BIG News!

Woke up with a start at 2 am last night. Probably several things.

First thing that happened was a call from one of my contracts. She had called my third place of employment to schedule an evaluation and was told I did not work there anymore!

News to me! Now, I don’t get there a lot but the plan was for me to go and do a case or two when called. Maybe something like once every six weeks or so. I was never told I was being fired!

Of course it turns out someone got something wrong but it did get me to thinking. Once again, how does one graciously bow out or – hopefully equally graciously – be shown the door? Inquiring minds.

The second thing that has me a little anxious is my big ‘field trip’ tomorrow. I am going to do some sightseeing on Manhattan with an acquaintance from school. First time that far away from home without my husband since my sight loss. I know it can be done, but it is still a little scary.

Third thing: I saw Regillo yesterday. My eyes are getting worse slowly. (I am not so sure about the slowly part!) He confirmed scotomata (aka blind spots) get darker but did not necessarily say they go black. He said that he would not expect a central vision loss to cover 60 degrees of arc. That wide a loss would be ‘extreme’. Those two answers at least get us slightly closer to settling two of my burning questions from this Spring.

The big news, though, is he wants to try me on lampalizumab next winter. It appears the phase 3 clinicals are going to wind down by the end of the year and phase 4 trials will be starting.

People, the numbers of subjects in phase 4 trials is BIG. HUGE! Phase 4 trials take place after the FDA approved the marketing of a new drug. The drug is made available to the public through local physicians. They look for effects and side effects in diverse populations.

What this means for you is simply this: the first actual TREATMENT for geographic atrophy may only be six months away! This is the first breakthrough!

Lampalizumab is an injectible drug. It has been proven to slow the progression of geographic atrophy and to “reduce the area of geographic atrophy” by 20%. Dosing occurs monthly or every six weeks.

Will I do it? Probably. I really believe stem cell replacement of RPEs is the way for me to go, but it is taking forever and I don’t have time for forever. Lampalizumab can be administered locally and would avoid lots of trips to Philly. I don’t like the idea of intravenous injections but I don’t like the idea of a vitrectomy either! A 20% decrease in disease progression might win me enough time (and macula!) to have a more successful intervention later.

If you have dry AMD and geographic atrophy, it might be worth your while to broach the subject of lampalizumab with your retinologist. Let him know you are interested. This could just be the start of something big for all of us.😁

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Biochemistry Redux

Doxycycline and I have a ‘history’. Not totally a good one. Doxy is the medication given prophylactically when you are bit by a tick. Some doctors recognize waiting for the red ‘bull’s eye’ of Lyme disease before treatment may not be a good idea; others don’t.

The second time I was tick bit I had a doctor that gave me the doxy as a precaution. The first time I was bit I had a doctor who withheld it.

Having some clue of what can happen to a body that has contracted Lyme’s, I was livid. Fortunately – or unfortunately – I had access to about half a vial of veterinary doxy. See it coming?

Do not try this at home! I took the doggie doxy and apparently took a little too much. Doxycycline produces photosensitivity. I won’t bore you with the chemistry (I researched it at the time), but suffice it to say, the molecular structure of doxy is such that it will store light energy and release it over time. You ‘sunburn’ from the inside out! Don’t need a reference for this. This is personal experience talking. I had second degree sunburn in about a half an hour.

The moral of that story is avoid doggy doxy. Once more I am the star of a cautionary tale. Oy vey!

But the reason I even mention doxy and our conflicted relationship is this: Oracea is doxycycline and it is being researched as treatment for geographic atrophy. There may be hope for my relationship with doxy yet!

According to the good people at Medscape (3/12/17) doxy is being researched as a method of treating low-grade inflammation resulting from alternative complementary pathway activity in geographic atrophy.

The alternative complementary immune system in me is ‘the gang that couldn’t shoot straight’. My good cells are being taken out by ‘friendly fire’. Reducing the effects of the alternative complementary immune system in me would be a good thing. [Lin/Linda: Sue’s referring to what she found out from a genetic test she had. Click here to read more about this.]

The Medscape article veers into uncharted waters for me but I will attempt to translate. It appears doxy can interfere with some of the molecular pathways – read series of actions that are supposed to produce something – that end up creating the conditions that lead to geographic atrophy. It lists oxygen species, matrix metalloproteinase, caspase activation, cytokine production and complement activation. Oh, good grief! Social scientist here! Never took biochemistry.

