keraflex

[Lynn White]

It's not just testimonials which are hard to come by (for any of the procedures mentioned in this thread); it's any sort of even faintly robust clinical trial data from well constructed studies. While anecdotal information certainly has its uses, it's no substitute for independent peer reviews of actual patient outcomes by qualified and experienced clinicians.

One of the issues with clinical studies is that they take a long time. Once you are started on one, you can't really change direction, even if what you are testing is shown to be ineffective early on. Therefore, you have to be really certain you have covered all the angles before running a definitive trial.

When new procedures are being developed, however, one needs the ability to change direction as the results come in, so that the technique can be perfected. This cannot be done within the scope of a clinical trial.

People waiting for new procedures for any condition are in a cleft stick. Do you jump in at the experimental stage or do you wait until a procedure has done the rounds of years of clinical trials? Its often the way that by the time a procedure is widely adopted, it is already out of date.

So Longhoc, it really is totally impossible to offer up exciting new treatments that simultaneously have years of clinical trials to back them. Life doesn't work like that. If you wait for the clinical evidence then you are talking about 5-10 years at least before anyone gets the independent chance to have access to a new procedure. If you leap in the moment someone has a bright idea without any clinical evidential backing, then the associated risks are very large.

So please, everyone, try and look at this in a balanced way. If your eyes are deteriorating rapidly anyway, the risk of a new procedure is worth it. If you are in early stages or have reasonably stable vision, then you do need to weigh the odds very carefully indeed.

Lynn

[longhoc]

Hi Lynn

My comments were intended to be taken in the context of the posts on this thread which is: people who are being asked to pay for their treatment.

You're quite right of course -- you cannot magically jump straight from the theoretical basis for what might be a new treatment and land hey-presto in a state of known safety and effectiveness for that treatment. You have to move along the line of increasing knowledge and reducing risk. That line starts off pretty much with 0% known facts, 100% assumptions and the highest risk. You then progress in fits and starts until you hopefully arrive at 100% known facts, zero assumptions and low risk. This takes time and the amount of time varies. One of the variables is the throughput of patients and for rare conditions like Keratoconus, that throughput isn't all that great. So timescales are longer and thus the period of uncertainty is lengthy too. I accept all that. I also accept that people are quite at liberty to pick where they are happy being on that risk/reward trade-off. More on that last sentence in a moment.

What I have a great deal of concern about is where patients who are considering a treatment which is at the low on facts / with lots of assumptions / and higher risk end of the spectrum and yet being asked to make anything more than a token contribution towards the cost of the treatment.

It's well enshrined in commercial law that when one party offers goods or services for a consideration, they make overt or implied representations and warranties about what they are selling. This serves to protect both the vendor and the customer. So the first thing I would seek if I was considering the treatment under discussion here is what, if anything, the provider is claiming about the intended benefits. I cannot find anything in the public domain on this for the procedure we're talking about. Of course, it might be entirely appropriate that this disclosure happens when the patient is getting advice from the provider of the treatment. But it would seem to me that it is in everyone's interests if that information is at the front end of the sales process even if it is in a generalised form. People with a disease like Keratoconus are in a vulnerable position. One of the best methods for reducing the possibility of people making bad choices for themselves is full disclosure before, during and after the point of sale. While I'll be optimistic and believe that this disclosure is provided in the "during" and "after" stages, it would boost my confidence no end if I could see it in the "before" stage too.

Next, I would look to validate the claims. Again, I can find nothing by way of published data of whatever kind. I've certainly heard of this procedure for several years and it does seem to stretch credulity that no data is available to share even with lots of caveats such as small sample sizes and limited duration follow-ups. Even if the sample size was, say, 10, if you can get some indication of MBCV pre- and post- procedure and the breakdown of individual results in the sample, you could draw some -- admittedly flawed -- conclusions.

