What does “Follow the Science” Really Mean?

Science is taking a big hit these days. It is difficult to view the news without seeing or hearing individuals speak on behalf of “science” often while contradicting it. We see individuals on social media being critical of science, politicians touting or bashing it, and entire industries praising or dismissing it, depending upon their political or personal views. So, I thought it might be helpful to provide a “science refresher” that helps us all understand what it really should mean when we say, “Let’s follow the science.”

THE SCIENTIFIC METHOD

Let’s take a trip back to Junior High School science class to talk about the Scientific Method. The Scientific Method (according to Wikipedia) is “an empirical method of acquiring knowledge that has characterized the development of science since at least the 17th century. It involves careful observation, applying rigorous skepticism about what is observed, given that cognitive assumptions can distort how one interprets the observation.” The key to the scientific method is to remove subjectivity from the conclusions drawn. There are several steps to the Scientific Method (some say 6 steps, others 8… I’ll split the difference and use 7 in my list):

  1. Observe (ask a question) – In this first step, we must understand what problem we are trying to solve or what question we are trying to answer. Unless we can adequately and accurately describe the problem, we won’t truly be able to determine if our work was successful. Lewis Carroll once said, “If you don’t know where you are going, any road will get you there.” The same is true in science. If you are a scientist investigating potential weed killers, you begin your work by asking, “What chemicals might be useful in eliminating dandelions from the lawn without harming desirable grass?” You have described a problem or question that is clear, concise, and is measurable.
  2. Background research – The next step in the scientific method is to conduct some basic assessment or research to determine an approach you can use to solve your problem. For killing dandelions, you might do a literature search on herbicidal chemicals. For solving medical issues, you might evaluate case numbers, incident rates, severity, prevalence, etc. The purpose of this step is to prepare you for the next critical step.
  3. Develop a hypothesis – This step is perhaps the most important step of the Scientific Method because everything that comes next hinges upon whether it addresses your proposed hypothesis. Will xyz chemical kill dandelions without harming grass? Will this new drug substance cure that specific medical issue (or at least mitigate it)? In essence, the hypothesis determines what you test, how you test it, and how you’ll evaluate the data to reach a conclusion.
  4. Test or experiment – Testing your hypothesis involves developing a protocol that identifies the methods you will use, how much testing will occur, what controls will be in place (controls ensure that you are measuring a targeted response to eliminate other factors), and what criteria will be used to assess your results. The Scientific Method requires that your testing protocols be written and specific to allow independent duplication of results. Unless your experiments and results can be independently repeated and verified, you have not eliminated all doubt in your results. For your dandelion killer, you will identify how much chemical to apply, when, and how to measure results… all compared to a control lawn that is not treated. In drug studies, the clinical studies usually occur in phases from phase I (small experimental groups) to phase IV (large-scale studies treating hundreds or thousands of patients). 
  5. Data analysis – Once the testing is completed, an assessment of data is required. Typically, this analysis will utilize statistical methods to compare the test group (treated) against the control group (untreated). Unless there is a clear, statistically valid difference in the results, the treatment is not successful. 
  6. Reach and report conclusions – After all data are analyzed, conclusions are reached. Have you proven your hypothesis as true? Did the treated group outperform the untreated group? What have you learned regarding the treatment? Are there additional studies needed? Conclusions should be objective… untainted by personal views or thoughts not observed or results not obtained during the experimental step.
  7. Communicate results – Finally, all good science is made available to others in the pursuit of knowledge and advancement of the field of study. Others should be able to replicate your studies and, perhaps, build upon what you have learned. Unless you are willing to share results (or publish them), your conclusions may be considered questionable.

This is the Scientific Method. Every scientist should know, understand, and utilize these steps when reaching conclusions about unknown scientific topics. This is what it really means to “Follow the Science.”

So, what does all this mean to us in this day of scientific misinformation? What should we look for when trying to decide for ourselves what to believe or not? How can we be discerning when reading news articles or watching TV reports of scientific happenings?

I believe there are 10 things to watch for when trying to decide what to believe. Let’s look at my list:

  1. Science is based on facts, not opinions – Don’t believe “scientific” reports what cannot be supported by data. Just because someone wants it does not make it true. Science must avoid personal opinions, expedience, politics, and greed.
  2. Be skeptical – When someone touts “science” be sure you assess the information based on what I’m sharing with you here. Don’t believe it just because someone wants it… or even if you want to believe it. Claims must be based on the facts ascertained through appropriate scientific methodology.
  3. Conclusions must address a specific problem (or hypothesis) – I have personally seen too many claims made based on hearsay or random results. If you throw enough spaghetti onto the wall, some is bound to stick. Ask how the objective results tie back to the specific problem or question the study was trying to answer.
  4. Experimentation must include proper controls – Unless a study is comparing treated subjects versus untreated, it is impossible to show that the treatment is effective. Unless the final conclusions state something like “… when compared to the untreated population…”, it may not hold up under scientific scrutiny.
  5. Data must be statistically relevant – Just because a treatment shows “…10% improvement versus the untreated group…” doesn’t mean the results are statistically relevant. If the test populations are small, this improvement may just be a random result. 
  6. Conclusions must tie to both the problem and the data – Don’t be fooled by conclusions that do not address the test protocol and hypothesis. There are many individuals that will attempt to interpolate one set of results to another problem or issue. 
  7. Results must be repeatable – True scientific results are always repeatable. If you cannot show the same result under the same conditions, you cannot be assured that the results are true or legitimate. Likewise, researchers that are unwilling to share their methods and data may be attempting to hide true results.
  8. Conclusions must be open to review and scrutiny – Science is empirical, but it welcomes healthy debate. Many scientists disagree about the conclusions of studies, but they are willing to have discussions openly and honestly. When you see individuals avoiding discussion or debate, it should raise questions about the legitimacy of the study.
  9. For medical products, safety, purity, and effectiveness must be proven – When dealing with medical products (drugs, medical devices, etc.), it is imperative (and required by FDA and global health authorities) that the products be proven safe, pure, and effective. These authorities are highly professional and not impacted by political or other pressure to approve products that fail to meet these criteria. Thus, in my opinion, if a product is approved (or, in the case of some, have received emergency approval), they have met these thresholds for use.
  10. Science is not untrue simply because we don’t like the results – Just because we don’t like the results, doesn’t mean the results are not correct or true. Science is objective. That does not mean that it is totally free from scrutiny, review, or debate… it simply means that science has no room for subjectivity. Certainly, scientists often offer opinions. But these are typically based upon extensive experience conducting true scientific studies or is based on their expert knowledge given the objective data available.

