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Today's
Stories
January 10,
2007
Robert Fantina
Punishing
Deserters: Prosecution or Persecution?
January 9,
2007
R. T. Naylor
The
Somalian Labyrinth
Jonathan Cook
Israel's
Purging of Palestinian Christians
Mike Ely and Linda Flores
The Smithfield Strikers: No Longer
Hidden, No Longer Hiding
Joshua Frank
The Democrats and Iran: More Bellicose Than Bush
Norman Solomon
The Headless Horseman of the Apocalypse
Sen. Russell
Feingold
An Open Letter to President Bush: So Now You Want to Snoop Through
Our Mail?
Joe Allen
Justice for the Omaha Two: Black Power, Racism and COINTELPRO
in the Heartland
James T. Phillips
"Lasciate Ogne Speranza, Voi Ch'Intrate": The Hell
That is Iraq
Brian Concannon
Resolutions for Haiti
Leonard Peltier
When the Truth Doesn't Matter: 30 Years of FBI Harassment and
Misconduct
Website of the Day
Kick Out the Jams, MFers!: Meet the New RRC
January 8,
2007
Werther
Why
We Fight
Jeff Leys
The Occupation Project: a Campaign of Civil Disobedience to End
Iraq War Funding
Paul Craig Roberts
Nuking Iran
Shulamit Aloni
Israeli Apartheid: Sorry, This Road is For Jews Only
Dave Lindorff
The Party of Invertebrates Reverts to Form
Sunsara Taylor
The Democrats' First Day: Same As It Ever Was
Seth Sandronsky
Syndicated Error: George Will and the Minimum Wage
Dr. Susan Block
Baghdad Cockfight Ends in Snuff Film
Website of the Day
Watch CounterPuncher Sunsara Taylor Take on Bill O'Reilly!
January 6 / 7, 2007
Alexander Cockburn
The
War and the NYT
Franklin C.
Spinney
Stalingrad
on the Tigris
Paul Craig
Roberts
The
Urge to Surge
Ralph Nader
Democrats in the Spotlight
Walden Bello
Globalization in Retreat?
Marleen Martin
The Needle and the Damage Done: Tortured in the Death Chamber
Brian Cloughley
We Do What We Like: Return Our Rapist or Else ...
Uri Avnery
The Kiss of Death
Saul Landau
Fidel Castro in the Fields
Ron Jacobs
From Cointelpro to the Patriot Act: a Legacy of Torture
Joseph Nevins
Crimes Against Humanity from Ford to Saddam
William S. Lind
A State Restored? Somalia and 4GW
Gary Leupp
Attention John Conyers: Impeach the President!
Elisa Salasin
Bringing Life to Numbers
George Ciccariello-Maher
Beyond
Chavistas and Anti-Chavistas: Deepening the Bolivarian Revolution
Stefan Wray
Confronting Recruiters: the Story of the Bush Street Raiders
Michael Leonardi
Toward an International Moratorium: Italy's Crusade Against the
Death Penalty
Richard Rhames
Reality TV: Triumph of the Thugs
Jeffrey St. Clair
Playlist: What I'm Listening to This Week
Barbara LaMorticella
Two Poems
Website of the Weekend
FBI Witch Hunts
Song of the
Weekend
End Times: a Soundtrack
January 5, 2007
Jorge Mariscal
Growing
the Military: Who Will Serve?
John Walsh
Clash of the Elites: Beltway Insiders vs. Neo-Cons!
Christopher Brauchli
The Great Relaxer: Bush and Federal Regulations
Travis Sharpe
No More New Nukes, Please
Tom Barry
Hawk for Hire: Roger Noriega's New Gig
Linda Schade
/ Kevin Zeese
Americans Voted for Peace: Has the New Congress Already Let Them
Down?
Tiffany Ten Eyck
Workers' Centers and Unions: a New Alliance
Mahmoud El-Yousseph
A Challenge to Pelosi
Lucinda Marshall
3003 Funerals: "And They're Still Burying Ford!"
Website of
the Day
Van the Man: Warm Love
January 4, 2007
Patrick Cockburn
The
Martyrdom of Saddam Hussein
Winslow T.
Wheeler
A Guide to Earmarks: Will the Democrats' Reforms Do Anything
to Curb Pork Barrel Spending?
M. Shahid Alam
Has Regime Change Boomeranged?
Raed Jarrar
So This is Plan B? The US Attack on Saleh Al-Mutlaq's Headquarters
Bert Sacks
Can the US Legally Kill Iraqi Children?: a Challenge to the Supreme
Court
Kathy Rentenbach
Report from Oaxaca
Stephen Fleischman
The Rain of Riches: Bonuses, Then and Now
George Bisharat
Carter's Truths
Peter Rost, MD
Hail the Hangman, Jail the Cameraman!
Evelyn Pringle
Can Eli Lilly be Held Criminally Liable for Zyprexa?
Website of the Day
Courage to Resist
January 3,
2007
Kathy Kelly
Wrapped
Around a Bullet
Paul Craig
Roberts
His Last Hurrah: Bush Cuts and Runs from Reason
William Johnson
No Worker is Illegal: SEIU Members Push Their Union to Change
Its Policy on Immigration
Stan Cox
Under a Brown Cloud: Money vs. the Monsoon
Trita Parsi
A Lose-Lose Situation with Iran
Declan McKenna
Ireland's Slavish Hostility Toward Cuba
Joe Bageant
Dispatch from the Chinese Landfill
Nicola Nasser
Somalia: New Hotbed of Anti-Americanism
Missy Beattie
Dead Wrong
Website of
the Day
Pharmed Out
January 2, 2007
Michael Watts
Oil
Inferno
Amina Mire
Return of the Warlords: Death and Destruction for Somalis
James Brooks
Pushing the Wedge in Palestine
Alevtina Rea
The Tyrant is Dead! Long Live ... ?
Al Krebs
Global Food Security: a Call to Action
Peter Rost
Invitation to a Hanging: the Saddam Hussein Execution Video
Niranjan Ramakrishnan
A Deadly December
John Stanton
Appetites for Destruction
Website of the Day
Out Now: Petition
January 1,
2007
Patrick Cockburn
Iron
Man, Tin God: the Meaning of Saddam Hussein
Uri Avnery
What
Makes Sammy Run?
Joshua Frank
Eliot Spitzer's Constitutional Hang Up: Architect of New York's
Patriot Act
December 30
/ 31, 2006
Weekend Edition
Alexander Cockburn
2006,
Hard to Call It Vintage, But 2007 Could Finally Be Bobby Byrd's
Year
Patrick Cockburn
Iraq
2006: a Nation Soaked in Blood Tears Itself Apart
Paul Wolf
Dying for Our Sins: A Lawyer for Saddam Describes How His Execution
on the First of Eid May Transform Him Into a Martyr
Manuel Garcia,
Jr.
Executing
Saddam, Protecting the Rackets
Tariq Ali
Saddam
at the End of a Rope
Paul Craig Roberts
The New Dark Age: Official Lies, Dogma and Unaccountable Power
Douglas Valentine
At the End of My Rope: Hanging With Saddam
Brian M. Downing
The New Iraq Policy: Escalation
Michael Donnelly
Injustice in Black and White: the Duke Non-Rape Case
Stephen Lendman
Did Sharon Order the Assassination of Arafat? The Revelations
of Uri Dan
Fred Gardner
Comes Now the Ghost of "Decrim:" Nixon and Marijuana
Bailly / Caudron / Lambert
Who Owns Ikea?: the Opaque Legacy of Ingvar Kamprad
Ralph Nader
The Prospects for Progressive Politics
Nick Dearden
The War on Terror Hits Africa
Elizabeth Weill-Greenberg
The Third Degree: an Interview with AC Thompson on the Origins
of the CIA's Secret Rendition Flights
Missy Beattie
In Harm's Way: How Our National Coward Describes War
Ron Jacobs
Sigh of the Oppressed: Religion and Politics
Dan La Botz
Defend Illegal Immigrants: Help Them! Harbor Them!
