Tag Archives: ofloxacin

Study Shows that Quinolone Ear Drops Increase Rates of Eardrum Perforation in Children

A recent study published in Clinical Infectious Diseases, “Quinolone Ear Drops After Tympanostomy Tubes and the Risk of Eardrum Perforation: A Retrospective Cohort Study” found that children who were prescribed quinolone (fluoroquinolone) ear drops were significantly more likely to experience perforated eardrums than those who used an alternative, non-fluoroquinolone, antibiotic ear drop – neomycin.

In the study, researchers tracked Medicaid data for almost 100,000 children who underwent ear tube surgery (tympanostomy). The researchers then compared post-operative eardrum perforation rates after kids were given either quinolone or neomycin antibiotic ear drops.

The researchers found that children who received quinolone ear drops were 60% more likely to suffer eardrum perforations than those who received neomycin ear drops, and the rates of eardrum perforation were even higher in the children who were given quinolones together with steroids.

One of the study’s authors, Almut Winterstein, noted, “Evidence on quinolones’ detrimental effects on soft tissues, animal studies, clinical trials and observational studies overwhelmingly point to the possibility that quinolones could contribute to the development of persistent eardrum perforations.”

Comments from Victims

When a story about this study was posted on The Fluoroquinolone Wall of Pain Facebook page, several people noted that their children had suffered adverse effects of fluoroquinolone ear drops. The comments included:

“My 14 year old was prescribed Cipro drops multiple times when he was younger for ear infections and after tubes were put in twice. Last month he had surgery to repair a hole in his eardrum. Now I know better…10 years ago I didn’t know.”

“Our daughter was prescribed these for years–always had a bottle on hand to start if we suspected an infection (as per her doctor) Now at 17 she’s had two progressively invasive surgeries to repair an ear tube hole that keeps popping open. She also has hearing loss due to surgeries. Next up is a specialist and a more invasive graft to get it to close. Definitely going to follow up on this research and results……”

“My daughter had two sets of tubes with these drops prescribed both times. At 6, the doctors determined she needed a 3rd set but would not give them to her due to severe perforations of her ear. They dismissed the perforations as caused by ear drum ruptures from ear infections. Now they are telling me that she may always have pressure related problems and may never be able to scuba dive. I refused the drops for her after I was floxed in 2015 by taking Cipro.”

It is absolutely heartbreaking to hear of children being hurt by fluoroquinolones. My heart aches for the parents of these children as well. They are victims of these drugs too.

Quinolones/Fluoroquinolones Damage Connective Tissues

I’m really glad that this study was done, and I commend Doctors Alrwisan, Antonelli, and Winterstein for conducting it. I hope that pediatric ENTs will hear about this study and understand that quinolone/fluoroquinolone ear drops are dangerous, and that they can lead to perforated ear drums and other health complications.

I understand that the alternative to quinolone/fluoroquinolone ear drops, neomycin, has adverse effects as well, but it does not damage connective tissues or lead to eardrum perforation at near the rate that quinolone/fluoroquinolone ear drops do. Quinolone/fluoroquinolone ear drops are dangerous, and they’re not only dangerous to ears. As Bill’s Story on www.fqwallofpain.com notes, other connective tissue problems can occur after using quinolone/fluoroquinolone ear drops. Bill states:

“I went to see my doctor and was prescribed ciproxin eardrops for an ear infection.They didn,t seem to help my ear so went back to doctors and told him my shoulders were very sore and I had a strange rash on my back.He suggested I may have tendonitis.”

Another “floxie” friend stated that:

“Ofloxacin Eardrops have ruined my life. It has left me disabled in horrible pain totally bedridden.”

Fluoroquinolones, in any form, are dangerous drugs that adversely affect all bodily systems–from tendons, to nerves, to hormones, to the gut biome, and more.

Fluoroquinolones should never be used unless a person is facing a life-or-death need, AND there are no safer alternatives. For all the children in the study who were given quinolone ear drops after ear tube surgery (tympanostomy), there was an alternative. Though the alternative, neomycin, is imperfect, it is safer than quinolone/fluoroquinolone ear drops.

Delayed Effects

Fluoroquinolone adverse effects are often delayed for weeks, or even months, after administration of the drug has stopped. This makes recognition of fluoroquinolone adverse effects difficult, to say the least. Retrospective cohort studies, such as, “Quinolone Ear Drops After Tympanostomy Tubes and the Risk of Eardrum Perforation: A Retrospective Cohort Study” are a good way to identify delayed adverse effects of fluoroquinolones. The researchers who conducted “Quinolone Ear Drops After Tympanostomy Tubes and the Risk of Eardrum Perforation: A Retrospective Cohort Study” looked at years of medical data (from 1999 to 2006) to determine that the rates of eardrum perforation were higher among those who were prescribed quinolone/fluoroquinolone antibiotic ear drops than those who were prescribed neomycin antibiotic ear drops. The eardrum perforations didn’t happen immediately upon administration of the quinolone/fluoroquinolone ear drops, rather, they were a delayed effect that was only uncovered by looking through medical records.

Fluoroquinolone toxicity resembles many recognized illnesses, including all autoimmune diseases, many neurodegenerative diseases, fibromyalgia, ME/CFS, psychiatric illnesses, digestive problems, autonomic nervous system disorders, diabetes, and more. It would be fascinating, informative, and useful if studies were conducted that looked at medical records of people who had been prescribed antibiotics, then compared future health outcomes to see if those who were prescribed fluoroquinolone antibiotics were more likely to be diagnosed with autoimmune diseases, fibromyalgia, ME/CFS, psychiatric illnesses, digestive problems, autonomic nervous system disorders, diabetes, etc. than those prescribed non-fluoroquinolone antibiotics. I would certainly bet on a strong correlation between fluoroquinolone use and many illnesses, but my bets mean nothing until the studies get done. I am hopeful that more studies examining the long-term effects of fluoroquinolones on multiple areas of health get done. It is only with research, data, and science, that the harm that these drugs do will be adequately recognized.

