Another reality is there’s not much money to be made in making new antibiotics, so we saw a lot of drug companies who left the field of antibiotic development because of this combination of factors, that it was getting really hard to discover, to develop new antibiotics, and you don’t make a lot of money in selling these drugs, so the market really wasn’t there. …I can’t tell a patient who has a resistant infection, “If we can get you through this next six months or this next year, there’s going to be a great drug that’s coming.” Or I can’t tell oncologists, for example, “Well, six months from now we’re going to have therapies to offer you; we’re going to have something to combat these infections.”
The drugs aren’t there. And we know it takes a long time to get drugs from the development stage through testing and into the market. Right now, I can’t tell you when you’re going to have a new antibiotic to treat these highly resistant Gram negatives. The best I can say is it’s probably going to be several years, but I can’t point to one that’s in development and say, “We’re going to have that one in three years.”
There is a temptation to be snarky here. "We don't have effective antibiotics? No problem--get some turtle dung, eye of newt and blood of frog and go to town. Maybe some fire...yeah, lots of fire." Unfortunately, this is actually kind of real and is another reason why we should be spending a lot of taxpayer money on developing new therapies. Instead, the Rs are worrying about a bad software site. Bengazi. The fucking national debt that they exploded, TARP that they demanded. Here's the thing -- if we have a succession of plagues caused by diseases we could have treated but now can't, everyone is vulnerable. EVERYONE. The weaker and less healthy will get sick first, but everybody will be at serious risk. This demands a systemic response to which the Ryan-Boehner-Barton-McKeon response will be something along the lines of denial, blaming Obama, scheduling days of prayer and perhaps having Teddy Cruz's dad, the faith-healing Cuban minister (Santeria, anyone?) do some TV faith-healing. After all, it's OK in their minds to swear in to the Congress by TV?
Of course, the Randian-Markets are Magic crowd can indicate the cited interview. After all, this was on PBS, on Frontline. Commie bastards! And the guy in question is a government scientist. Pointy-headed, drone! A damn take wants us to worry...ok, how about the head of R&D from Pfizer, Dr. Charles Knirsch? The drugs aren't there. They're not even working on them...
Q. But did that mean that you had to close down the antibiotic thing to focus on vaccines? Why couldn’t you do both?
A. Oh, good question. And it’s not a matter of closing down antibiotics. We were having limited success. We had had antibiotics that we would get pretty far along, and a toxicity would emerge either before we even went into human testing or actually in human testing that would lead to discontinuation of those programs. Again, the science was difficult, and we have these other platforms, these vaccine platforms that are state of the art that we think that the prudent allocation of capital addressing very, very important medical need, we would devote the resources to those programs.
Q. So you decided essentially to shift the capital away from antibiotics and toward vaccine platforms.
Q. And there were, according to people we’ve talked to, promising compounds at that time. You certainly had what some people described to us as the best and the brightest in the world working on some of these things at Pfizer. But you just said to me that there were problems with them and that there were difficulties, so I just wonder, was this program not the best and the brightest and one of the best in the world?
A. I don’t know which programs you’re referring to. Could you be more specific? Some of these programs right now haven’t even been moved into animal testing.
Now, I want any reader to understand this -- Pfizer is doing this not because they're greedy bastards, or at least, not solely because they are greedy bastards. They're doing because they see antibiotics as a dead end and they need to do something else which is going to require some hard and expensive research, development and clinical trials taking years. They didn't see the "return on innovation," and saw too much risk due to the difficulties of the science involved and the "uncertain regulatory pathways." In other words, things cost too much to do, too much risk of failure and then it just takes time to get a drug through testing, even if it's fast tracked. Should the new antibiotic cause serious side effects that outweigh the benefits, the legal liabilities are incredible. "So, get the divining rod out, Myrtle, we need to find a new well and different magic beans."