Unless I'm missing something though, there's nothing. This means that the only consumer protection you're entitled to is to rely on good faith dealing. Remember when I said earlier that of course people should be free to make their own risk/reward trade-offs ? Yet in an almost text-book case of information asymmetry, the supplier holds all the cards and the prospective patient has nothing -- or very little -- by way of independent opinion to rely on. So on what basis, exactly, are we to be evaluating our risk tolerance level here ?

But wait ! It gets worse ! Not only are you being asked to part with your money with only the thinnest of customer redress protection in terms of product liability, you'd be in an extremely weak position if you had to bring any malpractice claim should things go wrong. Not that I am at all suggesting that the suppliers in question are not operating to the very highest standards and provide exemplary care. But sometimes, with the best of intentions, things can go wrong and accidents do happen. Yet by agreeing to the terms offered (from what I can tell), this is being explicitly marketed as an early trial or an experimental procedure. You more-or-less waive any malpractice litigation rights because you'd have to prove negligent intent -- as opposed to accident or omission. This is much, much harder.

Trying to be balanced, I do really appreciate the difficulties of trying to innovate in the absence of a potential mass-market for the resultant treatment. I was going to use the analogy of a car manufacturer who is developing a new electric / battery powered car. In order to get real-world data, the manufacturers typically provide pilot vehicles free of charge (or at a lease payment way, way below the economic cost of providing the car) to consumers who are willing to participate in a trial. The users get a free or very low cost car, the manufacturers get their data. But that would be a bogus argument for both sides in the situation we're talking about here. For the provider of a potential treatment for Keratoconus, they're not going to make enough return on their investment in anything other than a very long payback timescale because the size of the market is tiny. Even if you hike up the unit cost, just how many machines are going to be sold worldwide ? And for the patient, it's not like you can just go out and pick another treatment option. Your options are really very limited. So any sort of market mechanism is broke before it has started.

But the bottom line for me is that I'm not at all convinced the approach being undertaken here is the right one. It seems to me like a medical Gresham's Law in effect. Bad clinical development practice will drive out good. By which I mean, if people with Keratoconus want new treatments in the future, we're going to end up having to pay for their development ourselves because that is what we're starting to do -- unprompted. Our behaviours will demonstrate that it's okay for the NHS and the insurance industry to shirk their responsibilities in funding product and drug treatment. "Niche" diseases will be left to be self-financing via direct patient payment. If we end up with that, it will be a truly lamentable state. By acquiescing to it, though, the message we're sending is "bring it on".



Cheers

Chris

[drink]

I think i have to agree with chris and Lynn, very well said and worth a read for anyone. It is the truth and reality, people sometimes get a bit desperate and start opting for these treatments without really having a good realistic think about what they/WE are about to do, and the the consciences for the longer run if it does go 'wrong' or 'doesn't work', and we are paying for it, so the last thing we also want to do is part with alot of hard earned cash for something that might not work or go worse. Money is money end of the day, it comes and goes, but your eyes, you/WE may only have one chance with them. I think being patient is the way to do it. But at the same time, having keratoconus like the rest of you guys and girls on here i can fully understand it can be hard at times.

I have been looking at treatments such as keraflex personally for quiet some time (few years) now as my eyes have been progressing and going downhill. But been holding out on having any surgery done, just not entirely confident with much out there, specially with a family to feed, if i lost my sight my job is the first thing to go. So people just as what has been said above by Chris and Lynn, please try not to rush into anything you are not entirely sure about, even when you do go for something, please try not look at the cheapest place/the most expensive, try go for a reputable place. ALso please ensure you are fully aware of what you are getting yourself into with new treatments for which there isn't much info/testimonials out there.

Im not really that vocal, thats my 2p worth hope it made sense.

[Lynn White]

Chris,

We are really on the same page here! I do have my concerns about this procedure for the same reasons you do - lack of easily accessible follow up. Patients are not really in the most critical state of mind when clutching at treatment straws. You also make excellent points about the consumer issues surrounding such surgeries.

