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Robert I. Misbin

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Robert I. Misbin (born 1947) is an American physician and author. Throughout his career in the Food and Drug Administration, he was an advocate for safer drugs to be developed in a way that did not exploit patient volunteers.

Early life and career

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Robert (Bob) Misbin was born in Brooklyn March 20, 1947. [1][2][3] He graduated from Brooklyn College and Johns Hopkins School of Medicine. While at the University of Florida he studied the relationship between insulin and the liver using intrinsically labeled tritiated insulin that he synthesized using tissue he isolated from rat pancreas. [4] He has written several articles and books about diabetes and medical ethics. [5][6] Frequently quoted is his work on lactic acidosis, a rare but fatal complication of the popular diabetes drug metformin. [7][8][9]

In 1995, Dr. Misbin joined the Food and Drug Administration (FDA) and was the principle medical officer for insulin analogs and other drugs to treat diabetes. His letter to The Washington Post demanding higher standards for approval of new drugs made him unpopular with his superiors. [10][11] His letter to U. S. Senator John Ashcroft led to the removal of the diabetes drug Rezulin after dozens of cases of liver failure had been reported without definitive action by the FDA. [12][13][14][15][16] The series of articles about Rezulin by David Wilman in the Los Angeles Times won the Pulitzer Prize in Investigative Reporting in 2001. Later, Dr. Misbin cautioned that the diabetes drug Rosiglitazone (Avandia) might paradoxically increase cardiovascular disease instead of decreasing it and recommended a safety trial to evaluate this risk. At a Congressional hearing June 6, 2007. Representative Henry Waxman quoted Dr. Misbin’s April 1999 review “ the increase in body weight and undesirable effects on serum lipids is cause for concern… It cannot be assumed that treatment with rosiglitazone will decrease the risk of heart disease”, and asked FDA commissioner Andrew von Eschenbach why the agency did not take seriously the concerns expressed by Dr. Misbin. [17] The failures of the FDA in the approval of Avandia were the subject of an exposé in TIME magazine. [18] Finally, Dr. Misbin bucked his superiors after the approval of the diabetes drug Symlin despite reports of automobile accidents brought on by the lower blood sugar caused by use of this drug with insulin. [19] But Dr. Misbin’s judgment has been the subject of criticism. [20] As of year 2024, Symlin is still marketed in the US but has not been approved elsewhere.

Dr. Misbin left the FDA in September 2010 after having called upon the agency to learn from its previous mistakes and change how it approves new drugs to treat diabetes. [21][22]In 2019, journalist Sharyl Attkisson reported Misbin’s advice to patients with diabetes about how to avoid the high cost of insulin analogs. [23]

In addition to diabetes, Dr. Misbin has an interest in medical ethics. He was especially critical of how the FDA allowed drug companies to withhold active treatment from patients to make patients eligible to enroll in drug trials in which many would only get a placebo. [24]He is especially interested in terminal care issues [25]and was a consultant to the Virginia legislature when it considered medical aid in dying in 2018. [26]

Musical contributions

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In retirement, Dr. Misbin has pursued his lifelong love of opera and classical music. He brought together Levine School of Music and Washington Performing Arts Society to develop a chamber music competition for greater Washington. [27]Through his alma mater at Johns Hopkins University, he developed a program to educate children in inner city Baltimore on how to play string instruments. [28][29]He was a cofounder of Partners for the Arts [30][31]and helped develop the “Ambassador Ensemble” of the Chicago Metamorphosis Orchestra Project.[32][33]His noncommercial website ClassicalWashington.com promotes concerts in greater Washington.

