ADR’s Are Here To Stay, and Getting Worse

This is what happens when you have five years to do nothing other than think about what hit you, and how things could have — and should have — been different.    In this section and the next couple of ones, I express some of my views about ADR’s in general.

 

Pharmaceuticals and Their ADR’s Are Here to Stay

From the day we’re born in this society, and throughout our lives, our bodies and cells are assaulted not only with viruses and bacteria, but now, with legalized pharmaceuticals as well.    Numerous rounds of vaccinations start the day we’re born.   Pain medications from aspirin for mild aches to oxycodone for more serious or chronic pain will be offered.   Antibiotics of all kinds will be offered for simple, presumed, and suspected infections as well as more serious and complicated life-threatening infections.    Statins, insulin, and thyroid medication prescriptions start ballooning in the middle aged population, and will often be offered as a first line offense, before dietary and lifestyle changes.   If you ever need a surgery, you will be exposed to general anesthetics and pre-anesthetics, and if you ever get cancer, you will most likely be offered some form of chemotherapy drugs.    And huge amounts of psychoactive drugs, from innumerable anti-depressants and anti-anxiety pills, to sleeping pills, to ADHD and Alzheimer’s medication, will be offered for every stage of life, from the very young up through the elderly.  The direct-to-consumer marketing by Pharma, along with pills and medications of any type often being the first-line approach to any problem, guarantees that we can’t escape it.   Nearly 70% of the population is on one prescription drug, more than 50% are on two, and 20% are actually on five or more prescription medications in this country.   And this doesn’t even include all the illegal drug temptations – cocaine, meth, heroin, and others.  Both Pharma – and the Drug Cartels which are increasingly looking more and more like Big Pharma’s twin – appear to be winning the war on drugs.   “Just Say No” obviously hasn’t worked in the past and isn’t working now.

Every single person who is born in this country – and possibly in the world – will be exposed to some kind of legal pharmaceutical during their life.    And this means that every single person in this country – and probably in the world – will also be exposed to, and probably experience — some kind of adverse drug reaction (ADR) from those drugs.   These adverse drug reactions can range from a simple bout of transient nausea, slight rash, or “feeling funny”, to long term chronic pain and disability, to outright death.   But with ADR’s becoming the fourth leading cause of death in this country, a major reason for millions of ER visits, and leaving untold numbers of patients permanently disabled or harmed, costing billions of dollars extra annually, it’s a big problem.   And a growing one, as we continue to use increasing amounts of legalized pharmaceuticals throughout our lives from the day we’re born until the day we die.

 

Pharmaceuticals:  The Miracles and the Perils

If it sounds like I’m leading up to an “anti-pharmaceutical” rant, I’m really not.  People tend to forget what life was really like before the basics such as vaccination, antibiotics, anesthetics for pain free surgeries, and other drug classes came along.  Children died or were permanently crippled from polio.   People died from simple urinary tract or other infections turning complicated and deadly.     My parents lost childhood friends due to diphtheria, smallpox, tuberculosis, and infected broken legs.   In my own practice as a veterinarian, I helped and saved the life of many a pet with vaccinations, antibiotics, and other pharmaceuticals.    I also saw animals from underserved and low income areas die from preventable diseases due to lack of vaccination and antibiotics.  Pharmaceuticals have improved and saved many lives, sometimes miraculously.   There is absolutely no doubt that more people have lived longer and better quality lives as a result of the era of modern pharmaceuticals developed in the last 100 years or so.   I am one of them too.   I would not have made it past the age of 26 due to a one-in-a-million freak life-threatening condition requiring emergency surgery, complete with all the anesthetic drugs, pain medications, antibiotics, fluids, sterile technique, and all the wonderful knowledge modern medicine had to offer, needed to save my life.   So I’m a big believer in using the fruits of ethical curiosity-driven science and medicine in its truest, most honorable and noble form — to improve the health and welfare of individuals and society as a whole.

