October 2014

Out of Balance: The Unbridled Power of the Pharmaceutical Industry

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A staggeringly large number of people are hurt or killed by pharmaceuticals each year. Medical mistakes and pharmaceutical induced injuries are the 4th most common cause of death in American hospitals (1).

Casualties reveal that the medical system is broken, and it is broken in ways that are systemic, complex and difficult to fix.

Every large system that works well has a foundation of checks and balances that keeps power from being too concentrated. Unchecked power corrupts – it has been shown to be true millions of times throughout history. The need for checks and balances on the power of pharmaceutical companies is just as great as the need for checks and balances on the power of any given branch of the government. There are organizations, individuals and institutions, that should be checking and balancing the power of pharmaceutical companies, and keeping them from maiming and killing thousands of people each year; but those organizations and institutions are failing. They are not keeping the pharmaceutical industry in check, and thus, the problems with the pharmaceutical industry are systemic.

Here is a list of institutions and groups of people who are supposed to be protecting the public from the pharmaceutical companies, but who are not:

The FDA does not Regulate the Pharmaceutical Industry

It’s self-evident that the FDA is failing. Deaths from pharmaceuticals don’t get to the point where thousands of people needlessly die each year while using drugs as prescribed when a regulatory agency is doing its job. “Every week, about 53,000 excess hospitalizations and about 2400 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(2).” This sorry state of affairs doesn’t happen with a regulatory agency that is working properly to protect the people.

Most people assume that the FDA tests drugs for safety. They don’t. The FDA reviews tests performed by the pharmaceutical companies, the same company that developed the drug and stands to profit from the drug(3). It’s a system that is rife with conflicts of interest and perverse incentives that allow dangerous and/or ineffective drugs onto the market.

The FDA is approving drugs that are linked to cancer in clinical trials (new diabetes drugs, Farxiga and Invocana showed high incidence of bladder cancer in clinical trials (4). CANCER. When it is discovered after drugs are released onto the market that they are cancer-causing, the FDA doesn’t remove them from the market or insist that pharmaceutical companies try again to make a better formula that DOESN’T CAUSE CANCER, they simply make the warning label longer – as is the case with TNF inhibitors like Humira and Enbrel (5,6).

Those at the FDA are apparently incapable of making connections between drugs and chronic diseases. When the FDA added the risk of permanent peripheral neuropathy to the 43 page warning label for fluoroquinolone antibiotics, they noted that the mechanism for action that caused the peripheral neuropathy was mitochondrial dysfunction. There are hundreds of studies that link mitochondrial dysfunction to every chronic disease of modernity (Alzheimer’s disease, Parkinson’s, autoimmune diseases, chronic fatigue syndrome / M.E., fibromyalgia, etc.), but rather than restrict the use of dangerous mitochondria damaging drugs like fluoroquinolones, they just increased the length of the label, and people keep getting sick from these drugs (7).

The FDA is not looking out for the people. The notion that they are actually protecting people from dangerous drugs is laughable.

The Courts Rule in Favor of the Pharmaceutical Industry

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?

It’s not that easy.

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. So, for example, if you develop a severe psychiatric illness like bipolar disorder or severe depression after taking Chantix, an anti-smoking drug, you can’t sue the manufacturer of the drug, even if your declined mental health ruins your life, because the warning label for Chantix says that serious psychiatric ill-effects have followed treatment with Chantix (8).

If the side-effect that you suffer from isn’t listed on the warning label for that drug, you’re not much better off than you are if it is. If it’s not listed on the warning label, the connection between the drug and the disease is not established and proving that the drug caused the adverse reaction is close to impossible.

Additionally, those who take generic drugs have no legal recourse against the manufacturers of the drugs, thanks to the U.S. Supreme Court. On June 24, 2013, the U.S. Supreme Court ruled 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” (9). 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 taking cases of people hurt by generic drugs.

The justice system is doing a horrible job at providing justice for those who have been hurt by pharmaceuticals. In not getting justice for the people who have been hurt by pharmaceuticals, they are giving the pharmaceutical industry no incentive to stop hurting people.

