FDA withdraws approval for breast cancer drug Avastin after declaring it medically useless, but says doctors can still prescribe it

(NaturalNews) Several years after declaring it to be not only medically useless but also dangerous, the US Food and Drug Administration (FDA) has officially withdrawn approval for the $100,000 breast cancer drug Avastin. In a statement, FDA Commissioner Margaret Hamburg said that Avastin has never been proven to be safe or effective, but also in the same breath noted that doctors can still prescribe the drug if they feel like it. “FDA recognizes how hard it is for patients and their families to cope with metastatic breast cancer and how great a need there is for more effective treatments,” Hamburg is quoted as saying by The Pittsburgh Tribune-Review . “But patients must have confidence that the drugs they take are both safe and effective for their intended use.” After being rapidly approved for use by the FDA back in 2007, Avastin quickly generated more than $1.7 billion for its producer Genentech within the first year. When the FDA finally got around to actually reviewing the drug after approving it, though, the agency discovered that Avastin does not lengthen the lives of breast cancer patients, and that it carries with it severe side effects that include death (http://www.naturalnews.com/023524_drug_avastin_cancer.html). In her 69-page report on Avastin, Hamburg wrote that Avastin’s side effects include high blood pressure, bleeding, heart attack or heart failure, and the development of perforations in the nose, stomach and intestines. In at least one case, a patient taking Avastin has died from infection. But the way the FDA is handling the situation shows how blatantly biased it is towards the drug industry. Avastin was proven dangerous and ineffective several years ago, but the FDA allowed it to remain on the market. Now, it has decided to withdraw approval for Avastin, but is still allowing it to remain on the market. If Avastin had been a dietary supplement in the same predicament, the agency would have immediately withdrawn its approval (if it would have approved it in the first place), and demanded that it be removed from the market. The agency likely would have also shut down Avastin’s manufacturer, as it has done a lot worse to supplement companies that produce safe and effective natural treatments. Sources for this article include: http://www.lef.org/news/LefDailyNews.htm?NewsID=11921&Section=Disease

FDA withdraws approval for breast cancer drug Avastin after declaring it medically useless, but says doctors can still prescribe it

(NaturalNews) Several years after declaring it to be not only medically useless but also dangerous, the US Food and Drug Administration (FDA) has officially withdrawn approval for the $100,000 breast cancer drug Avastin. In a statement, FDA Commissioner Margaret Hamburg said that Avastin has never been proven to be safe or effective, but also in the same breath noted that doctors can still prescribe the drug if they feel like it. “FDA recognizes how hard it is for patients and their families to cope with metastatic breast cancer and how great a need there is for more effective treatments,” Hamburg is quoted as saying by The Pittsburgh Tribune-Review . “But patients must have confidence that the drugs they take are both safe and effective for their intended use.” After being rapidly approved for use by the FDA back in 2007, Avastin quickly generated more than $1.7 billion for its producer Genentech within the first year. When the FDA finally got around to actually reviewing the drug after approving it, though, the agency discovered that Avastin does not lengthen the lives of breast cancer patients, and that it carries with it severe side effects that include death (http://www.naturalnews.com/023524_drug_avastin_cancer.html). In her 69-page report on Avastin, Hamburg wrote that Avastin’s side effects include high blood pressure, bleeding, heart attack or heart failure, and the development of perforations in the nose, stomach and intestines. In at least one case, a patient taking Avastin has died from infection. But the way the FDA is handling the situation shows how blatantly biased it is towards the drug industry. Avastin was proven dangerous and ineffective several years ago, but the FDA allowed it to remain on the market. Now, it has decided to withdraw approval for Avastin, but is still allowing it to remain on the market. If Avastin had been a dietary supplement in the same predicament, the agency would have immediately withdrawn its approval (if it would have approved it in the first place), and demanded that it be removed from the market. The agency likely would have also shut down Avastin’s manufacturer, as it has done a lot worse to supplement companies that produce safe and effective natural treatments. Sources for this article include: http://www.lef.org/news/LefDailyNews.htm?NewsID=11921&Section=Disease

FDA to pull 500 unapproved drugs from market after allowing them to be sold for decades

