WASHINGTON — Some officials at the Food and Drug Administration have reacted to the news of a generic drug scandal like Hamlet's mother denied a murder rap — they protest too much.

Rumors about favoritism and collusion in the approval of generic drugs have Deen bouncing around the FDA since 1981, when a drug company sent a fur coat to an FDA chemist as a gift to his wife. The rumors turned to urgent complaints more than two years ago when a handful of drug companies alerted FDA officials that bribery was rampant in the agency's generic drug division — that some companies were greasing palms and, in return, their applications for approval were greased, too.

Yet top officials in the FDA would have you believe that the scandal was born last spring when someone was finally caught. Drug companies with a front row seat on the FDA's drug approval process describe repeated attempts to get the agency to investigate itself. They say they butted up against an agency with no system to field complaints and a rogue generic drug division with invisible leadership. Those close to FDA Commissioner Frank Young describe him as a tentative leader, a consensus man who consults everyone before he makes a decision.

When the generic drug scandal went public, one of Young's advisers told him he should "out-Kemp Jack Kemp" — in other words, clean house at the FDA with the same gusto that Housing and Urban Development Secretary Jack Kemp is purging HUD. But instead Young decided to blame the drug companies for taking advantage and Congress for passing laws that he says swamped his staff.

Interviews and documents obtained by our associate Jim Lynch indicate that Young and others in the FDA had plenty of warnings. Agency officials overseeing the generics division apparently chose to do nothing or felt powerless. In the spring of 1987, two pharmaceutical companies — Mylan Laboratories Inc. and Barr Laboratories — met with top FDA officials to blow the whistle. They complained about Charles Chang, chief chemist in the generics branch, and alluded to collusion between Chang and other drug firms. Barr and Mylan knocked on plenty of doors but say they-got no cooperation. Barr finally took its serious'allegations directly to Young in July 1988 and accused the FDA of sharing Barr's trade secrets with a competitor. The comoany eot no response to its detailed letter.

Mylan took the investigation into its own hands and found enough evidence on Chang to shake up the FDA. Chang and two other chemists have since pleaded guilty to accepting gratuities from drug companies. Barr finally did hear from the FDA. On the day that Barr's president testified before Congress about problems inside the agency, FDA inspectors gave Barr a surprise inspection. The FDA now claims the timing was a mistake, not retaliation. Young has hardly out-Kemped Jack Kemp. He reassigned one official who had early warnings about the problem, and he rerouted the chain of command around another. Young's boldest move has been to order "bribery awareness" classes for his troops. If they needed the classes to recognize a bribe, they shouldn't have been hired in the first place.

by Jack Anderson

A CRISIS IN CONFIDENCE

What Happened To the Old FDA?

By: Cynthia Drasler, MBA

Originally published in the Sept/Oct 2006 issue of Mystic Pop Magazine

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 Nesss 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 1970s 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 FDAs 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 FDAs 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 Mercks 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 FDAs 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 US 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 2000s. 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.