Demand for congressional hearings into FDA process on Dendreon’s Provenge

December 18, 2007
The below is from the blog of -
Howard (Jack) West, MD
Dr. West serves as the Founder and Managing Member of OncTalk, LLC. He is a medical oncologist and Director of Medical Therapeutics for Thoracic Oncology at the Swedish Cancer Institute in Seattle, Washington.

Request for Congressional Inquiry into Drug Approval Process

  Returning to a situation I’ve written about in a couple of prior posts about the contentious saga of the Dendreon (local Seattle company) investigational vaccine Provenge for prostate cancer (posts here and here), three senators have requested a congressional inquiry into the FDA decision to withhold approval of provenge after it had been recommended for approval by an advisory committee to the FDA, as described in a story here.  As described in the second of the posts listed above, this issue was pursued primarily by the group CaretoLive, comprised of prostate cancer advocates and some investors who feel that there was far too much onco-politics in the high level FDA recommendations for who would participate in the final committee, and that two key academic oncologists who served on the committee had potentially significant conflicts of interest that may have denied provenge a completely fair opportunity, and in the process denied prostate cancer patients a potentially helpful treatment.

continued at: 

http://onctalk.com/2007/12/14/request-for-congressional-inquiry-into-drug-approval-process/

I have been following this issue and I am so happy to see that a congressional hearing is likely to investigate the conflicts of interest (COIs) of a couple of the participants on the FDA advisory committee re:  Provenge.  This has only occurred because of the advocacy of the prostate cancer community who were appalled by the FDA decision-making process in this instance.  If I was a journalist, this would make a very interesting book IMO as this scenario outlines how FDA advisory committee members are not neutral/objective, have their own turfs to protect both in terms of ideology/approaches about treatment but also with regard to which companies they are on the boards of, what hedge funds their family members may be representatives of, etc.  It has been an eye-opener for me watching the Provenge saga unfold and I am very thankful that there are people fighting this FDA decision as it stinks of corruption and greed.  

Most of all, that the prostate cancer community has managed to raise such a stink about the delay of Provenge as a treatment for end-stage prostate cancer sufferers, have kept at this issue until it has reached the point of a congressional hearing in the U.S.,  is a tribute to the human spirit that says enough is enough - this is a travesty. 

Human Rights Day – 10 December 2007

December 10, 2007


 
The universally recognized Human Rights Day marks the anniversary of the adoption of the Universal Declaration of Human Rights on 10
December in 1948 in Paris.

On this coming Human Rights Day, 10 December 2007, the United Nations will launch a one-year intensive programme of activities
leading up to the commemoration next year of the 60th anniversary of the Declaration under the slogan: dignity and justice for all of us.

The adoption of the Universal Declaration was followed by the adoption of the Covenants of Economic, Social and Cultural Rights
and on Civil and Political Rights, and a vast array of human rights conventions and treaties promoting and protecting the rights of children, women, minorities, indigenous peoples, migrants, disabled persons; eliminating racial and all other discrimination to name but a few. They have been ratified by the majority of UN Member States and together form a remarkable body of international human rights law.

Implementation of these set standards remains a challenge.  While the universal human rights standards and their oversight have
been strengthened over the years, forces and trends (by states and private companies) that threaten and undermine these universal human rights continue unabated. Weapons profiteers develop machines that threaten and violate the human right to life and prevent the realisation of other fundamental freedoms. Our planet and its finite resources  are threatened by those who choose profit over the right of future generations to exist.  

While billions of dollars are wasted extending the arms race to outer space and developing a new generation of nuclear weapons,
1.2 billion people have no access to clean water and are forced to drink filthy, disease-ridden water.  Fatal shortages and mismanagement of water resources is already a source of conflict.  It is predicted that two thirds of countries will experience severe water shortages by 2025, and if these predictions are accurate, resource wars will  increase globally. Water is not a service to be commoditized, but a common good to be protected, and it is a human need, as well as a finite
resource on our common globe.

Since its inception in 1915, the Women’s International League for Peace and Freedom (WILPF) has worked for all human rights to be respected. We have equally worked for the prevention of war and the eradication of militarism, believing that these conditions negate human rights. We are convinced that human rights cannot exist without peace and freedom.

