Natural Resources Defense Council, Inc. et al v. United States Food and Drug Administration et al

Filing 33

DECLARATION of Jennifer A. Sorenson in Support re: 19 MOTION for Summary Judgment.. Document filed by Center For Science In The Public Interest, Food Animal Concerns Trust, Natural Resources Defense Council, Inc., Public Citizen, Inc., Union Of Concerned Scientists, Inc.. (Attachments: # 1 Exhibit A, # 2 Exhibit B, # 3 Exhibit C, # 4 Exhibit D, # 5 Exhibit E, # 6 Exhibit F, # 7 Exhibit G, # 8 Exhibit H, # 9 Exhibit I, # 10 Exhibit J, # 11 Exhibit K, # 12 Exhibit L, # 13 Exhibit M, # 14 Exhibit N, # 15 Exhibit O, # 16 Exhibit P, # 17 Exhibit Q, # 18 Exhibit R, # 19 Exhibit S, # 20 Exhibit T, # 21 Exhibit U, # 22 Exhibit V, # 23 Exhibit W, # 24 Exhibit X, # 25 Exhibit Y, # 26 Exhibit Z, # 27 Exhibit AA, # 28 Exhibit BB, # 29 Exhibit CC, # 30 Exhibit DD)(Sorenson, Jennifer)

EXHIBIT BB
TO DECLARATION OF
JENNIFER A. SORENSON
WHO World Health Day 2011 FAQ

World Health Day 2011
Frequently Asked Questions
1. What is antimicrobial resistance, commonly known as drug resistance? What is the difference
between antibiotic, antimicrobial and antiretroviral resistance or so called “superbugs”?
> Drug resistance (also known as antimicrobial resistance) is the natural process through
which disease organisms – bacteria, viruses, parasites, fungi and other pathogens – develop
resistance over time to the medicines used to treat them. As resistance develops, these
medicines become progressively less effective – and eventually they lose their effectiveness.
Drug resistance is a consequence of the use, and particularly the misuse, of antimicrobial
medicines. “Superbugs” is the name often given to pathogens found in hospitals that acquire
resistance to all standard antimicrobials. This is concerning and is the reason why rational use
of antimicrobial drugs is so important.
2. Why has WHO chosen drug resistance as the theme of this year’s World Health Day?
> Drug resistance is becoming more dangerous, as more microorganisms develop or acquire
resistance to the medicines used to treat them. Modern healthcare depends substantially
on antibiotics and other antimicrobial medicines to treat conditions that would previously
have proved fatal. Today, there is more resistance – and there are fewer new antimicrobial
medicines in the pipeline – than ever before. That is why WHO is calling on governments to take
urgent action to prevent and control drug resistance.
3. Why is drug resistance a global concern?
> The development of resistance to drugs used to treat infections threatens our ability to treat
disease and to protect the advances made in global health in recent decades. The invention
of antibiotics and other antimicrobial drugs has changed the course of human history. People
in every country today have benefitted from the development of antimicrobials. But their
effectiveness is under threat. We must do everything in our power to preserve these drugs for
future generations. Some of the greatest achievements of global health -- treating tuberculosis,
malaria, HIV, pneumonia, diarrhoea and other killer infectious diseases -- are at risk as drug
resistance rises. Without effective drugs, we cannot prevent death and disease; the world risks
losing the progress that’s been made on the Millennium Development Goals.
4. What will WHO be doing on World Health Day 2011?
> On World Health Day, WHO will be calling for intensified global commitment to safeguard
antimicrobial medicines for future generations. WHO will introduce a policy package setting out
what governments and others can do to combat the spread of drug resistance. These are the
key policy measures:

For more information, go to:
http://www.who.int/world-health-day/2011

COMBAT DRUG RESISTANCE

No action today, no cure tomorrow

- Commit to a comprehensive, financed national plan with accountability and civil society
engagement;
- Strengthen disease surveillance and laboratory capacity;
- Ensure uninterrupted access to essential medicines of assured quality;
- Regulate and promote rational use of medicines, including in animal husbandry, and
ensure proper patient care;
- Enhance infection prevention and control;
- Foster innovations, and research and development of new tools.
5. What can governments do?
>> Governments can take the lead by introducing comprehensive policies to prevent the
emergence of drug resistance and ensuring these policies are adequately resourced.
6. What can consumers do?
>> Antimicrobial drugs are a precious resource for everyone on the planet. Like any global
good, we have a responsibility to protect this resource and to use it responsibly. Consumers
can help by only using antibiotics and other antimicrobial drugs when they are prescribed
for use, and always completing courses of medicine. When people only take part of a
course of treatment, this contributes to the development of drug resistance.
7. What can doctors do?
>> Doctors can come under pressure from patients and inappropriate pharmaceutical
marketing to prescribe medicines when it may not be necessary. It is important that all
health professionals, including doctors, resist this pressure. Doctors can help by explaining
to their patients when antibiotics and other antimicrobial drugs are appropriate, and when
they are not. Also, doctors can inform their patients of the benefits of completing a course
of medicine when it is prescribed, rather than stopping the treatment as soon as they start
to feel better.
8. What can pharmacists do?
>> Pharmacists have an especially important role to play, because in most settings they are
the ones distributing antimicrobial medicines to patients. Like other health professionals,
pharmacists can ensure that patients understand the importance of taking only the
medicines that are prescribed to them, and completing the full course of treatment.
9. What can the pharmaceutical industry do?
>> The research and development of new medicines is vital to help protect future generations.
As drug resistance develops, new medicines are needed, as well as new ways of using
existing medicines. Currently, there are very few new antimicrobial medicines, diagnostics
or vaccines in the R&D pipeline. For example, fewer than five per cent of drugs currently in
the pipeline are new antibiotics. The industry should engage with partners to overcome the
barriers to R&D. Better incentives are also needed to encourage more R&D into this vital
area.

10. What should governments and others do to provide incentives for research and
development of new antimicrobial drugs?
>> This is an important issue and in fact this week (April 5 - 7) WHO is hosting the first
meeting of the Consultative Expert Working Group on Research and Development:
Financing and Coordination. The work of this group, its findings and methods, will be
available via the WHO Public Health, Innovation and Intellectual Property website. It is due
to report to the World Health Assembly in 2012 as one part of WHO’s actions under the
global strategy and plan of action on public health, innovation and intellectual property.
11. Is this just about people misusing antibiotics?
>> Certainly, misuse of antibiotics is part of the problem – but drug resistance is much
broader than that. Because drug resistance is a natural process, all microorganisms
could eventually develop resistance to the medicines used to treat them. However,
implementation of national policies and rational use of medicines by providers and
patients, combined with infection control, can help considerably in slowing down the
development and spread of resistance.
12. What has WHO done about this issue in the past?
>> WHO has been working to address drug resistance for many years and established
successful mechanisms and programmes. For example, today, there are surveillance
systems monitoring the effectiveness of medicines used to treat Tuberculosis (TB),
malaria, HIV and gonorrhoea, as well as antibiotics used in animals. WHO also has a longstanding programme on rational use of essential medicines and drug quality regulation.
It has developed policy on infection control and has sponsored the Patient Safety Alliance.
The world now needs to move forward and implement the policy package that has been
developed.
13. Is this something new? Why is WHO talking about drug resistance now?
>> Drug resistance is not new; it has been emerging since the discovery of the first
antimicrobial drug. However, drug resistance keeps emerging and spreading rapidly.
There is also a shortage of new antimicrobial drugs being developed to treat resistant
microorganisms. WHO has now developed a package of policies that governments can put
in place to tackle drug resistance. It is now essential for the world to work together and
speed up the response to this problem.
14. What is the cost of drug resistance?
>> There is no global data for the cost of resistance. However, we do have good evidence from
Europe and from the United States. In the European Union, 25,000 people die each year
as a result of infection by multidrug resistant bacteria, at an estimated cost to healthcare
systems of €1.5 billion per year. In the US, medical costs attributed to drug resistant
infections are estimated at more than $20 billion each year, with more than eight million
additional days spent in hospitals as a result. The total cost to society amounts to more
than $35 billion a year.

15. Which countries are doing well in responding to drug resistance and which are not
doing so well? Is anyone to blame?
>> Drug resistance is a global public health issue; resistant organisms have arisen in many
countries. Even countries with strong health systems face difficulties in controlling their
spread. It is essential that countries set up strategies for prevention and control, including
improved surveillance for resistance, rational antibiotic use in humans and animals,
strengthening national drug regulatory authorities, and strengthening infection prevention
and control in healthcare. Successful control of multidrug-resistant microorganisms has
been documented in many countries, and the existing and well-known prevention and
control measures can effectively reduce generation and spread of multi-drug resistant
organisms if rigorously and systematically implemented.
16. Is surveillance failing globally - why do we know so little?
>> There have been major improvements in surveillance for some specific diseases. In
Multidrug-resistant TB, for example, surveillance has been carried out in 114 countries and
is supported by a network of laboratories.
There are still major gaps. This includes in expanding surveillance of hospital-acquired
infections. Latin America has shown what can be done with limited resources. Many
European countries through the European Centre for Disease Control (ECDC) are providing
a powerful model that WHO is helping the rest of Europe to adapt and pursue. In the
Eastern Mediterranean Region, Asia and Africa, nascent surveillance networks need to be
revived and funded.