What Happened to Informed Consent?
I have never been anti-pharma, nor anti-vaccines. I even worked on a project to bring EUA COVID-19 monoclonal antibodies to high-risk patients, and it was extremely successful. Years ago, I personally participated in a clinical trial for a drug that ended up being a blockbuster game-changing medication for me personally, and for millions of people in the US alone.
I’ve spent my career working in specialty pharmacy. Many people don’t know what that is. Specialty pharmacies are not drug manufacturers. They are pharmacies that supply medications that are much more complex than the medications you pick up at your local retail pharmacy. They have cold chain storage requirements, often are administered by nurses via infusion (intravenously), and they are expensive. This has certainly given me a front row seat to the runaway cost increase of medications over the past two decades, but the flip side is I’ve seen serious debilitating diseases/conditions become fairly easily managed with new medications. I give these details to show that I’ve not generally been a big skeptic of our healthcare system.
As a child in the 1980s, I received a blood product that was tainted. This happened in the US, Canada, the UK, and many other places. Google “tainted blood 1980s” if you’re interested. I consider myself blessed to have escaped contracting HIV, but I contracted what at the time was called Non-A, Non-B Hepatitis. Little was known about it, and I grew up (for as long as I can remember) knowing I had a chronic infection in the form of a virus that slowly attacks the liver, and not knowing how this was going to impact my life. Eventually this became known as Hepatitis C (HCV).
Although the monitoring of my liver function showed no ill effects from HCV, right out of college I found myself with great health insurance and a good job that was not a career job. I decided to try the treatment to eradicate the virus despite the short-term and longer-term side effects. It was 48 weeks of interferon and ribavirin hell, and the outcome… it didn’t work.
About a decade ago gastroenterologists (GI) began holding off on that treatment protocol for patients whose liver could wait. There were some promising drugs in the development pipeline, and my GI doc was one of the ones at the forefront of the potential new drugs.
In 2014 I got the call from him. “There is a stage-three clinical trial for a drug, stand-alone with no interferon or ribavirin, that is perfect for your situation” was the gist of the call, “can you come in soon?” I did go in, and I met with more people than I had ever met in the GI department including the study coordinators. We spent hours going through the informed consent process, and I felt confident that this was the right thing for me. Then things came to a halt. My wife was pregnant, and the part of the trial I was eligible for had nothing to do with pregnancy. My doc went to bat for me, and the principle investigator okayed it. However, my wife and I had to review even more informed consent documents and agree to abstinence or two barriers of contraception because she was pregnant and planning to breastfeed. I’ve signed fewer documents to buy a house and open an LLC business.
It was a 12-week course of therapy and the only side effects were feeling weird for a few days at the beginning (like when you start a strong anti-biotic) and heartburn. It worked, I cleared the virus, and the medication was FDA approved as Harvoni.
What is mind boggling to me is how informed consent, for Covid-19 vaccines, has gone out the window. People who mention side effects, question the long-term safety, or even quote the VAERS data (the government’s own vaccine data!) are being censored and silenced on most social media platforms. Some employers are now starting to mandate the jab and I don’t understand how that is remotely legal or ethical given its EUA status. Even once FDA approved, I don’t see how I can give informed consent without seeing a couple years of data, and even at that point how do I interpret this data since they decided to vaccinate the placebo control group?
Pharma companies can’t give physicians pens with their logos or their drug’s logos, but now it is okay to give bribes to people to get the jab. In fact, you can get free marijuana (which is still illegal according to federal laws) if you get the jab (which is being paid for with federal dollars).
So here I am. Someone who got infected by HCV from a tainted blood product which was a failure of the healthcare system, but I believed in our healthcare system so much I have worked in it for almost twenty years, have always been vaccinated, and I personally participated in a clinical trial!!! I am not an “anti-vaxxer” etc., but I find the censorship and coercion to take a novel therapy that hasn’t been thoroughly studied to be abhorrent. Even worse, not only has informed consent gone out the window there is a full-on propaganda push for people to just accept without questions this unknown treatment. Something is very wrong.
