….Spiritual reading
November 10
Let’s turn to anger today. There is a lot of it around, and you are all visited by it from time to time.
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Sometimes it is a salutary thing. Like a flood, it can cleanse and leave behind a landscape that is both open and free of obstacles. We’ll return to this form of anger later.
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Most often, though, it destroys that which has been built up with loving care and attention, and like a flood, it can raze those treasures in an unguarded instant or two.
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As you know, anger arises almost inevitably from sorrow. From the inability to get or effect or do that which you want. The reasons may be high-minded, or arise completely from self-interest or greed. It really matters not, for the match that most ofen ignites the tinder is constructed of disempowerment.
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Disempowered, not getting that which you want to get (whether it be human rights for all, or the job you were qualifed for, or the admiration you wanted from someone you care about)… there is an internal conflagration that tends to break out.
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Your mind, sometimes in conjunction with your heart and your body, has identifed something it thinks would be advantageous and then takes whatever steps seem appropriate to get it. Sometimes, it must be added, this means none whatsoever. But when the desired outcome does not occur, this is a slight to the ego, a blow struck against the mastery of the individual, a lid placed on his or her ability to expand, to be and to have all that this particular self identifes as right to be or have or do.
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Then, of course, the anger, the incendiary energy, fares and either gets directed outward, sometimes leveling its object, or it can be suppressed and smolder in the heart of its creator for a long, long time.
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Whichever direction it goes, there is often a high price to be paid.
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Anger is rarely an issue outside of the human realm. On earth, animals in the wild fight for what they need to survive, but never, to our knowledge, feel the impulse to ‘get even.’ They get what they need if they can, and if they can’t they move on and look elsewhere. A mother defends her babes, but if one is snatched despite her best efforts, she turns her attention to the ones remaining. Imagine a mother opossum who, having shepherded her latest litter into independence, set off to harass the coyote who had dined on one of her children.
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It is an odd picture, is it not?
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Equally unlikely is a vision of that opossum mother castigating herself endlessly for being a bad mother, for having caused her baby’s death through her own negligence, and sinking into lethargy and depression.
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Animals are, well, “philosophical” about life. They take responsibility for their part and leave the rest to something much larger. They lack ego and they lack the notion of desire as you know it. They are not ‘wronged’ as you so often are, and they do not feel the need to vindicate themselves.
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Anger is just not part of their experience. It is uniquely human and in many ways it describes the boundaries of human folly.
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Maybe you can see where we are going here? We’ll explicate, none-the-less. Obviously, the less attached you are to your desires, the less anger you are going to experience. Because everyone has occasion to be disappointed in their desires. And as a rule, anger is both painful and destructive, not to mention
distracting, so if it can be encountered less often, that is a boon.
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How to do that? Well, the more you are able to ally with greater forces than your own limited self as you plot your course through life, the more you will easily accept what actually is on offer. If you simply must have a particular job, you might get it, but if you don’t, the cascade of negative emotions could drown you.
Or light that fire. If instead, you wanted the job that best suited you, the one that would help you achieve the most at the moment, esecially if you allow that you have no idea what that might look like, then the loss of a specific possibility does not leave you embattled. Instead of ‘losing’ to the universe, you are in
reality being guided and cared for. To approach your life in this manner clearly reduces the chances that you fnd yourself at odds with what is, and thus disempowered and fuming.
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And in a sense, this is the model the animals live. They never question the ‘rightness’ of a particular occurrence. They accept it and act accordingly. There is nothing wasted on raging at the universe or any of its actors. It is, we must note, a good place to start.
Wild animals have their ‘stuff’ too, but in this case, they really do offer a wonderful example of how to live in concert with the winds of universal intent. They are free from the suffering that your desires and disappointments create for you. Not to mention the devastating effects that anger has on both the one from whom it arises and anything at which it is directed.
