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CURRENT EVENTS:


Dec.2014 LauraHillenbrand FaceTheNation
ME+Unbroken Interview HERE -

AND
Dec 2014 ~ "NIH"P2P4ME"

NIH="InsufficientResearch"=DUH !
Treatment= more"SELF Management"
DraftReport HERE
AND
Nov.2014- "Plague"-Published !!
VOA-PodcastAudioInterview HERE
Hardcover+Kindle+AudioBook
Amazon USA Link HERE









Tuesday, November 30, 2010

#95~ CDC Website Reply = more bupkiss, Part 2

HOW MANY CDC OFFICIALS DOES IT TAKE TO ANSWER A SIMPLE QUESTION?

 I was SO Impressed by THIS fellow blogger's post that I asked and 
was granted permission to rePost  their last blog so that it could get even WIDER Coverage because THIS issue is of IMPORTANCE to us  
and this kind of treatment "Can NOT Stand." Period.
I have added the Underlining and Color for Emphasis. 

It is MY Hope that your reading of this interaction will AGAIN show you
just How Much we need to Concentrate on the CDC and their usage 
of the WRONG Definition of Our illness ~ NEXT !!! 

************************************************

Question: 
 How Many CDC Officials Does it Take to Answer a Simple Question?
Answer: More than 10
                                                                                                                                                                                                                                           The Question

The question that I posed to the CDC was:
Do these treatment and management options for CFS 
apply to ‘Canadian Consensus Criteria’ CFS patients or 
only ‘CDC criteria’ CFS patients?
                                                                                                                                                                                                                                                     I have perpetually posed this innocuous question to the CDC since July. 
After sending over 40 emails containing this question to more than 10 different CDC personnel over the period of 125 days, I have today finally received an ‘answer’ to my question.
                                                                                                                                                                                                                                                  I should not have needed to pose the above question to the CDC as their website should have stipulated who the treatment and management options detailed on their website were aimed at. The hundreds of thousands (if not millions) of people worldwide who fulfill the Canadian Consensus Criteria (CCC) for CFS should not have to go to the lengths that I have gone to in order to get this question answered. The CDC has a hegemonic status in relation to CFS authority and research. Patients should not have question such a fundamental issue relating to whether the CDC’s ‘treatments and management’ options apply to CCC CFS patients.

Without this clarification, a large number of patients remain uncertain of the nature and application of the CDC’s ‘Treatment and Management’ options for CFS. It is not only a case of omission of information but also potentially a case of hundreds of thousands of CFS patients’ trialing an inappropriate treatment regime based on the CDC websites inadequacy through lack of stipulation. In essence, my question was necessary due to the inadequacies and omissions on the CDC website.
                                                                                                                                                                                                                                      Catch 22

This is a quote from the Switzer et al. XMRV paper that I believe alludes to the CDC’s potential contingency plan that entails playing the ‘different illness’ card:
                                                                                                                                                                                                                                                  “The physical findings in persons meeting the Canadian definition may signal the presence of a neurologic condition considered exclusionary for CFS and thus the XMRV positive persons in the Lombardi et al. study may represent a clinical subset of patients.”
                                                                                                                                                                                                                                            The main purpose of my email was to clarify what is a contradictory perspective on CFS by the CDC. I asked whether   the CDC believes that these treatments http://cdc.gov/cfs/general/treatment/options.html are useful for those fulfilling the Canadian Consensus Criteria.
                                                                                                                                                                                                                                                If they answer “yes” then they are grouping all CFS cases together. If XMRV turns out to be the ‘major player’, the CDC won’t be able to claim that Canadian Consensus Criteria CFS is a different illness to CDC criteria CFS. In essence, they will still be held accountable for their past actions and will not be able to avoid the long overdue accountability factor.

