Without a doubt the work done by the pharmaceutical, biotech, clinical research, drug development industry and the Food and Drug Administration is worthy of this distinction for 2020. What was accomplished is just short of miraculous.
The federal government (FDA) and the corporations cut no corners. I have no doubt that everything was done according to established good clinical principles. What was done was the speeding up of the regulatory processes; decreasing the workflow processing time. Turn around time on data review and decision making was the focus. The researchers and the reviewers of the data had Covid-19 treatments and vaccines at the forefront of their priorities.
The typical time for vaccine development to get approved is 4 years. The first two approved were done within 12 months!! There are several more in development.
We are now beginning to see the impact the vaccine is having in the decline of daily new cases. Many people have now received their second dose.
The United Kingdom began vaccinating their population one week earlier than the US and you can see the impact to their daily new cases as well. This has me very encouraged. I’m hopeful that by Memorial Day, we’ll be back to dining out and meeting in person, traveling to conferences, vacations, etc.
Nathan Yates has spinal muscular atrophy and is a professor or economics and finance. Here’s an excerpt of his article on the price of a new drug to treat his condition. The bold in the text below is mine. The
As someone who has lived with spinal muscular atrophy for all 30 years of my life, I was perplexed and disappointed that the recent approval of Novartis’ gene therapy Zolgensma was immediately overshadowed by outrage over the drug’s price: $2.125 million.
The Food and Drug Administration’s decision was a pivotal day for those of us in the SMA community. Zolgensma, approved for children under 2, is the only one-dose treatment option for any category of SMA patients and has been highly effective in clinical testing so far.
Sure, it’s the world’s priciest drug. But instead of debating the level of financial profit that is appropriate for Novartis, let’s focus on the needs of patients. How are we going to get treatments for rare diseases if there’s not a financial incentive for doing it? Therapies are being developed because people think they can sell them for a profit. We don’t like to talk about it, but pharmaceutical companies exist to make money. Don’t we realize, though, that all of society profits from each disease we cure and each baby that is saved from SMA and other deadly diseases?
As a professor of economics and finance, I believe that the cost-related complaints being thrown around social media are short-sighted. Shortly after Zolgensma’s price was announced, I even told a friend, “This is a good problem to have.” Why? It’s a twofold answer:
Competition – drives cost down
Long term value – each successive drug that’s approved will be an improvement – whether that’s injected by IV once instead of into the spinal column every 4 months or made into a pill for once a day dosing. drug
LaunchBio (LaunchBio) holds events on the first Thursday of the month in Durham, NC. They are held in the Chesterfield Building in the downtown area. The building was formerly a cigarette manufacturing building. It has now been converted and there is incubator lab space for drug discovery and development.
It is a great opportunity for networking with people involved in the clinical research industry. Here I am enjoying a Durty Bull Lager beer and conversation with Peter Weiman and David Holland (they’re drinking the IPA that was being served).