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The Skinny on Faustman's Phase 2 :  The Cure of Diabetes Type 1, or Diversionary Tactic? Dare We Dive In?

 

Newsletter #8, June, 2014

 

 

             We have, well, good news and we have bad news.  The good news is that Phase 2 of Dr. Faustman’s trials using BCG to cure Diabetes Type 1 are underway as of this month (June 2014).  Kudos to Dr. Faustman and her team for all their hard work in preparation!  

 

            The bad news is that the dosage and timing are nowhere near what she had originally asked for.

 

 

PHASE 1 -- TAKING THE FIRST PLUNGE

 

            In 2010 the Faustman lab reported results of Phase 1.  The methodology used was 2 doses of BCG at 0 and 4 weeks.  This is the standard therapeutic dose prescribed for TB.


             From Faustman's patent of 2003/2009 we know that the best recommended dosage based on her studies so far, was very different.  Quote:

 

……it is also desirable to induce endogenous TNF-alpha production either through stimulation with Bacillus Clamette-Guerin (BCG) or other immune adjuvants such as CFA, or by the direct administration of TNF-alpha. For example, one may administer BCG at least biweekly or, desirably, three times a week. Again, one skilled in the art can determine individually the dosing of the cells and TNF-alpha or BCG by analyzing a blood sample twice a week for evidence of the elimination of the phenotype of the pathogenic cell.    …………and to determine the correct dose of TNF-alpha or BCG, we may look for the elimination of TNF-alpha in vitro sensitivity.

 

…….. Exemplary doses of TNF-alpha that may be administered to a patient are approximately 40 μg/m2 or 200 μg/m2. Other exemplary doses include doses between 2×106 and 5×106 mg daily for two doses in one week. Patients with an autoimmune disease may tolerate higher doses of TNF-alpha and/or may require lower doses for treatment….

 

Any combination therapy described herein, e.g. a therapy which uses MHC class I expressing cells and TNF-alpha induction, may be administered until the disease is successfully treated. For example, this therapy may be continued for approximately 40 days; however, this time-period may readily be adjusted based on the observed phenotypes. Additionally, the dose of TNF-alpha can be adjusted based on the percentage of cells in blood samples  …..  indicating the amount of remaining autoimmune cells.

 

Reference:

 https://www.google.com/patents/US7628988?pg=PA1&dq=faustman+diabetes+type+1&hl=en&sa=X&ei=ln9FU72PF8OdyQGE74HwDw&ved=0CDUQ6AEwAA

 

(Taken near the end of the article, from the 10th to the 12th paragraph previous to the footnotes).

 

            This means that Faustman’s recommendation for treating Dt1 requires BCG given at least 2 times per week, and optimally at 3 times per week.  Also note that 40 days is the most desirable duration, but it can readily be extended based on the biomarkers.    

 

            Compare this to the methodology used in Phase 1:

 

Arms

Assigned Interventions

Experimental: E

BCG vaccination

Biological: BCG

BCG vaccination at 0 and 4 weeks

Placebo Comparator: P

Saline vaccination

Biological: Saline

Saline vaccination at 0 and 4 weeks

 

Ref:

www.faustmanlab.org/docs/academic/JournalPone0041756.pdf

 

            Since the patent recommends a very different methodology than what was actually used in Phase 1, are we to assume Phase 1's methodology was not of Faustman’s choosing?  Were the parameters actually used reasonable and fair?  Was the amount of BCG given in Phase 1 too small to encourage a therapeutic response, considering the safety record of BCG (80 years with ONE BILLION people treated for tuberculosis since 1928)?  Especially since the original timing and dosage was recommended by a respected doctor and professor who obviously knows her subject?

 

            It is true that scientific studies begin with very low doses in human trials for most medications, especially those that have just been discovered and whose safety hasn’t been observed over time.  So have there been any studies done using higher doses of BCG?  Surprisingly yes.  Take a look at this study: 

www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM163039.pdf

Quote: 

Patients received TICE® BCG (50 mg; 1 to 8 x 108 CFU) intravesically, once weekly for at least 6 weeks and once monthly thereafter for up to 12 months. A longer maintenance was given in some cases.
(from the top of the second page under the heading "Clinical Studies")
 
 
Compare this to what was used in  Phase 1: 
 
0.1 mg of BCG (1.6 -3.2 x 10 (6) at 0 and 6 weeks. 
 
