Mike Adams, the Health Ranger See article keywords and concepts | Not much reform in the fda reform bill
Even worse, there's really not much reform in the fda reform bill in the first place. There's no call for a criminal investigation of the crimes that have been committed against the American people by top FDA officials, nor is there any attempt to use RICO Act laws (racketeering laws) to investigate the organized crime ring currently being run by Big Pharma and the FDA. | | Congress has reached agreement on a House / Senate compromise regarding the recently passed fda reform legislation that aims to improve the safety of pharmaceuticals. The bill will now move to the White House where it is expected to be signed by the President.
While this new fda reform bill still lacks crucial safety provisions for U.S. | | If this is fda reform, God help us all when the next President starts talking about health care reform. | | Overall, there's really not much reform in today's fda reform bill. There's not even a ban on direct-to-consumer drug advertising -- an unjustifiable practice that's directly responsible for the huge increase in drug side effects (adverse events reporting) and drug deaths over the last few years. As I have stated on this website many times, it is no exaggeration to say that the number of Americans killed by FDA-prescription drugs each year greatly exceeds the number of Americans killed in the entire Vietnam War. | | Of course, all this doesn't mean that drug companies won't find some new way to game the system, deceive consumers and block meaningful fda reform. Nearly every clinical trial published today is already rigged to deliver results that favor drug companies, and it is a well known fact in the drug testing industry that individuals and companies who don't deliver favorable results quickly end up jobless or blackballed from the industry. Thus, there's a huge flaw in this idea that publicly publishing clinical trial results will instantly make drug companies honest. | | While this new fda reform bill still lacks crucial safety provisions for U.S. consumers (such as banning direct-to-consumer drug advertisements), it at least kept two key provisions intact that may help prevent drug companies from engaging in the routine deceptions that have propped up industry profits at the expense of public safety:
1) Big Pharma will not have immunity to lawsuits brought by consumers harmed by dangerous prescription drugs. As you may know, drug companies (and even the White House and FDA) have lobbied for granting drug companies blanket immunity from all injury lawsuits. | Mike Adams, the Health Ranger See article keywords and concepts | REPPED: This is part two of an article on fda reform. Return to part one.
The next thing that should be done in reforming the FDA is to reverse some of the dangerous and poorly made decisions put in place by the FDA over the last few years. The most obvious of these is the legalization of direct-to-consumer advertising by drug companies. This decision was made in 1997 and it allowed drug companies to place ads on television, in magazines, newspapers, billboards and other media with the purported goal of "educating" consumers about prescription drugs. And yet the very premise is laughable. | Mike Adams, the Health Ranger See article keywords and concepts | Under Republicans no fda reform ever took place. Big Pharma owns so many Republicans that all meaningful legislation to curtail the deaths and injuries of American citizens at the hands of Big Pharma and the FDA had been completely thwarted for the past six years. Under Democratic control sweeping fda reform favorable to Big Pharma was proposed and the majority of meaningful reform was blocked or seriously watered down. Which is worse? As Kennedy stated in his opening remarks today, S1082 (the Kennedy/Enzi FDA bill) was an "elaborate scheme. | Mike Adams, the Health Ranger See article keywords and concepts | Horton was outraged and called for FDA reform:
"In the case of Vioxx, the FDA was urged to mandate further clinical safety testing after a 2001 analysis suggested a 'clear-cut excess number of myocardial infarctions'. It did not do so. This refusal to engage with an issue of grave clinical concern illustrates the agency’s in-built paralysis, a predicament that has to be addressed through fundamental organizational reform."
But Dr. Horton didn't stop there. He also explained, "...with Vioxx, Merck and the FDA acted out of ruthless, short-sighted, and irresponsible self-interest. |
Too Profitable to CureBrent Hoadley, Ph.D. See book keywords and concepts | | Reputation of the FDA in Shambles after Vioxx Scandal; Calls for Wholesale fda reform, , 11/10/2004.
• American Consumers Suffering as More New Drugs Debut in US, Analysis Shows, Pugh and Borenstein, Knight-Ridder, 12/18/2004.
