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Fantasy pharma

30 Jan 2008 08:45 am

The left, of course, has its own fantasy solution set: drugs should be both innovative and cheap.

But clinical trials for a single successful drug cost $500 million, and not because the labs have outrageous administrative overhead. Even if the government were in charge of running them, they would still be on the hook for that $500 million, which would have to come out of taxes. We can get existing drugs on the cheap by essentially stealing the property of shareholders in drug firms, who risked a lot of money on drugs that they reasonably expected to be profitable under existing laws. But that's a one-trick pony. We cannot get new drugs at bargain basement prices.

Many people are holding out the hope that the government can somehow substitute for the pharmas, bolstered by the ludicrous claim that the government really discovers all the drugs. This is arrant nonsense; government-funded research discovers targets that might someday turn into drugs, if the Big Pharma chemists can: find a molecule synthesis can be economically mass produced; keep the molecule from killing rats, mice, dogs, or humans; get the molecule into a form that does not have to be directly injected into the bloodstream; tweak the molecule so that the liver doesn't immediately chew it into pieces that no longer affect your target; and shepherd the entire thing through years of clinical trials. That's just off the top of my head; research chemists will undoubtedly have more.

There is no evidence of a nationalized industry that consistently does cost effective innovation. Yes, you have a list of things invented by the government--but that number is a small fraction of a fraction of one percent of the number of things in the private sector. If the universe of products were your house, the government would have invented one washer inside the tap of your bathroom sink; the private sector would have developed every other thing you use. Even where the government is given credit for "inventing" something, such as DARPANet's invention of the internet; it turns out that 99% of the process of actually turning it into a product that was useful to end-consumers was handled by private actors, most of them corporations like Netscape, Microsoft, and AOL.

This is why when you start to make a list of all the state-run economies that have produced large numbers of innovative products with a high level of consumer satisfaction, you have to throw your privately manufactured gel pen aside in disgust. For whatever reason, the government is just not good at producing innovation.

Before you say it, I know that you are leaning forward in your chair, your eyes alight, preparing to demand "What about the military?!" and lean back triumphantly in your chair. My friend, have you ever taken a close look at the military procurement process? It costs a fantastic amount of money to generate products that often aren't even wanted by the end users--how many times have you read about some military service being forced to buy some gargantuan piece of equipment they don't want because the thing is being manufactured in a key congressman's district? This is how we spend four percent of our national income on something that most of the American public never sees. Forgive me if I'm not excited about applying the same process to health care.

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Comments (155)

Even if we keep the model of having private research to develop drugs, we should have the final clinical trials done by a government agency at taxpayer expense. Having this part of the process controlled by those with a finachial stake in the outcome of the trials is what leads to the hiding of adverse information and the marketing of dangerous drugs. The current system of having comanies do the testing on their own products is inherently corupt!

"What about the military?!"

Actually, extremely sophisticated military hardware may be the exception that proves the rule. The procurement process is a politician-produced nightmare, but the US military has managed to develop some very advanced weaponry.

One key reason that government doesn't tend to be very good at innovation is that the incentives aren't good. But in the case of the military, their people could die at some point if they don't have good stuff, plus they'll lose encounters and look bad.

Basically, our military knows that it may have to 'compete' with other militaries. The problem with most government bureuacracies is that they don't face competition, but the military knows that it may face it in a life-or-death setting. That makes a difference.

Another thing we could do that would really help controll costs in health care and have a low implementation cost would be to follow the Austrailian model for getting information to phasicians. They like us have pharma reps calling on MD's giving them only the information that sells their drug. Instead of restricting the free speach rights of these companies as some on the left would like us to the Austrailian government does studies comparing drugs head to head (something that drug companies are loath to do because their drug might loose) and have government drug reps who visit MD's just like the sales reps do and give them information about which treatment is most cost effective at controlling a given condition. It turns out that the newest and most expensive drug is not always the best (even though that would be the safe way to bet absent other information).

Pharma innovation "health care system", Megan. And happy belated birthday!

Not that I know a lot about these issues (so maybe the following is not an apt analogy). But why do innovations in semiconductor technology keep driving down the price of hardware? Nowadays a pc that retails for $400-$500 has more processing power than a supercomputer built 10-15 years ago. Was all that innovation in microchip technology cheap? Why is the pharma and health care industry so different? Who don’t innovations drive down costs of drugs? While I don't think the solution is to get the government involved, I do think that the U.S. Pharma industry is greedy and monopolistic. Why are the same drugs cheaper in Canada? It makes no sense.

Rum raisin,

Costs of drugs do fall. Compare the price of generics to the cost of a new drug. But prices are high on new drugs while they are under patent so the company can make back what they spent on drugs that failed.

Military history suggests that rapid innovation in military hardware tends to happen during wars. Wars provide lots of field trials. Flying coffins get replaced by Sopwith Camels.

Even so, it is worth remembering that Harry Truman made his reputation in WWII by exposing fraud and mismanagement in the war industries. The reaction of centralized planners was sadly predictable:

"The Roosevelt administration had initially feared the Committee would hurt war morale, and Under Secretary of War Robert P. Patterson wrote to the president declaring it was "in the public interest" to suspend the committee.

http://en.wikipedia.org/wiki/Harry_S._Truman

Innovations in hardware like computers and other electronics are generally ways to do things better and cheaper. Electronics companies are researching new methods of manufacturing, new materials, etc... to make their products do more for less.

The equivalent in pharma would be a new way to make an old drug or improved manufacturing processes. These sorts of innovations probably do happen, but the marginal cost of a pill is pretty low, so there's probably not much incentive to spend a lot of money reducing it even more.

