Ross Silverman, formerly known as the Bloviator, has moved his excellent medical policy blog to a new site, the Public Health Press. And he has managed to choke me up with only seventeen syllables.
On the subject of public health, and while I have Ross’s attention, there was some brief discussion here the other day about the scope of the role of the federal government (specifically, the National Institutes of Health) in pharmaceutical research.
I’ve done enough work with pharmaceuticals to know how much I don’t know. It’s a complicated subject, and difficult to summarize. But Derek Lowe makes a genuine contribution here. He’s a research scientist at a pharmaceutical company, and he shares his perspective on what the NIH does and doesn’t do.
For a competing persepective, see Marcia Angell in the New York Review of Books. Upon rereading, I don’t think that her case is very strong.
I’m convinced that pharma companies are heavy marketers, and I know that most of the new drugs released are non-innovative “me-too” drugs. I know that pharma companies bend the spirit of the law, and sometimes the letter (starting around page 16, warning: .pdf), in order to gain more time earning enormous profits under patent protection.
But are big pharma companies innovative? On the question of the proportion of credit for drug development owed to pharma companies vs. public money, I don’t know what to think. Angell writes:
As hard as it is to believe, only a handful of truly important drugs have been brought to market in recent years, and they were mostly based on taxpayer-funded research at academic institutions, small biotechnology companies, or the National Institutes of Health (NIH).
But then later, she writes:
Increasingly, (large pharmaceutical companies) rely on academia, small biotech startup companies, and the NIH for (discovering new drugs). At least a third of drugs marketed by the major drug companies are now licensed from universities or small biotech companies, and these tend to be the most innovative ones.
Well…
Comments, as always, are open.
At the risk of being seen as a fool for not reading Derek’s comments first (I’ll get to them), the Angell piece seems a bit off the mark. It makes sense that innovative new drugs are “based” on research done on the public dime, because that is what the public dime is for. Drug companies do the heavy lifting of making the drug effective and safe, while public research often identifies drug targets or chemical structures that might be more effective. I can sit in my lab at the public university and do research for research’s sake (which is great!). If I find something cool and valuable, I can a)publish it, b)patent it, c) sell it to a drug company, or d) some combination of the three above. If I find something cool but not valuable, I can a) publish it and b) write a grant to find out more. If I find out nothing, i can a) get denied tenure and b) not get another job. See, the system works!
Even if we take on face value the claim that a large proportion of “innovative” drugs have their origins outside of big pharma, we would still be left with the question of how to take those innovative compounds from the pages of Nature to the doctor’s office.
It takes tremedous resources to develop a promising compound to the point where it wins FDA approval. Big pharma is very good at managing this process. There is reason to believe that the public sector simply couldn’t manage this process as effectively.
Drug development and clinical trials are typically outside the mission of research universities and rightly so. It would be greatly dillutive for the biomedical faculty of Harvard or UCLA to spend their time doing clinical trials. Clinical trials are certainly intellectually difficult undertakings in their own right, but not nearly so much as basic research. Quite simply, most academic researchers would be bored with the types of research (neccessary though it may be) that pharma companies perform. And universities aren’t especially good at managing large scale enterprises efficiently. Universities do very specialized and difficult things - but they excel at neither doing them quickly or doing them at low cost. The same can be said for the NIH.
In my view, as a socialist, this question is an irrelevance. The argument is that patents are needed to protect the major innovation which is allegedly going on in the pharmaceutical companies.
If those companies would be unable to innovate without patents, there’s a simple solution to that: Nationalise them!
Or at the very least, socialise the funding of pharmaceutical R&D labs.
Why not?
The standard argument against government funding of “short-term” research is that it is “inefficient”.
But this ignores the very real inefficiencies of the present model:
1. Government-granted monopolies, e.g. patents, result in windfall profits, caused by the monopolist exploiting the consumer. In a competitive production model, by contrast, profits would be minimal - all drugs would be equivalent to “generics” (unpatented drugs) today.