Certainly, the context of this piece is the discussion we have all heard surrounding the COVID-19 pandemic. Much of what we hear or read cites “science” as the basis for requirements, restrictions, lockdowns, mandates, and limits. Some of this has at its core, true scientific information. However, much does not. Let me give some examples:

Science-based observations

  • Proper masks have been proven to be effective barriers against viral pathogens
  • All the approved COVID-19 vaccines have been proven to reduce the risk of serious infection
  • Proper distancing, ventilation, and sanitation can reduce the risk of COVID-19 transmission in some indoor environments

Whether you like it or not, the scientific data are conclusive that each of the above statements are true. Scientific studies have been conducted that unequivocally prove each. That does not mean that they are 100%. It simply means that the preponderance of statistically based data provides objective evidence that the statements are true.

NOT Science-based observations

  • If one cloth mask is good, wearing 2 or 3 will double or triple your protection
  • You don’t need a vaccine if you take enough of the right vitamins and nutritional supplements
  • If you wear a mask into the restaurant and remove it completely at the table while you talk and eat, you are still protected from COVID-19 infections

Each of these statements has been touted as “following the science” without any evidence that they are true. This reminds me of the adage, “If enough people say it with enough conviction, it must be true whether or not it is.”

So, I hope this has been a helpful refresher. My takeaway is this… don’t allow someone fool you by touting as science something that has not nor could likely ever be proven using the rigors of true science. Be skeptical but have an open mind as you sort through the information presented to you in the news or on social media.

Living without regrets

Summer finally ended for me a couple weeks ago. We winterized our lake cottage, shut everything inside, played one last round of golf with our northern friends, and said good-bye (for now) to our group of best friends for nearly 40 years. It was a glorious summer!

Looking back on the summer, our list of fun activities was endless… concerts, kayaking, fishing, family times, biking, ice cream (multiple times, I might add), board games, great food, quiet times on the deck, and wonderful times creating memories. Our summer was full, enjoyable, and lived without regrets.

There were some not-so-great times, as well. We said final good-byes to two wonderful friends… one passing with time to properly show his love to family and friends… one passing suddenly in the night. Both were wonderful individuals that loved their families, loved God, and lived full and fulfilling lives. Did they live their lives without regrets? I do know that each left a lasting impact on the lives they touched. Knowing them was a true gift to me!

So many individuals I know seem to be burdened with regrets. They look back on events of their lives with a “coulda, shoulda” attitude. They are so weighed down by these regrets that they fail to experience the joy of today or the hope of tomorrow. Yes, when given a chance, most of us would probably make a few different decisions in life but moving past them is important for our lives today.

How can we live today with no regrets? What is the secret to contentment now? The philosopher in me has pondered this for some time now and I would like to offer 6 suggestions that can help any of us live our lives with fewer regrets. See if you agree:

  1. Recognize that each past event is like a jigsaw piece in the masterpiece of our lives – I like to think of my life as a giant jigsaw puzzle that is shaped and built over the entirety of my life. It began back in my childhood playing baseball in my backyard with 15 friends in a small town. Other pieces were added as I grew, went to school, and began a family. Each event, good or bad, represents a piece of the puzzle that will someday be complete. I didn’t always understand why certain things happened, but, looking back, I can now see how I wouldn’t be me without them. Some of those pieces were difficult or resulted from my bad decisions. But they still fit in the puzzle. The puzzle will be complete someday and it will be clear why things happened as they did. Many pieces are already formed and in place, so nothing I do today can change them… nor should I linger on them. Don’t regret the past, learn from it… savor the memories… let the past make you a better person today.
  2. Get out and do things today… even if they involve risks – Studies have been conducted in which individuals on their deathbed are asked what regrets they had in life. Nearly everyone listed things they DIDN’T do rather than things they DID do as regrets. Let’s learn from that! What is it that you’ve always wanted to do that you have yet to try? Are you waiting for every detail to fall into place before you feel confident to decide? If we all waited until our confidence was 100%, we’d never try anything new. I frequently talk to others about the best time to retire. I am a strong advocate for individuals to retire the very first day they are financially able. Time continues to march along and the window of opportunity to enjoy our retired life is often limited by health or other uncontrollable factors. Do something! Don’t look back and regret it.
  3. Realize that joy and contentment are, to a significant extent, choices that we make… we control them – I often hear individuals talk about how joy and contentment will come into their lives in the future… when their children finish college or when their finances are better or when work gets better or when they become a partner or whatever. Someone once said, “A good day is defined, not by what happens during the day, but by how you react to those things that occur.” By the same token, joy and contentment are what currently resides inside us. We have already decided if we are living our life with joy or whether we are just trying to survive the day. Joy is a choice. The day we DECIDE that we will live and share a life of joy, regardless of what comes our way, is the day that we become more content in what we have and what we do.
  4. Savor today… tomorrow is not promised – She had a nice day with her husband. They were looking forward to an upcoming trip and had already started planning their winter in Florida. Tomorrow promised to be a enjoyable day… However, tomorrow never came for my friend this past July. Life is fragile. Despite our best plans, we cannot control our lives beyond this moment. Even though we know this intellectually, we still busy our days making plans, keeping our calendar current, and assuming that our time here will play out as we have imagined. When we begin living our lives as if today is our last day on earth, we start to see just how unimportant today’s worries really are. Ask yourself this question, “Will my biggest problem or worry today matter to anyone a year from now?” Stop assuming that your time is unlimited…. Stop worrying about the minor details of life…. Start savoring the joys of your life more.
  5. Make your life a gift to others – Life is a gift. We are the recipients of this gift. But we are a gift to others. How many times a day do you think of someone else in your life? I often think of my Dad and Mom drinking coffee in the mornings when I have my own. I think of my grandchildren in school. I wonder what my friends are doing during the day. I often remember many others in my life no longer with us. Others in our lives are doing the same thing! I think we would all be amazed at how many people in our lives think of us every day! Our life is a gift to others. We need to live our lives in a way that will enhance that gift. I want my grandchildren to have fond memories of me. That is why I try to be a positive influence in their lives. Consider the fact that you are on the hearts and minds of many others every day. Make those thoughts and memories positive; bring a smile to their faces when they think of you.
  6. Live your life with hope for your future – Too many people regret their past to the point that they fail to plan for the future. I’m not really talking about the short-term future here, but their eternal future. When you have peace with God, you attain an entirely different perspective on regrets of the past because you have been forgiven. God sent Jesus into the world to mend the broken relationship we have with Him because of sin. When we accept Jesus as our Lord, our past is forgiven, our present is enhanced, and our future is certain. If you wonder more about what this looks like, you can learn more here (What is your hope?).