To move this discussion on, do you have any idea what would be a better model? You are right in saying that the NHS simply do not want to afford certain treatments despite ample evidence that they work. This is down to funding issues and I am not sure how we get round this? Development of new drugs and treatments IS expensive - so who pays? In a condition like keratoconus, which is relatively rare, we are also reliant on work done in many different countries and already you have seen people on this thread who have reported going "out of country" in order to access new treatments and how can we hope to control that aspect? It is all very frustrating.

For what its worth Ttuf, I feel epi off CXL DOES have enough follow up to make its case though we still only have study evidence for around 10 years , so do not know the long term effects. However, the medium term effects have proved to be beneficial in halting KC and improving corneal shape and vision, albeit slowly.

Lynn

[drink]

Yes i agree, if i was to have any surgery done at this moment in time, it would have to be epi off cxl, even the 'on' looks impressive and realistsic (down to earth type of way).

[longhoc]

Hi Lynn

Yes, it's going to be a tall order to remedy the current not exactly ideal state of affairs. And the challenge is going to be, in my opinion, laid fair and square with those of us who have Keratoconus. I say that with some reluctance because it does smack of blaming the victims. But if we wait for the big agencies to come to our assistance, we'll have a very long wait. And as you rightly say, with a progressive condition, the limited window of opportunity for some treatments to be at their most effective is finite. So I think we have to set aside a natural sense of "this just isn't fair" and get on with it.

"It" being -- when we come across a treatment option we're interested in, we have to be prepared to battle with either the NHS or our insurers (depending on which route we want to pursue). And saying that, I don't underestimate for a second the difficulties that will bring. The initial response will inevitably be to get knocked back.

For the NHS, it will take persistence and the willingness to escalate and appeal via the (tortuous sounding) channels which are open to the public and enlist support from others if possible. For Keraflex, for example, I'd say to anyone seriously considering this procedure to make themselves known to each other and collectively as a group approach the supplier and offer to work with them on the NICE process for getting a new procedure evaluated under the Medical Technologies Evaluation Programme (http://www.nice.org.uk/aboutnice/whatwe ... cttoep.jsp). Simultaneously, you should also review the NHS Constitution (http://www.nhs.uk/choiceintheNHS/Rights ... 9Mar09.pdf) and see if the refusal to consider the new treatment is in breach of it. I suspect it may be for Keratoconus, for the reasons Lynn and I already covered in this thread. If you think the Constitution is breached, there is a remedy available (see the Constitution document in the link above). Again, better to do this collectively. You could do it as an individual, but it is alas easier to brush off a single patient than a group acting together. You also have to be committed to getting publicity generated where you can.

If it is an insurance claim, a different approach is needed. At face value, your policy's T's and C's would seemingly immediately rule out anything with even the faintest whiff of "experimental" about it. But as rightly alluded to by Lynn, all medicine by its very nature is experimental because the medical profession is always trying to improve on it. True revolutionary breakthroughs in treatments seem to me to be fairly rare occurrences. More common, and probably going on since when Hippocrates was in practice, is that new procedures inherit elements of older ones but add new refinements to get over constraints or shortcomings. When you try to decipher the insurance company's definition of experimental against the actual definition of the new procedure, it never fits. Keraflex is a perfect example because it contains elements of "conventional" crosslinking with the newer microwave reshaping aspect. Insurers have gone to great lengths to broaden the definition of "experimental" so they can create a black hole, and few procedures can truly fit under their definitions of "customary". To be blunt, "experimental" means what they say it means.

A lost cause then ? No, far from it. You can follow the four basic steps I've written up below:

1. Ask the insurer to explain what is experimental about this procedure. Keep a record of their response. Most people think the insurance company is looking out for them, so they look to the insurer as almost an authority on what is the best treatment for them. Don't fall into this trap. As a rule of thumb, you must challenge authority at every corner. This is especially important when it's an insurer you're dealing with.

2. All Private Medical Insurance (PMI) plans have an appeals process that you should follow. Your health insurer will give you information on how to initiate a formal appeal. If you're not satisfied with that, you can initiate an external appeals process (this depends on your PMI product, how you were sold it, and what aspect you're appealing against -- I'm always ready, willing and able to help anyone with an appeal !).

