Random Thoughts – Randocity!

Cytokine Storm Syndrome: The Drug Trial That Went Wrong

Posted in botch, business, medical by commorancy on October 13, 2018

Here’s a story about six men, in 2006, who endured the fight for their lives after a drug trial went horribly wrong. The above program runtime is 58m 15s. Let’s explore.

Method of Action

As soon as the method of action of this drug was revealed in this documentary, my first thought was, “Uh oh”. Trying to teach the immune system to do anything is somewhat akin to attempting to steer a flood away from a town. The immune system attacks foreign invaders. That they injected this drug not knowing exactly how many receptors it might bind to was a severe “UH OH” moment before I even watched this. I already know how unpredictable the immune system can be. To intentionally try to tame the immune system to solve a medical problem is essentially playing with fire.

Too Many Mistakes

There were a number of mistakes made during this trial as well.

  • Not enough separation between patient injections
  • When reactions began to occur, the trial should have been halted until determining each injections patient’s reaction extent. Isn’t the point to document the reactions?
  • Waiting too long to determine the problem and attempt countermeasures.
  • The trial doctor was horribly uninformed of reaction possibilities
    • Because doctor was uninformed of side effects, the facilities were ill prepared to handle what came after
    • Not enough drugs or equipment handy to handle medical complications

Trial Paradigm Failure?

The 10 minute separation between the patients was far too quick a succession, particularly when you’re screwing with the immune system, to fully understand how the drug might react. When the first patient began experiencing problems, the trial should have halted further injections to assess the already injected patients. This trial simply threw caution to the wind and endangered all of its trial participants even when they had huge red warning flags from patient 001.

That the doctor wasn’t self-informed on the possible reactions and had to spend valuable time to seek information later, “Wow”. If that’s not the very definition of uninformed, I don’t know what is. Before a single vial was injected, the doctor should read and understood each and every possible manufacturer side effect including having enough known remedies handy. You can’t know what you don’t know, but you can know what is written down by the manufacturer. Not reading and comprehending that literature fully before starting the trial is a huge mistake. If he had fully understood the ramifications of cytokine storm syndrome before injecting a single patient, he could have had started countermeasures much, much sooner in these patients.

If he wasn’t proficient in cytokine storm syndrome, he should have had a doctor on standby should the patients need another opinion.

The almost fatal mistake here was the attending doctor bought fully into the hype of the manufacturer that “nothing bad” would happen after injection. That’s called taking things for granted. Trial drugs are experimental for a reason and must be treated with all of the seriousness and respect they deserve.

Patient Trials

While it’s critically important to trial medicines in humans, it’s equally important to perform those trials in as safe a manner as humanly possible. This includes performing these trials in facilities capable of handling the load of every patient in the trial potentially crashing. If there’s not enough equipment in the hospital facility to handle that number of simultaneous crashes, then the trial needs to be moved to a hospital that can handle this patient load.

No trial clinic should be waiting for ambulances, equipment and medicines to arrive from around the city. All of this should be immediately on-hand, ready and waiting. To me, that’s a huge failing of the company that scheduled this trial. That company should definitely be held accountable for any problems that arise from being ill prepared at its clinic facilities.

Cytokine Storm Syndrome

One of the possible side effects after the doctor read the manufacturer’s literature of the trial drug TGN-1412 was a cytokine storm. He only read this after the trial had started and patients were already suffering. Cytokine storm is when the body’s immune system reacts systemically over the whole body. It can cause basically rapid shutdown of organs including fever, nausea, redness (heat) because the body’s immune system is attacking… well basically everything. That this reaction was fully documented in the drug’s literature is telling. It says that the manufacturer knew this was a possible complication, yet the trial doctor didn’t look at this literature until it was nearly too late.

Of course, by that time other doctors had been consulted in the midst of crashing patients, these other doctors felt the need throw their own wrenches into the works by claiming the drug itself may have been tainted or improperly stored, prepared or handled… possibly causing these patients to have an systemic infection. Throwing this wrench into the works was also reckless by those additional doctors who joined in on the action. Perhaps they needed to also ready the manufacturer’s literature before jumping to that conclusion.

It’s good that someone finally decided the correct course of action was to treat for cytokine storm as the manufacturer’s reactions suggest, but not before one of the trial patients had ended up with dry gangrene losing his fingertips and parts of his feet. A horrible ending to a drug trial that was ill prepared and improperly staffed for that kind of a drug reaction.

