ppp 03-31-08

Quote of the day: Space is big. You just won't believe how vastly, hugely, mind- bogglingly big it is.

I mean, you may think it's a long way down the road to the chemist's,

but that's just peanuts to space.

Douglas Adams, The Hitchhiker's Guide to the Galaxy

What day of the year can you buy a frank at the ballpark and be assured that it has not spent days soaking in wiener water? That right… the first day of baseball season. Each player starts the day with a perfect season… no errors… no strike-outs… no injuries… just a fresh start and a world of opportunities. By September the realities have been tabulated ad nauseum… balls, strikes, run, hits, errors… and not all who started the season will finish on the field.

A new drug approval and launch are a lot like opening day at the ballpark. The pre-season (pivotal studies) has proven that the player can take the field. No post marketing side effects and all the potential of previous blockbusters. Not all will be super stars but many will be great utility players. The FDA’s post marketing surveillance is the ultimate score keeper. How many hives, hiccoughs, bleeds, bruises, morbidity and mortality occur? These are weighed against hitting averages and ERA (earned recovery averages) as they are pitted against diseases, conditions, and dysfunctions. Some veteran players, like certain brands of heparin, will be sent to the minor league to work on the basics in hopes of returning to “the big dance”. Those that continue to fall short will be told to “grab a soda and a hotdog and enjoy the game from the stands”.

ps. Best answer this week to the question "How are you?" was "Great...good... well Ok so far... but it's still early"

pps. Occasionally, some of the links require FREE registration.... I'm sure you can handle THAT slight inconvenience.

1) You are an April fool if you are not using new prescription pads by Tuesday

Originally set to begin last October, Medicaid now requires at least one protection feature on all prescription blanks. THIS October you will have to have ALL THREE protection schemes in place or risk not receiving reimbursement.

2) The Governator’s State grants temporary stay of mandatory drug tracking

This January all drugs used in Cal-ee-forn-ya were to be traceable PER INDIVIDUAL CONTAINER from the manufacturer through the wholesaler to the pharmacy using RFID or bar coding. Because of the impossibility of complying on such short notice, all prescription drug sales to Californian would have to stop. The California anti-counterfeiting plans will be put on hold for 2 years as presidential candidates push for more “Canadian” drugs, highly susceptible to the abuses all sane people wish to stop.

FDA is looking into report that the anti-asthmatic drug Singulair increases the incidence of suicide. Suicidal thinking was recently added to the product labeling so this is something in addition.

It appears that middle-aged patients who have abdominal fat (the apple figure) are 2 to 4 times more likely to have dementia 30 years later in life. The most telling line in the abstract is that 50% of adults have midline obesity at midlife.

Viagra found in “STEEL BLUE” and “HERO” products. Could be lethal if these are ingested and nitrates administered.

Warnings also for other products that have caused hair loss, muscle cramps, diarrhea, joint pain and fatigue.

Capsaicin in a patch form reduces neuropathic pain in HIV patients. Works by depleting the pain transmitter known as “substance P”. If it works here it just might also work for diabetic neuropathy.

Marijuana use after a heart attack appears to contribute to mortality. Those who suffered a “heart attack” were 2 to 4 times as likely to die as non-users.

The anti hunting folks appear to be taking a new tack in the wind. North Dakota is destroying all of the venison donated to the food shelves because of “lead contamination” found in 5 samples. This represents 2 and a half tons of venison... protein rich food. How lead from a heart shot could end up in the deer’s hind quarter, or vice versa, begs many physics questions. Next thing to be proposed will be a ban on venison that the planned-deer-population-growth-people will have injected with contraceptives (rather than allowing hunters to harvest them).

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