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Multidrug-Resistant Tuberculosis and
Access to Essential Drugs:
The Coming Storm
Amsterdam, November 25-26, 1999
Jim Yong Kim, MD, PhD
Partners In Health
Harvard Medical School
June 1997
Publication of the
WHO-IUATLD
Global Report on
Drug Resistance
Surveillance
"Where it's in 1 to 2 percent of the cases, then it's not a major
factor, but in some places drug resistance is showing up in up to
22 percent of the cases...When you get up in that range, you've
got a very serious problem. Treating them with DOTS has no
effect. The danger is that in not dealing with multi-drug-resistant
strains now, in 20 to 40 years, we could perhaps have a
majority of cases be multi-drug-resistant, and that would be like
starting over in the fight against TB.”
Dr. Nils Daulaire, Global Health Council,
Source: Judy Mann, “We Skimp on TB Treatment at Our Peril,” The Washington
Post, November 5, 1999, Pg. C11
August 1996
DOTS-Plus project initiated in Lima’s Northern Cone by Socios en
Salud and Harvard/Partners in Health.
Differential Pricing of Second-Line
Anti-Tuberculous Drugs - July, 1999
$6,534
$4,494
$4,399
$4,093
$688
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$350
$139
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$45
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$1,518
$1,282
Ka
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Am
$4,597
$7,296
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$6,000
$5,000
$4,000
$3,000
$2,000
$1,000
$0
$72,000
am
$10,000
$9,000
$8,000
$7,000
$804
April 1998
Participants at
Harvard University
meeting resolve to
initiate DOTS-Plus
strategy for
treatment of MDR-TB
in resource-poor
settings
DOTS Plus: An Introduction
“DOTS-Plus is a case management strategy
designed to manage MDRTB using second-line
drugs within the DOTS strategy in low- and
middle-income countries.”
World Health Organization, Working Group on DOTS-Plus for MDR-TB 1999
October 1998
Meeting at White House hosted
by Hillary Clinton to discuss TB
and MDR-TB in the former
Soviet Union. Attendees
include James Wolfensohn,
Gro Harlem Brundtland,
George Soros. Mrs. Clinton
pledges support for efforts to
contain MDR-TB. CDC
initiates program in Russia.
January 1999
Meeting at World Health
Organization in Geneva of
non-governmental
organizations and national
TB programs interested in
starting DOTS-Plus
programs. WHO Working
Group on DOTS-Plus for
MDRTB is established.
August 1999
Submission of
application to add 2nd
line anti-TB drugs to
the WHO Model List of
Essential Drugs
WHO Model List of Essential Drugs
Proposed Entry for 2nd line Drugs
80 Countries and Territories in which DrugResistant TB has been Reported
Algeria
Argentina
Australia
Azerbaijan
Belarus
Belgium
Benin
Bolivia
Botswana
Brazil
Burkina Faso
Cameroon
Canada
Chile
China
Colombia
Cote d'Ivoire
Cuba
Czech Republic
Djibouti
Dominican Republic
Ecuador
England and Wales
Estonia
Ethiopia
Finland
France
Georgia
Germany
Guatemala
Haiti
Hungary
India
Indonesia
Iran
Northern Ireland
Israel
Italy
Japan
Kazakhstan
Kenya
Korea South
Kyrgyzstan
Latvia
Lesotho
Lithuania
Mexico
Nepal
Netherlands
New Zealand
Nicaragua
Nigeria
Pakistan
Paraguay
Peru
Philippines
Poland
Portugal
Puerto Rico
Romania
Russia
Scotland
Serbia
Sierra Leone
South Africa
Spain
Swaziland
Sweden
Switzerland
Taiwan
Tanzania
Thailand
Tunisia
Uganda
Ukraine
United Kingdom
United States
Uruguay
Vietnam
Zimbabwe
MDRTB: A Public-Health Catastrophe
Percentage of isolates
Drug resistance patterns in Tomsk,
1997-1999
40
1997
30
1998
20
1999 (first 6
m onths)
10
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Tim Healing, M.D., MERLIN
Presented July 5, 1999, Cambridge, MA
They have moved the dialogue along so that
people can stop fighting one another and start
fighting the disease.
Dr. William Foege, Gates Foundation
Source: Judith Miller, “In Fight Against Tuberculosis, Experts Look for Private Help,”
The New York Times, p. A8.