I'm honestly not knocking big Pharma so much as capitalism -- the unchecked Capitalism and greed advocated by the Republican Party of the "de-regulate, we're sorry BP, Enron didn't do anything wrong" era. Dr. Krnirsch speaks about public-private partnerships involving government research, universities and what really amounts to cross-fertilization between the various big and small pharmaceutical firms as scientists move between academe, government and business. Frankly, this is one place where the revolving door is not only not a problem for the nation, but where it works to our advantage. But, the fact is that scientific research is part of that "discretionary" funding thing shut down as non-essential during the latest Tea Party led unpleasantness. We're spending a lot less on pure science than we used to, and people like Palin, Cruz, Lee, Bachmann, Demint, Anne Coulter, Hannity and O'Reilly and so on delight in laughing at research studies and the boundary-less nature of what government has funded in the past.
Basic research costs more and more because it's less and less basic, and science is pretty much boundary-less by it's nature. If you are a PhD in biology specializing in primates, you have a deep understanding of math, statistics, chemistry, and some familiarity with physics, earth science and other more esoteric things besides how monkeys work. Basic science and hard science is not something best left to the private sector because the private sector, even the hugely financially successful Pharmaceutical industry, is not designed to take on high risk, low return efforts.
The ideal drug for Pfizer is Viagra, which was initially developed as a tool for hypertension. The physiological effect of lowering blood pressure in the male reproductive organs those allowing better circulation was a side effect that became the reason for the drug's existence. As it came closer and closer to going off patent, Pfizer began to look at it as a mechanism for combating teenage hypertension. In fact, lower doses of the drug are marketed for some types of hypertension but are off patent; the primary money-making purpose for the drug is ED and those patents do not expire until 2019. However, there's nothing to prevent a physician from subscribing the lower dose and less expensive and possibly generic version for ED. They'd just have to prescribe multiple pills...When Canada allowed manufacture of generic Viagra, Pfizer countered by lowering the prices for the real stuff and then appealed saying that the Canadian legal system had erred. As a result, Canada invalidated all the patents on Viagra in Canada.
Scientific and medical research is not about making money; pharmaceutical firms are about making money. As we shift funding for research more to the private sector and less to the public sector, there will be less of the hard science and more of what might be considered technology, which can be described reasonably as the effort to take some scientifically known elements and apply them to resolve engineering problems of one type or another. Writing computer code is an example of a technological use of known scientific processes (coding, math logic, binary math, etc. etc. etc.) some of which is invisible to the writer and can be. But, re-designing the structure of micro-processors to depend on some as yet unknown principle of quantum mechanics or organic as opposed to inorganic chemical compound is science; the basic science lies in discovering that as yet unknown principle or compound.
Business excels at technology because the risk is an engineering solution; not so much at the other aspects of the continuum. The firm answers to the shareholders who may not be willing to absorb the losses of failed experiments trying to turn peanut butter into jet fuel. (That image is homage to Jerry Harvey and the Abilene Paradox, a great explanation for what's going on in Congress and the Republican party. Thank you Dr Harvey for again helping us all understand.) S
o, how do we get the hard science done? Lots of it is done in the great research universities around the world, funded by foundations, Pharma and government. In this country, the only organization that can absorb the cost and the risk of this sort of research -- consider it to be a form of scientific infrastructure -- is the Federal Government. Not funding that risks not having the next great innovation; more to the point, in this incredibly complex organism that is the human community, it risks not being able to respond to the next crisis because no one has even thought of the problem.
The return on investment for a firm in basic science is really limited; the return for the nation on all infrastructure -- intellectual, technological, industrial, transportation, communication -- is incredible largely because the nation is the only one who can afford to do it. To those who worry about burdening future generations with debt, I suggest they consider if the future generations would like to have a future based on eye of newt and fire in hovels and caves connected by goat carts where strep throat and pneumonia kill 50% of the population before age 12, or something marvelous. If it all falls apart, the debt is going to be not an issue; survival will be questionable. We are a community, all in this together; failing to act that way as our right wing compatriots recommend is infuriating, and amusing, and really just an awful idea. The good news is when the universal pandemic comes, like the black death, plutocrats and senators and their families and supporters will suffer as much if not more than the poor, hungry, weak and those who serve them. However, it's cold comfort -- doing something now seems a far better approach than this when it's too late.