In January last year, a letter was sent to the highest levels of United States government by FDA scientists and doctors accusing top FDA officials and attorneys of violating laws, suppressing and altering scientific findings and conclusions, abuse of power and authority, and retaliation against those who’ve spoken out. The FDA has finally acknowledged that the letter is authentic.
The public’s health is at risk. Those of us who follow the FDA’s rulings are aware of its inconsistencies and approvals based on severely flawed science. This letter, though, documents some of the incidents and names people involved. The names go to the very top of the agency, including the commissioner. It’s been well over a year. So far, all that appears to have been accomplished is verification of the fact that it was written by genuine FDA employees.
With the lives of Americans at stake, that simply isn’t adequate. This should be treated as one of the nation’s highest priorities—and it should be handled in public. Instead, it’s quite hush-hush. If anything’s happening, there’s no way the public would know.
In the meantime, a well-documented corrupt agency charged with securing the safety of medical devices and drugs is being granted—and unilaterally taking—immense power over people’s lives. They’re determining what can be called a drug, and have gone so far as to state that even soup can be a drug if a health claim is made for it. The FDA is out of control—and though much of its malfeasance has been well documented, it continues to grab and be gifted with power.
What’s in the Letter
The letter states:
America urgently needs change at FDA because FDA is fundamentally broken, failing to fulfill its mission, and because re-establishing a proper and effectively functioning FDA is vital to the health of the nation.
The letter then goes on to quote from the November 2007 FDA Science Board Report:
‘The FDA is also central to the economic health of the nation, regulating approximately $1 trillion in consumer products or 25 cents of every consumer dollar expended in this country annually. … [Ellipsis is in the letter.] The importance of the FDA in the nation’s security is similarly profound. … [Again, ellipsis is in the letter.] Thus, the nation is at risk if FDA science is at risk. [Emphasis in letter.]
The authors then state the purpose of their letter:
The purpose of this letter is to inform you that the scientific review process for medical devices at FDA has been corrupted and distorted by current FDA managers, thereby placing the American people at risk. Through this letter and your action, we hope that future FDA employees will not experience the same frustration and anxiety that we have experienced for more than a year at the hands of FDA managers because we are committed to public integrity and were willing to speak out. Currently, there is an atmosphere at FDA in which the honest employee fears the dishonest employee, and not the other way around.
The letter goes on to state that the Director of the Office of Device Evaluation (ODE) has:
* Ordered physicians and scientists to ignore FDA Guidance documents.
* Knowingly allowed subordinates to issue written disciplinary actions for failure to change scientific opinions.
* Issued illegal documents that are not publicly available and would circumvent scientific and legal requirements.
* Failed to properly document significant decisions.
* Made and allowed false statements in FDA documents.
* Allowed manufacturers to market unapproved devices.
* Removed Black Box warnings FDA experts recommended.
* Bypassed FDA experts and failed to properly label devices.
* Excluded FDA experts from meetings when manufacturers didn’t want them there.
Three specific device approvals referenced were:
* Interference by former FDA chief Andrew von Eschenbach in approval of a knee device.
* A computer-aided mammography device’s approval over the unanimous vote against it by all FDA experts after a phone call from Congressman Christopher Shays.
* Daniel Schultz’s approval of a device to prevent scar tissue in spite of the scientists’ unanimous opinion against it.
Specific names brought up included Commissioner Andrew von Eschenbach and his assistant Commissioner for Accountability and Integrity, Attorney Bill McConagha, the highest level officials of the FDA. von Eschenbach resigned as of Obama’s inauguration.
The scientists’ and physicians’ names have been withheld for their protection.
The FDA has now officially acknowledged the existence of the letter and that it came from employees of the agency. It’s been well over a year, and that appears to be all that’s happened so far. The same writers followed their first letter of January 2009 with another in April 2009. In it, they reemphasized their concerns and broadened them to include the FDA’s Center for Drug Evaluation and Research (CDER), pointing out that a federal court had found that a drug had been approved because CDER’s top personnel “didn’t have a choice”. They had to “ignore the science and the law” to approve it or they would “be removed from their positions of authority”. They further listed several other incidents.
This is the same FDA that is the final arbiter of vaccine approval. If they approve a vaccine, then no matter how severe its effects—including death and destruction of life’s quality—and no matter if the manufacturer was fully aware of the dangers, it is now impossible to sue.
This is the same FDA that is grabbing power, even to the point of taking control of things that are more properly called food, such as supplements, vitamins, and Cheerios (though this author would quibble with the concept of Cheerios as food).
The FDA is out of control—at least, we must hope that’s the case. If not, then it’s acting according to higher-level instructions. That concept is terrifying to consider. Yet, the apparent lack of action in response to the scientists’ and physicians’ letter leaves one to question just what is really going on.