According to Wikipedia, reactive oxygen species are a normal byproduct of the metabolism of oxygen. In times of environmental stress on the cells, levels can build. It ties in with oxidative stress.

Matrix metalloproteinase are enzymes that break down matrix proteins (don’t ask because I don’t know!). Caspases are enzymes having to do with programmed cell death and cytokines are used by cells to send messages to other cells.

Did I mention I am not a biochemist? Don’t understand it except to say it all – magically! – has something to do with causing divots in maculas. Doxy is supposed to, maybe, could be, slow it down.

Clinical trials of doxycycline – under the brand name of Oracea – are underway. Check clinicaltrials.gov for locations near you. I doubt they would give you too much, but just the same, try to stay out of the sun! Continue reading “Biochemistry Redux”

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The Waiting Game

Yesterday was my third appointment with Regillo. Quite frankly I was hoping for great things. Hoping I would get a definitive answer and it would be positive! No such luck. My ‘answer’ was another “maybe”.

What criteria are they using? No clue. I was told my eye condition certainly qualifies me. Beyond that, I got no inkling of what I need to do to move up the list.

After a year and a half, I am getting more and more frustrated and antsy. If there is a way to become a prime candidate, I don’t know what it is.

Anatomy of the eye-click on the image for more information

I did learn a few things. Contrary to what I read, the good doctor says everyone has a suprachoroidal space (SCS). [Lin/Linda here: the SCS is the space between the sclera (outer part of eye) and choroid (space below RPEs).  It’s important in both clinical studies Sue is referred to because both insert the stem cells into this space; more about the clinical trials below). Not sure why the difference between what I read and what he said. I know I read something about ‘forcing’ (my term) an SCS in guinea pig eyes. They did it by injecting saline solution between the appropriate layers. Maybe the difference is between having a space and having a medically useful space? I might be wrong but I got the impression the delivery system works better when there is fluid in the SCS. Maybe not. Anyway, everyone has one. I am just not sure if you need the fluid to accommodate the delivery system. If you really want to know, check with your eye doctor. I am still trying to piece this all together.

The next thing I found out was the Ocata/Astellas study may resurrect sooner than I was originally told. I had heard two years or more and now I am being told 2017. Sweet.

I was asked which one I preferred. The one I would prefer is the first one to come to fruition! I will be dancing in the streets to be asked to participate in either one of them.

So that is where I stand now. I have been given two strong maybes. Is that a guarantee I will get something or do two nothings equal nothing? It is driving me crazy!

So back to practicing my distress tolerance skills. I have to ACCEPTS my situation. Engage in activities and contribute to others. I have to compare my situation to those of others and be grateful; things could be worse. Doing things to laugh will help me to have opposite emotions and I can push away problems I cannot solve at present. I can also have pleasant thoughts and intense sensations that distract me from my frustrations. It can be done. I have done it for a year and a half. I can keep on.

written 12/16/2016

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Beware Snake Oil

Happy Sunday to you! Lin and I have been emailing back and forth. Since I have another glimmer of hope about the clinical trials, we have been talking stem cells.

I am very optimistic about stem cells. I have known from the instant I saw the Wills studies on clinicaltrials.gov that it was the way I would be going.

I have not wavered in nearly a year and a half and I am not wavering now.

That said, do you remember when I talked about the three states of mind? I try very hard to stay in wise mind on this issue. Wise mind is the melding of emotional mind and reasonable mind. Emotional mind fuels but reasonable mind guides.

Going online we have noticed a lot of what I can only call testimonials to amazing new treatments. These popular press articles all talk about one person – that was one, 1, uno – person who has recovered his or her sight due to this miraculous, revolutionary new procedure, whatever it might be. To me, it seems stem cells have become the new snake oil.

OK. Now some of you just got your hackles up. Calm down. Sometimes snake oil worked. Not saying it did not. However, until it was evaluated pretty thoroughly we did not know a great deal about what it was, what it could do including harm, etc. Lots of harm has been done in the name of treatment.

For example? Blood letting. A president no one ever thinks of, Rush, was killed by bloodletting. It was an acceptable practice. I don’t imagine many of you have had blood removed to cure a disease but I am guessing you may know one person who has. Bloodletting is a proven treatment for Polycythemia Vera, a condition in which there are too many red blood cells. A treatment may have a beneficial use. We just need to find out what that use is. And we need to do it scientifically…at least in my not so humble opinion.

I am cautiously optimistic about stem cells. I have an internationally known doctor at an internationally known facility. The two studies I am signed up for are funded by large, reputable corporations. I even have the informed consent documents already!