2. Because of their short-term profit-making focus, pharmaceutical companies are naturally conservative. Even in the arena of patentable drugs, they tend to explore the space of drugs conservatively, focusing on what they know, which might well be suboptimal.
3. Relatedly, alternative approaches to patented drugs, which aren’t easily patentable tend to be ignored for years by pharmaceutical companies (because they aren’t profitable), government funders (which are biased towards helping businesses make a profit), and therefore doctors.
Patents produce massive distortions in the medical market. They must be abolished.
As I pointed out to Derek, to obsess on this point is to miss the larger issue.
No-one that I know of is denying that drug companies discover new drugs, so taking that as the argument is to miss the point.
Different people are upset with drug companies for various reasons, but among others these reasons include
- the decision as to which complaints to try to solve (ie which drugs to pursue)
- the way these companies not only sell drugs but are now attempting to manipulate the political process (Canadian imports, anti-“socialized medicine” ads, Australian Free Trade Agreement)
- the feeling that there is something more than a little sleezy about running ads that pretend to be informative (“ask your physician about…”) but are basically just your standard ad designed to increase demand
- a feeling that the industry is happy to warp the scientific process to suit its ends (eg not publishing drug trials that didn’t work out, pressure brought to bear on scientists to support a particular point of view etc)
The larger issue is not that the drug industry produces drugs, it is the question of whether it is the optimal system for doing so.
Would a different system with different incentives produce different results? An system that (and this is just a rough example of what could be) replaced at least some of the existing accountants and patent lawyers with people who certified how many people owed their lives to this drug, and that allowed them to boast of this fact (and strive for higher rankings) would obviously bias the behavior of individuals in a certain way. Replace this with rankings based on how many American lives are saved and you get different incentives. Replace with how many “hours of increased life” and different results again —- and all, of course, very different from the current incentives where recognition flows to how many dollars the drug generated.
There are, less ambitious, ways of tackling the other problems. Was it a good idea to let drug companies advertise to the public? Perhaps that should be rolled back.
Is there evidence that a few huge companies generates better results than a shared infrastructure (ie delegate certain task to the NIH) along with severe caps on the maximum size of a pharma company?
There are ideological answers to all these questions, of course, but for those of us who aren’t wedded to an ideology, these are empirical questions to which the answers are not a priori obvious.
Lowe’s explanation is indeed enlightening. But the flip side of the myth about drug companies’ stealing NIH discoveries is that public funding plays an minor role in the development of beneficial drugs (which is how the last discussion started).
In addition to the billions in basic research the NIH conducts, drug companies are publically subsidized through huge tax breaks on R&D spending - reducing their overall tax burden by as much as 40%.
Thanks, Ted, for linking to Ross’ new site.
I was worried that he’d get lost in the move.
It still bothers me a bit, because he is not getting as much fine discussion in comments there as he is here!
Ted,
Thanks for the kind words, and the link to the site. The explosion in traffic led to some interesting blogosphere ethnography data on what drives people to web sites.
s_bethy,
This morning, I changed over my comment code to Haloscan from the ridiculous Blogger comment format. Hopefully that, along with announcements like these, will raise the volume of discussion at my site.
“I don’t think that it’s useful to lump together universities (implying public money) with small biotech firms (implying private money.)”
Err, small biotech firms are privately-funded to a point. But NIH, SBIR, ATP grants are, more often than not, what gets a biotech firm off the ground and through the lean periods in private funding.
Right now, Biotech Venture Capitalists in Silicon Valley don’t want to talk to you unless you have data for trials in humans; the lack of liquidity because of the limited numbers of IPOs, and the failure of genomics/proteomics to produce short-term results*, has made them much more risk-adverse.
Hence the failure of a *lot of platform companies funded in 1997-2000: they had lots of neat lab technology, but they were a long way from anything therapeutic.
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