The Politics Of Health: Feature ArticleBig Pharma & the FDA Strike Oil While Injuring MillionsMonday, September 11, 2006Byron Richards, CCN 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.
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.
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.
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.
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.
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.
Other Feature Articles:
The shocking death of Tim Russert last Friday has left an entire nation wondering what happened. He was a model patient, doing everything his doctors asked. All major media have run articles trying to explain the nuances and difficulties in treating coronary artery disease. These articles find little fault in Russert’s care, trying to create the idea that his heart attack was just too hard to predict and that all that could have been done for him was done. I beg to differ. His death represents the failure of standard medical care to produce a positive result – an occurrence that is all too common in today’s world.
Legions of well wishers look on as Senator Ted Kennedy struggles for his life, fighting against one of the most difficult types of brain tumors. Ironically, it may be the drugs he has so adamantly promoted that are the straw that broke the camel’s back, leading to his brain tumor.
The latest stone thrown at the 200-billion-dollar-a-year cell phone industry came from a study by neurosurgeon Vini G. Khurana entitled Mobile Phone-Brain Tumour: Public Health Advisory. His meta-analysis of existing cell phone studies may not contain a lot of new information; but his rather alarming message was carried by media around the world: “there is a growing body of statistically significant evidence for a relationship between the overall length of use of a mobile phone and the delayed occurrence of a brain tumor on the same side of the head as the ‘preferred side’ for mobile phone usage.” He claimed a 2-4 fold increased risk following 10 years of regular use.
On April 2, 2008 CNN spent the day bringing awareness to the problem of autism. Larry King’s segment, which included Jenny McCarthy along with a panel of guests, was particularly enlightening. My hat is off to Jenny, a celebrity mother who is making it quite uncomfortable for the Center for Disease Control (CDC) to ignore parents of autistic children seeking answers. Why does a mom have to do the work of the CDC? The answer is rather simple: our government’s zeal to insist on too many vaccines while ignoring the actual risks is the driving force behind the autism tragedy.
The Senate is about to approve legislation (Mothers Act – S.1375) which mandates the indoctrination of pregnant and nursing mothers into the use of extremely dangerous psychiatric medication. We already know this class of medication poses serious health risks to both mother and baby. Consequences to the baby are now proven to cause nerve-related changes that can adversely affect health for a lifetime.
Immediate Consumer Action is Needed to Stop Mothers Act The Mothers Act is pending legislation that will indoctrinate hundreds of thousands of mothers into taking dangerous psych drugs. It is a great example of how the Big Pharma lobby controls Congress to the detriment of health, as well as needlessly and dramatically inflating the costs of our health care system for everyone. Like any piece of legislation it purports to address a troubling issue – in this case the mood distress of mothers following birth known as postpartum depression. It is true that 10% - 15% of women need some assistance in dealing with this topic – but the majority of them sure don’t need it from Big Pharma. That is the Big Lie.
It now appears that the FDA Chief Andrew von Eschenbach, M.D. has committed perjury before Congress. Unlike Roger Clemens, who also seems to be putting his foot in his mouth before Congress, von Eschenbach’s actions appeared to have allowed unnecessary deaths to Americans – hardly the mission of the FDA. By contrast, Roger Clemens is simply causing death to his own reputation. Hopefully Congress can quit wasting taxpayer money on baseball and get to the bottom of what is really going on at the FDA.
Several high profile human cardiovascular drug experiments have turned into disasters for Big Pharma. These findings are sure to shake the misguided consumer confidence in drugs as a mainstay of preventive cardiovascular health. Hanging in the balance are billions of dollars of fraudulent drug sales based on the flimsy argument that changing numbers (blood sugar, cholesterol, or blood pressure) with the use of toxic drugs is somehow the same as actually being healthy…
Women across the country are being duped to consume billions of dollars worth of bone poisons under the false pretense that if they take them long enough they will not develop osteoporosis. Even the FDA is becoming alarmed by the side effects of these bone drugs. The biggest selling drug in this class is called Fosamax, made by Merck – the very same company that killed thousands of Americans with Vioxx while hiding cardiovascular risks from the FDA and patients. Does anyone trust them?…
Considering that tens of millions of Americans now take statins to lower cholesterol, the following headline was conspicuously absent from the major media this month: “Statins Found to Turn On Gene that Causes Muscle Damage.” It’s now a fact of science; a new study shows that taking statins destroys your muscle to a greater or lesser degree. And let’s not forget that the heart is a muscle.
