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Adverse Drug Reactions (ADRs): We’re ALL at Risk

Published on February 26, 2024

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I’m lying in my bed, with my arms and legs straight out. I figured out pretty fast that any stress whatsoever on the tendons, makes things worse for days, weeks even. “Stress” includes not only trying to walk or use my arms or legs for any reason at all, but also simply bending my arms, or my knees, or my fingers, in one position for too long. What’s “too long”? Maybe 3-5 minutes or so. I can’t use crutches or a wheelchair, because both of those involve use of my arms and shoulders and hands, which are also out of commission. I can’t type or use the computer, because every tendon in my fingers, hands, wrists, and arms are affected and severely painful. I can’t hold up a book to read, because the weight of the book is too much and I can’t bend my arms, without increasing the tendon pain. The weight of the sheets on my toes causes severe pain in the tendons there. There must be tendons around the eye muscles too, because it hurts simply to move my eyes. So I lay there in my bed, with my arms and legs flat out, with my head still and my eyes closed, waiting. Waiting for what, I’m not sure. It’s hard to believe that I went jogging and bike riding and swimming only a few days ago. I’m also in shock. How in the world could a simple antibiotic that I took for a simple UTI do this to me?

My Journey into the Frustrating World of ADR’s Begins

In March 2010 I took the antibiotic Ciprofloxacin for a simple UTI, and within days became one of the millions of people in this country who experience an Adverse Drug Reaction (ADR) every year to a pharmaceutical drug that is deemed “safe” for use. My adverse reaction, as extreme as it was, unfortunately is not as “rare” as the public is led to believe. It turns out there were tens of thousands of other people, and possibly many times more that, also suffering from the same and similar reactions as I was as a result of this class of very popular antibiotics. There were no “Black Box Warnings” on my drug insert, and the warnings that were listed on the insert didn’t even remotely accurately describe what I was going through then, and continue to go through today.

I’ve been disabled ever since, often times going months without leaving the house, or even getting out of bed, as a result of those few pills. As I lay there waiting, I didn’t know if I was waiting to die or to live. With no known treatment, cure, or detox, or even any idea of why this happens in the first place to some of us, there was nothing left to do but wait. Whatever was known about these reactions came from the victims themselves, observations painstakingly accumulated over time, sharing information that was now available on the internet. Pharma, the FDA, and the medical and pharmacy professions were noticeably and conveniently absent in having any knowledge, concern, clue, or curiosity about these reactions and why this happens in some people, or what to do about it. Their role in all this apparently ended the minute I took the drug.

I’ve had plenty of time to lay around and think about things in the past five years, given that I can’t do much else. And understandably, I’m not too happy about this situation. It didn’t take me too long to figure out that my life, or what was left of it, was simply going to be a nameless, faceless, long lost forgotten statistic when it came to my ADR. There was no help on the way for me from the medical profession, the FDA, or Pharma to help me with my ADR, and as far as I could tell, absolutely no interest in learning anything from it by any of these parties either. And if there was one thing that became quite clear, it’s that everything was skewed in everyone else’s favor but mine when it came to my ADR. My physicians, pharmacists, the FDA, and of course Pharma, didn’t want to even acknowledge my ADR due to culpability and liability issues – which meant none of the numerous physicians I saw even bothered to report my ADR to anyone anywhere or the FDA. Without this acknowledgement, insurance companies didn’t want to pay for any “excessive testing” outside of the basic “Top 40 Diagnoses” screening tests for a non-existent problem. With “nothing wrong” on paper, I was denied any form of disability payments and probably considered to be a hypochondriac and/or malingerer trying to commit disability fraud. Even the legal profession, as hungry as they are for business, wasn’t interested in me once they found out I took the generic, since there is no legal recourse available with generic drugs. Everyone else in this chain of events walked away from my ADR unscathed, except, of course, me. I’m the one stuck living with it every minute of every day, with no assistance, and no end in sight. I’m the one scouring the internet, reading everything I can about my symptoms, reviewing the available research, paying for my own medical testing, looking for something, anything that will give a clue as to what this drug did to me and how to fix it.

The only other thing I can say about this scenario is that I’m actually not alone in my frustration and anger about this. There are millions of people out there who have been harmed by a pharmaceutical drug, vaccine, or medical device, in the same boat I am. Most of us have felt this same sense of abandonment by “the system”. Each one of us does the best we can, trying to figure out how to pick up the pieces of a life destroyed by a pharmaceutical prescribed to us by the medical profession, and deemed “safe” for use by Pharma and the FDA.

We’re All Sitting Ducks, Sacrificial Lambs, and Play Russian Roulette When it Comes to ADR’s

Several issues have become quite clear to me since I got hit with my ADR. First, is that for the most part, everyone, from Pharma to physicians and pharmacists, to end consumers like you and me, accept that ADR’s are a part of the deal. A lot of rules and regulations are in place in a supposed effort to ensure that a pharmaceutical is safe for “most” of the population. And therein lies the unspoken fact. At the end of the day, no matter how much effort has been put into safety, it’s accepted that there will always be some people that will react negatively to a drug. There’s an implicit acceptance, regardless of how unpalatable it might be, that “some always have to be sacrificed for the greater good”. We just hope that sacrificial lamb won’t be us or those we love.

Secondly, is that pharmaceutical use, and their ADR’s, are here to stay. In the US, 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. Between 1990 and 2008, U.S. spending on prescription drugs increased from $40 billion to $234 billion. And this doesn’t even include all the over the counter meds. As a society, “Just Say No” has never worked for any drug, and that includes legal pharmaceuticals. Increasing right along with this pharmaceutical epidemic, are the “serious and fatal event” ADR’s, which have quadrupled in the past decade, even by the woefully inaccurate and under reported FDA records. Every single person reading this is at risk for experiencing one or more ADR’s in their lifetime. These ADR’s may be mild and transient, or severe, disabling, and long term or lifelong. They might even be those “fatal events” the fast talking monologues on the drug commercials always warn you about. The point is, no one reading this is safe or exempt from them. Even people who are very “anti-Pharma” may find themselves on the operating table in the ER someday, being given any number of pharmaceuticals without the opportunity for “informed consent”. We are all at risk, and basically sitting ducks when it comes to ADR’s. I rarely took any medications or supplements, and had only taken antibiotics a few times in the first 50 years of my life. Despite that, I let my guard down once — it only took a few pills, and there was no going back from that mistake. I read the drug insert carefully, which talked about how a little transient mild nausea or GI upset might be the worst ADR, and further on down, mentioned “if you develop a pain in your Achilles tendon, call your doctor”. There was no hint in these warnings that these symptoms could be so extreme, permanent, disabling, and that “my doctor” had never heard of it and had no clue what to do about it either.

Third, is that pharmaceutical companies of course want to minimize, downplay, and outright deny ADR’s because they don’t want to open themselves up to culpability and liability issues and lose profits. From the limited “safety studies” that Pharma does on a drug pre-market, to “publishing bias” of only publishing research studies with data in their favor, to minimizing and hiding the adverse effects as they sell their products to the medical profession and us, Pharma does all they can to get a drug to market and profit from it. Once the drug gets to market, the big experiment occurs, as the drug is unleashed en masse on the general population. For those taking the drug, it’s essentially a game of Russian Roulette, no matter how “informed” you are. At that point in time, if things go wrong, it usually takes tens of thousands, hundreds of thousands, or millions of people suffering severe ADR’s before any action, if any, is taken (think Thalidomide, DES, and more recently, Vioxx). YOUR life may be wrecked, but it’s no big deal to Pharma, the FDA, or even your doctors. If you experience a severe ADR, their lives will continue on, while your life becomes just another long lost statistic, simply considered the “cost of doing business”.

Pharma: The Untouchable Behemoth

It can seem pretty hopeless at times. Physicians and pharmacists get their extremely biased information on the drugs they prescribe directly from Pharma via Pharmaceutical Sales Representatives. These reps get more training in marketing and selling, than in knowing anything about the products they’re selling. If the more curious and ethical physicians actually do take the time to look up the research, they will see biased research studies funded by Pharma, all minimizing the risks while highlighting the benefits. The FDA, who relies on Pharma to do the research studies and present the findings on safety and efficacy of drugs, as well as relies on Pharma as a large source of funding for their own organization, is equally in the dark and basically impotent, as they now see Pharma as their main client to serve, and not the public. And we, the people? We’re the sacrificial lambs, the sitting ducks, and the true massive post surveillant “research study” when we play Russian Roulette with safety and efficacy of any drug Pharma puts out. The icing on the cake for Pharma is that they can laugh all the way to the bank, no matter how many people are harmed, in the meantime. If, despite Pharma’s best attempts, a drug indeed is found to be unsafe, their main goal is to sell the hell out of it to keep bringing in profits until they are absolutely and overwhelmingly forced to remove it from the market.

