Tag Archives: drugs that aren’t better than a placebo

The FDA Notes that Fluoroquinolones are no Better than Placebos

For the FDA’s November 5, 2015 meeting to review “The Benefits and Risks of Systemic Fluoroquinolone Antibacterial Drugs for the Treatment of Acute Bacterial Sinusitis (ABS), Acute Bacterial Exacerbation of Chronic Bronchitis in Patients Who Have Chronic Obstructive Pulmonary Disease (ABECB-COPD), and Uncomplicated Urinary Tract Infections (uUTI)” a 617 page report was released by the FDA. You can access it HERE if you want to read it in its entirety.

In the next several posts, I will summarize and comment on the report. The following is post 1 of the summary/commentary:

The report starts by noting that fluoroquinolones have never been shown to be safe or effective treatments for sinusitis, bronchitis for those with COPD, or uncomplicated urinary tract infections. No placebo-controlled trials were conducted when approving fluoroquinolones as treatments for these diseases. Per the FDA:

“Antibacterial drugs approved before the 1980s were in general used as the control antibacterial drugs in NI trials. Because placebo-controlled trials were not used as a basis for the approval of those drugs, a treatment effect of the control antibacterial drugs over placebo had not been clearly established for ABS, ABECB-COPD, or uUTI. Thus, these active-controlled studies may not provide a reliable means to evaluate efficacy of antibacterial drugs for these indications.”

No placebo-controlled studies were used for approval of fluoroquinolones (or any other antibacterial drugs, apparently) in the treatment of sinus infections, bronchitis for those with COPD, or uncomplicated urinary tract infections. It’s just now occurring to the FDA that without placebo-controlled trials, they may not have reliable evidence of the efficacy of these drugs. Ya think?

The report goes on to note that the Cochrane Collaboration concluded the following about treatment of sinusitis with antibiotics:

“The Cochrane Collaboration conducted a review of antibacterial drugs for treatment of clinically diagnosed acute rhinosinusitis in adults and provided this statement in their conclusion: ‘Taking into account antibiotic resistance and the very low incidence of serious complications, we conclude that there is no place for antibiotics for the patient with clinically diagnosed, uncomplicated acute rhinosinusitis’ (Lemiengre, van Driel, et al, 2012).”

Additionally, regarding bronchitis in those with COPD, the FDA report notes that, “Clinical practice guidelines for treatment of ABECB-COPD published by the American College of Physicians stated, ‘Among patients with mild attacks, there were no significant differences between those who received antibiotics and those who received placebo.’”

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The case regarding uncomplicated urinary tract infections is a bit more convoluted, but the report does note that, “In a study (of patients with uncomplicated urinary tract infections) that used ibuprofen as a control, there was no treatment difference on symptom resolution in comparison to an antibacterial drug.”

We rely on the FDA to evaluate drugs to make sure that they are safe and effective. Fluoroquinolones are far from safe—they lead to multiple musculo-skeletal and nervous system adverse effects (most of which are described in the 43 page warning label for Cipro/ciprofloxacin). I was assuming that they were at least effective. It turns out that fluoroquinolones are no more effective than a placebo at treatment of sinus infections, bronchitis or uncomplicated urinary tract infections. (They’re no more effective than a placebo at treating prostatitis either – see THIS POST.) People are getting poisoned and severely hurt by fluoroquinolones–for no good reason. Fluoroquinolones are no more effective than a placebo at treating many of the conditions they are prescribed for, and people would be far better off taking a sugar-pill than they are taking a topoisomerase interrupting chemo drug that is no more effective than a placebo.

The FDA approved fluoroquinolones for use in treatment of sinus infections, bronchitis for those with COPD, and uncomplicated urinary tract infections based on the assumption that they were safe and effective, not on actual studies showing that assumption to be true. They are not safe, and they are no better than a placebo for treatment of these conditions. For more than 30 years, the FDA has been using false assumptions and faith, rather than evidence established by placebo-controlled trials, as the basis for approving dangerous drugs for treatment of benign infections that the body can fight off using its immune system (or a placebo).

