written by reader Responses to Comments & Short Takes

"Doc Gumshoe" Looks at Chronic Fatigue Syndrome and the FDA’s Proposed Restrictions on Painkillers, among other topics

By Michael Jorrin, "Doc Gumshoe", November 20, 2013

[ed. note: We feature the writings of Doc Gumshoe, our favorite medical scribe, every few weeks here at Stock Gumshoe. He is not a doctor, but we value his insight, research, contrariness and skepticism … and, most importantly, his ability to explain complex health issues for our readers. He generates a lot of discussion with his pieces, so today he decided to share some longer responses to a few of the questions and comments that have come up in recent pieces. As always, his words and opinions are his own and we continue to welcome feedback on Doc Gumshoe’s commentaries or on any of our other work. You can see all of Michael’s previous commentaries here.]

Antibiotics in animal feed

Several readers responded sharply to my brief mention of the use of antibiotics in animal feed, noting that I gave the topic short shrift and didn’t condemn it, beyond saying that it shouldn’t be used to promote faster growth so that these creatures could get to market sooner and make more profits for the agribusiness concerns.

This is an exceedingly complicated topic, and the best I can do is offer some observations.

I entirely agree that the best way of raising animals for food, whether chickens, cows, sheep, pigs, or any other, is to give them as much space as possible and permit them to roam as they feed.   Keeping them penned in cramped spaces (besides being inhumane) maximizes the potential for disease and increases the proportion of fat to lean meat – i.e., not good for the animals, and not good for the human consumers of the animal meat.

Using antibiotics to control outbreaks of disease seems to me rational, with the emphasis on controlling outbreaks.   Routine use of antibiotics to prevent outbreaks is another matter.

It is certainly the case that restricting the use of antibiotics in animal feed would raise the price of meat, since the animals would grow more slowly and take longer to get to market.   And raising the price of meat might also have some beneficial consequences – some people might eat less meat and more fruits and vegetables.   The emphasis in that sentence is on “some people.”   Unfortunately, this is unlikely to be the response of many Americans to higher meat prices – especially poorer people, who would be most affected by higher prices and who are already consuming a diet that is low in fruits and vegetables and high is sugar, salt, and fats.   So restricting the use of antibiotics in animal feed might have the unintended consequence of pushing the poorest onto an even unhealthier diet.

It was pointed out that antibiotics fed to animals wind up in manure, in the soil, and in the water supply, and there have been instances where these have been implicated in creating antibiotic-resistant pathogens.   Putting small quantities of antibiotics containing tetracycline and ampicillin in cattle feed has resulted in levels of the pathogen Escherichia coli that are resistant to both drugs approaching 40% in the feces.   Resistant E. coli, in turn, have been found in vegetables raised for human consumption on farms that are close to cattle feedlots, and there have been outbreaks of resistant E. coli in humans traced to salad greens from those farms.   This is not a good thing!

There has been some confusion in the press and media regarding the so-called “flesh-eating” bacteria cases.   These are not caused by resistant E. coli, but usually by a variant of Group A Streptococcus pneumoniae, and don’t seem to have any connection with resistance due to antimicrobials  in animal feed.

So, the bottom line appears to be that routine use of antibiotics in animal feed can lead to resistant pathogens that can cause disease in humans.   A question that has not been answered is, are there adverse consequences in using antibiotics to control the spread of disease in animals.   There has never been an easy fix for this.   And preventing the transmission of diseases from animals to humans has presented many major problems over the years.   We recall the killing of hundreds of thousands of chickens in Chinese cities to try to prevent the spread of avian flu, and also the killing and burning of millions of cattle in the U. K. to prevent the transmission of mad cow disease, not to mention the extermination of entire herds of cattle potentially infected with anthrax.   This is not to say that those particular diseases could have been controlled by putting antibiotics in the animal feed.

On balance, it doesn’t look to me as though totally banning the use of antibiotics in animal feed is feasible, as long as a big proportion of the human race gets a lot of its protein from meat.   But it certainly could be limited and controlled.

