Archive for category Science/Technology

Dengvaxia until 2015

Dengue fever symptomslooks clearer to me now, after my first article (link), the Senate hearing (link) and more research. After the 2012 SONA where President Aquino mentioned initial successes in dengue prevention, there were newspaper articles which mentioned a rise in dengue (link), doubting its success. What I wonder is if the increased spread of dengue is related to climate change and to rapid urbanization in the Philippines – with the slums that result, the stagnant pools of water you often have there and of course a population density that makes it easier for the mosquito to travel from person to person.

Phase 3 Tests

The development of Dengvaxia goes way back, but the two most important Phase 3 tests started in June 2011 – one in Asia and one in Latin America (link). CYD 14 (Asia) had over 10 thousand volunteers while CYD 15 (Latin America) had almost 21 thousand volunteers. The active phase of CYD 14 ended in December 2013, that of CYD 15 in April 2014, with Sanofi reporting the success of Phase 3 some months later (link). Phase 3 is needed to apply for approval. The Philippines played a key role in all three test phases (link): 3,500 children were from the Philippines, setting up clinical trial sites in Alabang, Muntinlupa City (Phase 1); Barangay Del Remedios in San Pablo City (Phase 2); and Barangay Guadalupe in Cebu City along with Barangay Del Remedios (Phase 3) with Dr. Maria Rosario Capeding, head of the Department of Microbiology of the Research Institute for Tropical Medicine (RITM)  – an agency of the Department of Health – playing a key role (link), including writing key scientific papers (link) and even experiencing how her own child got dengue (link). Seems the most important seroprevalence data came from San Pablo (link).

Since national data on seroprevalence (how many % of the population had virus exposure) did not exist, it was extrapolated to some areas where dengue is endemic (link). Some might consider this a doubtful methodology, but then again such authorities as Balik-Scientist Dr. Edcel Salvana have mentioned approximately 87% as the seroprevalence (see my previous article) and I see no reason to doubt that they are right, give or take a certain margin. He also writes (link) about why he sees the vaccine as good – if used properly. What is also important, however, is that the Phase 3 studies (link) included an active phase of follow-up for one year after the last dose of vaccine in the series (25 months from dose 1) and include a hospital-based follow-up period of four additional years. The follow-up phase for the Asian phase 3 study seems to have ended in November 2017.

A related research paper (with Dr. Capeding as a co-author) says that in the ongoing longer-term follow-up (from year 3 to year 6) to assess safety, we are monitoring the incidence of hospitalization for dengue as a surrogate end point for disease severity in order to evaluate a potential predisposition in vaccinated persons to increased severity of disease. I do wonder if there is a relation between the planned end of the follow-up phase and the warning by Sanofi not to vaccinate seronegatives (people without any virus exposure) anymore due to risk of severe dengue.

Getting Things Ready

In July 2014, then-Health Secretary Enrique Ona (link) sounded quite confident about the new vaccine (link) and the hope then was that it would be out by July 2015. The success of the Latin American study was announced by Sanofi on Sept. 3, 2014 (link). President Aquino met with Sanofi representatives on Nov. 9, 2014 (link) which was pretty soon after these events, then a year later in Paris on Dec. 1, 2015 when he was there for the Climate Change Conference – a meeting that was openly mentioned in the Philippine press (link), not done stealthily as some are insinuating.

There also was a dinner in Paris in May 2015 (link) involving ex-Secretary Garin and Sanofi, and before that Sanofi submitted papers for Philippine FDA requirements in January 2015 (link). Mexico, Brazil and the Philippines (link) approved the vaccine in December 2015. The end of December brought a number of events which were seen as rushed, which President Aquino in the hearing explained as being in order to get things done in his term, saying the new administrations often lose time in the beginning, and also explained why budget maneuvers were needed (link).


Now for Questions

Assuming the best (which I do now after having seen how Aquino acted at the hearing) there are still a number of questions. There were still some years of observation being conducted, who knew about this and who was (not) informed including possible risk factors, if already known then? As for monitoring, Dr. Melgar who was with the DOH when the program started has this to say (link): I know that the Family Health Office and the Epidemiology Bureau of the DOH have been doing due diligence in monitoring all adverse effects from the beginning. Sounds properly done.

Dr. Salvana would be the right person to ask on seroprevalence, and on why certain extrapolations were considered OK. I am satisfied with that for now, what I computed in my previous article still stands – those who WILL get sicker should be few. And I believe Aquino didn’t know the science.

What one knows

depends on eyes, ears and brain – and on their human and man-made extensions, meaning the people who inform and educate you. We all know about the information overload modern social media brings with the world practically spilling into our brains, including all sights and sounds. What more is a President constantly subjected to a barrage of information? So he needs his people. To filter what is important and what is not, to give him what he needs to be able to make decisions. What if they mislead him? He has to counter-check if possible. Mayors in cities have it much easier.

It is I think possible to get an intuitive feel for a city. Mayor Duterte may have known Davao in and out, therefore being instinctively able to tell bullshit from truth. At national level it isn’t that easy. Spurious drug lists have shown the limits of an intuitive, seat of the pants approach to governing. At national level and even more in specialized areas, one may need to have additional sources. Seems that the Presidential Management Office would have specialists (link), even if I am not sure if they are used as extensively and as focused as the staff of Germany’s Federal Chancellery (link) which has the job to (translated from German) obtain and keep ready the information the Chancellor needs for his/her work. Its divisions mirror related ministries and directly contact them for detailed information: Division 1 for interior and justice, Division 2 for foreign, defence and development affairs, Division 3 for social, health, labor, infrastructure and social matters, Division 4 for financial and economic matters, Division 5 for Europe and Division 6 for intelligence matters. With a nerve center like that, no need to rely only on Ministers – who are also politicians after all.

