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:
http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/SurgeryandLifeSupport/LASIK/ucm061479.htm
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.
,
D
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
To: 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.
(THIS
REPRESENTS BILLIONS OF DOLLARS ANNUALLY IN REVENUE FOR THE OPTHALMIC INDUSTRY
THAT WOULD NOT HAVE HAPPENED WITHOUT LASIK STAYING APPROVED).
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:”
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
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?
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)
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
