https://www.iambrookjackson.com/_files/ugd/9df0bc_794f8fbb3e1f49e6a2030ab09da77c16.pdf

ARGUMENT
The Statement supports Relator’s assertions that payment was contingent upon the vaccine
receiving emergency use authorization (“EUA”) and that the FDA in making that decision was reliant
upon the accuracy of the data produced in the clinical trials. If, as Relator witnessed and alleges, the
clinical trial protocol was egregiously broken, then the very basis upon which the EUA was granted
would be irrelevant. The government initially recognized the merits of Relator’s claims. The government
made several requests to extend its deadline to either intervene or allow Relator to continue
independently, ultimately deliberating for nearly a year prior to the unsealing of this action. Had the
government truly believed at the time, as they now try to claim, that Relator’s complaint was devoid of
evidence, they would never have required such ample time to investigate. Clearly, the government had an
interest in her allegations upon the initial filing of this action.
While the United States styles its Statement of Interest as supportive of Respondents’ motions to
dismiss, the United States agrees that a FCA claim for fraud in the inducement can be maintained if the
allegations create an inference that clinical trial violations could have “altered FDA’s approval or
authorization decision.” Id., at PageID 2056. The United States claims the inference must be that the
violations at the Ventavia site “actually” altered the FDA’s decision, but the FCA pleading standard is
not one of actuality but of materiality. Id.; See 31 U.S.C. § 3729(a)(1)(B) (imposing liability under the
FCA on any person who “knowingly makes, uses, or causes to be made or used, a false record or
statement material to a false or fraudulent claim”). Whether a false statement is material depends on
whether the false statement has a “natural tendency to influence, or is capable of influencing, the decision
of the decision making body to which it was addressed.” Neder v. United States, 527 U.S. 1, 16, 119

Indeed, the statute expressly defines “material” as “having a natural
tendency to influence, or be capable of influencing, the payment or receipt of money or property.” 3

As recognized in U.S. ex rel. Longhi v. U.S., 575 F.3d 458 (5th Cir. 2009): “All that
is required under the test for materiality, therefore, is that the false or fraudulent statements have the
potential to influence the government’s decisions.” Id., at 470.
In the context of presumptions within the vaccine manufacturer immunity statute, 42 U.S. Code §
300aa–22(b)(2), the Southern District of Texas has held: “The Court cannot accept the fact that the FDA
licensed the vaccines as prima facie evidence that Defendants complied with all regulations […].”
Blackmon v. Am. Home Products Corp., 328 F. Supp. 2d 659, 666 (S.D. Tex. 2004). Similarly, the United
States cannot properly assert that the FDA’s approval, or its continued confidence in Respondents,
operates as evidence that Respondents complied with applicable regulations.
Clinical trial fraud influences the FDA’s decision to grant an EUA as this authorization is always
based on the “totality of the scientific evidence available.” See Doc. 70, PageID 2057-58. The United
States posits ipse dixit that given Ventavia’s clinical trials were “only about 3 percent, or approximately
1,500 of the nearly 44,000 total clinical trial participants” and that was not enough to alter the FDA’s
decision to grant EUA. Id. This analysis, however, does not track the materiality inquiry given proper
inquiry is whether the fraud has the “potential to influence the government’s decision.” See Longhi,
supra, 575 F. 3d at 470. If, as the United States suggests, clinical trial violations may form the basis for a
claim of fraudulent inducement under the FCA, then the only relevant pleading question is whether the
clinical trial violations could potentially influence the FDA’s decision to grant EUA. See Doc. 70,
PageID 2054 (recognizing that “it may be possible to articulate a viable FCA claim based on materially
false or fraudulent statements made to FDA related to a drug or vaccine authorization or approval.”).

..

Even if the EUA was a forgone conclusion - as suggested by the United States, regardless of fraud
at any level given the FDA’s blind faith in Respondents, the relevant inquiry remains whether the clinical
trial violations as pled by Relator could potentially influence the decision making of an objective and
unbiased FDA. Given that the EUA analysis focuses on the “totality of the scientific evidence available,”
and since Relator has pled that “approximately 1,500 of the nearly 44,000 total clinical trial participants”
produced fraudulent data, Relator has sufficiently pled materiality. As a matter of law, a known
threshold of 3% fraudulent data could have “potentially” influenced the FDA’s decision to grant EUA.
And, to the extent it is even necessary, Relator can add to this 3% fraud threshold given that she has since
obtained data from other contracted research companies demonstrating similarly flawed clinical trial data.
Such blatant fraudulent activity at one testing site should also reasonably raise suspicion over the
accuracy of data produced at other sites. Further, the protocol established an end-point number of 164.
Am. Comp., Ex. 6, Doc. 17-1, PageID # 1029. The date for data cut-off for the final efficacy analysis was
November 14, 2020, when a total of 170 confirmed COVID-19 cases were accrued.1 A 3% reduction in
the final population studied for efficacy draws the final number of participants dangerously close to the
minimum established end-point number. Thus, 3% is significant.
Clinical trial fraud is not only a sound basis for a FCA claim, it is also the basis for criminal
charges.2

..

In the Amended Complaint, Relator detailed specific problems with the clinical trials including
the unblinding of participants, all deviations from which would have significant potential to affect both
the risks and benefits reported to the FDA; failure to obtain informed consent; failure to report participant
deaths; and trial data that was fabricated, altered, and hidden from the FDA, easily satisfying plausibility
under the FCA pleading standard. Relator witnesses numerous other clinical trial protocol violations:

1. Relator pled Ventavia failed to report “temperature excursions,” which impacted benefit and risk
by reducing potency and/or reducing potentially reactive agents in the injection.

2. Relator pled that doses of the frozen vaccine concentrate were required to thaw for thirty minutes
before administration, but Ventavia employees were told to hold the frozen concentrate in their
hand to speed up the thawing. This has the potential to change the chemistry and effects.

3. Relator pled clinical trial participants were given their second injection outside of the protocolmandated nineteen to twenty-three day window. On at least four occasions the vaccine
concentrate was over-diluted, which directly affects potency and reduces potential side-effects.

4. Relator pled Ventavia failed to report Serious Adverse Events (“SAEs”) to Pfizer and Icon,
though that information was available via the clinical trial participants’ “electronic diary” entries.
This is perhaps the most egregious violation not only of clinical trial protocol but of public trust.

5. Relator pled Ventavia’s documentation practices were careless, sloppy, inaccurate, and many
times falsified. Pfizer had access to this data and equally failed its oversight responsibilities which
rightfully draws the presumption that data from other clinical trials is just as bad if not worse.

Each act of fraud directly impacted the risk-benefit calculation, which is a key inquiry in granting EUA.
Bypassing protocol taints results, period. Respondents’ failures have a clear and direct impact on the
most important aspects of the FDA’s decision to grant EUA.

https://www.iambrookjackson.com/_files/ugd/9df0bc_794f8fbb3e1f49e6a2030ab09da77c16.pdf

Defendant Pfizer Inc. (“Pfizer” or the “Company”) moved to dismiss this action on April
22, 2022. (ECF 37.) Pfizer’s arguments for dismissal are strong, and the United States—the
named plaintiff in this action—has filed a Statement of Interest agreeing that dismissal is
appropriate. (ECF 70.) Pfizer recognizes that the Court has a heavy workload. The Company
files this brief, respectfully, to bring Pfizer’s pending motion to the Court’s attention and reiterate
Pfizer’s previous request for oral argument.

...

On October 4, 2022, the U.S. Department of Justice (“DOJ”) took the extraordinary step
of filing a Statement of Interest Supporting Dismissal of the Amended Complaint. (ECF 70.) It
is not unprecedented for the Government to file statements of interest supporting plaintiffs in
declined qui tam actions. But the Statement of Interest here is entirely different. It sides with the
defendant, Pfizer, and the other defendants, and urges the Court to dismiss Relator’s lawsuit
because it fails to identify any “false or misleading” claims, its allegations are “implausible,” and
the United States continues to have “full confidence” in Pfizer’s COVID-19 vaccine. (ECF 70 at
6, 11–12.) In short, the Government has concluded there was no fraud here and agrees with Pfizer
that the Court should dismiss this case. To the best of Pfizer’s knowledge, the Government’s
submission is one-of-a-kind; never before has the United States filed a statement of interest seeking
outright dismissal of a relator’s FCA claims.

This unusual development seems to provide a compelling reason for an oral hearing on
Pfizer’s motion to dismiss. That motion was fully briefed as of October 27, 2022. (ECF 75.) To
promote efficiency and judicial economy, the Court has twice refused to start discovery pending
resolution of dispositive motions. (ECF 58, 86.) Under the current scheduling order, discovery is
set to commence on March 15, 2023, one month from today. (ECF 86.) Pfizer would be willing
to present oral argument on or before this date, should the Court deem it helpful.

https://www.iambrookjackson.com/_files/ugd/9df0bc_7c4ba252339448a2a50d3ba75393bc69.pdf

...