             Therefore if 50 mg of BCG was used in the cancer study, and 0.1 mg of BCG was used in Phase 1, then Phase 1 was ordered to use 500 times less the amount than in the cancer study.
 
             As well, the cancer study was allowed one dose of BCG weekly for 6 or more weeks and Phase 1 was allowed a total of two doses, one dose 4 weeks apart.
           

          The above dosage of the cancer study now at this very moment continues to be prescribed for Bladder Cancer!  Truly, how safe is BCG?  Well, obviously safe enough for the delicate health of cancer patients.

            Is this a joke?  Is there perhaps some human will behind this pseudo-science?

 
ONWARD TO PHASE 2

 

          Phase 1 was considered a success because even after 2 doses of BCG, an ultra-sensitive test assay showed a small change in biomarkers, indicating therapeutic improvements that would not have been there otherwise.  Most notably the increase of C-peptides.   But the change was so small that Faustman planned an increase in both timing and dosage for Phase 2.

          Faustman went on record as saying that Phase 2 would be different than Phase 1.  Examples: 

 

Quote:  “Researchers report that humans who got low doses of the vaccine began to demonstrate transient increases in insulin production. At Massachusetts General Hospital, medical experts are getting ready to try higher doses of the vaccine in larger groups of people.” source: http://health-guide-healthy.blogspot.ca/2012/01/can-type-1-diabetes-be-reversed.html

 

Quote:  “The researchers expect that more frequent or higher BCG dosing than was used in this trial will be needed for long-term elimination of insulin-autoreactive T cells and a sustained restoration of C-peptide secretion and insulin production.”

source: http://www.massgeneral.org/about/pressrelease.aspx?id=1495

 

Quote:  “Faustman hypothesizes that the optimal dosing of BCG has not been utilized in previous trials.”

source: http://en.wikipedia.org/wiki/Denise_Faustman

 

Quote:  “The prospect of a cure A Phase II study, which will explore higher doses and an extended dosing schedule, is currently being planned.”

 source: http://conquerdiabetes.org/category/diabetes-news/

 

Quote:  “Phase II research has begun to further assess what dose and schedule is required to make BCG a viable diabetes therapy."  source: http://www.diabetes24-7.com/2012/01/02/what-will-the-dragon-year-2012-do-for-diabetes/

 

Quote:  “… next step, a Phase II human study, is currently being planned, with the goal of identifying a drug dose and schedule that will put advanced type 1 diabetes into remission for longer time periods and to greater degrees in the hope it will change complications and blood sugar control.”   source: http://www.iacoccafoundation.org/diabetes-research/current-research

 

Quote:  “Since she observed an increase the number of these dead cells after both doses of the vaccine, she also believes that the dose they used in the study is probably too low. - See more at: http://asweetlife.org/feature/faustman-lab-research-how-excited-should-you-be/#sthash.3NMHKpYe.dpuf

 

Quote:  “The question is, can we use this old-fashioned, cheap drug and find out the right dosing to decrease the bad white blood cells so the pancreas can kick in?" Faustman said.

Source:  http://www.wcvb.com/Shot-May-Reverse-Type-1-Diabetes/11287018#!INezD

 

Quote:  “She also said it's not yet certain whether more frequent doses or higher doses would be needed to restore more pancreatic function, but it may matter how long someone has had the disease.  source:   http://www.drugs.com/news/tb-vaccine-promising-new-way-fight-type-1-diabetes-39728.html

 

In this article Dr. Faustman suggests that the dosage and frequency could be adjusted or modulated for each individual depending on their biomarkers.

Quote:  “The next step is to find, in a Phase II study, the possible dose and frequency of administration of BCG vaccinations that will benefit patients with type 1 diabetes.  For Phase II, we will design a trial that is able to detect BCG’s effect on established diabetic patients — in particular, the best dose and timing of drug administration. In Phase II of the clinical trial, we will start the important process of testing the dose and frequency of drug administration to eliminate the disease in diabetic patients”

http://www.faustmanlab.org/docs/newsletters/Faustman_updates_f09.pdf

 

Dr Faustman said : In Phase II, we will attempt to do this as we seek to identify the dosing and timing (How much should be given? How frequently?) of treatment that will have a clinical effect. source: Faustman  Lab Facebook May  21 2012  https://www.facebook.com/FaustmanLab/posts/220016671451622

 

HOW DIFFERENT IS PHASE 2?               

