Risk Assessment, It Doesn’t Look Good

I worked in pharmaceutical development for many years, where one of my tasks was to perform risk assessments of drugs and biologicals. This involved weighing the risks (toxicities) of a new drug against the benefits (efficacy), to decide it the drug should be allowed to go on the market. I retired a few years ago and have since discovered that there’s a lot more to risk assessment than just drugs. Once I escaped the treadmill of relentless workaholism, I had time to notice that life is basically one big risk assessment, and it doesn’t look good. Risk Assessment

Perhaps it would be helpful to start with a couple of examples of drug risk assessment, to give you an idea of what I’m talking about. An example of a drug risk assessment would be a drug, say a new antiviral called kicksgermsass (I’m making these up as I go so I don’t offend any real pharmaceuticals) that is being developed to treat Herpes. The Phase I, II and III clinical trials showed 42% efficacy at lowering Herpes virus levels below the level of detection. The reported toxicities include headache, vomiting, diarrhea, suicidal tendencies, a growing obsession with adopting a pet orangutang, and heart stoppage. Since there are other treatments on the market for Herpes, and Herpes isn’t always fatal, the conclusion might be that perhaps, maybe, possibly one shouldn’t allow this drug on the market. Risk Assessment

Another example might be a drug, say a new male potency drug call ohhappyday, that results in a guaranteed two-hour erection of twice the normal size. The Phase I, II and III clinical trials, carried out in men aged 25-95, set records for the most volunteers in the history of clinical trials. Results showed that there was a 99% chance of the drug being effective. The only reported side effect was depression, and that was only in men who couldn’t get into the trial. There were no headaches, changes in blood pressure, no toxicities at all. So, the conclusion here would be that the drug should be allowed on the market. Unfortunately, it is likely that the price for this drug would be prohibitive for all but the one percenters for the foreseeable future, until it goes generic. Risk Assessment    

Now that I’ve provided you with these two virtually useless examples of risk assessment as it relates to drug development, I’ll get on with how risk assessment pertains to life in general. The first thing that comes to mind is moving to Florida. That’s probably because I recently met Ian and Nicole. Risk Assessment

We used to live in Southern Virginia. Then January and February started throwing weeks of nine-degree weather at us overnight. My wife decided she wanted to be a beach girl, and I got tired of turning blue. I confess that I did a lousy job of assessing risk in this situation. I should probably fire myself. Risk Assessment  

I knew the benefit would be not turning blue (no nine-degree winters), and that seemed like a good thing. I also knew that hurricanes existed as a potential risk. But at that time a hurricane was just something I’d seen on TV. I had never experienced one first-hand and had no frame of reference for understanding. In fact, when I told my wife that hurricanes brought to my mind visions of The Wizard of Oz, the poor woman just shook her head and pointed out that Dorothy was actually carried away by a tornado. Risk Assessment

In all fairness to me, movie special effects tend to normalize things like natural disasters and reduce the scare factor. And in reality, a tornado is a smaller spinny thing that happens over land, whereas a hurricane is a much larger spinny thing that usually starts over the water. See, I was right…kind of. Risk Assessment

We moved to Florida in 2020, and one month later Hurricane Isaias chased us away via mandatory evacuation. We fled to North Carolina to a rental for the next month. This year we thought we’d made it through hurricane season, and then along came Ian, a nasty guy that kicked the crap out of Florida. Risk Assessment

We happened to be out of town when Ian hit and were very lucky that our condo came out unscathed. But we spent many hours sitting in our daughter’s apartment in New York watching Storm Center on TV and trying to use mind control to keep Ian away from our condo. I don’t know about you, but that mind control thing gives me a headache, and doesn’t work so well. Maybe it helps to be a little green guy. Risk Assessment

At that point we started to relax since it was almost Thanksgiving, well beyond the worst of hurricane season. And then along came Nicole. For the past two days my wife and I sat in our condo looking out through the hurricane-resistant windows while 35-45 mph winds tossed bathtubs full of water around with terrifying energy (and this was only a tropical storm). Risk Assessment

There was flooding and roads washing out and beaches disappearing. (I didn’t see Dorothy fly by, but apparently that only happens with tornadoes). This was the first hurricane/tropical storm I had experienced first-hand. Let’s just say that nine-degree nights have started looking pretty good, and blue’s my favorite color. If I ever have to face a cat 4 or 5 hurricane, I’m moving to Montreal. Risk Assessment

I don’t mean to beat on Florida (read THE REALTOR’S CURSE for more), but another part of my risk assessment involved the charming animal life that I didn’t take into consideration. For example, we looked into joining a boat club near St. Augustine. We went to visit their facility on the St. John’s River. While walking on one of their floating docks on the way to look at the boats, we saw an eight-foot alligator basking in the sun on the riverbank about five feet from us. Risk Assessment