As the Universal Declaration of Human Rights enters its 60th year, and as the new Human Rights Council struggles to monitor and
implement the universal standards for justice and human rights developed through exhaustive debate by governments and civil society, women have the right, the responsibility, and the sense of solidarity to defend, reclaim and realise human rights for all, as they have done, and continue to do for themselves.

The sad reality is that too often under the false pretext to protect women, women are denied the right to education, mobility,
the right to their own body and the free choice to plan their own future. All over the world, women have to struggle for basic human rights on many levels.
 
Exercising the right to have an equal voice in international policy-making and the questions of war and peace, The
Women’s International League for Peace and Freedom calls for:

-  the right of peoples to exercise political and economic sovereignty over their land and its resources;
-  the right of peoples to live without fear of violence, occupation or military rule;
-  the right of people to sustain themselves from their environment, to practice self-sufficiency and to be independent from
    companies, governments, and states who may try to coerce them into exploitative policies;
-  the right of women to receive equal pay for equal work;
-  the right of all people to be free from sexual slavery, other forms of bonded labour and exploitative conditions of work;
-  the right of all people to have an equal and informed say in their government’s policy creation and implementation.
 

Best Wishes,
Secretary General
Women’s International League for Peace and Freedom

www.wilpf.ch
http://www.PeaceWomen.org

“The End of America”: Feminist Social Critic Naomi Wolf Warns U.S. in Slow Descent into Fascism”

December 4, 2007


at http://www.democracynow.org/2007/11/28/the_end_of_america_feminist_social

In her new book, "The End of America: Letter of Warning to
a Young
Patriot", Naomi Wolf says the United States is on the road
to
becoming a fascist society, right under our very noses.
Wolf outlines
what she sees as the ten steps to shut down a democratic
society and
argues that the Bush administration has already implemented
many of
these steps. Wolf is the author of several books including
the 1990s
feminist classic, "The Beauty Myth."

“FDA’s Refusal to Approve New Cancer Vaccine - The Plot Thickens - Part I News”

November 28, 2007

Washington, DC: Dying prostate cancer patients waiting for the approval of Provenge, a new life-extending cancer vaccine, are being held hostage by an FDA infested with industry insiders with enormous financial interests in what has become a multibillion dollar cancer treatment racket for drug companies, cancer researchers, and treatment providers alike.

On May 8, 2007, FDA Commissioner Andrew von Eschenbach refused to approve
Provenge for men with end-stage prostrate cancer and instead, issued a Complete Response letter to Seattle-based Dendreon, the vaccine’s maker, requesting more data that may not be available until 2010.

Cancer patients and advocacy groups say intentionally delaying the approval of new therapies for terminally ill patients in order to protect profits in the research and treatment industry should be a criminal offense, and they are calling on Congress and the Security and Exchange Commission (SEC) to conduct a full investigation of the conflicts of interests involving the FDA officials responsible for the non-approval of Provenge.

As for the data requested by the FDA, an accurate assessment of the full effects of Provenge on survival can not be assessed easily because many of the participants in the clinical trials are still alive many years after they received the vaccine.

In a perverse twist of fate, because patients are living longer with a vaccine that works, it will take longer to provide the FDA with the data it requested.

“Dr Drug Rep” - url for NYT’s article

November 26, 2007

"Dr Drug Rep"

November 25, 2007

http://www.nytimes.com/2007/11/25/magazine/25memoir-t.html?em&ex=1196226000&en=14f86674a4b9bfd7&ei=5087%0A

This article is by a psychiatrist who became a spokesperson for Wyeth’s anti-depressant drug Effexor XR.  I found the comments about data-mining by pharmaceutical companies in tracking the medications that physicians prescribe so that reps. can hone their strategies to target specific physicians and psychiatrists with their sales-pitches enlightening.  People in poor health, especially those suffering from depression, are unlikely to challenge their doctors as they just want to feel better. 

“Corporate culture: rewarding the rich at the expense of the poor” (article url)

November 11, 2007

at http://www.thepost.ie/post/pages/p/story.aspx-qqqt=THE+INSIDER-qqqs=themarket-qqqs=computersinbusiness-qqqid=28095-qqqx=1.asp

New book I want to read

October 6, 2007

The Secret History of the War on Cancer by Devra Davis (Basic Books, $27.95).

