Sam Watson’s journal round-up for 26th March 2016

Every Monday our authors provide a round-up of some of the most recently published peer reviewed articles from the field. We don’t cover everything, or even what’s most important – just a few papers that have interested the author. Visit our Resources page for links to more journals or follow the HealthEconBot. If you’d like to write one of our weekly journal round-ups, get in touch.

Affordability and availability of off-patent drugs in the United States—the case for importing from abroad: observational study. BMJ [PubMedPublished 19th March 2018

Martin Shkreli has been frequently called “the most hated man in America“. Aside from defrauding investors and being the envied owner of a one-of-a-kind Wu-Tang Clan album, the company of which he was chief executive, Turing Pharmaceuticals, purchased the sole US approved manufacturer of a toxoplasmosis treatment, pyrimethamine, and hiked its price from $13 to $750 per tablet. Price gouging is nothing new in the pharmaceutical sector. An episode of the recent Netflix documentary series Dirty Money covers the story of Valeant Pharmaceuticals whose entire business was structured around the purchase of drug companies, laying off any research staff, and then hiking the price as high as the market could bear (even if this included running their own pharmacies to buy products at these inflated prices). The structure of the US drug market often allows the formation of monopolies on off-patent, or generic, medication, since the process for regulatory approval for a new manufacturer can be long and expensive. There have been proposals though that this could be ameliorated by allowing manufacturers approved by other trusted agencies (such as the European Medicines Agencies) to sell generics in the US while the FDA approvals process takes place. The aim of this paper is to determine how many more manufacturers this would allow into the US drugs market. The authors identify all the off-patent drugs that have been approved by the FDA since 1939 and all the manufacturers of those drugs that were approved by the FDA and by other trusted agencies. No analysis is given of how this might affect drug prices, though there is a pretty obvious correlation between the number of manufacturers and drug prices shown elsewhere. The results show that the proposed policy would increase the number of manufacturers for a sizeable proportion of generics: for example, 39% of generic medications could reach four or more manufacturers when including those approved by non-FDA bodies.

Why internists might want single-payer health care. Annals of Internal Medicine [PubMedPublished 20th March 2018

The US healthcare system has long been an object of fascination for many health economists. It spends far more than any other nation on healthcare (approximately $9,000 per capita compared to, say, $4,000 for the UK) and yet population health ranks alongside middle-income countries like Cuba and Ecuador. Garber and Skinner wondered whether it was uniquely inefficient and identified or questioned a number of issues that may or may not explain the efficiency or lack thereof. One of these was the administrative burden of multiple insurance companies, which evidence suggests does not actually account for much of the total expenditure on health care. However, Garber and Skinner say this does not take into account time spent by clinical and non-clinical staff on administration within hospitals. In this opinion piece, Paul Sorum argues that internists should support a move to a single-payer system in the US. One of his four points is the administrative burden of dealing with insurance companies, which he cites as an astonishing 61 hours per week per physician (presumably spread across a number of staff). Certainly, this seems to be a key issue. But Sorum’s other three points don’t necessarily support a single-payer system. He also argues that the insurance system is leading to increasing deductibles and co-payments placed on patients, limiting access to medications, as drug prices rise. Indeed, Garber and Skinner note also that high deductibles limit the use of highly cost-effective measures and actually have the opposite effect of reducing productive efficiency. A single payer system per se would not solve this, it would need significant subsidies and regulation as well, and as our previous paper shows, other measures can be used to bring down drug prices. Sorum also argues that the US insurance system places an unnecessary burden from quality measures and assessment as well as electronic medical records used to collect information for billing purposes. But these issues of quality and electronic medical records have been discussed in the context of many health care systems, not least the NHS, as the political and regulatory framework still requires this. So a single-payer system is not a solution here. A key difference between the US and elsewhere that Garber and Skinner identify is that the US permits much more heterogeneity in access to and use of health care (e.g. overuse by the wealthy and underuse by the poor). Significant political barriers stand in the way of a single payer system, and since other means can be used to achieve universal coverage, such as the provisions in the Affordable Care Act, maybe internists would be better directing their energy at more achievable goals.