I read an obituary this week for an individual that died at the age of 90-something. One of the comments read, “… She lived her life with very few regrets…” That’s what I plan to say at the end of my life. How about you?

Why I was one of the very first in line to take the Covid-19 vaccination

In the autumn of 2020, I volunteered to be in the clinical study for the Johnson & Johnson (J&J) vaccine against the Covid-19 virus. At that time, the Covid-19 pandemic was at its peak. Most schools were offering only remote learning. Many restaurants were closed or serving only carryout food. Mask mandates were nearly universal and the free life that we had known up to that time was in turmoil.

When I received the call saying that I (and my wife) had been selected to participate in the J&J vaccine clinical trial, there was no hesitation from either of us. We accepted the first date available and excitedly joined the study. We received our one-shot vaccination in early December 2020 with a 50% chance that we received the vaccine versus the placebo, but we were glad to participate. Late that night, we both awoke with mild side effect symptoms (chills, body aches, and, in the morning, fatigue) that subsided within 12 hours. So, we felt encouraged that we both received the live vaccine.

Why would we want to participate in a clinical trial for a vaccine that had never been commercialized previously with unknown potential side effects? Why would we potentially put ourselves at risk taking a vaccine with unknown safety or effectiveness?

Today, several vaccines have been in use globally for a number of months (3 in the US). A recent study cited by USA Today (USA Today by Taylor Avery published 7/12/2021) says that these vaccines have saved 279,000 US lives and prevented 1.25 million hospitalizations in their first six months of use. Yet, upwards of 40% of the US population remains unvaccinated. I am not writing this to be critical of anyone that has made the choice to not get a Covid-19 vaccination, but to just provide a few of my own reasons for being in that first group of individuals to be vaccinated:

  • My personal education and knowledge – My graduate studies included full semester courses in both virology and human immunology. So, I learned a bit about how viruses work and how our bodies respond. Vaccines are developed to teach our bodies to build antibodies to components of the virus particles that, when the real virus attacks us, will inactive the ability of the virus to infect us. The mRNA and J&J vaccines do this differently, but both have proven effective in providing this needed immunity. According to Dr. Adam Brady, Infectious Disease Specialist and Chair of the Samaritan Coronavirus Task Force (https://www.samhealth.org/about-samaritan/news-search/2021/02/09/covid-19-vaccine-side-effects-compared-to-other-vaccines) the side effects for the Covid-19 vaccines are greater than those experienced typically for a flu vaccine, but slightly less than you might experience for a shingles vaccination. There are slight risks with any vaccine, but there is no scientific reason why the Covid-19 vaccine should be more risky than any other.
  • My work experience in the pharmaceutical industry – I have worked in the pharmaceutical industry for over 40 years. During that time, I have hosted over 100 FDA inspections, provided thousands of communications to FDA, heard hundreds of FDA presentations at meetings, and read thousands of articles by FDA professionals. Though I have not always agreed with FDA individuals, I have never doubted their mission to provide only safe and effective products to consumers. In fact, the one thing that causes them to lose sleep is that they will approve a product that ends up doing more harm than good. They stake their professional reputation and life on the fact that they have done everything possible to protect the consumer. They often talk to industry about how they treat every decisions as though their own kids or grandkids will be using these products. Thus, I KNOW that their approval decisions for these products was based on science, not politics or outside pressures. It is simply not possible that these products could have been approved without adequate safety data. Consider the practicalities of an approval decision of this magnitude. Knowing that hundreds of millions of individuals would take a product and the visibility associated with it, would YOU want to be in a position to approve such a product unless you knew for certain that the data proved its safety? No FDA individual that I have ever known would rush, short-cut, or give less than a full review for such a decision.
  • My personal risk/benefit analysis – Life is full of risk versus benefit decisions. When the clinical study vaccine became available, my wife and I were faced with the very real risk of Covid-19 infection (we personally know many individuals that have had Covid-19) versus the minuscule risk of an adverse vaccine reaction. The risk of Covid-19 was undoubtedly higher (let’s say 1 in 100, for example) versus the adverse reaction risk (probably 1 in 1,000,000 or less). To me, it was a no-brainer. On a personal note, a close relative had Covid-19. This individual is about my age with no underlying risk factors. He was severely sick for about 3 weeks and still, one year later, has “long COVID” impact… increased anxiety, lingering cough, etc. Covid-19 presents a very real risk that far outweighed adverse reaction risk.
  • My appreciation of living freely – I want to live my life freely, without worrying about undue Covid-19 risks. I knew that if the J&J vaccine worked, it would totally change my ability to do the things I had always done without that underlying fear of catching the virus. Today, we know that our hopes were realized… the vaccine is so effective in preventing the most severe infection that we were quickly able to resume living life without Covid-19 worries. We don’t worry about transmitting Covid-19 to our grandkids. We don’t worry when we eat in a restaurant. We go to concerts. We are experiencing life much like we did before Covid-19. Certainly, there are no guarantees in life. There are rare cases in which individuals that have had the Covid-19 vaccination have been infected, hospitalized, or experienced death. However, that was also always the case with other vaccines, as well. However, it appears that the vaccines prevent over 95% of individuals from contracting a severe case.
  • My love for my family – Covid-19 quickly became a killer disease. Stories emerged within weeks of its emergence in the US of otherwise healthy individuals dying from Covid-19. It was especially severe for those with underlying conditions and those over 65 years of age. So, we knew we were in that most vulnerable population of individuals. We have three children and seven grandchildren. To protect them (and, from their perspective, to protect us), getting the vaccine early removed, to a large extent, the possibility of either putting them through the agony of watching our demise OR experiencing a long absence from them while we all quarantine. For all of the reasons noted above, taking the vaccine for us was an easy decision.

