August 11, 2013

Vaccine Trials Course at Johns Hopkins University, Institute of Higher Brain Washing. I Mean... Learning.

So biomed mom Shannon Strayhorn took a class on from my alma mater, Johns Hopkins University, on vaccine trials.  She offers us a little insight into the brain washing that is taking place inside the halls of "higher learning."

So I took a class this summer from Johns Hopkins on VAX trials.  The class was "Vaccine Trials: Methods and Best Practice".  I started taking as many vaccine/health/eviro health classes as possible because I think we need to approach the subject from every imaginable way. Knowing what is being taught and what kind of conversations are bring had is important to being able to provide truth in a public way. Of course every time I said something they would say it has to be backed up with science (I had all the links on there).

They would not read them. Then they would respond that they needed to be peer reviewed medical/science papers (they were if they bothered to read). Then without reading they would repeat again that there is no science.

I would bang my head and once again share all the links (pages of them). Then I would get "well millions of them couldn't possibly be wrong" (Ha!).
In response of course I asked them to read the science and feel free to counter it with their own to prove me wrong (none could or did-not one paper). So then they would give me their resumes...blablabla...I have a PhD, I work in the industry, etc.

So of course I shut up...NOT!

I kindly said while I am soooooo impressed with their degrees and careers that I find it scary that someone so educated could in fact get to that point considering they couldn't even be bothered to read the science, and couldn't counter one little mom like myself. I asked if it was necessary to post my resume too? I was told we are just parents who are so clueless and don't understand what the difference is between causation and correlation, that the discussion was going to be stopped because it was off topic, and that it wasn't necessary to counter what I shared because the science was in and definite. Definitely in.

Bahahaha....oh it is in....but it is clearly not showing what they want!

It was completely out of their typical playbook:

1. Deny science.
2. Pretend parents are dumb.
3. Make it all about Wakefield and say things he never said.
4. Pretend no other science exists.
5. Use your PhD to convince people they must believe you because you are smarter.
6. When panicked reference their idol Offit.
7. Deny any corruption or financial ties unless you need to defend why you think Wakefield was wrong in which case that is allowed.
8. Claim correlation and say how you understand the stupid parents are desperate and how bad you feel for not having answers and in same breathe say they must not understand science.
9. Deny any and all proof that pharma has a history of lies and corruption and if someone points that way redirect and say how awesome of a job you do taking safety as the priority.
10. Pretend you have no idea who Thorsen is or if pressed claim it doesn't matter.
11. Use terms like "studies in other countries" (because people won't know) or say crap like "mercury has been removed" (use MMR because you think that is what we want to hear) or if all else fails talk about antigens.
12. Blame parents.
13. Accuse parents of following newspapers, and celebrities.
14. Repeat there is no science.
15. Repeat your degree.

Oh and i totally fell for that too....because you know I am just another desperate, uneducated, Mom, who clearly knows nothing. Bring it on!!

Just for the record I will say that the discussion is mostly driven by those enrolled and the instructors mainly just redirected and said these subjects where off topic although we did get into it over the idea that the science is "in". The peers if you will, carried the wonderful condescending comments. The class itself was not very controversial and really about just what "should be done and how in trials" and other than the discussions and a few things I personally didn't agree with, it was not a bad class and actually refreshing seeing a different side (by the books without corruption-the way things should be!

P.S. Ended with a 98% in the class.  No clue how that is possible when I am so dumb.

 Seems they just wander around campus repeating, "There is no science. There is no science. There is no science."  Sorry to break it to ya... but there is more than just a little bit of science.

No wonder it is getting so easy for us to do this work.  They just get more and more absurd.

Course info:


Vaccine Trials: Methods and Best Practices
Karen R. Charron, BSN, MPH, CCRC
Associate Lecturer
Center for Immunization Research

