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Today's
Stories
January 8,
2008
Paul Craig
Roberts
No
Jobs for the New Economy (or the Old)
January 7,
2008
Chris Floyd
There
Will Be Blood: But No Justice for Iraq Atrocities
John Blair
Remove That Man! Creeping Fascism in Indiana
Uri Avnery
The Case of the White Bird
Andy Worthington
Who Are the Gitmo Saudis?
Binoy Kampmark
Needling the Convict: Lethal Injection and the Supreme Court
David Macaray
Women on Strike
Ralph Nader
Obamarama: the Politics of the Smooth Mood
Michael Donnelly
It's the War Vote(s), Stupid!
Ron Jacobs
Ron Paul's Run: Is Being Against the War Enough?
Gideon Levy
The Hostile President
Dave Lindorff
A Real 9/11 Cover-Up? Sibel Edmonds, Turkey and the Bomb
Website of
the Day
Plagues and Pleasures on the Salton Sea
January 5 /
6, 2008
Douglas Valentine
Good
Guys in Black Hoods
Kevin Young
The
US Occupation and Popular Opinion in Iraq
Richard Rhames
Saddam
Who?
Saul Landau
Bush Snatches Defeat from Victory
Marc Lynch
Why Bush's Iran Strategy is Failing
Robert Fantina
Iowa, Democrats and the Iraq War
Donna Volatile
Antiwar Soldier: an Interview with Jonathan Hutto, Sr.
Jelle Bruinsma
Norman Finkelstein in The Netherlands
Bob Sutcliffe
Remembering Andrew Glyn, Rebel Economist
Harvey Wasserman
Anti-Nuclear Renaissance
Missy Beattie
Why Obama Can't Save Us
David Swanson
Remembering the Separation of Powers
Jacob Hornberger
The Importance of the Padilla Case
Shepherd Bliss
Survival Tools from Kokopelli Farms
Ron Jacobs
Bleeding Kansas
Poets' Basement
Patti Smith, B.R. Gowani and Peter Buknatski
Website of the Weekend
Jimmy Dean Sausage Call Complaint
January 4,
2008
Cockburn /
St. Clair
A
Good Night in Iowa
Jonathan Cook
War Crimes Airbrushed from History
Paul Craig Roberts
Thinking for Yourself is Now a Crime
Stan Goff
Ron Paul's Monkeywrench
Dave Lindorff
Clinton's Iowa Flop Exposes DLC Myths as Frauds
Niranjan Ramakrishnan
To Pindi Station
Allan Nairn
U.S. Elections Over Before They Began
Joshua Frank
The Failures of Sectarianism
Peter Morici
Economy on the Skids
Mary McInnis
Iowa Cocky-Us: How to be a Caucus Tease
Website of the Day
The Return of Obama Girl
January 3,
2008
Fatima Bhutto
Farewell
to Wadi Bua
Pam Martens
The
Free Market Myth Dissolves into Chaos
Joanne Mariner
The Presidential Candidates and Torture
Zoltan Grossman
Remember the '80s: Social Movements Between Woodstock and the
Web
David Domke
The Echoing Press and Huckabee
Norman Solomon
Edwards Reconsidered
Nikolas Kozloff
Return of the Faux Liberal
Jacob G. Hornberger
The Padilla Case and the Future of Habeas Corpus
Martha Rosenberg
Quit Picking on Huckabee's Son, Michael Vick
Russell Means
This Property is Condemned: a Notice to Those Occupying Lakotah
Lands
Website of the Day
WolfQuest
January 2,
2008
Jeff Taylor
The
Left and Ron Paul
M. Shahid Alam
The Life and Death of Benazir Bhutto: a Pakistani Tragedy
Gary Leupp
Madness Compounding Madness: Calls for Intervention in Pakistan
Paul Craig Roberts
Criminals with Badges
Heather Gray
Georgia's Racist Death Penalty
Fred Gardner
and Shobhit Arora
Dr. Strangelove's Nemesis
David Macaray
Labor Unions and Taft-Hartley
Benjamin Dangl
Fear and Loathing in Bolivia
January 1,
2008
Iain A. Boal
City
of Disappearances
B. R. Gowani
Benazir's Death in Crisistan
Shahid Mahmood
Bhutto and the Press
Linn Washington,
Jr.
Old Injustices Endure: From Crack Sentences to Racial Profiling
Harvey Wasserman
Taking Leonard Peltier to Iowa: the Moral Low Point of the Clinton
Era
John Ross
2008, Already a Year to Forget
Website of the Day
The Thrill is Gone: BB and Gladys
December 31,
2007
Alexander Cockburn
Goodbye
2007 and Good Riddance!
Tariq Ali
Pakistan, the Aftermath
Liaquat Ali Khan
The Perfidy of Pakistan's Rulers
Wajahat Ali
After Bhutto, a Nuclear Pakistan?
Robert Fisk
Who Killed Bhutto?
Ajai Sahni
Myths and Realities About Benazir Bhutto and Pakistan's Dark
Future
Marwan Bishara
You Say Talk, I Say Attack: The Middle East and the US Presidential
Election Campaigns
Uri Avnery
The Beilin Syndrome
Mark T. Harris
Does This Happen in Canada?