But as is typical with human beings throughout our history, if a little bit is a good thing, then more and more of it is supposed to be a better thing.   We appear to have moved from “a good thing” into excess mode, offering – or pushing – pills for almost anything you can think of (and hadn’t thought of until Pharma gave it a name or pointed it out).   “Pills for everything and everyone” may be a good goal for quarterly profits, but not necessarily for our health anymore.   Pharmaceuticals have also harmed many lives, sometimes irreparably (such as mine).    And Pharma, with their voracious appetite for marketing their products as the sole solution to any and every problem, along with minimizing or outright denying many of the ADR’s of their products, isn’t helping things any.   Increasingly, the benefits and even miracles of modern pharmaceuticals are being overshadowed by the ADR’s, the reckless and irresponsible use of them, and the distrust people are developing for “Big Pharma” in general.   I am one of those people now, too.   My healthy and active lifestyle came to an abrupt end with those few pills of a simple antibiotic that was supposed to be a safe treatment for my simple UTI.  The adverse effects are permanent, leaving me chronically disabled with pain and suffering, and constantly questioning if I have a quality of life worth living.   Pharma helped give me my life at age 26, but took it all away at age 50.   Ironically enough, one of the major claims of Pharma is that their products not only are supposed to improve quality of life, but extend it as well.   So according to Pharma, they were going to help me get into my eighties or nineties intact.   So much for that.

 

Warnings, Warnings, and More Warnings

I am just one of the millions of faceless statistics that occur each year.  ADR’s have become a big problem in this country.   Something needs to change, and avoiding pharmaceuticals altogether, which some extremists promote, simply isn’t going to happen, if the past is any prediction of the future.    There are numerous approaches and suggestions for tackling this growing problem, and for the most part, almost all of them involve increasing warnings to consumers/patients about the possibility and risks of adverse events.   For example, warnings are increased on drug labels, more warnings are added to pages and pages of package inserts, and “Black Boxes” are placed around warnings for extra emphasis.   Task forces, organizations, and websites abound to include even more warnings not covered by the other three so that patients can be “informed”.   Long monologues of warnings occur in fast talking commercials while happy music plays over visions of people with happy lives now that they’re on a drug that can cause long lists of problems, including “fatal events”.   Despite all these warnings, the problem continues, unabated.   And all these solutions have one underlying theme in common:  ultimately, this approach basically makes patients responsible and liable for any adverse events which may occur.   Pharma has “done their part” with their warnings, and the only other time they seem to take action post marketing when it comes to safety is when they are literally forced to remove a drug from the market with the threat of enough litigation.  But that’s not usually until thousands, or hundreds of thousands, or millions of people have been irreparably harmed or killed first and the legal profession has made millions in profits in the process.  Nowhere have I seen suggestions of a plan to make Pharma more responsible, accountable, or proactive and actively engaged in helping to solve the problem of ADR’s post marketing (through any route other than the long and arduous legal liability route).

I’m not against putting out more warnings for the drugs we take, whether those warnings come from the FDA or the general public.   If that’s the only or best route we have available to us right now, then I’m all for it.   And I’d like to give acknowledgement and a big “Thank You” to all the folks currently working hard on this particular angle of the problem, because it’s so important.   But having been a victim of a severe ADR myself, I found myself questioning a lot of things as a result.  And one of those things included wondering if there was anything that could be done to improve this situation, other than simply adding more warnings.

 

The Current Four Major “Solutions” to the ADR Problem

For the most part, consumers seem to accept this arrangement that shunts the responsibility of ADR’s away from Pharma, away from physicians and pharmacists, and directly on to them.   If one reads the “comments” section often provided to an article such as this one, or an article written by someone who was harmed by a drug and now wants to warn the public about it, some common patterns emerge in these responses.    I tend to lump these comments into one of four general response categories, which I call:   “Personal Responsibility”, “Every Drug Has Its Risks”, “Physician Knows Best”, and “Evil Pharma – Go ‘Natural’”.    The next time you read the comments under a news story or article trying to warn the public about how “Drug X” harmed them and could harm others, I’m sure you’ll quite easily see comments falling into one of these four categories for yourself.   In the next four paragraphs, I describe a little more about these “belief categories”.   Why?  Because each of them is always proposed as a “solution” to the problem of ADR’s, even though none of them works or actually protects the public from these ADR’s.  So let’s look at them in more detail.

