FDA must be made accountable for scientific misbehavior

A most important FDA file somehow was emailed to me and, as a consumer health researcher, retired healthcare professional, consumer health author/journalist/blogger, and certified paralegal, after reading it, I feel it is my moral duty to share it with all citizens in the USA.

Someone [name redacted] at the U.S. Department of Health and Human Services/FDA [PDF] sent the then recently-inaugurated president, Barack Hussein Obama, a letter, which I will parse in part below. Also, a CERTIFIED document, including a notarized affidavit signed by Sarah Kotler, the Denials and Appeals Officer in the Division of Freedom of Information, Office of Public Information and Library Services, Office of Shared Services, Office of the Commissioner, United States Food and Drug Administration, was provided to an unidentified receiver, regarding serious ethical and fraud problems within the U.S. Food and Drug Administration (FDA). Since I did not receive copies of what Kotler supplied in No. 4, I cannot speak to them. Furthermore, The Wall Street Journal published an article about some of FDA's problems in its Oct. 22, 2009 online issue.

However, in the letter to President Obama dated April 2, 2009, there is much to comment about:

"...the misdeeds of FDA officials. Recent press reports revealed extensive evidence of serious wrongdoing by Dr. Andrew von Eschenbach, Dr. Frank M. Torti, top FDA attorneys, Center and Office Directors, and many others in prominent positions of authority at FDA. As a result, Dr. Frank M. Torti, Acting Commissioner and the FDA's first Chief Scientist, abruptly left the Agency.

But, the many other FDA managers who have failed to protect the American public, who have violated laws, rules, and regulations, who have suppressed or altered scientific or technological findings and conclusions, who have abused their power and authority, and who have engaged in illegal retaliation against those who speak out, have not been held accountable and remain in place. [CJF emphasis added]

On Monday, March 30, 2009, Dr. Joshua Sharfstein, newly appointed Principal Deputy Commissioner, assumed the position of Acting Commissioner until Dr. Margaret Hamburg is confirmed. Numerous FDA physicians and scientists are certain that Dr. Hamburg and Dr. Sharfstein will bring the necessary change to FDA to guarantee integrity, accountability, and transparency, to ensure that all future decisions are solely based on science and in accordance with the laws, rules, and regulations. However, sweeping measures are needed to end the systemic corruption and wrongdoing that permeates all levels of FDA and has plagued the Agency far too long. [CJF emphasis added]

The latest example of wrongdoing was reported on March 23, 2009 from a Federal District Court Judge who ruled that FDA's decision on the Plan B drug1 was "arbitrary and capricious because they were not the result of reasoned and good faith agency decision-making." 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. ^{[1, pg. 1]} [CJF emphasis added]

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.2 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."³ [CJF emphasis added] ^{[1, pg. 2]}

On January 7, 2009, FDA physicians and scientists wrote to Mr. John Podesta⁴: "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 reestablishing a proper and effectively functioning FDA is vital to the physical and economic health of the nation."⁵ [CJF emphasis added] ^{[1, pg. 2]}

Every U.S. citizen needs to know about—and read—the above paragraph, which is profoundly disturbing insofar as the redacted signer of the April 2, 2009 letter relays in no uncertain terms the corruption, dishonesty, and lack of integrity that is lorded over honest employees at the FDA. Obviously, the FDA was/and still-may-be a cesspool of scientific criminals of the first order. However, President Obama apparently still has done zilch, nada, nothing about investigating and prosecuting the perpetrators at the FDA, thereby guaranteeing legal prosecution for offenders, which was the apparent request of that letter writer.

So, what did the president do instead? He appointed Margaret Hamburg, MD, FDA Commissioner and Dr. Joshua Sharfstein as Principal Deputy Commissioner of the FDA. No prosecutions that I've heard of! Does anyone reading this article know of any? If so, please list them in the comment section, and thanks.

Neither has Congress, who has oversight over the FDA, done anything to investigate and prosecute the apparent putrid modus operandi that existed/exists at the U.S. FDA, as one can assume from what is said next in that six-page letter:

On January 13, 2009, the NY Times⁶ reported that FDA officials allowed "improper political influence"⁷ to guide official FDA actions. The Director of the Office of Device Evaluation, Dr. Donna-Bea Tillman, approved8 a medical device used for the detection of breast cancer despite the fact that all of the FDA experts involved recommended against approval of the device three times. Dr. Tillman's decision to overrule the FDA experts "followed a phone call from a Connecticut congressman [Christopher Shays]." [CJF emphasis added.]

[Question: Why would a Congressman, who should have known better, apparently put in a 'good word'?]

On January 26, 2009, FDA physicians and scientists wrote to you directly9 seeking your help and recommending that "you remove and hold accountable all managers who have ordered, participated in, fostered or tolerated the well-documented corruption, wrongdoing and retaliation at the Agency." That letter was prompted by concerns that FDA officials were planning to investigate physicians and scientists in retaliation for the January 13, 2009 story in the NY Times . These concerns were well-founded. [CJF emphasis added.] ^{[1, pg. 2]}

[Comment: Mr. Obama apparently still has not ordered an investigation and/or prosecution, which the letter writer requested! Why?]

