Month: July 2007

by Ed Silverman
Published at Pharmalot.com

Last month, a dozen advocacy groups began an e-mail petition to convince drugmakers to disclose their contributions. Now, they’ve written to each ceo, along with Phrma and the International Federation of Pharmaceutical Manufacturers Associations, to make a direct appeal.

Once again, their effort cites Lilly’s recent decision to do so, at least in the US, and so the groups – which now number nearly 40 and include Public Citizen and the Center for Science in the Public Interest – implore all drugmakers to follow suit, and to do so on a global basis. The reason? Their concern that donations result in off-label marketing by groups receiving funds; mask the agendas of public policy groups that debate policy issues, and allow researchers to circumvent normal disclosure requirements.

We’ll let you know if anyone responds. Meanwhile, to see the letter and the complete list of advocacy groups, you can visit PharmaDisclose.

For Immediate Release
For More Information, contact: Robert Weissman or Sarah Rimmington, Essential Action, 202-387-8030

Big pharmaceutical companies should disclose all of their charitable and educational grants and gifts, a broad coalition of dozens of public health and consumer organizations worldwide urged today.

See below for the text of the letter and a full list of signatories.

“There is quite extensive evidence that pharmaceutical industry charitable and educational grants have been abused to influence public health and public policy decisions improperly,” the public health coalition asserted in a letter sent to the largest pharmaceutical companies and industry trade associations.
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Among the signers of the letter are: Essential Action, the American Public Health Association, Families USA, Health Action International regional hubs in Africa, Asia Pacific, Europe and Latin America, Oxfam International and Public Citizen.

“Big Pharma has used its charitable and educational funding to influence key public policy debates, affect doctors’ prescribing decisions, and over-promote diseases and drug treatments,” says Robert Weissman, director of Essential Action. “Disclosure of industry funding of think tanks, patient groups, and continuing education courses doesn’t cure this problem, but it is a start.” The Washington, DC-based Essential Action promotes pharmaceutical industry transparency and organized the letter.

Pharmaceutical industry charitable and educational contributions have received special attention in the United States because of widespread abuse of continuing medical education courses. Purportedly educational programs sponsored by industry may improperly promote drugs, including for off-label uses.

Independent consumer groups around the world have repeatedly found industry-funded patient groups promoting particular medicines, and industry-friendly public policies, without sufficient regard for safety concerns.

Public health organizations have also repeatedly confronted industry-allied think tanks and advocacy groups that advance industry-favored policies — for example, in op-ed pieces — without disclosing their industry ties.

In May, one major company, Eli Lilly, began publishing its charitable and educational contributions in the United States. The public health coalition letter urges the other companies to follow Lilly’s lead, on a global basis.

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Adapted for each company, the following letter was sent to the CEOs of Pfizer, GlaxoSmithKline, Sanofi-Aventis, AstraZeneca, Novartis, Merck, Johnson & Johnson, Roche, Wyeth, Bristol-Myers Squibb, Abbott Laboratories, Schering-Plough, Boehringer-Ingelheim, Takeda and Bayer. The letter was forwarded under a cover to the heads of the Pharmaceutical Researchers and Manufacturers Association of America, and the International Federation of Pharmaceutical Manufacturers Associations. A modified version was sent to Eli Lilly, which has adopted a disclosure system for its U.S. charitable and educational contributions, but for overseas contributions.

July 26, 2007

Jeffrey B. Kindler
Chief Executive Officer
Pfizer
235 East 42nd Street
New York, NY 10017

Dear Mr. Kindler

We are writing to urge you to publish a complete list of all of the charitable and educational grants and gifts made by Pfizer, its subsidiaries, affiliates and associated foundations. This list should be made available on your company website, include the amounts of each grant and the recipient, and cover grants and gifts made on a global basis. Such a system of disclosure would impose minimal burdens on your company, since it must already compile this information, but the disclosures would have significant public benefits.

There is quite extensive evidence that pharmaceutical industry charitable and educational grants have been abused to influence public health and public policy decisions improperly. For example:

+ Purportedly educational programs sponsored by industry may improperly promote drugs for off-label uses.(1)

+ Policy think tanks and advocacy groups that receive funding from the pharmaceutical industry often weigh in on important policy debates — for example, in op-ed pieces — without disclosing their industry ties.(2)

+ Patient organizations receiving industry support often tout products sold by corporate donors, but fail to highlight safety concerns. These groups may also over-promote diseases and drug treatments sold by their corporate donors.(3) They may lobby for inclusion of products on government formularies without disclosing their industry ties, and favor the products of corporate sponsors over others.(4)

+ Charitable organizations may be used as a conduit to fund doctors or their research, circumventing normal disclosure requirements and rules.(5)

Disclosing industry funding to charitable and educational organizations is by no means a complete cure for these and related problems — many of us support much stronger restrictions or outright bans on many industry sponsorship practices — but it is a start.