Brand new drugs, on the other hand, are more like inventing an entirely new technology that does something other technologies just don't do. The research isn't into reducing the cost or making the product more efficient, it's in developing an entirely new drug that does something other drugs don't do. I'm sure that drugs that are similar to existing drugs are cheaper to develop than drugs that do something that has never been done before. However, a lot of the cost of bringing a new drug to market is in getting FDA approval, which is a process that every drug must go through and requires a lot of studies and probably hefty liability, insurance, and risk management costs.

As far as the military goes, the goal of the military is to be the most effective, NOT the most efficient. We can afford to outspend our enemies so we don't have to make every dollar go as far as possible. Our military is NOT cheap and while they probably try not to waste their material, I'm sure that soldiers in the field aren't counting bullets when they're under attack... the military isn't a good model for maximising efficiency.

Re: the military and innovation

Isn't most of the new military technology developed by private defense contractors (GD, Raytheon, Lockheed, etc), simply being commissioned or paid by the government? The result being that you DO get really great innovation, but at extremely high cost?

Of course this supports, rather than refutes, your argument that
1. private companies do most of the innovating
2. trying to move that to government will not lower costs

The other element that makes comparing military technology to medical technology nonsensical is the breath of demand for the product in the general population. No person in your neighborhood desperately demands that he or she be able to personally utilize an F-22 at an affordable price, thus Lockheed is allowed to make a lot of money on each one, which means that they were willing to sink massive amounts of capital to develop it. Everybody in your neighborhood demands, or knows someone who demands, that they be able to personally utilize the newest cancer drugs. Start having the government, by direction of Congress, "negotiate" prices of a drug, prices which members of Congress use as a means of boosting their electoral chances, and private capital will no longer flow as readily to the area of drug innovation.

If people really thought that private capital was unimportant to drug innovation, they would be advocating that patents no longer be issued.

Private companies DO do most of the innovating, where defense technologies are concerned - but not only does government involvement raise the price, its procurement process is agonizingly slow: the Air Force issued the requirement for the F-22 in 1981; the first production model was delivered in 2003.

Was all that innovation in microchip technology cheap? Why is the pharma and health care industry so different? Who don’t innovations drive down costs of drugs?

Actually, yes, processor development is quite cheap compared to health care, and always will be, for three very good reasons.

The first is that computers are much, much simpler than the human body. A computer chip is designed to do one thing, and one thing only -- process binary numbers as fast as possible. It's really easy to test whether a new chip design is successful, because all you need to know is if it does process the numbers faster, if it gets the right answers, and make sure it doesn't do anything nasty like overheat and melt. Testing those things is simple enough that you can actually automate a lot of it.

Of course, it's possible that you might miss something in testing, such as the Pentium floating-point bug from the mid-nineties. In that case, you're up for a little public ridicule, but that's pretty cheap. If you missed something really really bad like a tendency to melt and become a useless lump of metal, you might have to issue a public recall and replacement. However, nobody dies from these things, and you're not likely to be on the receiving end of billion-dollar lawsuits. So you don't have to conduct large-scale exhaustive tests under all possible conditions, or look for consequences which might only be visible years and years later.

Finally, most of the processor development going on right now is incremental innovation. We're figuring out how to make them smaller, run cooler, and to pack as many of them together as possible. We are also not designing radically new chip architectures. The computer you're reading this on uses essentially the same basic architecture as a computer bought in the early 2000s, and is not fundamentally dissimilar from the chips of the early nineties, when the x86 architecture first arose. In medical terms, it's the difference between one antibiotic and another, rather than the discovery of antibiotic drugs.

Megan: Right-on on drugs, a little wrong about the relative weight of DARPA-funded stuff in the Internet.
And the x86 architecture is a actually late-seventies thing. The original IBM PC had an 86 series processor (the 8088) and was released for sale in 1981. In 1990 people were buying 386s (third generation, after the 8086 and the 80286) and the 486 was around the corner.

Megan,

You vastly underestimate the role that government already plays in innovation. A great number of developments come directly out of NIH and are then used by the medtech sector. It is true that innovation would be affected but not as dramatically as you make it seem. Let's not forget that along with drawbacks, there are perks in having the government play a more active role. As Jon Cohn has pointed out, an innovation council or however it would be set up would be more likely to take a longview in allocating resources.

"What about the military?!"

You'd kinda need a private military to be able to make the comparison there.

I wonder if there's any way to compare the innovativeness of the US military to that of the private security firms in Iraq?

@ jj: "innovation council"?? Shouldn't it be "Innovation Council"??

From there is one small step to Pharma Five Year Plans...

Censor: yeah, it's a typo, I meant to say eighties.

Re DARPA and the early Internet, Censor is also right that Netscape and the like didn't do much actual *development*. Mostly, all they did was popularize it. The big deal about the early Netscape/Mosaic was that it was able to display images, but that's a user interface thing, not a fundamental technology development.

Early Internet development also depended at least as much on universities like Stanford and Berkeley as it did on DARPA. In many cases, such as the development of TCP/IP, DARPA mainly provided the funding, and academics actually did the legwork. Also, commercially funded research labs such as Xerox PARC did significant protocol research.

"Let's not forget that along with drawbacks, there are perks in having the government play a more active role. As Jon Cohn has pointed out, an innovation council or however it would be set up would be more likely to take a longview in allocating resources."-jj

A good case could be made for the government to increase its funding for basic research, but that is quite separate from the question of whether to impose price controls on drug companies (or to use the government's monopsony power, which amounts to the same thing).

What McArdle wrote is clearly correct: there is a tradeoff between affordability ad innovation. Reduce the rewards for private innovation and you will get less of it.

