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The Food and Drug Administration has ordered Merck & Co. to correct numerous manufacturing deficiencies at its main vaccine plant. The agency ... released a warning letter sent to Merck's chief executive, Richard T. Clark, that states FDA inspectors determined manufacturing rules are not being followed at the plant in West Point, Pa., just outside Philadelphia. The plant, which recalled two vaccines in December over sterility problems, makes a number of children's vaccines and four for adults. The nine-page letter states FDA found "significant objectionable conditions" in the manufacture of vaccines and drug ingredients during repeated inspections from Nov. 26 to Jan. 17. According to the heavily redacted warning letter, Merck officials didn't thoroughly investigate when vaccine batches inexplicably failed to meet specifications, even if batches had been distributed, and some combination measles-mumps-rubella shots that failed "visual inspection for critical defects" were distributed anyway. Production of two vaccines made at West Point — PedvaxHIB, to prevent Haemophilus influenza type B, and Comvax, a combination vaccine for Haemophilus B and hepatitis B — stopped last year and 1.2 million doses of them were recalled after a sterility problem was discovered in October. The plant also makes ProQuad, which protects children against measles, mumps, rubella and chickenpox; hepatitis A, hepatitis B and meningitis vaccines for children and adults; and Gardasil, to protect young women against cervical cancer.
Note: For further revelations from reliable sources on the dangers of vaccines, click here.
Last week, it was a $200 billion cash-for-bond swap for the banks. This week, it was a $200 billion bond-for-bond swap for the big investment houses. If they keep this up, pretty soon you'll be able to walk into any Federal Reserve bank and hock that diamond brooch you inherited from Aunt Mildred. Forget all that nonsense about the Bernanke Fed being too timid or behind the curve. In the face of what is turning into the most serious financial market crisis since the Great Depression, the Fed has been more aggressive and more creative in using its limitless balance sheet -- in effect, its ability to print money -- than at any time in history. We can argue till the cows come home about whether this is a bailout for Wall Street. It is -- but only to the extent that it is also a bailout for all of us, meant to prevent a financial and economic meltdown that drags everyone down with it. In broad strokes, we're going through a massive "de-leveraging" of the economy, wringing out trillions of dollars of debt that had artificially driven up the price of real estate and financial assets, and, more generally, allowed Americans to live beyond their means. Fed officials warn that this de-leveraging is nowhere near finished. It's anyone's guess how long this credit crunch will last, but the chances are that we'll have several more market meltdowns and Fed rescues before it's over, probably in the fall. Until then, the dollar will continue to get hammered and stocks will continue their fitful decline. And if the last two financially induced recessions are any guide, it will be well into 2009 before the economy hits bottom, followed by a couple of years of slow growth and "jobless" recovery.
Note: The title of this article is quite revealing. A bailout for the big banks is considered to be a bailout for everyone. If you believe this, we most highly encourage you to read our powerful two-page summary of the banking cover-up available here.
The Food and Drug Administration is set to announce as early as next week that meat and milk from cloned farm animals and their offspring can start making their way toward supermarket shelves. The decision would be a notable act of defiance against Congress, which last month passed appropriations legislation recommending that any such approval be delayed pending further studies. Moreover, the Senate version of the Farm bill ... contains stronger, binding language that would block FDA action on cloned food, probably for years. The FDA has hinted strongly in the past year that it is ready to lift its "voluntary moratorium" on the marketing of milk and meat from clones and their offspring, saying that the science led them to that decision. But public opinion has been negative on the issue, with some saying that not enough safety studies have been conducted and others concerned about the health of the clones, which are far more likely than ordinary farm animals to die early in life. A handful of U.S. companies have pushed for marketing approval. Margaret Mellon of the Union of Concerned Scientists, an advocacy group, said she had read the entire 678-page draft risk assessment and found it to be "long on assumptions and short on data, and especially short on the data that are directly relevant to food consumption safety." Of particular concern, she said, was that even though the vast majority of clones die either before birth or soon after, those that survive are deemed normal. She said the FDA should withhold approval at least until it has a regulatory plan in place that will give it an ability to track food from clones and watch for human health impacts. Others have called for mandatory labeling so consumers can avoid products from clones. The FDA has said that lacking any safety concerns, it will not demand such labels. The Agriculture Department has also declared that meat from clones cannot be deemed organic.