Pfizer, in partnership with BioNTech, developed a COVID-19 vaccine using mRNA
vaccine technology.7
In July 2020, the U.S. Army Contracting Command selected Pfizer as the
awardee of a Project Agreement under which Pfizer would deliver 100 million doses of an FDA
authorized or approved vaccine to the Government on a firm fixed price per dose basis, in
accordance with a Statement of Work (SOW).
8
The introductory section of the SOW for the
Project Agreement explains that the “intent” of the project is “to demonstrate that Pfizer has the
business and logistics capability to manufacture 100M doses of its currently unapproved mRNAbased COVID-19 vaccine for the Government.”9
For “background and context,” the SOW
explains that “Pfizer will meet the necessary FDA requirements for conducting ongoing and
planned clinical trials, and with its collaboration partner, BioNTech, will seek FDA approval or
authorization for the vaccine, assuming the clinical data supports such application for approval or
authorization.”10 The SOW expressly recognizes that the vaccine “clinical trials are regulated by
the FDA and HHS,” and specifies that “there is no need for separate regulation by the U.S. Army
Medical Research and Materiel Command.”11

While clinical activities are described in the background section, the scope section of the
SOW states that clinical activities not related to the manufacturing of the vaccine are “out-of
scope” for the project as Pfizer and BioNTech have funded, and will continue to fund, those
clinical activities “without the use of Government funding.”12

..

https://www.iambrookjackson.com/_files/ugd/9df0bc_b7e94cf398e74b35a9182f27e685348b.pdf

UNITED STATES DISTRICT COURT
FOR THE EASTERN DISTRICT OF TEXAS
BEAUMONT DIVISION
UNITED STATES OF AMERICA
ex rel. BROOK JACKSON,
Plaintiff,
- v -
VENTAVIA RESEARCH GROUP, LLC;
PFIZER INC.; ICON PLC,
Defendants.
CASE NO. 1:21-CV-00008-MJT
ORAL ARGUMENT REQUESTED

PFIZER’S MOTION TO DISMISS RELATOR’S AMENDED COMPLAINT
AND MEMORANDUM OF LAW IN SUPPORT

Defendant Pfizer Inc. (“Pfizer”) respectfully moves, pursuant to Federal Rule of Civil
Procedure 12(b)(6), to dismiss Counts I and II of the operative complaint in the above captioned
matter, which Plaintiff-Relator Brook Jackson (“Relator”) filed on behalf of the United States
under 31 U.S.C. § 3730(b), the qui tam provision of the False Claims Act (“FCA”). The Court
should dismiss the complaint as to Pfizer because: (1) the complaint does not plead a false or
fraudulent claim; (2) its allegations were not material to the Government; and (3) Relator may not
pursue the claims against Pfizer without the Government first pursuing them in an administrative
proceeding.

...

In July 2020, while Pfizer’s vaccine was still under development, DoD entered into an
agreement with the company, as part of Operation Warp Speed, to purchase the first 100 million
doses of the vaccine if FDA later authorized or approved it. (Am. Comp. ¶ 133.) This was before
Pfizer and BioNTech commenced their placebo-controlled efficacy trial, now known as the
“landmark study.” (Id. at ¶ 133.) Because of pandemic-related exigencies, the agreement was not
a standard federal procurement contract, but rather a “prototype” agreement executed pursuant to
4
U.S. Dept. of Defense, Immediate Release: Trump Administration Announces Framework and
Leadership for ‘Operation Warp Speed,’ May 15, 2020, https://tinyurl.com/3yajcvnd.
5
U.S. Dept. of Health & Human Servs., Food & Drug Admin., Development and Licensure of
Vaccines to Prevent COVID-19: Guidance for Industry, June 2020,
https://www.fda.gov/media/139638/download.
6
U.S. Dept. of Health & Human Servs., Food & Drug Admin., Emergency Use Authorization for
Vaccines Explained, Nov. 20, 2020, https://tinyurl.com/46esw485 (“Under an EUA, FDA may
allow the use of unapproved medical products, or unapproved uses of approved medical products
in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions
when certain statutory criteria have been met, including that there are no adequate, approved, and
available alternatives.”).
Case 1:21-cv-00008-MJT Document 37 Filed 04/22/22 Page 11 of 37 PageID #: 1391
7
10 U.S.C. § 2371b, which as of January 1, 2022 is now cited as 10 U.S.C. § 4022. (Am. Compl.,
Ex. 10 at 1079.) Such agreements are executed under DoD’s Other Transaction Authority
(“OTA”) and, as a statutory matter, are not subject to the Federal Acquisition Regulation (“FAR”),
which is the primary regulation otherwise used by Government agencies in their acquisition of
supplies and services with appropriated funds. See 10 U.S.C. § 4022(f)(2); see also NSTI, LLC v.
Defense Energy Ctr. of Excellence, No. 19-03854, 2020 WL 1321530, at *1 (S.D. Tex. Mar. 17,
2020) (“Other Transactions are legally binding contracts that are generally exempt from federal
procurement laws and regulations[.]”). Relator’s allegation that FAR applied to Pfizer’s OTA
agreement, (see, e.g., Am. Compl. ¶¶ 140-143), is simply wrong.7
The key terms of the OTA agreement—the “Contract at Issue” forming the basis for
Relator’s complaint (Am. Compl. ¶ 133)—are found in two instruments: (1) a Base Agreement
executed on July 20, 2020; and (2) a Statement of Work (“SOW”) executed on July 21, 2020.
7
U.S. Dept. of the Air Force, Other Transaction Authority (OTA) Overview,
https://www.transform.af.mil/Projects/Other-Transaction-Authority/ (“Other Transactions
(‘OTs’) are legally binding instruments that may be used to engage industry and academia for a
broad range of research and prototype projects and include the option to extend to production. OTs
are typically defined by what they are not: they are not standard procurement contracts, grants, or
cooperative agreements. As such, they are generally not subject to the federal laws and regulations
that apply to government procurement contracts [such as] FAR[.]”).
Case 1:21-cv-00008-MJT Document 37 Filed 04/22/22 Page 12 of 37 PageID #: 1392
8
Relator attached the SOW to her complaint as Exhibit 10, and this Memorandum attaches the Base
Agreement as Exhibit A.8


The SOW provides that DoD would pay $1.95 billion—or $19.50 per dose—for Pfizer’s
vaccine, contingent on the company first securing FDA approval or an EUA for the product. (Am.
Compl. ¶ 135.) The SOW describes a “large scale vaccine manufacturing demonstration” that
imposes no requirements relating to Good Clinical Practices (“GCP”) or related FDA regulations.
(Am. Compl., Ex. 10 at 1080.) It states explicitly that Pfizer’s “clinical trials” are “out-of-scope,”
“not related” to the agreement, and that the relevant studies were undertaken at Pfizer’s expense
“without the use of Government funding.” (Am. Compl., Ex. 10 at 1087.) Again, Relator’s
allegation that the SOW somehow tied payment to Pfizer’s compliance with every particular of
the clinical protocol or related FDA regulations, (see, e.g., Am. Compl. ¶¶ 275, 278), is mistaken
and refuted by the SOW itself

...

Relator also fails to acknowledge that the SOW, which is attached as an exhibit to her
complaint, states explicitly that Pfizer’s clinical development activities for the vaccine were “outof-scope” and not funded by the Government under the OTA. (Am. Compl., Ex. 10 at 1087.) The
parties included this language because Pfizer, not the Government, was the entity footing the bill
for the very significant costs of the landmark study. For this reason, neither the “Pfizer-DoD
contract” referenced in the complaint, nor the invoices submitted under that agreement, make any
mention of the FDA clinical trial regulations that Relator identifies as supposedly “material to the
[G]overment’s decision to pay the claims.” (Am. Comp. ¶ 281.) Instead, the agreement is crystal clear that the Government could only withhold payment for delivered doses if FDA actually
withdrew authorization or approval of Pfizer’s vaccine. (Am. Compl., Ex. 10 at 1095.)

...

At all relevant times, Pfizer’s vaccine has been authorized, approved, and thus eligible for
payment by the Government. The United States has continued to purchase the product with full
knowledge of the information and allegations arising from Relator’s eighteen days at Ventavia.21
And the Government continues to make the vaccine “free to everyone age 5 and older living in the
United States, regardless of immigration or insurance status.”22 The Government has not wavered
19 Courts routinely take judicial notice of uncontested facts published on a party’s own website,
and it is appropriate for this Court to do so here. See, e.g., O’Toole v. Northrup Grumman Corp.,
499 F.3d 1218, 1224-25 (10th Cir. 2007) (holding district court abused discretion by failing to take
judicial notice of information posted on defendant’s website); Granlund v. Burbank Hill Cmty.
Ass’n., No. 19-01439, 2020 WL 5498075, at *4 (C.D. Cal. Aug. 5, 2020) (“Courts have found it
proper to take judicial notice of a party’s own website pursuant to Fed. R. Evid. 201.”); Raymond
v. Blair, No. 09-5507, 2010 WL 11537936, at *4 n.2 (E.D. La. Oct. 8, 2010) (“The court may take
judicial notice of the information provided on a party’s website.”).
20 It is appropriate for the Court to take judicial notice of this document, which Relator published
on her own website, as well. See supra note 19.
21 U.S. Dept. of Health & Human Servs., Biden Administration Purchases Additional Doses of
COVID-19 Vaccines from Pfizer and Moderna, Feb. 11, 2021, https://tinyurl.com/36m5fyz3;
Pfizer Press Release, Pfizer and BioNTech to Provide U.S. Government an Additional 50 Million
Pediatric Doses of COVID-19 Vaccine to Support Further Preparedness for Future Needs, Oct. 28,
2021, https://tinyurl.com/3zntrv5w.
22 U.S. Dept. of Health & Human Servs., COVID-19 Vaccines, https://tinyurl.com/yyjuu8xt.
Case 1:21-cv-00008-MJT Document 37 Filed 04/22/22 Page 21 of 37 PageID #: 1401
17
from the FDA’s statement that it continues to have “full confidence in the data” underlying its
authoritative approval of Pfizer’s vaccine.23

...