Media Ties to the Pharmaceutical Industry Hamper Objectivity

If you read a newspaper, news based magazine, or watch television news, you will be bombarded with advertisements for pharmaceuticals. A quick review of a few issues of Time, U.S. News and World Report and Reader’s Digest revealed that 15% of the advertisements in those “news” magazines were for pharmaceuticals. Television news programs are even worse with constant bombardment of advertisements for antidepressants, erectile dysfunction drugs, etc.  How can we expect the news media to cover the dangers of drugs and the malfeasance of the pharmaceutical industry when advertisements from the pharmaceutical industry provide a significant portion of the revenue for those media sources?

I don’t believe that the media can be objective toward those who ensure their livelihood. Don’t bite the hand that feeds you, as they say – and the mainstream media is well-fed by the pharmaceutical industry.

Doctors and the Pharmaceutical Industry

Doctors generally know too little about the drugs that they prescribe. Most are not pharmacologists and they count on the FDA to tell them whether or not a drug is safe to use.

In some ways, I feel sorry for doctors. They don’t intend to hurt people with pharmaceuticals – they mean to help people with pharmaceuticals. There are good drugs that do what they’re supposed to do and even save lives. But the entire medical profession seems to have lost critical thinking skills when it comes to evaluating the appropriate use of powerful drugs. Drugs can do harm, and many pharmaceuticals do more harm than good. Admitting that will not mean that any physician has to have his or her prescription pads taken away.

There is an appropriate time and place for every type of health therapy – nutritional, herbal, pharmaceutical, etc. – but the dependence of physicians on the exclusive use of pharmaceuticals has made them so entrenched in the system, and so dependent on the pharmaceutical industry, that the questioning of the appropriateness of drug therapies is rarely done. Doctors aren’t keeping the pharmaceutical companies in check by questioning them and refusing to tolerate the inordinate number of harmful drugs going through their office because doctors cannot operate without those dangerous drugs. It’s a sad state of affairs.

Some push-back on the pharmaceutical industry by doctors is entirely appropriate. They should push back on the pharmaceutical industry – for their patients and for their conscience.

Pharmacists and the Pharmaceutical Industry

Pharmacists understand the mechanisms of drug actions. They are trained in pharmacology. They are the gate-keepers for dispensing drugs to the public. I cannot, for the life of me, figure out why there isn’t more uproar among them about harmful drugs.

Scientists and the Pharmaceutical Industry

Everything that I know about biochemistry, cellular biology, how drugs interact with cells, etc. is from journal articles written by scientists. I thank them very much for their work. It is with science that the fraud and crimes against humanity perpetrated by the pharmaceutical industry will be revealed.

Unfortunately, the pharmaceutical and agricultural biochemical corporations have a strangle-hold on much of the work being done by scientists. Objectivity and scientific principles are lost as health research is corrupted by corporate funding at multiple levels. Selection bias has been demonstrated repeatedly, showing that negative results in drug research are not published. Scientists are put in a difficult position as their status and livelihood depend on publishing (publish or perish) so, they must only publish positive findings. Moreover, much of their work and their institution’s research funding comes from the pharmaceutical companies, either directly with drug development or testing grants or indirectly via the NIH inasmuch as the NIH won’t fund adverse events research but only that which has the possibility of a drug discovery. Researchers who dare to question the safety of a particular drug are often disciplined by their institutions for fear that the institutions will lose the millions of dollars drug companies funneled to them, and then if the researcher does speak out, the personal campaigns against them by the drug companies will end their research career. It’s a very untenable position for anyone with a brain and a conscience.

Even though I understand that research scientists are in a difficult position, I get frustrated with the lack of screaming and grand-standing that I don’t see from the scientific community. Scientists have the tools to see the damaging effects of pharmaceuticals. They have the intelligence to connect the dots. They have the credibility to make a difference in people’s lives. They have the ability to save lives. But most aren’t screaming about the harm caused by drugs, partly for the reasons listed above, and partly because they seem to be stuck in an outdated mode of caution and gentlemanliness. They know that they can say that a drug is associated with a higher incidence of cancer, but they are reluctant to say that the drug CAUSED the cancer. They can say that a drug had hugely harmful effects on the cells of rats, but they are reluctant to make any recommendations about human use of those drugs based on those studies of rats – even though the rats are effectively canaries in the coalmine and screaming about hurt rats may prevent future hurt humans. I understand this caution and the rules of science. But it would be really nice if more scientists were using their credibility and intelligence to push back against the pharmaceutical industry.