The industry has begun to make some modest moves in the direction of disclosure. As you know, one major pharmaceutical company, Eli Lilly, recently began publishing its charitable and educational contributions, at least in the United States. And the Association of the British Pharmaceutical Industry’s code of practice requires disclosure of support for patient groups, though not disclosure of the amounts.

It is time now for each company to fully disclose charitable and educational contribution information, on a global basis.

We look forward to your response.

Sincerely,

Essential Action,
Washington, DC, USA

Agua Buena Human Rights Association
San Jose, Costa Rica

AIDS Healthcare Foundation
Los Angeles, CA, USA

Albanian Consumers Association
Tirana, Albania

Alliance for Human Research Protection
New York, USA

American Medical Student Association
Reston, VA, USA

American Public Health Association
Washington, DC USA

Association of Conscious Consumers
Budapest, Hungary

Breast Cancer Action
San Francisco, California, USA

The Center for HIV Law and Policy
New York, NY, USA

Center for Policy Analysis on Trade and Health (CPATH)
San Francisco, California, USA

Centre for Safety and Rational Use of Indian Systems of Medicine
Aligarh, India

Community HIV/AIDS Mobilization Project (CHAMP)
New York, NY, USA

Consumers Association of Bangladesh (CAB)
Dhaka, Bangladesh

Consumer Information Network
Nairobi, Kenya

Consumers Union
Khujand City, Tajikistan

DES Action USA
Columbus, OH, USA

Families USA
Washington, DC, USA

Federation of Malaysian Consumers Associations (FOMCA)
Selangor, Malaysia

The Finnish Consumers’ Association
Helsinki, Finland

Forum for Protection of Public Interest
Kathmandu, Nepal

Ghaqda tal-Konsumaturi
Valletta, Malta

Global AIDS Alliance
Washington, DC, USA

Health Action International Africa
Nairobi, Kenya

Health Action International Asia Pacific
Colombo, Sri Lanka

Health Action International Europe
Amsterdam, The Netherlands

Health Action International Latin America
Lima, Peru

Health GAP
New York, NY, USA

Initiative for Medicines, Access & Knowledge
Delhi, India/New York, USA

Integrity in Science Project, Center for Science in the Public Interest
Washington, DC, USA

KEPKA – Consumers’ Protection Centre
Thessaloniki, Greece

Knowledge Ecology International
Washington, DC, USA

National Committee for Responsive Philanthropy (NCRP)
Washington, DC, USA

National Research Center for Women & Families
Washington, DC, USA

National Women’s Health Network
Washington, DC, USA

New View Campaign on Women’s Sexual Problems
New York, NY, USA

Oxfam International
Oxford, UK

Our Bodies Ourselves
Boston, MA, USA

Planet Poz
Albuquerque, New Mexico, USA

Positive Malaysian Treatment Access & Advocacy Group (MTAAG+)
Kuala Lumpur, Malaysia

Public Citizen
Washington, DC, USA

Togolese Consumer Association – Association Togolaise des Consommateurs (ATC)
Lome, Togo

Universities Allied for Essential Medicine
Montréal, Canada

Women and Health Protection
Toronto, Canada

Professor Brook K. Baker
Northeastern U. School of Law
Boston, MA, USA

Warren Bell, MD CM CCFP
Active Staff member and President of Medical Staff
Shuswap Lake General Hospital
Salmon Arm, BC, Canada

Dolors Capellà
Barcelona, Spain

John Carroll
Christian Health Association of Malawi
Lilongwe, Malawi

Mardge Cohen, MD
Cook County (Stroger) Hospital
Chicago IL, USA

Sean Flynn, Associate Director
Program on Information Justice and Intellectual Property
American University Washington College of Law
Washington, DC, USA

Andrew Herxheimer
London, UK

Emily Johnston
Philadelphia, PA, USA

Stuart Jones
Wales, UK

Karyn Kaplan, Director, Policy and Development
Thai AIDS Treatment Action Group (TTAG)
Bangkok, Thailand

Gaelle Krikorian
Paris, France

Abby Lippman, PhD
Montreal, Canada

Nicholaus Mamseri
Dar-es-salaam, Tanzania

Sisule F. Musungu
Geneva, Switzerland

Suerie Moon, PhD Candidate and Doctoral Research Fellow
Kennedy School of Government, Harvard University
Cambridge, MA, USA

