Magnifisyncopathological

I was gone for the last few days due to a visit to McKinney Falls State Park on Saturday. I was a dumbass and didn't wear proper clothing and didn't use insect repellant. The result was upwards of 50 chigger or chigger-like bites clustered around my ankles, thighs, and crotch. Several friends were also bit, but I displayed symptoms quicker and swifter.

Sunday night was spent contemplating not going to work. Very early Monday morning was spent cursing whatever forces of nature brought forth the necessity of the bastards that had bitten me. I didn't make it in to work Monday or Tuesday, and therefore didn't make it in to access the Net.

The itching was awful. I have never experienced anything like it. As Nina Bicknese said, "There is no creature alive that can cause more torment for its size than the chigger." Brushing up against a bite mark with clothing or furniture would set the welt off, so I spent most of my time either naked or mostly naked on my futon in front of the TV.

I went to HEB shortly after enduring a periodic "itching outbreak" and realized I needed something to combat the symptoms. I picked up a generic hydrocortisone cream and a unit of Chiggerex to complement a HEB anti-itch antiseptic spray I bought a while back. All of them took an hour or so to really kick in, they mostly cut down on the intesity of the itch, and they all lasted less than a few hours before the itching came back full force.

While shopping, I noticed all the various hydrocortisone-based creams didn't go over 1% in potency. It didn't matter if one was "maximum strength" or not; they were all at 1%. The other products that didn't have hydrocortisone had either benzocaine or lidocaine. Chiggerex had the former at 5% potency and the HEB Mercuroclear spray had the latter at 2.5% potency. Both benzocaine and lidocaine sound like they'd be up my alley; anyone who's heard of novocaine knows what I'm talking about. I wanted quick and real sensation deadening, chiefly because I knew I was suffering from temporary - yet acute - symptoms. Doctors know how effective benzocaine and lidocaine are for topical anesthesia.

Well, I was disappointed with the medications I tried and nothing else in HEB was available in stronger potencies, which meant that just about any place I might go to find over the counter drugs wouldn't have stronger drugs either. As I sat at home, trying not to bump the angry red welts all over my waist, crotch, and ankles, I began to wonder why the strengths of these drugs were so uniformly similar. The Food and Drug Administration immediately popped into my mind as a potential culprit. Certainly there are others out there in America who, like me, wanted fast and effective treatment of intense itching and preferred an anesthetic-based approach with enough strength to numb the are of application. There's money to be made here. The only reason I could think of why such products weren't available is government meddling. Are my antipruritic needs being oppressed???

So today, as most of the bites have calmed down and only a few itch with the same intensity as a few days ago, I decided to see if the FDA dicked around with the anti-itch drug market. And, of course, it has. I was able to find more than 50 pages of rules, deliberations, tentative monographs, and regulations regarding hydrocortisone and other external analgesics. The sickening degree of federal micromanagement in the drug industry is almost as annoying as the itching behind my knees. I was particularly pissed off with the exact requirements for labeling. A company can't even write it's own directions without the feds stepping in and taking over.

Spending a few minutes digging around the FDA's Center for Drug Evaluation and Research confirms my libertarian suspicions. Active ingredients are limited in many different ways: the dosage, combination with other ingredients, potency, and what they can be advertised to accomplish. For example:

Products containing colloidal oatmeal have been formulated in the following dosage forms: Lotion (1 and 10 percent colloidal oatmeal), cleansing cream (8 percent colloidal oatmeal), shampoo (5 percent colloidal oatmeal), and cleansing bars (30, 50, and 51 percent colloidal oatmeal) (Refs. 4, 46, and 47). The agency has calculated the approximate minimum and maximum concentrations of colloidal oatmeal that have been used as follows: For regular colloidal oatmeal, a range of 0.023 to 0.625 percent when used as a tub bath soak (Refs. 29, 34 through 38, and 44), a range of 0.24 to 1.2 percent when used as a foot bath soak (Refs. 30, 31, and 34), a range of 0.24 to 15 percent in aqueous solution when used in a wet pack (Refs. 30, 31, 32, 34, and 45), and a range of 3.75 to 15 percent in aqueous solution when used as a topical lotion (Refs. 30, 32, and 34); for oilated colloidal oatmeal, a range of 0.003 to 0.03 percent when used as a tub bath soak (Refs. 35 and 39 through 43).