 

            The NIH trials page describing Phase 2, which came out last month in April of 2014, describes Phase 2 methodology as follows: 

 

Arms

Assigned Interventions

Experimental: Bacillus Calmette-Guérin

2 BCG vaccinations spaced 4 weeks apart during the first year and then 1 vaccination every year for the next 4 years

Biological: Bacillus Calmette-Guérin

2 BCG vaccinations spaced 4 weeks apart during the first year and then 1 vaccination every year for the next 4 years

   

 

             Now look carefully at what it actually says:   “Two doses for the first year…” means that a total of two (2) doses will be given in the first year.  Then after the first year, four more doses will be given in four years, i.e. one dose will be given per year.  !!

 

            Compare this once again to Phase 1:   

 

Arms

Assigned Interventions

Experimental: E

BCG vaccination

Biological: BCG

BCG vaccination at 0 and 4 weeks

Placebo Comparator: P

Saline vaccination

Biological: Saline

Saline vaccination at 0 and 4 weeks

 

 

            Allow me to interpret this as follows:  In the first year, Phase 2 has dosage and timing exactly the same as Phase 1.  (and the results were almost NIL)  In the four following years of Phase  2,  there will be another four Phase 1’s, but with even less BCG administered.  So results are expected from five Phase 1’s in a row, at an even less potency than Phase 1?

 

            Literally speaking, the 6 doses in five years of Phase 2 are an increase in frequency compared to 2 doses in one year, but scientifically?  Especially since the Faustman Lab found that the therapeutic effects of BCG rapidly wore off after 14 days.    

Ref:

 https://www.google.com/patents/US7628988?pg=PA1&dq=faustman+diabetes+type+1&hl=en&sa=X&ei=ln9FU72PF8OdyQGE74HwDw&ved=0CDUQ6AEwAA

 

About half way through the patent, 2nd  paragraph after Table 3

 

            Our question is then:  why isn’t this therapeutic effect encouraged in Phase 2 by having continuous doses at least every 14 days?  Does it seem to you like the proven therapeutic effects are NOT being encouraged by this methodology?

 

SOMETHING’S NOT QUITE RIGHT HERE    

 

            We emailed the Faustman lab to confirm the methodology for Phase 2 and received an email from an assistant that Faustman had indeed chosen these parameters.

            So the dose and timing is confirmed.  Why, then would Dr. Faustman settle for a methodology that was so different from the ideal dosage in the patent?   It’s clear from the interviews and her patent that the original intention was to test BCG at a much higher dosage in Phase 1, and definitely more than in Phase 2!!

            As we have seen, safety of BCG is not an issue.  Then why are the doses spaced so far apart there would be NIL, ZIPPO, NADA, ZERO therapeutic effect?  Like why?

 

THE SNAKE IN THE GRASS

 

            The reason is that the FDA (Food and Drug Administration in the US) is involved in setting protocol for trials and studies.  In fact, no study is activated until the FDA approves it.  So why would the FDA be SO VERY cautious at approving a safe level of a medication that would cure Dt1? 

 

           When one looks at the record of accusations against the FDA, one sees a pattern emerging.   Some of the proven practices of the FDA include

 

1.  Picking and choosing which studies to base drug approvals, i.e. ignoring reports that showed dangerous drug side effects.

 

2.  Passing dangerous drugs that were tested for only 3 (three) months!  (Compare this to 80 years and counting for BCG on Diabetes type 1!) 

 

3.  Contracting out studies to people who were not qualified, and not even scientists.

 

4.  Former employees reported being coerced into passing drugs with questionable results.

 

                And many, many more tactics that show flagrant unprofessionalism that is not in the public interest.  There are so many stories by whistleblowers and of fines given to BigPharma for their less than healthful practices, you can google it and find almost endless instances.  Or you can go to newsletters # 6 and #7 of this website (in ‘Blog’ section) entitled “Waiting for FDA Approval” and “The FDA and You; Up Close and Personal”  www.hdiabetes.com

 

              So why would a regulatory agency that should have health of the public as their most important concern be found intentionally rigging trials and test results of drugs that would hurt or kill people?  Because the sale of those drugs make a lot of money for pharmaceutical companies before death and damage becomes too obvious to ignore!