 

Study citation:

Adel Alrwisan, Patrick J. Antonelli, Almut G. Winterstein; Quinolone Ear Drops After Tympanostomy Tubes and the Risk of Eardrum Perforation: A Retrospective Cohort Study. Clin Infect Dis 2017; 64 (8): 1052-1058. doi: 10.1093/cid/cix032

Prescription for Disaster – 22 years later

Bitter Pills Fluoroquinolone Toxicity Book

In Stephen Fried’s 1994 Washington Post article, Prescription for Disaster, Fried describes his wife Diane’s terrifying reaction to Floxin (ofloxacin), a fluoroquinolone antibiotic. It’s a wonderful, award-winning article on which Fried’s follow-up book, Bitter Pills: Inside the Hazardous World of Legal Drugs, was based. I highly recommend that you read both the article and the book.

This quote from Prescription for Disaster summarizes both well:

“Before Diane’s frightening experience, I had always thought of prescription drugs as pretty much idiot-proof. Your doctor tells you to take them, so you do, assuming that the worst that can happen is they won’t work. It turns out the worst that can happen is that you drop dead. The next worst is that your body is permanently damaged. Less worse, but still not very good, is that you suffer for hours, days or weeks with something your doctor may or may not recognize as a drug reaction — from one drug or an interaction. It may or may not go away by itself.”

Though both Prescription for Disaster and Bitter Pills are about the hazards of prescription drugs generally, both have quite a bit of information about fluoroquinolone toxicity, and Diane’s personal story of a severe CNS adverse reaction to Floxin is discussed in-depth.

In Prescription for Disaster, Fried notes:

“I KEEP WANTING this story to end, but it never does. Late last year I got a call from a producer of Oprah Winfrey’s show. She wanted to do a program on adverse drug reactions because she had just had one — to Floxin. Diane and I appeared on the program, along with several other people we had met through the original article, and since then I’ve gotten a steady stream of calls. Many of them are from people who had almost the same reaction Diane did, but weren’t as lucky to have doctors who at least recognized a drug reaction and were willing to learn what they didn’t know about how to treat it. I’ve talked to people whose spouses have lost their careers in the aftermath of drug reactions, people whose fathers attempted suicide because of depression that seemed to have been triggered by quinolones.”

We all want this story to end. More than 22 years later (Prescription for Disaster was published in April, 1994), it is still going on. Thousands of people are hurt every year by fluoroquinolones. People are experiencing tendon ruptures that leave them in horrible pain, exhaustion that leaves them bed-bound, gastro-intestinal issues that leave them unable to eat, CNS issues that leave them unable to work, peripheral neuropathy that leaves them in permanent pain, and more. I sincerely hope that the story of people becoming chronically ill and disabled after taking Cipro, Levaquin, Avelox, Floxin, or their generic equivalents, ends soon. It’s not a good story, it would be nice if it ended sooner rather than later.

On the WONDERFUL site, http://fluoroquinolonethyroid.com/, the author notes the following about the publication of Prescription for Disaster in 1994:

For anyone who thinks that the FQ ADR’s are something new, think again. It’s an old, old story, this one, which actually goes back much farther than 1994. But this article highlights how Pharma, FDA, flox victims, the ignorant and dismissive medical profession, even publicity on shows like GMA, Dateline, Donahue, and even Oprah — they were all there —  it’s all happened before — way back in 1994. It’s all been completely ignored; and in fact, sales of FQ’s continued to increase and soar exponentially during the past 20 years. I, and who the hell knows how many others just like me, have been “floxed” since then. Had the FDA, Pharma, and the medical profession done their job back then, my life (and many others) might have been spared.

Don’t think Pharma or the FDA is just finding out about these ADR’s now. They’ve known. They’ve known for a very, very, long time. And they’ve done absolutely nothing about it.

So when you hear all the Pharma companies make their same old tired and outright spurious statements over and over again about how “Safety is our greatest concern, and these antibiotics have been prescribed safely for the last 20-30 years without problems,“ and the FDA says “We take these safety issues very seriously and are looking into it,“ you’ll know what bullshit that is. There is a historical record accumulating, and this article is just one example for you to post in rebuttal.    Remember:  the internet saves everything now. There will be less and less places for Pharma to hide as time goes on and the number of victims the world over continue to grow.

FQ’s are once again in the news. We can only hope that this time, it will be different.

Yes, we can hope that this time will be different. We need to stay vigilant though, and continually push, so that the pharmaceutical companies, the FDA, and even many doctors and nurses cannot get away with the lies of, “Fluoroquinolones have an excellent record of safety and efficacy,” and, “Side-effects are rare,” and, “There is no known mechanism for fluoroquinolones to cause multi-symptom, chronic disease,” and, “Multi-symptom, chronic diseases are in patient’s heads – they don’t really exist,” and, “Fluoroquinolones aren’t connected with autoimmune diseases, fibromyalgia, ME/CFS, POTS, arthritis, psychiatric illnesses, thyroid autoimmune diseases, etc.” Those lies have been told over and over again since fluoroquinolones first entered the market in the 1980s. Repetition doesn’t make them true, but it sure helps to reinforce the lie.

