I am writing to share with you my recent experience with Olympus Corporation. The executive summary is that based on my experience, I cannot recommend investing in the Olympus Corporation or using any of their endoscopy equipment or working for them.
On June 23, 2022, I got a message from Olympus Recruiting:
I’m impressed with your background and wanted to see if you’re open to new opportunities!
Olympus is currently hiring for a Principal Sterilization Microbiologist. This role is responsible for providing Sterilization Microbiological expertise to the Olympus Surgical Technologies America group. This role will ensure that the Operational activities in regard to biocompatibility, cleaning, disinfection, and sterilization are in compliance with internal and external requirements and regulations.
This position is located on-site in Brooklyn Park MN.
For a full list of Job Duties and Required Qualifications, please visit https://careers.olympusamerica.com/job/Brooklyn-Park-Principal-Sterilization-Microbiologist-MN-55443/897560800/
About Olympus: Olympus is a leading global med-tech company focused on medical device innovation and technology. For over 100 years, Olympus has been progressing industry solutions to help medical professionals prevent and detect disease. At Olympus, our work exemplifies our core values of integrity, empathy, agility, a long-term view, and a sense of unity.
If you’re interested in learning more about this role and in scheduling an initial conversation, please reply to this message with your phone number and email address, and I can forward your resume.
I followed the link to look up the job qualifications. I also did some research on the Olympus Corporation. I found a Class 2 Device Recall on 14,447 duodenoscopes (EVIS EXERA II DUODENOVIDEOSCOPE OLYMPUS TJF-Q180V; posted December 10, 2021). Here is the link to the FDA page for more information: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=190170. As of 1/17/22, Olympus is replacing the duodenoscopes at no cost with redesigned scopes with a disposable cover.
Duodenoscopes are used in endoscopic retrograde cholangiopancreatography (ERCP) procedures to diagnose and treat diseases in the pancreas and bile ducts. Design flaws made them difficult to clean. This led to several outbreaks of antibiotic-resistant “superbug” infections and scope redesigns.
Now it is clear why a new microbiologist is needed. Under the old guard, Olympus experienced a massive product failure that required them to redesign their duodenoscopes and give them away for free to try and save their market share and probably avoid lawsuits.
Looking at their marketing tactics and the timing of the redesign (product launch June 2020) and recall (December 2021), it is clear that Olympus and the FDA already knew they had a problem that was seriously harming people long before they stopped selling the product. So, they knowingly hurt people, which is the worst form of evil.
Still, Olympus Corporation deserved a chance to repent. That means feeling so bad about what you have done that you will never do it again. That is the road to salvation.
Therefore, hoping that they were looking for someone who has repeatedly troubleshooted and uncovered chronic problems with equipment that were overlooked by incumbent personnel in multiple organizations across very diverse technologies, I sent my cover letter and CV. Here is my cover letter, and my CV is posted at the end of this blog post:
Thank you so much for your email! I am very interested in the role of Principal Sterilization Microbiologist. I read the full list of Job Duties and Required Qualifications, and I believe that I have relevant skills and experience that make me an excellent candidate for this role.
I have a Ph.D. degree in Microbiology and Immunology along with significant and successful work experience. As Director of Development for a start-up company, I worked with a trauma surgeon and I coordinated and attended a Pre-Investigational New Drug (Pre-IND) meeting with the FDA for a parenteral drug formulation for severe blood loss. While working at Eli Lilly and Company, I was instrumental in developing a rapid-acting insulin product for injection that is still on the market. I prepared the clinical trial materials and created supporting documentation for FDA approval, including SOPs. While working more than full-time at a law firm, I passed the patent bar on the first attempt, showing that I am a fast learner of complicated federal laws, regulations, and guidelines.
I enjoy interacting with different areas within and outside of organizations. Working on the Minnesota Partnership for Biotechnology and Medical Genomics, I coordinated a multi-disciplinary team including pathologists, bioinformaticians, molecular biologists and protein biochemists to achieve project goals within tight deadlines. The project was very successful, resulting in numerous publications and patents. As a Laboratory Head and Project Leader at F. Hoffmann-La Roche in Basel, Switzerland, I led a drug discovery and development program, including collaborations across departments and sites and interactions with external consultants. Again, my work was instrumental in achieving multiple patents.
I have excellent computer and communication skills, especially writing in general and technical writing in particular. Perhaps most importantly, I have superior problem-solving skills. For example, both at F. Hoffmann-La Roche and the Mayo Clinic, I was able to troubleshoot the microarray facilities and uncover and solve serious problems that had been plaguing the organizations for years.
