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Hundreds of thousands have died while life-saving drugs awaited FDA approval

While combing social media for today's podcast talking points, I ran across an interesting tweet from Bernie Sanders.

Yesterday, the Washington Post highlighted a story involving Gilead Sciences. It seems Gilead has created a drug that can better serve those with HIV, but has held it from the market while their previously released, and less effective drug rides out the rest of its patent protection.

This move might sound dirty, but it's unfortunately just a part of doing business. They've got a license to sell a product for 3 more years, and they don't want to replace the product they're selling with the new version until they have to. Of course, your quick reaction might be that anyone who says something like that is cold, heartless, and doesn't care about the lives of others.

Consider a different scenario. Let's say Honda invents a new airbag that makes their cars safer. This new airbag will save lives. Of course, they've still got hundreds of thousands of the current model cars sitting in car lots around the country. When they invent this new airbag technology, would you recommend that they immediately remove all of their current models from the market and replace their airbags, or should they just put the new airbag in next year's model?

I'd assume that in the scenario I just laid out, rationality would prevail. Those driving Hondas right now will know that they are safe, but not as safe as they might be when next years model comes out. This all gets clouded when talking about the healthcare system, but the business/consumer principle should remain the same.

If we are going to play this game..

Bernie Sanders and his supporters go on to say that Gilead Sciences should be held responsible for the thousands of people who may die without this new medication.

  • What about the fact that the medication might not exist at all if Gilead had not invented it in the first place?

  • What about all the people that died in the years before they invented this medication?

If you are the creator of a live saving mechanism, can you be held responsible for not using it to save lives? That's an interesting idea, since you would seemingly not have been held responsible for those people's deaths if you chose not to invent the medication in the first place..

What about the thousands that have died while waiting on the FDA?

The FDA is famously slow at approving new medications that can potentially save lives. In fact, what's interesting is that if it were the FDA that took 3 more years to approve the medication, I doubt Bernie would say a word.

Let's look at a 2014 article in the New York Post by Henry L Miller:

To put it less charitably, FDA routinely drags its feet on the approval of products critical for the prevention or treatment of fatal diseases that are far more common in this country than Ebola.
Why expend the agency’s time and energy on a drug that will be used rarely, if at all, in the United States?
Consider the saga of Bexsero, a vaccine for meningitis B.
Bexsero was approved last year by the European Union, Australia and Canada — but it still hasn’t gotten an FDA OK, though outbreaks continue to occur on US campuses. (The most recent one killed a Georgetown University student this month.)
Citizens have shown initiative while bureaucrats stall. The mother of a UC-Santa Barbara student sent her son to England to be immunized with Bexsero.

Miller continued by bringing in the story of a new drug created to treat IPF:

Another example: pirfenidone, a drug meant to treat a pulmonary disorder called idiopathic pulmonary fibrosis, or IPF, which kills tens of thousands of Americans each year. The disease’s cause is unknown, and there are no FDA-approved therapies.
But pirfenidone is marketed in Europe (since 2011), Japan (2008), Canada (2012) and China. The drug won EU approval on the basis of three randomized, double-blind, placebo-controlled studies — one done in Japan and the other two in Europe and the United States.
Why is the FDA waiting? In 2010, an advisory committee of outside experts recommended approval, but agency officials demanded another major clinical study.
The results, published last May, were impressive. Pirfenidone markedly improved several laboratory and clinical measures of lung function and, most important, reduced the probability of death from IPF.
The FDA will probably OK the drug by year’s end. But in four years of delay, IPF will have killed more than 150,000 US patients.

"FDA civil servants have failed miserably to hold up their end of the bargain. We deserve better."

Some other great articles about particular drugs the FDA has either failed to approve, or were on a significant time delay;

The list of delayed medications due to bureaucratic nightmare goes on-and-on. At the end of the day it's honestly difficult to tell whether or not the FDA has been a net benefit to patients in the US. Drugs seem to get faster approval in every other developed nation. Nations that, by the way, Bernie and others want to use as examples of perfect healthcare systems.

Why the double standard?

If America's leftists want to complain about the delaying of a drug based on sadness for the lives that might be lost, that's fine, but it's difficult to take them seriously when they have such blatant disregard for the many failures of the FDA. What's the death toll from medications that could have saved lives, but then were delayed by the FDA? We will never truly know. Although, I'm sure Bernie will have a death count projected for Gilead Sciences by next week.