Miscellaneous Musings

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Pharmaceutical Profits At Risk ?

“Humira is forecast to contribute revenues of around $58 billion between 2013 and 2017, while Enbrel is forecast to contribute $45 billion. Thus Humira will further cement its status as one of the industry’s biggest selling products of all time….”
Pharma’s Biggest Blockbusters
Brand name Primary indication(s) Peak year (to date) Peak year sales ($m) Product type
Lipitor Dyslipidemia 2006 13696 Small molecule
Plavix Atherosclerosis 2011 9318 Small molecule
Humira Autoimmune diseases 2012 9265 Biologic
Seretide Asthma/COPD 2011 8148 Small molecule
Enbrel Autoimmune diseases 2011 7830 Biologic
Abilify Schizophrenia 2011 7363 Small molecule
Crestor Dyslipidemia 2011 7021 Small molecule
Rituxan Autoimmune diseases 2011 6798 Biologic
Remicade Autoimmune diseases 2011 6782 Biologic
Losec Dyslipidemia 2000 6260 Small molecule
Avastin Colon, lung, renal cancer 2010 6216 Biologic
Seroquel Schizophrenia 2011 6177 Small molecule
Diovan Hypertension 2010 6053 Small molecule
Herceptin HER-2 + breast cancer 2011 5947 Biologic
Singulair Asthma 2011 5479 Small molecule
Lantus Diabetes 2011 5452 Biologic
Zocor Dyslipidemia 2002 5445 Small molecule
Nexium Gastroesophageal reflux 2007 5216 Small molecule
Zyprexa Schizophrenia 2010 5026
Small molecule
The peak sales of biologics indicated for autoimmune disease (bold) in the table above totaled over 30 billion U.S. dollars.  This figure does not include associated doctor’s visit, testing, and possible treatment for adverse events.   Also of note are the other conditions in this list of top selling drugs, which themselves add another 40 billion in sales, and are very likely associated with biome depletion, as well.   These diseases  include:  Diabetes, listed once; GERD listed once; Asthma, listed twice; and Schizophrenia, listed three times.   That’s a pretty big chunk of the best selling drugs and associated diseases, totaling over 70 billion dollars.   It is possible that, these diseases might be inexpensively prevented, or treated, by helminthic therapy and biome reconstitution.   If so, there is a considerable sum of money at stake here.   I fear how industry, and their lap dogs in government, might react if profits were genuinely threatened by an inexpensive, easily available, natural therapy.
[ *Footnote: the biologic Rituxan, listed above, is the brand name of Rituximab, mentioned in my October 17th posts on Speculation About Biome Depletion and CFS.]

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Speculation about Biome Depletion and CFS: Preface 

As I have said before on this blog, my own career in ill health began in my late teens with a bad case of mononucleosis.  I was never the same after that, and soon descended into full blown Chronic Fatigue Syndrome.   In the decades that followed, I have heard the same basic story  repeated many times from other people with CFS.  They say, “I had a bad case of mono., then I was never the same.”

Having CFS has been accurately described as like being in a black hole, a theoretical point in space-time of immense, crushing gravity.   Information comes into the black hole, but information cannot go back out.   You doctor tells you that he can find nothing wrong with you, all your tests are normal.   You hear him.  Then you reply, “But doctor, I’m SO profoundly ill.  SOMETHING has to be wrong with me !”  The doctor doesn’t respond, though.  He can’t hear you.   He can’t hear you, because you’re in the black hole.  The black hole of CFS.   Once you cross the event horizon, into the black hole, information comes in, but no information can go back out.

        After you exhaust yourself trying to get someone’s attention, you soon look around and realize, “Hey, I’m not alone. There’s millions of other lost souls floating around in this black hole too”.   Then you begin to talk amongst yourselves.   You ask questions like, “How did you come to be in this place?”, and “Why are we all here ?”.    Someone says, “I came here from Japan.”   Another says, “I came from the U.S.”   Then others join in, “I’m from Canada.  I’m from Australia.  I’m from the U.K.”.   And we are all having the same experience, in the black hole – the black hole of CFS.
         Soon, we begin to make friends.   Sometimes, these are the only friends we have.   Family and old friends often can’t hear us.   The medical profession can’t hear us.   The government won’t hear us.  Nobody seems to hear us.  But we can hear each other.
      “I know why we are here”, someone says, “It’s because of the tremendous increase in electro-magnetic radiation we are being exposed to !”.   “Perhaps.”, answers another, “But I think it is primarily all the man-made chemicals”.    “I think it is toxic molds”, someone pipes in.   “I think it is vaccinations.   They don’t work, and are harming us”, says a shy woman.   “No !  You’re all wrong”, chimes in an assertive man, “Vaccinations do work.  That’s just the problem !  They are allowing children to survive, children who would have died in former times.  Vaccinations are genetically weakening our species.  CFS cases just represent these genetic weaklings, who should have died as infants, but didn’t.  So curse God and die !”   A long hush falls over the crowd.   The silence is finally broken by someone who timidly offers, “Could junk food and lack of breastfeeding have anything to do with it ?”   “What about strange viruses ?” someone asks.   And the possibilities continued to be added, as each spoke in their turn.   There were whispers of:  top soil erosion and nutrient depletion of our foods; NPK based fertilizers applied to our crops; too much stress; lack of sleep; lack of exercise, sunshine, and fresh air;  social isolation and modern alienation; occult dental infections and root canals; antibiotics and dysbiosis; mercury and other heavy metals; glutathione depletion; oxygen toxicity; methylation blocks; too little nutrition;  too much nutrition, and not enough fasting; childhood sexual abuse; fluoride; socialism; depression; the above ground testing of atom bombs in the 1950’s; and plagues from the Devil.  All these were all cussed and discussed inside the black hole – the black hole of CFS.
       And so it has gone for three, long, long, decades ever since the scourge of CFS first began to fall upon the globe.