Andrew Wimmer
An Act of Contrition: the Peace Movement in 2007
Dr. Carol Wolman, MD
Psychiatrist: Impeach Bush for Good of Country
Martha Rosenberg
New Year's Resolutions for Big Pharma
Dick J. Reavis
News Before It Happens: Bush's 2007 MLK Day Speech
Jeffrey St.
Clair
Listening to James Brown and His Followers
Poets' Basement
Grima, Curtis, Davies, Orloski and Engel
Website of
the Weekend
Charlie Fowler's Photolog: a Life at Altitude
Music Video of the Weekend
"We're Winning the War on Drugs!"
December 29, 2006
Bill Quigley
A
Tale of Two Sisters: Why is HUD Spending Tens of Millions in
Katrina Money to Bulldoze 4,534 Public Housing Apartments in
New Orleans?
Norman Finkelstein
The Dershowitz Treatment
John Borowski
Curb Your Environmentalism: Laurie David and Me
Abid Mustafa
The Re-Talibanization of Afghanistan
Greg Moses
World Responds to Palestinian Family's Jailing Despite Media
Blackout
Uri Cohen
Stand Up for Herod: a Seasonal Story of Ancient Palestine
Bailly / Caudron
/ Lambert
The
Secrets in Ikea's Closet
Website of
the Day
Justice for New Orleans
December 28,
2006
Norman Finkelstein
The
Ludicrous Attacks on Jimmy Carter's Book
Anthony Cowell
Highway Robbery: Privatizing New Jersey's Toll Roads
John Ross
Gateway to the Next Mexican Revolution?
Hilaria Cruz
I'm Going to Stay Right Here: Story of a Oaxacan Prisoner
Greg Moses
Palestinian Immigrant Jailings in Texas
Brittany Bond
The Blood Trail of Luis Posada Carriles, Washington's Preferred
Terrorist
Website of
the Day
Godfather of Soul and Father of Funk
December 27,
2006
Alexander Cockburn
Farewell
to Our Greatest President: Adieu, Gerald Ford
Faruq Ziada
Is
There a Sunni Majority in Iraq?
Christopher Brauchli
Burning EPA's Books: What They Don't Want You to Read Might Save
Your Life
Michael Ortiz
Hill
Journey to Vietnam: Dare We Not Say Genocide?
Nikolas Kozloff
Saving
Caracas
Mark Schneider
Why Hope? Reasons for Optimism
December 26, 2006
Peter Stone
Brown
James
Brown: Please Don't Go
Tito Tricot
Chile: the Ghosts of Torture
Gary Leupp
Cowboys Differ on Iran Attack: Cheney/Bush vs. the Baker Commission
John V. Walsh
Dershowitz vs. Carter in Beantown: Peace Movement AWOL, Again
Reza Fiyouzat
Red Christmas: Why Santa Was Hot in China This Year
Ron Jacobs
The Golem: a Conversation with Marc Estrin
Website of
the Day
JB:
Prisoner of Love
December 25, 2006
Saul Landau
A
Jeep Trip with Fidel
Lang / McGovern
To
Surge or Not to Surge?
Michael Dickinson
Should Stupid Thoughts Be Crimes?: Deny Santa If You Will, But
...
Website of
the Day
James Brown, RIP
December 23 / 24, 2006
Marjorie Cohn
What's
Going On?
Jeffrey L.
Gould
The Capital of Salvadoran Memory: El Mozote After 25 Years
Diane Christian
The Rape of Iraq
William Loren
Katz
From the Raid on "Fort Negro" to Iraq: Lessons from
the First US Invasion
Greg Moses
This War Can't be Made Right by Winning
M. Shahid Alam
An Islamic Civil War: Chaos by Design?
Fred Gardner
Exposé as Inoculant: HRT, Zyprexa, Lilly and the Press
Dave Lindorff
Crime of the Century
Azmi Bishara
Ways of Denial
Ralph Nader
The BCS: a Monopoly on College Football
Seth Sandronsky
Fiscally Imperiled Social Security?
William Hughes
Cop Assaults Activists at Lockheed Protest
Ron Jacobs
Making Stones Weep
Jeffrey St.
Clair
Playlist: What I'm Listening to on New Year's Eve
December 22,
2006
David Rosen
Bush's
Foreign Sex Policy: Imperialism's Second Front
Christopher
Brauchli
When the Secret is the Question: Secret Prisons, Top Secret Interrogations
John Ross
Flashlights
in the Tunnel of Hate
J.L. Chestnut,
Jr.
Political
Sell-Outs in Black and White
Rahul Mahajan
Dennis Kucinich: Maverick or Stalking Horse?
Arthur Neslen
Provoking Civil War in the Occupied Territories
Peter Rost, MD
The Secrets of His Success: Fired Pfizer CEO Walks Away with
$198 Million
Website of
the Day
10 Ways to Change the World in 2007
December 21, 2006
Rosa Mariam
Elizalde
An
Interview with Gore Vidal: "I am Jealous of Cuba"
Arundhati Roy
Breaking the News
Brian Cloughley
Poppies Rising: Afghanistan's Drug Catastrophe
Daniel White
Jimmy Carter in Austin: Time to Come Clean on the Shoot Down
of That Itavia DC-9
John V. Whitbeck
On Israel's Right to Exist
Sam Smith
Still Smearing Ralph Nader for 2000
Paris Reidhead
GM Ice Cream: Something's Fishy in Your Good Humor Bar
Kevin Wehr
Denying Disaster: Katrina and the Case for Impeachment
Website of the Day
Pesticides and Amphibians: a Vital New Database
December 20, 2006
Gabriel Kolko
Rumsfeld
and the American Way of War
Winslow T.
Wheeler
The Pentagon Measures the Chaos in Iraq
Tariq Ali
The War is Lost
Saree Makdisi
Israel, Apartheid and Jimmy Carter
Bruce Jackson
Saying "Oh!": John Mohawk and the Power to Make Peace
Dave Lindorff
Democrats Walk Into a Bush Trap on Iraq
Leslie Radford
The Winter Harvest of the South Central Farmers
Dave Jansson
Divided We Stand, United We Fall: Secessionists Confront the
Empire
Johnny Barber
Jesus is a Terrorist
Website of
the Day
Is It for Freedom?
December 19, 2006
Alexander Cockburn
Democrats
Prepare to Fund Longer War
Jonathan Cook
End
of the Strongmen
Greg Moses
Globalized Gulag: Palestinian Refugees and Children Held in Hutto,
TX Jail
Sean Penn
Georgie,
There's a Crowd Downstairs
Dave Lindorff
Innocents Abroad: Cracking Down on Gitmo Detainees Despite Overwhelming
Evidence Most Are Not Terrorists
Ralph Nader
Going
Postal
Laura Carlsen
Latin America's Pink Tide?