Inspired by Thomas Mann’s novella Mario and the Magician [34] about the rise of fascism under Mussolini, Dr Misbin wrote the libretto for Briscula the Magician,[35] an opera that had four performances in Rockville Maryland just before the pandemic in March 2020. [36][37]He also composed original music in the style of New Orleans jazz to a section of Briscula. This piece was performed at the Arts Club of Washington on February 11, 2023. [38]

References

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  1. ^ John Hopkins Peabody Institute, “Misbin New Directions String Ensemble”. https://peabody.jhu.edu/explore-peabody/community-engagement/tuned-in/misbin-new-directions-string-ensemble/.
  2. ^ Partners for the Arts, Vice President Emeritus. April 21, 2024. https://partners4thearts.org/bio-robert-misbin/
  3. ^ Hopkins News & Publications, “Misbin Is ‘Tuned In’ to Sharing his Compassion for Classical Music”. Feb. 2, 2022. https://www.hopkinsmedicine.org/news/articles/2022/02/making-string-music-hip/
  4. ^ Journal of Biological Chemistry, “Insulin Metabolism in Rat Hepatocytes”. 1983. https://ouci.dntb.gov.ua/en/works/9joBA6Z7/
  5. ^ ResearchGate.net: lists 67 publications by Robert I. Misbin. https://www.researchgate.net/profile/Robert-Misbin/
  6. ^ Goodreads.com Robert Misbin’s books. https:3//www.goodreads.com/author/show/152229.Robert_Misbin/
  7. ^ Bismarck State College newsletter, “The Phantom of Lactic Acidosis Due to Metformin in Patients with Diabetes”. July 2004. https://bismarckstate-psb.primo.exlibrisgroup.com/discovery/fulldisplay/cdi_proquest_journals_223061630/01ODIN_NBJ:nbj
  8. ^ NIH, National Library of Medicine: “Phenformin – Associated Lactic Acidosis: Pathogenesis and Treatment”. Nov. 1977. https://pubmed.ncbi.nlm.nih.gov/921092/
  9. ^ National Library of Medicine, New England Journal of Medicine, Jan 22, 1998. https://pubmed.ncbi.nlm.nih.gov/9441244/
  10. ^ Washington Post, “A Possible Drug Fix?” Aug. 23, 1998. https://www.washingtonpost.com/archive/opinions/1998/08/24/a-possible-drug-fix/8afa0dde-22fe-4c36-94ee-ff453af51599/
  11. ^ Public Citizen, “Letter Supporting Dr. Robert Misbin’s Criticism of FDA Policies”. Aug. 25, 1998. https://www.citizen.org/article/letter-supporting-dr-robert-misbins-criticism-of-fda-policies/
  12. ^ Los Angeles Times, “FDA Investigating Rezulin Clinical Trials”. March 15, 2000. https://www.latimes.com/archives/la-xpm-2000-mar-15-mn-9107-story.html/
  13. ^ CBS News, “FDA Whistleblower Resigns”. May 5, 2000. https://www.cbsnews.com/news/fda-whistleblower-resigns/
  14. ^ Los Angeles Times, “The Rise and Fall of Drug Rezulin”. June 4, 2000. https://www.latimes.com/archives/la-xpm-2000-jun-04-mn-37375-story.html/
  15. ^ The Conversation, “Drug Safety Relies on People Like David Tackling the Goliath of Big Pharma”. June 10, 2013. https://theconversation.com/drug-safety-relies-on-people-like-david-tackling-the-goliaths-of-big-pharma-14878/
  16. ^ Tampa Bay Times, “Top 10 Reasons Why Whistle-blowers are Heroes”. Feb. 15, 2002. https://www.tampabay.com/archive/2002/02/15/top-10-reasons-why-whistle-blowers-are-heroes/
  17. ^ Lots of Finger Pointing at Congressional Hearing on Avandia. June 1, 2007. https://www.mdedge.com/endocrinology/article/53424/diabetes/lots-finger-pointing-congressional-hearing-avandia/
  18. ^ Time, “After Avandia, Does the FDA Have a Drug Problem?” Aug. 12, 2010. https://time.com/archive/6597461/after-avandia-does-the-fda-have-a-drug-problem/