 

            How did pharmaceuticals crawl its way into the conversation?  For those people who don’t watch the news or read the internet, it’s well known Big Pharma controls and runs the FDA through its advisory boards—i.e. all the people who sit on the FDA’s  advisory boards ARE FROM PHARMA COMPANIES.  Plus the FDA and Pharma have a revolving door of employees working for one and then the other continuously. 

 

            Therefore is it any wonder the FDA would marshal all its activities and pronouncements into making money for Pharma?  That’s why the FDA is not cautious at all in trials of potentially dangerous drugs WHEN THERE IS MONEY TO BE MADE.  But extremely cautious in approving the trial of a drug that has already been proven safe BUT WHERE THERE WOULD BE MONEY LOST IF A CURE WERE FOUND??

 

            In fact why would Pharma and their tentacle the FDA  NOT do everything in their power to confound, stop, sabotage, block, wreck, postpone results, waste time on trials, and otherwise PREVENT results that would prove the cure of Diabetes Type 1??  This isn’t an agency, it’s a farce.   It’s not an effort at compassionate cure of a scourged disease.  It isn’t even science.  It’s an apostasy.  And the perpetrators should be tried for CRIMES AGAINST HUMANITY for blocking this cure and others.  They’re no more than mercenaries – hit men with a science degree!

 

THE STRANGLEHOLD

 

            Coming back to the fact mentioned earlier that the FDA has been proven to coerce its employees to pass dangerous drugs; this begs the question:  would they coerce researchers as well? 

 

              If you recall earlier in this article we reported that emails from 2 of Dr. Faustman’s assistants said that she herself chose the methodology for Phase 1.  So do YOU think she changed her mind about the methodology?  No we don’t either.  Not in the least!  Considering the bullying tactics and immoral nature of the FDA, we have no doubt that the FDA is not beyond pressuring Faustman to accept a less than fair methodology.

 

            The meeting with the FDA took place in private so we don’t know how it was phrased.  It may have been something like:  “We highly recommend that you choose this methodology” or any number of different ways.  That way it would have been Faustman’s choice.  But she probably didn’t have much of a choice.  And the FDA is off the hook!

 

            Dr. Faustman will never go against the authority of the FDA.  We admire her to no end for soldiering on with BCG trials for so long while the FDA has all along so severely restricted these trials.  She is truly an angel of mercy! 

 

            But the FDA has tied up her wings so she can’t even move!  Being prohibited from sharing the content of the meetings (or threatened may be a more accurate word), she cannot openly say that the FDA has prevented her from having the methodology she knows will cure Diabetes type 1. 

 

THE BULLY AND HIS PREY -- US

 

            If it goes ahead as it is, the ridiculousness of Phase 2 will produce not even a nanoparticle of results in 5 years.

 

              The public will either lose interest or see that the built-in failure of Phase 2 will cause a result so small that no lasting reversal could possibly happen.  The public will see that spending so much on ZERO results is a huge waste of time and finances.  And would be very less likely to publicly fund another such study.  And this is exactly what the FDA/Pharma wants!  i.e. For the only source of funding of this study -- the public -- to just give up!  

 

              In addition, because the trial is for 5 (five) years, this will make it seem like a study is being done, ALL THE WHILE NOTHING IS BEING DONE.  And Big Pharma will continue to rake in the profits for testing strips, insulin, syringes, pokers, anti-depressants for all the setbacks this frustrating disease causes, etc., etc.  Oh their tactics!

 

            Let me say again that we believe that Dr. Faustman cannot change anything about Phase 2.  She has to say she chose those parameters.  We believe she has been threatened by the FDA and cannot change those parameters.  It would be hurtful and unkind to criticize her.

 

            But then do we just sit back and let the bully win? 

 

            Abandoning this study now will be abandoning the only study even close to approaching the cure.  Faustman seems to be the only researcher in history to have the courage and independence to stand up to the FDA and keep on going in the face of their stalling tactics.

 

             This is not a simple problem.  We at hdiabetes.com don’t know the answer.  But we need to report our findings so you at least understand what’s happening / where your $ is going.  It’s a shame because the results are probably just around the corner using this safe drug using the right methodology and dosing schedule.

 

            WHAT CAN WE DO TO PREVENT THIS INJUSTICE FROM HAPPENING? Share your ideas and comments under article at  hdiabetes.com website.  Click here to share your comments and ideas

UPDATE OCTOBER 2014: We found a solution in October nsl. Read more The Importance of Methodology in Curing Type 1 Diabetes or Other Disease

 

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Editors, Hdiabetes.com

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