(NaturalNews) For years, prescription cold and cough medicines like Cardec, Rondec, Organidin, Pediahist, and hundreds of other drugs have been available to patients, even though none of them have ever received approval from the US Food and Drug Administration (FDA). The FDA recently decided to crack down on the unapproved stray drugs, ordering 500 of them to be pulled from the market. “We have serious concerns about them because we just simply don’t know what is in them, whether they work properly or how they are made,” said Michael Levy, director of the FDA’s Division of New Drugs and Labeling Compliance, in a statement. Many of the drugs involved in the culling have been available since before the FDA even had an approval system, which is why they continue to be sold at many drug stores. But the agency also says it does not know how many of the drugs are even still available or being sold, since many people have since switched to similar FDA-approved products that are available without a prescription. The FDA says the pull was also instigated by various drug complications that have been reported via the agency’s adverse event reporting system. But the main goal of the effort is to bring all unapproved drugs into FDA compliance by pushing their manufacturers to undergo the agency’s multimillion dollar approval process. However, the FDA does not seem all that concerned about the drugs it has approved that are quite popular in the adverse event department. Serious complications from the human pappillomavirus (HPV) vaccine Gardasil, for instance, have received little to no attention from the FDA (http://www.naturalnews.com/Gardasil.html). Manufacturers have 90 days to stop producing the unapproved drugs and 180 days to stop shipping them. Sources for this story include: http://www.prnewswire.com/news-releases/fda-prompts-removal-of-unapproved-drugs-from-market-117237278.html http://www.nydailynews.com/news/national/2011/03/02/2011-03-02_fda_pulls_cardec_rondec_organidin_and_pediahist_agency_says_cold_meds_could_pose.html

FDA uses flawed analysis to target raw milk cheese

(NaturalNews) A recent raw cheese study put out by product liability firm Marler Clark has generated a stir in the mainstream media. According to the report, documented cases of foodborne illness due to raw cheese consumption have risen in recent years, which has prompted the U.S. Food and Drug Administration (FDA) to consider altering guidelines for raw cheese production. But what the report fails to explain is that illness cases from pasteurized cheeses are nearly the same as they are for raw cheeses throughout the past several decades, and that the supposed “rise” in illness cases from raw cheese is really more of a statistical manipulation than actual fact. A recent Grist report on the matter explains that, according to statistics from the U.S. Centers for Disease Control and Prevention (CDC), for the 26 years between 1973 and 1999, there was not a single reported case of illness from either raw milk or pasteurized milk cheeses. Only in the last decade has there been an increase in both cases, with raw cheese illness cases slightly surpassing pasteurized cheese illness cases. In 2008, however, there was not a single reported case of illness from raw milk cheese. But there were 45 reported cases of illness from pasteurized cheese that year, indicating that contamination obviously occurs after pasteurization. And while between 2000-2009 there were slightly fewer illness reports from pasteurized cheeses than there were from raw cheeses, one person died from pasteurized cheese poisoning while there were no deaths from raw cheese. What these and the rest of the statistics illustrate is the fact that whether or not a cheese is raw or pasteurized, it can still cause foodborne illness. Just because a cheese is raw, in other words, does not mean it is more dangerous than pasteurized cheese, and the statistics largely show this. But the FDA and mainstream media, in their typical anti-raw milk fashion, have once again begun condemning raw cheese as dangerous based on skewed information presented to them. And if the FDA rules that the 60-day aging requirement for raw cheese be extended to 90 or 120 days as is expected, the decision will eliminate from the market producers of softer raw cheeses that require less aging time. Even worse, the FDA may even decide that raw cheese it dangerous and outlaw it completely, eliminating the fast-growing artisanal raw cheese segment entirely. Just like with raw milk, raw milk cheese is not inherently dangerous because it is raw. Poor handling and unsanitary conditions are the primary causes of foodborne illness, both in raw and pasteurized products. So targeting and banning raw products does nothing to solve contamination problems and everything to further the illogical anti-raw agenda. Sources for this story include: http://www.grist.org/article/2011-02-10-what-will-the-fda-do-about-the-60-day-aging-rule-for-raw-milk#comments http://www.marlerblog.com/legal-cases/the-raw-milk-beat-goes-on-a-look-at-the-literature-and-the-60-day-raw-milk-cheese-aging-rule—updat/

