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Sign-on Letter in Response to Critical Shortage of Penicillin for Syphilis Treatment in U.S.

Sign-on letter to Pfizer urging an immediate response to the nationwide shortage of pencillin G benzathine, the standard treatment for primary and secondary syphyilis.

July 21, 2017

Ian C. Read
c/o Margaret M. Madden
Senior Vice President and Corporate Secretary
Chief Governance Counsel at Pfizer Inc.
235 East 42nd Street, 
New York, New York 10017

Dear Mr. Read,

We the undersigned urge Pfizer to adequately and promptly address the penicillin G benzathine (Bicillin-LA) shortage to ensure normal quantities in the United States. Bicillin-LA remains the preferred treatment for primary and secondary syphilis in adults, infants, and children, and the only approved treatment for syphilis in pregnant women. As the only manufacturer of pencillin G benzathine in the United States, Pfizer’s inability to provide adequate quantities of Bicillin-LA has left the Food and Drug Administration, the Centers for Disease Control and Prevention, and many city and state health departments scrambling to ration existing stockpiles of the drug and develop contingency plans.

Pfizer first reported a manufacturing delay in April 2016, but projected the shortage would be limited to the summer of 2016. More than a year later, the problem persists, with Pfizer reporting that the shortage will likely continue through the end of 2017. Given the unreliability of Pfizer’s timeline and its vague explanations of the manufacturing complications, key stakeholders are worried the situation will deteriorate further and extend into 2018.

Shortages of Bicillin-LA have been a recurring  concern in the US in recent years. In 2002 Wyeth-Ayerst, the previous manufacturer of Bicillin-LA, created shortages in North America when it halted production of the product at a Canadian plant. In 2005, shortages reoccurred and persisted for nearly five years.[i] As we head into our second year of the most recent shortage, it is imperative that Pfizer not only invest all available resources to address the manufacturing problems, but be forthcoming with all stakeholders impacted by the shortage regarding the reason(s) for the delay and the company’s plans to safeguard against shortages in the furture.

The timely diagnosis and treatment of syphilis is a major public health priority in the United States.  Between 2014 and 2015, the national primary and secondary syphilis rate increased 19% to 7.5 cases per 100,000 population, the highest incidence reported since 1994.[ii]

While much of the increase has been disproportionately experienced among gay and bisexual men, incidence also increased 27.3% among women in the same time period. Consequently, there has also been an increase in rates of congenital syphilis, which may result in stillbirth or infant death in up to 40% of cases. In 2015, there were a total of 487 reported cases of congenital syphilis, for a national rate of 12.4 cases per 100,000 live births. This rate represents a 6.0% increase relative to 2014 (11.7 cases per 100,000 live births) and a 36.3% increase relative to 2011 (9.1 cases per 100,000 live births).

Because Bicillin-LA is the only approved syphilis treatment for pregnant women, they remain an extremely vulnerable population when shortages occur. While alternative regimens for primary and secondary syphilis infections are theoretically possible in other populations, treatment becomes more complicated—with patients having to adhere to multiple daily doses over two weeks—and inferior to the penicillin G benzathine start of care, particularly from a public health perspective. The syphilis epidemic has already proven challenging to control, most notably in gay and bisexual men. If affected communities and public health officials in the United States must rely on a single manufacturer for the standard of care, that manufacturer must be held accountable for dereliction of duty to maintain adequate quantities. Unexplained manufacturing delays not only endanger the successful treatment of syphilis, it endangers efforts to cure people in a timely manner, stop onward transmission, and bring down rising new infection rates.

Affected communities and key stakeholders need to know the exact causes of the current shortage, including how Pfizer executives plan to use their enormous wealth and power to fix this situation and prevent it from happening again. Pfizer is reported to have total assets of $168 billion and is noted by Forbes as one of the American companies with the largest stockpiles of cash.[iii] We would hope that with such impressive resources, some shortage prevention efforts are well-funded and already making significant progress.