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There is plenty of evidence that fluoroquinolones are dangerous, destructive drugs that can lead to chronic illness and disability for many. There is also evidence that the mitochondrial destruction done by fluoroquinolones is similar to that of mitochondrial destruction found in people with autoimmune and other “mysterious” diseases. The evidence isn’t even new. They’ve known since 1994 that these drugs are damaging to the point of being disabling. They know, they just choose not to do anything meaningful about it. It is possible to put meaningful restrictions on dangerous drugs that ensure that they are only used when appropriate (in life-or-death situations) and that proper informed consent is given before the drugs are administered. Rather than making these meaningful changes though, the FDA and the pharmaceutical companies have chosen to largely ignore the problem.

Everyone who has gotten “floxed” since 1994 has been hurt because of willful ignorance on the part of the FDA. They claim, over and over again, that these reactions are new, and that they’re just now hearing about them. I realize that news sinks in slowly in a bureaucratic institution like the FDA, but 22 years is ridiculous and, frankly, unacceptable. They knew that these drugs were dangerous then, because people told them back then. They know that these drugs are dangerous now, because people have told them again. Research has also accumulated since 1994, and there are hundreds, if not thousands, of articles about the dangerous effects of fluoroquinolones published in journals (here’s a sampling of just a few – https://floxiehope.com/fluoroquinolones-links-resources/).

When is this going to stop? When will the FDA start doing it’s job and adequately regulating these dangerous drugs? How many more people have to get hurt by fluoroquinolones? How many more times do we have to scream at them and tell them what they already know – what they have known for more than 22 years – that fluoroquinolone adverse reactions are severe and devastating? It’s ridiculous. This mess should have been stopped 22 years ago. The FDA should have made meaningful changes to prescription guidelines for fluoroquinolones in the 1990s. If not then, they should have done so in 2008 when Public Citizen sued the FDA in order to get the black box warning about tendon ruptures added to the fluoroquinolone warning labels. Since meaningful reform didn’t happen then, how about now? The FDA just had a hearing about the risks of fluoroquinolones, and found that the risks outweigh the benefits in treatment for many common infections. They have the opportunity to enact meaningful change now, and they should do so.

I doubt that they will make meaningful, appropriate changes though. Business will go on as usual. People will continue to be hurt by fluoroquinolones. People who should know better (FDA personnel, Pharma scientists, doctors, etc.) will insist on saying that these adverse-reactions are rare, and thus insignificant and untrue. It’s a shame, because they are incorrect. These adverse reactions are severe, devastating, and not near as rare as they should be.

So… we have to keep screaming. We have to keep telling the news media about our reactions, writing to anyone who might listen, filing reports with the FDA, writing articles and blog posts, petitioning scientists, talking to friends, sharing articles, etc. We have to keep banging the drum until they listen.

I’m not sure how long this process will take. It’s been 22 years since Prescription for Disaster was published. I hope that it doesn’t take 22 more.

 

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Can Fluoroquinolones Activate Mast Cells?

What is the connection between fluoroquinolone toxicity and mast cell activation / histamine intolerance? Can fluoroquinolones trigger mast cell activation and histamine intolerance?

The symptoms of mast cell activation are similar to those of fluoroquinolone toxicity. According to Mastocytosis Society Canada, the symptoms of mast cell activation are:

skin lesions or sores, skin rash, spots, redness, hives, persistent fatigue, itching, flushing & severe sweating, joint, bone pain, headaches, tachycardia (racing heartrate), eyes tearing/dry, eye pain, persistent body/tissue pain, difficulty exercising, vertigo, episodes of low body temperature, unexplained Vitamin B12 deficiency, scents/odors/chemical reactions, difficult menses (females), numbness & tingling in face and extremities, skin feels on fire, unexplained anxiety, sudden drops in blood pressure, fainting, persistent diarrhea, vomiting, unexplained weight loss, cognitive impairment, sinus problems, chest pain, vision problems, hair loss, mouth sores, nausea, swelling & inflammation, odd reactions to insect stings, anesthesia difficulties, anemia, thyroid problems, decreased bone density, unexplained weakness, shortness of breath, sunlight sensitivity, temperature (hot/cold) sensitivity, difficulty with foods, drinks, anaphylactoid reactions, anaphylaxis, gastrointestinal pain, bloating, unexplained medication reactions, enlarged liver/spleen, liver/spleen/bladder/kidney pain, enlarged lymph nodes, frequent urination, recurring infections, neuropathic pain, constipation, iron deficiency, unexplained bruising, bleeding, malabsorption, intermittent tinnitus or hearing problems.

That’s a pretty comprehensive list of fluoroquinolone toxicity symptoms too. (Though, as I discussed with Dr. Wahls in episode 14 of The Floxie Hope Podcast, all of the multi-symptom, chronic diseases of modernity have more in common with each other than they don’t, and should probably all just be categorized as cellular dysfunction disorders and treated similarly.)

Several floxies who have been able to get a diagnosis from a doctor have come back with a diagnosis of mast cell activation, or a disease that is related to mast cells. For example, one floxie friend’s doctors have diagnosed him with eosinophilia, a disorder that is related to mast cells and histamine intolerance. Other floxies have been diagnosed as histamine intolerant, and instructed to go on a low-histamine diet. As noted above, many floxies have symptoms of mastocytosis, and it is possible that fluoroquinolones activate mast cells and trigger mastocytosis.