  19. ^ Wall Street Journal, “An FDA Reviewer Battles the Drug his Boss Approved”, by Anna Wilde Mathews. Oct. 26, 2005
  20. ^ TuDiabetes. “Some Detail on Symlin’s Rocky FDA History”. https://forum.tudiabetes.org/t/some-detail-on-symlins-rocky-fda-history/24814/ July 2007.
  21. ^ NBC News, “Tough Rules for Diabetes Drugs Sought”, Nov. 27, 2007. https://www.nbcnews.com/id/wbna21990017/
  22. ^ CBS News, “FDA: Guardian or Rubber Stamp?”, July 12, 2001. https://www.cbsnews.com/news/fda-guardian-or-rubber-stamp-12-07-2001/
  23. ^ “What Many Diabetics Don't Know: You Can Buy Inexpensive, Over-the-counter Insulin in U.S”., by Sharyl Attkisson. https://sharylattkisson.com/2019/07/what-many-diabetics-dont-know-you-can-buy-inexpensive-over-the-counter-insulin-in-u-s/
  24. ^ Washington Post, “A Possible Drug Fix?” Aug. 23, 1998. https://www.washingtonpost.com/archive/opinions/1998/08/24/a-possible-drug-fix/8afa0dde-22fe-4c36-94ee-ff453af51599/
  25. ^ New England Journal of Medicine, “Physicians’ Aid in Dying”. Oct. 31, 1991. https://www.nejm.org/doi/abs/10.1056/NEJM199110313251811/
  26. ^ “Medical Aid-in-Dying (MAID) Final Report by the Joint Commission on Health Care”. September 18, 2018. https://jchc.virginia.gov/5.%20staff%20report.%20medical%20aid%20in%20dying%20for%20jchc%209.18.18%20mtg-1.pdf/
  27. ^ Washington Performing Arts, “Misbin Family Memorial Chamber Music Competition”. https://www.washingtonperformingarts.org/misbin-family-memorial-chamber-music-competition/
  28. ^ John Hopkins Peabody Institute, “Misbin New Directions String Ensemble”. https://peabody.jhu.edu/explore-peabody/community-engagement/tuned-in/misbin-new-directions-string-ensemble/
  29. ^ Hopkins News & Publications, “Misbin Is ‘Tuned In’ to Sharing his Compassion for Classical Music”. Feb. 2, 2022. https://www.hopkinsmedicine.org/news/articles/2022/02/making-string-music-hip/
  30. ^ Partners for the Arts, Vice President Emeritus. April 21, 2024. https://partners4thearts.org/bio-robert-misbin/
  31. ^ Partners for the Arts, “In Honor of Bernard Misbin and Miriam Wacksman”. April 21, 2024. https://partners4thearts.org/in-honor-of-bernard-misbin-and-miriam-wacksman/
  32. ^ John Hopkins Peabody Institute, “Misbin New Directions String Ensemble”. https://peabody.jhu.edu/explore-peabody/community-engagement/tuned-in/misbin-new-directions-string-ensemble/
  33. ^ Hopkins News & Publications, “Misbin is ‘Tuned In’ to Sharing his Compassion for Classical Music”. Feb. 2, 2022. https://www.hopkinsmedicine.org/news/articles/2022/02/making-string-music-hip/
  34. ^ The New Republic, “The Evil Musician Casts a Spell”. Aug. 15, 2016. https://newrepublic.com/article/136045/evil-magician-casts-spell/
  35. ^ Briscula the Magician Opera in Two Acts. March 7, 2020. https://briscula.org/
  36. ^ WBJC, Maryland’s Classical Music Station. “New (and Old) Opera Comes to Bel Cantanti”. https://www.wbjc.com/2020/wbjc-programs/interviews/new-and-old-opera-comes-to-bel-cantanti/
  37. ^ MD Theater Guide. Opera Review: “Briscula the Magician” at Bel Cantanti Opera. March 7, 2020. https://mdtheatreguide.com/2020/03/opera-review-briscula-the-magician-at-bel-cantanti-opera/
  38. ^ Washington Arts Ensemble, “I Love It When You Do Me Like You Do”. https://www.youtube.com/watch?v=qY74jYSER5I
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