Carlos Villarreal
The
Well is Poisoned: Victory Requires an Immediate Pull-Out
Website of
the Day
Chuck Spinney on the Pentagon
December 18, 2006
Luis J. Rodriguez
En
Lak Ech: Chicanos, Mayans and Mel Gibson
Norman Solomon
Washington Refuses to End the War: Powell, Baker, Hamilton--Thanks
for Nothing!
Uri Avnery
Lebanon: War Without a Plan
Ron Jacobs
More Troops, More Body Bags
Phil Gasper
Afghanistan: Bush's Other War Unravels
Behrooz Ghamari-Tabrizi
Iran's Elections: The World Isn't Florida and Bush Isn't Its
Supreme Leader
William Blum
The United States of Punishment
Jim Goodman
So What's the Big Deal If Wal-Mart Makes a Mistake?
James Brooks
Talking Surge: Let's Kill Some More Before We Go
Maria C. Khoury
Walking Into the Art World: Designing a Palestinian Academy for
the Arts
Website of the Day
Got Powell
December 16 / 17, 2006
Weekend Edition
Vijay Prashad
A
Perilous Way to Socialism
Saul Landau
Filming Fidel
Anthony Arnove
The US Occupation of Iraq: Act III of a Tragedy of Many Parts
Paul Cantor
The Puppet and the Puppeteer: Pinochet and Kissinger
Annie Nocenti
Baluchistan's Fight: The Khan of Kalat Gathers the Tribes
Nicole Colson
Hard Times on the Killing Floor: Smithfield's Rotten Record
Stephen Gowans
Tehran's Holocaust Conference
Jordan Flaherty
A Catastrophic Failure: Foundations, Nonprofits and the Second
Looting of New Orleans
Fred Gardner
Dustin Costa Faces 15 to Life
P. Sainath
There's No Such Thing as a Free Cow
Seth Sandronsky
The Democrats and Social Security: Watch What the Party Says
and Does
Nadia Hijab
An AIPAC Shot Across Baker's Bow?
Deb Reich
Dear Santa, (Or Someone): Greetings from the Occupied Holy Lands
Susie Day
Cops Shoot Another Rich White Man!
Albert Wan
Why Does It Take 50 Bullets?
Missy Beattie
Will the Next Leader Stand Up? Please!
Martha Rosenberg
Kicking the Wyeth Habit Saves Women's Lives
Lee Ballinger
The Devil's Highway: Clinton, Border Checkpoints and the Deaths
of the Yuma 14
Michael Dickinson
Kingdom of Fear
Jeffrey St.
Clair
Live/Evil: Listening to Miles Davis
Poets' Basement
Davies, Buknatski and Ford
Website of
the Weekend
"I Heard It Through the Grapevine"
December 15,
2006
Eliza Ernshire
Palestinian
"Civil War" and the Israeli Chocolate Ration
Virginia Tilley
What
Are You Going to Do Now, Israel?
Mike Ferner
Roll Call for the Choir: If They Vote for War, Occupy 'Em!
John Ross
Mad Mel's Mayan Apocalypse
Fred Wilhelms
The Flip Side of Ahmet Ertegun: Where Did You Get Those Shoes?
Kevin Zeese
Dennis Kucinich's Strange Mission: Can You Be a Real Anti-War
Candidate in a Pro-War Party?
David Severn
Social Engineering Begins at Home: Jeffrey Skoll, Billionaire
Philantropist
Dave Lindorff
Sen. Tim Johnson Death Watch: Senate Gridlock May Be Best Outcome
Sunsara Taylor
As American as Shopping and Torture
Website of
the Day
June 2, 2004: When Iraq Was There For The Looting
December 14,
2006
Jonathan Cook
The
Recognition Trap
Riz Khan
An Interview with Jimmy Carter
Jason Hribal
Kasatka, the Sea World Orca
Pennick / Gray
The Plight of Black Farmers: Racism in the US Farm Program
Richard Levins
That Embezzled Anti-Castro Money
Pat Williams
The College Crisis: Universal Access, Student Loan Debts and
Pell Grants
Peter Rost, MD
Simply Irresistible: Do Women Prefer Bad Boys?
Website of
the Day
The Sound of Rummy
December 13,
2006
Patrick Cockburn
Iraq
is Beyond Repair
Greg Moses
The Dixie Chicks Come Home to Roost
Elizabeth Schulte
Hungry for the Holidays
Joshua Frank
Death By Coke
Debra Eschmeyer
Corporations Control Your Dinner
Leon Hadar
Baker's Rescue Mission: Too Little, Too Late
Peter Rost, MD
I've Been a Very Bad Boy
Margaret Knapke
Mow bé and Malachi, Presenté!
Reza Fiyouzat
Are Cows Free?
Fred Wilhelms
A Last Minute Appeal: If You Know One of These Musicians Let
Them Know They Are Owed Money--By Friday!
Website of
the Day
The Crimes of Augusto Pinochet
December 12, 2006
Fernando A.
Torres
The
Last Man of the Junta: an Open Letter to Kissinger from One of
Pinochet's Political Prisoners
Paul Craig
Roberts
America's
Injustice System is Criminal
Stephen Soldz
Abusive Interrogations
Uri Avnery
Baker's Cake
William S. Lind
Knocking Opportunity: From Vulcans to Vultures in Iraq
Missy Beattie
Convicted for Our Convictions: Trespassing for Truth at the UN
Dave Lindorff
The 35-Year Long Scream: Torture, Impeachment and a Vietnam Vet's
Tears
George Pyle
Our Perverse Farm Plan: Where Christmas Comes Every Five Years
Norman Solomon
Is the USA the Center of the World?
Website of
the Day
Citizens' War Tribunal
December 11,
2006
Virginia Tilley
Banning
Mandela
Roger Burbach
The Condor Model: the Atrocities of Pinochet and the US
Col. Douglas MacGregor
There's Only One Option Left: Leave!
Fawwas Traboulsi
Lebanon on the Brink
Ron Jacobs
Death of a Pig: Poetic Justice for Pinochet
Gideon Levy
The Cruel Line into Gaza: Elbow to Elbow, Like Cattle
Mary McGrane
Burning Books at Harvard Law
Bernardo Ruiz
The Disappeared of Oaxaca: a Message from One of the Actors in
Apocalypto
Website of the Day
La Cancion de la Unidad
Video of the
Day
Killing
Castro: Congresswoman as Contract Killer?
December 9
/ 10, 2006
Weekend Edition
Alexander Cockburn
Liberal
Consensus for More Troops in Iraq
Sen. Gordon Smith
Out of Iraq: Cut and Run or Cut and Walk
Greg Grandin
Jeane
Kirkpatrick, Mid-Wife of the Neo-Cons
Paul Craig Roberts
How Many More Will Die for Bush's Ego?
Col. Dan Smith
The Vietnamization of Iraq: Inside the Military Training Program
Ralph Nader
The Man from NAM: John Engler's Trail of Destruction
Behrooz Ghamari
The Donkey and the Date: Iran's Upcoming Municipal Elections
Rev. Willliam Alberts
Doing Unto Others: Pastor Haggard and President Bush
James T. Phillips
The James Gang: "Did You Kill Her?"
Bennis / Leaver
A Bi-Partisan Occupation
Dave Lindorff
A Congress of Hucksters and Pipsqueaks
Nikolas Kozloff
Robert Gates and Venezuela: Another Saber Rattler in Latin America
Seth Sandronsky
Activating White Racism
Lucinda Marshall
McKinney and Karpinsky: Silenced for Telling the Truth
Mike Whitney
Something's Gotta Give: James Baker vs. the Lobby
John V. Whitbeck
Recommendation No. 80
Faisal Kutty
Is the Universal Declaration of Human Rights Merely a Western
Construct?
