Source: http://www.herbertnevyaslasik.com/?page_id=8
Timestamp: 2019-07-23 05:46:15
Document Index: 743239591

Matched Legal Cases: ['§ 321', '§ 352', '§ 360', 'art 803', 'art 812', 'art 50', 'art 812', '§ 812', 'ART 812', '§ 812']

FDA Related – This website is not owned by Dr Herbert Nevyas
This page is to show the deficiencies of following Federal standards, protocols, and regulations BEFORE, DURING, and AFTER an FDA sanctioned investigational study.
Before The Nevyases’ Study
It started with Ed Sullivan, the guy who built the “Nevyas Laser”, a man already under scrutiny by the FDA…
“Ed Sullivan, doing business as ExSull, Drexel Hill, Pa, has been put on notice by the FDA that the agency regards him “clearly as a manufacturer with multiple manufacturing sites” subject to FDA rules and regulations and, if he makes another one of these excimer lasers “which are unapproved devices,” he will be in violation of the federal Food, Drug and Cosmetics Act and subject to legal penalties, according to top-ranking FDA officials within the national Division of Enforcement.” [as written in The Journal of Refractive Surgery – Volume 11 (5) * September/October 1995 * News and can be found at the url address http://www.slackinc.com/eye/jrs/vol115/news1.htm]
And the FDA knew that! From the affidavit Herbert Nevyas submitted to the FDA, it tells of Ed Sullivan building their laser. However, documents show Mr. Sullivan in teleconferences and meetings with the doctors and their liaison with the FDA well after this article was written.
After I received inspection reports even less redacted from the FDA regarding inspections of the Nevyas’ facility, the FDA promised “to do what they could to help me”, but then refused after copies of the inspection reports were returned. In fact Les Weinstein, the CDRH Ombudsman, outright told me (through his secretary) he could no longer have any communication with me.
The inspection reports of Sullivan’s facility below were obtained via the Freedom Of Information Act. Regardless of these reports and the articles written concerning ‘Homegrown Lasers”, is this what the FDA considers “protecting the public’s safety”?
PAGE 11 PAGE 12 PAGE13 PAGE 14 PAGE 15
The following letters are from the FDA to Drs. Herbert Nevyas and Anita Nevyas-Wallace throughout their investigational study, and after their study was terminated. Despite continued deficiencies as noted below, the FDA kept granting the Nevyases approvals for their study. Based on documents received during my med mal and the recent Nevyas v. Morgan lawsuits, I believe the Nevyases constantly misrepresented themselves and their study to both Schullman Associates (the Nevyases IRB), the FDA, and the courts:
All ‘page’ text this page designate links to documents which should open in new window.
Again and again and again, but the doctors claimed numerous times under oath theyâ€™ve never done anything to violate any FDA rules, regulations, or protocols:
The ophthalmic laser used at your facility to perform Laser-Assisted In Situ Keratomileusis procedures is a medical device under Section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. Â§ 321(h), because it is intended for the use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment or prevention of disease, or to affect the structure or function of the body.
Our inspection revealed that this device is misbranded under section 502(t)(2) of the Act, 21 U.S.D. Â§ 352(t)(2), in that your firm failed or refused to furnish material or information respecting the device that is required by or under section 519 of the Act, 21 U.S.C. Â§ 360i, and 21 CFR Part 803 â€“ Medical Device Reporting. Significant violations include, but are not limited to, the following:
We reviewed your firmâ€™s response dated April 2, 2012, and concluded that it is not adequate because it did not include a copy of your firmâ€™s MDR procedures. Your firm should take prompt action to correct the violations addressed in this letter. Failure to promptly correct these violations may result in regulatory action being initiated by the FDA without further notice. These actions include, but are not limited to, seizure, injunction, and civil money penalties. Also, federal agencies may be advised of the issuance of Warning Letters about devices so that they may take this information into account when considering the award of contracts.
