Tuesday, April 7, 2015

A Very Corrupt FDA/CDRH Of Directors, Commissioners, And FDA Employees PAID To Purposely Injure The American Public They Were Supposed To Serve

-A Broken And Corrupt FDA/CDRH Infiltrated by The White Collar Medical Mafia-

Please consider the history of the egregious FDA/CDRHapproval of LASIK devices and especially how the pattern of corruption continues through 2015. This has resulted in hundreds of thousands of permanent eye injuries in the US, and several confirmed cases of suicide.  

David Muller (www.Avedro.com) and the Summit Excimer Laser history: 

In the 1990's, two companies were in competition for the Excimer laser market, VISX, Inc. and Summit Technology, which was later acquired by the ophthalmic giant, Alcon. Both companies needed FDA-approval for photorefractive keratectomy (PRK), a predecessor of LASIK. Summit, based in Waltham, Massachusetts, was headed by its founder, Chairman of the Board and CEO, David Muller. Muller was at the center of a scandal surrounding Summit's application to the FDA. In 1996, Paul Weyrich’s American Investigator television series reported that Muller had paid the late Senator Edward Kennedy’s 1994 re-election campaign $1 million plus $500,000 to the Democratic National Committee to get Kennedy to pressure the FDA to release Summit’s laser on to the market. Weyrich’s program also alleged, among other things, that an FDA employee had leaked to Muller trade-secret documents from competitor, VISX. Several federal investigations were launched, including one by Congressman Joe Barton, but no charges were ever filed. Summit received FDA-approval six months before VISX, but Muller was fired by Summit's board hours before Weyrich's program aired.  

LASIK and corneal Ectasia: 

It wasn't long after the introduction of PRK before eye surgeons began performing LASIK off-label. (LASIK was more marketable because it was associated with less pain and faster visual recovery than PRK.) According to Morris Waxler, PhD, then FDA ophthalmic device chief and the man most responsible for FDA-approval of LASIK, the agency was concerned about LASIK's widespread use in the absence of safety studies. So the FDA encouraged eye surgeons to conduct LASIK clinical trials and bring them to the agency for approval.   

But there was a problem. In addition to so-called "side effects" (dry eyes, night vision problems, etc.), LASIK caused insidious permanent structural damage and biomechanical weakening of the cornea. The weakened cornea may begin to deform, or protrude, long after the surgery, even years after the endpoint of clinical trials. This condition is known as corneal Ectasia. Corneal Ectasia causes poor vision which is uncorrectable with glasses and may lead to the need for corneal transplant. Likely tens of thousands of patients, and perhaps even more, have developed corneal Ectasia after LASIK in the U.S. alone.  

Failure to report corneal Ectasia after LASIK: 

As you know, the Medical Device Reporting regulation (21 CFR 803) requires that post-LASIK corneal Ectasia and other device-related adverse events be reported to the FDA. LASIK surgeons don't report adverse events and life-altering complications after LASIK, including Ectasia, to the FDA as required, but they maintain private records of Ectasia cases. LASIK surgeons are clearly more concerned with preserving the public's false perception of LASIK as a safe surgery and in avoiding lawsuits than in complying with federal regulation intended to protect public health.  
What is Post LASIK-Refractive induced ECTASIA?
When the FDA conducted approximately 30 inspections of LASIK facilities between 2009 and 2012, it appears that every facility inspected was found to be non-compliant with the Medical Device Reporting regulation.  

The American Society of Cataract and Refractive Surgery (ASCRS), a 9,000 member-strong professional organization of cataract and refractive surgeons, maintains a private database of corneal Ectasia after LASIK. A link to the database can be found on the organization’s website, but it is password-protected.  

The media reported a class action lawsuit against TLC Laser Eye Centers, one of the largest corporate providers of LASIK in the country. As part of the discovery process, TLC was forced to turn over documentation of its secret files of patients who developed corneal Ectasia.  

In a presentation given by a Cleveland Clinic surgeon during a private meeting of LASIK surgeons, the surgeon stated that Ectasia cases are not being reported. Says the surgeon, "If we look at our own practices, I think the Keratectasia incidence is a lot higher, just like you alluded to, but it's not being reported because of the litigious nature of what's going on. A lot of us obviously don't report it because these are patients being referred in to us." 