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Speculation about Biome Depletion and CFS: Preface continued

From my own perspective, while these are fascinating ideas (some processing more merit than others – Ahem), I always felt like there was something missing.  Sure, one prominent thing out of these, or all of them working in concert, could produce the phenomena of CFS, but I just kept having the nagging feeling that there was something very important that I wasn’t seeing.  I sensed that, figuratively speaking, there was an elephant in the room.  Perhaps, it was hiding cleverly behind the sofa ?   Once the elephant stood up and exposed himself, I would be astonished, and say, “Now, I see !”

But I never thought I’d live to see the elephant.  I didn’t even know if an elephant really existed.  You see, many CFS patients have long ago ceased dreaming of a cure.   A few still cling to the hope of simply knowing why their lives were ruined.  Others have even abandoned the hope of that small consolation.   I thought I would draw my last breath, and still never know, “Why ?”.

However, since learning about the worms and biome depletion, I now find myself wondering, “Has the elephant stood up ? !   Are my eyes playing tricks on me ?”.   I must admit, my eyes are still trying to focus.  I’m still trying to take in the enormity of what I seem to be beholding.   Please read the thoughts, and links, I have provided below, then see what you think for yourself.

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Speculation about Biome Depletion and CFS: Part 1

       The first thing I would like to note here is that, the Epstein Barr Virus (EBV) has long been implicated in CFS.   As I mentioned, my own case of CFS began with a bad case of mononucleosis in my late teens.   And I’ve heard many stories similar to my own.
      Moises Velasquez-Manoff in his timely book, “Epidemic of Absence”, gives evidence that late contraction of EBV in developed countries is actually an example of biome depletion in itself.   Naturally, this makes some people uncomfortable.  It is OK to speak of bacteria in regards to biome depletion.  Some may even be willing to venture so far as to include worms in the idea of biome depletion.   But viruses ?   No way.  That’s just going to far.  Or is it ?
     There is evidence to indicate that an EBV infection contracted early in life is usually a non-event.  It may even “train” the immune system in some positive ways.
     Moises says, that in earlier times, when things weren’t so sterile, parents had a practice of making baby food for their infants by simply chewing the food into a paste, then feeding the infant the already masticated food and spittle.   This practice insured that infants were infected with EBV very early in life.              http://www.livescience.com/19435-pre-chew-baby-food.html
      Epigentically speaking, we can speculate that the immune system quickly adapted to early EBV infection, and then perhaps, it even became expectant of it.    Recall, from an evolutionary perspective, “the inevitable may soon become the necessary”.

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Speculation about Biome Depletion and CFS: Part 2

Recently, it was accidentally discovered that the B-cell depleting drug, Rituximab, was able to put some CFS patients into remission, so long as they continued to take the drug.   This is widely seen as a significant observation.  It is related to immune dysregulation in the B-cells of CFS patients.   This finding is particularly significant in that, the Epstein Barr virus (EBV) likes to infect B-cells.   EBV likes to infect B-cells, and loiter there for a lifetime.  http://phoenixrising.me/treating-cfs-chronic-fatigue-syndrome-me/immune/antivirals-and-immunemodulators/rituximab-rituxian

       Then we have the interesting information that, there is a class of B-cells, known as B-regulatory cells, or B-regs.   I get the sense from the literature that human B-regs have not been known for very many years, and are not well studied as of yet.   Evidence this paper from 2011:  http://www.ncbi.nlm.nih.gov/pubmed/20962324
       This paper, also from 2011, is very interesting.   It has to do with B-reg induction by Helminthes.   http://www.jacionline.org/article/S0091-6749(11)00767-6/fulltext    This paper is long and complex, but very much worth your time.   Apparently, helminth infection recruits the production of more B-regs.  B-regs produce the anti-inflammatory cytokine IL-10.   They also seem to expand the production of their cousins in the T-cell line, the T-regs.  T-regs also produce IL-10, lowering inflammation, and promoting immune tolerance.
       Finally, this paper from 2014 showed induction of B-regs (and T-regs) by helminth infection, and a significant reduction in the disease activity of Multiple Sclerosis(MS):   http://www.ncbi.nlm.nih.gov/pubmed/25015286    Multiple Sclerosis has long been associated with EBV infection,  and suspected as a causative agent.
         So, to draw this all together:   EBV infection later in life has long been associated with the development of CFS (and MS).  In fact, EBV infection later in life, may itself been seen as form of biome depletion.  EBV loiters in the B-cells.  Rituximab depletes B-cells, and has put some longstanding cases of CFS into remission.  This suggests a dysregulation of B-cell function.   Helminthes have been shown to induce regulatory B-cells, B-regs (and T-regs).  B-regs produce the anti-inflammatory cytokine IL-10, and help promote immune tolerance.   Call me crazy, but I think there might be something going on here.   Could the modern plague of Chronic Fatigue Syndrome be yet another disease associated with Biome Depletion ?
           Help me, dear friends !   Do my eyes perceive a hulking beast rising behind my sofa ?   Doth this beast have a trunk ?   Do my eyes decieve me, or doth thou see’st it also ?
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