Furthermore, the letter went on with:

On March 13, 2009, one week after another episode detailing wrongdoing and improper political influence involving top FDA officials was published in the Wall Street Journal,¹⁰ Acting Commissioner Dr. Frank M. Torti and FDA attorneys sprung into action. Their solution— send an FDA-wide email11 admonishing FDA employees that they "must comply with ... obligations to keep certain information ... confidential ... [including] e-mail 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." [CJF emphasis added.] ^{[1, pg. 2]}

Readers will note an emphatically threatening tone, "violation ... can result in disciplinary sanctions and/or individual criminal liability! Apparently, the real criminals were being safeguarded from would-be whistleblowers! And, honest FDA employees were being threatened big time, i.e., criminal liability!

Congress, where are you; why aren't you doing your job citizens are paying you to do; and please get out of Big Pharma's lucrative back pockets! According to the The Center for Public Integrity:

It's actually the pharmaceutical industry that spends the most each year to influence our lawmakers, forking over a total of $2.6 billion on lobbying activities from 1998 through 2012, according to OpenSecrets.org. (Source)

That should be illegal, and stopped immediately, as it seemingly amounts to nothing more than 'payola' or 'play and pay to go'! with and at the U.S. Congress.

Furthermore, why wasn't the Attorney General investigating apparent crimes within the FDA?

These threats did not escape the scrutiny of Senator Chuck Grassley,¹² Ranking Member of the U.S. Senate Committee on Finance. ^{[1, pg. 3]}

However, Senator Grassley sent a letter to Dr. Torti on March 24, 2009 wherein part of what he said was:

"Whistleblowers are some of the most patriotic people I know—men and women who labor, often anonymously, to let Congress and the American people know when the Government isn't working so we can fix it." ^{[1, pg. 3]}

Additionally,

The Wall Street Journal¹³ and FDA documents¹⁴revealed efforts by top FDA officials (including Dr. von Eschenbach, Dr. Torti, Mr. William McConagha, and other FDA attorneys) to cover-up their attempts to improperly influence, obstruct, impede and distort the due and proper administration of the FDA scientific regulatory process involving a knee implant device. According to the Columbia University Journalism Review ,¹⁵ "the [Wall Street ] Journal describes a process in this case that's, well, corrupt. I don't know what else you'd call it. It even has a smoking gun."¹⁶ [CJF emphasis added] ^{[1, pg. 3]}

Along with this:

A letter¹⁷ from Senator Grassley to Dr. Torti dated March 6, 2009 indicated that Dr. Schultz and top FDA attorneys had concealed the fact that two of the authors of a major publication presented to the advisory committee in support of the knee implant device, had affiliations with the device manufacturer ("the first author of the article is [the manufacturer's] Vice President of Scientific Affairs," Senator Grassley noted). [CJF emphasis added] ^{[1, pg. 3]}

The above extrapolations are a 'smidgen' of what's in the six-page letter. Some other fraud-type gems are included, but this one is most explicit:

Dr. Schultz was accused of "stacking the committee to get the decision the company wanted," and of falsely stating in an official document that the conclusions reached by the advisory committee were "clear" and "unanimous"—to the contrary, they were not. [CJF emphasis added] [1, pg. 3]

[Question: Does that also go on in getting vaccines licensed?]

Another,

The culture of wrongdoing and cover-up is nothing new but is part of a longstanding pattern of behavior. For example, in July 2005,18 Dr. Daniel Schultz "approved a medical device against the unanimous opinion of his scientific staff,"19 overruling "more than twenty FDA scientists, medical officers and management staff." [CJF emphasis added] ^{[1, pg. 3]}

How about this:

Amazingly, just 3 weeks ago, on March 6, 2009, it was reported by the consumer advocacy organization Public Citizen that Dr. Tillman "approved a [medical] device that has failed to demonstrate any clinical benefit" and that showed "trends toward higher risks of death."² [CJF emphasis added] ^{[1, pg. 4]}

The letter further states:

Much work remains to be done at FDA and all pending matters need to be addressed. The wrongdoing revealed in the Wall Street Journal involves top FDA officials and requires immediate investigation. Astoundingly, since May 2008,29 Dr. von Eschenbach, Dr. Torti, Mr. McConagha, and numerous top FDA officials, have been well-aware of other serious wrongdoing, and failed to take any actions, while the physicians and scientists who spoke out and refused to comply have suffered retaliation. [CJF emphasis added] ^{[1, pg. 4]}

Needless to say, there still is much that needs to be investigated and purged from within FDA's 'fiefdom of pseudoscience', especially regarding vaccines, I allege. Two examples that need to be revisited, thoroughly dissected, and legally prosecuted are:

1. the Simpsonwood meeting of June 2000 regarding Thimerosal/ethylmercury and the CDC's Dr. Verstraeten's initial findings, and his subsequent findings after the Simpsonwood meeting—reworked VSD data and release of the VSD data


2. William Thompson, PhD, admitting to fudging reports regarding autism being associated with vaccines and mercury. Both the above were CDC events that impacted FDA's decisions about vaccines.
   