The FDA is aware that complications of LASIK including corneal Ectasia are not being reported. FDA officials have been made aware of secret files and private databases of Ectasia cases. But the agency refuses to act.  
Who is David Muller and how is he knowingly injuring Americans with his LASIK lasers and (CCL) Corneal Collagen Cross-Linking? 

Corneal collagen cross-linking is a novel treatment for corneal Ectasia after LASIK (and a similar corneal disease known as Keratoconus, which occurs naturally). It involves saturating the cornea with riboflavin followed by UV-A irradiation, which induces a stiffening effect similar to aging in the cornea and 'may' halt progression of corneal Ectasia. It carries a long list of potential complications and universal adverse effects such as transient corneal haze.  

Former Summit founder, David Muller, founded Avedro, Inc. in 2007, its stated mission to "advance the science of corneal collagen cross-linking to help patients with corneal disorders." Avedro is currently seeking FDA-approval of a corneal collagen crosslinking system for treatment of Keratoconus and post-LASIK corneal Ectasia. Why the move from selling lasers to crosslinking corneas? 
Because Muller knows something about LASIK that the industry and the FDA have been keeping quiet for years: LASIK permanently weakens the cornea in all eyes treated, and this puts every LASIK patient at risk for developing corneal structural failure known as corneal Ectasia. Now Muller (a potential criminal and possibly more dangerous than ISIS), stands to make millions again selling a system to treat patients for the disease he helped create. Outside of the US, crosslinking is already being performed as a prophylactic, simultaneously with primary LASIK.   

The FDA held a Joint Meeting of the Dermatologic and Ophthalmic Drugs Advisory Committee and Ophthalmic Device Panel on 2/24/2015 to consider Avedro's NDA for it's corneal collagen crosslinking system. I attended that meeting and spoke during the open public hearing. I recommended that the advisers vote that 1) post-refractive surgery indication not be approved for cases without documented evidence of progression of the disease, 2) if corneal collagen crosslinking is approved, its labeling include a black-box warning of potentially disabling eye injury, and 3) crosslinking not to be performed as a prophylactic, simultaneously with primary Lasik—which would effectively pile additional risks and adverse effects onto an already harmful unnecessary surgery.    

Eight additional speakers recommended against approval or limited approval. The FDA, without explanation, has refused to publish the slides of the open public hearing speakers at that meeting. My last slide called for the large ophthalmology professional organizations to earmark foundation funds to assist injured LASIK patients with the burdensome costs of rehabilitation.  

FDA malfeasance placing industry interests over public health: 

The FDA approved LASIK devices in spite of an approximate 20 percent incidence of dry eyes and night vision problems persisting beyond the end point of the clinical trials. Small patient populations and short-term follow-up in clinical trials were insufficient to detect less common but potentially debilitating complications such as late onset corneal Ectasia. 

Morris Waxler petitioned the FDA in 2011 to withdraw approval of LASIK devices citing dry eyes, night vision problems, and risk of corneal  Ectasia, among other serious problems with LASIK. The FDA denied the petition, presumably at the direction of current FDA ophthalmic device chief, Malvina Eydelman, M.D., an ophthalmologist with close ties to the industry.   Malvina Eydelman should be criminally investigated for malfeasance and violation of FDA/CDRH ethic laws, as she wasted $1,000,000 in a scientific Quality of Life safety LASIK study that didn't prove safety but rather that LASIK should be banned and Americans should be informed that it's much more unstable, dangerous and regressive than originally thought...But she didn't take this stand.  Instead, she proved that she is put in her position as a pawn for the industry to protect profits and not American families.  She is more of a threat to American families than ISIS. 

Eydelman has a history of protecting industry interests over public health. In 2006, Eydelman dropped an important patient-protection requirement from excimer laser approval letters, which required eye surgeons to provide prospective LASIK patients with a copy of the laser patient labeling prior to undergoing LASIK. The labeling contains data from clinical trials, which shows that approximately 20 percent of patients report troubling symptoms, such as dry eyes, double vision, starbursts, halos and night driving problems six months after LASIK.   

Moreover, the FDA has failed to take action on several other citizen petitions asking for a variety of actions against LASIK, several reports of LASIK-related suicides, numerous letters and emails from the public concerning LASIK problems, countless false and misleading LASIK ads, and hundreds of LASIK-injury reports filed with the agency by LASIK patients.  