Brenda Norrell
Resistance and Censorship
Website of the Day
A People United Will Never Be Defeated
December 29
/ 30, 2007
Alexander Cockburn
Options
in America: Kill Yourself or Have a Baby
Tariq Ali
Indignation and Fear Stalk Pakistan
Fawzia Afzal-Khan
My Encounter with Benazir Bhutto
Gary Leupp
The U.S. and Pakistan After 9/11: Blowback from an Unholy Alliance
China Hand
Pakistan Stares Into the Abyss
Jacob Hornberger
Stop Medddling in Pakistan
John Chuckman
Pakistan and the Failure of Quick-Fix Politics
Missy Beattie
Evaluating Bush with the Bhutto Corruption Standard
Ralph Nader
Who Will Take the Next Step?
Fidel Castro
There Hasn't Been a Day in My Life When I Haven't Learned Something
Robert Fantina
The Sham of Homeland Security
Greg Moses
Beauty from the Heart of Texas
Catherine Lutz
What We Can Not See: Art and Bombing
Kristin Van
Tassel
Seeing in the Dark
Kim Nicolini
Redacted: Brian DePalma's Scream of Outrage
Phyllis Pollack
Keith Richards Runs With Rudolph Once More
Poets' Basement
Landau, Gibbons and Davies
Website of
the Weekend
Driving Karachi in Search of the Perfect Naan
December 28,
2007
Farzana Versey
The
Complex Electra
Wajahat Ali
A
Pakistani Requiem
Binoy Kampmark
Death in Rawalpindi: Bhutto and Her Legacy
Ayesha Ijaz
Khan
Not Dead Yet: The Pakistan People's Party Still Survives
Anthony DiMaggio
Turkey's Bombing of Iraq
Ray McGovern
Creeping
Fascism
Jim Goodman
Biofuels, the Biggest Scam Going
Ron Jacobs
Transcending the Colonizer's History: Iran, a People Interrupted
Russell Hoffman
Mini-Nukes by Toshiba
John Murphy
Greens Gone Wild
Website of the Day
Guiliani Campaign Official: "Only Rudy Can Defeat the Muslims"
December 27,
2007
Dilip Hiro
A
Tragedy Foretold: Will Bhutto's Death be a Boost for Her Party?
Murtaza Shibli
Who Killed Bhutto?
Stephen Soldz
Fallujah,
the Information War and U.S. Propaganda
Bill Quigley
Locked
Outside the Gates
Paul Craig Roberts
The Great American Lock-Up
Omer Subhani
Killing Bhutto: What Happens Next in Pakistan?
Marjorie Cohn
The Torture Tape Cover-Up: How High Does It Go?
Allan Nairn
Cataclysm By Money Whim
Jacob G. Hornberger
Smearing Ron Paul: Shame on the NYT
Norman Solomon
Channeling Suze Orman
Patrick Irelan
Rumsfeld Spills the Ink
Ben Tripp
Pass the Razor Blades
Website of the Day
Quagmire, For What It's Worth
December 26, 2007
Charles Tripp
From
One Saddam to Fifty
Paul Armentano
No-Knock, You're Dead
Rannie Amiri
Lebanon in Search of a Government
Stanley Heller
Brzezinski and Charlie Wilson's War
John Walsh
Two Unreasonable Men
Martha Rosenberg
The Strange Career of Scott Gottlieb
Norman Madarasz
Bolivia Amends New Constitution and Faces Mutiny from Within
Website of
the Day
Cockburn at the Battle of Ideas
December 25,
2007
Patrick Cockburn
Conscience
and Empire
December 24,
2007
Andrea Peacock
A
Dark Ride on the Border
Tariq Ali
Thinking of Edward Said
Uri Avnery
Help! A Ceasefire!
Jill Jameson
Burma is Not Back to Normal: A Trip from Rangoon to Mae Sot
Steve Melendez
Russell Means Goes to Washington
Mike Whitney
The Big Fix
Chuck Munson
Not Getting It About New Orleans
John Walsh
Clueless Crusaders
Farzana Versey
Tony Blair and the Hawking of Religion
Richard Neville
Dreaming of a White House Christmas
Website of the Day
Back in the USSR
December 22 / 23, 2007
Alexander Cockburn
Mike
Huckabee's Ascending Chariot
Ralph Nader
Politics
and Profits: How the Oil Cartel Gets Its Way
Andy Worthington
Intelligence Failures, Battlefield Myths and Unaccountable Prisons
in Afghanistan
Ahmad Faruqui
The Comedian of Pakistan
Bill Moyers
Society on Steroids
Rev. William
E. Alberts
Blessed are the Peacemakers
Timothy J. Freeman
From Kant to Lennon: Can War Really be Over?