This is nothing really new. If you live long enough, or read history, you will see the same old story over and over again, whether in the pharmaceutical industry or any other industry. And if you think your doctor or the medical profession is any smarter than the rest of us, think again. As I discussed here, in another writing:

“My own mother was “prescribed” cigarettes – yes, that’s right – as part of her “prenatal care”, she was told to start smoking by her doctor while pregnant with my younger sister “to prevent hemorrhoids”. We can laugh, or be aghast now at such a notion, but an entire generation, including the medical profession at the time, was repeatedly brainwashed by the corporations manufacturing these products, and they would leave no stone unturned in promoting the “health and safety” of their products for the sole interest of their own profits.” (See: here, and here. And for anyone wondering, the ‘science’ behind this is that nicotine constricts blood vessels. And yes, this is exactly how my mother started smoking at age 32).

I provide this example simply to highlight the fact that medical professionals are subject to the same corporate and cultural forces that we all are. Drugs that would never be blithely and indiscriminately prescribed today, such as Thalidomide, DES, Vioxx, and many others were routinely prescribed by physicians in the not too distant past, and this apparently includes “cigarettes” as well. The point being, is the drug your doctor prescribing you today the result of a judicious, prudent, and well thought out approach deemed absolutely necessary for your health? Or is it simply the latest fad promoted by Pharma, the next big blockbuster drug for their coffers, being offered you even when safer, less expensive, or better alternatives may exist?

“Your doctor” is subject to the same forces everyone else is, and they happen to be a very important target for Pharma in particular. Most physicians are honorable, trying to do the best they can with the information they have, but the fact is, they might not know any more than you do if what they’re selling (prescribing) you is a necessary and lifesaving drug, or a ‘cigarette’ of a drug. It turns out, when it came to my particular ADR, plenty of medical professionals have been hit and suffer from the same ADR’s. I sure wish I had known that before I took the drug, because now I’m one of them.

The odds are overwhelmingly in Pharma’s favor and against us. And despite everything I’ve written, I’m not really “anti-pharmaceutical”. I’m well aware pharmaceuticals and modern medicine have helped and saved many lives. I happen to love both science and medicine, and 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. The problem is, that’s not a description of current day Pharma. Phrases more apt to come to mind with the word “Pharma” now include: Corporate Greed, Profits at All Costs, America’s legal Drug Cartel, White Collar Drug Dealers, and “Pharmageddon”. The medical profession is allowing themselves to be reduced to Pharma’s “drug pushers”, pushing pills for everything and everybody even if they’re not necessary or downright dangerous, with drugs as the first and sole option offered even when other options such as healthy lifestyle changes can help.

Given these odds, is there anything we can do to protect ourselves? Is there anything we can do to demand change?

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More people than ever are reading Hormones Matter, a testament to the need for independent voices in health and medicine. We are not funded and accept limited advertising. Unlike many health sites, we don’t force you to purchase a subscription. We believe health information should be open to all. If you read Hormones Matter, like it, please help support it. Contribute now.

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This article was first published on June 8, 2015.

Iatrogenic Illness and Pharmaceutical Side Effects

by Mike Gaskins

Published on January 29, 2024

3718 views

Are you familiar with the phrase “iatrogenic illness”? An affirmative answer is more likely among the readers of this website than the public at large, but I would argue that even we (those of us who frequent this website) don’t give it the attention it deserves. In fact, if we changed the way we looked at iatrogenic illness, it could reframe the way we look at the entirety of medicine.

The Effect of Side Effects

Iatrogenic means an ailment that is actually caused by a medical examination or treatment. Perhaps the reason it receives less attention than it should lies in the fact that the classification would usually require an admission of guilt from the person most likely to identify it. Most doctors aren’t inclined to draw attention to the fact that something they did caused a new problem.

Consequently, we tend to associate iatrogenic illnesses with things like infection after a surgery, where it happens despite the medical team’s best efforts to prevent it. And, the only time we weigh the iatrogenic effect of pharmaceuticals being administered comes in extreme cases, like chemotherapy, where the patient and their family often weigh the quality of life versus the quantity.

However, we really should start considering the quantity of effect versus quality much sooner in life.

The Primary Effect

Think about the early development of a new drug and then consider this old phrase:

“There are no side effects, only effects.”

When a new drug is in development, the chemical engineers have a sense of what the desired effect will be, largely because most new drugs are variations on existing medications. But, this focus on a primary effect can lead us to discount the other effects on the body. It’s as if simply labeling an effect as a ‘side effect’ trivializes it in our minds.

What we must keep in mind is that by introducing these compounds into our bodies, we open ourselves up to the potential to experience any and all of the various effects. The doctor may give it to us to treat a specific ailment, but the reality is we’re susceptible to the entire array of effects.

Granted, these other ‘side’ effects may not happen as frequently as the ‘primary’ effect, but are drug makers still failing to give them proper attention as they weigh the benefit-to-risk simply because of how they may negatively impact marketing?

Creating a Drug Market

Let’s look at a couple of examples to see how marketing ultimately determines which is the ‘primary’ effect of a drug. We will begin with a brand so familiar it has almost become a generic term for analgesics.

In the late 1800s, an inexperienced pharmacist mistakenly sent acetanilide instead of naphthalene to a couple of French doctors who were experimenting with treatments for intestinal parasites. By chance, the doctors soon discovered the new compound reduced fever in some patients and later realized it offered some level of pain relief.

While unexpected, the ‘side’ effects were marketable. That’s why nearly 150 years later acetanilide, which metabolizes in the body to become acetaminophen, is still marketed under the brand name Tylenol, and has become synonymous with its ‘primary’ effects of pain relief and fever reduction, rather than its effect on parasite motility.

What about the other effects – the less marketable ones? Liver damage would probably fall into that category, And, despite the long history, researchers didn’t really start looking into the impact of acetaminophen toxicity on livers in both adults and children until this millennium. It makes one wonder how many people suffered severe liver damage before it caught researchers’ attention.

To some extent, the failure to notice the negative effects can be chalked up to human nature. As we look for the hook to hang our hat, we aren’t likely to notice the corner of the dresser until our little toe ultimately discovers it at a most inopportune time.

One Effect Stands Out

Drug makers aren’t completely oblivious to ‘side’ effects as they develop a new drug. In fact, they become acutely aware of secondary effects when they provide the potential for more profits.

It is a well-known story that the makers of one new drug being developed for high blood pressure and angina discovered that the drug also effectively induced erections in many of their male patients. Once they stripped away the labels of primary effect versus side effects, it probably didn’t take Pfizer’s MBAs long to recognize Viagra’s potential.

Rather than join the crowded, competitive field of blood pressure drugs, they had the opportunity to essentially create a new market catering to those suffering from impotence.

Of course, erectile dysfunction sounds much more like something that needs to be treated so they put their ad budget toward branding the ‘ailment’ as much as the new drug and it paid off in spades. Viagra managed to stay in the range of $2 billion in each year of its patent protection.

Don’t Take Your Eye Off the Ball

The drug and medical industries, which are so clearly on top of the ball when it comes to drug outcomes and profitability, have an abysmal record when it comes to drug outcomes and actual patient experience. It is precisely this focus on profits that clouds their vision, and turns side effects into new symptoms.

This is problematic with any drug, but none more so than with birth control because the patient is typically young and healthy. Plus, I can think of no other drug that is designed to be given to a healthy patient with the intent of stopping a natural process.

Given the disease-free state of so many patients who begin birth control, you would think this is one drug where it would be easy to identify an iatrogenic effect when side effects begin to arise. However, this is rarely the case, and the story of a young woman who recently contacted me provides a perfect example.

A Pattern of Side Effects

After seven years of taking birth control pills, Alexa changed over to the Mirena IUD. She began to notice facial hair growing and mentioned it to her doctor. He ran some tests and discovered her DHEA-S levels were high. A subsequent ultrasound revealed the classic string of pearls on her ovarian tissue, and she was diagnosed with PCOS.