In 2008, injured LASIK patients begged the FDA/CDRH to listen to their claims of being purposely injured for $4,000 per patient, when the LASIK CENTERS knowingly knew that these patients would have permanent injuries such as:
-Permanent Dry Eye.
-Permanent CORNEAL THINNING that promotes astigmatism and refractive elective surgery induced ECTASIA.
-Permanent UVC damage that accelerates the aging process of the eye and guarantees the physicians future "CATARACT SURGERIES" in 15 years post LASIK.
-Permanent LASIK FLAPS that never heal and only seal the edge like a "TUPPERWARE LID."

The FDA/CDRH is BROKEN.  They are a white collar mafia and there is an attack on American Families and generations of American and foreign families that think the FDA stands for such high levels of medical standards when in reality the FDA/CDRH does ZERO testing and instead only relies on submissions by the sponsors, OEM's, and medical industry.

FDA employees need to be criminally investigated, arrests need to be made, and a complete restructuring of the FDA/CDRH needs to happen immediately to protect American and Foreign citizens...

Wednesday, February 25, 2015

Thursday, January 15, 2015

"FDA Ethics Violations Alleged In FDA LASIK Study!" By Jim Dickinson, Editor of www.FDAWeb.com

"FDA Ethics Violations Alleged
in FDA LASIK Study"   

Article:  01/15/2015     Permission by FDAWeb.com To Reprint original article below:
Two injured LASIK patients this week filed separate written complaints seeking government investigations into the conduct of the recently reported FDA/National Eye Institute/Department of Defense LASIK Quality of Life Collaboration Project, alleging patient informed consent violations and sponsor conflicts of interest. 

Atlanta business analyst and project manager Michael Patterson asked the NIH to begin a "criminal investigation" into the conduct of the recently completed LASIK Quality of Life Collaboration Project, alleging that it presented false safety and study purpose information to over 500 subjects who underwent the LASIK procedure. 

The slides of preliminary results from that study and delivered in October to the American Association of Ophthalmology by CDRH director of ophthalmic devices Malvina Eydelman showed, Patterson’s complaint says, that “severe symptoms” including loss of two lines of best corrected vision were not considered adverse events “despite the indicated impact on work productivity, coping, social desirability, depression/anxiety, severity, etc.  In addition, one of the … research investigators indicated that only serious adverse events were even reported.” 

Patterson’s complaint alleges that researchers “were not concerned about the informed consent or safety of the subjects who had LASIK in the study itself. This was very unethical in my opinion and I’m asking for a formal investigation. This happened because the researchers ignored evidence that LASIK itself was not safe” as reportedby former CDRH branch chief Morris Waxler, who found a 20%-plus rate of LASIK adverse events. 

“Regarding the clinical trial informed consent,” the complaint says, “the five different research centers for the PROWL2 study (each had a separate IRB that likely did not even evaluate the ethics of the LASIK part of the study) used entirely different LASIK informed consents that do not include many of the things on the other consent forms, and are also intentionally misleading per the standard practices done by the LASIK surgeons. … There was no balance in the information they were given...  

“The consent forms included in this complaint (I have them from two of the five centers from PROWL2) did not include information that the flap NEVER heals,” the complaint continues. “One of the two (why not both?) indicated the flap is weaker after LASIK but that does not give the full extent of the problem. The entire eye is weakened because the outer 1/3 is the strongest part and it loses over 97.5% of its former strength after a LASIK flap is cut. This can cause a lot of other problems. Where does the consent form indicate the lasers use UVC light (the most dangerous carcinogenic wavelength according to a 2011 W.H.O. study) that causes premature cataracts to develop?  Where were they told of the risk of retinal or vitreous problems caused by LASIK? Both consent forms implied that LASIK problems are usually temporary (and ‘rare’ in the first place), but ‘may’ be permanent. This is FALSE. The fact is that LASIK problems occur in 45% of patients (who had no symptoms before LASIK according to the PROWL2 data), are usually permanent and are only rarely temporary.” 

The second injured LASIK complainant, Fort Lauderdale microjet sales broker Dean Kantis, charges in a 1/15 lengthy, illustrated complaintto the HHS Inspector General that the $1 million collaboration project “actually proved that LASIK (elective surgery, not necessary in the first place), has inflicted permanent damages into 30% or more eyes at months 3-6, post-LASIK and yet … Malvina Eydelman spun the study as if it was safer than ever. So my question to you is, “Would you fly in an airplane that crashed 1 in 3 flights?”