Cough, cold medicines could kill your child

(NaturalNews) Since 2007 when drug manufacturers agreed to withdraw from the market over-the-counter cough and cold medicine products sold for children under two, emergency rooms have seen 50 percent less visits from injured or killed babies and toddlers. But these medicines are still being sold for older children, even though they are highly dangerous and many parents continue to ignorantly give them to their younger children under the false impression that they are safe. According to the U.S. Centers for Disease Control and Prevention (CDC), safety concerns prompted the companies to withdraw such products branded specifically for younger children. The U.S. Food and Drug Administration (FDA) had put out a warning that cough and cold medicines invoke “serious and potentially life-threatening side effects,” even when used according to instructions. But none of that prompted the agency to actually withdraw the offending medicines from the market. They simply encouraged manufacturers to update use and safety labels to says that the products are not safe to use in children under the age of two years old. But after studies showed that the products were dangerous even in older children, the Consumer Healthcare Products Association updated labels again in 2008 warning parents to only administer the medicines to children over age four. However in 2009, the U.K.’s Medicines and Healthcare Products Regulatory Agency (MHRA) issued a warning that cough and cold medicines are actually not safe for children under six years old, either. In fact, the agency even implied that the medicines are largely useless altogether because cough and cold symptoms will generally go away naturally in the same amount of time, regardless of whether or not such medicines are used (http://www.naturalnews.com/026269_medicines_health_cold.html). To learn more about the dangers of cough and cold medicines, why they do not work, and how you can prevent and treat colds naturally, visit: http://www.naturalnews.com/cold_medicines.html Sources for this story include: http://www.usatoday.com/yourlife/parenting-family/babies/2010-11-22-coldmeds22_st_N.htm

Adderall has extreme side effects, but FDA says keep taking it

(NaturalNews) The attention deficit hyperactivity disorder (ADHD) drug Adderall is known to cause serious physical side effects including heart attack, stroke, elevated blood pressure and heart rate, and even sudden death. The U.S. Food and Drug Administration (FDA) is aware of this and more, but insists that people continue taking the drug anyway. Adderall is basically a cocktail of various amphetamine stimulants and is often referred to as “prescription speed”. And because it is similar in makeup to illegal methamphetamines, it is highly addictive. So in addition to its many side effects, users will have a difficult time functioning without Adderall once they start taking it. Adderall also comes with a full slate of mental side effects as well as physical ones. Ironically, the drug can actually cause behavior to become worse, leaving one to wonder how or why such a drug was ever approved as a legitimate medicine to treat a disorder that it may actually aggravate. Taking Adderall can also thwart proper brain function, increase behavioral aggression, and even cause episodes of psychosis in which the patient becomes maniacal and starts hearing voices. In other words, it is absolutely insane for this dangerous drug to be on the market, let alone be touted as a safe medicine for children. And the FDA is aware of the seriously dangerous nature of this drug because it warned the public back in 2009 about its many extreme side effects. The FDA conducted its own study of Adderall’s effects on children and early data pointed to the fact that the drug increases the risk of sudden death in children. But neither the study nor any of the other facts about the drug’s dangerous effects prompted the FDA to actually pull the drug from the market. In fact, the FDA made a point of denying the results of its own study and insisting that patients continue to take the drug. The best way to deal with ADHD is to focus on getting proper nutrition, which includes supplementing with powerful superfoods. Cleansing the body of built-up toxins and feeding it with rich nutrients is the number one priority when trying to maintain mental clarity and boost energy and focus. Remember to avoid excessive caffeine, refined sugars and processed foods, because these things only help to intensify the undesirable symptoms. Sources for this story include: http://topnews.us/content/218105-despite-detrimental-side-effects-adderall-fda-advises-not-stop-giving-drug-patients

