Abigail Alliance, Cancer, Steroids and the FDA

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?

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For what it's worth, I'm with you on this one. I can understand the desperation of facing death due to a terminal illness, and I understand that desperation makes you do things you thought you never would. Desperation is not a good frame of mind to be in when making decisions that are going to affect not only yourself, but everyone else.

I'm glad you brought up the connection between the mindset of desperation and the mindset that allows a person to cheat, especially in this case where the cheat is physically dangerous. How much does fear motivate any of us, to do 'good' or 'bad' things? I'll be mentally chewing on that one all day.

By Lorri Talley (not verified) on 09 Aug 2007 #permalink

It's interesting to read your idea about the results of legalizing steroid use in sports. For years now I've been advocating the institution of the Pharmaceutical League where the real competition would be between the drug companies sponsoring the teams and the athletes would be regarded as nothing more than vehicles for the various chemical cocktails.

Of course, I'm not one of your big sports fans.

By Sean Craven (not verified) on 09 Aug 2007 #permalink

In weightlifting competition, they do have separate categories, tested and untested. I imagine this would be quite difficult to do in sports with many teams and players, however.

Hah! (to Sean's post). Of course, the world is the pharmaceutical league.

Nic, the thought experiment that you propose was carried out on Slate by Dan Engber

I'm not sure what the outcome would be but I'm sure it wouldn't be good. It's ironic that the NFL is so much stronger than the MLB on steroids when wouldn't you think it would be the other way around, given the feel and fan base of each game? Whatever the reason, kudos to the NFL.

Thanks for the lead to the very interesting article. As someone who's got an interest in the phenomenon of professional sports but no desire to watch or follow them (it wasn't until I was in my late thirties that I realized that when my dad took me to ballgames he intended for me to enjoy myself... go figure) I miss out on a lot of interesting data.

The fact that the split in weightlifting is tested and untested rather than clean and doped is a fascinating one -- a choice between purity and stealth immediately presents itself. Then there's the guy who wants to prove that his genetics beat anyone else's steroids...

I used to be into weight training and I got to the point where I'd outgrown the Nautilus and Universal machines, but when I looked into the free weight room I saw a culture that I wasn't willing to deal with -- ex-cons and steroid freaks are exactly the kind of bad influences I don't need.

I do have a strong interest in the arts, though, and I think that creative performance enhancement hasn't been examined closely enough. For instance, divide writers into drinking and non-drinking categories and you'll see that drinkers and reformed drunks seem to have a real competitive edge. And that isn't even going into music, where the really spectacular abuse goes on. I'd say it's time to start testing urine...

By Sean Craven (not verified) on 10 Aug 2007 #permalink

One reason the NFL is more strict is the players (and their union) realize that unlike in baseball, in football you are not merely risking your own health by taking steriods. In baseball it is seen as more of a personal choice. In football you risk your own health AND that of everyone you hit with your steroid enhanced body.

Hey, my life changed when I ran across the noun 'lylies.' Haysoos kristos!

By Sean Craven (not verified) on 10 Aug 2007 #permalink

While your argument that allowing Abigain Alliance access to Stage II drugs would severely change the structure of FDA approval, I don't believe your argument of fairness is completely on par with the analogy used to represent it. Right now, there are, of course, certain fundamental unfairnesses in health care based on one's ability to pay and one's access to insurance, yet no one concludes that this unfairness is likened to cheating. Furthermore, "cheating", as defined by www.m-w.com, is "to deprive of something valuable by the use of deceit or fraud." Abigail Alliance propounded the idea that the right to experimentals after Stage I was a fundamental right, which, by definition, cannot be deprived of ANYONE. If we all would have the same access and ability, it does not follow that this would constitute cheating.

By Brad Davidsen (not verified) on 18 Sep 2007 #permalink

Since its discovery four years ago, WNS has continued to spread across the continent. Just last month, both Maryland and Ontario reported their first confirmed cases of WNS. The disease is believed to be spread from one cave to another both by infected bats and by cavers who may carry the fungus on their clothing or gear. In an attempt to prevent the spread of WNS, many private land owners with caves on their properties have put up signs or even barriers to prevent people from going inside. While this may help stem the spread, additional solutions are going to be necessary.

153 scientists from 20 countries participated in the survey of Espiritu Santo in the South Pacific, scouring caves, mountains, reefs, shallows, and forests collecting species. Out of over 10,000 species collected, the researchers are predicting that as many as 2000 may be previously unknown to the scientific community. Some pics from the National Geographic story are below, but we encourage you to visit this article and this article for more in depth descriptions of the creatures.

I don't know whether Bill Bennett is an actual idiot or is spoofing an idiot, but either way I feel compelled to drop a clue bomb. Here's a hint, Billy boy: The phrase "new to science" means new... TO SCIENCE!!! Yes, anyone who lived on this island probably already knew about many or even all of these creatures. But the rest of the world didn't. Unless those people were actually sharing that knowledge with the wider community of scientific inquiry - publishing species descriptions, engaging in cladistic analysis designed to find the place of these species in the web of life, etc. - then their knowledge was in no way part of the world of science.

Yikes! I've not heard of this disease, and after bugs, bats are my next favourite critters! I am greatly disheartened to see that it occurs in my province (Ontario). Do we know if it affects certain species only, or is it a generalist killer?

As a clue I should perhaps mention that the 6000 scientists participating in LHC experiment (you might have heard about it) are from 70 different countries.

Shandooga - you're such a troll. With the utter miscomprehension of biology and evolutionary theory you've displayed over the years, is there really any call for you be on science blogs when you know that no one here will agree with you or appreciate your misguided ID/creationist arguments?

Keep doing what you're doing, Bleimans. Your irreverent and entertaining take on zoology and all its forms is a breath of fresh air--you are the Daily Show/Colbert Report of Scientific news!

Evolution is something that just happens. The animals that had traits better suited to survival in this environment lived long enough to pass on these traits to their offspring. In many instances, one of these traits it something that is referred to as 'camouflage'.

Sean, shame on you for the LOBSTAAAAA song that is now stuck in my head. But I think that was in my Karma (from last time I mentioned the Rock Lobsta!).

Wow, such hostility. It's a real shame that you'd all rather fight about who found them first or why they are there than to just stop and appreciate the magnificent species many of us are seeing for the first time. When conserving nature becomes more important than nature itself, what's the point? Look for the beauty in life, be thankful you can see it before its gone.

I hate capers too! And I hate anybody who's willing to have anything to do with them. And while I'm at it, I suggest we take down the Bleiman brothers for providing a forum for their mention.

If any animal has a real shot at comeing back from extinction, my money's on the Cheetah or some other well-preserved animal that we have modern samples from... not from an animla that's been extinct for 100+ years and we're hoping some fragments of recovered DNA will be viable.

Seriously, I don't see any anti-Japanese comments upthread. I do see comments criticising the Japanese habit of killing and eating endangered species. If it were Belgians or Botswanans that hunt whales under the cynical cover of "research", those comments would have referred to the Belgians or Botswanans instead.

"Woe to you, blind guides! You say, 'If anyone swears by the temple, it means nothing; but if anyone swears by the gold of the temple, he is bound by his oath.'" - Matthew 23:16.