The FDA and the Trolley Problem

As a general rule, I'm not a big fan of big government. In my opinion, most government agencies that seek to regulate aspects of our lives are ineffective and wasteful at best and destructive at worst.

The Food and Drug Administration (FDA) was, until recently, a government agency that I was on board with. I was comforted by the fact that the foods I bought at the grocery store or the prescription drugs I took were tested and vetted by (assumed) experts to ensure that I wouldn't die by ingesting them.

There is a cost to this, however, and the cost is that the process of getting a new drug through all the myriad of government regulations takes a considerable amount of time and money.

In the United States, a new drug takes an average of 12 years to get to market. On top of that, only 1 in 5,000 drugs will make it from the experimental stage to final production. In terms of cost, it can take up to $2.6 Billion to develop a new drug (granted, that number could be inflated as the linked article points out, so the more realistic numbers could be in the low billions or hundreds of millions). Either way, still a ton of money and a huge investment/risk. Good luck being a mom and pop pharmaceutical company.

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To understand the ramifications of this, let's consider a somewhat dark thought experiment known as the "trolley problem"...

In the trolley problem, imagine that an evil psychopath has tied five innocent people to a railroad track, and releases a trolley that is hurdling towards them. Now imagine that you are in control of a switch that can cause the trolley to divert to a different track...to which there is only one person tied. What do you do?

There are some variants to the problem that can be used to think of different ethical dilemmas, but we will just consider the original case for now.

The thought experiment is rather dark since in either case, someone has to die. The question is do you willingly allow five people to die, or do you actively cause one person to die? The logical answer is to switch the track so that only one person dies, but there is an ethical argument for not doing anything and allowing the five people to die. In the latter case, you are absolving yourself of responsibility, since it's not your fault that the psychopath has set up this terrible situation.

If, however, you switch the track and knowingly divert the trolley so that it kills one person, then you have a sense of responsibility in the situation. Instead of passively allowing death, you actively participate in it!

What does this dark thought experiment have to do with the FDA? Well, quite a lot.

While it might be comforting to know that there is a huge government agency making it very difficult to get a drug pushed through the market without rigorous testing, what is the cost of doing this?

Besides a huge investment on the part of the drug company in question that is producing the drug (which makes it harder to be a drug company, thus limiting the number of drug companies that can compete, thus limiting selection for drugs, thus making drugs more expensive...), the process of getting a new drug to market takes a lot of time.

This may not seem like a large price to pay for the peace of mind that a drug won't kill you, but consider this: how many people die from not allowing the drug to get to market? What if someone developed a drug that completely cured any type of cancer by just taking a few pills? In the United States alone, almost 600,000 people die each year from cancer. Such a drug that cured it completely would undoubtedly save millions of lives over the course of many years.

Now consider that the FDA, with all of their regulations and red tape, prevents the drug from coming to market as fast as it could. What if the drug could get to market in, say, 7 years, but FDA regulations lengthen that time to the average of 12; a difference of 5 years. In that time, about 3 million people would die from cancer because they didn't have the drug.

If the company was allowed to sell the drug to the public unregulated, then there would be a good chance that it would have defects, and could cause harm to the first group of people that take it. There would undoubtedly be a public backlash against a company that willingly sold a drug to people that harmed them, and the creators of the drug would undoubtedly feel responsibility for harming people.

But what if the drug that initially kills say, a hundred people, goes on to be perfected and eventually saves millions? I'm no mathematician, but it seems like saving millions would be worth the cost of hundreds. And who knows if it would even cost hundreds of lives? Even if a company lacks regulation, it still has to compete in the marketplace. A doctor isn't going to prescribe a medication to a patient if he/she thinks it is too risky, and if a person died as a result of taking a medication, then their loved ones would undoubtedly sue the company responsible. Such an event would also not be met well by the general public, and the company's competitors would probably leverage it against them.

With all this in mind, major pharmaceutical companies probably wouldn't concoct drugs on a whim, throw them into the market, and hope for the best. They'd still do rigorous testing, but just do it in a way that they see fit, which could be more effective than the way a government regulatory agency sees fit.

The main problem I have with many government regulatory agencies is that they deprive you of choice. Instead of being diagnosed with an illness and a doctor telling you that you can either go with a well-tested treatment that has maybe a 50% chance of mild recovery and a 50% chance of no effect, or a new treatment that is not well-tested, but has a 90% chance of total success and a 10% chance of making things worse, wouldn't you want the choice? Maybe you decide not to go with the new treatment, but wouldn't you prefer the freedom to make the decision instead of the decision to be made for you?

When government gets involved with something, they are basically saying that they can make the decision better than you can. For some people, this may be true, but for the vast majority I think that free choice would allow for much better results.

I'm not completely against the idea of the FDA, because I like that foods have to be labeled with ingredients and nutrition information, and companies may find ways to take liberties with that if left unregulated. But do we really need (or want) the level of regulation that prohibits innovation while simultaneously driving up the cost of drugs?

It may be unethical to pull the lever and watch the trolley kill one person, but wouldn't the other five people thank you?

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