Join the MedsWatch crowd

We’re looking for researchers to join the team in Indonesia and the UK

“Substandard and falsified medicines are a growing problem….” Most reports on the subject start with something like that, before going on to tell us that fake and crap medicines damage health, waste money, and undermine confidence in health systems. But ARE they a growing problem? We actually don’t know, because no-one has been measuring medicine quality in a systematic way over time. DO they damage health and waste money? Yes, obviously, but how much, we’ve no idea, because no-one has been measuring or even estimating impact systematically at a national level .

We’re going to try to do exactly those things, in Indonesia, and we’re looking for people to help us, in Indonesia and the UK. The work on prevalence of poor quality medicines will be based in Indonesia; it will be led by Universitas Pancasila, under Yusi Anggriani and Elizabeth Pisani. Though the health and economic impact measures will be applied to Indonesian data in collaboration with institutional partners in Indonesia, methods development for these parts of the work will be based at Imperial College in the UK, and will be led by Kalipso Chalkidou and Adrian Gheorghe. Imperial is already hiring a research assistant for a London-based post; at UP, in Jakarta, we’ll be hiring research assistants, data managers, engagement managers and others in September.

For administrative reasons, the Imperial job description is quite generic. To give a bit more background, here’s what we’ll be trying to do over the course of what we expect to be a three year project:

  1. Bring together data from a wide variety of instructional sources relevant to medicines available to Indonesian patients  (data regarding procurement, market, regulation, reimbursement, trade etc.)
  2. Analyse the data using a flagging system which helps indicate which products are most at risk of being falsified or substandard, and develop a sentinel surveillance framework.
  3. Conduct sentinel surveillance of medicines in 9 districts across Indonesia, and test the selected medicines to ascertain their quality.
  4. Combine the results with market and other data to develop national estimates of the prevalence of substandard and falsified medicines.
  5. Combine the results with reimbursement, burden of disease and other data to develop national estimates the health impact of substandard and falsified medicines.
  6. Combine the results with market, procurement and other data to develop national estimates the economic impact of substandard and falsified medicines.

Throughout this work, we’ll be working in consultation with the national medicine regulator and people from Indonesian institutions and companies with an influence on policies that affect the quality of medicines. We also hope to engage with the World Health Organization Member State Mechanism on falsified and substandard medical products, which is currently working to improve risk-based post market surveillance for poor quality medicines.

If you have good quantitative data skills, are not afraid of hard work, and are interested in medicine quality, public health surveillance, incentives in pharma procurement and/or the political economy of decision-making in health, we want to hear from you. If you speak Indonesian and have any inside knowledge of the pharma industry or medicine markets, and/or know your way around public procurement/ JKN policies and BPJS data, we are even more keen hear from you (including if you are based in the UK). You won’t get rich working with us, but you will get to work (hard!) with a bunch of curious people from different backgrounds who try to keep research grounded and useful, and who believe that learning new stuff should be fun.

Disclaimer: The information provided in this note is entirely informal, and aims only to try to make sure that the people who are likely to be most interested by the work know about it. It has no binding influence on Imperial’s recruitment process. To apply for the Imperial research assistant post, please take note of the requirements in the formal job ad, including full pdf job description. These over-ride the extra information given in this note. The deadline for applications is August 13th. End of disclaimer.

Untuk yang di Indonesia: kalau tertarik gabung sama tim kami di Universitas Pancasila (mulai September/Oktober 2020), tolong hubungi info@medswatch.org dengan CV. Nanti, kalau jobdes yang resmi sudah keluar, kami akan kontak kembali.

Quality-by-association? The knock-on effect of sloppy regulation in rich countries

With COVID-19 diagnostics, “stringent regulatory authorities” are anything but stringent. Opportunistic companies (and DJs) profit, while poorer countries are hoodwinked.

School children are not generally allowed to grade their own homework, for fear that they’d give themselves a 10 for work that really only rates a 4. In the US and Europe, however, makers of COVID test kits can give themselves any grades they like: tests are being waived through on a self-certified basis.