That's from the Federal Register, Vol. 68, No. 107 last June. Page 33366. And that's just for using oatmeal as a barrier skin protectant! Imagine the bullshit the FDA throws in the face of people wanting to sell more complicated drugs.

Actually, that final monograph (available in HTML text or PDF) has some neat things worth quoting, such as:

Estimates of relabeling costs for the type of changes required by this rule vary greatly and range from $500 to $15,000 per SKU depending on whether the products are nationally branded or private label. The agency assumes the same weighted average cost to relabel (i.e., $3,600 per SKU) that it estimated for the final rule requiring uniform label formats of OTC drug products (64 FR 13254 at 13279 to 13281). Assuming 2,000 to 2,500 affected OTC SKUs in the marketplace, total one-time costs of relabeling would be $7.2 to $9.0 million. Because frequent labeling redesigns are a recognized cost of doing business in the OTC drug industry, these costs may be less. Manufacturers that make voluntary market-driven changes to their labeling during the implementation period can implement the regulatory requirements for a nominal cost. The final rule would not require any new reporting or recordkeeping activities.

The cavalier tone continues, amazingly, into the next paragraph:

This final rule may have an economic impact on some small entities. The agency's Drug Listing System indicates that about 700 marketers will need to relabel, and that this relabeling will be prepared by about 200 manufacturers, most of which are private label or contract manufacturers. Based on the Small Business Administration's determination that a small firm in this industry has fewer than 750 employees, roughly 70 percent of the firms are considered small.

"We're not certain this will impose a burden on doing business."

"But...you just mentioned what you think are the estimated financial burdens this revised rule will impose."

"We're not certain-"

"And you also take the time to estimate the breadth of businesses affected by this new rule. See, you say:

For example, assuming average industry costs, a small company that had 5 products with 3 SKUs each, for a total of 15 SKUs, would experience a one-time cost of $54,000 (15 x $3,600). A small private label manufacturer with the same product line and 10 customers per SKU, for a total of 150 SKU's, would experience a one-time cost of $540,000 (150 x $3,600). If one or more products needed to be reformulated, the costs would increase by $100,000 to $500,000 per reformulation.

...and you persist in trying to weasel your way out of being honest?"

"We're not certain-"

"Dammit! Listen to me!"

Finally, the crown jewel:

The agency has determined under 21 CFR 25.31(a) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment.

I understand this was written in the context of the woodsy, air quality, pollution definition of environment. However, the wording still strikes me as a terrible indication of the mentality in charge. The "human environment" no longer rhetorically includes our financial lives. Any honest assessment would show that these rules do indeed have a significant effect on the human environment and on humans directly.

Like how I really, really wanted a powerful topical nerve signal supressor to kill off the distractingly strong itchy spots all over my lower body. If, under a true capitalist system, I had been able to get ahold of such an OTC product and I had an adverse reaction to it, it's my responsibility to deal with the consequences. Rather than paying about $8 for what I got at HEB that day, I would have greatly preferred paying $10 for a mid-grade ointment containing X% of lidocaine or some other topical anesthetic knowing that within minutes of applying it, the itching would stop and I'd have to deal with a small patch of numbness for a while.

I'm not a doctor nor do I aspire to be one, so I could be dangerously wrong about the safety of this kind of drug. Perhaps if my free market system offered a lotion containing 10% benzocaine and I tried it, my skin would turn black and my breathing would drop precipitously. If those were the dangers such a concoction might pose, the manufacturer wouldn't be able to stay in business if it didn't warn of them.

In any case, I've suffered through my first bout with a chigger infestation and I survived.

They aren't lying about how bad it itches. It's rough.