Treating MDR-TBA Challenge Throughout

ECA

Public Health Practice II

The Historical Setting

• Why is there growing DRUG RESISTANCE in TB…- Long treatment course- Drug side effects- Inappropriate drug use and poor surveillance

POOR COMPLIANCE or BAD DOTS vs. - Poor quality drugs

- HIV- War economic, social and political strife- Poverty

The Historical Setting (cont.)

One Side…

• MDR-TB is too expensive to treat in poor countries and it distracts attention and resources from drug susceptible cases

• DOTS alone will stop outbreaks

• MDR is not as contagious or virulent as drug susceptible TB

• Treatment is expensive and lab work difficult

Historical Setting (cont.)

The Other Side…

• There is a moral imperative to provide care to individual patients

• It is essential to control MDR-TB for fear of its growth

• DOTS can amplify resistance

• If we have the technology (ie Second-line drugs) we should treat the sick patients

The Vicious Cycle

No international consensus on how to treat MDR-TB

Allows high drug prices

Primary reason to not start projects

Working Group for DOTS-PLUS

• Need to generate political will

• Need to show manufactuers there is high demand - …So they can still profit?

• Need lower prices

• Need to avoid making the drugs too widely available- Concern for black market that would breed resistance

Strategy One:Perform a Market Analysis

• Who are the manufacturers?

- Monopoly w/ EXPENSIVE patents- Monopoly wo/patents- Multiple

• Prioritize most expensive drugs

• Check for Quality Assurance

Strategy Two:Unified Approach to Big Pharma

• Create single negotiating body

• Medecins Sans Frontieres represented ALL buyers for the initial 2000 patients

• Plans for the International Dispensary Association to continue

Strategy Three:Establish A Market

• Problem = Lack of Competition

• Added to Essential Drugs List- Facilitates in-country registration- Under “reserve anti-infective agents”

• Stimulate excitement in the generic drug industry

• Two Markets:(1) Countries with programs and $$$(2) Estimated # of global cases (growing!)

Strategy Four:Negotiation

• The “Tiered-Tender” System- Biggest contract to manufacturer with lowest price and highest quality- Then smaller proportions to select companies

• Long term outcome goals:- Low prices- High quality- More competition

Range of decrease in prices is 38.3% to 98.45%

Strategy Five:Advantages to Suppliers

• Ex 1: Monopoly with small second-line TB sales- Humanitarian commitment

• Ex 2: Generic drug maker- Involvement in high profile int’l opportunity

Also…- Creation of Green Light Committee- Registration of Drugs- Plan long term continuous production

Green Light Committee• Guarantee low price access to sound pilot projects and also monitors ongoing projects

• Minimize black market further resistance

• Requires countries to:- Need functional DOTS program- Government commitment AND funding- Coordinated organization and management- Case-finding strategies- Laboratory diagnosis techniques- Treatment and follow-up strategies- Information Systems

Green Light Committee

Two NGOs- MSF- Royal Netherlands TB Association

• Two NTP (National TB Programs)- Estonia- CDC

• Academic Institution- Harvard Medical School

• WHO 2 replaced q3yrsEach with 1 vote

Additional Strategies:• Research and Development for NEW drugs (Its been 30 yrs!)

• Diagnostics for Chest xray neg or extrapulmonary TB?

- Serology or PCR?- Goal of 85% case detection

• Vaccine Development- BCG with more immunogenicity- Listeria monocytogenes “actin-rocket”

3 by 5• Create AIDS Medicine and Diagnostics (AMDS)

- Coordinator- No direct purchasing- Information clearinghouse for manufacturers, procurement agents and treatment programs- “Technical” tools to help supply cycle

such as expert teams and improve security- Eventual plan to establish buyer networks

• Create WHO Procurement, Quality, Sourcing Project- Pre-qualification board to assess manufacturers

and products to assure high quality