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Chapter 8 Page 8
The Conventional Medical Paradigm
Despite the extreme conflict of interest that exists when a company that is the sponsor of an application for drug approval is also the party that tests its own drug for safety and efficacy, over the years FDA medical reviewers have discovered grounds to call into question the safety and efficacy of drugs. Nevertheless, political appointees who run the agency quite frequently have demanded that drugs be approved for marketing even when evidence exists to call safety and efficacy into question.
In 2004, Dr. David J. Graham, the Associate Director of the FDA Office of Drug Safety, had had enough. Year after year he watched with horror as political bosses within the FDA did the drug companies’ bidding by overruling agency medical reviewers and approving drugs for market that those bosses knew were unsafe. Graham went to Senator Charles Grassley, then head of the Senate Finance Committee, with the evidence proving that the American people were the victims of FDA abuse, were being given unsafe drugs to further the interests of some of the largest pharmaceutical companies in the world.
In the September/October 2005 issue of the Assocation of Certified Fraud Examiners’ publication, Fraud Magazine, Dr. Graham explained in an extensive interview government-industry collusion at the FDA, a collusion that imperiled and sacrificed the lives of Americans in service of the financial interests of pharmaceutical companies.
FDA is inherently biased in favor of the pharmaceutical industry. It views industry as its client, whose interests it must represent and advance. It views its primary mission as approving as many drugs as it can, regardless of whether the drugs are safe or needed. . . . The pro-industry bias leads to an environment where FDA tends to see things from industry’s perspective. Many are the advisory committee meetings where the drug company presentation and the FDA presentation are virtually super-imposable. It makes you wonder who wrote the presentations. . . . Safety isn’t on the radar screen regardless of what FDA officialdom would have you believe. Scientifically, FDA uses statistics in a biased manner that favors industry at the expense of patient safety. You see, when FDA reviews a new drug, it assumes that the drug is safe, and it facetiously asks the company to prove that it’s not safe. Of course, there is no incentive for a company to prove that their drug is not safe because then FDA might not approve it. So, with a nod and a wink, drug companies jump through very low hoops that FDA sets up for safety, and the public pays in two ways—with their money and their lives . . . . What has emerged is a lethal triangle involving FDA, the pharmaceutical industry and Congress. Pharmaceutical money funds FDA and exerts great influence with Congress. FDA allows deadly drugs onto the market and Congress pretends that nothing is the matter.