Hindsight

I know it’s easy to both see and say all of this in hindsight. But, I have worked at many companies where the all mighty buck is rules… basically, “Do it for as cheaply as possible”. The saying, “You get what you pay for” applies in every situation. I’ve worked for many organizations that blaze ahead with projects without fully evaluating all consequences of their actions. They do this simply because they want the product out the door fast for the least amount of money. They don’t care what problems might arise. Instead, they deal with the problems along the way. If that means throwing more money at it later, so be it. Just don’t spend it now.

To me, that’s reckless. Thankfully, I have never worked for a medical organization at all. I’ve chosen to stay away from that line of work for the simple reasons of what this level of recklessness can do when put into the hands of medical organizations. This trial should be considered the very definition of reckless and what can happen when the all mighty buck is more important than patient’s lives. Thankfully, the NHS stepped in on behalf of the patients and treated them as the sick patients they were, not guinea pig trial participants.

I encourage you to watch the program in full. Then please leave a comment below if you agree or disagree.

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The “Accusation War”

Posted in equality, gender by commorancy on October 4, 2018

The gender fight is now firmly underway. The lines have been drawn. With near constant accusations from women against men in power, this is the new Women’s Movement. A movement that has gained so much traction and power, many women now wield it callously and with reckless abandon. Let’s Explore.

Women’s Movements and Accusation Power

From the Suffragettes to Women’s Liberation to today’s “Accusation War” paradigm, we are firmly entrenched in a yet another gender war. A war in which the casualties are now primarily aimed at men in power. From Harvey Weinstein to Bill Cosby to Al Franken to Brett Kavanaugh.

The #metoo movement has now realized exactly how much power an accusation holds and how much power an accuser wields with that accusation. Accusations now have the power of, at best, causing death threats, family disruption, slander and malice towards those impacted. At worst, an accusation can cause loss of employment, loss of family, loss of money to legal fees and court costs up to including prison time if convicted.

I’m not in any way saying that some of these accused men are entirely innocent. I am also not saying that all of these accusing women are innocent, either. It’s very easy to take something out of context and blow it way out of proportion, particularly if said event happened decades earlier at a frat party.

Mind over Matter

The difficulty with decades old encounters is that there is no way to get any proof of said event. That proof is long gone. The only possibly corroboration of said event is if a third party was there to witness it. Otherwise, it is firmly “He Said, She Said”. The question is, when only two parties have any knowledge of the event, who are we supposed to trust?

Do we side with the woman who claims sexual abuse? Do we side with the man who states nothing occurred? This is the fundamental dilemma in “He Said, She Said”.

Unfortunately, in the court of social media opinion on sites like Twitter, these folks believe themselves to be judge, jury and executioner. The United States legal system is based on “Innocent until proven guilty”. Yet, social media and to some degree the commercial news media have always taken the stance, “Guilty until proven innocent”. This means holding one of these two parties out to dry. People say and do the most callous things towards others when they have a vehement belief. Take it down a notch, people.

In “He Said, She Said” situations, I simply can’t side with either. There’s no way to know who’s right and who’s wrong. It simply cannot be determined. Unfortunately, with the #metoo movement, social media seems to primarily side with accuser and against the accused. It just takes one female to step out and claim anything she wishes, even making it up as she goes along to exact revenge on the accused. It doesn’t matter whether the allegations are fact or fiction, it matters that the accusation was levied. That’s the point that women have come to understand. This is the power the accuser wields so very callously.

Manipulation

The act of manipulating a situation is an act of power. If you can manipulate a situation for your own benefit, then you hold that power. Many women have now come to understand the level of power that can be levied by mere words.

I’m not saying that some of those words are untrue. Unfortunately, there’s no way to know what is true and what is false when only two people are involved in a situation. This is especially true when the event was decades ago. I’m certainly empathetic to their plight that they claim, but there is no way to determine the validity of those words without some measure of proof or witnesses.

Manipulation of situations by making false accusations shouldn’t be without peril. Right now, women can levy statements and ruin people’s lives and walk away unscathed. This is the problem that needs to be addressed.

