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Posts Tagged ‘vaccine safety’

Sorry Kennedy, Being Anti-Vaccine Does Not Mean You’re Pro-Safe Vaccine

February 21, 2017 2 comments

Last week, Robert F. Kennedy Jr., of the World Mercury Project, orchestrated a major publicity stunt designed to question the safety of vaccines.  Since he had no real evidence to present, and the same accusations which have been repeatedly refuted for years, he attempted to garner attention by offering journalists a glimpse at a new anti-vaccine celebrity and the promise of a $100,000 challenge. 

During an hour-long press event on Wednesday, Kennedy was joined by other vaccine critics such as ‘Vaxxed’ movie producer Del BigTree, San Antonio District Attorney Nico LaHood, Tony Muhammed of the Nation of Islam and celebrity actor, filmmaker and father of an autistic child, Robert DeNiro.

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Robert F. Kennedy, Jr. addressed a small gathering of people at last week’s  press conference.

While each had their turn to suggest there was a worldwide scientific conspiracy to lie about vaccine safety, Kennedy concluded by announcing that he would give a $100,000 award to any American journalist who could produce a study that proved that the level of thimerosal used in vaccines was deemed to be safe.

(Of course, since he failed to mention the fee required to participate in the challenge, made no reference to a scientific expert(s) who would assist in evaluating the science, and refused to accept the mountains of studies that already exist on the subject, his promise of a payout was seen by many as an elaborate publicity scam.)

On Thursday, Kennedy continued his crusade on Capitol Hill by renting out a Congressional briefing room and attempting to lure legislators with the involvement of celebrity Robert DeNiro. While staunch vaccine refusers were invigorated by these meetings, hanging on the hope that Kennedy could possibly make inroads with the current administration and put an end to vaccine injury once and for all, the reality is that hardly anyone was listening.

With about 40 people in attendance on Wednesday, and not one member of Congress showing up on Thursday, it’s safe to say that Kennedy’s message is only echoing among those who already support him.  Even DeNiro appeared to have lost interest since he was notably absent from Thursday’s event on Capitol Hill.

As expected, there have already been dozens of commentary that address Kennedy’s misinformation.  However, there is still one statement he made that I feel the need to address.

Kennedy claimed, “I’m not anti-vaccine.  I’m pro-safe vaccines.”  

It’s understandable for people to say,“Yes, I vaccinate, but I don’t feel completely certain that vaccines are safe.” Since we’re unable to guarantee that vaccines will be 100% safe, this “pro-safe vaccine” battle cry is an effective way to appeal to parents who don’t have the time, the understanding or the inclination to delve into the science that supports the widespread use of vaccines.

cf8oebjwqaa6l2nBy using this “pro-safe vaccine” label, Kennedy and others like him play into the emotional need of parents to protect their children while dangerously misleading them into thinking that vaccines are far more dangerous than the diseases they prevent.  In essence, this statement is used to help anti-vaccine crusaders turn vaccine safety into a personal and anecdotal issue, when we should all be demanding that vaccine safety be investigated and addressed with scientific objectivity.

Kennedy continues to try to discredit his critics by questioning, “Why wouldn’t anyone be agreeable to studying vaccine safety?”  He seems to suggest that anyone who isn’t “with” him in arguing that vaccines aren’t safe, is simply against safe vaccines.

This couldn’t be further from the truth.  Vaccine experts ARE agreeable to studying vaccine safety. In fact, that is largely what they do. But unlike Kennedy, they don’t rely on anecdotal evidence.  They demand scientific evidence and they go to great lengths to get it. 