Mast cell disorders are considered to be rare, but, according to Mastocytosis Society Canada, “escalation in the prevalence of these patients worldwide has resulted in a flurry of medical research ongoing in numerous countries. This indicates that these disorders may not be rare, but rather have been commonly misidentified and unfortunately for patients worldwide, commonly undiagnosed. Since approximately 2005, every year there are new theories, classifications, and adjustments to the mastocytosis definitions due to escalation of patients presenting with these disorders worldwide.”

I found the following information connecting fluoroquinolones and mast cell activation / mastocytosis:

  • From the International Journal of Tissue Reaction’s article, Effect of levofloxacin and ciprofloxacin injection on permeability of the tail vein in mice and skin microvasculature in rats, “These results suggest that LVFX and CPFX increase vascular permeability through the induction of histamine release from mast cells in rodents.” (LVFX is levofloxacin and CPFX is ciprofloxacin.)
  • From the Journal of Pharmacy and Pharmacology’s article, Characterization of Histamine Release Induced by Fluoroquinolone Antibacterial Agents In-vivo and In-vitro, “Intravenous injection of levofloxacin and ciprofloxacin at 1–10 mg kg−1 produced dose-related elevations in plasma histamine level in anaesthetized dogs. In contrast, levofloxacin was devoid of plasma histamine increment in anaesthetized rats at 100 mg kg−1, whereas ciprofloxacin at the same dose caused endogenous histamine release. Levofloxacin and ciprofloxacin induced non-cytotoxic secretion of histamine from all mast cells tested in a concentration-dependent manner, whereas rat skin and peritoneal mast cells were thirty- to one-hundred-times less sensitive to the effect of fluoroquinolones as compared with the canine skin mast cells.” Note that in studies beagle puppies have been made lame by fluoroquinolones.
  • From the Archives of Toxicology’s article, Differential response of mast cells separated from various organs and basophils of dogs to the fluoroquinolone antimicrobial levofloxacin, “Histamine releases induced by the fluoroquinolone antimicrobial levofloxacin (LVFX) were investigated using mast cells separated from various organs and peripheral basophils of dogs, being the most susceptible species to quinolone derivatives, in both in vivo and in vitro systems. An intravenous infusion of LVFX at 30 mg/kg over a 30-min period produced endogenous histamine release from 5 min, and a maximum at 30 min, in which the plasma LVFX concentration was approximately 50 µM. A close correlation (r=0.87, n=20) between histamine and LVFX concentrations in plasma during the infusion was observed. In the in vitro study, LVFX at 30 µM or more caused histamine release from mast cells separated from the liver and skin, but not from the gastric mucosa, lung, and peripheral basophils. More exactly, the liver mast cells were most susceptible to LVFX among the organs tested. On the other hand, compound 48/80, a prototype histamine liberator, elicited the histamine release from the liver or skin mast cells at 10 µg/ml, and the calcium ionophore A23187 at 1 µM exhibited the histamine release from the mast cells derived from all organs examined. Histochemical analysis revealed that the liver and skin mast cells had positive reaction for both alcian blue and safranin staining, but the gastric mucosa and lung mast cells were only positive for alcian blue staining, indicating that LVFX preferably activated the connective tissue-type mast cells rather than the mucosal-type mast cells. The degranulation of the liver and skin mast cells brought about by either LVFX or compound 48/80, unlike the calcium ionophore A23187, was blocked by pretreatment with pertussis toxin, suggesting the involvement of pertussis toxin-sensitive G proteins. The results obtained from the canine experiments strongly suggest that LVFX induces histamine release from the connective tissue-type mast cells distributed mainly in the liver, somewhat in the cutaneous tissue, through the activation of pertussis toxin-sensitive G proteins.”

The articles noted above are all from animal studies, not human studies, but they show that fluoroquinolones can activate mast cells and histamine release in mammals, and it’s reasonable to think that they may do the same things to humans that they do to dogs. Also, the similarity between fluoroquinolone toxicity symptoms and mastocytosis symptoms, though not a smoking gun, indicate that further studies of the affects of fluoroquinolones on mast cells should be done.

A few good resources for people with mastocytosis, and it’s possible that floxies are in that category, are:

  1. Dr. Theoharides web site
  2. Mastocytosis Society Canada web site
  3. The Low Histamine Chef web site
  4. Alison Vickery’s web site

I suspect that mast cells are profoundly affected by fluoroquinolones and that mast cell activation is a big part of fluoroquinolone toxicity. The potential options, and mechanisms for fluoroquinolone toxicity, are mind-boggling. Add mast cell activation to the list.

 

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FDA Testimony

Generic Fluoroquinolone Testimony FDA

Me practicing my speech. I won’t wear my fleece hoodie for the real thing. :p

I’m in Washington D.C. and will be testifying to the FDA at approximately 8:30 am EST on Friday March 27, 2015.  Rachel Brummert, President of the QVF will be testifying at approximately 3:50 pm EST the same day.

You can view our testimony through the webcast link noted in this FDA meeting announcement – http://www.fda.gov/Drugs/NewsEvents/ucm431265.htm

Rachel and I will do our best to tell stories of pain and suffering caused by fluoroquinolones, and to encourage the FDA to change the rules that are keeping people who are hurt by generic drugs from gaining recourse through the justice system.

A couple of notes – I wasn’t able to fit in all of the stories that were sent to me.  I had to cut many poignant stories because of time–I’m allowed to speak for 5 minutes.  Everyone who sent me your story – THANK YOU!  I wish that I could tell them all!