“Canada Refuses Entry to CODEPINK Cofounder Medea Benjamin and Retired Colonel Ann Wright”

October 5, 2007

WASHINGTON - October 3 – Two well-respected US peace activists, CODEPINK and Global Exchange cofounder Medea Benjamin and
retired Colonel and diplomat Ann Wright, were denied entry into Canada today (Wednesday, October 3). The two women were headed to Toronto to discuss peace and security issues at the invitation of the Toronto Stop the War Coalition.

At the Buffalo-Niagara Falls Bridge they were detained, questioned and denied entry. They will hold a
press conference on Thursday afternoon in front of the Canadian Embassy in Washington DC to ask the Canadian government to reverse
its policy of barring peaceful protesters.

The women were questioned at Canadian customs about their participation in anti-war efforts and informed that they
had an FBI file indicating they had been arrested in acts of non-violent civil disobedience.

Press Conference:
WHEN: Thursday, October 4th at 1pm
WHERE: Canadian Embassy, 501 Pennsylvania Ave NW,
Washington DC

"In my case, the border guard pulled up a file showing
that I had been arrested at the US Mission to the UN where, on
International Women’s Day, a group of us had tried to deliver a peace petition
signed by 152,000 women around the world," says Benjamin. "For
this, the Canadians labeled me a criminal and refused to allow me
in the country."

"The FBI’s placing of peace activists on an
international criminal database is blatant political intimidation of US
citizens opposed to Bush administration policies," says Colonel
Wright, who was also Deputy US Ambassador in four countries. "The
Canadian government should certainly not accept this FBI database as the
criteria for entering the country."

Both Wright and Benjamin plan to request their files from the FBI through the Freedom of Information Act
and demand that arrests for peaceful, non-violent actions be expunged from international records. "It’s outrageous that Canada is
turning away peacemakers protesting a war that does not have the support of either US or Canadian citizens," says Benjamin.

"In the past, Canada has always welcomed peace activists with open arms. This new
policy, obviously a creature of the Bush administration, is
shocking and we in the US and Canada must insist that it be overturned. Four
members of the Canadian Parliament–Peggy Nash, Libby Davies, Paul
Dewar and Peter Julian– expressed outrage that the peace activists
were barred from Canada and vow to change this policy.

ED - Harper’s NEW government in action!  Glad to see that Paul Dewar stepped up to the plate but what about Jack Layton and other progressives? 

For those in the Edmonton area……. Mel Hurtig Annual lecture on the Future of Canada featuring Heather Mallick

October 3, 2007

For those in the Edmonton area…….


The Department of Political Science at the University of
Alberta

cordially invites you to the

Second Mel Hurtig Annual Lecture on the Future of Canada,

Featuring…

Heather Mallick, celebrated Canadian journalist, on

"Pox Americana? How the US will take over Canada."


When: Thursday, October 4, 2007 at 7:30 PM
Location: Telus Centre on the University of Alberta main
campus
111 St. & 87 Avenue, Edmonton, AB


Admission: Free -  All Are Welcome!


BIO: Heather Mallick currently writes Stand on Guard  for
CBC.ca and a
feminist column for Chatelaine magazine. She has worked as
a reporter,
copy editor and book review editor at various Toronto
newspapers. She
challenged the Bush administration unrelentingly in a
column for the
New York Times Syndication Service. Her As If  political
column in the
Globe and Mail interrogated, with stinging wit,
contemporary
neoconservatism and its peculiar faiths.

Ms. Mallick has won National Newspaper Awards for both
Critical
Writing and Feature Writing. Her first book, Pearls in
Vinegar, was
published in 2004 and her second, Cake or Death, a
collection of
original essays about how to find consolation for the pain
of life in
the Bush era, was published by Knopf Canada in the spring
of 2007.
Stylistically, Heather Mallick has been compared to
Margaret Atwood,
Jeanette Winterson, and American commentators such as
Maureen Dowd and
the late Molly Ivins. Her writing is described as "smart
and
provocative," "frank and funny," "sultry, stoic and
sarcastic," and
"never dull."


Comment re: Tempest over Provenge article

September 26, 2007

 

For some reason blogsome’s spaminator interpreted this comment as spam whereas it is an excellent comment.  FYI.

Certainly one of THE fairest and one of the more
comprehensive posts on the Provenge saga I\’ve read on the net. Thank
You! for getting most all of this story as you wrote it
right.