More on Lyme disease

Several readers suggested that doctors are reluctant to diagnose Lyme disease even when the symptoms point to it, because they are afraid of being in some way discredited in the eyes of the established medical community.   Some even suggested that doctors might opt for a diagnosis of a disease other than Lyme, for which the treatment was straightforward, out of self-interest, including, possibly, a profit motive.

I acknowledge that the diagnosis and treatment of Lyme is something of a puzzle.   However, some things are clear:

In parts of the country where Lyme is prevalent, a patient who presents with typical Lyme symptoms, especially the bulls-eye rashes, will likely be treated for Lyme without waiting for positive blood tests.   Doctors know about the disease and want to kill the little buggers before they hide in hard-to-reach parts of the body.

Patients with Lyme symptoms who have positive blood tests, such as ELISA, confirmed by Western blot or cerebrospinal fluid with Lyme antibodies, will definitely be treated for Lyme.

Patients with some of the many symptoms which can be associated with Lyme, but without positive test results, are a challenge.   There are many, many other diseases and conditions which can produce some of those symptoms, and not infrequently, the same patient might have more than one condition causing separate symptoms.

Infectious disease physicians are understandably highly reluctant to put a patient on a course of antibiotics without any clear evidence that there is a pathogen present for the antibiotics to target.   That’s like shooting bullets at a ghost.   And with the known risks of antibiotics such as creating resistant bugs, it’s as though those bullets that were aimed at the ghost could hit an unintended target.

However, there are practitioners and organizations that are devoted to the cause of diagnosing patients with chronic Lyme who don’t have positive Lyme blood test results.   I am not accusing these folks of being influenced by a profit motive, but you have to wonder.

RA Comments

Several readers have mentioned Anatabloc, and said it had “never been accused of having any side effects.”   I don’t know anything about Anatabloc, but will do some sleuthing (see below).   But perhaps the reason Anatabloc is not thought to have any adverse effects (AEs) is because supplements are not regulated by the FDA, are not required to disclose any AEs that they produce, and do not publish the same kinds of prescribing information that regulated prescription drugs are required to publish.   In contrast, prescription drugs must disclose any AEs that occur in clinical trials more frequently with the drug than with placebo.  The AEs associated with biologics are clearly stated in the prescribing information and stressed in all the direct-to-consumer advertising.

Readers have pointed out, by the way, that at least part of the reason pharma companies state all the AEs in their advertising is not so much to protect patients, but to protect themselves from legal liability.   That is, “don’t say we didn’t warn you!”   However, my main point stands, which is that drugs are required by law to disclose adverse effects.   Supplements are not required to do that – some do, but many don’t.

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A better way to assess the safety of many drugs is by looking at the data in registries, which compare the rates of AEs in huge numbers of patients with the standardized incidence rate in the general population.   Registries reflect the experience of “real-world” patients rather than just the experience of patients in clinical trials.   While clinical trials often exclude patients with comorbidities, registries include every patient who has been prescribed certain classes of drugs.   For example, in the US, the CORRONA (Consortium of Rheumatology Researchers of North America) registry has data on 40,000 patients with RA, and there are similar registries in many other countries.

What the registries tell us is that although biologics vary among themselves with regard to safety, the increased risk to life and health due to biologic AEs is much lower than the risk from untreated RA disease progression.

A reader pointed out correctly that RA is a disease of connective tissue, which is not limited to tissue in joints, but is present throughout our bodies, and suggested that many or most of the deaths in RA patients may be due to related inflammatory processes in the heart.   There is certainly an inflammatory component in heart disease, and one of the markers of inflammation that is used to assess disease activity in RA is also tracked in patients at risk for heart disease, namely C-reactive protein, or CRP.   At the same time, the particular molecules that drive the disease process in RA don’t seem to be active in the heart disease process, so it’s not likely that we’re going to find any single solution.