Producer of a 10-minute Youtube movie on LASIK, Kantis alleges a conflict of interest with CDRH’s Eydelman “and possibly the director of devices, Jeffrey Shuren, in showing ‘biases’ to the medical industry” by “protecting the profits, safety studies, financial interests, and reputations of physicians in and around the safety studies involved with PRK/LASIK/Refractive Surgery, and this has been going on since the 1990s …”

Kantis’ complaint asserts that the proof of this high LASIK adverse effects rate can be seen in any grocery or pharmacy ─ “Notice all of the post-LASIK dryness drops? … ” His complaint says there are now more than 4,000 MedWatch reports on LASIK and PRK events “and growing yearly, mostly created by injured patients, and not by their physicians, so you can imagine how much larger this number and epidemic would grow to if physicians and trained staff were reporting every ‘retreatment/enhancement,’ ‘dry eye prescriptions for Restasis,’ and ‘other visual disturbances.’ Yet, they aren’t reporting them because they know that no one is policing them ─ especially the FDA.”      

About FDAWeb:

The publisher of Dickinson’s FDA Webview is Ferdic, Incorporated, a 1982-established company founded and continuously led by James G. Dickinson, who first began reporting and analyzing FDA news in 1975 at FDC Reports, Inc., publisher of the Pink Sheet and other trade newsletters. Two years later, while still at FDC Reports, Dickinson came under the notice of other publishers and was soon supplying his analytical reports about FDA and related Washington activities to Drug Topics, Scrip World Pharmaceutical News (UK), Pharmaceutical Technology, Pharmaceutical Executive, the Pharmaceutical Journal (UK), Clinica (UK), Animal Pharm (UK), the Australian Journal of Pharmacy, New Zealand Pharmacy, Drug News & Perspectives (Spain), Medical Device & Diagnostic Industry, and Medical Marketing & Media.
In 1978, Dickinson conceived the idea upon which FDA Webview would later be based, establishing the first daily FDA news service for the pharmaceutical industry in Washington Drugwire. Ahead of its time, this was a daily single-sheet Western Union Mailgram providing between five and eight specialized news capsules each morning, based on Dickinson’s exclusive FDA sources. The service was too expensive, however, and it ceased publication the following year.   Dickinson consolidated his many journalistic activities in 1982 under an independent company he established with his wife, the former Sheila Ferguson (Ferdic is a combination of their two last names), and in 1984 they launched the twice-monthly Dickinson’s FDA, a unique analytical newsletter covering FDA regulation of pharmaceuticals, medical devices, biologics and veterinary medicines. followed by Dickinson’s Pharmacy and Dickinson’s PSAO (two pharmacy-oriented monthlies).    In 1992, the company launched Dickinson’s FDA Inspection, a monthly newsletter focusing on in-depth analysis of FDA enforcement and compliance actions, co-edited with a former FDA prescription drug labeling compliance director, Rudolf Apodaca. In 1993, this publication was merged with Dickinson’s FDA in a new monthly, Dickinson’s FDA Review, with former FDA Denver District director John Scharmann as consulting editor.  Today Dickinson continues as Editor, Publisher and President of Ferdic, Inc, which has a staff of writers, researchers and office personnel under the direction of Washington Editor David McFarland.

Telephone: 1-800-659-6858
Fax: 1-717-731-1427
Email: info@fdaweb.com
Web site: www.fdaweb.com 

Dean Kantis
Sent: Thursday, January 15, 2015 8:25 AM
To: snydermanj@mail.nih.gov
Cc: DEAND@od31em1.od.nih.gov; hancockk@od.nih.gov; raisdanais@od.nih.gov; fb@niaid.nih.gov; Dean Kantis
Subject: Criminal Investigation Involving FDA Employees: Malvina Eydelman Re: LASIK FDA APPROVAL/FALSIFIED SAFETY STUDIES since 1995.

January 15th, 2015

“The Public Is Being Completely LIED To, Deceived, And Purposely Injured By LASIK Centers”

Re: LASIK elective surgery / FDA / CDRH Executives are not following FDA protocol…

“Dear HHHS Inspector General,”

First, thank you for putting 15 minutes aside today, to take the time to investigate my accusations.  In fact, to save you time, here’s a “mini-film” that we created to succinctly explain this problem:
https://www.youtube.com/watch?v=2TtbxM-jUXA .