Please notify this office in writing within fifteen business days from the date you receive this letter of the specific steps your firm has taken to correct the noted violations, as well as an explanation of how your firm plans to prevent these violations, or similar violations, from occurring again. Include documentation of the corrections and/or corrective actions (including any systemic corrective actions) that your firm has taken. If your firmâ€™s planned corrections and/or corrective actions will occur over time, please include a timetable for implementation of those activities. If corrections and/or corrective actions cannot be completed within fifteen business days, state the reason for the delay and the time within which these activities will be completed. Your firmâ€™s response should be comprehensive and address all violations included in this Warning Letter.
Your firmâ€™s response should be sent to: Food and Drug Administration, Center for Devices and Radiological Health, Office of Surveillance and Biometrics, MDR Policy Branch, White Oak Building 66, 10903 New Hampshire Avenue, Room 3208, Silver Spring, Maryland 20993. Refer to the Unique Identification Number #306398 when replying. If you have any questions about the contents of this letter or wish to discuss MDR reportability criteria or schedule further communications, please contact: MDR Policy Branch at (301) 796-6670 or by email at MDRPolicy@fda.hhs.gov.
Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your firm. It is your firmâ€™s responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violations noted in this letter and in the Inspectional Observations, Form FDA 483, issued at the close of the inspection, may be symptomatic of serious problems in your firm. Your firm should investigate and determine the causes of the violations and take prompt actions to correct the violations and bring the device into compliance. Sincerely yours, /S/ Steven D. Silverman Director Office of Compliance Center for Devices and Radiological Health
PAGE 1 â€“ There was no documentation to show that the CI notified the IRB about all amendments, changes of significant deviations to the protocol [per IRB requirements] prior to implementation. For example, the FDA granted your firm an increase in the number of subjects you could treat with your investigational device on Jan. 20, 1999. IRB. Annual Review dated 7/29/00 does not indicate the IRB knew about population increase. The IRB did not approve the population increase until. August 28, 2000, 20 months later.
PAGE 1 â€“ 1. You must still provide responses to deficiencies 1, 2, 3, and 5 froth our letter of February 6, 2002. 2. You did not provide the requested information in your response to deficiency 4.
PAGE 2 â€“ 4. In response to deficiency 8, you have indicated how you will verify your current accountability for visits that have already past. After your internal audit is complete and you have more insight as to the reasons for any problems with accountability, please directly address the original issue outlined in previous deficiency 8: please describe how you intend to improve subject follow-up and data reporting during the rest of the course of your IDE study.
PAGE 3 â€“ Attachment: In a reply to Dr. Morris Waxler, FDAâ€™s Chief Medical Device Examiner, Dr. Herbert Nevyas states â€œSince the close of business on July 28, 1997, neither I nor anyone else has used the laser. I certify that, unless and until FDA approves the IDE application for that device, neither I nor anyone else will use the laser to treat patients. I have notified all of my employees, as well as anyone with access to the laser, that the laser may not and will not be used until there is an approved IDE in effect for that laser. I declare that to the best of my knowledge the foregoing is true and correct.â€
Nevyases Deviations and discrepancies continue almost 5 years into their study â€“ Letter from the FDA to Nevyases:
PAGE 1 â€“ Please address the following, questions and concerns with regard to this submission, which also applied to the previous, delinquent, annual report as outlined in FDAâ€™s letter of April 10, 2001, and for which we never received a response:
PAGE 2 â€“ 5. Please provide tables (similar to those requested for initial treatments) and narrative summarizing the results of the IDE substudy of enhancements for 25 subjects/50 eyes that had undergone treatment prior to implementation of the IDE, and of the data from enhancements performed for eyes enrolled under the IDE. Please provide separate analyses for the first enhancement, second enhancement, etc.
PAGE 3 â€“ 1. Please note that, based on the stability analyses you have provided in this submission, we do not agree that the time point of stability is at 12 months postoperatively as you have indicated, and, in fact, may be earlier for some of the indications.
