
Merck transposed its own clinical study results of 34 deaths in the Vioxx group and 12 in the placebo group to 29 deaths in the Vioxx group and 17 in the placebo group when it submitted data to the FDA write Bruce Psaty, MD, PhD; and Richard Kronmal, PhD, professors at the University of Washington in JAMA. Worse, Merck knew as early as 2001 that participants in Vioxx trials who had Alzheimer's disease were dying at three times the rate of those taking placebo.
Articles extolling Vioxx as the Super Aspirin were also a product of Merck machinations says another article in JAMA. They were actually ghostwritten from Merck's own research with doctors' "guest author" names attached as an afterthought write Joseph S. Ross, MD, MHS, Kevin P. Hill, MD, MHS and two other authors on the basis of 250 court documents they examined.
In fact this week Merck's ghostwriting was actually banned as part of a new, $58 million multistate settlement over deceptive Vioxx marketing--in addition to the $4.85 billion it is paying to plaintiffs--that also requires Merck submit future TV commercials to the FDA before airing.
Merck marketing, with Schering-Plough, of Vytorin, the cholesterol drug exposed as no more effective than generics in January, is also under scrutiny in a House Energy and Commerce Committee investigation.
In fact it was the investigation, begun in December 2007, that pried loose the results of the Enhance study which Merck and Schering-Plough were sitting on since April 2006-- despite clearance by consultant Michiel Bots--while they tried to change end points apparently to spin the data and unloaded Schering-Plough stock, say published reports.
"I would like for the companies to explain why they didn't proceed with data analysis after Dr. Bots' independent consultation report indicated the data were 'fine,'" Rep. John Dingell (D-Mich.), chairman of the committee, said to The Star-Ledger.
In May, a House Energy and Commerce subcommittee hearing into deceptive drug industry marketing also looked at Merck's multimillion dollar "cholesterol from two sources: food and family" Vytorin campaign in light of the suppressed Enhance study results.
"Many consumers may not have taken Vytorin had they been aware of the study results," said Rep. Bart Stupak (D-Mich.) to Deepak Khanna, senior vice president of the Merck and Schering-Plough joint venture, according to The Star-Ledger.
Nor are other Merck drugs doing well.
Fosamax, Merck's osteoporosis drug, was already facing more than 100 suits for causing osteonecrosis of the jaw or jaw bone death--added to its warning label in 2005--when a new wrinkle emerged. Women who took Fosamax were twice as likely to have atrial fibrillation, a chronically irregular heartbeat, as those who didn't says an article in the April 28, 2008 Archives of Internal Medicine, echoing a New England Journal of Medicine article last year.
And Singulair, Merck's allergy and asthma pill is under FDA review for possible suicide side effects.
But even as jokes appear about the number of Merck staffers required to change a light bulb--10 to call it a breakthrough, 10 to conference call Wall Street, 10 to suppress evidence it's been done before and more safely and one to change the bulb--Merck is repeating its mistakes.
In April, it tried to launch a new cholesterol drug, Cordaptive, that combines niacin, a B vitamin which raises HDL but causes facial flushing with laropiprant, an anti-flushing drug, without waiting for study results, like it did with Vytorin.
Not only did the company want to start marketing before safety studies were completed and while admitting "theoretical" safety concerns about the drug’s effect on liver according to the The Star-Ledger, this week Merck abruptly halted a 900 patient laropiprant study altogether with many asking why.
"I am concerned whether the reasons for terminating this trial are commercial or scientific," said Dr. Steve Nissen, chairman of cardiovascular medicine at the Cleveland Clinic, according to the Associated Press.
Nor is the science behind Cordaptive--that raising HDL, or good cholesterol will result in fewer heart attacks and strokes--reliable, says The Star-Ledger's George E. Jordan.
"The utility of biomarkers was turned on its ear in a study of GlaxoSmithKlein's diabetes pill Avandia, which found it lowered blood sugar in patients but resulted in elevated heart risks," he writes. "Vytorin dramatically reduced LDL, but it worked no better at clearing clogged arteries than a generic drug five times less expensive."
No wonder the FDA rejected Cordaptive out of hand, causing Merck to cut 1,200 sales jobs and add to its anti-fan club.
Merck didn't even do simple market research. Vitamin and drug stores have been selling flush free niacin for years. A bottle costs about $9.95. END
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