Hugh Sansom
Smearing Jimmy Carter: an Open Letter to the New York Times
Robert Gold
My South American Journey: Impunity in Colombia
Boots Riley
Crash and Burn: an Urgent Message from The Coup
Jeffrey St.
Clair
Playlist: What I'm Listening to This Week
Poets' Basement
Engel & Buknatski
Website of
the Weekend
Alive in Mexico
December 8, 2006
Patrick Cockburn
The
Iraq Study Group's Cautious Appraisal
Leutisha Stills
Just
How Progressive is the Congressional Black Caucus?
Norman Finkelstein
The Media Lynching of Jimmy Carter
Will Youmans
Mr. Lieberman Comes to Washington: Brookings Hosts an Ethnic
Cleanser
Peter Rost, MD
What Went Wrong at Pfizer?
Jonathan Demme
My Friend Bruce Langhorne: a Great Musician Needs Your Help!
Ray McGovern
Senate Democrats Give Gates a Free Pass
Lucinda Marshall
What She Wore
Tariq Ali / Robin Blackburn
The Lost John Lennon Interview
Website of
the Day
John Lennon's FBI Files
December 7,
2006
Alex Friedman
Rev.
Phelps' Hate-Fueled Fanatics Find a Home in the Kansas Prison
Industry
Maureen Webb
Risk Scoring and the National Insecurity State
Paul Craig Roberts
Catastrophe Still Awaits
Dave Lindorff
Prosecutor Admits: Mumia Abu-Jamal Had "No True Defense"
Matt Vidal
Drug Pushers, Inc.: Power and Profit in the Legal Drug Trade
Yifat Susskind
Looking for a Few Good Principles: What Should be Done in Iraq
Rodriguez / Jones
NYPD's Death Squads: From Diallo to Sean Bell
Website of
the Day
2006, Remixed
December 6, 2006
Robert Bryce
Omitting
the Obvious with James Baker: From the S&L Crisis to the
Iraq Study Group
William S. Lind
The Boomerang Effect: When Will the First IED Strike Cincy?
Zoe Blunt
The Clearcut Truth About the Great Bear Rainforest
Corporate Crime Reporter
The New Conventional Wisdom: Prosecute Individuals, Not Corporations
Amira Hass
A Regrettable Indifference: Israel's Treatment of Palestinian
Prisoners
Richard W. Behan
The Surreal Politics of Premeditated War
Sophie McNeill
Why Hezbollah is Broadcasting Sunday Mass
December 5, 2006
Virginia Tilley
Apartheid
Israel: a Beacon of Hope?
Sharon Smith
The New Washington Consensus: Blame the Victims in Iraq
Joe Bageant
Somewhere a Banker Smiles
Ron Jacobs
A War Washington Can't Win
Norman Solomon
Media Consensus, Stay in Iraq!
Mike Whitney
Rumsfeld's Final Snowflake: "I Was Just About to Change
Everything ... "
Derrick O'Keefe
Regimes Unchanged: Chavez's Victory Strengthen's Cuba
Julian Assange
The Road to Hanoi
Missy Beattie
Bush, the Unhappy Helmsman
Website of
the Day
Lessons of Suez and Iraq
December 4,
2006
Alexander Cockburn
Gaza
and Darfur
George Ciccariello-Maher
Tears of the Escualidos: Election Diary, Venezuela
Ray McGovern
Lame Ducks, Hold That Nomination!: a CIA Insider's Take on Gates
John Ross
Repression on the Menu in Mexico
Walden Bello
Hurricane Milton: Friedman, Bayonets and Markets
Peter Rost,
MD
Pfizer's Clueless Executives
Stephen Lendman
The Withering of the Bush Dynasty
Gideon Levy
This Ceasefire will Go Up in Flames
Website of the Day
The "Babes" of Hizbullah?
December 2
/ 3, 2006
Weekend Edition
Barucha Calamity
Peller
The
Dirty War of Oaxaca
Paul Craig
Roberts
Is Bush Sane?: When Denial Goes Pathological
Ralph Nader
The Big Boys of Financial Crime
Winslow T.
Wheeler
Committee of Enablers: Is Gates Fit to Serve? Are the Senators?
Amira Hass
The Checkpoint Generation
Maymanah Farhat
Depoliticizing Arab Art: Christie's and the Rush to "Discover"
the Arab World
Dave Lindorff
Fighting the Iraq War--At Home
Fred Gardner
Dr. Jimenez Defends His Practice Methods
Col. Dan Smith
The Semantics of Civil War
Raed Jarrar
Maliki's Monopoly of Power
Seth Sandronsky
US Prison Nation: Locking Up Surplus Labor
K.-Y. Taylor
The Bride Wore Black: the Shooting of Sean Bell and the Resurgence
of American Racism
Yifat Susskind
Greed, Dogma and AIDS
David Rosen
Made in China: the Global Trade in Sex Toys
Ron Jacobs
All Hands on Deck!: the New Pirates of the Caribbean
Nikolas Kozloff
Venezuela Prepares to Vote
Talli Nauman
Fighting La Choya: the Secret Toxic Dump on the Border
Alan Gregory
Shadow Trout: Why Hatchery Fish Aren't Real
Joe Allen
RFK and Hollywood Mythmaking: Emilio Estevez's Beatification
of Bobby Kennedy
St. Clair /
D'Antoni
Playlist: What We're Listening to This Week
Poets' Basement
Davies, Engel, Ford and Orloski
Website of
the Day
Demo for Oaxaca
December 1,
2006
Greg Grandin
Midnight
in Mexico: Calderón's Inauguration Behind Closed Doors
Linn Washington,
Jr.
The
Mumia Case After 25 Years: Still More Keystone Kops Antics
George Ciccariello-Maher
Sleeping with the Enemy: At Home with the Anti-Chavistas
Brian J. Foley
Taking Responsibility for Iraq
Dave Zirin
Rebel Athletes: Organizing the Jocks for Justice
Joshua Frank
The Montana Formula: Jon Tester's Neopopulism
Chris Floyd
Hideous Kinky: Thomas Friedman Comes Undone
Ingmar Lee
Atomic Porker Strikes Indian Point Nuke Plant
Manuel Garcia,
Jr.
Dark Fire: the Fall of WTC 7
Website of the Day
No Gun Ri Revisited
Video of the
Day
Drunken Hack Goes Ape at Aussie "Pulitzers"
|
January
10, 2007
The Big Business of Medicine
How
the FDA Protects Big Pharma
By EVELYN PRINGLE
Why would Americans trust the FDA to
regulate the pharmaceutical industry? Since the Bush administration
took office the FDA has become the industry's partner in crime.
The most notorious protection
scheme put in place by the FDA and Big Pharma is the preemption
policy that bans private lawsuits against drug companies in state
courts once a drug and its label have been approved by the FDA.
On January 18, 2006, the FDA
issued new rules for the labeling of prescription drugs, and
in the preamble to the rules on page 43, the FDA says, State
law actions "threaten FDA's statutorily prescribed role
as the expert Federal agency responsible for evaluating and regulating
drugs," requiring lay persons to second-guess its expert
assessments of a drug's risks and benefits.