PAGE 4 â€“
PAGE 1 â€“ We regret to inform you that your supplement is disapproved and you may not implement the change in your investigation. Our disapproval is based on the following deficiencies: 1. An important function of the software in the device is to control the beam delivery hardware (iris size, slot movement, synchronizing iris/slot with laser pulses, etc.) in the creation of an ablation pattern. This area, however, is not discussed at all in the Software Requirement Specifications document.
PAGE 2 â€“ The deficiencies identified above represent the issues that we believe need to be resolved before your IDE application can be approved.
PAGE 3 â€“
PAGE 1 â€“ The Food and Drug Administration (FDA) has reviewed the supplement to your investigational device exemptions (IDE) application proposing two new clinical protocols to evaluate the spherical ablation algorithm. We regret to inform you that your supplement is disapproved and you may not implement the change in your investigation. Our disapproval is based on the following deficiencies which, unless otherwise specified, relate to both protocols:
PAGE 2 â€“ 3. You have not provided in your protocol the methodology for performing any of the clinical evaluations. For each clinical evaluation, please specify the testing procedures and instruments that will be used, including the lighting conditions and charts you will use to measure distance vision and near vision, etc.
PAGE 3 â€“ 7. Your protocol states that subjects must have a best spectacle corrected visual acuity (BSCVA) of at least 20/40 in each eye in order to be enrolled in the study. Please be advised that while we find this criteria acceptable for subjects with high myopia (>7 D MRSE), in order for subjects with low myopia (< 7 D MRSE) to be enrolled, we recommend a BSCVA of at least 20/25 in each eye. Please revise your protocol accordingly, or justify not doing so.
PAGE 4 â€“ 21. The Conclusion section of the consent form stares, â€œThere is always a possibility of one or more late complications That were not known or anticipated at the time of this writing (1997).â€ It also states, â€œLASIK is investigational surgery and as such, it has not yet been completely and exhaustively studied by the FDA and medical researchers in this country.â€ Please update the consent form as necessary in keeping with current knowledge including the additions previously mentioned. Please revise the second statement to Improve its accuracy: LASIK is no longer investigational, it has never (page 5) been studied by the FDA, and the FDA does not regulate LASIK, only the devices used for the procedure.
PAGE 5 â€“ 28. There are discrepancies in the way you refer to the protocols throughout the submission. For example, in the Introduction you refer to the new protocols as NEV-97-002 (Myopia/Myopic Astigmatism) and NEV-97-003 (Hyperopia/Hyperopic Astigmatism). However, the myopia protocol itself has been labeled with the protocol number NEV-01-002. To avoid confusion, please make all necessary revisions in any future submission to correct such discrepancies.
PAGE 6 â€“ With respect to the profiles of your ablated PMMA samples:
PAGE 7 â€“ The deficiencies identified above represent the issues that we believe need to be resolved before your IDE application can be approved. In developing the deficiencies, we carefully considered the relevant statutory criteria for Agency decision-making as well as the burden that may be incurred in your attempt to respond to the deficiencies.
PAGE 8 â€“ 34. Please be advised that for possible future pre-market approval, although 300 eyes total are needed to support overall safety, data from approximately 125 eyes are needed to support eachindication for which approval is being sought.
PAGE 1 â€“ Please address the following questions/concerns, as well as provide the information requested in the tables enclosed with this letter.
PAGE 2 â€“ 8. With regard to your future PMA submission, you have indicated that only subjects treated with the â€œnew centration techniqueâ€ will be included in the PMA, and that you have selected the eyes treated between 2/19/98 and 11/22/99 as the cohort to support the safety and effectiveness of the device. We would like to clarify that data from all subjects treated. under the IDE should be included in the PMA. The main PMA cohort on which the decision of the safety and effectiveness of the device will mainly rest may be limited to all eyes treated with the new centration technique, but not to only those enrolled during a given period of time, as you appear to have suggested.