Note: For lots more reliable information on how big business takes huge risks with the food we eat, click here.
According to a former AT&T employee, the government has warrantless access to a great deal of Internet traffic should they care to take a peek. As information is traded between users it flows also into a locked, secret room on the sixth floor of AT&T's San Francisco offices and other rooms around the country -- where the U.S. government can sift through and find the information it wants, former AT&T employee Mark Klein alleged Wednesday at a press conference on Capitol Hill. "An exact copy of all Internet traffic that flowed through critical AT&T cables -- e-mails, documents, pictures, Web browsing, voice-over-Internet phone conversations, everything -- was being diverted to equipment inside the secret room," he said. Klein ... said that as an AT&T technician overseeing Internet operations in San Francisco, he helped maintain optical splitters that diverted data en route to and from AT&T customers. One day he found that the splitters were hard-wired into a secret room on the sixth floor. Documents he obtained [from] AT&T showed that highly sophisticated data mining equipment was kept there. Conversations he had with other technicians and the AT&T documents led Klein to believe there are 15 to 20 such sites nationwide, including in Seattle, Los Angeles, San Jose, San Diego and Atlanta, he said. Brian Reid, a former Stanford electrical engineering professor who appeared with Klein, said the NSA would logically collect phone and Internet data simultaneously because of the way fiber optic cables are intertwined. He said ... the system described by Klein suggests a "wholesale, dragnet surveillance." Of the major telecom companies, only Qwest is known to have rejected government requests for access to data. Former Qwest CEO Joseph Nacchio, appealing an insider trading conviction last month, said the government was seeking access to data even before Sept. 11.
The medicines long used by parents to treat their children's coughs and colds don't work and shouldn't be used in those younger than 6, federal health advisers recommended. "The data that we have now is they don't seem to work," said Sean Hennessy, a University of Pennsylvania epidemiologist. The recommendation applies to medicines containing one or more of the following ingredients: decongestants, antihistamines and antitussives. In two separate votes ... the panelists said the medicines shouldn't be used in children younger than 2 or in those younger than 6. A third vote, to recommend against use in children 6 to 11, failed. The panel's advice dovetails with a petition filed by pediatricians that argued the over-the-counter medicines shouldn't be given to children younger than 6, an age group they called the most vulnerable to potential ill effects. The American Academy of Pediatrics and other groups back the petition. But FDA officials and panelists agreed there's no evidence they work in older children, either. Still, panelists held off from recommending against use in those 6 and older. And some said they feared such a prohibition wouldn't eliminate use of the medicines by parents. "They will administer adult products to their children because they work for them or feel they work for them," said the panel's patient and family representative, Amy Celento of Nutley, N.J. Some of the drugs — which include Wyeth's Dimetapp and Robitussin, Johnson & Johnson's Pediacare and Novartis AG's Triaminic products — have never been tested in children, something flagged as long ago as 1972 by a previous FDA panel. An FDA review found just 11 studies of children published over the last half-century. Those studies did not establish that the medicines worked in those cases, according to the agency.
Note: For a powerful exposé of corporate and government corruption in the health industry, click here.
The Bush administration ... plans to turn again to a legal tool, the “state secrets” privilege, to try to stop a suit against a Belgian banking cooperative [known as Swift] that secretly supplied millions of private financial records to the United States government. The “state secrets” privilege, allowing the government to shut down litigation on national security grounds, was once rarely used. The Bush administration has turned to it more than 30 times, seeking to end public discussion of cases like the claims of an F.B.I. whistle-blower and the abduction of a German terrorism suspect. Most notably, the administration has sought to use the privilege to kill numerous suits against telecommunications carriers over the National Security Agency’s eavesdropping program. Swift is considered the nerve center of the global banking industry, routing trillions of dollars each day among banks, brokerage houses and other financial institutions. Its partnership with Washington ... gave Central Intelligence Agency and Treasury Department officials access to millions of records on international banking transactions. Months after the Sept. 11, 2001, attacks, Swift began turning over large chunks of its database in response to a series of unusually broad subpoenas from the Treasury Department. Two American banking customers ... sued Swift on invasion-of-privacy grounds. [Steven E. Schwarz, the lawyer for the plaintiffs, said the Swift program] “is an Orwellian example of government overreaching and unfettered access to private financial information that is not consistent with the values upon which our country was founded. We’ve seen a real erosion of the ‘state secrets’ privilege in the last year. I think it is from overuse. We’ve seen it used in record numbers, in situations where it was inappropriate, and the courts are starting to recognize that.”
