Hello
I 'd like to know something about ROXFIBAN.
Is it a biotechnologic drug? I'm a french journalist who publish monthly a
newsletter in french about biotechnology and GMO. that's why if this drug
is made buy genetic engineering, I'will wriute an article about this problem.
Thanks a lot,
Best regards
Christophe NOISETTE
www.infogm.org

At 13:42 29/01/01 -0500, you wrote:


>From:  Vera Hassner Sharav,  President
>CIRCARE: Citizens for Responsible Care & Research,
>               A Human Rights Organization
>              Tel. 212-595-8974    FAX: 212-595-9086
>              veracare@...
>
>
>FYI
>
>"Super-aspirin" pill "is turning out to be a super-failure, perhaps even a
>deadly one."
>
>"Everybody thought this would be the next zillion-dollar drug," says Dr.
>John Ambrose of St. Vincent's Hospital in New York City.
>But "study after study has ended badly -- even shockingly" with 35% more
>deaths reported in patients given these anti-blood clotting drugs in
>clinical trials.
>
>Two articles (below, AP/CNN and CBS-HealthWatch) report that cardiologists
>are split about the continuation of Dupont's multi-site clinical trials that
>will involve 2,200 patients to test its anti-blood clotting drug, Roxifiban.
>
>According to the articles (below) Dupont refuses to halt clinical trials on
>patients whereas the other pharmaceutical companies "have thrown in the
>towel on this line of research because the drugs seem to do more harm than
>good."
>Defending the continuation of Dupont's trial, is Harvard's Christopher
>Cannon, MD, a cardiovascular specialist who (the articles report) chairs
>Brigham & Women's Hospital data safety monitoring board, the committee
>overseeing the roxifiban trial.
>
>What information, we wonder, are the patients being given before they sign
>consent?
>According to CBS, "The study's sponsor turned down a request to provide the
>informed consent document, which participants must read before joining the
>trial."
>
>An online survey by a prominent heart organization (www.theheart.org) who
>polled its readers--mainly cardiology professionals--found that 95% would
>not sign up themselves.
>
>Would Vice President Dick Cheney consider signing up?
>
>~~~~~~~~~~~~~~~~~~~~~~~~
>
>
>
>http://healthwatch.medscape.com/medscape/p/gcommunity/HNews/HnewsPrint.asp?R
>ecID=232917
>Heart Drug On Its Deathbed
>
>
>By Eric Sabo
>
>Jan. 29 (CBSHealthWatch)--Getting patients to test some unproven treatment
>for the sake of science is no easy task, but consider the troubles facing
>investigators for a study on the experimental anti-blood clotting drug,
>roxifiban:
>
>
>Out of some 4,300 heart disease patients who have been studied so far, there
>were roughly 35% more deaths in the groups given a similar type drug
>compared to those who took something else.
>
>Other pharmaceutical companies have thrown in the towel on this line of
>research because the drugs seem to do more harm than good.
>
>And a leading heart expert is calling for a ban on human tests of roxifiban
>and other like-minded therapies until scientists can figure out what went
>wrong.
>
>Would you join this trial? An online survey by a prominent heart
>organization (www.theheart.org) found that 95% of their cardiology readers
>would not sign up themselves. But some researchers are hoping that as many
>as 2,000 patients with peripheral artery disease will put aside these
>concerns to take part in the ongoing roxifiban study, which is being
>sponsored the drug's manufacturer, Dupont Co. It could be a hard sell.
>
>Despite promising results when heart patients are given these drugs
>intravenously, the pill form has proved disappointing. A review published in
>the January 16 issue of the journal Circulation sums up the gloomy
>experience with the drugs to date: All told, four trials of three different
>so-called oral glycoprotein inhibitors failed to prevent heart attacks and
>strokes in patients with underlying heart problems. Instead, the drugs
>seemed to cause considerable harm, which some blame on inherent limitations
>in the way this class of therapies is designed.
>
>"All these drugs share the same problems," says Eric Topol, MD, a heart
>specialist at the Cleveland Clinic who lead one glycoprotein drug trial and
>is now calling for an end on similar experiments.
>
>Nevertheless, Dupont is currently the only company pursuing large-scale
>human tests of a glycoprotein pill. The lead investigator, William Hiatt,
>MD, from the University of Colorado, admits there is reason for caution, but
>he says they are taking extra steps to ensure that the subjects are as safe
>as possible.
>
