In the U.S., the Food and Drug Administration is the foremost agency responsible for protecting public health. But an agency cannot look out for the public’s best interest if it is riddled with “systemic corruption and wrongdoing.” Those where the words used in a letter to the president of the United States, dated April 2, 2009, from the FDA’s Office of Device Evaluation.1
The letter’s signees have been redacted, but Sarah Kotler, the FDA’s director of the Division of Freedom of Information, who not only is privy to, but has custody of, official records from the FDA, said in a sworn affidavit that the letter is certified and authentic.2
It details that Dr. Frank M. Torti, who at the time was the FDA’s acting commissioner and first chief scientist, abruptly left the agency after the press revealed evidence of serious wrongdoing. However, “many other FDA managers who have failed to protect the American public” were not held accountable and remained in their positions, even after the following offenses:3
Violating laws, rules and regulations
Suppressing or altering scientific or technological findings and conclusions
Abusing their power and authority
Engaging in illegal retaliation against those who speak out
Top FDA Leaders Ignored Science and the Law
In one example of wrongdoing, the letter describes a federal district court judge’s decision to overturn the FDA’s restrictions on the Plan B emergency contraception pill in order to make it available over-the-counter.4 The judge said the FDA’s decision to restrict access to the pill was “arbitrary and capricious because they were not the result of reasoned and good faith agency decision-making.”5
Instead of making a decision based on science, the FDA’s motives were political in nature and once again failed to put public health first, the letter alleges. Even top officials at the agency were pressured to conform to the agency’s motives or risk retaliation in the form of job loss or demotion. The letter reads:
“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 FDA.”6
Honest FDA Employees Fear the Dishonest Employee
FDA physicians and scientists also wrote a letter in 2008 to the House Energy and Commerce Committee to advise that FDA officials had distorted the scientific review process of medical devices and then retaliated against those who spoke out. It came out in January 2009 that the FDA had approved a medical device to detect breast cancer even though FDA experts had advised against its approval on three separate occasions.
The New York Times again described the actions as politically motivated, and FDA physicians described a culture of dishonesty and fear of reprisal. In a letter from FDA scientists to John Podesta, former White House Chief of Staff, dated January 7, 2009, it’s stated:
“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. Disturbingly, the atmosphere does not yet exist at FDA where honest employees committed to integrity and the FDA mission can act without fear of reprisal …
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 physical and economic health of the nation.”
After The New York Times and The Wall Street Journal published stories in 2009 detailing the FDA’s “improper political influence” and other wrongdoing, FDA attorneys and Torti sent an agency-wide email telling employees they “must comply with … obligations to keep certain information … confidential … [including] email to and from employees within FDA [that document the] deliberative process” and threatening that “violation … can result in disciplinary sanctions and/or individual criminal liability.”
Further FDA documents show Torti and other top FDA officials attempted to cover up manipulations of the scientific review process for a knee implant medical device, in which a committee of outside experts were misled and manipulated. It was concealed, for instance, that one of the publications used to support the device was written, in part, by researchers with affiliations to the device manufacturer.7
Culture of Wrongdoing Is Longstanding
The patterns revealed in the letter reveal a longstanding pattern at the FDA, including the approval of medical devices against the opinions of scientific staff, even when the opinions were unanimous and in cases where the devices showed no clinical benefit and higher risks of death. The letter revealed:
“… on March 6, 2009, it was reported by the consumer advocacy organization Public Citizen that Dr. [Donna-Bea] Tillman [director of the Office of Device Evaluation] ‘approved a [medical] device that has failed to demonstrate any clinical benefit’ and that showed ‘trends toward higher risks of death.’
