Dr. Morris Waxler's FDA Petition to Permanently Ban LASIK

[kurt]

You can show support of Dr. Morris Waxler's Citizen's Petition to the FDA, which calls for

1. Withdraw FDA approval (PMA) for all LASIK devices
2. Issue a Public Health Advisory with a voluntary recall of LASIK device

by signing this online petition in support of Dr. Waxler's Citizen Petition.You need not display your name, if you so choose.

Background on Morris Waxler:
Dr. Morris Waxler is the former Branch Chief in charge of FDA approvals of LASIK devices between1996-2000. On January 6th, 2011, a Citizen's Petition was submitted to the FDA by Waxler Regulatory Consultancy.

Thanks,
Kurt Krueckeberg

[lboogie]

Oh this makes me so sick.... the petition is great, I just feel so duped, dumb, screwed, depressed, hopeless.

I haven't been here in a while, and hadn't checked in on the state of LASIK for a long time. Just took the time visit my laser center's web page - looks they have the best in new laser technology! Too bad I had crappy old technology. And again - I can't believe it's a university facility! Grrrrrrrrrrrrrrrrr.

Okay, I should be done now. I just worry so terribly about the future of my eyes. I would not wish this on anyone, but for some reason, I can't muster the strength to be an advocate for change. So thank you, those who are!

Happy new year everyone.

[kurt]

Thanks for taking the time to sign.

[Guest]

Signed! Thanks for posting this!

Makes me wonder if LASIK won't end up like tobacco... you know... how the tobacco companies denied for years that smoking was harmful, and then it all came out into the open... It's disgusting how the Lasik industry is misleading people... just disgusting... Makes me want to vomit.

[kurt]

Thank you for signing and an update on the petition in support

Thanks so much for signing. A German translation of the petition in support was posted on www.operationauge.com, a German language site, that includes a complication forum.

The link is here. The title "Petition der Bürger, die dem FDA vorlegt wurde" translates as "Petition of the Citizens, which was submitted to the FDA".

[y-gwair]

I signed. I'm particularly disgusted by the very aggressive marketing campaigns that have started here in the UK.

I get regular emais from Optical Express, even more after I clicked a 'find out more' link (to see what information they gave about the dangers of dry eye), only to find it had sent a form that claimed I had requested further information; the person who phoned to follow this up received a steaming earful from my husband I'm glad to say; we had a yet another marketing call the next day, despite having told them that I suffered from autoimmune dry eye and under no circumstances would be interested in their services.

[Rebecca Petris]

I would encourage those who have been harmed by excimer laser surgeries, or whose family or friends have, to sign this. It's therapeutic to feel like you're doing something, and I think that the more publicity there is for Dr. Waxler's effort, the more people who might be considering LASIK will be likely to step back and, at the very least, take a closer look at the risk-reward equation before they take the leap. Anything that can induce due caution is good. It just breaks my heart when people with significant risk factors subject their eyes to more risk without ever having been presented with really objective information. Instead, marketing materials masquerade as medical fact.

Back in the early days of LASIK activism the idea of calling for a ban on excimers was terribly controversial and divisive. I personally was never in favor - for practical reasons. In those days it was hard enough to get ANY recognition of problems associated with LASIK (let alone remediation) and I always used to feel - just my personal opinion obviously and no reflection on others - that the more extreme forms of activism could be counterproductive for a variety of reasons.

But much time has passed and, among other things, the LASIK dry eye connection is so well established now. The numbers of people who have been harmed are substantial. Obviously a large percentage of people have had successful surgeries with perfectly satisfactory outcomes. But what about those who didn't?

As we know so well here in our community, the physical, emotional and financial devastation that ensues is way out of proportion to the perceived risks of the procedures.

One of my biggest concerns with LASIK has always been that it often has the most appeal to those who have risk factors which are not identified as such because they are subclinical or borderline. I'm talking, among others, about the people who want to be out of contacts because their contacts are increasingly uncomfortable. So often this is because of mild dry eye symptoms. But many doctors still encourage patients to believe that LASIK is the answer because it will free them from contacts - without explaining that it will present its own insults to their ocular surface health. Some come away just grand. Others inexplicably find their balance tipped into that slippery slope we know so well here of true dry eye hell that may wreck havoc with their lives for a couple of years at least.

If there were a formula we could use to figure out who will be harmed and who won't, it would all be so easy. But there isn't.

[pete0085]

I think part of the problem are the side affects are not well known. On the radio I always hear ads regarding Lasik and special deals for one eye, etc. I know one of the morning DJ's is getting his done next week and is advertising it in a promo.

I personally did not know lasik could cause severe dry eye until I came onto this site a few years ago. I once did think about lasik, but with my MGD dry eye condition, I could never consider it.

