Merck seeking emergency us authorization for molnupiravir, new COVID-19 drug

molnupiravir

Pharmaceutical giant Merck announced a new drug to treat COVID-19, called molnupiravir, which appeared to cut the risk of hospitalization and death by nearly half for at-risk patients. Furthermore, Merck will be seeking an emergency use authorization for it immediately.

Although this may sound like good news, and if you are reading the news about this drug, you’d think it was a miracle, I want to make sure that everyone understands several important factors about this drug’s safety and effectiveness profile. It is not a miracle, but it may be an important addition to the treatment protocols for COVID-19 patients, especially those at the highest risk of hospitalization or death.

This is not a worthless drug, at least for COVID-19, such as the horse dewormer, ivermectin, that has become popular with the pseudoscience crowd. Molnupiravir was designed from the beginning as an anti-viral drug.

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Did Japan ban Gardasil? No, but the anti-vaccine crowd loves the trope

Japan Banned Gardasil

One of the most popular zombie memes and tropes of the anti-vaccine movement is that Japan banned Gardasil, the HPV vaccine. And like most of those zombie memes and tropes, the facts are a lot different than the anti-vaccine claims. Shocking, I know.

Although I don’t quite understand the reasoning, the anti-vaccine world absolutely hates Gardasil, possibly more than any other vaccine other than COVID-19 vaccines (of course). These zealots maintain that the HPV vaccines cause all kinds of harm to teens and young adults. Yet, there are literally mountains of data derived from numerous huge epidemiological studies that the Gardasil cancer-preventing vaccine is one of the safest vaccines on the market.

So if you really want to prevent cancer, one of the best ways available to you is getting the HPV vaccine. The idea is so simple, yet is clouded by the myths about HPV vaccines – one of the most popular, of course, is that Japan banned Gardasil. Let’s examine this fable with a critical and skeptical eye.

Spoiler alert – Japan did no such thing.

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Diane Harper, star of anti-vaccine memes, supports HPV vaccines

Diane Harper

If you have any interest in HPV vaccines, you’ve probably heard about Diane Harper, who the anti-vaccine religion claims was a “lead Gardasil researcher” who came out against the vaccine. Many of us were never convinced that she was really anti-vaccine, although she seemed to have vacillating views on the HPV vaccine depending on a variety of random factors, including who was feting her at any particular point in time.

Dr. Harper was a frustrating character in the conversations about the HPV vaccine. Although some (but certainly not all) of her comments about the vaccine could be construed as an anti-HPV vaccine, her publications, and many other public comments, seemed to clearly show that she was a supporter of the vaccine.

A few writers in the scientific skeptic blogosphere have contacted her, either in person or through interviews, and most have come away with the impression that she was solidly in support of the vaccine. However, and I have no evidence of this whatsoever, she always seemed to be biased against Gardasil, manufactured by Merck, so maybe she had some personal vendetta. We will probably never know, I suppose.

But a recent announcement should put an end to the Diane Harper anti-Gardasil meme – well I’m more cynical than that, I know the vaccine denier mob will keep bringing it back like a zombie. So, let’s take a look at Dr. Harper and her announcement. No one should be surprised.

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HPV vaccine myth debunking – all the science facts fit to print

I’ve written nearly 200 articles on the HPV vaccine, debunking one myth after another. Despite the new COVID-19 vaccines being a recent target of various anti-vaccine myths and tropes, it has nothing on the FUD disinformation propaganda pushed against the HPV vaccine.

Like I did with the COVID-19 vaccines, I wanted to create easy-to-use charts for those of you who need a quick reference to debunk the nonsense out there.

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Vaccine profits from Big Pharma – let’s take a closer look at this trope

vaccine profits

The old myth of the huge Big Pharma vaccine profits – it’s the subject of so many memes, tropes, and outright lies from the anti-vaccine activists. These vaccine deniers, who not only lack knowledge of science but also of basic corporate finance, believe that every Big Pharma CEO relies on vaccines for their next bonus check, which they use to buy their new Ferrari to show off to imaginary vaccine-injured children.

I am not naive – public corporations have an obligation to their shareholders and employees to maximize profits. That’s capitalism, I suppose.

But where this trope goes off the rails is when you realize that vaccine profits would be eclipsed by medical industry profits if Big Pharma simply stopped producing vaccines – mass epidemics would mean that hospitals would be filled with patients, just look at the COVID-19 pandemic. It’s ironic that the anti-vaxxers claim that Big Pharma’s greed gives us vaccines, but if they were truly greedy they’d be out of the vaccine business.

This article is not going to be as much science as I usually do – it’s going to focus on finance and accounting. Yes, I’m a finance and accounting geek as much as I am a science aficionado. 