What about you? First of all, I would like to think I could influence you to only go someplace with the credentials Wills Eye Hospital has. If that is not possible, ask questions and do your homework without committing to anything. Remember desperate people are vulnerable people. Also, even if the people you are dealing with are decent human beings, their theories or procedures could be faulty or simply not right for you.

What questions to ask? The American Speech, Language and Hearing Association – of all places – published a very nice list (with extensive links; gotta love those speech teachers!) in What to Ask When Evaluating Any Procedure, Product or Program. Read this. Take a copy with you and ask the questions. If you don’t get decent answers, turn around and walk out. Use your desperation, fears, hopes as the fuel but let your reasonable mind do the steering. Stay in wise mind on this one, guys.


Lin/Linda here:  Sue wrote this in December, 2016.  Yesterday (March 16, 2017) an article was published in the New England Journal of Medicine about 3 women who became blind after stem cell injections for which they paid $5,000 from an unnamed clinic in Florida.  The news spread fast and articles were published and widely shared by large news organizations (NPR, CNN, the major TV stations ABC, CBS, and NBC and the New York Times), by macular degeneration organizations (The Macular Degeneration Partnership, Macular Degeneration Association and The Macular Society in the UK) and by several professional organizations for those in the field of vision & eye care.

What went wrong?  This article Three people left blind by Florida clinic’s unproven stem cell therapy says it best from what I’ve read:

  • First there is almost no evidence that the fat/blood stem cell combination the clinic used could help repair the photoreceptor cells in the eye that are attacked in macular degeneration.
  • The clinic charged the women $5,000 for the procedure. Usually in FDA-approved trials the clinical trial sponsor will cover the cost of the therapy being tested.
  • Both eyes were injected at the same time. Most clinical trials would only treat one eye at a time and allow up to 30 days between patients to ensure the approach was safe.
  • Even though the treatment was listed on the clinicaltrials.gov website there is no evidence that this was part of a clinical trial, and certainly not one approved by the Food and Drug Administration (FDA) which regulates stem cell therapies.

 

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Third Chakra

It seems to be motivation week. The BARD book I was able to find by the second author my nephew suggested is entitled “Drive: The Surprising Truth About What Motivates Us” (No clue. I have not downloaded it yet; it’s also available on amazon.com) Then in yoga my yogini had us concentrating on the third chakra. The third chakra is said to be concerned with a sense of purpose and self-motivation. OK. THEN I was accused of lacking motivation in seeking treatment for my AMD! Really?

I sort of get it. How many diseases can you think of that not only have no cure but no real treatment? (Wear your sunglasses and take your vitamins???? What kind of treatments are they? Where are the pills? The funny machines?)

If people cannot fathom there really is no treatment, how can they understand we are not getting treatment? Not going for treatment? Just obviously unmotivated, we are.

And then you tell them you have been waiting for over a year to get into a clinical trial and they really think you are crazy. Why have you waited that long? You just march right in there and tell them you are going to be included in this! Why aren’t you motivated to get this taken care of?

So, perhaps I have not been forceful enough.  Perhaps they just have not noticed me and they are gathering up more motivated candidates. Perhaps I have my approach all wrong.

I have been asking around and doing my research. I have a fellow yogini who works at a research hospital. Totally unrelated body part, but the ways research progresses should have parallels; right?  She is going to ask about the flow of these things. Are their trial subjects more aggressive? Does it take those researchers forever to get their stuff together and get it on the road? Inquiring minds and all that.

I also went onto that purveyor of all things known, the web and particularly Wikipedia, and looked up recruiting for clinical trials. According to dear, old wiki, the recruiting business is a billion dollar venture. Recruiting is the most time-consuming aspect of research and is responsible for the failure to meet many, many clinical trial deadlines.

All of which begs the question: why are they not calling me? I am certainly not playing hard to get!

All the other materials I turned up on clinical trial recruiting were of the same variety. Those articles talked about the problems finding people who are willing, able and appropriate for participation. While I feel their pain, my problem is the opposite. I want to understand why no one is calling me. Is there a handbook for this somewhere? What is proper etiquette for seeking a position as a lab rat? I have NEVER had this much trouble landing a job!

So, no, I am not unmotivated.  My third chakra is working just fine; thank you. I am playing a game to which I do not know the rules and I am afraid of pushing too hard. People don’t pick shrinking violets but they don’t pick prickly people either. Anybody own an old rule book for this stuff? I could use a little guidance.

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