Prescription drugs are the 4th leading cause of death in America. (1) People know this to be true, they know it to be appalling, but it’s still seen as incomprehensible and absurd. How could medicine hurt so many people? We all know that side-effects happen, but they are thought to be rare. They must be rare, right? We all know some good, kind, generous, thoughtful doctors who want nothing more for their patients than health and happiness, so they certainly aren’t giving their patients drugs that hurt them, are they? We know that the FDA is a federal bureaucracy, so it must be too restrictive of the pharmaceutical industry, right? And the FDA is supposed to protect consumers, so we’re as safe as we can be, right? And people can sue, so the legal system must be keeping the bad aspects of the medical system in check, right? All of these questions, and many more, bring up some cognitive dissonance for people when they’re faced with the fact that prescription drugs, used as prescribed, kill an inordinate a number of people. It brings up the questions -
How do prescription drugs get to be the 4th leading cause of death in America? How does that happen?
Here is a tale of how prescription drugs, used as prescribed, kill people.
Kerstin (age 30) comes down with a urinary tract infection. It’s a Saturday so her regular doctor’s office is closed. Urinary tract infections are painful so she knows that she can’t wait ‘til Monday to get treatment. She goes to an Emergency Services Clinic close to her house. She tells them that she has a urinary tract infection and they write her a prescription for Cipro (Ciprofloxacin – a fluoroquinolone antibiotic). They do not culture her urine because they don’t have the time or capacity to do so. It doesn’t matter what kind of bacteria is in her urine though, they know that Cipro will kill it because Cipro is a broad-spectrum antibiotic and it will kill all the offending bacteria in her urinary tract, plus some.
Kerstin is relieved. Her painful urinary tract and bladder are about to be healed.
Kerstin takes two 500 mg. pills of Cipro two times a day for a week. On the 5th day of taking Cipro, Kerstin starts to feel a bit off. Her bladder feels full even when it isn’t, she has dark “floaters” interfering with her vision and she feels anxious. She doesn’t think anything of these things. They’re strange, but not too worrisome. She doesn’t think for a second that they could be due to the antibiotic that she is taking. Kerstin finishes the seven day course of Cipro. Her urinary tract infection is gone and she is pleased about that. Her bladder fullness, floaters and anxiety come and go and she doesn’t think much of them.
Ten days pass in which Kerstin feels fine. On the eleventh day after she has finished taking Cipro, she starts taking ibuprofen to treat menstrual cramps. On the thirteenth day after she has finished taking the Cipro, it feels as if a bomb goes off in her body. Her hands and feet swell to twice their normal size. It becomes painful for her to walk or to do anything with her hands. Her knees are burning as if every tendon in them is inflamed. She is weak. She develops hives all over her body. Her anxiety levels are sky-high.
Kerstin goes to the doctor. The doctor says that the hives are a result of an allergic reaction and tells her to take Benadryl. Kerstin asks the doctor why she can barely walk when she was going to the gym daily just a few days earlier. The doctor says that she doesn’t know, but that she will run tests.
Kerstin takes Benadryl but it doesn’t seem to help. She goes back to the doctor for something stronger. She is put on prednisone.
The swelling in her hands and feet goes down, but her other symptoms worsen. She develops insomnia. She sprains her wrist while opening a jar. Intermittent pain throughout her body, but especially in her legs, begins. She loses her memory and has trouble concentrating.
Her test results come back. They are all “normal.”
Her pain worsens. She is diagnosed with Fibromyalgia. She asks the doctor who diagnoses her with Fibromyalgia how she could have gone from being healthy and active to being disabled and in pain, now with a diagnosis of Fibromyalgia. The doctor mutters something about mysterious diseases and unexplained symptoms. Kerstin asks if her symptoms could be related to any of the medications that she took – Cipro, ibuprofen and prednisone. The doctor says no. More tests are run to see if there are other causes of Kerstin’s symptoms.
Kerstin is put on Lyrica to help her with her Fibromyalgia pain.
