The first question that comes to mind: What do lung problems, allergies and rheumatology have to do with viral myalgic encephalomyelitis, morphed into chronic fatigue syndrome by the CDC, with NIH complicity?
I have emailed them to inquire whether treatments for HIV/AIDS are also reviewed by DPARP, and if not, why not. I also asked whether antiretroviral drugs being used to treat XMRV and MLVs, and the drug Ampligen, will be reviewed by this division.
The announcement: (notice that the headline says "drugs" but the body of the article says "products".)
Assignment of Drugs Developed to Treat Chronic Fatigue Syndrome (CFS)
"The Office of New Drugs (OND) recently announced a jurisdiction decision for products to treat chronic fatigue syndrome (CFS).Applications for products being developed to treat chronic fatigue syndrome had previously been assigned to at least six different review divisions within OND. Across these applications, a variety of different endpoints have been evaluated in assessing products for CFS. More recently there has been interest in the development of endpoints such as instruments that rely upon patient reported outcomes. Developing such tools may help facilitate development of new products to treat patients with CFS and allow for a better means for assessment of the benefits such products provide to patients.
The search for an underlying etiology or etiologies for CFS continues. Further research to understand the underlying etiology of CFS and the pathophysiology of the condition may also help in the development of new products.
In order to work effectively with internal and external stakeholders on developing clinical trial endpoints (e.g., PRO instruments designed for assessing patient symptoms and response in CFS) and clinical trial designs, OND leadership have agreed to assign all CFS applications to a single OND review division, the Division of Pulmonary, Allergy, and Rheumatology Products (DPARP). This will allow for a coordinated and consistent process for review of products being developed for the treatment of CFS. In addition, consolidation to one division should allow for efficient and effective review, development of expertise within this area, and provide a single point of contact for CFS applications for stakeholders external to FDA.
Effective immediately, all new applications for drug and therapeutic biologic products for CFS, regardless of the proposed mechanism for the therapeutic product or primary endpoint, will be assigned to DPARP. Existing active applications (NDAs and INDs) will be transferred to DPARP in an orderly manner (timing to be mutually agreed between the DPARP and the currently assigned division)." [end of statement]
It could be good news: at least now FDA is admitting there may be drugs and "therapeutic biologic products" developed for the treatment of "CFS". Let's hope that won't include the latest antidepressant or antianxiety drugs, developed especially to treat the "personality disorders" and "depression" due to "childhood sexual abuse" that the CDC has been foisting off on a gullible public and compliant medical industry for decades. (I can't bear to call it a "profession" anymore although I readily admit there are still some professionals in the industry.)
The announcement says they will take into consideration patient reports of efficacy. This could be good news, too, if they should begin to listen to patients like Kelvin Lord and Mary Schweitzer on Ampligen.
The (possibly) bad news: Well, what do lung problems, allergies and rheumatology have to do with viral myalgic encephalomyelitis, morphed into chronic fatigue syndrome by the CDC?
I emailed them. You can, too. Their comment form:
http://www.accessdata.fda.gov/scripts/email/cder/comment.cfm
This is their email address:
druginfo@fda.hhs.gov
Interesting. I think your analysis is right on- while ME doesn't really fall under pulminology, at least it's not a move to push everything for "CFS" under psychology and psychotherapy. However, the fact that they must be looking at drugs to treat ME is a good sign, I think.
ReplyDeleteThe article mentions "allergies," though. I wonder if that means that there are immunologists involved? THAT could be good news. If that's the case, perhaps they are leaving out the word "immunology" to avoid controversy?
Yes, if I just read the words, it looks like good news. Unfortunately, the past malfeasance of CDC and NIH make me so suspicious that I look for the hidden meanings - that might not be there.
ReplyDeleteI hope you're right about the immunologists' potential involvement. I look forward to the answer to my question about Ampligen. I've said elsewhere, Of course FDA can't approve it; how can they approve a drug for a disease the CDC says doesn't exist, except in our heads? So, how they treat Ampligen from now on will be a big clue. I read on the net that the company is gearing up to produce it in Mexico, but it didn't say if that would be the only location.
And I really want to know if HAART drugs for HIV are being reviewed by DPARP. Someone (Prof Rancaniello?) has said there are lots of drugs "on the shelf" that didn't turn out to be effective against HIV, but might be against XMRV or related MLVs.
I, too, read immunology and auto-immune disfunction as the connection. Asthma (pulmo), allergy, and lupus + RA (rheum) can be seen as at least somewhat similar. Pulmo's also see a lot of infectious disease (TB, flu's, SARS) too. AIDS was initially pegged from a rare pneumonia (plus a rare cancer) that kept turning up in young, gay men.
ReplyDeleteThe question of AIDS drugs is very important, though. Investigations will probably start at the drug makers but approval would be FDA. Will this group have, or bring in, the expertise for these drugs?
I'm hoping this is progress but nothing except concrete evidence (say, a drug approval or good research by the FDA) will convince me this isn't another way to make us disappear.