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

[pete0085]

I posted the petition on my facebook page. I encourage everyone else to do the same. It's the best way to get the word around and make others aware.

[kurt]

Thanks for signing and to those in Italy, the UK, New Zealand, India, and many U.S. states.

[kurt]

thanks

Thanks to the 295 signers as of this noon.

[kurt]

From the article Center for Device and Radiological Health (CDRH) Disowns Statutory Authority Over LASIK Ads 01/31/2011, which appeared in Dickinson’s FDA Webview, an online, subscription-based interactive Web site that watches the U.S. Food and Drug Administration:

Meanwhile, nearly 300 people have signed an online forum supporting a petition filed earlier this month by former CDRH ophthalmic devices director Morris Waxler, seeking an immediate ban on the procedure because of its unacceptable adverse events rate.

The complete the article includes interviews with two patient advocates and is available on Facebook.

[kurt]

Thanks to petition signer #321 Mr. Wayne Gorsek, founder of http://www.vitacost.com/.

[kurt]

Thanks to #358

Thanks to #358.

[Guest]

I like the updates! Keep 'em coming Kurt!

[poppy]

I haven't had lasik surgery nor do I have any close friends or family harmed by it. I signed the petition however as I believe I have been personally affected by lasik, due to the fact that opthalmology in our city has been entirely taken over by a huge private lasik factory who have no interest in meeting our city's needs for eye care services.

[kurt]

Thanks

Thanks for your comments. While I believe the petition is a compelling news story, it has yet to catch fire in the mainstream press. So news has to be passed the old fashioned way by word of mouth ("Say, have you heard about this Waxler Petition. He claims the FDA was mislead. He was a manager, too, in charge of clinical trials").

[Rebecca Petris]

I haven't had lasik surgery nor do I have any close friends or family harmed by it. I signed the petition however as I believe I have been personally affected by lasik, due to the fact that opthalmology in our city has been entirely taken over by a huge private lasik factory who have no interest in meeting our city's needs for eye care services.

You know, that is such a good point. I mean, more broadly than your city. LASIK has really changed ophthalmology itself in many ways, and not for the better.

[kurt]

Politics Daily article on Citizen Petition

Politics Daily has just published an article on the Waxler Regulatory Consultancy's Citizen Petition to the FDA to withdraw support for LASIK devices and issue a public health advisory.

The last two paragraphs from the article:

Finally last month, Waxler filed a formal citizen's petition to his former government employer requesting the FDA withdraw approval for all LASIK devices and to issue a public health advisory for recalling the equipment. The industry is working on newer models and newer methods so nearsighted consumers will still be able to get their vision remodeled (insurance companies still won't pay for it, probably). Since it was filed, the petition has been reposted on the Internet by numerous supporters.

In his petition, Waxler says manufacturers and also "clinics, refractive surgeons, and agents withheld and distorted safety and effectiveness data" and, he alleges, "in a classic example of the fox guarding the henhouse," the "collaborators" routinely hide reports of LASIK injuries from FDA by settling lawsuits out of court. He also claims that equipment makers have "cherry-picked, withheld, and hid data from FDA" that he believes show LASIK with "excessive adverse event" rates of 22 percent. Waxler also submitted "confidential information" on the matter to FDA's criminal investigation arm.

The FDA has not yet commented publicly about Waxler's petition but an FDA spokeswoman told Politics Daily "it is a citizen's petition and we will review it." The LASIK experts have not commented either.

[kurt]

Dr. Waxler's comment on the article

The article in Politics Daily (see previous post) allowed readers to comment. One who did was morriswaxler8, obviously Dr. Morris Waxler himself, the author of the Citzen Petition.

Thanks Ms Goldstein for a superbly written article on LASIK. My heart goes out to the thousands of people injured by LASIK. For those have had perfect outcomes: hooray for you! Please reserve compassion for those who have been blinded or are in perennial pain or cannot drive at night. To the policeman I know who lost his job because of untreatable dry eyes, to emergency room physician who is about to lose his job because he cannot drive at night and the many others with heartbreaking life problems due to LASIK. Don't blame the victim for not knowing enough, not selecting the "best" surgeon, or going to a "cheap" LASIK outlet. I wrote my petition based on a detailed analysis of the scientific and clinical literature. I discovered to my great surprise that the evidence shows that LASIK devices cause permanent damage to eye that mostly cannot be repaired. Moreover, it occurs regardless of the particular LASIK devices or (apparently) the surgeon. Also, I listened carefully to injured LASIK patients whose eyesight has been ruined. I listened to those who had perfect outcomes too, some of whom are mothers, fathers, sons, and daughters who had terrible. I took thousands of hours to read submissions by manufacturers to FDA in support of LASIK devices. What I discovered astonished me! Adverse events were re-labelled to obtain FDA approval. Purposefully reporting dry eyes, night driving, halos and other adverse events as negligible six months after LASIK when the data submitted to FDA clearly shows that these adverse events occur at more than 20% at 6 months or longer after LASIK. Read my petition and you will learn a lot about why you should not have LASIK, perform it, or recommend it. First do no harm!

[kurt]

salon.com article on LASIK and the Waxler Petition

Excerpts from Feb 16th, 2011, article from salon.com: What we still don't know about LASIK:

The hero here is a man named Morris Waxler, whom I wrote about last year for Salon. Waxler is a Ph.D. and a former branch chief of the FDA's Center for Devices and Radiological Health from 1995 to 1999. He was, in effect, the man responsible for approving Lasik vision enhancement lasers in 1997. Since that time, he has become rabidly anti-Lasik, publicly admitting that the FDA "screwed up" when it approved it.

Now he's taken his activism a step further. Last month, he filed a petition calling for the FDA to withdraw approval

"for all Lasik devices and issue a Public Health Advisory with a voluntary recall of Lasik devices in an effort to stop the epidemic of permanent eye injury caused by lasers and microkeratomes used for Lasik eye surgery."

.....This is potent stuff. And it doesn't seem to be the rantings of a bored retiree. "The idea that I had such a hand in getting a product on the market that was messing people's eyes up is disgusting," he says.

"My wife said, 'Why are you getting back into that mess? Leave it to other people.' But I couldn't leave it alone. The more I discovered about it, the worse it got. Rereading the applications to the FDA that I once read and reviewed and reviewing the published literature since then -- it's not a pretty picture."

[Mawsky]

Had no idea

Wow, I have not had LASIK but was deffinately considering it, my niece works for a eye center, that does lots of surgeries, as well as LASIK, I have seen one of their opthamalogists, who has never done any tests on my dry eyes, but my son had his LASIK done about two years ago, thank God he had no dry eye or other side effects, he was so thrilled that I wanted to lose my glasses too I can't even imagine what my life could have been like. I still don't know why my eyes are so dry, everyone I know has been happy with their lasiks proceedures. Thankful I never did this.

[Raginator]

Is anything good going to happen because of this petition?

I feel like we could throw a million names at the FDA and they still won't listen.

I haven't heard of anyone from the FDA who has shown a genuine concern over people who report problems from Lasik.
How many names must be collected?
And, why should the FDA be concerned over a list?

I'm playing Devil's advocate.
I've been disappointed before.
Thank you all.