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Burzynski Research Institute Consent Form, Protocol BT-22 2004-09-29: http://www.circare.org/info/bri/bri_consent_bt-22-20040929.pdf
FDA Consumer Information Access to Investigational Drugs Outside of a Clinical Trial (Expanded Access): http://www.fda.gov/ForConsumers/ByAudience/ForPatientAdvocates/AccesstoInvestigationalDrugs/default.htm
FDA Guidance for Industry Expanded Access to Investigational Drugs for Treatment Use — Qs & As (Draft) 2013-05-08: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM351261.pdf
Frequently Asked Questions — Statement of Investigator (Form FDA 1572) — Information Sheet 2010-06-02: http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM214282.pdf
FDA Guidance for Industry Investigator Responsibilities — Protecting the Rights, Safety, and Welfare of Study Subjects 2010-03-09: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM187772.pdf
21 CFR 50 Protection of Human Subjects Informed Consent [cut to the chase: 21 CFR 50.20 General requirements for informed consent; 21 CFR 50.25 Elements of informed consent]: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?CFRPart=50&showFR=1
21 CFR 56 Institutional Review Boards [cut to the chase: 21 CFR 56.107 IRB membership; 21 CFR 56.111 Criteria for IRB approval of research]: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?CFRPart=56&showFR=1
21 CFR 312 Investigational New Drugs: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?CFRPart=312&showFR=1
Index of FDA Information Sheet Guidance(s) for Institutional Review Boards (IRBs), Clinical Investigators, and Sponsors : http://www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/GuidancesInformationSheetsandNotices/ucm113709.htm
Serial No. 105-103 Patient Access to Alternative Treatments: Beyond the FDA House Committee on Government Reform and Oversight 1998/02/04 and 12: http://www.circare.org/info/bri/serialno_105-103.pdf
The BRI Institutional Review Board, Inc. is a 501(C)(3) nonprofit organization located at 9432 Old Katy Road, Ste. 370, Houston, TX 77055-6349
U.S. Food & Drug Administration
BRI-IRB Form FDA 483 2013-07-07: http://www.circare.org/info/bri/bri-irb_fda483_20130207.pdf
BRI-IRB Form FDA 483 2002-02-15: http://www.circare.org/info/bri/briirb_fda483_20020215.pdf
BRI-IRB FDA Establishment Inspection Report 2002-02-15: http://www.circare.org/info/bri/briirb_fdaeir_20020215.pdf
FDA to BRI-IRB 2002-05-07: http://www.circare.org/info/bri/fda_briirb_20020507.pdf
BRI-IRB Form FDA 483 2008-12-10: http://www.circare.org/info/bri/briirb_483_20081210.pdf
BRI-IRB FDA Establishment Inspection Report 2008-12-10: http://www.circare.org/info/bri/briirb_eir_20081210.pdf
BRI-IRB Company Response to FDA 2009-04-02: http://www.circare.org/info/bri/bri_to_fda_20090402.pdf
BRI-IRB Company Response to FDA 2009-10-28: http://www.circare.org/info/bri/bri_to_fda_20091028.pdf
BRI-IRB Company Response to FDA 2009-11-30:http://www.circare.org/info/bri/bri_to_fda_20091130.pdf
FDA to BRI-IRB (undated): http://www.circare.org/info/bri/fda_to_bri_undated.pdf
FDA Warning Letter to Burzynski Research Institute IRB 2009-10-05:http://www.circare.org/fdawls/burzynskiriirb_wl_20091005.pdf
Internal Revenue Service
Burzynski Research Institute IRB IRS Form 990 FY 2009: http://www.circare.org/info/bri/bri-irb_irs990_2009.pdf
Burzynski Research Institute IRB IRS Form 990 FY 2010: http://www.circare.org/info/bri/bri-irb_irs990_2010.pdf
BRI-IRB Roster 2012-06-07: http://www.circare.org/info/bri/bri-irb_roster_20120607.pdf
Carleton C. Hazelwood, Ph.D. IRB Chair. Dr. Hazelwood is a member of the board of directors of the Burzynski Research Institute, Inc.; although he doesn't own stock he has a fiduciary duty to the business. In my opinion this constitutes an apparent and actual conflict of interest and I believe he would be obligated to recuse himself from voting on protocols submitted by Dr. Burzynski, president and chairman of the board of directors of the Burzynski Research Institute, Inc. Further, in my opinion it's a terrible idea to have an IRB chair who needs to recuse himself from voting on studies that apparently constitute the large majority of the IRB's business. Whether or not the IRB SOPs allow the chair to vote, it strikes me as a needless waste of time and talent because, ideally, the chair is held in great respect by IRB members and it's to him that members look for guidance on resolving controverted issues. Dr. Hazelwood's bio states:
CARLTON HAZLEWOOD, PH.D. has been a Director of the Company since 1997. He also serves as Chairman of the IRB, an independent review board for the Company's clinical trials designated according to federal regulations. Dr. Hazlewood currently operates his own consulting company, Research Consultant's International, is president of Petroclean, L.L.C. and is an adjunct professor at Kingwood College. In addition, Dr. Hazlewood was employed in various capacities by the Baylor College of Medicine from 1965 until December 31, 1997, where he was a professor of Molecular Biology and Biophysics. Dr. Hazlewood received his Ph.D. in Medical Physiology from the University of Tennessee. Dr. Hazlewood is a prolific writer on medical topics and has been recognized for his research with numerous awards, honors and research grants. (1)
Roscoe Lycurgus Van Zandt, M.D., Alternate Member. Dr. Van Zandt is licensed to practice medicine in Texas and reports Gynecology as his primary practice area. In 1992 Dr. Van Zandt reportedly conducted a study in Mexico in which he tested shark cartilage on eight women with advanced breast cancer, according to an alternative cancer handbook. Another website clarifies that Dr. Van Zandt's study was cited by I. William Lane in his book Sharks Don't Get Cancer. Lane was subject to FDA and FTC enforcement actions for unsubstantiated claims and misbranding. Ultimately in 2004 Lane was enjoined by the U.S. District Court for New Jersey from selling shark cartilage and other products, compelled to make restitution to consumers, and ordered to destroy remaining products. (2)
Gary L. Harvey, MBA Vice Chair
Waylon V. House, Jr., Ph.D.
