Sometimes there’s a race to market between two or more similar-seeming drugs. One may be way ahead of the others in its stage of clinical research and regulatory filings. Does that mean the others are worthless me-too’s? Not if the first crashes and burns in Phase III on the basis of efficacy and/or safety and one or more of the stragglers proves more worthy. Without getting specific, this happens.

Other times, as with antiviral or oncology drugs, the human stakes can be so high that a me-too drug in an existing class could be considered a worthwhile advance even if it affords only a modest incremental improvement in efficacy or tolerability.

Finally, although first-in-class drugs can carry medical science to new heights, they can also prove — often at an exorbitantly expensive late stage of development — to possess fatal flaws that rightly keep them from entering the market, or (if too subtle to be picked up in Phase III) get them pulled from the market later on. In my day job, over the past several decades, I’ve seen this happen far more often than dazzling successes.

That’s just to point out that developing truly novel medications is a spectacularly high-stakes game. A company’s rational calculus may net out in favor of paths of lesser resistance. In such cases, the system that gave rise to the calculus may be at greater fault than those acting on the calculations.

As to your second paragraph, I hope everyone in the GG family can enjoy their hard-earned rest for the rest of this month. Here’s to peace in the new year, and wishing health and strength to all of you.

As to us:

We’ve been under a massive attack for last two weeks both hacking attempts and Distributed Denial of Service attacks. We had to bring the site down we were already planning to take advantage of the proximity of Eid and Christmas to move the more important parts of “Guides” to separate servers, bring in new facilities for members, harden the site, etc. This made doing that even more important and a lot more stressful.

Nur Khaled and Mohammed have put up the Christmas greeting which means I can take it easy tomorrow I doubt we will post anything further. Or do much posting until January.

I suspect the NIH grant process is now polluted by industry plants who came in through the revolving door.

Actually, the NIH is one of the few executive branch bureaucracies that hasn’t been completely destroyed by the Bush regime. The overwhelmingly vast majority of career civil servants who administer the peer review and grant portfolio systems are Ph.D. and/or M.D. biomedical scientists who are not political appointees. Only the head of the NIH itself is truly a political appointment; even the heads of the individual institutes that make up the NIH are genuine biomedical scientists.

There has been no politicizing/privatizing revolving door at NIH. This is not to say that there haven’t been ideologically driven decisions–e.g., most prominently, in the case of embryonic stem cell research–made that relate to NIH. But NIH is one of the few executive agencies that hasn’t been severely tainted by the Bush regime.

Maybe this is because they don’t grant Ph.D.s in the biomedical sciences at Regent University!

I sat in on house sub committee hearings and it was an eye opener.