FDA Not Powerful Enough: Needs to Regulate Economy and Environment Too

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Science is publishing today what at first appears to be a fairly innocuous Policy Forum article on assessing the health and safety impacts of genetically modified salmon. AquaAdvantage salmon have been submitted under new animal drug application process for pre-market approval by the Food and Drug Administration. The agency is currently mulling over the largely specious health and environmental concerns posed by these salmon genetically enhanced to grow much faster while eating less feed. The FDA is basically asking whether or not eating the enhanced salmon poses any greater health and safety concerns than eating unenhanced salmon. 

The Policy Forum authors think this focus on health and safety is too narrow. Instead they want the FDA is consider a much wider range of issues, e.g, the effects of salmon farms on the environment and the impact of cheaper salmon on public health. As the authors put it in a press release about their article:

"Instead of focusing on the safety of a food taken one portion at a time or whether it was produced through genetic modifications or through classic breeding, a more useful approach would be to evaluate whether society is better off overall with the new product on the market than without it, (emphasis added)" says Jonathan B. Wiener, William R. and Thomas L. Perkins Professor of Law at Duke Law School. …

"The approval of genetically modified salmon will set an important precedent for other transgenic animals intended for human consumption," Smith says. "It's essential that FDA establishes an approval process that assesses the full portfolio of impacts to ensure that such decisions serve society's best interests.(emphasis added)"

In general, the way "society" has so far determined what new products or services are in its "best interests" has been for entrepreneurs to bring them to market and see if anyone has any interest in buying them. If they can make a profit that means enough people in "society" think their benefits outweigh their costs. If they can't make a profit, then not. The FDA's approval process for new drugs is already way too cautious. Empowering the agency to make pre-market technology assessments based on politically-contested economic, public health and environmental rationales would be a grave blow to future innovation.

This proposal has more than just a whiff of the precautionary principle, the evilest meme of the 21st century, about it.

For more background see my colleague Katherine Mangu-Ward's, "Let Them Eat Frankenfish."

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49 responses to “FDA Not Powerful Enough: Needs to Regulate Economy and Environment Too

  1. Thomas L. Perkins Professor of Law at Duke Law School”

    Idiot. Total fucking moron. Yet, he teaches at an allegedly prestigious law school. Believing that the FDA is qualified to determine what is best for society is no different than believing the earth is flat or that dinosaurs and man once walked the earth together. Yet, unlike to first two superstitions, belief in the FDA is rewarded. We are so fucked.

    1. You beat me to it. If I were one of this guy’s students, I would be in the President’s office demanding a refund of my tuition for having been taught by an obvious moron.

      If I had a degree from Duke, I would be hanging my head in shame right now.

      1. to be more specific…

        “a more useful approach would be to evaluate whether society is better off overall…”

        If you actually try to assign real meanings to these words, instead of just stringing them together to sound good, you will realize almost instantly what a stupid statement it is.

        1. But isn’t stringing together words that sound good but mean nothing or something absurdly stupid the golden ticket to success in academia?

          1. Maybe in Law. My colleagues in mathematics would laugh in my face if I said something like this.

            1. That’s why mathematicians get paid the big bucks.

              1. Maybe we need a professional licensing cartel to restrict access to the profession…then we could get paid more.

            2. Not just law but any of the humanities or cargo cult I mean social sciences.

              1. The amount of stupid, self-serving, psuedo-scientific garbage that comes out of humanities and social science departments should bring shame upon any university that has the slightest interest in academic integrity. Most of their studies set out to prove their hypothesis instead of testing it, and they cherry pick data points even worse than the ICCC.

                Now a large chunk of these moron profs and students are serving in our government, god help us.

        2. In their eyes, there are no decision to be made by the individual in determining their own good, there is only the decision made by a bureaucrat to determine whether society stands to gain. Fuck that piece of shit professor.

          Technocrats interfering with what I decide to eat brings to mind Mencken’s quote: “Every normal man must be tempted at times to spit on his hands, hoist the black flag, and begin to slit throats.”

          1. Collectivism is incredibly creepy. It is such a repulsive, disgusting human tendency, and is even worse when taken to the extremes of “for the good of society”.

          2. It seems like coming to this site always makes me feel that temptation. Seriously.

          3. Where do the technocrats come down on Monster Truck Rallies?

            On the face of it, I’d be OK with banning them as an abomination. However, after going to a couple, I have to say that the glee on the faces of my kids as big noisy trucks smash everything on the floor of the Metrodome into flinders is worth every penny of the $17 I have to pay to get us in.

            As a bonus, after sitting in the stands at a monster truck rally with the hoi polloi, I feel as smug as a Duke law professor for a couple of weeks. Then my car breaks and I have to pay $$$ to one of those Polaris wearing rednecks to fix my car, at which point I remember that I am a dork with no real skillz except for programming.

  2. Don’t denigrate the Precautionary Principle. It is the key to all government action, and God only knows where we would be without the Department for the Prevention of Alien Influence.

  3. I’m thinking tar and feathers really isn’t what Mr. Perkins needs. A good horsewhipping seems more the ticket.

    But that’s just me.

    I’d be curious to hear this law professor identify the enumerated power that enables the government to ban private activities that it determines is not in society’s best interests.

    He’s such an idiot, I’m guessing he’d go with the General Welfare clause.

