By Byron J. Richards, CCN
October 5, 2007
On September 27, 2007 the president signed the hotly debated FDA “reform” legislation into law, which does nothing but give the highly dysfunctional FDA management team more power. FDA ineptitude is costing Americans dearly. The FDA does not need more power or money, it needs management that truly has the health and well-being of consumers as its top priority. FDA crimes of commission and omission are becoming more evident with every passing day. Here are some of the top recent headlines.
FDA Condones Unsafe Human Experiments
The New York Times reports that the FDA fails to ensure the safety of millions of people who participate in experimental clinical trials. In fact, the government doesn’t even have any idea how many of these experiments are taking place. The FDA haphazardly follows up on less than 1%, and when problems are found little or nothing is done.
The New York Times outlines several horror stories of individuals stuck in an unscrupulous system, as well as the near total lack of FDA oversight. This is one more example of FDA ineptitude – which is comprised of a very long list of transgressions against the citizens of this country. Let’s call a spade a spade, the FDA is little more than a police force bully serving as the gatekeeper to profits for elite companies at the expense of human health. Taking any drug is like playing Russian roulette.
FDA, Bush, and Republicans Attack Citizen’s Health Rights
The FDA reform legislation passed by the House and Senate shows just how corrupt the politics for profit system in America has become. The idea that citizens would have no right to sue a drug company when they are injured or killed by a medication is a difficult pill to swallow. Especially in light of multiple scandals, many ongoing, wherein the FDA and drug companies selectively hide important risks from the public in an effort to protect the profits of Big Pharma at the expense of human health.
The Bush administration and a majority of Republicans are beholden to the Big Pharma golden idol and are doing everything in their power to directly undermine rights of all Americans. At issue is the legal point known as preemption, which means a ruling at the federal level that preempts or supersedes rights of a citizen in state courts. The Republican Big Pharma cartel, who have been instructing the FDA on policy, have concocted a labeling scheme for drugs that says once the FDA approves a label for a drug then it is free of all legal liability – in essence blocking the rights of citizens to sue in State court.
This borders on the insane. Seldom are the risks of approved drugs known at the time of approval. The FDA has a track record of hiding safety information from the public to protect its sagging image and the profits of Big Pharma. The FDA has thousands of drugs on the market and has no clear idea of their risks. Deaths from drugs have doubled in the last five years. Big Pharma has proven consistently that it puts profits ahead of human health – even when death is a known risk.
In the current FDA reform legislation, House Democrats were barely able to negotiate a weak compromise that keeps open the right of citizens to sue, keeping the issue in a confused court system that is split on pending cases. The issue is now coming before the Supreme Court, and being Republican dominated, is likely to go the way of Big Pharma.
Meaningful FDA reform has been degraded into a profit preservation plan for Big Pharma, with truly meaningful health protection and health rights for out citizens taking a back seat.
Media is Part of the Big Pharma Cartel
Have you ever wondered why the media speaks so highly of drugs and paints safe and effective dietary supplements as either not effective or even dangerous? As the House and Senate finally agreed to a near useless FDA reform and financing package it became painfully clear that advertising dollars were far more important than health or safety of Americans.
Big Pharma had been so beaten up by its fraudulent and deceptive marketing of dangerous drugs that it focused its lobbyists on minimizing damages and maintaining its monopoly on high prices for drugs in the U.S. compared to any other country in the world – something Senate Republicans were happy to support (in return for Big Pharma $$$).
The surprise came on direct to consumer advertising which Big Pharma didn’t even try to defend as the were sure they had no leg to stand on. Media and advertising lobbyists realized they were about to loose a huge cash cow. They went into full swing and spent a fortune to portray a restriction on direct to consumer advertising as a violation of Big Pharma’s first amendment rights. The rights of Big Pharma to deceive, injure, and kill Americans are preserved – with the media as a main player in the con game and the blessing of a congress on the take.
Drug-related Deaths and Serious Injuries Have Doubled
The FDA reports that between 1998 and 2005 deaths and serious injuries from drugs has doubled, a rate of injury significantly faster than the increase in prescriptions. 51 drugs are responsible for the increase, with new biotech drugs that modulate the immune system at the top of the list. 85% percent of those suffering did not have any label warning that the drug they were taking could produce the serious health problem, injury, or death.
While it is nice that the FDA filled out a report card on its post-marketing drug surveillance competency, it does not change the fact that the grade is an F. For decades the FDA has done the dirty work of the drug companies, allowing dangerous drugs like Vioxx on the market and when a hundred thousand people die the cases are all tied up in court indefinitely. Now the FDA wants to become a drug company. It is little wonder that 75% of Americans don’t trust the FDA.
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