That’s obviously potentially dangerous for patients, because sometimes the tests aren’t really up to scratch. A case in point is the rapid antibody tests made by Chinese company Hangzhou Alltest Biotech Co Ltd. While they claim that the tests are 92.9% accurate for early-developing markers, and 98.6% for later antibody markers, a careful validation in a clinical setting in Spain (yet to be peer reviewed), showed that the test was very good at spotting uninfected people – it gave no false positive results. But it was only able to correctly identify infected people around 47% of the time two weeks after onset of symptoms, though the proportion did climb further after about a month. And there’s no information at all about how the test performed among people who never had symptomatic infection – the very people we’d need to identify if we were testing to selectively release people with some immunity from lockdown. Oxford University, which tried to validate the Hangzhou Alltest test kits among others, said that none of the rapid diagnostic kits they tested was good enough to use widely. No surprise, then, that both Spain and the UK sent back test kits they had bought from Hangzhou Alltest and other Chinese manufacturers.

Find it hard to believe that companies get to just self-declare the accuracy of their tests? Actually, it’s worse than that. European and American distributors can buy tests made by other companies in other countries — China, say, or India — rebrand them to look like they were made in Europe or the US, and then send them through the system based on declarations about effectiveness made by the original manufacturers, even giving themselves the coveted “CE” mark of quality, without anyone ever checking whether the tests work or not. Some do this enthusiastically, because they know that masking the product’s origins — and making it look like it comes from a country with a strong regulator — works really well as a marketing ploy, both at home and in export markets.

A particularly enthusiastic rebrander is Dutch company Inzek International Trading, which sells tests under the brand Biozek. Its website declares “Biozek medical is a Netherlands based manufacturer with wide ranges of IVD products…” What it does not say is “…which we buy from Chinese companies, rebrand, and re-sell to other countries, encouraging them to believe that these products have been validated by European regulators”. But, as this great piece of investigative journalism from OCCRP reveals , that’s exactly what they do.

The trick works brilliantly. Biozek is reported to have sold 1.5 million COVID-19 test kits to over 20 countries. These include Indonesia, where state-owned pharmacy giant Kimia Farma has bought 300,000 repackaged Hangzhou Alltest kits. In the Indonesian media, Biozek staff and their local distributors were absolutely brazen in puffing out smoke and flashing mirrors to create an illusion of “European-made” quality. In a press release, Biozek’s Mustafa Hamid lied said “The test was developed and produced under the regulations of the EU and the Netherlands, which are very tight.” Meanwhile, the distributor in Indonesia, Erro Verschoor of MACH-E, had the gall to accuse other manufacturers of taking advantage of the current crisis. “We’ve seen many tests, even certified ones, go to market and then fail to meet regulated standards. In the end those products get sent back, or their use is prohibited in Europe. We’ve noticed that many governments and organisations don’t want to take the risk, so in the end they decide to collaborate with us to buy our test kits.”

In my school days, that would have been referred to as “bare-faced cheek”, though these days my choice of words might be stronger. Not least because it does seem that Biozek went to considerable lengths create the illusion that the tests they were selling to Indonesia were European made. According to OCCRP:

Andi Prazos, a director at Indonesia’s Kimia Farma, said the state company had been convinced the tests were Dutch made. Kimia staff were even given a tour of Inzek’s production facility in the Netherlands before placing their order, he said.

Other savvy marketers have been playing the same game on a smaller scale. According to the UK’s Sun newspaper (not one I regularly quote, I admit) London-based DJ Enay has been pimping Biozek products through social media channels, using the fantasy European badge of quality.  

I leave you with the Sun’s screenshot of the DJ’s promotional Snapchat, and the deliciously ironic possibility that the low accuracy “mentioned by the Spanish government” actually refers to the very kits that he is flogging.

DJ Enay's Snapchat ad for COVID tests

Indonesia, USA: medicine pricing causes common headaches

The US and Indonesia are very different, but medicine reimbursement policies in both countries sometimes encourage pharmacies to limit stocks of cheaper drugs

As COVID-related news, research reports, papers, blog-posts and general pontification flood across my desk, I’ve been trying to fish out the bits most likely to signal existing or up-coming assaults on the quality of medicines. And one of the things I find most interesting is that the same risk-indicator fish seem to be swimming in very different bodies of water.

