Supplement to LinkedIn

Louis Sheehan, J.D., CPhT

9650 Milliken Avenue, Apt 4107

Rancho Cucamonga, California 91730

717.503.8335

Lsheeh14@students.kgi.edu

LINKEDIN: http://www.linkedin.com/in/louis0j0sheehan

SUMMARY STATEMENT

Results-oriented, organized, thorough, and resourceful professional majoring in Regulatory and Clinical Affairs.

EDUCATION 

Keck Graduate Institute                  

Claremont, CA       2014 – 2015

  • Wrote Phase-II Clinical Trial SOPs, Protocols, and Budget for theoretical contraceptive.
  • Lead team for submission of mock IND application to FDA for Alicaforsen (drug for ulcerative colitis).
  • Analyzed in vitro glucose monitoring system in accordance with ISO 15197 Protocols.
  • Reviewed Medtronic’s recently approved 510 (k) for CRT-D Defibrillator to assess for new indications.

Pharmacy Technician Certification 10054681;  CA 143371.

Harrisburg University of Science and Technology  

Harrisburg, PA           2009 – 2011 

B.S. in Biotechnology & Biosciences

Internship at Dauphin County Coroner’s Office

Magna Cum Laude GPA 3.86

 

University of Maryland School of Law, J.D.

Baltimore, MD               1982 – 1985

Taxation

Johns Hopkins University, B.A

Baltimore, MD               1978 – 1982

       Social and Behavioral Sciences

SELECTED COURSEWORK

Introduction to Food and Drug Laws and Regulations

Regulation of Drugs and Biologics

Clinical Trial Design, Conduct and Strategy

Medical Devices

In Vitro Diagnostics

Molecular Basis of Disease

Pharmaceutical Development

Bioscience Business

Fall 2010           Senior Project: Particle Radiation Detection

  • Hypothesis: Different atomic particles travel in distinct patterns through space and react in particular ways to magnetic fields.
  • Approach: The construction of a magnetized and ionizable sealed and saturated environment (a cloud chamber) in which the condensed nuclei identify the paths of the varying particles.
  • Results: The paths of Alpha and Beta particles were identified and the interaction of Alpha particles with a magnetic field were quantified.

Spring 2010      Junior Project: Gene Therapy

A recent successful use of Gene Therapy was the treatment of X-linked adrenoleukodystrophy.

  • Paper investigating the preparation and utilization of various delivery systems for Antisense Oligonucleotides in Gene Therapy.
  • Antisense Oligonucleotides are synthetic genetic materials which bind to coding areas of mRNA (the sense strand) thereby neutralizing the targeted translation and thus inhibiting the production of the targeted protein.
  • Numerous viral and non-viral delivery systems were investigated including lipid-based, polymer-based and nanotechnology-based vectors.

RECENT EMPLOYMENT

2000 – 2014 Self-Employed Attorney

  • Negotiated divorce/QDRO issues relating to pension allocations.
  • Investigated facts, monitored trials and negotiated settlements relating to medical malpractice.

1991 – 2000 Assistant Counsel, Public School Employees’ Retirement System (PSERS)

  • Represented PSERS in administrative hearings and court appearances. My first case was (successfully)concluded by Pennsylvania’s Supreme Court.
  • Advised PSERS’ staff on issues and submitted numerous filings involving Trusts, Guardianships, Wills, Severance Arrangements, POAs, taxes, accounting and debt collections, investment contracts, the IRS and the Pennsylvania Department of Revenue.

AWARDS & VOLUNTEER WORK

Johns Hopkins Scholar.

National Merit Scholar.

WITF Public Broadcasting – Led Call Center for Smart Talk Television Program.