If they answer “no” then they are admitting that people satisfying the CCC don’t apply to their own recommended CFS treatments. This has the secondary effect of an admittance that the entire CDC CFS program doesn’t apply to CCC patients. Consequentially, patients fulfilling the CCC would be distanced from the CDC and no longer fall within their domain.
                                                                                                                                                                                                                                              My original question should not be perceived as a trap for the CDC but rather a question that seeks clarification of their position relating to the CCC.
                                                                                                                                                                                                                                    Obtaining an Answer

It has almost been a full-time job seeking an answer from the CDC to the above question. This journey began in July and has involved 42 out of my 43 emails sent to different CDC officials being ignored and unanswered. I have even created pseudonyms and ulterior email addresses in the hope that an email from one or both of these variables will result in an answer to my question however I still received no reply. After receiving no answer to my question for more than 2 months and more than 25 emails, it became evident that the CDC was either grossly incompetent and/or purposely avoiding answering my question.
                                                                                                                                                                                                                                     During September, my fourth email to CDC-Info containing my question resulted in this reply:
                                                                                                                                                                                                                                               “We escalated your inquiry to the appropriate CDC program. If you would forward us your phone number, they would like to call and discuss your question with you.”
                                                                                                                                                                                                                                        Rather than detailing a simple written reply to my question, I became skeptical of a more involved reply method by the CDC. After ignoring my repeated question for several months, I wondered why they wanted to provide a laborious phone conversation answer as opposed to a standard email reply. Several possible explanations for this atypical phone conversation answer became apparent to me.
  1. It was possible that the CDC did not want to provide a quoted answer to my question which is what a written response may entail however a phone response would not due to legal restrictions.
  2. The CDC may have been aware that I am from Australia (possibly through the means of googling my name or email address or locating my IP address) and hence may have cunningly played the ‘phone call card’ as a means of avoiding answering my question (or not being required to answer my question) due to the international nature of it.
                                                                                                                                                                                                                                                  I considered my options and momentarily felt as if I would never receive a reply to my question due to the several logistical prohibiting factors preventing an international phone conversation with the CDC. I was still determined to receive a written response from the CDC. I then sent multiple emails to the CDC detailing the nature of my disability which encompasses my inability to partake in phone conversations. I emphasized that I expected my disability to be accommodated for and I asked for a written reply to my question. After countless emails to multiple CDC officials asking that my disability be accommodated for, I still received no reply.
I then compiled this letter and emailed it to the CDC:
                                                                                                                                                                                                                                            My Letter

“I have recently been on the receiving end of disability discrimination due to actions from CDC officials. I originally emailed this question to CDC-info on the 9/22/2010
                                                                                                                                                                                                                                                “I am emailing CDC-Info to seek clarification on an article on the CDC website regarding “Treatment and Management Options” for CFS: http://cdc.gov/cfs/general/treatment/options.html
                                                                                                                                                                                                                                             My question is “Do these treatment and management options for CFS apply to ‘Canadian Consensus Criteria’ CFS or only ‘CDC criteria’ CFS?”
                                                                                                                                                                                                                                         Thank you for taking the time to read my email and I am eagerly awaiting your response.”
                                                                                                                                                                                                                                          CDC-Info informed me that my email was forwarded to “subject matter experts” within the CDC. It was requested that I email my phone number so one of these experts could answer my question by phoning me: We escalated your inquiry to the appropriate CDC program. If you would forward us your phone number, they would like to call and discuss your question with you.”
                                                                                                                                                                                                                                                   I responded to this request:
                                                                                                                                                                                                                                               “I appreciate the offer of discussing this question over the phone however the nature and severity of my CFS makes this impossible for me. I am unable to hold a phone or talk for even short periods of time. Considering the nature of my disability, I’d be very grateful if my question was answered through other means such as an email. My reference number is SR #:1-112150438”
                                                                                                                                                                                                                                                 I sent this above email on the 9/22/2010 and I was informed that  
(My) comments have been forwarded to the appropriate CDC program for their information.”
                                                                                                                                                                                                                                            After waiting for several weeks (on the 10/10/2010) I again sent an email asking that the nature of my disability be accounted for and I receive an email answer as opposed to phone answer. I was again informed that “(My) comments have been forwarded to the appropriate CDC program for their information.”
                                                                                                                                                                                                                                         After more than 6 weeks, I have still not received a reply to my emails requesting that the nature of my disability be accommodated and my question be answered in writing (by email.) These actions have breached several legal requirements.  Below the legal regulations are listed pertaining to disability discrimination. Highlighted in yellow are the specific laws breached by the CDC in this process and highlighted in red are the semantic aspect of the laws revealing violation (in this blog entry I have instead indicated the parts of the laws that have been breached in bold.) I have sent this email through ‘CC’ to Dr. Frieden.