PAGE 1 â€“ The Food and Drug Administration (FDA) granted approval of your investigational device exemptions (IDE) application on August 7, 1997. As part of your responsibilities as sponsor of a significant risk device investigation, you are required to submit a progress report to FDA and to all reviewing institutional review boards (IRBs) on at least a yearly basis. We have not received a response to FDAâ€™s November 10, 1999 request for additional information regarding your August 1998 â€” August 1999 annual progress report (enclosed).
PAGE 2 â€“
PAGE 1 â€“ 1. Please separate IDE subjects from pre-IDE subjects in all of your tables, or report only on IDE subjects.
PAGE 1 â€“ Our review of the inspection report submitted by the district revealed deviations from Title 21, Code of Federal Regulations, (21 CFR), Part 812 â€“ Investigstional Device Exemptions and Part 50 â€“ Protection of Human Subjects and Section 520(g) of the Act. The deviations noted during the inspection were listed on form FDA-483, â€œInspectional Observations,â€ which was presented to and discussed with you at the conclusion of the inspection.
PAGE 2 â€“ Use of the Summit laser at your Marlton, New Jersey site for off-label procedures is not included in your IDE protocol. Moreover, enhancements approved under your IDE do not include hyperopic procedures. It is therefore considered a protocol violation to retreat subjects of your IDE study using the Summit laser and performing hyperopic LASIK.
PAGE 3 â€“ While your Marlton, New Jersey site has a Summit laser, the advertisement does not specify a location. Future advertisements should specify the location(s) of approved lasers, as the enclosed advertisement would not be appropriate for soliciting subjects for your IDE study. All promotional materials designed to solicit participants or to inform subjects about the IDE study need to be approved by the reviewing IRB.
PAGE 1 â€“ Please be aware of the following: In Table 1-1, the data appear to be quite scattered, with some subjects actually increasing in sensitivity during glare (e.g., see BC & CB at 3 cycles per degree (CPD)), while others are severely compromised (see ZM). In order to reduce variability in the data in the contrast sensitivity study, the person administering the test should have experience in this test and the subjects should be well trained prior to testing.
PAGE 2 â€“ We continue to be concerned that your ablation is likely to have multifocal properties, which means some light will be out of focus even at the best focal plane.
PAGE 1 â€“
Nevyasesâ€™ Co-Investigators (dated 10/01/98)
â€œConditionalâ€ Approval Letter from the FDA to Nevyases:
PAGE 1 â€“ FDA cannot approve your request as proposed because you have not shown stability of manifest refraction, and you have not presented sufficient detail for your hyperopic retreatment. FDA will conditionally approve, however, an expansion to include myopia and myopic astigmatism retreatments at this time.
PAGE 2 â€“ This approval is being granted on the condition chat, within 45 days from the date of this letter, you submit your agreement to: 1. conduct the investigation within the modified limit, i.e., retreatment for myopia or myopic astigmatism only; 2. extend the minimum time between the initial operation and the retreatment to 3 months; and, 3. retreat only eyes which are â€œwhite and quietâ€ and in which refractive stability has been documented with two manifest refractions taken at least 30 days apart at less than 1 diopter ofâ€”change, confirmed by topography.,
Approval Letter from the FDA to Nevyases dated 05/14/98 Re: Contrast Sensitivity & Increased â€˜Subjectsâ€™:
PAGE 1 â€“ â€˜Conditionalâ€™ approval for substudy and increase of â€˜subjectsâ€™.
PAGE 2 â€“ We acknowledge your request in your original IDE (dated March 18, 1997) to conduct a study at one site with 400 eyes low myopia and 590 eyes high myopia for each of two investigators (single site total of 1980 eyes or 990 subjects). We believe that adequate safety information has been provided to allow the initiation of your study with a small expansion of an additional 75 subjects (150 eyes). We will allow you to expand to the full number of subjects for this study (990) after you have received approval of supplements addressing the following deficiency from our letter of October 3, 1997 (enclosed). No additional expansions of your IDE will be granted until supplements containing the following information are approved:
PAGE 3 â€“ You should also give serious consideration to the following items which are considered essential for the analysis of your data for the purposes of determining safety and effectiveness for a future PMA application: Deficiencies 5 through 16, excluding deficiency 14, in our letter of October 3, 1997.
