We have long documented many cases of FDA-approved killer drugs and agency interference in a person’s right to natural medicine (and much of this information and more is collected in our new FDA Death Meter website, as we discuss in our lead article this week).
But when the FDA’s own scientists send a letter to Congress exposing outrageous cases of retaliation against those refusing to sign off on unsafe, unproven, ineffective products, it’s clear the corruption at the FDA is far-reaching and thoroughly entrenched. Pressure to approve dangerous drugs and devices is coming from top managers with ties to big business.
Can you imagine working in an atmosphere where the honest employee fears the dishonest employee, and not the other way around?
How can anyone trust the FDA’s claims that a particular food or drug or medical device is safe to eat or put in or on your body, when the former director of the agency, Margaret Hamburg, has been accused of racketeering? She’s charged with suppressing important information about the antibiotic Levaquin, which has caused the death of over 500 people and seriously injured 10,000 more. If guilty, why would she do this? We don’t know. But according to documents filed in federal court, her husband’s hedge fund held half a billion dollars worth of stock from Johnson & Johnson, the drug’s manufacturer. On May 12, 2016, after it had been on shelves for years, the FDA stated that Levaquin can result in “disabling and potentially permanent serious side effects.”
Here is more of what scientists inside the agency are saying:
• As early as 2008, FDA scientists warned Congress that their “good science” was being overruled by rigged advisory committees stacked with industry shills or doctors intent on protecting their own treatments. Anybody who dared speak out was targeted for retaliation. They pointed to a breast cancer detection device unilaterally approved by Dr. Donna Bea-Tillman, Director of Device Evaluation, after it failed experts’ recommendation for approval—three separate times. Noncompliant scientists were threatened with “criminal liability” if they told anyone outside the Agency what was going on.
• In 2009, FDA scientists and physicians sent a letter to incoming President Barack Obama, to put an end to the “culture of “wrongdoing and cover-up” at the FDA. They pointed to the allegation that Dr. Daniel Schultz, director of the Center for Devices and Radiological Health (CDRH), had used his position at the FDA to further the agenda of product manufacturers—in one case overruling the entire FDA staff.
• And there is more—much more. A second letter lists close to a dozen examples of wrongdoing and corruption allegedly perpetrated by the Director of the Office of Device Evaluation, including:
• Ordering physicians and scientists to ignore FDA Guidance documents;
• Removing black box warnings recommended by FDA experts; and
• Allowing subordinates to issue written threats of disciplinary action if physicians and scientists failed to change their scientific opinions and recommendations to conform to those of management.
In short, to quote the letter, the “culture of wrongdoing and cover-up is nothing new but is part of a longstanding pattern of behavior.”