The People Must Resist Pharmaceutical Industry Marketing

Without the FDA, the media, the justice system, doctors, pharmacists or scientists standing up to the pharmaceutical companies and putting a check on their (currently unmitigated) power, patients are left to fend for themselves. Unfortunately, most patients don’t have the time or capability of doing the necessary research to determine the safety of any given drug. Patients depend on the system to have checks and balances to keep them safe, but those systems that are supposed to be providing checks and balances are failing.

I don’t think that the pharmaceutical companies are evil entities that are conspiring to decrease the world’s population. But I do think that they are profit motivated businesses with obligations to enrich their shareholders, and that their obligations to enrich their shareholders are in direct conflict with any mission of making the people that they sell drugs to healthy. There is an inherent conflict of interest born from the fact that sick, especially chronically ill, people are the best customers of pharmaceutical companies. A poisoned, sick, population is in nobody’s interest except those who leach money from the ill.

Systematic corrections are needed to fix the problem of an obscene numbers of casualties from the pharmaceutical industry.

Stopping the pharmaceutical companies from hurting people is the right thing to do.  I hope that the FDA, the media, the justice system, doctors, pharmacists and scientists start doing so.

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Sources:

  1. Journal of American Medicine, “Incidence of Adverse Drug Reactions in Hospitalized Patients
  2. Harvard University Edmond J. Safra Center For Ethics, “Risky Drugs: Why the FDA Cannot be Trusted
  3. FDA Drug Development and Approval Process
  4. Huffington Post Healthy Living, “Farxiga, Just Approved by FDA, Uses New Approach to Treat Diabetes
  5. Medscape Medical News, “FDA Safety Changes: Humira
  6. FDA Warning Label: Humira
  7. Department of Health and Human Services Public Health Service Food and Drug Administration Center for Drug Evaluation and Research Office of Surveillance and Epidemiology, Pharmacovigilance Review, April 17, 2013, “Disabling Peripheral Neuropathy Associated with Systemic Fluoroquinolone Exposure
  8. Chantix Warning Label
  9. New York Times, “In 5-4 Ruling, Justices Say Generic Makers Are Not Liable for Design of Drugs

Image by wirestock on Freepik

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Quick News: HRT, Gallstones and Gallbladder Disease

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Hormone replacement therapy or HRT, used by millions of women worldwide to minimize the severity of menopausal symptoms, is associated with increased risk of gallbladder disease necessitating surgery to remove the gallbladder. A recently published, very large (+70,000 women), longitudinal study assessed the risk for gallstones, gallbladder disease and gallbladder removal in women who used synthetic HRT medications either in patch or oral form.

The researchers found a significant increase in cholecystectomy – the surgical removal of the gallbladder as a result of complications related to gallstones in the women who used synthetic HRTs. The risk was was so high that researchers estimated that over five years, 1 in every 150 women who use HRT would require a surgery.

Over five years, about one cholecystectomy in excess would be expected in every 150 women using oral estrogen therapy without a progestagen, compared with women not exposed to menopausal hormone therapy. 

Dr. Antoine Racine of South Paris University, study author

The study also showed that using oral, estrogen only HRT, as is more common in the US and UK than in France where the study was conducted, poses a greater risk for gallbladder disease than the either oral HRT with a progestogen or the transdermal HRT patch. Indeed, the transdermal and gel HRT formulas showed little increase in expected numbers of cholecystectomy. It should be noted that the increased gallbladder disease is in addition to the already well-documented increases in heart disease, stroke, breast cancer and blood clots. It may be time to reconsider synthetic HRT therapies and look toward more natural treatment options.

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Helping a Loved One Suffering from PTSD

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Recently, I wrote about the biological impact of PTSD. You can read the first article of the series here.

