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

Pfizer Hid Evidence That HRT Causes Cancer

(NaturalNews) A Philadelphia jury has found drug giant Pfizer Inc. guilty of deliberately ignoring evidence that hormone replacement therapy (HRT) drug Prempro increased women’s risk of breast cancer, ordering it to pay unspecified damages to defendant Connie Barton. Millions of women used Prempro and other HRT drugs up until 2002, when the groundbreaking Women’s Health Initiative study found that taking the drugs significantly increased women’s risk of breast cancer and death from cardiovascular disease. The risk was so striking that researchers called an early halt to the study out of concern for participants’ lives. The drugs were — and still are — marketed to relieve the symptoms of menopause, such as hot flashes, mood swings and night sweats. More recent research suggests that HRT drugs also increase women’s risk of dying from lung cancer. Although Prempro was marketed by Wyeth, Pfizer assumed liability for Wyeth’s prior actions when it purchased the company in October. According to Barton’s lawyers, Wyeth was aware of the risks of Prempro well before the release of the Women’s Health Initiative results, but made no efforts to withdraw the drug from the market or warn women or doctors of its effects. “They knew back in the 1970s that these drugs had the potential to cause breast cancer,” said attorney Esther Berezofsky, “so they didn’t have the studies done.” When negative results began to emerge, Berezofsky said, Wyeth attempted to downplay them. The jury agreed, ruling not only that Prempro had caused Barton’s case of invasive breast cancer, but that the drug company was to blame. Before its acquisition, Wyeth also admitted to practices such as ghostwriting articles for publication in medical journals, promoting off-label (unapproved) uses of drugs and making lavish gifts to doctors. Pfizer claims the company has since abandoned these policies. The Barton case is only one of 9,000 Prempro-related lawsuits filed in the United States to date. Of eight cases to go to trial, five have ended in “guilty” verdicts for the company. Pfizer has appealed all five. Sources for this story include: www.dailyfinance.com.

McCain bill threatens access to vitamins and supplements

(NaturalNews) Senator John McCain (R-Arizona) has introduced a new bill called The Dietary Supplement Safety Act (DSSA) of 2010 (S. 3002), that, if enacted, would severely curtail free access to dietary supplements. Cosponsored by Senator Byron Dorgan (D-North Dakota), the bill would essentially give the FDA full control over the supplement industry. Most of the industrialized world has incredibly restrictive laws governing supplements. People worldwide often purchase supplements from the U.S. because they are freely available at low costs. All of this could change, however, if DSSA passes. DSSA would change key sections of the Federal Food, Drug, and Cosmetic Act (FD&C), undoing protections in the Dietary Supplement Health and Education Act (DSHEA) of 1994, effectively eliminating free access to supplements. The importance of DSHEA The passage of DSHEA resulted from millions of Americans who worked hard to reinforce their freedom to buy and sell supplements. At the time, the Food and Drug Administration (FDA) was alleging that nutrients like CoQ10 and selenium were dangerous and should be pulled from the market. Though weak in some areas, DSHEA established a foundation upon which free access to dietary supplements would be protected from attacks by drug companies and the FDA. What prompted DSSA? McCain’s DSSA bill emerged in response to illegal steroid use among Major League Baseball players. Likely instigated by pharmaceutical interests, the bill is being posited as necessary to prevent supplement adulteration. The FDA already has the power to pull supplements from the market that are contaminated but it has not been doing its job. DSSA is not only unnecessary, but it would actually reward the FDA for its failures. DSSA would also strip DSHEA and give full control of the supplement industry to the FDA. Registration requirements DSSA would mandate that all supplement companies register with the Secretary of Health and Human Services (HHS), which oversees the FDA. Any company that refuses to register and comply with HHS would be subject to hefty fines, the classification of its products as “adulterated”, and their removal from the market. The new system would burden manufacturers with significant new costs that would cause supplement prices to increase. A new taxpayer-funded bureaucracy would also be created to conduct inspections and oversee compliance. Reporting requirements DSSA would require all “non-serious adverse events” received by supplement companies to be reported to the government, regardless of whether or not the events are related to the supplements for which they are submitted. Pharmaceutical companies would have access to these reports which they could use to petition the FDA to have supplements removed from the market. The FDA could also arbitrarily pull supplements from the market if it believes it has “reasonable probability” that there may be a problem. FDA would decide which supplements are legal Perhaps the most chilling aspect of DSSA is that it would allow the HHS Secretary to establish a list of permitted supplements. Reversing common law, which assumes all is legal unless restricted, DSSA would allow only what is permitted to be legal. In a nutshell, DSSA would increase supplement costs for consumers, grant incredible new power over the supplement industry to the FDA, and drastically limit the availability of supplements. Drug companies could also use the bill to remove supplements from the market, patent them, and sell them as drugs! It is absolutely critical to contact your Congressmen and oppose this bill. LifeExtension Magazine has a convenient “Action Alert” page in which to do so. Sources: Senator McCain Files New Bill That Attacks Your Access to Supplements and Repeals Key Sections of the Dietary Supplement Health and Education Act – Alliance for Natural Health The Dietary Supplement Safety Act of 2010 – Senator John McCain New Bill Seeks to Ban Consumer Access to Dietary Supplements – Life Extension Foundation About the author Ethan Huff is a freelance writer and health enthusiast who loves exploring the vast world of natural foods and health, digging deep to get to the truth. He runs an online health publication of his own at http://wholesomeherald.blogspot.com.