   The clearance/approval of medical devices that were not made in accordance with the laws, rules and regulations, need to be re-visited. [CJF emphasis added] ^{[1, pg. 4]}

   
   

[That's not the only issues that need re-visiting at FDA. Vaccine licensing studies and all data associated with every vaccine approval process must be re-visited.]

Dr. Paul G. King, PhD, who is an analytical chemist and mercury-in-vaccines researcher/investigator, wrote the Introduction for my book, Vaccination Voodoo What YOU Don't Know About Vaccines , stated very clearly and pointed out how the FDA does not abide by its own rules and regulations regarding safety of vaccines.

Regarding the Vaccine Safety Datalink Data that Dr. Verstraeten reworked to find there was no connection with Thimerosal and neurological damage, e.g., autism, in children, readers need to understand what really happened:

Under pressure from Congress and parents, the Institute of Medicine convened another panel to address continuing concerns about the Vaccine Safety Datalink Data Sharing program. In February, the new panel, composed of different scientists, criticized the way the VSD had been used in the Verstraeten study, and urged the CDC to make its vaccine database available to the public.

So far, though, only two scientists have managed to gain access. Dr. Mark Geier, president of the Genetics Center of America, and his son, David, spent a year battling to obtain the medical records from the CDC. Since August 2002, when members of Congress pressured the agency to turn over the data, the Geiers have completed six studies that demonstrate a powerful correlation between thimerosal and neurological damage in children. One study, which compares the cumulative dose of mercury received by children born between 1981 and 1985 with those born between 1990 and 1996, found a "very significant relationship" between autism and vaccines. Another study of educational performance found that kids who received higher doses of thimerosal in vaccines were nearly three times as likely to be diagnosed with autism and more than three times as likely to suffer from speech disorders and mental retardation. Another soon-to-be published study shows that autism rates are in decline following the recent elimination of thimerosal from most vaccines. (Source)

As an aside, and from what I know, Thimerosal still is in multidose vaccines/vials. However, I suggest reading the ingredients for each vaccine at this CDC website to find out which vaccines contain Thimerosal. You just may be surprised!

The April 2009 letter to President Obama ends with this:

All FDA employees who are committed to public integrity, who follow the laws, rules and regulations, who use science to promote public safety and health, and who have the courage and patriotism to speak out, must be protected and must have their professional lives restored. We ask that you accept nothing less. ^{[1, pg. 5]} [CJF emphasis added]

In all fairness, so too must MDs and healthcare professionals, who are vaccine safety advocates, working to get the FDA to re-visit and re-evaluate Big Pharma's 'science' that FDA apparently may have accepted against FDA employees' condemnation or neglected to investigate during the licensing process.

In view of what's admitted in the 2009 letter, it is only a logical conclusion that skullduggery probably went on with vaccine science and licensing. Just as the letter writer was concerned, so is this writer concerned about pseudoscience and secret meetings to redefine/redesign data and studies.

That 2009 letter was copied to 6 U.S. Senators and 8 Members of the U.S. House of Representatives, and to 2 individuals at FDA and 2 others at HHS. Plus, there were 29 footnotes. The letter writer was dead serious!

Also in the file I received was a copy of the letter to John D. Podesta, Presidential Transition Team, dated January 7, 2009—signer redacted, which in the second paragraph on the first page sets a disturbing tone:

The letter to Mr. Podesta ended with this paragraph:

Nothing is more emphatic about the culture of fraud and pseudoscience at the U.S. Food and Drug Administration than the information provided in the two letters sent to the newly elected president's transition team and then to Barack Obama, three months into his first term as president.

In light of all the scientific fraud and other ethical issues at the FDA, it is incumbent upon President Obama, the Congress, and the Attorney General of the USA—even now—to investigate thoroughly the various departments of the FDA, it's revolving door hiring policy with apparent vested interest corporations, e.g., Big Pharma and Monsanto, and place an embargo on all vaccines public service vaccine announcements and 'mandates', etc. until a thorough and independent review of all vaccine submissions, trials, records, and data for licensure can be reviewed by independent scientists, who have no affiliation or vested interest with vaccine manufacturers, since the FDA actually does no physical/scientific testing of vaccines or pharmaceuticals to prove what manufacturers say/provide actually is scientifically proven.

The president, Congress, HHS/CDC/FDA must do what the taxpayers of the USA pay them to do: Provide factual, ethical, and transparent medical science, not "consensus science."

The FDA needs an entire overhaul from the top down!

Reference

^[1] Six-page HHS/FDA 4/2/09 Letter to Pres. Obama [PDF]

Resources

About the author



Catherine retired from researching and writing, but felt compelled to write this article.

Catherine J Frompovich (website) is a retired natural nutritionist who earned advanced degrees in Nutrition and Holistic Health Sciences, Certification in Orthomolecular Theory and Practice plus Paralegal Studies. Her work has been published in national and airline magazines since the early 1980s. Catherine authored numerous books on health issues along with co-authoring papers and monographs with physicians, nurses, and holistic healthcare professionals. She has been a consumer healthcare researcher 35 years and counting.

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