Then, this past Fall the trick-or-treaters got their own scare when a very large gator sauntered up the middle of the street in a neighborhood across A1A from us. I knew there were gators in Florida, but this is a little too up close and personal. Risk Assessment

Then there are the sharks and poisonous snakes. I realize there are sharks in the ocean that occasionally snack on some poor surfer. But during a recent flood there was a news report with video of two sharks swimming down the main street of a nearby town. Risk Assessment

Also, we live in a beachfront development, with a two-minute walk to a walkway over the dunes to the beach. After a recent heavy rainstorm, we received an email from our condo association warning to watch where we walk for a few days. Apparently, the rattlesnakes and other poisonous snakes get chased out of the dunes by heavy rain and come to visit. Again, I did not have this information when making my original risk assessment of moving to Florida, or my conclusion would have been turning blue not so bad after allRisk Assessment

The transportation industry also involves a considerable amount of risk assessment. For example, there’s the recent major push to purchase an electric car to save the environment. However, there’s also an increasing number of reports of exploding batteries in electric cars, even more so if they get wet as in a flood. And if you park one in your garage attached to your house, your homeowner’s insurance skyrockets. Risk Assessment

So, the risk assessment here is apparently “explode or refuse to save the environment”? Let me just say that if the side effect here is blowing up, I’m not going to enjoy the environment very much if my parts are spread over a city block. Risk Assessment

Then there’s the trains and planes. When Covid was at its worst, this risk assessment was easy. Get on an airplane, breath everyone else’s exhaled air, and get Covid, or stay home. So, home I stayed, or I drove somewhere in a non-exploding gasoline powered vehicle. (Good thing I was a professional risk assessor; like no one else could figure this out?). Risk Assessment

Now the risk assessment for planes and trains has changed somewhat. It is apparently possible to fly or take a train without catching fatal Covid; you might catch a less lethal strain. Due to the lack of staff because apparently everyone quit their jobs during Covid, the risk assessment is more along the lines of If I buy a ticket, will the damned plane or train actually go anywhere, or will they just send me a refund? At least the toxic side effect here is not death. There’s just no benefit at all. The only side effect is irritation because you won’t make it to grandma’s 100th birthday party after all. Risk Assessment

Allow me to explain. My wife has tried to visit her sister who lives out West three times. All three times the flight was either cancelled or didn’t leave in time for her to make her connecting flight. My wife and I tried to fly to NYC to visit our daughter, and the flight was canceled. We then tried to take Amtrak, and the train never showed up. Conclusion, America is broken. Risk Assessment

Risk assessment, if I want to go anywhere, I need to drive there, and preferably in a non-exploding vehicle with a range of more than the length of an extension cord. The good news with this risk assessment, there are no fatal side effects (unless someone comes up with an electric airplane, but then it wouldn’t take off anyhow due to lack of flight crew). The bad news, there’s only a 30% chance of you ever going anywhere. Although so far, we have dutifully received refunds with each cancellation or failed departure. Again, the main toxic side effects are headache from the irritation and nausea at the thought of America being so broken. Risk Assessment

There’s also risk assessment involved in purchasing a vehicle, be it a car or truck. I already discussed the exploding EV, benefit, no gas needed and risk, kaboom! There is another risk assessment involved here, be it gasoline powered or electric powered vehicle. There’s this thing (Another America is Broken thing) called the supply chain. Risk Assessment

Apparently even gasoline powered vehicles are now mainly rolling computers that require hundreds of computer chips per vehicle. These chips control unimportant things like getting gas to your engine and your safety systems. Safety systems include non-skid systems, brakes, acceleration, cruise control. There’s also all types of radar devices to keep you from backing into things, running over things, turning into someone else’s lane, etc. Risk Assessment

Those pesky computer and cell phone companies like Apple and Microsoft are apparently hording what few computer chips are being made. Since these chips are also mostly made in China, companies in that country probably get first dibs. So, when you go to buy a new car, you might not find any on the lot. Or, alternatively, the cars and trucks on the lot may, or may not, have all their computer chips in place. Risk Assessment

If you are lucky enough to find a car with enough computer chips to actually run, you still might not get some of the extras that you pay for. For example heated seats, air conditioning, turn signals, radar-driven safety features, brakes…you get the idea. So, the risk assessment here is, if I buy a vehicle, will it actually run? If so, will it actually stop when I apply the brakes? Risk Assessment

Benefits: you have a car. Risks: it might not run, stop, or be safe. Demanding a test drive will help with this decision. But there is a similar risk assessment involved here as well (Will it run? Will it stop?). And keep in mind that electric vehicles are basically a computer with a massive battery on wheels…lots more computer chips required. Risk Assessment

