FDA Deputy Commissioner tough on medical devices resigns

(NaturalNews) After serving less than two years as the Deputy Commissioner of the U.S. Food and Drug Administration (FDA), Joshua Sharfstein recently announced that he is resigning from his position at the agency to become head of Maryland’s Department of Health and Mental Hygiene. During his time at the FDA, Sharfstein took some aggressive steps to crack down on unsafe medical devices that were on the market, which some say may have played a role in his ultimately stepping down. Sharfstein was not always a friend to the industry that he regulated, which is uncharacteristic of most higher-ups at the FDA. He played an important role in sparking the Avandia safety review that led to the unsafe drug earning tighter use restrictions, for example. And he also went after medical device manufacturers that have long taken advantage of the poor regulatory standards employed by the FDA. One of the most aggressive courses of action Sharfstein took during his time at the FDA was the prosecution of drug company executives, rather than just the companies themselves, for crimes committed. GlaxoSmithKline, for instance, saw one of its top lawyers indicted as part of a joint investigation by both the FDA and the U.S. Justice Department. Under Sharfstein’s leadership, the FDA seemed to be headed somewhat in the direction it should have been headed all along — it was actually beginning to hold the industries it regulates responsible for the unsafe drugs and medical devices they produce, while also prosecuting the individuals in those industries found responsible for illegal activity. On the other hand, Sharfstein also set up the 2009 FDA press conference to announce that electronic cigarettes contain certain questionable chemicals like diethylene glycol that the agency says may be unsafe. This is at the same time that FDA-approved nicotine patches with the same chemicals are being sold to consumers without question. Sources for this story include: http://online.wsj.com/article/SB10001424052748704723104576061692596851936.html http://www.nytimes.com/2009/07/23/health/policy/23fda.html

Diabetes drug researcher admits drug trials are unethical and dangerous

(NaturalNews) A drug researcher who presided over the trial that first raised concerns over the diabetes blockbuster Avandia has warned that further tests of the drug’s safety would be unethical. In 2009, David Juurlink of Sunnybrook Health Sciences Center in Toronto was the lead author of a study that compared rates of heart failure and death among older diabetics taking Avandia (known generically as rosiglitazone) and those taking Actos (pioglitazone), another drug in the same family. That study found that patients taking Avandia were 30 percent more likely to suffer heart failure or death. Now Juurlink has joined with Sidney Wolfe, director of health research for Public Citizen, to call for the cancellation of another planned Avandia-Actos comparison study, known as the Thiazolidinedione Intervention in Vitamin D Evaluation (TIDE) trial. The TIDE trial is to be performed by Avandia manufacturer GlaxoSmithKline at the behest of the FDA, which in 2007 ordered the company to conduct further safety studies of the drug. The FDA’s order came after it required the company to put a “black box” warning on the drug’s packaging about the risk of heart attack and heart failure. The strong results of the 2009 study make any further comparison unethical, Juurlink and Wolfe have warned. The TIDE trial would expose “thousands of high-risk patients with diabetes to a drug with an unfavorable safety profile and clinical advantage over its comparator,” they wrote in an open letter to the FDA. The TIDE study is due to be carried out in 14 different countries, including Third World countries such as Chile, India, Latvia, Mexico and Pakistan. “[The] price of definitive proof” that Avandia is unsafe, “will almost certainly be measured in the lives of study subjects who have been incompletely informed about the risks and benefits of participation,” Wolfe and Juurlink wrote. All drugs in the thiazolidinedione class, including Actos and Avandia, have also been linked to increased risk of anemia, edema, macular edema, bony fractures and acute liver injury. Sources for this story include: http://latimesblogs.latimes.com/booster_shots/2010/05/diabetes-drug-trial-unethical-and-dangerous-researcher-charges.html.

GlaxoSmithKline pushing dangerous Avandia drug on thousands in new global clinical trial

