Drug data reveal sneaky side effects:
An algorithm designed by US scientists to trawl through a plethora of drug interactions has yielded thousands of previously unknown side effects caused by taking drugs in combination. The work, published today in Science Translational Medicine1, provides a way to sort through the hundreds of thousands of 'adverse events' reported to the US Food and Drug Administration (FDA) each year. “It’s a step in the direction of a complete catalogue of drug–drug interactions,” says the study's lead author, Russ Altman, a bioengineer at Stanford University in California. Pills in pill boxes. A program predicts the potential side-effects of mixing different pills. Although clinical trials are often designed to assess the safety of a drug in addition to how well it works, the size of the trials needed to detect the full range of drug interactions would surpass even the large, late-stage clinical trials sometimes required for drug approval. Furthermore, clinical trials are often done in controlled settings, using carefully defined criteria to determine which patients are eligible for enrollment — including other conditions they might have and which medicines they can take alongside the trial drug. Once a drug hits the market, however, things can get messy as unknown side-effects pop up. And that’s where Altman’s algorithm comes in. “Even if you show a drug is safe in a clinical trial, that doesn’t mean it’s going to be safe in the real world,” says Paul Watkins, director of the Hamner–University of North Carolina Institute for Drug Safety Sciences in Research Triangle Park, North Carolina, who was not involved in the work. “This approach is addressing a better way to rapidly assess a drug’s safety in the real world once it is approved.”
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Altman and his colleagues have been studying drug–drug interactions as a way to understand how a person’s genes influence their response to pharmaceuticals. To do that, he says, you must first have a good picture of the molecular mechanisms that underlie drug responses. “Adverse events are incredibly valuable clues to what these drugs are doing in the body,” Altman says. “They can tell you the other pathways in the cell that are being tickled by these drugs.” But reports of adverse drug events are notoriously prone to bias. For example, cholesterol-lowering treatments are more often taken by older patients, and so conditions associated with ageing, such as heart attack, could be wrongly linked to a drug as a side effect. Altman and his colleagues reduced this bias by adopting an approach sometimes used in observational clinical trials. They developed an algorithm that would match data from each drug-exposed patient to a nonexposed control patient with the same condition. The approach automatically corrected for several known sources of bias, including those linked to gender, age and disease1. The team then used this method to compile a database of 1,332 drugs and possible side effects that were not listed on the labels of those drugs. The algorithm came up with an average of 329 previously unknown adverse events for each drug — far surpassing the average of 69 side effects listed on most drug labels. The team also compiled a similar database looking at interactions between pairs of drugs, which yielded many more possible side effects than could be attributed to either drug alone. When the data were broken down by drug class, the most striking effect was seen when diuretics called thiazides, often prescribed to treat high blood pressure and edema, were used in combination with a class of drugs called selective serotonin reuptake inhibitors, used to treat depression. Compared with people who used either drug alone, patients who used both drugs were significantly more likely to experience a heart condition known as prolonged QT, which is associated with an increased risk of irregular heartbeats and sudden death. A search of electronic medical records from Stanford University Hospital confirmed the relationship between these two drug classes, revealing at roughly 1.5-fold increase in the likelihood of prolonged QT when the drugs were combined, compared to when either drug was taken alone. Altman says that the next step will be to test this finding further, possibly by conducting a clinical trial in which patients are given both drugs and then monitored for prolonged QT. What should the drug regulators do with the thousands of possible side effects Altman and his team uncovered? That is a complex problem, says Watkins, who adds that regulators will have to factor in the availability of alternative treatments and the magnitude and seriousness of the side effect, among other considerations. Altman, who serves as an adviser on the FDA’s Science Board, says that he plans to present his results to the agency. He suggests that the algorithm could be used with the FDA’s existing drug-surveillance programs to remove bias. However, he points out the enormity of the task: “We’ve just released a database with 10,000 or more adverse events,” he says. “I do not expect the FDA to uncritically take these results and add them to every drug label.”
Leaked documents reveal US diplomats actually work for Monsanto:
Biotech giant Monsanto has been genetically modifying the world's food supply and subsequently breeding environmental devastation for years, but leaked documents now reveal that Monsanto has also deeply infiltrated the United States government. With leaked reports revealing how U.S. diplomats are actually working for Monsanto to push their agenda along with other key government officials, Monsanto's grasp on international politics has never been clearer. Amazingly, the information reveals that the massive corporation is also intensely involved in the passing and regulations concerning the very GM ingredients they are responsible for. In fact, the information released by WikiLeaks reveals just how much power Monsanto has thanks to key positions within the United States government and elsewhere. Not only was it exposed that the U.S. is threatening nations who oppose Monsanto with military-style trade wars, but that many U.S. diplomats actually work directly for Monsanto. What the leaked documents reveal -- Military style trade wars, government corruption. In 2007 it was requested that specific nations in the European Union be punished for not supporting the expansion of Monsanto's GMO crops. The request for such measures to be taken was made by Craig Stapleton, the United States ambassador to France and partner to George W. Bush. Despite mounting evidence linking Monsanto's GM corn to organ damage and environmental devastation, the ambassador plainly calls for 'target retaliation' against those not supporting the GM crop. In the leaked documents, Stapleton states: "Country team Paris recommends that we calibrate a target retaliation list that causes some pain across the EU since this is a collective responsibility, but that also focuses in part on the worst culprits. The list should be measured rather than vicious and must be sustainable over the long term, since we should not expect an early victory. Moving to retaliation