The absolute insanity of the pharmocracy, measured in deaths

Let's have a look at a document submitted to the FDA by ALZA Corporation, which has (according to Wikipedia) become part of Johnson & Johnson. The original source of the document is a PDF that has circulated on some websites I do not wish to link directly here, but the clever reader will be able to find them with The Google. Here's where I start to get angry:

Mylan’s response to the concern about cutting a matrix system into pieces seems to assume, erroneously, that the issue is whether cutting the product into pieces would accelerate drug delivery. Cutting a matrix system would permit the abuser to control the fentanyl dose, thus preventing toxic or fatal amounts, whereas the inability to control the dose from a reservoir patch is apparently an important factor underlying the relatively low rate of abuse of Duragesic©.

Read what is being said here. ALZA is suggesting that Mylan's fentanyl patch is more readily abusable than those of the ALZA patch because abusing the ALZA patch is more likely to be fatal. Fatality, here, is a good thing. Have a look at the kind of thing they're suggesting, just to see how absurd this actually is.

Apart from the ease with which abusers could extract a controlled dose of fentanyl through buccal or sublingual absorption from a piece of a matrix system, a study summarized in our petition showed that abusers who wanted fentanyl for injection or smoking could rapidly extract much more fentanyl from a matrix system than from a reservoir system by soaking the products in common solvents. Mylan objects to the validity of this study since it used Janssen’s matrix system, which Mylan says has a different adhesive system and more fentanyl than the Mylan product.

Although the unavailability of the Mylan product required us to use the Janssen product in this study, there is no reason to believe that the different adhesive systems and fentanyl loads could be responsible for the very large differences in percentage yield between the matrix system and Duragesic©. For example, the use of rum as a solvent extracted over 90 percent of the fentanyl in the matrix system but less than 10 percent from Duragesic©.

Because the patch can be soaked in solvents, and then the solvents subsequently evaporated off and the substrate (that is, the adhesive along with the fentanyl) prepared for injection, ALZA sees a high potential for abuse from the Mylan patch, but again, not for the ALZA patch. But read carefully: the good folks at ALZA actually suggested using rum as a solvent. There are so many things wrong with this. First and foremost, if a user is going to be not just combining ethanol with fentanyl but using ethanol as a solvent to pull an estimated dose of fentanyl, which is active at microgram levels, the question of whether they are being deterred from abuse is moot. The question becomes, again, is there a high likelihood of fatality in that case. The answer is of course yes. Also immediately coming to mind is these people are veritably publishing a recipe (I have omitted other sections which detail, and I do quote, "party use" of the Mylan patch) for abusing a competitor's product.

This is so irresponsible as to be simply repugnant. On the one hand, these people want to emphasize increased lethality in medication as a means of preventing abuse, and on the other, they want to "mine the waters" and provide a dangerous way for "kitchen chemists" to extract fentanyl (in quantities certainly high enough to kill them). I just cannot wrap my head around the logic here. They are seriously requesting medicines be made more lethal to prevent abuse. Abuse by people who, seemingly, are willing to misuse the products anyways, and go to the length to apply solvents to extract them! What absolute insanity!

There were several public responses to this, one of which seems to be rather tongue-in-cheek:

Having a mouthful of vodka or rum during abuse would therefore be expected to greatly accelerate release of the drug from the matrix. We would certainly be interested in hearing about the dissolution studies that were done, for example, in a glass of 151-proof rum. By adding a little lemon juice of vinegar to the rum we would expect that we could not only greatly accelerate drug release but we could also complete the conversion of base to citrate all in the mouth using edible reagants. We think that it should be fairly easy to design and carry out a study to test this hypothesis but don't want to give the impression that we think that we are biochemists. We're just two doctors working in the heartland. If we can figure this out then we expect that others with a grounding in chemistry similar to ours - e.g., today's college freshmen - could come up with a better chemical strategy.

