The FDA: An Agency Out Of Control - Part 1 of 2
Friday, February 09, 2007
Byron J. Richards, Board Certified Clinical Nutritionist
The FDA is steamrolling its way to a grand vision of repressive health care based on profits for Big Pharma and new biotech companies at the expense of human health.
A current case in point is the heart bypass drug, Trasylol, a medication often given so patients don’t bleed too much during surgery. A study published in the February 7, 2007 issue of the Journal of the American Medical Association showed that Trasylol was found to significantly increase the risk of death in the subsequent five-year period following heart bypass surgery. The data predicts that for the 246,000 Americans receiving this drug in 2005, over 19,000 will needlessly die in the following five-year period. FDA warnings in early 2006, weak as they were, curtailed the blockbuster growth of the drug, and it appears the drug lost about 20% of its sales compared to 2005. This means that roughly 15,000 Americans receiving Trasylol in 2006 will needlessly die over the next five years because the FDA twiddled its thumbs to protect Bayer from an avalanche of lawsuits, even while Bayer lied point blank to the FDA (the Justice Department should be investigating). You heard me correctly, the head of the FDA, Andrew von Eschenbach, made an administrative decision to leave Trasylol on the market to protect Bayer, brushing aside a blatant Bayer cover-up. Of course, the problem is ongoing in 2007, exposing innocent Americans to unnecessary risk that is likely to result in an additional 1000 deaths per month (over the next five-year period).
Bayer was expecting Trasylol to be its next blockbuster drug and was in Phase III trials to use the drug for all kinds of common operations (these trials were dropped in January 2007). While Bayer made $291 million on the drug in 2005, the drug generated over 1.2 billion in treatment fees for the friends of Bayer due to all of its damaging side effects. This information was published in a January 2006 article in the New England Journal of Medicine. The study showed that Trasylol doubles the risk for kidney damage, causes 10,000 patients per year to require dialysis for life, increases heart attack risk by 48%, increases heart failure risk by 109%, and increases the risk of stroke by 181%. I mean really, what would you expect from a drug that promotes clotting in someone with clogged arteries??? Thus, since at least January of 2006 the FDA has had the data, heart surgeons have had the data, and Bayer executives have had the data. At what point does criminal neglect enter in to the picture? Following this information Bayer did its own independent study, hid the results from the FDA because they were so bad, and lied to an FDA advisory panel telling it that Trasylol was safe (see link in previous paragraph). Yet, von Eschenbach still didn’t take the drug off the market.
Trasylol has been on the market since 1993 with about 4 million users worldwide. Based on the statistical evidence in the new study, this translates to about 320,000 unnecessary deaths around the globe (almost half are Americans). What punishment is there for German executives who kill Americans? And what about the doctors who are well aware of Trasylol risks and use it anyway (never informing the patient)? What motivates them? How much is Bayer paying them in perks to use the drug? The Justice Department should be investigating. There are older drugs that are 1% to 4% of the cost of Trasylol, work by a different mechanism, don’t kill people, and don’t generate the additional billion or more in treatment costs each year.
Andrew von Eschenbach, as head of the FDA, has some serious explaining to do. Yes, this is the same Andrew von Eschenbach that was permanently appointed head of the FDA by the Senate in the lame duck session of Congress. Both sides of the aisle sold out American citizens (see how your senators voted), allowing the von Eschenbach appointment to go through (paid for by the Big Pharma lobby). The only Senator with any significant fortitude and honor was Charles Grassley (R-IA), whose Senate confirmation testimony regarding Andrew von Eschenbach on December 7, 2006 was accurate, frank, and to the point:
“People ought to be ashamed of saying Dr. Andrew von Eschenbach has done a superb job in the position he is currently occupying [acting head of the FDA].…That is an insult….In my interactions with the Department of Health and Human Services and the FDA these last 8 months, I have seen a complete and utter disrespect for congressional authority and hence the law.…This body [the Senate] should not walk hand in hand with the executive branch and sit idly by as instances of abuse and fraud continue to endanger the health and safety of American people…Under Dr. Von Eschenbach, the FDA has not only avoided transparency, it also has threatened those who are trying to desperately expose the truth….”
America has huge problems with health care and the quality of care. Big Pharma owns both political parties and the White House. Big Pharma owns the FDA. The head of the FDA is now a Big Pharma biotech sales rep. Big Pharma owns the American Medical Association. Big Pharma sponsors numerous “scientific” journals as well as funds the research they publish. Big Pharma owns the researchers in many academic institutions. Big Pharma owns the pen and pencil of almost every doctor in America. Big Pharma owns the mainstream media, and will use it to downplay problems and openly attack dietary supplements (their only real competition). The FDA is headed on a path of becoming a full fledged drug company. Big Pharma is stealing the profits of corporate America and the wealth of American citizens through the creation of a sickness industry paid for by corporations and taxpayers, and fully sanctioned by the federal government. Yet, the American public is unable to act while Rome burns. It is truly a sad state of affairs, rotting away the very pillars of our democracy.
In order to have any faith in the human spirit I need to take the view that the American public is simply uneducated and that ignorance is bliss, from the point of view of Big Pharma. All I can do is try to inform. To do so I am taking the rather unusual step of publishing my expose book, Fight for Your Health: Exposing the FDA’s Betrayal of America, on NewsWithViews.com. Each week I will release a chapter or two, along with a few brief comments as to the current situation with any topics discussed in the chapter. If enough people actually comprehend what is going on we may be able to rise above the rather significant problems that challenge our nation. This is a gift; please pass it along to your friends.
Fight for Your Health
THIS IS A STORY ABOUT HEALTH. It is not your typical health story; it is the real story of how your health and the health of your children are being seriously compromised.
The real story shows that the FDA has spent the last hundred years boosting the profits of drug companies and eliminating competition to those companies, acting as a misguided police force that has little to do with public safety. The trend has progressively worsened over the hundred-year period and reached a new low in 1992, when President William Jefferson Clinton allowed the FDA to accept millions of dollars in drug company money to help approve drugs, a practice that continues to this day.
The problems worsened in recent years, as President George W. Bush actually turned portions of the FDA itself into a drug company, responding primarily to the interests of Wall Street. He installed a new FDA chief and second-in-command who have multiple connections to drug companies and Wall Street (Andrew von Eschenbach, M.D., and Scott Gottlieb, M.D.). Public safety is low on the list. Citizens’ rights are low on the list. Rushing new and expensive unproven drugs onto the market is now a top priority. Of course, stamping out competition remains an important duty.
The quality and safety of health care are major concerns for Americans, especially regarding our children. Consumers actively look for the best options to maintain their health. Our society uses a combination of traditional medical and alternative approaches in an effort to harness the best of both worlds. This is all about to change; there is a new vision for American public health. It is a plan sponsored and promoted by the Bush administration, the FDA, and drug companies. It is based on the new politics of the emerging global economy, at the expense of personal health freedom. For part 2 click below.
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