“Personal Responsibility”:    The “Personal Responsibility” crowd believes that reading the warnings, the Black Boxes, and the pages and pages of information provided by Pharma and the FDA will somehow protect them from adverse events.  People who believe in this approach think that it is ultimately the consumer’s responsibility to decide whether or not to take a drug.  In five minutes or less, the consumer, who may know nothing or little about science, health, medicine, or pharmaceuticals is supposed to read the size 5 font on drug insert warnings, or better yet, the 20, 30, 40, or 50 page drug information package, and then, independently from their physician and pharmacist, evaluate whether or not they “should” in fact, take this drug for their condition.   The fact that Pharma has supposedly done the safety and efficacy studies, and that the FDA has approved the drug as safe, and that we as taxpayers are paying them for this service, means nothing.   The fact that their doctors and pharmacists, with years and years of combined education, are actively recommending this drug for them means nothing.   This is because consumers and patients as the final endpoint user are ultimately responsible for their choice (which by definition, means their decision is ultimately “independent” from anyone else’s).   They are just supposed to somehow know more than Pharma, the FDA, and the medical profession combined, as to whether or not this particular drug is safe for them and their individual physiology within minutes from the information, which is provided by Pharma and the FDA.   If you read everything you can and refuse to take the drug, you are considered a non-compliant patient, and an arrogant “know it all” by your doctors, and 100% to blame if your medical condition deteriorates as a result.   On the other hand, if you read all the information, and follow your physicians’ recommendations, and you experience an adverse drug reaction anyway, well—that’s your fault too.   You read the long list of possible adverse effects, and you knew the risks, so why did you take the drug?   Either way, you lose.   In my opinion, ultimately, there is very much of a “blame the victim” mentality with this approach, under the guise of “informed consent”.    The true fact is, of course, that you can read all about the adverse effects all you want, and if you decide to take the drug anyway because you’re feeling backed into a corner and desperate, all the reading in the world isn’t going to protect you.   Which leads us to the next category.

“ Every Drug Has It’s Risks”:    Then there are the folks who are resigned to “Every drug has side effects and risks”.   This group fully acknowledges this possibility, and are resigned to the fact that this is the way it is.    Basically it’s a numbers game that hopefully doesn’t involve them when it comes to the adverse effects.   Sometimes this group will also take the approach of “No one would ever take any drug if you read all the warnings, so don’t read them”.    It’s kind of a combination “fatalistic/hopeful” approach.   Fatalistic, because there’s nothing you can do about it except play Russian Roulette with these drugs.   Hopeful, because hopefully statistics are in your favor, Pharma and FDA and your doc has done their job and made sure this drug is safe for you, and you won’t be the one to get hit.   In a very real sense, these folks are hoping the FDA, Pharma, and the medical profession know what’s best and basically even admit it’s just kind of a “close your eyes” type of thing and hope it’s not you.   Even if they don’t trust Pharma or the FDA in the least, they are resigned to the risks — but can always hope.   Like the lottery, “someone’s gotta get hit” – but in this case you really really hope it’s not you.

“Doctor Knows Best”:   The “Physician Knows Best”, or “Trust Your Doctor” crowd is the one group that does tend to think someone else should at least share the blame of your adverse event, if not be outright responsible, and that someone is your doctor.  It’s your doctor’s responsibility to warn you, and be responsible for, all of the ADR’s of the drugs they prescribe.   Uh-huh.   Let’s see how well that works.   First of all, the doc’s information comes from Pharma, who is minimizing, ignoring, or outright denying these ADR’s as much as possible lest they lose profits.   In the same way that Pharma is trying to lie to you, they are trying to lie to your doctor – and often succeeding.  They are not only trying to lie to your doctors, they are trying to buy them too (See John Oliver’s “Marketing to Doctors“; skip to 15:20 for the “TV Commercial” if nothing else).    After that, there are hundreds, probably thousands of different medications out there your doctor “should know”.   With 10-50 pages of ADR’s and warnings for each of those drugs, I doubt your doctor – or anyone – is going to have all that information in their head.   That’s on top of knowing everything else they have to know about, like everything they learned in medical school and their specialties.   No one is a walking encyclopedia, and that includes physicians.   Lastly, with whopping 10-20 minute appointments, they better talk as fast as those folks on the commercials just to get it all out.   Somewhere during the appointment, they are supposed to listen to you and provide a diagnosis as well.    And if an ADR does occur?   Physicians don’t want to admit it for a whole bunch of reasons, and they won’t report them to the FDA either, for those same reasons.   You’re on your own again if you get hit.   Even if you think your doctor should be responsible for any ADR’s, you’ll find out pretty quickly that’s not the way it works if it happens to you.  There aren’t a whole lot of doctors who are willing to give up their entire career they worked a lifetime for, go bankrupt when they can’t pay back their hundreds of thousands of dollars in school loans they may still have as a result, and give up all the good the medical profession has to offer, just to stick their neck out and go against Pharma, and their hospital or office employer, for YOUR adverse reaction.   No matter how badly they may feel about what happened to you, it’s a hell of a lot easier for them to keep practicing while you become a long lost statistic.   And pharmacists?   Well they’re not to blame either – they simply hand out what the doctor ordered.