Anthony DiMaggio
Democrats Continue to Capitulate on Iraq
Fred Gardner
Molecule of the Year, Cannabiodiol
Paul Krassner
Enhanced Hazing Techniques
Seth Sandronsky
17 Years of Meanness: Repealing California's Three Strikes Law
William Loren
Katz
Christmas Eve Freedom Fighters: Recalling the Battle of Lake
Okeechobee
Michael Dickinson
In the Dungeon of the Zabita
Ron Jacobs
Why Leon Russell Still Matters
David Vest
Doyle Bramhall's "Is It News?"
Poets' Basement
Orloski, Davies and Ford
Website of the Weekend
George W. Hates Santa
December 21,
2007
John Ross
New Massacres Loom in Mexico
Jacob Hornberger
Nothing Can Morally Justify the Invasion of Iraq
Dick J. Reavis
A
Way Out of the Newspaper Abyss
Jeff Cohen
and Norman Solomon
The 2007 P.U.-litzer Prizes
Peter Morici
Business as Usual as Recession Looms
Jack McCarthy
Let Us Now Praise Judith Regan (Even If She Did Sleep with Bernie
Kerik)
Raúl Zibechi
Sex and Revolution
Steve Early
How the Presidential Candidates Made Me an Atheist
David Macaray
Union Aftermath
Patrick Bond
Zuma, the Center-Left and the Left-Left in S. Africa
Lakota Freedom Delegation
A Declaration of Independence from the USA
Website of
the Day
Solomon v. Beck: Tale of the Tape
December 20,
2007
David Rosen
Mitt
Romney's Secret Life as a Pornographer
Alan Farago
The
Huckster and the Wreckage: Jeb Bush and the Subprime Mortgage
Crisis
Laura Carlsen
Standing Up to NAFTA
Ashley Dawson
The Return of the Bread Riot
Wayne Smith
and Jennifer Schuett
Cuba Changes, US Policy Stagnates
Website of
the Day
How to Talk to a FoxNews Reporter
December 19,
2007
Saul Landau
Is
the NIE Bush's Watergate?
Paul W. Lovinger
Hillary the Hawk
Norman Solomon
The Mad Corporate World of Glenn Beck
Dave Zirin
George Mitchell's Drugs of Choice
Marjorie Cohn
Bush Still Spinning Iranian Nukes
Sen. Russell
Feingold
The Iraq War is Exhausting Our Nation
Sonja Karkar
A Christmas Reflection on Palestine
Anthony Papa
Open the Drug Gulags
Christopher Ketcham
Pave the Holy Lands with Good Intentions
Davey D
Britney's Little Sister is Pregnant: Should We Blame Hip Hop?
Website of
the Day
When Republicans Use the F-Word on TV
December 18,
2007
R. F. Blader
The
Politics of Teen Pregnancy
George Wuerthner
Gunning for Wolves in Idaho
Steven Higgs
Can the NAFTA Superhighway be Stopped?
Vijay Prashad
Encounters with Ghadar
David Macaray
The Free Rider Problem
Ralph Nader
Nine Books That Make a Difference: a Reading List for the Holidays
Eva Liddell
Privatizing War Abroad, Invading Privacy at Home
Martha Rosenberg
While the Bodies are Still Warm: Drugs, Shrinks and Shooters
Dave Lindorff
When Impeachment is Out of Print
Peter Morici
The Consequences the Trade Deficit
Website of
the Day
Ron Paul: How Fascism Will Come to America
December 17,
2007
Mike Whitney
Staring
Into the Abyss
Tom Barry
Planning
the War on Immigrants
Uri Avnery
A
Gaza Masada?
Greg Moses
Crossing the Line in Texas
Allan Nairn
Terrorism; Counter-
Terrorism: Excuses for Murder
Patrick Bond
South Africa's Fight Between Hostile Brothers
Stephen Lendman
Police State America
Charles Jonkel
Grizzly Right of Way
Laray Polk
An Inside-Out Crisis in Gaza
Stephen Fleischman
Pawns in Their Game
December 15
/ 16, 2007
Peter Linebaugh
A
People's Penny for the Magna Carta
Howard Zinn
Bomb After Bomb
Standard Schaefer
The Greening of Big Tobacco
Raymond J.
Lawrence
Let's Take Christ Out of Christmas
Alan Farago
Down on Desolation Row: the Vultures and the Growth Machine
Saul Landau
Lord Byron and the Bad Tourists
Jenna Orkin
Lying to "Reassure" the Public: Bush's EPA and the
Post-9/11 Toxic Air Cover-Up
Ahmad Samih
Khalidi
Why a Palestinian "State" is a Punitive Construct
Robert Fantina
Politics By Photo-Op
Missy Comley
Beattie
Resistance Amid the Ruins
Ramzy Baroud
Of Mormons and Muslims
James L. Secor
A Vision for China's Future
Elijah Wald
Ike Turner's Music Won't be Forgotten
Website of
the Weekend
The Alliance for the Wild Rockies Needs (and Deserves) Your Support
December 14,
2007
JoAnn Wypijewski
The
Dirty Cad: What Giuliani's Sex Life Tells Us About Him
John Ross
Iraqi
Refugees Return: One Cruel Hoax
Jacob Hornberger
Terror Suspects Belong in Federal Court
Andy Worthington
Guantánamo and the Supreme Court: What Happened?