Penalities for False Allegations

If a woman makes a claim against a man regarding sexual misconduct and those allegations are found to be false, this needs a heavy penalty. It needs to incur a penalty that makes any false accusers think more than twice about accusing someone simply because they can. The penalty of falsely accusing anyone should be as harsh as it is for the accused. Employers need to see the false accuser in the same light as the accused as far as job credibility. A false accuser should lose their job, their family and anything else near and dear. Additionally, falsely accusing someone of sexual misconduct needs additional legal support. It should become at least a misdemeanor if not a felony to falsely accuse someone.

In court, making false statement is governed by perjury. Without seeing the inside of a courtroom, perjury doesn’t apply. However, slander and defamation does, but these aren’t punishable nearly enough when someone falsely accuses.

As I said, the penalty against a false accuser must be as severe as the penalties against a person found guilty of sexual misconduct. I might even class false accusations of sexual misconduct with the same legal penalties as those being accused of sexual misconduct including being put onto the sexual offender registry. After all, falsely calling someone a sexual offender means that you have become a sexual offender by abusing sexual offender laws to legally implicate someone else. It’s only fair you become what you claim someone else is. Eye for an eye and all that.

Someone reading may think, “That’s a little harsh”, but think about it. If someone is willing to lie to falsely convict a sex offender, then the laws need to reverse when the lie is uncovered. If you falsely accuse someone of a thing, you become that thing. It’s only fair to make the false accuser endure the same laws they were attempting to force on someone else. This includes putting the false accuser onto the sexual offender registry.

Again, false accusation penalties must be severely handled to make people think twice about falsely accusing another of something as severe as sexual misconduct.

False, Genuine, Time and Clouded Thinking

The mind becomes a grey area when time (and substance abuse) gets involved. Some of us may sport eidetic memory, but most of us don’t. Recalling exact details many years ago can be difficult and tricky. These memories can easily become clouded and conflated by later events, introduced by a friend’s faulty memories, distorted images and overall limited recall.

The problem I have with accusing people of sexual misconduct under these cloudy circumstances is that it has immediate and severe consequences, particularly if the person holds any measure of celebrity. Consequences that can cause death threats, divorce, ostracization, loss of career, loss of friends and family with possible mental health issues that result.

Yet, we have so many callous accusers jumping on the #metoo bandwagon who may not properly recall the events of the night in question. Perhaps they were sexually molested in college during a drunken frat party, but conflated that event to a more traumatic interaction much earlier in life. Perhaps they have a memory planted in their head. Perhaps it’s simply revenge. It’s far too easy to conflate similar events in the mind and misremember something that didn’t actually happen.

Being Absolutely Certain

This is why it’s important to be absolutely certain when making accusations of sexual misconduct. If you have any doubts exactly when, where, who or how it happened, don’t accuse. If you need to discuss an event that you think may have happened, discuss it with a therapist or a priest in confessional. Talk about it. Get it out and discuss it. But, don’t accuse someone unless you are absolutely certain of that it occurred and by the accused. Simply because you have a 20 year old memory of something in your head doesn’t mean it’s real 20 or 30 years later. If you had friends there with you, talk to them about it. Make sure they saw what you saw. If they can’t corroborate your recollection of events, perhaps you need to stop trying to act on it and definitely don’t accuse. The #metoo movement is not the place incorrect memories and cloudy recall.

In a cloudy memory situation, I’m not saying someone didn’t get molested. But, time and substance abuse have ways of screwing with your head. Make absolutely certain that what you remember is actually what happened. If you were bombed out of your head that night, how do you know what you did or how you acted? If you were drugged by someone at a party and you can’t recall anything from the night before, this is a situation first for a therapist (unless you have absolute proof, such as a rape kit having been performed the day after).

If have no knowledge of the event, but simply feelings and what you remember after waking up from your drunken stupor, accusing anyone of someone could turn into accusing the wrong person.

Alcohol and Drugs

One common theme with many accusations is drugs and/or alcohol. This means that many accusations happened at parties under the influence. If you’re at a party and you suspect something happened between you and someone else, you should try to confirm what happened with the other party and any other witnesses. Alcohol and drugs have a way of making people say and do things under the influence they may not otherwise say or do.

When you come out of that drug or alcohol induced stupor, you may then try to piece together what happened in your mind. The mind wants to make reason from chaos. This means potentially fabricating ideas about who, what, when, where and why. For this reason, accusing someone over a substance induced stupor means you could easily falsely accuse someone based on incomplete or even fabricated memories.

