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cure type 1 diabetes

Big Pharma is NOT hiding the cure to type 1 diabetes

Here is another conspiracy or myth that I need to debunk — some corners of the internet claim that Big Pharma is hiding the cure for type 1 diabetes. Trust me on this, they’re not.

I know it’s hard to believe this considering all the news about the high price of insulin in the USA, but finding a cure for type 1 diabetes is difficult, and it might be impossible. Big Pharma isn’t hiding the cure, it doesn’t have one. No one does, it doesn’t exist.

This article will discuss type 1 diabetes and why it’s so difficult to find this elusive cure. It’s a complex disease, which I bet most don’t quite understand unless they have the disease.

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vaccines COVID strokes

The bivalent COVID vaccines are not linked to strokes

The anti-vaccine world has jumped on some safety signals that seem to indicate that the bivalent COVID vaccines are linked to strokes. This group has shown how it misuses preliminary data to try to make false claims about every vaccine, especially the COVID-19 vaccines. This leads to false claims about these vaccines.

This post is going to examine what was found on VAERS, what is a safety signal, and what the FDA and CDC did to determine that there was no link between the bivalent COVID-19 vaccines and stroke. Even though this link has been dismissed, you just know that the anti-vaccine world will push it for the next few months.

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clinical trials drug development

Clinical trials success rates — it’s tougher than you think

There seems to be a myth, often promoted by your favorite anti-vaxxers, that once a drug enters clinical trials, the FDA approves almost anything. They want you to believe that the pharmaceutical companies are in the pockets of the FDA. If they are, Big Pharma ought to change its policies, because the vast majority of drugs that enter clinical trials don’t get approved.

This article will discuss the drug development process plus the success rate of drugs that enter phase 1 clinical trials. You can use it to debunk those claims that somehow a new vaccine or drug got a straight shot to FDA approval without any oversight.

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flu COVID-19 mRNA vaccine

Combination flu and COVID mRNA vaccine starting clinical trials

Pfizer and BioNTech have announced the start of a phase 1 clinical trial for a new mRNA vaccine that prevents both the flu and COVID-19. The new vaccine targets these two severe respiratory diseases with one jab.

Although during the past three years we have focused on the COVID-19 pandemic, the seasonal flu is also a dangerous disease. During the 2019-2020 flu season, the last one before COVID-19 mitigation efforts reduced the risk of flu, 390,000 Americans were hospitalized from the flu. And over 25,000 died.

So, a new mRNA vaccine (with all of its advantages to tailor the vaccine to the key antigens on the virus) that combines both flu and COVID-19 can be an effective weapon against these two diseases. In a couple of years, if all goes well, we will be able to get a season flu-COVID-19 mRNA vaccine that has been manufactured for the season’s prevalent variants of both diseases.

Let’s take a look at what we know about this new vaccine and the phase 1 clinical trial.

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respiratory syncytial virus

Respiratory syncytial virus, flu, and COVID-19 — the “tripledemic”

I rarely write about the respiratory syncytial virus (RSV), but the number of people infected by the virus, especially children, is leading to a fear of a tripledemic that includes RSV, the seasonal flu, and our constant nemesis, COVID-19. I guess this is the time I start writing more about the respiratory syncytial virus because everyone needs to be aware of this infectious disease.

This post will review what respiratory syncytial virus is, why it is so dangerous to children and seniors, and whether a vaccine is available.

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XBB variant

New XBB variant of COVID-19 — bivalent booster vaccine works

Here we go with a new, kind of scary version of COVID-19 — the XBB variant, which is just one of several variants that are spreading across the world. I think we’ve heard and read about so many variants over the past two and a half years that it might appear to be background noise.

But the new XBB variant probably shouldn’t be ignored — it spreads faster and seems to evade the immune system. These two issues alone can become problematic as we enter the winter months.

This article will look at this variant (though I’m just picking on one out of dozens that appear to be circulating) because XBB seems to be a bit more virulent than others. But there’s good news too — the new bivalent COVID-19 vaccine boosters from Pfizer and Moderna appear to protect against the new variant.

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Oxford malaria vaccine

New Oxford malaria vaccine shows strong safety and effectiveness

Although it may seem like all we talk about are the COVID-19 vaccines, there is a new malaria vaccine developed by Oxford University that has shown a strong effectiveness and safety profile in phase 1/2b clinical trials. Control of malaria has been a goal of scientists for a long time, a potential malaria vaccine is something that should be celebrated widely.

If all goes well, the Oxford malaria vaccine could be approved by late 2023, saving children in many parts of the world from this scourge.

A new paper has been published that provides details of the clinical trial, which I will review below.