>"We aren't just blindly continuing this study," says Hiatt. "There has been
>a lot of hand wringing and thoughtful consideration as to what should
>happen."
>
>More than 200 patients have enrolled in the study so far, and Hiatt says
>they will stop the trial if a once a month review of the data turns up any
>problems. But Topol of the Cleveland Clinic says that similar precautionary
>measures in their glycoprotein drug study didn't find dangers until it was
>too late.
>
>"We followed the patients closely, but that wasn't good enough," he says.
>
>Should patients enrolled in the roxifiban study be made aware of these
>warnings? Hiatt says that the subjects are fully informed about any
>potential risks. The study's sponsor turned down a request to provide the
>informed consent document, which participants must read before joining the
>trial.
>
>"Specifically we state in the consent form that other studies using drugs
>similar to roxifiban did not demonstrate benefits, and in fact showed excess
>side effects, including death," Hiatt explains in an e-mail.
>
>"Technically, we don’t have to do that since it's a different drug," he
>says.
>
>But Topol argues that patients might need to know more. "Any drug may have a
>risk of death, but this is a much bigger deal," he says.
>
>At the very least, the subjects should be made aware that this class of
>drugs has been associated with 35% higher death rate, according to Topol.
>
>"If patients aren't being told that," he says, "then that's bad stuff."
>
>Christopher Cannon, MD, a cardiovascular specialist at Harvard University
>who sits on committee overseeing the roxifiban trial, says he is sure that
>all the safe guards are in place. After much deliberation, an independent
>review board agreed that roxifiban poses less of a risk than the other drugs
>and is certainly important enough to continue on in testing.
>
>"You have to also look at the ethics of denying a population that may lose a
>potentially effective agent because of the safety concerns from other trials
>being extended on to this one," says Haitt.
>
>Still, there is enough general unease that investigators will stop the
>roxifiban study at the first signs of trouble. On January 30th, researchers
>plan to review lab tests to see if there is any indication that the drug ups
>the risk for a heart attack or stroke.
>
>"If we find any abnormalities, we might stop this trial," Hiatt says. "If
>that happens, this drug class is probably history."
>
>  © 2001 by Medscape Inc. All rights
>
>~~~~~~~~~~~~~~~~
>
>http://www.cnn.com/2001/HEALTH/01/27/super.aspirin.ap/
>AP / CNN
>
>Heart doctors debate ethics of testing super-aspirin
>
>Topal has directed two large studies of super-aspirin
>
>January 27, 2001
>Web posted at: 8:34 p.m. EST (0134 GMT)
>
>BOSTON (AP) -- Super-aspirin is turning out to be a super-failure, perhaps
>even a deadly one.
>
>Five years ago, when large-scale testing began, researchers were optimistic
>that the drug would improve on the plain two-cent variety, which is still
>the most important medicine for heart disease.
>
>But study after study has ended badly -- even shockingly. Now some believe
>the pharmaceutical industry should call it quits. Stop the testing, they
>say, because super-aspirin may actually kill more volunteers than it saves.
>
>The drugs are a class of blood thinners known technically as IIb/IIIa
>antagonists. They are already injected to keep blood vessels flowing
>smoothly after angioplasties and mild heart attacks. But drug companies
>envisioned a larger market for these medicines in a new pill form.
>
>The medicines are not to be confused with an entirely different class of
>drugs -- the cox-2 inhibitors, including Celebrex -- which are used to treat
>arthritis and are also sometimes called super-aspirin.
>
>Instead, they would be taken by millions of people with bad hearts to ward
>off heart attacks, strokes and death. Just like aspirin, the thinking went,
>only more effective, and of course, a lot more expensive.
>
>The companies have spent hundreds of millions to prove super-aspirin works
>as well in practice as it ought to in theory. About 42,500 volunteers have
>tested four slightly different kinds in five large studies.
>
>Each time, though, the outcome was the same. Super-aspirin not only fails to
>prevent heart attacks; it actually kills people.
>
>Enough, says Dr. Eric Topol, cardiology chief at the Cleveland Clinic. He
>figures that in those five studies -- two of which he directed -- between
>150 and 200 volunteers probably died from the treatment itself.
>
>Nevertheless, the testing continues. A study of DuPont Pharmaceutical's
