#82~ CFSAC Testimony by Tom Hennessy, Jr

TMH has give me permission to reprint his CFSAC Testimony to this blog.
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To: Wanda K. Jones, Dr. PhD

     Executive Secretary

     CFSAC

     HHS

     200 Independence ave. SW

      HHB Room 712E

      Washington, DC 20201

Dear Dr. Jones,

                     As a 24 year bed bound M.E., FMS and CFS patient, and an attendee of most of these meetings from the inception in 1994 of the first CFSCC (that we FOUGHT for  for 5 years, with Dr. Phil Lee from SF, CA, the ASST. Sec. for HHS under Donna Shalala to get the first one started) until 2004 or 2005. I finally gave up because the head of HHS either never READ the recommendations of the HONEST members of the panel, or never acted on them! 

                    When Dr. Phil Lee pushed Congress to create the first CFSCC, it was the ONLY such committee dedicated to only ONE disease in the Entire government! The very first charter called for the person in Dr. Lee's seat (the number two person in the entire US health services. At the time this included ALL Social Security, ALL Medicare, All medical departments of the US government. Dr. Lee and Donna Shalala were in charge of $662 BILLION per year. This was Twice the Pentagon budget at the time!) to CHAIR the meeting twice a year.

                        I heard some government employees complaining during a coffee break that they had NEVER seen such a committee dedicated to a single disease before, and they went on to say that it must have been because of the "clout" of the CFS patients. HAH! we have soo much clout, that out of a $32 billion NIH budget, we don't get enough money to purchase paper clips for a single study, let alone anything close to what 17 million or more sick, homebound and many bedbound patients around this big world need and deserve.

                         Because of the new found interest in this brutal condition with XMRV research at WPI and other centers around the world, and also, because I have watched YOU, Dr. Jones actually try to run a fair meeting, I would like to request a speaking slot for 5 min. I have a little apple computer with a tiny camera that could be used on video testimony if you have a set up for it. or I can type something up and email it in. I am stuck in a nursing home in Florida. I don't have a printer close by, or large envelopes to mail in my testimony. If someone could print out my testimony in your office, maybe that would suffice. So, I can phone in my testimony, or email it in, or give it over a video link from my little personal computer. I am now destitute and recovering from a broken back, cracked ribs, crushed sternum, cracked occipital bones and crushed vertebrae in my neck from a little auto accident I had where I blacked out on the way to the ER and I hit the back of a broken down semi tractor trailer near Fort Lauderdale, Florida.

                       I was recovering from a 4 day visit to a local hospital in which the insurance company that i contracted with to help cover some costs that Medicare didn't cover, and they put me through half a dozen tests because of my severe high blood pressures 187/117, and weird heart spasms I was going through because i was to ill to attend daily detox treatments that the insurance company might pay for because of the extreme neuropathies probably related to lyme disease, which is often a co-factor in M.E., FMS, CFS, GWS and related disorders. Like many other M.E.  patients, my illness has worsened over the years. I call it Myalgic Encephalomyelitis, which was the name given to this condition by people who actually KNEW something about this condition. There has been a WHO code 93.3 for neurological M.E. for about 40 years. The truly Awful CDC "CFS" definition of 1988, called the Holmes Criteria,  was a garbage diagnosis put together mostly by NON experts, when the REAL experts refused to sign off on the work product that the mid level government bureaucrats tried to force upon the real M.E. experts back in 1987. The Holmes criteria for "CFS" was put into the annals of Internal medicine way back in March of 1988. I  have been VERY sick, every single day since i first collapsed on October 23, 1987.  good timing! This disease is cruel beyond the imagination of most mere mortals.

                Since we M.E. patients have had TERRIBLE luck with many of the "CFS" personnel at HHS over the years, I must mention that I have heard quite GOOD reports about you from my friend Marly Silverman from PANDORA and other sources. I have heard that you have pushed for phone or email submission of patient speeches to be more accommodating to some of the sickest patients on the planet. Thank you for that. Regarding the videocasting of the meetings and allowing more people to give testimony. THANK YOU for that!

                 For years, I lived in the basement of my late father's home in Potomac, Maryland and I used to drive in with the testimony of half a dozen sick people from around the country. People who were too sick to make it to Washington, D.C. or too broke to afford a ticket to DC, would email me their testimony so that it could be read OUT LOUD to the CFSAC committee. Supposed summations of patients' testimonies were supposed to make it into the record, but this rarely happened in the early days.