The FDA and their office of Internal Affairs is a “broken entity.”  For whatever reason, they refuse to look into a matter where one of their “Directors” spent $1 million on a 6.5 year Quality of Life LASIK Safety Study (attached) that actually proved that LASIK (elective surgery, not necessary in the first place), has inflicted permanent damages into 30% or more eyes at months 3-6, Post LASIK and yet the Director of the FDA, Malvina Eydelman, spun the study as if it was safer than ever.  So my question to you is, “Would you fly in an airplane that crashed 1 in 3 flights because that’s about the safety/efficacy of LASIK and the FDA won’t issue the proper PHA “Public Health Advisory” to warn the consumers who think because it’s FDA APPROVED, that means it’s 99.99% safe/effective when in reality, it’s not.  Even the ex-chief of medical devices who led the team to the FDA APPROVAL of LASIK, Dr. Morris Waxler, petitioned the FDA back in Jan. 6th, 2011 and has since been ignored and “black flagged” by the FDA and other corresponding governmental departments.

Where Is The Proof:

Go into any grocery store or pharmacy.  Notice all of the POST LASIK DRYNESS DROPS?  Even your own Dr. Frederick Ferris put this into his presentation a few months ago at the AAO/Chicago conference in Oct. 2014.  The consumer is not being protected, and if you look at everything the FDA/CDRH has done since the inception of LASIK, they only protect the industry and are “tapped” into their positions and put their by industry to hurt competition and to maximize profits whatever the cost to the consumer who thinks their BILLIONS annually are spent to make sure that this kind of malfeasance and egregious behavior is non-existent.

Probable Cause:

If you see my email below, one of many, you will see that we have issued no fewer than 4 complaint cases accusing the FDA of “misappropriation of funding” aka “malfeasance,” and that the Director of Ophthalmology, Malvina Eydelman, blew through 6.5 years to push this problem/epidemic out when it shouldn’t have taken more than a year, and now after the study concluded (started back in 2009), and after $1,000,000.00 USD has been spent, the study (attached: called “Malvina Eydelman FDA-NEI Prowl Results”) showed according to her depiction, “that LASIK is the most studied procedure and is safer now than ever before…”  In fact, she was so excited to start off the AAO that she was the first presenter to share the supposed “good news” and set the pace.

 We are accusing of both Jeffrey Shuren and Malvina Eydelman of the following:

• a violation of any law, rule, or regulation,
• mismanagement,
• a gross waste of funds,
• an abuse of authority, or
• a substantial and specific danger to public health or safety

Who is Dr. Perry Rosenthal:

Even Dr. Perry Rosenthal, Assistant Ophthalmologist, Harvard University and founder of the Boston Foundation For Sight, is an outspoken critic of LASIK yet complains that his studies that “warn that LASIK is a bad idea and inflicts disease and inflammation” will not get picked up by any of the journals.  In other words, anyone or anything that doesn’t “BOAST” that LASIK is completely safe/effective 95% or more of the time, won’t get published and that person who did such will be “black listed” by the industry and by his/her peers.

Dr. Rosenthals Credentials: 

What is BioShape Known For Proving And Why Hasn’t Their Study Been Published By The Ophthalmic Journals:
BioShape is a company that has proven that every LASIK eye surgery, permanent flap/scar creation, has always has “KNOWN PERMANENT INJURIES” and yet a group of American Opthalmologists appointed by Alcon knew this when they hired Daniel Kluting and Stephan Schrunder (Attached:  Bioshape 2004, 2005, 2006 results of studies), yet they were fired since they proved that LASIK was a Titanic and was proven to create a “Permanent Golf Divot” into each of it’s victim’s cornea, creating a loss of 98% of the eye’s tensile strength, creating permanent Dry Eye or existing Dry Eye made much worse, and lastly creates “Uneven Tear Film Distribution,” to name but a few known permanent injuries of which, the industry is stating “these are just mere temporary symptoms and side effects and will go away in a few months or at the latest by Months 3-6…” Yet they don’t go away and the industry knows this, and has known this all along.  These are instead properly referred to as:  “PERMANENT INJURIES – ADVERSE EVENTS – SERIOUS ADVERSE EVENTS” and the industry won’t use these proper terms as then they would have to file the appropriate MDR Medwatch Injury Cases/Reports Here into the FDA’s Reporting system which no one at the FDA is policing or reading anyway: 

