Tailspin - An Editorial

There comes a point in any flight when the speed going down cannot be decreased by manipulations of the plane’s parts, and a crash is inevitable – a veritable “point of no return.”

Such a point is reached by industry as well. When society has dictated so much regulation by law that creativity is completely stifled by it, a point of no return has been reached, and the life process that was fueled by such creativity stops. So it seems to be with the US pioneer drug industry.

Our regulatory system is such that we cannot have even the simplest medicine put on the market without crushing expense of testing and, whether medical or mechanical (read manufacturing and quality). Our drug companies, to make profits, have to spend over a billion (and geometrically growing) dollars to get a drug to market, such that without such “blockbuster” sales in the scope it is not economically feasible to develop products, although companies do develop lesser-selling products, but their effect on the overall population is much less.

Our aging population, raised on a ‘“spend, spend, spend” like there is no tomorrow’ mentality, is fast approaching its unproductive age, in which it is cast aside like an outmoded shoe or sweater, and the prospects of surviving and spending are phenomenally less than they were during the productive years. And, because with age comes infirmity due to the wearing out of the machinery, so to speak (one for which preventive maintenance is no inhibitor of the process, just an extender of the inevitability of failure), our abilities to pay the price needed for pharmaceuticals needed to keep the machinery in functioning condition has generally lessened to the point that it seems attractive enough for us to seek out the cheapest way possible to maintain such status quo. So it is becoming with the pharmaceutical industry, in order to maintain its sales, and to maintain its profitability, it is heading away from the unrequited expense of R&D to the less expensive production of generic drugs. Going to Mexico or Canada for our drugs isn’t going to work, because they won’t have the drugs to sell pretty soon.

Why is it that the once most formidable producer of excellent pharmaceuticals is becoming little more than a shell of its former self – a producer of tonnage commodities? Several things have happened.

First, we have burdened the industry with crushing costs incurred due to our litigiousness. If we can’t earn it we can sue for it and accomplish our financial independence through settlements. Because of that, the Food and Drug Administration, considering the risks involved, has regulated the industry severely in order to minimize those risks. It is not an anti-industrial activity, but a pro-public activity that it has done so. We now have some of the highest imaginable quality requirements (which have transcended the United States and have worked their way into the international stage as well), the cost for which must be passed along to the consumer, and while the overall costs are actually less with quality systems than without, those costs still must be borne by someone.

Secondly, because of the adverse effect profiles of any pharmaceuticals, and the need for proof of efficacy, we have caused the industry to incur incredible costs for testing of the pharmaceuticals we must take, over 3 arduous phases, before we can even consider putting the products on the market – tests so arduous and expensive that 80% of those products entering phase 1 will fail before any submission is filed, such that the overall costs for those products that do make it will push the costs even higher.

And this leads full circle to the aging population whose primary need is survival and diminished costs, due to the expiration of the benefits that have supported them for so long. Thus, in order to meet those needs, the industry is abandoning the extreme expense involved with R&D for new products and is turning to mass production of existing therapies that will keep us going until we reach the grand exit. Breakthroughs may come where there are not so many crushing regulations on testing of pharmaceuticals (not that they are not necessary, but they are crushing nevertheless).

Add to that a third problem, one of our technical ability to break the genetic code so that we see that some drugs only work in a part of the population. Rather than develop pharmaceutical congeners that will work in the other part of the population, the added expense of research in that arena is causing medical practice to devolve into “personalized medicine,” in which only those for whom a therapy will work will have the ability for it to work (those that can afford it, that is); the rest, well, you had a good run – try these generic therapies if the government doesn’t put the quietus on you – sayonara.

We need to wake up and realize that there may just be products out there that can work for all of us, but to make it we will need a strong industry. Unfortunately, the time may already have been passed for that industry to be in the United States. We may have to look elsewhere.