               And EVERY darn Time, over the years from the late 1990's to the mid 2000's, the staff from the CDC or NIH or HHS, would make it HARDER to give legitimate testimony, not easier. These people should have been PROSECUTED for the harassment they gave me and other patients. First, they accused me of MAKING up testimonies of various people who I did NOT know , who had been seeking me out on the internet, because I had offered to READ the actual testimony of sick patients. Then, on a subsequent meeting, I was told at the last minute, that I had to have a SIGNED and Notarized statement saying that I was allowed to give the testimony of that person. This was a completely new and arbitrary rule. I  was already bedbound and was simply trying to allow people who were too ill or too poor to come to D.C. in person to just participate in their legal and legitimate attempt to get the care that their Tax dollars had paid for. 

                 And what did i get for these efforts to help my fellow very sick colleagues? Harassment in the extreme!

                The behavior of members of the HHS, CDC and NIH staff was criminal!

                 Another time, they  called my home at 7:15 pm on a Friday night, before a Monday morning meeting to say that the new Asst. Sec for HHS had just called them and told them that No ONE was allowed to read other people's testimonies any more, for ANY reason, unless the writer of the speech was in attendance. Since it was snowing at the time. and it was after 7 pm on a Friday night, I KNEW for a FACT that there was NO Asst. Sec for HHS in his or her office on a Friday night when it had been snowing since noon. So, I KNEW that the staff member who was calling me, was lying. All the local TV stations were saying how schools and government offices were shutting down early for the weekend since noon time, so that people could go and pick up their children for the day. This supposed meeting had taken place at 6:30 pm on this Friday night, when we had school closings and government office closing bulletins, since 12 noon. The ENTIRE reason for the phone call was to harass and disorient me. But the fool who called forgot that our family had lived in the DC area for 30 years, and i knew how the town worked. especially government offices.

                No person "that high up" the HHS food chain would even know who spoke about what disease, let alone care enough to stifle a troublesome advocate on a Friday night, over a snowy weekend. The newly appointed asst. Sec. for HHS would not even CARE who read who's testimony at some meeting for a committee that the particular HHS big shot had not even attended the meeting that was called for in the CFSAC charter. These people NEVER listened to or responded to the testimony of the professional members of the CFSAC, let alone  the sickest of the sick anyway! It was heartbreaking that many very, very sick Americans, and their friends around the world, would work for weeks or months on their 5 minute testimony, hoping and praying that it might make a difference. And those of us who KNEW better, knew that these great speeches would end up in the circular file, destined to become liners for the recycle bins, rather than being kept as a legitimate document on how we might actually help some very sick people find treatment for one of the most vicious medical conditions in the world. Many of the people who wrote to me, could not feed themselves. or sit up to eat. Many drank their meals through straws. The debility of this condition is just amazing. Between emails, post cards, hand written letters and beautifully typed Resumes and 10 page missives about how their once brilliant career was ruined, I have read more than 22,000 such letters. I would not believe it myself, if i did not live through it.

                    Even last week, I witnessed some portly buffoon, a Dr. Stoye, who was in charge of the Q and A for the first XMRV meeting at the NIH. He couldn't have been more rude and condescending if he tried. I have lived outside America for more than 5 years, and I am fairly worldly, but to have someone who is NOT American running a meeting at the NIH, where the New Director, of the NIH, Dr. Francis "the singing doc" Collins opened the meeting saying that it was a "momentus" time and that "great things" were expected from this panel, it was a less than auspicious display. Director Colllins charged Dr. Anthony Fauci of the NIAID, with dispensing the top virus hunter in our country to work with these Retrovirologists to get to the bottom of the XMRV mystery and whether it does or does not cause all or part of this vicious disease. 

                         The world wide press was interested enough to run more than 325 media articles in the past two weeks because a top NIH and top FDA researcher had mostly backed up the work of the Lombardi et al group from the WPI last year, that claimed that the newly discovered XMRV retrovirus, only the third known retrovirus in the world after HTLV-1 and HIV, MIGHT have something to do with the misery experienced by at least 17 million people around the world who suffer unbelievable nerve and muscle pain, cognitive impairment, completely non-restorative sleep, AND the distrust and derogatory smears from former friends and family alike. Most of us can NOT get even barely adequate medical care. There are very few palliative care items available for even minimal care, even after at least 30 years of top government officials KNOWING that this is a serious medical condition.