Finally, I just wanted to mention how much I believe in endoscopy and Olympus’ other technologies. I was misdiagnosed due to lack of endoscopy, and I suffered for many years and do not have children because of it.
Attached please find my CV. Please let me know if I can provide any additional information.
Marie Kube, Ph.D.
I never heard anything back from the recruiter. When I followed up with her, this is what she said:
“Hi! Apologies for overlooking this on your resume, but we are looking for candidates with 10 years related medical device experience. Ty!”
Such alarming incompetence has motivated me to write this blog post to warn people that you could go in for a routine diagnostic procedure and get infected with a “superbug” that is resistant to antibiotics. Even when the corporation discovered its mistake, it let more people be harmed while it tried to save itself. And now, months later, Olympus is still looking for a Principal Sterilization Microbiologist!
I have peer-reviewed publications in quality journals proving my competence as a scientific researcher. I have patents proving my competence as an inventor. I have numerous articles published in technical magazines proving my competence as a communicator. I even have a product on the market, still! Yet I cannot get a job as a scientist because I am honest and science isn’t.
Imagine going in for a diagnostic procedure or treatment and getting infected with a pathogen that cannot be killed and eats away at you from the inside out. And then imagine that the responsible corporation and regulatory body knew of the problem, but let you be harmed anyway until the failed product was redesigned and launched.
No wonder most of our water is now contaminated with PFAS and most of our food is tainted with pesticides and other cancer-causing chemicals. No wonder the USA spends the most on healthcare and has the worst health.
Here is my CV:
Dr. Marie D. Kube, Ph.D.
Ph.D., Microbiology and Immunology, Indiana University School of Medicine, Indianapolis, IN, 1997, GPA 3.98/4.00
B.A., Chemistry (with minor in Mathematics), with distinction, University of Colorado at Denver, CO, 1990, GPA 3.87/4.00
Zumba® Instructor 2019-Present
- Zumba® dance fitness instructor, Twin Cities Recreation Centers and dance studios
- Current Certificate of Completion, American Heart Association Heartsaver® First Aid CPR AED Program
Minneapolis Community & Technical College (MCTC), Minneapolis, MN
- Assisted Dr. Michael G. Klug in developing and updating the curriculum and assessments, in grading, and in the preparations for his Molecular Biology BIOL 2500 course and laboratory that he taught Spring 2010, 2011, 2012, 2013, 2014, 2015, 2016
University of Minnesota, Minneapolis, MN
- Consultant for development and commercialization of new technology
Director of Development 2007-2010
VitalMedix, Inc., Hudson, WI
- Developed a parenteral drug formulation for severe blood loss
- Planned and managed outsourcing of active pharmaceutical ingredient manufacturing, analytical assays, and pre-clinical safety & efficacy studies
- Coordinated with team members, external contractors and consultants for Pre-Investigational New Drug (Pre-IND) meeting with the FDA, including writing a well-received submission document with pre-clinical and clinical study plans
- Prepared and delivered technical presentations for current and potential investors and other stakeholders
- Wrote grant applications
Patent Agent (Reg. No. 59,744) 2005-2007
Fish & Richardson P.C., Minneapolis, MN
- Prepared and prosecuted numerous patent applications in the field of biotechnology
- Participated in patentability, due diligence, and freedom to operate analyses
Research Associate 2003-2005
Mayo Clinic, Rochester, MN
- Performed research for the prostate cancer biomarker discovery project of the Minnesota Partnership for Biotechnology and Medical Genomics
- Developed, optimized, and validated molecular biological methods
- Coordinated a multi-disciplinary team (including pathologists, bioinformaticians, molecular biologists, and protein biochemists) to achieve project goals within tight deadlines
- Generated, analyzed, presented, and published results
Contributing Editor 2002-2003
Reed Business Information, Morris Plains, NJ
- Published 16 articles about cutting edge technologies in Drug Discovery & Development and Genomics & Proteomics trade journals
- Interviewed high-level executives in small, medium, and large biotechnology and pharmaceutical companies
Laboratory Head and Project Leader 1999-2002
F. Hoffmann-La Roche, Basel, Switzerland
- Project leader of a drug discovery and development program, involving collaborations across departments and sites (Palo Alto, CA and Basel, Switzerland)
- Designed pre-clinical testing strategies
- Trained and supervised technicians
- Developed and validated in vitro assays
- Screened and characterized compounds
- Presented results to peers, management, and external scientific experts, advisors, and consultants
- Conducted research in obesity and type 2 diabetes as a postdoctoral researcher prior to being promoted
- Applied genomics (real-time, quantitative PCR and microarray technology) to study hypothalamic control of food intake in rodent models of food deprivation and overeating
- Inventor on U.S. Patent No. 6,900,227; U.S. Patent Application Publication No. 20050143373; and International Patent Application Publication No. WO2004013120
Indiana University School of Medicine, Indianapolis, IN
- Facilitator for the Problem Based Learning Section of Medical Microbiology J601 for medical students (8/1996 to 12/1996)
- Instructor for Nursing Microbiology Lab J210 (1/1996 to 5/1996 and 8/1994 to 12/1994)
Associate Pharmaceutical Chemist 1990-1993
Lilly Research Laboratories, Eli Lilly and Co., Indianapolis, IN
- Developed the formulation for Humalog®
- Supported manufacture of clinical trial batches
- Provided supporting documentation for FDA approval
- Collaborated with statisticians to apply multivariate statistical methods to design experiments and analyze data
- Performed research on protein aggregation and protein crystal agglomeration in relation to physical stability of protein products
Honors and Awards
- Esther L. Kinsley Ph.D. Dissertation Award, Indiana University. This is the highest honor for research that Indiana University bestows upon its graduate students. Indiana University awarded 336 Ph.D.’s in 1997 across all disciplines, and only one degree recipient was given the Kinsley Award.