The Lyrica seems to help some of her pain but her mental symptoms get worse while she is on it. In addition to her already existing memory and concentration problems, Kerstin develops brain-fog. She feels slow, stupid and like she is living in a dream. She gains 15 pounds in two months. Her hair starts to fall out. She feels suicidal. She is taken off of Lyrica by her doctor.
Kerstin continues to have problems in her joints, especially her wrists, knees and ankles, so she is not surprised when she is diagnosed with Rheumatoid Arthritis. She starts seeing a Rheumatologist who puts her on Humira. Humira decreases some of her inflammation symptoms but many of her other symptoms remain. She receives Humira treatments for 2 years.
After two years of Humira treatments, Kerstin is diagnosed with hepatosplenic T-cell lymphoma – cancer. She dies on the operating table when her surgeon attempts to remove the lymph nodes on her neck that had been affected by the cancer. She is 34 years old when she passes away.
Kerstin’s story is fictionalized, but it is far from fantasy. Stories like hers happen every day. A large portion of her story is my own and it was both true and horrifying to experience. Stories that are significantly worse, where a doctor’s injection site turn into a staph or MRSA infection to start the whole process, or where anti-psychotic medications that the patient are put on drive her to homicide or suicide. And I didn’t delve into the PAIN that comes with Fluoroquinolone Toxicity (Cipro is a fluoroquinolone and the others are just as bad, if not worse), so it’s a light fictionalized version – with the hope that you’ll find the horror to be believable, because it is very, very real for too many people.
The Explanations, Journal Articles and Facts behind Kerstin’s Story
I don’t expect you to accept the story above as fact without some thorough explanation. Here is the information behind my assertions:
The antibiotic that Kerstin took is Cipro (Ciprofloxacin). Cipro is a fluoroquinolone antibiotic, along with Levaquin, Avelox, Floxin and a few other less commonly used drugs in the fluoroquinolone class. Fluoroquinolone antibiotics are the “big guns” of antibiotics. They are broad spectrum antibiotics that will kill all bacteria in their path. (2) They are frequently prescribed to treat urinary tract infections (3) because they penetrate kidney tissue well (4).
Cipro, and all the other fluroquinolones, have terrible side-effects. Many of the awful side-effects that can be experienced, often all at once, are listed on the Cipro Warning Label. However, many things are left off of the warning label, they are listed on http://www.ciproispoison.com/.
Additionally, here are articles backing up Kerstin’s symptoms:
Vision Floaters – The JAMA article entitled “Oral Fluoroquinolones and the Risk of Retinal Detachment” notes that fluoroquinolones increase the incidence of Retinal Detachment (5). If the connective tissue in your eye is damaged, visual disturbances, including floaters, can result.
Anxiety – The Journal of Neurosciences in Rural Practices’ article entitled “Levofloacin-induced Acute Anxiety and Insomnia” notes that Levofloxacin (another fluoroquinolone – Levaquin) can induce anxiety and insomnia (6) Cipro/Ciprofloxacin can do the same.
Bladder fullness – This is a symptom that I experience, along with many other people suffering from Fluoroquinolone Toxicity. I’m not completely sure what it stems from, but here are a couple of possibilities. This article in the Journal of Urology entitled “Role of Mitochondria in Ciprofloxacin Induced Apoptosis in Bladder Cancer Cells” notes that Cipro disturbs the mitochondria in bladder cells and causes apoptosis (cell death) (7). It is also possible that the feeling of bladder fullness is a result of dysglycemia as it is noted in an article in Medscape Medical News that fluoroquinolones increase the risk of severe dysglycemia in diabetics. Additionally, “one fluoroquinolone antibiotic, gatifloxacin (Tequin, Bristol-Myers Squibb), was already withdrawn from the US market in 2006 due to the risk for severe dysglycemia” (8)
Pain and swelling in hands and feet – This symptom can be more succinctly described as peripheral neuropathy. The FDA issued an update to the labels for fluoroquinolones noting that PERMANENT Peripheral Neuropathy is a possibility in August, 2013 (9). This neuropathy may stem from destruction of the Myelin caused by the fluoroquinolone.
