Fuck You, FDA

I dunno whether it's a manifestation of good intentions or the result of behind-the-scenes lobbying, but recent FDA actions has led to a number of effective medications being taken off the market.

The FDA has only really been certifying the effectiveness and safety of all medications since the early sixties. Prior to that point in time, medications could be certified, but they didn't have to be. When the mandatory certification rules were originally put in place, products on the market prior to that date were grandfathered. Makers could seek certification under the new rules, but they were not required to.

Starting around 2007, the FDA set about rectifying this situation. The FDA decided that any prescription medications previously grandfathered and still on the market would have to be put through the certification process. Unfortunately, because all such products are well outside of patent protections, any pharmaceutical company that would undertake the costs of getting the certification would have little financial incentive to do so.

Certification costs money and research time. Making such investments is usually rewarded by having a market-lock on a particular drug - but only if it's a new drug. Old drugs would be granted no such guaranteed return on investment. So, for the most part, these old drugs are simply being forced off the market as neither the original patent holders or the low-margin generics makers are undertaking the expense to certify.

I wouldn't even know about this, but for the fact that a drug that worked for me was taken off the market, last year (or the year before). I suffer from migraines. My doctor had periodically prescribed me Midrin to help with them. Midrin was available for cheap and it was effective for many of my migraines. Now, it's not available. Now, my options are only new and expensive drugs. Worse, these new drugs have much shorter track-records, so overall efficacy and long-term safety is very much "unknown". Even better, many new drugs aren't covered by health insurance or are covered as "top-tier" non-generic co-pay structures. So, where I previously could get enough effective meds to last me half a year for less than $30 (insured or not), I now have to cough up a $60 co-pay for less than a dozen pills (without insurance, that dozen pills would be over $300). Even better than this price increase is that several of these more expensive drugs just don't work. And, of the options that do, the side-effects lists are pretty daunting.

But, I feel so much safer now. I feel so protected by the FDA. So, kudos to those fuckers for putting policies in place that sound (sorta) reasonable in theory but turn out to be absolutely horrible in practice. I guess this is the result of the FDA being yet another government agency bought and paid for by big business.

They've Got Names for Everything

I like StumbleUpon, a lot. It's the perfect tool for those who are easily bored, short of attention-span or constantly novelty seeking. I use it on a daily basis. One (of the many) interests I have checked-off in my StumbleUpon profile is "psychology". It was my major in college, so I guess I should be interested.

Today, it sent me a link on "metabolic syndrome". Now, I'm not a doctor. So, I'm not claiming I suffer this (if, in fact, this is even something one can suffer). I don't consider myself to be a hypochondriac. Though, who knows: by classic definitions, I may be. But, since I'm not in the habit of diagnosing myself, I can't say for sure. All I do know is that I seem to have a number of the markers. But, really, that's besides the point.

In reading the article, there was the line:

Those with metabolic syndrome are not only more likely to suffer heart attacks and other severe complications, but often lose many years of life.

I dunno: maybe it's less that the syndrome actively kills you as much as, it leaves you in a mental state where you're just "ready to go" a lot sooner than others might be. I look at my dad's easily-preventable death by heart attack at age 62 and the mental and physical manifestations I saw in him before then, and I can't help but think that the "ready to go" was part of it. I know that, were it not for my obligations, I'd probably just start walking until I either found something or I dropped in my tracks. I frequently think that many of the obligations I've set myself have been a weak attempt at succumbing to the "ready to go" feeling that is always with me.