When she questioned her birth control, the doctor insisted that she NEEDED to be on birth control or she would likely end up with endometrial cancer. She felt almost like he was using cancer to threaten her into continuing with birth control. He began to discuss other medicines she would also need to treat her condition.

But, she knew that her ovaries had been fine before starting on Mirena, and just couldn’t accept what the doctor was telling her. She searched online and found the patient information pamphlet for her IUD and learned that the documented side effects include “cysts on ovaries” and “facial hair.”

Alexa opted to take supplements to help balance her hormones and began charting her cycle after removing the IUD. Her cycle normalized quickly, her mood stabilized, and her energy rebounded.

It was the first time she began to realize how much the synthetic hormones had dragged her down over the years. She began to take inventory of all the “symptoms” that she encountered after starting birth control that might have actually been “side effects.”

Not only had the doctor recently missed that the two symptoms (facial hair, ovarian cysts) he used to diagnose PCOS were clearly listed as side effects of the contraceptive device he inserted, but she began to question previous interactions.

The IUD contributed to multiple vaginal infections, which in turn, led to several antibiotic prescriptions, but her doctor never acknowledged that the IUD could have played a role, even though these types of infections had never been a problem prior to the IUD.

She could see a pattern developing.

Then, she remembered when she first started taking The Pill at age 15. She experienced her first bouts of depression, which triggered new scripts for Paxil and then Lexapro.

Depression and anxiety represent some of the most common side effects of hormonal birth control. Yet, they are treated as mere symptoms of a new, unrelated disease by a vast majority of doctors.

A Cascade of Symptoms

I wonder how many young women have lived a similar experience? They unwittingly trade in their health for a cascade of symptoms.

When you hear a story like Alexa’s, you begin to understand why 131 million people in the US take at least one prescription drug, with the average being 4 prescriptions. We lead the world, spending $1,376 annually per capita on these drugs, nearly 50% more than our nearest competitor, Germany.

I don’t mean to insinuate that these new symptoms aren’t in fact new diseases. The subsequent effects of birth control often manifest as long-term, even chronic, new diseases. It isn’t uncommon for synthetic hormones to trigger an autoimmune disease, nor is it uncommon for depression to linger long after a woman stops taking birth control.

These long-term consequences are precisely why the next time your doctor casually hands you a prescription and you feel compelled to bite your lip and not ask the questions bouncing around in your head, ponder the phrase “iatrogenic illness” and don’t be afraid to start questioning the doctor.

After all, you will be the one living (or dying) with the consequences.

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More people than ever are reading Hormones Matter, a testament to the need for independent voices in health and medicine. We are not funded and accept limited advertising. Unlike many health sites, we don’t force you to purchase a subscription. We believe health information should be open to all. If you read Hormones Matter, like it, please help support it. Contribute now.

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This article was originally published on September 26, 2022.

Adverse Drug Reactions Are Like Earthquakes

by Lisa Bloomquist

Published on September 25, 2023

6886 views

adverse drug reactions are like earthquakes

I often compare adverse drug reactions to earthquakes. People die in earthquakes. More people die from taking pharmaceuticals. Per Ethicist, Dr. Donald W. Light, “Every week, about 53,000 excess hospitalizations and about 2,400 excess deaths occur in the United States among people taking properly prescribed drugs to be healthier. One in every five drugs approved ends up causing serious harm, while one in ten provide substantial benefit compared to existing, established drugs.”

Earthquakes destroy lives, homes, towns, bridges, cities, etc. Likewise, pharmaceuticals can destroy muscles and nerves, induce peripheral neuropathy and mental illness, lead to a variety of multi-symptom chronic diseases, etc.

Earthquakes happen suddenly and without warning. Systemic illness brought on by pharmaceuticals often also happens suddenly and without warning. A myriad of symptoms can afflict a victim of pharmaceuticals in a matter of weeks or months – essentially simultaneously. It is as if every cell in the body of the victim has been shaken and damaged – leaving chronic illness and pain where health, wellness and vitality once stood.

There is ongoing damage after an earthquake. Aftershocks occur. For those suffering from chronic illness brought on by a pharmaceutical, relapses can occur. A new insult to the system, even one that would be benign to someone who was not already knocked down, can throw a person suffering from an adverse drug reaction into a tailspin of pain and suffering.

There is collateral damage after an earthquake when deaths occur not from the shaking of the earth itself, but from the damage done by the earthquake. When a person is hit by a pharmaceutical induced illness, there is also collateral damage. Not only does the health of the victim suffer, but other areas of life do too. Their relationships are burdened. Jobs are often lost. Homes are often lost. Money is lost.

Infrastructure is damaged when an earthquake hits a city. Systemic, chronic pharmaceutical induced illnesses (as opposed to allergic reactions or transient, easy to treat “side-effects”) damage multiple systems of infrastructure within a victim’s body. Systems upon which all aspects of health are built – the microbiome, the endocrine system, mitochondria, cellular homeostasis, etc. – are shaken and damaged by pharmaceuticals.

Earthquakes are terrifying to live through. So are adverse drug reactions.

Earthquakes vary in intensity. So do adverse drug reactions.

Some cities recover from the earthquake that knocked them down. Others are so devastated, so destroyed, that they will, sadly, never recover. The same is true for victims of adverse drug reactions.

The metaphor is apt but it is not complete (no metaphors ever are). There is one huge way that adverse drug reactions are nothing like earthquakes.

Earthquakes are natural disasters. Adverse reactions to pharmaceuticals are man-made disasters.

No one is held responsible for the earthquake, because no one caused the earthquake. It is a natural event and we are all at nature’s mercy. Pharmaceutical induced illnesses are not something that happens in nature or something that happens because of fate; they are something that occurs because of the negligence of companies and the humans that operate those companies. The makers of pharmaceuticals should be held responsible for the damage that their products do. There should be justice for the victims of pharmaceuticals.

If you’re hurt by a drug, you can sue, right? After all, the United States is the most litigious country in the world. People sue for all sorts of things all the time, surely those who are legitimately hurt by pharmaceuticals have legal recourse, right? And the legal system must be keeping pharmaceutical companies from hurting people, right?

Unfortunately for both the victims of pharmaceuticals, justice for victims is rare. Victims are unable to gain justice for multiple reasons, one of which being – if the “side-effect” of a drug that you suffer from is listed on the warning label for the drug, you can’t sue the drug companies for failure to warn. For example, if you suffer from repeated tendon ruptures that lead to pain and disability after taking Avelox/moxifloxacin, a fluoroquinolone antibiotic, you can’t sue the manufacturer (Bayer) because the warning label states that Avelox and other fluoroquinolones “are associated with an increased risk of tendinitis and tendon rupture in all ages.” Never mind that the warning label says nowhere that the structure of every tendon in your body can be altered permanently by the drug – lawyers won’t take the case because patients were “warned” by the label.

The Supreme Court did victims of pharmaceuticals no favor when they ruled on June 24, 2013, that generic drug manufacturers could not be held liable for the effects of the pharmaceuticals that they manufacture. A New York Times piece pointed out that, “The decision is a significant victory for the generic drug industry, but further narrows the recourse for people who are injured by such drugs.” People who have been hurt by a drug manufactured by a generic drug company have no recourse now – no chance for justice – regardless of how horribly they are harmed by a drug. Lawyers aren’t even looking at cases for people hurt by generic drugs.

Justice isn’t easy to come by. It rarely happens for victims of pharmaceuticals.

Pharmaceutical induced illnesses are just like earthquakes. No one is held responsible for the damage done. There is no justice for the victims. They are left to pick up the rubble of their lives on their own.

Information about Fluoroquinolone Toxicity

Information about the author, and adverse reactions to fluoroquinolone antibiotics (Cipro/ciprofloxacin, Levaquin/levofloxacin, Avelox/moxifloxacin and Floxin/ofloxacin) can be found on Lisa Bloomquist’s site, www.floxiehope.com.

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More people than ever are reading Hormones Matter, a testament to the need for independent voices in health and medicine. We are not funded and accept limited advertising. Unlike many health sites, we don’t force you to purchase a subscription. We believe health information should be open to all. If you read Hormones Matter, like it, please help support it. Contribute now.