                          It has been DISGRACEFUL by any stretch of the imagination.

                  

                      Dr. Jones, we are not a bunch of meretricious valetudinarians. It is a crime to be so sick and to be treated SOO badly by the very government officials that are charged with taking care of us, and getting to the bottom of what is causing all this misery should be Agenda Item #1. 

                 Back in 1989, I claimed that we were losing at least $9.1 BILLION in government revenues Per YEAR from just lost tax revenues from what these sick folks would be paying, if we were not so sick. Dr. Jones, I repeat, That was way back in April of  1989. That number now is closer to $20 Billion per year!. and what do we spend on researching M.E. and CFS? 
a mere 3 or 4 million...and most of that has 
been siphoned off to pet projects of other researchers.

                       All the while, those of us who speak up are exposed to the kind of harassment i just described from the very people that our taxes pay to help fix our health problems. It is immoral and it should be illegal. Until you came along, Dr. Jones, this was NOT the exception, this was the rule.

                       I was in the room, lying on my foam pad when Dr. Phil Lee, who has been a friend of mine since 1987 , two years before I collapsed, openly chastised these people, but nothing ever happened. To be so sick and then to get hassled for simply trying to testify before a meeting of people who were trying to do good work, but who were totally ignored by our government leaders was disheartening in the extreme. I hope that with the discovery of XMRV things will change for the better. But, sadly, I am not as sanguine as our newbies are. Fool me once, shame on you! Fool me twice, shame on me!

                       Until I see serious amounts of money and top researchers assigned to this terrible plague, I will have to be counted as a skeptic.

                      I sincerely, hope and pray that you will prove me wrong.

                     Thank you for your time. 

Sincerely,

Thomas M. Hennessy, Jr.

http://www.rescindinc.org

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Thank You Tom for sharing your Testimony with those that have not been present for all of these Crimes to the American Citizens and our Humanity. I also wanted to include this for those that have not read Osler's Web yet to get just a taste of the rude behavior we have been 

 subjected to since the beginning...

Please watch this video and SEE just HOW Critical and What a Difference REAL research "applied in a timely manner" CAN DO to Help many of us with many of these different associated illness... Thank You.

#74~ The Politics and Science of Blood~FDA Style

Informal Report from the FDA's Blood Safety Advisory Committee Meeting

"It’s All About the Prostate, Folks."

Reprinted with the permission of the author 

Heidi Dunlap Bauer.

reported ~ July 26, 2010

I’m sure there will be much more reporting regarding the FDA Blood Products Advisory Committee meeting from today, but since I did make the effort to attend, I thought I would try to report as best as I can from my experience. My plan was first to tape Dr. Judy Mikovits speaking. I was under the impression that she would be allowed to speak somehow at the last minute. I had planned on taking a camcorder, but decided against it and took a voice recorder instead. I didn’t even use that though because all slides were copied onto handouts to be picked up at the door. The room was huge and filled with scientists, press and very few patient advocates, or at least very few who used the public time to speak. Kim McCleary was there, but I recognized few familiar faces aside from Wanda Jones. Even in the fourth row back from front, I was half a room away from the committee. This was far different than the CFSAC meetings I’ve attended with their cozy, cramped storage rooms. I was fortunate enough to see Dr. Mikovits enter and forced myself over to greet her and introduce myself. She graciously allowed me to glue myself to her for support, meaning she allowed me to sit with her during the meeting. I found out quickly that there were no accommodations made last minute for her to speak. She was sent to be a presence in the audience, and I hoped, a reminder that the good guys are still vigilant about our government finally getting this right.


The chair, Blaine Hollinger, M.D., opened with a statement I had previously read in an email. He stressed that the XMRV portion was information only and no recommendations or decisions would be made during this meeting. This seemed reasonable given that it was being videoed by the FDA along with a transcript being released eventually. My general impression afterwards is that this was simply a show for the public, a nice, safe, production meant to dispel “public panic” and focus almost solely on Prostate Cancer when XMRV was mentioned. To me, it is still reprehensible that prostate cancer (PC) receives respectful nods of approval and NIH funding when they have at best a 23% positive XMRV rate, and they only have found that in a highly specific type of PC that affects young men with a particularly aggressive form of PC. Add to that not even one replication study that backs those figures up (plus a couple negative studies) and they are in a worse situation than the Science study, which had a 67% positive rate, 95% with improved assays, and has a positive replication study pending publication. Yet, it is all about the prostate.