With its headquarters located in the heart of Manhattan on 42nd street, not far from Treatment Action Group and several other signatories of this letter, we would welcome an immediate in-person meeting with Pfizer to discuss solutions. TAG can be reached by emailing Jeremiah Johnson. At a minimum we expect prompt, transparent communication about the shortage to be immediately shared with affected communities to ensure all stakeholders are engaged in efforts to rectify this unacceptable situation and to prevent future recurrences.

Sincerely,

The following organizations:

ACRIA
New York
New York

ACT UP New York
New York,
New York

Action Wellness
Philadelphia
Pennsylvania

AIDS Alabama
Birmingham
Alabama

AIDS Foundation of Chicago
Chicago
Illinois

AIDS Project New Haven
New Haven
Connecticut

AIDS Project of the East Bay (APEB)
Oakland
California

Albany Damien Center
Albany
New York

Alliance for Living
New London
Connecticut

Alliance for Positive Health
Albany
New York

Amida Care
New York
New York

Bay Area Healthy Living Support Communication Platform-(BayHeal)
San Francisco
California

Berkeley Free Clinic
Berkeley
California

Callen-Lorde Community Health Center
New York
New York

Church Ladies for Choice
New York
New York

Coachella Valley Community Research Initiative
Palm Springs
California

Desert AIDS Project
Palm Springs
California

Disabled In Action of Metropolitan NY
New York
New York

Equitas Health
Columbus
Ohio

H.O.P.E. Alliance
Albuquerque
New Mexico

Health GAP
Washington
District of Columbia

House of Blahnik, Inc.
Philadelphia
Pennsylvania

Housing Works
Brooklyn
New York

Housing Works, Inc.
New York
New York

Howard Brown Health
Chicago
Illinois

International Foundation for Alternative Research in AIDS
Portland
Oregon

Iris House
New York
New York

Latino Commission on AIDS
New York
New York

Los Angeles LGBT Center
Los Angeles
California

Louisiana AIDS Advocacy Network, Inc.
Lafayette
Louisiana

Migrant Clinicians Network
Austin
Texas

National Coalition for LGBT Health
Washington
District of Columbia

National Coalition of STD Directors
Washington
District of Columbia

National Health Coalition
Vancouver
Washington

National Network of STD Clinical Training Centers
Winston-Salem
North Carolina

National Network of STD Prevention Training Centers
New York
New York

Needle Exchange Emergency Distribution
Berkeley
California

New Jersey Association on Correction
Trenton
New Jersey

NMAC
Washington
District of Columbia

NNPTC
Denver
Colorado

Okaloosa AIDS Support & Informational Services, Inc.(OASIS)
Ft. Walton Beach
Florida

PeterCares House
Greenbelt
Maryland

POZabilities
San Diego
California

Prevention Access Campaign
Brooklyn
New York

Pride for Youth/Long Island Crisis Center
Bellmore
New York

Professionals For Humanity (PROFOH)
Houston
Texas

Project Inform
San Francisco
California

Red Gym Men's Club
Syracuse
New York

Silver Creek Strategies
Novelty
Ohio

Siouxland Community Health Center
Sioux CIty
Iowa

Siouxland Pride Alliance
Sioux City
Iowa

Span, Inc.
Boston
Massachusetts

The Center For Black Equity Baltimore
Baltimore
Maryland

The CHANGE Coalition
New Orleans
Louisiana

The Hepatitis C Mentor and Support Group-HCMSG
New York City
New York

Trillium Health
Rochester
New York

Unity Fellowship Church
Brooklyn
New York

Women With A Vision, Inc
New Orleans
Louisiana

The following individuals:

Ace Robinson
Long Beach
California

Adam Bowen
San Jose
California

Adam Martin
New York
New York

Alice Gandelman
Oakland
California

Amita Gupta
Baltimore
Maryland

Andrea Cipriani
Oakland
California

Andy Humm
New York
New York

Anna Forbes, MSS
Kensington
Maryland

Anthony Gonzalez
San Francisco
California

Arthur Moswin MD
Chicago
Illinois

Audrey Sokoloff
New York
New York

Bella TSANG
Long Island City
New York

Bishop Pat Bumgardner
New York
New York

Bobby J. Long
San Diego
California

Bonnie Richardson
Chicago
Illinois

Brad Dalton
Houston
Texas

Brandon Kennedy
Chicago
Illinois

Brenda Wolfe
Chicago
Illinois

Bruce Richman
Brooklyn
New York

Bryan Jones
Cleveland
Ohio

Cameron R.Wolfe
Durham
North Carolina

Candace Kugel, FNP, CNM
Clinton
New York

Carl Stein, MHS, PAC
San Francisco
California

Caroline Teschke MD
Portland
Maine

Christine Snyder
Buffalo
New York

Christopher Destache
Omaha
Nebraska

Christopher Taylor Edwards
New York
New York

Clyde Johnson
Philadelphia
Pennsylvania

Clyde Johnson
Philadelphia
Pennsylvania

Courtney Voss
Sioux City
Iowa

Darlene Robertson
Port Barre
Louisiana

David Hubbell
Oak Park
Illinois

Debra East
Lander
Wyoming

Deliana Garcia
Austin
Texas

Derrick Mapp
San Francisco
California

Diana Nilsen
New York City
New York

Dominic Orlando
Lisle
Illinois

Dominique Cooper
Bethesda
American Samoa

Dr. Paul Bellman
New York City
New York

Dr.Rev.Abraham Calleros,PA,DD,HWHP
Yucca Valley
California

Drew Gibson
Washington
District of Columbia

Eamonn Vitt MD
New York
New York

Eduardo Culbeaux
Chicago
Illinois

Edward C Fagan
Kansas City
Missouri

Edward Kantor, MD
Charleston
South Carolina

Elizabeth Capone-Newton, MPH
Portland
Maine

Elizabeth Crutsinger-Perry
Olympia
Washington

Elizabeth Hagan
Philadelphia
Pennsylvania

Emily Sanderson
Brooklyn
New York

Eric Jannke
Palm Springs
California

Forrest Williams
New York
New York

Fred Schaich
Portland
Oregon

Garvin Scott McCurdy
San Francisco
California

Howard A. Grossman, MD
West Palm Beach
Florida

Ingrid N. Floyd
Plainfield
New Jersey

Irvin Parker IV`
New York
New York

Jacob Levi
London
New York

James Gilday
New York
New York

James Krellenstein
New York
New York

Jason Stout
Durham
North Carolina

Jeanmarie Zippo RN
Philadelphiia
Pennsylvania

Jeffrey Tornheim
Baltimore
Maryland

Jim Pickett
Chicago
Illinois

Joanne Alonso Byars
Fort Pierce
Florida

Joanne L. Delaney
Boston
Massachusetts

John Hamlin
Stamford
Connecticut

John McNevin
Seattle
Washington

John Nelson
Belleville
New Jersey

John Schuster
Washington
District of Columbia

John Stryker
Chicago
Illinois

Johnny Guaylupo
New York
New York

Joseph K Tate
Berkeley
California

Joseph Robert Winn
Arlington
Massachusetts

Joseph William Dluzak
New York City
New York

Joshua Thaden
Durham
North Carolina

Julie Fitch
New Orleans
Louisiana

Kathi Roussel
Buffalo
New York

Keith R. Green
Chicago
Illinois

Kelly Dooley
Baltimore
Maryland

Kenneth Hecht
Berkeley
California

Kenneth Wilson
Durham
North Carolina

Kevin Goetz
Los Angeles
California

Kurt Kemmerer
Portland
Oregon

Larry Kramer
New York
New York

Laura Morrison
New York
New York

Lauren Gauthier
New Orleans
Louisiana

Leiba Frans
Brooklyn
New York

Leslie Hughes