So, after all of the concerns
raised about the FDA's failure to protect consumers against dangerous
products over the last several year, by top experts from all
over the world, the FDA has hereby declared itself the sole authority
on decisions regarding prescription drugs, including whether
a drug's label contains adequate descriptions of indications
for use, risks and benefits.
In an October 6, 2006, articled
titled, "The Doctrine of Preemption," Stan Kaufman
aptly refers to the new policy as the "Doctrine of Preemptive
Crony Capitalism." When announcing this multi-billion dollar
immunization gift to Big Pharma, the FDA told drug makers:
"We think that if your
company complies with the FDA processes, if you bring forward
the benefits and risks of your drug, and let your information
be judged through a process with highly trained scientists, you
should not be second-guessed by state courts that don't have
the same scientific knowledge."
A statement saying the complete
opposite was made in 1996, by the FDA's Chief Counsel in a speech
that said the FDA had a "longstanding presumption against
preemption" and that "FDA's view is that FDA product
approval and state tort liability usually operate independently,
each providing a significant, yet distinct, layer of consumer
protection."[
The preemption claim reverses
a long-standing policy of permitting State actions intended to
protect consumers and undermines the States' ability to protect
their citizens, yet State and local entities were given no opportunity
to object to it.
Under Executive Order 13132,
issued first by President Reagan, and then reissued by President
Clinton, the FDA is supposed to consult with State and local
authorities about the effects of each regulation it issues that
affects the States.
Nowhere in the proposed rule
did the FDA provide notice or seek comment on the preemption
provisions added to the preamble. In the only proposed rule known
to State and local officials, the FDA said that the regulation
would not preempt State law. In fact, the language published
in the Federal Register on December 22, 2000, explicitly stated
that "this proposed rule does not preempt state law."
The rule requested comment
on products liability issues, but only by asking whether the
new "Highlights" section raised liability concerns
and, if so, how the FDA might alleviate those concerns without
eliminating the Highlights section. This request can hardly be
called "notice" of the preemption statement that suddenly
appeared in the preamble in 2006.
By relying on this false representation,
State and local authorities were robbed of any opportunity to
object to the preamble. In a January 2006, letter to Michael
Leavitt, Secretary of Health and Human Services, the National
Conference of State Legislators called the regulation a "thinly
veiled attempt on the part of FDA to confer upon itself authority
it does not have by statute."
The NCSL also stated the failure
to allow for an appropriate comment period constitutes "an
abuse of agency process and complete disregard for dual system
of government."
Ken Suggs, president of the
Association of Trial Lawyers of America, was quoted in the January
19, 2006 Washington Post, as saying, the "fact that the
drug industry can get the FDA to rewrite the rules so that CEOs
can escape accountability for putting dangerous and deadly drugs
on the market is the scariest example yet of how much control
these big corporations have over the political process."
Legal experts point out that
it was never the intent of Congress to preempt private lawsuits
in State courts, and that in fact, when Congress was considering
the Food, Drug, and Cosmetic Act of 1938, it specifically rejected
a proposal to include a private right of action for damages on
the ground that such a right already existed under State common
law.
According to Houston attorney,
Robert Kwok, who handles complex pharmaceutical litigation involving
drugs such Fosamax, Norvasc and SSRI antidepressants like Celexa:
"The real losers from
this attempted power grab would be the millions of Americans
who depend on safe drugs. Without the protection of state laws
Big Pharma can ride shipshod over Americans who are injured by
their unsafe drugs. That's unacceptable and I'm seeing even conservative
judges resist it."
Many members of Congress have
also weighed in on the issue and reaffirmed that Congress never
intended to preempt State claims in a February 23, 2006, letter
to Michael Leavitt, Secretary of Health and Human Services, from
Representatives Henry Waxman (D-Calif.), John Dingell (D-Mi.),
and Sherrod Brown (D-Ohio).
Rep. Maurice Hinchey (R-NY)
and Senator Edward Kennedy (D-MA), have threatened to fight preemption
through legislation if necessary. Rep. Hinchey issued a press
release on January 18, 2006, immediately after the policy was
announced, stating that the "FDA has once again gone to
bat for the drug industry by fully endorsing a policy that shelters
pharmaceutical companies from Americans who want to file lawsuits
because a drug has made them or a loved one seriously ill, or
in some cases caused death."
Rep. Hinchey also called it
"the latest example of the FDA sticking its nose where it
does not belong and treating the drug companies as clients rather
than regulated entities."
The FDA's language on page
38 of the preamble that states "whether it be in the old
or new format, the Food, Drug and Cosmetic Act preempts conflicting
or contrary state law," appears to imply that the preemption
policy is retroactive.
Part of the language also says
that lawsuits against doctors are preempted for failure-to-warn
patients of risks associated with a drug, apparently even when
a drug is prescribed "off-label," for a use other than
those approved by the FDA.
"Pre-emption would include
not only claims against manufacturers," the FDA states,
"but also against health-care practitioners for claims related
to dissemination of risk information to patients beyond what
is included in the labeling."
The FDA has never before, in
its entire history, claimed that a drug label preempts actions
against health care professionals for failure-to-warn patients
about risks. In fact, labels carry no information about the risks
or benefits of "off-label" uses.
Critics see this language as
an attempt to immunize all the doctors who the industry has convinced
to over-prescribe drugs to treat conditions or patient populations
for which the drugs have never been approved as safe and effective
to increase profits.
"Doctors need to be held
just as accountable as the drug manufacturers when things go
wrong," attorney Kwok says.
"The profession of medicine
is in danger of being totally co-oped by the business of medicine,"
he warns, "with more and more of the burden is being placed
on the consumer."
"And with only minimum
consumer protection standards set by the FDA, that isn't very
reassuring," Mr Kwok notes.
"I predict there could
be a flood of litigation," he says, "before FDA policy
changes any more."
In any event, restrictions
that the FDA places on drug labeling do not prohibit drug companies
from disseminating warnings about a danger by other means. When
it originally promulgated these regulations, the FDA made clear
that:
These labeling requirements
do not prohibit a manufacturer, packer, re-labeler, or
distributor from warning health
care professionals whenever possibly harmful adverse effects
associated with the use of the drug are discovered. The addition
to labeling and advertising of additional warnings, as well as
contraindications, adverse reactions, and precautions regarding
the drug, or the issuance of letters directed to health care
professionals (e.g., "Dear Doctor" letters containing
such information) is not prohibited by these regulations. 44
Fed. Reg. 37434, 37447 (June 26, 1979).
One of the main authors of
the new labeling rules was the FDA's Chief Counsel at the time,
Daniel Troy, who in previous employment fought the FDA in court
to allow drug companies to promote drugs to doctors for "off
label" use.
Its now obvious when looking
back, that Mr. Troy was appointed by the Bush administration
to implement tort reform under the guise of preemption, and under
the cover of the Office of Chief Counsel at the FDA.
In the midst of the Vioxx and
SSRI antidepressant disasters, instead of going after the drug
makers for knowingly injuring hundreds of thousands of consumers
with dangerous products, Mr. Troy devoted the majority of his
time on the clock to filing five amicus briefs on behalf of Big
Pharma to be used against the very citizens who were paying his
salary.
In his briefs, Mr. Troy focused
his main attention on protecting the profits of the makers of
SSRIs, drugs second only to Vioxx when it comes to the concealment
of studies and information about harm that if revealed, could
have prevented tens of thousands of deaths and injuries over
the past 20 years.