There are likely other causes and reasons for Peripheral Neuropathy being a result of Fluoroquinolone Toxicity, including the production of neurotoxins caused by the drugs (10) and the fracturing of DNA (11).
Skin problems like hives/uticaria/rashes are listed on the warning label
Tendon pain/tear/strain/rupture – This adverse effect is so well documented that fluoroquinolones carry a black box warning about the danger of rupturing a tendon on the top of the warning label. An article in Musculoskeletal Medicine entitled “Musculoskeltal Complications of Fluoroquinolones: Guidelines and Precautions for Usage in the Athletic Population” notes that young, healthy, athletic people’s muscles and tendons are adversely effected by fluoroquinolones (12)
Fibromyalgia – Mysterious, sometimes intermittent, sometimes constant, pain is common among those with fluoroquinolone toxicity. The information above about peripheral neuropathy should ring a lot of bells for those diagnosed with Fibromyalgia. Additionally, Carboxylic Acid is attached to the quinolone molecule (13). It is a known neurotoxin. (14 and 15) Also, a quinolone studied in the article “Cytotoxcicity of Quinolones toward Eukaryotic Cells” notes that quinolones “kills cells by converting the (topoisomerase) type II ezyme into a cellular poison.” (16) Cellular poisons can lead to pain.
A diagnosis of Rheumatoid Arthritis – Per Toxicologist, Professor Joe King, “when a cell is malfunctioning (due to a mutation caused by a toxin or radiation) the body deems it alien and begins and autoimmune response as a defense mechanism. Thus producing positive autoimmune antibodies in lab tests, but in actuality you don’t really have the disease, it is bad cells. For example I test positive for rheumatoid arthritis (RA), but I don’t have RA, I have Fibrillan Connective Tissue destruction upon biopsy. But the doctor reads the lab report for RA and recommends anti-inflammatory steroids. Bad diagnosis, because the problem is not RA but Fibrillan and steroids will dissolve the Fibrillan faster.” Also per Professor King, “the cells in your tissue, organs, etc. are not functioning correctly, there is a mutation in there somewhere and the body is reacting to this weird cells as alien, thus producing an inflammatory process (which is painful).” Additionally, it should be noted that Cipro was found to cause chromosomal abnormalities in immune system cells. (17)
I mentioned NSAIDs and steroids. Both NSAIDs and steroids are contraindicated with fluoroquinolones (18 and 12). Please note that Kerstin didn’t take NSAIDs or steroids at the same time as the Cipro. Both NSAIDs and steroids are contraindicated for any person who has ever experienced an adverse reaction to a fluoroquinolone, likely because of the production of acyl glucuronides, “which are chemically reactive electrophiles formed by carboxylic acid-containing drugs” (15) and/or because of the depletion of the CPY450 enzymes by quinolones/fluoroquinolones that leave the body unable to metabolize other drugs (19 and 20).
How do fluoroquinolone ANTIBIOTICS cause all that harm? The harm that they cause is in the essence of the way they work. They are the “first antibacterial agents that efficiently inhibited DNA replication.” (21) Antibiotics in the penicillin and cephalosporin classes, by comparison, work by disrupting bacterial cell walls, not by doing anything to bacterial, or human, DNA. Fluoroquinolones also form “a poisonous adduct on DNA” (21). Fluoroquinolones cause chromosomal abnormalities in human cells (17) and also have tumor killing qualities (22). While that might sound great on the surface, if you read between the lines you’ll note that if these drugs kill tumor cells, they kill human cells. Fluoroquinolones cause apoptosis, programmed cell death, at a massive rate (23). Patient studies have shown, through a DNA Adduct Mass Spectrogram Analysis, that quinolone molecules have adducted to their DNA. Adducting to and breaking human DNA can cause every single one of the problems that Kerstin experienced, all of the problems listed on the FDA warning label for these drugs, and more. It’s a bad idea to mess with human DNA and chromosomes – a look back at the history of Agent Orange will tell you why this is true.
