OPEN LETTER
FROM CLINICIANS AND RESEARCHERS
TO MILES WHITE, ABBOTT CEO

In order to convey to Abbott CEO Miles White the outrage among health care providers and researchers in response to his decision to retaliate  against Thai patients for the lawful compulsory licenses issued by the Thai  government, groups are circulating the international sign-on letter below. This  letter will be delivered ahead of Abbott's Annual General Meeting for  shareholders, in Abbott Park, Illinois on April 27, 2007.

For the many people who are concerned about Abbott's unacceptable  actions, but who are not clinicians or researchers, please contact us to find out  more about what you can do to be part of this campaign.

To endorse, please send your name, location (city and country) and  affiliation (for identification purposes only) to Asia Russell at:  asia@healthgap.org or call +1 267 475 2645.  The current deadline for sign on is end of day Thursday, April 18. Please take a moment to forward this timely request to  contacts in your networks.

Supporting documents:

PhRMA lies and Distortions - Thai Compulsory Licenses

The Eight Deadly lies of Big Pharma

Standing Up To Abbott's Decision to Withhold Registration and Marketing
of Life-Saving Medicines - A New Variant of Pharmaceutical Apartheid

A New Low in the Pharma Drug Wars - Abbott Withdraws Seven Medicines in Thailand

To: Abbott CEO and Chairman Miles White

From: Clinicians and researchers around the world

Miles White
Chairman and CEO
Abbott Laboratories
100 Abbott Park Road
Abbott Park, IL 60064

Dear Miles White,

We, the undersigned, are disappointed and outraged by Abbott’s  decision to stop marketing new medicines in Thailand and to withdraw all applications  to register medicines in the country.

Abbott has decided to retreat from the Thai market in retaliation to Thailand’s lawful decision to issue compulsory licenses for three medicines,  including for two antiretrovirals: efavirenz and lopinavir+ritonavir (Kaletra). These compulsory licenses will achieve reductions in costs and will  increase access to critically important medicines in Thailand, something protracted  negotiations between the Thai government and Abbott unfortunately did not achieve.

Abbott’s decision to deny medicines to Thai patients is an inappropriate response to the lawful actions of a country addressing its urgent  public health needs in a manner that is completely consistent with its international obligations according to the World Trade Organization’s Agreement on  Trade Related Aspects of Intellectual Property Rights (TRIPS), and it is also
consistent with Thai national law.

Furthermore, you are clearly attempting to set a precedent and send a  message to other developing countries that they, too, will be punished in this  fashion should they decide to use their lawful right to issue compulsory  licenses to increase access to medicines. This is unacceptable.

Importantly, your decision identifies you as an outlier among  pharmaceutical companies: at this point in time time we are aware of no other  pharmaceutical company that has ever responded as you have in reaction to the  issuance of compulsory licenses.

If Abbott believed that Thailand’s actions were not consistent with  their TRIPS commitments then there are legal avenues by which to contest this.  However, by withdrawing registrations for essential medicines from the Thai  market, such as heat-stable lopinavir+ritonavir--an essential antiretroviral adapted  for hot climates and particularly important for tropical countries like  Thailand--Abbott has chosen instead to hold Thai patients hostage.

As clinicians and researchers from around the world we find this  unacceptable and demand that you reverse your decision immediately.

Sincerely,

<list in formation>

Alice Furumoto-Dawson, Ph.D.
Sr. Research Associate
Center for Interdisciplinary Health Disparities Research
Institute for Mind & Biology
University of Chicago
Chicago, Illinois, USA

Andrea C. Ely, M.D., M.Sc.
Assistant Professor of Medicine
Division of General and Geriatric Medicine
University of Kansas Medical Center
Kansas City, Kansas, USA

Andrea C. Ely, M.D., M.Sc.
Assistant Professor of Medicine
Division of General and Geriatric Medicine
Kansas City, Kansas, USA