>super-aspirin, called roxifiban, began last July. It will enroll 2,200
>patients in North America and Europe by the end of this year.
>
>Should DuPont let the study go on? Is it even ethical to do so? Top-tier
>cardiologists argue both sides.
>
>Some agree with Topol. Considering the results so far, these drugs are too
>dangerous to keep testing on people. Others contend the study's risks will
>be slight if it is stopped at the first hint of trouble. Furthermore, there
>are reasons to think roxifiban will work better than the other
>super-aspirins, they say, and it would be tragic to give up on a treatment
>that could still prove to be a life saver.
>
>An effective super-aspirin could certainly be that. As good as aspirin is,
>it reduces the risk of death from heart disease by only about 20 percent,
>and doctors yearn for something more powerful.
>
>But doubts that super-aspirin will ever be the answer have grown over the
>past two years. The latest setback came shortly before Christmas. A
>committee of doctors held its quarterly meeting at a Boston hotel to go over
>data from BRAVO, a big study of a super-aspirin called lotrafiban.
>(Cardiologists love to give their studies catchy acronyms. BRAVO stands for
>Blockade of the IIb/IIIa Receptor to Avoid Vascular Occlusion.)
>
>The committee, called the data and safety monitoring board, worked
>independently of the study's lead doctors and corporate sponsor, SmithKline
>Beecham. Its job was to make sure the study was not hurting anyone. It had
>the authority to peek at the ongoing results, something the other doctors
>involved c by 36 percent. A statistical fluke? Unlikely. The chance of that
>was perhaps one in 100,000.
>
>Many of the extra deaths seemed to be cardiac arrests, which could have been
>triggered by blood clots, the very thing super-aspirin is supposed to
>prevent. But still, no one was sure.
>
>In their injected form, IIb/IIIa antagonists are widely used and considered
>highly effective. They work by subduing platelets, the blood cells that form
>clots. When injected, the drugs can stifle platelets' tendency to clump
>together by 90 percent or more. This is useful in some hospital situations
>when the risk of dangerous clots is especially high. But the probability of
>unintended and possibly disastrous bleeding is too high to continue this
>treatment indefinitely.
>
>The pill form is less powerful. It inhibits platelets about 50 percent.
>Still, this is potent medicine, and it seemed logical it would help people
>with serious heart disease, since misguided clots are the primary trigger of
>heart attacks and strokes.
>
>"Everybody thought this would be the next zillion-dollar drug," says Dr.
>John Ambrose of St. Vincent's Hospital in New York City.
>
>Researchers have several theories about what went wrong. Maybe super-aspirin
>somehow triggers heart cells to commit suicide. Or perhaps it sets off a
>wave of inflammation.
>
>However, the leading theory is that the pills fail because of their halfway
>action. In hindsight, it appears that partially disabling the body's
>clot-making machinery this way is a bad idea.
>
>These drugs, whether injected or swallowed, work by sticking to the
>fibrinogen receptod in every test done, and it is perfectly reasonable to
>test it. We are doing that as carefully as possible," says Dr. Christopher
>Cannon of Boston's Brigham and Women's Hospital, head of the data monitoring
>board.
>
>But opinions among cardiologists are split over whether the drug is
>different enough to reasonably expect a better outcome. Among those in doubt
>is Duke's Tcheng.
>
>"I agree with Eric 100 percent," he says. "I think the roxifiban trial
>should be stopped. Unless you have a completely different therapeutic
>approach, not just a different drug, you are more likely than not to repeat
>history."
>
>Dr. Donald Easton, a neurologist from Brown University who co-chaired BRAVO
>with Topol, also admits to misgivings about the study. But he thinks it
>should continue because of the possibility it will produce a useful, needed
>medicine to prevent the leading cause of death.
>
>"I try to keep in mind on the positive side that these drugs do work in
>other situations, and the disease we are treating is not acne," Easton says.
>"It's death and disability."
>
>Copyright 2001 The Associated Press.
>
>  ~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~
>
>
>
>
>
>Community email addresses:gwolbrin@...
>   Post message: Bioethics@egroups.com
>   Subscribe:    Bioethics-subscribe@egroups.com
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>
>Shortcut URL to this page:
>   http://www.egroups.com/community/Bioethics

