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Thursday, September 23, 2010

Pharma and the FDA's Threat to Health and Life

by David Speigel

A recent, not yet published

study

by Donald Light, a sociologist and professor of comparative health policy at the University of Medicine and Dentistry of New Jersey found that 85% of new drugs offer few if any benefits and are dangerous. The i

neffectiveness of antidepressants was called "jaw-dropping" and prescription drugs were seen as a significant cause of death. The paper also pointed out that drugmakers spend "two to three times more on marketing than on research." Light refers to a "two-tier market" for drugs that are lemons, with doctors getting misleading information which is passed on to patients which he calls "the risk proliferation syndrome." In Ed Ed Silverman's description of Light's work, the risk proliferation syndrome is based on "corporate, government, and medical practices that maximize the number of drugs put on the market with risks of adverse reactions and then maximize the number of people induced to take them."
The medical community's ties to the pharmaceutical industry is so pervasive that the Journal of the American Medical Association has called for medical associations to sever ties to the industry. Beatrice Golomb, MD, Ph.D has reported that all levels of scientific evidence has been manipulated by the industry

At the same time, the multinational pharmaceutical industry is moving forward to remove its competition, safe supplements.

Starting on April's Fool's Day, 2011, there will be an EU food-supplement clampdown which will override consumer choice as "... hundreds of food supplements and thousands of health-benefit claims concerning food supplements will be banished from the European market as each European Union member state enforces the EU Supplements Directive of 2002."
According to Jonathan Emord who has defeated the FDA more times in federal court than any other attorney in American history, "The system discriminates against small companies and new market entrants in favor of large companies and incumbent sellers because it presumes all products sold without incident to be unlawful unless proven – based on clinical trial evidence – to be safe and bioavailable. Proof, in the form of scientific dossiers, must establish to EFSA's satisfaction that products intended for sale are safe and bioavailable. No claims may henceforth be made unless scientific dossiers establish to EFSA's satisfaction that the claims are proven to a near conclusive degree. The dossiers are expensive, roughly[B1] US $500,000 or more per submission. At least 90 per cent of the companies in this market cannot afford to submit a dossier and so must either cease sales altogether or reduce product offerings to those that others succeed in getting approved.
The same effort to end access to supplement is occurring in the US. Five bills have been introduced so far this year to shut down access to supplements in the US, when one includes the most recent, S 3767 introduced September 13th.

"... contrary to what the media has been saying (and many members of Congress believe), dietary supplements are indeed fully regulated. The FDA has complete authority to regulate supplements in three important ways:
  1. It can take any supplement off the the market that is unsafe, mislabeled, misbranded, adulterated, or makes false or misleading claims. (The FTC also has the power to stop any fraudulent advertising.)
  2. It is charged with enforcing the 1994 Dietary Supplement Health and Education Act (DSHEA), which holds supplement manufacturers to "good manufacturing practices" (industry standards for product quality) as defined by the FDA itself.
  3. It collects and takes any necessary action based on "adverse event reports," that is, any reported negative reactions to dietary supplements.


The American Medical Journal, reporting only on one supplement, vitamin D, is unequivocal in stating that "Adequate vitamin D status is necessary and beneficial for health ..." It then goes only to point out that "deficiency plagues much of the world's population," before enumerating a long list of disorders and diseases that vitamin D is crucial in relation to: "In addition to reducing the risk for bone disease, vitamin D plays a role in reduction of falls, as well as decreases in pain, autoimmune diseases, cancer, heart disease, mortality, and cognitive function. On the basis of this emerging understanding, improving patients' vitamin D status has become an essential aspect of primary care. Although some have suggested increased sun exposure to increase serum vitamin D levels, this has the potential to induce photoaging and skin cancer, especially in patients at risk for these conditions."

It is not incidental that the AMJ mentions mortality. They are not saying that vitamin D is "just something nice"
or "just something helpful" but that maintaining adequate levels of vitamin D is a life and death issue. The Journal suggests autoimmune diseases, pain, falls, bone disease, cancers and deaths can be reduced and at no risk, "Vitamin D deficiency and insufficiency can be both corrected and prevented safely through supplementation."

If the AMJ article is accurate about the necessity of vitamin D for lowering not only some of the most dreadful diseases people can endure but mortality itself, there is no other way to view Congressional bills to give power to the FDA to remove supplements, as anything other than a dire threat to the lives of all people in the country.


And the pharmaceutical industry is doing more than selling lemon-drugs that are killing large numbers of people, or working to remove access to supplements crucial for health and life. They are now shifting to drugs and vaccines for healthy people.

"The new paradigm is that people need drugs before they get sick, as a sort of "protection" against sickness. Drugs, in essence, are being positioned as nutrients — things the human body needs in order to be healthy. .... That's why babies are injected with vaccines within minutes after being born."

The marketing move away from only treating only extends the target market from only the sick to everyone in the world markets through fear.

To accomplish the shift from selling to the sick to selling to everyone requires disease mongering be raised to a very high level. The pharmaceutical industry through its deep ties to the Bush administration, through Bush-corrupted science agencies and through mass media, have created waves of fear around "pandemics" - the danger than millions might die - to push the H1N1 vaccines.

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