Blanca Baldoceda, MD
PCC Salud Family Health Center
Chicago, Illinois, USA

David Egilman MD, MPH
Clinical Associate Professor Of Community Medicine
Brown University
Attleboro, Massachusetts, USA

David G Legge
Associate Professor
School of Public Health
La Trobe University
Bundoora, Australia

David Hoos, MD,  MPH
Mailman School of Public Health
Columbia University
New York, New York, USA

Deborah V. Edidin, M.D
Northwestern University Feinberg School of Medicine
Glencoe, Illinois, USA

Donna Barry NP MPH
Advocacy and Policy Manager
Partners In Health
Boston, Massachusetts, USA

Dr Anil Paranjape
Consultant, Public Health
Mumbai, India

Dr Anna Gilmore
European Centre on Health of Societies in Transition
London School of Hygiene and Tropical Medicine
Keppel Street
London, UK

Dr Peter Mansfield, GP
Research Fellow, Discipline of General Practice,
University of Adelaide
Australia

Dr. Agnes Vitry
Senior Research Fellow
School of Pharmacy and Medical Sciences
University of South Australia
Adelaide, Australia

Gregory P. Melcher, M.D.
Professor of Clinical Medicine
Sacramento, CA
University of California, Davis School of Medicine
Department of Internal Medicine
Division of Infectious Diseases

Jennifer Cohn, M.D.
Health GAP
Philadelphia, Pennsylvania, USA

Jim Yong Kim, M.D., Ph.D.,
Director
François-Xavier Bagnoud Center for Health and Human Rights
Harvard School of Public Health

Joel E. Gallant, MD, MPH
Johns Hopkins University School of Medicine
Baltimore, Maryland, USA

Joseph Millum, Ph.D., Fellow
Department of Clinical Bioethics
National Institutes of Health
Bethesda, Maryland, USA

Josiah D. Rich, M.D., M.P.H.
Professor of Medicine and Community Health
Brown University
The Miriam Hospital
Providence, Rhode Island, USA

Joyce C. Lashof, MD
School of Public Health
University of California, Berkeley
Berkeley, California, USA

Judy Dasovich, MD
Medical Director
The Kitchen Clinic
Springfield, Missouri, USA

Louise Ivers MD, MPH, DTM&H
Director, HIV Equity Initiative, Partners In Health, Haiti
Instructor in Medicine, Harvard Medical School
Boston, Massachusetts, USA

Marc A. Snyder, MD
Medical Director
St. Luke's Hospital Emergency Department
San Francisco, California, USA

Mardge Cohen, MD
Director of Women's HIV Research
CORE Center
Chicago, Illinois, USA

Mark Tyndall BSc MD ScD FRCPC
Michael Smith Foundation for Health Research Senior Scholar
Associate Professor of Medicine
University of British Columbia
Program Director, Epidemiology
BC Centre for Excellence in HIV/AIDS
Head, Division of Infectious Diseases
St. Paul's Hospital
Vancouver, British Columbia, Canada

Michael H. Fox, Sc.D.
Associate Professor
Department of Health Policy & Management,
KUMC School of Medicine

Michael Herce MD, MPH
Senior Resident, Internal Medicine & Global Health Equity Program
Brigham & Women's Hospital
Boston, Massachusetts, USA

Michael T. Wong, MD
Assistant Professor of Medicine
Harvard Medical School
Senior Clinical Advisor, Ryan White Title 3 Program
Dimock Community Health Center, Roxbury, MA
Beth Israel Deaconess Medical Center
Division of Infectious Diseases
Boston, Massachusetts, USA

Michel D. Kazatchkine, MD
Département d’Immunologie Clinique
Hôpital Européen Georges Pompidou
Paris, France
Patricia Rush, MD
Primary Care Plus
Oak Park, Illinois, USA

Paul Farmer, MD, PhD
Maude and Lillian Presley Professor of Social Medicine
Chief, Division of Social Medicine and Health Inequalities
Harvard Medical School
Co-Founding Director, Partners in Health
Boston, Massachusetts, USA