Report a LASIK Problem:


If the FDA checks, they would now find that there are over 4,000 Medwatch Cases for LASIK and PRK elective and irreversible procedures known, and growing yearly.  Mostly, created by patients and not by their physicians, so you can imagine how much larger this number and epidemic would grow to if physicians and trained staff were reporting every “retreatment/enhancement,” “dry eye prescriptions for RESTASIS,” and “other visual disturbances.”  Yet, they aren’t reporting them because they know that no one is policing them…especially the FDA or CDRH!
Please now see the bottom thread of this email to see how the FDA continues to ignore this.  When I called into the FDA’s Office of Internal Affairs, they “hung up on me.”
So my advocacy work is completely disrespected, all pro bono, since the FDA seems “broken and incoherent” when anything negative is mentioned or reported regarding LASIK/PRK elective surgery.

See for yourself below!

Thank you.


From: Dean Kantis
Sent: Tuesday, December 16, 2014 12:21 PM
To: Gonzalez, Alberto
Cc: Jim Dickinson; 'Morris Waxler'; Dean Kantis; Larry Pilot
Subject: Criminal Investigation Involving FDA Employees: Malvina Eydelman Re: LASIK FDA APPROVAL/FALSIFIED SAFETY STUDIES since 1995.

December 16, 2014

Hello Mr. Alberto Gonzalez:
(FDA Office of Internal Affairs)
I called today to check in and see if any progress has been made on my case report and unfortunately for me, was unable to reach you, but instead reached a Mr. McCormick who was extremely naiveté and rude by not wanting to give me the time of day on anything and
hung up on me.  He knew who I was and called me Mr Kantis.  I then called back and a Mr. Rubin picked up.  He tried to answer my simple question asked which was “who is in charge at the FDA of deciding whether or not this case/complaint is going to be investigated” and tried to pawn me off on an ex FDA compliance department employee who I know of doing the same thing, called Mr. David Buckles who is no longer at the FDA/CDRH and was working under Steven Silverman who heads Compliance.

Anyway, to my dismay, this department has been completely rude, totally unprofessional, and “hanging up” like a bunch of children playing games and pranks, isn’t the way to handle a consumer who is helping your department for FREE to police/register possible medical criminals.
The fact that I’m being blown off again, by a department who is being paid by our hard earned tax paying dollar adds further insult to injury.  Lastly, may I ask you the same question “Who at the FDA/CDRH is in charge of deciding whether or not this case is going to be investigated?”

Thank you for the courtesy of your reply.


My best to you,
Dean A. Kantis

From: Gonzalez, Alberto [mailto:Alberto.Gonzalez@fda.hhs.gov]
Sent: Friday, December 5, 2014 1:02 PM
To: Dean Kantis
Subject: RE: Criminal Investigation Involving FDA Employees: Malvina Eydelman Re: LASIK FDA APPROVAL/FALSIFIED SAFETY STUDIES since 1995.


Mr. Kantis,

I received your email which will be forwarded to the attention of my supervisor.

Thank you.


SA Alberto L. Gonzalez

FDA Office of Internal Affairs

(240) 276-9393


From: Dean Kantis
Sent: Friday, December 05, 2014 12:52 PM
Whistleblower.Ombudsman@oig.hhs.gov; Gonzalez, Alberto; West, Robert
Cc: 'Morris Waxler'; Jim Dickinson; Dean Kantis; 
Roger Davis; Michael Patterson; Larry Pilot
Subject: Criminal Investigation Involving FDA Employees: Malvina Eydelman Re: LASIK FDA APPROVAL/FALSIFIED SAFETY STUDIES since 1995.

