Waxler Regulatory Consultancy LLC1/6/11 1 of 32
Waxler Regulatory Consultancy LLC
1920 Arlington PlaceMadison, WI 53726-4002608-219-7547mwaxler@charter.net
January 6, 2011Division of Dockets ManagementFood and Drug AdministrationDepartment of Health and Human Services5630 Fishers Lane, rm. 1061Rockville, MD 20852Dear Sir or Madam:Waxler Regulatory Consultancy LLC submits the attached Citizen Petition under Sections201, 301, 510, 513, 519, and 520 of the Food Drug and Cosmetic Act and 21 Code of FederalRegulations to request the Commissioner of Food and Drugs to withdraw FDA approval(PMA) 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 andmicrokeratomes used for LASIK eye surgery.Please contact me if you have questions.Respectfully submitted, _______________________________________ Morris Waxler, Ph.D.PresidentAttachment
Waxler Regulatory Consultancy LLC1/6/11 2 of 32
CITIZEN PETITION
Waxler Regulatory Consultancy, LLC submits this petition to the United States Food and DrugAdministration (FDA) under 21 Code of Federal Regulations (CFR) § 10.30, and sections 201, 301, 510,513, 519, and 520 of the Federal Food, Drug, and Cosmetic Act (FDCA) to ask FDA Commissioner Dr.Margaret Hamburg to stop the epidemic of permanent eye injury caused by lasers and microkeratomesused for LASIK eye surgery. Data are provided as factual grounds in support of this petition, andrequests fall under FDA jurisdiction under 21 CFR, Part 5.10. 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 investigationssubcommittee and other congressional leaders in this matter.Many thousands of eyes have been damaged beyond repair by LASIK devices since the 1990s.Approximately 700,000 eyes will receive refractive surgery with LASIK devices by the end of year 2011.Thus, more than four thousand six hundred (4,630) are projected to face blindness due to surgicallythinned and bulging corneas (keratectasia).
*
This is an addition to the many thousands of LASIK patientsalready suffering from keratectasia. In addition, more than 70,000 LASIK patients (140,000 eyes) willsuffer by the end of 2011 with persistent adverse effects including but not limited to night visiondisturbances, dry eye, glare, and halos.
†
These LASIK-induced adverse events have occurred from using both early and late model LASIK technologies. Also, upwards of 43 percent of LASIK patients will bewearing corrective lenses 6 to 12 months after surgery
‡
and in about 7 years fifty-five percent will beunhappy with their vision and the number of eyes that lost 2 or more lines of visual acuity will havedoubled.
§
I.
ACTION REQUESTED
I, Morris Waxler
**
, am the former Branch Chief in charge of FDA approvals of LASIK devices between1996-2000. I request FDA commissioner, Dr. Margaret Hamburg, take the following actions:
Withdraw FDA approval (PMA) for all LASIK devices
Issue a Public Health Advisory with a voluntary recall of LASIK devices
II.
FACTUAL GROUNDS
Manufacturers and their collaborators (including but not limited to clinics, refractive surgeons, andagents) withheld and distorted safety and effectiveness data (Section A) submitted to the Food and DrugAdministration (FDA) so that LASIK devices would appear to have:
o
A FDA-acceptable adverse event rate of
≤
1%, rather than the true rate of at least 20%
b
o
Only temporary adverse effects when, in fact, some persist for 6 months to many years
b
o
>90% effectiveness when the true rate is approximately 57%
††
*
Keratectasiarateof0.66%.SeeSectionB5
†
Adverseeventrateof20.0%.SeeSectionsA1,A2
‡
SeeSectionA4
§
SeeSectionB8
**
WaxlerRegulatoryConsultancyLLC
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Table1
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Starting during my tenure, FDA decision-making on LASIK devices was dominated by LASIK surgeons working hand-in-glove with LASIK manufacturers. Data recently brought to light exposesthis 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 itscollaborators. 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), andreports of adverse events (including but not limited to 21 CFR 803; 812; and 820) when theymanufactured and distributed LASIK devices in interstate commerce within the United State as:
•
Homemade lasers (“black boxes”)
•
Imported investigational lasers (“grey boxes”)
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Illegal key cards (“Bermuda cards”) and
•
“Off-label” photorefractive keratectomy (PRK) lasersAs a consequence the FDA was deprived of knowledge of the full extent of LASIK injuries prior to andduring FDA reviews of documents submitted in support of the safety and effectiveness of LASIK devicesunder 21 CFR 812 and 21 CFR 814. In addition, LASIK manufacturers and their collaborators withheldsafety and effectiveness information from their investigational device exemption (IDE) reports to theFDA. 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 thatclearly showed LASIK with excessive adverse event rates (greater than 1%). These activities were anindustry-wide effort, organized wholly or in part by the manufacturers and their collaborators in order tocircumvent FDA law and regulation. I will submit CONFIDENTIAL information on these mattersseparately to FDA’s Office of Criminal Investigation.Published scientific data shows LASIK devices induce an average adverse event rate of about 22% that persists beyond six months to five or more years. Moreover, the published data (Section B) shows thatLASIK 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)
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Compromises night vision
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Have unstable vision corrections that regress
•
Require eye care that otherwise would not be needed
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