Professor D. H. Broom
National Centre for Epidemiology and Population Health
The Australian National University

Rainward Bastian, MD
Director, Difäm – Gesundheit in der Einen Welt
Difaem - German Institute for Medical Mission
Germany

Ramya Srinivasan, MD
San Francisco, California
University of California San Francisco and Children's Hospital
Oakland, California, USA

Roberta J. Lee, RN, MSN, MPH
Assistant Professor of Clinical Nursing
University of Cincinnati
Cincinnati, Ohio, USA

Robert L. Cohen, MD
Manhattan, New York, USA

Sara Levin, MD
Staff Physician, Internal Medicine
Contra Costa Regional Medical Center
Martinez, California, USA

Stephen Raffanti MD MPH
Chief Medical Officer
Comprehensive Care Center
Associate Professor of Medicine
Divsion of Infectious Diseases
Vanderbilt University

Sural Shah
Hershey, USA
Medical Student/Clinical Research Fellow Penn State
University College of Medicine American Medical Student Association

Susan Cu-Uvin, M.D.
Professor, Obstetrics-Gynecology and Medicine
Director, The Immunology Center
The Miriam Hospital
Brown University
Providence, Rhode Island, USA

Talal Khan MD
Kansas University Medical Center
Kansas City, Kansas, USA

Wah-Yun Low, Ph.D
Health Research Development Unit
Faculty of Medicine, University of Malaya
50603 Kuala Lumpur, Malaysia

Wendy Armstrong, MD
Cleveland Clinic
Cleveland, Ohio, USA

ORGANIZATIONAL ENDORSEMENTS:

American Medical Students Association (AMSA), USA

AIDS Treatment Activists Coalition, Drug Development Committee, USA

Nava Kiran Plus, Nepal

May 9, 2007

After placing Thailand on its 2007 301 priority watch list for an alleged "lack of transparency and due process" in issuing compulsory licenses and "its weakening respect for patents," the USTR has shown its true colors in its reported May 8 "Action Plan" for Thailand.  Because the U.S. cannot back up its claim that Thailand violated the international TRIPS agreement or Thai law and because it cannot even explain how Thailand's repeated negotiations with drug companies and publication of a 100-page rationale for its compulsory licenses violated any known norms of transparency and due process, the USTR has turned to its true agenda - acting as a bullyboy for Big Pharma in imposing even stronger patent and data-related monopolies on Thailand.  In a truly ironic twist, the USTR has failed to publicly disclose its Action Plan in advance of its meeting with the Commerce Ministry on May 14, showing how strongly it values the alleged principle of "transparency."

The US previously sought similar "action" terms in its free trade agreement negotiations with Thailand.  At that time, in February of 2006, AIDS activists and others protested vigorously against the USTR's pro-Pharma agenda and temporarily halted trade negotiations in Chang Mai.  Now, fifteen months later, the US has dressed up its FTA demands and repackaged
them as an "Action Plan," where Thai acquiescence is allegedly necessary to remove Thailand from the priority watch list and from the escalating threat of US trade sanctions.

A close look at the alleged details of the Action Plan shows how the USTR is carrying water for Big Pharma.

First, the USTR seeks patent term extensions for regulatory delays in issuing patents or in registering medicines.  Although patent terms already run for a long 20 years, more is better for drug companies like Abbott and Merck that would like to have the right to charge monopoly prices and exclude generic competitors for an even longer period of time.