Now, it coud be that we are not at the optimum--that we have gone too far in favor of innovation at the expense of affordibility. If so, then it makes sense to make some changes.

In general, it is bad public policy to resort to a heavy-handed government solution when a market solution is available. In this case, the government solution would be price controls. The market solution would be to reduce the length of patent protection.

The latter approach offers a more efficient way to shift the balance in favor of affordability. So there is no need for price controls (nor any kind of "single-payer" monopsony).

I can think of one nationalized industry that did very well at innovation. The old Soviet Military-Industrial complex was wonderfully innovative. Of course, it was the only part of the Soviet Union that had to deal with real competition, it's competitors being western defense industries.

While not a roaring success, the Communist bloc didn't do a bad job with military innovation - the AK-47 and MIG were damn good weapons and much cheaper than their US counterparts. One reason military procurement is so screwed up is that the has so much damn money that they inevitably make the perfect the enemy of the good.

What McArdle wrote is clearly correct: there is a tradeoff between affordability ad innovation. Reduce the rewards for private innovation and you will get less of it.

So, increase the rewards for public innovation. What's so hard about that?

I forgot: Government bad! Market good!

liberalrob, you're missing the point. Sure you can increase the public reward, but then you're not reducing costs, and the argument is to use government's monopsony power to reduce costs.

So if you want to use single payer to reduce costs, you give up innovation. If you want to continue innovation, you can't cheap it out.

that's a user interface thing, not a fundamental technology development

Understanding that user interface design is a fundamental technology is how Steve Jobs got rich.

Come on, liberalrob, though you and I often disagree, I had always thought you an honest interlocutor. But you are misrepresenting what I wrote (as the astute SG seems to recognize). As I started my post:

A good case could be made for the government to increase its funding for basic research.

Indeed, I'm inclined to think the government ought to increase funding for research (since there are positive externatlities involved). So "Government bad! Market good!" is not a reasonable summary of my views here.

I'm still inclined to think you honest. Probably this was just a slip.

Rum_raisin: Price of *output* does fall in the pharma industry. A drug will often replace something that e.g. required surgery, and be cheaper and less risky than the surgery, even with the patent in force.

Patents are less of an issue in the computer industry because, in order to copy someone, you have to invest a hell of a lot of money, and buy up a lot of expertise that isn't cheap. The corrolary to Moore's Law is that production costs for new chips *rise* exponentially. Thus, the high natural barriers to copying give them a built-in kind of patent that pharmas don't have.

The Netscape Browser was built off the Mosaic Browser, developed at a public university (UIUC) at an NSF-funded institution (NCSA). The WWW was developed by a government funded institution in Europe (CERN).

Microsoft did virtually nothing in the early days of the internet to popularize it, Bill Gates himself said it was his biggest mistake as boss.

It's true that private companies picked up the ball and ran with it, but by the time companies realized they could make money off the internets, 99% of the hard work was already done.

Atlee Breland: The point about Netscape, AOL, etc. isn't that they did the basic technology research, although I'm sure they did a fair amount (and I agree with Ralph Pheland, as well). But that they did the research and legwork to take DARPAnet and turn it into a consumer-accessible product, which is an equally important function. Similarly, NIH and research universities do a lot of basic research on biochemistry, but it's the pharma companies who take the basic research and turn it into usable products.

On the military: I'm reminded of Milton Friedman's division of spending into four types. Single-payer health-care is spending other people's money on other people; it will be wasteful and inefficient. Military spending is, in some sense at least, spending other people's money on yourself: you try to get the best possible, but don't try to control costs. Which is exactly what we see.

Megan,

I do agree with your point that government cannot effectively substitute for the pharmas (not atleast in the near future) especially because the government would have to face similar financial constraints as that of the pharma companies, which usually accounts for the increased price of these drugs. But, we should not underestimate the large number of factors the government has in its favour, the presence of highly equipped research institutes with well qualified research scientists, the state of the art clinical trial facilities and not to mention the easy marketing options.

Megan,

I do agree with your point that government cannot effectively substitute for the pharmas (not atleast in the near future) especially because the government would have to face similar financial constraints as that of the pharma companies, which usually accounts for the increased price of these drugs. But, we should not underestimate the large number of factors the government has in its favour, the presence of highly equipped research institutes with well qualified research scientists, the state of the art clinical trial facilities and not to mention the easy marketing options.

Here's how you manage pharma research for the public good without taking over the industry...

Determine what drugs are needed but are not being produced. Offer a huge reward for the first company that brings a successful drug to market. Something on the order of hundreds of millions of dollars to a couple of billion, depending on the relative importance of the drug.

The reward could even depend on the patent status... a lower level if the drug company also keeps the patent, more if they release it to the public domain..

Let the drug companies fight for the prize. If no one takes the offer, it's not high enough. Over time, the rewards can increase if a drug is needed badly.

Incremental goals could be set for basic research, too... like identifying a receptor, synthesizing a molecule in the lab, etc...

But clinical trials for a single successful drug cost $500 million, and not because the labs have outrageous administrative overhead. Even if the government were in charge of running them, they would still be on the hook for that $500 million, which would have to come out of taxes.

As far as I can tell, this is a fantasy stastistic. Apparently this all goes back to one study, the 1991 DiMasi study, in which several, er questionable, methodologies were adopted.