If we were to go back in history, we would see plenty of examples of how our current vaccine safety protocols have successfully identified problems and taken steps to address them.  Consider the history of the rotavirus vaccine.  The vaccine was withdrawn in 1999 after scientists associated it with a rare intestinal problem called intussusception.  This would not have been identified if it weren’t for the vaccine safety monitoring systems that we currently have in place.  And what about the nasal spry flu vaccine which was pulled just prior to this flu season?  The Advisory Committee on Immunization Practices (ACIP) decided not to recommend the vaccine based on low efficacy studies, especially among children.  Again, an example of action taken by one of our current vaccine oversight committees.  There are plenty of other examples of vaccines being pulled from the market – the whole cell pertussis vaccine (DTP), Lyme vaccine, and oral polio to name a few. These instances occurred because of the vaccine safety protocols in place. Read more…

Multiple Vaccine Oversight Committees Ensure Our Public Safety

January 11, 2017 125 comments
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This guest post has been written by Dr. Dorit Reiss, Professor of Law at the University of California Hastings College of Law.  Dr. Reiss is a regular contributor to various blogs and law journals, where she utilizing her legal expertise to examine the social policies of immunization.

Regulating Vaccine Safety, by Dr. Dorit Reiss

According to yesterday’s news reports, long-time vaccine critic Robert F. Kennedy, Jr. met with President-elect Donald Trump. 

screen-shot-2017-02-15-at-8-56-35-pmFollowing their meeting Kennedy reported that an offer was made to lead a new commission on vaccine safety and scientific integrity. As one would imagine, this has caused concern for immunization advocates and elation among anti-vaccine activists. It is, at this point, unclear whether Kennedy’s statements are true, as a Trump spokesperson issued an email statement that Forbes reported as follows:

“The President-elect enjoyed his discussion with Robert Kennedy Jr. on a range of issues and appreciates his thoughts and ideas. The President-elect is exploring the possibility of forming a commission on Autism, which affects so many families; however no decisions have been made at this time. The President-elect looks forward to continuing the discussion about all aspects of Autism with many groups and individuals.”

While Trump’s intentions in meeting with Kennedy may still be unclear, this is a good opportunity for us to review the specific ways in which vaccine safety is regulated here in the U.S., and the oversight committees that monitor vaccines pre and post licensure.

To begin, it is safe to say that vaccine safety is heavily regulated in the United States, with multiple systems overseeing the vaccine enterprise.

It would be hard to hide a problem if one existed. Further scrutiny reveals that vaccines are very safe and that when problems occur, they are quickly discovered and addressed.  It is important to also note that many of the same vaccines used in the U.S. are also studied and used in other countries. Even if the U.S. apparatus was completely flawed, it would be hard to hide any dangers in this age of global communications, intra-government collaboration and oversight.

Vaccine Regulation in the United States

The U.S. is a regulatory state and vaccines are no exception. The vaccine licensing process goes through multiple stages of vaccine testing and approval, as depicted in the CDC infographic pictured at right.journey-of-child-vaccine_sm.png

However, before a vaccine can even begin the clinical trial phase in humans, a request must be submitted to the FDA in the form of an Investigational New Drug application, which requires toxicology and animal data. (For more details on this regulation, you can refer to the resource here.)

This is followed by clinical testing, which is also heavily regulated as can be seen in a review of these references here and here.

While the FDA is underfunded and understaffed, and may not have the ability to constantly monitor all trials, companies know that FDA monitoring is to be expected and they must assume their trials will be reviewed.

Furthermore, once the clinical trials are complete, there is an additional layer of review. The sponsor and FDA present the results of the clinical trials to the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC). Most members of this committee are not part of the FDA; instead the committee is comprised of consumer representatives, as well as experts in relevant fields, many of whom work in universities or hospitals.  The current roster for the Committee can be found here.  The committee is further governed by the Federal Advisory Committee Act (FACA), which requires pre-announced public meetings.