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This article was originally published on June 23, 2014.

The Promise of Drug Safety

by Mike Gaskins

Published on August 24, 2023

1481 views

What they say:

“Birth control is the safest, most tested drug on the market.”

What their tone says:

“Did you just crawl out from under a rock?”

I am not even sure the drug companies say this anymore. They don’t need to. It is buried into the psyche of a significant number of people who are willing to repeat it ad nauseam. Consequently, the masses hear it so frequently that they accept it as truth. It has become a part of our collective consciousness that few people question.

These implied messages that exist as a sort of “common sense truth” in our culture are not limited to birth control. Drugs occupy such status in our zeitgeist that you could probably quote a mantra implying the safety of nearly any of the most familiar drugs.

“Statins have been around for decades, and they’re the most prescribed drug in the world.”

“Accutane has to be safe. They wouldn’t give teens a dangerous drug for something as innocuous as acne.”

“Ritalin is a cute little pill they give kiddos to help them sit still.”

As Georg Cantor famously said, “A false conclusion once arrived at and widely accepted is not easily dislodged; and the less it is understood, the more tenaciously it is held.”

Beyond Statins and Birth Control

Pharmaceutical companies cultivate and manipulate these implied messages to their benefit. They know that we want their pills to work, and we want to believe any bad outcomes are rare. Consequently, we do not question the commonly accepted messages… until it is too late.

It would be an understatement to say Larry and his wife, Carly learned that the hard way. As Carly studied to become a nurse, she became more aware of the side effects associated with the steroids in hormonal birth control. She assumed she was safe because she had been taking them without issue since she was 18 years old.

However, when she turned 32, she discovered the limits of that carefree confidence. While undergoing a scan for something else, Carly learned that her liver had several large lesions, known as adenomas. The doctors told her they were a rare side effect caused by her hormonal birth control, and if left unattended, they could become cancerous. The doctors highly recommended surgery to remove the lesions.

The implied message behind the stated “rarity” of her condition was that Carly had simply lost the genetic lottery. She did not question how rare adenomas as a birth control side effect actually are.

Ultimately, she elected to have the expensive and very painful surgery to remove the large lesions. Then, she and Larry returned to life as normal. By itself, this event was not enough for them to seriously question Big Pharma’s implied messages – because said messages are “not easily dislodged.”

A Weakened State

A couple of years later, Larry started to notice he was losing strength in his arms and legs. At work, he found it harder to lift gear that had previously been no problem. As things progressed, he noticed that all his motor skills were getting “sloppy.” His feet felt floppy and kind of slapped as he walked.

He discussed it with Carly, and they agreed that it probably had something to do with his Ehlers-Danlos syndrome, an inherited disorder that had affected his joints for most of his life. They hoped that building in more time to rest and not overdoing it at work would help. However, over time, things progressed, and Larry feared it was something worse. Lately, he had trouble eating correctly and swallowing. Even breathing had become more of a task than any involuntary bodily function should be.

The couple began visiting specialist-after-specialist in an effort to untangle the mystery that was quickly growing more urgent. Multiple tests, scans, and even a $20,000 whole exome study of his DNA offered little more than educated guesses. The couple was told that Larry could have everything from ALS (Lou Gehrig’s disease) to limb-girdle muscular dystrophy, and with each pseudo-diagnosis, the implied message was that he had been issued a death sentence.

The specialists made little effort to hide that they were grasping for straws with each diagnosis; many seemed uninterested in the challenge of digging for a real, substantiated diagnosis. But, Larry and Carly found hope in one neurologist who seemed genuinely interested in finding answers for them. Her passion and dedication kept them going — right up until it became the vehicle that delivered them to their lowest point, when she told them that she was moving away because New Orleans had become too unsafe.

Out of the Darkness

Mentally, the couple felt like they were flailing out of control. With the exodus of their favorite doctor, the insurance company said their only option was a residency clinic. Larry was not excited about turning over his complicated case to a resident. How could he expect a medical student to find answers to an enigma that had stumped so many experienced physicians? But, if something is presented as your only option, you tend to roll with it, and that’s what Larry did.

The sympathetic young doctor-in-training listened intently as Larry laid out the narrative of his complex “patient history.” When he mentioned their attempts to land an appointment with the leading neurologist in the state of Louisiana, the resident said he might be able to facilitate a meeting (if not an appointment). That doctor’s office was right across the hall, and the resident thought he might be able to arrange something.

This was huge! The doctor’s schedule was packed, and there was no chance he would be taking new patients anytime in the near future.

Indeed, the good doctor agreed to meet with them after completing his rounds one evening. They sat on a hospital bed at the end of a long corridor waiting as the sun outside faded into evening. The anticipation made the wait seem longer, but it was worth it the moment he stepped into the room in his jeans and a polo shirt.

While this was not an appointment, the couple clung to a hope that his forensic analysis of their journey could lead to some pearls of wisdom. Maybe he could steer them in a new direction – anything that could help them feel like they weren’t just wandering through the desert alone.

For the next two hours, they shared every detail they could recall. The doctor interjected occasionally to ask questions. Most of his curiosities had already been explored. Disappointment was welling up in their souls. As the meeting began to wind down, it felt like this was going to be yet another pointless waste of time, but at least they did have the curiosity of a great mind that was now thinking about their case.

Then, as he was leaving the room, the doctor turned around and asked a question that changed the course of their lives forever, “Are you taking statins?”

Are You Taking Statins?

Even though Larry affirmed he was taking Lipitor and that the symptoms had commenced shortly after he started taking the drug, the doctor said it was a long-shot, but he asked them to run a test for anti-HMGC Reductase antibodies.

The test came back positive, and Larry was informed that he had a VERY rare disease known as statin-induced necrotizing autoimmune myositis. The implied message – he had really lost the genetic lottery. What are the chances that one couple could end up with two of these lottery tickets from hell?

We will get back to that. But first, this was not the end. It was the beginning of a different journey!

Sure, Larry had a diagnosis in hand, but he also had a LONG road ahead of him. The “implied messages” became much more overt.

What they said:

“We don’t see you going back to work…”

“You’re on disability, right?”

“You can get extra services if you will just apply for Medicare…”

What their tone said:

“This is your lot in life.”

“You will never be independent again.”

“Give up!”

Larry and Carly literally had to fight for his right to be self-sufficient. Carly spoke up when she thought his prednisone dose was too high. She used her medical knowledge as a nurse to be a strong advocate for her husband.

When one doctor expressed doubt that Larry would ever be able to regain his strength and essentially suggested they should give up, Carly exclaimed, “Get him back to 40%, and he will run the rest of the way!”

Striving for Normal

The trek back to (almost) normal has been and will continue to be arduous. Here’s what the treatment looks like that keeps Larry alive. Two days every month he goes into his doctor’s office to receive an IVIG (Intravenous Immunoglobulin) injection, which is a biological agent of pooled antibodies from thousands of people around the globe. Each injection takes six or seven hours and costs $64,000. That’s a little over $1.5 million per year.

On top of that, Larry takes 21 pills every day. That costs him about $500 per month out-of-pocket with his insurance plan.

So far, Larry’s insurance has covered the treatment, but he fears the day will come when they find a way to drop him. He has already had a taste of what life would be like without this treatment plan. The demise would be quick. His ability to walk and lift objects would go first, then his ability to speak. After that, he would need a feeding tube and then a respirator that would simply prolong the agony.

But, Larry does not dwell on what could be. He is too busy living his life and being grateful that things are (almost) back to normal. With that normalcy, Larry and Carly have begun to question some of the “common sense truths” and “implied messages” tied to the drug industry, “truths” that might actually be more like the “false conclusions” Georg Cantor spoke of.

Cholesterol as a Four-Letter Word

Most Americans grow up thinking of cholesterol as a bad word. More recent attempts to distinguish between good and bad cholesterol have done little to shift this perception. Before questioning some of the commonly held beliefs about statins, it is necessary to reframe our understanding of cholesterol.

First, your liver and intestines make cholesterol naturally, and let’s be clear – that is a good thing! You need cholesterol because it plays a key role in the production of vitamin D, bile, and hormones. It is also an essential building block of cell membranes throughout your body, and only about 20% of your cholesterol comes from the foods you eat.

Cholesterol is a waxy substance transported throughout the body by particles made up of proteins and fats, known as lipoproteins. There are two main classifications of these particles: high-density lipoproteins (HDL) and low-density lipoproteins (LDL), which you most likely know of as “bad cholesterol.”

