What you describe is essentially a form of bootstrapping, which is a legitimate statistical method. However, there are important limitations that cannot be overlooked.

First, the constructed data are still being created from real data. Ethics is not just about preserving patient privacy, although that is a very important aspect. It's also about taking into consideration how the data will be used. Does the patient consent to this use, and if they are unable to consent, how should this be taken into consideration? Medical science has not had a stellar track record with respect to ethical human experimentation (e.g., Henrietta Lacks, the Tuskegee syphilis study, MKUltra--and that's just in recent US history). There is a documented history of patient collected data being used in ways that those patients never even conceived, let alone anticipated or consented. Caution must be exercised whenever any such data is used, even indirectly.

Second, this kind of simulated data is problematic to analyze from a statistical perspective, and any biostatistician should be aware of this: there is no such thing as a free lunch. The problem of missing data--in actual patients!--is itself difficult to address, since methods to deal with missingness invariably rely on various strong assumptions about the nature of that missingness. So to make inferences on data that is entirely simulated is, at the very least, as problematic as analyzing partially missing data.

Third, the current state of LLMs, and their demonstrated tendency to distort or invent features from noise (which is arguably the primary mechanism by which they operate), is such that any inferences from LLM-generated data would be questionable and should not be considered statistically meaningful. It could be used for hypothesis generation, but it would not satisfy any kind of statistical review.

It all comes back to what I said in another comment: you can't have it both ways. If you can draw some statistically meaningful conclusion from the data, then that data came from real-world patients and must pass ethical review. If you don't need ethical review because the data didn't come from any real patient, then any inferences are dubious at best, and are most likely just fabrications that cannot pass confirmatory analysis.

The purported claim is that "because the AI-generated data do not include data from actual humans, they do not need ethics review to use."

But if the data only represent actual patients in a "statistical" sense (whatever that means), how can the research be CERTAIN that it has captured appropriate signals or effects that are observed in such data? And I say this as a statistician who has over a decade of experience in statistical analysis of clinical trials.

There is a fundamental principle at work here, one that researchers cannot take the better part of both ways of the argument: any meaningful inference must be drawn on real world data, and if such data is taken from humans, it must pass an ethics board review. If one argues that AI-generated data doesn't need the latter because it is a fabrication, then it doesn't meet the standard for meaningful inference. If one argues that it does meet the standard, then no matter how the data was transformed from real-world patient sources, it requires ethics board review.

In biostatistics, we use models to analyze data to detect potential effects, draw hypotheses or make predictions, and test those hypotheses to make probabilistic statements--i.e., statistical inferences--about the validity of those hypotheses. This is done within a framework that obeys mathematical truth, so that as long as certain assumptions about the data are met, the results are meaningful. But what "statistically naive" people consistently fail to appreciate, especially in their frenzy to "leverage" AI everywhere, is that those assumptions are PRETTY FUCKING IMPORTANT and using an LLM to generate "new" data from existing, real-world data, is like making repeated photocopies of an original--placing one model on top of another model. LLMs will invent signals where none originally existed. LLMs will fail to capture signals where one actually existed.

This might not be such a good idea as Vegas was begging Canada to come back. Their tourism isnâ(TM)t what it used to be and talk of 51st state has turned off Canadian tourism.

and the boys were already ten and eleven years old when I entered their life

I hope you got a good relationship with them! My son can't even talk yet. So, right now, he's just this cute thing that runs around and causes trou^H^H^H^Hgood things to happen.

Well, some of that is for classes for people who can't see that default 3-pixel wide scrollbar on Windows 11 in high contrast dark mode. :-)

Fair. Just making fun of Windows 11.

Yeah, you're blessed to have one of each. Until they start conspiring against you, which you KNOW is going to happen.
ha!

Hopefully we'll raise them better than that. And let them see us honoring our parents.

You charge to "upgrade" to Windows 11? How evil are you? :P

For all my pro-life ramblings, we were granted only one child.

Precious. I feel bad you couldn't have more though. G-d has been very generous to us.

Keeping up with two toddlers after age 50 can't be easy.

And yet i wouldn't trade it for anything! Thank G-d, we have a lot of help. Especially, when some neighboring girls come by to take our son for a walk. G-d bless them all.

In fact, it is UNETHICAL to use a placebo control in any clinical trial of an investigational product for which the existing standard of care already includes a product on the market.

In plain English, it is entirely unethical to give participants a placebo to test the efficacy of a new flu vaccine when we already have existing vaccines on the market. Doing so denies participants in the study from accessing effective treatment. If you have to test against a placebo, it will be impossible to recruit participants, because nobody will take the chance to receive placebo when they could just go to the pharmacy and get vaccinated.

There are only two possible explanations for such a position: either gross ignorance of basic scientific and ethical principles for conducting medical research in humans, or deliberate malicious intent to stop all research of investigational drugs. It doesn't actually matter which one is the reason. Both are entirely unacceptable.

The fact that a huge segment of the American population does not understand even the most basic scientific principles is the reason why many people will die needlessly.

I agree that this therapy is not without significant risks, so it's not to be taken lightly.

That said, the long-term health outcomes of T1DM are also significant. So the way I see this development is that it is one more step on the path toward finding a durable, safe, and effective cure. And if approved, it may offer some patients another choice, one that of course should involve an informed discussion with competent healthcare providers.

