Tag Archives: clinical investigations

Doctors for the Truth Speak Out in Madrid, Denounce Covid-19 “False Pandemic”

With the participation of hundreds of professionals from all over the world, “Doctors for the Truth” stated that Covid-19 is a false pandemic created for political purposes. They urged doctors, the media and political authorities to stop the operation, by spreading the truth.

In a context of great excitement and worldwide expectation, the Doctors for Truth Association was presented at a press conference on Saturday, July 25 in Madrid.

The group, led by doctors Natalia Prego Cancelo and Angel Luis Valdepeñas, made a direct connection with the extra-parliamentary commission of doctors from Germany, the Epidemiologists group from Argentina, and doctors from the United States and Argentina.

The event began with the intervention of Heiko Schöning, representative of the German Extra-Parliamentary Commission for the Study of the Coronavirus. There were online interventions by professionals from Argentina and the United States. It concluded with a review of the 4 fundamental points of interpellation to the Government and Spanish authorities by the Association of Doctors for Truth.

The presentation, in an event room of the Madrid Press Palace, was attended by more than 400 people, including general and alternative media, doctors, and assistants. Data, figures, analysis and reflections were exposed that show the incoherent and harmful nature of the measures that are being applied worldwide pertaining to Covid-19.

“A world dictatorship with a sanitary excuse.”

“This is a world dictatorship with a sanitary excuse,” was stressed at the end of the meeting. Doctors agreed that:

  • Coronavirus victims did not outnumber last year’s seasonal flu deaths.
  • Figures were exaggerated by altering medical protocols.
  • The confinement of the healthy and the forced use of masks have no scientific basis.
  • The disease known as Covid-19 does not have a single infectious pattern, but a combination of them.

“There are crossed toxic patterns,” said Angel Luis Valdepeñas. “On the one hand, the electromagnetic contamination of fi5v-ghee, and on the other, the influence of influenza vaccination. There is an interaction and empowerment, which must be investigated”.

Angel Luis Valdepeñas underlined at the end of the meeting:

“We must tell our governments that they NEVER OCCUR to compel us to vaccinate, or even recommend it, for the slightest sense of prudence.”

Valdepeñas concluded his final intervention asking the press for “an effort of responsibility that we have not seen so far”, and criticized the “continuous bombardment of information on the pandemic, without weighing neither the quantity nor the quality of the information”. The doctor indicated that when the media talk about “new outbreaks”, they should clarify that these are only positive tests, but that 98 percent [of the population] are “healthy, asymptomatic people.”

At the end of the event, the panelists took to the streets followed by the numerous attendees to the cry of Freedom!

Together they walked to the Plaza de Callao, the usual meeting place for the 2020 Movement. There they chatted, for more than 2 hours, with attendees and people who had not been able to access the room.

However, this too may get the chop, when the ‘fact-checkers’ decide something here is not in line with Govt. policy.

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This was originally published by Contra información on July 26, 2020. Translated by Mark Taliano

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Eliminating Informed Consent on Human Experimentation with Vaccines and Drugs

The 21st Century Cure Act would demand that the Food and Drug Administration (FDA) add an exemption from informed Consent requirements for those clinical trials that pose no more than minimal risks and the appropriate safeguards protecting the right, safety and welfare of subjects.

Informed Consent Waiver

The above can be found in section 3024 – Informed Consent Waiver or Alterations for Clinical Investigations.

So what they are saying now they don’t have to obtain informed consents to test vaccinations or drugs on humans beings if it has been determined that the proposed pose no more than minimal risks.

Let’s review the Exemption  for Devices for Investigational Use

(g)(1) The purpose of this section to encourage to the extent consistent with the protection of public health and safety and ethical standards, the discovery and development of useful devices intended for human use and to that end to maintain optimum freedom for scientific investigators in their pursuit of that purpose.

In other words, you can get an exemption for certain conditions.

Question: if you don’t have informed consent in clinical trials experimentation on people, then how does anyone knows you are not part of an experiment?

If sponsors and clinical researchers not longer has to tell you that you are part of it or get your consent to informed you what they are doing? That may sound a little crazy.

Further source of research:

The 21st Century Cures Act Implications

Say Goodbye to Vaccine Safety Science by Barbara Loe Fisher

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A Risk-Based Approach To Monitoring

A risk is any uncertain event or condition that might affect your project. Not all risks are negative.

No single approach to monitoring is appropriate or necessary for every clinical trial. FDA recommends that each sponsor design a monitoring plan that is tailored to the specific human subject protection and data integrity risks of the trial.

Not all risks are negative
Some events (like finding an easier way to do an
activity) or conditions (like lower prices for certain
materials) can help your project! When this happens,
we call it an opportunity… but it’s still handled just
like a risk.

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avoid_mitigate
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Image Source: Head First PMP, by Jennifer Greene, PMP and Andrew Stellman, PMP

FDA has also recognized this fact and come out with a “Guidance for Industry Oversight of Clinical Trial Investigations – A Risk Based Approach to Monitoring”. As per this guidance the objective of the guidance is “to assist sponsors of clinical investigations in developing risk-based monitoring strategies and plans for investigational studies of medical products, including human drug and biological products, medical devices, and combinations thereof”.

Unfortunately, a lot of people in the industry are speaking about risk-based monitoring, but few have a broad understanding of the whole life-cycle process. Great opportunities exist for savings, but then again, most EDC platforms dont work effectively with risk-based monitoring. Switching to risk-based monitoring increases rather than decreases work because it can break the EDC workflow – refuting much of the value of EDC.

In conclusion, Risk-based monitoring is yet another desperate attempt to deal with what all Electronic Data Capture (EDCs) systems have failed to deliver – quality of clinical data.

Source: FDA Guidance

Your comments and questions are valued and encouraged.
Anayansi Gamboa has an extensive background in clinical data management as well as experience with different EDC systems including Oracle InForm, InForm Architect, Central Designer, CIS, Clintrial, Medidata Rave, Central Coding, OpenClinica, Open Source and Oracle Clinical.

 

anayansi gamboa