This week I want to look at what you can do if you have a friend or loved one who you think is suffering or has been diagnosed with PTSD. Specifically, in honor of Father’s Day I’m going to write about helping the brave men in our lives, who are often fathers and soldiers. Statistically, in the military women are more likely to suffer from PTSD, but women are also more likely to seek treatment than men. Culturally, men are taught to be strong and brave, characteristics that are reinforced in the military. Not only are men less likely to get treatment or talk about their symptoms with loved ones, they are more likely to suffer from angry or violent outbursts, as well as drug or alcohol abuse. Let’s look at what you can do to help a loved one who is suffering from PTSD.

Research

If a family member is diagnosed with cancer, what is the first thing you do? Research. Whether it’s asking the doctor five billion questions or reading medical journals, you want to know everything you can about the disease so you can find the best way to treat it. PTSD is no different. In order to understand the diagnosis, you have to research it. Read first hand accounts on blogs, news articles, books or research journals. Read through the information on the VA’s National Center for PTSD, click on the links of studies, journals and other resources listed on the site. In the military we are taught to know our enemy. You can help your loved one by knowing their enemy.

Write

In grad school, I taught a creative writing class at the Balboa Naval Hospital in San Diego. It was one of the most rewarding and challenging experiences in my life, because I know that it helped some of the vets start writing through their demons. Writing can be a very healing process. Buy your loved one a blank journal and a writing book for healing, like Writing out the Storm or Writing as a Way of Healing (I used both of these for my class). He/she might decide to share their writing with you or others, but be respectful as it is a very personal project and they might not wish to share what they write. While teaching this class, one young Marine told me that he would sit and write for hours and at the end of it just deleted the file. This was his healing process. It will be different for everyone individually. If you are having difficulty dealing with a loved one who is withdrawn or depressed as a result of PTSD, it can be beneficial for you to keep a journal as well. You may choose to share your writings with your partner/loved one or keep it personal.

Encourage

Remember, men are less likely to talk and address their feelings. Whether it’s biological or cultural doesn’t matter right now, getting them help does. As a veteran, I can tell you it’s very difficult to talk about things that happened in the military to people who were not in the military. Trying to get an appointment at the VA can be equally as frustrating. Outside of the VA there are also Vet Centers that provide a broad range of counseling, outreach, and referral services to eligible veterans in order to help them make a “satisfying post-war readjustment to civilian life.” Technically they are part of the VA, but fall under a different chain of command. I can personally speak for their services. The counselors and employees are all veterans and provide a very warm and safe environment for vets struggling to readjust. This isn’t just for OIF/OEF vets, any veteran from WWII and Korea to today can seek service there. Also, since 2003, Vet Centers furnish bereavement counseling services to surviving parents, spouses, children and siblings of service members who die of any cause while on active duty, to include federally activated Reserve and National Guard personnel. For counseling and other services, this can be a good alternative to trying to fight for an appointment at the VA.

Protect Yourself and Your Family

Members of the military are trained to kill. Violence becomes second nature even though it goes against human nature. We are desensitized to violence by chanting, “Kill, kill, kill,” during every drill, meal and exercise. If someone you know is having flashbacks, nightmares or is extremely jumpy and owns a weapon, which most veterans probably do as a self-defense measure, make sure they keep the weapon unloaded. After being trained and experiencing combat, individuals are conditioned to immediately reach for their weapon and kill. This reaction can lead to an accident in the home if someone is simply up in the middle of the night looking for a snack or using the bathroom. If a weapon is unloaded, the time it takes to load the weapon is time for the veteran to gain situation awareness. Encourage your loved one that he/she can still protect the house, but this three-second delay can be enough to stop a gut reaction from accidentally firing the weapon.

Anger is also a natural reaction to readjusting and carrying the memories and feelings of PTSD. If your loved one acts violently towards you or your children, leave immediately. It does no good for anyone to stay in that situation. Anger doesn’t always lead to violence, but can make it difficult to communicate. The National Center for PTSD suggests setting up a time-out system using the following tools:

  • Agree that either of you can call a time-out at any time.
  • Agree that when someone calls a time-out, the discussion must stop right then.
  • Decide on a signal you will use to call a time-out. The signal can be a word that you say or a hand signal.
  • Agree to tell each other where you will be and what you will be doing during the time-out. Tell each other what time you will come back.
  • While you are taking a time-out, don’t focus on how angry you feel. Instead, think calmly about how you will talk things over and solve the problem.