Merck Sat on Data Showing Vioxx Risks for Years Before Pulling Drug

(NaturalNews) A recent study published in the Archives of Internal Medicine has revealed that information about heart risks from pharmaceutical giant Merck’s Vioxx drug was available in 2000, four years before the Merck pulled the drug from the market. Because the information was not published and made public, Merck sat on it until a later clinical trial openly revealed that the drug was causing strokes and heart attacks. Dr. Harlan Krumholz, study author from the Yale University School of Medicine, noted that he obtained pertinent safety data about Vioxx only after a lawsuit was filed against Merck by those who had been injured by the drug. It was discovered that out of the 30 studies conducted by Merck prior to when Vioxx was withdrawn, only 18 of them had been published. Six were published after the drug was withdrawn and six were never published at all. After mulling through the study data, one trial at a time, Krumholz and his team clearly identified a link between Vioxx usage and increased heart attacks and strokes in patients. Based on when the studies were conducted, the connection was visible as early as December of 2000. Ron Rogers, a Merck spokesman, denied the claims that any link could be observed and decried the methods used by researchers to come to this conclusion, despite acceptance of the findings following a rigorous peer review process. Rogers stated that the company’s own extensive analysis showed no connection between Vioxx usage and increased cases of heart attack and stroke prior to the time when it was removed from the market, emphasized that the company had no prior knowledge of Vioxx’s dangers. However in 2004, the Wall Street Journal (WSJ) reported that it had seen internal Merck emails exchanged between company executives that expressed concern over Vioxx’s tendency to increase the risk of heart attack. The entire series of emails clearly indicated that Merck knew about the dangers of Vioxx and was doing its best to conceal the information. Dating back to the late 1990s, early emails contained dialogues about how to craft a study that would minimize the truth about Vioxx. An email from March of 2000 sent by Merck’s research chief, Edward Scolnick, expressed clear affirmation that heart problems associated with Vioxx were “clearly there” and that it was a “shame.” When questioned about the emails, Merck once again denied the allegations, claiming that the emails were taken out of context. Merck never provided an explanation as to what the emails were referring to in their supposed proper context. Thousands of injured patients and company shareholders filed a class action lawsuit against Merck following its removal of Vioxx from the market. Merck appealed the lawsuit on the grounds that “sufficient” information about the drug’s risks were available when the drug hit the market. Merck succeeded in convincing a U.S. district judge to dismiss the lawsuit because it was filed after the two-year statute of limitations ended. However an appeals court in Philadelphia reversed the decision on behalf of the many shareholders who lost a great deal when Vioxx was suddenly removed from the market, which caused Merck’s stock values to plummet. Since it was determined that shareholders could not have known what was coming based on the information that was made publicly available, the Supreme Court is going to evaluate the case and make a decision on it next year. Merck also agreed to a $4.85 billion settlement, one of the largest in history, on behalf of the thousands who filed personal injury lawsuits against the company due to serious injuries caused by Vioxx. (These cases were different from the ones included in the initial class action suit). The drug giant said it agreed to the settlement because the litigation process would have taken countless years to resolve, most likely hurting the company’s reputation even further. At the very least, drug safety tracking once receiving approval from the FDA to go to market needs a major overhaul. Dr. Krumholz and his colleagues stressed this point following their Vioxx discoveries. When fraud and criminal behavior are involved, as has shown to be the case with Merck, justice must be served. The Vioxx scandal illustrates an important fact about the drug industry in general. Big Pharma continually gets away with massive impropriety. Its business practices, from research and development to marketing, are wrought with dishonesty, manipulation and downright fraud. There is arguably no other industry that gets away with its crimes as much as the pharmaceutical industry does. The consequences are also the most severe, costing millions of people their health and oftentimes their lives. Bringing the issue to light as often and loudly as possible will only go so far. Massive reform, in some way, shape, or form, must be implemented if there is ever going to be an end to the madness. Sources for this story include: http://www.reuters.com/article/idUSTRE5AM4MV20091123, http://money.cnn.com/2004/11/01/news/fortune500/merck/index.htm

« Previous Page