The belief is that these low-density lipoproteins can form fatty deposits in your blood stream. If their levels get too high, they can interfere with blood flow and could eventually contribute to blood clots.

The Role of Statins

By 1976, the villainization of cholesterol had been in full-force for years, and researchers knew that the enzyme, HMGC reductase, controlled the rate of cholesterol production in the body. So, Japanese microbiologist, Akira Endo’s discovery of a biological agent that inhibited the production of this enzyme sent the drug industry into a frenzy.

From there, the developmental plan was pretty straightforward. They would create a drug that throttled the liver’s natural production of HMGC reductase. This would lead to less cholesterol, and theoretically less heart disease. And voila, you would have another new drug that could be handed out like candy.

Today, statins are the most prescribed drug class in the United States, with nearly 40 million people taking them every day. They also lead the way in the United Kingdom with nearly six million Brits taking them daily. However, continental Europe has taken a different approach, and the fallout has led to what has been labeled a Statins War.

While the US and UK have moved toward prescribing statins for anyone with a 5-10% risk of cardiovascular event, other European countries contend that the risks of side effects do not justify such a low threshold. For many of these countries, statins are only prescribed to try and prevent a second heart attack.

What Are the Risks?

Critics suggest that even the attempt to isolate “bad cholesterol” is based on a fallacy. They maintain that the body produces both forms of the lipoprotein for a reason, and that there has been no evidence proving a link between LDL and heart disease. However, statins have definitely been linked to some significant side effects, such as increased risk of Type 2 diabetes, memory loss, and muscle damage. In fact, one of the most common complaints associated with statins is muscle pain ranging from mild to demobilizing, but the industry has made a concerted effort to downplay this concern.

They claim your chances of experiencing any kind of muscle pain is only about 5%. Despite being such a low percentage, the drug companies allege that enough people have heard about muscle pain as a consequence that it has spawned what the industry describes as a kind of phantom, psychosomatic pain. In a play on the term “placebo effect,” they call it a “no-cebo” effect. In other words, the pain you think you feel is not real.

Their ironic, illogical attempt at drug-splaining has made its way into your local doctor’s office as well. When physicians were at a loss in diagnosing Larry’s ailment, they suggested he might be faking the symptoms – this is a common philosophy of modern Western medicine – “When in doubt, gaslight the patient.”

Muscle Damage

Scientists do not yet know exactly how statins damage muscles, or why it affects some people more than others.

Statins were designed, developed, and marketed with the entire focus on how it affects the production of a single enzyme within the liver. It accomplished what they wanted, but they ignored the unintended consequences.

Anytime you throw a natural process out-of-balance, secondary effects will occur. Recently, a team at the Max Delbruck Center (MDC) in Berlin conducted a study to see what effect the removal of this central enzyme might have on muscle tissue. They discovered that some 2,500 genes in the cells regulated differently, and this altered the production of more than 900 proteins. The head of MDC’s Myology Lab, Professor Simone Spuler concluded, “It is quite obvious that normal amounts of statins applied as active substances exert dramatic structural, functional and metabolic effects on the muscles.”

So, we may not know exactly how statins damage muscles, but we can see mountains of evidence that confirm something unsavory is happening. Perhaps doctors should stop acting surly when they don’t have answers and focus on finding those answers instead.

Inner Strength (and an Awesome Wife)

There are a lot of things that Larry wishes would have happened differently, beginning with that fateful day when his doctor first prescribed Lipitor. His cholesterol test came back a little high for the first time ever and because of his family history the doctor strongly recommended he start statins. Larry asked if he could try exercise and changes to his diet first, but the doctor insisted.

Larry tries not to dwell on the past or things he cannot change now. He accepts that his diagnosis is incredibly rare. However, he also knows that it is probably severely under-diagnosed. Very few doctors have the patience and wisdom to sleuth out this diagnosis.

Beyond that, he knows that muscle damage in general is not nearly as rare as the industry would have us believe. Some studies show that up to 20% of people who take statins develop myopathy.

Now that Larry belongs to the world of those who have been injured by statins, other people share their stories with him. He is blown away by the number of people who tell him they had to stop taking statins because the muscle-related side effects were affecting their quality of life. This is not a rare problem.

In the end, Larry no longer cares whether he lost the genetic lottery or any of the other implied messages they may want to throw at him. He knows a lot of women would have run away after hearing what his recovery process was going to be like, but Carly showed a resolve and determination that was almost superhuman – still working her nursing job through the day and then coming home to help him sort through his recovery. Her dedication and faith in him is what inspired him to take off running when they got him back to 40%.

Though necrotizing autoimmune myositis will always represent a persistent, unpleasant wrinkle in his life, Larry celebrates the accomplishment – knowing that he has not let it define him nor dictate how he lives his life.

Carly, too, considers herself fortunate that the damage inflicted on her body by hormonal birth control was not worse, for it surely could have been.

A New Resolve

Ultimately, the monstrous attacks on their bodies at the hands of dangerously overprescribed pharmaceuticals solidified their marriage. Each had the opportunity to demonstrate their commitment, not only to each other, but to the oath that joined them in sickness and in health. In the battle, individually and collectively, they developed an immunity to the implied messages of modern medicine and the tone in which they are delivered.

In their triumph, they have become health advocates for themselves and take nothing the doctors say at face value.

Perhaps Larry and Carly’s spirit of determination can inspire us all to cling to this new, and very real “common sense truth.” We should strive to be advocates for our own health and make sure we are fully informed before consenting to any treatment, especially when it involves a drug that is handed out like candy.

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Thinking About Side Effects

by Chandler Marrs, PhD

Published on September 29, 2022

5008 views

I have been thinking a lot about how we characterize the side effects of drugs. Truth be told, that is a topic that I have pondered on a number of occasions since beginning this website. More often than not, we have no idea about the true breadth and depth of these reactions. We think we do, because assuming some semblance of understanding, even an incomplete one, is what allows us to operate in this space, but when we unpeel the layers of that supposed understanding, it is difficult not to be impressed by how little we actually know.

The manufacturers of these products are required to report adverse reactions and side effects before a drug reaches the market and surveil reactions in the broader population after it reaches the market. From here, regulatory agencies, physicians, researchers, and consumers are expected to trust that we know how these drugs do or do not work. Importantly, we are encouraged by this understanding that any negative reactions experienced will be rare, time-limited, and easily mitigated by other medical products. The possibility that there might be side effects not identified by the original research, that ‘rareness’ is relative, and that ill-effects may not be time-limited or easily corrected is difficult to digest. It throws a wrench in the very foundation of the heavily fortified trust in all things modern medicine.

In reality, it is very difficult to ascertain the scope and depth of potential side effects. This is due in part to the complexity of the interactions between the drug, the human, and the totality of his/her environmental exposures and stressors and in part to the economic underpinnings of these endeavors. If one had to include a broader array of variables in a drug trial, no drug would ever be approved, at least not in a timely or cost-efficient manner. Instead, the initial trials utilize the most healthy of participants, perhaps excluding the disease process in question, and all other variables are excluded, both from the subject pool itself and analytically. Who wants to trial a drug on individuals typical of those who would be taking the drug; on individuals with multiple, often chronic comorbidities, for whom both chronic and acute polypharmacy are the norm and not the exception? No one. That would unfavorably skew the data. Better to have a clean subject pool and limit a priori what might be considered an adverse reaction to those that fall within the typically narrow anaphylactic framework and those that are directly related to the purported mechanisms of action of the drug itself. Addressing potential off-target effects must be eliminated or minimized; ditto for potential interactions between the drug and the unique characteristics of the individual. A clean sample and favorable data are the goal.

To that end, adverse reactions research, analyses, and reporting become a ‘see no evil’ approach. If we do not acknowledge the possibility that these reactions exist, then for all intents and purposes, they do not. This means that only the most severe and ‘on-target’ or anaphylactic reactions may be recognized. Any off-target reactions or side effects are labeled as rare and attributed to extraneous variables, unrelated to the drug but entirely related to some inherent weakness of the human who takes the drug.