You can seek counseling together or separate to learn how to deal with anger management.

Conclusion

Remember, PTSD doesn’t just affect veterans of the Iraq war and other current conflicts/wars. My sister recently started raising chickens for eggs and meat and when our grandfather stopped by he said he couldn’t help butcher the animals. “I made a promise that I would never harm a living being after the war,” he told her. Grandpa was a tank driver in WWII and was in the Battle of the Bulge. Growing up he never mentioned the war, but after I joined the Marines he told me a handful of stories. Each time his face changed and I could tell he has carried something with him since that time. Let’s encourage our veterans to seek the help they might need so they don’t have to carry their burdens any longer. By creating or helping them find a safe environment to talk, we can help them find the road to freedom from the anxiety, anger, obtrusive thoughts, and other burdens that come with experience war or trauma.

In the coming weeks I’ll be looking into PTSD in female veterans, how our hormones might affect PTSD and if there are any differences between PTSD in male and female veterans.

More on PTSD:
The Gift of Fear
VA Benefits for Female Vets
Memorial Day Reflection

 

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Hypersensitivity to pain, my ass!

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A multitude of reports have emerged in recent years denoting the over use of pain killers and other medications. With narcotic pain killers, in particular, data suggest a four-fold increase in opioid use since 1999, and over 100,000 deaths by opioid overdose during same time period. The data also indicate a close correspondence between the increase in prescriptions for pain killers and pharma sponsored marketing, ‘research’ and policy changes that have inculcated medical agency guidelines over the last decade.

For women, this is a particularly troubling trend, as other research indicates we are the primary targets of narcotic prescribing; women take 50% more pain killers than men. We also take 36% more medications than men in general. Speculation about why women take more pain killers than men, often involves psychosocial characteristics including a reduced sensitivity to pain, a predisposition to pain causing diseases, and a predilection to report the pain to one’s physician. Women seek out medical treatment at a much higher rate than men.

What often fails to get mentioned is that:

  1. Pain medications don’t work  as well in women because as we’ve reported before few females, rodents or otherwise, are used in the development of these medications.
  2. Even when female animals or women are used in drug development research, cycling hormones are not analyzed as factors in the effectiveness of the medication.
  3. For the myriad of pain related disorders affecting women, many lack evidence-based diagnostic criteria (less than 30% of Ob/Gyn practice guidelines are based on actual evidence) and frequently physicians and the lack of effective diagnostic criteria hastens many to presume an underlying psychosocial or mental health issue.

I personally think the psychosocial arguments that women are more sensitive to pain than men are nonsense. Rather, I think there is a lot more inherent to our physiology that makes pain related conditions not only more likely, but more difficult to treat.

Consider for example, the menstrual cycle and childbirth. These amazingly complex, biochemically radical, pain-inducing, often life-altering experiences are just a ‘normal’ part of female existence. I dare any man to experience the exponential and repeated cyclic change in biochemistry, akin to a repeated drug addiction and withdrawal pattern, that is the female menstrual cycle. The myth of female hypersensitivity to pain, based largely upon the ineffectiveness of pain or medications that were never designed for her changing biochemistry, is just that, a myth. And though I do admit, some humans are more sensitive to pain than others, the contrived experimental methods that designate women as hyper-sensitive do great damage to our understanding of women’s health and the differing pharmacokinetics across the menstrual cycle, pregnancy, postpartum or menopause.

And then of course, there is endometrial sloughing, necessitating a cramping mechanism to propel the tissue outward or the grandmother of all pain experience, childbirth where women deliver 8lb humans through a cavity opening that expands only to 10 centimeters, often times choosing to not utilize pain medications. These ‘normal’ events of a woman’s life are not indicative of a ‘hypersensitivity to pain’.