    1. Interstate commerce clause man. It is the Swiss army knife of federal government stupidity.

  4. Yet again, it’s Atlas Shrugged coming to life.

    1. I remember reading Atlas Shrugged and thinking it was cartoonish and overwrought. The 21st Century is proving me to be a fool.

      1. I tell newbies to A.S. to get ready to be screaming in horrified recognition of current people and affairs.

        The Road to Serfdom has that effect, too.

        1. My father, someone who liked the book but is not an objectivists, always refers to Rand as “an okay novelists, lousy philosopher, and incredible futurist”. This was in the 1980s. You can debate the first two. But damned did he nail it on the third one.

  5. The people at FDA are very, very wise.

  6. The precautionary principal mean that we cannot take an action until we COMPLETELY ASSESS THE AFFECT of the precautionary principal. Therefore, precautionary wise, I think to follow the precautionary principal means that we cannot implement the precautionary principal until we have irrefutable proof that the precautionary principal does no harm…just wouldn’t be prudent (said in a Dana Garvey voice, impersonating Bush I)

  7. If I were the AquaAdvantage folks I would start looking at foreign markets ASAP.

    BTW, why does a fish need to be approved for consumption? Are we at the point where every new food product needs approval before it can be brought to market? This is absolutely ridiculous.

    1. Psst.

      (opens trenchcoat)

      Wanna buy a fish for consumption?

      1. kinda looks like an eel…
        not that there is anything wrong with that…

        1. That’s my pet mudpuppy. Get your mind out of the gutter.

        2. Sexist!

          You assumed that that only men can sell illicit food items? Obviously anyone selling a funky, fish smelling item in a back alley is going to be a womyn.

          Just hope she isn’t from WV and has a knife.

    2. Depends on where you fry your fish.

    3. Fish is a gateway food. It could lead to _____________.

      1. Lead poisoning…

  8. Interracial sex will make us all prey to Behemoth! Cut it out!*

    *That isn’t Sherman Hemsley who’s serving as mutant snakehead bait, but it sure looks like him

  9. But the proposal wouldn’t necessarily make FDA more cautious. The principal author in the press release said:

    Lower prices for salmon would have significant public health benefits. Consumers would have access to a less expensive source of healthy protein and omega-3 fatty acids, which have well-documented health benefits.

    So the sponsor of the appl’n to market a food might get a break on the safety front if it looked somewhat in doubt. Considering that the current interpret’n doesn’t take such benefits into account, this might alleviate some of the bias vs. GMO foods in licensing. I say, go for it!

    1. Maybe even Mickey D. could make the Fish into a Happy Meal (except for S.F.).

    2. Robert: That’s why this particular article is so subversive-it suggests that the process the researchers want to establish might well conclude that enhanced salmon are “best” for society this time. Never mind that pre-market FDA approval slows innovation and might conclude that some techs in the future are socially undesirable.

      1. Yes, the State agrees, first enhanced salmon, then enhanced subjects, er, citizens…

    3. First, a bureaucrat will always weigh a possible or even imaginary risk far more heavily than the benefits.

      One need not look any further than the bans against GMO plants in many countries in the world, which is already allowing people to starve in the name of ‘protecting’ them.

  10. “Put my fishy in da four loko pool! Oh yeah!”

  11. In general, the way “society” has so far determined what new products or services are in its “best interests” has been for entrepreneurs to bring them to market and see if anyone has any interest in buying them. If they can make a profit that means enough people in “society” think their benefits outweigh their costs. If they can’t make a profit, then not.

    But, Ron, this “market system” is simply too icky and slow for those hungry for action and top-down control. Government experten and technikern, instead, have the mental wherewithal of the very gods to decide these things for us…

    1. Verile, Washington, D.C. is the new Mt. Olympus, and verily, the gods who dwell there look upon us and smirk…

      1. ‘verily’

  12. Ugh. You really want a bunch of unelected bureaucrats making decisions about what should be allowed based on “how it will affect society as a whole” ?

    This is why I hate people so much.

    1. All that hate is going to give you wrinkles, cutie pie.

  13. I did a short stint at the FDA in Rockville as a contractor. In telling me the what and why of my job, my supervisor boasted that the FDA regulates something like 70% of the entire economy.

    He was a fine fellow, and I don’t know if that statistic was accurate, but the idea gives me the creeps, especially given some of the knuckleheads I saw walking those halls.

  14. Where is FDA and their Precautionary Principle when it comes to TSA’s radioactive pornscanners?
    Oh sorry, it’s only applied to restrict behavior…

  15. that means enough people in “society” think their benefits

    Sacre-bleu M. Bailey, you would have the people make decisions for society?

    “Le societe’ est moi.” – Typical elitist twit

  16. See, I’m honestly wondering how people think of society like this? Does it hurt? Because to me, it’s just a bunch of individuals, everything the sum of its parts, but for some it’s something else, and I wonder how exactly they conceive of what’s added or subtracted.

    Salmon don’t really negatively impact the environment, and modified ones certainly won’t any more than “natural” ones. In any case, if they do cause real damage to property, we have systems that already exist to deal with it as long as the company can be held accountable. Whether society benefits from an AquaAdvantage salmon is then determined by whether folks are willing to pay to eat it. Simple, done.

  17. After reading all the comments, I wonder if any has read the paper at all. The main message in the paper is that since it is FDA?s jobb to analyze the consequences of a new GM salmon, they should look at positive effects also, and not just the negative ones.

    They could of course write that FDA should not care and allow everything, however sometimes you have to accept the world you live in.

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