A federal advisory committee on Tuesday recommended approval of the first bird flu vaccine for humans, despite concerns about its safety and evidence that the shots won't protect most people. The panel said although the vaccine had significant shortcomings, it was safe and effective for use during a pandemic or in high-risk situations, such as military deployment to regions facing an outbreak. The government plans to buy and stockpile enough doses for 20 million people. [The] director of the FDA's vaccine office told the panel that the vaccine was a stopgap measure. "There are numerous vaccines under development that are potentially better than this one," he said. The bird flu strain known as H5N1 originated in Asia. Although it rarely infects people, experts fear a mutation could make it easily transmissible, triggering a pandemic. From the start of 2003, 167 people, mostly in Asia, have died of the virus, according to the World Health Organization. In clinical trials, a two-shot series of the Sanofi vaccine provided protection in 45% of adults who received the highest dose, according to an FDA analysis this week. No serious side effects were detected among the 450 healthy adults who participated in a clinical test. However, some panel members were concerned that the trial was too small to reveal rare side effects. Some experts also worried about possible allergic reactions to the vaccine because it requires a massive dose — 12 times that of the seasonal inoculation.
Note: Who pays for and who profits from the purchase of these 20 million vaccine doses? It's pretty clear that the taxpayer covers the costs and the big drug companies make huge profits. Fear is quite useful for driving up profits. For lots more on profiteering from the avian flu, click here.
Two of three former Enron Corp. traders accused of driving up energy prices during California's power crisis were each sentenced Wednesday to two years of court-supervised release in federal court. Timothy Belden ... was sentenced after pleading guilty in October 2002 to one count of conspiracy to commit wire fraud. Belden's plea was the first prosecution of anyone related to the West's energy crisis in 2000 and 2001. He had faced up to five years in prison, and must forfeit $2.1 million. The second defendant, Jeffrey Richter, was a lower-level trading manager ... who also pleaded guilty to two counts related to manipulating energy prices. He had faced up to five years and agreed to pay a $410,000 fine. Internal company memos describe how Belden's trading unit took power out of California at a time of rolling blackouts and shortages and sold it out of state to elude price caps. Enron bought California power at cheap, capped prices, routed it outside the state, then sold it back into California at vastly inflated prices. The crisis played a role in Pacific Gas & Electric Co.'s bankruptcy and will leave California consumers paying abnormally high electricity prices for years. Transcripts of Enron energy traders showed them openly discussing manipulating California's power market during profanity-laced telephone conversations in which they merrily gloated about ripping off “those poor grandmothers” during the energy crunch. On the calls, other traders openly and gleefully discussed creating congestion on transmission lines and taking generating units off-line to pump up electricity prices.
Note: So while California taxpayers cough up hundreds of millions of dollars as a result of Enron's scheming and thousands of employees across the U.S. lost their entire pensions, the result of the first prosecution of anyone related to the Enron scam is probation? For lots more on this, click here.