**********          PAGE 2

CLINICAL TRIAL GONE WRONG

by Louis Sheehan

As a result of a Food and Drug Administration (“FDA”) inspection, in 2005, Paul H. Kornak (variously as “site coordinator” or “Kornak”) signed a Plea and Cooperation Agreement [1],[2] and in 2008 Dr. James A Holland (variously as “clinical investigator” or “Dr. Holland”) was the subject of a Sentencing Memorandum [3],[4] both due to their involvements, in part, in a clinical trial resulting in the death of Mr. James J. DiGeorgio. Among other fraudulent activities, the site coordinator had misreported test results which had the effect of concealing Mr. DiGeorgio’s insufficient liver and kidney functions, whereby and subsequent to the first trial dose Mr. DiGeorgio expired. In the teeth of numerous indications [5] that the site coordinator was engaging in criminal behavior and acknowledging his responsibility to maintain accurate records, the clinical investigator rationalized the site coordinator’s behavior as being that of a well experienced employee and excusable for varying reasons. Curiously, despite the fact that this matter is thoroughly revealed in both FDA and court documents, none of the peer-reviewed publications of the chemotherapy study make mention of any aspects of the criminal activities. [6]

A component of the FDA’s mandate to evaluate and approve or deny medications for marketing is the performance of audits of clinical trials vis-à-vis statutory, regulatory, and other guidance.[7] At its core, comportment with the FDA’s guidance establishes the effectuation of good clinical practices and the protection of subjects’ human rights. Ipso facto, compliance tends to suggest the acquisition of appropriate clinical data and non-compliance suggest otherwise. Normally a complaint investigation takes about a week, but in this case the FDA remained on-site for 50 days. The FDA reviewed the files of at least 50 subjects and flagged every one. [8]

Among many other (often criminal) violations, Kornak lied [9] about having any prior conviction(s). Additionally in this matter, Kornak falsified records relating to:

  1. electrocardiograms (as well as to whether or not the subjects actually had electrocardiograms),
  2. laboratory analyses,
  3. an ejection fraction,
  4. blood draws on reported dates,
  5. a final surgical pathology report,
  6. an operative note,
  7. a letter,
  8. a radiology report,
  9. an urology progress note, and
  10. an urethrocystogram. [10],[11]

Regarding Dr. Holland, he dismissed a monitor’ expressed concerns about Kornak’s documentation and behavior with the explanation that Kornak was appropriately experienced. Three months later Kornak admitted to Dr. Holland that he had placed information into a subject’s record in this clinical trial that actually related to another subject on another day at another hospital. At this point, Dr. Holland excused Kornak’s behavior on the basis of Kornak’s inexperience! Further and frieghteningly, Dr. Holland admitted he did not look at Mr. DiGeorgio’s blood chemistry test results which showed Mr. DiGeorgio did not fit within the study’s parameters and Mr. DiGeorgio had insufficient liver and kidney functions.

Kornak was disbarred for life vis-à-vis the FDA, sentenced to 71 months imprisonment and to pay restitution to the study sponsors in the amount of $639,000 as well as an additional amount to the victims. Dr. Holland was disbarred for five years.[12] Subsequently, Dr. Holland was employed by Archbold Memorial Hospital in Thomasville, Ga. Archbold Memorial Hospital represented that Georgia’s medical board had found no evidence of misconduct on the part of Dr. Holland. [13]

Interestingly, none of the peer-reviewed articles of and/or referring to this specific clinical trial performed under the auspices of Kornak and Dr. Holland include any allusions – let alone specific references — to the criminal activities.[14] However, the FDA has undertaken no effort to organize and communicate criminal findings [15] thus creating an environment wherein relevant and significant information is difficult or even impossible to find.

[1] United States of America v. Paul H. Kornak, Criminal Action No. 03-CR-436 (FJS). January 18, 2005. http://www.circare.org/lex/03cr436.pdf Accessed March 7, 2015.

[2] See also: NOOH issued to Paul H. Kornak, May 4, 2009

http://www.fda.gov/RegulatoryInformation/FOI/ElectronicReadingRoom/ucm181014.htm Accessed Match 7, 2015.

[3] United States of America v. James A. Holland, Criminal Action No. 07-CR-202 (FJS). http://www.circare.org/lex/07cr202_20080317.pdf Accessed March 7, 2015.

[4] Se also: NIDPOE issued to James A. Holland, September 22, 2004

http://www.fda.gov/RegulatoryInformation/FOI/ElectronicReadingRoom/ucm105756.htm Accessed March 7, 2015.

[5] Records were falsified relating to 69 people in this matter alone.

[6] Charles, S. (2015). Research Misconduct Identified by the US Food and Drug Administration Out of Sight, Out of Mind, Out of the Peer-Reviewed Literature.. JAMA Intern Med. http://archinte.jamanetwork.com/article.aspx?articleid=2109855 Accessed March 7, 2015.

