Tag: stem cell

Please Be Cautious

Waiting to go and buy a new, cheap, power mower and then get dropped off at the Y. I have been trying to use my long weekend ‘wisely’.

Translated: I will be more tired when I start the work week than when I ended the last one.

Getting things done, though. Including blog pages?.

So, how are ya? Do you remember that debacle in Florida several months back? Three blind in Florida due to a bogus and botched stem cell procedure.

The FDA sort of moves in glacial time but it does move. In May the FDA filed for permanent injunctions against that stem cell ‘clinic’, US Stem Cell Clinic, and one other one, California Stem Cell Treatment Center.

US Stem Cell – I always get a little wary when anyone ‘wraps himself in the flag’ as it were. Truth, justice and the American way? – has said they will vigorously defend themselves and cited “the rights of a patient and physician to decide whether or not to use a patient’s own cells for a therapeutic purpose without government interference”.

While that sounds lofty and very ‘American way-ish’ I wonder about a few little things like informed consent and the Hippocratic Oath. How many of us can truly say we understand stem cells well enough to be ‘informed’? The farther away medicine gets from mustard plasters and chicken soup, the harder it is for the average guy on the street to be able to give informed consent. Basically, when the medicos start talking, it comes down to having faith in the guy who is talking at you. What if your trust is misplaced?

Bringing us to the Hippocratic Oath. “First do no harm.” Believe it or not, those words are not in the oath, but close enough. Then there are a few statements about honoring those who have come before (as well as others working in the field I assume) and being part of a society. Not to mention not being ashamed to say one does not know. Hmmmmm….

Were these people open to peer review? Were they working for the good of society and advancing knowledge like a standard clinical trial or were they working for themselves…at $5,000 a procedure?

If you don’t play by the rules, the ref takes you out of the game. Simple.

And while the FDA is nitpicky – and who would NOT want all of the lice eggs out of her hair?!?! – they are not heartless. This does not apply to us because AMD is not a fatal disease, but the FDA approves the great majority of compassionate use requests it receives from the terminally ill. In other words if you have a fatal disease and you believe an experimental drug or procedure will help to save you, ask and you will receive.

How often does that happen? According to Fox News (March 13, 2018) the FDA approves 99% of requests.

So once again, please be cautious. Yes, you have a right to make foolish choices, but please don’t. Don’t let someone get you all fired up about the government trampling on your rights with your treatments. I am not a fan of big government but someone has to vet this stuff and I have not heard of any better process than the clinical trials process. Have you?

But that is just my opinion..

[Lin/Linda: here’s a new report that came out after Sue wrote this page: Woman says experimental stem cell procedure for eye disease was “too good to be true”]

Written May 28th, 2018

Next: Hawaiian Eye

Home

Behold the Turtle

Two days down on a three-day weekend. I am doing reasonably well with my ‘to do’ list. Progress through those is a good thing. It makes me feel a bit more accomplished.

I sent an Easter greeting to the researchers who will be conducting the clinical trial I have been trying to get into.  The answer I got was the trial that was slated to launch in March (never believe those predictions!) is now in startup phase and should be ready this Summer. Maybe.

Of course, I was hoping – still AM hoping! – to be a first draft pick lab rat and for the research to actually begin this Summer.  It will work out better for my schedule.

Not that the world revolves around moi…although it would make things a lot easier. You know what I am saying?

Of course, the treatment I have been wishin’ and’ hopin’ and thinkin’ and prayin’ (with apologies to Dionne Warwick way back in 1958) for is a stem cell treatment. Regenerative medicine. Therefore it was with interest that I read the article Nine Things You Should Know About Stem Cells that was shared in the Facebook group.

The article says there are complications that may occur with any treatment. The trial I am signed up for involves a vitrectomy.  Vitrectomies almost inevitably lead to cataracts. The stem cells themselves may trigger an innate, immune response that could cause more damage. Then there is the possibility the stem cells could be contaminated and cause infection. Or they might migrate and cause a growth.  There are dozens of potential SNAFUs. Most of us are old enough and wise enough to know there is no such thing as a sure thing.

If clinical trials were sure things they would not be called experiments. They would be called certainties. Who said “Behold the turtle. He only makes progress when he sticks his neck out”? (Found it. James Bryant Conant). Sometimes you have got to stick your neck out. You do it with thought. You do it with your eyes wide open but you do it.

Doing this trial will automatically make me ineligible for any other trials. That is just the way it works.  It is important the researchers know the results they got are a result of THEIR treatment. Not the result of a treatment you had somewhere else.

It is for that reason you chose a clinical trial with a treatment you have researched and believe in. We have a Facebook group member whom Lin told me was offered a trial with a treatment he was not sold on. He turned it down. You get one trial. You get one shot at this. Pick something you know about and believe in. [Lin/Linda: you can read about Facebook group member Bob O’Connell’s decision making process on page 2 of his Guest Author’s pages]

Those were just two points under the first of the nine reasons; believe it or not. I will look at the rest and may just write a follow-up page. Maybe not.  Right now, it is bedtime for this ‘turtle’.  Catch ya later!