I am generally appreciative of the materials posted to the list by
CIRCARE, because they alert us to serious abuses in science and
medicine that need to be addressed.  The Wesley J. Smith article
"Cloning Reality" is a different type of article from the many others
supplied by CIRCARE in that, rather than dealing with actual
abuses, the author speculates about possible future abuses.

It is good to attempt to predict a bad turn of events so as to take
preventive measures.  However, I have not been convinced by the
Smith article that cloning is inherently evil or that it necessarily
leads to evil.  Cloning is a tool which may be used for numerous
different purposes.  I found about a list of nearly a dozen at web
site http://www.religioustolerance.org/cloning.htm.  Each proposed
use has to be evaluated separately.

In the article Smith's main concern is eugenics.  The fact that
cloning may be used in the service of eugenics is not a reason to
ban all cloning.  In fact, cloning seems to have little to do with
eugenics.  Cloning does not modify the genome or eliminate traits
eugenicists might consider undesirable.  All it could do for
eugenics is to gradually propagate modifications that would have
been produced by other means.  If the goals of eugenics are the
real problem, a more direct approach would be to ban eugenic
modification of the human genome.

Phil Tompkins
Amherst, Massachusetts

Genetics and Insurance Information Gathering Day

What: The Human Genetics Commission (HGC) is holding a genetics and insurance
information gathering
day. The aim of this meeting is to hear and discuss all sides of the 'genetics
and insurance'
debate with experts and stakeholders.
Where: Royal Commonwealth Club, 18 Northumberland Avenue, London, SW1.
When: 10.00am – 4.00pm, Friday 9 February 2001.
Who: Speakers for the day include:
Mr Harry Cayton, Alzheimer's Society
Professor Angus McDonald, Herriott Watt University
Professor Andrew Read, British Society for Human Genetics, Manchester
Mr Stephen Sklaroff, Association of British Insurance.


Members of the public are invited to attend but tickets are limited and
available on a first come,
first served basis. Please contact Margaret Straughan at the HGC on 020 7972
1518 or email HGC with
your details.

For press information please contact Barney Wyld or Charlotte Grant in the HGC
press office on 020
7838 4897 or e-mail: hgcpressoffice@...

http://www.dti.gov.uk/hgac/

'WHOSE HANDS ON YOUR GENES?'

A consultation on the storage, protection and use
of personal genetic information

The Human Genetics Commission (HGC) is an independent body that advises the
Government on policy
issues in the field of human genetics.

We are currently looking at the uses of personal genetic information, to see
what if anything
should be done to address people's concerns about possible abuses of such
information. We have
identified a broad range of questions about these issues which we are putting to
public
consultation, and will then draw up our recommendations in 2001.

These questions are set out in detail in the main section of text, along with
relevant background
information. We have also summarised key issues and questions in the 'tick-box'
summary section for
people who would prefer to give a shorter response.