Amber Bickford Cox, MPH, CCRC
Research Associate
Center for Immunization Research
This course will explore the process of evaluating investigational vaccines in clinical trials including informed consent, recruitment, enrollment, safety evaluation, and quality data collection.
About the Course
Vaccines are evaluated through a series of clearly defined controlled studies to assess these investigational products for safety, immunogenicity and efficacy before they are approved for licensure.  All clinical vaccine trials are bound by international ethical guidelines and, in the case of US trials, Food and Drug Administration (FDA) regulations.
Good Clinical Practice is defined by the International Conferences on Harmonization (ICH) as: “A standard for the design, conduct, performance, monitoring, auditing, recording, analysis, and reporting of clinical trials that provides assurance that the data and reported results are credible and accurate, and that the rights, integrity and confidentiality of trial subjects are protected.”
That’s a tall order, so how is it done?  Individuals who enroll as subjects in these trials play an essential role in the development and evaluation of new and improved candidate vaccines.  They are average citizens who volunteer to roll up their sleeves and, in the process, make a tremendous difference in society.  So why do they volunteer and what safeguards do we put in place to protect their rights, safety and well-being while in the trial?  What are the responsibilities of the investigators, sponsors and ethics committees who conduct and oversee these trials? 
Along with our colleagues, we will introduce you to how GCP is applied in clinical vaccine trials to ensure proper and ethical scientific conduct. The course will use examples from real vaccine trials to demonstrate the application of the FDA Code of Federal Regulations and ICH GCP Guidelines to explore methods and best practices involved in implementing phase I and II vaccine clinical trials.  This short course offering through Coursera is based on our work at the Center for Immunization Research and an in-depth graduate course taught at the Johns Hopkins Bloomberg School of Public Health.
We hope it inspires you to work in this exciting field.
Course Syllabus
This course will cover the following topics: A brief review of vaccine history and types; how vaccine trials are conducted, including which data are collected and how those data are managed and evaluated; appropriate processes to ensure human subjects protection and informed consent; methods for recruitment and enrollment of participants; and vaccine safety assessment. Upon successfully completing this course, students will be able to:
Describe the types of vaccines in use today
Describe how vaccines are evaluated in phase I and II clinical trials
Identify key regulatory requirements, considerations and ethical standards for human subjects protection and informed consent. 
Discuss how clinical trials are conducted with an emphasis on quality data and protection of the rights, safety and well-being of volunteers.
Recommended Background
The pre-requisite for this class is a basic understanding of vaccines.  For those without this background, the CDC Epidemiology and Prevention of Vaccine-Preventable Diseases (Pink book) is an available resource providing information on routinely used vaccines and the diseases they prevent! http://www.cdc.gov/vaccines/pubs/pinkbook/index.html.
A course on Vaccines is also taught by Paul Offit through Coursera which may be helpful to those enrolling in this course but is not required. 
Course Format
The course will involve weekly lectures followed by a short assessment assignment.
FAQ
Who should enroll in this course?
The audience for this class includes: Those currently working in clinical trials, pre-clinical development, regulatory and ethical review of research and students of public health, medicine, nursing, and biological sciences
Do I need a textbook for this course?
All the material needed for this course can be found on the web or within the lectures. The course will reference the US Code of Federal Regulations 21 CFR 50, 56 and 312 and the ICH Standards of Good Clinical Practice E6. You can also find electronic versions on the web. USFDA and ICH GCP E6. For those with strong interest in this field, we recommend that you purchase a printed GCP reference book at www.clinicalresearchresources.com.
Syllabus
Course Schedule
- Week 1
Course Overview (Karen Charron and Amber Cox)
Lecture 1: Type of Vaccines, How Vaccines are Administered, and the Vaccine Development Process (Neal Halsey)
Lecture 2: Essential Elements of a Vaccine Protocol (Karen Charron)
- Week 2
Lecture 3: Characteristics and Outcomes of Vaccine Trials (Clayton Harro)
Lecture 4: Protection of Human Subjects (Amber Cox)
- Week 3
Lecture 5: Vaccine Trials in Pediatric Populations (Elizabeth Schappell)
Lecture 6: Vaccine Management and Preparation (Hye Kim and Vivian Rexroad)
- Week 4
Lecture 7: Data Management, Quality Assurance, and Quality Control (Karen Charron)
- Week 5
Lecture 8: Community Involvement and Recruitment (James Williams)
Lecture 9: Study Start-Up and Implementation (Karen Charron)
- Week 6
Lecture 10: Screening Volunteers (Karen Charron)
Lecture 11: Enrollment and Implementation Procedures (Karen Charron)
- Week 7
Lecture 12: Safety Assessments and Management of Adverse Events (Anna Durbin)

10 comments:

Casey Erica Banks said...

I would like you to send me the 'evidence' in the form of scientific papers you offered that were refused. Please be aware that because a publisher claims that a publication is peer reviewed does not actually mean that it meets the strict academic criteria for peer review. Indeed there are many publications that claim such and merely get other people they know with qualifications and an interest in the area to act as peer review members - it goes way beyond that. That is editorial board; but many of the publishers do not understand the difference and claim it is peer review. Thanks

provaxquacks said...