After the licensing process is complete, there are several monitoring systems in place.  Read more…

Debunking John Stone’s “DeStefano Rides Again” and the CDC “Whistleblower”

January 12, 2016 2 comments
journalsEvery Child By Two is pleased to launch another article in their Expert Commentary series with links to in-depth articles available on the Every Child By Two website.  This series features guest writer Joel A. Harrison, PhD, MPH, a retired epidemiologist who has worked in the areas of preventive medicine, infectious diseases, medical outcomes research, and evidence-based clinical practice guidelines. Dr. Harrison volunteers his time to provide in-depth and expert analysis of articles which ultimately make false claims about the safety of vaccines.  Today we will feature Dr. Harrison’s latest paper, Debunking Antivaccinationist John Stone and the CDC “Whistleblower”: A Review of John Stone’s “DeStefano Rides Again: GSK Rotavirus Vaccine Study Loses 80% Of Cases And 18 Deaths”

by Joel A. Harrison, PhD, MPH

I’ve written several articles for Every Child By Two. Each of them shows clearly the poor scholarship, deficient science, and often lack of common sense contained in articles written by antivaccinationists. The bottom line is they don’t know what they are talking about. If people are to decide on whether to vaccinate their children or not, it should be based on scholarly, well-grounded science, and reflect basic common sense, not claims made by people who are deficient in these.

John Stone is the UK editor for the online blog, Age of Autism. In a recent article, Stone writes: 

Frank DeStefano, the CDC’s Director of Immunization Safety and the lead author at the centre of CDC whistleblower William Thompson’s allegations about destroying MMR/autism data, is involved in another case of apparently hiding data, this time involving intussusception and death, in a newly published paper concerning the safety of GSK’s rotavirus vaccine, Rotarix.

Last month, Representative Posey revealed to Congress that Thompson told Dr Brian Hooker in a taped telephone conversation regarding the DeStefano MMR paper that:

Sometime soon after the meeting, we decided to exclude reporting any race effects, the co-authors scheduled a meeting to destroy documents related to the study. The remaining four coauthors all met and brought a big garbage can into the meeting room and reviewed and went through all the hard copy documents that we had thought we should discard and put them in a huge garbage can.

The new CDC based study of GSK’s Rotarix vaccine by Haber et al., of which DeStefano is senior author and therefore responsible for research integrity, admits a small association with the serious condition of intussusception (an intestinal obstruction secondary to the inversion of one portion of the intestine within another). The paper states that from February 2008 to December 2014 the Vaccine Adverse Event Reporting System (VAERS) “received 108 confirmed insusceptible reports after RV1” (Rotarix). However, a careful review of the database reveals no less than 565 cases for the period. The paper claims to have excluded only 4 reports as unconfirmed (making a total of only 112). (Stone, 2015a; reposted 2015b)

In an Addendum posted a day after the reposting of his article, Stone writes:

I took this article down for 24 hours to consider the points made by “n davis” and “n davis is correct”. I had overlooked the fact that the paper selects US cases only – that there are only a trickle of cases from the US against a relative flood from abroad – and this is basis of massive selection bias, particularly in relation to deaths. It also shows that the US reporting system while always vastly inadequate is wilting. Pharmaceutical companies are required by law to forward reports from abroad where they come to their attention: there is nothing in n davis’s claim that these reports were unavailable to DeStefano – anyone interested in the safety of the vaccine to US children or any other would have considered all of the reports. (Stone 2015c)

Summary

Read more…

Why Delay Vaccines For Your Child?

October 8, 2015 57 comments

I hear this often.  

“I plan to vaccinate, but I’m going to wait until my child is a bit older and better able to handle the vaccines.”  

And this.

“I’ll vaccinate my child.  I just prefer to space them out for my child and only do one at a time.”

Parents who choose to delay vaccines, or design their own vaccination schedule, do so because they believe it will be safer for their baby.

They typically want their children to be protected from preventable diseases, but they’re not convinced they need to follow the CDC’s recommended schedule in order to do that.

Some parents find it hard to accept that one schedule can be suitable for all children and so they feel more comfortable with a schedule that they design themselves – one which gives them the freedom to administer their children’s vaccines one at a time, or maybe even when the child is older.  Some parents make these decisions because they’re concerned that the recommended schedule somehow puts their child at risk of suffering some adverse event or reaction.  Essentially, parents who delay vaccines, or space them out, believe they’re providing a safer option for their child.