PAGE 1 â€“ Offers suggestions from the FDA should the Nevyases submit their PMA.
PAGE 1 â€“ In your â€œSubstudy for Same-Day Versus Different Day LASIK Treatment for Fellow Eyesâ€: a. Please revise your informed consent document rider for same day surgery to state that the second eye will be rescheduled if there is a complication or an adverse event with the first eye.
PAGE 2 â€“ Your statement in the rider to the informed consent document that â€œâ€¦There have been no failures or malfunctions of the Willis Excimer Laserâ€, should be removed or altered. It may unduly influence potential same day fellow eye surgery candidates into believing that the Nevyas Excimer Laser cannot fail. FDA recommends that you remove this statement or alter it to read: â€œThere have been no failures or malfunctions of the Nevyas Excimer Laser to date.â€
The following pages are an Investigator Agreement issued by the FDA to a Sponsor/Investigator of an investigational study. Nevyas refused to signâ€¦
PAGE 1 â€“ Investigator agreement signed by Anita Nevyas-Wallace
PAGE 2 â€“ Investigator agreement signed by Herbert Nevyas
PAGE 3 â€“ â€œI informed Mr. Kane, that Mr. Sullivan told me that the excimer laser that he would build, is considered a custom device and would not be regulated by the FDA. Mr. Sullivan completed the assembly of the laser in the fall of 1995, and the first patient was treated (using LASIK) in January 1996.â€
PAGE 4 â€“ â€œI did not maintain any written records of the design specifications, nor did I receive any written design specifications from Mr. Sullivan.â€
PAGE 5 â€“ â€œThis patient is not part of the patient population included in my IDE submission. I have treated a total of 252 patients, from January 1996 to the present date (6/30/97),â€
PAGE 6 â€“ â€œI affirm that the information on this and the previous pages, is accurate, to the best of my ability. I have read, but would not sign this affidavit.â€
PAGE 1 â€“ The Food and Drug Administration (FDA) has reviewed the supplement to your investigational device exemptions (IDE) application. Your application remains conditionally approved because your supplement adequately addressed only deficiency 2 cited in our October 3, 1997 letter.
PAGE 2 â€“ You are reminded that prior to a request for expansion beyond 150 subjects, you should provide adequate responses to deficiencies 5 16 in our letter of October 3, 1997.
PAGE 1 â€“ We acknowledge receipt of your institutional review board (IRB) approval (supplement 3). Supplement 4 responds to our conditional approval letter of August 7, 1997 and requests: an increase crease in treatment range from -6.75 ID to -22 ID; approval to study simultaneous bilateral treatment; and, approval to retreat approximately 125 patients previously treated with this laser prior to IDE approval.
PAGE 2 â€“ Requests for additional subjects for enhancements for prior clinical patients will be evaluated as additional data is submitted to support stability of the procedure.
PAGE 3 â€“ You agree that you will not perform retreatment procedures for subjects initially treated under this IDE. Retreatment (enhancement) for subjects initially treated under this IDE is appropriate only after your preliminary data demonstrate safety and indicate the time point of stability of the procedure. You may begin retreatment procedures only after FDA has approved your retreatment study plan and data to support stability.
PAGE 4 â€“ PAGE 5 â€“ PAGE 6 â€“ PAGE 7 â€“ PAGE 8 â€“ PAGE 9 â€“ PAGE 10 â€“ Deficiencies listed.
â€˜Conditionalâ€™ Approval Letter from the FDA to Nevyases dated 08/07/97:
PAGE 1 â€“ Your application is conditionally approved because you have not adequately addressed deficiency #2 cited in our May 8, 1997 disapproval letter.
PAGE 2 â€“ This approval is being granted on the condition that, within 45 days from the date of this letter, you submit information correcting the following deficiencies.
PAGE 3 â€“ Deficiencies listed.
PAGE 4 â€“ Deficiencies listed.
