Multidrug-Resistant Tuberculosis and Access to Essential Drugs: The Coming Storm

1
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
2
June 1997Publication of the WHO-IUATLD Global
Report on Drug Resistance Surveillance
3
"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
4
August 1996DOTS-Plus project initiated in Limas
Northern Cone by Socios en Salud and
Harvard/Partners in Health.
5
Differential Pricing of Second-Line
Anti-Tuberculous Drugs - July, 1999
6
April 1998Participants at Harvard University
meeting resolve to initiate DOTS-Plus strategy
for treatment of MDR-TB in resource-poor settings
7
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

8
October 1998Meeting 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.
9
January 1999Meeting 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.
10
August 1999Submission of application to add 2nd
line anti-TB drugs to the WHO Model List of
Essential Drugs
11
WHO Model List of Essential Drugs Proposed Entry
for 2nd line Drugs
12
80 Countries and Territories in which
Drug-Resistant TB has been Reported
Algeria Dominican Republic Kenya Russia
Argentina Ecuador Korea South
Scotland Australia England and Wales
Kyrgyzstan Serbia Azerbaijan Estonia
Latvia Sierra Leone Belarus Ethiopia
Lesotho South Africa Belgium Finland
Lithuania Spain Benin France
Mexico Swaziland Bolivia Georgia
Nepal Sweden Botswana Germany
Netherlands Switzerland Brazil Guatemala
New Zealand Taiwan Burkina Faso Haiti
Nicaragua Tanzania Cameroon Hungary
Nigeria Thailand Canada India
Pakistan Tunisia Chile Indonesia
Paraguay Uganda China Iran Peru
Ukraine Colombia Northern Ireland Philippines
United Kingdom Cote d'Ivoire Israel Poland
United States
Cuba Italy Portugal Uruguay Czech
Republic Japan Puerto Rico Vietnam
Djibouti Kazakhstan Romania Zimbabwe
13
MDRTB A Public-Health Catastrophe
Drug resistance patterns in Tomsk, 1997-1999
Tim Healing, M.D., MERLIN Presented July 5, 1999,
Cambridge, MA
14
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.
15
Decrease in First-Line Anti-Tuberculous Drug
Prices 1991-1998
16
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.
17
High Grade Drug ResistanceA 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
18
Public-Private partnerships based on the
anti-malarial model
New Drugs/Vaccines for MDR-TB?
New legal incentives for commercial drug
development
Realistic assessment of current incentive
structure
All efforts coordinated through WHO Global TB
Drug Facility
19
MDR-TB The Symbolic Project
From Option to Imperative
Protecting the Future
Pay Up Now or Pay More Later
Righting Market Failures
20
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. Wal
l Street Journal, Aug 27, 1999
21
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
22
New Drugs for MDR-TB

• Enough Resources for RD?
• Effective Incentive Structure?
• Drug Development Process?
• Clinical Trials Apparatus?
• Malaria, Onchocerciasis as Models?
• Who Will Pay?

23
The Challenge of MDR-TB

• Make 2nd line drugs accessible to DOTS-based TB
  control programs make it possible for
  NTPs/NGOs to avoid cost-based design of MDR
  regimens.
• Strict control of access to 2nd line drugs
  through NTPs 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 todays globalized world. Use MDR-TB to
  increase funding for all TB control programs
  MDR-TB is the ultimate example of market
  failure.

24
Global inequalities in income and living
standards have reached grotesque proportions.

• United Nations Development Program
• Human Development Report 1999

25
Inequality in the World
Shares of World GDP, 1997
26
Globalization The Winners

• The 3 richest officers of Microsoft have more
  assets (gt140 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
27
(No Transcript)
28
(No Transcript)
29
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