You can thank a Daniel Brookoff for that one. Noven Pharmaceuticals, who manufactured (manufactures? I've never seen it) a "matrix" type patch, had this to say:

ALZA's suggestion that fentanyl can be more easily extracted from matrix systems for smoking or injection is equally flawed. Soaking the patch in a substance such as methanol, a metabolic poison, for several hours is neither a quick nor easy way for an abuser to gain access to the opioid. In fact, after soaking the patch, the user would need to undertake further steps to extract the drug from the noxious adhesives mixed with it in solution, as well as removing the methanol itself.

ALZA's argument that soaking the Duragesic© patch results in lower yield of fentanyl than soaking a matrix patch [the Mylan/Noven patches] is misplaced. ALZA ignores the fact that virtually the entire concentrated dose of fentanyl contained in the reservoir of Duragesic© patch can be obtained merely by cutting open the reservoir, which can be done quickly and easily. In comparison, any fentanyl obtained from soaking a matrix patch would be mixed with chemicals that would grossly degrade the purity of the drug, as noted above. Thus, in contrast to ALZA's "Room Temperature Soak" chart [provided in the original letter] measuring the yield of fentanyl in solution after several hours of soaking, a user can obtain a virtually undiluted yield of abusable fentanyl in seconds from the Duragesic© patch.

So it is very tangled indeed. What everyone seems to agree on, though, is that the Duragesic© patch is both highly abusable and highly fatal. Which, again, seems to be a win. Why again are we waging this war on patients?

They did what??

According to the leaker, force-placed insurance works precisely the same way. The processes within Balboa have been industrialized such that people are only doing one step of a multi-step process, over and over, and never see the full picture. Processing speed is a focus and is financially rewarded. The bonuses require people to process 200 to 2,000 loans per day, depending on the job function.

There's been kind of a dodgy "leak" reported concerning a large bank. One analysis of the leak is the source of the above quote. I find it kind of shocking that the system described seems to fit very neatly into my experience of the contracting world. I often use the following metaphor:

Imagine a group of engineers. One engineer is very good with avionics and he's working on a system to control the flight of a new aircraft. He writes software, generally. He may consult with other engineers building the electromechanical systems, or serve as a subject matter expert.

Another engineer is an aerodynamicist and perhaps works with CFD (although often, you'd have a CFD specialist working in a somewhat detached position from the aerodynamicist). This engineer is working on control surfaces. Occasionally he may exchange emails with the avionics guy to let him know how the flight package is going to work.

The next engineer is working on payload. He wants to be able to carry 2770 kilograms, and needs the payload to be modular so that just about anything can be carried, given it meets certain density and power requirements.

Of course, there has to be a guidance person on board our project, so there's an engineer who is working with GPS constellations, JTIDS/LINK16/etc, and he probably has the occasional conversation with the first engineer, avionics guy, to make sure that the two of them can reliably and consistently share information. But, in my experience, they're working with a standard that's been agreed-upon in the contract. So they may not actually talk, but they're probably both working towards the same standard of information exchange, or a data layer, or something.

Next, you've got a guy who's doing propulsion. Propulsion engineer is working on a powerplant that has some kind of peculiar restrictions on weight and size, but he's got an idea of how to make that work, and so he is diligently at work making a very high thrust-to-weight ratio turbofan that has a short service window.

I could really go on here, adding in people like project managers, IT staff, and the like, but the moral of this story is that all these engineers are working on a cruise missile. In general, they do not know this, and the only way they'd all figure this out is if you put them in a room and had them draw their individual parts on a whiteboard. We do this for all sorts of reasons in "The Industry," which I won't go into here. But I find it truly shocking that the banking industry, of all people, has mechanized their process to the extent we have in the bombs-and-killing industry. Perhaps on reflection, it's not so very surprising, but I don't normally consider myself to be one of the tinfoil hat people who equates banking with The Devil and Big Evil in general.

A second possibility here is that any industry that becomes this mechanized is almost guaranteed to be – at best – up to no good or – at perhaps worst – downright evil. The major difference between "murder" and "genocide," for example, is mechanization. And there are any number of people who will tell you the Industrial Revolution is the root of all the modern world's problems, from disease to poverty and class inequality. I'm not really one of them. But it's kind of easy to see how the argument can be made.