First, the $500 million is a projected, not actual estimate. Second, the study neglected the tax credits available, something on the order of one third of the money actually spent on R&D, that is, only .66 on the dollar. Third, the opportunity costs vary as estimates on rate-of-return varies (in the original DiMasi study, he used an annualized 9%, and his original figure was not $500 million, but $231 million. Later revisions went up to 14% on rate-of-return . . . an unrealistic amount for most of us.) Fourth, the drugs for which this figure was derived were not representive drugs, but the most expensive kind possible, new chemical entities (NCE's), and not the ones they acquire from other research organizations (like - drumroll - public universities.)

And so on and so forth. The actual costs to bring to market new drugs is more like $100 million or less.

Not that the actual figures matter that much; it's just that "500 million dollars" seems designed to provoke an emotive response rather than a reasoned one. "100 million dollars" much less so in these debased days. Que to Dr. Evil saying in rounded caps One. Million. Dollars. BWAHAHAHAHAHH!

I'm still inclined to think you honest. Probably this was just a slip.

I'm frustrated with the constant drumbeat of free market free market free market all the time in response to things that the free market doesn't do well, like prioritize any aspect of health care, because you can't quantify the public good in an economic formula. Apologies if you aren't so committed to that position. I saw "McArdle is clearly correct" and that was all I needed to see; I disagree with her position.

In general, it is bad public policy to resort to a heavy-handed government solution when a market solution is available.

But not in this case, right? Because a market solution is apparently NOT available.

Megan,

I do agree with your point that government cannot effectively substitute for the pharmas (not atleast in the near future) especially because the government would have to face similar financial constraints as that of the pharma companies, which usually accounts for the increased price of these drugs. But, we should not underestimate the large number of factors the government has in its favour, the presence of highly equipped research institutes with well qualified research scientists, the state of the art clinical trial facilities and not to mention the easy marketing options.

One key reason that government doesn't tend to be very good at innovation is that the incentives aren't good.

Which of course is why private enterprise came up with quantum mechanics, electron microscopes, discovered the structure of DNA, figured out how to sequence genes, publishes most of the articles in 'Nature', 'NEJM', 'Jama', etc.

No, I'm pretty sure that the record shows just the opposite of what you claim. Now why would that be?

Rob,

What exactly are you disagreeing with here?
The basic claim is that government takeover of drug development cannot reduce costs without also reducing innovation.

Even if we ignore public choice theory for a moment, it will be just as expensive for the government to develop and test a consumer-ready drug as it is for private industry to do so. Medicine is expensive, and there's just no way around that.

Actually, yes, processor development is quite cheap compared to health care, and always will be, for three very good reasons.

What are you smoking? Moore's law?

Heedless, are you _really_ claiming that the government would spend large sums of money to come out with what are essentially reformulations of an old drug? You know, like pharmaceutical companies do? I have a hard time believing that.

Someone tell Megan that a normative judgment is not equivalent to a solution.

Larry Geater wrote: Having this part of the process controlled by those with a finachial stake in the outcome of the trials is what leads to the hiding of adverse information and the marketing of dangerous drugs. The current system of having comanies do the testing on their own products is inherently corupt!

This would only be an accurate statement if one of the fantasies of the uberLibers actually came true: disbandment of the FDA. Within any aspect of the pharma industry that falls under FDA jurisdiction (including, incidentally, delivery systems like hospital machinery for controlling IVs and such), FDA auditors are more feared than the IRS. They are extremely thorough, to the point of questioning stray marks on a piece of test documentation; they have been known to rigrously search random trash cans on an auditee's site; and if they ever feel like they're not getting the whole story, they only need to make one phone call and your business is suspended from the industry, effective now. Don't like it? Fine, here are the 15 flaming hoops you need to jump through in order for your product to be recertified. Some of them may cost you in excess of $1M each by the time you've met all the requirements -- hope you've got that much money.

This doesn't eliminate the potential for fraud or carelessness, but it certainly cuts it back to levels that are, at worst, equal to what would occur in a government-run institution.

"Because a market solution is apparently NOT available."-liberalrob

Yes, a market solution is avaliable. We could just reduce the extent of the patent protection for drugs. That would certainly reduce prices for consumers.

In a perfectly free market, there would be no patents at all. We grant patents to encourage innovation, but it might well be that we have gone too far in granting monopoly protection for new drugs.

So far I have not seen any convincing arguments that price controls would be a better solution. The government has never been very good at setting prices, as the painful history of the Soviet Union makes clear.

SoV wrote: Which of course is why private enterprise came up with quantum mechanics, electron microscopes, discovered the structure of DNA, figured out how to sequence genes, publishes most of the articles in 'Nature', 'NEJM', 'Jama', etc.

The government can also produce a nuclear bomb from the ground up when the urgency is high enough and money is no object, but that doesn't mean the government is "good" at innovation when measured in terms of monetary efficiency.

Also worth noting that several of the innovations you have cited are primarily informational in nature, providing the basis for e.g. pharmaceutical innovations but not actually producing the innovations themselves; and in any case, were really the cascaded fruits of a long series of discoveries, some public and some private.

I'm pretty sure that the record shows just the opposite of what you claim.

I don't think so. There are (at least) two kinds of innovation here, basic research innovation (e.g., discovery of DNA structure) and engineering innovation (making something useful out of fundamental discoveries). Most of the effort and cost of innovation are in engineering, not basic research. Most of the unpredictability is in basic research, not engineering. It makes sense for government to fund basic research, because you never know what you might find or when you might find it, but you need to keep looking anyway. It makes far less sense for government to fund engineering, because the problems are along the lines of "how can we make this thing scale." Market forces provide excellent incentives for doing engineering innovation, but lousy incentives for doing basic research.

And, once again, SOV makes comments that clearly show he has no knowledge on what he comments.

Pray tell, what are these drugs that private pharma acquires from public universties? How many of them are there? What is the brand name of these drugs? I am sure a citation happy person such as yourself has this information handy.