According to Public Citizen: The March 6, 2009 approval by Dr. Tillman ‘bears an eerie resemblance to another device, Intergel, an anti-scarring device intended for pelvic surgeries that also demonstrated reduced scarring without clinically validated outcomes. …
Less than two years after Intergel was approved [by Dr. Schultz], the company removed the product from the market due to reports of post-operative pain, foreign body reactions and tissue scarring requiring repeat surgery, including three deaths among women who received it. This history should have given the FDA pause before once again approving a similar device with a questionable safety record.”8
Perhaps it’s not surprising, then, that a revolving door also exists between FDA officials and Big Pharma — and a much-used one at that. Research published in The British Medical Journal (BMJ) suggests conflicts of interest are rampant, as a concerning number of FDA employees leave the agency to work for the drug industry.9
The researchers analyzed data on FDA hematology-oncology drug approvals from 2006 to 2010 along with medical reviews conducted from 2001 to 2010. They then discovered the subsequent jobs of the former FDA medical reviewers that worked on those drug approvals.
Out of 55 people, 15 left their job at the FDA to work or consult for the biopharmaceutical industry (another 29 continued working at the FDA in some capacity while the rest of the jobs could not be determined).
Cozy Ties Between the FDA and Big Pharma
Even past FDA Commissioners are likely to end up taking a position with the pharmaceutical industry. After leaving the top leadership position at the FDA, nine out of the last 10 commissioners in the past 33 years have gone on to work for pharmaceutical companies.
This stretch began when Arthur Hayes went on to join E.M. Pharmaceuticals in 1986 after resigning as commissioner in 1983.10 The last to join this group is the most recent FDA commissioner, Scott Gottlieb, who joined Pfizer as a member of their board.11
During his term at the FDA, Gottlieb pushed several policies intended to speed up drug approvals and use the power of the FDA12 to encourage greater use of biosimilars, or generic copied versions of more costly biologic drugs used to treat autoimmune diseases and some cancers.13
One manufacturer of biosimilar drugs is Pfizer, which had complained about perceived roadblocks to making these drugs more available. With Gottlieb on the board of directors at Pfizer, this may help the company navigate the FDA rules and regulations more easily.
Although the FDA has been in focus, other government agencies, including the U.S. Centers for Disease Control and Prevention, raise similar concerns.
In 2002 Dr. Julie Gerberding was the first woman to be appointed as a director for the CDC.14 While there she overhauled the structure of the organization causing many of the senior scientists and leaders to leave, as she replaced them with those who had ties to the vaccine industry.
During her years at the CDC, the FDA approved the Gardasil vaccine for human papilloma virus vaccination manufactured by Merck. In 2009, Gerberding left the CDC and later became the president of Merck’s vaccine division.15
Similar to the FDA, a group of senior CDC scientists in 2016 sent a letter to the CDC raising concerns about the conflicts of interest and industry ties that appear to be so common among CDC leaders.16 The letter specifically addresses several areas of “particular concern,” including:
A coverup of accurate screening data for the CDC’s Wise Woman Program. Despite, a multimillion-dollar investment, the number of women screened during the program fell short of expectations. Officials misrepresented actual screening numbers, “cooked” the data to make results “look better than they were” and manipulated data in “irregular ways.”
Resources allocated to domestic programs for Americans being directed toward global health and research issues.
A questionable relationship between Barbara Bowman, Ph.D., former director of the CDC’s Division for Heart Disease and Stroke Prevention, and Coca-Cola; she left the agency unexpectedly two days after her close ties with Coca-Cola were revealed.
Michael Pratt, senior adviser for Global Health in the National Center for Chronic Disease Prevention and Health Promotion at the CDC, has also allegedly promoted and led research for the soda giant.17
Meanwhile, while greenlighting drug approvals, the FDA has been targeting natural treatments like CBD oil and, rather than cracking down on the prescription opioids that are the root of the opioid epidemic, the FDA has gone after a natural plant called kratom.
Making Smart Health Decisions
When it comes to making health decisions for yourself and your family, it’s crucial to do your research from legitimate independent sources to get the truth. Due to rampant conflicts of interest, you can’t always blindly trust the health organizations that state they’re looking out for public health.
If you’re trying to address a health issue, make full use of all the resources available to you, including your own common sense, philosophical framework and reason. Ideally, you’ll also have a trusted holistic health care practitioner who can help to guide you and ensure you’re making positive choices to further your health at a foundational level.
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