Supply of a Cancer Drug May Run Out Within Weeks

Pricing/volume/distribution channel is a combination which needs to be considered whenever a new product is marketed, or even when it isn’t working as expected.

Any company has a choice between selling a lot of product at a low price, or less product at a higher price; the distribution channel affects the price that the market will bear (think of the price difference between audiophile cables or bought-at-an-electrician’s ones, or cosmetics).

There’s nothing wrong with setting the pricepoint a company thinks will work best, in principle. The problem is, what to do when it directly affects people’s health? And, do countries which do not consider their people have a right to healthcare (or only if they can pay for it or through the ER) have any right to complain? After all, if people don’t have a right to healthcare, they don’t; why should private companies make an effort to provide what governments won’t?

In that specific case, the company was already being sued by several well-known not-for-profits for their distribution policies. They had also suffered from the Indian government declaring several of their patents invalid in India, thus allowing Indian companies to make those products: the reaction to the first was “that’s why we have lawyers”, to the second was to market a new product which chronified a rare cancer at a very high price in the US, give it for free to Indian patients whose doctors had certified they could not pay that price (translation: to anybody in India who’d gotten diagnosed with it), and not market it at all in the rest of the world.

The country they saw as their enemy got a bribe of sorts, and one which would be more likely to benefit people in a position to make decisions about patents than those who couldn’t (one of the examples of “look how good we are!” from the intranet was an Olympic athlete from a rich-people sport, whose reaction upon getting the diagnosis had been to jump on the first plane to Philadelphia and get a second opinion there - what % of Indians can do that?).

I think more and better international collaboration and clarification re. patents and industrial practices would be helpful, but it’s not easy.

Why has no libertarian viewpoint I’ve ever seen, acknowledge that, just as government actions A, B and C have unintended consequences, so too does government inaction? Every conceivable decision made by any possible decision-making agent has unintended consequences, therefore the existence of such is not part of a cogent argument for anything.

Apparently, they’re in trouble:

And last year,

And here’s the inspection report. (warning: PDF, 33 pages)

This is not quite right. There are no fixed prices; instead, law provides that Medicaid receive either the “best private price” at which a manufacturer sells a drug or a price 15.1% below the average manufacturer price for that drug, whichever is lower – in other words, it’s still a market price, albeit a distorted one. Medicare used to piggy-back on that arrangement for low-income (“dual-eligible”) patients, but then Part D came along and covered a lot more people, but established a market-based private provider system that relies on competition to keep prices low. The current administration is looking at restoring the Medicaid price system for dual-eligible patients, and keeping the rest of Part D unchanged (if I have it right – as 48, I’m not worrying about any of these details yet). And, of course, there’s a small percentage of drugs that are paid for as part of medical care provided under Medicare Part B, which uses the “Average Sales Price plus 6%” formula – nothing I’ve said above takes Part B into account or applies to it.

Interesting.

Imagine the outrage, though, if unsafe, unsterile, incorrect dosage methotrexate were to make it to market? Shutting down production has an associated cost, for sure, but I think the alternative could possibly be worse.

I’ve dealt with the quality control testing side of a sudden production increase in response to a drug shortage at another generics company. My company had the manufacturing capacity to do so - by moving up a production run by a few weeks from a planned schedule, so raw materials were, fortunately, in place - but had to defer manufacturing of (IIRC) 2 other products… one of which reached near-critical as that delay triggered an impending shortage of that drug, thereby causing it to be moved up in the manufacturing schedule… it’s a vicious cycle.

I know that for the initial drug production increase, overtime was made mandatory for a lot of people in the company, and negotiations had to be done with the unions working the manufacturing areas to get stuff done. I put in about a week’s worth of 14 hour days in the lab, as did several coworkers trying to get the quality control testing done for the first lot. We had the luxury of a weekend before the ID testing for finished product release came due, but then the second of (IIRC) 4 manufacturing lots (different dosages) came in for quality control… in short, it was hellish. It didn’t help that some of the testing was very finicky stuff (the impurities assay was a bitch) and we were pretty much told that there was no room for error or retesting if we made a mistake.

All this was to cover one market shortage due to a breakdown at the competitor’s company… it wasn’t in response to an FDA or voluntary suspension of operations. I can’t even imagine the hell we would have gone through had we needed to pick up the market slack full-time.

There was also the time where a common raw, non-active, ingredient supplier called all the companies it sold to up and said “all those barrels we just sent you…they’re all bad.” That didn’t come into the lab so much, but I know it was a walking nightmare for the schedulers, management and production people because it was a raw ingredient found in a lot of drugs. Luckily there were other sources able to meet our needs, but I imagine that their quality control chemists were crying themselves to sleep over the haunting sounds of an HPLC pump…

There are no unintended consquences of a thing not happening., unless it has previously been established as the complete norm. Libertarians take the (quite reasonable view) that no government regulation is the natural state, and that it ought to be treated as the default, both because it’s a lot easier, and because it’s true; no natural human relationship exists solely as a result of government.

Second, governments act slowly, erratically, and bluntly in direct proportion to the power of their action, hence their actions tend also to cause immense and unpredictable side effects. These are usually negative, because any random more change is likely to be negative than positive.