Decrease in “First-Line” Anti-Tuberculous Drug
Prices 1991-1998
50%
40%
RIF (300 mg)
30%
PZA (500 mg)
20%
EMB (400 mg)
10%
INH (300 mg)
0%
% Decrease
The costs of the resurgence of tuberculosis have been phenomenal.
From 1979 through 1994, there were more than 20,000 excess
cases of the disease in New York City… Each case cost more than
$20,000 in New York dollars, for a total exceeding $400 million. In
addition, as many as one third of patients with tuberculosis were
hospitalized because of inadequate follow-up… Care will [further] be
required for those who become ill in the years and decades to come.
These costs easily exceed $1 billion and may reach several times
that amount. Thus, despite their cost, efforts to control tuberculosis
in the United States are like to be highly cost effective.
-Thomas Frieden, CDC
Source: Frieden TR, Fujiwara PI, Washko RM, et al. 1995.
High Grade Drug Resistance
A Grim Reality in Peru
LV
» 11 yo male dx with TB in 1998
» Received and failed 2 treatments
» R to H, R, E, Z, S, KM, CM, THA, CPX
» S to CS (AMK, RFB, CLR pending)
CC
» 23 yo male dx with TB in 1996
» Received and failed 3 treatments
» R to H, R, E, Z, S, KM, CM, THA, CPX, AMK, RFB, CLR
» S to CS
Public-Private partnerships
based on the anti-malarial model
New legal incentives for
commercial drug development
Realistic assessment of
current incentive structure
New Drugs/Vaccines
for MDR-TB?
All efforts coordinated
through WHO Global TB
Drug Facility
MDR-TB – The Symbolic Project
From Option to Imperative
Protecting the Future
Pay Up Now or Pay More Later
Righting Market Failures
“Gates Earmarks $750 Million To
Spur Work on Vaccines”
“With other foundations and international agencies expected to at least match the
Gates foundation's donations, the effort, called the Children's Vaccine Trust Fund,
is expected to grow to at least $1.5 billion….The effort would address what some
economists call the "market failure" that has discouraged drug companies from
investing in vaccines for diseases primarily affecting people in developing
countries.”
Wall Street Journal, Aug 27, 1999
A Response from the
Pharmaceutical Industry
“Drug companies say they welcome the initiative but remain
skeptical that it can alter the fundamental economics of
immunizing children in poor countries.
‘At 50 cents a dose for a vaccine that would ordinarily be $10 a
dose, it's hard to say that all the volume in the world would
make a difference,’ says Dr. Thomas Vernon, vice president of
the vaccine division of Merck & Co., of Whitehouse Station,
N.J.”
Wall Street Journal, Aug 27, 1999
New Drugs for MDR-TB
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Enough Resources for R&D?
Effective Incentive Structure?
Drug Development Process?
Clinical Trials Apparatus?
Malaria, Onchocerciasis as Models?
Who Will Pay?
The Challenge of MDR-TB
• Make 2nd line drugs accessible to DOTS-based TB control
programs – make it possible for NTP’s/NGO’s to avoid “costbased” design of MDR regimens.
• Strict control of access to 2nd line drugs through NTP’s and
WHO Working Group on DOTS-Plus for MDR-TB.
• Develop innovative strategies for new drug development.
• Understand the symbolic importance of TB and MDR-TB in
today’s globalized world. Use MDR-TB to increase funding
for all TB control programs – MDR-TB is the ultimate
example of “market failure.”
“Global inequalities in income and living standards
have reached grotesque proportions.”
United Nations Development Program
Human Development Report 1999
Inequality in the World
Poorest 20%
1%
13%
Middle 60%
86%
Richest 20%
0%
20%
40%
60%
80%
Shares of World GDP, 1997
100%
Globalization – The Winners
• The 3 richest officers of Microsoft have more assets
(>$140 billion) than the combined GNP of the 43 least
developed countries (600 million people).
• Net worth of 200 richest people increased from $440
billion (1994) to $1 trillion (1998).
• 49/100 largest economies in the world are corporations.
United Nations Development Program
Human Development Report 1999
Rats and roaches live by competition under the
laws of supply and demand; it is the privilege of
human beings to live under the laws of justice
and mercy.
Wendell Berry