No, I don’t buy this mumbo jumbo that women are somehow more sensitive to pain than men. If anything, most women have a higher tolerance to everyday pain than most men. But there is a rationale to perpetuating this myth; it limits innovation in women’s health.

Why innovate when a company can make billions prescribing the same old medications at higher and higher dosages, to more and more people? Why address the needs of half the population, when one can blanket the market with drugs for the entire population?  And to that point, why develop more accurate diagnostic criteria or more effective medications for conditions that only effect a small subset of the total population; especially when medications developed over 50 years ago can be used?  If these medications are addictive, have side effects that necessitate other medications and are extremely difficult to withdraw from, well then, those are just added bonuses. It’s a wonderful business model, albeit a little less than ethical.

Despite the obvious marketing excess, we as consumers bear as much responsibility for the increase in narcotic prescriptions as does the pharmaceutical industry. We are letting this happen. Let’s face it, it is much easier to take a pill to make the pain go away (or eat a pint of ice cream to alleviate stress) than go after the root problem. It is difficult to address root causes. It is especially difficult if one is suffering from a medical condition that is chronic, pain-inducing, poorly understood, not easily diagnosed, and for which there are no effective medications. Women disproportionately suffer from these types of conditions – think fibromyalgia, endometriosis or even migraines.  We also make 80% of all family medical decisions. So ladies, we need to stand up and begin educating ourselves and our families about health and disease. We must demand more research and we will probably have to lead it ourselves.

 

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Side Effects and Unintended Consequences of Popular Pharmaceuticals

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After experiencing an adverse reaction to a popular antibiotic, ciprofloxacin, that involved destruction of my tendons, muscles, and cartilage, as well as my centralperipheral and autonomic nervous systems, I was left with questions that no one seemed to be able to answer – What did ciprofloxacin do to my body?  What happened that made it feel as if a bomb had gone off in me?  Why was I fine after taking ciprofloxacin once, but was far from fine after taking it a second time?  Why can some people tolerate ciprofloxacin and other fluoroquinolone antibiotics with no ill effects, but others can’t and are destroyed by a single prescription?  And the most important question of all – How could I put my body and mind back together again?

I scoured research journals for answers to these questions. The answers that I found were daunting.  I found that ciprofloxacin and other fluoroquinolone antibiotics are topoisomerase interrupters – meaning that they disrupt the enzymatic process of bacterial DNA replication (and mitochondrial DNA replication).  I found that fluoroquinolones deplete intracellular magnesium.  Depletion of intracellular magnesium has multiple health consequences including disruption of more than 300 enzymatic processes.  I realized that both enzyme depletion and magnesium depletion lead to mitochondrial dysfunction.  I found that mitochondrial dysfunction leads to high levels of oxidative stress and that oxidative stress wreaks havoc on multiple areas of health.  I discovered that the carboxylic acid molecule in fluoroquinolones can be metabolized into poisonous metabolites in the liver. I learned how feedback loops between multiple biological systems work together and those compensatory feedback loops make repairing damage difficult.

The more I learned about the complex interactions occurring in my body, the more I realized that the number of unknown factors is far greater than the number of known factors. I realized that, as much as I wanted easy answers and quick solutions, there were none available. Because of the complexity of the human body, as well as individual differences in both genetics and environment, I doubt that easy answers will ever be available. Any one of the many complex systems within the human body can be studied for a lifetime without knowing everything about it. The multiple systems within our bodies are interconnected, difficult to comprehend, poorly understood and truly amazing. Human life is astoundingly, beautifully, mind-bogglingly complex.

Mind Blowing Complexity 

This chart of metabolic pathways shows just one level of biochemical complexity in the human body. Click and take a look. Amazing, isn’t it?  I find the pathways to be both incredibly daunting and beautiful at the same time. As complex as that chart is, it doesn’t include everything. There are additional layers on top of it – genetics, epigenetics, equally complex charts about the microbiome, endocrine system, bioenergetics, etc.

