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The pharmaceutical industry was in for a shock this month when it was revealed that Novartis included faulty data when it applied for the regulatory approval of its contentious gene therapy, Zolgensma – oh ‘big pharma’ just when I was beginning to trust you.
ovartis was already in the spotlight over the cost of Zolgensma which sells for $2.1 million – and now the FDA has lambasted the company, even mentioning potential ‘civil or criminal penalties.’ The issue stems from Novartis subsidiary Avexis discovering the faulty data before Zolgensma was approved by the FDA. Novartis was notified about the inaccurate data in March, but only notified the FDA at the end of June, one month after the gene therapy’s approval. While Novartis, and indeed the FDA, support Zolgensma’s efficacy and human clinical trials data, the fact that the company hid the truth while waiting for regulatory approval casts suspicion into Novartis’ motives. In the June edition of EPM I argued that people shouldn’t be surprised when drug companies price treatments highly. After all, they’re businesses first and foremost right? But Novartis’ actions indicate a company that is only motivated by profit and one that is unwilling to be transparent about its data -
EDITOR’S DESK actions of which undermine the importance the FDA holds as the body responsible for regulating drugs. This goes against Novartis CEO Vas Narasimhan’s aim of restoring trust with society, which he outlined as one of his five key priorities at the company’s annual press conference in 2018.
So now it stands to the FDA to hold Novartis responsible, with a lack of affirmative action potentially resulting in further misconduct from the industry. But more so Zolgensma represents just another bullet point in pharma’s long list of scandals. Which is a shame as numerous developers work tirelessly to try and improve the world’s health, yet won’t be heard above the uproar of yet another misdemeanour from ‘big pharma’. The question now stands whether pharmaceutical companies will improve the ways they operate when communicating with both regulatory authorities and more importantly the public. After all, you’d think after so many scandals involving price gouging, patent blocking, shortages and more, pharmaceutical companies would be more concerned about protecting their public image. I’m not so certain. After all, investors have failed to penalise Novartis’ stocks, showing that as long as a company is set to be profitable minor public scandals won’t affect their share prices too harshly. As mentioned previously this year, Zolgensma’s approval isn’t without merit. If it offers children with spinal muscular atrophy (SMA) a chance of life, then the drug’s approval can be applauded. But Novartis does need to be held accountable, if only to stop the pharmaceutical industry from getting away with malicious practices that put the rest of the industry in a bad light. I look forward to when we can start promoting the good work life sciences companies are doing instead of relying on scandalous headlines. Hopefully this isn’t too far ahead in the future.