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In the wake of shocking reports on how the FDA, terrified of being outed for its questionable practices, spied on its own employees in the hopes of rooting them out before they could become whistleblowers, a new story has emerged on how deep the deceit goes. From marginalizing safety reports to not reading them at all―and then going ahead and approving the drugs in question―the FDA once more stands accused of being little more than a rubber-stamping agency for Big Pharma.
Explosive revelations of an intensive spy operation by the FDA on its own scientists emerged last month. Using sophisticated spy software, the agency tracked and logged every move made by the targeted individuals. The program even intercepted personal emails and copied documents on their personal thumb drives.
The targeted scientists had expressed concern over the agency's approval of dangerous medical imaging devices for mammograms and colonoscopies, which they believe expose patients to dangerous levels of radiation. Now, another whistleblower has stepped forward, and what he has to say about the agency's drug safety reviews is shocking even to the jaded...
Ronald Kavanagh was a drug reviewer for the FDA in the Center for Drug Evaluation and Research from 1998 to 2008. In a recent interview he reveals how the FDA bypassed or ignored safety issues on major drugs approved during his employment. In an interview for the online news magazine Truth-Out, he tells Martha Rosenberg1:
"In the Center for Drugs [Center for Drug Evaluation and Research or CDER], as in the Center for Devices, the honest employee fears the dishonest employee.According to Kavanagh, people would be shocked if they knew just how malleable safety data is. As examples, he points out that human studies are typically too short and contain too few subjects to get a clear picture of potential risks. In such a scenario, even a single case of a serious adverse event must be taken very seriously, and data from other longer term safety studies also need to be carefully analyzed. Kavanagh claims he has seen drug reviews where the medical safety reviewer completely failed to make such evaluations prior to the drug's approval.
There is also irrefutable evidence that managers at CDER have placed the nation at risk by corrupting the evaluation of drugs and by interfering with our ability to ensure the safety and efficacy of drugs. While I was at FDA, drug reviewers were clearly told not to question drug companies and that our job was to approve drugs. We were prevented, except in rare instances, from presenting findings at advisory committees.
In 2007, formal policies were instituted so that speaking in any way that could reflect poorly on the agency could result in termination. If we asked questions that could delay or prevent a drug's approval - which of course was our job as drug reviewers - management would reprimand us, reassign us, hold secret meetings about us, and worse. Obviously in such an environment, people will self-censor."
There's no telling how many ineffective and/or dangerous drugs and medical devices have been approved and ushered into market through sheer intimidation and bullying, either by pharmaceutical companies or FDA management. Perhaps even more shocking are the revelations that some of the internal rules and regulations of the FDA are clearly designed to thwart serious safety reviews from the get-go.CLICK BELOW TO READ MORE
According to Kavanagh:
"[H]uman clinical pharmacology trials are typically done in Europe, yet clinical pharmacology reviewers at FDA have been barred from analyzing this information prior to studies being conducted in the US. Without being able to do this, we are unable to detect evidence of risks early and cannot provide guidance that would help with the development of the drug in terms not only of safety and proving efficacy, but also with the efficiency and cost effectiveness of the drug's development."
The Natural Resources Conservation Service owns 987 cars, 3,387 light-duty trucks, 4,341 four-wheel-drive light-duty trucks, 767 medium-duty vehicles, 33 heavy-duty vehicles, and one bus. Medium-duty vehicles, according to GAO, can be cargo vans and work trucks while heavy-duty vehicles include dump trucks and other large vehicles.
Our goal is not just a sustainable, nutritious, abundant food supply, but also thriving ecosystems that support a diversity of life. In the next century, NRCS will not only continue to tackle familiar challenges like ensuring clean water and healthy soil, but will also rise to meet new issues, such as clean air, clean energy, climate change, and new technology.This boondoggle agency has been absorbing taxpayers’ dollars ever since 1935. That was early in Roosevelt’s New Deal. It used to be called the Soil Conservation Service, but that’s so very 1935! “NRCS has expanded to become a conservation leader for all natural resources, ensuring private lands are conserved, restored, and more resilient to environmental challenges, like climate change.” Climate change. Right.
Science and technology are critical to good conservation. NRCS experts from many disciplines come together to help landowners conserve natural resources in efficient, smart and sustainable ways. Whether developed in a laboratory or on the land, NRCS science and technology helps landowners make the right decisions for every natural resource. NRCS succeeds through partnerships, working closely with individual farmers and ranchers, landowners, local conservation districts, government agencies, Tribes, Earth Team volunteers and many other people and groups that care about the quality of America’s natural resources.
August 15, 2012 4:00 A.M.How Did Harry Reid Get Rich?
His career in public service has ended up being remarkably lucrative.
iTry this thought experiment. Imagine that someone grows up in poverty, works his way through law school by holding the night shift as a Capitol Hill policeman, and spends all but two years of his career as a public servant. Now imagine that this person’s current salary — and he’s at the top of his game — is $193,400. You probably wouldn’t expect him to have millions in stocks, bonds, and real estate.
But, surprise, he does, if he’s our Senate majority leader, whose net worth is between 3 and 10 million dollars, according to OpenSecrets.org. When Harry Reid entered the Nevada legislature in 1982, his net worth was listed as between $1 million and $1.5 million “or more,” according to the Las Vegas Review-Journal. So, since inquiring minds inquire, let’s try to figure out how Reid’s career in public service ended up being so lucrative. He hasn’t released his tax returns, which makes this an imperfect science, but looking at a few of his investments helps to show how he amassed his wealth.
In 2004, the senator made $700,000 off a land deal that was, to say the least, unorthodox. It started in 1998 when he bought a parcel of land with attorney Jay Brown, a close friend whose name has surfaced multiple times in organized-crime investigations and whom one retired FBI agent described as “always a person of interest.” Three years after the purchase, Reid transferred his portion of the property to Patrick Lane LLC, a holding company Brown controlled. But Reid kept putting the property on his financial disclosures, and when the company sold it in 2004, he profited from the deal — a deal on land that he didn’t technically own and that had nearly tripled in value in six years.
How Reid acquired that land is interesting, too. He put $10,000 into a pension fund his friend Clair Haycock controlled, to take over the 160-acre parcel at a price far below its assessed value. Six months later, Reid introduced legislation that would help Haycock’s industry, a move many observers said appeared to be a quid pro quo, though Reid and Haycock denied that the legislation was the result of a property deal.
We don’t know how much more money Reid has or how he made all of it. For that, we’d have to see his tax returns.
by wp: tax returns that strangely he says are private and will not make public. HYPOCRITICAL, WOULDN'T YOU SAY???