If confronted with the prospect of negative reactions or even simply negative data e.g. the drug does not work, it is incumbent upon those involved to utilize analytical tools that highlight the good and hide the bad. Data or participant responses that do not fit the desired narrative must be cleaned or removed, post hoc. When that does not work, it is common to select complex statistical methods that no one but the statisticians themselves understand to obfuscate negative findings. Inasmuch as few physicians and even fewer consumers understand even the most basic statistics, this all but eliminates any questions regarding the veracity of the findings. What is written in the abstract or summary is all that will matter. The lede is buried in the stats so that everyone involved might trust in the medication’s safety, trust in their own knowledge, and move comfortably along with their lives.

I admit, this is a cynical perspective, but it is hard-won. After a decade of publishing HM, researching the analytical methodologies employed by drug companies, of investigating the mechanisms of action of many popular and presumed safe drugs, it is difficult not to be jaded. So flimsy are the safety and efficacy data that one is hard-pressed not to question everything. And so here I am amidst a global pandemic for which multiple products have been rushed to market. Pressure to use these products is intense and I and others are left with the sinking feeling that we do not yet know what we think we know about these products or even what we do not know. What we do know is that the developers and manufacturers of these products have a long and well-established history of shady research practices, of burying negative data, of vilifying anyone who questions these practices, and of financing unquestioning support from politicians, ‘thought leaders’, media, and generally, anyone who might be of use. It is not difficult to recognize those same practices at play here but the desire to be safe quells those concerns for most. We’ll take anything and do anything to end this mess, except perhaps ask why we are here in the first place.

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More people than ever are reading Hormones Matter, a testament to the need for independent voices in health and medicine. We are not funded and accept limited advertising. Unlike many health sites, we don’t force you to purchase a subscription. We believe health information should be open to all. If you read Hormones Matter, like it, please help support it. Contribute now.

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This article was published originally on November 4, 2021.

The Epidemic of Silence with Adverse Drug Reactions

by Lisa Bloomquist

Published on July 26, 2017

3903 views

One of the more bothersome feedback loops that keeps adverse drug reactions from being recognized is that patients stay silent about their pain and suffering, and therefore their pain and suffering is not recognized or appreciated, and everyone gets to continue to think that dangerous drugs are safe and that adverse reactions are rare. Seeing is believing and neither doctors nor other patients see the ill effects of drugs, in part because we aren’t screaming.

Of course, there are some patients who are screaming at the top of their lungs about the pain and suffering caused by the drug that hurt them – Gardasil, Fluoroquinolone Antibiotics, Lupron, Humira, to name but a few, and are systematically disregarded. Patient disregard, a problem that has bothersome consequences and feedback loops as well, but a topic for another post. This post is about the silence that surrounds adverse drug reactions and how that silence is keeping the problems caused by these drugs from being addressed. It is also about recognizing the rational for suffering in silence, to express my empathy, and to encourage those who are silent to use their voice to help heal themselves and help others.

Silence and Self-Preservation

Silence afflicts the ill for a variety of reasons. There is a lot of shame associated with getting sick. Those who are sick, sadly, often feel that they are less capable, less worthy, less appreciated and less loved as a result of their sickness. To the best of their ability, they hide that they feel unwell, out of fear that they will not be seen as capable of doing their job, of caring for their family, of functioning, either physically or mentally as they did before becoming ill. Silence serves as a form of self-preservation; a blanket of fear that keeps the rejection at bay.

An Element of Guilt

Those who are hurt by a drug or vaccine often feel responsible for the role that they played in taking the medication that hurt them. Some feel guilty for insisting on the prescription from their doctor, or administering the drugs to their child, or self-medicating, and they hide in shame and remain silent.

Mental Health

A lot of the adverse effects of pharmaceuticals are central nervous system related, meaning that many areas of mental health are effected. People are notoriously ashamed and silent about mental health issues. It is easier to deal with anxiety, memory loss, depression, panic, and other symptoms, alone, in silence, than it is to speak up about what happened. After all, if you speak out about experiencing mental health issues, you run the risk of being labeled as crazy.

Additionally, many adverse drug reactions take a toll on every system in the body and therefore it is difficult to describe what is going wrong. How does one explain, to anyone, that EVERYTHING is going wrong? It’s too difficult and sick patients sound and feel crazy, so they stay silent.

Reverence and Respect

Questions are typically asked of the experts, the doctors who prescribed the drugs, the people whose job it is to heal or fix those who are suffering from health problems. Sadly and commonly, when a patient asks her doctor if a medication caused serious side-effects and the doctor denies the possibility that the prescription drug could cause such pain, patients assume that the doctor is right. They might also assume, as a patient asking for help, they are not entitled to question their doctor’s expertise. After all, the doctor went to school for a long time and knows what he or she is talking about… right? So patients assume that they are wrong, their doctor is right, and they remain silent.

Demonizing the Injured Patient

One does not have to look far to see a person who is criticized for telling their story of pain caused by a pharmaceutical. Those who tell their stories of pain and suffering, especially those who tell their story loudly, are often demonized as being anti-medicine or anti-vaccine. They are sometimes accused of being conspiracy theorists, or responsible for the death of those who die from preventable diseases. It is easier to be silent about pain than to be accused of being an anti-vaccine conspiracy theorist, so those who are hurt, but who don’t want to be labeled and demonized, stay silent.

When Doctors Suffer

Those in the medical field are not exempt from adverse drug reactions. Though some doctors, nurses, and pharmacists stay away from drugs on principle, many of them prescribe themselves the same drugs that they prescribe their patients. Sometimes they have an adverse reaction to those drugs. The emotional hardship that I presume these medical professionals experience when they are hurt by a prescription drug may be enough to keep them silent. Silence seems easier than questioning one’s entire world view and profession.

End the Epidemic of Silence – Speak Up

There are many other plausible, personal reasons why people stay silent about the horrifying reactions that they have to prescription drugs. All of them feed into the real risks of these drugs being under-recognized. The silence is, sadly, as much of an epidemic as the pain.

Silence, though understandable, is a problem. How will anyone recognize the problems that exist, if those who know about them, who have personal expertise in the unfortunate area of adverse drug reactions, don’t tell their stories? Doctors, the FDA, the pharmaceutical manufacturers and others involved in the medical field will continue to think that disabling and severe adverse reactions are rare, or that something else “must” be the cause of a patient’s pain, until they hear similar these stories over and over again.

It is only when the voices of the victims are louder than the pharmaceutical advertisements and sales reps that the real dangers of these drugs will be realized. I encourage everyone who has experienced an adverse reaction to a drug to share their story. Post it here on Hormones Matter. Post it on your personal blog or Facebook page. Shout it from the rooftops. The stories of the pain caused by adverse drug reactions are important. They matter. Your health matters and the health of those who hear your story and heed your warning, matters.

Even if concerned citizens and victims can’t stop the travesty of the pharmaceutical industry being the 4^th leading cause of death of Americans, we can stop the travesty of the silence that surrounds the situation. I know that it’s difficult and that in a lot of ways silence is easier, but I would like to encourage you to please, please tell your story – because it matters.

Information about Fluoroquinolone Toxicity

Information about the author, and adverse reactions to fluoroquinolone antibiotics (Cipro/ciprofloxacin, Levaquin/levofloxacin, Avelox/moxifloxacin and Floxin/ofloxacin) can be found on Lisa Bloomquist’s site, www.floxiehope.com.

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This article was published originally on Hormones Matter in October 2013.

Warning: Fluoroquinolone Antibiotics may Ruin your Life

by Lisa Bloomquist

Published on May 12, 2015

4679 views

Much of the recent debate (in the media and at the FDA) about fluoroquinolone safety has focused on whether or not people are being adequately warned about the dangers of fluoroquinolones. This argument has always bothered me because it assumes that if people are adequately warned of the risks of fluoroquinolones (or other drugs), the adverse effects that they suffer from are somehow okay.

I don’t think that it’s possible for warning labels on fluoroquinolone antibiotics to be “adequate,” and I think that chasing adequacy on the warning label is the wrong goal.

How could a drug warning label adequately warn someone of the possibility of their life being ruined? How could someone possibly be properly warned that every aspect of their health could be stolen from them? How could it be described on a warning label that you may live in pain for the rest of your life, you may lose your mental health, you may never be able to do the physical activities that you used to love and that every aspect of life that you’ve established (your relationships, your career, etc.) can be taken away from you by an adverse reaction to a drug? (Some of the stories of pain caused by fluoroquinolones can be found on the FQ Wall of Pain.)

