BIG PHARMA & THE FDA STRIKE OIL WHILE INJURING MILLIONS
By Byron J. Richards, CCN
September 11, 2006
Over one million Americans have been killed by Big Pharma in the last decade. Tens of millions have been seriously injured. Every person knows someone whose life has been damaged or snuffed out by Big Pharma. Consumers call for improved safety. Politicians pretending to respond to consumer outrage have now introduced legislation that, if passed, would create a new FDA�a Big Pharma FDA. At the same time, good legislation that would begin to address the multitude of major FDA problems has been scuttled.
The FDA Appears Hopelessly Broken
The FDA fails to require adverse event reporting during clinical trials, refuses to disclose after-market adverse events reported to it�claiming they are �trade secrets,� doesn�t require drug labels to state many known risks, allows massive off label use of dangerous drugs (even on children), has an inadequate system for following up on drugs in the market, and can�t even keep track of the names of drugs presently on the market.
Scientists within the FDA are routinely pressured to alter science to fit administrative and bureaucratic priorities. Major funding to the FDA comes from drug companies, who negotiate how they will be regulated. The FDA is seeking to make sure that no citizen can sue a drug company when they are injured or killed by a drug. Doctors are poorly informed or prevented from learning about many side effects of medications they prescribe on a daily basis, and are under constant high pressure sales from drug reps. Medical and administrative errors compound safety issues. And the consumer market is flooded with glitzy and misleading ads touting the glory of dangerous drugs.
I have extensively documented these FDA ploys, plans, and deceptions that harm so many Americans in my book, Fight for Your Health: Exposing the FDA�s Betrayal of America and in my previous NewsWithViews.com articles.
Congressional Attempts to Correct the FDA are Fruitless
Various bills have been introduced that seek to rein in Big Pharma and get the FDA doing its job. Rep. John F. Tierney (D-MA) has introduced HR 4429. This bill would create an independent office within the FDA to regulate the safety and effectiveness of drugs already on the market. It is a major conflict of interest for the FDA to approve new drugs as well as monitor the safety of the same drugs. This bill is identical to S. 930 introduced by Sen. Charles Grassley (R-IA).
Rep. Maurice D. Hinchey (D-N.Y.) introduced HR 2090. This bill also calls for a new office within the FDA for post-market drug safety. Additionally, it would eliminate the huge conflicts of interest regarding �expert� advisory panels full of industry-friendly advisors, the FDA acceptance of Big Pharma money to approve drugs, and negotiations between Big Pharma and the FDA as to how drug companies will be regulated.
Rep. Henry Waxman (D-CA) introduced HR 3196: Fair Access to Clinical Trials Act, cosponsored by 41 Democrats. It would require full disclosure of adverse events occurring during clinical trials, information the FDA currently helps Big Pharma hide from the public. Sen. Christopher Dodd (D-CT) has introduced S 470, a Senate version of the bill.
None of these bills can even get a committee hearing. True reform at the FDA, while hundreds of thousands are needlessly injured every month, is tied up by the FDA itself, the lobbies of Big Pharma, their friends at the White House, and legislators who line their pockets with blood-stained drug company money.
Drug Companies Hide Their Safety Data
Drug companies go to great lengths to hide the adverse effects of their drugs. One example is that they actually negotiate with the FDA on how they will be regulated, an utterly incomprehensible compromise to safety and health. They pay the FDA user fees to speed up drug approvals; $232 million in 2004. The FDA is now addicted to this junk-food funding source, accounting for half of their total drug review budget. The current user fee arrangement expires in October of 2007. However, negotiations for a new arrangement are intensively under way, as reported in the Wall Street Journal on September 1, 2006.
Negotiators for Big Pharma include former FDA employees. The FDA is seeking to get 66% of their drug review budget covered by the new agreement. Top FDA execs freely admit the FDA is overextended, which is why the agency does such a shoddy job on drug safety today.
Of course, Big Pharma pays out to be protected from the FDA�s enforcement actions, like paying the mob for protection. There is no other situation in government where an industry needing to be regulated gets to negotiate how they will be regulated. Big Pharma balks at their money being spent on review of their drug ads or monitoring their systems for tracking and reporting adverse events. Truthfulness and safety are very low on the Big Pharma priority list.
Big Pharma Introduces its Own �Safety Legislation�
On August 3, 2006 Senators Michael Enzi (R-WY) and Edward Kennedy (D-MA) introduced S 3807: Enhancing Drug Safety and Innovation Act of 2006. Never has a name been more misleading. It should be called �Exposure of Americans to Risky Medications and Creation of a New FDA Drug Company Act of 2006.�
Instead of creating an independent office within the FDA to monitor drug safety, this legislation creates a new office within the FDA to act as a drug company. It will be named the Reagan-Udall Institute for Applied Bio-Medical Research and it will be funded by special interests in Big Pharma and the biotech industry. Its job is to sponsor the fast track approval of risky medications onto the market. This legislation is seeking to turn the FDA�s risky Critical Path initiative into a full scale government agency. It is an attempt to fund and sanction the corrupt FDA/Big Pharma plan I thoroughly explain in Fight for Your Health: Exposing the FDA�s Betrayal of America.