Also, this hearing is not about fluoroquinolones specifically.  It is about the fact that generic drug manufacturers cannot be held legally responsible for the damage done by their products.  Many people who have been hurt by various generic drugs will be testifying.  Generic drug manufacturers will also be testifying.  I can’t imagine what they’ll say though.  Are they actually going to argue that they shouldn’t be held responsible for the safety of their products?  Probably.  But if they can’t be held responsible for the damage done by their products, who will be held responsible?  The FDA?  Last I checked, suing government agencies wasn’t possible.  Generic drug manufacturers need to be held responsible for the damage caused by their drugs.  I hope that the FDA does what is in their power to make generic pharmaceutical companies liable for the drugs they make.

 

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Testifying for Justice for Victims of Generic Drugs

Thousands of victims of generic ciprofloxacin, levofloxacin, moxifloxacin and ofloxacin have been unable to pursue legal recourse because of a couple of Supreme Court decisions that ruled that generic drug manufacturers cannot be held liable for harm caused by their products.

You can read more about these horrible Supreme Court decisions in this June, 2013 New York Times article, “In 5-4 Ruling, Justices Say Generic Makers Are Not Liable for Design of Drugs.

People are just as legitimately hurt by generic drugs as they are by name-brand drugs.  Arbitrarily taking justice away from a person because they were hurt by a generic drug is infuriating and wrong.

I have been given the opportunity to do something about this horribly unjust situation.

I have been invited by the American Association for Justice to speak at a Congressional Hearing on Capitol Hill on March 26th and to testify at a FDA hearing on March 27th regarding the lack of legal recourse for those hurt by generic pharmaceuticals.

This is a VERY exciting opportunity and I am honored to be able to tell Congress and the FDA about the harm that generic fluoroquinolones have done, and to encourage them to enact legislative changes that enable those who have been harmed by generic drugs to seek recourse and gain justice.

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Rachel Brummert, President of the Quinolone Vigilance Foundation, will also be presenting/testifying and you can learn more about what this opportunity will involve for both of us by reading the March 6th post on www.saferpills.org, “Executive Director Rachel Brummert speaking at Congressional Hearing and FDA Hearing.

It would be great if as many stories as possible about the pain caused by generic fluoroquinolones could be heard.  There are a couple of ways that you can share your story of pain caused by a generic fluoroquinolone, and the lack of justice available to you.

First, you can submit a comment to the FDA.  Instructions on how to do so can be found in the March 4th post on www.saferpills.org, “Generic Drug Victims: Share your story.”  I encourage EVERYONE to submit their story as a public comment.  Public comments really do make a difference!

Second, both Rachel and I would love to share some of your stories in our testimonies.  If you can please email either of us your stories, and what you would like us to say on your behalf to Congress and the FDA, we will appreciate it!  My email address is floxiehope@gmail.com and Rachel’s is Rachel@saferpills.org.  Rachel and I will coordinate so that we can tell as many stories as possible within the time allotted to us.  We can’t promise that we’ll be able to get to everyone’s story, and we will need to edit the stories for time and relevance, but we would love to share as many impactful stories as possible.  Please send either me or Rachel your stories / what you want us to say on your behalf, asap.  We need to get a drafts of what we are going to say to the American Association for Justice by the end of this week.  Sorry for the time crunch and thank you very much!

Thank you,

Lisa

 

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Antibiotic Resistance – Can We Please Stop Being Stupid?

Can I just complain about how ridiculously STUPID the over-use of antibiotics in agriculture is?  Antibiotics are regularly used prophylactically in livestock in order to fatten up the animals and to compensate for the abhorrently unsanitary conditions in commercial feedlots.   Neither of those things are okay in the least.  They are appalling in themselves.

But if you don’t care that pigs, cows, chickens and turkeys are dirty and fat, you may say, “so what?”

The “so what” is that pathogenic bacteria are QUICKLY adapting to antibiotics and are getting stronger.  This is speeding up the process of antibiotic resistance among bacteria that can not only make livestock sick, but can also make humans sick.  When YOU get sick with one of these bacterial infections that is resistant to antibiotics, well, you may be screwed, because even fluoroquinolones don’t touch some of these nasty, antibiotic resistant, bacteria.

According to the CDC:

“Each year in the United States, at least 2 million people become infected with bacteria that are resistant to antibiotics and at least 23,000 people die each year as a direct result of these infections. Many more people die from other conditions that were complicated by an antibiotic-resistant infection.”

For a while the CDC, FDA and others, led by the pharma and big-ag lobbies, tried to BS (lie to) us all by saying that antibiotic resistance in livestock had nothing to do with antibiotic resistance to humans.  The 2013 CDC Report on Antibiotic / Antibmicrobial Resistance settled that argument as it noted that:

“Antibiotics are widely used in food-producing animals, and according to data published by FDA, there are more kilograms of antibiotics sold in the United States for food-producing animals than for people… This use contributes to the emergence of antibiotic-resistant bacteria in food-producing animals. Resistant bacteria in food-producing animals are of particular concern because these animals serve as carriers. Resistant bacteria can contaminate the foods that come from those animals, and people who consume these foods can develop antibiotic-resistant infections. Antibiotics must be used judiciously in humans and animals because both uses contribute to not only the emergence, but also the persistence and spread of antibiotic-resistant bacteria.”

Here is a good article in Wired explaining the CDC report – “CDC Threat Report: Yes, Agricultural Antibiotics Play a Role in Drug Resistance.”