(NaturalNews) Back in February, I wrote an article about how a Senate Finance Committee report revealed that GlaxoSmithKline, the maker of the diabetes drug Avandia, knew that its drug was dangerous and caused heart attacks; yet GSK went out of its way to hide this important information from the public and kept on selling Avandia . Now, GSK has now decided to launch a global clinical trial of this dangerous drug that could potentially harm thousands of people. Both FDA and GSK scientists have found that Avandia is dangerous and significantly increases the risk of heart attacks, but the drug remains on the market to this day. FDA officials have rejected sound scientific evidence demonstrating the dangers of the drug, including evidence from the FDA’s own scientists. (Read all about the Avandia scandal in my previous article on the subject .) Meanwhile, GSK is moving forward with a global clinical trial that it says will compare the safety of Avandia with other diabetes drugs in its class. In other words, according to press reports, GSK knows Avandia is dangerous, but it’s choosing to go ahead with a trial anyway… a trial that could put the lives of thousands of people at risk. Real scientists say Avandia drug trial is unethical and dangerous Dr. David Juurlink, chief of clinical pharmacology and toxicology at Sunnybrook Health Sciences Center in Toronto, and Dr. Sidney Wolfe, director of health research for the consumer advocacy group Public Citizen, have petitioned the FDA to stop the GSK drug trial . Citing concerns that the trial is “unethical” and “dangerous”, the two are doing what the FDA itself should be doing – assessing the evidence and coming to a rational conclusion about risk versus benefit. After all, it was Dr. Juurlink’s 2009 study which already found that Avandia increases the risk of heart failure and death by 30 percent more than another diabetes drug in the same class. Not only has Avandia been proven to be dangerous, it’s been proven to be even more dangerous than the competition. And numerous studies years before found that Avandia increases the risk of heart problems and death, prompting the FDA to issue two black-box warnings for the drug back in 2007. But at this point, it doesn’t seem to matter how many people suffer and die from Avandia because the FDA somehow doesn’t believe there is “conclusive evidence” that Avandia is dangerous, so pharmacies everywhere continue to sell it. And even though GSK knows that Avandia is statistically responsible for an increase in deaths, it continues to push this drug on the masses. GSK guilty of negligent deaths? If you really think about it, what GSK is doing amounts to negligent homicide. The company is knowingly and willfully selling a dangerous drug that’s killing people, and now it wants to subject even more people to unnecessary risk of death through a medically unnecessary clinical trial that’s global in scope. I say “medically unnecessary” because there have already been a number of studies verifying that Avandia is dangerous. Why create another trial with 16,000 participants to reveal what we already know? How many more people need to suffer or die before the FDA pulls the drug from the market? The sheer lunacy of what’s taking place here in the name of “medicine” and “science” is shocking — even to those of us who follow the crimes and corruption of Big Pharma on a regular basis. Real scientists and doctors know this behavior by GSK is appalling, and apparently so does much of the public who, according to new reports , are refusing to even participate in the trial. GSK can’t even get Americans to participate in the trial, so it’s moving to third-world countries/h1> Typically when drug companies conduct clinical trials, they pay people a sum of money to act as guinea pigs for a new drug. (Sadly, many people are willing to ingest experimental substances for a couple hundred bucks). However according to a recent Wall Street Journal article, GSK can’t even get Americans to sign up! You see, the average joe has more common sense than the FDA, and a lot of people know that Avandia is dangerous. The Wake Forest University Baptist Medical Center in North Carolina, for example, which is one of GSK’s study sites, has “not succeed[ed] in recruiting anybody” in over a year. And this is during a time when a lot of Americans are out of jobs and desperately need the cash. So what does GSK do in response? It opens dozens of new sites in third-world countries where it can prey on innocent poor people who are less informed about the dangers of Avandia. In fact, this is part of the reason why Dr. Juurlink and Dr. Wolfe are urging the FDA to stop the trial. They recognize how evil it is for GSK to exploit ill-informed people from other countries when things aren’t going so well for Avandia back at home. In targeting low-income third-world study subjects, GSK is demonstrating itself to be a ruthless, money-hungry organization that has no qualms about exploiting human lives to achieve its profit goals. The inhumanity of the medical-industrial complex The whole Avandia fiasco is truly indicative of the way the medical-industrial complex operates. You would think that after all the studies and trials proving its dangers, the countless lawsuits and the official government report, that GSK would at least back down from this drug. Not only has GSK continued to deny the obvious truth about Avandia’s risks, but now it is shamelessly pressing forward to expand the market for Avandia around the world. (Remind you of anything? How about Big Tobacco?) It seems obvious that Avandia should be pulled from the market and GSK investigated for its role in pushing a knowingly harmful drug. At the very least, there should be a moratorium on the sale of the drug until GSK can prove the safety of Avandia. But in the real world, this dangerous drug is being treated as safe and its producer is allowed to continue using it on human guinea pigs around the world. If GSK was a person, that person might be classified as a serial killer (and the FDA would be considered its accomplice). Both GSK and the FDA, if they were people, would be pursued for their crimes against society. But because they are two of the key organizational players in the global medical-industrial complex, they continue to perpetrate their crimes without consequence. This may be changing, though, as people wake up to the truth. The fact that GSK can’t get U.S. participants to sign up for its Avandia clinical trials says to me that people are really starting to recognize “the emperor has no clothes.” Big Pharma’s lies can only continue for so long before the truth is exposed.