TITLE 28—JUDICIAL ADMINISTRATION
CHAPTER I—DEPARTMENT OF JUSTICE
PART 35 — NONDISCRIMINATION ON THE BASIS OF DISABILITY IN STATE AND LOCAL GOVERNMENT SERVICES
Subpart A — General
  § 35.101 Purpose.
The purpose of this part is to effectuate subtitle A of title II of the Americans with Disabilities Act of 1990 (42 U.S.C. 12131), which prohibits discrimination on the basis of disability by public entities
§ 35.104 Definitions.
                                                                                                                                                                                                                              Disability means, with respect to an individual, a physical or mental impairment that substantially limits one or more of the major life activities of such individual; a record of such an impairment; or being regarded as having such an impairment.
                                                                                                                                                                                                                                                 (1)(i) The phrase physical or mental impairment means –
(A) Any physiological disorder or condition, cosmetic disfigurement, or anatomical loss affecting one or more of the following body systems: neurological, musculoskeletal, special sense organs, respiratory (including speech organs), cardiovascular, reproductive, digestive, genitourinary, hemic and lymphatic, skin, and endocrine;
 (ii) The phrase physical or mental impairment includes, but is not limited to, such contagious and noncontagious diseases and conditions as orthopedic, visual, speech and hearing impairments, cerebral palsy, epilepsy, muscular dystrophy, multiple sclerosis, cancer, heart disease, diabetes, mental retardation, emotional illness, specific learning disabilities, HIV disease (whether symptomatic or asymptomatic), tuberculosis, drug addiction, and alcoholism.
                                                                                                                                                                                                                                               (2) The phrase major life activities means functions such as caring for one’s self, performing manual tasks, walking, seeing, hearing, speaking, breathing, learning, and working.  
(4) The phrase is regarded as having an impairment means-
(i) Has a physical or mental impairment that does not substantially limit major life activities but that is treated by a public entity as constituting such a limitation;
(ii) Has a physical or mental impairment that substantially limits major life activities only as a result of the attitudes of others toward such impairment; or 
                                                                                                                                                                                                                                     Public entity means –
(1) Any State or local government;
(2) Any department, agency, special purpose district, or other instrumentality of a State or States or local government; and

