Hyping a New Drug that Treats Pancreatic Cancer

Headlines today are reading, “A study found a drug used to treat ovarian cancer doubled the lifespans of pancreatic cancer patients” (Guzman, 2020). Sounds great, right? A new drug study reports that a new drug called Lynparza from AstraZeneca, based in the UK, “nearly doubled the time patients lived without disease progression” (AstraZeneca website). Let’s look at what this actually means by analyzing the study (Golan et al, 2019) that led to the FDA approving the drug for pancreatic cancer. First, let’s assume the paper is a valid study, and all of the 19 physician-authors were actually involved in the study and acted without fraud. Those are big assumptions though, given that ghostwriting, i.e. someone other than the physician does the research and writes the medical paper, is rampant in medical centers where physicians are on the byline of a medical paper (Lacasse and Leo, 2010). Fraud among physicians on the byline of medical research papers is rampant too (Relman, 1983), and has been described by the former editor of the New England Journal of Medicine, Arnold Relman, M.D., as part of the “medical professionalism in the United States is facing a crisis” (Relman, 2007). Dr. Relman’s sentiment has been echoed by many others, including another former editor of the New England Journal of Medicine, Marcia Angel, M.D., who has written, “It is simply no longer possible to believe much of the clinical research that is published, or to rely on the judgment of trusted physicians or authoritative medical guidelines. I take no pleasure in this conclusion, which I reached slowly and reluctantly over my two decades as an editor of The New England Journal of Medicine” (Angell, 2009).

Now, assuming no fraud in the Golan et al (2019) paper, what are the results? The drug increased the length of life by 3.6 months compared to a placebo: “The median progression-free survival was significantly longer in the olaparib group than in the placebo group (7.4 months vs. 3.8 months; hazard ratio for disease progression or death).” That is about a 50% increase in survival. For the gain in 3 months survivability, one must consider the possible negative side effects: The most common side effects with Lynparza (which may affect more than 1 in 10 people) are tiredness, nausea (feeling sick), vomiting, diarrhea, dyspepsia (heartburn), cough, headache, dysgeusia (taste disturbances), decreased appetite, dizziness, upper abdominal pain (stomach ache), dyspnoea (difficulty breathing), anemia (low red blood cell counts), leucopenia (low white blood cell counts), neutropenia (low levels of neutrophils, a type of white blood cell that fights infection) and thrombocytopenia (low blood platelet counts) according to the European Medicines Agency. Further, given that this drug was just approved in December 2019, and that many drugs are not fully understood until used by a large number of people 4-7 years following approval and used in the market by a diverse group of patients, the negative side effects are likely not well understood (Downing et al, 2017).

Because pancreatic cancer involves the immune system, and those who live the longest with this cancer may have elevated T-cell activity in the tumor and in their blood (Balachandron et al, 2017), if the patient does things to better activate T cell function, such as eating fiber (Trompette et al, 2018), survivability may be improved. I have more to say about this in my new book: “Thinking and Eating for Two: The Science of Using Systems 1 and 2 Thinking to Nourish Self and Symbionts.”

References

Angell M (2009) Drug Companies & Doctors: A Story of Corruption. The New York Review of Books, Jan. 15, 2009.

Balachandron et al (2017) Identification of unique neoantigen qualities in long-term survivors of pancreatic cancer. Nature, 551: 512–516.

Downing NS et al (2017) Postmarket Safety Events Among Novel Therapeutics Approved by the US Food and Drug Administration Between 2001 and 2010. JAMA. 317(18):1854-1863

Golan T et al (2019) Maintenance Olaparib for Germline BRCA-Mutated Metastatic Pancreatic Cancer. N Engl J Med, 381:317-327

Guzman J (2020) FDA green-lights promising new pancreatic cancer drug treatment. A study found a drug used to treat ovarian cancer doubled the lifespans of pancreatic cancer patients. The Hill, Jan. 17, 2020.

Lacasse JR, Leo J (2010) Ghostwriting at Elite Academic Medical Centers in the United States. PLoS Med 7(2): e1000230. https://doi.org/10.1371/journal.pmed.1000230.

Relman AS (1983) Lessons from the Darsee Affair. N Engl J Med 1983; 308:1415-1417.

Relman AS (2007) Medical professionalism in a commercialized healthcare market. JAMA. 298(22):2668-2670. doi:10.1001/jama.298.22.2668.

Trompette A et al (2018) Dietary Fiber Confers Protection against Flu by Shaping Ly6c– Patrolling Monocyte Hematopoiesis and CD8+ T Cell Metabolism. Immunity. 48(5):992-1005.e8.

Published by Dr. Greg Maguire, Ph.D.

Dr. Maguire, a Fulbright-Fogarty Fellow at the National Institutes of Health, is a scientist, innovator, teacher, healthcare professional. He has over 100 publications and numerous patents. His book, "Adult Stem Cell Released Molecules: A Paradigm Shift To Systems Therapeutics" was published by Nova Science Publishers in 2018.

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