It's important to keep in mind that healthcare is not a "one size fits all" thing. Two patients that have the same condition can respond very differently to the same therapy. Before the discovery of insulin, diabetics literally just...died. So on the path to understanding this relationship between the individual patient and the selected therapy, medical science can only offer a range of treatment options. At one time, humans believed in bloodletting, lobotomies, and arsenic to treat various illnesses. We built leper colonies. And in some places in the world, menstruation is still considered "dirty." We have made many advances, but there are still many more to be discovered.

I'd rather use a slower browser that honors the user's choice of extensions--in particular those that block malicious content and privacy-violating advertising trackers--than an ostensibly faster browser that is created by a company whose entire business model is to gather as much tracking data about you in order to sell it to advertisers.

There are alternatives to both Firefox and Chrome. But choosing to use Chrome because Firefox isn't perfect is either the height of idiocy, or being paid to promote Google products.

Birth defects due to thalidomide approval outside of the US were extensive, and you conveniently ignore this. That wasn't some media psyop: 20000 affected embryos for a drug marketed to prevent morning sickness is not something to trivialize, and the fact that it was not approved in the US meant that many American families were spared this horror.

It's ironic that you mention Type I and Type II errors, yet conclude--without any apparent consideration of such errors as they apply to the establishment of efficacy and safety--that somehow "Montana has the right idea." How would they have the right idea if anyone can choose to receive unapproved drugs before any data collection and statistical analysis is performed? That to me suggests you don't have the faintest clue about what a Type I error means.

This is a horrible plan on so many levels.

An investigational treatment that has passed Phase I only has the most basic pharmacokinetic and safety data gathered. There's virtually no efficacy data. The layman who thinks that patients with serious and unmet medical needs should have access to such treatments before efficacy is established, believes so because "what other options do they have?" Their logic is that they should be "free" to try anything.

But the primary reason why this logic is flawed is because a very high proportion of treatments at this stage of clinical development are inadequate--they are either ineffective or unsafe, or both. The second reason--one that never crosses the layman's mind--is that providing such early access would cripple trial enrollment. If even one state passes legislation to circumvent regulatory oversight, then patients will simply demand access through that state, rather than enroll in a trial and deal with the burden of following the trial protocol and procedures. And this will absolutely cause statistical and ethical problems with analyzing efficacy and safety in a trial context. The result will be either a serious delay in securing marketing approval for therapies that do succeed, or even worse, pharmaceutical companies will simply sidestep the regulatory process entirely and just start make marketing claims for untested compounds. After all, why bother spending hundreds of millions of dollars on a development program to secure approval if one state lets people try whatever they want?

One more comment: drug companies do have a pathway for patients in dire need. It's called "compassionate use" or "expanded access." So it's not like there's a brick wall preventing patients from accessing investigational therapies when they do not meet the inclusion criteria for a trial. But opening the floodgates is going to hurt way more people than it might help.

This is exactly correct, and it also furnishes a rebuttal against the claim that AI generated "art" is not theft any more than it would be theft for a human to study, learn from, and draw upon the works of other humans. If that were true, these models would not need to be trained on original, real-world data--it could simply train itself. But model collapse is very real, and the desire of companies to steal original content from its creators by any means possible amounts to a tacit admission that the output is neither original nor on equal footing with the human-created data it was trained on.

Yes, the output can be impressive; it can mimic or even surpass human-created work in some ways. It can be incredibly useful and meaningful. But that is only because it was trained on data that had those properties to begin with. Existing AI models are not truly creative in nature, and the inability to self-train is proof.

I am dismayed that a virologist would say such things, as I would expect them to know better. The truth is that we simply do not know. There is insufficient evidence to predict whether or not the current human population has any clinically significant immunity to this H5N1 subtype. We do not even know whether or not it will mutate to become more transmissible from human to human.

Yes, there are some basic principles at work that might suggest that preexisting infections and vaccinations for human influenza could confer some degree of protection. But that's such a broad and superficial notion--it doesn't convey any sense of the extent of protection, if any. The 1918 flu pandemic ("Spanish flu") that killed millions of people, of course did not occur in a totally immunologically naive population with respect to human influenza, so what justifies any assertion that our existing exposure to human influenza will confer protection against H5N1 in any meaningful way?

In any population there will be intrinsic variability in which some people will be more susceptible to worse clinical outcomes, and others who will be less susceptible. We do not yet know who these people are, because this disease is not yet pandemic or endemic. We still don't even know who these people are for COVID-19, which has become endemic. I would have thought that especially among the scientifically literate, people would have learned something from the COVID-19 pandemic with respect to making predictions or assertions about the behavior and impact of infectious diseases on a population. I've long since given up on the general population learning anything. But I am deeply disappointed that a virologist would speculate on such matters, as the message inevitably becomes further distorted by journalists and then politicized and warped beyond all recognition by a self-absorbed and uneducated public.

If there is evidence for association or a dose-response relationship, then what is the underlying causal mechanism? That's the real question. Alcohol consumption has other health effects, many of which are detrimental. So before this research can be considered useful, it has to explain what is happening at a metabolic level; e.g., what is alcohol consumption doing to lipoprotein synthesis or endogenous cholesterol.