The reports are in.  The scientific consensus has been stated.  Over-use of antibiotics in agriculture is hurting humans.  So, perhaps we should stop over-using antibiotics in agriculture.  That seems like a good idea.  Too bad the big-ag and pharma pockets are deep and they control the hearts and minds of legislators.  More info on that can be found here – http://www.healthline.com/health/antibiotics/politics-pork-and-poultry-why-legislation-has-not-passed

As bacteria in livestock become resistant to penicillin and sulfa antibiotics, fluoroquinolones will be used more frequently.  Fluoroquinolones already are being used in livestock, just not as frequently as other, safer, antibiotics.  But as bacteria become resistant to safer antibiotics, fluoroquinolone use will surely increase.  For humans as well, as antibiotic resistance increases, fluoroquinolone use will increase.  Doctors will have to pull out the “big guns” because the smaller ones will no longer work.

Antibiotic resistant bacteria are not only harming livestock and people, they are harming the earth itself.  The animals that are given antibiotics excrete those antibiotics (everybody poops – and pees) and the antibiotics go onto the earth / the soil.  This messes up the microbiome of the soil (yes, soil has a microbiome) and more antibiotic resistant bacteria thrive in the soil.  That’s the topic of THIS POST.  Our earth is, literally, getting floxed.  It’s going to get worse too, as stronger and stronger antibiotics become preferred in agriculture, because the traditional ones are no longer doing the job.  The fluoroquinolones will hurt the animals that they are given to, destroy the microbiome of the soil, and leave us Floxies with nothing to eat.  Great.

I wish I didn’t think this was going to happen in my lifetime, but I fear that it will.

The antibiotic arms race will likely continue, with increasingly powerful antibiotics being developed to compensate for antibiotic resistance.  Those synthetic antibiotics will likely have the same, or worse, devastating “side-effects” as fluoroquinolones.  Destruction of the microbiome and destruction of mitochondria is consequential for human health, animal health, and the health of the earth itself – the soil.  Though the importance of the microbiome is starting to be recognized, it may be too late to stop destroying our microbiome with antibiotics.  (The alternative is to fight pathogenic bacteria with helpful bacteria.)  We are accustomed to turning to drugs, and to wantonly killing bacteria.  I don’t see us stopping any time soon.

The bacteria will die – because there isn’t any political will to stop being foolish with antibiotics.  The insects (pests) will die – because there isn’t any political will to protect them from pesticides.  The bees will die – because corporate profits are, apparently, more important than our food supply.  The frogs will die – because no one understands non-linear hormonal responses.

Perhaps, with a painful number of human deaths from this ridiculousness, we’ll, collectively, stop being so stupid.  Maybe.  Because 23,000 human deaths per year (from antibiotic resistant bacteria) haven’t made policy-makers do squat about the over-use of antibiotics in agriculture.  Recommendations for prudent antibiotic use are put into place, but no actual changes are made.  Recommendations.  Recommendations will do nothing to solve this problem – nothing.

P.S. – Sorry for not being hopeful.  Here’s something I hope – I hope that the canaries in the coal mine are listened to.  That’s what we are – canaries.  Is anyone listening?

 

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Fluoroquinolone Induced Gene Upregulation and ROS

The article, “The Fluoroquinolone Levofloxacin Triggers the Transcriptional Activation of Iron Transport Genes That Contribute to Cell Death in Streptococcus pneumonia” is difficult.  It’s not light reading.  I wish it was.  I wish the articles that have information about how fluoroquinolones affect cells were easy to understand and to read.  I wish that we had easy, simple answers about how fluoroquinolones lead to the myriad of adverse events that are listed on the FDA warning labels for them.  I wish that more was known about how fluoroquinolones work.  I wish that a list of definitions wasn’t necessary at the beginning of this blog post.  But this stuff is hard, and a list of definitions is necessary, so, hereyago (some definitions paraphrased from the Wikipedia article because it’s easiest and I’m not a biochemist – for more info, go to the wiki page, or elsewhere):

Reactive Oxygen Species (ROS):  “Reactive oxygen species (ROS) are chemically reactive molecules containing oxygen. Examples include oxygen ions and peroxides. ROS are formed as a natural byproduct of the normal metabolism of oxygen and have important roles in cell signaling and homeostasis.  However, during times of environmental stress (e.g., UV or heat exposure), ROS levels can increase dramatically. This may result in significant damage to cell structures. Cumulatively, this is known as oxidative stress. ROS are also generated by exogenous sources such as ionizing radiation.”  ROS can be incredibly nasty.  They can lead to cellular damage, including DNA damage, and are related to every chronic disease there is.  They’re also related to ageing.  As damage from ROS (also called oxidative stress and free radicals) accumulates, ageing and the diseases of old age occur.  Interestingly though, ROS are not all bad.  They serve as signaling mechanisms within cells and play a large role in turning genes on and off (epigenetics).  They need to be in balance.  If they’re not in balance, a whole lot of things can go wrong.  They’re kind of like tequila.  A shot of tequila mixed with lime juice and other goodies, is excellent in a margarita.  But if you drink the whole bottle, and then mix it with some whiskey, it’s really bad and destructive.  The ways that ROS work within cells is not linear and difficult to study.  Not a whole lot is known about ROS or how they affect human health.  The article, “Exercise-Induced Oxidative Stress: Cellular Mechanisms and Impact on Muscle Force Production” has a really nice over-view of various ROS and their effects.  It’s easier to think of them as different  alcoholic drinks though.  Some are beer – pretty benign unless you have a ridiculous amount of them.  Others are potent – more like Everclear – and they can do a lot of damage to you quickly.

