"The only thing necessary for the triumph of evil is that good people do nothing." - Edmund Burke

Overview

nnocent Casualties exposes the Food and Drug Administration’s attempts to deny Americans access to nutritional products, including banning certain nutrients widely used in other countries and attempting to have vitamins classified as prescription drugs.

In 1989, the FDA stopped a promising AIDS nutritional therapy to protect the interests of the pharmaceutical companies (see Innocent Casualties for documentation). Innocent Casualties documents a government agency so radical that, in 1992, its agents burst into a doctor’s office – guns drawn – to seize vitamins and herbs.

In 2011, the orthodox medical establishment is still promoting misinformation about the safety and effectiveness of alternative treatments at the expense of public health. It is profit that is threatened, not science. Through research and eye-witness narrative, Elaine Feuer raises the question of whether the American medical establishment has evolved into an "undercover dictatorship."

Chapter 2 Preview - Vioxx Recall

he FDA is finally being scrutinized by mainstream media and congress as a result of approving Vioxx, Paxil, and various drugs for children without giving warning labels of the dangers.

Vioxx is the RX drug that has been in the news the most since 2004. Merck, the billion dollar pharmaceutical company, as well as the FDA, did not disclose the high risk of heart attacks or strokes which accompanied this arthritic painkiller. Dr Steven Nissen, interim Chairman of Cardiology at the highly regarded Cleveland Clinic, reported that Merck intentionally misrepresented an analysis of data from a follow-up review of patients involved in the clinical trial that resulted in pulling Vioxx from the market. Dr. Nissen warned: "It's important that we inform people about this because patients who have taken the drug will need increased surveillance by their physicians and increased awareness of their risks in the year subsequent to stopping the drug. And that risk may extend beyond a year; we simply don't know."

In the September 2004, Merck was forced to take Vioxx off the market after a three-year study demonstrated that Vioxx doubled the risk of heart attacks and strokes in patients taking it for at least eighteen months.

A May 2006 study in the Canadian Medical Association Journal states that Vioxx may raise the risk of heart attacks for patients who took the drug for less than two weeks: More than 25 percent of 239 patients who had heart attacks did so in less than thirteen days of being on the drug.

There are thousands of lawsuits from people who claim to have adverse heart problems in 2005, and Merck was unable to counter the data that Dr. Nissen exposed. Merck’s attorneys insist that the one-year follow-up data should protect Merck from lawsuits filed by people who suffered heart attacks or strokes after they had stopped taking Vioxx. However, Nissen countered Merck’s claim: "What counts is the relative risk as you go forward, and the bottom line is there is a constant risk even after the drug is stopped." A year after stopping the medication, Merck insisted that patients who took Vioxx in their clinical study had no greater risk of heart attacks or strokes than those who took placebos. Although there were twenty-eight heart attacks or strokes in the Vioxx group compared to sixteen in the placebo group, Merck claimed that those numbers were not statistically significant.

Dr. Nissen has patient data documentation which proves that Merck’s information is total fabrication: "In the one year after Vioxx was stopped there was a 75 percent greater risk of having an adverse event. What this means is that, surprisingly, in the year following discontinuation of Vioxx the relative risk remained approximately as high as it was when people were actually taking the drug. That is very clear from the data. What is important is that the hazard stays constant even after you stop the drug."

FDA’s Responsibility Re: Vioxx

Dr. David Graham, a Senior Scientist who has worked for twenty years as an FDA Safety Expert, was interviewed on 60 Minutes in February, 2006: Dr. Graham blames the FDA for allowing such a dangerous drug as Vioxx to be marketed. According to Dr. Graham, who still works at the FDA, "There is a system in place now that will guarantee that unsafe drugs remain on the market." FDA safety experts have no power, verses FDA agents who approve drugs. One half of the FDA’s funding comes from the major pharmaceutical companies, to speed up the process of developing their drugs. If an FDA safety expert raises questions concerning safety, FDA approval agents almost always ignore them.

In 2002 there was enough dangerous evidence that Merck added a label concerning the hazards re: Vioxx. By 2004, Dr. Graham conducted an FDA approved study on Vioxx, and Graham recommended that all high doses of Vioxx should be banned. Dr. Graham was then "pressured" by the FDA: He was maligned as a scientist and threatened via phone calls by high level FDA agents who pretended to be "whistle blowers." (The telephone callers were identified by Graham’s attorney.) When questioned by the Senate Finance Committee, the FDA denied all of the above. Ray Martin, president of Merck, told members of the Senate that he took Vioxx off the market the moment he knew it was dangerous, claiming that his wife took it. Merck has lost $2.5 billion in annual sales from Vioxx, and there are about 50,000 lawsuits filed against Merck by former patients and their families. On July 17, 2008, Merck & Co. stated that it would fund the $4.85 billion settlement to resolve to approximately 50,000 lawsuits related to Vioxx.

FDA’s Criminal Role Re: Vioxx

en of the thirty-two FDA advisory committee members voted to allow the continued sale of Vioxx, and all of them had previously acted as paid consultants for Merck. Twenty-eight percent of committee members and voting consultants disclosed substantial financial dealings from consulting agreements, contracts, grants, and investments with Merck. Nineteen percent of the consulting agreements were worth over $10,000, and 30 percent of the investments involved over $25,000. Twenty-three percent of the contracts and/or grants exceeded $100,000.

Bottom Line

he FDA is as responsible as Merck Pharmaceuticals for allowing Vioxx to be on the market when it knew that the drug was extremely dangerous. The evidence demonstrates illegal conflicts of interest between FDA agents and Merck.

An April 24, 2006 report by the Government Accountability Office criticized the FDA's motives which compromised drug safety - listing organizational dysfunction, bureaucratic politics, and ineffective enforcement over pharmaceutical companies. According to Dr. Graham: "In my opinion, the FDA has let the American people down, and sadly, betrayed a public trust. The one and only client of the FDA must be John Q. Public." On 14 January 2009, FDA scientists sent a letter to President-Elect Barack Obama, stating that the FDA is "corrupt and distorted… placing Americans at risk" by censoring scientific debate within the FDA by its use of intimidating tactics:

"Managers have ordered, intimidated and coerced FDA experts to modify scientific evaluations, conclusions and recommendations in violation of the laws, rules and regulations, and to accept clinical and technical data that is not scientifically valid."

So who is looking out for the public’s safety? Does anyone still think the FDA is protecting Americans from harmful or deadly products? As long as the drug safety scientists at the FDA continue to be intimidated and threatened, the FDA’s clients will continue to be the pharmaceutical companies. Given the deaths caused by Vioxx, there is no question that the FDA is in a war against humanity.