[7] US Food and Drug Administration, Office of Good Clinical Practice. Information sheet guidance for IRBs, clinical investigators, and sponsors: FDA inspections of clinical investigators. June 2010. http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM126553.pdf.%20Accessed%20July%2016 Accessed March.7, 2015.

[8] Sontag, D. (2005). Abuses Endangered Veterans in Cancer Drug Experiments. The New York Times, February, 6, 2005. http://www.nytimes.com/2005/02/06/nyregion/06vets.html?pagewanted=print&position&_r=0 Accessed March 7, 2015.

[9] Kornak had attended a medical school for a limited time period. Previously, Kornak forged his credentials in several states and obtained (and eventually lost) medical licenses. While not part of this particular conviction, Kornak also made representations to subjects that he was a medical doctor. Sontag, D. (2005). Abuses Endangered Veterans in Cancer Drug Experiments. The New York Times, February, 6, 2005. http://www.nytimes.com/2005/02/06/nyregion/06vets.html?pagewanted=print&position&_r=0 Accessed March 7, 2015.

[10] The FDA believes Kornak was involved in five fraudulent studies. Sontag, D. (2005). Abuses Endangered Veterans in Cancer Drug Experiments. The New York Times, February, 6, 2005. http://www.nytimes.com/2005/02/06/nyregion/06vets.html?pagewanted=print&position&_r=0   Accessed March 7, 2015.

[11] Again, while not a component of this conviction, in 2001 Kornak told a Mr. Steubing that Mr. Steubing was well-suited for a clinical trial relating to Mr. Steubing’s gastroesophogel cancer. Subsequently, a three-drug combination was given to Mr. Steubing approximately six times. Each infusion made Mr. Steubing so ill he had to be hospitalized after each administration. Mr. Steubing died in March 2002. Sontag, D. (2005). Abuses Endangered Veterans in Cancer Drug Experiments. The New York Times, February, 6, 2005. http://www.nytimes.com/2005/02/06/nyregion/06vets.html?pagewanted=print&position&_r=0 Accessed March 7, 2015.

[12] Federal Register Volume 75, Issue 42 (March 4, 2010) http://www.gpo.gov/fdsys/granule/FR-2010-03-04/2010-4449 Accessed March 7, 2015.

[13] Sontag, D. (2005). Abuses Endangered Veterans in Cancer Drug Experiments. The New York Times, February 6, 2005. http://www.nytimes.com/2005/02/06/nyregion/06vets.html?pagewanted=print&position&_r=0 Accessed March 7, 2015.

[14] See:

(a) Ajani,J.A.  Docetaxel in combination for advanced gastric cancer. Gastric Cancer. 2002;5(suppl 1):31-34.

(b) Ajani,J.A, Fodor,M.B, Tjulandin,S.A,  et al.  Phase II multi-institutional randomized trial of docetaxel plus cisplatin with or without fluorouracil in patients with untreated, advanced gastric, or gastroesophageal adenocarcinoma. J Clin Oncol. 2005;23(24):5660-5667.

(c) Messing,E., Kim, K.M., Sharkey, F.,  et al.  Randomized prospective phase III trial of difluoromethylornithine vs placebo in preventing recurrence of completely resected low risk superficial bladder cancer. J Urol. 2006;176(2):500-504.

(d) Tannock,I.F, de Wit,R., Berry,W.R.,  et al; TAX 327 Investigators.  Docetaxel plus prednisone or mitoxantrone plus prednisone for advanced prostate cancer. N Engl J Med. 2004;351(15):1502-1512.

(e) Van Cutsem, E., Moiseyenko, V.M., Tjulandin, S.,  et al; V325 Study Group.  Phase III study of docetaxel and cisplatin plus fluorouracil compared with cisplatin and fluorouracil as first-line therapy for advanced gastric cancer: a report of the V325 Study Group. J Clin Oncol. 2006;24(31):4991-4997.

[15] Charles, S. (2015). Research Misconduct Identified by the US Food and Drug Administration Out of Sight, Out of Mind, Out of the Peer-Reviewed Literature.. JAMA Intern Med. http://archinte.jamanetwork.com/article.aspx?articleid=2109855 Accessed March 7, 2015.

