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An alternative model

By Dalia Alnuaimi | 26 Jul, 2016

Today, after our class on the Coartem challenge, I realized that we all don't like the existing model of innovating, developing and researching new drugs and devices. The least sympathetic crowd because that current model is for profit and because we think it abuses the needy through their need after it uses them for its research. The most sympathetic ones in the group were just realistic and pointed that A) that model works in bringing new innovations and B) Models that were not for profit failed in the past.
And I think the consensus (okay, it came with varying degrees of agreement) was that we have no currently operating and viable alternative.
But I came to think of our group as a highly driven and innovative group, If anything I think it would be a good exercise to brain storm an alternative model ourselves and try to criticize where the strengths and weaknesses lie.

For example:
The model I can think of is a sort of consortium of participating governments and NGOs, the consortium acts like the shareholders of an organization with a similar structure to a "pharmaceutical company" that studies, develops and manufactures drugs independently for the top 4 or 5 mortality causes then sells them at cost. The whole process should not be for profit.

Strengths: This model should help provide a not-for-profit producer of drugs with goals that align with the needs of poorer populations. The funds coming from multiple NGOs and governments may help alleviate the cost somewhat and stabilize the funds since they come from multiple sources.
Weaknesses: It is costly, it may cheaper to procure the drugs as they are now than to develop and make them for the members of the consortium and it will need a long time before it can show results.

I'm very enthusiastic that we can find a solution, but then again I just had too much coffee and that could be the reason.

Replies

 

Rameez Qudsi Replied at 10:50 PM, 26 Jul 2016

Hello,

Thanks for raising this recurring issue Dalia - it certainly seems
frustrating that only for-profit models exist for the vast majority of new
drug development, but practically it seems challenging to find another way.

The whole problem is rooted in the incredibly high cost of drug
development, which is largely a necessary consequence of 1) the incredibly
high risk (most chemicals explored fail to yield good drugs) and 2) the
incredibly high cost of taking a useful drug through clinical trials and
approval.

I think any attempt at an alternative process must demonstrate how it will
both obtain and recover these large costs, or alternatively focus on how to
reduce the costs in the first place (an even harder challenge).

Paul Nelson Replied at 7:27 AM, 27 Jul 2016

I recall an estimate that to achieve the status of an FDA approved new Drug requires $500 Million.

Dalia Alnuaimi Replied at 8:55 AM, 27 Jul 2016

The costs vary according to how you calculate it and the drug in question from 1-5 billion dollars. and 10-15 years to be approved from the date of the patent, patents are typically 25 yrs long, after that the drug can become generic.

In this URL you will find a diagram that estimates that a drug costs in total more than 4 Billion dollars to be approved http://www.pharmafocusasia.com/strategy/drug-development-challenges ,

While in this article, http://www.slideshare.net/mconghuyen/reengineering-early-phase-cancer-drug-de.... The estimate is close to 1.2 billion dollars.

Both images for both estimates are attached.

I am not advocating for drug companies. I'm just pointing out that the current for profit model is not capable of doing what is needed. Thus a new model needs to be designed.

Attached resources:

Jing Luo Replied at 10:01 AM, 27 Jul 2016

Pharmaceutical patents, like all utility patents expire 20 years from the
date of filing in the United States.

In most other countries (WTO-member countries) patent terms are also 20
years.

The estimates for how much it costs to "develop" a new drug are
controversial, to say the least. It certainly is expensive and
time-consuming, but to view the entirety of the drug development process as
a single flow-diagram where all R&D costs are attributed to pharma is
grossly oversimplified and probably even a bit myopic.

Dalia Alnuaimi Replied at 10:29 AM, 27 Jul 2016

I see your point, and it is quite valid. I think, however, that it is important to look at those numbers as a gross overlook at the hurdles we'd want to overcome if we want to design an alternative to the currently unsatisfactory model.

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