Random Thoughts by Mike Serovey

FDA sides with the little guy... for a change

2012-10-03T09:04:00.000-07:00

This is copied from Daily Dose with William Campbell Douglass II, M.D.

FDA sides with the little guy... for a change
It's like the school bully complaining that the kids from the chess club are picking on him.

The bully in this case, of course, is a drug company. Specifically KV Pharmaceuticals, and they're griping that a bunch of compounding pharmacists -- sorry guys, but you're the chess club -- have "stolen" the company's drug.

And just like in the cliché Hollywood movies, this bully got his comeuppance -- in court, not on the playground, but the result is the same: The bully is done for.

KV, as you may recall, slapped a patent on an inexpensive hormone treatment given to women at risk of a preterm birth -- a treatment that compounding pharmacists had been making for years for about $10 a shot.

That adds up to $200 after the 20 treatments needed during a high-risk pregnancy.

KV's version initially cost $1,500 a pop -- or $30,000 per pregnancy -- so you can see why there was a huge outcry when the pricing was announced. The company quickly cut that price in half, but who's going to pay even that much when the chess club is still selling it for $10 a pop?

So KV did what drug companies do best. No, not make a better drug... they sent their lawyers after the pharmacists, issuing everything short of death threats.

Business as usual, so far -- but here's where the story take an unusual turn: The FDA told KV to back the heck off and said it would allow the pharmacists to keep making their cheap version of the drug.

Shocked? Me too. Then, KV took the FDA to court, asking a judge to force the agency to stop the pharmacists.

And now, the judge has spoken -- KV lost, and the company's goose is so cooked that it could go under. They already filed for bankruptcy in August, and winning this lawsuit was pretty much the company's last hope.

Lesson for today: Don't mess with the chess club.

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Mental Health in the USA

2011-09-29T14:54:00.000-07:00

I recently went to a chess club in Tampa and was told that members of this club were flaming a chess player on Face Book. This player has displayed some inappropriate behavior at chess tournaments in the past year and some other players wanted the tournament director to ban this offending player. The TD knows that he has to take action or these complaining players will stop attending his tournaments that are already getting poor turnouts. However, this offending player has a mental health issue that he is taking medications for and the TD knows this. The TD has contacted the US Chess Federation about this and has yet to get any guidance on this issue because they are aware that banning a handicapped person from chess tournaments can lead to a lawsuit.

It seems to me that some of the complaining players are somewhat aware that something is off about the offending player and instead of trying to help him they provoke him in order to justify getting him banned. The TD has decided to suspend the offending player for one month in order to pacify the complainers and still be fair to the handicapped player. I see why this is necessary but really think that some people could be more understanding of those who have mental health issues and try to help them or control their behaviors instead of just flat out rejecting someone over things that they have little control of! There is no shame in having a health issue whether it be cancer or schizophrenia! Some day the judgmental idiots that live in the USA may come to realize this!

Hello World!

2011-09-29T14:36:00.000-07:00

I have been wanting to start this blog for some time now but have been too lazy to do it until today. The search engines will have difficulty classifying this blog because it does not have a theme. I may post things on this blog that some people may find offensive. My intent is not to offend anyone but to provoke thought and discussion on various topics. Two things that no one has ever called me to my face are boring and politically correct! I intend to inform my readers and express my honest opinions on various topics.

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