Eli Lilly's Trial For COVID-19 Antibody Treatment Halted For Safety Reasons

Discussion in 'Miscellaneous Health Discussions' started by haidut, Oct 13, 2020.

  1. haidut

    haidut Member

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    Just, wow!
    The bad news for the nascent COVID-19 industry just keep piling on. Just a a few hours ago I posted about the J&J vaccine trial put on hold, and this was the second (out of 4 total) human trials put on hold.
    Another COVID-19 Vaccine Trial Halted Due To Serious Side Effects

    Now, we have another human trials put on hold due to a serious adverse event (SAE), but this time it is not a vaccine trial but a treatment trial using with a synthetic monoclonal antibody, similar to ones given to cancer patients by IV infusion. The monoclonal treatments are notorious for their severe side effects, which are sometimes lethal. To make matters worse, they often cause secondary cancer in patients using them as cancer treatments. I can't imagine FDA approving a COVID-19 treatment that has PML or cancer as a side effect, but we have been (unpleasantly) surprised by the FDA before so I don't have much hope this agency will do the right thing in a such a politically charged situation.
    Eli Lilly pauses trial of its monoclonal antibody to treat coronavirus - CNN
    "...Drugmaker Eli Lilly said Tuesday it is pausing its trial of a combination antibody treatment for coronavirus for safety reasons. Usually, clinical trials are paused because a volunteer has suffered a side effect or become ill, but the company did not say what happened. "Safety is of the (utmost) importance to Lilly," a spokesperson told CNN by email. It said the trial's Data Safety Monitoring Board (DSMB), an independent group of medical experts who monitor clinical trials, recommended the pause."

    "...The trial, evaluating Lilly's investigational neutralizing antibody as a treatment for COVID-19 in hospitalized patients, is sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH). Lilly is supportive of the decision by the independent DSMB to cautiously ensure the safety of the patients participating in this study," the company said in the statement."

    @Drareg @Regina @boris @jb116 @tankasnowgod
     
  2. Kram

    Kram Member

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    I am no expert on clinical trials but these news articles make it sound like adverse events and pausing trials is fairly common so it's really not that big of a deal (although it also demonstrates how risky pharma drugs can be). Not sure you have noticed this, but I can't tell you how many stories I have read of how "healthy" people with no underlying condition have died from covid. They typically mention how the person was skinny (not advocating for obesity here) and a long distance runner and I can't help but think that cortisol and other stress mediators had to have played a role but maybe I am jumping to conclusions...

    Also, just saw pfizer is going to start testing its vaccine on kids. I am paraphrasing the doctor mentioned in the article but...you're basically saying you need to vaccinate kids for a virus that largely seems to be asymptomatic or produce symptoms of the common cold??

    Pfizer to start testing its Covid-19 vaccine in kids as young as 12 - CNN

    A team at Cincinnati Children's Hospital will begin vaccinating teenagers aged 16 and 17 this week, and will move to enroll 12-to 15-year-olds later, said Dr. Robert Frenck, director of the Vaccine Research Center at the hospital.

    "We really think a vaccine for adolescents and children is going to be critical for getting Covid under control," Frenck told CNN in a telephone interview.
    "I think one of the things that is important to remember is that although the death rate for children with Covid is lower than in older adults, it's not zero," he said, noting that more than half a million children have been diagnosed with coronavirus in the US. "It is not a nonexistent infection in children."

    Frenck also believes more children have been infected with coronavirus than the official data show. "I think we are probably under detecting the number of kids that are infected because they are not getting sick enough to where a parent says they need to go to a doctor," he said.
    "Most of the time in kids, you have a young kid at home and they have a runny nose, they have a cough -- you are not going to bring them to a doctor," he added.
    "And most of the time, what a coronavirus causes is a cold."
     
  3. OP
    haidut

    haidut Member

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    So, you think the halting of 3 trials in the matter of a month or so, all related to COVID-19, is just a normal state of affairs? There are 4 total Phase III clinical trials for vaccines, and two of them are currently halted. Why presume nothing when the (albeit limited) evidence so far points to safety issues, which are well-known to plague viral vaccines. Namely, one of the COVID-19 vaccine trials was halted due to patients getting "transverse myelitis" - i.e. the more socially acceptable (and vague) name for polio-type diseases - known to occur exactly as a side effect of vaccines against polio, swine flu, avian flue...and now (unsurprisingly) COVID-19. The data on what percentage of new vaccines trials are halted due to safety reasons is very limited but the current estimates are in the single digit percentage points. So, while 2 out of 4 (50%) is not a big enough sample to draw conclusions, I'd personally start with that as a suggestion of lack of COVID-19 vaccine safety and modify that belief as new evidence emerges (if any).
     