- Travel Fellowship, Committee on Institutional Cooperation’s Women in Science and Engineering Initiative, 1997
- Sigma Xi Graduate Student Research Competition, Indiana University School of Medicine, Honorable Mention, 1996
- Travel Fellowship, Indiana University Purdue University at Indianapolis Fellowship -Committee, 1995
- University Graduate Fellowship, Indiana University, 1994
- National Science Foundation Graduate Fellowship, Honorable Mention, 1994
- Outstanding Chemistry Student, The American Institute of Chemists Foundation, 1991
- Outstanding Undergraduate Student in the College of Liberal Arts and Sciences, University of Colorado at Denver, Finalist, 1991
- H.A. Arnold Scholarship, 1989-1990
- Colorado Dean’s List Scholarship, 1986-1987
- Regent’s Scholarship, 1985-1986
Publications (in chronological order)
a. Peer-reviewed journal articles
Kube, D.M., and A. Srivastava. (1997) Quantitative DNA Slot Blot Analysis: Inhibition of DNA Binding to Membranes by Magnesium Ions. Nucleic Acids Res., 25:3375.
Kube, D.M., S. Ponnazhagan, and A. Srivastava. (1997) Encapsidation of Adeno-Associated Virus Type 2 Rep Proteins in Wild-Type and Recombinant Progeny Virions: Rep-Mediated Growth Inhibition of Primary Human Cells. J. Virol., 71:7361.
Qing, K., X.-S. Wang, D.M. Kube, S. Ponnazhagan, A. Bajpai, and A. Srivastava. (1997) Role of Tyrosine Phosphorylation of a Cellular Protein in Adeno-Associated Virus Type 2-Mediated Transgene Expression. Proc. Natl. Acad. Sci. USA, 94:10879.
Ponnazhagan, S., P. Mukherjee, X.-S. Wang, K. Qing, D.M. Kube, C. Mah, C. Kurpad, M.C. Yoder, E.F. Srour, and A. Srivastava. (1997) Adeno-Associated Virus Type 2-Mediated Transduction in Primary Human Bone Marrow-Derived CD34+ Hematopoietic Progenitor Cells: Donor Variation and Correlation of Transgene Expression with Cellular Differentiation. J. Virol., 71:8262.
Qing, K., B. Khuntirat, C. Mah, D.M. Kube, X.-S. Wang, S. Ponnazhagan, S. Zhou, V.J. Dwarki, M.C. Yoder, and A. Srivastava. (1998) Adeno-Associated Virus Type 2-Mediated Gene Transfer: Correlation of Tyrosine Phosphorylation of the Cellular Single-Stranded D Sequence-Binding Protein with Transgene Expression in Human Cells In Vitro and Murine Tissues In Vivo. J. Virol., 72:1593.
Wang, X.-S., B. Khuntirat, K. Qing, S. Ponnazhagan, D.M. Kube, S. Zhou, V.J. Dwarki, and A. Srivastava. (1998) Characterization of Wild-Type Adeno-Associated Virus Type 2-Like Particles Generated During Recombinant Viral Vector Production and Strategies for Their Elimination. J. Virol., 72:5472.