                                                                                                                                                                                                                                        Subpart B — General Requirements
§ 35.130 General prohibitions against discrimination.
(a) No qualified individual with a disability shall, on the basis of disability, be excluded from participation in or be denied the benefits of the services, programs, or activities of a public entity, or be subjected to discrimination by any public entity.
(b)(1) A public entity, in providing any aid, benefit, or service, may not, directly or through contractual, licensing, or other arrangements, on the basis of disability –
(i) Deny a qualified individual with a disability the opportunity to participate in or benefit from the aid, benefit, or service;
(ii) Afford a qualified individual with a disability an opportunity to participate in or benefit from the aid, benefit, or service that is not equal to that afforded others;
(iii) Provide a qualified individual with a disability with an aid, benefit, or service that is not as effective in affording equal opportunity to obtain the same result, to gain the same benefit, or to reach the same level of achievement as that provided to others;
(iv) Provide different or separate aids, benefits, or services to individuals with disabilities or to any class of individuals with disabilities than is provided to others unless such action is necessary to provide qualified individuals with disabilities with aids, benefits, or services that are as effective as those provided to others;
(v) Aid or perpetuate discrimination against a qualified individual with a disability by providing significant assistance to an agency, organization, or person that discriminates on the basis of disability in providing any aid, benefit, or service to beneficiaries of the public entity’s program;
 (vii) Otherwise limit a qualified individual with a disability in the enjoyment of any right, privilege, advantage, or opportunity enjoyed by others receiving the aid, benefit, or service.
                                                                                                                                                                                                                                                (2) A public entity may not deny a qualified individual with a disability the opportunity to participate in services, programs, or activities that are not separate or different, despite the existence of permissibly separate or different programs or activities.  
(7) A public entity shall make reasonable modifications in policies, practices, or procedures when the modifications are necessary to avoid discrimination on the basis of disability, unless the public entity can demonstrate that making the modifications would fundamentally alter the nature of the service, program, or activity.
(8) A public entity shall not impose or apply eligibility criteria that screen out or tend to screen out an individual with a disability or any class of individuals with disabilities from fully and equally enjoying any service, program, or activity, unless such criteria can be shown to be necessary for the provision of the service, program, or activity being offered.
(g) A public entity shall not exclude or otherwise deny equal services, programs, or activities to an individual or entity because of the known disability of an individual with whom the individual or entity is known to have a relationship or association.
§§ 35.152 – 35.159 [Reserved]
                                                                                                                                                                                                                                      Subpart E — Communications
§ 35.160 General.
(a) A public entity shall take appropriate steps to ensure that communications with applicants, participants, and members of the public with disabilities are as effective as communications with others.
(b)(1) A public entity shall furnish appropriate auxiliary aids and services where necessary to afford an individual with a disability an equal opportunity to participate in, and enjoy the benefits of, a service, program, or activity conducted by a public entity.
(2) In determining what type of auxiliary aid and service is necessary, a public entity shall give primary consideration to the requests of the individual with disabilities.
                                                                                                                                                                                                                                                  I trust that this situation will be rectified and I will receive a written (emailed) reply to my original question: “I am emailing CDC-Info to seek clarification on an article on the CDC website regarding “Treatment and Management Options” for CFS: http://cdc.gov/cfs/general/treatment/options.html My question is “Do these treatment and management options for CFS apply to ‘Canadian Consensus Criteria’ CFS or only ‘CDC criteria’ CFS?
Regards”                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                      I should emphasize that I am actually unable to use the phone due to my ME/CFS and have not made or received a phone call for more than 2 years. After sending this letter to the CDC, I received a prompt reply with an answer to my original question. This indicates that the CDC was very well aware of my question for the entire 4 month period and they purposely did not answer it. They only compiled an answer to my question when they were legally obliged to. This process of withholding treatment information by a government health authority group is the epitome of unethical.
                                                                                                                                                                                                                                            The CDC’s Answer

“Thank you for your recent inquiry to CDC regarding chronic fatigue syndrome (CFS). As the director of the CDC division that has responsibility for the CFS program, I am sending you this response after consulting with others at CDC who received your inquiry. I understand that a previous CDC response had included an offer to have a CDC physician contact you by phone, but that you prefer to receive a written reply to the following question: “I am emailing CDC-Info to seek clarification on an article on the CDC website regarding ‘Treatment and Management Options’ for CFS: http://cdc.gov/cfs/general/treatment/options.html. My question is ‘Do these treatment and management options for CFS apply to ‘Canadian Consensus Criteria’ CFS or only ‘CDC criteria CFS?’”
                                                                                                                                                                                                                                              In response to your question on treatment and management, CFS by any definition is based on a core set of problems: fatigue, a set of symptoms that is unique to the person but derived from a recognized list, and consequences of the fatigue and the symptoms. CDC follows the 1994 International Case Definition for CFS; however, the use of any definition requires the identification of underlying processes and core symptoms that need symptomatic treatment for improvement of overall health. Many of the treatment and management options listed on the CDC CFS website are similar to those listed in the symptom management and treatment section of the Canadian consensus document (for example, recommendations on sleep disturbance and exercise). However, any patient with CFS should consult with their healthcare professional on recommended treatment and management options based on individual symptoms.  
                                                                                                                                                                                                                                               As noted on the CDC website, the management of CFS can be as complex as the illness itself. There is no known cure for CFS, no prescription drugs have been developed specifically for CFS, and symptoms vary over time. There are a number of treatment and management tools available for CFS, such as those described on the CDC website http://www.cdc.gov/cfs/general/treatment/index.html.  
                                                                                                                                                                                                                                                   I hope the information in this response is useful to you in your struggle to manage this difficult illness.
Sincerely,

