Excellent point, but one correction for you: Messner is Tyrolian (Italian). Just a friendly FYI.

You do realize the paradox in believing that the world is entirely defined by physics and that "fate" (aka determinism) is false? To reconcile your world view, you need to have a mechanism that allows for free will, even if based in randomness. Are QM events truly random? Could they impact the atomic and macro level? Is that your definition of free will? Or are you a dualist? (Which would directly contradict your other stance.)

Otherwise, you need to accept that physics rules all and fate (determinism) is real.

Literally. The subjects were tested for changes in sexual functioning via the Sexual Quality of Life-Female (SQOL-F) and International Index of Erectile Dysfunction (IIEF) Questionnaires. The authors reported no improvement in the men, but in the women... bingo!

With a mean age of 75.5, and improved sexual response and quality of life, they'll be preying on millennials and gen-Y.

I agree that it likely won't be replicated in a larger trial, but not for the reasons that you state.

Dose response can be straightforward in small molecule drugs, like aspirin. It becomes more complicated in biologic drugs, like granulocyte colony stimulating factor (filgrastim). We don't really know how it will work with stem cells, and the authors do list biologically plausible reasons why they don't see a dose response.

The real issue (besides the really low # of subjects) is the statistical analysis. They compare change from baseline (outcomes at 6 months vs. baseline) within a treatment group and look for statistical significance. What they should be doing is comparing change from baseline within a group vs. the change from baseline of the placebo group. See how the error bars of the 100 M group at 90 and 180 days overlap with the error bars of the placebo group in figure 2A? Not statistically different from placebo.

Granted, it would be crazy effective if it were statistically significant vs. placebo in such a small trial. However, their poor use of statistics (including no accounting for multiple analyses) is a major red flag. But this is about raising VC, as others might have pointed out. Multiple authors with MBAs rather than professional degrees (PhD, MD) is a giveaway.

There are a number of companies that will take the ashes from cremation and use them to make a diamond. Wouldn't that be respectful for the ancestor? Turn them into a diamond, make a pendant, and they can be remembered daily. Brings an entirely different meaning to the phrase "family jewels".

What if AC shows up? All of them? Good grief, the venues would experience the Slashdot effect in real life.

Moderators, gird your loins for that one!

Again, I assert that you are mistaken, or misunderstood my last comment.

The newer patents, that Allergan is arguing allow commercial exclusivity, will expire in a couple of years. After that, anyone can sell generic Restasis. It is not indefinite exclusivity from generic competition. In your example, with a cancer drug, the patent shouldn't be granted because the applicant is not the inventor, sovereign immunity or not. Likewise, the longer process to invalidate the patent will still exist and be applicable, sovereign immunity or not. It's the shorter process (IPR) that can be skipped due to sovereign immunity.

As for Restasis, it's the formulation, i.e., the concentration of cyclosporin and other ingredients, that is patented. They didn't patent cyclosporin itself.

Anyway, in another comment I conceded that this could be a problem if real patent trolls exploit it, so I can see why the loophole should be closed. In the particular incidence in TFS, I found it to be more of an interesting piece of legal maneuvering. But I still think there are other problems that need to be addressed, that aren't getting this much attention.

It doesn't matter if the lay person sees it for what it is. Every day that generic competition for Restasis is delayed equals millions of dollars of revenue for Allergan. This is not about a perpetual monopoly on selling cyclosporin eye drops, it's about delaying generic competitors coming to market. It was never meant to be a winning strategy, only a delay tactic.

Nobody denied A, but is this loophole is being exploited by an army of patent trolls? This example (Allergan and the formulation patents for Restasis) was the first, to my knowledge, but I'm curious to know if there are legitimate patent trolls using this loophole.

Either this has gone under the radar for 5+ years (America Invents was passed in 2011), or Allergan was one of the first to find it. But you sort of made a fair point: it could be exploited by real patent trolls, so let's close it now.

(I don't consider pharma companies patent trolls, in the classical sense of the term, as they look to fiercely fend off generic competition, which will come to the market eventually, rather than sue others for violating their patents.)

I don't think you understand this "loophole". It's not about patenting something that someone else created, it's about delaying the invalidation of patents by forcing a process with a longer timeline.

The particular example is not about a patent for cyclosporin, it's about a patent for the formulation of Restasis, which contains cyclosporin.

Hmm, if only there were some source of high density energy underwater. Like something that could have precipitated the origins of life on Earth?

This has been known for a while, but perhaps not broadly known, and not by "the general public". The link to the ICLAC in TFS is evidence of that.

The actual paper will answer your questions, but briefly: people make mistakes in maintaining cell lines, and contamination is easier than you think, particularly in primary cell lines.

I didn't see the authors mention if reproducibility sorts this out, if someone can't reproduce the results in another cell line or in an animal model, the original results are considered context dependent.

Really? This is the biggest problem of the patent system, requiring an immediate legislative fix?

The FDA Advisory Committee materials and presentations are here, for those interested.

Note that this is for a very specific genetic cause of blindness, where a mutation in a gene for an enzyme results in effective loss of that specific enzyme. The drug is a retroviral vector encoding only the missing gene. Other causes of blindness, genetic or otherwise, wouldn't benefit from this treatment.

Pretty amazing, and a long time coming for gene therapy, since Jesse Gelsinger's death prompted a long close look at using adenoviral vectors for gene therapy.

...you have to break a few eggs. A few lives lost every year due to "terrists" are a small price to pay for freedom.

I am willing to risk the ridiculously small chance that my family and I will die in a terrorist incident in order to preserve our freedoms, despite continued government attempts to erode them (Patriot Act, etc.). I'd like to think that anyone sufficiently educated in mathematics and history would logically come to a similar conclusion.