How Fauci and Grady Degraded the Standards of Ethical Requirements for Clinical Research in the US Compared to the Rest of the World
In reading Nuremberg, The Belmont Report, and now the Helsinki Declaration, I can say that up to 2020, US had far lower ethical standards for human subjects research than WMA. Now? None.
Both WHO and the US HHS suffer from a form of ethical blindness when it comes to vaccine research. Foregoing long-term vaccine safety studies in favor of retrospective analysis of real-world data, these agencies fail to recognize that post-marketing (and post-EUA) studies are de facto uncontrolled, non-randomized prospective clinical trials conducted without proper consenting procedures.
If you’ve read the Nuremberg Code, the Belmont Report, and the Declaration of Helsinki, you’d know that protections are supposed to be in place not for some people undergoing some clinical studies, but instead are considered to be required to be in place for all people undergoing any clinical studies.
Where the US had departed (prior to 2020) from the rest of the countries that backed Helsinki (WMA) and participated in its updates included, according to Kimmelman et al. (2009) included:
- Disclosure of conflict of interest
- Public disclosure of study design
- Benefit for populations in which research is conducted (beneficence)
- Reporting of accurate results and publication of negative findings
- Access to treatment after research has been conducted
- Restriction of use of placebo in a control group where effective alternative treatment is available
The departure formally came when issues related to HIV clinical trials run in less wealthy countries seemed to depart from Helsinki standards. Rather than work to reconcile differences with Helsinki, US companies, and the US government came up with a different international standard called “Good clinical practice” – standards in place in the EU (codified as Directive 2001/20/EC), and the US (enforced as policy by NIH), all backed by Pharma.
The departure of the US and the EU from the countries that continue to abide by Helsinki serves to empower those running clinical trials at the expense of those individuals taking on the risk of new drugs and vaccines – both in the risk of poor efficacy and in the risk of potential safety issues.
Well, it turns out that Fauci was at the forefront of the war on ethical research, arguing against the requirement of the use of placebos in HIV drug trials in Africa.
Fauci’s insistence on no placebo arm in HIV drug trials in Africa is an example of bluster and posturing on morality to hide the negative consequences (harm) of the drug AZT. We’ve seen this bluster and posturing all along with COVID-19 vaccines, and Fauci’s denial of the efficacy of early treatment. He rolls over so many of the principles of medical research ethics – and ethics of care – those that were meant to be sacrosanct to protect the interests and well-being of individuals, as outlined in Nuremberg, Helsinki, and the Belmont Report.
Medical hubris has been the modus operandi of Fauci well before COVID-19.
It’s time to revisit why and how it came about that the pharmaceutical companies are able to write the rules by which they conduct clinical research.
(See link for article)
Please see Jeremy R. Hammond’s antidote to government and mainstream media’s disinformation:
- To briefly review, in Part I of this newsletter series, we looked at some illustrative examples the FDA’s willful intent to mislead.
- In Part II, we looked at how the FDA deceives about the risk to children of dying from COVID-19.
- In Part III, we looked at how the FDA deceives about the risk to children of being hospitalized for COVID-19.
- In Part IV, we looked at how the FDA deceives about the risk to children from “Long COVID”.
- In in the last installment, Part V, we looked at how the FDA deceives about the risk to children of myocarditis from COVID-19 versus the risk of myocarditis from vaccination.
FDA Colluded With Moderna to Bypass COVID Vaccine Safety Standards, Documents Reveal
According to Alexandra Latypova, an ex-pharmaceutical industry executive, documents obtained from the U.S. Department of Health and Human Services on Moderna’s COVID-19 vaccine suggest the U.S. Food and Drug Administration and Moderna colluded to bypass regulatory and scientific standards used to ensure products are safe.
After analyzing 699 pages of studies and test results “supposedly used by the FDA to clear Moderna’s mRNA platform-based mRNA-1273, or Spikevax,” Latypova told The Defender she believes U.S. health agencies are lying to the public on behalf of vaccine manufacturers.
“It is evident that the FDA and NIH [National Institutes of Health] colluded with Moderna to subvert the regulatory and scientific standards of drug safety testing,” Latypova said.
“They accepted fraudulent test designs, substitutions of test articles, glaring omissions and whitewashing of serious signs of health damage by the product, then lied to the public on behalf of the manufacturers.”
(See link for article)
Biden, Pharma Pressured Top FDA Officials to Approve Booster Timeline, Emails Reveal
Judicial Watch today announced it received 112 pages from the U.S. Food and Drug Administration that show top officials being pressured by “companies and for that matter the administration, who try to impose timelines [sic] that make no sense.”
The records were produced to Judicial Watch in response to a February Freedom of Information Act (FOIA) lawsuit against the Department of Health & Human Services (HHS) that was filed after HHS failed to respond to a Sept. 3, 2021, FOIA request for records of communication from the former director and deputy director of the FDA’s Office of Vaccines Research and Review, Dr. Marion Gruber and Dr. Philip Krause, respectively (Judicial Watch v. U.S. Department of Health and Human Services (No. 1:22-cv-00292)).
Drs. Gruber and Krause reportedly resigned during the White House’s push to approve the COVID-19 vaccine “booster shots.”
(See link for article)
The FOIA requests and lawsuits uncover a substantial amount of info on many COVID issues including a FBI inquiry, NIAD’s money and grants to EcoHealth Alliance and Wuhan for bat coronavirus research, Fauci emails citing ties between Wuhan and EcoHealth, Gates’ involvement with the Chinese government, HHS records showing a grant application for “gain of function” research on bat RNA, viruses, and genetic manipulation of SARSr-CoV WIV1 strain, HHS records showing the Pfizer lipid nanoparticles were found in the liver, adrenal glands, spleen, and ovaries of test animals 8-48 hours after injection, safety lapses at U.S. biosafety labs, and HHS records showing NIH officials tailored confidentiality forms to China’s terms.
HFDF ANNOUNCES LEGAL ACTIONS IN PARTNERSHIP WITH DAILYCLOUT
Leslie Manookian, HFDF President, has partnered with Dr. Naomi Wolf, DailyClout CEO, to hold the FDA accountable for its unscrupulous and unlawful approval of remdesivir for all patients, and COVID injections for young children.