Danuta Batog, CDT
Daniel Hrna, R.Ph., J.D. Alternate Member (4)
Lawrence Ermis, CHT
David Hodges, D. Min.
Vicki Jones Sullivan, B.S. Ed.
Steve P. Sullivan, M.Th.
Erich Fruchtnicht, M.S.
Dale B. Haufrect, M.D., M.A. Second Vice Chair (spelling corrected fromHaufreet) On 2002-05-17 Dr. Haufrect, a neurologist, entered into an Agreed Order with the Texas Medical Board in which he voluntarily and permanently surrended his medical license, based on his inability to practice medicine with reasonable skill and safety due to illness. Between 2001 and 2007 Dr. Haufrect served as associate director at the Institute of Biological Research where he worked with Dr. Arthur Dale Ericsson to develop a new product for treatment of Chronic Inflammatory Demyelinating Polyneuropathy. This connection is disturbing because on 2008-03-31 FDA initiated disqualification proceedings against Dr. Ericsson for multiple violations of FDA regulations for drug trials, including but not limited to violation of a clinical hold. FDA noted that Dr. Ericsson received a warning letter in 1993 for the same violation. The FDA warning letter to the BRI-IRB, dated 2009-10-05 (see above) appears to focus on IRB violations with regard to approval of Dr. Ericsson's study, i.e. approval prior to submission of an IND application and enrolling subjects in defiance of a clinical hold. I believe that FDA's undated letter to BRI-IRB (above) regarding proposed corrective actions in response to the warning letter refers at item no. 3 to Dr. Ericsson's disqualification to conduct studies under IND. Dr. Haufrect is currently a director with Interpreting Physicians Network, a provider of telemedical services.(3)
Stanislaw Burzynski, M.D., Ph.D. FDA Office of Prescription Drug Promotion Untitled Letter 2012-10-18: http://www.circare.org/info/bri/burzynski_fdauntitled_2012.pdf
Promotional Material: http://www.circare.org/info/bri/burzynski_fdauntitled_promo_2012.pdf
Stanislaw Burzynski, M.D. (Clinical Investigator Inspection) Form FDA 483 2001-08-10: http://www.circare.org/info/bri/burzynski_fda483_20010810.pdf
Stanislaw Burzynski, M.D. FDA Establishment Inspection Report 2001-08-10: http://www.circare.org/info/bri/burzynski_fda-eir_20010810.pdf
Stanislaw Burzynski, M.D. Clinical Investigator Response to FDA 2001-09-23: http://www.circare.org/info/bri/burzynski_fda_20010923.pdf
FDA to Stanislaw Burzynski, M.D. 2002-04-29: http://www.circare.org/info/bri/fda_burzynski_20020429.pdf
The Burzynski Research Institute, Inc. is a publicly traded corporation located at 9432 Katy Freeway Houston, TX 77055
Securities & Exchange Commission
Burzynski Research Institute SEC index of filings: http://preview.tinyurl.com/9hyjget
Burzynski Research Institute, Inc. Annual Report Form 10-K 2013-05-29: http://www.sec.gov/Archives/edgar/data/724445/000110465913045361/a13-13348_110k.htm
Partial Clinical Hold on Phase II and Phase III Clinical Trials
In a letter dated June 25, 2012, the Company informed the FDA of a serious adverse event which may have been related to the administration of Antineoplastons. On July 30, 2012, the FDA placed a partial clinical hold for enrollment of new pediatric patients under single patient protocols or in any of the active Phase II or Phase III studies under IND 43,742. The FDA imposed this partial clinical hold because, according to the FDA, insufficient information had been submitted by the Company to allow the FDA to determine whether the potential patient benefit justifies the potential risks of treatment use, and that the potential risks are not unreasonable in the context of the disease or condition to be treated. The FDA cited 21 C.F.R. § 312.42(b)(2)(i), 21 C.F.R. § 312.42(b)(1(iv), and 21 C.F.R. § 312.42(b)(3)(i), as grounds for imposition of a clinical hold; and 21 C.F.R. § 312.305(a)(2), a criteria for expanded access use. The FDA advised the Company that until it resolved the matter to FDA's satisfaction, the Company could not enroll new pediatric patients in any protocol under such IND. The Company later notified the FDA in a September 24, 2012 letter that it was closing pediatric protocol BT-10 (under IND 43,742) for enrollment effective September 25, 2012, and that it would also terminate the protocol once all active patients had completed the study.