There is nothing on the other side of the scale. The “noncompliance” that Relator alleges—
failure to abide by the clinical trial protocol, FDA regulations, and FAR provisions—are not
“labeled conditions of payment” under the OTA agreement between Pfizer and the United States.
See Escobar, 579 U.S. at 191. Nor does the alleged noncompliance go to the “very essence of the
bargain” between the parties, which entered into a “large-scale manufacturing demonstration” and
agreed explicitly that Pfizer’s clinical development activities would be “out-of-scope.” See id. at
194 n.5. After all it was Pfizer, not the Government, that funded the landmark study. In addition,
Relator “has made no allegations that . . . the continued approval [of Pfizer’s vaccine] persisted
for reasons other than non-materiality.” See Porter, 810 Fed. App’x at 242 n.7.


...

False records and statements must also be “material” to the Government before they can
give rise to an FCA violation. 31 U.S.C. § 3729(a)(1)(B). Here, again, the complaint falters
because the United States has been aware of Relator’s allegations for well over a year, and yet
FDA continues to authorize and approve Pfizer’s vaccine, DoD continues to pay for it, and DOJ
declined to intervene in Relator’s lawsuit. The “lack of any further action” by the Government
“shows that the FDA viewed the information, including that furnished by Relator[], differently
than Relator[] do[es].” See Nargol, 865 F.3d at 35 (affirming dismissal of qui tam claims for lack
of materiality). And, as discussed previously, her complaint proffers no explanation for the
“continued approval” of Pfizer’s vaccine “other than non-materiality.” See Porter, 810 Fed. App’x
at 242 n.7. As a result, the Court should dismiss both of Relator’s causes of action against Pfizer.

...


CONCLUSION
For all of these reasons, Pfizer respectfully asks the Court to dismiss Counts I and II of
Relator’s complaint under Rule 12(b)(6), with prejudice. Pfizer also requests oral argument on
this motion.

Respectfully submitted,
Dated: April 22, 2022 By: /s/ Carlton E. Wessel
Carlton E. Wessel (pro hac vice)
DLA PIPER LLP (US)
500 Eighth Street, NW
Washington, D.C. 20004
Telephone: 202.799.4000
Facsimile: 202.799.5000
Carlton.Wessel@us.dlapiper.com
Andrew J. Hoffman II (pro hac vice)
DLA PIPER LLP (US)
2000 Avenue of the Stars
Suite 400, North Tower
Los Angeles, CA 90067
Telephone: 310.595.3000
Facsimile: 310.595.3300
Andrew.Hoffman@us.dlapiper.com
Meagan D. Self
Texas Bar No. 24078453
DLA PIPER LLP (US)
1900 North Pearl Street
Suite 2200
Dallas, TX 75201
Telephone: 214.743.4500
Facsimile: 214.743.4545
Meagan.Self@us.dlapiper.com
Tommy L. Yeates
Texas Bar No. 22151100
MOORE LANDREY, LLP
905 Orleans Street
Beaumont, TX 77701
Telephone: 409.835.3891
Facsimile: 409.835.2707
tyeates@moorelandrey.com
Attorneys for Defendant Pfizer Inc.

https://rumble.com/v1rs05s-te am-enigma-whistleblower-us-dod-plan-to-exterminate-population-sasha-latyp.html

jeste vic k tomu predchozimu .. nechci tu tahat nejaky komentare k tomu, ale precejen mozna vysvetleni vhodne, co tu vlastne ma jako znamenat

jak to chapu ja - COVID vakciny mely byt armadni projekt (countermeasures) na zabijeni populace, a veskere testovani vakcin bylo proto ze zakona nepovinne(?), a udajne jen jako fasada "Large Scale Vaccine Manufacturing Demonstration" (udajne mel Pfizer zajistit jen fasadu pro verejnost zatimco na vakcinach pry - dle odtajnenych prezentaci - pracovali jini subkontraktori)

Pripad whisteblowerky Brook Jackson ma byt pripadem, kdy Pfizer se hajil tim, ze oni meli jen ukol ten podvod zaridit, takze nemaji pravni odpovednost, a zaloba Brook Jackson mela byt pozastavena... coz pokud se nepletu, soud zamitl, takze ten pripad whisteblowerky se asi projednava dal

Z PDF textu soudnich podkladu je take videt, ze kontraktorem Pfizeru resp. Advanced Technology International byla skutecne armada.

Tedy ty posty posledni tady se tykaji dvou ruznych veci (lidi), aby to nekoho nematlo :-) Ale celkem uzce souvisejicich

https://twitter.com/bmj_latest/status/1504376499939467264


Covid-19: Researcher blows the whistle on data integrity issues in Pfizer’s vaccine trial | The BMJ
https://www.bmj.com/content/375/bmj.n2635

BMJ 2021; 375 doi: https://doi.org/10.1136/bmj.n2635 (Published 02 November 2021)
Cite this as: BMJ 2021;375:n2635
Read our latest coverage of the coronavirus pandemic
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Paul D Thacker, investigative journalist
Author affiliations
Revelations of poor practices at a contract research company helping to carry out Pfizer’s pivotal covid-19 vaccine trial raise questions about data integrity and regulatory oversight. Paul D Thacker reports

In autumn 2020 Pfizer’s chairman and chief executive, Albert Bourla, released an open letter to the billions of people around the world who were investing their hopes in a safe and effective covid-19 vaccine to end the pandemic. “As I’ve said before, we are operating at the speed of science,” Bourla wrote, explaining to the public when they could expect a Pfizer vaccine to be authorised in the United States.1

But, for researchers who were testing Pfizer’s vaccine at several sites in Texas during that autumn, speed may have come at the cost of data integrity and patient safety. A regional director who was employed at the research organisation Ventavia Research Group has told The BMJ that the company falsified data, unblinded patients, employed inadequately trained vaccinators, and was slow to follow up on adverse events reported in Pfizer’s pivotal phase III trial. Staff who conducted quality control checks were overwhelmed by the volume of problems they were finding. After repeatedly notifying Ventavia of these problems, the regional director, Brook Jackson (video 1), emailed a complaint to the US Food and Drug Administration (FDA). Ventavia fired her later the same day. Jackson has provided The BMJ with dozens of internal company documents, photos, audio recordings, and emails.

Play Video
Video 1
Whistleblower Brook Jackson tells The BMJ about her experience working on the Pfizer covid-19 vaccine trial

Poor laboratory management
On its website Ventavia calls itself the largest privately owned clinical research company in Texas and lists many awards it has won for its contract work.2 But Jackson has told The BMJ that, during the two weeks she was employed at Ventavia in September 2020, she repeatedly informed her superiors of poor laboratory management, patient safety concerns, and data integrity issues. Jackson was a trained clinical trial auditor who previously held a director of operations position and came to Ventavia with more than 15 years’ experience in clinical research coordination and management. Exasperated that Ventavia was not dealing with the problems, Jackson documented several matters late one night, taking photos on her mobile phone. One photo, provided to The BMJ, showed needles discarded in a plastic biohazard bag instead of a sharps container box. Another showed vaccine packaging materials with trial participants’ identification numbers written on them left out in the open, potentially unblinding participants. Ventavia executives later questioned Jackson for taking the photos.

Early and inadvertent unblinding may have occurred on a far wider scale. According to the trial’s design, unblinded staff were responsible for preparing and administering the study drug (Pfizer’s vaccine or a placebo). This was to be done to preserve the blinding of trial participants and all other site staff, including the principal investigator. However, at Ventavia, Jackson told The BMJ that drug assignment confirmation printouts were being left in participants’ charts, accessible to blinded personnel. As a corrective action taken in September, two months into trial recruitment and with around 1000 participants already enrolled, quality assurance checklists were updated with instructions for staff to remove drug assignments from charts.

In a recording of a meeting in late September2020 between Jackson and two directors a Ventavia executive can be heard explaining that the company wasn’t able to quantify the types and number of errors they were finding when examining the trial paperwork for quality control. “In my mind, it’s something new every day,” a Ventavia executive says. “We know that it’s significant.”

Ventavia was not keeping up with data entry queries, shows an email sent by ICON, the contract research organisation with which Pfizer partnered on the trial. ICON reminded Ventavia in a September 2020 email: “The expectation for this study is that all queries are addressed within 24hrs.” ICON then highlighted over 100 outstanding queries older than three days in yellow. Examples included two individuals for which “Subject has reported with Severe symptoms/reactions … Per protocol, subjects experiencing Grade 3 local reactions should be contacted. Please confirm if an UNPLANNED CONTACT was made and update the corresponding form as appropriate.” According to the trial protocol a telephone contact should have occurred “to ascertain further details and determine whether a site visit is clinically indicated.”

Worries over FDA inspection
Documents show that problems had been going on for weeks. In a list of “action items” circulated among Ventavia leaders in early August 2020, shortly after the trial began and before Jackson’s hiring, a Ventavia executive identified three site staff members with whom to “Go over e-diary issue/falsifying data, etc.” One of them was “verbally counseled for changing data and not noting late entry,” a note indicates.

At several points during the late September meeting Jackson and the Ventavia executives discussed the possibility of the FDA showing up for an inspection (box 1). “We’re going to get some kind of letter of information at least, when the FDA gets here . . . know it,” an executive stated.

Box 1
A history of lax oversight
When it comes to the FDA and clinical trials, Elizabeth Woeckner, president of Citizens for Responsible Care and Research Incorporated (CIRCARE),3 says the agency’s oversight capacity is severely under-resourced. If the FDA receives a complaint about a clinical trial, she says the agency rarely has the staff available to show up and inspect. And sometimes oversight occurs too late.