So, for those of you that have not yet decided whether to take this vaccine or for those of you resistant, why put yourself through the torture of “never knowing if today is the day” when a simple injection can significantly reduce this worry? As pressure mounts by government agencies, employers, and others, saying “no” to the vaccine may even carry greater personal impact relating to your education, possible career opportunities, or personal freedom. To me, making the decision to live my life as I choose without that ongoing, nagging fear of contracting a potentially fatal illness was an easy one.

Our politicians and news media have made this entire issue a messy one. We have been given mixed messages, contradictory information, shifting science, threats, and political advice about this vaccine. However, at the end of the day, you should rely upon the science (which I believe is unequivocal) and your own risk/benefit analysis, not emotion or fear. Either decision you make has risks, but which is most likely to impact you and those you love more severely? Saying “yes” to this vaccine does NOT mean that you have capitulated to the pressures of others. It simply means that you have done your homework and made the best decision, based on what you know, for you and your family. And, if you still believe that “no” is the best answer for you, I respect that. I simply wanted to share my own personal rationale for the decision I made back in December 2020. Have a great day!

The Philosophy of Risk in GXP Operations

How should we view risk when operating in a GXP environment? How much risk should we allow or tolerate? Can we ever get comfortable with ANY amount of risk?

We all have probably heard or read about one firm that recently lost several million doses of COVID-19 vaccine due to a manufacturing error. What might in the past have been a simple matter of financial impact to that firm today is an international incident. Not only do several million individuals miss a potential life-saving vaccine injection, but that firm’s past and present GMP issues have now been exposed. Everyone now knows the name of that firm and assumes, based on publicity, that the company’s products are potentially less than desired quality. Though I am not familiar with the circumstances of the manufacturing issues at that firm, it is safe to say that, in retrospect, some may say that too much risk was assumed or inadequately mitigated.

Is there a philosophy we should adopt when it comes to risk in GXP operations? In my book, Pragmatic GXP Compliance (available at Amazon at this link: https://www.amazon.com/Pragmatic-GXP-Compliance-Successfully-inspections/dp/B089M425M3/ref=sr_1_1?dchild=1&keywords=eldon+henson&qid=1619704518&sr=8-1), I discussed many practical applications of GXP compliance and how we should not simply avoid any risk. However, I think there are some larger, more philosophical, broader concepts on GXP risk that I think deserve some attention.

Allow me to discuss four of these concepts here:

ZERO RISK MUST NOT NECESSARILY BE OUR GOAL

Is is possible to avoid all risks in GXP operations? Certainly, the answer to that question is YES. However, your business may not be able to survive such an approach. For example:

  1. The Quality Unit could eliminate all risk by refusing to release any batch – if you never release a batch, you never incur regulatory or consumer risks
  2. To ensure that every unit is perfect, you could do 100% sampling and testing – sure, you would have no remaining product to sell, but at least you would have eliminated any risk
  3. You could hire an inspector to shadow every manufacturing and quality employee to ensure that every operation was done perfectly

You get the point… there is a balance we must seek in which our goal is not to completely eliminate all risk (too impractical, costly, or impossible), but it is to eliminate or avoid undue risk.

I am certainly not inferring that we must take more risks than necessary. There are situations in which doing more to eliminate risk is warranted. Let me provide an example in the area of Regulatory Affairs. Assume you are working to attain approval for a new product that will generate $365 million in annual revenues. Essentially, for every day of delay in achieving approval, your company loses $1 million in revenue. When assembling your regulatory submission, you always have options relating to more/less testing, additional scenarios, extended studies, more/less clinical participants, etc. In such a case, it may make more financial sense to do more upfront prior to submission to reduce the possibility that you will receive a Deficiency Letter which could delay approval many months. So, the question is, “Do we do more now (either in costs or time) to eliminate the risk of a Deficiency Letter with the assumption that we lose $1 million each day we don’t have approval?”