Mah, C., K. Qing, B. Khuntirat, S. Ponnazhagan, X.-S. Wang, D.M. Kube, M.C. Yoder, and A. Srivastava. (1998) Adeno-Associated Virus Type 2-Mediated Gene Transfer: Role of Epidermal Growth Factor Receptor Protein Tyrosine Kinase in Transgene Expression. J. Virol., 72:9835.
Rogers-Evans, M., A.I. Alanine, K.H. Bleicher, D. Kube, and G. Schneider. (2004) Identification of novel cannabinoid receptor ligands via evolutionary de novo design and rapid parallel synthesis. QSAR & Combinatorial Science, 23(6):426.
Kosari, F., A.S. Parker, D.M. Kube, C.M. Lohse, B.C. Leibovich, M.L. Blute, J.C. Cheville, and G. Vasmatzis. (2005) Clear Cell Renal Cell Carcinoma: Gene Expression Analyses Identify a Potential Signature for Tumor Aggressiveness. Clin. Cancer Res., 11:5128.
Kube, D.M., C.D. Savci-Heijink, A.-F. Lamblin, F. Kosari, G. Vasmatzis, J.C. Cheville, D.P. Connelly, and G.G. Klee. (2007) Optimization of Laser Capture Microdissection and RNA Amplification for Gene Expression Profiling of Prostate Cancer. BMC Molecular Biology, 8:25.
Vasmatzis, G., E. Klee, D.M. Kube, T. Therneau, and F. Kosari. (2007) Quantitating Tissue Specificity of Human Genes to Facilitate Biomarker Discovery. Bioinformatics, 23:1348.
Kosari, F., J.M.A. Munz, C.D. Savci-Heijink, C. Spiro, E.W. Klee, D.M. Kube, L. Tillmans, J. Slezak, R.J. Karnes, J.C. Cheville, and G. Vasmatzis. (2008) Identification of Prognostic Biomarkers for Prostate Cancer. Clin. Cancer Res., 14:1734.
Alig, L., J. Alsenz, M. Andjelkovic, S. Bendels, A. Bénardeau, K. Bleicher, A. Bourson, P. David-Pierson, W. Guba, S. Hildbrand, D. Kube, T. Lübbers, A. Mayweg, R. Narquizian, W. Neidhart, M. Nettekoven, J-.M. Plancher, C. Rocha, M. Rogers-Evans, S. Röver, G. Schneider, S. Taylor, and P. Waldmeier. (2008) Benzodioxoles: Novel Cannabinoid-1 Receptor Inverse Agonists for the Treatment of Obesity. J. Med. Chem., 51(7):2115.
b. Technical reports
Kube, D.M. Chemical Genomics Energizes Discovery. Drug Discovery & Development, March 2002, Vol.5, No.3, p45.
Kube, D.M. Mining for Molecular Interactions. Genomics & Proteomics, April 2002.
Kube, D.M. Automatic DNA Purification and Sequencing Evolve. Drug Discovery & Development, July/August 2002, Vol.5, No.7, p38.
Kube, D.M. Genomics and Proteomics Continue to Pave the Way to the Clinic. Genomics & Proteomics, July/August 2002.
Kube, D.M. Multitalented Proteins Play a Key Role in Therapeutics. Genomics & Proteomics, September 2002.
Kube, D.M. A Model Approach to Streamline Drug Discovery. Drug Discovery & Development, October 2002, Vol.5, No.9, p59.
Kube, D.M. OLA, MDI, PEG: the latest words in drug delivery. Drug Discovery & Development, November 2002, Vol.5, No.10, p81.
Kube, D.M. Good Manufacturing Practice is Getting Better. Drug Discovery & Development, December 2002, Vol.5, No.11, p63.
Kube, D.M. Picking Potential Drugs with In Vitro ADMET Models. Drug Discovery & Development, January 2003, Vol.6, No.1, p50.
Kube, D.M. Metabonomics Treats Attrition in Early Drug Discovery. Drug Discovery & Development, March 2003, Vol.6, No.3, p45.
Kube, D.M. Profiles of Blockbuster Drugs and Effective Drug Targets. Drug Discovery & Development, March 2003, Vol.6, No.3, p73.
Kube, D.M. A Multidisciplinary Approach to Target Validation. Drug Discovery & Development, April 2003, Vol.6, No.4, p37.
Kube, D.M. Innovative Assay Platforms Drive Proteomics Research. Drug Discovery & Development, April 2003, Vol.6, No.4, p45.
Kube, D.M. Mass Spectrometry: Drug Discovery’s Essential Tool. Drug Discovery & Development, May 2003, Vol.6, No.5, p71.