In one example CIRCARE and the US consumer advocacy organisation Public Citizen, along with dozens of public health experts, filed a detailed complaint in July 2018 with the FDA about a clinical trial that failed to comply with regulations for the protection of human participants.4 Nine months later, in April 2019, an FDA investigator inspected the clinical site. In May this year the FDA sent the triallist a warning letter that substantiated many of the claims in the complaints. It said, “[I]t appears that you did not adhere to the applicable statutory requirements and FDA regulations governing the conduct of clinical investigations and the protection of human subjects.”5

“There’s just a complete lack of oversight of contract research organisations and independent clinical research facilities,” says Jill Fisher, professor of social medicine at the University of North Carolina School of Medicine and author of Medical Research for Hire: The Political Economy of Pharmaceutical Clinical Trials.

Ventavia and the FDA
A former Ventavia employee told The BMJ that the company was nervous and expecting a federal audit of its Pfizer vaccine trial.

“People working in clinical research are terrified of FDA audits,” Jill Fisher told The BMJ, but added that the agency rarely does anything other than inspect paperwork, usually months after a trial has ended. “I don’t know why they’re so afraid of them,” she said. But she said she was surprised that the agency failed to inspect Ventavia after an employee had filed a complaint. “You would think if there’s a specific and credible complaint that they would have to investigate that,” Fisher said.

In 2007 the Department of Health and Human Services’ Office of the Inspector General released a report on FDA’s oversight of clinical trials conducted between 2000 and 2005. The report found that the FDA inspected only 1% of clinical trial sites.6 Inspections carried out by the FDA’s vaccines and biologics branch have been decreasing in recent years, with just 50 conducted in the 2020 fiscal year.7

RETURN TO TEXT
The next morning, 25 September 2020, Jackson called the FDA to warn about unsound practices in Pfizer’s clinical trial at Ventavia. She then reported her concerns in an email to the agency. In the afternoon Ventavia fired Jackson—deemed “not a good fit,” according to her separation letter.

Jackson told The BMJ it was the first time she had been fired in her 20 year career in research.

Concerns raised
In her 25 September email to the FDA Jackson wrote that Ventavia had enrolled more than 1000 participants at three sites. The full trial (registered under NCT04368728) enrolled around 44 000 participants across 153 sites that included numerous commercial companies and academic centres. She then listed a dozen concerns she had witnessed, including:

- Participants placed in a hallway after injection and not being monitored by clinical staff
- Lack of timely follow-up of patients who experienced adverse events
- Protocol deviations not being reported
- Vaccines not being stored at proper temperatures
- Mislabelled laboratory specimens, and
- Targeting of Ventavia staff for reporting these types of problems.


Within hours Jackson received an email from the FDA thanking her for her concerns and notifying her that the FDA could not comment on any investigation that might result. A few days later Jackson received a call from an FDA inspector to discuss her report but was told that no further information could be provided. She heard nothing further in relation to her report.

In Pfizer’s briefing document submitted to an FDA advisory committee meeting held on 10 December 2020 to discuss Pfizer’s application for emergency use authorisation of its covid-19 vaccine, the company made no mention of problems at the Ventavia site. The next day the FDA issued the authorisation of the vaccine.8

In August this year, after the full approval of Pfizer’s vaccine, the FDA published a summary of its inspections of the company’s pivotal trial. Nine of the trial’s 153 sites were inspected. Ventavia’s sites were not listed among the nine, and no inspections of sites where adults were recruited took place in the eight months after the December 2020 emergency authorisation. The FDA’s inspection officer noted: “The data integrity and verification portion of the BIMO [bioresearch monitoring] inspections were limited because the study was ongoing, and the data required for verification and comparison were not yet available to the IND [investigational new drug].”

Other employees’ accounts
In recent months Jackson has reconnected with several former Ventavia employees who all left or were fired from the company. One of them was one of the officials who had taken part in the late September meeting. In a text message sent in June the former official apologised, saying that “everything that you complained about was spot on.”

Two former Ventavia employees spoke to The BMJ anonymously for fear of reprisal and loss of job prospects in the tightly knit research community. Both confirmed broad aspects of Jackson’s complaint. One said that she had worked on over four dozen clinical trials in her career, including many large trials, but had never experienced such a “helter skelter” work environment as with Ventavia on Pfizer’s trial.

“I’ve never had to do what they were asking me to do, ever,” she told The BMJ. “It just seemed like something a little different from normal—the things that were allowed and expected.”

She added that during her time at Ventavia the company expected a federal audit but that this never came.

After Jackson left the company problems persisted at Ventavia, this employee said. In several cases Ventavia lacked enough employees to swab all trial participants who reported covid-like symptoms, to test for infection. Laboratory confirmed symptomatic covid-19 was the trial’s primary endpoint, the employee noted. (An FDA review memorandum released in August this year states that across the full trial swabs were not taken from 477 people with suspected cases of symptomatic covid-19.)

“I don’t think it was good clean data,” the employee said of the data Ventavia generated for the Pfizer trial. “It’s a crazy mess.”

A second employee also described an environment at Ventavia unlike any she had experienced in her 20 years doing research. She told The BMJ that, shortly after Ventavia fired Jackson, Pfizer was notified of problems at Ventavia with the vaccine trial and that an audit took place.

Since Jackson reported problems with Ventavia to the FDA in September 2020, Pfizer has hired Ventavia as a research subcontractor on four other vaccine clinical trials (covid-19 vaccine in children and young adults, pregnant women, and a booster dose, as well an RSV vaccine trial; NCT04816643, NCT04754594, NCT04955626, NCT05035212). The advisory committee for the Centers for Disease Control and Prevention is set to discuss the covid-19 paediatric vaccine trial on 2 November.

Footnotes
Provenance and peer review: commissioned; externally peer reviewed.

Competing interests: PDT has been doubly vaccinated with Pfizer’s vaccine.

This article is made freely available for personal use in accordance with BMJ's website terms and conditions for the duration of the covid-19 pandemic or until otherwise determined by BMJ. You may download and print the article for any lawful, non-commercial purpose (including text and data mining) provided that all copyright notices and trade marks are retained.

Coronavirus (covid-19) Hub usage terms
https://bmj.com/coronavirus/usage
References
↵Bourla A. An open letter from Pfizer chairman and CEO Albert Bourla. Pfizer. https://www.pfizer.com/news/hot-topics/an_open_letter_from_pfizer_chairman_and_ceo_albert_bourla.
↵Ventavia. A leading force in clinical research trials. https://www.ventaviaresearch.com/company.
↵Citizens for Responsible Care and Research Incorporated (CIRCARE). http://www.circare.org/corp.htm.
↵Public Citizen. Letter to Scott Gottlieb and Jerry Menikoff. Jul 2018. https://www.citizen.org/wp-content/uploads/2442.pdf.
↵Food and Drug Administration. Letter to John B Cole MD. MARCS-CMS 611902. May 2021. https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/jon-b-cole-md-611902-05052021.
↵Department of Health and Human Services Office of Inspector General. The Food and Drug Administration’s oversight of clinical trials. Sep 2007. https://www.oig.hhs.gov/oei/reports/oei-01-06-00160.pdf.
↵Food and Drug Administration. Bioresearch monitoring. https://www.fda.gov/media/145858/download.
↵FDA takes key action in fight against covid-19 by issuing emergency use authorization for first covid-19 vaccine. Dec 2020. https://www.fda.gov/news-events/press-announcements/fda-takes-key-action-fight-against-covid-19-issuing-emergency-use-authorization-first-covid-19.

FDA oversight of clinical trials is “grossly inadequate,” say experts | The BMJ
https://www.bmj.com/content/379/bmj.o2628

BMJ 2022; 379 doi: https://doi.org/10.1136/bmj.o2628 (Published 16 November 2022)
Cite this as: BMJ 2022;379:o2628
Maryanne Demasi, investigative journalist
Author affiliations
maryannedemasi@hotmail.com
Covid-19 vaccines and drugs were developed at “warp speed” and now experts are concerned that the US Food and Drug Administration inspected too few clinical trial sites. Maryanne Demasi reports

On 25 September 2020, the US Food and Drug Administration (FDA) received a complaint by Brook Jackson who had been working for Ventavia Research Group, a Texas based company hired to run clinical trials for Pfizer’s covid-19 mRNA vaccine. Jackson, a regional director, had witnessed problems at three trial sites she was overseeing and complained to an FDA inspector about a range of problems including falsified data, unblinded patients, and inadequately trained vaccinators who were slow to follow up on adverse events. “I thought that the FDA was going to swoop in and take care of everything. What I was reporting was so important,” Jackson told The BMJ. The FDA did not, however, inspect the trial sites in question.

This lack of oversight was not an isolated case, The BMJ has learnt. Regulatory documents show that only nine out of 153 Pfizer trial sites1 were subject to FDA inspection before licensing the mRNA vaccine. Similarly, only 10 out of 99 Moderna trial sites2 and five of 73 remdesivir trial sites3 were inspected.

Now, facing a backlog of site inspections, experts have criticised the FDA’s oversight of clinical trials, describing it as “grossly inadequate.” They say the problem, which predated covid-19, is not limited to a lack of inspections but also includes failing to notify the public or scientific journals when violations are identified—effectively keeping scientific misconduct from the medical establishment.

The FDA is “endangering public health” by not being candid about violations that are uncovered during clinical trial site inspections, says David Gortler, a pharmacist and pharmacologist who worked as an FDA medical reviewer between 2007 and 2011 and was then appointed as a senior adviser to the FDA commissioner in 2019-21.