On November 29, 2007 the FDA made a rather surprising, almost honest announcement. It said that it could not protect Americans from the dangers of drugs. A 56-page report by its Subcommittee on Science and Technology stated the FDA “suffers from serious scientific deficiencies and is not positioned to meet current or emerging regulatory responsibilities.” This blistering report on the life-threatening shortcomings of the FDA was released with the stamp of approval of the head of the FDA, Commissioner Andrew von Eschenbach. The flagrant disregard for human health by the FDA…
Oprah has done an immense favor to millions of American women by helping them understand that a malfunctioning thyroid gland may indeed be part of their weight and health problems. After writing openly about her thyroid problem in the October 2007 Oprah Magazine, she then went into the nature of thyroid problems on her TV show.
The United States Health Freedom Assembly met October 12 – 14, 2007 at the William Mitchell College of Law in Saint Paul, MN, a gathering of many of the top state, federal, and international health freedom advocates, organizations, and industry. The meeting took on a tone of extreme importance as the FDA has issued policy and obtained broad new regulatory authority over health freedom in the past 12 months. The FDA is seeking to undermine the law known as DSHEA (Dietary Supplement Health and Education Act of 1994), the cornerstone of health freedom in America. Emboldened by its new powers the FDA is now poised to trample the first amendment rights of companies and Americans who seek to explain or understand how nutrition can support health. The FDA campaign has begun.
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. (D-NJ), John Dingell (D-MI), Henry Waxman (D-CA), and others falsely proclaimed that they were doing America a favor by passing this sweeping FDA-supported legislation that grants the rouge agency more power and money, and even transforms it into a quasi drug company.
The FDA, emboldened by its transformation into a drug company, has embarked upon an anti-American plan of interfering with business and intentionally eliminating various dietary supplement companies from the market. The FDA announcement came on Friday, June 22, 2007 under the guise of a final rule for dietary supplement good manufacturing practices (CGMPs). Within this 800 page rule the FDA states, “We find that this final rule will have a significant economic impact on a substantial number of small entities.... Establishments with above average costs, and even establishments with average costs, could be hard pressed to continue to operate. Some of these may decide it is too costly and either change product lines or go out of business.... 140 very small [less than 20 employees] and 32 small dietary supplement manufacturers [less than 500 employees] will be at risk of going out of business.... costs per establishment are proportionally higher for very small than for large establishments....The regulatory costs of this final rule will also discourage new small businesses from entering the industry.”
Under the false pretense of improved food and drug safety the FDA is re-inventing itself as a kingpin drug company. This charade has so far hoodwinked virtually all members of Congress. The Senate has already approved this FDA transformation. The House will bring similar legislation out of committee next week, with a vote in the full House likely in July.
The Andrew von Eschenbach FDA era is upon us. The Avandia scandal is the tip of the iceberg. Is anyone ready? The words “illicit financial collusion” have been replaced by the politically correct term, “collaboration.”
The penalty in China is death, in America its business as usual. Zheng Xiaoyu, the former head of China’s FDA, was sentenced to death for accepting $832,000 in drug company bribes and for dereliction of duty. Like China, our country is in the middle of a drug and food safety crisis. Why is FDA Commissioner Andrew von Eschenbach, M.D. getting a free pass? Why did the Senate just pass legislation (S.1082) that gives von Eschenbach significantly more power to do whatever he pleases? And exactly what is it that von Eschenbach is doing?
Senate Attempts Damage Control – House Braces for Onslaught Senators were taken off guard by the public outrage over the passing of bill S.1082 with language that can be used to seriously harass dietary supplements by enabling the FDA to apply drug-related risk analysis to the safety of food and food ingredients (and thus dietary supplements).
The FDA is Acquiring New Powers to Suppress Alternative Health Your right to have free access to safe and highly effective dietary supplements is under an intense multi-pronged FDA attack. On May 14, 2007 the Supreme Court sided with the FDA by deciding not to hear the case of Nutraceutical v FDA, letting stand a federal appeals court ruling that permits the FDA to use drug-related risk/ benefit analysis to determine if a nutrient is safe.