First up was Dr. Indira Hewlett. She presented an overview of the upcoming speakers and topics - three positive studies, including the Science paper, Silverman’s work and the German study, which found XMRV in respiratory secretions. Then the several negative papers are mentioned. As scientific courtesy dictates, the possible reasons for discrepant findings were listed, including the study populations, geographic differences, and “other unknown factors”. I mentally inserted, power, money, and politics as the “unknown” factors.


Dr. Silverman spoke next and disclosed his affiliations with Abbott Laboratories as both his research support and patent licensing and consulting. I’m going to move on past this one since there was nothing new presented here. I have read about that paper much too often. I’m starting to think I’ve read too much in general, because over 50% of the topics and slides were familiar information to me.  

Next, was Dr. Peter Ganz of Health Canada. Overall, they are not convinced that XMRV is the cause of ME/CFS, but they have employed what he called “Regulatory Perspectives” meaning “Lack of consensus does not require adherence to the status quo” and “What are the potential risks to blood recipients?” He called for further studies to establish XMRV as the underlying cause of human diseases in infected individuals. Hear, hear! Get the assays right, fund the studies and get on with it already. Prove the causative aspect so we can move on to answering the dozens of other questions this discovery brings about. How about - How is it transmitted exactly? How does it reach the brain? Is one person more at risk than another? What determines severity? All I could think of is what a waste of time this all is when researchers could, and SHOULD, already be in their labs, well funded, to hammer out the details. And, give the majority of the money to the WPI while I’m making my wish list. If anyone can pull a miracle out of a shoestring budget, they can. They’ve done it before.


Dr. Michael Hendry from the CDC study was up next. We all know the paper. We all know the Publisher’s Clearing House manner of patient selection used. If my cat could speak and answer a phone in Georgia or Kansas, I’m sure he would have been chosen for the study, providing that he could also pull off being female. Sometimes I’m surprised it’s the mouse and not the cat that XMRV derives from. Cats seem to naturally have the CDC version of a fatiguing illness. I was happy to see Dr. Suzanne Vernon pull the CDC paper apart quite well with a critical blow toward the CDC assuring patients this was a study designed NOT to find XMRV. No one expected anything other than that, of course. At least, no one with both eyes open. Dr. Vernon’s emphatic statement also leads me to believe the tides are changing. Compared to the harsh, critical blows Dr. Vernon gave to the Science paper early on, none of which could find fault with the virology, only a harping on the need for more patient information, her attack of the CDC paper at least momentarily could lead one to believe she is aligning herself with the burgeoning group of believers that XMRV is strongly linked with ME/CFS and is likely causative.


The worst part of Dr. Hendry’s presentation for me was after it was over. We are used to the lying, the manipulation and the sheer audacity to give false information as though they are facts. But, when asked by Dr. Hollinger if the PCR gag was the same as the Lombardi study, he said “Yes.” A bold faced lie. It’s one thing to read about these moments, but it’s quite another to see the lying in person, not to mention the slight swagger of Dr. Hendry as he walked back to his seat. It was during the questioning that Dr. Mikovits rose up to answer a question that I unfortunately missed. Dr. Hendry’s one slide had written on it “Developed sensitive mouse sequence specific qPCR to detect contamination with mouse DNA. XMRV positive DNA samples tested for mouse contamination.” Dr. Mikovits stood up and made sure everyone knew that these were sequenced and isolated. All 20 samples sent by the WPI were confirmed positives. It was hard to judge by body language what the reaction was. I kept looking over at Coffin though, who is so easy to pick out with the beard, hoping he’d ask a question or get involved. This meeting seemed to be about keeping things stiff and calm though. I half expected the Queen of England to show up with that much composure to go around. But, the only one deserving of a royal title in my book is Dr. Mikovits and she wasn’t even invited to speak. I was happy she was there as a reminder to all who the queen bee really is in the XMRV game.