Drug companies are accused today of endangering public health through widescale marketing malpractices, ranging from covertly attempting to persuade consumers that they are ill to bribing doctors and misrepresenting the results of safety and efficacy tests on their products. In a report that charts the scale of illicit practices by drug companies in the UK and across Europe, Consumers International - the world federation of consumer organisations - says people are not being given facts about the medicines they take because the companies hide the marketing tactics on which they spend billions. "Irresponsible marketing practices form a serious, persistent and widespread problem among the entire pharmaceutical industry," says the report, which analyses the conduct of 20 of the biggest companies. Scandals such as the withdrawal of Vioxx ... show that unethical drug promotion is a consumer concern. Merck withdrew the drug in September 2004, but allegedly knew it could increase the chances of heart attacks and strokes from 2000 and has been accused of manipulating study results to play down the risk. More than 6,000 lawsuits have been filed against the company in the United States by people who claim they suffered heart attacks as a result of the drug. There is no room for complacency when drug companies spend twice as much on marketing as on research...but do not publish information on their drug promotion practices.
Vaccine industry officials helped shape legislation behind the scenes that Senate Majority Leader Bill Frist secretly amended into a bill to shield them from lawsuits, according to e-mails obtained by a public advocacy group. E-mails and documents written by a trade group for the vaccine-makers show the organization met privately with Frist's staff and the White House about measures that would give the industry protection from lawsuits filed by people hurt by the vaccines. Frist, along with House Speaker Dennis Hastert, R-Ill., ordered the vaccine liability language inserted in a defense spending bill in December without debate and in violation of usual Senate practice. In a written statement, Frist spokeswoman Amy Call stated that the senator had promised publicly to include the vaccine liability protection in the defense spending bill. She did not address the issue of the influence of industry lobbyists.
Note: For one-paragraph summaries of media articles showing why the vaccine makers want this protection, click here.
A new book looks at how pharmaceutical companies are using aggressive marketing campaigns to turn more people into patients. In their new book, “Selling Sickness: How the World’s Biggest Pharmaceutical Companies Are Turning Us All Into Patients”, Ray Moynihan and Alan Cassels examine how the drug industry has transformed the way we think about physical and mental health and turned more and more of us each year into customers. Moynihan...a regular contributor to the British Medical Journal [discusses] how -- and why -- drug makers have begun targeting people who aren’t sick. The so-called preventives are where the big money are: like the bone-density drugs or the cholesterol [-lowering] drugs. Increasingly we’re seeing the marketing shift to those types of drugs. People talk about the "worried well." There are many ways in which the drug companies target those people. There’s an informal alliance between the drug companies and aspects of the medical profession and aspects of the patient advocacy world who all seem to have interests in defining more and more people as ill. Americans make up less than 5 percent of the world’s population but the U.S. makes up...half of total spending on drugs.
Despite calls for more transparency after revelations about the side effects of ibuprofen, the FDA has withheld 28 pages of information on a new wave of painkillers. Vital data on prescription medicines found in millions of British homes has been suppressed by the powerful US drug regulators, even though the information could potentially save lives. An investigation by The Independent on Sunday shows that, under pressure from the pharmaceutical industry, the American Food and Drug Administration routinely conceals information it considers commercially sensitive, leaving medical specialists unable to assess the true risks. Dr Peter Juni, one of the team of Swiss investigators who helped to expose the risk of the new-generation drugs, claims his efforts were obstructed by the FDA. "Too often the FDA saw and continues to see the pharmaceutical industry as its customers, a vital source of funding for its activities, and not as a sector of society in need of strong regulation."
When the drug industry came under fire last summer for failing to disclose poor results from studies of antidepressants, major drug makers promised to provide more information about their research on new medicines. But nearly a year later, crucial facts about many clinical trials remain hidden. Eli Lilly and some other companies have posted hundreds of trial results on the Web and pledged to disclose all results for all drugs they sell. But other drug makers, including Merck and Pfizer, release less information and are reluctant to add more, citing competitive pressures. As a result, doctors and patients lack critical information about important drugs ... and the companies can hide negative trial results by refusing to publish studies, or by cherry-picking and highlighting the most favorable data. GlaxoSmithKline agreed to pay $2.5 million to settle a suit ... alleging that Glaxo had hidden results from trials showing that its antidepressant Paxil might increase suicidal thoughts in children and teenagers. Federal laws require the disclosure of all trials and trial results to the F.D.A. But companies are not required to disclose trial results to scientists or the public. Under pressure from the editors of medical journals, the major drug companies in January agreed to expand the number of trials registered on clinicaltrials.gov. Three companies have filed only vague descriptions of many studies, often failing even to name the drugs under investigation. For example, Merck describes one trial as a "one-year study of an investigational drug in obese patients."