Couple comments…

1. While \"reported\" that Hussain of
University of
Michigan
and Scher of Sloan Kettering allegedly received \"death
threats\", there has been NO REPORTS that:
a. a police report has been filed which, of course, would
bring the emailer to justice is short order as tracking
emails over the net is child\’s play to law enforcement

b. The alleged \"death threats\" have not been made public
nor have they been reported to be have seen by anyone other
than the good doctors. Reports only state what the good
doctors say… without proof!

Where are these threats and what do they say?

3. As to the \"threat\" wishing cancer on the male \"The
Cancer Letter\" staff… this NON-peer reviewed, rumor
publication has a staff of TWO… Paul Goldberg and his wife
which is published out of their Washington DC home\’s basement.
  Hardly a reputable or mainstream cancer
publication–especially having no peer review of their OPINIONS.

3. As noted in the above comment/article, Howard Isador
Scher of Sloan Kettering is on the Board of Directors of the
hospital as well as an Executive of that institution. In
those capacities, he surely must makes decisions at Sloan
Kettering regarding their business and financial matters as
well as admininstering to
prostate cancer patients.

Those positions are NOT part of the below 17 Conflicts of
Interest found on the internet involving Scher.

Scher reported only 3 COI\’s to the FDA per his filing in
late February available at the FDA website which appears to
be composed of ownership of 1 stock and 2 competing
industry interest.

Internet research shows the following for Scher thus far
and please particularly note #1 and #17:

1. NOVACEA: grants & research support; STUDY CHAIR of
DN-101; Direct competitor to Provenge

2. GPB BIOTECH: financial conflict of interest per Scher in
MedPage

3. PHARMION: financial conflict of interest per Scher in
MedPage

4. SANOFI-AVENTIS: grants & research support

5. BRISTOL MYERS SQUIBB: consultant, grants & research

6. MILLENNIUM PHARMCEUTICALS: grant of research support

7. COUGAR BIOTECHNOLOGY: principal investigator; advisory
board;

8. INNOVIVE PHARMACEUTICALS: principal investigator

9. INFINITY PHARMACEUTICALS: principal investigator

10. BIOGEN-IDEC: jointly held stock with spouse

11. PFIZER: jointly held stock with spouse

12. GENTA: scientific advisory board (as of March 6, 2007;
since removed from web, but cached)

13. CONFOMA THERAPEUTICS: scientific advisory board

14. DEPARTMENT of DEFENSE: Principal Investigator PC
Clinical Trials-P1 and P2

15. AMBRILIA BIOPHARMA INC: Principal Investigator PCK3145,
Phase I/II

16. MEDIVATION, INC: principal investigator MDV3100

17. PROQUEST INVESTMENTS: consultant, scientific advisory
board; Limited Partner FINANCIAL interest

There appears to be a significant and disturbing difference
between his 3 disclosures to the FDA and the alleged 17
COI\’s found so far on the internet. It seems
incomprehensible for someone with the training and education Scher has to
\"forget\" so many apparent COIs… that is simply beyond
all reasonableness and suggests intentional dishonesty or
deceit.

Even more disturbing is the FDA\’s Office of Inspector
General and others at the FDA to whom this information has been
supplied and their apparent failure to investigate these
charges that Scher has more COI\’s than he disclosed to
them. When such information is provided and such allegations of
potential federal law violation is involved, any ordinary
citizen has the right to expect our government to
investigate such allegations timely and thoroughly.

As a \"temporary government employee\" at the FDA, he is
obligated, under Federal law, to provide full and complete
disclosure. If he didn\’t, he may have the potential for
liability for law violation(s) as well as for providing false
data to the FDA under which he secured a waiver in order to
participate on the Provenge AC meeting March 29th.

Hope that you\’ll look further into these alleged Conflicts
of Interest; it gives all the indications of a very foul
stench and suggests illegality and corruption.

Those wanting to help cancer patients can check at the CARE
TO LIVE website to see what contributions they can make or
to check on the status of the lawsuit against the FDA in
seeking to secure faster access to potentially life-saving
or life-extending cancer treatments.

… and remember, 83 men die needlessly each day from
prostate cancer. Those totals are over 11,000 men since May 9th,
2007. Compare that to the Iraq War casualties of some
3,800 men since March 2003… quite a difference, yet it is
disgusting to see the loss of so many American men in both
cases.

Please help prostate cancer victims!!!