Allan Nairn
"Shoot Them on the Spot": Rewarding War Crimes
Dave Zirin
The Mitchell Report: Absolving the Owners
Dave Lindorff
The First Cut is the Deepest
Misty MacDuffee
Toxic Grizzlies
Ben Terrall
What Happened to Lovinsky Pierre-Antoine?
Dr. Mustafa
Barghouthi
Prerequisites for Peace
Website of the Day
Sen. Kit Bond: "Waterboarding is Like Swimming"
December 13,
2007
Paul Craig
Roberts
Shrinking
the Dollar from the Inside-Out
Mike Whitney
Dershowitz for the Defense--of Waterboarding
Ron Jacobs
Blank Check DemocratsL the Great War Funding Conspiracy
Norman Solomon
The USA's Human Rights Daze
Peter Morici
The Dragon and the Toothless Dog: China Doesn't Flinch
Sandy Mayes
Blocking the Strykers: 13 Days of War Resistance at Port Olympia
Franklin Lamb
The UN in Lebanon: Whose Mission Is It Fulfilling?
Jacob Hornberger
Don't Reform the CIA, Abolish It
Nadim Rouhana
An Interloper in My Own Land
Dave Zirin
On Pigskin and Petrol
Website of the Day
Rachel's Needs (and Deserves) Your Support!
December 12, 2007
Allan
Nairn
US Intelligence is Tapping Indonesian
Phones
Alan
Farago
How Sprawl Eats Its Young
Ray
McGovern
Torture, Lies and Videotape
Winslow
T. Wheeler
The Phony Pentagon Budget Cuts
Evan
Jones
The Raid on Great Western: Why an Australian Bank Might Spell
Doom for the US Farm Belt
James
Petras
An Open Letter to Sarkozy on the Exchange of Political Prisonsers
Joel
Hirschorn
The Horserace Fiction: Clinton, Obama and the Democratic Machine
Joshua
Frank
Why Ron Paul Deserves Our Attention
Sherry
Wolf
Why the Left Should Reject Ron Paul
Dan
Bacher
Survey of a Fish Graveyard
Website
of the Day
Men Eating Bugs
|
January
8, 2008
A Perpertual Leaker
of Inside Dope
The
Holes in Bush's FDA
By EVELYN J. PRINGLE
The steady leaking of insider information
about products under review by the FDA has caused enormous losses
for average American investors since the Bush Administration
took control of the agency six years ago.
There are several ways that
investors can profit from this type of insider information. The
first is obvious, buy the stock because approval of a product
will almost certainly raise a company's stock value. Investors
who know about the decision ahead of time can bet the farm based
on that information.
But investors who are tipped
off that a product will not be approved can do the opposite.
They can bet that company's stock value will fall by selling
the stock short knowing full-well that the minute the news of
non-approval becomes public, the stock's value will drop like
a rock.
When the leaking of this type
of information occurs, the losers are always the investors who
play by the rules and make bets based on the best public information
available. Unfortunately, in many instances, these are the very
people who can least afford the loss.
One high-ranking member of
the Bush Administration's FDA, Dr Richard Pazdur, has been one
of the leakers in two cases involving cancer drugs that caused
investors to lose vast amounts of money.
The first case devastated investors
when a company's stock value dropped more than $1.5 billion in
less than 3 weeks after Dr Pazdur tipped off the Cancer Leadership
Council's legal counsel Samuel Turner that the FDA planned to
reject the application for approval of a cancer drug the week
before the decision was scheduled to be sent to the main sponsor,
ImClone, on December 28, 2001.
At that time, Mr Turner also
was a registered lobbyist for a number of pharmaceutical companies,
including Bristol-Myers Squibb, which just happens to be the
largest manufacturer of chemotherapeutic drugs.
Bristol-Meyer tipped off ImClone
owners Harlan and Sam Waxal, and family members immediately started
selling their stock. An investigation by the SEC later determined
that the Waksals sold more than $10 million worth of stock in
the 48 hours before the FDA's rejection of the application for
drug was made public.
According to a June 16, 2002
report on Newsbytes News Network, short sellers also made millions
by placing bets that ImClone's stock value would fall in the
weeks before the FDA publicly rejected the application.
The House Committee on Energy
and Commerce investigated the insider trading in this case, and
a subcommittee held a hearing on June 13, 2002. At the start,
the chairman noted that there were two stories here.
One, he said, "will be
more fully told by the SEC and the Justice Department as it examines
how the FDA process and what appears to be some rather amoristic
players conspired in a way that allowed insider trading to potentially
occur and an awful lot of investors to lose a lot of money while
insiders were trading on information that was available only
to them."
"The other story,"
he noted, "is about the process at FDA and how the FDA process
allowed this to happen."
A transcript of the hearings
shows that when members of Congress asked directly who within
the FDA leaked the information to Bristol-Myers, Dr Pazdur and
the rest of the Bush Administration officials talked in circles
and never answered.
But in the end, somebody pulled
some strings because Dr Pazdur got off Scott free, which probably
accounts for his lack of fear when engaging in similar, behind-the-scenes
activities in 2007.