Just think about the adverse effect of chronic insomnia. If you can’t sleep: you can’t think—and it’s difficult to hold down a job when you can’t think, relationships are difficult if your mind is sleep deprived and you can’t take care of your children or spouse, hormones are thrown out of whack by lack of sleep and your ability to exercise and regulate your appetite is negatively affected—both of which adversely impact over-all health, your ability to handle stress is diminished and autonomic nervous system dysfunction can result from dysregulation of your sympathetic and parasympathetic nervous systems, and more. (And if you’re prescribed Ambien for your sleep difficulties, you’re 3-5 times more likely to DIE than those who don’t take sleep aids SOURCE). From just that one symptom of fluoroquinolone toxicity, a life can be seriously disrupted—and there is not a single victim of fluoroquinolone toxicity who only has just one symptom—most have dozens. The effects of any one of the symptoms of musculo-skeletal or nervous system destruction can be ruinous to a person’s life.

The warning labels on fluoroquinolones are not adequate, and they won’t be adequate until they say something pretty close to, “These drugs can ruin your life.”

Pharmaceutical Adverse Effects

Yes, all drugs have side-effects. We’ve all heard it a million times. Pharmaceuticals are inherently dangerous. We all know that. But other things that are inherently dangerous aren’t given a blank check for causing harm like pharmaceuticals are. For example, cars are inherently dangerous. You can die in a car wreck. You can die from a car hitting you. They are dangerous and we all know it. But if someone murders you with a car, you can still hold the driver responsible. If someone drives under the influence of alcohol or drugs, they can be held responsible for the damage they caused. If a car has a defect and harm is caused to a person because of that defect, the car manufacturer can be held responsible for the harm caused.

On the other hand, it is difficult–often impossible–to hold drug manufacturers responsible for the harm that their products cause. If an adverse effect is listed on a warning label, you cannot sue because “you were warned.” If an adverse effect isn’t listed on a warning label, you cannot sue because you can’t prove that the drug hurt you. And if you get the rare opportunity to sue when drug labels change, you’ll be out of luck if you took a generic drug, as the Supreme Court made several decisions that made holding generic drug manufacturers responsible impossible.

Drug Manufacturer Responsibility

People who have been maimed by prescription drugs should not be fighting for adequate warnings on drug labels (though it is a step in the right direction and I don’t object to any proposed fluoroquinolone warning label changes). We should be fighting for justice and being able to hold the pharmaceutical companies and doctors who hurt us responsible for the harm that they have done.

In “A Public Policy Plan to utilize the Pharmaceutical Industry and Pharmacogenomics to reduce serious Adverse Drug Reactions, develop Personalized and Individualized Therapy, and provide a Functional Map of the Human Genome” (which is highly recommended – click the link and read the essay – it’s well worth your time) by JMR on http://fluoroquinolonethyroid.com/, it is noted that:

“Currently, their (the pharmaceutical companies) responsibility in this issue appears to end with the “appropriate warnings” provided in size 5 font on the drug inserts or via fast-talking monologues over the “happy commercials” on TV as they market directly to the consumer. And it’s usually only until enough people are maimed or killed that legal action or the FDA will actually make a difference in their behavior. There is a “buyer beware” mentality under the guise of “informed consent” – which is essentially “blaming the victim” for their own adverse reaction – but as far as the drug companies are concerned, they’ve “done their part”. The reality is, if the pharmaceutical companies and the FDA were truly concerned about the “health and safety” of the population they market to, they would put their money where their mouth is and take some of their billions in profits to study and research 1) who and why some people have these adverse reactions, 2)how to prevent these adverse reactions from happening, and 3) how to effectively treat them so as to return health and functionality to those who have been severely hit. Ultimately, this will help patient consumers by better identifying risk factors for individuals, and preventing these adverse reactions from occurring as well as provide appropriate treatments when they do occur.”

Pharmaceutical company profits are astronomical. Yet they contribute NOTHING to solving the significant problem of adverse drug reactions. They do NOTHING to take responsibility for the role that they play in devastating lives with their chemical concoctions. A very good solution to this problem is proposed in “A Public Policy Plan to utilize the Pharmaceutical Industry and Pharmacogenomics to reduce serious Adverse Drug Reactions, develop Personalized and Individualized Therapy, and provide a Functional Map of the Human Genome,” and I hope that the plan that JMR outlines is, someday, enacted.

Lack of Justice for Victims

Every once in a while the media gets a hold of a story of someone being monetarily-compensated for an injury caused by a drug or vaccine. These stories give the impression that it is possible for people to gain compensation from drug companies for injuries incurred. This is not the experience of any of the victims of fluoroquinolones. Most fluoroquinolone victims have run into a dead-end when pursuing justice and recourse against the pharmaceutical companies that hurt them. (And is there any amount of money that can really compensate for chronic pain, or injury to all of the tendons in your body, or loss of your life as a person who could think, move and work?)

Currently, the only thing that victims of fluoroquinolones can sue for is “failure to warn.” It’s the only thing lawyers are taking cases for. Victims can’t sue for catastrophic, life-altering, debilitating adverse effects that are listed on the warning label. Some of the things listed on the Cipro/ciprofloxacin warning label include seizures, psychotic reactions, insomnia, tendon ruptures, peripheral neuropathy, pain, and a lot more. If symptoms are listed on the warning label, the patient/victim is considered to be “warned.” Again, how is it possible to adequately warn someone of the risk that their life may be ruined by seizures, psychotic reactions, insomnia, tendon ruptures, peripheral neuropathy or debilitating pain?

If the warning labels for Cipro/ciprofloxacin, Levaquin/levofloxacin, Avelox/moxifloxacin, Floxin/ofloxacin, and all other fluoroquinolones, had a highlighted black-box warning that said the following, maybe the argument of “you were warned” would hold a little weight:

“WARNING: THERE IS A SMALL, BUT SIGNIFICANT RISK THAT THIS ANTIBIOTIC MAY CAUSE WHOLE BODY TENDON, LIGAMENT, AND CARTILAGE DAMAGE, PERIPHERAL NERVE DAMAGE, CENTRAL NERVOUS SYSTEM DAMAGE, AUTONOMIC SYSTEM DAMAGE, ENDOCRINE SYSTEM DAMAGE, CARDIAC DAMAGE, GENOME (DNA) DAMAGE, AND MITOCHONDRIAL DAMAGE. These adverse effects may range from mild to severe, and may cause temporary or permanent crippling and partial or total disability. These reactions may occur immediately, or may be delayed for up to an unknown period of time after stopping the drug. It is unknown at this point in time who may be affected, and for what severity and duration. Prior exposure to these antibiotics may increase this risk in subsequent exposures. Taking this drug safely in the past does not guarantee that you will not have a reaction in the future. If this risk is acceptable to you for your current condition, then take this drug. However, if this is an unacceptable risk to you, be aware there are many alternative antibiotics available for most people with equal efficacy and less risks for your condition.” From “Responsible Use of Fluoroquinolone Antibiotics: The responsible, moral, and ethical approach (vs. the profit approach).”

Additionally, the list of items on Cipro is Poison that are not currently on the warning labels for fluoroquinolones, should be added to the warning label in order to “adequately warn” patients and physicians alike.

Objective: Real Change, Real Responsibility

The failure of the FDA to force the pharmaceutical companies to take responsibility for the harm that their drugs do is reprehensible. The failure of the legal system to give justice and recourse to victims of pharmaceuticals is also abhorrent.

Permanent, devastating harm is being done by fluoroquinolones and other pharmaceuticals. Though better information on warning labels may be helpful, the objective of those seeking systemic change shouldn’t be changes in the warning labels, it should be pharmaceutical company responsibility for harm done, and justice for victims.

Postscript: Responsible Use of Fluoroquinolones

Please click the links on “A Public Policy Plan to utilize the Pharmaceutical Industry and Pharmacogenomics to reduce serious Adverse Drug Reactions, develop Personalized and Individualized Therapy, and provide a Functional Map of the Human Genome” and “Responsible Use of Fluoroquinolone Antibiotics: The responsible, moral, and ethical approach (vs. the profit approach).” They are both insightful, informative, thoughtful proposals. Just a small sampling of the stories of victims of fluoroquinolones can be found on the FQ Wall of Pain.