“The lack of full transparency and data sharing does not allow physicians and other medical scientists to confirm the data independently and make comprehensive risk-benefit assessments,” continues Gortler, who is now a fellow at the Ethics and Public Policy Center thinktank in Washington DC.

Paused during the pandemic
Between March and July 2020, at the peak of pandemic restrictions, the FDA paused its site inspections and only “mission critical” inspections were carried out. Gortler says, however, that this was the time that the FDA should have ramped up its oversight, not scaled back, especially since covid-19 products were being developed at warp speed and intended for millions of people. “The drug companies took appropriate measures to keep staff safe, which is exactly what the FDA could and should have done,” said Gortler.

A former staffer in the FDA’s Office of Criminal Investigations was also concerned about the agency’s failure to fully tackle Jackson’s complaint about falsified data in Pfizer’s mRNA vaccine trial. In an email dated March 2021, they wrote, “Having worked at the FDA, I see it as surprising, for many reasons, that the agency turned a blind eye . . . They likely feared the criticism they undoubtedly would have received for holding up a vaccine (which they knew they would eventually approve anyway) at the expense of untold lives lost.”

The former FDA employee, who signed a non-disclosure agreement and did not respond to interview requests, went on to write, “My point here is that instead of the regulators protecting the public, they were complicit. At the time, they may have been doing what they believed to be the right thing under extraordinary circumstances. But now, they may soon have some explaining to do.”

The FDA told The BMJ it takes oversight of clinical trials seriously and had adapted to travel restrictions, publishing draft guidance4 for remote regulatory assessments. This guidance describes virtual inspections using live streaming and video conferencing and requests to view records remotely.

Gortler, who is a credentialed FDA inspector, laughed at the proposition. “You can’t do a remote inspection. That’s like saying I’m going to arrest somebody remotely. You have to be there on site and look at every nuance such as cleanliness, organisation, staff coordination—even their body language. During a pandemic, the FDA could’ve put inspectors in hazmat suits if they wanted to, there’s no excuse for not going onsite.”

Historical failure to oversee
The FDA has a long history of failing adequately to oversee clinical trial sites. A report in 2007 by the Department of Health and Human Services’ Office of the Inspector General found the FDA audited less than 1% of the nation’s clinical trial sites between 2000 and 20055 and was highly critical of the agency because it did not have a database of operational clinical trial sites.6 In response to the report, the FDA said it created a dedicated task force and “developed new regulations and guidance further to improve the conduct of clinical trials and enhance the protection of people participating in clinical trials.” The BMJ asked to interview a member of this task force, but the FDA denied our request.

In 2015, Charles Seife, professor of journalism at New York University, conducted an analysis of published clinical trials between 1998 and 2013 in which an FDA inspection found significant evidence of objectionable practices.7 A total of 57 published clinical trials had significant evidence of one or more problems: 39% had falsification or submission of false information, 25% had problems with adverse events reporting, 74% had protocol violations, 61% had inadequate or inaccurate recordkeeping, and 53% failed to protect the safety of patients or had problems with oversight or informed consent. Furthermore, only 4% of the trials that were found to have significant violations were mentioned in the study’s journal publications.

A 2020 Science investigation analysed the FDA’s enforcement of clinical research regulations between 2008 and 2019 and concluded the agency was often light handed, slow moving, and secretive. It said that the FDA rarely levelled sanctions and when it did formally warn researchers about breaking the law, it often neglected to ensure that the problems were remedied.8

It has been 15 years since the Office of Inspector General report and the FDA still has no record of how many clinical trial sites are operating across the US and abroad. The agency told The BMJ it does not compile an annual list of clinical investigational sites submitted for review because it is “resource intensive.”

“It’s unacceptable,” said Gortler. “All it would take is sending a blanket communication to all sponsors or applicants requesting they provide a list of all their international and domestic clinical trial sites. Also, the FDA should publish the names, inspection dates, and unredacted findings at each of these sites clearly on its website, not buried somewhere, nearly impossible to find.” He believes the agency should have implemented a policy decades ago. “The public has a right to learn immediately about any violations before choosing to use an FDA regulated product,” he says.

Some 65% of the FDA’s funding for the evaluation of drugs comes from industry user fees and in return the agency has mandated deadlines for decisions on new product applications. Some experts argue this has been a major contributor to the FDA being rushed and having insufficient resources for other critical activities.9

Insufficient staff and low morale
Historically, the FDA has faced challenges recruiting and retaining sufficient medical staff to meet its needs. According to a Government Accountability Office report published in January 2022, the turnover rate for FDA staff in key scientific areas was twice that of other government agencies in 2007, leaving the agency unable to fulfil its mission.10 Around 70% of the FDA’s career employees working in 2008 were eligible to retire by the end of 2014. Moreover, in 2018, medical product staff in “mission critical” occupations had salaries that were at least 20% lower than the average private sector salary for the same occupations, contributing to low morale. A news report said the pressures of work during the pandemic had led to two FDA reviewers dying by suicide.11

Despite the estimated hundreds of thousands of clinical trial sites in operation across the US and abroad, the FDA told The BMJ that it only has 89 inspectors for its bioresearch monitoring programme, which assure the quality and integrity of data submitted to the agency in support of new product approvals and marketing applications. The FDA told The BMJ it is recruiting more inspectors to reach its yearly average of 100.

“I don’t think that it is a sufficient number of staff to do that kind of level of oversight,” says Jill Fisher, professor of social medicine at the University of North Carolina. “The FDA must have enough of a presence to dissuade investigative sites from committing fraud,” she continues.

Secrecy of inspection findings
Occasionally, the FDA will uncover objectionable practices, such as failure to obtain informed consent, falsification of data, or violations in adverse event reporting.

The FDA publishes its inspection reports12 but the database is not comprehensive, nor are the reports proactively disclosed. When they are disclosed there can be extensive redactions making it difficult to link problems to a particular drug or clinical trial. “FDA redactions can render the document useless—it’s to the point of being comical,” says Gortler, whose current work focuses on FDA oversight and accountability. “Public health information should not be redacted like that,” he says.

The FDA does not typically notify journals when a site participating in a published clinical trial receives a serious warning, or alert the public about the research misconduct it finds.13

Rafael Dal-Ré, physician epidemiologist at the Health Research Institute-Fundación Jiménez Díaz University Hospital, Madrid, Spain, finds this concerning14 and points to the example of the anticoagulant drug rivaroxaban.

The FDA inspected trial sites of the Record 4 trial and identified serious deficiencies at eight of the study’s 16 trial sites.14 The violations were so numerous and severe that the FDA excluded the trial from its pile of evidence during the drug’s approval. But when the study was published in the Lancet in 200915 there was no mention of the data integrity problems and the paper has been cited more than 1100 times by others.14 When The BMJ sought comment from the authors of the Record 4 study, some said they were not fully aware of the data integrity problems prior to our inquiries. The lead author, Alexander Turpin, said he was seeking more information from the drug company. The Lancet told The BMJ it was looking into the matter.

“If research misconduct is identified, the FDA may reject the affected data from the product’s safety and efficacy evaluations, but then fail to disclose these data in the product labelling,” added Dal-Ré.

Gortler finds it unconscionable that the FDA withholds this information from the public. “Misconduct should be released immediately. It’s malpractice not to; it’s irresponsible,” he says.

In response to the criticism the FDA said that it does not always monitor all publications of data that were submitted to the agency, nor does it have the authority to demand that a journal retract an article.

Road to reform
Fisher says the FDA needs better resourcing. “The clinical trials industry has become a complex global enterprise, and the FDA does not have the resources to oversee all the research that is happening, even within the US. The FDA needs to be better funded and staffed to conduct inspections. At a minimum the agency needs to inspect sites when complaints or concerns have been filed,” she says.

Gortler doesn’t agree, however, that the FDA is under-resourced. With a total budget of $6.1bn in 2021, he suggests the agency needs to be leaner and more efficient, with employees interested in improving public health. “The bottom line is that the FDA has over 18 000 full time employees, more than any other drug regulatory agency by far, so it could have retrained and retooled anybody to tackle the need for increased inspections,” he says. “Half of its budget, about $3bn, is discretionary, which means it could have hired contractors, retirees, or repurpose existing workers. It chose not to. The FDA was just yawning its way through the pandemic. The entire agency is broken.”

“It felt like we were being told to hide things”: FDA’s approval of antibiotic Ketek
In 2004, the FDA approved Sanofi-Aventis’s new antibiotic Ketek (telithromycin) for outpatient treatment of community acquired respiratory tract infections. Since then, it has been implicated in hundreds of reported cases of severe liver injury and dozens of deaths, triggered two Congressional hearings, and led to reforms of the agency’s processes. In 2007, the FDA added a warning to Ketek’s label and removed all indications except for bacterial pneumonia.

David Ross was an FDA medical reviewer who led the initial safety review for Ketek in 2001, as part of a 10 year career at the agency’s Center for Drug Evaluation and Research. In his original review Ross, now an associate clinical professor of medicine at George Washington University School of Medicine and Health Sciences, found that Ketek’s risks included liver injury and other serious adverse events that were concerning given the millions of antibiotic prescriptions written annually for respiratory tract infections.16

In 2001, the FDA recommended to Sanofi-Aventis that the company gather additional safety data. Sanofi-Aventis conducted Study 3014, a 24 000 patient safety study done in only five months. The FDA’s limited resources only allowed one out of 1800 sites to be inspected initially.

The agency decided to inspect the highest enrolling site, reasoning that failure to find any problems there would allow all the other sites to be considered clean. “The FDA inspector found evidence of blatant fraud almost immediately. For example, patients being enrolled at times when the clinic was supposedly closed,” said Ross.