A bit more about Anatabloc    

Recalling the instruction of Miss Charlotte Truesdell, my high school advanced algebra teacher, I applied myself to learn a bit more about Anatabloc.   I learned that the active ingredient is an alkaloid called anatabine, which is found in tobacco.   Other than the advertising material put out by the producers, I found a couple of mentions in the media.   One was a segment on a television station in Midland, Michigan – WNEM-TV – that starts out with a testimonial from a local woman who reported that her pain was successfully treated with Anatabloc.   She got the supplement in the course of a clinical trial, and the investigator in Midland, one Dr Wilson, was interviewed by the TV station. Here’s the clip:

Or an excerpt if you prefer not to listen:

The creators of Anatabloc promote the supplement for anti-inflammatory support of the immune system. This is potentially helpful for a variety of conditions.

“Alzheimer’s disease, Parkinson’s disease, autism, epilepsy, schizophrenia – things that we never before had any idea what the etiology of the disease could be. Heart disease, diabetes, arthritis, inflammatory disease of the bowels like Crohn’s disease, and on and on… And one of the most intriguing diseases is fibromyalgia,” said Dr. Wilson.

Anatabloc, which comes in pill or lozenge form, is based on a substance called “Anatabine” that is found in tobacco plants.

That’s right, tobacco. After you take a pill, it enters your body and interacts with a protein in your cells.

The resulting cell adopts a  natural    anti-inflammatory process in the body. Researchers say it’s very effective and promising in the battle against chronic pain.

And there was also a story in the Richmond (VA) Times-Dispatch on July 21, 2013.   Here’s an excerpt:

Anatabloc is sold at stores of health and wellness chain GNC, and Star Scientific is trying to get other stores to carry it. For instance, Westwood Pharmacy on Patterson Avenue and Westbury Pharmacy on Three Chopt Road carried the product but have not stocked it for about three months.

Star Scientific promotes Anatabloc through radio and online advertising — and it even has a billboard at The Diamond in Richmond.

Beyond the celebrity endorsements for Anatabloc, Star Scientific has suggested in public statements that the supplement, which contains an ingredient called anatabine along with Vitamin A and Vitamin D3, might be able to do a lot more than just soothe aches and pains.

In its marketing of the product, the company says Anatabloc helps users “reduce inflammation and support a healthy metabolism.”

While Star Scientific has not made any explicit claims that Anatabloc can cure diseases, it has put out at least 15 news releases since April 2010 announcing or detailing various scientific studies backed by the company and indicating that anatabine could mitigate the underlying causes of conditions such as Alzheimer’s disease, multiple sclerosis, thyroiditis and traumatic brain injuries.

The reason for all that, the company says, is because of anatabine’s anti-inflammatory properties.

But no independent research has been done, and Anatabloc, like other dietary supplements, is not directly regulated by the U.S. Food and Drug Administration in the same way that medical drugs are regulated.

Anatabine does appear to be anti-inflammatory in test tube and animal studies, but absent clinical trials in humans, its long-term health effects for people are unclear, said David Schardt, senior nutritionist for the Center for Science in the Public Interest, a nonprofit health advocacy group.

“In this respect, Anatabloc is like a lot of other dietary supplements that make explicit or implicit claims that exceed the scientific evidence,” Schardt said.

Star Scientific declined to comment for this article. A spokeswoman said it would be inappropriate for the company to participate in an article about Anatabloc at this time.

I have no specific comments on those stories, other than that Dr Wilson, quoted in the WNEM-TV clip, is way out of line making statements about the potential benefits of Anatabloc in advance of the evidence.   Only four clinical trials with Anatabloc are currently registered: in rosacea (a dermatologic condition), Alzheimer’s disease, autoimmune thyroiditis, and tobacco dependence – none in RA, or most of the disease mentioned by Dr Wilson.

Beyond that, I checked for published scientific data on anatabine, which is the “active ingredient,” and came up with just a tiny few bits.   Anatabine may possibly have benefit in chronic lymphocytic autoimmune thyroiditis and autoimmune encephalomyelitis, and also may lower amyloid beta (a factor in Alzheimer’s disease) in vitro and in animal studies.   But the great majority of the published material on anatabine has to do with its presence in tobacco smoke and with smoking cessation efforts.

