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VC: Rumors of Its Non-Brokenness are ... Wrong

24 points by cwan 16y ago

lkrubner 16y ago
It is unfortunate that, in the USA, the FDA and EPA keeps such a heavy lid on innovation in the biotech sector. Whereas the tech industry had the luck of being allowed to run relatively free for 50 years, the biotech industry needs to get approval for anything it might want to do. It seems to me likely that at some point in the 21st century the biotech sector might lead a revolution in the economy similar to what the tech sector was able to achieve 1960-2000, but sadly, the biotech sector faces so many checks and limits, that the pace of innovation will probably not be allowed to ever match what the tech sector achieved in the past. Some have argued that the FDA needs to heavily regulate everything in biotech, so as to protect lives, but this argument cuts 2 ways - the heavy regulation also freezes out a certain amount of innovation that would also save lives. More so, the FDA insists that any treatment that is approved must work for a known illness, and it has steadfastly refused to define "aging" as an illness, so no business can go after aging by itself and have any hope of meeting with regulatory approval. And aging is a major contributor to illness and death. More so, the biotech industry includes a lot of areas of research that have nothing to do with human health, but these other applications of the technology tend to run into the regulatory limits of the EPA. Genetically engineered bacteria that can break down various toxins are useful, and have been approved. Genetically engineered organisms that have novel applications would have to work their way through an approval process that might take many, many years. All of this raises the costs of accomplishing anything. Millions of dollars get spent on lawyers, who haggle with the regulatory authorities - we can only dream of how much good might be accomplished if that money could be spent on research. There are, of course, good arguments why these regulatory agencies should exist, but since they exist, they also must defend their legitimacy, which leads them to often exaggerate the dangers that they are, in theory, protecting us from. Thus defenders of the FDA paint a grim picture of what life would be like without it. And yet, the FDA, like any regulatory body, tends to be staffed by people who come from the industry that it is regulating, and so, over time, the FDA tends to develop a viewpoint in keeping with the industry. This is known as "regulatory capture". The worst aspect of this is that the regulatory bodies come to identify with the established players in an industry, while looking upon newcomers with a certain amount of unearned wariness. The combination of regulatory capture and wariness of newcomers leads to situations where the FDA is slow to act against reports of e coli at a plant owned by a well known meat producer, while at the same time, acting slowly to allow novel uses of, say, stem cells to repair damaged tissues. Thus people die from those very things that the FDA was first enacted to protect us from (food poisoning - the FDA was created in part by public revulsion to what the public read in Upton Sinclair's novel, The Jungle), while at the same time the FDA "protects" people from novel treatments that might save lives.

24 points by cwan 16y ago

It is unfortunate that, in the USA, the FDA and EPA keeps such a heavy lid on innovation in the biotech sector. Whereas the tech industry had the luck of being allowed to run relatively free for 50 years, the biotech industry needs to get approval for anything it might want to do. It seems to me likely that at some point in the 21st century the biotech sector might lead a revolution in the economy similar to what the tech sector was able to achieve 1960-2000, but sadly, the biotech sector faces so many checks and limits, that the pace of innovation will probably not be allowed to ever match what the tech sector achieved in the past. Some have argued that the FDA needs to heavily regulate everything in biotech, so as to protect lives, but this argument cuts 2 ways - the heavy regulation also freezes out a certain amount of innovation that would also save lives. More so, the FDA insists that any treatment that is approved must work for a known illness, and it has steadfastly refused to define "aging" as an illness, so no business can go after aging by itself and have any hope of meeting with regulatory approval. And aging is a major contributor to illness and death. More so, the biotech industry includes a lot of areas of research that have nothing to do with human health, but these other applications of the technology tend to run into the regulatory limits of the EPA. Genetically engineered bacteria that can break down various toxins are useful, and have been approved. Genetically engineered organisms that have novel applications would have to work their way through an approval process that might take many, many years. All of this raises the costs of accomplishing anything. Millions of dollars get spent on lawyers, who haggle with the regulatory authorities - we can only dream of how much good might be accomplished if that money could be spent on research. There are, of course, good arguments why these regulatory agencies should exist, but since they exist, they also must defend their legitimacy, which leads them to often exaggerate the dangers that they are, in theory, protecting us from. Thus defenders of the FDA paint a grim picture of what life would be like without it. And yet, the FDA, like any regulatory body, tends to be staffed by people who come from the industry that it is regulating, and so, over time, the FDA tends to develop a viewpoint in keeping with the industry. This is known as "regulatory capture". The worst aspect of this is that the regulatory bodies come to identify with the established players in an industry, while looking upon newcomers with a certain amount of unearned wariness. The combination of regulatory capture and wariness of newcomers leads to situations where the FDA is slow to act against reports of e coli at a plant owned by a well known meat producer, while at the same time, acting slowly to allow novel uses of, say, stem cells to repair damaged tissues. Thus people die from those very things that the FDA was first enacted to protect us from (food poisoning - the FDA was created in part by public revulsion to what the public read in Upton Sinclair's novel, The Jungle), while at the same time the FDA "protects" people from novel treatments that might save lives.