Angry Toxicologist

What do the Abigail Alliance and steroid use have to do with each other? Read on.

The US DC Court of Appeals on Tuesday overturned the finding for the Abigail Alliance and ruled for the FDA (supported by the American Society of Clinical Oncology (ASCO), and the National Organization for Rare Disorders (NORD)). The finding was basically that there is no Constitutional Right (big 'R') for access to experimental drugs. The court was divided (8-2, not following conservative/liberal lines) but even I and see through the minority opinion that you have the right to save your life by any means and that is protected under the due process clause (may not be deprived of life, liberty, or property without due process or something very similar). Clearly, we don't let people do anything they want in the name of saving themselves, the dissent is too broad (as the majority points out).

What the court doesn't take on, and really can't is the fact that easy access to experimental drugs before they are proven safe and effective will ruin drug development for people with serious diseases. If companies are allowed to sell an experimental drug at profit, there will be little incentive to get the drug through the rest of the expensive testing phases to make sure it's safe and effective. I should note that the FDA has a program that allows people to get access to experimental drugs as long as the company will provide it without making a profit; you can imagine how popular that is. Also, it will be more difficult for companies to recruit patients for their trials to test out the new drugs. All in all, it would be a huge failure for people that want safe and effective drugs. The Abigail Alliance says that some people are willing to take the extra risk if the disease is life threatening. What they don't think through is the fact that if the changes they want are made, they will be affecting everybody. Some patients don't want to risk spending year of life they have on something that has serious toxicities that isn't really doing anything. If that's the case, why not take nothing? If you are going to go through serious toxicitity (with chemo drugs for instance), wouldn't you want to know that there's a good chance that it's helping you?

Beyond what you and I want though, the fully developed drugs would become much harder to get through the process - therefore, less safe and effective drugs - a loss for everyone. That's why ASCO and NORD are behind the FDA on this one.

What does this all have to do with steroids?

I asked my other half last week, "Why don't sports authorities just say that doping and steroid use is okay and then the playing field will be even. It wouldn't be cheating then." I felt somewhat uncomfortable with this but I couldn't come up with a reason against it. It's not cheating if everyone's allowed to do it. It would be like getting laser eye surgery to make your eyes better than 20/20 (I'm looking in your direction Tiger Woods). This was the answer: It's not about cheating, it's unfair to all the guys that don't want to take a dangerous substance to play. That's it. It's not about cheating, it's about the right of all the other guys to play baseball or cycle or whatever without having to take dangerous substances.

There are a lot of other examples of this but these are two recent ones where people don't get that it's not all about them, it's about what their actions do to everyone else. I could be wrong, though. What do you think?