The inspector reported her findings to FDA’s Office of Criminal Investigations, with serious protocol violations subsequently found at several other high enrolling sites. Eventually, the site investigator pleaded guilty to fraud and served a 57 month prison sentence.

At a 2003 public meeting of the FDA’s anti-infective advisory committee, data from Study 3014 were presented to the panel without disclosing the numerous violations and data integrity problems found at the initial trial site, which sparked a criminal investigation. Janice Soreth, Ross’s division supervisor at the time, has previously said that there was no intention to deceive the committee and that the violations were not disclosed so as not to compromise the ongoing criminal investigation.17 But Ross says he was appalled: “I felt like we were being told to hide things from the advisory committee.”

Unaware of the integrity problems, the committee voted 11 to 1 to recommend approval of Ketek. The FDA granted the drug approval on 1 April 2004. In a memorandum from the FDA, the agency said it was “difficult” to rely on Study 3014 for its approval because of the data integrity problems, instead using spontaneous adverse events reports for its understanding of Ketek’s overall risk-benefit profile, which goes against standard drug review practice.18 The first Ketek associated death from liver injury was reported to the FDA seven months later.16

A series of events unfolded during the drug approval process, which would later be revealed at a Congressional hearing in 2007. Ross testified under oath that when he submitted his follow up safety review in 2004, concluding that Ketek carried far too much risk to ever be approved for relatively minor conditions such as bronchitis and sinusitis, Soreth asked him to “soften” the language so that it would give the leadership “more wiggle room.” He told the hearing he sent Soreth a revised version for signing but—without telling her—also put the original in the electronic archive. Soreth did not testify in the hearing and denies this allegation. “No one ordered a change in Dr Ross’s review. He was free to keep his original draft,” she told The BMJ. “His review, moreover, did not include Aventis’s final submission to the agency.”

Ross left the division after Ketek’s approval in 2004 and then left the FDA in 2006, saying “the FDA did nothing for months and they just watched as the adverse event reports piled up. Lives could and would have been saved if the FDA acted sooner than it did to publicise Ketek’s risks and put a boxed warning on the drug.”

Whether it was Ross or Soreth who was right about this, the Ketek controversy led to the FDA Amendments Act of 2007, which stated that a reviewer’s work “shall not be altered by management or the reviewer once final.”

The FDA declined to respond when contacted by The BMJ. A spokesperson for Sanofi said the company complied with all the investigations at the time and that it no longer sells Ketek.

Footnotes
Competing interests: I have read and understood BMJ policy on declaration of interests and have no relevant interests to declare.

This feature has been funded by the BMJ Investigations Unit. For details see bmj.com/investigations

This article is made freely available for personal use in accordance with BMJ's website terms and conditions for the duration of the covid-19 pandemic or until otherwise determined by BMJ. You may download and print the article for any lawful, non-commercial purpose (including text and data mining) provided that all copyright notices and trade marks are retained.

Coronavirus (covid-19) Hub usage terms
https://bmj.com/coronavirus/usage
References
↵FDA. Summary basis for regulatory action: Comirnaty. 2021. www.fda.gov/media/151733/download.
↵FDA. Summary basis for regulatory action: Spikevax. 2022. www.fda.gov/media/155931/download.
↵FDA Center for Drug Evaluation and Research. Summary review: other relevant regulatory issues. 2020. www.accessdata.fda.gov/drugsatfda_docs/nda/2020/214787Orig1s000SumR.pdf#page=29
↵FDA. Conducting remote regulatory assessments: draft guidance for industry. July 2022. www.fda.gov/media/160173/download.
↵FDA Department of Health and Human Services. The Food and Drug Administration’s oversight of clinical trials. 2007. www.oig.hhs.gov/oei/reports/oei-01-06-00160.pdf.
↵Tanne JH. FDA is failing to oversee human clinical trials, report says. BMJ2007;335:691.3. doi:10.1136/bmj.39356.358796.DB pmid:17916839CrossRefPubMedGoogle Scholar
↵Seife C. Research misconduct identified by the US Food and Drug Administration: out of sight, out of mind, out of the peer-reviewed literature. JAMA Intern Med2015;175:567-77. doi:10.1001/jamainternmed.2014.7774 pmid:25664866CrossRefPubMedGoogle Scholar
↵Piller C. Official inaction. 1 October 2020. www.science.org/content/article/fda-s-own-documents-reveal-agency-s-lax-slow-and-secretive-oversight-clinical-research.
↵Demasi M. From FDA to MHRA: are drug regulators for hire?BMJ2022;377:o1538. doi:10.1136/bmj.o1538 pmid:35768073FREE Full TextGoogle Scholar
↵US Government Accountability Office. FDA workforce: agency-wide workforce planning needed to ensure medical product staff meet current and future needs. 2022. www.gao.gov/assets/gao-22-104791.pdf.
↵Eban K. “A tsunami of randoms”: how Trump’s covid chaos drowned the FDA in junk science. Vanity Fair. 19 January 2021. www.vanityfair.com/news/2021/01/how-trumps-covid-chaos-drowned-the-fda-in-junk-science.
↵FDA. Inspection observations. www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/inspection-references/inspection-observations.
↵Doshi P, Godlee F. The wider role of regulatory scientists. BMJ2017;357:j1991. doi:10.1136/bmj.j1991 pmid:28450290FREE Full TextGoogle Scholar
↵Dal-Ré R, Kesselheim AS, Bourgeois FT. Increasing access to FDA inspection reports on irregularities and misconduct in clinical trials. JAMA2020;323:1903-4. doi:10.1001/jama.2020.1631 pmid:32324205CrossRefPubMedGoogle Scholar
↵Turpie AGG, Lassen MR, Davidson BL, et al., RECORD4 Investigators. Rivaroxaban versus enoxaparin for thromboprophylaxis after total knee arthroplasty (RECORD4): a randomised trial. Lancet2009;373:1673-80. doi:10.1016/S0140-6736(09)60734-0 pmid:19411100CrossRefPubMedWeb of ScienceGoogle Scholar
↵Ross DB. The FDA and the case of Ketek. N Engl J Med2007;356:1601-4. doi:10.1056/NEJMp078032 pmid:17442902CrossRefPubMedWeb of ScienceGoogle Scholar
↵Soreth J, Cox E, Kweder S, Jenkins J, Galson S. Ketek--the FDA perspective. N Engl J Med2007;356:1675-6. doi:10.1056/NEJMc076135 pmid:17442912CrossRefPubMedWeb of ScienceGoogle Scholar
↵Graham DJ. Telithromycin and acute liver failure. N Engl J Med2006;355:2260-1. doi:10.1056/NEJMc066372 pmid:17124030CrossRefPubMedWeb of ScienceGoogle Scholar

Vaccine trial misconduct allegation – could it damage trust in science?
https://theconversation.com/vaccine-trial-misconduct-allegation-could-it-damage-trust-in-science-171164

This article has been updated and certain passages, which are the subject of disagreement between parties referred to in the article, have been removed.

The success of medical research has been one of the few positives of the COVID pandemic. The effectiveness of vaccines in preventing deaths (see graph below), is particularly impressive given the short time in which they were developed. But if recent allegations from a whistleblower about a Pfizer vaccine trial can be proven, they would indicate that time and financial pressures may have led to serious misconduct.

The whistleblower is Brook Jackson, previously a regional director at a Texas-based contract research organisation called Ventavia, who supplied an account to the BMJ. She alleges that Ventavia falsified data, “unblinded” patients (that is, researchers could see who was receiving the vaccine and who the placebo), employed inadequately trained vaccinators, and was slow to follow up on adverse events during one of the final trials.

Given the size of the vaccine trial, and the many centres involved, bad data from a few rogue centres is unlikely to fatally undermine the evidence needed for licensing the Pfizer vaccine. But it is important to examine allegations because research misconduct is a serious issue, especially if linked to a vaccine being given to millions of people. If the alleged activity turns out to be true, there must be severe consequences for Ventavia and those involved.

The international rules for conducting clinical trials are described in the World Medical Association’s Declaration of Helsinki. This document lays out the conditions and considerations needed for researchers and doctors to act with integrity when conducting research.

Research integrity has two aspects, both of which are alleged to have been a problem at Ventavia. Poor record-keeping, glossing over errors and drugs stored inappropriately are breaches of methodological integrity, while reports of participants waiting in corridors (when they were supposed to be under observation) and delays in following up side-effects are breaches of ethical integrity.

While ethics and safety regulators play an important role in the design and conduct of trials, ethics committees and inspectors cannot be aware of everything that goes on. Ethical conduct in particular is based on trust that researchers will carry out their work under the rules agreed with the ethics committee. Similarly, safety regulators are not in the position of policing all aspects of trials. In this case, while the US regulator (the Food and Drug Administration) was reportedly trying to monitor the trial, it only inspected nine out of 153 sites, not including any of the Ventavia sites.

A spokesperson for Ventavia provided the following comment:

Ventavia is aware of recent accusations in an article written by Paul Thacker [investigative reporter and author of the BMJ article]. Mr. Thacker did not contact Ventavia prior to publication. These same accusations were made a year ago, at which time Ventavia notified the appropriate parties. The allegations were investigated and determined to be unsubstantiated. Ventavia takes research compliance, data integrity, and participant safety very seriously, and we stand behind our work supporting the development of life-saving vaccines.