Kirsten Myhr
RELIS Drug Information Centre
Oslo, Norway

Malgorzata Niepokulczycka, President
Polish Consumer Federation
Warsaw, Poland

Chan Park
Lawyers Collective, HIV/AIDS Unit
Delhi, India

Gordon Schiff
Senior Attending Physician, Cook County Stroger Hospital
Professor of Medicine, Rush Medical College
Chicago, IL, USA

S.K. Smith
Tamarack Communications
Edmonton, Alberta, Canada

Bill Vaughan
Consumers Union
Washington, DC, USA

Ann Woloson
Prescription Policy Choices
Hallowell, ME, USA

(1) See, e.g., “Warner-Lambert to Pay $430 Million to Resolve Criminal & Civil Health Care Liability Relating to Off-Label Promotion,” U.S. Department of Justice news release, May 13, 2004 (“The company also sponsored purportedly ‘independent medical education’ events on off-label Neurontin uses with extensive input from Warner-Lambert regarding topics, speakers, content, and participants”). For a fuller discussion of this issue, see “Use of Educational Grants by Pharmaceutical Manufacturers,” Committee Staff, Committee on Finance, U.S. Senate, April 2007.

(2) See, for example, Philip Shenon, “On Opinion Page, Lobby’s Hand is Often Unseen,” New York Times, December 23, 2005.

(3) Tinker Ready, “Divided Loyalties?; Nonprofit Health Advocacy Groups Like to Portray Themselves as Patients’ Allies. Can They Serve Corporate Benefactors at the Same Time?.” Washington Post, February 7, 2006.

(4) Thomas Ginsberg, “Donations tie drug firms and nonprofits: Many patient groups reveal few, if any, details on relationships with pharmaceutical donors,” Philadelphia Inquirer, May 28, 2006.

(5) Reed Abelson, “Charities Tied to Doctors Get Drug Industry Gifts,” New York Times, June 28, 2006.
ISSUE AREAS:

For Immediate Release
For more information, contact:
Robert Weissman, Essential Action, 202-387-8030 (o), 202-360-1844 (cell), [email protected]
Asia Russell, Health GAP, 267-475-2645, [email protected]
Brook Baker, Health GAP, 617-373-3217, [email protected]

Comment and Analysis on Revised Intellectual Property and Access to Medicines Provisions in Peru and Panama Trade Agreements
Essential Action and Health GAP

The final Peru and Panama texts incorporate the terms of the earlier “concept paper” negotiation between the House Ways and Means Committee and the U.S. Trade Representative, for better and worse, with few changes. Our statement on the conceptual deal is available here.

It remains the case that the Peru/Panama trade deals will leave patients worse off than they would be with no agreement. The agreements enhance monopoly protections for medicines beyond those required under the World Trade Organization’s Agreement on Trade-Related Aspects of Intellectual Property (TRIPS), and will worsen public health.

These revised trade agreements are less bad than the original versions, in some notable ways. If the deals are adopted — and we hope they are not — it will be important that Peru and Panama aggressively incorporate in their implementing legislation (and subsequent revisions) the flexibilities that have been added thanks to the negotiating efforts of the Ways and Means Committee.
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More generally, the revised trade deals now set a ceiling for the TRIPS-plus measures that can be imposed on developing countries. No country negotiating trade or investment agreements or frameworks, or responding to unilateral demands from the United States, should ever accept more than has been included in these deals, which have been accepted by the pro-Pharma Bush administration.

However, as the Ways and Means Committee has insisted, the Peru/Panama trade deal terms are not a template for future trade agreements. This is what the committee was able to negotiate for an already finalized text. Any future agreements should be expected to be more public health-friendly.

The days of the U.S. government trade bureaucracy reflexively carrying water for Big Pharma are coming to an end. The revisions extracted by the Ways and Means Committee are one sign. The strong opposition evidenced by Members of Congress to USTR pressure on Thailand for its lawful issuance of compulsory licenses is another.

Regarding specific revised terms:

1. The revised text preserves the obligation to provide 5 years of data exclusivity (16.10.2), which is the top TRIPS-plus priority of Big Pharma. Data exclusivity provides monopoly protections separate from those provided by patents, or forces generic companies to undertake unethical, redundant, time-consuming and relatively expensive clinical tests. The monopoly protections afforded by data exclusivity can delay generic competition in cases where a pharmaceutical product is not patent protected, or where a compulsory license has been granted on a patent. Because the compulsory license on a patent only covers the patent right, a generic firm may be barred from entry by the data exclusivity rules, which effectively prevent it from gaining marketing approval.