will make clear that the current path has real costs to EU interests and could help strengthen European pro-biotech voices." The undying support of key players within the U.S. towards Monsanto is undeniably made clear not only in this release, but in the legislative decisions taken by organizations such as the FDA and USDA. Legislative decisions such as allowing Monsanto's synthetic hormone Posilac (rBGH) to be injected into U.S. cows despite being banned in 27 countries. How did Monsanto pull this off? The Biotech juggernaut managed to infiltrate the FDA positions responsible for the approval of rBGH, going as far as instating the company's own Margaret Miller as Deputy Director of Human Safety and Consultative Services. After assuming this position, Miller reviewed her own report on the safety and effectiveness of rBGH. Many US diplomats pawns of Monsanto's GM agenda. While it may be shocking to you if you are not familiar with the corrupt influence of Monsanto, the cables also show that many US diplomats are pushing GMO crops as a strategic government and commercial imperative. Interestingly enough, the U.S. focused their efforts toward advisers to the pope specifically, due to the fact that many Catholic figureheads have openly voiced their opposition to GM foods. With this kind of political influence, is it any wonder that many food staples are now predominantly GM? Nearly 93% of U.S. soybeans are heavily modified conservatively, with many other staple crops coming in at similar numbers. U.S. diplomats have unique opportunities to spread honest and intellectual campaigns that can serve to better mankind and end suffering, however they are instead spreading the roots of Monsanto deeper and deeper into international territory. As a substitute for the betterment of mankind, these paid-off diplomats are now spreading environment desecration and health destruction. As if there wasn't already enough information to reveal Monsanto's corruption, the biotech giant also spends enormous amount of money lobbying government each year. Monsanto spent an astonishing $2 million lobbying the federal government in the 3rd quarter of 2011 alone, according to mainstream sources. Why so much cash? The government lobbying focuses on issues like regulations for GM crops and patent reforms. This 'legal' form of persuasion is the reason government agencies like the USDA and FDA let Monsanto roam freely. Satisfying government officials' financial vested interest is all that matters when dealing with corrupt mega-corporations like Monsanto. As long as these financial ties continue to exist, Monsanto will continue to reign over the food supply and continue to wreak devastation to the environment, ecosystem, and humankind.
FDA Shut’s Down Amish Farm For Selling Fresh Milk:
The FDA once again has crossed the line and won its two-year fight to shut down an Amish farmer who was selling fresh raw milk to eager consumers in the Washington, D.C., region after a judge this month banned Daniel Allgyerfrom selling his milk across state lines and he told his customers he would shut down his farm altogether. The decision has enraged Mr. Allgyer’s supporters, some of whom have been buying from him for six years and say the government is interfering with their parental rights to feed their children. But the Food and Drug Administration, which launched a full investigation complete with a 5 a.m. surprise inspection and a straw-purchase sting operation against Mr. Allgyer’s Rainbow Acres Farm, said unpasteurized milk is unsafe and it was exercising its due authority to stop sales of the milk from one state to another. Adding to Mr. Allgyer’s troubles, Judge Lawrence F. Stengel said that if the farmer is found to violate the law again, he will have to pay the FDA’s costs for investigating and prosecuting him. His customers are wary of talking publicly, fearing the FDA will come after them.“I can’t believe in 2012 the federal government is raiding Amish farmers at gunpoint all over a basic human right to eat natural food,” said one of them, who asked not to be named but received weekly shipments of eggs, milk, honey and butter from Rainbow Acres, a farm near Lancaster, Pa. “In Maryland, they force taxpayers to pay for abortions, but God forbid we want the same milk our grandparents drank.” The FDA, though, said the judge made the right call in halting Mr. Allgyer’s cross-border sales. “Intrastate sale of raw milk is allowed in Pennsylvania, and Mr. Allgyerhad previously received a warning letter advising him that interstate sale of raw milk for human consumption is illegal,” agency spokeswomanSiobhan DeLancey said. Neither the FDA nor the Justice Department, which pursued the legal case, provided numbers to The Washington Times on the cost of the investigation and court fight. Fans of fresh milk, which they also call raw milk, attribute all kinds of health benefits to it, including better teeth and stronger immune systems. Raw milk is particularly popular among parents who want it for their children. In a unique twist, the movement unites people on the left and the right who argue that the federal government has no business controlling what people choose to consume. In a rally last year, they drank fresh milk in a park across Constitution Avenue from the Senate. But the FDA says it concluded, after extensive study along with the Centers for Disease Control and Prevention, that raw milk is never safer than pasteurized milk. It disputes those who say pasteurization — the process of heating food to kill harmful organisms — makes it less healthy. Many food-safety researchers say pasteurization, which became widespread in the 1920s and 1930s, dramatically reduced instances of milk-transmitted diseases such as typhoid fever and diphtheria. The FDA began looking into Mr. Allgyer’s operations in late 2009, when an investigator in the agency’s Baltimore office used aliases to sign up for a Yahoo user group made up of Rainbow Acres customers. The investigator placed orders for fresh milk and had it delivered to private residences in Maryland, where it was picked up and documented as evidence in the case. By crossing state lines, the milk became part of interstate commerce and thus subject to the FDA’s ban. At one point, FDA employees made a 5 a.m. visit to Mr. Allgyer’s farm. He turned them away, but not before they observed milk containers labeled for shipment to Maryland. After the FDA first took action, Mr. Allgyer changed his business model. He arranged to sell shares in the cows to his customers, arguing that they owned the milk and he was only transferring it to them. Judge Stengel called that deal “merely a subterfuge.” “The practical result of the arrangement is that consumers pay money toMr. Allgyer and receive raw milk,” the judge wrote in a 13-page opinion. Grassfed On the Hill Buying Club has about 500 active members. Liz Reitzig, a mother who has become a raw-milk activist and is an organizer of the group, said the lawyers who pursued the case against Mr. Allgyer ought to “be ashamed.” “Many families are dependent on the milk for health reasons or nutritional needs, so a lot of people will be desperately trying to find another source now,” she said.