John's point is a good one. As economists have long recognized, the government is reasonably good at basic research (which is not really excludable), while private firms are better at tailoring that research to the specific needs of consumers. This again explains (in part) why the Soviet Union was able to develop some first rate scientists, and yet unable to develop consumer products that would really enhance welfare.

Those who are interested in what sorts of polcies can spur innovation, increase growth and enhance welfare might want to start with this interview with Paul Romer (perhaps the top expert on economic growth in the world), and go on to other works by and about the man.

As Romer explains, the tremendous improvement in living standards over the last 100 years or so is due to a combination of a high degree of economic freedom and good institutions (including, crucially, well-established property rights):

Interviewer: What do you see as the necessary preconditions for technological progress and economic growth?


Romer: One extremely important insight is that the process of technological discovery is supported by a unique set of institutions. Those are most productive when they're tightly coupled with the institutions of the market... Freedom may be the fundamental hinge on which everything turns.

the government is reasonably good at basic research (which is not really excludable), while private firms are better at tailoring that research to the specific needs of consumers.

This is also why public research labs are so stuffed with equipment built by private firms. Academics invented lasers and electron microscopes, but most often today they buy such things off the shelf.

rwe: In a perfectly free market, there would be no patents at all.

You mean in a perfectly free market that lacks a kind of property right you don't like.

We could just reduce the extent of the patent protection for drugs. That would certainly reduce prices for consumers.

And reduce private investment in future cures. No free lunch.

ScentOfViolets: The only thing correct in your 500 vs 100 million post is that the figures don't matter much. Debating over whether drug research costs a HUGE amount or megaHUGE is irrelevant, and if your argument hinges on drugs being $100 million to develop rather than $500 million, your position is fundamentally flawed.

*Whatever* the true cost of R&D, it WILL increase over time, no matter what, for the simple reason that researchers, and human action in general, go for the lowest-hanging fruit first. If a drug doesn't cost $500 million to develop now, some other drug or treatment in the future will, and if government reserach can't make it happen, and the private sector profits aren't sufficient to justify the research, then NO ONE gets the cure, ever, at any price.

Something to think about.

I'm frustrated with the constant drumbeat of free market free market free market all the time in response to things that the free market doesn't do well, like prioritize any aspect of health care, because you can't quantify the public good in an economic formula.

I'm frustrated with the constant drumbeat of people who clearly don't understand how markets work making silly claims about what they can't do.

The government can also produce a nuclear bomb from the ground up when the urgency is high enough and money is no object, but that doesn't mean the government is "good" at innovation when measured in terms of monetary efficiency.

Also worth noting that several of the innovations you have cited are primarily informational in nature, providing the basis for e.g. pharmaceutical innovations but not actually producing the innovations themselves; and in any case, were really the cascaded fruits of a long series of discoveries, some public and some private.

Uh huh. So why, pray tell, didn't private enterprise invent computers, lasers, electron microscopes, etc?

I mean, obviously, what with the goverment being "monetarily inefficient" and all.

I'm pretty sure that the record shows just the opposite of what you claim.


I don't think so. There are (at least) two kinds of innovation here, basic research innovation (e.g., discovery of DNA structure) and engineering innovation (making something useful out of fundamental discoveries). Most of the effort and cost of innovation are in engineering, not basic research. Most of the unpredictability is in basic research, not engineering. It makes sense for government to fund basic research, because you never know what you might find or when you might find it, but you need to keep looking anyway. It makes far less sense for government to fund engineering, because the problems are along the lines of "how can we make this thing scale." Market forces provide excellent incentives for doing engineering innovation, but lousy incentives for doing basic research.

So then what's the difference between the two that we can see? I've already mentioned computers, lasers, electron microscopes, etc. Those aren't engineering? The original transistor(officially, that is, there is an unofficial version) was done by Bell Labs. Shockley did research that showed that in certain substances (semiconductors) electrons behaved more as if they were confined in two-dimensional sheets rather than some sort of free atomic gas. Sounds like original research to me. Otoh, the techniques to manufacture raw silicon of the necessary purity was done by the University of Minnesota, I think. Anyway, some university. That sounds pretty much like engineering.

There is this to consider as well: if you're claiming that would drug companies do is more along the lines of engineering, then they really aren't doing any real R&D to discover new drugs, are they? They're either ringing through the changes of old formulations, or else figuring out new fabrication techniques. By this standard, Ford trying out new kinds of resins for deformable bumpers is doing "research".

Not quite the risky leap into the wild blue yonder the cheerleaders would have us believe, eh?

The first working laser was made by Theodore H. Maiman in 1960 at Hughes Research Laboratories in Malibu, California, beating several research teams including those of Townes at Columbia University, Arthur L. Schawlow at Bell Labs, and Gould at a company called TRG (Technical Research Group).

Link.

It's actually rather hard to pin down the "inventor" of the laser, given that the theoretical work preceded the practical application, and masers preceded lasers.

The story of the electron microscope (and for that matter the electronic computer, especially if we're talking about a semiconductor computer) is similar, with academics and industry both making major contributions.

SOV, the $100 million is a lowball figure beloved of anti-pharma activists, but with, AFAIK, less basis in fact as the $800 million figure beloved of conservative op-ed writers. It is the figure for a single clinical trial, not the entire clinical trial process. When you factor in things like all three phases of the trials, cost of capital, administrative overhead, requests for more data from the FDA, etc., the lowball figure is $300 million, the median estimate is $500 million, and the highball figure, which includes opportunity costs, is $800 million.