The mantra of “all drugs have side-effects” is often spewed by people who think that side-effects are acceptable. But with any veil of acceptability comes the assumption that dangerous drugs are at least effective. Fluoroquinolones aren’t even effective at treating sinusitis, bronchitis or uncomplicated UTIs—diseases that they are prescribed for thousands of times every day. They are no better than a placebo at treating those conditions. They are neither safe nor effective and people would be better off taking snake oil than they are taking ineffective drugs that deplete mitochondrial DNA and lead to tendon ruptures, permanent peripheral neuropathy, serious central nervous system adverse effects, and more.

Fluoroquinolones are neither safe nor effective. Every person who has been hurt by a fluoroquinolone taken to treat sinusitis, bronchitis or an uncomplicated UTI was hurt because of the FDA’s ineptitude and their inability to realize that antibiotics need to go through placebo-controlled trials just like every other drug.

This situation, where the FDA approves unsafe and ineffective snake-oils to be sold by the pharmaceutical juggernauts as long as they are labeled as “antibiotics,” is only going to get worse with the passage of the 21st Century Cures Act. The 21st Century Cures Act will encourage the production of new antibiotics, regardless of their safety profile or mechanism of action. In an op/ed article in the New England Journal of Medicine, it is noted that:

“The proposed legislation would make immediate changes with respect to new antibiotics and antifungals by enabling their approval without conventional clinical trials, if needed to treat a ‘serious or life-threatening infection’ in patients with an ‘unmet medical need.’ In place of proof that the antimicrobial actually decreases morbidity or mortality, the FDA would be empowered to accept nontraditional efficacy measures drawn from small studies as well as ‘preclinical, pharmacologic, or pathophysiologic evidence; nonclinical susceptibility and pharmacokinetic data, data from phase 2 clinical trials; and such other confirmatory evidence as the secretary [of health and human services] determines appropriate to approve the drug.’ Antimicrobials approved in this manner would carry disclaimers on their labeling, but there is no evidence that such a precaution would restrict prescribing to only the most appropriate patients. If passed in its current form, the bill would also provide hospitals with a financial bonus for administering costly new but unproven antibiotics, which could encourage their more widespread use. The bill gives the secretary of health and human services the authority to expand this nontraditional approval pathway to other drug categories as well, if “the public health would benefit from expansion.”

Don’t think for a second that the FDA is keeping snake-oils off the market. They’ve been allowing drugs that are more dangerous than snake-oils, and no more effective, to be sold to the American public for years.

I hope that they at least try to undo some of the damage done in the November 5th meeting. We shall see.

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Cipro is no better than a PLACEBO at treating chronic prostatitis / chronic pelvic pain syndrome

It is noted in the book, A Headache in the Pelvis, that, “Ciprofloxacin, one of the most powerful antibiotics, on a long-term basis proves to be only as effective as a placebo” for treatment of chronic prostatitis / chronic pelvic pain syndrome (CP/CPPS).

I just about fell out of my chair when I read that.

Ciprofloxacin, not only one of the most powerful antibiotics, but also one of the most dangerous antibiotics, is NO MORE EFFECTIVE THAN A PLACEBO for treatment of chronic prostatitis.  Despite their lack of effectiveness, “Quinolones, such as ciprofloxacin, are commonly used to treat CP/CPPS because of their excellent penetration into the prostate.”

Ciprofloxacin penetrates the prostate, and every cell in the body well, but that doesn’t seem like a good enough reason to give it out to the 9-12% of men who suffer from prostatitis if it is NO MORE EFFECTIVE THAN A PLACEBO in treating chronic prostatitis.

Let’s do a cost/benefit analysis of ciprofloxacin versus a placebo.

Placebo

Benefits:  Some potential alleviation of symptoms, as well as potential increases in physical and mental health scores.  (The placebo effect is amazing – it’s not the same as doing nothing.)

