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

[kurt]

Dr. Waxler's claims

The FDA has to respond to Dr. Waxler's petition. They don't have to respond to an open letter supporting it. He claims:

LASIK manufacturer Manufacturers and their collaborators (including but not limited to clinics, refractive surgeons, and agents) withheld and distorted safety and effectiveness data (Section A) submitted to the Food and Drug Administration (FDA) so that LASIK devices would appear to have:

* A FDA–acceptable adverse event rate of ≤1%, rather than the true rate of at least 20%
* Only temporary adverse effects when, in fact, some persist for 6 months to many years
* >90% effectiveness when the true rate is approximately 57%

Data recently brought to light exposes this partnership for what it was: a classic example of the fox guarding the henhouse, wherein the primary arbiters of safety and effectiveness of LASIK devices were the device manufacturers and its collaborators. Surgeons used LASIK devices in violation of required manufacturing quality controls (21 CFR 820), patient protections (including but not limited to 21 CFR 50; 54; 56; and 812), and reports of adverse events (including but not limited to 21 CFR 803; 812; and 820) when they manufactured and distributed LASIK devices in interstate commerce within the United State as:....

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, they hid LASIK injuries from FDA within the context of out–of–court settlement of innumerable lawsuits.

He is claiming the actually harm LASIK causes was successfully hidden from the FDA.
See this video of his interview on MSNBC

[Guest]

Oooo... watched the video... was disappointed.

1) When Dr. Waxler spoke about dry eye, starbursts, vision distortions etc it was not explained how severely these things can affect one's life. I suspect that most of the viewers watching that would think "Dry eye... big deal... use some drops... so what if 20% of post-lasik people need eye drops once in a while... Starbursts... no big deal... lots of people see a bit of a starburst coming from lights when driving at night... who cares... how bad can it be? Vision distortions from Lasik? This guy must be exaggerating... they never would have approved LASIK in the first place if it was so bad... Everyone I know who's had it says it was the best thing they've ever done for themselves!"

I'm glad Dr. Waxler was interviewed and all, since it will hopefully bring more attention to the perils of Lasik... but I think people need to have it explained to them in detail exactly WHY these adverse effects can be so bad. Also, when quoting a stat like 20% of people who have lasik have these effects, it needs to be specified (if known) exactly how many of those people have severe lasting effects vs. those who consider the adverse effects a worthwhile trade off for the benefits of surgery.

2) Near the end of the video when Dr. Waxler correctly points out to the journalist that just because he seems to have a good outcome now that doesn't mean he won't have a bulging cornea or need a corneal transplant later, did you catch the slight smile on the journalist's face? He wasn't buying into any of Dr. Waxler's concerns... journalist says he is just focusing on the positive aspects of it... (mind you, I suppose if I were him, a post-Lasik patient with a good outcome, the things that Dr. Waxler was saying might scare the crap out of me if I allowed myself to really think on it... so I suppose it's better for his mental health if he tells himself this kind of crap can't happen to someone like himself)

It was a fluff piece of journalism - the journalist should have dug deeper to find out WHY these adverse effects are so bad... what is the impact on people's lives when THEY are one of those 20% with a suboptimal outcome? etc. But hey, the journalist said himself that he prefers to focus on the positive... whatever...

Don't mean to sound grumpy, (I AM glad you posted the link to this )... it's just that I expect more from journalists than what most of the ones i see tend to report...

[kurt]

, I suppose if I were him, a post-Lasik patient with a good outcome, the things that Dr. Waxler was saying might scare the crap out of me if I allowed myself to really think on it... so I suppose it's better for his mental health if he tells himself this kind of crap can't happen to someone like himself)

You know, I was thinking virtually the same thing. Maybe he secretly considers himself fortunate. Early in the interview, he aksed Dr. Waxler something like, "but aren't patients warned they can have these--I think it's called bursts of light?". Of course, he doesn't have a clue what that actually means.

[Raginator]

Discussing the connection between Lasik and dry-eye is almost like talking about global warming. Some people believe global warming is happening, some people don't believe global warming is happening and some people are open to the idea.

When talking about Lasik and dry eye, it is very important to articulate your thoughts well.

I'm not saying that all people who have Lasik will develop dry-eye. Some will. And how long does it last? That varies. For many, it goes away in weeks to months. For some, it lasts years or longer. And how severe is it? That varies also.