SOV:

Nobody's saying that the public sector doesn't have a useful role to play in funding basic research. The claim is that the private sector is better at evolving and refining commercial products than the public sector. Do you find this claim controversial?

And as an aside, according to Wikipedia the concept of the laser came from Albert Einstein, the first laser patent was granted to Bell Labs, and the first working laser was produced at Hughes Research Lab, i.e., the laser was privately produced.

I am sure a citation happy person such as yourself has this information handy.

You are, Yancey, and I mean this in the nicest possible way, and idiot. If you want to see some of those cites, you need to say, publicly, that cites are good things, that any argument should be backed up with facts, cites, quotes etc. I also want you to say that you don't tend to do this - you certainly haven't done much in that department that I can see - and that your opinion is uninformed opinion of the guy off the street.

Bottom line, moron: don't simultaneously sneer at cites (which is itself the mark of a negligible entity) and demand them.

But this raises an interesting point: does anyone here besides Yancey want to state that cites, sourcing, et al, are bad things?

Anyone? I want to know, because if anyone really think that, I don't want to waste my time in any sort of conversation with that person.

the government is reasonably good at basic research (which is not really excludable),

Is it? I thought that argument was that if you subsidise something e.g. research, you get more of it than if you did not subsidise it.

This is not proof that research will be done better or cheaper simply because it is done on the goverments dollar.

SOV,

Coming from almost any other commenter, I might actually be insulted by you, but you have consistently shown yourself to be someone not to be taken seriously.

However, I still await your citation (citations are often good, especially if the citation itself is actually accurate in it's information) of all the drugs private pharma has acquired from university labs (stolen and otherwise), and sold in the market and collected all the profits. Put up of shut up, as they say.

SOV, the $100 million is a lowball figure beloved of anti-pharma activists, but with, AFAIK, less basis in fact as the $800 million figure beloved of conservative op-ed writers.

If that's what you think, where's your research? I've pointed to mine, and that's just one source. Let me post it again so that you can criticize it:

http://www.citizen.org/documents/ACFDC.PDF

I don't claim it isn't partisan, btw, but it's certainly no more partisan than the pro-pharma formulations we've seen so far, and arguably much less. Check out the credits of the reviewers of this paper, then look at page four for the overview, and finally page seven for critiques of how that $500 million figure was arrived at.

I don't know about you, but neglecting to mention the tax credits one gets for R&D and refusing to factor them in strikes me as pretty dicey accounting, for example. If you dispute this, or any other finding, let me know, tell me why, and post your sources.

It is the figure for a single clinical trial, not the entire clinical trial process. When you factor in things like all three phases of the trials, cost of capital, administrative overhead, requests for more data from the FDA, etc., the lowball figure is $300 million, the median estimate is $500 million, and the highball figure, which includes opportunity costs, is $800 million.

Again, I'd like to see your sources, see if they followed the appropriate methodologies, who funded those sources, etc.

I'm willing to be convinced, as always, but one thing I will not be convinced by is shoddy scholarship, or worse still, a complete lack of cites to bolster an argument.

one thing I will not be convinced by is shoddy scholarship, or worse still, a complete lack of cites to bolster an argument.

Neither will anyone else.

But hey, if you don't want to give Yancy cites re: drugs developed at NIH, then just give him the names, and I'm sure he can dig up the cites himself

ScentOfViolets and Megan_McArdle: What did I say about arguments that hinge on R&D costing $X always and forever...?

Not quite the risky leap into the wild blue yonder the cheerleaders would have us believe, eh?

By your own (disputed) source, bringing a new drug to market is $100 million dollars. Are you claiming that putting $100 million dollars into something that might fail isn't risky?

What is the argument you are trying to make? That producing a new drug is such a trivial undertaking (it's only $100 million dollars!) that there's no sensitivity to the ROI. Or that the public could pick up the drug development costs with the cost savings to be realized from monopsony purchasing. Or that you're just a dick who enjoys being contrary without any larger point implied.

What the hell are you trying to say?

"Computers" may have been invented by some government research program, but the computer on my desk was refined and made many times more powerful, cheaper, and smaller by private companies.

I read the report on R&D costs and price controls for drugs and commented on it in the other thread on drug prices. In short, it really makes a weak case.

Right now, the market for drugs (and other medical procedures) is distorted by the fact that consumers typically face fixed costs (low co-pays) and don't have any incentive to shop around. Insurance companies respond by aggressively denying claims and strong-arming providors into reducing all of their prices.

What we need to do is figure out how to get pricing signals back to the consumer. I would like to see percentage co-pays rather than flat co-pays for most procedures or possibly just let ocnsumers pay for day-to-day stuff and only use insurance for unexpected high costs (you know, like it was actually "insurance" instead of "insurance + medical spending account").

Then we could actually see if the market works.

I also like the prize model for funding research... it means that tax payers only pay for successful research and the cost is known before you start.

SoV:

Your own study (p. 3) says that "DiMasi’s original $231 million figure does not represent what companies actually spend
to discover and develop new molecular entities. Rather, it includes the cost of all failed
drugs and the expense of using money for drug research rather than other investments."

Um - if a drug fails during clinical trials, the drug company doesn't get its money back. Any claim to derive the cost of drugs that doesn't include the cost to develop the (large) number of drugs that don't make it to market is inherently bogus. That sort of argumentation renders the remainder of the argument highly suspect at best.

You know, I'm really upset about the cost of entertainment. I think we should cap movie theater prices at $2, and if necessary set up a government agency to finance and/or produce movies.

What do you guys think? Can't miss, right?