Kube, D.M. Power of Automated Protein Fractionation. Genomics & Proteomics, May 2003, Vol.3, No.4, p36.
Kube, D.M. Rational Drug Design Enables Informed Decision-Making. Drug Discovery & Development, June 2003.
c. Presentations and published abstracts
Kim, Y., and D.M. Kube. (1991) Doppler Electrophoretic Light Scattering Analyzer for Determination of the Zeta Potential of Human Insulin Particles in Suspension. Lilly Research Labs Symposium, Indianapolis, IN.
Kube, D.M., S. Ponnazhagan, and A. Srivastava. (1995) AAV-Mediated Cytopathic Effect on Primary Human Bone Marrow Stromal Cells. VIth Parvovirus Workshop, Montpellier, France.
Srivastava, A., X.-S. Wang, S. Ponnazhagan, S.Z. Zhou, D.M. Kube, and M. Yoder. (1995) Parvovirus-Based Vectors for Human Gene Therapy. VIth Parvovirus Workshop, Montpellier, France.
Kube, D.M., S. Ponnazhagan, and A. Srivastava. (1995) Encapsidation of the Adeno-Associated Virus Type 2 Rep Proteins in Progeny Virions: Rep-Mediated Growth Inhibition of Primary Human Bone Marrow Stromal Cells. Blood, 86(10):3990.
Kube, D.M., S. Ponnazhagan, and A. Srivastava. (1997) Encapsidation of AAV Rep Proteins in Progeny Virions: Wild-Type and Recombinant AAV-Mediated Growth Inhibition of Primary Human Cells. International Parvovirus Workshop, Heidelberg, Germany.
Qing, K.Y., B. Khuntirat, C. Mah, D.M. Kube, X.-S. Wang, S. Ponnazhagan, S.Z. Zhou, V. Dwarki, M.C. Yoder, and A. Srivastava. (1997) Adeno-Associated Virus-Mediated Gene Transfer: Correlation of Tyrosine Phosphorylation with Transgene Expression in Human Cells In Vitro and Murine Tissues In Vivo. Blood, 90(10):525.
Qing, K., X.-S. Wang, D.M. Kube, S. Ponnazhagan, A. Bajpai, and A. Srivastava. (1997) Role of Tyrosine Phosphorylation of a Cellular Protein in Adeno-Associated Virus Type 2-Mediated Transgene Expression. International Parvovirus Workshop, Heidelberg, Germany. (Blood, 90(10):526).
Ponnazhagan, S., P. Mukherjee, X.-S. Wang, K. Qing, D.M. Kube, C. Mah, C. Kurpad, M.C. Yoder, E.F. Srour, and A. Srivastava. (1997) AAV-Mediated Transduction of Primary Human Bone Marrow-Derived CD34+ Cells: Donor Variation and Correlation of Transgene Expression with Cellular Differentiation. International Parvovirus Workshop, Heidelberg, Germany.
Srivastava, A., S. Ponnazhagan, X.-S. Wang, K. Qing, P. Mukherjee, B. Khuntirat, D.M. Kube, C. Mah, and M.C. Yoder. (1997) AAV and Parvovirus B19 Vectors for Human Gene Therapy. International Parvovirus Workshop, Heidelberg, Germany.
Mah, C., K.Y. Qing, B. Khuntirat, S. Ponnazhagan, X.-S. Wang, D.M. Kube, M.C. Yoder, and A. Srivastava. (1998) Adeno-associated Virus 2-Mediated Gene Transfer: Role of Epidermal Growth Factor Receptor Protein Tyrosine Kinase in Transgene Expression. Blood, 92(10):150A.
Weigel, K.A., D.M. Kube, and A. Srivastava. (1998) Human Endothelial Cell-Specific Transgene Expression Mediated by a Recombinant Adeno-Associated Virus 2-Parvovirus B19 Hybrid Vector. Blood, 92(10):382B.
Kube, D.M., C.D. Savci-Heijink, A.-F. Lamblin, G. Vasmatzis, J.C. Cheville, D.P. Connelly, and G.G. Klee. (2005) Optimization of Laser Capture Microdissection and RNA Amplification for Gene Expression Profiling of Prostate Cancer. American Association for Cancer Research, Anaheim, CA.
Benzodioxole Derivatives, U.S. Patent No. 6,900,227, U.S. Patent No. 7,576,088, Hoffman-La Roche.
Novel Benzodioxoles, International Patent Application Publication No. WO2004013120 (granted in Australia, European Patent Office, India, Republic of Korea and New Zealand), European Patent Specification No. EP 1 532 132, F. Hoffman-La Roche.