In a teleconference on January 9, 2013 between the FDA and the Company, followed by a letter of the same date, the FDA notified the Company that the agency was placing IND 43,742 on partial clinical hold, due to a lack of a complete response to the issues raised by the FDA and what the FDA deemed a misleading, erroneous, and incomplete investigator brochure. The FDA cited 21 C.F.R. § 312.42(b)(2)(i) and 21 C.F.R. § 312.42(b)(1)(iii), as grounds for imposition of a clinical hold. The FDA further advised the Company that until it resolved the matter to the FDA's satisfaction, that the Company could not enroll new adult or pediatric patients in any protocol under such IND. The FDA also placed protocols B-52 and B-54 on clinical hold due to what the FDA deemed to be an unreasonable and significant risk of illness or injury to human subjects. The FDA cited 21 C.F.R. § 312.42(b)(2)(i) and 21 C.F.R.§ 312.42(B)(1)(i), as grounds for imposition of a clinical hold. The FDA advised the Company that until it resolved the matter to FDA's satisfaction, the Company could not legally conduct the identified clinical studies under such IND.
In a letter dated April 9, 2013, the Company responded to the issues raised by the FDA in its January 9, 2013 letter to the Company. In a letter dated May 9, 2013 from the FDA, the FDA advised the Company that the Company's April 9, 2013 letter was not a complete response to all the issues listed in the FDA's letter dated January 9, 2013, and the FDA also identified the issues that were not fully addressed by the Company's response. The FDA further advised the Company that until it satisfactorily addressed all the issues in the FDA's letter dated January 9, 2013, that the FDA could not complete its review, and the clinical hold could not be removed.
SRB Pharmacy, 12707 Trinity Dr. #177 Stafford, TX 77477, owned by Stanislaw R. Burzynski, M.D. Texas Board of Pharmacy, accessed on 2013-08-30: http://www.tsbp.state.tx.us/dbsearch/phy_zoom.asp?id=21976
Southern Infusion Therapy, 9432 Katy Fwy, Ste. 200 Houston, TX 77055, owned by Southern Family Pharmacy, Inc. and Stanislaw R. Burzynski, M.D. Texas Board of Pharmacy, accessed on 2013-08-30: http://www.tsbp.state.tx.us/dbsearch/phy_zoom.asp?id=19860
1. Annual Report Form 10-K 2013-05-29, Part III Item 10 Directors, Executive Officers and Corporate Governance http://www.sec.gov/Archives/edgar/data/724445/000110465913045361/a13-13348_110k.htm#Item10_DirectorsExecutiveOfficers_165804. Item 11 Executive Compensation, provides additional information:
Directors do not receive any compensation for serving as directors; however, directors are reimbursed for all ordinary and necessary expenses incurred in attending meetings of the Board of Directors or otherwise incurred in their capacity as directors. In addition, any director also serving as a director of the IRB, the independent review board for the Company's clinical trials designated according to federal regulations, is compensated by the IRB approximately $1,200 annually for serving as a director of the IRB.
2. Texas Medical Board Physician Profile, accessed on 2013-08-30: http://preview.tinyurl.com/kxbhglj What Doctors Don't Tell You. Wallace Press (2000) p. 110, accessed on 2013-08-30: http://preview.tinyurl.com/ltbkhzk. Curezone Alternative Cancer FAQs, no. 85 Shark Cartilage: http://curezone.com/diseases/cancer/faq.asp#Shark%20Cartilage. Barrett, S. Government Action Curbs Shark Cartilage Claims. Quackwatch. Accessed on 2013-08-30: http://www.quackwatch.org/04ConsumerEducation/News/shark.html.
3. Texas Medical Board Physician Profile, accessed on 2013-08-30: http://preview.tinyurl.com/k3ly7yj. Dale Haufrect, M.D. LinkedIn, accessed on 2013-08-30: http://www.linkedin.com/pub/dale-b-haufrect-md-ma/a/89b/223 FDA NIDPOE Letter to Arthur Ericsson, M.D. http://www.circare.org/fdawls3/ericsson_20080331.pdf; FDA NOOH Letter to Arthur Ericsson, M.D. 2009-03-04: http://www.circare.org/fdawls3/ericsson_20090304.pdf; FDA disqualification, Arthur Ericsson, M.D. Accessed on 2013-08-30: http://preview.tinyurl.com/pvug58l. Even more: FDA warning letter to Arthur Ericsson, M.D. and RxIBR Corporation 2006-01-27: http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2006/ucm075778.htm
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