So, it seems to me that we’re in “wait and see” mode on Anatabloc.

Chronic fatigue syndrome

At least one reader requested some Doc Gumshoe sleuthing on this exceedingly puzzling condition.   When I say that I know nothing about chronic fatigue syndrome (CFS), I place myself squarely in the center of the established medicine community, which also basically knows nothing about CFS.   I have been waiting for someone to bring it up, because it’s just the kind of condition that most torments people – the person with CFS definitely knows he or she has something, and the doctor accepts the symptomatology, but can’t offer much help.   An indication of just how little the medical community knows about CFS is the published “data” (and I use that term loosely here) on its prevalence in the US: from 0.006% to 3.0%.   That’s a range of 50 orders of magnitude.   And here’s a bit of a clinical paper:

Despite more than a decade of research, the etiology of chronic fatigue syndrome remains elusive. Many theories for the pathophysiology of chronic fatigue syndrome have been suggested, with earlier theories focusing on the prominence of symptoms that suggested an acute viral illness or a psychiatric disorder. Subsequent investigations have documented abnormalities in rather disparate domains, including brain structure and function, neuroendocrine responses, sleep architecture, immune function, virological studies, exercise capacity, and divergent psychological profiles.  Despite the demonstration of abnormalities across these and other domains, such findings remain largely isolated observations, with the interactions and relationships among them unexplored. (Afari N, Buchwald D Am J Psychiatr 2003;160:221-236)

That was back in 2003, but I haven’t seen a lot of concrete evidence about CFS recently either.   However, while digging around in PubMed (which indexes medical research around the globe) I came across at least one promising clue, viz: CFS may be linked with mitochondrial dysfunctions leading to depleted synthesis of adenosine triphosphate (ATP).   Without getting too technical, mitochondria are bodies in the cell that convert glucose into usable energy; basically, they pack energy into adenosine diphosphate (ADP) by adding a third phosphate unit.   The ATP molecules then cruise around dispensing the extra packets of energy where they are needed.   Any kind of dysfunction that interfered with this process could well lead to the range of symptoms that people with chronic fatigue syndrome experience.

Up to now, treatment for CFS has focused on alleviating symptoms by whatever means works.   This includes cognitive therapy, various forms of exercise, and drugs that don’t target any essential pathology but do help patients feel a bit better.   However, research into mitochondrial dysfunction could lead to genuinely effective forms of treatment.   As the auto mechanic says, you have to know what’s wrong before you try to fix it.

FDA may tighten rules on narcotic painkillers: good thing or bad thing?

The painkillers in question contain hydrocodone, alone or in combination with acetaminophen; brand names include Vicodin and Lortab.   The FDA has recommended a change in the classification of some of these opioid painkillers from Category III to Category II, the category which now includes OxyContin. The change would have to be blessed by the Department of Health and Human Services, and there are strong voices both pushing for the change and opposing it.   Pushing for the change are the constituencies that are most concerned with drug abuse, and they have powerful evidence on their side.   Drug overdose deaths, in the old days, mostly happened when a junkie got overeager with the needle.   Not any more.   Three quarters of those deaths are due to prescription drugs – legal opiates – and the number of those deaths has quadrupled in the past 15 years.

Opposing the change are the constituencies that are most concerned with patients experiencing pain who legitimately need pain medication.   What the change from Category III to Category II would mean can be boiled down to three main points:

  • Patients could not get a prescription for more than a 90-day supply of the drugs, and would have to be seen by a physician to have the prescription refilled.
  • Doctors could not phone or email the prescription to a pharmacy.   The patient would have to take the prescription to the pharmacy to get it filled.
  • Both doctors and pharmacists would have to maintain special and detailed records of all prescriptions, and in the pharmacy, the drugs would have to be kept in special secure storage.