December 5, 2014

Dear OIG, OCI, and HHS Offices of Criminal Investigation,

My complaint for a Criminal Investigation from an external FDA Office: 
There is a conflict of interest with the Director of Ophthalmology, Malvina Eydelman, and possibly the Director of Devices, Jeffrey Shuren, in showing “biases’” to the medical industry, Protecting the profits, safety studies, financial interests, and reputations of physicians in and around the Safety Studies involved with PRK/LASIK/Refractive Surgery, and this has been going on since the 1990s (see bottom of this email Part 1-7).  How can the OIG, OCI, and HHS work in harmony to conduct an investigation into the matters of LASIK NEVER BEING WORTHY of FDA Approval, the original studies / ongoing safety studies prove, that the lasers used in LASIK are about as safe as going up in an airplane and crashing 1 in 5 flights.  This is why we need your attention into this matter.  The public thinks that because LASIK is FDA Approved, that means that it’s 99.99999% safe or that means to them that if they fly in an airplane, they have a 99.99999999% chance of safely flying…This is certainly NOT the case and the FDA needs to do the right thing and warn the consumer since the industry chooses to deceive the consumer.  If you take the time to thoroughly investigate this, you will find the same thing, that LASIK should have never have been approved and represents a danger to the public!

First, I’m contacting the OIG due to YOUR WEBSITE stating this:
Disclosure by current and former Federal employees and applicants of the following types of wrongdoing are covered by the Whistleblower Protection Act of 1989:
• a violation of any law, rule, or regulation,
• mismanagement,
• a gross waste of funds,
• an abuse of authority, or
• a substantial and specific danger to public health or safety

A little background about what has transpired since I have had LASIK on Aug. 24th, 1999:

As a consumer, I feel very wronged, that the FDA and Medical Agencies would allow a permanently injured/disabled person like myself to get sued for $2million dollars by my LASIK doctor
Nick Caro in Chicago/IL, in an effort to show me that he can try to quiet me from speaking out about his 60+ LASIK LAWSUITS.  Maybe he knows something that I don’t know about no one
investigating or policing his center?  Or…that all of my attempts to have Dep’t of Regulations investigate him and follow doctors that lied to me, to protect him, would get DENIED.  Perhaps…
But hopefully with this email, you will prove me wrong.

Please understand, I have turned in no fewer than 15 complaints over the past 6 years into the investigation of LASIK officials involved in the FDA Approval of LASIK, The Safety Studies involved in the original FDA Approval of LASIK, and the continued Safety Studies Involved in LASIK.  In addition, by hearing from no fewer than several thousand injured LASIK patients that have all said the same thing, we have concluded that there is a Medical Coverup/Conspiracy involved at the highest Director positions inside FDA/CDRH and those physicians and OEM medical Executives that continue to make millions/billions annually off of the sale of:  1.  LASERS used for LASIK and PRK Refractive Surgeries.  2.  Future Surgeries/Enhancements/Retreatments.  3.  The Micro-Keratome
Blades and FemtoSecond Lasers used in Refractive Surgeries.  4.  Post LASIK Restasis Prescription and Dry Eye Drops for LASIK Dryness.  5.  Early need for accelerated aging of the eye and Cataract Surgeries.  5.  Misc:  Office Visits, Ectasia/Keratoconus induced surgeries, Corneal Transplants, Vitrectomy surgeries, etc.


PETITIONS to FDA continue to be IGNORED:  Dr. Morris Waxler oversaw the group that approved LASIK back in 1996/1997.  Flash forward to Jan. 6th, 2011:  Dr. Waxler petitions the FDA to immediately “PULL THE LASIK FDA APPROVAL” and issue a “CRIMINAL INVESTIGATION.”
http://lifeafterlasik.com/LASIK%20Morris%20FDA%20Petition%20Jan%206%202011.pdf.  See attached, official correspondence of Petition/Petition Denial to Morris by FDA.

Waxler on TV begging the consumers to listen and to NOT DO LASIK or trust the FDA:

Dr. Oz LASIK Warning:  “Stated 1 in 5 eyes are permanently being ruined:”

We spoke out against LASIK at the April 2008 hearing, but the entire Panel of Ophthalmologists wearing glasses hasn’t replied to us since:
https://www.youtube.com/user/FDALasikHearingVideo/videos .

Mini Film we made that explains this in a few minutes:
https://www.youtube.com/watch?v=2TtbxM-jUXA .

Malvina Eydelman/Jeff Shuren:  Directors of Ophthalmology and Devices:
-Why aren’t physicians such as Nick Caro/Chicago, IL who ruined my eyesight and has accumulated 60+ LASIK LAWSUITS

Being disciplined as FDA/CDRH is supposed to be doing (3 years imprisonment and $1million in fines is what the FDA’s website shows):

-$1m was just spent on another “4 year Supposed Safety Study” to see whether or not LASIK meets FDA approval guidance, which it still does not, and the study proved that they don’t know…(See attached presentation by Malvina Eydelman:  FDA – NEI PROWL RESULTS).