Complicated activity
Medical research is a complicated activity and the careful work needed to produce reliable results often takes a long time. Indeed, recent problems at a UK testing centre – where around 43,000 people may have been wrongly told that their COVID test was negative – show that it is easy to make mistakes, even when conducting the same laboratory process tens of thousands of times. For this reason, universities and other research institutions are required to provide training in research integrity, alongside having processes to detect and investigate serious integrity issues.

In parallel, work by research funders, academic societies and research charities is continuously trying to identify the pressures that lead to integrity issues. Perhaps unsurprisingly, time and money pressures frequently top the list. As the COVID dust starts to settle, more allegations like this will undoubtedly be made.

While misconduct is always regrettable, it is not unexpected. Sometimes the scientific method can be presented in an almost mythical way as if it is somehow entirely objective. This view is incorrect.

In reality, science is a human activity conducted by people with different motivations. But perhaps the difference between science and other activities is that systematic efforts are made to check and confirm results. This does not stop some worrying that science has a “reproducibility crisis” (the problem that not all experiments can be repeated), or that there is a great deal of research waste (research with no societal benefits), or that misconduct requiring retractions does occur, but scientists are aware of these problems and are trying to address them.

Take, for instance, the former physician Andrew Wakefield’s fraudulent research – published in The Lancet, but subsequently retracted – which claimed a link between the MMR vaccine and autism. This was a clear and serious breach of research integrity, and although it caused a lot of harm, it also led to thousands of studies both refuting the fraudulent research, but also arguably advancing vaccine science to the point that it was able to contend with SARS-CoV-2 when it arrived. The Wakefield scandal also caused a great deal of self-reflection and many positive actions trying to prevent such things from ever happening again.

COVID science has produced some amazing results, but it is still too early to fully assess the overall value of the research efforts. Given the vast amount of funding, and thousands if not millions of researchers working on COVID, alongside the successes there will inevitably be more examples of alleged misconduct – leading, inevitably, to sensationalist headlines. But when this happens, it is important to remember how many lives the vaccines and other treatments have saved. Yes, science is a human activity. Yes, integrity can be a problem. Yes, fraud and misconduct will occasionally occur, but science also produces remarkable results.

Video from Stockholm Conference, Lakaruppropet, January 21, 2023
https://www.bitchute.com/video/LerpitTRzKAJ/

Corona Investigative Committee, Session 140
https://www.bitchute.com/video/12cFNsOQvM9H/

I was invited to speak about the DOD involvement in countermeasures, and also comment on the recent Project Veritas undercover video release of "Pfizer manipulating viruses" story.

21 U.S. Code § 360bbb–3 - Authorization for medical products for use in emergencies | U.S. Code | US Law | LII / Legal Information Institute
https://www.law.cornell.edu/uscode/text/21/360bbb-3
(k)Relation to other provisions
If a product is the subject of an authorization under this section, the use of such product within the scope of the authorization shall not be considered to constitute a clinical investigation for purposes of section 355(i), 360b(j), or 360j(g) of this title or any other provision of this chapter or section 351 of the Public Health Service Act [42 U.S.C. 262].

related

Pfizer Asks Court to Dismiss Whistleblower Lawsuit Because Government Was Aware of Fraud
https://www.theepochtimes.com/health/pfizer-asks-court-to-dismiss-whistleblower-lawsuit-because-government-was-aware-of-fraud_4578832.html

The lawyer representing whistleblower Brook Jackson said Pfizer is arguing the court should dismiss Jackson’s lawsuit alleging fraud in Pfizer’s COVID-19 clinical trials because the U.S. government knew about the wrongdoings but continued to do business with the vaccine maker.

A lawsuit filed by whistleblower Brook Jackson alleging Pfizer and two of its contractors manipulated data and committed other acts of fraud during Pfizer’s COVID-19 clinical trials is paused following a motion by the defendants to dismiss the case.

In an interview with The Defender, Jackson’s lawyer said Pfizer argued the lawsuit, which was filed under the False Claims Act, should be dismissed because the U.S. government knew of the wrongdoings in the clinical trials but continued to do business with the vaccine maker.

Under the False Claims Act, whistleblowers can be rewarded for confidentially disclosing fraud that results in a financial loss to the federal government.

However, a 2016 U.S. Supreme Court decision that expanded the scope of a legal principle known as “materiality” resulted in a series of federal court decisions in which fraud cases brought under the False Claims Act were dismissed.

As interpreted by the Supreme Court, if the government continued paying a contractor despite the contractor’s fraudulent activity, the fraud was not considered “material” to the contract.


Pfizer is a federal contractor because it signed multiple contracts with the U.S. government to provide COVID-19 vaccines and Paxlovid, a pill used to treat the virus.

“Pfizer claims they can get away with fraud as long as the government would write them a check despite knowing about the fraud,” attorney Robert Barnes said.

The other two defendants in the case are Ventavia Research Group, which conducted vaccine trials on behalf of Pfizer, and ICON PLC, also a Pfizer contractor.

In an attempt to strengthen the False Claims Act’s anti-retaliation provisions and install new safeguards against industry-level blacklisting of whistleblowers seeking employment, Congress in July 2021 introduced the False Claims Amendments Act of 2021.

In December 2021, Pfizer hired a well-connected lobbyist, Hazen Marshall, and the law firm Williams & Jensen to lobby against the bill.

Pfizer previously was heavily fined in connection with the False Claims Act. As part of a 2009 settlement, the company paid $2.3 billion in fines — the largest healthcare fraud settlement in the history of the U.S. Department of Justice — stemming from allegations of illegal marketing of off-label products not approved by the U.S. Food and Drug Administration (FDA).

“Pfizer, one of the most criminally fined drug companies in the world, wants to weaken the laws that hold them accountable,” Barnes told The Defender.

Congress has taken no action on the False Claims Amendments Act since November 2021, when the bill was added to the Senate’s legislative calendar.

Barnes said the outcome of Jackson’s case against Pfizer is significant not just for his client, but also for the American public.

“This case will determine if Big Pharma can rip off the American people using a dangerous drug that harms millions without any legal remedy because they claim the government was in on the scam.”

Jackson was a regional director for Ventavia for a brief period in 2020 but was fired after she notified the FDA about issues with Pfizer’s vaccine trials.

After she was fired, she gave The BMJ a cache of internal company documents, photos and recordings highlighting the alleged wrongdoing by Ventavia.

The documents she provided contained evidence of falsified data, blind trial failures and awareness on the part of at least one Ventavia executive that members of the company’s staff were “falsifying data.”

Jackson’s documents also provided evidence of administrators who had “no training” or medical certifications, or who provided “very little oversight” during the trials.

Jackson filed her complaint in August 2021, in the U.S. District Court, Eastern District of Texas, Beaumont Division, alleging Pfizer, Ventavia and ICON “deliberately withheld crucial information from the United States that calls the safety and efficacy of their vaccine into question.”

A district court judge in February unsealed Jackson’s complaint, which included 400 pages of exhibits.

According to the complaint, Jackson, who had more than 15 years of experience working with clinical trials, “repeatedly informed her superiors of poor laboratory management, patient safety concerns and data integrity issues” during the approximately two weeks she was employed by Ventavia.

“Brook [Jackson] brought a Qui Tam action and a retaliatory discharge case against Pfizer and others for fraud on the people concerning Pfizer’s false certifications to the U.S. Department of Defense about the safety and efficacy of their COVID-19 vaccine,” Barnes said.

A Qui Tam case refers to a provision under the False Claims Act that allows individuals and entities with evidence of fraud against federal programs or contracts to sue the wrongdoer on behalf of the U.S. government

“She was part of the clinical trials, witnessed extraordinary malfeasance, blew the whistle, and was quickly fired after she blew the whistle.”

Barnes said his legal team will in August file its opposition brief to Pfizer’s motion to dismiss, and the judge may rule on the motion to dismiss by fall 2022.

(PDF) US District Court for Eastern Texas - USA ex rel, Brook Jackson v. Ventavia Research Group - recently unsealed qui tam action against vaccine entities: Pfizer Inc., Icon PLC, and Ventavia Resear...
https://www.academia.edu/71772143/US_District_Court_for_Eastern_Texas_USA_ex_rel_Brook_Jackson_v_Ventavia_Research_Group_recently_unsealed_qui_tam_action_against_vaccine_entities_Pfizer_Inc_Icon_PLC_and_Ventavia_Research_Group_LLC

White Noise | Official Trailer | Netflix
https://www.youtube.com/watch?v=SgwKZAMx_gM


The eerie parallels between Netflix's "White Noise" and the Ohio train derailment disaster | Salon.com
https://www.salon.com/2023/02/15/noise-ohio-train-derailment/

read "White Noise" in San Francisco, miles from home. I was living in the golden state for an all-too brief time, so far from rural Ohio where I was raised and where I would return to raise my child. In the sunshine, the beach a mere drive away, it seemed like a fine place to disappear into Don DeLillo's 1985 novel about an Ohio college professor and his large family whose lives are upended by a toxic airborne event. I enjoyed the novel at the time. I don't think I could read it again, not now, not in this world and not knowing what I do about my home's long history of exploitation by industry and ecological disaster, a legacy that is ongoing.

In the book "White Noise," winner of the National Book Award, Jack Gladney, his wife Babette and their many children from various marriages are forced to evacuate after a train derails near their pastoral Ohio home, causing an explosion which morphs into a dangerous, toxic cloud. Sound familiar?

Related

EPA issues rare veto, halting Alaska's Pebble mine
Shortly after Noah Baumbach adapted and directed a film version of "White Noise," now streaming on Netflix, starring his partner Greta Gerwig and Adam Driver, a freight train carrying hazardous chemicals derailed in rural Ohio. The story is still developing, and the environmental impact may not be fully known for years, but the tragedy bears an eerie resemblance to many elements of the film.