Fenton Reaction:  “Iron(II) is oxidized by hydrogen peroxide to iron(III), forming a hydroxyl radical and a hydroxide ion in the process. Iron(III) is then reduced back to iron(II) by another molecule of hydrogen peroxide, forming a hydroperoxyl radical and a proton. The net effect is a disproportionation of hydrogen peroxide to create two different oxygen-radical species, with water (H+ + OH–) as a byproduct.”  Basically, iron can “donate or accept free electrons via intracellular reactions and help in creating free radicals.”  Free radicals are ROS.  Some of the nastiest ROS are created in the Fenton Reaction – hydroxyl radicals and hydroperoxyl radicals.  (“Exercise-Induced Oxidative Stress: Cellular Mechanisms and Impact on Muscle Force Production” has good info on both of those.)

Type II topoisomerases, gyrase and topoisomerase IV:  “Type II topoisomerases maintain DNA topology and solve the topological problems associated with DNA replication, transcription, and recombination (20). Gyrase introduces negative supercoils into DNA (21), whereas topo IV relaxes DNA and participates in chromosome partitioning (22). Chromosomal topology in Escherichia coli is maintained homeostatically by the opposing activities of topoisomerases that relax DNA (topo I and topo IV) and by gyrase.” (from “The Fluoroquinolone Levofloxacin Triggers the Transcriptional Activation of Iron Transport Genes That Contribute to Cell Death in Streptococcus pneumonia”)

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You got all that?  Even the definitions are difficult.  Now onto some highlights of the article, “The Fluoroquinolone Levofloxacin Triggers the Transcriptional Activation of Iron Transport Genes That Contribute to Cell Death in Streptococcus pneumonia.”

Basically, the researchers found that levofloxacin upregulated genes that are involved in iron uptake and triggered the Fenton reaction in certain bacteria.  The increase in reactive oxygen species that ensued contributed to the lethality of the levofloxacin.

There are a few interesting things that should be noted about this.  First, levofloxacin can upregulate genes.  How consequential is this?  Can eukaryotic genes be upregulated, or can only bacterial genes be upregulated?  What about mitochondrial genes?  What does upregulation of bacterial, mitochondrial and even eukaryotic nuclear genes do to the person who has taken levofloxacin?

Some interesting research is being conducted about the relationship between the microbiome and genetic, heritable traits.  This National Geographic article, “The Most Heritable Gut Bacterium is… Wait, What is That?” notes some of the relationships that are being explored.  Our genes can affect our microbiome, our microbiome can affect our genes, can the genes of our microbiome affect…. US?  Where does the microbiome stop and where do we begin?  Those are all questions that have not yet been answered.  Unfortunately, fluoroquinolones, like levofloxacin, are thoroughly messing up our microbiomes and even causing the upregulation/expression of certain genes.

The second thing of note from the article is that the upregulated genes caused the activation of the Fenton reaction in the bacterial cells.  Again, how does this affect our microbiome?  How does it affect US?  Hydroxyl radicals and superoxide anions are nasty ROS that damage everything in their wake.  What happens to the health of the microbiome, and the host (the person) when their gut is suddenly full of toxic ROS?  Leaky gut syndrome?  Autoimmune reactions?  The multi-symptom, chronic illness that is fluoroquinolone toxicity syndrome?

There is quite a bit of evidence that fluoroquinolones do to mitochondria what they do to bacteria – disrupt the process of DNA replication and reproduction and lead to destruction and cell death.  I think that mitochondrial destruction has a lot to do with fluoroquinolone toxicity.  However, I don’t think that the role of disruption of our microbiome and destruction of our gut bacteria should be overlooked.  The signaling that goes on within our microbiome, and between “us” and our microbiome, is critically important and poorly understood.  Triggering bacterial DNA destruction and death, upregulation of genes and the Fenton reaction – which leads to production of highly destructive ROS, is a very, very, very bad idea – even if it just stays within the microbiome.

The conclusion of “The Fluoroquinolone Levofloxacin Triggers the Transcriptional Activation of Iron Transport Genes That Contribute to Cell Death in Streptococcus pneumonia” is that:

“In conclusion, we have shown for the first time that fatDCEB transcription is regulated by the supercoiling level. The primary effect of the interaction of LVX-topo IV is the upregulation of the operon by local increase in DNA supercoiling. This upregulation would increase the intracellular level of iron, which activates the Fenton reaction, increasing the concentration of hydroxyl radicals. These effects were observed before the inhibition of protein synthesis mediated by LVX. All these effects, together with the DNA damage caused by the inhibition of topo IV, would account for LVX lethality. The possibility to increase FQs’ efficacy by elevating the levels of intracellular ferrous iron remains open.”

Because, apparently, seeing the big picture of the symbiotic relationship between the microbiome and the rest of the organism (the person), isn’t the goal.  The goal is to kill bacteria.  It’s ridiculously short sighted.  Sigh.

Because we’re in Floxieville, there has to be a paradox.  Supplementing iron helped me more than just about anything else.  Iron is one of the few supplements that made me feel markedly better immediately after taking it.  Other Floxies have reported that their ferritin levels are low post-flox.  The role of the Fenton reaction in fluoroquinolone toxicity would lead one to think that iron should be the last thing that a Floxie might need or want.  It helped me though.  I had more energy and even my tendons felt better when I started supplementing iron.  I don’t know if this has something to do with the kind of iron in my supplement/body – FE3 or FE2 – or if the iron had been converted to other chemical compounds and I needed to replace it, or what.  I do know that, as I said in the beginning of this post, this stuff is hard.

