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Ellyn
Joined: 16 Jul 2000
Posts: 4454
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BIG PHARMA @ FDA STRIKE OIL WHILE INJURING MILLIONS
 Tue Sep 12, 2006 2:46 am
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BIG PHARMA & THE FDA STRIKE OIL WHILE INJURING MILLIONS
By Byron J. Richards, CCN
September 11, 2006
NewsWithViews.com
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.
© 2006 Truth in Wellness, LLC - All Rights Reserved
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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
Charter Member 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!
E-mail: byron@truthinwellness.com |
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Ellyn
Joined: 16 Jul 2000
Posts: 4454
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| MUTINY BY AN FDA ADVISORY PANEL
Sun Oct 15, 2006 3:10 am
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MUTINY BY AN FDA ADVISORY PANEL
By Byron J. Richards, CCN
October 12, 2006
NewsWithViews.com
The FDA has created its own monster. Could it be that an FDA advisory panel actually has enough impartial members to be truly concerned about the health and well being of all Americans? No doubt, the top FDA officials were squirming in their boots as five current and past members of the Drug Safety and Risk Management Advisory Committee went public with their call for sweeping changes at the FDA.
The October 9, 2006, issue of the Archives of Internal Medicine contains the article “FDA and Drug Safety: A Proposal for Sweeping Changes.” The lead author is Curt D. Furberg, M.D., Ph. D., an expert in epidemiology and biostatistics and current member of the FDA safety committee. He is a professor at the Department of Public Health Services, Wake Forest University School of Medicine. In an interview by Amanda Gardner, HealthDay reporter, Dr. Furberg states:
"Congress cannot leave them [the FDA] on their own….What's missing is a strong, dynamic leadership to make some changes….The main problem is the voice of drug safety is not heard….There's a lot of unhappiness, low morale, people don't communicate….The leadership does not get the message….For a decade, they've [the FDA] had problems, and they've done very little. They deny their problems, and they can't fix them. We're saying Congress has to step in to give them authority, give them money, oversee their operations and make sure drug safety is a priority.”
This criticism comes from a collection of experts that the FDA assembled to give them advice on the safety of drugs. Numerous experts on the Drug Safety and Risk Management Advisory Committee felt the FDA was not following their advice regarding needed drug-safety improvements. The message is loud and clear: The FDA, an agency that maintains a cozy and profitable relationship with Big Pharma, is incapable of protecting the American public from harm.
Drug Safety and Risk Management Advisory Committee
This particular committee is unique among FDA advisory committees in that it deals in a general way with the topic of drug safety, including the need for post-marketing surveillance. Other FDA advisory committees usually focus on one drug or topic area. The importance of this committee has been elevated since the Vioxx scandal.
Grumbling from committee members has been going on for some time. While the committee feels they have made some inroads, progress has been on simple issues that can be acted on in a short period of time. On the tough issues, the core problems of drug safety at the FDA, the FDA has been slow to adopt committee recommendations that would protect Americans from harm.
Why Won’t the FDA Protect Our Children?
The FDA was shocked when earlier this year the Drug Safety and Risk Management Advisory Committee voted 8 to 7 to place a black box warning for cardiovascular risk on all ADHD medications. Such a move would cost Big Pharma dearly, eroding the ten billion dollar children’s market in ADHD meds, antidepressants, and atypical antipsychotic meds. Americans are worried, and rightfully so, that the true risks of these medications are being hidden and downplayed thus placing an entire generation of children in danger.
The FDA thought the advisory committee was going to review depression and suicide risk relating to ADHD medication. Instead, the meeting spun out of FDA control and resulted in a major catastrophe, from the perspective of the FDA. In no way, shape, or form did the FDA want the committee delving into cardiovascular risk in the manner they did. Of course, the FDA does not have to follow the advice of their advisory panels. But how could they prevent more fallout on their already existing lax-on-safety image problem, especially when their own appointed panel of experts is telling them to act quickly to protect children? Stunned, FDA spokesperson Robert Temple offered this lame explanation, “You don’t want to over scare people with data that aren’t very solid.”
In high-level damage control the FDA shunted the issue to a different advisory panel, one that would water down the recommendations. One month later the new panel stated a black box warning for cardiovascular risk was not warranted. The FDA strategy is clear; if one panel warns of a need for safety, another panel can be used to quell concern. After the cover up meeting Temple stated, “The committee was not impressed with the level of cardiovascular risk to children.” Twenty-five reported cardiovascular deaths from ADHD medication don’t impress the FDA when Big Pharma blockbuster profits are at stake.
However, safety advisory panel member Steven E. Nissan, M.D., was not going to take this insult lying down. After all, the safety of our children was at stake. Dr. Nissan launched his attack in the New England Journal of Medicine. On April 6, 2006, his article was published, ADHD Drugs and Cardiovascular Risk. In it, he outlines the significant cardiovascular risk of this class of medication and the committee’s plea for the FDA to act decisively. To this day, the FDA ignores the severity of the problem, which in my opinion is simply to protect the profits of Big Pharma.
Americans Must Respond
The unusual and public call for reform by members of the Drug Safety and Risk Management Advisory Committee tells us the FDA is hopelessly broken. When members of their own committees feel the agency is not listening and putting the well being of Americans in jeopardy, it is time to act.
Americans must wake up before it is too late. The FDA, the White House, and elite leaders of both parties are owned by Big Pharma. True reform at the FDA must occur, and will not occur unless American citizens demand it and actually know what is going on.
Already, Senators Michael Enzi (R-WY) and Edward Kennedy (D-MA) have introduced a sham safety bill (S3807) that is a gift to Big Pharma and actually intends to make part of the FDA a drug company! It is clear that politicians will work deceptive spin under a pretense of safety.
Big Pharma must be banned from all lobbying and drug advertising. The 80,000 drug reps that routinely bribe doctors with perks, as well as their “free” samples, must be stopped. The FDA needs total reorganization with a focus on drug safety. Big Pharma’s illegal off-label drug promotions to children, via the TeenScreen program, require criminal investigation. All user fees paid by Big Pharma to the FDA, which currently amounts to over half the FDA drug approval budget, must be discontinued.
The current Bush-appointed FDA leadership, such as temporary head Andrew von Eschenbach and second in command, Scott Gottlieb, must have all their extensive Big Pharma connections fully exposed. There is a reason they want to speed drugs to the market, reduce safety testing, and prevent Americans from suing drug companies when drugs injure and kill our people.
© 2006 Truth in Wellness, LLC - All Rights Reserved
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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
Charter Member 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!
E-mail: byron@truthinwellness.com
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