Who exactly are these people calling themselves the FDA today, and what did they do with the old FDA?  The old FDA was a critical part of the checks and balances set up by Congress to be the arbiter between our American capitalistic business structure and public safety.   The old FDA tried hard to protect the American public from over-zealous pharmaceutical companies.  They routinely stared down the pharmaceutical industry and kept them on the straight and narrow.  They acted like Elliot Ness's "untouchables" during prohibition.  They were fearless, relentless and demanded meticulous, rigorous pharmaceutical testing procedures, with the emphasis on rigor. They were the good guys in the white hats without a hint of scandal in their relationships with the companies they regulated.  They were on the side of safeguarding public health, pure and simple.  If the old FDA ever approved a drug that killed or hurt people, they changed their procedures to make sure it didn't happen again and Congress was always watching. It was the old FDA that demanded sweeping changes in the way pre-clinical testing was done on all drugs following the thalidomide disaster in the 1950s.  Thalidomide was a drug given to pregnant women that caused children to be born without arms and legs. The changes in pre-clinical testing, demanded by the old FDA gave birth to Teratology, the science of how drugs affect developing fetuses.  Teratology studies have been required on all drugs since then to prevent another epic disaster like thalidomide from happening again.  The old FDA would routinely discipline pharmaceutical companies who submitted sloppy scientific reports.  They even threatened to close down the GD Searle Company in the 1970's for substandard testing procedures.  These were the actions of the old FDA, the one I remember - the one I miss.  The old FDA answered to Congress and Congress answered to the American public. This was a great system; it worked well for all Americans to create a medical industry that was the envy of the world.  I miss that system.  I miss the old FDA.  I really do.

The new 21st century FDA is unrecognizable from the old FDA.  The new FDA looks more like the marketing department of the pharmaceutical industry, than a regulator of it.  It certainly isn't acting like it has the best interest of the American public at heart anymore.  Not only is there a revolving door between members of the FDA and the corporate boards of pharmaceutical companies, but their allegiance seems to have changed from protecting  the  physical health of the American public to protecting the financial health of the name brand pharmaceutical industry.  Scandals are rampant and include the resignation of recent FDA Commissioner Crawford, only 3 months after being confirmed by Congress.  He resigned amid allegations of obvious financial ties to companies he was regulating, and lying to Congress.  Then there was the USA Today article a few months ago reporting that 54% of the experts hired by the FDA to evaluate drug safety studies have shameful financial ties to the companies they are regulating, and they are completely unapologetic about it.  All of this is occurring while the new FDA claims objectivity and concern for the safety of the American public.

Since Congress changed the method of funding the FDA in 1992, its power and budget has grown, but its accountability to the American public has diminished.  The new FDA's attitude of omnipotence is understandable since Congress has been unwilling to challenge the new FDA on its decisions since 1992, with few exceptions.  Even with the recent Vioxx scandal, there has been an amazing silence from Congress about the accountability of the new FDA.  I am deeply disturbed by this lack of Congressional over sight, and consider it a big part of the new FDA's declining image with the public.   Because of the recent financial scandals and the fact that a substantial portion of its budget is funded by the pharmaceutical and chemical companies that it regulates, I have personal doubts about the safety of newly approved drugs.    For example, when I heard Merck's new vaccine for cervical cancer was recently approved I was skeptical.  They are encouraging girls and young women between the ages of 8 and 26 to get the vaccine.  My first thoughts were, "Should I really make an appointment for my high school aged daughter to get it?  Is this vaccine really safe?  Did the FDA seriously evaluate it?  Or, was the approval more of a haphazard scan of the testing data to get this vaccine on the market fast to help Merck recoup their financial losses from the "Vioxx scandal."  I'm not sure about anything the new FDA says or approves anymore.  Is this vaccine going to be found to be harmful to the girls and young women who receive it 5 years from now?  I'm not sure...