Clinical Trial Gone Wrong3.7.15.1.docx

**********          PAGE 3

COLON CANCER: TREATMENT

     As a general proposition and when followed, treatment can be broadly organized into the following categories:

  • treatment of malignant polyp or invasive non-metastatic disease,
  • treatment of metastatic disease,
  • post-treatment surveillance, and
  • survivorship.

Staging is performed after abdominal exploration, specimen examination, lymph node analyses – preferably 12 nodes or more – and identification of location at other body components, and is further refined by including an analysis of the radial margin which is defined to be the deepest penetration of the tumor into soft tissue. [1]

Unfortunately, it is clear not all physicians follow recommended guidelines. [2]

Treatment of Polyp/Invasive Non-metastatic Cancer

Unless a polyp is a ‘sessile’ polyp — in which case a colectomy is recommended — a polyp is generally resected during a colonoscopy or at least marked and subsequently observed. [3]   If the cancer is invasive albeit non-metastatic, in anticipation of a colectomy the treating physician should perform a complete blood count, a pathological tissue examination, relevant CT baseline scans, an antigen review, and a standard profile of the patient’s chemistry. [4]

Assuming the cancer is resectable, either a laparoscopic or traditional surgery is used to perform both a colectomy and the complete removal of regional lymph nodes.   The amount of bowel excision is location-dependent and should include the associated arterial complex. A study has shown similar results obtained by either traditional or laparoscopic surgery. However, laparoscopic procedures have appreciably shorter hospital stays. especially when performed at high procedure volume hospitals. [5] Laparoscopic techniques should not be used if there is colon perforation or obstruction or if the cancer is invasive.

The application of adjuvant chemotherapy turns on the disease staging. Stage I patients do not receive such therapy. The various stage two categories are offered the options of observation or a range of chemotherapeutic agents. Those diagnosed with Stage III cancers are given adjuvant therapy for six months after surgical resection. Studies have shown that there are measureable benefits in having chemotherapy as soon as possible after diagnosis. [6] There is a dearth of studies of treatment of the elderly, although as a practical matter use of chemotherapy declines with age. [7]

Stents are reserved for cases of distal lesions where the proximal colon can be decompressed subject to later colostomy as necessary. [8] If circumstances are such that the patient is unable to go resection, chemotherapy is recommended.

Treatment of Metastatic Cancer 

As many as 60% of patients diagnosed with colorectal cancer experience metastases with as many as 90% of such diagnoses involving liver disease with the lungs being the second most common destination. [9] Perhaps as many as 50% of those who die from colorectal cancer actually succumb to liver cancer. [10] The local cancer is, of course, resected or if comorbidity precludes resection, is ablated via various processes including radiofrequency and microwave techniques. Options exist for concurrent liver resection with supporting therapies. [11] Subsequent to such resections – including that of the liver – the patient is again given six months of adjuvant chemotherapy.

Genetic analysis can influence the types of chemotherapy used. For example, roughly 40% of colorectal cancers are associated with mutations in the coding region of the KRAS gene. [12] Such cancers show no response to therapies based on either panitumumab or cetuximab. [13]

Post treatment Surveillance

Subsequent to surgery and any chemotherapy, the physician should monitor the patient for therapeutic complications, recurrence(s) and to observe for any new neoplasms which are at an early stage. Psychological reactions should also be noted.

Less pervasive monitoring is suggested for Stage I patients as more harm might be caused by repeated CT-related radiation, stress associated with repeated clinical visits and scans, and there are increased possibilities of false positives with more frequent testing. Rather, Stage I patients should be given more frequent colonoscopies. [14]

Survivorship

In conjunction with post treatment surveillance, the patient should be guided with a survivorship plan. Such plan should include variables that have been associated with improved outcomes such as healthy dietary choices, smoking cessation, consistent exercise, immunizations, and periodic screening.

