Professionalism/Dr Daniel Merenstein, Medical Screening, and Professional Discretion
Dr. Daniel Merenstein is a tenured professor at the Georgetown University School of Medicine who studies antibiotics, probiotics, and HIV. He is also the director of research in family medicine and has worked on grants totaling over $100 million. He has published over 100 articles and has been cited over 7000 times since 2008. However, in 2003, near the beginning of his career, Dr. Merenstein was sued for medical malpractice for failing to order a prostate-specific antigen (PSA) test for a former patient.
Dr. Merenstein's Malpractice SuitEdit
Background on Prostate Cancer ScreeningEdit
Prostate cancer is the second leading cause of cancer death in men in the United States and seldom produces symptoms until it is incurable. Due to the nature of this disease, there is a need for accurate diagnostic tests for prostate cancer. PSA testing was developed and became widely employed as a diagnostic method starting in the 1990s, and throughout the 1990s to the 2000s, it was estimated that PSA testing reduced the prostate cancer mortality rate by greater than 53%.
However, PSA testing has drawbacks as well, as elevated PSA levels can be caused by other conditions besides prostate cancer. PSA screening is also unable to distinguish between low-risk, indolent tumors and more high-risk, aggressive ones. As a result, widespread PSA testing has led to concerns about over-diagnosis and over-treatment of prostate cancers that can lead to side effects like incontinence and impotence. In response to these concerns, the US Preventative Services Task Force (USPSTF) recommended against PSA testing in the early 2010s and PSA testing declined by 25-30% during this time period. However, in 2017, the USPSTF backtracked on its earlier recommendation, instead advising that clinicians inform men 55-69 years old about the potential benefits and harms of PSA screening and that shared decision making should be employed.,
Evidence-Based Medicine versus Standard of CareEdit
Two concepts that are at odds in Dr. Merenstein's malpractice suit are evidence-based medicine (EBM) and standard of care. EBM is a medical concept and is defined as "the conscientious, explicit and judicious use of current best evidence, combined with individual clinical expertise and patient preferences and values, in making decisions about the care of individual patients." Standard of care is a legal concept, and is defined as "that which a minimally competent physician in the same field would do under similar circumstances."
The Malpractice SuitEdit
In July 1999, Dr. Merenstein, then a resident in Family Practice, saw the plaintiff, a healthy 53 year old male, for a physical exam. Dr. Merenstein discussed the risks and benefits of prostate cancer screening with the plaintiff and together they decided to not undergo testing. A few years later, the plaintiff saw a different doctor who ordered PSA testing without discussion of risks and benefits. The plaintiff's PSA level was elevated and he was diagnosed with incurable advanced prostate cancer.
In 2003, the plaintiff sued Dr. Merenstein, alleging that he "did not practice the standard of care in the Commonwealth of Virginia." In response, Dr. Merenstein wrote that "one may have argued that we were practicing above the standard of care, but there is no legal precedent for such an argument."
Ultimately, Dr. Merenstein was exonerated but his residency was found liable for $1 million. In this specific case, the idea that physicians should practice the standard of care was upheld, even if it conflicts with "evidence-based medicine."
Ethical Issues and Professional DiscretionEdit
Discretion is defined as the power of free decision or latitude of choice within certain bounds. Professional discretion is when discretion is applied in a professional capacity.
Principles of Medical EthicsEdit
Decision making in medicine can be guided by the four principles, described below, that were first outlined by Beauchamp and Childress in 1979. These principles are one of the factors that doctors have to take into account when exercising professional discretion.
Ultimately, treatment decisions are made by the patient
Physicians have a duty to provide the best care for their patients.
Physicians are obligated not to harm their patients.
Medical decisions must be made fairly. An illustrative example is a list of patients that need a scarce resource, a set of lungs for transplantation. How should these people be prioritized in the list? Moral conventions, legality, and personal rights are a few points that must be carefully considered to reach a justifiable policy in high stakes decisions.
Additional Ideas that Guide Medical Practice and Decision MakingEdit
Evidence Based Medicine (EBM)Edit
Evidence is gathered from research and eventually forms the basis of clinical practice guidelines (CPG), which are frequently used when establishing standard of care in legal cases. Developing a CPG can take years. Physicians are compelled to give patients the best care, but this is constantly evolving. When is evidence sufficient to recommend a course of treatment that diverges from guidelines? This is a grey area left to the discretion of clinical professionals. Ethical principles like beneficence and non-maleficence must be a factor in these decisions.
EBM is based on the supposition that the evidence is produced from reliable research. However, many medical schools are focusing on teaching students how to incorporate evidence into their practice rather than appraising soundness of evidence. Als-Nielsen et al. (2008) found that “conclusions in trials funded by for-profit organizations may be more positive due to biased interpretation of trial results.” A study by the ESHRE Capri Workshop Group posits “It has been estimated that 85% of all research funding is actually wasted, due to inappropriate research questions, faulty study design, flawed execution, irrelevant endpoints, poor reporting and/or non-publication.” It also concluded that “much of the published medical research is apparently flawed, cannot be replicated and/or has limited or no utility.” The clinical professional must decide on what evidence they will base their practice.
Physicians can practice in a manner that is legally safer by reducing the involvement of the patient in their care and ordering potentially unnecessary tests and referrals. This choice implies reduced patient autonomy. Defensive medicine has been estimated to add $45 billion (in 2008 dollars) to the cost of healthcare. After Dr. Merenstein's lawsuit, PSA screening increased. These cases influence decisions that clinical professionals make when providing care to patients.