Costs:  The potential for “nocebo” effects exists – the experience of adverse effects based on the expectation of adverse effects.  A placebo is a sugar pill though, and the potential for adverse effects is negligible.

Ciprofloxacin

Benefits:  Some potential alleviation of symptoms, as well as potential increases in physical and mental health scores.  (Same potential benefits as the placebo.)

Costs:  Ciprofloxacin and other fluoroquinolones can kill people – DEATH is a potential effect.  If they don’t kill the patient, they can still structurally weakening of every tendon in one’s body, cause mitochondrial dysfunction and potentially increase the risk of all of the diseases related to mitochondrial dysfunction (including neurodegenerative and autoimmune diseases), lead to serious central nervous system adverse effects including seizures, anxiety, depression, suicidal ideation and intracranial pressure, cause liver and kidney failure, PERMANENT peripheral neuropathy, and more.  There is a 43 PAGE warning label for ciprofloxacin.  Many things are missing from the warning label, and a list of some of the adverse effects can be found HERE.  When patients are given ciprofloxacin, they are not only risking a single adverse effect listed on the warning label, they are risking multiple, devastating effects that may be permanent.

Opting for the sugar pill seems pretty reasonable—better, actually.

It is criminal to subject people to a drug as dangerous as ciprofloxacin for a condition that it isn’t effective at treating.  It is NOT a benign drug.  It is a topoisomerase interruptera chemo drug – and it should NOT be used frivolously.  Ciprofloxacin, and all the other fluoroquinolones, should only be used in life-threatening situations and they should NEVER be used for conditions that they are not proven effective at treating.  They should NEVER be used in situations where they have been shown to be no more effective than a placebo.

This isn’t rocket science.  Don’t give people dangerous drugs that don’t even have the potential for helping them.  It’s not hard.  But men with CP/CPPS are given ciprofloxacin, and other fluoroquinolones, as if they’re candy, to “treat” their condition.  It’s absurd.

The study that found that CP/CPPS is no more effective than a placebo was published in the Annals of Internal Medicine in 2004 and it was entitled “Ciprofloxacin or Tamsulosin in Men with Chronic Prostatitis / Chronic Pelvic Pain Syndrome: A Randomized, Double-Blind Trial.”  The article notes that:

“Chronic prostatitis / chronic pelvic pain syndrome (CP/CPPS) is a common disorder and accounts for approximately 2 million visits to physicians annually in the United States.  The substantial impact of CP/CPPS includes bothersome lower urinary tract symptoms, sexual dysfunction, reduced quality of life, and increased health care expenditures.  The syndrome is diagnosed only on the basis of symptoms, principally pain or discomfort in the pelvis region.  No objective measures can help define the disease.  Although bacteria can infect the prostate, most men with prostatitis have a negative midstream urine culture, indicating that bacteria may not be the cause of their symptoms.”

“Because the cause of CP/CPPS is unknown, affected men receive many empirical therapies.  The 2 most common treatments prescribed by physicians are antimicrobial agents and a-adrenergic receptor antagonists, although there is little objective evidence to support their use.  Quinolones, such as ciprofloxacin, are commonly used to treat CP/CPPS because of their excellent penetration into the prostate and broad spectrum coverage for uropathogens and other organisms traditionally believed to be associated with the syndrome.” 

After completing a randomized, double-blind trial on men suffering from CP/CPPS, and comparing those who received ciprofloxacin, tamsulosin, a combination of both ciprofloxacin and tamsulosin, and a placebo, it was concluded that, “Ciprofloxacin and tamsulosin did not substantially reduce symptoms in men with long-standing CP/CPPS who had at least moderate symptoms.”

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Ciprofloxacin, and other antibiotics, are given to men with non-bacterial prostatitis for no good reason whatsoever.  They are often given long courses as well – 6 to 12 weeks of the drugs.  That’s a long enough course for many of the men who are given these drugs to cross their tolerance threshold for the drugs and get floxed.

