Deceiving the Public

This new bill panders to concerns of Americans regarding the safety of drugs. This legitimate worry is used by Kennedy and Enzi to garner support when in reality the bill does just the opposite - exposing Americans to almost unfathomable new drug risks and dangers while simultaneously making it possible to remove super safe, therapeutic, and helpful dietary supplements. The entire Critical Path initiative is a plan to race new and untested powerful biological drugs onto the market and experiment on patients all over the country – throwing caution to the wind as far as drug safety is concerned.

While S1082 also pretends to address the issues of drug safety, in reality all the needed Big Pharma loopholes are firmly in place. Additionally, the establishment of a clinical trial database as written in this proposed law will enable Big Pharma to hide experimental and undesirable side effects. Instead of full disclosure we will have a sterilized clinical trial database that will have the net effect of being used as a tool by Big Pharma to promote off label use of drugs. This is a far cry from disclosure that results in safety.

In response to the Kennedy con Charles Grassley (R-IA) immediately attacked the legislation on the floor of the Senate:

“The bill [S1802] does not address the outstanding critical problem that the office responsible for post-market drug safety lacks the independence, lacks the authority to promptly identify serious health risks and take necessary steps that will protect the public. As I think we all agree, the FDA is in desperate need of major overhaul.”

The problem for Grassley, and all Americans, is that his true safety reform measures for the FDA are being held hostage by the HELP committee which is under the control of Kennedy and Enzi. His proposed legislation is S. 468: Food and Drug Administration Safety Act of 2007 and S. 467: Fair Access to Clinical Trials Act of 2007. As Grassley told the Senate:

“Let me be clear: Big Pharma does not like these bills. FDA management does not like these bills. Lobbyists are spending hours upon hours lobbying against these bills…What is wrong with establishing a separate center within the FDA--not outside the FDA, within the FDA--with its only job being that of a watchdog for those drugs already in the market?...What is wrong with supporting a clinical trial registry and results database that also requires sponsors to reveal their negative trials?...I propose there is nothing wrong with any of these proposals.”

The situation is rather grave for all Americans. Kennedy has attached repressive legislation to replace the PDUFA funding thereby ensuring that his agenda will come before the Senate for a vote. The only real opposition to the legislation is coming from Grassley, who is attacking the weakness in FDA reform regarding drug safety and clinical trials. An even greater threat to the public – turning the FDA into a drug company and creating new regulatory powers that can be used to attack dietary supplements and remove them from the market – is being ignored by everyone – until now. Kennedy knows he can defeat Grassley and keep Grassley’s bills from ever seeing the light of day. Can Kennedy defeat the American public? Solving this problem is up to you.