PAGE 5 â€“ We have enclosed the guidance document entitled â€œSponsorâ€™s Responsibilities for a Significant Risk Device Investigationâ€ to help you understand the functions and duties of a sponsor.
PAGE 1 â€“ FDA is aware that a number of physicians are using lasers for refractive surgery to treat patients even though there is no PMA or IDE in effect for their lasers. Based on the results of our investigations, we believe that you are currently using your laser to treat patients.
PAGE 2 â€“ Accordingly, on July 28, 1997, we called you to notify you that use of your excimer laser to treat patients would violate the Act and requested that, if you are presently using the laser to treat patients, you immediately cease doing so.
PAGE 3 â€“ We also want you to know that if FDA approves your IDE application, you would be able to use your laser to perform only specific procedures on a limited number of subjects to demonstrate the safety and effectiveness of your laser for those procedures. Studies conducted under such an IDE would be subject to all IDE regulations. See 21 C.F.R. Part 812. For example, you would be prohibited from promoting and commercializing the laser, and from representing that the device is safe and effective.
PAGE 1 â€“ The Food and Drug Administration (FDA) has reviewed your investigational device exemptions (IDE) application. We regret to inform you that your application is disapproved and you may not begin your investigation. Our disapproval is based on the deficiencies listed below.
PAGE 2 â€“ Deficiencies listed.
PAGE 3 â€“ Please explain the low effectiveness and safety outcomes achieved in your prior clinical studies and specify what steps you are taking to improve your results. Your refractive and visual outcomes were reported at one month as: MSRE for low myopes, < 57% were within ID and < 35% were within 0.5D; less than 60% achieved BUCVA > 20/40; complication and adverse events occurred in > 2% of the cases.
PAGE 4 â€“ Please provide your agreement (or justification for not agreeing) that retreatments done to improve refractive outcome are NOT considered as treatment failures, whereas retreatments done to achieve resolution of an adverse event ARE considered as treatment failures.
PAGE 5 â€“ Your description of study procedures, examination conditions and techniques is not adequate. Please provide a detailed description of each procedure, test and instrument to be used in the study.
PAGE 6 â€“ For your follow-up visit schedule, the text on page 20 of the protocol appears to be inconsistent with the chart on page 43 of the protocol. In addition, please justify your statement on page 20 that measurement of corneal topography will be at the discretion of the investigator.
These reports were asked to be returned because “There was too much information the general public should not be aware of” and “was not only applicable to the doctors’ study, but all studies” (Quotes were from Les Weinstein, the Ombudsman of the FDA’s CDRH division).
The FDA’s Mission Statement: The FDA is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nationâ€™s food supply, cosmetics, and products that emit radiation. The FDA is also responsible for advancing the public health by helping to speed innovations that make medicines and foods more effective, safer, and more affordable; and helping the public get the accurate, science-based information they need to use medicines and foods to improve their health.
In light of media attacks on the FDA the past couple of years or so regarding drugs, I find it most disturbing nobody really ventures into the area of medical devices.
Specifically lasers used for LASIK. You hear so many advertisements about the ‘good’ of this procedure, what about the ‘other side’?
Throughout this website I’ve explained what happened during the use of an Investigational Laser, and the results based on my experience. I’ve complained to the FDA since 2000 about my doctors’ study, their laser, what happened to me, and everything in between. For the first 3 years, I’ve been bounced from 1 person/department to another, and it wasn’t until December 2004, I finally got to have a conference with key personnel in the FDA CDRH’s Office of Compliance, the Office of Device Evaluation, and the Ombudsman. Too little, Too late!
The results of the meeting basically was that the doctors did not damage enough people to warrant disciplinary action (such as LaHaye), and that their study was no longer going on.
They were generous enough afterwards to release via the Freedom Of Information Act (FOIA) documents relating to 2 inspections of their facility, edited of course.
Those reports were asked to be returned because “There was too much information the general public should not be aware of” and “was not only applicable to the doctors’ study, but all studies”. I was told in order for the FDA to help me, I must help them, by returning the inspection reports.