• FDA Delays Response to Drug Suit, , Associated Press, 11/4/2004.
• "Risk-Free" Drugs Don't Exist, Business Week Online, 2/23/2005.
• Testimony of Barbara Atkinson, MD on House Bill 2355, KUMC Campus News, 3/17/2005.
• FDA to Review "Missing" Drug Company Documents, Jeanne Lenzer, , 1/1/2005. | Mike Adams, the Health Ranger See article keywords and concepts | I oppose this new Evilization Act and will hold out for a better law that actually creates meaningful fda reform. | Mike Adams, the Health Ranger See article keywords and concepts | Last year's Institute of Medicine report labeled FDA management as dysfunctional causing fda reform to pick up momentum. To deflect public outrage S1082 was created by Kennedy and Enzi, in close consultation with the FDA and Big Pharma. As you might expect from such a meeting of the minds, the bill is really a Big Pharma-sponsored con job and it actually increases the power of dysfunctional FDA management.
Unfortunately for Big Pharma and the FDA, Charles Grassley (R-IA), a man concerned with true and meaningful safety reform, has gone through S1082 with a fine tooth comb. | Mike Adams, the Health Ranger See article keywords and concepts | Under Democratic control sweeping fda reform favorable to Big Pharma was proposed and the majority of meaningful reform was blocked or seriously watered down. Which is worse? As Kennedy stated in his opening remarks today, S1082 (the Kennedy/Enzi FDA bill) was an "elaborate scheme."
The final passage of S1082 was never in doubt (final vote was 93-1). In fact, Kennedy and Enzi gave Big Pharma a 40 yard head start in a 100 yard dash; it wasn't much of a contest. Their legislation perpetuated the user fees allowing Big Pharma to buy mob-like protection from the FDA. | Mike Adams, the Health Ranger See article keywords and concepts | It staged a song and dance about "FDA reform" while selling out the future of America's health to a tiny but powerful group of ultra-wealthy corporations that now virtually rule this country. There is nothing in the new law worth celebrating unless, of course, you are the CEO or major shareholder of a Big Pharma corporation, in which case you will like be stunned at just how cheaply and easily U.S. lawmakers can be bought.
Notice, too, that this sellout crosses party lines and involves both Democrats and Republicans. Only one Congressman, Rep. | | The passage of this fda reform law is merely one more sign of how thoroughly committed the U.S. Congress is to creating a future of death, disease and bankruptcy for the American people. You gotta give 'em kudos on consistency, however. At least the lawmakers are predictable.
Welcome to the United States of Big Pharma.
Comments by Byron Richards
On Wednesday, July 11, 2007 the House passed HR.2900 without allowing the Ron Paul (R-TX) amendments to protect dietary supplements. Representatives Frank Pallone, Jr. | Mike Adams, the Health Ranger See article keywords and concepts | REPPED: The White House is taking steps to kill the fda reform legislation recently passed in the House of Representatives that would require drug companies to publicly post clinical trial results so that doctors, researchers and the public could review them. According to a report in Inside Health Policy, the White House sent congressional staff an "unofficial statement of administration policy" that opposes this provision in the House bill. | Mike Adams, the Health Ranger See article keywords and concepts | Realizing that meaningful fda reform legislation is not likely again for ten years numerous Senators are backing the Dorgan amendment to S1082. The amendment enables U.S. citizens to buy drugs from Canada and other industrialized nations. This will save us at least 50 billion dollars over the next ten years and cut the price of many drugs in half. Those opposing the amendment, which includes most of the major proponents of S1082 and the Bush administration, are the ones clearly on the payroll of Big Pharma. Their excuse for not supporting it is flimsy -- that it will cause safety problems. | Mike Adams, the Health Ranger See article keywords and concepts | Clearly what we need is genuine fda reform, not making the FDA even more addicted to industry money. But don't expect to see any real reform efforts until there's a changing of the guard in Washington, as the current administration is quite cozy with Big Pharma.