GlaxoSmithKline deliberately hid evidence of Avandia harm, says Senate report

(NaturalNews) GlaxoSmithKline, maker of the diabetes drug Avandia, knew the drug was linked to tens of thousands of heart attacks but went out of its way to hide this information from the public, says a 334-page report just released by the Senate Finance Committee. (http://finance.senate.gov/press/Gpress/2010/prg022010a.pdf) This report also accuses the FDA of betraying the public trust, explaining that FDA bureaucrats intentionally dismissed safety concerns found by the agency’s own scientists. The report says that Big Pharma’s drugs “put public safety at risk because the FDA has been too cozy with drug makers and has been regularly outmaneuvered by companies that have a financial interest in downplaying or under-exploring potential safety risks.” Sales of Avandia were $3.2 billion (yes, billion) in 2006. According to a statistical analysis in the report, if all the diabetics currently taking Avandia were put on a “safer” drug, it would avert 500 heart attacks and 300 cases of heart failure every month in the United States alone. Presently, hundreds of thousands of Americans are still taking this drug, and hundreds will continue to die each month as a result, according to the report estimates. This report, championed by U.S. Senators Grassley and Baucus, is the result of investigators pouring through more than 250,000 pages of documentation gathered from GlaxoSmithKline and the FDA. The document reveals some rather startling facts about the dangers of Avandia, including evidence from the FDA’s own scientists who concluded that Avandia was associated with 83,000 heart attacks . GlaxoSmithKline intimidates scientists This investigative report also reveals that GSK engaged in the intimidation of physicians, saying: “GSK executives attempted to intimidate independent physicians, focused on strategies to minimize or misrepresent findings that Avandia may increase cardiovascular risk and sought ways to downplay findings that a competing drug might reduce cardiovascular risk.” “Patients trust drug companies with their health and their lives, and GlaxoSmithKline abused that trust.” said Sen. Baucus. (Gee, really? Is anyone really surprised that GSK put its own financial interests ahead of a few thousand human lives?) A separate letter sent to FDA Commissioner Margaret Hamburg by Senators Baucus and Grassley added, “the totality of evidence suggests that GSK was aware of the possible cardiac risks associated with Avandia years before such evidence became public.” The FDA’s own research also showed Avandia to be associated with a significant increase in heart attack risk, yet the FDA did nothing to protect the public. The agency’s own scientists wrote in 2008, “There is strong evidence that rosiglitazone [Avandia] confers an increased risk of [heart attacks] and heart failure compared to pioglitazone [a rival drug on market].” This evidence went completely ignored at the FDA. The FDA’s famous Dr David Graham — the key whistleblower on the Vioxx scandal — concluded from his own research, “Rosiglitazone should be removed from the market.” Even the American Medical Association — a long-time defender of Big Pharma’s drugs — admitted Avandia was dangerous. Its journal, JAMA, wrote in 2007: “Among patients with impaired glucose tolerance or type 2 diabetes, rosiglitazone use for at least 12 months is associated with a significantly increased risk of myocardial infarction and heart failure, without a significantly increased risk of cardiovascular mortality.” The New England Journal of Medicine also warned about the safety of the drug in an article published in 2007. Despite these multiple warnings, an FDA panel voted 22 – 1 in favor of keeping Avandia on the market. This is no surprise, of course, to those who know how the FDA really operates (and where its priorities really lie). Analysis: What does it all mean? Are you kidding me? A drug company hid data that its high-profit drug was linked to increased risk of heart attacks? A drug company intimidated physicians and got away with hoodwinking the public while raking in billions of dollars in sales for a drug that the FDA’s own scientists said should be pulled from the market? Sounds like business as usual at the FDA, the “sweep it under the rug” division of the pharmaceutical industry. Once again, Dr David Graham turns out to be the sharpest guy in the room while having the courage to tell the truth even when surrounded by an agency full of morons and criminals. The drug industry must hate this guy. But they can’t get rid of him because he’s one of the very few scientists in the FDA who is actually committed to protecting the public . Gee, what a concept, huh? The FDA as a whole abandoned that idea so long ago that virtually nobody there even remembers what it means. Protect the public? What do you mean? As in, lose profits by banning dangerous drugs that just happen to be making big money? That’s unthinkable at the FDA as we know it today. The agency exists to promote pharmaceuticals , not to limit their sales just because a hundred thousand people happen to drop dead each year from taking FDA-approved drugs. When it comes to safety vs. profits, the FDA chooses profits for Big Pharma time and time again. Do the math on this: If Avandia is linked to 83,000 heart attacks, and if roughly 50% of those are fatal (that’s just an estimate), then Avandia could conceivably be the cause of 40,000 deaths . The terrorist attacks of 9/11 killed roughly 3,000 Americans, and yet just one drug that has been mysteriously kept on the market by the FDA appears to have killed more than ten times as many Americans as the terrorists . So what does that make the FDA? More dangerous than the terrorists, of course! So why is the FDA still allowed to operate in America if it’s such a dangerous organization that’s killing so many American citizens? Because it’s profitable, of course! There’s one thing that’s true about both WAR and MEDICINE: As long as the right corporations are making money, it really doesn’t matter how many people die in the process. And for all those diabetic Americans struggling to find improved health right now, there’s something you desperately need to know: There’s a price to putting your faith in the FDA, the drug companies and your pill-pushing doctor. That price may very well be your own life. Diabetes has a cure, you know. You can reverse it in as little as four days by changing your diet. Read the books on diabetes by Dr Gabriel Cousens or Dr Julian Whitaker. Or read more about diabetes right here on NaturalNews: http://naturalnews.com/diabetes.html Here’s the full report from the U.S. Senate (PDF): http://finance.senate.gov/press/Gpress/2010/prg022010a.pdf Sources for this story include: CNN http://edition.cnn.com/2010/HEALTH/02/20/avandia.study/?hpt=T1 NY Times http://www.nytimes.com/2010/02/20/health/policy/20avandia.html PharmaTimes http://www.pharmatimes.com/WorldNews/article.aspx?id=17434