Keyword: fda
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For decades, fluoride has been marketed and heralded as essential for good dental hygiene and used in most toothpastes and mouthwashes. In addition, parents have been routinely encouraged to give their kids cavity-fighting fluoride treatments when they visit the dentist. ... But that was then and this is now. In a surprising reversal, last month EPA’s announced that it intends to lower the maximum amount of fluoride in drinking water because of growing evidence supporting the chemical’s possible deleterious effects to children’s health. In 2006, the National Academy of Sciences report that found dental fluorosis – caused by too much...
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The bureaucratic assault on cancer treatments. The White House now claims it is so alarmed about declining private pharmaceutical research that the government must create a new multibillion-dollar R&D center. Perhaps it should consult the Food and Drug Administration, which thinks it is approving too many new drugs, especially for serious diseases like cancer. That's the message of this month's remarkable FDA hearing to grill six major drug makers on the alleged shortcomings of the "accelerated approval" process. Congress created this fast-track for promising drugs for unmet medical needs in 1992, but the FDA bureaucracy thinks it is too friendly...
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Influenced by the president’s mandate to “bend the health care cost curve,” the Food and Drug Administration (FDA) is preparing to deny late-stage breast cancer patients access to the critical, but expensive, life-extending drug Avastin. The FDA wants to “de-label” the drug, a move that would force patients with insurance or Medicare coverage to pay for the drug out of their own pocket in order to survive. Now patients groups are speaking out. Led by the Susan B. Komen Foundation for a Cure, 15 patient advocacy groups have petitioned the FDA to reverse their effort to ration the drug. In...
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The death of a 2-year-old Houston boy from a rare infection blamed on contaminated alcohol wipes may be only the first casualty tied to allegedly shoddy sterilization practices by a Wisconsin medical products firm. Since msnbc.com reported Feb. 15 about the death of Harrison Kothari , who was infected with the same type of rare bacteria that sparked the recall of tens of millions of pads and swabs, dozens of people have stepped forward to say they may have been sickened, too. At the same time, government documents obtained by msnbc.com showed that federal Food and Drug Administration inspectors knew...
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The California Healthcare Institute (CHI) and The Boston Consulting Group (BCG) have released a report highlighting the critical role of the U.S. Food and Drug Administration (FDA) in today’s biomedical research and innovation ecosystem, and the need for a strong, science-based agency and an efficient, consistent and transparent regulatory process. The report, , titled “Competitiveness and Regulation: The FDA and the Future of America’s Biomedical Industry”, has underlined that an increasingly unpredictable approval process at the FDA has negatively impacted public health, the economy, job creation, American competitiveness and innovation. This report represents the first study to quantify approval timelines...
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I’d call this quite the intellectual challenge. At what point do you stop testing and start distributing new drugs that will help people live healthier lives? Walter Williams points out an important issue influencing the drug approval process.People are physiologically unique, that’s why some drugs may work very well for an individual while others do not. The side effects can be all over the place too. Common side effects for Lisinopril, a popular drug to treat high blood pressure, include cough, diarrhea, dizziness, headache and tiredness, but there are many other side effects that preclude the user from taking the...
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WASHINGTON — The Food and Drug Administration will evaluate brain-controlled prosthetic arms in a new program designed to bring innovative medical devices to market faster. The arm system, developed by the Defense Advanced Research Projects Agency, uses a microchip implanted in the brain to record and decode signals to neurons that control muscles linked to the prosthesis. The device is intended "to restore near-natural arm, hand and finger function to patients suffering from spinal cord injury, stroke or amputation," according to an FDA press release Tuesday morning. The prosthesis will serve as a pilot submission to the FDA's Innovation Pathway,...
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The US Department of Agriculture continues its unprecedented give-away to big agriculture monster Monsanto and its Genetically Modified (GMO) seeds. On Friday, while the media was preoccupied with the Superbowl and Egypt’s rioting, the USDA quietly announced it was deregulating Monsanto’s GMO sugar beets – despite a court order. This move comes just a week after the agency had gone back on its own plan to regulate GMO alfalfa to at least attempt to keep it from contaminating organic farms. Secretary of Agriculture Tom Vilsack had been floating a plan to limit the area where the GMO crop could be...
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The Food and Drug Administration, which has long maintained that it has nothing to do with drugs used in executions, has quietly helped Arizona and California obtain a scarce type of anesthetic so the states could continue putting inmates to death. The shortage of sodium thiopental has disrupted executions around the country. But newly released documents show the FDA helped import it from Britain. Most state prison systems use sodium thiopental to put inmates to sleep before administering pancuronium bromide, a paralyzing agent, and potassium chloride, which stops the heart. But the drug has been in short supply since last...