Unfortunately, the opposite can be true.

Deviating from the well-tested and recommended schedule can actually put a child at greater risk of disease, without ever reducing their risk of adverse events.  Parents often fail to see the harm in spacing out vaccines, but they also fail to acknowledge the increased risk of disease and the data that supports the safety of the recommended schedule.

How can it be safe for such a small child to receive so many vaccines at a single visit?

Some parents worry that too many vaccines administered at such a young age may overwhelming a baby’s immune system.  Some might even believe that this could lead to injury or developmental delay.  It’s understandable that parents have these fears, but a good hard look at the science indicates that there is simply no evidence to support those fears.

Vaccines are designed to facilitate a baby’s own immune system, not overload it like the diseases have been known to do.  From the moment a baby is born they grow and thrive in a largely unsterile environment. Every day a baby’s immune system is bombarded with trillions of new threats in the air they breathe, on the hard surfaces they touch, and in everything they put in their mouths.

While children today receive more immunizations than their parents did, today’s vaccines are safer and contain less antigens.  Antigens are the elements of the vaccine that contain the weakened or killed versions of the germs that cause the disease.  They are the critical part of the vaccine that stimulate the immune response.  A child who receives all the recommended vaccines based on the 2014 childhood immunization schedule may be exposed to up to 315 antigens through vaccination by the age of 2However, in 1980, that figure was as high as 3,041 antigens.  So the argument that today’s schedule is more dangerous simply because there are more vaccines is simply not supported. Read more…

Why My Kid Won’t Be Getting These New Vaccines Anytime Soon

September 11, 2015 7 comments

There’s a part of me that understands why some people are hesitant to get newly approved and recommended vaccines.

“I don’t want my child to be a pharmaceutical guinea pig.”

“The vaccine hasn’t been around long enough.  How can we really know the long-term side effects?”    

“I didn’t have half the vaccines that kids today get and I survived.  Why do we bother to give so many vaccines for diseases that aren’t even all that serious?”

These are the kind of comments I’ve heard in school, at the doctor’s office, on the playground with other parents, or posted as comments on social media. While I understand that people may be hesitant, and sometimes even fearful, of something new, I tend to address my concerns by learning more about whatever it is I’m afraid of.

Since I began contributing to this blog six years ago, I’ve tried to address some of the most popular immunization concerns I’ve heard from other parents.  In sharing what I’ve learned, It is my sincere hope that others will be better able to make informed immunization decisions based on the sound scientific evidence that I include in my posts.

However, the approval of two new vaccines (HPV9 and MenB) have actually caused me much concern and distress lately.

It’s not that I’m worried about the dangers of these new vaccines.  Quite the contrary.  

I’ve sat through enough presentations at immunization conferences and committee meetings to appreciate the extensive amount of data that is collected and analyzed by hundreds of scientists and doctors as a vaccine makes it’s way through the various phases of clinical trials.

img3I’ve become familiar with the elaborate process that leads to FDA approval, and I’ve witnessed discussions by the Advisory Committee on Immunization Practices (ACIP) when they’ve considered modifications or additions to the recommended vaccine schedule.  By the time a new vaccine is ever recommended for my child, the vaccine has already been administered to thousands of people in clinical trials and the vaccine’s efficacy and potential adverse effects have already been well documented.  In fact, many vaccines, are already being used in foreign countries for years prior to being approved here in the U.S.  This provides a considerable amount of safety and efficacy data for us to analyze prior to U.S. licensure and recommendations.

With all the available data that is scrutinized by so many experts, I’m not concerned at all about the vaccine’s safety.  What I am concerned about is how long it takes for the public to finally have access to these new vaccines after FDA approval and ACIP recommendation.