It would be nice to see some numbers of what percentage do suffer from long term dry eye affects.

Is there any petition similar in the US? I would sign in, but I can't read it. Is there an English version?

[pete0085]

I think part of the problem are the side affects are not well known. On the radio I always hear ads regarding Lasik and special deals for one eye, etc. I know one of the morning DJ's is getting his done next week and is advertising it in a promo.

I personally did not know lasik could cause severe dry eye until I came onto this site a few years ago. I once did think about lasik, but with my MGD dry eye condition, I could never consider it.

It would be nice to see some numbers of what percentage do suffer from long term dry eye affects.

Is there any petition similar in the US? I would sign in, but I can't read it. Is there an English version?

I am sorry, I must have clicked on the German think by accident. lol, that is why I could not read it. That was my bad.

[Guest]

I personally did not know lasik could cause severe dry eye until I came onto this site a few years ago.

The really crazy thing is that even some of the Lasik surgeons themselves appear to be unaware of this The guy who did my Lasik had told me prior to the procedure that there was no way that Lasik could cause permanent severe dry eye in a "properly screened good candidate" such as myself... he said worst case scenario was using drops maybe once a day (but even THAT was highly unlikely in his opinion).

Makes me wonder what they are told during their Lasik training... is this stuff just completely left out?? But then you'd think they'd catch on to the reality of permanent severe dry eye for some people after doing a few thousand Lasik procedures... I don't understand it... I really don't... maybe people like me really are just totally freakishly rare... Does what happened to me happen to 1 in a hundred patients? 1 in a thousand? 1 in 10 thousand? That info should be out there for patients prior to signing those blasted "informed" consent forms...

[shells]

Signed! Thanks for posting this.

-Shells

[kurt]

One of my biggest concerns with LASIK has always been that it often has the most appeal to those who have risk factors which are not identified as such because they are subclinical or borderline. I'm talking, among others, about the people who want to be out of contacts because their contacts are increasingly uncomfortable.

A friend and his wife called me over the summer because their daughter was interested in LASIK because, if I remember correctly, her brand of contact lenses were going to be discontinued. I tried to answer her questions factually and to avoid railing against LASIK.

As a result of the coversation, her mother later me that the doctor could not satisfactorily answer some of her daughter's questions.

Since author of the Citizen Petition is the former Branch Chief in charge of FDA approvals of LASIK devices between 1996-2000, there is now an Elephant in the room. The Citizen Petition is documented with over 100 footnotes.

[kurt]

Signed! Thanks for posting this.

-Shells

Thanks for taking the time to sign.

[kurt]

Petition's call for a Criminal Investigation because the FDA was deliberately duped

Three points on The Waxler Regulatory Agency's Citizen Petition.

1.) It calls for a criminal investigation:

From page 2

The urgency and enormity of the threat of LASIK devices to public health and safety indicate further need for involvement of FDA’s Office of Criminal Investigation (OCI), the House Energy and Commerce Committee's oversight and investigations subcommittee and other congressional leaders in this matter.


2.) It asserts the FDA was deliberately mislead:

From page 3

As a consequence the FDA was deprived of knowledge of the full extent of LASIK injuries prior to and during FDA reviews of documents submitted in support of the safety and effectiveness of LASIK devices under 21 CFR 812 and 21 CFR 814. In addition, LASIK manufacturers and their collaborators withheld safety and effectiveness information from their investigational device exemption (IDE) reports to the FDA. In addition, they hid LASIK injuries from FDA within the context of out-of-court settlement of innumerable lawsuits. Clinic-sponsored IDE studies cherry-picked, withheld, and hid data from FDA that clearly showed LASIK with excessive adverse event rates (greater than 1%). These activities were an industry-wide effort, organized wholly or in part by the manufacturers and their collaborators in order to circumvent FDA law and regulation. I will submit CONFIDENTIAL information on these matters separately to FDA’s Office of Criminal Investigation.


3.) The Waxler Regulatory Petition states LASIK is never a good idea:

From page 3

Moreover, the published data (Section B) shows that LASIK devices transform healthy corneas into sick corneas that:

• Never completely heal
• Are permanently weakened, vulnerable to trauma and inflammation
• Cause neuropathic dry eyes
• Have pathology that progresses annually
• Are vulnerable to blinding corneal bulging (keratectasia)
• Compromises night vision
• Have unstable vision corrections that regress
• Require eye care that otherwise would not be needed

[kurt]

There is a tide in the affairs of men.
Which, taken at the flood, leads on to fortune;
Omitted, all the voyage of their life
Is bound in shallows and in miseries.
On such a full sea are we now afloat,
And we must take the current when it serves,
Or lose our ventures.

My heartfelt thanks to the over 238 signers to date.