Fear of Reprisals Keeps Honest FDA Researchers Gagged
How the FDA keeps its researchers from saying what the agency wants kept quiet.
Many have leveled charges against the Food and Drug Administration (FDA) for corruption in the ranks. Recently, those concerns reached a new level of anger as scientists from the FDA sent new letters to Congress documenting serious cases of FDA retaliation for those who challenged orders by its senior management.
Among the many claims included in the letters is a federal district court case going back to 2009 that was summarized by FDA scientists in a 2009 letter to President Obama: “The latest example of wrongdoing was reported on March 23, 2009, from a Federal District Court Judge who ruled that [the] FDA’S decision on the Plan B drug [in a particular case] was ‘arbitrary and capricious because [it was] not the result of reasoned and good faith agency decision-making.’ [The] FDA’S top leaders at the Center for Drug Evaluation and Research (CDER) testified that they ‘didn’t have a choice and ... [weren’t] sure that [they] would be allowed to remain [in their positions if they] didn’t agree’ to ignore the science and the law. To the contrary, they should be removed from their positions of authority precisely because they didn’t follow the science and the law. The judge further ruled that there was ‘unrebutted evidence that the FDA’S [decision] stemmed from political pressure rather than permissible health and safety concerns.’ The improper political influence and the many departures from its own policies reveal that such FDA officials are incapable of ensuring integrity and science at [the] FDA.”
The same document cites another example: “On October 14, 2008, FDA physicians and scientists wrote to members of the House Energy and Commerce Committee reporting that top FDA officials at the Center for Devices and Radiological Health (CDRH) had distorted the scientific review of medical devices and then retaliated against those who brought this to light. Congressman John Dingell (then Chairman) and Congressman Bart Stupak (Chairman, Subcommittee on Oversight and Investigations) wrote to then FDA Commissioner Dr. Andrew C. von Eschenbach (since resigned), stating that there were ‘well-documented allegations that senior managers within CDRH’ had ‘acted in violation of the law ... [and that] sweeping measures may be necessary to address the distortion of science alleged by so many CDRH scientists.’”
“… violations of the federal Racketeer Influenced Corrupt Organizations Act (RICO) on behalf of Plaintiffs Terry Aston, John Fratti, Linda Martin, David Melvin, Ester Schulkin, and Jennifer Wilcox, who were directly and proximately injured by the intentional, willful, and negligent actions and inactions of each and every Defendant, including Johnson & Johnson, Johnson & Johnson Pharmaceutical Research & Development, L.L.C., Ortho-mcneil-janssen Pharmaceuticals, Inc., Renaissance Technologies, L.L.C., Peter F. Brown, Dr. Margaret A. Hamburg, Robert L. Mercer, and James H. Simons. Defendants, each and every one of them, acting in concert jointly and severally, through the use of the interstate mail and wires, entered into and furthered a conspiracy to illegally and criminally influence the Commissioner of the Food & Drug Administration and the Food & Drug Administration to mislabel and misbrand a drug in order to make and sell an inherently dangerous drug by defrauding consumers such as Plaintiffs in order to acquire and reap financial gain, including but not limited to:
“1) driving up or maintaining the price of shares of Defendant Johnson & Johnson stock
“2) increasing the financial holdings and value of Defendant Johnson & Johnson stock held by Defendant Renaissance Technologies, L.L.C.
“3) increasing Defendant Renaissance Technologies, LLC’S corporate income thereby increasing financial remuneration and gain to Defendants Peter F. Brown, Robert L. Mercer, and James H. Simons by virtue of Dr. Margaret A. Hamburg’s marriage to Peter F. Brown
“4) increasing corporate income of the officers of Defendant Johnson & Johnson, Defendant Johnson & Johnson Pharmaceutical Research & Development, LLC, and Ortho-mcneil-janssen Pharmaceuticals, Inc.
“5) avoiding potential lawsuits against Defendant Johnson & Johnson, Defendant Johnson & Johnson Pharmaceutical Research & Development, LLC, and Ortho-mcneil-janssen Pharmaceuticals, Inc.
“6) increasing the combined wealth of Defendants Dr. Margaret A. Hamburg and her husband, Defendant Peter F. Brown, by virtue of the above.” 2
For those wondering what the quote about the “combined wealth” is all about in the complaint, it has come to light that Dr. Hamburg’s husband’s hedge fund held over a half a billion dollars of stock from Levaquin’s manufacturer, Johnson & Johnson.
With the pressure of the growing public outrage over the FDA’S behavior in manipulating its staff, as well as word of the racketeering charges against Dr. Hamburg and the drug’s manufacturer hitting the press, the FDA finally ordered that Levaquin be removed from the market on May 12, 2016. It did so with the statement, long overdue, that the use of Levaquin can produce “disabling and potentially permanent serious side effects.”
With the manipulation process so embedded in the FDA, the government that supposedly provides oversight over it, and the drug companies whose executives’ billions of dollars in bonuses depend on it, this is far from the end of this story.
As just one more example, another letter by FDA scientists pleading for help had its own separate list of additional evidence of corruption, including the ordering of physicians and scientists to ignore guidance documents prepared by the FDA itself, removing black box warnings supplied by FDA experts and even allowing FDA subordinates to provide written threats of disciplinary action if physicians and scientists did not change their official scientific opinions and recommendations to properly align them with management.
The letter concluded that the “culture of wrongdoing and cover-up is nothing new but is part of a longstanding pattern of behavior.”
No one in any senior position seriously believes that even these letters, lawsuits and public allegations will change things quickly. But with strong public support for change, more lawsuits and perhaps one or two brave souls at the top, maybe that change will happen soon enough to prevent anyone else from being physically hurt because the wrong product was approved by a corrupt FDA.
1) Letter from FDA representatives to President Barack Obama on April 2, 2009.
2) Case Complaint 1:16-cv-00086, Document 1, Filed 01/18/16 by Terry Aston, John Fratti, Linda Martin, David Melvin, Ester Schulkin, and Jennifer Wilcox, Plaintiffs, vs. Johnson & Johnson, Johnson & Johnson Pharmaceutical Research & Development, L.L.C., Ortho-mcneil-janssen Pharmaceuticals, Inc., Renaissance Technologies, L.L.C., Peter F. Brown, Robert L. Mercer, James H. Simons, and Dr. Margaret A. Hamburg.