- O’Neill represents the best candidate to bring the FDA into the 21st century, into the age of startups, personalized medicine, and the rapid development of new drugs. He understands both the FDA as well as biotech startups. This gives him unique insight into how to reform the FDA, ensuring the FDA can be a partner, rather than a roadblock, for innovation. If the next 25 years can be as revolutionary for medicine as the past 25 years have been for computers, that would be tremendous, and O’Neill is determined to help us get there.
I'm sure that the process could be streamlined in many ways but there are real risks to pushing drugs out before they have been thoroughly vetted. Thalidomide babies is of course the go to horror story, of course there are others. It doesn't always appear that many of the drugs that make it through the process are always safe, it's a fucked up system and I wouldn't put my hopes on one of Donny's venture capital bros to make it better.
Watch daytime TV. There are so many lawyer commercials about hernia meshes, hip replacements, blood clot filters, baby powder, and medicines I can't even pronounce, let alone remember the names of. Chances are, the more these roadblocks are removed, the more of these kinds of recalls will pop up.
The author is associated with the Cato institute. He's also a proponent of "Free Cities," cities within a national boundary that don't have to comply with national laws like environment, human rights, workers rights. A return of the company town, unburdened by pesky shit like democracy. It's good for business! Freedom to innovate without the burdens of the last 150 or so years of social/cultural development! My best guess is that Jim O'Neill is an antisocial demon.
That explains quite a bit. Anytime I hear whining about regulations, my first thought is to wonder which people the author wants to throw into the furnace of industry. Life shouldn't imitate Dwarf Fortress.
No and I'd like to keep it that way :) While FL is a new offering, much of the road we are traveling had already been paved by ththe cord blood industry. We operate under the same criteria they do. I would be keen on an FDA that allowed for autologous stem cell treatments, meaning stem cells that are from you being put back into you. I think we should be allowed to expand and culture them and reintroduce them therapeutically. So far as I know there is not one documented case of autologous stem cell reintroduction having any negative effects. It's really easy to say the FDA should be more strict, have more bureaucracy etc. but there are real world implications, life and death implications. I fully realize that there are life-and-death implications of drugs that are hastily approved drugs have life and death implications as well. I think there's a common sense approach that could be found. I have realized over the course of my professional career is that the more familiar you are with an industry, vertical or area of business the more you realize how ridiculous the bureaucracy therein is. When you're outside of those areas you think that the health inspector in your town should have 1 million codes to hold your coffee shop hostage to and to keep us all safe. But when you run one, you see how bloated and ridiculous it is. Much of it is appropriate but so much of it is excessive.
Funny thing, Multnomah County Health has a terrific inspection program. They concentrate almost all their attention on basic issues that cause foodborne illness. They are looking for proper temps, date & rotation, basic storage procedures, and functioning well stocked hand washing stations. An inspector is more likely to give you a reasonable education on the ways that your current food handing practices are lacking than to bust your balls and write citations. Best health inspectors I've ever delt with. The respect they show workers and the honest interest they show in concentrating on truly dangerous practices makes me way more likely to listen to them, ask them questions and deal with them openly and honestly.
You are fortunate, that is not always the case, as I'm sure you know.
The great thing is that everyone in the process is more fortunate. The public, owners, workers and inspectors are all well served by the way they handle things. The guy who normally would have done my initial pre-opening inspection couldn't make it and a guy who was higher up was covering for him. I had an easy inspection, all my ducks were in a row and the issues he brought up were minor and a bit bullshity so we shit the shit for a bit. I mentioned how it seemed like they concentrated on a small list of really important issues and focused their energy in best practice education. He was delighted to hear this and said that preventing foodborne illness by concentrating on the half dozen ways that it's most commonly caused was a conscious decision of the department. They always try to start with education first and only go to hard ass enforcement as a 2nd option. I don't know how you apply this to the FDA but I'm sure that the FDA could learn something from MultCoHealth.
In humans. In the US (and other jurisdictions that follow FDA guidelines). That's important to keep in mind. If the chain were off, you'd see some real problems. For example, in rats if you give too many cells too quickly, you can easily cause a blood clot that is fatal. I'm sure this kind of thing happens at fly-by-night clinics in developing countries and probably isn't well reported. The FDA can be a big pain in the ass, and I'm all for speeding up the drug discovery process, but they also serve as a very important check on people who don't mind experimenting on humans. The bottom line is that industry and the FDA shouldn't be adversaries. We should work together to build safe products while stifling innovation as little as possible.So far as I know there is not one documented case of autologous stem cell reintroduction having any negative effects.