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VAERS facts

VAERS facts — contradicting anti-vaccine claims and beliefs

This article about VAERS facts, literally a FAQ, was written by Dorit Rubinstein Reiss, Professor of Law at the University of California Hastings College of the Law (San Francisco, CA), who is a frequent contributor to this and many other blogs, providing in-depth, and intellectually stimulating, articles about vaccines, medical issues, social policy, and the law.

Professor Reiss writes extensively in law journals about vaccination’s social and legal policies. Additionally, Reiss is also a member of the Parent Advisory Board of Voices for Vaccines, a parent-led organization that supports and advocates for on-time vaccination and the reduction of vaccine-preventable diseases. She is also a member of the Vaccines Working Group on Ethics and Policy.

Some of the new generation of anti-vaccine activists appear to have built their careers on misrepresentation of VAERS. One example is Dr. Jessica Rose, who apparently started her career as a legitimate young scientist, but at some point became a devoted anti-vaccine activist. Dr. Rose’s background is described by Orac thus:

Her background is more in the sort of computational biology that looks at protein structures and bioinformatics related to DNA sequences than it is to the sort of mathematical and statistical skill set necessary to delve into VAERS with any credibility. A perusal of her curriculum vitae, which is included on the profile, confirms my assessment, particularly her publication record, which includes a lot of molecular biology and virology, but nothing in the way of epidemiology.

In 2021, Dr. Rose joined the anti-vaccine organization IPAK as a research fellow, and she has published several papers in IPAK’s own publication, named Science, Public Health Policy, and the Law, whose editorial board is comprised of leading anti-vaccine activists.

Dr. Rose’s specialty appears to be doing bad analyses of VAERS and claiming, based on them, that COVID-19 vaccines are dangerous.

On August 9, 2022, Dr. Rose published a “Question and Answer” “facts” about VAERS, titled “A question and answer document on the subject of VAERS as a pharmacovigilance tool”. It is highly misleading. But it gave me an opportunity to provide information based on actual facts about VAERS.

If you want to see how it’s misleading, jump ahead to question 3 (and I hope you then go back and read the long discussion in questions 1 and 2).

I will repeat each question, answer it, shortly summarize Dr. Rose’s claims, and explain why they are misleading. Note that this discussion is limited to the mRNA vaccines and the J&J vaccine, which are the ones used in the United States and subject to reporting to VAERS – Novavax is newer and is not the subject of most of the misinformation from the anti-vaccine activists misleading people about VAERS. 

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Pfizer lyme disease vaccine

Pfizer-Valneva Lyme disease vaccine to start phase 3 clinical trials

We have some good news today, the Valneva Lyme disease vaccine, which will be distributed by Pfizer, is going to commence phase 3 clinical trials in the USA and Europe. For those of you who live in areas where Lyme disease is endemic, I’m sure you can’t wait.

This article will quickly review Lyme disease, the new vaccine, and how you might be able to volunteer for the clinical trials. Yes, you might be able to volunteer for the phase 3 clinical trials.

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pexels-photo-5878514.jpeg

Brook Jackson False Claims lawsuit against Ventavia COVID-19 vaccine clinical trial

This article about the Brook Jackson lawsuit claiming false payment claims for the Pfizer COVID-19 vaccine was written by Dorit Rubinstein Reiss, Professor of Law at the University of California Hastings College of the Law (San Francisco, CA), who is a frequent contributor to this and many other blogs, providing in-depth, and intellectually stimulating, articles about vaccines, medical issues, social policy, and the law.

Professor Reiss writes extensively in law journals about vaccination’s social and legal policies. Additionally, Reiss is also a member of the Parent Advisory Board of Voices for Vaccines, a parent-led organization that supports and advocates for on-time vaccination and the reduction of vaccine-preventable diseases. She is also a member of the Vaccines Working Group on Ethics and Policy.

Brook Jackson worked as an operator of three of Pfizer’s COVID-19 vaccine clinical trials sites for 18 days. Based on what she saw, she brought suit against the operator – Ventavia, the company that hired clinical trials site operators, ICON PLC., and Pfizer in the name of the United States under the False Claims Act. Jackson’s lawsuit claims, if true, may show that Ventavia had many issues in running the trial.

But they do not show fraud in relation to claims of payment from the federal government, which is the heart of a False Claims claim, and that alone should probably lead to her lawsuit being dismissed. The False Claims Act is not a catch-all tool for violation of FDA regulations. 

Again, even if true, they do not show a problem with Pfizer’s vaccine, a vaccine for which there is now extensive independent data on safety and effectiveness. 

Read More »Brook Jackson False Claims lawsuit against Ventavia COVID-19 vaccine clinical trial