Studies have correlated higher glycemic loads and high intake of sugar-beverages with increased risk of recurrence. [15] [16] Another study has found a relationship between greater consumption of dairy products and survival. [17] And yet another study has found a connection between a lower risk of recurrence and death and the consumption of whole grains, vegetables, fruits, and poultry as distinct from the typical American diet. [18] Finally, the literature includes an analysis concluding that vitamin D supplementation is protective. [19]

[1] Lykke, J.; Roikjaer, O.; Jess, P. The relationship between lymph node status and survival in Stage I-III colon cancer: results from a prospective nationwide cohort study. Colorectal Dis 201315, 559-565.

[2] Oliveria, S.A.; Yood, M.U.; Campbell, U.B.; Yood, S.M.; Stang, P. Treatment and referral patterns for colorectal cancer. Medical Care 200442, 901-906.

[3] Markowitz, A.J.; Winawer, S.J. Management of colorectal polyps. CA Cancer J Clinical 199747, 93-9112.

[4] Balthazar, E.J.; Megibow, A.J.; Hulnick, D.; Naidich, D.P.; Carcinomia of the colon: detection and preoperative staging by ct. AJR Am J Roentgenol 1988150, 301-306.

[5] Kuhry, E.; Bonjer, H.J.; Haglind, E. Impact of hospital case volume on short-term outcome after laparoscopic operation for colonic cancer. Surg Endosc 200519, 687-692.

[6] Biagi, J.J.; Raphael, M.J.; Mackillop, W.J. Association between time to initiation of adjuvant chemotherapy and survival in colorectal cancer: a systemic review and meta-analysis. JAMA 2011305, 2335-2342.

[7] Sanoff, H.K.; Carpenter W.R.; Stumer, T. Effect of adjuvant chemotherapy on survival of patients with stage III colon cancer diagnosed after age 75 years. J Clin Oncol 201230, 2624-2634.

[8] Huang, X., Lv B, Zhang S, Meng L. Preoperative colonic stents verses emergency surgery for acute left-sided malignant colonic obstruction: a meta-analysis. J Gastrointest Surg 201418, 584-591.

[9] Yoo, P.S,; Lopez-Soler, R.I.;, Longo, W.E.; Cha, C.H. Liver resection for metastatic colon cancer in the age of neoadjuvent chemotherapy and bevacizumab. Clin Colorectal Cancer 20066, 202-207.

[10] Kemeny, N. Management of liver metastases from colorectal cancer. Oncology 200620, 1161-1176.

[11] Bala, M.M.; Riemsma, R.P.; Wolff, R.; Kleijnen, J. Microwave coagulation for liver metastases. Cochrane Database Syst Rev 201310, CD010163.

[12] Baselga, J.; Rosen, N. Determinants of rasistance to anti-epidermal growth factor receptors agents. J Clin Oncol 200826, 1582-1584.

[13] Sorich, M.J,; Wiese, M.D.; Rowland, A. Extended ras mutations and anti-egfr monoclonal antibody survival benefit in metastatic colorectal cancer: a meta-analysis of randomized, controlled trials. Ann Oncol 2014.

[14] Rex, D.K.; Kahi, C.J.; Levin, B. Guidelines for colonoscopy surveillance after cancer resection: a consensus update by the american cancer society and us multi-society task force on colorectal cancer. CA Cancer J Clin 200656, 160-167.

[15] Meyerhardt, J.A.; Sato, K.; Niedzwiecki, D. Dietary glycemic load and cancer recurrence and survival in patients with stage III colon cancer J Natl Cancer Inst 2012104,1702-1711.

[16] Fuchs, M.A.; Sato K.; Niedzwiecki. D. Sugar-sweetened beverage intake and cancer recurrence and survival in CALGB 89803 PLoS One 2014, 9, e99816.

[17] Meyerhardt, J.A.; Sato, K.; Niedzwiecki, D.; Hollis, D. Association of dietary patterns with cancer recurrence and survival in patients with stage III colon cancer. JAMA 2007, 298, 754-764.

[18] Meyerhardt, J.A.; Niedzwiecki, D.; Hollis, D. Association of dietary patterns with cancer recurrence and survival in patients with stage III colon cancer. JAMA 2007298, 754-764.

[19] Ma, Y.; Zhang, P.; Wang, F. Association between vitamin d and risk of colorectal cancer: a systemic review of prospective studies. J Clin Oncol 201129, 3775-3782.

Colo10.12.14.1.docx

**********          PAGE 4

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Louis Sheehan
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