"Just about everybody is pretty serious about their chow," says Deborah Koons Garcia, enjoying the understatement. No matter how serious they are, though, Garcia knows most people don't realize that genetically engineered foods have quietly slipped into much of the American food supply, mostly from corn and canola. They're in an estimated 60 percent of all processed foods. "We are at a crossroads," says Garcia. She's spent the last three years ... making "The Future of Food," a documentary about GMO (genetically modified organism) foods. "Someone needed to make this film, because if this technology isn't challenged and if this corporatization of our whole food system isn't stopped, at some point it will be too late," says Garcia. "It became clear that GMOs are really a much bigger issue ... And it was really clear that there hadn't been a really good film that told the whole story from the cellular, from the microscopic level, all the way up to the global," Garcia says. Her 90-minute documentary ... expresses a strong point of view against letting new life forms loose on the land without long-term testing of the health effects and real government controls, especially labeling of foods. Garcia threads a clear path through the history, science and politics of GMO foods to a clear call for action.
Note: To view this highly educational film, which may encourage you to change your eating habits, click here.
http://www.sfgate.com/cgi-bin/article.cgi?file=/c/a/2003/10/11/MN20927.DTL
Gov.-elect Arnold Schwarzenegger is preparing a push to deregulate the state's electricity markets -- a move embraced by business leaders and some energy analysts but criticized by many Democrats and consumer advocates as a return to the failed policies that sparked California's energy crisis. "Deregulation has already cost the state $50 billion, give or take," said Mike Florio, senior attorney for The Utility Reform Network. "Why on earth anyone would want to do that again is mystifying to us." Florio also said he was suspicious of Schwarzenegger's idea because former Enron Corp. Chairman and CEO Ken Lay met with the actor and others in the spring of 2001, when Lay was pushing deregulation in California. Schwarzenegger has said he doesn't remember details of the meeting.
Note: What was Schwarzenegger doing meeting with the CEO of Enron well over two years before the recall vote which gave him the governorship of California? Could it be big business had plans for him?
Former fugitive Pablo Duran, Sr., who sat down in an exclusive interview with FRONTLINE for its investigation Trafficked in America, has pleaded guilty to encouraging illegal entry of Guatemalan nationals, some of them minors, for financial gain. His plea and conviction are part of a major trafficking plot in 2014 that saw Guatemalan teenagers smuggled across the border into America and compelled into grueling labor at egg farms in Ohio against their will. Duran, Sr., also known as Pablo Duran Ramirez, is one of seven people to have been convicted for their role in the case. Duran Ramirez admitted he had been fully aware some of the people brought on at Trillium Farms in Ohio were undocumented minors, and that the process of getting them to Ohio involved bullying and strong-arm tactics. Duran Ramirez co-owned a contracting company, Haba Corporate Services, which Trillium Farms hired and paid approximately $6 million to between 2013 and 2014 to find workers. One family ... owed Castillo-Serrano $15,000 for shuttling their son into the United States. The family put the deed of their house on the line as collateral. Once in the U.S., the young Guatemalans were sent to the egg farm to work off their parents’ debt - and routinely had most of their paycheck confiscated to cover it. If they complained, they became targets. “Many of my friends told me that they received death threats,” one former Trillium employee [said]. “They would kill their father or mother, if they didn’t want to pay or work.”
Note: For more along these lines, see concise summaries of deeply revealing news articles on corruption in the food system and in the corporate world.
Chickens slowly freezing to death, being boiled alive, drowned or suffocating under piles of other birds are among hundreds of shocking welfare incidents recorded at US slaughterhouses, according to previously unpublished reports. An investigation by the Guardian and the Bureau of Investigative Journalism looked at hundreds of inspection logs from the USDA detailing incidents in poultry plants across the country. Inspectors recorded numerous incidents where: chickens suffocated to death beneath other chickens when they piled up on a conveyor belt that had stopped due to a mechanical failure; chickens drowned after entering the scalding tank while conscious; thousands of birds died of heat stress ... or alternatively, freezing to death. In one incident in January, more than 34,000 chickens froze to death while being kept overnight outside a slaughterhouse in a truck. The ... findings have fuelled concerns that a post-Brexit trade deal with the US could see the UK flooded with chicken produced to lower welfare standards. This follows last year’s transatlantic row over chlorinated chicken, which prompted political interventions in both countries. The violations were witnessed between 2014 and this year at some of the largest poultry processors in the country as part of the national inspection system.