For the Nth time, basic research, in the areas relevant to drug discovery, does things like detmining new biochemical pathways that influence things like blood pressure or a cancer cell's ability to evade death or blood sugar levels. Some of the proteins or enzymes involved in said pathways will appear to be good targets for a drug. This is where drug companies step in. They, in the aggregate, spend much more than the government spends on basic research each year. In so doing, they often find that actually, target A is a crappy drug target because of unavoidable side effects, or a second, redundant pathway that compensates for the first. So the government-funded basic research is not an infallible launching pad for the private sector at all, though it is of course invaluable; moreover, in validating or disproving some of the assumptions coming from government-funded basic research, the pharma industry winds up doing quite a bit of 'basic' research on its own. Research programs fail for other reasons too, of course, so even if the suggested target proves to be a good one, many programs will wind up churning through a lot of money. Drug discovery costs are dwarfed by clinical trial costs, however. I agree with Megan that the $1bn value is usually high, but the $100 million is laughable for reasons too numerous to go into. In total, a program that gets to phase III and fails usually will burn close to a billion dollars from conception to RIP. Tax breaks aren't going to bust that down to $100 million, folks. Most failures don't get that far, so the average will be much lower - if we count programs that don't even reach the clinic, the average might be MUCH lower - nevertheless aggregate R&D stats are widely available and the fact that they are larger than, say, the NIH budget for biology research ought to tell everyone not named 'Scent of Violets' something.

The $800 million figure comes from the best study in the literature, which is indeed Dimasi, whose most recently published work on this (i think) is 2003.

See The price of innovation: new estimates
of drug development costs
Joseph A. DiMasi a,∗, Ronald W. Hansen b, Henry G. Grabowski, Journal of Health Economics 22 (2003) 151–185

Citing Public Citizen as a serious source of impartial information is laughable.

SOV:

Nobody's saying that the public sector doesn't have a useful role to play in funding basic research. The claim is that the private sector is better at evolving and refining commercial products than the public sector. Do you find this claim controversial?

While I don't dispute the basic point of this claim if one includes the general caveats, I didn't think this was the claim being disputed; the claim I take issue with is that the drug companies charge the prices they do because of the high cost of risky research, and that any attempt to tamper with this would inevitably result in fewer drugs being brought to market (there's a hidden assumption there that the drugs are actually useful in sense of having a positive impact on health.)

Not quite the risky leap into the wild blue yonder the cheerleaders would have us believe, eh?

By your own (disputed) source, bringing a new drug to market is $100 million dollars. Are you claiming that putting $100 million dollars into something that might fail isn't risky?

No. I am saying that the risk is not as large as claimed, in part because what is risked is not has great as being claimed. Are you trying to draw an arbitrary line? That seems nonsensical, since every business routinely risks sums of money. Pharmaceutical companies are no different from any others; in particular, note that auto companies will invest millions, tens of millions, hundreds of millions of dollars on new lines of autos, and some of those new entries are quite definitely lemons. _And_ they do R&D as well. Do you see them justifying their pricing on the high cost of research? No, you do not.

What is the argument you are trying to make? That producing a new drug is such a trivial undertaking (it's only $100 million dollars!) that there's no sensitivity to the ROI. Or that the public could pick up the drug development costs with the cost savings to be realized from monopsony purchasing. Or that you're just a dick who enjoys being contrary without any larger point implied.

What the hell are you trying to say?

Posted by SG

Sigh. I'm giving you one chance. Only one chance, clear? My point is as above, and further, in a prior post, I wrote this:

And so on and so forth. The actual costs to bring to market new drugs is more like $100 million or less.


Not that the actual figures matter that much; it's just that "500 million dollars" seems designed to provoke an emotive response rather than a reasoned one. "100 million dollars" much less so in these debased days. Que to Dr. Evil saying in rounded caps One. Million. Dollars. BWAHAHAHAHAHH!

So I clearly noted that quoted figures from the industry seemed to be hign at least in part to evoke an emotive 'gosh that's a lot of jack' feel, _as_well_as_also_noting_ that $100 million is still a lot of money, just not as emotive a figure.

Now, I have been polite, and shown where you erred. If you pop off like you did again, I really don't much care to talk to you anymore. And in fact, in a classic case of projection, I would not be at all surprised if you were looking for a fight.

If that's not the case, fine, but if so, if I were you, I would be mending some fences. A word to the wise, eh?

SOV,

I am still waiting for that citation.

(Sound of crickets....)

Do you see [auto makers] justifying their pricing on the high cost of research? No, you do not.

Do you see auto makers "justifying" their pricing at all? They don't have to "justify" their prices, because everyone understands if you don't like them, you don't have to pay them. Just enter the car equivalent of the "generic" market at your local used car dealer.

Furthermore, everyone recognizes that the marginal cost of a car is substantial, and must be paid; the marginal cost of a pill is next to nothing.

Drug makers face a constant drumbeat of criticism for high prices in light of low marginal costs. Hence, the need to "justify" these prices in terms of their costs, one of which is R&D.

SoV:

Your own study (p. 3) says that "DiMasi’s original $231 million figure does not represent what companies actually spend
to discover and develop new molecular entities. Rather, it includes the cost of all failed
drugs and the expense of using money for drug research rather than other investments."


Um - if a drug fails during clinical trials, the drug company doesn't get its money back. Any claim to derive the cost of drugs that doesn't include the cost to develop the (large) number of drugs that don't make it to market is inherently bogus. That sort of argumentation renders the remainder of the argument highly suspect at best.