In the case of these two new vaccines (HPV9 and MenB) my personal experience has been far from ideal.  It’s been at least three months since the new ACIP recommendations and yet I’m still unable to locate a single dose of either vaccine within a 50 mile radius of my home.  To make matters worse, I’m hearing reports from parents who are getting inaccurate information about the availability of these vaccines. Read more…

Had Olmsted Been Right About Measles Vaccine, He’d Still be Wrong

May 28, 2015 1 comment

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Like many other scientists and vaccine advocates, Joel A. Harrison, PhD, MPH strongly believes that if parents are to decide whether or not they should vaccinate their children, than they should base their decisions on scholarly articles that represent well-grounded, solid science.  However, as a retired epidemiologist, Dr. Harrison is committed to helping people make these important decisions by providing in-depth and expert analysis of articles which make false claims about the safety of vaccines.

In his fourth article in the Every Child By Two Expert Commentary series, Dr. Harrison exposes Age of Autism founder, owner and chief editor, Dan Olmsted, for dangerously misinforming people.  Dr. Harrison’s latest paper, Wrong About Measles, Cancer & Autism: A Review of Dan Olmsted’s Article “Weekly Wrap: Measles, Cancer, Autoimmunity, Autism”, critiques an article by Olmsted that claims measles vaccination is tied to a higher incidence of cancer.

Olmsted wrote an article called “Weekly Wrap: Measles, Cancer, Autoimmunity, Autism” which claimed that a recent study used a measles vaccine to treat multiple myeloma. He went on to speculate that measles may have had a preventative effect on cancer and that vaccinations led to increasing rates of cancer.  He even goes as far as to claim “wild-type measles . . . performs some unsuspected function in preventing the occurrence of cancer.”

In this fourth submission to the Every Child By Two Expert Commentary series, Dr. Harrison exposes the many deficiencies in Olmsted’s article, which appears to have based on two newspaper accounts of the research.  Dr. Harrison is quick to clarify that a measles vaccine was not used in the stated study.  Instead, a genetically engineered measles virus strain was designed to specifically target cancer cells.  Olmsted thereby fails to recognize that the measles virus had been modified and not the measles vaccine, which raises question as to whether he read and/or understood the study in the first place.  What’s unsettling is that both the newspaper articles that Olmsted references in his article are clear on that detail.

It is therefore not difficult for Dr. Harrison to conclude that Olmsted starts off with an inaccurate premise about the use of a measles vaccine in treating multiple myeloma.  However, even if he had been right about the use of a vaccine, he would have still been wrong about the implications he drew from it.  Read more…

Expert Commentary – Don’t Sacrifice The Good (measles vaccine) For The Perfect

February 16, 2015 17 comments

journalsEvery Child By Two is pleased to launch the next article in their Expert Commentary series that will be permanently housed on the Every Child By Two website and referenced here on Shot of Prevention. This series features guest writer Joel A. Harrison, PhD, MPH, a retired epidemiologist who volunteers his time to provide in-depth and expert analysis of articles which ultimately make false claims about the safety of vaccines.

Today we will feature Dr. Harrison’s latest paper Don’t Sacrifice The Good For The Perfect: A Review of Cathy Jameson’s “A Strong Message About Vaccines.” which critiques a recent article by a vaccine skeptic that downplays the seriousness of measles disease and the public’s concern over the outbreak that continues to spread throughout the nation.  Cathy Jameson complains that the measles vaccine is not 100% effective and implies that the vaccine industry cannot be trusted because they benefit from profits on their products.  However, as Dr. Harrison states, “then one should not trust any product since everything sold is done so to make a profit.”

Dr. Harrison states in his introduction

“Though it’s unfortunate that the measles vaccine doesn’t perfectly protect everyone, it does protect most, preventing unnecessary suffering, hospitalizations, disabilities, and even deaths. And, if everyone were vaccinated, then the risks to those with weaker immune systems would also be significantly reduced. In other words, Don’t Sacrifice the Good for the Perfect

Click here to begin reading Dr. Harrison’s latest expert commentary.