Ginger, this will be my last comment tonight, because I know you've probably had it with that nut-job. I just wanted to give you a link that I hope will help you permanently ban people like that.

http://www.mybloggerlab.com/2012/06/how-to-block-ip-address-on-blogspot.html

Good night, Ginger, and thank you.

Artie Christou said...

First Amendment, Taylor! I'll keep adding this until you leave it and I have oodles of patience and time - and excellent timing! And if I am to be banned, ban Gambolpotty and Provax as well because they have been just as bad! Ban them, and I'll shut up.

Gambolpotty, you are the child here. You are a coward and an idiot and won't defend yourself from rightful challenges. That is a perfect example of a lack of rationality. This isn't about seeking attention for me. This is about proper scrutiny, which you are running away from as fast as you can! That's why I'm harassing you or rather reading you the riot act, because you deserve it little boy/girl. You wouldn't let an unruly child behave the way you have would you? Would you? It's your mental health that's in question here! You're the one who needs help, not me.

Provaxquack, that is not rational no matter which way you slice it! AND it IS running away. Look out Usain Bolt! I'm not harassing Taylor with my comments. I'm reading the riot act to Gambolpotty! You'd ignore a child? What a shithouse parent you'd make! A ranting child should be shut up and both of you are ranting children!

Seeking out a person's name for a lawful reason is not stalking. Yeah by the book it's legal to have an unvaccinated kid but that doesn't make it right!

Ginger Taylor said...

Artie... do you know what the first amendment is? It means that Congress cannot make a law abridging your freedom of speech.

It does not mean that I have to let you in my house and listen to what you say. There is a whole internet out there for you and lots of places that will tolerate you inappropriate behavior.

Fly Artie... be free.

provaxquacks said...

Sorry, one more...

http://www.chethstudios.net/2009/08/how-to-block-users-from-visiting-your.html

Good night.

Artie Christou said...

You WILL listen to what I have to say, Taylor, because you are a dangerous little witch who needs to be told! YOU are the inappropriate one and you admitted it to Wacka as well! I saw you! You going back on that now? You're a coward as well!

The First Amendment has plenty of private precedents. This isn't your house. It's Blogger's! I'm not flying until you start listening - or ban those other two jackasses like I said!

Ginger Taylor said...

Mr. Christou,

You are so far over the line that your behavior is now threatening me.

Do not write to me again.

Any future contact with me or on this blog will be considered harassment.

Artie Christou said...

So ban those other two. Show some integrity!

provaxquacks said...

Ginger,

If the two suggestions I gave you above do not work, there is a third alternative. It may not be ideal, but it will certainly remove the problem from your site.

You can always turn on moderation. That way, any time he posts, you can catch the comment before it shows up on your site. You can move it to a spam folder, or even create a folder so that you can maintain a living document of his harassing behavior for when you decide to take legal action. Take screenshots of the current comments that he has left, then delete them, if you want.

Since you are the owner of this blog, and since you have established that his comments are unwelcome and are crossing a line, showing dangerous and obsessive behavior that you feel is a threat to you and your family, you can legally press charges. Find out the cyber-harassment laws in your state and the state that the fool is commenting from and talk to a lawyer. His repeated and angry, hate-filled rhetoric shows that this individual is seriously unstable, and I feel he may do something dangerous.

I find it interesting, though, that Wacka hasn't chimed in. Curious.

Gambolputty said...

Ah, I was wondering what happened. It would appear as if the child just migrated his hate and immaturity over here.

He must truly be a sad, hateful person to hinge his life on someone responding to his inanity. A "rightful challenge?" This is an internet blog site, not a scientific journal. Why would I respond to such a childish and hateful individual? Doing so would be irrational. It is treating someone as the inconsequential child that he is. His foot stamping and foaming-at-the-mouth tantrums are the mark of someone who has some severe mental issues. I'm being quite serious when I say that I fear for his mental health and safety.

I am curious what lawful reason he's going to trump up for stalking myself and PQ, though. Is someone ignoring pleas for attention against the law?

Ms Taylor, if you'd like, I can get you in contact with someone who has dealt with these types of sick individuals. He may be able to provide you with a few pointers on how to legally proceed in defending yourself from internet creeps and cyber-stalkers.