Where was the help when I needed it most? Like BEFORE I and others were subjected to be a guinea pigs!
The inspection reports although edited, should have added credibility to what I’ve been saying all along. I believe these reports, along with all of the other documentation showed that the doctors involved:
Deviated from standard of Care during the length of their investigational study.
Violated standards, protocols, and federal regulations during this time.
Submitted false documents to their Institutional Review Board (IRB), and the FDA, regarding outcomes, adverse event cases, and enrollment in their study.
Told patients to get them included into their study, in telling them they were ‘good candidates’, when in fact they were not.
Performed LASIK on HUNDREDS of people prior to FDA’s approval for their IDE AND informed consent!
HOWEVER, months after receiving the inspection reports, documentation was submitted during discovery in the current litigation (which should have been produced during the med mal lawsuit) to prove the dates on the inspection reports wrong. How can the FDA offer protection to the people of the this country, when they make those kind of mistakes?
From the Department of Health and Human Services Office of the Inspector General
Purpose: To examine the FDA’s selection of clinical investigators for inspection and FDA’s discipline of those clinical investigators found in violation of FDA’s regulations. (June 2000)
With flaws found in LASIK studies, why does the FDA allow doctors who were involved in these studies to continue to do more studies, such as Intacs? Improper data, investigators not properly screening candidates, and lack of responsibility by the Institutional Review Boards who are not 100% efficient are creating casualties who should not be.
If the FDA can believe flawed reports from LASIK research, who’s to say the reports from Intacs studies were not flawed as well?
More on INTACS…
World Medical Association Declaration of Helsinki: Recommendations Guiding Medical Doctors in Biomedical Research Involving Human Subjects
Adopted by the 18th World Medical Assembly, Helsinki, Finland, 1964 and as revised by the World Medical Assembly in Tokyo, Japan in 1975, in Venice, Italy in 1983, and in Hong Kong in 1989.
21 C.F.R. Â§Â§ 812.7
CHAPTER I–FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
PART 812–INVESTIGATIONAL DEVICE EXEMPTIONS
Â§ 812.7 Prohibition of promotion and other practices. A sponsor, investigator, or any person acting for or on behalf of a sponsor or investigator shall not: (a) Promote or test market an investigational device, until after FDA has approved the device for commercial distribution.
Biomedical research involving human subjects must conform to generally accepted scientific principles and should be based on adequately performed laboratory and animal experimentation and on a thorough knowledge of the scientific literature.
The design and performance of each experimental procedure involving human subjects should be clearly formulated in an experimental protocol which should be transmitted for consideration, comment and guidance to a specially appointed committee independent of the investigator and the sponsor provided that this independent committee is in conformity with the laws and regulations of the country in which the research experiment is performed.
Biomedical research involving human subjects cannot legitimately be carried out unless the importance of the objective is in proportion to the inherent risk to the subject.
Every biomedical research project involving human subjects should be preceded by careful assessment of predictable risks in comparison with foreseeable benefits to the subject or to others. Concern for the interests of the subject must always prevail over the interests of science and society.
The right of the research subject to safeguard his or her integrity must always be respected. Every precaution should be taken to respect the privacy of the subject and to minimize the impact of the study on the subject’s physical and mental integrity and on the personality of the subject.
Physicians should abstain from engaging in research projects involving human subjects unless they are satisfied that the hazards involved are believed to be predictable. Physicians should cease any investigation if the hazards are found to outweigh the potential benefits.
In publication of the results of his or her research, the physician is obliged to preserve the accuracy of the results. Reports of experimentation not in accordance with the principles laid down in this Declaration should not be accepted for publication.
In any research on human beings, each potential subject must be adequately informed of the aims, methods, anticipated benefits and potential hazards of the study and the discomfort it may entail. He or she should be informed that he or she is at liberty to abstain from participation in the study and that he or she is free to withdraw his or her consent to participation at any time. The physician should then obtain the subject’s freely-given informed consent, preferably in writing.