What this would probably mean for many patients is that their pain would be undertreated.   This could happen for lots of reasons.   They have a hard time getting to the doctor, and put off going.   Doctors are reluctant to take on the additional record-keeping – there’s already too much! – and try to manage their patients’ pain with less potent drugs.   And doctors are already reluctant to prescribe Category II drugs, because they’re afraid that it will make them targets of drug enforcement agencies.

The medical establishment has a long and unfortunate history of undertreating pain.   There’s a basic assumption that pain, after all, is a symptom of some underlying pathology, and the real job of the physician is to discover the real cause of the pain, and treat that, and the pain will go away.

Well, maybe the real cause can be identified and maybe it can’t.   And maybe the pain will go away and maybe it won’t.   In the meantime, the pain is there, and it’s messing with the patient’s life.   If there weren’t any way to treat pain, then the stiff upper lip might have to be the answer.   But there are effective and basically safe ways to treat pain.   Addiction is not a major problem when patients take opiates to reduce the burden of pain. Patients in pain ought to be able to have their pain treated with the best agents now available, and not have obstacles thrown in their path.

I am not denying that addiction, and overdosing, are serious problems.   The terms of art in the painkiller biz are “abuse, misuse, and diversion.”   Serious problems, certainly.   But I think they can be dealt with in other ways.

There are fraudulent “pain clinics” in which a “doctor” writes prescriptions for huge quantities of opiates after a very brief chat with the “patient,” and the “patient” walks a few steps to the “pharmacy” where he loads up on these drugs, and then the “patient” gets back on the bus to wherever he came from and peddles the drugs to the addicted.   It would crimp their style a bit if they could only get a 90 day supply, but it wouldn’t stop the traffic.

A different kind of enforcement is needed.   The top-down FDA change from Category III to Category II won’t do much good, and it could do genuine harm to those most in need.   I say, “bad thing.”

* * * * * * *

Thanks again for all your comments, and for the lively discussions.   As I’ve said before, I am not an MD, but I’ve been keeping up with the medical literature for more than 35 years.   I continue to be an optimist, based on the really significant progress in many disease states that has taken place in that time.   But I’m also a skeptic, remembering the many highly touted “breakthroughs” that have not quite turned out as anticipated.   I’m certainly aware that the profit motive drives many courses of action, in health-care as in the sordid world of business.   However, I definitely do not believe in conspiracy theories – for instance, that the FDA is in cahoots with Big Pharma to conceal “cures” from the public, so that pharma can continue to peddle treatments.  When there are genuine cures, Big Pharma is out in front of the Big Parade, along with the 76 Trombones!



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December 3, 2013 8:56 pm

> is because supplements are not regulated by the FDA,

Please stop repeating old wives tales. If you lack experience with dietary supplement industry regulations, pass commenting on them (or your perceived lack thereof).

There are both voluntary and mandatory AERs for supplements, but the fact is such adverse events are orders of a magnitude low (even if underreported) compared to pharmacuetical drugs and doctor/hospital-induced deaths. The topic is really not worth wasting much time on except to ignorant maroons like Sen. Dick Durbin and other crony capitalists. What good do all the AERs for drugs and doctors do anyway? Only a relatively few squeaky wheels ever the the public grease courtesy of trial lawyers (which now looks to be on the downswing as judges get more and more fed up). Either way, its all ultimately about the money train, not promoting optimal health.

Lyme disease and the commonly associated infections (Borealis, et al.) do not need a definite diagnosis to treat it. The standard detection protocol promulgated by the CDC is mostly worthless anyway, having a high false negative rate. The reason Lyme, et al. eludes successful treatment is it has the ability to protect itself from synthetic or natural antibiotics by forming and hiding behind biofilm shields and incurring resistance. Dissolve the biofilm along with antibiotic therapy will finally eradicate the damn bug. Likewise for chronic fungal and yeast infections. I recommend everyone do it as a yearly prophylactic as chronic and/or hidden infections are an increasing burden as one ages.

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