In the more recent case, the
continued short selling in Dendreon's stock following the Provenge
Advisory Committee meeting of March 29, 2006, despite the fact
that the Committee recommended approval of the drug, surely indicates
that information leaked to Wall Street from inside the FDA guaranteed
that the drug would not be approved.
On May 9, 2007, when Dendreon
announced to the public that the FDA had issued the company a
Complete Response Letter instead of an approval letter, the market
value of Dendreon dropped more than 60% in one day.
The known people behind the
"leaks" in this case are Dr Pazdur, along 2 members
of the Advisory Committee who were chosen to participate on the
panel by Dr Pazdur. When persons serve on these committees, they
become "special government employees," and are subject
to the same rules and regulations as all government employees.
When the Provenge Committee
recommended approval, there were two votes taken. The first was
on safety and the vote was 17-0 that the drug was safe. The second
was on efficacy and the vote was 13-4 that the drug demonstrated
"substantial evidence" of efficacy, the federally mandated
standard.
The approval of this new cancer
vaccine represented a grave threat to the multi-billion dollar
chemotherapy industry. Dendreon is the first company to seek
approval of a drug in a promising new class of immunotherapies
that direct the body's own immune system to attack only cancer
cells, unlike chemotherapy which destroys cancer cells but damages
healthy cells and the immune system as well.
Provenge sought approval to
treat men in the final stage of prostate cancer whose only option
is months of chemotherapy with the drug Taxotere, which causes
debilitating side effects and extends life on average 2.5 months.
In applying for approval, Dendreon
submitted a study that showed 3 injections of Provenge extended
life by nearly double that chemotherapy and the side effects,
if any, consisted of flu-like symptoms for one or 2 days.
If the new immunotherapies
turn out to be as effective as some experts claim, chemotherapy
and radiation treatments could become obsolete in the not to
distant future. Dr Pazdur knew this all too well. In fact, his
fear was that if Provenge were to be approved, it would establish
a new standard of care for late stage prostate cancer patients
and from then on testing of new therapies would be up against
Provenge.
He was also ticked off about
the fact that the FDA had chosen the Center for Biologics Evaluation
and Research to control the Provenge Advisory Committee instead
of the Center for Drug Evaluation and Research, which he controlled.
So as a back-door means of
regaining control, he recruited his two partners in crime, Dr
Howard Scher, from the Memorial Sloan-Kettering Cancer Center,
and Dr Maha Hussain, from Michigan University, to serve on the
Advisory Committee to assist him in thwarting Dendreon's bid
for the approval of Provenge.
Both of these doctors have
made a fortune from their involvement in the cancer treatment
and research racket over the past 2 decades. And they also stood
to lose a fortune if the chemo-cartel was dismantled.
Investors had every reason
to believe that Provenge would be approved once the Advisory
Committee voted for approval. The FDA had never refused to follow
a recommendation by its own experts to approve a drug for dying
cancer patients who had no other options.
While testifying at the hearing,
Dr David Penson, Associate Professor of Urology and Preventative
Medicine at the University of Southern California, told the panel:
"If you turn this drug down, it will likely set back the
innovative field of active cellular immunotherapy in cancer many,
many years."
He warned that the Committee's
decision "will not only affect prostate cancer patients,
but it may have an effect on the larger population of oncology
patients in general."
Dr Hussain and Dr Scher were
positioned on the panel to do everything in their power to make
sure the vaccine was not approved. But their best efforts failed
and within two weeks after the panel voted to approve the Provenge,
Dendreon stock had nearly tripled in value and analysts were
predicting that the vaccine could bring in $1 billion annually.
However, it was soon obvious
that something was up, because the short sellers were still betting
millions that the stock value would fall. On April 29, 2007,
Bloomberg reported that shares were being sold short "at
a record pace" as investors "bet the company's experimental
prostate-cancer drug will fail to win approval from U.S. regulators."
All totalled, 33.9 million
shares were sold short by the end of April. In hindsight, figuring
out why people would engage in such risky betting was a no-brainer.
The only people who could have known that Dendreon stock was
headed for a nose-dive on May 9, 2007, because the FDA was going
to overrule it's own panel by denying the approval of a cancer
drug for dying patients for the first time in history, were the
people who made it happen.
As late as May 7, 2007, Prohost
Biotechnology, a firm that evaluates companies and publishes
a monthly newsletter for investors, was calling Dendreon a good
investment on its web site, stating: We Have A New Pick "DENDERON
AGAIN."
The web site went on to explain
why the firm was predicting that the short sellers were wrong
in betting against the company, by stating in part:
This time, positive investors/analysts
are determined to neutralize the shorters' efforts. Why not,
if the verdict is expected in 10 days only and the committee,
which was appointed by the FDA itself has already voted 17-0
in favor of safety and 13-4 in favor of efficacy?
We are with the approval, Prohost
said. "As a matter of fact, we expect it on May 15, based
on many facts, the most important is the result of the FDA committee's
voting."