And, so we continue and see Dr. Hewlett appear again with information on the assays they are using. I really need to sit down and talk with someone soon about assay development to understand that all better. Right now, I simply trust that Dr. Mikovits and Dr. Frank Ruscetti know what they are doing better than anyone else in the world, because as of yet, good assays seem to be eluding most scientists. I kept thinking, Judy’s made this insanely easy for them. She says here, try this. It will work. They say, no. We’ll do it our way hoping we can trump you. So, basically, there is still a problem with assays. Period. Then why, please, would Dr. Hewlett want to examine HIV patients in Cameroon and Uganda with an assay that has yet to be proven? Why would the other study that searched for XMRV in over 560 HIV+ patients in Chicago use an ineffective assay as well? Not one HIV+ patient in either study had XMRV. I’m fine with that if that is true. An HIV patient doesn’t need another hit like XMRV. However, with 4% of the healthy population carrying XMRV, does it not seem likely that at least a few HIV patients would be able to contract it as well? I’m not a scientist though, but I’d like to make sure my tax money goes to the right place to find those answers out. In my dreams I think of filling out my next tax form and seeing a place that says, “Would you like to donate $3 to WPI?”

Next up was the Blood XMRV Scientific Research Working Group report by Graham Simmons. This group has just about all the names we are familiar with and then some: Harvey Alter, Jerry Holmberg, Frank Ruscetti, Roger Dodd (you remember him from the May transcripts referring to the “perception” of an XMRV emergency rather than a real emergency), Suzanne Vernon, Judy Mikovits, John Coffin, Shyh-Ching Lo, Bill Switzer, etc. Presently, the main thrust of this group seems to be to find agreement on an effective assay. Graham Simmons concluded that "the study was too small to conduct meaningful statistical comparisons" and "more work on analytical panel development will need to be performed." The main labs in this group are WPI, FDA (Lo), FDA (Hewlett), NCI and BSRI.

Last up and the most interesting to me was the man with the Scottish accent, Dr. Stuart Le Grice. He said their goal is to create a group of 6 assays (Viral, DNA, RNA, Western blot serological (antibodies), serological (antibodies) and immunihistochemistry) that they are completely satisfied with and then go head to head with other assays to compare. If I’m not mistaken, he talked about a need to find XMRV directly from the sample as opposed to growing it in a cell line. I might have to wait for the transcripts to make sure of that one, but that seems like a fairly important leap in assay development.

I was impressed by one of his first slides:

"X-SCA: Single Copy XMRV DNA or RNA Detection – HIV DRP

Current status:

72 blinded samples of donor plasma, spiked with known quantities of XMRV DNA or RNA were tested using the X-SCA assay

*XMRV detected with SINGLE COPY sensitivity

*XMRV detected in plasma and whole blood with 100% accuracy

*No false positives or negatives"

It’s good to hear someone finally say they can find XMRV with this sort of accuracy. I often feel scientists are playing hide and seek for XMRV with their hands over their eyes saying, “I can’t find you.” In regards to a viral assay, which I believe looks for viral load, they have reduced the time on this to 3 days, and announced that there is information coming down the pipeline that it is now 1-2 days. The name of this assay is Viral DERSE (der’-see). All I could say is, “Wow!” I pictured the future where patients go to the doctor to find out if the retroviral is working and the test they got two days ago, covered by insurance (I dream big), gives an accurate picture for the doctor to consider. I’m not sure if I’m right or wrong on being impressed, but I caught Dr. Mikovits nodding quite a lot, so I must not be too far off.


And, so ended my four hour stay in Gaithersburg. After two brief public comments, one by an HIV patient and another by a CFS patient who calmly took 30 seconds to ask that the Alter paper be released, we were let go for lunch. I had no interest in their talk on Babesia. I hope it went well. At least this time the agenda didn’t have it pitted against XMRV as though it has to be a choice. I’m unsure if I will return to another FDA Blood Advisory meeting, but I am happy I went this time. I appreciate the friends who wished me well and wanted to hear my report. Thank you for reading and your continued support through this journey we’re all on. We strengthen each other every day just by being available. I hope we all continue to spread that support to the WPI and specifically to Judy and Annette, women we have assumed a first name basis with because of our appreciation for their sacrifice and dedication to ending our suffering. They are truly women of truth and integrity, and they deserve so much better than what they have received at the hands of the media, science and our government. They will win though. It’s imminent. 
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I would like to add my personal Immense Gratitude to Heidi for attending and being able to come home and write up such a Fantastic detailed and realistic report for us all to comprehend. She is truly a Gem and I was SO Happy that she was able to sit next to Dr. Judy Mikovits. Thanks for helping keep the patients and public informed in a timely manner.  There simply is not enough ways  for us to show our Appreciation to you for taking upon this task and following it up with your wonderful report back to us. Bless you !!!