Social ties in academia: a friend is a treasure. Review of Economics and Statistics [RePEcPublished 2nd March 2018

If you ever wondered whether the reason you didn’t get published in that top economics journal was that you didn’t know the right people, you may well be right! This article examines the social ties between authors and editors of the top four economics journals. Almost half of the papers published in these journals had at least one author with a connection to an editor, either through working in the same department, co-authoring a paper, or PhD supervision. The QJE appears to be the worst offender with (if I’ve read this correctly) all authors between 2000 and 2006 getting their PhD in either Harvard or MIT. So don’t bother trying to get published there! This article also shows that you’re more likely to get a paper into the journals when your former PhD supervisor is editing it. Given how much sway a paper published in these journals has on the future careers of young economists, it is disheartening to see the extent of nepotism in the publication process. Of course, one may argue that it just so happens that those that work at the top journals associate most frequently with those who write the best papers. But given even a little understanding of human nature, one would be inclined to discount this explanation. We have all previously asked ourselves, especially when writing a journal round-up, how this or that paper got into a particularly highly regarded journal, now we know…

Credits

Call for a model registry

Decision models can be very useful. They can also be very bad. ISPOR and SMDM recently got together to form the Modeling Good Research Practices Task Force and have produced a set of reports. One of the reports, by David Eddy and colleagues, considers Model Transparency and Validation. The authors discuss the importance of transparency and validation in ensuring model credibility. They provide an excellent set of best practices that all modellers should follow. Go and read it.

The problem

The apparent effectiveness of a health care intervention can be distorted in many ways. Ben Goldacre‘s new book does a pretty good job of covering these. When it comes to cost-effectiveness the opportunities possibilities for distortion increase exponentially. A recent paper investigated FDA actions against health economic promotions. Many companies seek to promote products based on their economic value of “saving money” or “lowering costs”. The most common type of economic violation was an implied claim of cost savings due to work productivity or functioning. One can imagine how an unjustified figure of this nature could go unrecognised in a model.

There will always be intentionally misleading models, with which regulators will have to deal. However, most researchers’ models will have validity issues in spite of good intentions. If Eddy et al’s best practices were adhered to by good researchers then bad models could be easily identified and amended. The authors argue that, to ensure transparency, each model should be accompanied by both technical and non-technical documentation available to interested readers. However, a feasible process of ensuring transparency in this way does not currently exist.

The solution

The solution is to establish a model registry and database. It is unrealistic to expect journal publishers to accept extensive appendices, to which additions would need to be made as a model is developed.

Setting up a registry and online database would be very simple. Inclusion in the registry should require a minimum submission to the database: Eddy et al’s proposed non-technical documentation. Further information and files could be optional. Each model, whether single-application or multi-application, would be assigned a registration number and a corresponding database entry and webpage. The webpage could include all of the technical and non-technical documentation required by Eddy et al’s best practices. It could also include relevant citations, manuals and code. The site should provide a means for feedback and discussion. As models are updated and improved, or used in other applications, details can be added about subsequent versions. I’m not convinced of the argument presented by Eddy et al regarding intellectual property. This is meant to be science; one wouldn’t expect a health researcher to keep their trial design secret. Regardless, a registry would further protect intellectual property rights. Copyright is an automatic right in most countries, and plagiarism or use without appropriate attribution could easily be recognised and acted upon in a transparent system. The registry would provide a means of ensuring appropriate attribution of intellectual property.

There will be costs associated with maintaining such a registry and database (web hosting, doi fees), but most would be achieved by the contribution of researchers’ time. Academics are well accustomed to pro bono work and this shouldn’t represent a serious barrier. The primary challenge would be in encouraging researchers to submit their models to the registry. Model registration could not be a pre-requisite for publication in the same way as trial registration, so researchers would have to see other incentives. I would see the primary benefit as increased citations. If people are allowed to use existing models this will lead to further citation of the original, which could be facilitated by the provision of a Digital Object Identifier and would promote model validation.

An open and transparent registry would enable the research community to investigate the validity of models, which may be used to inform policy decisions. A registry would also help prevent the duplication of efforts. So, I call on relevant organisations (ISPOR, SMDM, OHE, CRD etc) to establish a registry of this nature. If you don’t do it soon I’ll have to do it myself.

DOI: 10.6084/m9.figshare.1246218