Doubt is the legacy of the new FDA.  Even as recently as 10 years ago getting FDA approval for a new drug meant it had instant assurance of not only US but also global profitability.  Today that is changing.  Several European countries have started questioning the new FDA's approval of various drugs and genetically modified foods.  FDA approval no longer equates to instant global acceptance.  There is a crisis in confidence brewing not only in America but globally about the new FDA's objectives and motives.  We are in the beginning stages of it now, and neither the new FDA, Congress, nor the pharmaceutical companies show any evidence of concern.

For years, the new FDA has been trying to shut down the natural supplement industry, thereby eliminating competition for the pharmaceutical industry and eliminating health care choices for Americans.  Recently, the new FDA has been targeting bio-identical hormones for removal from the market.  If bio-identical hormones are banned, what's their next step?  These hormones are identical to the hormones that we have in our bodies.  Does this mean the new FDA believes that our natural inborn human hormones are dangerous too? Their basis for wanting to remove bio-identical hormones from the U.S. results from nothing more than a "consumer complaint" filed by Wyeth Pharmaceuticals (the manufacturer the leading synthetic hormones on the market) after several years of declining sales. Wyeth's sales have been free falling since their synthetic hormones (not bio-identical) were found to be dangerous for some women in the early 2000's.  Today, women are choosing more natural options for their hormonal needs, and Wyeth wants to take that option away with the help of the new FDA.  The process of name brand pharmaceutical companies filing "consumer complaints" to the FDA for the sole purpose of eliminating their competition has been increasing in the last few years according to a Washington Post article on July 3, 2006.  They have been exploiting a procedural loophole the size of a 747 that was put into place to alert the FDA to safety issues, but has been twisted by their stable of lawyers to try to ban competition.   This legal tactic is increasing health care costs by 100s of millions of dollars per month and serves to eliminate our freedom of medical choices.  If the name brand pharmaceutical industry is allowed to continue the perversion of this procedure, bio-identical hormones, nutritional supplements and generic drugs will be removed from the market.  Only name brand drugs will be allowed and we will be forced to pay whatever the name brand companies want to charge us.  Thankfully, Senator Trent Lott (Rep- Miss.) and Senator Debbie Stabenow (Dem-Mich.) are jointly working on a bill to stop this practice.  I am heartened by their efforts, it's an important step in the right direction.  I would like to see them start a movement to completely overhaul the FDA.

Don't forget that new FDA has approved herbicide and pesticide laced bacteria for insertion into the DNA of genetically modified foods. This approval was given with out requiring anything more than a 90 rat study, designed, conducted and interpreted by the chemical company profiting from it.  Also, after requiring almost no testing for these genetically modified foods, the new FDA has refused to require the labeling of them because the manufacturer of the foods doesn't want them labeled.  We are coming dangerously close to completely poisoning ourselves with synthetic chemicals (including pharmaceutical drugs) considering the hundreds of thousands of toxic chemicals allowed in every product and food we come in contact with.  Is it any wonder why every type of disease is skyrocketing and the cancer rate in America is now one in two?

A growing body of reputable scientific studies link synthetic chemicals used in everyday products to an increase risk for diseases ranging from allergies to cancer.  Our bodies are not able to metabolize these synthetic chemicals and they build up in our tissues, over decades of use, suppressing our immune systems until we get sick.  The American Medical Association (AMA) has identified a new illness caused by the buildup of toxic synthetic chemicals in our bodies called Multiple Chemical Sensitivities (MCS).   MCS is treated by a new medical specialty created by the AMA called the Environmental Medicine Doctor.  These doctors are MDs and are usually trained in Allergy/Immunology.  Yet despite the fact that the AMA acknowledges the health damage that synthetic chemicals cause, the new FDA just happily keeps approving any request by the pharmaceutical and chemical companies to unleash more synthetic chemicals onto the market with little or no consideration of the consequences to our long term health.

It is up to us to change this.  Call your congressional delegates and tell them that you want to stop the FDA from trying to take away alternative medical choices of for the sake of preserving pharmaceutical profits.

Cynthia Drasler, MBA Copyright July 2006.