Novartis and Data Manipulation on $2.1 Million Gene Therapy?

Novartis, one of the world’s largest pharmaceutical firms, is under FDA investigation. Novartis stock is taking a tumble because the company withheld data from the FDA in its application for approval of a gene therapy treatment for spinal muscular atrophy. The FDA investigation is a setback for the company that, as of 2018, was trying to put behind it a generic price-fixing scandal, improper marketing techniques, and a previous allegation of data manipulation.

The $2.1 million gene therapy treatment was given expedited approval by the FDA. Then Novartis revealed that it was conducting an internal investigation into possible data manipulation in the testing of the drug, Zolgensma. Novartis has fired two scientists and maintains that the conduct was isolated. However, there was a two-month delay in announcing the internal investigation, a delay that permitted the drug approval process to end successfully. Novartis has defended the delay by explaining that it did not want to tip AveXis executives on the existence of the internal probe. AveXis produces the drug, and Novartis said that it feared the executives there would interfere with the investigation. Somehow a defense that is based on the fact that you do not trust the executives of your contractor seems slightly off kilter.

Novartis assures that there is no concern for safety of the patients. An FDA commissioner tweeted that he expected there would be a finding of wrongdoing and that there would be consequences. Novartis also assures that the issue was isolated to a couple of rogue scientists. If the Barometer had a nickel for every time the phrase, “These were just a couple of rogues that we have now fired,” well, this blog would not be free.

There is no such thing as isolated-rogue responsibility when it comes to events this big. Given the company’s culture as of 2018, something more than firing a couple of scientists is probably in order.

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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