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Dorit Rubinstein Reiss – an index of her vaccine articles on this website

Dorit Rubinstein Reiss

Dorit Rubinstein Reiss – Professor of Law at the University of California Hastings College of the Law (San Francisco, CA) – is a frequent contributor to this and many other blogs, providing in-depth, and intellectually stimulating, articles about vaccines (generally, but sometimes moving to other areas of medicine), social policy and the law. Her articles usually unwind the complexities of legal issues with vaccinations and legal policies, such as mandatory vaccination and exemptions, with facts and citations.

Professor Reiss writes extensively in law journals about the social and legal policies of vaccination–she really is a well-published expert in this area of vaccine policy, and doesn’t stand on the pulpit with a veneer of Argument from Authority, but is actually an authority. 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 disease.

She was also one of the many contributors to the book, “Pseudoscience – The Conspiracy Against Science.”

Many bloggers and commenters on vaccine issues will link to one or more of her articles here as a primary source to counter an anti-vaccine claim. The purpose of this post is to give you a quick reference to find the right article to answer a question you might have.

Below is a list of articles that Dorit Rubinstein Reiss has written for this blog, organized into some arbitrary and somewhat broad categories for easy reference. This article will be updated as new articles from Professor Reiss are published here. We also may update and add categories as necessary.

Because she has written over 160 articles for this website, there is a vast amount of information about vaccines and the law, I have created a search engine that allows you to quickly find a specific article written by Professor Reiss on this website by using any keywords that you want. This should help speed up your search for just the right article that she has written.


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National Vaccine Injury Compensation Program facts

national vaccine injury compensation program

This article about the National Vaccine Injury Compensation Program 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 the social and legal policies of vaccination. 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 disease.

In this post I explain how one goes about proving a case in the  National Vaccine Injury Compensation Program (NVICP), and how that differs from proving a case in the civil courts, focusing on what it means to have a no-fault program and proving causation.

I will use a case that started with the tragic death of a young child after a vaccine to illustrate the complexity and operation of the program, and also to address the idea of federal preemption, and how it limits the ability of those claiming vaccine injuries to use state courts for their claims.

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COVID19 vaccine clinical trials – over 30 candidates being tested on humans

COVID19 vaccine

This article about COVID19 vaccine trials will be regularly updated as new clinical trials are registered or early results are published about an ongoing trial. Again, this article will focus on COVID19 vaccine trials – treatments and diagnostic tests are outside of the scope of this article.

Keeping up with COVID19 vaccine candidates has gotten out of hand, so for brevity, I’ve created a separate list of coronavirus vaccine trials. The interest in clinical trials for a new COVID19 vaccine is unprecedented, so I thought this might be the best way to keep loyal readers up-to-date.

Recently, the World Health Organization (WHO) has listed over 140 COVID19 vaccine candidates, which is amazing, but it is way too difficult to tell which ones have any chance of actually becoming a real product.

Right now, there are at least 30 COVID19 vaccine candidates in clinical trials – this article will analyze these coronavirus vaccine trials. Every single day, a new COVID19 vaccine candidate enters clinical trials, so this may be out of date within a few hours! 

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Dr. Diane Harper, lead Gardasil scientist’s actual HPV vaccine research

Diane Harper

Anti-vaxxers love their false authorities, such as the infamous Tetyana Obukhanych. They also love to invoke Dr. Diane Harper as the authority of choice with regard to HPV vaccines. Obukhanych is truly a false authority, but Dr. Harper is much more complicated.

Because vaccine deniers lack any scientific evidence supporting their unfounded beliefs about vaccines, they tend to rely upon unscientific information like anecdotes, logical fallacies, misinterpretation of data, or false authorities to support their case about the lack of safety of vaccines.

The so-called “lead Gardasil researcher,” Dr. Diane Harper, a former “consultant” to Merck and GSK, had some responsibilities in the clinical trials for their HPV vaccines. But the claims about whether Dr. Harper supports or dislikes those vaccines are substantially more complicated than what the anti-vaccine zealots would like to claim about her.

Amusingly, every few months the social media haunts of the anti-vaccine crowd explode with claims that Dr. Diane Harper, lead Gardasil researcher, hates HPV vaccines.

Let’s take a look at the story and see what we find.

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Merck whistleblowers – mumps vaccine lawsuit motions and updates

merck whistleblowers

This article about the so-called Merck whistleblowers 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 the social and legal policies of vaccination. 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 disease. She is also a member of the Vaccines Working Group on Ethics and Policy.

In August 2010 Stephen A. Krahling and Joan A. Wlochowski (“the relators”), former Merck virologists and often called “Merck whistleblowers,” filed suit in the name of the United States – a so-called qui tam action, where the prosecution shares any fines or penalties with the two virologists  – against Merck.

They claimed that by faking effectiveness testing, Merck misled the United States government as to the effectiveness of the mumps component of its  MMRII vaccine (a vaccine that protects individuals against mumps, measles, and rubella). In 2012  a clinic and two MDs filed a class action against Merck claiming a violation of the Sherman Act – monopolistic, anti-competitive behavior resulting from the fraud – and violation of various state laws. (U.S. v. Merck and Chatom v. Merck). The suits were handled together.

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