Australian courts rule that Vioxx should never have been approved for sale

(NaturalNews) Australian courts recently ruled that Vioxx, a popular prescription painkiller, should never have been approved and allowed on the market. The case represents the world’s first successful class action lawsuit against a drug company for damage caused by its drugs. Merck, the drug giant that produced Vioxx, was deemed by the courts as negligent for failing to properly inform doctors who were prescribing the drug about the dangers and health risks associated with the drug. As a result, thousands of patients around the world have suffered severe injury or death because of Vioxx. Graeme Peterson, a 59-year-old man represented in the case, was awarded the equivalent of about $266,000 for injuries inflicted upon him by Vioxx. He suffered a heart attack from the drug in 2003 that has left him unable to work since. He took the drug for more than four years, and still keeps a Vioxx tablet with him as a reminder of what almost killed him. Though great for Australians, injured patients in the U.K. have not had the same success. Norman Lamb, a member of the British Parliament, explained that he and others have been trying to convince Merck for years that it should compensate the many British citizens who were injured by the drug. But Merck continues to deny liability and the British government has failed to successfully negotiate a settlement. “Ministers made promising noises then after a meeting between the Government and the company they weakened their position. I believe that the ministers came under pressure from the company and their own civil servants to shut up,” explained Lamb in a U.K. article. Unfortunately, this is typically the case with most drug company lawsuits. The Australian case is a landmark victory that should typify how class action lawsuits against drug companies are handled and hopefully a similar victory will one day be achieved for the many British cases of Vioxx injuries. One such case involves Raymond Eaton, whose wife died from heart problems that were likely caused by Vioxx. Mrs. Eaton, who had been suffering from a severely debilitating form of rheumatoid arthritis, was immediately prescribed Vioxx upon its release. The drug helped her pain, but four years later, she suffered a coronary from which she never recovered. Since she never had any heart problems prior to taking Vioxx, Raymond is convinced that the drug was responsible. Over 80 million people around the world were taking Vioxx prior to its being pulled from the market, and many lawyers from other countries have been awaiting the outcome of the Australian litigation. The success of the case established a precedence for Merck’s liability due to negligence, providing a way for the thousands, if not millions, of injured patients around the world to receive restitution for damages caused by Vioxx. Sources for this story include: http://www.independent.co.uk/news/world/australasia/vioxx-ruling-gives-hope-for-payouts-to-british-lsquovictimsrsquo-1917042.html

Drug side effects "neglected, restricted, distorted and silenced" by drug companies

(NaturalNews) New research shows that information on potentially lethal side effects of the blockbuster painkiller Vioxx was “neglected, restricted, distorted and silenced” by pharmaceutical giant Merck, writes London-based physician and author John Briffa in The Epoch Times . Vioxx was first approved for sale in 1999 and quickly became a top seller. Yet according to an analysis published in the Archives of Internal Medicine , clear evidence existed by 2001 that the drug increased the risk of cardiovascular thrombotic events, including heart attack, stroke and death. This evidence was contained in studies conducted by and for Merck. “Most of the information we are using in this study was never published, or if it was published, they never included the key safety data,” co-author Harlan Krumholz said. It has been proven Merck promoted Vioxx through the popular industry practice of ghostwriting articles and scientific studies for publication in respected medical journals. In addition, a recent article in the British Medical Journal shows that the company employed tactics designed to “neutralize” and “discredit” doctors who tried to raise concerns about Vioxx. Yet Merck still insists that it did not know about the heart risks of Vioxx until 2004, when it voluntarily withdrew the drug from the market. Practices like those Merck used to promote Vioxx are widespread in the drug industry, as revealed by numerous recent lawsuits against companies for concealing drug side effects, illegally promoting drugs for off-label uses, and using questionable marketing techniques. Briffa notes that Merck may now be engaged in an attempt to save the image of the cholesterol-reducing drug ezetimibe (also marketed as Vytorin), which does not appear to reduce the risk of heart attacks but may actually increase the risk of cancer death. “Never mind, though, because it appears Merck has managed to find some scientists who claim that this association is likely to be due to chance, even though the stats show it’s very unlikely to be due to chance,” Briffa writes. “Let’s hope history isn’t repeating itself.” Sources for this story include: www.theepochtimes.com.