Your anger—and all of you feel it from time to time—can be diminished as you are able to let go of your need to control entirely from the place of ego, of small self, of human persective. The more you are able to surrender the fnal outcome to the divine, the less you set yourself up for the fall that always precedes anger.
This is something we urge you to work toward in your life, if only because you will be freer and more peaceful as a result. Your energies will be more available for the things that really matter to you and you will ultimately be much more powerful, much stronger, if you join forces with the universal ones
instead of struggling to hold your own without a functioning compass. This is true self-interest at work.
But what of things that just aren’t right? How about war and torture and ruthless greed? What of rape and murder and genocide? How about wanton destruction of the earth in pursuit of wealth? Is it not inherently good to be angry about such bad things? Should you really be surrendering your impulse to fury when undeniable harm is done?
Here is where it becomes a litle more complex. Here is where it becomes essential to locate the source of your anger. Te anger that you feel when your will is obstructed comes from the ego, from the mind.
You have set yourself upon a course and you have desired an outcome that suits you. A person, a place, a thing. You want. But when you look out and see cruelty and disregard for both the human and divine in other beings, the heart is broken. You feel pain that is subtly different from the pain you feel when you don’t get something you long for.
Yes, it can be said that you long for justice, freedom and peace on your planet. For all. But it arises from the heart and not from the mind.
Just check out a few of the things you want. See if by feeling into them you can identify the origin of the longing. We think you will see that there is a difference, that the rage that screams against wrongs done is sourced from the heart, while fury that comes from insurmountable obstacles comes from a litle lower down. Or higher up. You should look for your own experience, as it varies. But there is a difference, and if you are to handle anger skillfully, you need to be able to fnd it.
Anger that arises from the heart is based in love, empathy and oneness. Anger that arises from the will is based in ego identification and separation. You can lessen the impact of the later by surrendering not the longings, but a measure of the specifics of your personal direction to the universe. You can use the former to move toward oneness if you stay in the place of its origin—in the heart.
What often happens is that a broken heart leads to anger which manifests as the wild and uncontrolled conflagration of the ego. Take your anger about something bad that people do to one another or the earth, and act from love. Allow your actions to be fueled by the anger, which is a powerful force. But act from love. For that is the seat of the anger and the only balm will be to make more love in the world.
However you move from your broken heart, whatever you do, do it with an energy of love. This doesn’t mean you have to put flowers in the
barrels of guns, but it means that the energy which underlies your actions must be pure love. Otherwise, you have strayed into the very territory you abhor.
Please watch yourself closely in regard to your anger and that of others. Think about what we have said and see how it might apply to your own life. There is enough sufering; it is time to let go of that which is both needless and energetically consuming. See how far you can get toward setting yourself free from this uniquely human curse. Get rid of that which serves you not, and fnd strength to love more in precisely that which would otherwise shut down your heart. Alchemy, dear ones. Be masters.
With all our love, without fail.
(Elizabeth West)
….Pot pourri
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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, 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.
Feature BMJ Investigation
Covid-19: Researcher blows the whistle on data integrity issues in Pfizer’s vaccine trial
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
- Paul D Thacker, investigative journalist
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, 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.
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
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:
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Participants placed in a hallway after injection and not being monitored by clinical staff
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Lack of timely follow-up of patients who experienced adverse events
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Protocol deviations not being reported
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Vaccines not being stored at proper temperatures
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Mislabelled laboratory specimens, and
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Targeting of Ventavia staff for reporting these types of problems.
American philanthropist Bill Gates has warned of a “bioterrorist smallpox pandemic” which could arise if we don’t learn valuable lessons from Covid-19. pic.twitter.com/lCZH6l5uSK
— talkRADIO (@talkRADIO) November 4, 2021
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Matthew McConaughey Says He Won’t Vaccinate His Kids https://ca.style.yahoo.com/matthew-mcconaughey-says-wont-vaccinate-120325987.html
Not bad for a half-jew, though he said he himself was vaxed.