Another risk assessment with buying a car nowadays is of an even more serious nature. New vehicles are basically rolling computers. Many are now connected online to allow for constant software updates. This also allows Junior to play his/her online video games while in the car. Therefore, they are subject to hackers taking control of the onboard computer. Risk Assessment

The benefit is that you have transportation and Junior has a way to play online video games. The risk is that a hacker (probably about the same age as Junior) might take control of your vehicle and drive you off a cliff, or into a tree, or a lake, or someone’s living room. And worse, this hacker might do this in response to a challenge from some online website or social media site. So, the risk here is that you might get to find out if our car can fly, or float, or climb a tree. My old 1969 Volkswagen Beatle is looking pretty good about now. Risk Assessment

Buying a house nowadays includes some interesting risk assessments. The first involves interest rates. Apparently according to the federal government, inflation is 8.6%. According to my wife, who does the grocery shopping, it’s about 400%. (Gas prices also fall into this category). Therefore, to fight this runaway inflation, the Fed is increasing interest rates. Risk Assessment

So, regarding buying a house, the benefit is that you will have a roof over your head. The risk is that if you don’t act soon, you’ll be paying 17% interest. That’s what it was back when a certain peanut farmer was in the White House. Therefore, the risk is that you’ll be able to either pay your mortgage or buy food. Forget the car. You won’t have to decide between gasoline or electric; you won’t be able to afford one at all. Risk Assessment

Even more fun is the risk assessment for buying a home near the beach. Again, the benefit is that you’ll have a roof over your head, and maybe even a short walk to the beach. If you’re an ex-politician, you’ll probably be able to afford beachfront after having ravaged the US Treasury and/or selling your political influence, as most of them clearly do. Risk Assessment 

The risks? You could be paying a high interest rate. And if you listen to the ecoterrorists and certain politicians your neighbors will all be of the aquatic variety, as in sharks, octopi, sea turtles…you get the idea. This is because due to global warming, the oceans are rising so fast that Florida will be underwater by somewhere between tomorrow and the year 3025. Risk Assessment  

This is the same kind of accuracy that the National Weather Service uses to predict the path of hurricanes. Hard to do a valid risk assessment with data involving such a large standard deviation (as in plus or minus infinity). It seems strange to me that those same politicians keep buying up ocean-front property. But perhaps they just don’t let risk bother them. Or they know something I don’t. This wouldn’t surprise me, or my wife, or my children, or anyone who knows me. I do know that 70 years ago my sainted grandmother used to call politicians lyin’, cheatin’, thievin’ scum. That doesn’t appear to have changed much. Risk Assessment

I read about perhaps the best example of a risk assessment I’ve ever seen the other day. Strangely enough, this involves the drug industry, in this case vaccines. I read that the FDA approved the latest Covid vaccines for the Omicron variants. According to what I read in an online article from Yale University School of Medicine, their decision was based on all the clinical data from the original Covid vaccines and the results of a mouse study. Risk Assessment

In all fairness to the FDA, this virus apparently mutates at such a rapid rate that it is very difficult to generate sufficient human/clinical data to evaluate a given mutation of the virus before it is replaced by a new mutation. Therefore, to some extent I understand their rationale for making this decision. Risk Assessment

However, it is my understanding that the new vaccines are considerably different from the originals, in that they are bivalent (they include gene sequences from both the original Covid virus and the new Omicron strain). This thought gives me pause with respect to using only the original clinical data. Furthermore, myocarditis has been reported as a rare side effect, and I kind of prefer my heart undamaged. I’m also not sure they have sufficient efficacy data in humans yet to determine if the vaccines work with the Omicron variant. So, I can’t speak to that aspect. Risk Assessment

Therefore, the risk assessment from my very limited information, much of it from the national news, which I don’t trust at all, is, as follows. Benefit: I don’t know if the new vaccines work with Omicron or not. I don’t have access to the clinical data, there doesn’t seem to be very much for the Omicron vaccines anyhow, I have been retired for seven years, and now write murder mysteries. Risk: reported rare cases of myocarditis and any other side effects listed on the various Covid vaccine labeling. Risk Assessment

And it’s probably safe to take the vaccine if you’re a mouse. Since last time I looked in the mirror I was not a mouse, I honestly don’t know what the hell I’m going to do. Why would anyone listen to me anyhow? I freakin’ moved to Florida! Risk Assessment

If you liked this blog post, you’ll love my medical mystery novels. They are fun reads full of twists, turns, and laughs, and an absurd exaggeration or ten. To read the first three chapters of the books free, and for links to buy the books, go to johnjjessop.com