Stephan S. Monroe, PhD
Director,
Division of High-Consequence Pathogens and Pathology
National Center for Emerging and Zoonotic Infectious Diseases
Centers for Disease Control and Prevention”


Conclusion

It is striking that it took Dr. Monroe- someone very high up within the CDC to reply to the original question. It is also doubly curious that Dr. Monroe consulted with other CDC officials about what content was included within his letter. He stated that “I am sending you this response after consulting with others at CDC.” All of this for just a commonplace question. In a subsequent blog entry, 
I will present a critique of Dr. Monroe’s letter.

Original Article
Thanks again for letting me share this most important "CDC bupkiss" with the public. You are TRULY a valuable courageous Advocate that we ALL Respect. ♥
*******************************************************
This Must BE our Main Goal so that we can Get the symptoms of P.E.M.
included as we ALL know that it is the Major Hallmark of ME, and that the CDC purposely does not include it, so they can keep us under their
improper treatments of CBT and GET, which have NEVER been proved to help a Virus let alone a Retrovirus that many of us have. This illness may "effect our brains" BUT it is Most Definitely "Not All in our Heads" by their meaning of that phrase. 

Rest UP Now and Get Ready for the Next Wave of being an 
Advocate for YOURSELF and the 17 million around the World that 
are being Humiliated, Traumatized, Insulted, and DENIED 
proper Research and Treatment for this illness. 
They are indeed Guilty of Many Crimes against ALL of us. 

We will enumerate the list in the days to come.. 
....this "Band will NOT play on" much further.. 
THEY are Out-numbered not only by us, but also by the TRUTH.

PLEASE make sure everyone you KNOW sees what we have to go thru just  to get an answer from this Brain dead Organization that can't even answer a simple question without much delayed consultation over a bupkiss answer.

All of your comments and thoughts are appreciated.

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Monday, November 15, 2010

#94~ Dr. Mikovits 4th Anniv ~ WPI Research Director



I would personally like to take this opportunity to "Give Thanks" TODAY, on this, the 4th Anniversary of Dr. Judy Mikovits becoming the Research Director at the Whittemore Peterson Institute.


Because of the the persistence of the WPI and Dr. Mikovits unwavering determination 
to find the Real True Honest cause of ME/CFS and her insistence to meticulous methods 
and continually detailing her progress and her co-operation with other Medical Research Organizations AROUND the world, we CAN ALL say "without a Doubt" that it WAS her 
participation in the "Oct 2009 Science Paper" that has put ME/CFS back ON the radar of the medical and patient community.

Dr Mikovits Bio:  she's one smart cookie :)



"Dr. Mikovits spent more than 20 years at the National Cancer Institute in Frederick MD during which time she received her PhD in Biochemistry and Molecular Biology, investigating mechanisms by which retroviruses dysregulate the delicate balance of cytokines in the immune response. This work led to the discovery of the role aberrant DNA methylation plays in the pathogenesis of HIV. Later in her career at the NCI, Dr. Mikovits directed the Lab of Antiviral Drug Mechanisms (LADM) a section of the NCI's Screening Technologies Branch in the Developmental Therapeutics Program. The LADM's mission was to identify, characterize and validate molecular targets and to develop high-throughput cell-based, genomic and epigenomic screens for the development of novel therapeutic agents for AIDS and AIDS-associated malignancies (Kaposi's sarcoma). Formally trained as a cell biologist, molecular biologist and virologist, Dr. Mikovits has studied the immune response to retroviruses and herpes viruses including HIV, SIV, HTLVI, HERV, HHV6 and HHV8 with a special emphasis on virus host cell interactions in cells of the hematopoietic system including hematopoietic stem cells (HSC). Dr. Mikovits' commercial experience includes serving as a senior scientist and group leader at Biosource International, where she led the development of proteomic assays for the Luminex platform that is used extensively for cytokine activity assessment in therapy development. She also served as Chief Scientific Officer and VP of Drug Discovery at Epigenx Biosciences, where she led the development and commercialization of cell and array-based methylation assays for drug discovery and diagnostic development. Dr. Mikovits has co-authored more than 40 peer-reviewed publications that address fundamental issues of viral pathogenesis, hematopoiesis and cytokine biology. "