We must also not take risks when patient safety is potentially compromised. There are simply times when we must do more, spend more, and mitigate more to protect and serve our ultimate consumers. However, it is possible to do more potential consumer harm by striving for zero risk. Speed to market must be a consideration when dealing with life-threatening situations. Gretchen Rubin Voltaire once said: “Don’t let the perfect be the enemy of the good.” All factors must be considered when assessing your tolerance for consumer risk. Balancing the risk with the overall benefit must be a part of these conversations and action.

GXP REGULATIONS ALLOW AND RECOGNIZE SOME RISKS

Many individuals believe that GXP requirements are black or white with no room for alternatives. This is simply not true. Most experienced regulatory investigators understand this and allow for options where GXPs allow. Let’s look at one simple example. What is required by 21 CFR 211.142 (a)? This requirement simply states:

“Written procedures describing the warehousing of drug products shall be established and followed. They shall include: (a) Quarantine of drug products before release by the quality control unit.”

Notice that it does NOT state how these requirements must be met. This is a perfect example of how GXPs allow some flexibility in compliance. Let’s list some of the possible ways you can comply with this:

  1. Physical segregation – this system requires that you have separate physical storage locations for acceptable (released) and unacceptable (unreleased) products. You can only ship product from the physical location with released goods. And, you only store released goods in that location. Individuals constantly verify and monitor what is stored in that area.
  2. Visible indicators – this system requires that you place a visible indicator on each pallet or container of product as to its status (Hold, Released, OK, Not OK, etc.). Individuals shipping products will only select products that have a visible “released” status and this status is reviewed prior to shipment.
  3. Computer systems – this system involves a computerized inventory system that tracks through barcodes or other technology the status of all items. The system will select items to be shipped and verifies the released status of items before it will allow shipment. The system is validated to ensure that it properly functions under all circumstances.
  4. Combination systems – Most firms use a combination of approaches to fulfill this requirement. They may physically segregate and use computer systems. They may only physically segregate failing or non-conforming lots and use computer systems for typical operations.

The point is that GXPs allow us to design systems that fulfill the requirements, yet meet our own system needs.

Have you ever considered the origin of validation? Validation was not specifically discussed in the original GXP regulations issued in the 1970’s. Yet, it has become one of the most important elements of GXP manufacturing and testing. Validation originated because firms and regulators realized that we could never eliminate all risks in producing healthcare products. Thus, we needed a system for verifying that batches were consistent and acceptable beginning to end and from one day to the next. Validation became the means for ensuring that our components, processes, people, systems, testing, and controls all work together to provide consistency throughout the life of a process. Because we cannot test or inspect 100%, validation became the means for ensuring the quality of our products. Though most firms utilize similar approaches to validation, each firm must design its own approach.

My key point here is that there are multiple ways for complying with most elements of GXPs. The design of GXP requirements recognizes that each firm and each product is different. Finding an approach to comply and yet manage associated risks is the key challenge faced by healthcare industries. Someone once said (perhaps it was me) about those managing GXP operations:

“Anyone can make GXP decisions when dealing with black or white. We earn our pay by managing the gray.”

Finding a way to manage the everyday risks we face differentiates the excellent from the mediocre.

AVOIDING OR MITIGATING UNDUE RISK SHOULD BE OUR TARGET

If we cannot eliminate all risks, finding means to avoid or mitigate risks becomes our target. What risks are acceptable and which must be avoided? Much has been written about the topic of risk identification, assessment, and mitigation, so it is not my intent here today to restate that. However, I want to make two key points:

  1. We must identify our approach to risk tolerance – the first step in managing risks is to identify which risks we are willing to take, how far we go to mitigate these risks, and the potential impact if we are wrong. One approach is to develop a hierarchy for risk decision-making. When we understand our philosophy or approach to risk, that can guide the actions of every employee. For example, I have seen this hierarchy used:
    • Risk to patient safety – we will take no actions that will pose a risk to patients
    • Compliance to specific GXP requirements – we will always comply with specific GXP requirements
    • Compliance to industry standards or expectations for GXP requirements – we will always comply with requirements we know are expected
    • Internal values, policies, procedures, mores, or requirements – internal requirements are important, but will not take precedence over those above
    • Cost considerations – cost will never trump risks to patients, compliance, or company requirements
    • “Red-face” test – though our actions pose no patient risk, comply with GXPs, and follow internal procedures, would I be embarrassed by my actions if my spouse read about them in the newspaper?
    • Expediency or preferences – My personal preferences always come last
  2. We must communicate and formalize our approach to risk – In my experience, many of the product quality, compliance, and safety issues that have arisen are due to one individual making a decision in the midst or production or testing. Unless that individual understands the risks – and the company philosophy on those risks – undesired outcomes can occur. You cannot overemphasize your approach to risks in communicating to employees and in how you reward actions around those risks. In short, by developing a culture that clearly identifies, articulates, and rewards actions around risks, you enhance the potential for correct decision-making in the midst of problem solving.

BE WILLING TO DESIGN (AND DEFEND) SYSTEMS/PROCESSES THAT MAKE SENSE FOR YOUR OPERATIONS

Finally, understanding that risks are normal and that GXPs recognize that not all risks can be avoided, we must be willing to design systems and processes that make sense for our operations. AND, we must have the confidence and courage to defend these processes and systems when challenged. Many firms are so risk averse that they will spend any amount of money, take any amount of time, or expend any amount of resources to even avoid having to discuss it during a regulatory inspection (read “An FDA-483 observation is not necessarily the worst thing that can happen” in my book). This approach is not courageous or pragmatic.

“If every decision was black or white, they wouldn’t need you. Anyone can make that kind of decision.”