Second, the USTR is seeking a five-year period of "data exclusivity", during which the Thai Food and Drug Administration would be prevented from relying upon data previously filed by the innovator in order to validate the safety and efficacy of equivalent generic products.  Instead, as the USTR and Pharma are fond of saying, the generic companies would be "free" to conduct costly, time-consuming, and ultimately unethical clinical trials to prove through other means what is already provable - namely that a generic that proves its therapeutic equivalence is just as safe and efficacious as an already marketed product.  Not satisfied with just five years of data exclusivity, the USTR/Pharma team is demanding that Thailand to add on another three years any time a drug company submits new clinical data to register a new formulation or a new use of an existing product. Data exclusivity is especially important to Pharma because sometimes drug companies do not even bother to file patent application on unproven medical
innovations in smaller and poorer countries.  They would rather wait until the product is fully developed and marketable to have another monopoly system beside patents to exclude generic competition.  That other system is data exclusivity.

Related to data exclusivity is the third restriction provision, patent/registration linkage, which turns the Thai Food and Drug Administration into a patent enforcement agency by requiring it to prevent registration of a follow-on generic product if a prior registrant claims that its patent(s) would be violated.  Although the FDA is in no position to confirm the merits of the drug company's patent claims, it assumes the burden of protecting patents even though the patent holder already has full means to protect its patent claims via infringement proceedings.

Fourth, the USTR wants to limit the grounds upon which compulsory licenses can be granted to national emergencies, competition cases, and public, non-commercial use.  This restriction is ironic in the current environment where both Abbott and the US are retaliating against Thailand for having actually issued one of the US-preferred licenses - those for public, non-commercial use.  Clearly, Thailand and other countries can and should issue licenses on these three grounds, but they should also be free to issue compulsory licenses on other grounds as confirmed both by the TRIPS Agreement and by the Doha Declaration on the TRIPS Agreement and Public Health.  They should also be free to make clear that their compulsory licenses override the monopoly bars posed by data exclusivity and patent/registration linkage provisions described above.

Fifth, the USTR is seeking to expand the required subject matter of patents by requiring that Thailand grant licenses on "plants and animals," on "diagnostic, surgical and medical procedures," and on "new uses of existing products."  In addition to now requiring that Thailand give up patent subject exclusions that are permissible under TRIPS, the USTR is pursuing
Pharma's agenda of being able to evergreen patents by claiming successful new uses of existing medicines.

Sixth, the USTR is seeking to prevent the use of pre-grant opposition procedures that help forestall the granting of weak or frivolous patents by allowing other interested parties to provide relevant information to the Thai patent office.  These procedures are currently being used to good effect in India both by generic companies and civil society activists.

The USTR, acting as the handmaiden for Big Pharma, is seeking to restrict Thailand's right to use TRIPS- and Doha-compliant flexibilities for accessing more affordable medicines to sustain its comprehensive, public-sector supported health care program.  Simultaneously, the USTR is
seeking to punish Thailand for using one of the few flexibilities, public non-commercial use licenses, that the USTR would theoretically leave on thetable.

Make no mistake - Abbott, Merck, Pfizer and the other big drug companies don't want an even playing field, they want monopolies so that they can sell high-price drugs to rich people in poor countries even if the non-rich must go without.  Rather than stand up for the human right of access to medicines, the USTR has once again chosen the side of the hugely profitable, transnational pharmaceutical industry.

To counteract this pressure, Thailand, its Commerce Ministry, and its people must stand firm against the US's hypocrisy and coercion. They must also continue to be supported by other developing countries and activists and by opinion leaders such as former President Clinton who just yesterday defended Thailand's right to issue compulsory licenses.

Professor Brook K. Baker, Health GAP
Northeastern U. School of Law
Program on Human Rights and the Global Economy

NGO Response to Abbott’s announced $1000 price for Aluvia
in Low- and Lower-Middle Income Countries

April 10, 2007

Health GAP, Student Global AIDS Campaign, American Medical Student Association, and Essential Action applaud that Thailand’s compulsory license, generic competition, WHO intervention, and activist pressure  have forced Abbott to offer a further 55% reduction in its tiered price  for low- and lower-middle income countries.  However, as clarified further below,
the price discounts still do not go deep enough or wide enough, and  Abbott has still withdraw Aluvia and six other medicines from the Thai registration process in retaliation for Thailand’s lawful exercise of  its right to issue compulsory licenses for priority medicines for  government,
non-commercial use.