HGC welcomes responses to any or all of the questions contained in both the main
section and the
summary by 28 February 2001.

We may wish, in future, to make the responses to this consultation exercise
publicly available. If
you are happy with this, please tick the appropriate box (present in Section 11
of the main text or
in your address details section of the summary), otherwise your views will be
treated in
confidence.

You can select the main text in one of two different formats, Portable Document
Format (PDF) or
Rich Text Format - click on the appropriate format. The summary section can be
replied to on-line
or can be printed out - select the HTML or the PDF link respectively.
If you choose to use a PDF file, you will need the appropriate version of the
Acrobat Reader; this
is freely available if you do not already have it. People with visual
difficulties may find it
useful to investigate access.adobe.com for services provided to improve the
accessibility of
Acrobat documents.

Main text for detailed responses   Summary and
tick box responses
PDF   on-line HTML
Rich Text Format   PDF


Please send written responses to:
Baroness Helena Kennedy
Chair, Human Genetics Commission
FREEPOST LON15502,
Maidenhead
SL6 2BZ

or email them to: hgc@....
    Further copies can be obtained by:
phoning 0800 555777 (for single copies),
faxing 01623 724524, or
emailing doh@...
(This had been incorrectly given as doh@...).

to take part in this public consultation, go here:

http://www.hgc.gov.uk/business_consultations2summary.htm


WHOSE HANDS ON YOUR GENES?
A SUMMARY

Please click in the boxes that apply and then click the Submit button at the end
of the form to
send your response to the Human Genetics Commission.

This form has 3 sections:
Section A: Personal genetic information
Section B: Why people have genetic tests
Section C: Uses of genetic information

http://www.medinfo.cam.ac.uk/phgu/newsletter/default.asp

NEWSLETTER No. 30, January 2001

The PHGU newsletter features news and views about genetics and genetics
research,
from a public health perspective. New items are added to the newsletter
throughout each month

The newsletter is written by Dr Alison Stewart (PhD), Chief Knowledge Officer,
Public Health
Genetics Unit. Statements and opinions contained in the newsletter do not
necessarily reflect the
views of the National Health Service.


Contents
  News    New reviews
  Journal club    Events

_______________________________________________________________________

Genetic Services Enquiry Centre
Confidential Enquiry into Genetic Counselling by Non-Geneticists (CEGEN)
http://www.medicine.man.ac.uk/geneticenquiry/counsell.htm



Existence and quality of written antenatal screening policies in the United
Kingdom: postal survey
http://www.bmj.com/cgi/content/full/322/7277/22

http://www.babymilkaction.org/press/press27jan01.html







Cameroon group launches Nestlé boycott -
More UK pop stars dump Nestlé
27 January 2001
Nestlé is coming under renewed pressure to end its aggressive promotion of
breastmilk substitutes
as an African group launches a boycott of its products, such as Nescafé coffee.
Meanwhile in the UK
more pop stars have blocked the use of their songs by Nestlé in a promotion for
the V2001 musical
festival or television advertisements.

The New Musical Express (dated 28th January - but available now) reports that
Ocean Colour Scene
and Shed 7 have joined Pulp, Dodgy and Ian Brown in taking action in support of
health campaigners
who are calling for Nestlé to bring their baby food activities into line with
the marketing
standards adopted by the World Health Assembly. According to UNICEF reversing
the decline in
breastfeeding could save the lives of 1.5 million infants around the world every
year. The European
Parliament investigated Nestlé in a Public Hearing last year (22nd November),
but Nestlé refused to
send a representative.

The Non-Governmental Organisation Cameroon Link decided to launch the boycott to
protest about
Nestlé's promotion of breastmilk substitutes in health facilities in Cameroon
and marketing
malpractice around the world. Nestlé is reportedly promoting Guigoz and Nan
infant formula in
health centres with film shows. Today Cameroon Link has been accepted as a
member of the
International Nestlé Boycott Committee (INBC), Baby Milk Action announces at its
AGM in Cambridge.
Baby Milk Action acts as the secretariat for INBC. Cameroon becomes the 20th
country where
nationals have launched the boycott and the first in Africa.