Be willing to defend what you do. Discuss the science behind your processes and systems. Demonstrate how you comply with GXP requirements and protect consumer safety. If you can do this with confidence, most regulatory investigators will be reasonable and open.

How to know when you are ready to retire

Today, I am sharing an excerpt from my most recent book, “Retirement is Underrated.” This chapter attempts to help you know when you are ready to finally make that difficult decision to break away from the workplace. Previous chapters have discussed in some detail each of the items included in the checklist. If you are interested in reading more, you can find the book on Amazon here (https://www.amazon.com/Retirement-Underrated-step-step-retirement/dp/B08W7DMX8X/ref=sr_1_3?dchild=1&keywords=eldon+henson&qid=1615902963&sr=8-3).

Overcoming the fears and anxiety of making that fateful decision

OK, now that you have a good handle on your financial situation, better understand your health insurance options, and feel you can transition to the “retired life,” what is keeping you from pulling the trigger and making that final decision? What is still holding you back?

Everyone has a different excuse for waiting to retire. For some, they want to finalize health items (such as a knee replacement). Others want to build just a bit more financial buffer. Still others want to ensure that they have everything at work in place before they go. Practical reasons hold back some, such as: “I’ll just wait until after bonuses are paid” or “I need to stay until after my daughter’s wedding.” I remember working with one man in the past that was still working as supervisor on a night shift. He was over 70 years old and I remember asking him why he still worked. His answer was, “There is so much drama around here, I just want to hang around to see what happens.” 

Let me offer a bit of courage or encouragement as you ponder the “when” question. Think of the 7 items below as your “to do” list. When you can check all of these boxes, you are ready:

Checkbox Checked with solid fillYour finances are in order – You have estimated your income and ongoing expenses and have confidence that you have adequate buffer to remain solvent throughout retirement. 
Checkbox Checked with solid fillYou know how you will approach health insurance – For those retiring before age 65, this means developing a plan to bridge that period until 65. This could be in the form of COBRA, Affordable Care plans, or private plans.
Checkbox Checked with solid fillYou are ready to make the emotional shift – You understand that your identity is not in your work, but in your character. You have a vision for retirement and have spoken to others about their experience and approach to retirement.
Checkbox Checked with solid fillYou have a plan for remaining physically active – You understand the need to have regular interaction with your physician and have plans for a lifestyle that involves activity.
Checkbox Checked with solid fillYou have identified a social network of other individuals – You and your spouse are ready for more day-to-day interaction. You have plans for staying in contact and re-acquainting with others to remain socially active.
Checkbox Checked with solid fillYou have assessed your need for part-time work – You have decided if you will work in retirement, what it will be, and how many hours per week you think is appropriate.
Checkbox Checked with solid fillYou have developed a plan for the first 90 days of retirement that will help your transition – You have a plan for how you will fill your time, what activities are important, and who will be in your social circle that cover the first 3 months of retirement.

If you can check each box, you are well prepared to make the move. Certainly, there is the feeling that, once you commit to retirement, there is no going back. That is true to some extent, but that should not inhibit your decision provided you have planned well.

In my own experience, the decision to retire was not all that difficult. I was able to check all the boxes for preparedness, but I do recall continuing to work for some time after I could have made the move. I used to say when others asked how much longer I planned to work, “I’m one bad day away from retirement.” Knowing that you can and are ready provides a significant sense of relief and confidence. Just knowing that you can make that decision any day provides an entirely different perspective as you make that drive to the office or worksite each day. 

I heard another retirement story just this week about an individual that delayed retiring. It seems this individual finally made the decision after a couple years of handwringing. His last day of work was on a Friday and his coworkers celebrated him with cake, punch, and a party. By Sunday, he had died. It seems he had a massive heart attack that he could not survive. The individual telling me this story, his coworker, said his death had a huge impact on others in that department. Many of his coworkers used his death as motivation to retire as soon as they were able. The man telling me this story ultimately retired the day after his 55th birthday. He said he never had a day in the 26 years since that he regretted retiring at that age.

Here is the bottom line… If you are ready financially, emotionally, and physically to retire, you have to ask yourself, “What is to be gained if I work one more day?” Maybe today is the day to make that decision and begin that important next chapter of your life.

In the next section of this book, we will look at “What’s next? Now that I’m retired, what do I do and how do I maintain the lifestyle I want?”

Best wishes to you as you contemplate this serious and life-changing decision.

What does it mean to be extraordinary?

I was struck by an Elon Musk quote: “I think it is possible for ordinary people to be extraordinary.” Sure, that sounds right… anyone can be extraordinary if they are just willing to do what it takes. All it takes is a bit of extra effort, right?

Let’s start by looking at the definition of extraordinary. A quick Google search says that extraordinary is very unusual, remarkable; going beyond what is usual, customary, or regular. In short, extraordinary means to be exceptional; above and beyond; outside the norm. It means not being content with just doing what it takes to meet minimal expectations.

So, how would I define extraordinary? What are some examples of extraordinary?