Abbott’s new price announcement confirms the importance of  generic competition and the necessity of using compulsory licenses to  curb abuses of monopoly power by pharmaceutical companies. Abbott’s price-discount announcement is mostly due to: (1) Cipla’s recent       announcement (April 1, 2007) to undercut Abbott’s price and offer Aluvia at $1560/pppy, (2) Thailand’s decision to issue a  compulsory license in response to the unaffordable price charged by  Abbott in Thailand other low- and lower-middle-income countries of $2200/ pppy,  and (3) increased civil society and political pressure exerted  upon the company in the last four weeks following its decision to de-register seven medicines from the Thai market.

Abbott has not yet agreed to reverse its illegal and unethical withdrawal of seven registration applications from the Thai drug regulatory process, including the application for Aluvia, the
heat-stable form of Kaletra that is most appropriate for use in a tropical country like Thailand.  Abbott may have violated  Thailand’s competition law by withdrawing these products; it has certainly violated patients’ human right of access to essential life-saving medicines.

Although this price is lower than what has been currently  offered by generic manufacturers, it is still twice the access price of the medicine(s) in least-developed and African countries ($500/ pppy), and will exert a heavy financial burden upon low-income and lower- middle income countries seeking to achieve universal access and  treatment. Abbott should provide Kaletra/Aluvia at one, no-profit price  to all developing countries.

Although Abbott’s price is temporarily lower than the price  offered by generic manufacturers, it is highly likely that generic prices will drop below $1000/pppy as an increasing number of patients require 2nd line anti-retrovirals, as generic producers reach economies-of-scale, and as generic versions of Aluvia are WHO pre-qualified and are thus purchasable with Global Fund money. Abbott’s price discount to Thailand, like its prior discount to Brazil, is primarily designed to reduce market demand that might incentivize efficient generic production.

Abbott must not be permitted to blackmail Thailand into  withdrawing any compulsory licenses in exchange for a promise to renew its registration application for Aluvia.  Thailand’s decision to  issue compulsory licenses was fully consistent with World Trade Organization intellectual property rules and obligations and with Thai law.  Likewise, the Ministry of Health should not be  forced to withdraw its compulsory licenses for efavirenz or Plavix.

Even if Abbott is offering a lower price for Kaletra/Aluvia,  it does not necessarily mean that Thailand should withdraw, or not  execute, its government use license.  There are strong reasons that  Thailand may wish to keep its compulsory license to ensure alternative  sources
 of supply, to develop and support domestic and/or regional pharmaceutical capacity, to incentivize generic competition,  and to subsequently procure lower-priced generic versions that are WHO-prequalified and registered in Thailand.

Thailand should only purchase Kaletra/Aluvia from Abbott to  ensure no-stock outs and reliable access across the country, and  should not enter into any long-term, binding contract that would make  Abbott the country’s sole supplier for multiple years and preclude future use/access of generic versions.  A prior decision by the  Brazilian government to enter into a long-term contract with Abbott for Kaletra/Aluvia has exerted a severe financial burden upon the National AIDS treatment program, and the Brazilian government now pays a price of $1596/pppy that is 60% higher than Abbott’s  new $1000 price.

The World Health Organization should be staunchly defending and supporting Thailand’s decision to issue a compulsory license, and should be providing technical support and assistance to the  Thai and other governments to enforce and implement compulsory licenses.
 Any price negotiations conducted by the WHO should be done  alongside and through national governments, and not done secretly with pharmaceutical companies.  Any price negotiations or transactions with the pharmaceutical industry should be open, transparent and
 inclusive to avoid any appearance of impropriety or undue  influence of the pharmaceutical industry upon the UN body.

Sponsors of this statement are seeking additional sign-ons.  Contact  Brook
Baker: b.baker@neu.edu   617-373-3217