Informally, USTR has agreed in the past that countries could override data exclusivity protections at least in cases where a compulsory license was issued. We had hoped that the final text would clearly state that countries can override data protections with compulsory licensing-like mechanisms, in cases where they have issued a compulsory license on pharmaceutical patents, but also in other cases. The final text does not provide this assurance, though it does include a “notwithstanding” clause (16.10.2(e)) that permits countries to protect public health in accordance with the Doha Declaration. If the agreement is adopted, we will work hard to advance an interpretation that says this must mean countries have the right to regularly override data protections with compulsory licensing-like mechanisms, but we fear the general and vague language of this provision will not give countries the confidence to do so.

It is true that, where partner countries rely on registration approvals in the United States in making their own registration decisions, the data exclusivity language offers the opportunity to limit the term of protection to just five years from the date of registration in the United States. This is an improvement from the even more onerous measures in CAFTA and other trade deals. There are some other technical limitations on data exclusivity that will limit its scope.

There is an interesting feature in the data exclusivity language that was not anticipated by the concept paper: Under 16.10.2(b), exclusivity is mandated for a reasonable period. Then: “For this purpose, a reasonable period shall normally mean five years from the data on which the Party granted approval to the person that produced the data for approval to market its product, taking account of the nature of the data an the person’s efforts and expenditures in producing them.”

This suggests that:

a. Five years is the norm, but it can be deviated from.

b. A country may require disclosure of at least some information about cost of producing the data as a condition of its routine grant of the 5 years of exclusivity. This is important, because Big Pharma routinely wildly overstates the cost of clinical trials and drug development,without providing any substantive evidence for its claims.

c. The reasonable period of exclusivity may be shortened on a case-by-case basis, at least in light of actual expenditures for R&D (if not, for this provision, on pure public health grounds). It is conceivable, at least in some cases, that these provisions could be used to justify substituting a cost-sharing approach for exclusivity. (Under a cost-sharing approach, a generic firm must pay a fair share of the costs of clinical trials, but is able to rely on those trials immediately.)

2. The revised text does eliminate mandatory pharmaceutical patent extensions for delays in the grant of a patent or regulatory approval. 16.9.6(c). Mandatory extensions pose enormous access to medicines problems. Because of the low patent review capacity in many developing countries, there is a significant and growing backlog of patent applications. Mandatory delays therefore threaten very prolonged periods of patent monopolies.

3. The revised text does eliminate the requirement for “linkage” — a prohibition on the drug regulatory agencies granting regulatory approval if a patent is claimed. The revised text language (16.11.3 and 16.11.4) is imperfect, but does eliminate the requirement. One unfortunate element is the requirement that alternative expedited patent enforcement mechanisms be provided before a product is placed on the market. Separately, from an implementation perspective, it is vital that countries include in the expedited process an opportunity for generic firms to challenge the validity of the underlying patents the brand-name firm is seeking to enforce. It is also the case that the provisions in 16.11.4 could be adopted by countries that have previously entered into TRIPS-plus agreements with the United States.

Linkage provisions turn drug regulatory agencies into patent enforcement agencies, even though such a duty is outside of their expertise and purpose. In the United States, which includes significant safeguards (the elements of 16.11.4, plus a large market and robust generic industry), linkage has nevertheless been subjected to considerable abuse, as recognized repeatedly by the Federal Trade Commission.

4. The revised text does incorporate the side letter on public healthinto the actual text. (16.13) Incorporation of the side letter is an improvement, but the general terms cannot override the more specific problematic provisions; and it is hard to put much stock in such terms, since USTR has repeatedly demonstrated its willingness to disregard such obligations in the past.

There are some positive changes to previous side letters.

The word “necessary” has been eliminated. The current text 16.13.1 reads that the chapter should not prevent countries “from taking measures to protect public health by promoting access to medicines for all.” The previous text said countries should not be prevented “from taking measures “necessary” to protect public health by promoting access to medicines for all .” Since “necessary” is a very restrictive term in international trade law, removing the term is an improvement.

Also, additional language from the Doha Declaration has been incorporated: “Accordingly, while reiterating their commitment to this Chapter, the Parties affirm that this Chapter can and should be interpreted and implemented in a manner supportive of each Party’s right to protect public health and, in particular, to promote access to medicines for all.” This should help give this provision some greater interpretive impact.