“Novartis Defends Decision to Keep False Data From FDA”

Now there’s a headline full of chutzpah. August 8, 2019, New York Times, p. B6.

There is no way to convince either the FDA or the public that Novartis did nothing wrong. Vas Narasimhan, CEO, offered the following explanations/justifications:

1. They are forcing out a small number of scientists who were involved in manipulating the data in the research for the company’s drug, Zolgensma, only the second gene therapy drug approved by the FDA.
2. The company wanted to wait until they had their information from their own internal investigation before telling the FDA.
3. The data manipulated were used only on mice in early phases of the research.
4. The tests that were manipulated were discontinued in the summer of 2018.
5. Patient safety was never threatened.

The FDA does agree that the data manipulations do not affect the safety or efficacy of the drug. If all of this is true, then why not just disclose? Ah, there would have been a delay. No approval, no sales, and no realized revenue. Zolgensma is a one-time treatment that costs $2.1 million. The only other drug on the market, Spinraza, can be used, but the patients must then take it for a lifetime. Novartis now copes with two problems — the negative data are now out there along with the manipulation word. However, the additional problem is that trust has been dissipated. The CEO added, “We are committed to rebuilding trust with society.” You better believe it because this is a drug given to infants to treat spinal muscular atrophy (400 babies a year are born with this disorder).

The failure to disclose to the FDA as soon as Novartis was aware of the manipulation of data (March, (2019) is problematic. The disclosure came in May, 2019, after FDA approval, and the first apologies followed in August. Too late! Law firms are already advertising for clients and families affected by taking Zolgensma.

Important drug. Critical for those 400 babies. What a shame that it will carry this shadow. Truth percolates — just disclose it when you know.

About mmjdiary

Professor Marianne Jennings is an emeritus professor of legal and ethical studies from the W.P. Carey School of Business at Arizona State University, retiring in 2011 after 35 years of teaching undergraduate and graduate courses in ethics and the legal environment of business. During her tenure at ASU, she served as director of the Joan and David Lincoln Center for Applied Ethics from 1995-1999. In 2006, she was appointed faculty director for the W.P. Carey Executive MBA Program. She has done consulting work for businesses and professional groups including AICPA, Boeing, Dial Corporation, Edward Jones, Mattel, Motorola, CFA Institute, Southern California Edison, the Institute of Internal Auditors, AIMR, DuPont, AES, Blue Cross Blue Shield, Motorola, Hy-Vee Foods, IBM, Bell Helicopter, Amgen, Raytheon, and VIAD. The sixth edition of her textbook, Case Studies in Business Ethics, was published in February 2011. The ninth edition of her textbook, Business: lts Legal, Ethical and Global Environment was published in January 2011. The 23rd edition of her book, Business Law: Principles and Cases, will be published in January 2013. The tenth edition of her book, Real Estate Law, will also be published in January 2013. Her book, A Business Tale: A Story of Ethics, Choices, Success, and a Very Large Rabbit, a fable about business ethics, was chosen by Library Journal in 2004 as its business book of the year. A Business Tale was also a finalist for two other literary awards for 2004. In 2000 her book on corporate governance was published by the New York Times MBA Pocket Series. Her book on long-term success, Building a Business Through Good Times and Bad: Lessons from Fifteen Companies, Each With a Century of Dividends, was published in October 2002 and has been used by Booz, Allen, Hamilton for its work on business longevity. Her latest book, The Seven Signs of Ethical Collapse was published by St. Martin’s Press in July 2006 and has been a finalist for two book awards. Her weekly columns are syndicated around the country, and her work has appeared in the Wall Street Journal, the Chicago Tribune, the New York Times, Washington Post, and the Reader's Digest. A collection of her essays, Nobody Fixes Real Carrot Sticks Anymore, first published in 1994 is still being published. She has been a commentator on business issues on All Things Considered for National Public Radio. She has served on four boards of directors, including Arizona Public Service (1987-2000), Zealous Capital Corporation, and the Center for Children with Chronic Illness and Disability at the University of Minnesota. She was appointed to the board of advisors for the Institute of Nuclear Power Operators in 2004 and served on the board of trustees for Think Arizona, a public policy think tank. She has appeared on CNBC, CBS This Morning, the Today Show, and CBS Evening News. In 2010 she was named one of the Top 100 Thought Leaders in Business Ethics by Trust Across America. Her books have been translated into four different languages. She received the British Emerald award for authoring one of their top 50 articles in management publications, chosen from over 15,000 articles. Personal: Married since 1976 to Terry H. Jennings, Maricopa County Attorney’s Office Deputy County Attorney; five children: Sarah, Sam, and John, and the late Claire and Hannah Jennings.
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