When obtaining informed consent for the research project the physician should be particularly cautious if the subject is in a dependent relationship to him or her or may consent under duress. In that case the informed consent should be obtained by a physician who is not engaged in the investigation and who is completely independent of this official relationship.
In case of legal incompetence, informed consent should be obtained from the legal guardian in accordance with national legislation. Where physical or mental incapacity makes it impossible to obtain informed consent, or when the subject is a minor, permission from the responsible relative replaces that of the subject in accordance with national legislation. Whenever the minor child is in fact able to give a consent, the minor’s consent must be obtained in addition to the consent of the minor’s legal guardian.
The research protocol should always contain a statement of the ethical considerations involved and should indicate that the principles enunciated in the present Declaration are complied with.
In the treatment of the sick person, the physician must be free to use a new diagnostic and therapeutic measure, if in his or her judgment it offers hope of saving life, reestablishing health or alleviating suffering.
In any medical study, every patient–including those of a control group, if any–should be assured of the best proven diagnostic and therapeutic method.
The refusal of the patient to participate in a study must never interfere with the physician-patient relationship.
If the physician considers it essential not to obtain informed consent, the specific reasons for this proposal should be stated in the experimental protocol for transmission to the independent committee (I,2).
The physician can combine medical research with professional care, the objective being the acquisition of new medical knowledge, only to the extent that medical research is justified by its potential diagnostic or therapeutic value for the patient.
In the purely scientific application of medical research carried out on a human being, it is the duty of the physician to remain the protector of the life and health of that person on whom biomedical research is being carried out.
The subjects should be volunteers–either healthy persons or patients for whom the experimental design is not related to the patient’s illness.
In research on man, the interest of science and society should never take precedence over considerations related to the well-being of the subject.
The above was obtained from the FDA’s website.
FDA News Bulletin
The FDA DID penalize one doctor for violating regulations and protocols:
Louisiana Ophthalmologist Fined $1.1 Million by FDA For Clinical Study Violations
A Lafayette, La., ophthalmologist and eye care center he owns have agreed to pay the federal government a total of $1.1 million in civil money penalties for violating federal laws related to the conduct of clinical studies. The violations involved studies of a laser system built by the ophthalmologist for LASIK treatment of nearsightedness.
In a settlement agreement signed today with the Food and Drug Administration (FDA), Leon C. LaHaye, M.D., will pay $150,000 and his LaHaye Center for Advanced Eye Care of Lafayette will pay $950,000 for clinical study violations that occurred on at least 175 occasions. In June 2002, FDA disqualified LaHaye from conducting further clinical studies.
â€œThis penalty sends a clear message that FDA will not tolerate conduct that can put patients at risk and erode the trust between research subjects and the medical research community,â€ said FDA Commissioner Mark B. McClellan, M.D., Ph.D.
To protect patients and to help ensure that tests of unapproved products will yield useful data, FDA regulations establish strict conditions under which clinical studies of medical devices may occur. For example, studies of high risk devices such as ophthalmic lasers must be conducted according to an investigational plan reviewed and approved by FDA and an investigator must obtain informed consent from each participant. In addition, the device cannot be used on patients before the study begins.
The civil money penalties complaint filed by FDA alleged that Dr. LaHaye and his center:
Used an unapproved laser on patients before the study began;
Treated more subjects than allowed under the study plan that was approved by FDA;
Ignored parameters of the study by treating nearsightedness beyond the permitted range and by treating astigmatism and both eyes of some patients;
Failed to submit complete, accurate, and timely reports to FDA about the ongoing study; and
Misrepresented to FDA that Dr. LaHaye was using an FDA-approved laser to treat patients when, in fact, the procedures were performed with an unapproved, experimental laser.
The 1976 Medical Device Amendments to the Federal Food, Drug, and Cosmetic Act give FDA the authority to impose civil money penalties. The payments do not go to FDA, however, but to the U.S. Treasury.
Today the parties filed the signed settlement agreement. This agreement will not take effect until it is approved by the Administrative Law Judge.