And even though there has been
an infinite number of reports over the past decade regarding
an increased risk of suicide with SSRIs, instead of withdrawing
the approval of the drugs, requiring more studies, or demanding
a warning be added to their label, Mr. Troy did nothing to protect
potential SSRI victims as Chief Counsel of the FDA.
In late 2004, Mr. Troy quit
the FDA to go back into private practice to once again represent
pharmaceutical companies openly against private citizens, only
with the added benefit of using the preemption defense he put
in place.
On October 9, 2006, Mr. Troy
published an article in the Legal Times, that said, "I
was also at the FDA while January's Physician Labeling Rule,
which contains a statement in its preamble about the FDA's pre-emption
authority, was written."
"And I now," he states
in an obvious ad for new clients, "advise and represent
companies confronting state-law claims that implicate the pre-emptive
effect of FDA requirements."
In the Times article, Mr. Troy
points out the importance of drug companies staying cozy with
the FDA to ensure success in future litigation. "Savvy companies,"
he wrote, "are recognizing that how they interact with the
FDA today may profoundly affect their pre-emption defenses in
the future."
"They are trying to ensure
their communications with the agency are as formal as they can
be," he said, "in light of commercial considerations
and the need to stay on the FDA's good side."
"More formal communications,"
he advises, "can help buttress a future case for why a particular
state law claim should be pre-empted."
In the article, Mr. Troy brags
that his filing of FDA briefs on behalf of Big Pharma "has
reduced the negative consequences of the current pharmaceutical-liability
regime."
But for once, he at least mentions
that it cost the tax payers plenty. "FDA involvement in
state-law cases is not an ideal solution," he writes, "not
least because each instance of such involvement involves the
costly investment of substantial agency resources."
It should be noted that two
years before Mr. Troy filed his first brief as a kick-off for
the preemption policy, the "costly investment of substantial
agency resources" went for an FDA brief, in which the FDA
acknowledged "the historic primacy of state regulation of
matters of health and safety" and the appropriateness of
a presumption against preemption where the state-law claims allege
defective design, negligent manufacturing, or failure-to-warn
in, Buckman v. Plaintiffs' Legal Committee, 531 US 341 (2001).
In the Legal Times,
Mr. Troy goes on to explain that the new labeling rule is intended
to limit the direct involvement of the FDA in lawsuits. "The
preamble to that rule," he says, "makes an official
statement of FDA's views on preemption easily available to courts
hearing state-law tort cases."
"If courts give appropriate
deference to this statement of FDA's considered judgment,"
he notes, "FDA will not be forced to file briefs in individual
cases."
Until reading this article,
its likely that most people had never realized that Mr. Troy
was "forced" to file briefs on behalf of Big Pharma
while he worked at the FDA.
In a March 31, 2006 paper,
titled, State-Level Protection for Good-Faith Pharmaceutical
Manufacturers, Mr. Troy can be found advising State lawmakers
to pass shield laws for Big Pharma based on a Michigan model,
to "help to reduce the negative consequences of the current
pharmaceutical-liability regime," he says.
"In so doing," he
states, "they would help to encourage the development of
new drugs, preserve the availability of existing drugs, reduce
upward pressure on drug prices, and assure rational prescribing."
Such a statement might be a
wee bit credible if it also included a suggestion for the lowering
of the multi-million dollar annual salary and benefit packages
enjoyed by Big Pharma CEOs or a reduction in the billions of
dollars that are spent each year on illegal off-label promotion
and marketing schemes.
For all the whining he does
about litigation keeping products off the market, Mr. Troy cannot
cite a single case in which a failure-to-warn claim interfered
with the FDA's federal regulatory authority or kept a drug off
the market. In fact, in a lecture to Big Pharma attorneys in
December 2003, on how to use the preemption defense, Mr. Troy
told the attorneys that the FDA had "no good evidence"
showing product liability concerns "keep good products off
the market," even though he had "combed the literature"
to find such evidence.
Apparently to help resolve
this nagging little problem, Mr. Troy told the defense attorneys
to pay for research to find some evidence to back this claim
even if it was weak, stating: "you guys really shoot yourself
in the foot by not funding research to this effect. ... I'll
even take anecdotal evidence and stories if you have them."
Mr. Troy filed the FDA's first
brief in support of Big Pharma in September 2002, in the California
Zoloft case titled Motus v. Pfizer, after he was contacted by
Pfizer attorney, Malcolm Wheeler, in the summer of 2002, requesting
that he get the government involved to help Pfizer win the preemption
argument.
Despite the fact that Pfizer
had paid Mr. Troy's law firm over $358,000 in the year before
he became Chief Counsel, Mr. Troy argued later that he did not
become involved in the case until after the 1-year grace period
in which employees may not participate in activities involving
former clients. From all public accounts, the time period elapsed
less then a month before he entered the case.
In the brief, Mr. Troy argued
that any warning that suggested a link between Zoloft and suicidality
would have been false and misleading, and the FDA would have
rejected any effort to add such a warning. However, that argument
contradicts 21 CFR § 314.126(b), which requires warnings
to be added based on reasonable evidence of an association, even
absent proof of a causal relationship. The preemption issue was
never decided in Motus because the case was concluded on unrelated
grounds.
Legal experts say the preemption
defense will not only be used in SSRI-related suicide cases,
it will be applied in SSRI cases involving the failure-to-warn
about other types of injuries and deaths caused by these drugs
as well.
For instance, Big Pharma will
no doubt attempt to preempt cases filed on behalf of infants
born with birth defects to mothers who unwittingly took the drugs
during pregnancy, such as with Lacee Shore, who was prescribed
Celexa during her first trimester of pregnancy and as a result,
her baby, Gavin Shore, was born with serious heart birth defects
and diagnosed with Shone's Complex, which can lead to the obstruction
of blood flowing to the body from the left side of the heart.
Gavin has already gone through
several surgeries in attempt to correct the heart defects and
will have to undergo more in the future.
The successful use of the preemption
argument in a case such as this, where the drug maker, Forest
Laboratories, could and should have warned doctors and pregnant
women about the possibility of birth defects associated with
Celexa, would leave the Shore family strapped with the burden
of life-long medical costs related to Gavin's condition.
According to attorney Kwok,
who is handling the Shore case, the birth defect situation is
even more devastating than with patients harmed by Vioxx because
the Celexa victims are so young. "Their whole lives,"
he says, "if they survive, will be under the threat of illness
and additional surgery, with a very poor prognosis."
Mr. Kwok points to a 1990 study
conducted at the University of Michigan that shows the outlook
for infants born with heart defects like Gavin is very poor.
"One quarter of patients die after their second operation,"
he says.
"The second operations
are very often necessary," he explains, "because of
the complexity of the heart problem."
Forest Labs knew about the
potential for birth defects caused by Celexa because more than
two years before Gavin was born, on June 9, 2004, Web MD reported
that the FDA was concerned about reports that SSRIs may cause
adverse effects to babies born to mothers taking the drugs late
in pregnancy.
According to Web MD, the FDA
had been receiving reports for 10 years. In fact, it said that
hundreds of reports on adverse effects in babies were received
involving all the SSRIs sold in the US, which would include Prozac,
Paxil, Luvox, Zoloft, and Celexa.
In July 2004, the FDA finally
asked the SSRI makers to change the labels, warning that some
infants had developed problems requiring tube feeding, respiratory
support, and prolonged hospitalizations.
On September 1, 2005, the BBC
reported that Danish and U.S. scientists found that cardiac birth
defects appeared to be 60% more likely in newborns when women
used SSRIs.