The Fluoroquinolone Levofloxacin Triggers the Transcriptional Activation of Iron Transport Genes That Contribute to Cell Death in Streptococcus pneumonia provides a good description of how fluoroquinolones work:

“The killing effect of FQs has been related to the resolution of reaction intermediates of DNA-FQ-topoisomerase complexes, which generates irreparable double-stranded DNA breaks (31). This could occur in E. coli by two pathways, one dependent on protein synthesis and the other independent of it. It has been shown that hydroxyl radical action contributes to FQ-mediated cell death occurring via a protein-dependent pathway (32). This result agrees with a recent proposal suggesting that, following gyrase poisoning, hydroxyl radical formation utilizing internal iron and the Fenton reaction (33) is generated and contributes to cell killing by FQs (34) as well as by other bactericidal antibiotics (35, 36). In this mechanism, proposed for Enterobacteriaceae (35, 37), the primary drug interactions stimulate oxidation of NADH via the electron transport chain that is dependent on the tricarboxylic acid cycle. Hyperactivation of the electron transport chain stimulates superoxide formation. Superoxide destabilizes the iron-sulfur clusters of enzymes, making Fe2+ available for oxidation by the Fenton reaction. The Fenton reaction leads to the formation of hydroxyl radicals that would damage DNA, proteins, and lipids (38), which results in cell death. Instead of a generalized oxidative damage, a recent study supports that the main action of hydroxyl radicals is the oxidation of guanine (to 8-oxo-guanine) of the nucleotide pool. The incomplete repair of closely spaced 8-oxo-deoxyguanosine lesions caused lethal double-strand DNA breaks, which would underlie much of the cell death caused by beta-lactams and FQs (39). However, recent investigations have questioned the role of hydroxyl radicals and intracellular iron levels in antibiotic-mediated lethality using antibiotic concentrations either similar to (40) or higher than (41) those used previously. The disparate results obtained using diverse antibiotic concentrations and times of treatment emphasize the complexity of the lethal stress response (42).”

Similar destruction happens in mitochondria.  As I mentioned though, even if it didn’t happen in mitochondria, and only happened in bacteria, that destruction and those reactions are horrible things to do to a person’s microbiome.  It is, after all, part of us.

All of the people at the FDA who think that it’s okay not to strictly regulate drugs that disrupt the process of DNA replication and reproduction, and lead to the upregulation of genes and induction of the Fenton reaction, which leads to high levels of highly reactive ROS, should be fired.  I’ve learned enough biochem in the last 3 years to know that induction of the Fenton reaction in any part of the body is a really bad idea.  The scientists at the FDA should be able to figure this out.

 

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Shades of Grey – The Good and Bad of Fluoroquinolones

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Here is a new post about fluoroquinolones on Hormones Matter –

Shades of Grey – The Good and Bad of Fluoroquinolones

From it –

“Fluoroquinolones can do good, but they can do harm too. Categorizing things in terms of good or bad is the natural inclination of most people, but it’s never that simple for drugs. All drugs can do good, but they can do harm too – hence the list of side-effects that comes with each prescription. We can’t yet ask for drugs to only do good, and never do harm – that’s not the way the world works. But we can ask for dangerous drugs to be used appropriately. It is ONLY appropriate for fluoroquinolones to be used in life-or-death situations when other antibiotics aren’t effective. To use them flippantly, and when they aren’t entirely necessary, is inappropriate and a violation of the Hippocratic Oath.”

I hate that cipro hurt me.  I hate that fluoroquinolones hurt any of us.  But I still don’t think that they should be banned entirely.  It is not unreasonable to demand that they be used sensibly though.  The amount of collateral damage done by FQs is unacceptable.  Collateral damage should be minimized.  It’s not too much to ask for.

 

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Fluoroquinolones Surpass Vioxx and Thalidomide in Harm Done

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In a May, 2014 letter to the U.S. SenateDoctor Jay S. Cohen said of fluoroquinolones, “In my 40+ years in pharmacovigilance, FQs (fluoroquinolones) surpass Vioxx and Thalidomide in the degree of permanent harm done.”  Let that sink in for a bit.

Fluoroquinolones – cipro/ciprofloxacin, levaquin/levofloxacin, avelox/moxifloxacin and floxin/ofloxacin – drugs that are seen as simple antibiotics (though they do severe cellular harm and are more appropriate for use as chemotherapy drugs), that are prescribed more than 20 million times per year in the U.S. alone – are doing more harm than Vioxx – a drug that led to more than 140,000 American heart attacks, and Thalidomide – a drug that has caused birth-defects and deaths of thousands of children world-wide.

Vioxx has been removed from the market, and the use of Thalidomide is severely restricted.  Fluoroquinolones, on the other hand, are prescribed with abandon, despite the fact that hundreds of studies have shown that they do severe cellular damage and thousands of patients have filed reports with the FDA noting that a variety of severe health problems have been experienced after taking a fluoroquinolone.

Transgenerational Side-Effects

I have argued that fluoroquinolones have transgenerational ill effects and that children are suffering because of the epigenetic effects of fluoroquinolones (HERE and HERE).  I have never hoped to be wrong about anything more than my assertions that fluoroquinolones are related to autism, but the possibility exists – because we really don’t know what the transgenerational effects of microbiome destruction and depletion of mitochondrial DNA are – and fluoroquinolones do, indeed, both obliterate the microbiome and deplete the only non-redundant form of DNA that we have – mitochondrial DNA.  (1)………………………………..

READ MORE ON COLLECTIVE EVOLUTION

http://www.collective-evolution.com/2014/06/25/these-popular-antibiotics-are-prescribed-to-millions-every-year-they-have-detrimental-effects-everyone-needs-to-be-aware-of-this/

 

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