Even though the metabolic pathways in the chart above are known (if they weren’t, they wouldn’t be in the chart), I suspect that the interactions between the metabolic pathways, and the connections between them and other complex systems, are not adequately considered in healthcare. How could they be? These pathways are so mind-blowingly complex, and so interconnected with layer upon layer of feedback and feedforward loops amplifying any disruption and miscalculation, that if we were to properly consider the ramifications of pharmaceutical alterations, no one would dare take most medications. We would recognize the limits of our abilities to predict and treat the inevitable unintended consequences of disturbing the balance within and among these systems. Since pharmaceuticals are a trillion dollar industry, it is safe to say that all of the potential effects of pharmaceuticals on these pathways are not fully considered.

Pharmaceuticals Disrupt Biochemical Pathways

Every pharmaceutical has an effect on those pathways. When the drug interacts with the metabolic pathways as expected, all parties involved are pleased. When the drug interacts in unexpected or unwanted ways, we say that there are “side-effects.” I wonder though, are there really side-effects, or is that just a more palatable expression about the limits of our understanding (and attention)? One could argue that if we paid more attention to the broader biological systems involved in human health, those “side-effects” would be entirely predictable. But we don’t. Instead we focus our medication efforts on narrowly defined targets, destroying a particular pathogen or amplifying or diminishing a specific cell cycle function, all the while ignoring that those processes are conserved systemically. Perturbations in one organism or one function, necessarily affects the entire system. Nothing happens in isolation.

If we were to consider the potential for drugs to initiate systemic reactions, and if the effects of drugs on metabolic pathways were properly regarded, fluoroquinolones and many other drugs and vaccines would not be on the market. But we don’t. Instead, we choose to believe that side-effects are rare and won’t happen to us. Those beliefs are bolstered by decades of marketing to physicians and patients, promoting the safety and efficacy of each drug, often long after science and the legal system have disputed those claims.

Fluoroquinolones, the drugs I know most about, deplete intracellular magnesium (note how many times you see Mg in the chart) and disrupt vital enzymatic processes (which are kind of important). Can you even imagine there not being unintended consequences to depleting vital minerals from a system that is as complex and interconnected as cellular biochemistry and metabolic pathways that determine human health?  I cannot imagine it, because after learning about how fluoroquinolones react in the body, I know too much to believe the marketing propaganda about any drug. Before my adverse reaction, however, I never gave the safety of antibiotics a second thought. It appears neither did my doctor, nor the millions of other physicians who have made the fluoroquinolone class of antibiotics the most prescribed and profitable antibiotics ever.

I know that there are some very smart scientists out there; people who are far more intelligent than I, who have a much better grasp of biochemistry – so why aren’t the dangers of fluoroquinolones more well-known? Why aren’t the side-effects entirely predictable? Why did I have to figure out all of this on my own, without help from the physician who prescribed the medication or the physicians I saw post reaction? Sadly, I have come to believe that most physicians and patients alike don’t want to recognize the complexity of human health; preferring instead to believe in our own intellectual supremacy. And as much as I appreciate the scientists who are doing the work on which I have based my assertions, I don’t think that there is anyone who understands the complex biochemical feedback loops sufficiently to guarantee that there won’t be unintended consequences when disrupting part of the system with a pharmaceutical.

Unintended Consequences

How can one avoid the unintended consequences that come with disruption of the biochemical interactions described in this chart?  Individualized medicine that takes into consideration genetic predispositions is one place to start, but it requires that we recognize the complexity of interacting systems and abandon our silver bullet approach to medicine. From where I sit, this is a long way off. Individualized medicine based on genetic predispositions barely exists. If we consider the complexity of a lifetime of environmental exposures, predicting how a particular drug will react in given individual is complex, if not impossible. For me, the most feasible way to avoid unintended disruptions and feedback loops is to avoiding pharmaceuticals (or at least use them very sparingly). Each medication has side-effects and unintended consequences. All drugs disrupt the very biochemical feedback loops necessary for keeping us healthy.

Avoid the Cause in Order to Avoid the Effect

Perhaps, I am the medical equivalent of a Luddite. Perhaps, I over-emphasize the harm done by pharmaceuticals and underestimate the good done by them because I was hurt by a drug. I see the unintended consequences of disrupting the delicate balance of biochemical pathways everywhere. All of the diseases of modernity can be traced to a disruption on the chart above (or maybe a disruption on the endocrine system chart, or the microbiome chart, or the epigenetics chart). People are sick; not cells in a petri dish – people. They are sick and they are suffering because of disruptions in their biochemistry.