The consequences of the DNA destruction done by fluoroquinolones is yet to be established. An article was published in Nature in September, 2013 connecting topoisomerase inhibiting drugs (fluoroquinolones inhibit topoisomerases II and IV (24)) with triggering the expression of autism related genes. I wrote about this on CE – http://www.collective-evolution.com/2013/09/18/a-horrifying-cause-of-autism-dna-damage-from-synthetic-antibiotics/ Of course, more studies need to be done to determine the implications of this study.
Studies of the DNA make-up of Gulf War Veterans and their children may also be revealing as all 1991 Gulf War Veterans were given Cipro prophylactically because of fear of anthrax (25). Likewise, in 2001 United States Postal Workers who took Cipro prophylactically, also to prevent anthrax, and any ensuing health issues that they have (57% reported side-effects -26) may be related to their exposure to fluoroquinolones.
Fluoroquinolone antibiotics are dangerous drugs that have been used recklessly since their introduction to the market as a first-choice broad-spectrum antibiotic. They are likely responsible for many of the “mysterious” illnesses that have been on the rise since the early 1980s when Cipro was patented by Bayer and Levaquin was patented by Johnson & Johnson. Everyone who has Fibromyalgia, Chronic Fatigue Syndrome, Thyroid Dysfunction, any Autoimmune Disease, Gulf War Syndrome, Leaky Gut Syndrome, Dysautonomia, etc. should look at their medical records to see if they have ever taken a fluoroquinolone. If a fluoroquinolone is in your past, fractured genes may have resulted, and thus your pain and suffering. Please note that adverse reactions to fluoroquinolones are often delayed for weeks or sometimes months or years after administration of the drugs has stopped and there is a tolerance threshold for metabolism of these drugs (20) so most people do not react to their first dose.
Lyrica and Humira
Here is the warning label for Lyrica – (link – Source 27) Please note that suicidal ideation is one of the acknowledged adverse effects caused by this drug. Weight gain, difficulty concentrating, etc. are also listed on the warning label. Patient reports (these people aren’t lying) can be found on askapatient.com – Lyrica.
Humira, Enbrel and other TNF inhibiting drugs CAUSE CANCER. This is well documented and known. The warning labels for both Humira and Enbrel state in a big black box warning that various cancers are associated with use of those drugs. In case it needs to be spelled out, cancer can be deadly.
Here is an excellent blog post about how Humira can kill, and how it is marketed – http://davidhealy.org/welcome-to-the-humiraverse/
Conclusions
It is often noted as people are bemoaning the unwillingness of the pharmaceutical industry to create more antibiotics, that there isn’t enough money to be made from antibiotics to encourage their production. (28) While there may not be much money to be made in selling antibiotics directly, there is a whole lot of money to be made in treating autoimmune diseases. Humira reached $7.9 Billion in sales (29) in 2011 despite the undisputed fact that it causes cancer. If a class of antibiotics can cause the body to react as it would if it had an autoimmune disease for an extended period of time (the ill effects of fluorouquinolones can be permanent but they typically last from 6 to 36 months), and therefore a person gets diagnosed and treated for an autoimmune disease, though they don’t actually have the autoimmune disease, they actually have an autoimmune reaction to a poisonous drug, the pharmaceutical industry has effectively taken an acute problem, an infection, and converted it into a chronic problem, an autoimmune disease. Chronic conditions mean repeat customers and the pharmaceutical industry makes billions. (I doubt that this process is a conspiracy or even planned on the parts of the people in the pharmaceutical industry. Rather, I think that it is caused by willful ignorance among those in the medical professions, encouraged by greed and a complete lack of checks and balances on the pharmaceutical companies, those that have the most to gain in creating repeat customers.)
People are being hurt by their medicine and it is unacceptable. If harm is impossible to avoid completely, it should be minimized. There is zero effort on the part of Doctors, Pharmacists, the FDA or anyone else to minimize adverse effects of drugs. If an effort were being made, we would not be in the tragic situation that we’re in, with the pharmaceutical industry being the 4th leading cause of death of Americans.