The Senate has sold out the American people. Anyone voting for change in the last election can now plainly see the shenanigans of a Democratic-controlled Senate. 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.”
For approximately four days Americans lived in a delusional state that they may soon pay drug prices the same as every other country in the civilized world. Euphoria over breaking the Big Pharma monopoly turned to disgust as the chameleon, Senator Edward Kennedy (D-MA), changed sides and lead a contingency of Democrats against fellow Democrats lead by Byron Dorgan (D-ND). By passing the Cochran amendment the Dorgan amendment is poisoned and will no longer be effective. Maybe Democrats are now learning what Republicans have known for some time – you can’t trust Kennedy.
In May of 2006, after months of research and investigation, I published my ominous findings in the book Fight for Your Health: Exposing the FDA’s Betrayal of America. Everything I predicted in this book is on the fast track to becoming reality. A majority of Americans, not informed on current events and unaware of the history involved, are silent. Mainstream media, one of Big Pharma’s largest clients, is silent. Only the power of the internet, which rivals the invention of the printing press in significance, is making it possible for individuals to understand what is going on.
There is still time to stop FDA, Inc. Bill S1082 is a bill that helps fund the FDA with Big Pharma money. It is known all over Capital Hill as Big Pharma-designed legislation. It is running into all sorts of credibility problems. A vote is likely on Monday – delayed due to all the opposition flooding the Senate by “we the people.”
S1082 Update – Tuesday’s Activity. Fight Erupts on Senate floor: As the Senate continues to debate the Big Pharma-friendly sweeping reform of the FDA a new problem for Big Pharma’s prize Senators has erupted and quickly turned into confrontation on the floor of the Senate. At stake is at least 10 billion dollars per year in exorbitant Big Pharma profits. In one corner is Big Pharma-puppet Orrin Hatch (R-UT), representing the Kennedy/Enzi drug cartel. In the other corner is a majority of Senators lead by Byron Dorgan (D-ND).
The combination of a lack of sun and cold weather invariably strains your mood as well as your metabolism. It is an energy-depleting form of stress, similar to having a daily argument with someone. If your energy systems…
S1082 Update – Monday’s Activity at the bottom of this article. Bill S1082: The Food and Drug Administration Revitalization Act (also called the Prescription Drug User Fee Act of 2007) is one of the greatest scams and con jobs ever foisted on the American public. Current FDA management is grossly incompetent on the subject of drug safety.
A new attack against health freedom, drug safety, and dietary supplements was launched last week by Senator Edward Kennedy (D-MA) with major support from Michael Enzi (R-WY). It is called the Food and Drug Administration Revitalization Act (S1082). This legislation was planned over the past few years working hand-in-glove with the FDA’s dysfunctional management and legal team – meaning this legislation was written for the profits of Big Pharma and Big Biotech AT THE EXPENSE OF SAFETY AND HUMAN HEALTH.
Americans are up in arms that our pets are being injured and killed by a toxin sent to America by a Chinese company. Melamine, a toxic fertilizer used in China, is the suspected culprit behind the deaths and injuries to potentially hundreds of thousands of our pets. The FDA assures us that this toxin has not entered the human food supply – does anyone believe in the competence of the FDA? It is only a matter of time before this type of problem happens to humans, as the inept FDA has no control over imported food intended for humans, let alone pets.
On February 13, 2007 the House Energy and Commerce Committee’s Subcommittee on Oversight and Investigations opened hearings lambasting the FDA regarding the safety of drugs. The opening statement by Chairman John Dingell (D-MI) set the tone, “It is clear … that the FDA is badly broken. I expect that before we finish this investigation, which is just getting underway, we will discover whether the problems we have found are due to the work of scoundrels, irrational penny-pinching, or because the doors to the FDA “hen house” have been thrown open to foxes. It may be a combination of all three.”
Wall Street, international bankers, President Bush, pharmaceutical companies, new biotech companies, the Rockefeller empire, and the FDA have created a new plan for public health. It is a grand vision based on profit. It will use the FDA and, as needed, the Department of Homeland Security as the regulatory police force that ensures compliance in the name of public safety. Legitimate objections may be overpowered in the name of national security.
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