The firm noted that the experts
on the panel would not have been chosen by the FDA if they were
not highly regarded researchers, medical doctors, and academicians,
and stated:
"If the results of voting
would have been 50-50, we would have understood the need for
the FDA to take a stand. But with a landslide voting in favor
of approval, we do not see why the FDA should hesitate to follow
the committee's recommendation of approval.
"Besides, the vaccine
is safe. It acts synergistically with the available treatments
and it helped desperate patients survive advanced prostate cancer."
But as it turns out, another
plot was put in action immediately after the news came out that
the panel recommended approval, in which government officials
at the FDA and the National Cancer Institute worked with Dr Scher,
and probably Dr Hussain, to compose letters with bogus reasons
why the FDA should not follow the recommendation.
Once the rough drafts were
edited, the letters were sent to the FDA by email and hardcopy,
and leaked for publication on the internet by "The Cancer
Letter," which just happens to be the same rag used to leak
insider information in the ImClone case.
The overly dramatic Dr Scher,
even went so far as to tell Thomas Fleming, another doctor who
just happened to send a letter to the FDA, disparaging Provenge,
which was also put out on the internet by "The Cancer Letter,"
that he could not sleep because he was so concerned over the
possibility of patients being harmed if Provenge was approved
and that's why he wrote the letter. Dr Fleming then noted that
he could not sleep either.
This is an utterly ridiculous
remark coming from Dr Scher, considering that he and Dr Hussain
voted with the majority 17-0 that Provenge was safe at the hearing.
The pharmaceutical companies
that stood to benefit the most from the non-approval of Provenge
were Novacea, Schering-Plough and Sanofi-Aventis because they
have billions of dollars invested in research, drug trials, and
cancer treatments involving therapies that would compete directly
with Provenge for the same late stage prostate cancer patients.
Dr Scher and Dr Hussain, as
well as her husband, are involved in dozens of studies conducted
by the same companies. Both Dr Scher and Dr Hussain are consultants
and members of the scientific advisory board for Novacea, which
produces Asentar together with Schering-Plough.
Asentar would directly compete
with Provenge and at the time of the Advisory Committee hearing,
Dr Scher was the co-lead investigator on trials of Asentar
According to www.portfolio.com,
Dr Scher is also an officer, member of the Board of Directors,
and a member of the Scientific Advisory Board of ProQuest Investments,
which was had mega-bucks invested in Novacea during 2007. However,
for some odd reason, ProQuest's web site no longer lists the
names for the Scientific Advisory Board.
Dr Scher and Dr Hussain have
also both received research funding from Sanofi-Aventis the maker
of Taxotere.
A review of Dr Hussain's most
current resume in fact, shows that she's been on one long global
junket funded by the cancer treatment and research racket for
close to 2 decades. She apparently began her journey in Bagdad,
Iraq, in1980, and 2 years later she was in the UK and a year
after that she ended up in Detroit, Michigan.
It looks like her home base
has been Ann Arbor, Michigan since late 2002, that is in between
her 6 trips to Canada, 3 to Hawaii, 3 to Puerto Rico, 2 to St
Thomas, 2 to Barcelona, and at least 1 trip to Japan, China,
Jordon, Lisbon, Monte Carlo, Bermuda, and Austria, in addition
to her 17 trips to California, 9 to Chicago, 4 to New Orleans,
5 to New York, 9 to Florida, and at least 38 trips to other states.
The list of excursions certainly
demonstrates that the good doctor enjoyed quite a lot of travel
on someone else's dime. In fact, her hotel fees alone would put
a bonifide hooker to shame.
Its impossible to determine
the amount of "research" funding funneled her way because
the amount is redacted for half of the grants listed. But at
a bare minimum, she had at least 28 million "current"
reasons to sabotage the approval of Provenge.
Under "Current Grant Support,"
she lists 11 grants, although 5 have no amounts. But the total
for the other 6 comes to over $28 million, and she will be receiving
income from a few of these grants for several more years.
Dr Hussain also lists another
2 grants as submitted, with all information redacted. She lists
5 under "Active Research," all involving treatments
for late stage prostate cancer, but not one includes the amount.
No dates are listed for these 5 grants either, which makes it
impossible to estimate how long she intends to profit from this
research.
The doctor also lists 30 funding
sources under "Past", but only 6 have amounts. The
total for those 6 comes to more than $20 million, so it would
probably be safe to say that if all amounts were to be listed,
Dr Hussain had at least 100 million good reasons to derail the
approval of Provenge.
All the plotting by persons
benefiting from the non-approval of Provenge might have gone
undetected if not for the non-profit advocacy group, Care-To-Live.
The group filed a lawsuit in Federal court against officials
in charge of the FDA, including Dr Pazdur and Dr Scher, seeking
an injunction to overturn the FDA's decision and to make Provenge
available immediately to extend the lives of dying prostate cancer
patients.
By filing the lawsuit, the
group was able to gain access to a lot of information and after
reading much of it, one thing's for sure, the government officials
involved in this sick plot will never be accused of wasting time
on the clock worrying about dying cancer victims.
