Ethical Dilemmas Contribute to 'Critical Weaknesses' in FDA Postmarket Oversight, Experts Say

 Ethical challenges are central to persistent "critical weaknesses" in the national system for ensuring drug safety, according to a commentary by former Institute of Medicine (IOM) committee members published August 22 in the New England Journal of Medicine.

With a caution against "reactive policymaking," committee co-chairs Ruth Faden, Ph.D., M.P.H., and Steven Goodman, M.D., M.H.S., Ph.D., with fellow committee member Michelle Mello, J.D., Ph.D., revisit the controversy over the antidiabetic drug Avandia that led to the formation of their IOM committee on monitoring drug safety after approval.

The Avandia postmarket trial, halted in September 2010, was "a lesson in how our current approach to the oversight of drug-safety and postmarketing research can fail both the public and the research participants," the authors write. With those lessons in mind, their independent commentary follows the May 2012 IOM report with a focus on the ethical challenges ahead.

The authors detail the IOM report's recommendations for maintaining the delicate balance of drug innovation and drug safety. Increased "fast-tracking" of drug approval for medical conditions with no effective treatment necessitates a counterbalance of increased postmarket oversight, the authors argue. They echo the IOM report's call for an independent ethics advisory board to the Food and Drug Administration (FDA), focused on postmarket research and safety surveillance.

"As the pace of the translation of discoveries from bench to bedside continues to intensify, so too does the imperative for thoughtful ethical governance throughout the lifecycle of a drug," the authors write.

The authors also amplify one of the IOM report's key ethics points -- the responsibility of the FDA to participants in postmarket research, particularly in randomized trials that determine which treatment they receive. The FDA has a unique ethical obligation to the welfare of research participants when requiring a postmarket study, the authors assert, which "cannot be handed off to contractors or the industry sponsor."

Read more.. 

http://www.sciencedaily.com/releases/2012/08/120822181226.htm

Government Has Been Covering up Radiation Danger for 67 Years

The U.S. and other governments have been covering up nuclear meltdowns for fifty years to protect the nuclear power industry.

It turns out that the U.S. tried to cover up the destructive nature of radiation produced by nuclear weapons 67 years ago. As Democracy Now reports:

The army was well aware in 1943 of the enormous potential for radiation dangers to civilians and military personnel as a result of the use of radioactive weapons ….

[The New York Times] was essentially putting out the official government narrative [regarding the bombing of Hiroshima and Nagasaki], which is that atomic radiation is not harmful, is not a major byproduct of the nuclear weapons program. You know, it’s only the blast that has essentially a very short impact. The reason that this has importance is that for really a half century, this narrative became the government’s response to all protests against nuclear power, the nuclear weapons programs of the 1950s and 1960s and the Cold War. So, [The New York Times] essentially set the table that the government was to occupy for the next half century as they disputed any attempt to rein in, you know, the rapid acceleration of nuclear weapons and power programs.

Nothing has changed. Governments worldwide continue to this day to cover up the amount – and health effects – of radiation released by military and energy facilities.

And the same considerations which drove the cover up in 1945 are still driving it. The archaic uranium reactor designs developed more than 40 years ago are good for making bombs.

 Read more.. http://globalresearch.ca/index.php?context=va&aid=32390

Gary Null, Ph.D., and Nancy Ashley, VMD - The Politics of Medicine

THE POLITICS OF MEDICINE

By Gary Null, PhD and Nancy Ashley, VMD

March 5, 2012 

In 2012, America has become the most overmedicated society in history. Indeed, there is a medication for every condition, and we believe these medications will make us happy, slender, full of energy, and attractive like the people in the television ads.  We are even told that we don’t take enough medications as the list of made-up diseases grows longer and longer:  restless leg syndrome, social anxiety disorder, overactive bladder, pre-diabetes, adult ADD.  We never stop to question why we need all these drugs.  We never even notice that they aren’t making us better, or that we can’t get off them once we start taking them.  Why do we refuse to see that despite all these medications we are nevertheless the sickest industrialized nation on earth?

America doesn’t profit from prevention.  There are no preventative programs for cancer, heart disease, arthritis, dementia, Alzheimer’s, or diabetes, for a simple reason:  it would compete with the massive profits of the medical industrial complex.  So instead we have become a nation of gluttons -- we sublimate our anxiety and fears with comfort foods and the government encourages it instead of offering us an honest look at cause and effect.  Protecting the financial interest of the fast food industry, the makers of potato chips, soft drinks, hamburgers, steaks, desserts, genetically engineered corn, and pesticides are a compliant FDA and USDA whose leaders have been hand-picked by the White House to represent the interests of manufacturers. There will be no advocacy from Congress whatsoever to help the health of Americans.  But what is the likely outcome if we continue with our current lifestyles?

We are witnessing a watershed of dysfunction.  The American media has assisted in creating this mythology.  They have not only protected the American medical paradigm and the pharmaceutical industry, but they have actually attacked physicians, scientists, whistle-blowers, and parents groups that have run into the medical bureaucratic juggernaut.  As a nation we have sunk so low as to allow our legislators to create laws based on what they are told by big business through the American Legislative Exchange Committee (ALEC), laws that mandate the Gardasil vaccine for girls and now boys or they can’t go to school, and laws that require that health care workers get the flu vaccine or lose their jobs.  All of this without the major media ever raising a single question:  is this real science, or science for sale?

We have decided to explore the politics of medicine and the consequences of therapies, physicians, scientists, advisors, government agencies, the media, and a vulnerable public who are unaware of how malignant the system has become – how pernicious, widespread, and in fact, endemic, the self-interest, greed and  bad science actually is.   Part I of our in-depth investigative report will show that American medicine is not only broken, but contributes to unnecessary injury and death into the millions of victims per year.  It has morphed into an extension of the pharmaceutical industrial complex – the friendly face with the white coat and the stethoscope.  We will now deconstruct this myth.

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A Gary Null Show Special Report: Gardasil - Child Abuse by a Vaccine

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