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Coming to a gas pump near you. Even if you can't drink and drive, your car can. A Virginia company is taking in truckloads of boozy caffeinated drinks, including Four Loko, and recycling the stuff into pure ethanol to be blended into gasoline. A crackdown on the beverages is leading wholesalers to send the drinks from their warehouses to waste management companies for handling. "We’re at full capacity," Brian Potter, a VP for MXI Environmental Services, told the Associated Press. "There are about 30 different products involved, and we’ve only seen a couple of them at this point. It could...
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Once again, outgoing House Speaker Nancy Pelosi, along with her sidekicks Waxman and Dingell, has used legislative "sleight-of-hand" to force through the “Consumer Assistance to Recycle and Save Act” (H.R.2751) with S.510 attached. Just today, the Bill passed on a vote of 215 For and 144 Against. It is rich irony indeed that the "Cash for Clunkers" reauthorization bill (H.R.2751) has provided the ride for S.510, another “clunker” that will unleash an avalanche of useless, business-killing paperwork upon the food industry and a swarm of parasitic FDA bureaucrats. The result will be, as we have said all along, a food...
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Strips from Abbott Laboratories Can Give Falsely Low Blood Sugar Readings WASHINGTON - The Food and Drug Administration said Wednesday that Abbott Laboratories is recalling up to 359 million testing strips used by diabetics because they can give falsely low blood sugar readings. The testing strips are used to help diabetes patients check their blood sugar levels. But the FDA says the products being recalled by Abbott can give inaccurately low measurements. As a result, patients may try to raise their blood sugar levels unnecessarily or fail to detect dangerously high blood sugar levels. The FDA said the problems are...
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Wikileaks continues to rock the political world by shedding light on conspiracies, corruption and cover-ups. The latest batch of diplomatic cables released by Wikileaks reveals what can only be characterized as a U.S.-led conspiracy to force GMOs onto European countries by making those countries pay a steep price if they resist. The cable reveals the words of Craig Stapleton, the US ambassador to France, who was pushing the commercial interests of the biotech industry by attempting to force GMOs into France. In his own words (below), he expresses his frustration with the idea that France might pass environmental laws that...
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ronically, the exact same day the FDA revoked Avastin's approval, its counterpart across the Atlantic did the opposite. The European Union's Committee for Medicinal Products for Human Use had conducted a similar investigation into Avastin in breast cancer treatment... Genentech, Avastin's developer, spent some $2.3 billion creating this treatment. In reaction to this decision, other drug firms will be less likely to make the investments required for research into advanced drugs.
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Medicine: The FDA has reversed its approval of a widely used cancer drug approved in Europe to treat breast cancer on the grounds it doesn't provide a "sufficient" benefit. Let the terminally ill and their doctors decide. One of the blessings of blocking the omnibus spending bill was that it included $1 billion for the implementation of ObamaCare. Yet the first effects are still being felt, the latest being the Food and Drug Administration's revoking of regulatory approval of Avastin to treat late-stage breast cancer. The reason given by the FDA was that the drug does not provide "a sufficient...
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On Tuesday, Congress passed food safety legislation providing the Food and Drug Administration (FDA) with new powers. Trying to halt a series of disease outbreaks in the nation’s food supply – and fresh off last summer’s salmonella outbreak and subsequent recall of 500 million eggs – the lame-duck Congress was under pressure to pump up the FDA’s inspection capabilities. And so it did. In essence, the FDA is now charged with preventing food-borne disease outbreaks rather than trying to contain them once rampant.
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New Antibiotics, Stat!The drug makers are in a bind — and public health is in danger. The development of new antibiotics has slowed to a trickle, just when we need them most. As drug-resistant bacteria are on the rampage worldwide, we find ourselves in a most precarious situation — one not unlike the pre-antibiotic era, before penicillin, when staphylococcal and pneumococcal infections were the dominant pathogens. Now MRSA (methicillin-resistant Staphylococcus aureus) kills more people than AIDS every year, and various multiple-drug-resistant organisms have appeared, leaving doctors with few therapeutic weapons for treating a number of prevalent infections. How did this...
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... "Republicans, however, later agreed to pass it by unanimous consent."
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An advisory committee to the federal Food and Drug Administration is recommending that people with chronic fatigue syndrome be barred from donating blood, amid concerns a retrovirus may be linked to the disease. The recommendation by the panel must now be reviewed by the FDA, which typically follows the advice of such panels but is not required to do so. An FDA spokeswoman said there was no timetable yet on a final decision. Judy Mikovits, who led the team of researchers that published the study in Science linking XMRV to chronic fatigue syndrome, said Tuesday's decision is a victory for...
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The breast milk Industry is charging users, which may or may not be covered by insurance,$3 – $5 per ounce according to Time Magazine. If one takes the average of $4 per ounce that equates $512 per gallon. While no numbers are available from HMBANA, according to their site “745,329 ounces of milk 2005″ was donated and “shared” throughout the United States. Of course a “Prescription” is needed for outpatient usage which may not be covered by Insurance. Believe it or not, that is a $3 Million Dollar industry. One wonders what current numbers apply here. (Update: According to NBC,...
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