James Achanyi-Fontem, President of Cameroon Link, said: "If every Cameroonian
joins in this
boycott, it may act as a powerful tool which may very quickly bring changes to
the marketing in
Cameroon. This action is a world wide action and Cameroon is not an exception as
far as violations
of the International Code and Resolutions are concerned."

Mike Brady, Campaigns and Networking Coordinator at Baby Milk Action, said: "I
implore journalists
and campaigners from around the world to take an interest in this issue. When
Nestlé malpractice is
exposed we are often able to bring about change. Acting locally really does have
a global impact."

For further information contact: Mike Brady, Campaigns and Networking
Coordinator, Baby Milk
Action, 23 St. Andrew's Street, Cambridge, CB2 3AX. Tel: 01223 464420. Mobile:
07946 352846

Latest media coverage: BMJ 27 January 2001

Notes for editors

For further information and for pictures for publication see the "codewatch" and
"resources"
sections. For information on the International Baby Food Action Network (IBFAN)
visit www.ibfan.org


The International Code of Marketing of Breastmilk Substitutes was adopted by the
World Health
Assembly in 1981 as a "minimum requirement" to be implemented by Member States
"in its entirety."
Subsequent Resolutions have addressed questions of interpretation and changes in
marketing
practices and scientific knowledge. Where water is unsafe an artificially-fed
child is up to 25
times more likely to die as a result of diarrhoea than a breastfed child. The
cost of formula can
lead to parents overdiluting formula, leading to malnutrition.


Cameroon brings the total of boycott countries to 20: Australia, Bulgaria,
Cameroon, Canada,
Finland, France, Germany, Ireland, Italy, Luxembourg, Mauritius, Mexico, Norway,
Philippines,
Spain, Sweden, Switzerland, Turkey, UK and USA. Nestlé is targeted because
monitoring finds it to
be responsible for more violations of the International Code and Resolutions
than any other company
and because it takes the lead in attempting to undermine government
implementation of these
measures.


In May 1999 the Advertising Standards Authority upheld all of Baby Milk Action's
complaints against
a Nestlé anti-boycott advertisement in which the company claimed to market
infant formula
"ethically and responsibly." (see press release). In 1995 Baby Milk Action was
called on to defend
claims made in a boycott advertisement. The ASA found in favour of Baby Milk
Action. The claims
were: "Over 4,000 babies die every day in poor countries because they're not
breastfed. That's not
conjecture, it's UNICEF fact" and "They [Nestlé] aggressively promote their baby
milks, breaking a
World Health Organisation code of marketing."


Marketing Week magazine asked Marjorie Thompson of Saatchi & Saatchi how Nestlé
should respond to
the bad publicity surrounding its baby food marketing activities and reported
(11th February 1999):
"She suggests the way to counteract the bad publicity is to go on the offensive
by using
advertising showing the benefits of Nestlé's financial contributions to
charities..." NCH (formerly
National Children's Homes) is one of the charities to refuse Nestlé money.
Others, such as the
British Red Cross, have accepted substantial sums and subsequently promoted
Nescafé (the principal
target of the boycott) and defended Nestlé's baby food marketing activities.


On 22nd November 2000 the European Parliament Development and Cooperation
Committee held a Public
Hearing into the baby food industry. IBFAN and UNICEF made presentations. MEPs
were shocked and
outraged when Nestlé refused its invitation to make a presentation on the
monitoring process it
claims to have put in place to ensure compliance with the marketing
requirements. For further
information contact Richard Howitt MEP, who arranged the Hearing, on + 32 2 284
5477 and see Baby
Milk Action's press release. Adidas was investigated at the same Hearing and
also refused to
attend. On the Mark Thomas Product on Channel 4 Television this week (25th
January), David
Husselbee, Global Director of Social and Environmental Affairs, Adidas, said:
"With hindsight we
accept that we should have been at the meeting in November". So far Nestlé has
made no such
admission.