The mantra of “all drugs have side-effects” has been so ingrained into the collective consciousness that we have come to think of it as acceptable that drugs have side-effects, and for drug side-effects to be devastating. In accepting this “better someone else than me” / “it can’t happen to me” attitude, we have given permission to the FDA to be inept, incompetent and lazy. In their ineptitude, they have ignored 15 years of research noting that commonly prescribed ANTIBIOTICS are damaging our DNA. We can only hope that this oversight caused by laziness and incompetence is not consequential to us all. Because I can accept the possibility that it may be worth it for society for me to be sacrificed so that we can have powerful antibiotics, but no drug of any sort, no matter what good it does, is worth sacrificing our collective DNA.
Post Script: The author’s web site, with more information about fluoroquinolones, is www.floxiehope.com
Sources:
1.Donald W. Light, “Risky Drugs: Why the FDA Cannot be Trusted,” Harvard University, The Lab @ Edmond J. Safra Center for Ethics. http://www.ethics.harvard.edu/lab/blog/312-risky-drugs?layout=default#stay-informed
Jane E. Brody, “Popular Antibiotics May Carry Serious Side Effects,” New York Times, September 10, 2012. http://well.blogs.nytimes.com/2012/09/10/popular-antibiotics-may-carry-serious-side-effects/?_r=1
Web MD, Antibiotics for Urinary Tract Infections (UTIs) http://www.webmd.com/a-to-z-guides/antibiotics-for-urinary-tract-infections-utis
DANA E. KING, M.D., ROBB MALONE, PHARM.D., and SANDRA H. LILLEY, PHARM.D., East Carolina University School of Medicine, Greenville, North Carolina, “New Classification and Update on the Quinolone Antibiotics” American Family Physician http://www.aafp.org/afp/2000/0501/p2741.html
Mahyar Etminan, et. al., “Oral Fluoroquinolones and the Risk of Retinal Detachment” JAMA, April 4, 2012—Vol 307, No. 13 http://211.144.68.84:9998/91keshi/Public/File/40/307-13/pdf/joc25028_1414_1419.pdf
Arun Kandasamy and D Srinath, “Levofloxacin-induced acute anxiety and insomnia” J Neurosci Rural Pract. 2012 May-Aug; 3(2): 212–214. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3410005/
OLIVIA ARANHA, et. al., “ROLE OF MITOCHONDRIA IN CIPROFLOXACIN INDUCED APOPTOSIS IN BLADDER CANCER CELLS” The Journal of Urology
Volume 167, Issue 3, Pages 1288-1294, March 2002 http://www.jurology.com/article/S0022-5347(05)65283-4/abstract
Lisa Nainggolan, “Fluoroquinolones Up Risk for Severe Dysglycemia in Diabetes” Medscape Medical News, http://www.medscape.com/viewarticle/809442 Based on this article http://cid.oxfordjournals.org/content/early/2013/07/23/cid.cit439.abstract
08/15/2013 FDA Drug Safety Communication: FDA requires label changes to warn of risk for possibly permanent nerve damage from antibacterial fluoroquinolone drugs taken by mouth or by injection http://www.fda.gov/Drugs/DrugSafety/ucm365050.htm
David A. Jernigan, “Lyme Toxins The Primary Cause of Your Symptoms” Townsend Letter. April, 2007. http://www.benbrew.com/lb/lyme5.pdf
G. Palu, et. al., “Quinolone binding to DNA is mediated by magnesium ions” Proc. Natl. Acad. Sci. USA Vol. 89, pp. 9671-9675, October 1992 Biochemistry http://www.pnas.org/content/89/20/9671.full.pdf
Mederic M. Hall, MD, Jonathan T. Finnoff, DO, Jay Smith, MD, “Musculoskeletal Complications of Fluoroquinolones: Guidelines and Precautions for Usage in the Athletic Population” 2011 by the American Academy of Physical Medicine and Rehabilitation, Vol. 3, 132-142, February 2011 http://www.levaquinadversesideeffect.com/wp-content/uploads/Documents/Hall-2011.pdf