How one leads

Could it be that Aquino relied too much on his Cabinet members alone? A second opinion is good not only when one goes to doctors privately! It may be even more crucial in matters of state. The fact that ex-Secretary Garin now seems to have connections to the other side is a bit interesting. Somewhat like how PNPs Napenas was a candidate for an opposing party in the 2016 elections. Trust, but verify is usually better. And even a highly efficient apparatus can be sidelined at times, as was shown recently by the controversy in Germany regarding the herbicide glyphosate (link).

Another possibility is what I sense – that Aquino tends to push through with things he wants to do, at some point no longer reconsidering. That is a very Filipino trait which his successor also has, as in the Philippines, too much reconsidering can make one lose respect. The other side dislikes it, yes. But there is to me not much evidence of significant counter-indications known at that time, at least in a form understandable to laymen or managers. Specialists speak in details, managers think in terms of consequences, that gap must always be bridged whether in IT – my field – or elsewhere.


My personal opinion

There are terms like “lighthouse customer” for those who adopt a certain product first. Sometimes vendors (in any industry including mine) manage to make lighthouse customers pay normal prices. Other customers negotiate a deal which fairly considers their role in being one of the first to buy. Possibly the Philippines bought too many vaccines to soon at a slightly too high price. Asking for a refund is a maximum demand Sanofi will probably not accede to. But maybe a rebate as not all things were really made clear, since around 800 thousand kids will have to be monitored and a few, hopefully very few, may have to be hospitalized, is an idea. Sanofi does not want the PR damage from a long public conflict – nor does the Philippines want to look like a backwater where they accuse foreign firms of witchcraft. There are many ways forward. But let us look at 2016-2017 next.

Irineo B. R. Salazar
München, 15 December 2017

Tags: ,

Task Force MRT-3

Metrobus Istanbul 2010

Bus rapid transit in Istanbul

MRT3 is a long-standing issue. Things need to be fixed. But the problem has many dimensions:

  • The MRT-3 is in disrepair. It cannot operate at full capacity.
  • Its designed capacity is insufficient to absorb people using EDSA.
  • Taking it down for repair is not feasible – traffic would get even worse.

A quick solution must also think of the future. This is where I had this idea today which I am now outlining.

Solution Proposal Summary

The solution that I consider the most sensible for the MRT-3 conundrum and EDSA traffic would have three phases:

  1. Build a BRT system similar to that in Istanbul.
  2. Shut down the MRT3 for overhaul.
  3. Operate both after the overhaul.

This sounds crazy but it is in my opinion feasible and helpful. Why do I think it is:

  1. BRT systems can be up and running very quickly.
  2. The MRT needs a total overhaul to run properly again.
  3. Both systems together would absorb a lot of people using EDSA.

One would need some experts to help a local core team run from DOTC and controlled there:

  • Experienced BRT people from cities that have it. Istanbul, Bogota, Curitiba or Brisbane, it doesn’t matter. To build and enable a local Filipino team.
  • Experienced subway/tram people from cities that have it. Munich, Prague, I don’t care. To build and enable a local Filipino operation/maintenance team.

IMHO the local teams should all be from DOTC. Build own capabilities to be competent in supervising subcontractors. Make sure real lessons are learned from past glitches.

Building the BRT

Bf Bln Sw, 126 552

1924 train coach from Germany

The BRT could be built up quickly using the following steps:

  • Built bus rapid transit lanes by fencing off one EDSA lane on each side. Simple barriers are I think enough.
  • Build provisional stops where the MRT-3 stops and stairs are at present. This should not be too hard either.
  • Have bus operators drive on the left-hand side in the BRT lanes. So that boarding is alway on the right of the bus.

The following could be the way to deal with the BRT system set-up:

  • BRT experts have a look at the roads to see whether there are any problems with setting up barriers and building stations.
  • Where barriers or stations cannot be built that easily, have the buses cross to the normal road and use it for a while.
  • Get the work on the barriers and stations done and make sure the bus contractors are all on board and use them on Day X.

The BRT would replace the buses chaotically blocking EDSA on the sides. So no loss by getting it running quickly.

Buses in the BRT system would go on as normal buses to wherever the bulk of people live. I think this can be found out.

Divide the concessions based on different lines – Makati-Fairview, Makati-Pasig, whatever. Let old normal concessions expire.

Overhauling the MRT-3

As for overhauling the MRT-3, look at what needs to be done in the following areas and make sure the current state of the system is meticulously documented to avoid conflict:

  • Overhead lines and rail tracks
  • Stations and access to them
  • Coaches and engines

Find local contractors for each area. Agree on technology transfer within what is possible if foreign partners are involved. Contracts should have strict delivery and quality clauses.

BRT and MRT

MRT-3 Manila train towards Ayala Station

MRT-3 near Ayala

As soon as the BRT and MRT are working in parallel, do the following:

  1. make the MRT fare more expensive than that of the BRT – to get back the cost of overhauling the system.
  2. Built new lines using the team that overhauled the MRT-3 and their subcontractors to use their capabilities.
  3. The same team should become fully local after a while, and take care of maintenance and operation of all lines.

This is to avoid the same problems from occuring once again after a few years.

Is this crazy?

Yes it is. But it is much crazier to let the system continue to rot. It is both a quick fix and a long-term solution.

Having two systems also means having a fallback option. Ideas to enhance this proposal are very welcome.

Irineo B. R. Salazar, München, 12. January 2016

Tags: ,