Wednesday, September 22, 2010

Pharma and the FDA's Threat to Health and Life

by David Speigel

A recent, not yet published


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.

Fear mongering, distortion of the truth, and/or ties to the pharmaceutical industry appear in the CDC's data on H1N1 cases being false by as much as 98%; in the CDC blocking an investigation of its H1N1 data; in the pandemic itself having been exposed as a corrupt scheme between vaccine companies and the WHO; in the leading "pandemic" expert at the WHO being under investigation for corruption; in researchers asking if the pandemic were PR and alarmist rather than science and why international scientists were expressing distrust of the CDC; in the British Medical Journal exposing that "key scientists advising the World Health Organization on planning for an influenza pandemic had done paid work for pharmaceutical firms that stood to gain from the guidance they were preparing;" in the head of the CDC who set up a pandemic division and allowed false CDC H1N1 data to go out subsequently taking a lucrative job at Merck over vaccines; in the CDC now being accused of falsifying data on miscarriages from the 2009 H1N1 vaccine; in the CDC saying the H1N1 vaccines were like all other flu vaccines thus didn't require testing while not divulging the H1N1 vaccines were experimental and contain nanoparticles associated with DNA damage; in the CDC ignoring a Canadian researchers showing that taking flu vaccines before H1N1 vaccines increased the risk of contracting H1N1 and letting manufacturers combine the two; in the CDC ignoring high rates of febrile seizures and narcolepsy in other countries from the 2010 "flu vaccine" (H1N1 vaccine combined with seasonal flu vaccine) while urging even more Americans (all over the age of 6 months) to take the vaccines; in the UPI study on the CDC ties to the vaccine manufacturers; in HHS urging media to censor vaccine concerns;

The shift from drugs for illness to vaccines for everyone has marketing logic behind it, and it was also based on two differences between drugs and vaccines. One, It is easy to tell if drugs are making people ill or killing them. The public becomes outraged and companies can be sued. But it is impossible to tell with vaccines, other than in the very immediate reactions after them and the CDC often ignores such reactions, as they have done with thousands of parents reporting their children's severe changes in behavior. Harm that occurs outside of that early time frame, and any chronic diseases vaccines may be causing are hard to link to the vaccines.

Thus, the battle continues between the CDC and parents insisting that vaccines have damaged their children. Rather than err on the side of caution - or even decency - and remove any item in vaccines that is a known neurotoxin, the CDC puts out a study at the beginning of the flu season, with mercury in those vaccines, asserting again there is no danger. For while the CDC is trying to ignore bizarre cases of narcolepsy and the greatly increased number of febrile seizures in children from the flu/H1N1 vaccine which are being reported abroad already, the issue of autism is much greater.

To admit any link between vaccines and the high level of autism occurring in children, would doom vaccines as their much invested in, ideal universal product. The world would simply not accept vaccines that are linked to causing a dreadful disease, now much fear of pandemics is generated. The bloom would be off the rose of vaccines as scientific miracles.

That "miracle" is the foundation upon which vaccines rest and brings up the second reason that vaccines are now favored. They require no science.

"There's another important shift taking place alongside the big vaccine push: A shift away from "evidence-based medicine" to a new medical paradigm of "dogmatic belief."

"Medicines that treat sick people ... have to be proven to work. There have to be clinical trials, and some percentage of those sick people (only 5% or so, typically) have to show some sort of improved response after taking the medicine. This is the so-called "gold standard" of modern medicine. But with vaccines, no proof of efficacy is required. No placebo-controlled studies need to be conducted at all. Vaccines can be openly marketed and prescribed without any evidence that they actually work."

The agency allowing all this to happen is the FDA. It is the agency passing drugs that kill and leaving them on the market even when that becomes clear, threatening those who attempt to inform the public of safer options for pain while imprisoning those who harm no one. It is the agency poised to remove safe supplements and has changed a rule that removes the most fundamental safety protections from vaccines. Its dangerous vaccine rule change occurred this spring.

"This past spring, the FDA took a hands-off approach to Merck's admission that DNA from a lethal pig virus is contaminating doses of RotaTeq vaccine being swallowed by millions of newborn babies. The FDA is arguing that the rule change is necessary to "reduce burdens on industry" and to provide "greater flexibility and reduced regulatory requirements." ....

There is no information about how much scientific evidence the drug companies will have to submit to prove the new ingredients are safe; or whether the FDA's Vaccine Advisory Committee will be able to review that evidence; or whether the American public will have a chance to comment before vaccine ingredients are changed. ....

Last year when federal health officials declared a pandemic H1N1 “swine flu” national emergency, drug companies put a full court press on the FDA to fast track licensure of highly reactive oil based squalene adjuvants [which hyperstimulate the immune system and have been associated with autoimmunity] and the use of new technology, like insect cells, [which could be contaminated with insect viruses] to make pandemic influenza vaccines. ....

Neither technology was licensed by the FDA last year but there are tens of thousands of doses of squalene that the federal government bought and is stored in warehouses waiting to be used.

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