Secrecy in science is corrosive

(NaturalNews) Secrecy undermines the practice of good science, charges Michael Schrage in an opinion piece published in the Financial Times , and governments need to step in and provide more incentives for open sharing of data. “On issues of the greatest importance for public policy, science researchers are less transparent than they should be,” Schrage writes. “That behavior undermines science, policy and public trust.” Schrage cites the recent scandal over emails stolen from the computers of climate researchers at the University of East Anglia as an example of the distortions caused by a modern climate of secrecy and competition in science. Although there is no evidence that researchers falsified data as some climate skeptics have alleged, the Associated Press concluded that “One of the most disturbing elements suggests an effort to avoid sharing scientific data with critics skeptical of global warming. … It raises a science ethics question because free access to data is important so others can repeat experiments as part of the scientific method.” Schrage also notes that only recently have many U.S. universities begun to require that drug researchers expose financial ties to the companies that make the products they are testing. “Too many scientists in academia, industry and government are allowed to get away with concealing or withholding vital information about their data, research methodologies and results,” Schrage writes. “That is unacceptable and must change.” Schrage notes that if drug companies were forced to share the results of all studies they conduct on new drugs, and not just positive findings, dangerous drugs would be less likely to be approved or could be pulled from the market sooner. As a step toward changing the secretive climate of science, Schrage suggests that public funding, nonprofit status and university certification all be made contingent upon the adoption of certain transparency standards. “Why should … taxpayers fund scientists who deliberately delay, obfuscate and deny open access to their research?” he writes. “Why should responsible policymakers in America, Europe, Asia and Latin America make decisions affecting people’s health, wealth and future based on opaque and inaccessible science? They should not.” Sources for this story include: www.ft.com; www.usnews.com.

FDA finally admits that asthma drugs can actually cause serious asthma attacks

(NaturalNews) The U.S. Food and Drug Administration (FDA) recently issued new restrictions for four popular long-acting asthma drugs. Novartis AG’s Foradil, GlaxoSmithKline’s Serevent and Advair, and AstraZeneca’s Symbicort, all contain an ingredient that relaxes airway muscles in the lungs which can cause asthma-related death. If not accompanied by other asthma drugs to offset this life-threatening side effect, the consequences could be fatal. These drugs have long contained a label that reads, “increases risk of asthma-related death”, but apparently this warning is not enough for this extreme class of medications. Known as long-acting beta-agonists (LABAs), these asthma drugs are used by roughly six million asthma sufferers to combat asthma symptoms. Ironically, LABAs are so dangerous that, if not combined with other asthma drugs, can actually cause an asthma attack. It defies logic to try to figure out how asthma drugs that can kill people by causing severe asthma attacks are considered to be useful and effective medicine. Instead of pulling these dangerous drugs from the market entirely as it should, the FDA is ordering that stronger labels be affixed to warn doctors and physicians about the extreme risks associated with taking the drugs. It is unclear from the agency’s press release exactly how it intends to strengthen the drugs’ current death warning. The FDA has indicated that it will require the drugs’ manufacturers to conduct education campaigns for medical professionals about how to safely use the LABA asthma drugs. The agency is also mandating that each manufacturer conduct additional studies to verify the safety of their drugs. Since 2002, the FDA had continually rejected all of the overwhelming evidence presented to it that LABAs are inherently dangerous. Only in 2008 did the FDA first admit that the drugs were dangerous, particularly for children and some adults. Prior to that, the agency seemed to be in agreement with a series of industry spin pieces concocted by the drug industry to defend the alleged safety of the drugs; this alone exhibits the FDA’s lunacy in asking the industry to conduct more of its own safety studies. While warning that the drugs should only be used “as necessary” seems like a step in the right direction, the FDA should be taking a leap to pull these drugs off the market. Many experts agree that these drugs are wholly dangerous, and that the industry has been aware of these dangers for nearly a decade. Once again, the FDA is giving lip service to the public it is supposed to be defending while protecting drug industry interests instead. Sources for this story include: http://www.google.com/hostednews/ap/article/ALeqM5gZ5T9BAqtpkmgEBVMTq6Z4-M_vjQD9DUO5DO0 http://houston.injuryboard.com/fda-and-prescription-drugs/fda-tougher-warnings-for-some-asthma-drugs.aspx?googleid=278382 http://www.glgroup.com/News/FDA-Should-Have-Banned-LABAs-Five-Years-Ago-29816.html http://online.wsj.com/article/SB122849265787282969.html?mod=googlenews_wsj&opattr=FDA%3A_Long-Acting_Asthma_Drugs_Increase_Asthma_Risks

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