Another case of leaking occurred
on March 1, 2006, when the FDA sent a letter to the Canadian
investment firm, Infinium Capital, that said the agency would
allow testing for a generic version of Vancocin, marketed by
ViroPharma, to be conducted in a test tube.
Two weeks later, after allowing
plenty of time for persons with the inside information to position
themselves to make a killing in the stock market, Infinium issued
a report on ViroPharma stating, "Generics . . . sooner than
you think".
According to an SEC filing
by ViroPharma, Infinium's report was the first public disclosure
of the new testing standard and:
"ViroPharma itself had
not previously heard that OGD had lowered its BE standard for
Vancocin. Nor it would seem, except those to whom OGD had privately
communicated, had anyone else."
ViroPharma's filing went on
to note that Infinium's report stated:
"Our recent communications
with the FDA regarding the approval process for a potential generic
competitor to Vancocin lead us to believe a generic could enter
the market 1-2 years sooner than current expectations."
What "recent communications
with FDA" might mean, the filing states, beyond the March
1, 2006 letter to Infinium, is unclear to ViroPharma. On March
16, 2006, Medindia.com dropped a bombshell when it informed the
public of the news by quoting analysts at Infinium as saying
it could mean a generic version would be available by early 2008.
"Previously, generic manufacturers
may not have been interested in developing this therapeutic due
to its low revenue potential; however, with the recent sales
growth of 133 percent in 2005, Vancocin is now on the radar screen,"
an Infinium analyst told Medindia.
Infinium's announcement caused
shares of ViroPharma "to dip by about 33 percent,"
according to Medindia. But in fact, Infinium's report triggered
a multi-day stock sell-off that cut the company's market capitalization
by 40%, or roughly $500,000,000.
The approval process prior
to the FDA's unexpected announcement required trials to be conducted
on humans. ViroPharma has filed a Petition to stop the approval
of generic versions with allegations that the FDA violated the
Freedom of Information Act, the Data Quality Act, the Administrative
Procedure Act, and its own Standards of Conduct.
Vancocin is used to treat hospital-acquired
bacterial infections in the lower gastrointestinal tract caused
by the bacterium Clostridium difficile. In order to be effective,
the drug must be released in one specific section of the intestines,
making its release mechanism far more difficult to replicate
than other drugs.
The release of an ineffective
version of Vancocin at this point in time would be especially
dangerous because recent studies have shown that cases of Clostridium
difficile-associated disease (CDAD) are increasing world-world.
The disease causes 400,000 cases of diarrhea and colitis each
year in the US, according to the US Department of Veterans Affairs.
In addition, a paper by Michel
Warney, et al., entitled, "Toxin Production by an Emerging
Strain of Clostridium difficile Associated with Outbreaks of
Severe Disease in North America and Europe," in the September
2005 Lancet medical journal, reported a new strain of C difficile
that produces up to 23 times more toxins than previous strains;
this strain has been implicated as the cause of a more severe
form of the disease
A May 11, 2007, report by the
Pennsylvania Health Care Cost Containment Council said that in
2005, patients with CDAD were hospitalized 2-and-a-half times
longer, charged over twice as much, and were 4 times as likely
to die as patients without the disease.
On average, the report notes,
patients with CDAD remain in the hospital almost 7 days longer
at a cost of $73,576, verses the average charge of $30,833 for
patients without the disease. A November 2007 report entitled,
"The Emerging Infectious Challenge of Clostridium difficile-Associated
Disease in Massachusetts Hospitals: Clinical and Economic Consequences,"
cites a "conservative estimate" of the annual cost
for CDAD management in the US as $3.2 billion.
People treated with antibiotics
are at the highest risk because antibiotics disrupt the balance
of bacteria in the GI tract, which allows C difficile bacteria
to multiply. CDAD is highly infectious and can spread by contact
with patients or touching surfaces contaminated with C difficile
spores. The severity of the disease ranges from mild cases of
diarrhea to painful colitis, bloodstream infections or death.
Years ago, CDAD was almost
exclusively limited to patients in hospital or long-term care
settings where infectious diseases spread easily. But there are
now widespread reports of patients developing CDAD outside hospital
settings, referred to as "community-acquired" CDAD,
and with no antibiotic exposure.
Recent studies indicate that
many cases may be caused by proton pump inhibitor drugs which
inhibit the production of gastric acid in the stomach that acts
as a defense against bacteria and spores, widely used by persons
with ulcers and other GI illnesses.
The December 21, 2005, Journal
of American Medical Association published a report by Canadian
researchers based on studies that determined that gastric acid-suppressant
drugs were associated with the rising cases of community-acquired
CDAD.
The researchers used the United
Kingdom General Practice Research Database and identified all
1,672 cases of CDAD recorded between 1994 and 2004 and found
that 1,233, or 74%, of the patients had not been hospitalized
in the year prior to the diagnosis and were considered community-acquired.
The study showed the increase
in community-acquired cases rose from less than 1 per 100,000
in 1994 to 22 per 100,000 in 2004 and during this same period,
prescriptions for antibiotics had decreased while prescriptions
for proton pump inhibitors had increased.
