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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Gardasil facts – debunking myths about HPV vaccine safety and efficacy

Gardasil safety and efficacy

The HPV cancer-preventing vaccine, especially Gardasil (or Silgard, depending on market), has been targeted by the anti-vaccine religion more than just about any other vaccine being used these days. So many people tell me that they give their children all the vaccines, but refuse to give them the HPV vaccine based on rumor and innuendo on the internet. This article provides all the posts I’ve written about Gardasil’s safety and efficacy.

As many regular readers know, I focus on just a few topics in medicine, with my two favorites being vaccines and cancer – of course, the Gardasil cancer-preventing vaccine combines my two favorite topics. Here’s one thing that has become clear to me – there are no magical cancer prevention schemes. You are not going to prevent any of the 200 different cancers by drinking a banana-kale-quinoa smoothie every day. The best ways to prevent cancer are to quit smoking, stay out of the sun, keep active and thin, get your cancer-preventing vaccines, and following just a few more recommendations.

The benefits of the vaccine are often overlooked as a result of two possible factors – first, there’s a disconnect between personal activities today and cancer that could be diagnosed 20-30 years from now; and second, people think that there are significant dangers from the vaccine which are promulgated by the anti-vaccine religion.

It’s frustrating and difficult to explain Gardasil’s safety and efficacy as a result of the myths about the safety and long-term efficacy of the vaccine. That’s why I have written nearly 200 articles about Gardasil safety and efficacy, along with debunking some ridiculous myths about the cancer-preventing vaccine. This article serves to be a quick source with links to most of those 200 articles.

And if you read nothing else in this review of Gardasil, read the section entitled “Gardasil safety and effectiveness – a quick primer” – that will link you to two quick to read articles that summarize the best evidence in support of the vaccine’s safety and effectiveness.

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BCG vaccine is priced too low – now, shortage for bladder cancer

bcg vaccine

You probably don’t know much about the BCG vaccine, because it isn’t used much these days. And no, it’s not one of the vaccines on the CDC immunization schedule for either adults or children. 

The Bacillus Calmette-Guerin vaccine, or BCG vaccine, was initially developed to prevent tuberculosis. The disease is caused by bacteria called Mycobacterium tuberculosis. The bacteria usually attack the lungs, but they can also damage other parts of the body. Tuberculosis is treatable with advanced medicines, but it takes a long time and can be expensive. Without treatment, the patient will die.

So, why does it matter that the BCG vaccine is priced too low or that we have a shortage of it? Well, it has a couple of important uses (one current, and one potential) that has driven demand for the vaccine. And it’s not because there’s a sudden worldwide epidemic of tuberculosis. Continue reading “BCG vaccine is priced too low – now, shortage for bladder cancer”

Vaxxed producer Del Bigtree – not credible on vaccines

vaxxed del bigtree

Over the past few months, Vaxxed producer Del Bigtree, who formerly worked on the show The Doctors, has made numerous statements about vaccines and vaccine safety. His claims about fraud by the CDC have been addressed in the past, and the evidence doesn’t support his beliefs. But the claims he makes about vaccines go beyond the movie, and he makes an effort to present himself as an authority on the issue.

Mr. Bigtree’s statements are consistently inaccurate, suggesting he is not a good source of information about vaccines. It’s impossible to address every single wrong claim Mr. Bigtree has made about vaccines, of course. But these problems should demonstrate that Mr. Bigtree’s claims about vaccines cannot be relied on. Continue reading “Vaxxed producer Del Bigtree – not credible on vaccines”

New hexavalent vaccine protects children against 6 diseases

hexavalent vaccine

On 26 December 2018, Sanofi and Merck jointly announced (pdf) FDA approval for a new hexavalent vaccine called Vaxelis. The new vaccine was developed to vaccinate children aged 6 weeks to 4 years old to protect them against diphtheria, tetanus, pertussis (whooping cough), polio, hepatitis B, and Haemophilus influenzae type B (also known as Hib). Sanofi and Merck stated that the companies are setting up production, and the vaccine should be available in the USA by 2020.

This new (for the USA) hexavalent vaccine is intended for intramuscular injection as a 3-dose series given at 2, 4, and 6 months of age. However, the initial dose may be given to infants as early as 6 weeks. The vaccine may be used to complete the hepatitis B immunization series. However, one additional dose of a pertussis-containing vaccine must be added to the 3-dose hexavalent vaccine schedule to complete the immunization against pertussis.

This vaccine will reduce the number of separate vaccinations from at least 4 down to 1. Reducing the number of times an infant needs to receive a shot is a benefit to the child, the parents, and the healthcare workers who perform the vaccinations.

Sanofi, Merck, and GSK have produced various formulations of this hexavalent vaccine outside of the USA since 2000. Merck and Sanofi submitted the application for this vaccine to the FDA in 2014 after completion of phase III clinical trials, which included over 1400 infants. The clinical trial showed that the new vaccine was equivalent, in terms of safety and effectiveness, to the older series of individual vaccines.

As discussed previously, spurious claims that hexavalent vaccines lack antigens and other nonsense have been debunked.

I am not sure why this vaccine took nearly two decades to reach the US market, but I’m sure someone in the anti-vaccine religion will invent some ridiculous conspiracy theory to say why. Nevertheless, this hexavalent vaccine is a very important addition to the list of vaccines available in the USA.

In spite of the FDA approval, the CDC’s Advisory Committee on Immunization Practices will need to review all of the data again before making a recommendation to change the US vaccination schedule. That will probably happen during the next couple of years.

This new hexavalent vaccine is a great benefit to preventing diseases that harm our children. I’m glad it’s coming to the USA.

Citations

Another study supports the Gardasil long-term safety

Gardasil long-term safety

I’ve written more than almost 200 articles about the safety and effectiveness of various versions of the HPV vaccine. As a result, I have focused a lot of those 200 articles on Gardasil long-term safety.

There have been huge studies, one that includes over 200,000 patients and another that includes over 1 million patients, that have provided solid and nearly incontrovertible evidence that support the Gardasil long-term safety – nevertheless, the anti-vaccine tropes and memes about the HPV cancer-preventing vaccine persist.

Though it is frustrating that some researchers publish “evidence” from small studies that are poorly designed in an attempt to invent issues with HPV vaccines if you look at the best designed unbiased studies, the facts are clear–Gardasil is safe and effective. It could be one of the safest and most effective vaccines since it was developed and studied in the era of harsh, and mostly unfounded, criticisms of vaccines by certain antivaccine activists.

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