The FDA Panels have become political activists that act as a buffer for the plutocracy while being willing to place the 'consumer' in the middle of decisions that easily can be out of their reach to understand.
The 'generation' of pharmaceuticals that attack 'the necessary fat' around the heart, such as Avandia and Zioxx are very dangerous. There is no need for them. There are very good alternatives and the risks DO NOT outweigh the benefits. Such 'generation of dangerous drugs' should only be considered in conditions where the prognosis of the patient is poor and there is a benefit to perscribe.
The FDA Panels are expensive and add to the burden of our health care system. Secretary Sebelius needs to re-examine the necessity of the FDA Panels and ANY benefit to their existance.
The FDA has to start taking a hardline against these pharmaceuticals. They are metabolized with body fat that is vital to its survival and not 'spare or obese fat.' This is ridiculous and there are better options then these drugs. This is a no brainer. PULL AVANDIA and review the 'integrity' of the "Panel Process."
FDA Panels Votes to Keep Avandia
Matthew Perrone
Drug Discovery & Development - July 15, 2010
WASHINGTON (AP) - GlaxoSmithKline's drug Avandia should stay on the market, federal health experts voted, but the controversial diabetes pill should be subject to new restrictions due to risky heart side effects.
A panel of Food and Drug Administration advisers voted 20-12 to keep the once blockbuster pill available for diabetics. But 10 panelists also called for limiting who can receive and prescribe the much-debated medication.
The vote marks a tough win for British drugmaker Glaxo, which is facing thousands of lawsuits from patients who say Avandia caused their heart attacks or strokes. While the company may fare better in court due to the panel ruling, sales of Avandia are likely to shrink to minuscule levels.
The FDA is not required to follow the advice of its panelists, though it usually does. FDA officials said they would review the recommendations and make a decision on Avandia as soon as possible....
http://dddmag.com/news-FDA-Panels-Votes-to-Keep-Avandia-71510.aspx
The troubling move toward theology on these Panels during the Bush/Cheney Administration is more then troubling. It is time to 'weed out' the process and how it was effected by these bozos.
...''The pattern of actions we are watching is troubling,'' Senator Hillary Rodham Clinton, Democrat of New York, said in an interview. ''It's one thing to have a political perspective, which all of us do. But we are going to be in trouble in this country if we start moving toward theology-based science or ideological research.''
Mr. Thompson and his aides have defended their selections. In a letter this week to Senator Clinton and Senator Edward M. Kennedy, Democrat of Massachusetts, Mr. Thompson denied that the administration uses a litmus test and said, ''We will continue to recruit the best scientific minds to serve.''
The issue also came up on Monday at the Senate confirmation hearing of Dr. Mark B. McClellan, President Bush's nominee for commissioner of food and drugs.
''Expertise and objectivity are important criteria for selection,'' Dr. McClellan told the committee, in response to a question from Senator Kennedy. But, he added, so is ''diversity of viewpoints.''
The committee changes come at a time when Mr. Thompson is restructuring the health and human services advisory system, which consists of 258 outside boards and panels. In any given year, Mr. Thompson said in his letter, his office can appoint roughly 450 people....
http://www.nytimes.com/2002/10/10/us/bush-s-science-advisers-drawing-criticism.html
The National Debt needs to be addressed. These panels are unnecessary as they divide their loyality between patients and Wall Street. Cut the budget and reduce the panels; dismiss their participants.