  4. Kram

    Kram Member

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    No...I said the news articles make it sound inconsequential since pausing trials is fairly common. From the J&J article

    "Following our guidelines, the participant's illness is being reviewed and evaluated by the ENSEMBLE independent Data Safety Monitoring Board (DSMB) as well as our internal clinical and safety physicians," the company said in a statement. ENSEMBLE is the name of the study.
    "Adverse events -- illnesses, accidents, etc. -- even those that are serious, are an expected part of any clinical study, especially large studies."
     
  5. tankasnowgod

    tankasnowgod Member

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    There are always many pharma trials going on for many types of drugs, so in a sense, halting of clinical trials probably does happen all the type. But, those trials never get this kind of exposure.

    Remember, these companies are aiming at potentially hundreds of billions of dollars, along with zero liability. These trials, theoretically, should be the best of the best of the best. For 50% of the vaccine trials to flame out that quickly, along with another "revolutionary" treatment in the same month? Oof. It's horrid press for these drug companies, no two ways about it. The question is, will most people even notice? I'm not all that confident in the majority of people these days, either.
     
  6. GAF

    GAF Member

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    Few, if any, healthy people have actually died of covid19. How do I know? Any "news" story that serves to advance an agenda of terrorist organizations such as Big Media, Big Harma, Big Politics and the NWO is BS. BS such as children are "super spreaders" and other endless terrorist nonsense that has vomited out of the mouths of Big Hair Heads on the "News" for the last 6 months, usually accompanied by Few Hair Head Expert Scientists, blabbing up their 401(k) with their terrorist made-up excessively serious pseudoscience phoney baloney concern for the millions, maybe billions, of unscientific soon to be dehumanized schmucks who actually believe them.
     
  7. tankasnowgod

    tankasnowgod Member

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    I've seen a few where they state "This 28 year old previously healthy man died from COVID 19 in May." And then, if you read a little further, they will state "This man had finished two years of cancer treatment in 2018."

    I agree with Jon Rappoport's conclusion on this- "Previously Healthy" is simply a technical term for "Previously not dead."
     
  8. Hugh Johnson

    Hugh Johnson Member

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    There are also over seven billion people in the world. I know a guy whose brother, around 20, just dropped dead suddenly for no reason. If you reported each case like that, it would seem young people are just dropping dead for no reason all the time, and need to do something right now!
     
  9. OP
    haidut

    haidut Member

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    Not very common, actually, as I mentioned in my first response to you. At least when it comes to vaccine trials. The best estimates are in the 3%-4% range of vaccine trials get halted due to SAE. Again, the data is very hard to come by as it is quite obvious a company has absolutely no interest in having the public learn one of its trials was halted (for whatever reason) and does everything possible to keep that information private/unreleased. It is one of the few examples of truly bad publicity, in violation of Barnum's motto (i.e. there is no such thing as bad publicity).
    Halting a trial is no simple matter, regardless of how benign the CNN article tries to make it. Studies show that when the participants are told the trial is halted due to an SAE up to 50% choose to drop out. So, the company that conducts the trial has to find up to 50% new eligible patients, which takes a lot of time and money. It is not as simple, which the article makes it out to be, as simply halting the trial, everybody going on pause for a while and then resuming with the same groups and number of patients. People are (usually) free to leave and when they hear there has been an SEA a good portion of them decide to drop out.
     
  10. tankasnowgod

    tankasnowgod Member

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    As an interesting aside to this, I was finishing reading a document found a lot of places online called "The Matrix and the U.S. Constitution." Here's a Web version- The Matrix and the U.S. Constitution – Educated in Law

    It seems to have been written about 2008/09, but this is an interesting footnote. Conspiratorial, sure, but check it out-

    2) I met a man who was once employed by Military Intelligence. He is now diseased. We became close friends and over time he confided in me something that had been bothering his conscience for many, many years. During his employment in the military he happened upon a scientific report by MI, prepared for the Congress. The report detailed a plan titled “How to reduce the population of the United States.” The conclusion reached in the report was through mass vaccinations to cure a fictitious pandemic!

    NOTE: As of June 2009, a former scientist, once employed by a large pharmaceutical company in the United States has disclosed that before resigning from his employer, former President Bush signed legislation that defers and eliminates the Federal Food and Drug Administration‟s mandatory product testing; defers and eliminates disclosure of possible dangers to the public; and defers and eliminates civil liability on the part of the FDA and the pharmaceutical company.

    NOTE: This scientist revealed that the President and Congress are expected to order mass vaccinations for a fictitious swine flu pandemic in the fall of 2009 and that the vaccine to be used contains small amounts of bird guano, a substance known to cause serious illness and death, and in several tests killed the lab animals that were injected. This scientist suggested that most of the soldiers who have died in the Middle East conflict, have died from these vaccinations, but no one is talking!