NAI-XUN CHIN AND HAROLD C. NEU, “Ciprofloxacin, a Quinolone Carboxylic Acid Compound Active Against Aerobic and Anaerobic Bacteria” ANTIMICROBIAL AGENTS AND CHEMOTHERAPY, Mar. 1984, p. 319-326, 1984, American Society for Microbiology http://www.ncbi.nlm.nih.gov/pmc/articles/PMC185508/pdf/aac00192-0027.pdf
José Antonio Vázquez, et. al. “Evaluation of toxic effects of several carboxylic acids on bacterial growth by toxicodynamic modelling” Microbial Cell Factories2011,10:100 http://www.microbialcellfactories.com/content/10/1/100
Urs A. Boelsterli, “Acyl Glucuronides: Mechanistic Role in Drug Toxicity?” Current Drug Metabolism (v.12, #3) p. 213-214 http://www.chemweb.com/journals/journals?type=issue&jid=13892002&iid=12003
Sarah H. Elsea, et. Al, “Cytotoxicity of Quinolones toward Eukaryotic Cells: IDENTIFICATION OF TOPOISOMERASE I1 AS THE PRIMARY CELLULAR TARGET FOR THE QUINOLONE CP-115,953 IN YEAST,” The Journal of Biological Chemistry, Vol. 267, No. 19, Issue of July 5, pp. 13150-13153 http://www.jbc.org/content/267/19/13150.full.pdf+html
PS Ambulkar, et. Al, “Genotoxic and cytotoxic effects of antibacterial drug, ciprofloxacin, on human lymphocytes in vitro” Nepal Med Coll J 2009; 11(3): 147-151 http://www.nmcth.edu/images/gallery/Editorial/xRZVmps_ambulkar.pdf
S. Mannino, et. al., “NSAIDs, Quinolones and Convulsions: An Epidemiologic Approach” Post Marketing Survellance 1992 p. 119-128 http://213.4.18.135:48080/10.pdf
HJ Xie, et. al., “Alteration of pharmacokinetics of cyclophosphamide and suppression of the cytochrome P450 genes by ciprofloxacin” Bone Marrow Transplantation (2003) 31,197–203. http://www.nature.com/bmt/journal/v31/n3/abs/1703815a.html
Dean P. Jones, et. al., “Mechanisms of Pathogenesis in Drug Hepatotoxicity Putting the Stress on Mitochondria” Mol Interv. 2010 April;10(2): 98–111. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2895369/
Arkady B. Khodurskyand Nicholas R. Cozzarelli, “The Mechanism of Inhibition of Topoisomerase IV by Quinolone Antibacterials” October 16, 1998 The Journal of Biological Chemistry, 273, p. 27668-27677.http://www.jbc.org/content/273/42/27668.full
Yi Xia, et. al., “Recent Advances in the Discovery and Development of Quinolones and Analogs As Antitumor Agents” Current Medicinal Chemistry, 1999, p. 179-194 http://books.google.com/books?hl=en&lr=&id=SJoxUN91vK4C&oi=fnd&pg=PA179#v=onepage&q&f=true
V Talla and PR Veerareddy, “Oxidative Stress Induced by Fluoroquinolones on Treatment for Complicated Urinary Tract Infections in Indian Patients” J Young Pharm. 2011 Oct-Dec; 3(4): 304–309. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3249743/?report=printable
2013 FDA Warning Label for Ciprofloxacin (Cipro) – http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019537s082,020780s040lbl.pdf
Patricia Kime, “New FDA warnings on Cipro may tie into Gulf War illness” Air Force Times, November 1, 2013. http://www.airforcetimes.com/article/20131101/NEWS/311010018/New-FDA-warnings-Cipro-may-tie-into-Gulf-War-illness
“Postal Workers Sue Bayer Over Cipro” http://www.yourlawyer.com/articles/title/postal-workers-sue-bayer-over-cipro
Lyrica Label http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021446s013s014lbl.pdf
Garcia Rey-C, “The role of the pharmaceutical industry. Why aren’t new antibiotics being marketed?” 2010 Nov;28 Suppl 4:45-9. http://www.ncbi.nlm.nih.gov/pubmed/21458701
Ben Comer, “Brand of the Year: Humira” PharmExec.com February 1, 2012 http://www.pharmexec.com/pharmexec/article/articleDetail.jsp?id=757392