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. 

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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

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“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."

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“ONE WEEK REMAINING IN THE NATIONAL PRO-CHOICE CANADA CONTEST!



 

Join us in celebrating 20 years of safe and legal
reproductive choice in
Canada!

To celebrate, we want to hear your thoughts.

Tell us why a "Pro-Choice Canada" is so important and you
could win a
trip to Ottawa and the chance to be on national television!


More expressive through art than through word?

Submit your pro-choice work of art and you could have your
artwork
featured on the cover of a book!



In January 2008, Canadians everywhere will celebrate the
20th
anniversary of the Morgentaler decision that decriminalised
abortion in
Canada and gave women the right to control their
reproductive health. We
want you to reflect and celebrate with us! Too often,
sexual and
reproductive health issues are silenced in our country…
we would like
to offer you the opportunity to share your story.

Tell us in your own words through an essay, song lyrics, a
poem, a rant
or a testimony why the pro-choice movement has been- and
continues to be
so important. Or, you may choose to express your pro-choice
sentiments
through a painting, a drawing, a photo or another form of
visual art.
Enter the contest as many times as you want, the options
are endless!

If you like the idea of empowering Canada but would rather
do so
anonymously… that’s ok too! We will be accepting
submissions from both
participants who wish to share their thoughts publicly and
from
participants who would like to see their work published
anonymously in a
book of pro-choice compilations. Of course, in order to be
considered
for the contest you cannot be anonymous, but we would love
to hear from
you either way.



To enter the contest, please visit
www.canadiansforchoice.ca
<http://www.canadiansforchoice.ca/>  and scroll down until
you see the
"Pro-Choice Canada Contest". You can either enter online,
or print off
the submission form and mail in your entry. Please share
this contest
announcement with family members, colleagues, clients and
friends.  Our
goal is to have a wide array of diverse stories and artwork
to present
to the Canadian population in January in celebration of the
Morgentaler
Anniversary. Be a part of this important event… share
your story!

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