Written April 1st, 2018 Continue reading “Behold the Turtle”

In the News

Real time: March 17, 2017. This Alsatian, Dutch, English, French, German and Welsh girl is, for today, Irish. Happy St. Patrick’s Day!

Patrick was, by historical accounts, a Romanized Brit taken by Irish slavers. Not that the Romans were choirboys. Etymologists say we got the word ‘slave’ due to the proclivity of Roman slave traders to go ‘hunting’ in the Slavic territories.

Anyway, Patrick reportedly had a vision and made his way to the coast where he was rescued. He later returned to Ireland to convert the people to Christianity. The end.

What does this have to do with AMD? Not much. I find it interesting. Knowledge is a good thing.

An informed populace is an empowered populace. An empowered populace is less gullible…and THAT gets me to my topic.

In real time, mid-March, there is a lot of hoopla about a ‘medical practice’ – and I use the term loosely – in Florida being shutdown for blinding three women with a stem cell ‘treatment’. These women also apparently paid top dollar for the ‘privilege’.

Using a lot of quotes here!

First point that absolutely everyone is emphasizing: stem cell therapy for AMD is NOT approved by the Food and Drug Administration.

Therefore, all stem cell therapy is experimental and you should never, ever, EVER have to pay for an experimental treatment. They pay you. Lab rat status, remember?

The studies I am signed up for are through a big, international recognized medical institution. They are being replicated around the world and they are being paid for by multinational corporations. If some backwater, single site clinic is offering AMD stem cell treatments to you for a fee, make your excuses and get out of there.

Not sure how in Hades these people got listed on clinicaltrials.gov. Someone screwed up there. What they were doing was not reported as anywhere near decent, standard experimental procedure.  [Lin/Linda: The clinicaltrials.gov website does have standards by which studies qualify for inclusion on the website but the NIH does not independently verify the scientific validity of each of the studies it lists.  Their answer, which is in the article above about these 3 woman, is that they put a disclaimer with each study.  So, it’s “buyer beware”.)

That said, also the knowledge is power stuff reiterated, I am going to start a short tutorial on what is basic experimental design. I will take several pages to do this so prepare for another mini-series. Consider yourself warned. Take a couple of days off or learn what a real experiment should look like. Your call. Continue reading “In the News”

SOS

J.R.R. Tolkien said once that “false hopes are more dangerous than fears.”

Every once in a while Lin and I hear someone make a claim about AMD that we know is not true. Then someone picks up on the claim, believes a foolproof treatment or cure has been found and they have been saved from blindness. This is only to have their hopes dashed a day or two later when the truth comes out. This can be heartbreaking to watch, let alone experience.

Right now, to our best knowledge, there is no cure or available treatment for dry AMD. There are a number of treatments being tested. Even the treatments most advanced in the process are several years away from being available to the general public.

The SOS has been sent. The cavalry is coming but they are still a very long ways away. It is up to us to hold out until then.

When I talk about medical treatments, I am talking only about drugs that will slow the deterioration process. To my knowledge there are no drugs that will regrow RPEs and/or photoreceptors. The drugs will not restore sight. If you have lost your photoreceptors, at this point in time you have lost your sight.

Stem cell replacement at present is for RPEs only. Remember RPEs are only servant cells. They take care of the photoreceptors. The pizza delivery guy may help to keep the neurosurgeon alive but we would not expect him to do brain surgery. Same concept. The RPEs will feed the photoreceptors but they won’t turn light into sight. The best we can hope for is for some of the photoreceptors that are at death’s door to be revived and start working again.

Dead photoreceptors are just that, dead photoreceptors. I have geographic atrophy. Photoreceptors that should be in that area are dead and gone. There is currently no way to get them back. The last I heard they were able to grow photoreceptors but they had been unsuccessful in having them connect with the rest of the nervous system. You have a cell phone in a deadzone. Your phone works great but the signal goes nowhere.

Am I saying have no hope? Hell, no. I live on hope. Just have realistic hope. Treatment is coming. Cures are coming. Just don’t expect them next Tuesday!

Why do people get so hung up by these crazy claims? First of all, they are desperate. Any port in a storm. Beyond that I am not sure. I wasn’t able to find a lot on the mechanisms behind false hope. Maybe it is better to feel better for a little while even if you are destroyed later. Sort of like substance abuse. It felt good at the time.

We try not to deal in rumors, just facts. If we say something you do not think is true, challenge us. If you read or hear something different from what you hear here, alert us to it and we will research it. Better yet, anybody capable of web research might volunteer to help us. There is a lot of information out there.

In the meantime, keep the faith but don’t go crazy. We are not there yet.

Continue reading “SOS”

Accessibility by WAH