The first course of treatment
for CDAD caused by antibiotics is to stop the antibiotics. But
if diarrhea continues and becomes severe, Vancocin is a treatment
of last resort for very sick patients which means there is no
room for error.
The FDA claims that dissolution
testing for the generic version can be done by creating a test
tube solution that replicates the environment in the lower intestine.
But experts say it would be next to impossible to replicate the
GI tracts of very ill and elderly patients to determine whether
the generic version will work the same in the targeted area.
Experts also point out that
drug interactions, such as those in patients on proton pump inhibitors
would make it hard to develop a solution that would replicate
the GI tract.
The approval of an ineffective
generic version of Vancocin, will subject millions of people
to potentially fatal risks because the patients who end up being
treated with this medication will have no second chances if it
fails.
The FDA is currently under
attack for doing the exact same thing by not requiring adequate
testing for the generic version of the antidepressant Wellbutrin.
The FDA approved the generic in 2006 and after a steady stream
of patients reported that they were experiencing serious side
effects, testing by ConsumerLabs, revealed that the time release
rate of the active ingredient was much faster than the release
rate in the original drug.
The consumer-product testing
group, ConsumerLab began investigating the drug after Joe and
Terry Graedon, authors of The People's Pharmacy column, came
to the group with complaints received from readers of their column.
While the Graedons had received complaints about generic drugs
before, "we had never received this volume of response,"
Joe Graedon, a pharmacologist, told MSNBC on October 12, 2007.
"In almost all cases people
were saying their depression returned," he said. Users also
complained about severe headaches, digestive problems, insomnia,
anxiety, and tremors.
ConsumerLab performed dissolution
testing on 6 samples of each medication and found that even though
both contained the same amount of the active ingredient, the
generic released nearly 50% of the ingredient in the first 4
hours verses 25% by Wellbutrin.
"It's been an eye-opener
for everyone," ConsumerLab President, Dr Tod Cooperman,
told MSNBC. "It makes you question whether generics are
always going to be equivalent to the original product."
"If these things are releasing
at such different rates," he advised, "it's hard to
believe they'd be acting the same way in your body."
"It would seem very difficult
to imagine that the results we saw would be acceptable results,"
Dr Cooperman told MSNBC.
He pointed out that the release
of the active ingredient more quickly could mean there is less
medication available to the patient later, and may explain why
patients experienced a return of their depression.
He said a time-release problem
might also explain why patients experienced more side effects,
such as headache, irritability and nausea, if they received a
high dose of the medicine upfront. "Too much Wellbutrin
can cause side effects, even the potential for seizure,"
he told MSNBC.
The Canadian firm Biovial filed
a petition with the FDA in 2005, asking the agency to require
generic makers to conduct more rigorous testing of generic versions
of Wellbutrin prior to their approval but apparently the agency
ignored the request.
An agency spokesperson told
MSNBC that the FDA does not require generic makers to do clinical
trials on hundreds or thousands of people as required for name
brand drugs. It only requires lab data and "bioequivalence"
testing in about 24 to 36 healthy volunteers showing that the
drug enters the bloodstream in a similar manner to the original
product.
Since the generic version was
approved, millions of consumers have switched to the drug to
save money which means a high number of patients may be experiencing
serious side effects without knowledge of the cause. Experts
say this whole problem could have been avoided had testing on
humans been conducted to check the release mechanism before millions
of scripts were written.
"Sustained release mechanisms
are not that easy to develop, and they tend to be proprietary
in nature," Michael Katz, clinical associate professor of
pharmacy practice and science at the University of Arizona College
of Pharmacy told MSNBC.
"It would be difficult
for a generic manufacturer to reproduce the same release characteristics
as the brand-name product," he stated.
"Such differences clearly
could have an impact on patients," he said, "and my
view is that sustained-release products are among the relatively
short list of products that should not be switched."
Experts say the time release
characteristics would be even more difficult to replicate in
a generic version of Vancocin, where the concern is not just
about how much of the drug is released into the blood stream
but rather in one specific section of the GI tract.
The leaking of information
in the Vancocin case is reminiscent of a major scandal that erupted
during the first Bush Administration in 1989, when FDA officials
were charged with taking bribes from generic makers and sharing
insider information.
On August 28, 1989, Time magazine
reported that an investigation by the Justice Department had
uncovered evidence that "some makers of generic pharmaceuticals
falsified laboratory test results and paid off FDA chemists to
gain quick Government approval for their products."
In that case, Charles Chang
the head of the FDA's generic division and two co-workers pleaded
guilty to accepting a total of $24,300 in illegal gifts in exchange
for preferential treatment for certain generic makers in July
1989, according to the Time report.
In the end, the generic scandal
during the first Bush Administration landed Mr Chang in federal
prison and caused 42 others and 10 companies to be convicted
on charges of fraud and corruption and the FDA Commissioner Frank
Young resigned in November 1989.
The crooks in the current Bush
Administration's FDA deserve the same fate.
Evelyn Pringle is an investigative reporter focused
on exposing corruption in government and corporate America. She
can be reached at: evelyn-pringle@sbcglobal.net
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