This Is Your Brain on Drugs

A previous missive bemoaned the death of the financial quant, which doesn't exactly break my heart. But we now have reporting that Kim Jong-Don has set out to kill off the bio-stat (or pharma quant). This is far more serious. If only because it's an assault on science. Clinical trials are important science, not FDA obstruction. But the Randians only see the real world through her kaleidescope glasses. David Frum, no bleeding heart lefty, said it all (on one of those left wing MSNBC interview shows), this will be the most corrupt administration in history.

Pay attention to the money. That is the story of the next four years. Organized self-dealing, self-enrichment of the Trump administration.

If there were any doubt that Kim Jong-Don and his cabal of Randians needed medical attention, read up this bit of legislation. Snake oil for all.

The bill includes a safe harbor provision which would prevent FDA from considering adverse events tied to administration of unapproved drugs to terminally ill patients under compassionate use. The bill would prohibit the federal government from using data or experiences from compassionate use "to delay or otherwise adversely impact review or approval" of a drug or device.

For those who don't follow the process by which medicines come to you, the major impact of this insanity would be to make controlled trials virtually impossible. There would be no incentive for critically ill patients to seek out clinical trials, and without controlled trials, no one would ever know whether DrugX actually works. And, of course, such snake oil would be nicely highly priced, since drug companies could make any claims they want. The other shoe: once enacted, these same clowns will write legislation compelling Medicare/Medicaid to pay for such drugs. Win/win for charlatans.

Here's the other really notable quote

A 2016 study commissioned by BIO found that from 2006-2015, an average of 63% of Phase I trials were completed successfully, while only 10% of drugs that entered Phase I were eventually approved.

Why all this is important? There are three primary phases of trial (some post-approval testing is called Phase IV). Phase I merely tests on, generally, a handful of individuals, whether the compound is deadly. Eventually, the compound goes through a (or two or three) large population, controlled Phase III trial, which provides sufficient data to demonstrate that it really has no nasty side effects and that, "It works, by Jove, it works!!!" So, of course, an inert compound will pass Phase I; be claimed to be a miracle cure for some nasty sort of cancer, say; be sold for a king's ransom; never undergo further efficacy trials; and rake in millions or billions of dollars to charlatans. Stupid people put Kim Jong-Don on his throne.