I'm having problems with that myself; it seems rather clumsily written. It seems that what they're trying to say was that (from the immediately proceeding point) that only a certain class of drugs, the NCE's, the most expensive kind to develop, were included in the study and that this was extrapolated into the average cost of all drug development, and further, the study improperly folded the costs of _all_ 'failed' drugs (I don't know what they mean by that term either) into a study that was looking at just the NCE's. I don't know, but you're certainly write that the cost of 'failed' drugs don't magically go away, if that's what they were implying.

However, in _same_ bullet point, it also mentions that in the original DiMasi study, the fact that part of that research money was a tax write-off was not accounted for, that in fact, after taxes they really only spent .60 of every dollar they claimed they spent on research.

Surely that was worth a mention, and if true, do you agree this is inflating the amount of money that was claimed to have been spent on research?

Further down, we read that the DiMasa estimates were much, much higher than any previous estimate - including one by the pharmaceutical industry itself.

Surely this sets off a few alarm bells, doesn't it?

SOV,

Look, I will make it easier for you: there were, by my count, 55 new drugs approved by the FDA in 2007 (a good year, by the way, compared to the immediately preceding years). How many of those were discovered and developed in the government laboratories before being bought and/or stolen by private pharma?

And a secondary question, while we are at it: how much was spent on R&D in 2007 by private pharma?

the fact that part of that research money was a tax write-off was not accounted for, that in fact, after taxes they really only spent .60 of every dollar they claimed they spent on research.

The significance of this depends on what is meant by "tax write off." 26 USC sec. 174 makes R&D either 1) an expense just like office supplies or electricity, or, at the election of the taxpayer, 2) a capital cost to be amortized over 60 months after the R&D yields revenue. Most pharmas are probably going to choose the former because it lets them recover even for failed drugs.

That means that buying research is treated the same, for tax purposes, as buying paper clips, and nobody thinks you need to include tax effects in declaring that your company spends $X annually on paper clips.

On the flip side, there are some special tax credits for research, which should be included in the calculation.

The $800 million figure comes from the best study in the literature, which is indeed Dimasi, whose most recently published work on this (i think) is 2003.

See The price of innovation: new estimates
of drug development costs
Joseph A. DiMasi a,∗, Ronald W. Hansen b, Henry G. Grabowski, Journal of Health Economics 22 (2003) 151–185

Citing Public Citizen as a serious source of impartial information is laughable.

Why is this the best study? As pointed out by my source[1] they neglected, among other things, to factor in tax breaks, and they improperly took the cost of a subset drugs (the most expensive to develop) and extended this to all drugs.

Surely you agree that those two practices alone are enough to ensure that this was not 'the best study'? (You do agree that what was done was not proper, right?)

[1]I have no problems with saying the study I cited was put out by a partisan group; to deny otherwise would be dishonest (hint, hint.) But that doesn't mean the points they raise are invalid, in fact, I'll even go so far as to post another link for the rebuttal and counter-reply to this report:

http://www.citizen.org/print_article.cfm?ID=6514

Uh huh. So why, pray tell, didn't private enterprise invent computers, lasers, electron microscopes, etc?

You can play that game all day, and eventually it will come back around to the same thing: basic research is where government excels, because most of it is extremely expensive and doesn't have immediate payoff benefits. Engineering the concepts further, however, usually works best in private industry.

The example of the computer is a very good one for this thesis -- yes, the original research that produced designs like, e.g., ENIAC was funded through government. The personal computer on your desk, however, owes 95% of its design and design legacy, and 85%+ of its manufacturing technology, to private enterprise. Other than its ability to process numbers and run on electricity, it has essentially zero commnality with the early, government-funded designs.

I mean, obviously, what with the goverment being "monetarily inefficient" and all.

Perhaps I was unclear. Government is good at the basic research stage precisely because it can dump obscene amounts of money in order to discover things that, of themselves, are very useful to know but have no immediate payback. Unfortunately, when government tries to engineer something, it does so by the same process, and then develops very little practical technology relative to the capital outlay. There are some public goods where this is unavoidable and necessary. For most things, however, it usually works better to hand the reigns to private enterprise, and let market forces determine how to allocate resources.

yes, the original research that produced designs like, e.g., ENIAC was funded through government.

Only if you ignore private industry's contribution to vacuum tube technology.

Other than its ability to process numbers and run on electricity, it has essentially zero commnality with the early, government-funded designs.

Unless you use FORTRAN.

Only if you ignore private industry's contribution to vacuum tube technology.

Well, yeah. But the lady is clearly stuck on the idea, so I gave her the most generous interpretation.

Unless you use FORTRAN.

HIISSSSSSSSSSSSSSS! *makes sign of cross with index fingers*

Do you see [auto makers] justifying their pricing on the high cost of research? No, you do not.

This is kind of a silly argument, for a number of reasons.

First, auto manufacturers don't bother justifying their prices, because no one is threatening to cap them by fiat.

Second, where the government does contemplate mandates that would affect the economics of auto manufacturing (e.g., safety, emission, and mileage standards), the manufacturers immediately bleat about R&D and manufacturing costs.

Third, R&D costs are relatively low in the auto industry (compared to pharma) because conceptually the automobile has been unchanged for most of a century. All the improvements have been small, incremental ones, and would be analogous in pharma to new formulations of existing drugs.

If the auto industry had to come out with new types of cars every five years or so (e.g., switch from internal combustion to batteries to fuel cells), then the industries would be more comparable.

Dimasi is the best study because it is; what other study would you compare with it? and its been widely recognized to be so. As to Public Citizen's objection to the use of before tax figures for R and D costs, i suggest you take a look at the very full discussion of the tax issues in the 2003 article.

from p.174: Hence, a straightforward calculation can be made to use our R&D cost estimates
as inputs in after-tax analyses of R&D rates of return (OTA, 1993; Grabowski and Verno