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.
Karen R. Charron, BSN, MPH, CCRCAssociate LecturerCenter for Immunization ResearchAmber Bickford Cox, MPH, CCRCResearch AssociateCenter 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.
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.
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.
The course will involve weekly lectures followed by a short assessment assignment.
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.
Course Schedule- Week 1Course 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 2Lecture 3: Characteristics and Outcomes of Vaccine Trials (Clayton Harro)Lecture 4: Protection of Human Subjects (Amber Cox)- Week 3Lecture 5: Vaccine Trials in Pediatric Populations (Elizabeth Schappell)Lecture 6: Vaccine Management and Preparation (Hye Kim and Vivian Rexroad)- Week 4Lecture 7: Data Management, Quality Assurance, and Quality Control (Karen Charron)- Week 5Lecture 8: Community Involvement and Recruitment (James Williams)Lecture 9: Study Start-Up and Implementation (Karen Charron)- Week 6Lecture 10: Screening Volunteers (Karen Charron)Lecture 11: Enrollment and Implementation Procedures (Karen Charron)- Week 7Lecture 12: Safety Assessments and Management of Adverse Events (Anna Durbin)