    NOTE: The people who have died of “swine flu” so far died because they were vaccinated with the vaccine that is planned to be given to the American population in the fall of 2009 and half of the World‟s population. The World Health Organization is expected to declare a pandemic and will request that President Obama and Congress order mandatory vaccinations in the United States. Anyone who refuses to take the “death vaccine” will be arrested as a Terrorist and will be committed into internment camps. As a Terrorist, no one is permitted a lawyer, a hearing or a judge, pursuant to the new Patriot Act passed by Congress after 911. The World Health Organization is owned by and is under the direction of the Rockefeller and Rothschild families. Do you now see the pattern unfolding?

    ----------

    As a side note, the same document also suggests that FDR was assassinated, and the only other place I have heard that suggestion from is Ray Peat.

    Since I just happened to read this today, I saw how perfectly it lined up with everything we've been discussing about this COVID vaccine. The only issue is......... why all the focus on the failed trials in in the MSM? I can almost see the idea that someone (or some group) is trying to show people what was planned. Only issue is, most people still don't seem to be aware, or even willing to ask questions despite everything the past 6 months or so.
     
  11. Maljam

    Maljam Member

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    Thanks for posting, its insane how reliant the general public are on taking one of these vaccines in order to get things back to normal. "I can't wait to get the vaccine so I can live my life again."
     
  12. Rand56

    Rand56 Member

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  13. Regina

    Regina Member

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    I have no trouble believing that.
    Meow
     
  14. ecstatichamster

    ecstatichamster Member

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    there is no requirement that a vaccine prevents the disease it is supposed to be for. The approval depends upon supposed safety and also surrogate endpoints, usually antibodies.

    The material on vaccines in the various state and federal websites talk about vaccine "coverage" but nothing much about what it must accomplish to prevent real sickness.

    The most disturbing thing is that often vaccines can clobber T cell immunity, and this is actually far more important and is not measured in any event, making the vaccine a complete and harmful scam.

    For instance
    Suppression by Thimerosal of Ex-Vivo CD4+ T Cell Response to Influenza Vaccine and Induction of Apoptosis in Primary Memory T Cells
    Thimerosal is a preservative used widely in vaccine formulations to prevent bacterial and fungal contamination in multidose vials of vaccine. Thimerosal was included in the multidose non-adjuvanted pandemic 2009 H1N1 vaccine Panenza. In the context of the analysis of the ex-vivo T cell responses directed against influenza vaccine, we discovered the in vitro toxicity Panenza, due to its content in thimerosal. Because thimerosal may skew the immune response to vaccines, we investigated in detail the ex-vivo effects of thimerosal on the fate and functions of T cells in response to TCR ligation. We report that ex-vivo exposure of quiescent or TCR-activated primary human T cells to thimerosal induced a dose-dependent apoptotic cell death associated with depolarization of mitochondrial membrane, generation of reactive oxygen species, cytochrome c release from the mitochondria and caspase-3 activation. Moreover, exposure to non-toxic concentrations of thimerosal induced cell cycle arrest in G0/G1 phase of TCR-activated T cells, and inhibition of the release of proinflammatory cytokines such as IFN gamma, IL-1 beta, TNF alpha, IL-2, as well as the chemokine MCP1. No shift towards Th2 or Th17 cells was detected. Overall these results underline the proapoptotic effect of thimerosal on primary human lymphocytes at concentrations 100 times less to those contained in the multidose vaccine, and they reveal the inhibitory effect of this preservative on T-cell proliferation and functions at nanomolar concentrations.
     
  15. R J

    R J Member

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    I kind of feel bad for the people who want to get the vaccine.
     
  16. Regina

    Regina Member

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    Yes. It is very sad. But they do not wish to look behind the curtain.
    The people who download "fact checker" apps will not wake up.
     
  17. R J

    R J Member

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  18. Drareg

    Drareg Member

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    IF YOU GET CANCER FORM THE ANTIBODY VACCINE AT LEAST YOUR STILL ALIVE, WOULD YOU RATHER BE ON VENTILATOR AND DIE FROM COVID19? (Covid cult logic, 2020)

    The company didn’t say what happened , let’s guess, it was a "pre existing genetic condition" of the inferior human we selected.
     
  19. Homo Consumericus

    Homo Consumericus Member

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    Any chance this monoclonal antibody trial might have been sabotaged so that ongoing vaccine trials would be favoured (especially since those are not going too well)? Trump spoke positively about Regeneron. We all saw what the cabal did when he voiced support for hydroxychloroquine. Within weeks they had a fraudulent study published in the Lancet claiming a causative relationship between HCQ and heart failure in covid patients (of course this study was fairly quickly retracted, but not before every HCQ proponent in the western world had been labelled a quack).
     
  20. jay123

    jay123 Member

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    I'm sure that the Serum Institute of India, Gavi, and Bill Gates will have smooth trials if you know what I mean?
     
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