If ciprofloxacin was effective at treating CP/CPPS, perhaps it would be worth the risk of getting floxed.  But ciprofloxacin isn’t effective at treating CP/CPPS.  It’s no more effective than a sugar pill and it is beyond ridiculous and wrong to expose men to a dangerous drug that doesn’t even help them.

CP/CPPS has been shown to be treatable through the techniques outlined in A Headache in the Pelvis: A new understanding and treatment for prostatitis and chronic pain syndromes.  The effective treatments include trigger point therapy and concomitant relaxation training.  More information about the treatments can be found in the article, “6-Day Intensive Treatment Protocol for Refractory Chronic Prostatitis/Chronic Pelvic Pain Syndrome Using Myofascial Release and Paradoxical Relaxation Training,” as well as on the web site http://www.pelvicpainhelp.com/.

Many symptoms of CP/CPPS, and other pelvic pain syndromes, react well to relaxation training and appear to be a response to stress and anxiety.  “Chronic pelvic pain reflects tension in the pelvic floor, initiated or exacerbated by cycles of mental tension, anxiety and stress.”  Pelvic pain syndromes are no more a choice than other bodily manifestations of stress such as heart attacks, back pain or tension headaches.  The pain is real and it is not “in the patient’s head.”  The brain is not separate from the body though, and what is going on in the head can have bodily manifestations.

The effects of ciprofloxacin, and other fluoroquinolones, on neurotransmitters may exacerbate CP/CPPS and other diseases related to stress and anxiety.  Fluoroquinolones block GABA-A receptors.  GABA receptors are the neurotransmitters that induce a calming response.  When GABA receptors are blocked by fluoroquinolones, anxiety, insomnia, fearfulness, loss of confidence, loss of self, psychiatric illness and even seizures can result.  Floxed patients often report being unable to relax, a reduced threshold for stress, autonomic nervous system dysfunction, and other symptoms of GABA neurotransmitter dysfunction.  Fluoroquinolones activate the sympathetic nervous system and disrupt the balance between the sympathetic and parasympathetic nervous systems.

If CP/CPPS is primarily a response to anxiety, stress and disregulation of the sympathetic/parasympthetic nervous systems, ciprofloxacin may not only fail to improve chronic pelvic pain conditions, it may exacerbate them.

Prescribing ciprofloxacin, or any other fluoroquinolone, to patients with chronic pain and non-bacterial prostatitis, is not only not helpful – IT IS HARMFUL, and may exacerbate the condition it is prescribed to treat.

Post-script note – Many people, especially elderly women, are given fluoroquinolones to treat asymptomatic urinary tract infections after a urinalysis shows bacteria in their urine.  It has recently been noted that URINE ISN’T STERILE.  And again, people are getting floxed for no good reason.

Sources:

A Headache in the Pelvis, a New, Revised, Expanded and Updated 6th Edition: A New Understanding and Treatment for Chronic Pelvic Pain Syndromes by David Wise and Rodney Anderson

Alexander RB, et al. “Ciprofloxacin or tamsulosin in men with chronic prostatitis/chronic pelvic pain syndrome: a randomized, double-blind trial.” Annals of Internal Medicine, 2004 Oct 19;141(8):581-9.

Anderson RU, et al. “6-day intensive treatment protocol for refractory chronic prostatitis/chronic pelvic pain syndrome using myofascial release and paradoxical relaxation training.” The Journal of Urology, 2011 Apr;185(4):1294-9. doi: 10.1016/j.juro.2010.11.076. Epub 2011 Feb 22.

“What is the mechanism by which the fluoroquinolone antibiotics (e.g., ciprofloxacin, gemifloxacin, levofloxacin, moxifloxacin) can increase a patient’s risk for developing a seizure or worsen epilepsy?Pharmacology Weekly, ©2008 – 2014 Pharmacology Weekly, Inc.

 

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