Researchers now try to discredit glucosamine chondroitin sulfate supplements
Always working hard on new ways to discredit nutritional supplements, conventional medical researchers have now found a clever way to attack nutritional supplements used to treat joint pain. | Mike Adams, the Health Ranger See article keywords and concepts | Congress is contemplating restricting drug advertising, and talk of fda reform is everywhere. The only thing holding the drug racket in place, in my opinion, is the Bush Administration, which remains strongly pro-drug and continues to enact legislation that amounts to little more than handouts to Big Pharma.
Exposing the lies of Big Pharma
The earthquake has begun, and the success of Kevin Trudeau's Natural Cures book is simply a sign that the public is ready to hear this message. | Mike Adams, the Health Ranger See article keywords and concepts | The vast majority of FDA employees -- especially in the drug safety office -- actually agree with most of this and they back the idea of radical fda reform that would take the bureaucrats out of power.)
There is apparently no limit to the number of people that a drug can kill in order for the FDA to consider it to be dangerous. You have to wonder, with this class of drugs killing more Americans than were killed in the Vietnam war and killing vastly more Americans than have ever been killed by terrorists, at what point does the FDA become more dangerous than terrorism? | Mike Adams, the Health Ranger See article keywords and concepts | That is, if serious fda reform doesn't dismantle the agency first.
Keep in mind that Merck and J&J can just reapply again next year. And the year after. And technically, the FDA doesn't have to listen to the advisory panel in the first place. They can just stamp "Approved!" on the drug, regardless of what the panel recommendations are.
But for today, consumers are just a little bit safer with statin drugs not being allowed as over-the-counter medications. Whether we actually have the FDA to thank for this is difficult to tell. Frankly, Dr. | Mike Adams See book keywords and concepts | Horton was outraged and called for FDA reform:
"In the case ofVioxx, the FDA was urged to mandate further clinical safety testing after a 2001 analysis suggested a 'clear-cut excess number of myocardial infarctions.' It did not do so. This refusal to engage with an issue of grave clinical concern illustrates the agency's in-built paralysis, a predicament that has to be addressed through fundamental organizational reform."
But Dr. Horton didn't stop there. He also explained, "...with Vioxx, Merck and the FDA acted out of ruthless, short-sighted, and irresponsible self-interest. | Carl Jensen See book keywords and concepts | UPDATE: Bioworld Today, an industry trade journal, warned its readers (6/19/96) that "industry advocates hoping for passage of fda reform legislation this year might be advised to start praying for a miracle." Any such prayers went unanswered, at least for the time being. Despite the efforts of Senate Majority Leader Trent Lott and House Commerce Committee chairman Representative Tom Bliley, the 104th Congress failed to approve Newt Gingrich's Draconian plan for gutting the Food and Drug Administration.
7. | Leonard G. Horowitz, D.M.D., M.A., M.P.H. See book keywords and concepts | It is against this background of possible risks of past viral vaccine studies, uncertain biological recombinants, bureaucratic censorship, a rising tide of medical consumerism in the information age, and an urgent need for legislative fda reform, that Dr. Horowitz's work contributes. At minimum, what you are about to read exposes many important facts which, unfortunately, few people realize and all would be better off knowing. At best, this important text raises far greater hope that by knowing their origin, cures for the many complex emerging viruses, including AIDS, may be forthcoming.
—W. | Stephen Fried See book keywords and concepts | But anti-regulatory forces had been able to attach to the PDUFA renewal various chunks of the myriad fda reform bills. And the drug industry, heading into its second straight banner year after massive consolidation, was feeling flush.
The combined Food and Drug Administration Modernization Act of 1997 was ultimately a watered-down version of some of the harshest FDA-bashing proposals, but it was still the first major agency reform bill in twenty years. | | Viagra got more ink and air time each day than the entire process of fda reform had received over the previous three years. In a mad dash for any new angle on the story, the media picked up on whatever drug safety issues it could find, as long as they could be spun into a story that included the words Viagra, penis and erection. So, the medication became a way of talking about everything from the horror of pill-mills, which were quickly set up so all the now-unemployed phen-fen docs could go into the Viagra prescription business, to the possible perils of "lifestyle" pharmacology. |
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