An Open Letter to Attorney General: Deceptive Practices, Truth-in-Advertising COVID-19
May 6, 2022
RE: Deceptive Practices, Truth-in-Advertising COVID-19 experimental mRNA vaccine; Request for Enforcement Action
Dear Attorney General Paxton:
I am one of 250 lawyers and over 2,500 volunteers (including doctors and immunologists familiar with the FDA approval process) reviewing over 55,000 pages of documents released by Pfizer Biopharmaceutical Company after court order. Pfizer attempted to avoid disclosure of this data for 75 years but was unsuccessful. I am writing to ask you to suspend the advertisements of the experimental mRNA vaccines within the State of Texas until such time as the advertisements fully inform the public of the experimental nature of the mRNA vaccines and all associated risks.
The Pfizer documents released were provided to Dr. Naomi Wolf, who initiated a fact-finding mission to disclose the dangers of the Pfizer experimental mRNA vaccine through researching the released documents for study inaccuracies and adverse outcomes. She has established a Pfizer working group on DailyClout.io and is coordinating the effort to inform the public of the findings. To date, Dr. Wolf has compiled a list of 18 issues that merit additional investigation and possible civil and criminal legal actions, including but not limited to, the following: (1) the Pfizer studies do not appear to be complete under the requirements set forth by the FDA for such studies, (2) outcomes for certain test subjects appear to be not included or possibly lost, and (3) the number of certain adverse reactions on a percentage basis are at a level that appear to be a major cause for concern. The discrepancies are glaring and should prompt an immediate halt to the advertisements that it is “safe and effective.” See Dr. Wolfe’s points, Exhibit A.
Thus far, our group has found a huge number, and in some cases, a very troubling percentage, of Adverse Events of Special Interest (AESI) which were manifest in the experimental mRNA vaccine trials and reported by Pfizer to the FDA. However, the FDA, CDC national news networks, major cable outlets or newspapers of national circulation have not reported these findings to the public. Myocarditis, pericarditis, neurological disorders, and deep vein thrombosis (blood clotting) are some of the serious side effects reported by Pfizer. I have attached the 9 pages of Adverse Events of Special Interest from the Pfizer documents for your review. See Exhibit B. Failing to provide the Adverse Events of Special Interest to the recipients of the experimental mRNA vaccine is in violation of law required by the Emergency Use Authorization (EUA) used to distribute it.
Issuance of an EUA experimental mRNA vaccination is expressly conditioned on a determination by the Secretary of HHS that “it is reasonable to believe–that the product may be effective in diagnosing, treating or preventing such disease or condition.” 21 U.S.C. §360bbb-3(c)(2)(A)(i). Moreover, the experimental mRNA vaccine prevents neither infection from, nor transmission of, COVID-19. Healthy children are not at risk for developing serious illness or death from COVID-19. The CDC abandoned the position that the experimental mRNA vaccines prevent infection or transmission of COVID-19 and now claim it is effective at reducing the risk of hospitalization or death. Hence, the authorization for the experimental mRNA vaccine is now clearly based only on its efficacy as a treatment for COVID-19 as it is established it does not prevent infection or transmission of the virus. Moreover, the FDA, as gate keeper for advertising of the experimental mRNA vaccine before it grants approval for the market, approved advertising that was scant at best. Therefore, the FDA and CDC are complicit in the violation of the EUA requiring informed consent to individuals. Manufacturers must submit their advertisements with the request for licensure. The FDA has approved the Pfizer advertisement without mention of the adverse effects listed, unlike any other drug advertisement in media today; therefore, informed consent does not appear to have been possible to date.
America’s Frontline Doctors have issued a letter authored by Dr. Robert Malone regarding the Emergency Use Authorization of the currently available experimental mRNA vaccines in the United States that highlights the federal government’s advantages to using the EUA method of approval over full FDA approval and the concomitant disadvantages to those who are coerced into taking such injections and to those who are damaged by such injections. See Exhibit C. In effect, the CDC is circumventing the statutory requirement of informed consent under the EUA. In addition to requiring people be informed of the known potential benefits and risks of inoculation, the EUA statute (21 U.S.C. §360bbb-3) also requires people be “informed of the option to accept or refuse” the experimental mRNA vaccine, of the consequences of refusal and of the available alternatives and their risks and benefits.
The EUA statute, 21 U.S.C. §360bbb-3(e)(1)(A)(ii)(I),(II) and (III), provides “with respect to the emergency use of an unapproved product, the Secretary to the extent practicable given the applicable circumstances described in subsection (b)(1), shall, for a person who carries out any activity for which the authorization is issued, establish such conditions on an authorization under this section as the Secretary finds necessary or appropriate to protect the public health include the following:
“Appropriate conditions designed to ensure that individuals to whom the product is administered are informed –
(I) that the Secretary has authorized the emergency use of the product;
(II) of the significant known and potential benefits and risks of such use, and of the extent to which such benefits and risks are unknown; and
(III) of the option to accept or refuse administration of the product, of the consequences, if any of refusing administration of the product, and of the alternatives to the product that are available and to their benefits and risks. (emphasis added).”