Information about Fluoroquinolone Toxicity

Information about the author, and adverse reactions to fluoroquinolone antibiotics (Cipro/ciprofloxacin, Levaquin/levofloxacin, Avelox/moxifloxacin and Floxin/ofloxacin) can be found on Lisa Bloomquist’s site, www.floxiehope.com.

Participate in Research

Hormones Matter^TM is conducting research on the side effects and adverse events associated with the fluoroquinolone antibiotics, Cipro, Levaquin, Avelox and others: The Fluoroquinolone Antibiotics Side Effects Study. The study is anonymous, takes 20-30 minutes to complete and is open to anyone who has used a fluoroquinolone antibiotic. Please complete the study and help us understand the scope of fluoroquinolone reactions.

Hormones Matter^TM conducts other crowdsourced surveys on medication reactions. To take one of our other surveys, click here.

To sign up for our newsletter and receive weekly updates on the latest research news, click here.

What Else Can I Do To Help?

Hormones Matter^TM is completely unfunded at this juncture and we rely entirely on crowdsourcing and volunteers to conduct the research and produce quality health education materials for the public. If you’d like help us improve healthcare with better data, get involved. Become an advocate, spread the word about our site, our research and our mission. Suggest a study. Share a study. Join our team. Write for us. Partner with us. Help us grow.

To support Hormones Matter and our research projects – Crowdfund Us.

Lipstick on a Pig: Stelara’s Unethical Ads

by Lisa Bloomquist

Published on February 26, 2015

4396 views

This 2014 commercial for Stelara is deplorable:

This commericial a disgusting example of everything that is wrong about pharmaceutical advertisements. It appeals to viewers’ vanity and insecurity – which we all possess – in order to sell a dangerous drug. The drug advertised, Stelara (a Johnson & Johnson product), causes cancer. The FDA warning label for Stelara notes that it can cause cutaneous squamous cell carcinoma, prostate, melanoma and breast and cancers, each of which can lead to death. It suppresses the immune system and leaves those who take it susceptible to dangerous infections, which can also lead to death.

Apparently it needs to be said, because there isn’t uproar and disgust in the general public over this wretched ad (and others like it for immunosuppressive drugs)–it is WRONG to utilize the same slimy sales techniques used to sell cosmetics in order to sell dangerous drugs that can severely hurt people and lead to their death. It is wrong to prey on people’s vanity and insecurity in order to sell them something that can hurt or even kill them. It is wrong to promote the frivolous and inappropriate use of a dangerous drug.

A drug like Stelara, that suppresses the immune system and can cause cancer, should not be used lightly and it is not even remotely appropriate to use it in order to have clearer skin. Just listen to the ad, “In a medical study, seven out of ten Stelara patients saw at least 75% clearer skin at twelve weeks.” Look at the model living a glamorous lifestyle, being adored, and flaunting her perfect skin, hair and body. This ad isn’t about helping people with plaque psoriasis, it’s about vanity and aspiration. It’s about selling a product and greed. It is not appropriate, and it even crosses the line of being wrong, to use manipulation and vanity to sell pharmaceuticals–especially pharmaceuticals that can cause cancer and death.

As is the case with all pharmaceutical ads, the risks associated with using Stelara are downplayed. At the end of the ad, after the marketers have thoroughly convinced the viewers (at least on a subconscious level) that if only they took Stelara they would look like the glamorous model in the commercial, a list of the most severe adverse effects is given. These risks include lowering one’s ability to fight infections, increasing one’s risk of cancer, headaches, seizures, vision problems, serious allergic reactions, and it is also stated that patients should, “tell your doctor if you, or anybody in your house needs or has recently received a vaccine.”

Do other people find that warning about not being around people who have recently been vaccinated to be concerning? It certainly piqued my interest when I first heard it. It made me wonder, “What is THAT about??” It made me wonder WHY people who are on Stelara shouldn’t be around those who have recently been vaccinated.

The written warning label for Stelara goes into a little more detail. It states, “People who take STELARA® should not receive live vaccines. Tell your doctor if anyone in your house needs a vaccine. The viruses used in some types of vaccines can spread to people with a weakened immune system, and can cause serious problems. You should not receive the BCG vaccine during the one year before taking STELARA® or one year after you stop taking STELARA®.”

Live vaccines include MMR (measles, mumps and rubella combined), chickenpox, nasally administrated flu, and rotavirus vaccines.

Additionally, recent studies have revealed that the whooping cough / pertussis vaccine can be spread from those who are vaccinated to those who are not vaccinated. A story published in the New York Times noted that, “’When you’re newly vaccinated (with the whooping cough / pertussis vaccine) you are an asymptomatic carrier, which is good for you, but not for the population,’ said Tod J. Merkel, the lead author of the study, who is a researcher in the Office of Vaccines Research and Review in the Food and Drug Administration.”

There is nothing okay about a vaccine spreading the disease that it is supposed to protect against. It is entirely indefensible. If a vaccine spreads disease it should be removed from the market. Try again, pharma companies that make live and whooping cough / pertussis vaccines. Not all vaccines spread the diseases that they are trying to prevent, so there must be some techniques and technologies that can keep that from occurring. Make it so, because endangering those who have suppressed immune systems is not acceptable.

Immune system suppressing drugs like Stelara, Humira, Enbrel, Remicade and others, are used by millions of people every day (it is estimated that 20% of the American population has an autoimmune disease, the diseases that these cancer-causing drugs are supposed to make more manageable). Everyone on an immunosuppressive therapy has a weakened immune system and is susceptible to catching a disease from someone who has recently received a live vaccine (or the pertussis/whooping cough vaccine). However, the people taking immune-suppressive drugs like Stelara aren’t the only ones who have compromised immune systems. Pregnant woman have compromised immune systems, so do people who are HIV positive or have AIDS, people going through chemotherapy, and many others.

The combination of live, virus containing, vaccines, along with a large portion of the population taking immunosuppressive drugs, may make the spread of diseases throughout the US population more common in the future. Unvaccinated people will be blamed, but perhaps more of the blame should sit with the pharmaceutical companies that are making billions off of suppressing people’s immune systems ($6.1 billion in immunosuppressive drugs like Stelara were sold in 2012 alone) and selling live virus vaccines.

Projections of diseases being spread through a population that is immune-suppressed are conjecture. It is not conjecture, however, that dangerous drugs are being sold via immoral marketing techniques. If it were demanded that there be truth in advertising, Tony’s story would be the advertisement one would see for Stelara:

Though Tony’s story is tragic, at least it is real. Pharmaceutical advertisements are not real. We all know, on some level, that pharmaceutical advertisements are not real. Perhaps it’s time we get angry about these types of commercials. Anger may even lead to change. At the very least, it’s time to get educated about the real risks associated with heavily marketed medications. The risks are real. The ads are not.

About the Author: Lisa Bloomquist was “Floxed” on her 32nd birthday by Cipro, a fluoroquinolone antibiotic. After 2 years of battling the mysterious health ailments that come with an adverse reaction to a fluoroquinolone, she has fought her way back to health. She is now fighting for recognition of the harm that these drugs can cause and hoping to help those who are suffering from them through their fluoroquinolone induced illness to find recovery. Her web site, Floxie Hope, highlights stories of hope and recovery. Mito Madness, also started by Lisa, focuses on the absurdity of ignoring the role of mitochondria in forming disease models.

Participate in Research

Hormones Matter^TM is conducting research on the side effects and adverse events associated with the fluoroquinolone antibiotics, Cipro, Levaquin, Avelox and others: The Fluoroquinolone Antibiotics Side Effects Study. The study is anonymous, takes 20-30 minutes to complete and is open to anyone who has used a fluoroquinolone antibiotic. Please complete the study and help us understand the scope of fluoroquinolone reactions.

Hormones Matter^TM conducts other crowdsourced surveys on medication reactions. To take one of our other surveys, click here.

To sign up for our newsletter and receive weekly updates on the latest research news, click here.

What Else Can I Do To Help?

Hormones Matter^TM is completely unfunded at this juncture and we rely entirely on crowdsourcing and volunteers to conduct the research and produce quality health education materials for the public. If you’d like help us improve healthcare with better data, get involved. Become an advocate, spread the word about our site, our research and our mission. Suggest a study. Share a study. Join our team. Write for us. Partner with us. Help us grow.

To support Hormones Matter and our research projects – Crowdfund Us.

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