  • In the fall semester at a midwestern university, 11,653 students made the Dean’s List for academic achievement. That is almost 52% of all undergraduate students! That either means that the school is full of academically outstanding students or that high grades are so easy to attain that it is almost a failure if you do NOT attain the Dean’s List. Do not expect any special recognition, awards, or recognition for merely doing what is expected or what everyone should be achieving. Certainly, it is a good thing to make the Dean’s List, but when 52% of all students achieve it, it is no longer considered special.
  • Don’t expect a pat on the back when you show up for work on time or do the “ordinary.” At each of my former employers, we all developed an annual list of objectives for the new year. We tracked our performance against these objectives which were specifically discussed at the year-end performance review. I recall numerous conversations with individuals that I managed in which, because they achieved their objectives, they felt their rating should be “exceptional” or “above expectations.” Yes, they may have achieved or exceeded results on these few objectives, but they failed to excel in their ordinary, base job functions. In essence, their overall performance was merely average, though their objectives were met. Extraordinary means that you accomplish something few others can do. It means your performance was greater than 90% of all others doing similar work.
  • I don’t think I’ve ever spoken to a hiring manager that said, “I just want to hire an ordinary candidate for this key position. It would be nice to do better than that, but I’ll just take what I get and hope for the best.” NO! Any legitimate leader will always seek to bring aboard the very best individual possible. So, what do you look for to find an extraordinary candidate? What differentiates an extraordinary candidate from an ordinary one? Let me provide a few examples. An extraordinary candidate:
    • Can provide a portfolio of demonstrated competence in prior jobs – Simply “holding” a position does not necessarily equate to competence. When I was looking to hire an exceptional candidate, I looked for evidence that the individual performed at a high level AND worked to pass that competence on to others. An exceptional candidate makes others around him/her better.
    • Can provide a list of specific accomplishments – The best predictor of success in a new position is to observe value in past positions. Accomplishments are more than simply performing a task or job… it is providing value to the organization that is measurable and specific.
    • Is one that does more than the minimum – I usually look for examples of how the candidate volunteered or assumed project or outside assignments. A candidate that gets personally involved in making the organization better is an individual that I expect will do the same in our organization.
    • Is independent and will help us avoid “group think” – The ordinary person often merely hopes to get through the day without creating waves, issues, or questions. The extraordinary person is not afraid to speak up, to offer a new perspective, and will challenge the status quo.
    • Will represent your values and the values of your organization to others well – An extraordinary individual will always represent the organization well and will demonstrate loyalty and trustworthiness. I usually looked for how the candidate spoke of prior leaders and organizations for clues regarding their integrity.

Being extraordinary is typically a matter of choices. An ordinary person chooses to accept mediocracy. An extraordinary person will make the choices and sacrifices necessary to go above and beyond. It doesn’t merely fall into your lap. So, is it possible for an ordinary person to be extraordinary? I believe the answer is “yes”… but becoming extraordinary means that we often do more than is expected, give more than we thought possible, and serve others even when we don’t have the energy. Being extraordinary means that we choose to make a difference in the organization and people we serve.

How are you viewed by others? Do they speak of you as being extraordinary? Will your children and grandchildren think of you as an extraordinary parent or grandparent? Would your spouse call you extraordinary? Today might be a good day to pause and consider the choices we make and how we hope to make better choices tomorrow.

New Book: Retirement is Underrated!

Today, I’m pleased to say that my third book has been published on Amazon. This one is titled:

Retirement is Underrated!: Practical step-by-step guide for making retirement the best time of your life

It is available on Amazon here: https://www.amazon.com/dp/B08W7DMX8X/ref=sr_1_6?dchild=1&keywords=eldon+henson&qid=1612978814&sr=8-6 in either paperback or Kindle version.

For those of you nearing retirement or even looking forward to that day, this book will help you get there faster and enjoy it more.

Taking the initiative to enjoy what comes, to share it with others, and to make a difference in whatever we do will be the ultimate yardstick for determining the success of our retirement.

Take a look and see if this book will help you prepare for retirement, enjoy it more when you get there, and learn the importance of finishing strong.

What if every employee was just like you?

Today, I would like to share an excerpt from my book, “Achieving your best day yet! A more fulfilling career… a more impactful life.” I think this piece touches on the issue of assessing employee performance that every leader faces. Yet, this question can also serve as that internal gauge with which we assess our own value within an organization, our community, or even our family. Take a few minutes to consider this critical question…

What if Every Employee was Just Like You?

I have frequently had discussions with colleagues about how to assess the performance or attributes of other employees. For example, what factors tip the scale when an employee is on the borderline of the highest rating at year end?  When assessing an employee’s performance, you naturally look at both their overall positive and negative contributions to the team or company.  However, it is often a challenge to determine exactly which way to go when that employee is squarely on the borderline between the two.  Or, if you are struggling to determine whether to hire a candidate, you might find yourself weighing the pros and cons to make that final hiring decision.

One of the ways I look at this situation to assist my decisions is to ask these questions about that individual, “What kind of company would we have if every employee was just like him/her? Would we have a great company?  Or, would it be mediocre?  Would our customers love working with us or hate it?”  It is amazing to me that when I ask these questions, my answer almost always becomes clear.  You form the culture of a company or team person-by-person, action-by-action.  And, having the wrong person can either make an unbelievably positive difference or it can destroy the team.   By making promotion, rating, and hiring decisions based on this set of questions, you can often see clearly the direction you should go.

In the same way, I find that asking those same questions about yourself during an introspective moment can have a profound impact on your own performance and direction. You might ask, “Would this company or team be better or worse if every employee performed just like me?  Or, behaved just like me?  Or, served others just like me?  Or, cared for others just like me?  Or, went the extra mile just like me?  Would this be a better place or more encouraging environment if every employee was just like me?”  If you can be honest about these questions, you can reveal ways that you can become a better employee, better person, or better friend.

Likewise, this same set of questions can help you self-assess in other areas of your life. If every spouse was just like me, would our society be better, happier, and more fulfilling?  If every father/mother was just like me, how would the kids of this world be different?  If every neighbor in our community was just like me, would this be a better place to live?  If every driver was just like me, would our roads be safer and happier?  If every friend was just like me, what would be different about our world?  It is never too late to make a difference.  It is never too late to make those around you better.  It is never too late to turn a bad day for someone else into a good day simply by serving their needs.  In short, it is never too late….