Studies show that women are
prescribed SSRIs twice as often as men and yet the drug makers
have made no effort to evaluate the use of these drugs with pregnant
women. And as a result, Mr. Kwok says, "new moms are finding
out too late that the Celexa they took was putting their unborn
baby in grave danger."
A successful preemption ruling
would go a long way as far as protecting profits against damage
awards based birth defects, because pregnant women represent
a major share of the market. According to a May 2005, study in
the Journal of American Medical Association, 80,000 pregnant
women are prescribed SSRIs in any given year in the U.S., which
means there are bound to be many cases where babies were born
with birth defects.
The majority of courts that
have addressed the preemption argument have ruled against it.
One of the first federal courts to specifically rule against
the FDA's preamble position was a Nebraska District Court on
May 31, 2006, in Jackson v. Pfizer, where the plaintiffs' son
took both Zoloft and Effexor and then committed suicide.
The parents alleged that the
drugs caused their son to commit suicide and Nebraska law required
additional warnings about the suicide risk. The drug maker defendants
moved for summary judgment claiming that the State law claims
were preempted by the FDA.
The court said that the claims
were not preempted because the federal regulations did not conflict
with State law and specifically held that there was no Congressional
directive that the field was preempted.
The court stated the FDA preamble
was not persuasive and pointed out that the Eighth Circuit had
adopted the proposition that the FDA prescribes only minimum
standards and the Fourth Circuit had declared that complying
with federal regulations does not release a manufacturer from
liability.
The court also noted that the
FDA "failed . . . to allow the states an opportunity to
participate in the proceedings prior to a preemption decision,"
and dismissed the FDA's brief stating that it "will not
treat amicus briefs as the force of law."
On May 25, 2006, a federal
court in Pennsylvania was the first to grant the FDA's preemption
rule full deference in a wrongful death and survival action,
with failure-to-warn claims against Paxil maker GlaxoSmithKline,
and generic Paxil maker Apotex, in Colacicco v. Apotex, Inc,
Civ No 05-cv-5500, 2006 WL 1443357 (E.D. Pa. May 26, 2006).
In this case, the plaintiff
alleged that his wife's suicide resulted from the drug makers'
failure-to-warn of the increased risk of suicide linked to Paxil
and its generic equivalent.
The judge on his own initiative,
invited the FDA to file a brief. The current Chief Counsel, Sheldon
Bradshaw, went to bat for the drug makers and filed a brief at
record speed within 20 days, urging the court to dismiss the
lawsuit on the basis of preemption, stating that in October 2003,
when Paxil was prescribed to the suicide victim, "there
was no reasonable evidence available at the time of an association
between adult use of the drug and suicide."
The FDA argued that any such
warning regarding an association between Paxil and suicide would
have been false or misleading, and thus would have constituted
misbranding under the FDCA.
The plaintiff responded by
arguing that the court should not afford deference to the brief
because 21 C.F.R. § 314.70, does permit manufacturers to
strengthen labels without FDA approval and the FDA has no authority
to simply declare that a drug is misbranded.
The court disagreed and determined
that it was to give significant deference to the amicus brief
based on the U.S. Supreme Court's decisions in Chevron, Medtronic,
and Geier which state that an amicus brief is an appropriate
form to express preemptive intent and held that the principles
of deference do not permit a court to question the FDA's interpretation
of its own regulations.
The plaintiff argued that the
preamble which was promulgated in 2006 could not be retroactively
applied to the October 2003, death of his wife. However, the
Court said that preemption could be applied retroactively because
the preamble simply clarified the FDA's "longstanding views
on preemption," and characterized the preamble as an "interpretive
rule," rendering retroactivity concerns "irrelevant."
The Court went on to say that
even if the preamble did not apply retroactively, it would have
found preemption anyway based on the views previously expressed
in amicus briefs by the FDA.
An appeal is pending on the
Colacicco decision, and the case has drawn amicus support from
a dozen scientists and doctors who contend that preemption "would
threaten the public health and eliminate an important counterpart
to the public health objectives of the FDA."
The national non-profit consumer
advocacy organization, Public Citizen, the Trial Lawyers for
Public Justice, a national public interest law firm, and the
Association of Trial Lawyers of America, an international coalition
of attorneys, law professors, paralegals, and law students, have
together filed an amicus brief supporting Mr Colacicco, stating:
"Products liability lawsuits
help to protect patients from drugs with undisclosed risks because
the potential for being held liable for harm caused by their
products provides a powerful incentive for drug companies to
make their products as safe and effective as possible and to
revise labels as soon as new risks become apparent.
"Furthermore, because
FDA lacks authority to subpoena documents from the companies
it regulates, products liability lawsuits help to uncover information
that can lead to safer products."
In fact, the group points out,
since at least several months before the victim's suicide, the
FDA had been reviewing data about a possible link between SSRIs
and suicidality, and the agency issued a Public Health Advisory
on the topic in October 2003, the same month that Mrs. Colacicco
died.
The amicus brief also notes
that the FDA's preemption statement lacks the "consistency"
needed to warrant any degree of deference because prior to 2002,
the FDA's consistent view was that State common law was not preempted
by federal drug regulation. "For example," the brief
wrote, "in both 1979 and 1998, in preambles accompanying
various drug regulations, FDA stated that state tort law did
not interfere with federal regulation."
In 1998, when addressing pharmacists'
provision of written patient information for "Medication
Guides," when issuing the final rule, the FDA rejected calls
for the agency to express an intent to preempt State regulation
of labeling requirements stating:
"FDA regulations establish
minimal standards necessary, but were not intended to preclude
states from imposing additional labeling requirements. States
may authorize additional labeling but they cannot reduce, alter,
or eliminate FDA-required labeling." 63 Fed. Reg. at 66384.
According to the amicus brief,
"The authority to regulate drug labeling may carry with
it the authority to address state drug labeling regulations,
but it does not carry with it authority to determine the preemptive
effect of federal regulation on state common-law compensation
systems."
It appears that the FDA's own
regulations acknowledge that preambles are not statements of
law and that they should not be presented as such in legal proceedings.
The amicus group states that
the preamble is not part of the regulation, will not appear in
the Code of Federal Regulations, and does not have the force
of law. "In fact," the brief notes citing FDA regulations,
"a longstanding FDA regulation provides that a statement
in a regulatory preamble constitutes only an "advisory opinion."
The FDA recognizes that an
advisory opinion may be used to "illustrate acceptable .
. . procedures or standard, but not as a legal requirement,"
the brief points out.
"Having made no effort
to legislate on the topic of drug-related damages remedies,"
the brief concludes, "Congress can hardly be said to have
authorized FDA to supersede the damages remedies traditionally
provided by the states."
There was an extremely important
preemption ruling handed down on June 9, 2006, in the Vioxx case
of Doherty v. Merck prior to the beginning of the actual jury
trial. Merck moved to dismiss the failure-to-warn claim arguing
that the preamble barred claims with respect to FDA approved
drugs.
The June 9, ruling from the
bench, drew massive attention to the case when New Jersey Superior
Court Judge, Carol Higbee, refused to exclude the claims.
"The preamble, as I see
it, is a political statement by the FDA," she said.
"The primary purpose of
it," she stated, "is to criticize state courts and
to set forth the FDA's position, not to criticize state courts
so much as to set forth the FDA's position that they believe
there should be federal preemption of all tort actions."
"What the preamble is
saying," Judge Higbee noted, "is the FDA should be
the final word."