-Malvina Eydelman's 6 year So Called QoL LASIK Safety Study proves LASIK is unsafe and immediately she has a responsibility to issue the proper consumer PHA "Public Health Advisory" to prevent any families from being permanently injured:


-See presentation by Fred “Rick” Ferris, Director of the NEI who actually is trying to get the medical community to look at the Dry Eye Disease problem that LASIK is causing:
 -Dr. Steven Schallhorn has made MILLIONS off of his Femtosecond Laser and LASIK, and yet is in charge of the Safety Studies ongoing?  http://lasikadvisory.blogspot.com/2013/08/is-steven-schallhorn-using-navydod-to.html .  Malvina is very close to Schallhorn and yet
this is allowed?

He and others like him, are teaching physicians to tell patients they should love their LASIK vision even if it’s distorted and blurred like this photo above and calling them a “success.”   Does this look like a "SUCCESS" to you?
-Any Safety Study that goes against the industry and the doctor who reports the study, is black listed, and it doesn’t get published in industry news:
http://lasikadvisory.blogspot.com/2013/07/harvard-medical-dr-perry-rosenthal.html .

-Epidemic?  Signs everywhere, just look:
http://lasikadvisory.blogspot.com/2013/03/avedro-ccl-treatment-for-kerataconus-or.html .

Even the Ophthalmic Industry is saying that there are "ethical" challenges, just look at their cover:

Go back to how LASIK got approved and you will find this investigation
(My apologies for the poor video quality, turn up and listen to what happened):

Part One:
http://www.youtube.com/watch?v=mXNN65PF_HA    (10 minutes)

Part Two:  http://www.youtube.com/watch?v=Z9THraSVkOs    (10 minutes)

Part Three:  http://www.youtube.com/watch?v=j_0hvMJsQyA     (10 minutes)

Part Four:  http://www.youtube.com/watch?v=BEVVXeJVL3U    (10 minutes)

Part Five:  http://www.youtube.com/watch?v=mOZS_eWRkdU   (5 minutes)

Part Six:  http://www.youtube.com/watch?v=PhSWNuXrYPg  (10 minutes)

Part Seven:  http://www.youtube.com/watch?v=2pTZ7Ffw9EE  (10 minutes)

Now...that we have given you background on the Summit Technologies founder/CEO, David Muller, put the pieces of the puzzle together and discover how LASIK ruined so many eyes and now those eyes are inflicted with "SICKNESS and DISEASE" and years later are coming in complaining of exponential and never ending problems.  So lets see what David Muller is up to now, years later, and why...Avedro's CCL "Cross Collagen Linking" Process To Help LASIK Flaps STICK and NOT POP:  http://www.youtube.com/watch?v=xXwvaFgad88  .

My speech at the 2008 Emergency LASIK Panel discussion begging the FDA and industry to help us and listen to us, nothing from them since:

In closing, my question is quite simple and please don’t take this as being a patrionizing question, but it is this:

“If you didn’t know all of this prior to now…meaning…you didn’t see or hear this on the news or have been warned about this by a doctor…by the FDA directly…then how would you or any other consumer know this danger prior to getting LASIK?”  If the answer is, “they wouldn’t know this or be warned,” then how is a consumer to be warned of this danger if the FDA continues to protect industry and only spin safety studies to “appear” to be safe when they are “not safe?”  And why aren’t physicians being held accountable for violating safety laws and why aren’t the Directors at the FDA implementing FDA protocol of (3) years imprisonment and $1million in fines as stated above on the FDA’s website/link page?  How is a permanently injured/disabled consumer like me to see this as “being fair” to the consumer when this is allowed to perpetuate and there is no response by any departments to injured consumers like myself who spent hours today typing this and doing this for free/pro bono in an effort to warn the public and protect the public?

Please investigate this…Please hold those accountable… Please follow your job descriptions, mission statements, Hippocratic oath sworn to "first" protect the consumer and in criminally investigating possible fraud, corruption, and crimes by FDA officials.  Please reply that you will look into this…

Thank you for your consideration…

My best to you,

Dean A. Kantis