“Evil Pharma – Go Natural”:   Finally, there are the folks who turn away from Western Medicine all together.  This group often believes Pharma, the FDA, and the pharmaceuticals themselves are useless at best, and evil at worst.   There’s sort of this belief, at least during the younger years, that if you eat organic and healthy and stay away from pharmaceuticals altogether, that you’re guaranteed to live longer and healthier.   Some in this group turn to all manners of natural and holistic measures, including numerous dietary supplements, as a way to control their health.   People who would otherwise never trust money-hungry Big Pharma, or the FDA “in bed with them”, have no problem trusting any number of other for-profit unregulated companies who supply supplements often targeting the same receptors and enzymes and proteins that the corresponding Pharma drugs do.   I have nothing against dietary and herbal supplements.   They are a wonderful alternative that exists not only as a supportive adjunct to traditional mainstream medicine, but also instead of it when the traditional medical system completely fails a patient (which seems to be happening with increasing frequency).   If nothing else, the entire industry of modern alternative and complementary medicine exists simply because the traditional mainstream medical industry seems to fail in so many cases.   I was also a big believer in health, fitness, and a good diet, rarely using pharmaceuticals myself.  So much for that.   Obviously, that didn’t help me in the end, either.

 

ADR’s:  We Can’t Avoid Them

If it sounds like I’m maligning these group beliefs, I’m not.  After all, I’m a part of this too, and I’ve rotated in and out of most of these beliefs throughout my own life.   But no matter what camp you find yourself in, the day may come when, despite your best intentions, you will be exposed to pharmaceutical drugs and their adverse effects.   Even if you’re the type to avoid or outright shun Big Pharma, you may find yourself undergoing emergency surgery someday, with no possibility of review for “informed consent” given to you for any number of drugs which you may receive.   You may find yourself in a life or death situation, and you decide to undertake conventional treatment as a last choice.   You may be a desperate parent, who doesn’t believe in drugs, but you’ve tried everything else, you’re out of money, and your child appears to be schizophrenic and dangerous.    You’ve read all the drug warnings and you’re scared to death, but the pain or the risks of your condition are too great, you’ve got to get back to work, your doctors are all saying you need this drug, and you feel backed into a corner.   Maybe you were passionately anti-Pharma in your younger years, but things are looking a little different now at age 60 after a knee replacement, kidney or heart transplant, or bout of cancer – and you’re a little more willing to consider what Pharma has to offer.  There are any number of reasons that people who are against pharmaceuticals may end up taking them anyway, even for the extremists.   There’s simply no escaping them – or the ADR’s that accompany them.

ADR’s are here to stay, and the questions are:  Is there anything that can be done to improve drug safety for all without needing three degrees to read and understand the full biochemical implications of the fine print on ADR’s to help you make your “informed consent” decision, playing Russian Roulette with your life, or turning away from pharmaceuticals altogether?   Are we all doomed to reside in one of the four big “belief systems” that I described, with no other options available?  Is there anything different that can occur that might possibly help the situation?

I don’t know what the definitive answers are – or even if there are ones.  But that’s never stopped me from thinking about questions like these.  In the next couple of sections, I describe one of the ideas I came up with.   I wrote it based on the premises that Pharma, and ADR’s, are here to stay and that we need a different way of dealing with them than what is being done currently and has been done in the past.

 

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