She refused to dismiss the
claims based on the preamble she said, because it "has nothing
to do with science." In conclusion, she told Merck defense
attorneys:
"It has nothing to do
with what happened back in 2000, 2001, 2002, when these issues
were being debated. It is contrary to the U.S. Supreme Court's
decisions. It is contrary to all the law on preemption.
"And I am not going to
allow you to use it."
Merck later enjoyed a victory
at trial when a jury decided that Vioxx was not the main cause
of Elaine Doherty's heart attack, but a favorable ruling on the
preemption issue prior to trial could have potentially saved
the company billions of dollars. According to the company's SEC
filings, as of October 9, 2006, Merck is a named defendant in
about 13,850 Vioxx cases in the New Jersey State court coordinated
litigation.
The next victory using the
preemption argument was a major win in August, 2006, when a California
court dismissed the Celebrex failure-to-warn claims against Pfizer,
In re Bextra and Celebrex Marketing Sales Practices and Product
Liability Litigation, No M: 05-1699 CRB, 2006 WL 2374742 (N.D.
CA, August 16, 2006).
In opposing the motion, the
plaintiffs argued that because the FDCA does not provide a monetary
remedy, Congress must not have intended the FDA to have authority
over damage claims and that the FDA's position on preemption
was not entitled to deference because it was clearly erroneous
and inconsistent with the regulations.
Saying the FDA specifically
considered the safety risks about Celebrex alleged in the lawsuit
and determined the risks should not be included on the label,
the court said the failure-to-warn claims "conflict with
the FDA's determination of the proper warning and pose an obstacle
to the full accomplishment of the objectives of the FDCA."
But the judge refused to dismiss
the false advertising claims. The plaintiffs argued that the
Celebrex ads were false and misleading because they exceeded
the labeled and approved gastrointestinal benefits and also minimized
the established risks of the drug.
Pfizer claimed that because
it submitted the ads for FDA approval, and the FDA did not object,
the FDA had determined that the ads were accurate and struck
a fair balance of the risks and the benefits of Celebrex.
However, the court refused
to preempt the claims without a record showing that the FDA had
reviewed each ad and approved it. The court also pointed out
the FDA's silence about whether its regulations preempt false
advertising claims, in contrast to its stated position on failure-to-warn
claims.
A little over a month later,
on September 29, 2006, across the country in New Jersey, the
court in McNellis v. Pfizer, refused to allow the preemption
defense based in part on the fact that the text of FDA regulations
had remained unchanged for years, and the regulations did not
conflict with New Jersey's failure-to-warn laws.
The McNellis Zoloft-suicide
case comes with a history. On December 29, 2005, the U.S. District
Court for the District of New Jersey had also denied Pfizer's
original motion for summary judgment. The court reasoned that
the FDA's approval of a label creates only a minimum standard
and that the drug maker may strengthen the warnings as long as
the new warning is not false or misleading.
* *
*
After the FDA published the
new rule and preamble with the preemptive language in January
2006, Pfizer filed another motion asking the court to vacate
the order denying summary judgment, or to certify the question
for interlocutory appeal
In opposing the motion, Ms.
McNellis said that the preamble amounted to nothing more than
the FDA's opinion on preemption; the same opinion expressed previously
by the FDA in amicus briefs, and the same opinion already rejected
by the court. It is irrelevant that this opinion now comes in
the form of a preamble to a regulation rather than an amicus
brief, she said.
In her brief filed on March
2, 2006, Ms. McNellis argued that the FDA had also exceeded its
authority, stating:
"In this instance, an
executive agency, the FDA, has expressed an opinion that Congress
has never agreed to. Without notice or comment, the FDA found
it within its jurisdiction to go against the wishes of Congress
as well as the wishes of those states which have product liability
failure-to-warn statutes."
Ms. McNellis also pointed out
that the last six courts to decide the issue "have found,
consistent with this Court's finding, that the FDA regulations
establish minimum requirements such that they do not preempt
state tort laws."
She also noted that the preamble
was not in effect at the time that her father committed suicide
as a result of taking Zoloft.
The court held that regulations
allow a drug company to increase warnings when new risks emerge,
that the Food, Drug and Cosmetic Act does not contain a preemption
clause, and that Congress gave no implicit empowerment to the
FDA to preempt State law.
Following the McNellis decision,
on October 16, 2006, a federal court in Pennsylvania refused
to grant the drug maker's preemption motion on the failure-to-warn
claims in Perry v. Novartis Pharma Corp, --- F Supp 2d ----,
2006 WL 2979388.
This case involved Elidel,
a drug used to treat eczema, prescribed to Andreas Perry when
he was 2-years-old. Six months after he began using the cream,
in October, 2003, Andreas was diagnosed with a form of cancer
known as lymphoblastic lymphoma.
Elidel belongs to a class of
drugs known as calcineurin inhibitors, so called because they
reduce immune activity by inhibiting the activity of the enzyme
calcineurin. Prior to the approval of Elidel for treating skin
conditions in children over 2 years of age, calcineurin inhibitors
were used as systemic immunosuppressants in organ transplant
patients.
Systemic use of the drugs has
long been known to increase the risk of cancer and the labels
on the drugs prescribed to organ transplant patients say so.
But because Elidel is applied topically for eczema, it was not
known at the time of approval in December 2001, whether long-term
use posed a risk of cancer.
This case illustrates why drug
companies must be made to alert the public of known dangers as
soon as they are known. On February 15, 2005, an FDA advisory
committee met to discuss calcineurin inhibitors. In particular,
reports of "off label" use of the drugs in children
under two caused concern for some members of the committee.
At the meeting, the committee
voted to add a "Black Box" warning about the possible
increased risk of cancer associated with the topical use of Elidel,
and the lack of long-term safety data on the use of the drug.
On March 10, 2005, the FDA
told the drug maker to add a "Black Box" warning and
issued a public health advisory about the possible cancer risk.
However, it was nearly a year later when Novartis finally got
around to adding a "Black Box" warning to Elidel's
label on January 19, 2006.
In their brief in opposition
to the preemption motion to dismiss, the plaintiffs said that
the FDA's broad claim of preemption is not entitled to deference,
"whether it is expressed in the January 2006 Preamble to
the Final Rule," or "in amicus curiae briefs
filed by the agency in support of drug manufacturers."
"The FDA's claims,"
the brief wrote, "which are tantamount to an advisory opinion,
lack the force of law and contradict the FDA's governing statute,
its regulations, and its regulatory purpose."
It also noted that the FDA's
current opinion directly opposes the FDA's longstanding views
on preemption. "For these reasons," the brief pointed
out, "a majority of courts that have considered this issue,
both before and after the FDA issued the Preamble, have held
that FDA approval of labeling does not preempt state failure-to-warn
claims."
In denying Novartis' preemption
motion, U.S. District Court Judge, Stewart Dalzell, of the Eastern
District of Pennsylvania, wrote in the decision that the FDA's
new "Preamble is not entitled to any special consideration
in our analysis."
Where the agency attempts to
"supply, on Congress's behalf, the clear legislative statement
of intent required to overcome the presumption against preemption,"
no deference is warranted, he noted.
In reaching its decision, the
court said preemption would only apply if a specific warning
about Elidel and pediatric cancer had been considered by the
FDA and found to be unnecessary and that had not happened in
this case.
In discussing the FDA's assertions
in its amicus brief, the court stated, "To be sure, because
of its expertise in the area, the FDA's construction of its own
regulations is likely to carry great weight."
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