World’s Most Expensive Drug

What do you do when you have the the most expensive drug in the world and need to get it approved? Correct. You manipulate the data behind it.

The Food and Drug Administration said Tuesday 
that Novartis submitted manipulated data as part of its application for a new gene therapy, and didn’t tell the agency until after the treatment was approved.

Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said the inaccurate information involved mouse data and was a “small amount of the totality” that was submitted. The faulty data didn’t raise concerns about the safety and effectiveness of the treatment, he said, adding that the therapy will remain on the market. 

But he stressed that the agency takes data integrity issues seriously and is continuing to investigate the situation. He said the FDA “will use its full authorities to take action, if appropriate, which may include civil or criminal penalties” against the manufacturer, AveXis Inc., a subsidiary of Novartis.

Isn’t that awesome? They had the balls to play with numbers to get Zolgensma cleared, a drug which only costs $2.1 million a treatment for spinal muscular atrophy.

I will give the FDA credit for catching them. And maybe it doesn’t change the effectiveness but it is still disgusting. Makes you wonder how many times this has happened for drugs over the years.

Douglas Farrago MD

Douglas Farrago MD is a full-time practicing family doc in Forest, Va. He started Forest Direct Primary Care where he takes no insurance and bills patients a monthly fee. He is board certified in the specialty of Family Practice. He is the inventor of a product called the Knee Saver which is currently in the Baseball Hall of Fame. The Knee Saver and its knock-offs are worn by many major league baseball catchers. He is also the inventor of the CryoHelmet used by athletes for head injuries as well as migraine sufferers. Dr. Farrago is the author of four books, two of which are the top two most popular DPC books. From 2001 – 2011, Dr. Farrago was the editor and creator of the Placebo Journal which ran for 10 full years. Described as the Mad Magazine for doctors, he and the Placebo Journal were featured in the Washington Post, US News and World Report, the AP, and the NY Times. Dr. Farrago is also the editor of the blog Authentic Medicine which was born out of concern about where the direction of healthcare is heading and the belief that the wrong people are in charge. This blog has been going daily for more than 15 years Article about Dr. Farrago in Doximity Email Dr. Farrago – [email protected] 

  1 comment for “World’s Most Expensive Drug

  1. Pat
    August 17, 2019 at 1:04 pm

    Did the FDA actually catch them? Or did Novartis semi-leak to plea for a lighter penalty, a business cost against the upcoming profit wave?

    Yeah, I’m that cynical.

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