Other professionals had to make ethical choices related to Dr. Merenstein. For example, Dr. Merenstein's insurance adjuster, Bill Rigsbee, encouraged him to settle in court. Rigsbee told Dr. Merenstein that the settlement would not affect any future insurance coverage, so Dr. Merenstein settled and the case was dismissed. But, what Rigsbee said was wrong, and Dr. Merenstein had trouble practicing medicine afterward because nobody wanted to insure him. While what Rigsbee did was probably beneficial for the insurance company - settling a lawsuit that could get larger if Dr. Merenstein was found guilty - it was dishonest to claim that settlement would have no adverse effects.
The legal professionals also faced ethical gray areas. When Dr. Merenstein sued his insurance company, a lower court dismissed his fraud claim on the grounds that Rigsbee's assurances were just his opinion. While they may not have been legally binding statements, they still greatly impacted Dr. Merenstein, and the dismissal was later reversed after Dr. Merenstein appealed. In the original malpractice case, the plaintiff's lawyer successfully fulfilled his professional duty to argue for his client. However, according to Dr. Merenstein, he "had the recommendations from every nationally recognized group supporting [his] approach and the literature is clear that screening for prostate cancer is controversial, [but] the plaintiff’s attorney argued otherwise." Lawyers have to walk a fine line between arguing for a client and arguing against experts or cherry-picking information to fit their case. Dr. Merenstein pointed out that what he was doing was in accordance with newer guidelines and "above the standard of care," but the plaintiff's lawyer brought in doctors who were still following the older methodology - ordering tests without consulting with patients. Whether or not new medical guidelines should be followed is certainly something that should be discussed, but it should be discussed among practicing doctors and researchers and not by lawyers in a courtroom.
Shortly after his trial, Dr. Merenstein reflected that because of the courtroom attack on evidence-based medicine and shared decision making, he was unsure whether or not he wanted to continue practicing medicine. However, his recent articles mention such things as the need for "clear, evidence based communication to consumers" and whether or not doctors' recommendations are "concordant with contemporaneous and current... guidelines." In a 2019 interview, he highlighted that he tries to "teach students importance of critically examining what is often taken for granted and to look for ways to improve our knowledge base." While Dr. Merenstein has remained committed to his original values, he also critically examines evidence in order to help doctors and patients make the best decisions.
- Snow, Seren. (2019). A commitment to evidence helps Merenstein thrive as a physician-scientist. Georgetown University Medical Center. https://gumc.georgetown.edu/gumc-stories/a-commitment-to-evidence-helps-merenstein-thrive-as-physician-scientist
- Daniel Merenstein's profile on Google Scholar. https://scholar.google.com/citations?user=GSbskZ0AAAAJ
- Tabayoyong, W., & Abouassaly, R. (2015). Prostate Cancer Screening and the Associated Controversy. The Surgical Clinics of North America, 95(5). http://dx.doi.org/10.1016/j.suc.2015.05.001
- Catalona, W. J. (2018). Prostate Cancer Screening. The Medical Clinics of North America, 102(2), 199–214. https://doi.org/10.1016/j.mcna.2017.11.001
- Harvard Health Publishing. (n.d.). Does prostate cancer screening matter? Harvard Health. Retrieved May 4, 2021, from https://www.health.harvard.edu/mens-health/does-prostate-cancer-screening-matter
- Swanson, J. A., Schmitz, D., & Chung, K. C. (2010). How to Practice Evidence-Based Medicine. Plastic and Reconstructive Surgery, 126(1), 286–294. https://doi.org/10.1097/PRS.0b013e3181dc54ee
- Moffett, P., & Moore, G. (2011). The Standard of Care: Legal History and Definitions: the Bad and Good News. Western Journal of Emergency Medicine, 12(1), 109–112.
- Merenstein, D. (2004). Winners and Losers. JAMA, 291(1), 15–16. https://doi.org/10.1001/jama.291.1.15
- Gillon, R. (1994). Medical ethics: Four principles plus attention to scope. BMJ, 309(6948), 184. https://doi.org/10.1136/bmj.309.6948.184
- Mackey, T. MAS. & Liang, B. MD. (2011). Virtual Mentor. 13(1) 36-41. doi: 10.1001/virtualmentor.2011.13.1.hlaw1-1101.
- Montori, V., MD & Guyatt, G.,MD. (2008) Progress in Evidence-Based Medicine. JAMA, 300(15) 1814-1816. doi:10.1001/jama.300.15.1814
- Als-Nielsen, B.,MD et al. (2003). Association of Funding and Conclusions in Randomized Drug Trials. JAMA, 290(7), 921-928. doi:10.1001/jama.290.7.921
- ESHRE Capri Workshop Group. (2018). Protect us from poor quality research. Human Reproduction, 33(5) 770-776. https://doi.org/10.1093/humrep/dey056
- Sullivan, Thomas. (2018). Defensive Medicine Adds $45 Billion to the Cost of Healthcare. PolicyMed. https://www.policymed.com/2010/09/defensive-medicine-adds-45-billion-to-the-cost-of-healthcare.html
- Krist, A. MD. et al. 2007. How Physicians Approach Prostate Cancer Screening Before and After Losing a Lawsuit. Annals of Family Medicine 5(2) 120-125 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1838685/
- Daniel J. Merenstein versus St. Paul Fire & Marine Insurance Company. https://www.ca4.uscourts.gov/Opinions/Unpublished/041631.U.pdf
- Sanders, M.E. et al. (2018). Probiotics for human use. Nutrition Bulletin, 43, 212-225. https://doi.org/10.1111/nbu.12334
- Krist, A. H. et al. (2007). Timing of repeat colonoscopy. American Journal of Preventive Medicine, 33(6), 471-478. https://doi.org/10.1016/j.amepre.2007.07.039