"How familiar this all seems to us," Jack (Driver) says in the movie. Salon unpacks the similarities between "White Noise" and the ecological disaster in Ohio.

01
The Ohio setting
Image_placeholderWhite NoiseGreta Gerwig as Babette and Sam Nivola as Heinrich in "White Noise." (Netflix)
"White Noise" is set in Ohio, where Jack teaches at a college aptly known as the College-On-The-Hill. He and his family live in the small, picturesque town of Blacksmith, which is fictionalized. The movie was filmed almost entirely in Ohio, a prep school in Willoughby, Ohio, filling in for the College-On-The-Hill. Other classroom, lab and student center scenes were shot at the University of Akron, Baldwin Wallace University and Kent State University while the family home is a real house in the college town of Oberlin.



In real life, the train derailed in East Palestine, Ohio, a small town near the Pennsylvania border. Some residents of East Palestine worked as movie extras during the filming of "White Noise" in their home state.

02
Train derailment
Image_placeholderWhite NoiseWhite Noise (Netflix)
"White Noise" is spilt into parts. The second part, titled "The Airborne Toxic Event" concerns what happens when a tanker truck carrying toxic, flammable material crashes into a passing train, due to the truck driver's drunk driving. The train derails in the countryside. Cars smash into each other and the tanker is crushed, releasing a viscous substance. A fireball erupts. The rest of the film deals with the aftermath of the crash, in both large and small, personal ways.



In East Palestine, on Feb. 3, a Norfolk Southern train with 20 cars containing hazardous materials derailed and then caught on fire. As Ben Ratner, one of the East Palestine locals who appeared as extras in "White Noise," told CNN, "The first half of the movie is all almost exactly what's going on here."

03
The cloud
Image_placeholderWhite NoiseWhite Noise (Netflix)
"There's lots of smoke, and I don't like the looks of it," Jack's teen son (Sam Nivola) says to him in the film, after the child has been studying the site of the train derailment through binoculars via the family's roof. In the movie, an explosion from the derailment causes a toxic cloud that can be viewed for miles. It looks uncannily like the real scene in East Palestine of the dark, purple-blue cloud witnessed over farmland and pastures (a cloud that emerged after the so-called "controlled release" of the train cars' chemicals). In the fictional film, the cloud later resembles a massive, purple-tinged storm cloud, which wouldn't be out of place in "Ghostbusters."

04
Conflicting emergency messages
Image_placeholderWhite NoiseChloe Fineman as Simuvac Technician in "White Noise." (Wilson Webb/Netflix)
In "White Noise," the family is first told to evacuate. Hours after the incident, believing the derailment and resulting explosion to be far enough away that it doesn't pose a threat, the family sits down to dinner when air raid sirens go off. Then the fire chief hurries through the neighborhood in his car, blasting a message to evacuate all residents. Jack's family flees in their battered station wagon. They don't get far, jammed on the road with all the other escaping families. But then the emergency broadcast on the radio tells them a different message: to stay inside and shelter indoors. No one should be outside, the new messaging says. Or on the roads.



The people in East Palestine — and possibly, in the entire Ohio River Valley area – are dealing with similar mixed messages. Hundreds were forced to evacuate as Norfolk Southern burned carcinogens from the crash. After merely a few days, people were told it was safe to return. But the EPA continues to monitor the air, residents have described burning in their eyes and fish, livestock and pets have all been reported dead or sick.

Want a daily wrap-up of all the news and commentary Salon has to offer? Subscribe to our morning newsletter, Crash Course.

05
Uncertain future
Image_placeholderWhite NoiseWhite Noise (Wilson Webb/Netflix)
In the last part of "White Noise," the main characters deal with their fear of death in various ways — though, as a seminal postmodernist story, perhaps "deal" is too strong a word. Little is truly resolved or seems certain.



So too East Palestine, Ohio, and multiple states bordering the Ohio River, may be facing an uncertain future. The derailed and burned cars contained dangerous chemicals including butyl acrylate, ethylhexyl acrylate, isobutylene, and especially concerning: vinyl chloride, which NPR describes as "a carcinogen that becomes a gas at room temperature." It breaks down in the sun, can cause headaches and dizziness, but it has severe long-term risks as well. NPR writes, "People who breathe the chemical over many years may also experience liver damage," and due to its "tiny atoms," residents can't just clean it off.



GoFundMe pages have been set up for East Palestine, with other charities for people and animals impacted by the disaster accepting donations as well.

https://edition.cnn.com/2023/02/15/us/newsnation-reporter-charges-dropped/index.html



The criminal charges filed against the NewsNation reporter who was arrested while reporting at a news conference in East Palestine have been dropped, Ohio Attorney General Dave Yost announced Wednesday.

Evan Lambert-McMichael was arrested after reporting live during a news conference last week held by Ohio Gov. Mike DeWine and other officials who were updating the train derailment in East Palestine, CNN previously reported.

Body camera footage shows officials approaching Lambert-McMichael and asking him to stop his reporting as it was too loud during the press conference. The footage also shows an argument break out and Ohio National Guard’s adjutant general, Maj. Gen. John Harris, approaching and pushing Lambert-McMichael.

Lambert-McMichael was charged with resisting arrest, a second-degree misdemeanor, and criminal trespass, a fourth-degree misdemeanor, according to Yost.

“While journalists could conceivably be subject to criminal charges for trespassing in some situations, this incident is not one of them,” Yost wrote in a statement. “The reporter was lawfully present at a press conference called by the Governor of the state. His conduct was consistent with the purpose of the event and his role as a reporter.”

In a statement on Twitter, Lambert-McMichael spoke about the incident.

“It is by design that reporters aren’t meant to become the story,” he began.

“I’m still processing what was a traumatic event fore me, in the context of a time where we are hyper aware of how frequently some police interactions with people of color can end in much worse circumstances. That is not lost on me,” Lambert-McMichael noted.

“I am doing alright. And I will be OK. I will also continue to do my job without fear or favor in service of the public. I also hope what happened to me shines further attention on the people of East Palestine, who rightly have questions about their safety in light of an environmental hazard,” he added.

DeWine said Wednesday on “CNN This Morning” he has “never had a problem” during any of the news conferences he’s held during his tenure as governor.

“This reporter who was reporting live from the back of the room never should have been asked to stop, never should have been told to be quiet,” the Republican governor told CNN’s Don Lemon and Kaitlan Collins. “That was a big, big mistake. And you know, the person who did that, I’ve explained to them and I’m sure that he’ll never, never do that again.”

https://edition.cnn.com/2023/02/11/health/ohio-train-derailment-white-noise/index.html

“The first half of the movie is all almost exactly what’s going on here,” Ratner said Wednesday, four days into their evacuation.

https://twitter.com/RepTroyNehls/status/1625591924555128832




East Palestine, Ohio, residents can safely go home, officials say : NPR
https://www.npr.org/2023/02/08/1155570564/east-palestine-ohio-train-derailment

EAST PALESTINE, Ohio — Evacuated residents can safely return to the Ohio village where crews burned toxic chemicals after a train derailed five days ago near the Pennsylvania state line, East Palestine Fire Chief Keith Drabick said Wednesday.

Authorities in East Palestine had warned that burning vinyl chloride that was in five of the derailed tanker cars would send hydrogen chloride and the toxic gas phosgene into the air. They said Wednesday subsequent air monitoring hasn't detected dangerous levels inside or outside the mile-radius evacuation zone, which stretched into Pennsylvania. Drabick said air and water samples taken Tuesday from the evacuation area show it's now safe, and the evacuation order is lifted. He thanked state and federal officials and agencies that helped with the emergency response over the past few days.

Ohio crews conduct a 'controlled release' of toxic chemicals from derailed train cars
NATIONAL
Ohio crews conduct a 'controlled release' of toxic chemicals from derailed train cars
James Justice of the U.S. Environmental Protection Agency said around-the-clock air monitoring has shown normal, un-concerning levels. Hundreds of data points from that "show that the air quality in the town is safe," he said.

He reiterated that there was a robust air monitoring system in place and data from that showed nothing at a level that would be cause for health concern. Monitors did detect toxins in the air during the controlled burn at the derailment site, but other samples outside that area did not.

Many nearby residents left shortly after the derailment, and others were ordered out before the controlled release of the chemicals because of concerns about serious health risks from it.

The commander of the Ohio National Guard previously said that members wearing protective gear would take readings inside homes, basements and businesses as officials aimed to ensure the air was safe before lifting the evacuation order.

Some residents have said they were worried about returning even if authorities say it's OK to go home.

The fire from the chemical release is no longer burning, and crews have started removing some of the wreckage.

About 50 cars, including 10 carrying hazardous materials, derailed in a fiery crash Friday night on the edge of East Palestine. Federal investigators say a mechanical issue with a rail car axle caused the derailment.

No injuries have been reported from the derailment or from the controlled release of the chemicals on Monday, but some people have complained about smelling chlorine and smoke in the air and having headaches.

Those just outside the evacuation zone in East Palestine and in neighboring Beaver County, Pennsylvania, had been urged to stay indoors as a precaution. Officials in neighboring counties have said air samples did not show any worrisome levels of contaminates.

At least one lawsuit has been filed over the derailment. An East Palestine business owner and two other residents sued the rail operator in federal court on Tuesday, alleging negligence by Norfolk Southern and exposure to toxic substances as a result. They're seeking to make it a class-action case for residents and businesses in the evacuated area and people who were physically harmed because of spilled chemicals at the site.

Norfolk Southern declined to comment on the lawsuit.