Before the WPI and Dr Mikovits the prior 10 years
I could hear the sound of the hallow empty vacuum
sucking the life out of all of us nonstop. 
NOW because THAT paper has revitalized the Research community , 
patient involvement and advocacy we all are 
vowing 
that THIS TIME we are going to grab this Golden Ring and 
NOT let GO until they have Found a CURE for ME/CFS.


This year after the CFSAC saw it's new Chair Chris Snell, PhD in April and 
the CFSAC~FDO Wanda Jones PhD, getting in contact with Dr Koh the Asst. Sec 
to Kathleen Sebelius, Sec of the DHHS that sits on the Obama Cabinet, 
and Dr Koh for the 1st TIME EVER attended part of the April CFSAC meeting.
I have absolutely NO DOUBT that it was Dr. Jones past history with the 
HIV retrovirus and her knowledge of the 3rd human retrovirus XMRV
that had now been connected to ME/CFS patients that prompted a 
First Time EVER Response from Kathleen Sebelius to the CFSAC regarding 
their recommendations to her. 
Here is her letter that was dated just 
Before the Sept. 2010 CFSAC meeting that has been 
documented here previously...






















As we all know, that Science Day was a smoke-screen for the truth that
that the following 2 days of the public meeting would uncover, particularly due to the Well Participated in "Time for Action" Campaign by the patients and the CFSAC members that have had First hand patient experience and could speak tho the Truth.

With this post I wish to accomplish 2 things..

Thank Dr. Judy Mikovits for her ground-breaking research that has been of tremendous help to us in advancing the "real science" and interest in our plight... 
...and thus because "at this present time" there is NO other Research place like WPI that has been totally built in conjunction with  a medical school and other researchers and a public/private partnership with the University of Nevada at Reno, that will include a patient clinic when it opens SOON, I hereby ask anyone reading this to PLEASE ask anyone that will possibly be asking you what you want for a Holiday gift.. ???  to....

Please just ask them to Donate to the WPI to help advance research, treatments and hopefully one day a Cure 4 ME/CFS patients with NeuroImmune diseases.
Donating can easily be done by clicking HERE. 
I am including the links so you can easily pass them on to those who might ask.
http://www.wpinstitute.org/help/help_donation.html
Those on Facebook can easily donate using the "Cure 4 ME" FB Cause page HERE.
and http://www.causes.com/causes/399439


The 2nd thing I wish to accomplish is 

...to bring your attention to helping our other "Sister Center" that we are working 
to get built on the East Coast of the USA, the future NEI Center (TM) 
that will be for  NeuroEndocrineImmune disorders.


This would also be a wonderful time if you haven't yet to "Please sign ONE of the petitions" asking Sec. Sebelius to meet with a representative from PANDORA concerning the NEI Center. This would be a perfect time to remind her how the future NEI Center would help and benefit those with NEI disorders.

HERE is the petition on change.org
and HERE is the petition on FB.
Please remember to ONLY sign ONE of the Petitions, OK.


Most of you already know that the Gift of Health is the Best gift you could give anyone. Please help us all reach this Dream for the 40 million of us with these illnesses. As the USA approaches their Thanksgiving Holiday next week
let us Help GIVE the Gift of Health by a simple donation and one signature.

After that~ your Thanksgiving meal, I promise, will taste Better ♥

I will NOT apologize for sharing this video 
with you again ♥ and Please "Sing Along"
Together we CAN DO This!!!





If you are now feeling Motivated and 
want to do MORE...
Please up Top Under where it says "Current Event"
and Click on Any RED Action and pick 
an action you would like to participate in 
Help us Spread the word of This Action also, OK?

♥ We "Thank YOU" from around the World ♥

PS: While you are here, please 
take my Reader Survey :D


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Tuesday, November 2, 2010

#93~ From Blood Ban to Drug Ban ~ collusion afoot ?



