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.