The legislation was crafted after extensive negotiations with Big Pharma and the FDA, meaning it contains everything they want. It provides lip service to consumer safety, the smokescreen that is being used to promote the legislation to the public. In reality, it is full of Big Pharma loopholes that will shift any real safety problems into Advisory Panels composed of Big Pharma members and affiliates (the same safety problem we have now).
It pretends to set up a database for clinical trial information to improve disclosure of side effects to the public. Instead, it specifically excludes all of the FDA/drug company experiments, including experiments on humans that will occur prior to a formal intervention trial. This means the most risky experimental information will forever be hidden from the public. Furthermore, the actual intention of this clinical trial database is not to give consumers more information about side effects of drugs, it is to act as a major marketing tool for Big Pharma to release results of clinical trials to support off label drug use. Such off label use could never meet the standards of safety for a full drug approval, thus, misleading clinical trials will create momentum for physicians to use drugs in ways they were not approved (condoning and worsening another current and noteworthy safety issue).
Enzi and Kennedy receive significant campaign funding from the health and pharmaceutical sectors. Even worse, these two men are in charge of the Senate committee that holds hearings on FDA-related matters and can easily bring this legislation to the floor of the Senate for a vote. This could happen in September or it could happen in a lame duck session of Congress after the fall elections. It could be added on to any house bill as an amendment, sliding it quickly to the President who would sign it in a flash. Unlike true FDA reform proposed by other Congressional leaders, this legislation is creating a government agency to further collusion between Big Pharma and the FDA.
FDA Leadership is Seriously Flawed
Enzi and Kennedy are also trying to get Andrew von Eschenbach appointed as the permanent head of the FDA. Von Eschenbach has repeatedly stated that the number one priority of the FDA is the fast track approval of new and unproven medications. The reason Enzi and Kennedy are failing to ask any tough questions at the von Eschenbach confirmation hearings is now painfully clear, they are completely behind the new FDA plan to expose Americans to undue drug risk and human experimentation for the profits of Big Pharma.
Take Action Now
Enough is enough. It is time to flood Enzi and Kennedy with objections to their outlandish proposed legislation. Let your own Senators know you oppose S 3807. Tell them you are outraged that Enzi and Kennedy are seeking to create a new office within the FDA to permit the FDA to act as a drug company.
Tell your Congressional representatives you support effective legislation that is intended to protect the American public from harm. (HR 4429, S 930, HR 2090, HR 3196, S 470) Tell them you are fed up with real FDA reform being squashed in committee by Big Pharma allies.
Demand that Enzi and Kennedy ask real questions about the financial connections of von Eschenbach and his numerous friends in the cancer industry. It is fairly obvious that the four billion dollar budget of the National Cancer Institute will wind up, via von Eschenbach�s cancer industry friends, funding this new FDA drug company so as to generate and sanction huge profits for the vested interests of the sickness industry. How much money will wind up in von Eschenbach�s pockets? How much money already has?
Von Eschenbach is focused primarily on developing and marketing new and risky drugs. He has no plan to effectively fix the numerous safety problems within the FDA, why? Why are Congressional leaders twiddling their thumbs while tens of thousands of Americans needlessly die?
The FDA must become something other than a drug company or front group protecting Big Pharma at the expense of human health. September 2006 is a pivotal month for the future of healthcare for all Americans.
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Byron J. Richards, Founder/Director of Wellness Resources, is a Board-Certified Clinical Nutritionist and nationally-renowned health expert, radio personality, educator, and author.
Richards encourages individuals to take charge of their health, stand up for their health rights, and not blindly succumb to propaganda from the vested-interests who profit from keeping Americans sick. Author of Mastering Leptin and Fight for Your Health, Richards is now joining forces with health freedom leaders in the U.S. and throughout the world. Visit his health blog for up to date happenings. www.truthinwellness.com
As founder of Wellness Resources, Inc. of Minneapolis, MN (since 1985), he has personally developed 75 unique nutraceutical-grade nutritional formulas. www.wellnessresources.com
of the International and American Associations
of Clinical Nutritionists (IAACN) (since 1991) Richards has presented
hundreds of educational classes to health professionals and individuals
who want to take charge of their health!
Of course, Big Pharma pays out to be protected from the FDA�s enforcement actions, like paying the mob for protection. There is no other situation in government where an industry needing to be regulated gets to negotiate how they will be regulated.