On the heels of the Fantastically attended UK Blood Ban Demonstrations all over the country yesterday covering all the mediums of BBC print, Berkshire radio, still images and video, and many "impromptu" educating classes at various Blood Donation Locations... there seems to be a "Trans-Atlantic Spoiler Alert" that needs to be Given ATTENTION By ALL patients + advocates  on BOTH sides of the Atlantic.
This does NOT ONLY effect ME/CFS patients !!!


Sunday night while everyone was celebrating Halloween, or planning for the 
next's days  Demonstrations, there seems to have ALSO been an orchestrated Trans-Atlantic gauntlet being thrown down in the UK and the USA regarding the usage of certain drugs that help patients, BUT their usage is being attacked via two different modes.


In the USA the news has been reported that  the FDA plans to start bringing "Criminal Charges" against Big Pharma CEOs for "OFF Label  Usage" as if the CEOs could know how and where their drugs are being RX'd. 

This is modeled on the questionable usage of the Park doctrine, that states company officers should be held liable for any illegal actions 
"by the corporation that the officer should have known about and been able to prevent."  
Here is a document that explains the Park Doctrine and HERE is a recent article explaining  the stakes we face. 

I don't mind the "Original Usage"  of the Park doctrine making sure that meds are not manufactured in unsanitary conditions, but this "Off-Label" trial balloon being floated here by the FDA Chief Litigation Attorney, Eric Blumberg, is seeking to "change corporate culture" in Big Pharma corporations.  

What I think he is forgetting is that many times there are NOT adequate approved drugs for many illnesses and many patients NEED and are Being Helped by these "Off Label" uses of many drugs..


This will be used to shut down "Off Label usage" and effect things like "LDN" and probably others I am not aware of....

The Timing of this Announcement seems "fishy" esp. after the UK NICE Guidelines Announcement  of their  making decisions about IF a Drug is "TOO Expensive" for  the stated purpose they could "effectively" decide what Dr's CAN prescribe or NOT within their medical system.

In the UK The National Institute for Health and Clinical Excellence, or NICE, scrutinizes the cost and clinical benefits of new drugs to determine whether the state health-care system should pay for them. If NICE decides that a drug... isn't worth its price tag, it advises doctors not to prescribe it, which effectively results in a ban. HERE is an article about this sad situation

ALL of this at the same time that already many patients with ME, Fibromyalgia and RSD and many other painful diseases are not able to get quality pain relief and we are fighting a backlash because the Dimwits at the Top do NOT realize that people that are "actually" taking pain meds CUZ THEY ARE IN EXCRUTIATING PAIN "ARE NOT GETTING HIGH" they are Simply trying to get some relief so the can even get some life back and be Functional.. 

Only those NOT IN PAIN get HIGH in this kind of situation.. This is SO Obvious to anyone that has a chronic pain to deal with that this is absolutely Ridiculous. Another case of Give the Politicians and FDA folks THAT KIND OF PAIN FOR A FEW MONTHS AND MAYBE THEY WILL UNDERSTAND ? Here is an article that speaks to the sad state of Pain Management in the USA currently.


I have a Really BAD Feeling about ALL of this...  It makes me believe in my gut that we are going to have to be MORE ProActive also about these issues and that means being more expressive by whatever means those in the effected county decide. But ONE THING is for SURE.. IF you "DO Nothing"  your ability to get the medicines you need WILL be effected, Trust me. This is NOT a Joke or False warning.


As they use to say on "SNL" (Saturday Night LIVE) during "Coffee Talk".... I sincerely ask you ALL to "Talk Amongst Yourselves" and decide how you want to address these issues, but they MUST be addressed....IMHO...but that's just 
"my opinion" based on years of observing the Medical Profession, the Governments involved and now the apparent "innocent co-incidental timing" of these edicts and pronouncements..

If it's smells like a fish, and is slippery like a fish, and wiggles when they explain their reasoning and excuses with logic that isn't logical .....it Must have scales.


You have been informed. What you do with this info now is up to you.


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