Some, few, most, many, all: Use these words carefully.

[Guest]

You know, I was thinking virtually the same thing. Maybe he secretly considers himself fortunate. Early in the interview, he aksed Dr. Waxler something like, "but aren't patients warned they can have these--I think it's called bursts of light?". Of course, he doesn't have a clue what that actually means.

Yup... and that's one of the big problems with those blasted consent forms... you sign it after the doc assures you that a) those things are incredibly rare and b) if things like starbursts, or dry eye DO occur, it is minor and easily dealt with... I bet 99.9% of patients signing those forms have no idea what they could be dealing with if they are one of the unlucky ones...

(Not saying all docs are like that or that those complications happen to a majority of Lasik patients, but I think they happen way more often than most lasik patients are led to believe...)

When talking about Lasik and dry eye, it is very important to articulate your thoughts well.

I'm not saying that all people who have Lasik will develop dry-eye. Some will. And how long does it last? That varies. For many, it goes away in weeks to months. For some, it lasts years or longer. And how severe is it? That varies also.

Some, few, most, many, all: Use these words carefully.

You are SO right... if one is not very careful to qualify one's statements people will tune you out the second they detect an exaggeration or inaccuracy (even if unintentional) in what you are saying. One has to be very careful so that one does not make an error here...

As I get more practice at explaining to people precisely WHY my dry eye is not the typical "use a few drops and forget about it" type, I find people seem to "get it" so much quicker now... hopefully some day it will save someone from dealing with what so many of us are here...

[kurt]

Petition as a website

I converted the Waxler petition into a website, which also has the MSNBC interview. It is available at www.lasikpetition.com and at www.lasikcomplications.com

[kurt]

Congratulations on your choice #399

Congratulations to signer #399 on her wise choice:

I was going to have Lasik performed until I read the several pages of possible complications and was very disturbed by it.

Check out the petition to withdraw lasik device approval.

[kurt]

Thank you Pat Sturdevant, MA, signer #458.

[Guest]

Love the updates Kurt! Thanks!

[kurt]

Thanks to fellow Hoosier Andrew Dickerson, IN, the 463rd signer.

[kurt]

Thanks to Linda Urquides, AZ signer #480.

[kurt]

Thanks to Oumalay Cavaiani, WI, signer #493

[kurt]

Thanks to Tina Rentmeester, WI, signer #498

[kurt]

Commissioner Hamburg mailed petition of support

Today I mailed the the Honorable Margaret Hamburg, FDA Commissioner, the 42 page document containing the signatures and comments of the first 505 signers, together with there comments, of the petition at http://www.thepetitionsite.com/1/support-petition-to-withdraw-lasik-approval/ .

Copies were also sent to the following individuals:

1. David Buckles, PhD, FACC, Ombudsman, CDRH, Office of Center Director

2. Gregory O'Connell, CDRN, Division of Postmarket Surveillance, Product Evaluation Branch I

3. Malvina Eydelman, M.D., Division Director, CDRH, Office of Device Evaluation, Division of Ophthalmic, Neurological, and ENT Devices

4. Christy Foreman, Director, CDRH, Office of Device Evaluation

5. Steven Silverman, Director, CDRH, Office of Compliance

6. Jeffrey Shuren, M.D., J.D., Director, CDRH, Office of the Center Director

7. Nancy Stade, Deputy Director for Policy, CDRH, Office of the Center Director

8. Doug Wood, Acting Director, Division of Postmarket Surveillance

The petition will be kept open.

My thanks to all who have signed.

[Hopeful2]

I added my signature today! It felt really good to tell them why LASIK needs to be removed from the market.

Lasik practitioners do not inform patients of the true risks to undergoing Lasik: dry eye PAIN, depression, loss of income, vision issues; loss of night vision, reduced contrast sensitivity, loss of best correctable vision, cost of post lasik complication treatments (drops, glasses, couselling, antidepressants, scleral lenses . . .) I don't believe that the above complications were listed on any of the waivers that I signed. What kind of informed consent is the lasik industry really getting from its patients? Who in there right frame of mind would agree to undergoing the procedures if they knew the true financial and emotional costs which may be incurred as a direct result of having the procedure??? Lasik needs to be removed before the lives of more patients and their families may be damaged.

****It is not too late to sign the petition. Follow the link in the post above. Please!****