Ten reasons not to enroll your healthy child into a clinical trial for an experimental agent
What will you do if adverse outcomes cannot be reversed?
My book, Clinical Trials: What Patients and Healthy Volunteers Need to Know, published by Oxford University Press in 2010, includes a chapter that discusses how to approach placing sick children into clinical trials. That is not what I am writing about in this Substack article.
During the COVID crisis, parents rushed to enroll their healthy children in clinical trials of what amounted to poorly tested and characterized experimental agents. Some of the children were severely harmed as a result of taking part in these clinical trials. This has really bothered me, because not only were children not at risk from COVID19, but when some of them were harmed, their parents found it extremely difficult to access medical care for them.
Why would parents enroll their healthy children in clinical trials of an experimental agent? Those that I have spoken to, and others that I have heard testify, have said that they wanted to do their part for society during the COVID crisis. They believed what can only be regarded as propaganda, that they and their children had a part to play, to slow the spread, to get us out of the crisis - you name it, they bought it.
So, what’s wrong with putting a healthy child into these types of clinical trials, or indeed any clinical trial? I’ll give ten reasons, but I can think of many more. Perhaps your child was harmed during a clinical trial. If they were, it is not my goal to send you on a guilt trip. However, we need to ensure that others are spared the harms that have been afflicted on your child or children. I know many of you feel that way and are sharing your testimonies with that goal in mind.
Here are my ten reasons:
REASON 1: Good Clinical Practice requires that anyone entering a clinical trial do so after giving their informed consent. Your children cannot give their informed consent. They have no capacity to understand the ramifications of your decisions on their behalf. They do not know if the experimental agent will harm their future generations, their ability to reproduce, or even their ability to grow and develop healthily. Indeed, because it is experimental you also do not have the capacity to understand the ramifications of your decision.
REASON 2: Healthy children are not at risk of COVID19. Consequently, administration of an experimental agent to them is not appropriate. The risk benefit in terms of known and unknown risks, is not in their favor. Unknown risks also include risks that can occur many years into their future, and even into the future of their progeny.
REASON 3: The COVID19 clinical trials have no real mechanisms for follow-up of those who took part in them. Gene-based injections are considered experimental and typically anyone administered these agents are followed for the rest of their lives for adverse effects. This is not done for the COVID19 experimental gene-based injections.
REASON 4: Healthy children want to spend time outside playing with their friends. No healthy child wants to be lying on a hospital bed undergoing blood draws, and having their blood pressure taken. Why put them through this, when there is nothing wrong with them?
REASON 5: If your child is harmed and their life is irretrievably destroyed, how will you feel? How will your child feel about your decision, when they realize that there was no valid reason for you to enroll them in the clinical trial?
REASON 6: The COVID19 clinical trials are conducted under emergency regulations. This means that those designing the experimental agents, and conducting the clinical trials have little incentive to proceed with care. They cannot be sued or held to account. Just think about that!
REASON 7: Many parents who placed their children in the COVID19 clinical trials were not given proper informed consent documents to read. The informed consent process was non-existent. When they reported their children’s serious adverse events to the clinical trial staff, they found that the serious adverse events were downgraded, and/or reported at a much lower level of severity and seriousness. This is fraud, yet the clinical trial, hospital and pharma staff were able to do this with impunity. Again, no one has ever been held to account for the fraud committed. The safety profile was therefore mis-represented for these experimental agents, giving other parents the impression that the experimental gene-based injections were safer than they actually were.
REASON 8: If your child dies during the clinical trial, even if they were extremely healthy before going into the clinical trial, you will be told that there is no proof that the death was caused by the experimental agent. Imagine how you would feel to lose your healthy child in this way, and then to be told that they would have died anyway whether or not they participated in the clinical trial.
REASON 9: Children are not always able to articulate their adverse feelings and symptoms. When a clinical trial is conducted as poorly as these clinical trials are, in the hope of ensuring a high level of uptake, and to reduce the level of hesitancy, children will not be encouraged to report their adverse feelings, and symptoms. Failure to follow up on these in a timely manner could lead to poor outcomes long after they exit the clinical trial.
REASON 10: Children are not small adults. By all means, enter the clinical trial if you feel that it is a good idea for you, and if you believe the risks are appropriate for your health, but do not enroll your healthy children.
In my opinion, enrolling healthy children in a clinical trial of an experimental agent is the height of virtue signaling. We saw a lot of it during the COVID19 crisis. Risks versus benefits must always be taken into account when placing children in clinical trials. The risks for these experimental agents are not in the favor of healthy children.
You don’t really need to go past reason #1. After that, it’s like arguing against child sacrifice: no logic should be necessary.
It boggles the mind that any rational parent would knowingly put their child in the way of potential harm, no matter how noble it might make them feel. A parent’s primary responsibility is to protect their children, even to the extreme of sacrificing their own life if necessary — there is no motivation more noble.