3. (run in conjunction with 2 above) Try to make a deal. If you're on the path to a graft because you've got no other options, your policy will almost certainly cover a graft. But you don't want a graft, you want an alternate procedure. Your policy must pay a benefit when you're entitled to it (the graft) so tell the insurer that if it comes to it, you'll have the graft and they will have to pay for it. But you're willing to cut a deal -- you'll sign a waiver to the right to the benefit of the graft but you want the policy to pay out the benefit for the new procedure instead. Note the this only works if the new procedure is cheaper than a graft ! But given the immense cost of a graft, it almost certainly will be. Of course, you have to take responsibility for your actions here -- it will not be possible to change your mind later and expect the PMI to pay out for the graft. But I'd guess for most people considering something radical and still in development, they are looking at every single alternative because they simply do *not* want to have a graft under any circumstances.

4. Write to the CEO of the PMI insurance company and tell them who you are, that your clinician recommended this treatment, that it's medically necessary for your continued good vision because the alternatives are too risky, that they have a limited amount of time to approve the procedure because your condition is progressive, and they have to give you an answer. Again, as with the NHS, media publicity can help a lot here.

I'll repeat what I said in my first sentence. It will not be easy. I think it's inevitable that you end up slipping into hopeful passivity that "someone" "somewhere" will do "something" to sort out the chicken-and-egg circular argument of getting access to treatments still in development. At the risk of being controversial, I don't think that's at all likely. It is going to be up to us who have Keratoconus to fight the vested interests who have nothing at all to gain by expanding the available range of treatments. If you've got the money, or can find it, that will be way, way easier than what you'll have to do to bring about the changes needed in the big players such as the NHS or the PMIs. I do hope though that there are sufficient bloody minded people out there who won't take "no" for an answer.

Of course, to do that, you have to be completely convinced about the merits of the treatment in question. But that's a whole different can of worms !

Thanks

Chris

[liam82]

Its dissappointing to hear that keraflex hasnt really panned out well yesterday.

I had crosslinking done, and its really improved my left eye but my optician just cannot get a contact lens that works on my eye, which is driving me mad and he says he doesnt think a lens will work on me.
Hes also asked me to consider giving up on contacts and just trying to get as good as possible vision with glasses.

Im starting to feel at the end of my rope, so was hoping one of these surgical procedures would be the answer

The idea of a sugical procedure that might help is a dream i guess.

Ah well.

[longhoc]

Sorry to read that Liam.

Forgive me if you've gone through this all before, but have you done the round of alternate lens types in addition to RGPs ? And also, now that you've got the crosslinking out the way, do you know if your cornea is up to having some sort of additional follow-up procedure e.g. LASIK ? (it needs to be stable and have a reasonable amount of thickness left).

Cheers

Chris

[a43]

Hello. I have been diagnosed with keratoconus since 2004, when I was 24. I am now about to turn 32 in a couple of month.

I am having keraflex epi-OFF with accelerated crosslinking done on my left, worse, eye in two days, Friday the 27th. The crosslinking will be performed three hours after the keraflex treatment.

I am lucky in that I do not need to worry about some of the aspects that might make the decision harder for some people, in that the procedure is fully covered by NHS here in Sweden, at least for sufficiently advanced cases like mine, and I only need to travel an hour and a half by car to Norrlands University Hospital, where professor Anders Behndig will perform the procedure. As a consequence, I have very little to lose, barring a total failure with actual negative results. Should the results be minimal, no money and little time is lost, and should a positive result regress in a few years, I suppose I could have it done again. I am also currently unemployed so missing work for any length of time is not applicable.

