BDF Response to the American Diabetes Association 5/24/16
Dr. Ratner, Bob – (Chief Medical Officer-ADA)
I must admit originally, I found your email from May 11th to be slightly evasive in nature and now believe my first reaction to be justified by the lack of response to our second e-mail.
Can you explain how it is that executives at ADA appear to be unable to answer questions as posed? I thought BDF’s question was simply put, does ADA accept or reject the position presently held by the NIH, JDRF and BDF that Brittle Type 1 Diabetes hereinafter BT1D is a rare disease in its own right and a separate and distinct form of T1D?
Your suggestion that BDF wait eight months for an answer as the PPC reviews the Standards of Care (SOC) for 2017 was unrelated to either our original intent or desired outcome. BDF did not ask in its original PPC proposal of March 3 (with attached supplement March 7) ‘How do you treat’? but rather quite simply…“Is Brittle Diabetes real or just a myth”?
One has to wonder how the NIH and JDRF were able to arrive at a conclusion utilizing evidence already contained in medical literature but ADA is unable to do so without a review of yet to be published works?
According to the 2016 edition of Standards of Care, the PPC “is also responsible for overseeing the review and revisions of ADA’s position statements and scientific statements”. It is BDF’s belief the PPC can even offer a consensus report or “expert opinion” which is not an ADA position. It certainly appears to suggest to us that the PPC can operate outside the framework of the SOC.
The purported modus operandi of the PPC is supposedly for its members to “systematically search Medline for human studies related to each section and published since January 1 2016” (the preceding year only). Recommendations are reviewed based on “new evidence or in some cases to clarify the prior recommendations or match the strength of the words to the strength of the evidence”. The PPC has followed this procedure for quite some time now.
Given that the NIH position statement was rendered in July 2013 and apparently not considered relevant by its absence in the 2014, 2015 and 2016 editions of SOC the only thing that is new in 2016 is the position of JDRF which isn’t on Medline because it’s posted as a blog statement and not as an article in a recognized scientific journal.
BDF requested ADA to re-review the past 95 years of medical literature to which ADA and the PPC appears to have closed a blind eye toward when it comes to the subject of Brittle Type 1 Diabetes. If in the course of 39 volumes of SOC publications BT1D has failed to make ADA’s classification list, how would waiting 8 more months make any difference? In section 2 of the SOC, the PPC states “that this section reviews most common forms of diabetes but is not comprehensive”, - “for additional information see ADA’s position statement issued in 2014 on the Diagnosis and Classification of DM”. There is no mention of uncontrolled, unstable, unpredictable, Labile or Brittle diabetes to be found in the PPC 2014 position statement supplement. In essence there is nothing that requires change.
The problem with the modus operandi established by ADA’s PPC is the built in assumption that the PPC never errs, has never omitted anything of substance or has ever been swayed by the medical paradigm of the year or decade which attracts the greatest flow of monies into research coffers. They appear to never retrace their steps any further back than one year in the course of the review process. So what would be the justification for BDF to wait eight months as instructed?
During these eight months while the PPC keeps those afflicted by physician diagnosed BT1D and their families in suspense, BDF will:
1. Persevere in its educational mission assisting those who are being diagnosed with BT1D by more adequately informed physicians, those clinical practitioners ADA appears to be reluctant to assist;
2. continue highlighting clinical trials geared to curing Brittle type 1 diabetes, a disease that continues to be unrecognized by some of the more myopic health care agencies;
3. develop and execute its mass media campaign highlighting these specific inequities which exist in the medical healthcare field;
4. continue to ask why organizations rich with copious amounts of donor and federal funds to the tune of hundreds of millions of dollars have yet to address questions of a five year gap in information flow between the basic researcher and the clinical practitioner or who have yet to establish regional advisory panels to assist clinical practitioners with difficult BT1D cases;
5. advance the cause of further clarification on exact amounts of monies being raised under the vagary of the diabetes banner as well as how and where that money is actually being spent;
6. continue its analysis of past practices of individual healthcare organizations which the media has already documented including negative statements which have yet to be refuted;
7. expand its social media campaign already aimed at raising awareness in today’s “court of public opinion”.
BDF has asked ADA to conduct a thorough review of the medical literature as was conducted by the NIH and JDRF and come to one position or another. There are two choices, Brittle Type 1 exists or it does not. Either way take a position as a “Health Organization”, or dare we suggest even as scientists, of its existence or nonexistence. This is binary, there is no room, nor should there ever be, for political vagaries or spin as seems to be the case. With the superfluous amounts of funding and the resulting resources at ADA’s disposal, this process should not take 8 months.
Sincerely, Emanuel (Manny) Sorge Ph.D. Chairman/President – BDF