Buffalo
New York

Linda Infelise
Phoenix
Oregon

Logan McMaster
Islin
New Jersey

Luis Lira
Chicago
Illinois

Marco Castro-Bojorquez
Los Angeles
California

Margaret McCarthy
New Haven
Connecticut

Mark Brennan-Ing, PhD
New York
New York

Mark Leno
San Francisco
California

Mark Wyn
Saint Louis
Missouri

Marty S. Player MD, MS
Charleston
South Carolina

Maryblaise Larson
Madison
Connecticut

Matthew Franck
Highland Park
New Jersey

Maureen Murphy
Vallejo California

Maxwell Ciardullo
New Orleans
Louisiana

Melanie Thompson, MD
Atlanta
Georgia

Meredith Clement
Durham
North Carolina

Meredith Short
Bloomington
Indiana

Michael A Toth
Arlington
Virginia

Michael C Shapiro
Laguna Niguel
California

Michael Longacre
Sagaponack
New York

Michael Luciano
Charleston
South Carolina

MJ  Schuman
New York
New York

Nelly Hugh-Jones
Baton Rouge
Louisiana

Nicholas Bennett
Lee's Summit
Missouri

Nicholas Rice
New York
New York

Nicholas Turner MD
Durham
North Carolina

Nick Debs
Eastham
Massachusetts

Paul Chambliss, MD MPH
New York
New York

Paul VanSteenwyk
Tucson
Arizona

Penny DeNoble
New Orleans
Louisiana

Pete Carney
Middle Village
New York

Peter M Caesar, LICSW
Newburyport
Massachusetts

Professor Rebecca Jordan-Young
New York
New York

Rae Leiner
Newburgh
New York

Randal Lucero
Albuquerque
New Mexico

Raymond Egolf
Palm Harbor
Florida

Reginlad Brown
Brooklyn
New York

Richard Cardillo
New York
New York

Richard Kelso
New York
New York

Richard Pucciarelli
Matawan
New Jersey

Richard Uniszkiewicz
Murfreesboro
Tennessee

Rick Runabear
Vancouver
Washington

Robert Benjamin, MD, MPH
Orindal
California

Robert Levaro
Tucson
Arizona

Robert Marshall
New York
New York

Ronald Carthen
Rochester
New York

Ronald E. Macon
Worcester
Massachusetts

Roy Wadia
Decatur
Georgia

Sandra M. Palleja, MD
Bridgewater
New Jersey

Sandra Montgomery
Amherst
New York

Sara Onesi
Pittsburgh
Pennsylvania

Scott Oakley
Los Angeles
California

Sean McShee
Fort Lauderdale
Florida

Seth M. Bloom, MD, PhD
Boston
Massachusetts

Shawn Peterson
Portland
Maine

Sheila Reeves
Portland
Oregon

Stacey Ravanesi
Forest Park
Illinois

Stephen Corbett
Boston
Massachusetts

Suzy Subways
Philadelphia
Pennsylvania

Syria Jackson
New Orleans
Louisiana

T. Bailey
Kansas City
Missouri

Ted Hoyle
Southold
New York

Thomas Earl Lewis
Fraser
Michigan

Timothy Frasca
New York
New York

Tom Grogan
Cincinnati
Ohio

Vanessa Haney
New York
New York

Victoria A. Cargill, M.D., M.S.C.E.
Newark
Delaware

Victoria Hoverman
Gaithersburg
Maryland

Wade Louis Rosenthal
Brooklyn
New York

William Boemer
San Rafael
California

Willy Quesada
Bridgeport
Connecticut

Witti Repartee
New York
New York

Xavier Erguera
San Francisco
California
 


[i] Wyber R, et al. Benzathine Penicillin G for the Management of RHD: Concerns About Quality and Access, and Opportunities for Intervention and Improvement. Glob Heart. 2013 Sep;8(3):227-34. doi: 10.1016/j.gheart.2013.08.011.

[ii] Centers for Disease Control and Prevention. Sexually Transmitted Disease Surveillance 2015. Atlanta: U.S. Department of Health and Human Services; 2016. https://www.cdc.gov/std/stats15/syphilis.htm

[iii] “Fortune 500.” Forbes. [Internet]. http://fortune.com/fortune500/list/