These systems are complex. The feedback loops between systems amplify the complexity and make mistakes and miscalculations difficult (impossible) to correct.

Disruptions in our biochemistry result in disease.

We live in a world of unintended consequences. Does anyone else see it?

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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Traveling Super Bacteria in Commercial Livestock

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With the trend in commercial livestock to raise large numbers of animals in small and confined spaces, fed a regular diet of antibiotic doused feed, it should be no surprise when those animals develop infections, even antibiotic resistant infections. According to the third annual report released by the FDA’s Center for Veterinary Medicine in 2012, antimicrobials sold or distributed for food-producing animals are increasing, rapidly, far and above human use, and despite recommendations to the contrary. In 2011:

  • 29.9 million pounds of antibiotics were sold in the US for meat and poultry production
  • 7.7 millions pounds of antibiotics were sold in the US for humans

Along with that increased usage comes an increased incidence of antibiotic resistant strains of bacteria found in the animals, the retail meats sold for human consumption and in the humans who raise these animals and consume these meats with overuse of fluoroquinolone antibiotics being one the main culprits.

More recently, researchers investigating the persistence of livestock associated antibiotic resistant staphylococcus aureus among the industrial hog workers in North Carolina, found that fully 86% of the workers (n=22) carried the livestock staph bacteria nasally over the course of the two week testing period that sometimes included 96 hours away from the hog farms. One worker carried methicillin resistant staphylococcus aureus (MRSA) persistently and 46% of the workers carried the more virulent strain of mutli-drug resistant staphylococcus aureus (MDRSA) at some point during the test period. The researchers observed that carriage of the bacteria continued even when the workers were away from the farms. Although it should be noted, most workers were at the farms over 50 hours per week and rarely had more than 24 hours off unless ill (in itself, a cause for concern).

Traveling Bacteria

As we learn more about the microbial environment, it becomes clear that organisms, human and animal, are walking bacterial ecosystems, with trillions of microbes upon and inside us. Which populations of bacteria predominate have as much to do with the host organism’s health and habits as with his/her exposures. Bacteria and other microbial pathogens are emerging as a flexible interface of sorts, between us and the environment.

From birth onward which bacteria thrive is moderated by the environment. A child born by cesarean in a hospital adopts the bacteria of the hospital setting, even the pathogenic ones, whereas a child born vaginally develops much of the mom’s microbial influence. More interestingly, a child born vaginally and at home, adopts the microbial patterns of her surrounds, even from that of the family pet. Indeed, across the lifespan, our bacterial exposures influence our microbiome. Living with pets, eating habits and environmental exposures change our microbial ecosystems, regularly and continuously, as we adapt to our surroundings – and these changes happen quickly.

Change the diet and the gut microbiome changes within days. Spend time in the hospital, your microbiome changes within hours. Buy a dog, enter a relationship, ditto. The totality your environment influences your microbiome. And so, it should be no surprise that the animals raised in deplorable conditions, would carry dangerous and deadly bacteria more frequently than animals raised on organic feed and in a more healthy environment. Similarly, it should no surprise that those who work with those animals carry those same deadly bacteria and that their health and the health of their families could be impacted by microbial environment in which they work, but it is.

Even though the importance of the microbiome has only recently come to light, common sense should tell us that the way we raise and grow our food is not healthy for the animals or for us. I suspect, our hunter-gatherer ancestors would not consume diseased animals, understanding the risk of illness to themselves, but we do, every day. Perhaps it is because we do not see the animals and the connection between their health and ours is lost; perhaps it is because some of these animals look healthy bolstered by growth hormones, antibiotics and other chemical toxicants; perhaps it is because we don’t want to see or to think about what we put in our mouths. Whatever the reason, commercial livestock practices are becoming increasingly dangerous to human health. Whether we recognize those dangers or not, we will bear the costs in the chronic illnesses that raising and eating those animals initiate.

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