It is a little discouraging to see some people here talk about failure and disappointing results, although it does seem to me that in some or most cases this is more due to exaggerated expectations than actual "failure". My vision is very poor in my left eye, vision is still very blurry with RGP lenses. In my right eye, it is better, but still poor and not fully corrected with RGP lenses either. My eyes are always dry and irritated, light hypersensitivity is pretty bad, in some days excruciating. I manage in my every day life, although with much inconvenience and I can not drive any more. I constantly strain my eyes to see. I have a hard time making out faces from more than a few meters away, making it awkward passing by people on the street, wondering whether I know them or not. The contacts, especially on the left eye, have a tendency to fall out or slip into the corner of my eye. I also suffer from myopia in both eyes and have had to wear glasses or contacts since I was 3 or 4 or something like that.

With this in mind, much of the talk of failed procedures does not seem so bad to me. I have never enjoyed anything even remotely resembling perfect vision for as long as I can remember, so maybe reaching decent acuity, good enough to drive for example, through the means of glasses or regular contacts would be something I would consider a massive, massive success. Just being able to get rid of the RGP lenses would be a huge relief. Even just having halos and the photosensitivity reduced would at least improve my life quality by a not insignificant degree. Achieving anything close to 20-20 vision is a concept I can't even fathom. The only thing I would call an outright failure is an actual negative result, and even so that might not matter too much as I am already depending mostly on my right eye.

I still keep my hopes down and try not to expect too much, but even reading about these negative experiences makes the procedure seem promising to me.

Lynn, I know you are extremely wary, and by all means justifiably so, of raising people's hopes about this procedure, but I would still very much appreciate if you could give an informed opinion based on an average of your experiences of whether my hopes for the outcome are within what can be reasonably expected.

I am very much aware of the fact that results vary significantly from individual to individual making any truly relevant estimation impossible, but taking into account that I have practically nothing invested in this, that possible regression in a few years is not too much of a concern, and that I seem to have a significantly lower threshold for what I would consider a success than most people who have had the procedure performed on them, do you think the chances are good that I will be satisfied? I am also fully aware that it may take several months before I can tell the end result, and also that my vision might very well be worse for the first few weeks or so.

I would also be interested in how long after the procedure it might be meaningful to start examining the possibilities of fitting regular contact lenses.

Naturally, I will ask professor Behndig the same questions, but a second opinion never hurts.

I will try to keep you guys updated on how I am progressing after I have had the treatment done; at the very least I will make a post a few days afterwards, after my first examination next week, and after my second examination in a month.

[a43]

Actually, I would like to rephrase my question for Lynn a bit.

What I would like to know is not really an opinion on what results I personally can reasonably expect, but rather an explanation in layman's terms of what you have been able to observe so far in your dealing with post-KXL patients. I have read a few reports but as I don't know my own values, the numbers basically mean nothing to me. I think the bad eye is -14.something for one value or the other.

So what I'm looking for is something like "most patients can at least manage with glasses or soft contacts post-KXL" or "it's common that advanced cases will still need RGP contacts" or "it varies to such an extent that out of people with equally advanced KC, some have achieved 20-20 vision and some have had little to no improvement at all after 12 months" or "in patients with KC stage III (or whatever) it has been unusual to see more than such-and-such level improvement" or something like that.

Of course, like you said, it is unwise to try to project others' results on oneself, but I am frustrated by not really being able to even tell at all what kind of results have been seen so far in general.

Again I would like to stress that I understand that it still remains many years before a definitive evaluation can be made regardless of what these early results have been.

I am rambling a little in both posts but pre-procedure anxiety has been setting in over the last few of days (although mostly about how I'll experience the procedure and rehabilitation period and less about the results) and I find it a little hard to focus and to think of anything else. I am becoming depressed because I keep telling myself that the results will probably be bad so that I won't be disappointed if they are. Probably not that sound of a defence mechanism. Even with expectations kept low I can't help but really, really hope that I will be able to get rid of the RGP lenses. I hate them so much.

PS. I also noticed that my question about how long it might take until you can start fitting lenses was already answered earlier.

EDIT: re-reading the thread I just noticed that you had at least partly addressed my question earlier in that you had not personally seen anyone revert to glasses.