(This book is available through Amazon.com at the following link: https://www.amazon.com/Achieving-your-best-day-yet-ebook/dp/B087ZRSXP8/ref=sr_1_1?dchild=1&keywords=eldon+henson&qid=1611286201&sr=8-1)

It’s not destiny, it’s a choice

Have you ever heard someone say, “I guess it’s just my destiny…” when discussing disappointments in life? I remember the story of one individual that frequently expressed his career disappointments. He was within a few years of retirement and lamented the fact that it seemed that everyone had passed him by. Whereas he believed he had worked conscientiously to serve his company, his title had never risen to that of younger, less experienced colleagues. He ultimately came to believe that “it was just his destiny” to fall short. He failed to realize that his own lack of commitment, dedication, and overall effort was largely to blame for his limited career.

Certainly, there are circumstances in life that we cannot control. Accidents occur. Downsizing happens. Pandemics emerge. Though we like to think so, we do not control every circumstance in our life. When things happen that are unwanted and unexpected, we can become upset, disappointed, and defeated. However, the one thing we can control in any situation regardless of our circumstances is our attitude. Wade Boggs, the Hall of Fame baseball player once said, “Our lives are not determined by what happens to us but how we react to what happens, not by what life brings us but the attitude we bring to life.”

So, you see, to a very large degree, our lives are largely not the result of random events that we neither control nor appreciate. Rather, our lives are defined by the choices we make, whether good or bad. When we learn this critical truth, our lives can change in ways we might never have considered. For example:

  • Your path in life is not defined by the disadvantages of your childhood, but by the choices you make to overcome them.
  • Your career is not defined by your title, your salary, or your office location, but by how you choose to treat others and the positive impact you make during that career.
  • Your relationships are not defined by mistakes you have made in the past, but by how you’ve used those experiences to grow and become a better person.
  • Your impact on others is not defined by what is visible on the outside, but by the visible manifestations of the character that resides on the inside.
  • Your future is not defined by the past, but by the decisions you make today.

Today would be a great day to put aside the belief that we have no control over destiny and believe that, to a significant degree, we determine our own destiny by the decisions we make.

Below are some thoughts from others that should also help you understand your own responsibility in creating your own destiny.

__________________________________________________________________________________________________________________

“The only person you are destined to become is the person you decide to be.” 
― Ralph Waldo Emerson

“Letting go means to come to the realization that some people are a part of your history, but not a part of your destiny.” 
― Steve Maraboli

“Destiny is not a matter of chance; it is a matter of choice. It is not a thing to be waited for, it is a thing to be achieved.” 
― William Jennings Bryan

“You are not the victim of the world, but rather the master of your own destiny. It is your choices and decisions that determine your destiny.” 
― Roy T. Bennett

“Don’t confuse poor decision-making with destiny. Own your mistakes. It’s ok; we all make them. Learn from them so they can empower you!” 
― Steve Maraboli

“The best years of your life are the ones in which you decide your problems are your own. You do not blame them on your mother, the ecology, or the president. You realize that you control your own destiny.” ― Albert Ellis

Christmas Memories

“Sometimes, you will never know the true value of a moment until it becomes a memory.” – Theodor Seuss Giesel (aka Dr. Seuss)

What do you remember about your Christmases as a child? Christmas was a big deal for my family. In fact, my mother would sometimes borrow money to buy Christmas gifts. Or, she would join a Christmas Club where you could contribute $5 or 10 a month beginning in January to have “extra” money for Christmas. 

Our Christmas tree was always up early to the point that by Christmas, thousands of dry, sharp needles had fallen to the floor. We decorated the tree with big light bulbs, glass ornaments that gradually reduced in numbers over the years, and an abundance of those silver foil icicles. 

We always visited Santa at the local American Legion Post and felt blessed to get a sack of chocolate cream haystack candy and an orange plus maybe a few nuts. 

Christmas morning was magical! We struggled to sleep and eventually, a rule was implemented that we could get our filled stockings any time after midnight, but we couldn’t wake up our parents until after 6am. Later, on Christmas Day, we visited my grandparents in the country.

At our own home, my wife and I have many special memories of Christmas. We always included church on Christmas Eve, special foods before bed, Swedish tea rings for Christmas breakfast, and fun family times on Christmas Day. 

On Christmas, I always remember the excitement my Mom and Dad experienced on Christmas. I remember our kids saying their parts in Christmas pageants. I remember assembling toys well past my own bedtime. And now, I remember more recent Christmases with our grandchildren. 

Yes, Christmas memories are special ones that should be cherished. I hope that in future years as my memory fades, I have somehow tucked these special memories in places that are protected and retained for the whole of my life.

Christmas should be cherished and savored, not rushed. I am hopeful that you are taking the time to soak in those special times you experience this season.

I am also reminded of the shepherds that were the first to hear about the newborn Savior on that first Christmas morning. In the book of Matthew 2: 9 – 10, it is said:

“An angel of the Lord appeared to them, and the glory of the Lord shone around them and they were terrified. But the angel said to them, ‘Do not be afraid. I bring you good news of great joy that will be for all the people.’”

The Good News… I hope that you believe that the real meaning of Christmas is that God became flesh and came to earth for us. He came to pay the price that we could never pay ourselves. The shepherds believed that. And, as a result, they were never the same. Experiencing the birth of Christ changed them. Hopefully, it has done the same for you. If you have not experienced this for yourselves, make this the year… make this the day.

“If you confess with your mouth that Jesus is Lord and believe in your heart that God raised him from the dead, you will be saved.” Romans 10:9

Have a Merry Christmas! I hope this is the best one you have ever experienced. I hope that you will pause to remember loved ones that have impacted your life. I hope that you will find great joy and create memories this year that never fade. All the best to you and your family from mine!