See Exhibit D. The individuals receiving the product are to be informed of the alternatives to the product. The CDC and FDA have, however, in their public announcements demonized the use of ivermectin and hydroxychloroquine and refused to approve them or any other safe, generic drug in treatment of COVID-19. Safe, available, alternative treatments that may be effective in prevention and treatment of COVID-19 should be judged by the same standard as the experimental mRNA vaccine. Members of Congress have admitted to taking these alternative treatments for COVID-19.
As mentioned, the CDC initially reported the experimental mRNA vaccines would protect against infection and transmission of COVID-19. However, the data started coming in and it became clear the experimental mRNA vaccines did neither. In fact, the experimental mRNA vaccines were injuring people. Additionally, the CDC has admitted to withholding large portions of COVID-19 data (effectiveness of boosters, hospitalizations, wastewater analysis, infections and deaths broken down by age, race, and vaccination status) citing concerns that the data could be misinterpreted and cause vaccine hesitancy. See Exhibit E. Both the EUA and full process for the experimental mRNA COVID-19 vaccines requires informed consent.
Prominent, world-renowned experts concur in the scientific findings and conclusions challenging the safety and efficacy of the COVID-19 experimental mRNA vaccine set out in this correspondence. Among other things, these experts promote the use of alternative treatment drugs off label, such as ivermectin and hydroxychloroquine, for COVID-19. Their findings and conclusions also have support in many peer-reviewed studies on COVID-19 – including some that had a relatively large number of subjects
However, the experimental mRNA vaccines continue to be marketed by manufacturers and the government, through public servicing messaging, as “safe and effective” for children ages 5 and up. The targeting of children for experimental mRNA vaccination in advertisements and public messaging by the government and media is particularly nefarious as the science is settled – healthy children are at a near 0% risk of suffering serious harm or death from COVID-19 and the experimental mRNA vaccines do not protect against infection or transmission of the virus. The public is simply not getting information critical to informed consent to treatment, a long-standing principle of American medical practice and jurisprudence.
The government has strongly advocated and spent millions in pushing the experimental mRNA vaccination message. See “Inside the $250 million effort to convince Americans the coronavirus vaccines are safe”, CBS News, December 23, 2020. As with all other medical advertisements, possible side effects are declared (in the fine print of written advertisements or at the end of commercial advertisements)–with one notable exception, COVID-19 experimental mRNA vaccines. Therefore, any advertising of experimental mRNA vaccines should include full disclosure and alternatives.
At a minimum, any advertisement of the Pfizer vaccine or other vaccines approved under EUA (Moderna, Johnson & Johnson, AstraZeneca) should:
- State that healthy children are at near 0% risk of serious harm or death from COVID-19
- That none of the experimental mRNA vaccines protect against infection or transmission of COVID-19
- List known Adverse Events of Special Interest (AESI) including, the serious risk of myocarditis or pericarditis in children and adults aged 40 or younger and the risk of immunocompetence.
- Provide accurate information on vaccine efficacy such as any benefits from the vaccine are of limited duration and boosters will be necessary; and
- Inform the public that long term effects from the vaccine are not known, and
- Provide basic information on alternative treatments.
The citizens of this state have the right to be honestly and fully informed of the risks associated with vaccination versus not being vaccinated–before they arrive at their appointment to receive the experimental mRNA vaccine–and this is especially so when the government or Pfizer or any other vaccine manufacturer target our children. The advertisements relay “safe and effective” and the drug warning label says something different. People are enticed by the “safe and effective” label and arrive at the vaccination site to find there is a catch. The bait and switch occurring at the vaccination site is deceptive and in violation of 21 U.S.C. §360bbb-3(e)(1)(A)(ii)(I),(II) and (III).
On behalf of our group, including the residents in the State of Texas, I ask that you investigate the advertising of COVID-19 experimental mRNA vaccines and the public service announcements/messaging from the CDC for unfair and deceptive advertising. I can think of no more compelling case for you to intervene on behalf of the citizens of this state than on behalf of the children who will be harmed by the FDA’s release of this next experimental mRNA vaccine targeting children this summer. The unfair and deceptive practice of marketing an experimental vaccine –the side effects of which cannot be fully known–as “safe and effective” creates a clear and present danger to public health.
Dr. Naomi Wolf and her volunteers stand ready to assist you in any way possible in your effort to bring the federal government into compliance. Thank you for your immediate attention to this most serious health concern and all you do for the State of Texas.
An Attorney at Law