For the reason of substance abuse, I find it much, much harder to take someone seriously who makes accusations after having been under the influence. That doesn’t make it fair and it doesn’t make what happened false, but it does make accusations, particularly years later, hold far less weight. This is why having physical evidence such as a rape kit is so important.

Children and Abuse

This article is intended to primarily discuss adults accusing other adults of sexual misconduct. That is, to discuss adults who should already know the rules of the game. I would be remiss not discussing child abuse situations, but the underlying agenda of the #metoo movement seems less about child abuse and more about screwing with celebrities and those in power by levying sexual misconduct allegations against youthful indescretions.

Let’s talk about children for a moment. For children who were abused during childhood, I definitely feel for their situation. It’s an impossible situation when an authority figure abuses their authority position to perform sexual acts on a child. Children are not capable of processing that information properly at a young age.

Of course, over time and with life experience into adulthood, we come to understand what happened and are able to grasp the situation more completely. But, the wounds don’t heal. However, by the time we understand what happened, it’s usually too late to bring charges. If it’s a family member, it’s even harder to bring charges as a child (or even as an adult). How can you reconcile jailing your brother, mother, father, sister, grandfather or grandmother? As I said, it’s an impossible situation, particularly if they are the person is a primary caregiver.

If the abuse occurred at school, it can still be just as traumatic. A coach, teacher or student may cause intimidation preventing telling anyone about the situation. Jailing one of these people is less stigmatic, but can be difficult depending on the person.

If the abuse happened by a priest, it is even worse in some cases. Yes, some people who want to abuse others do tend to gravitate towards employment situations let’s them act out their personal fantasies and proclivities. These people fully grasp their position of a trusted authority figure such as coach, priest, principal, teacher, doctor, etc. It makes it especially difficult to out these people for their sexual misconduct. That’s why they have those chosen those specific positions of authority.

However, the times are changing. No longer do priests, cops, coaches, doctors and teachers hold the blanket authority power they once held when accused. Since all of the accusations over the years, these positions of implicit trusted power have lost their veneer. There is no person you should trust implicitly simply by their job title. Everyone must learn to trust an individual by their actions, not by the job title they hold. Never implicitly trust someone simply because they are titled as a caregiver.

For children who suffer this level of abuse, I wish I had an answer. Opening up on the situation and discussing it much later in life may be the only answer.

Seek Therapy

If you’ve been sexually abused by anyone and you can’t cope, seek a therapist. As they say, there are some things you can’t unsee (or in this case, undo). Therapists are there to help you come to terms with what happened. They won’t make it right, but they can help you grasp the situation better, gain better understanding of it and hopefully come to terms with it.

If you want to publicly accuse someone of having done something, consult with a therapist first. They may be able to help you determine if what you remember is valid or conflated memories. You don’t want to accuse someone accidentally. Falsely accusing, if even accidental, is something you’ll have to live with for the rest of your life. Just like whatever sexual abuse encounter you remember having, falsely accusing someone, even if accidental, is not something you can easily take back. You don’t want to require even more therapy because you falsely remembered an event and accused someone of something they didn’t do.

Accusing Someone

If you’ve been sexually molested by someone, it’s fine to join the #metoo movement so long as you don’t call them out by name. If you want to out someone by name, you should do so only after talking with an attorney and only do so to the authorities. If you choose to levy a public accusation at someone on social media, I’d suggest you do so with concrete proof. Meaning, have a rape kit handy, have witnesses handy, have doctor’s who’ve examined you handy, etc. If you’re really intent on outing someone for an act they performed on you 20 years ago, make sure that you are calling them out for it properly. Even then, doing it through the authorities and a police report is better than doing it on Facebook and Twitter.

If you plan on calling out someone for sexual misconduct, call them out with proof. Make sure the person who you claim abused you can be convicted of their actions legally. Simply calling them out publicly with no intent on legal action tells me that there’s something fishy at work, that the accuser cannot be trusted. If the accuser is unwilling to make the accusation stick legally, then it simply comes down to, “He Said, She Said”, which by its very nature is an untrustworthy situation.

If the intent of the “Accusation War” is to create a rift between the genders, then this current gender war is the perfect way to go about it. Can we survive it?

If you have been sexually molested or have been accused of sexual molestation, I’d like to hear your stories in the comments below.

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