The root of this problem, Richards says, is the involvement of the pharmaceutical industry -- also known as "Big Pharma" -- in the FDA decision-making process.
"The top two positions at the FDA are now headed by Big Pharma representatives," Richards says. "The Bush-appointed new FDA leadership is intent on removing any brakes being applied to the drug approval process, quite happy to turn ill Americans into human guinea pigs."
One of the "Big Pharma representatives" Richards is referring to is Andrew von Eschenbach M.D., interim head of the FDA since October. Currently, von Eschenbach -- a Bush family friend, Richards notes -- is awaiting a Senate vote to decide if he should hold the position permanently.
"Von Eschenbach is up to his eyeballs in Big Pharma and elite political connections, making his confirmation likely," Richards said. He added that once von Eschenbach gets past the political hurdle presented by Plan B -- a controversial contraceptive drug currently awaiting FDA approval -- he plans to transform the FDA into another drug company.
"To avoid consumer confusion the FDA should change its name to something more fitting, like the Fast Drug Approval organization," Richards said.
FDA Deputy Commissioner for Medical and Scientific Affairs, Scott Gottlieb, M.D., is another connection Big Pharma is likely to exploit, Richards said. Gottlieb is an "expert at promoting biotech stocks on Wall Street," said Richards, adding that Gottlieb used to criticize the FDA for approving drugs too slowly before he joined the administration.
In addition to their drug company connections presenting a conflict of interest, both Gottleib and von Eschenbach have recently caused other controversy. Gottlieb was publicly criticized for not putting enough emphasis on consumer safety, and von Eschenbach had to cancel his National Cancer Institute going away party because the invitations apparently requested gifts, which violates federal law.
The von Eschenbach-run FDA also came under fire during a Union of Concerned Scientists (UCS) and Public Employees for Environmental Responsibility (PEER) survey of FDA scientists, which found that the agency was "perverting science for political and financial benefactors," Richards said. The report also quoted scientists who said that Congress, FDA management, and the media were too easily able to interfere with their work.
The FDA has also interfered with safe and effective nutritional supplements, Richards charges, but points out that, in contrast, warning letters to drug companies have declined dramatically.
"The FDA agenda is favorable to Big Pharma and the sickness industry," Richards said. "It is harmful to the personal health and health options of Americans."
The Plan B morning after pill is a hot-button issue in Washington, Richards notes, but he says the abortion issue is just a smokescreen for the real issues. Richards wants to know where President Bush's influence is when it comes to taking Plan B down.
"It is far more important to Bush that his drug-peddling friend gets into permanent power than it is to do something meaningful for what he pretends to believe in," he said.
Richards believes that Plan B is really a diversion to prevent close scrutiny of von Eschenbach. What, Richards asks, do Americans really know about von Eschenbach?
"It is quite clear that Andrew von Eschenbach has put in his time as an oncologist, researcher, and administrator involved with the cancer issue," Richards said. "Any person taking the time to look past the glowing resume quickly finds out that he is well connected to Big Pharma and his emphasis is on using drugs to manage disease; a highly profitable approach to health care for Big Pharma."
"In fact, this approach has very little to do with positive health outcomes for patients."
According to Richards, examination of von Eschenbach's "track record" would lead any reasonable person to keep him as far from the FDA as possible. In fact, Richards said, von Eschenbach is exactly the type of person the FDA should be keeping an eye on.
Von Eschenbach's ties to his country of birth, Germany, also cast his objectivity into doubt, Richards feels, especially with the FDA's cooperation with Germany and the rest of the Europe in drafting the codex alimentarius; something that Richard's says could "eliminate effective nutritional supplements and health options from the market."
President Bush appointed von Eschenbach head of the National Cancer Institute (NCI) in December of 2001, and then tapped him to head the FDA in October 2005. During this time, Richards says, von Eschenbach announced that the FDA's top priority would be "speeding new drugs to the market, and eliminating safety studies that prove effectiveness, in favor of new genetic technology."
"(Von Eschenbach) is entirely predictable. Is this what Americans want running a safety agency?" Richards asked.
Richards said that approval of von Eschenbach's role as permanent head of the FDA will likely be "rubber stamped" by Congress. This, Richards says, means the future of the American medical landscape is bleak. Richards said that, in the future, the FDA will be exposed as the corrupt agency it has always been after massive numbers of Americans die at the hands of Big Pharma and the FDA.
"Rules and laws will be crafted to placate the angry public, apparently to prevent such dangers from ever happening again," Richards said. "These rules will be twisted and avoided, for a small fee, by those they seek to regulate. And the politicians will look in the mirror, look in their wallets, and realize nothing has changed."
For more information on the FDA and its connections to Big Pharma, read "Fight for Your Health: Exposing the FDA's Betrayal of America," by Byron J. Richards.
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