Draft:Robert I. Misbin

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

Early Life and Career

Robert (Bob) Misbin was born in Brooklyn March 20, 1947.  <ref> John Hopkins Peabody Institute, “Misbin New Directions String Ensemble”. https://peabody.jhu.edu/explore-peabody/community-engagement/tuned-in/misbin-new-directions-string-ensemble/. </ref><ref> Partners for the Arts, Vice President Emeritus.  April 21, 2024.  https://partners4thearts.org/bio-robert-misbin/ </ref><ref> 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/ </ref>  He graduated from Brooklyn College and Johns Hopkins Medical School. 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. <ref> Journal of Biological Chemistry, “Insulin Metabolism in Rat Hepatocytes”. 1983. https://ouci.dntb.gov.ua/en/works/9joBA6Z7/ </ref> His articles and books are widely quoted. <ref> ResearchGate.net:  lists 67 publications by Robert I. Misbin. https://www.researchgate.net/profile/Robert-Misbin/</ref><ref> Goodreads.com  Robert Misbin’s books. https:3//www.goodreads.com/author/show/152229.Robert_Misbin/</ref>  Of particular importance is his work on lactic acidosis, a rare but fatal complication of the popular diabetes drug metformin. <ref> 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</ref><ref> NIH, National Library of Medicine: “Phenformin – Associated Lactic Acidosis:  Pathogenesis and Treatment”.  Nov. 1977. https://pubmed.ncbi.nlm.nih.gov/921092/</ref><ref> National Library of Medicine, New England Journal of Medicine, Jan 22, 1998.  https://pubmed.ncbi.nlm.nih.gov/9441244/</ref>

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. <ref> 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/ </ref><ref> 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/ </ref> His whistleblowing 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. <ref> 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/ </ref><ref> CBS News, “FDA Whistleblower Resigns”.  May 5, 2000. https://www.cbsnews.com/news/fda-whistleblower-resigns/ </ref><ref> 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/ </ref><ref> he 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/ </ref><ref> 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/</ref> 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’s unheeded warning about the danger of another diabetes drug, Avandia, led to an expose in TIME magazine. <ref> 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/ </ref> Finally, Dr. Misbin bucked his superiors after political pressure led to 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. <ref> Wall Street Journal, “An FDA Reviewer Battles the Drug his Boss Approved”, by Anna Wilde Mathews. Oct. 26, 2005</ref>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.  <ref> NBC News, “Tough Rules for Diabetes Drugs Sought”,  Nov. 27, 2007. https://www.nbcnews.com/id/wbna21990017/ </ref><ref> CBS News, “FDA: Guardian or Rubber Stamp?”, July 12, 2001. https://www.cbsnews.com/news/fda-guardian-or-rubber-stamp-12-07-2001/ </ref>In 2019, journalist Sharyl Attkisson reported Misbin’s advice to patients with diabetes about how to avoid the high cost of insulin analogs. <ref>“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/ </ref>

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. <ref> 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/</ref>He is especially interested in terminal care issues <ref> New England Journal of Medicine, “Physicians’ Aid in Dying”. Oct. 31, 1991. https://www.nejm.org/doi/abs/10.1056/NEJM199110313251811/</ref>and was a consultant to the Virginia legislature when it considered medical aid in dying in 2018.  <ref>“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/ </ref>

Musical Contributions

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. <ref> Washington Performing Arts, “Misbin Family Memorial Chamber Music Competition”.  https://www.washingtonperformingarts.org/misbin-family-memorial-chamber-music-competition/ </ref>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. <ref> John Hopkins Peabody Institute, “Misbin New Directions String Ensemble”. https://peabody.jhu.edu/explore-peabody/community-engagement/tuned-in/misbin-new-directions-string-ensemble/ </ref><ref> 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/ </ref>He was a cofounder of Partners for the Arts <ref> Partners for the Arts, Vice President Emeritus. April 21, 2024. https://partners4thearts.org/bio-robert-misbin/</ref><ref> 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/ </ref>and helped develop the “Ambassador Ensemble” of the Chicago Metamorphosis Orchestra Project.<ref> John Hopkins Peabody Institute, “Misbin New Directions String Ensemble”. https://peabody.jhu.edu/explore-peabody/community-engagement/tuned-in/misbin-new-directions-string-ensemble/</ref><ref> 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/ </ref>His noncommercial website ClassicalWashington.com promotes concerts in greater Washington. Inspired by Thomas Mann’s novella Mario and the Magician <ref> The New Republic, “The Evil Musician Casts a Spell”.  Aug. 15, 2016.  https://newrepublic.com/article/136045/evil-magician-casts-spell/  </ref> about the rise of fascism under Mussolini, Dr Misbin wrote the libretto for Briscula the Magician <ref> Briscula the Magician Opera in Two Acts. March 7, 2020.  https://briscula.org/</ref>, an opera that had four performances in Rockville Maryland just before the pandemic in March 2020. <ref> 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/</ref><ref> 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/</ref>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. <ref> Washington Arts Ensemble, “I Love It When You Do Me Like You Do”. https://youtu.be/qY74jYSER5I?si=T6Jj5BNw6vfMbJZJ</ref>

References

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. 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/

18. Wall Street Journal, “An FDA Reviewer Battles the Drug his Boss Approved”, by Anna Wilde Mathews. Oct. 26, 2005.

19. NBC News, “Tough Rules for Diabetes Drugs Sought”,  Nov. 27, 2007.  https://www.nbcnews.com/id/wbna21990017/

20. CBS News, “FDA: Guardian or Rubber Stamp?”,  July 12, 2001.  https://www.cbsnews.com/news/fda-guardian-or-rubber-stamp-12-07-2001/

21. “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/

22. New England Journal of Medicine, “Physicians’ Aid in Dying”.  Oct. 31, 1991.  https://www.nejm.org/doi/abs/10.1056/NEJM199110313251811/

23. “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/

24. Washington Performing Arts, “Misbin Family Memorial Chamber Music Competition”.  https://www.washingtonperformingarts.org/misbin-family-memorial-chamber-music-competition/

25. 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/  

26. The New Republic, “The Evil Musician Casts a Spell”.  Aug. 15, 2016.  https://newrepublic.com/article/136045/evil-magician-casts-spell/

27. Briscula the Magician Opera in Two Acts.  March 7, 2020.  https://briscula.org/

28. 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/

29. 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/

30.  Washington Arts Ensemble, “I Love It When You Do Me Like You Do”.  https://youtu.be/qY74jYSER5I?si=T6Jj5BNw6vfMbJZJ

EXTERNAL LINKS

1. INSULIN – History from an FDA Insider, by Robert I. Misbin.

https://www.amazon.com/INSULIN-History-Insider-Robert-Misbin-ebook/dp/B089GBLW58

2. https://classicalwashington.com/