Note: For more along these lines, see concise summaries of deeply revealing news articles on corruption in government and in the food system.
Last March, Tony Schmidt discovered something unsettling about the machine that helps him breathe at night. Without his knowledge, it was spying on him. From his bedside, the device was tracking when he was using it and sending the information not just to his doctor, but to the maker of the machine, to the medical supply company that provided it and to his health insurer. Schmidt, an information technology specialist ... was shocked. "I had no idea they were sending my information across the wire." Like millions of people, he relies on a continuous positive airway pressure, or CPAP, machine that streams warm air into his nose while he sleeps. Without it, Schmidt would wake up hundreds of times a night. As many CPAP users discover, the life-altering device comes with caveats: Health insurance companies are often tracking whether patients use them. If they aren't, the insurers might not cover the machines or the supplies that go with them. And, faced with the popularity of CPAPs ... and their need for replacement filters, face masks and hoses, health insurers have deployed a host of tactics that can make the therapy more expensive or even price it out of reach. A host of devices now gather data about patients, including insertable heart monitors and blood glucose meters. Privacy laws have lagged behind this new technology, and patients may be surprised to learn how little control they have over how the data is used or with whom it is shared.
Note: For more along these lines, see concise summaries of deeply revealing news articles on health and the disappearance of privacy.
The Department of Justice said it is filing a lawsuit against the state of California over its new net neutrality protections, hours after Gov. Jerry Brown signed the bill into law on Sunday. The California law would be the strictest net neutrality protections in the country, and could serve as a blueprint for other states. Under the law, internet service providers will not be allowed to block or slow specific types of content or applications, or charge apps or companies fees for faster access to customers. The Department of Justice says the California law is illegal and that the state is "attempting to subvert the Federal Government's deregulatory approach" to the internet. Barbara van Schewick, a professor at Stanford Law School, says the California bill is on solid legal ground and that California is within its legal rights. California is the third state to pass its own net neutrality regulations, following Washington and Oregon. However, it is the first to match the thorough level of protections that had been provided by the Obama-era federal net neutrality regulations repealed by the Federal Communications Commission in June. At least some other states are expected to model future net neutrality laws on California's. The original FCC rules included a two page summary and more than 300 additional pages with additional protections and clarifications on how they worked. While other states mostly replicated the two-page summary, California took longer crafting its law in order to match the details in the hundreds of supporting pages.
Note: Read how the Federal Communications Commission's net-neutrality policymaking process was heavily manipulated. For more along these lines, see concise summaries of deeply revealing government corruption news articles from reliable major media sources.
Sen. Elizabeth Warren on Tuesday introduced what she describes as the most ambitious anti-corruption legislation since Watergate. Warren's Anti-Corruption and Public Integrity Act ... aims to nix the influence of big money in politics. The legislation would "padlock" the revolving door in Washington by placing a lifetime ban on lobbying by former members of Congress, presidents and agency heads. The legislation would also expand the definition of who is a lobbyist to anyone who spends any time attempting to influence government. The proposal would also prohibit the world's largest companies, something defined by a company's annual revenue or market capitalization, from hiring or paying any former senior government official for four years after they leave government. Former senior officials would also have to file income disclosures for four years after federal employment. Warren's legislation would also ban members of Congress, cabinet secretaries, federal judges and other top government officials from owning and trading stocks. Currently, members simply need to disclose their stocks and trades. The bill would also create an entirely new office designed to police public corruption, called the Office of the Public Integrity, to strengthen enforcement and investigate possible violations.
Note: For more along these lines, see concise summaries of deeply revealing news articles on corruption in government and in the corporate world.
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