One example: reimbursement policies that incentivise legitimate pharmacies not to dispense the most affordable medicines, thus potentially sending patients to dodgier outlets where they are more likely to get fake medicines.

We see this in both the US and Indonesia, even though the two countries differ on virtually every health-care related measure. The US, one of the richest countries in the world, accepts that it’s fine to allow tens of millions of citizens to live without health insurance. Those that are insured have to choose between thousands of different private plans, each with different reimbursement policies. Meanwhile, lower-middle income Indonesia (which comes right after the US in population size, with close to 300 million citizens) has been working to provide at least basic health care to the whole population through one, mighty, national insurance system. The purchasing power that that confers has allowed Indonesia to do much more to bring down the price of medicine in the public sector (to the point where some medicines are arguably dangerously cheap). The fragmented US market seems to accept that, in general, medicine manufacturers should be allowed to charge whatever they can get away with; insurers and patients then decide what they can afford.

This very interesting analysis of variation in reimbursement rates in the US, from 3Axis Advisors [full report available at link], highlights the amazing range that insurance plans are willing to pay for the same medicine. For the same dose of generic azithromycin, for example, some insurers pay as little as US$0.11 while others pay $3.53 — over 30 times as much, for a product that consistently cost pharmacies between 53 and 69 cents to buy (HT @EdSilverman via Pharmalot).

A fair bit of the time, the reimbursement rate is less than the pharmacy paid for the medicine. Pharmacists may make up the loss with cross-subsidisation from other insurers (recouping the underpayment of the 11 cent insurers with cash sloshed their way by the three-dollar plans) or from other medicines. But where reimbursement is consistently below cost price, pharmacies don’t have much of an incentive to stock a medicine. And, as 3Axis observed (and we noted in our earlier blog post about the effect of COVID on medicine quality) the pandemic will likely exacerbate the problem, because producers will push up the price of medicines more quickly than payers will raise their reimbursement rates, making it even more unprofitable to dispense those meds.

The effect of this may be to push pharmacies to simply “short” the medicines which cost them money to dispense, offering patients instead the medicines they make money on. “Sorry, we’ve no generic azithromycin in stock, but I can offer you Zithromax, for cash…”

This is a dynamic we also see in Indonesia (though it will only apply to the handful of medicines which are reimbursed). The net effect of pushing patients towards out of pocket payment for more expensive medicines is to push them to buy medicines online, or in other unregulated outlets. That makes them easier prey for falsifiers.

In their blog post summarising the research, 3Axis listed some of the ways in which COVID-19 will push up the prices of generic medicines:

(Sound familiar?)

But nowhere do they address the question of reasonable or fair prices for generics, or any other kinds of medicines. The list price to pharmacies of 250mg azithromycin in the Indonesian market ranged from 29 US cents to two dollars in 2019 (compared with the 53-69 cent range actually paid by US pharmacies, according to 3Axis). The public procurement price for a pill with twice as much active ingredient (500 mg) was half as much — just 1778 rupiah, or 11 cents. Yet in the Indonesian market, Pfizer’s Zithromax 500mg sold to pharmacies at US$4.00 a pill — close to 40 times the public procurement price, and about the same as the “regular” cash price in the US, after applying the 90+ percent discount from the list price, according to the price comparison site Good Rx. But just take a look at the list price for something Good Rx describes as “an inexpensive drug” — US$ 434.65 for a product that the Indonesian government buys for 66 cents.

That’s an insane difference, and one that threatens quality from both sides. The Indonesian price is probably too cheap — it’s really hard to make and distribute a good quality antibiotic for 11 cents, even when you’re guaranteed a really big market. (New Zealand, which is notoriously good at driving a hard bargain for quality-assured medicines, pays 28 US cents for the same product.) But pricing medicines too high attracts falsifiers (who think just like pharma companies: why sell something cheap when you could sell the same thing more expensively?) And it drives patients who can’t afford the regular pharmacy list price into unregulated on-line stores, where everything is negotiable.