From:  Vera Hassner Sharav,  President
CIRCARE: Citizens for Responsible Care & Research,
               A Human Rights Organization
              Tel. 212-595-8974    FAX: 212-595-9086
              veracare@...


original message:
  From: "Bryan Vernon" <B.G.Vernon@...>
Subject: Re: Article on the Use of Third World People in US-F


>What nationality will the workers in this office be?

  I don't believe there are concrete plans to open an International office
anytime soon..... the U.S. Government hasn't even set up offices for the new
(almost 7 month old) Office of Human Research Protections (OHRP).  A smaller
staff is housed where its predecessor, the Office of Protection from
Research Risks (OPRR)was--in the National Institutes of Health, which is the
fox minding the chickens.....

Vera Sharav

Dear Clair,

Hope you are thriving.  Thanks very much for sending this on.
Best, Shelley Tremain



slowly@... wrote:
>
> Genetic Services Enquiry Centre
> Confidential Enquiry into Genetic Counselling by Non-Geneticists (CEGEN)
> http://www.medicine.man.ac.uk/geneticenquiry/counsell.htm
>
> Existence and quality of written antenatal screening policies in the United
Kingdom: postal survey
> http://www.bmj.com/cgi/content/full/322/7277/22
>
>
> Community email addresses:gwolbrin@...
>   Post message: Bioethics@egroups.com
>   Subscribe:    Bioethics-subscribe@egroups.com
>   Unsubscribe:  Bioethics-unsubscribe@egroups.com
>   List owner:   Bioethics-owner@egroups.com
>
> Shortcut URL to this page:
>   http://www.egroups.com/community/Bioethics

On 31 Jan 2001, at 12:56, Christian Munthe posed these questions:

> The article conjectures: "Human cloning is a crime against human dignity
> and humanity".
>
> Do you pepole agree? If so, why?
>
> If a person i created through a cloning procedure a la Dolly and this
> person suffers no serious damages, who have then been wronged? Why would
> that person be less "dignified" than other persons? And what does that
> MEAN?? The person would be just like all of us, it's just that his/her
> early history would be a bit different. In what way would other humans or
> "humanity" suffer from such an event?


Christian's questions deserve answers.  Since no one has
volunteered any, I thought I would try playing devil's advocate.  Here
are summaries of some arguments I have read.

THERAPEUTIC CLONING

It has been claimed that embryos have an inherent dignity that is
derived from or based on what has variously been described as
their "spiritual dimension" or their nature as persons or because
they are ends in themselves or because they are created in the
"image of God" or are gifts from God.

Therapeutic cloning, which would be done for such ends as to
create cultured tissues for use in transplantation, violates this
dignity by treating embryos as raw materials in a manufacturing
process.

REPRODUCTIVE CLONING

Reproductive cloning may involve selection of people on the basis
of some particular trait or traits so as to accomplish some purpose
other than simply reproducing. This implies "using" people and not
accepting them for who they are.

The resulting individual may claim a right to not have had his/her
characteristics preselected.

I would be very interested in any responses.

Phil Tompkins

May I invoke one of the elements of the Precautionary Principle (which many
of us have been fighting to get better-recognized in international and
domestic laws):  the burden of proof should be on the proponent of the new
technology, the one who wishes to alter the natural order of things.  it is
the proponents of cloning who must bear the burden of demonstrating why we
should do it, not my burden to prove that it is a crime or anything
else.  There are, in fact, no good reasons to do cloning, certainly none
that the proponents have put forward,  so we don't need to show it would be
"criminal".  Until they discharge their burden (if I may use the legal
terminology in analogy)  the obligation doesn't shift to us.

Phil


At 12:06 AM 2/3/01 -0500, Phil Tompkins wrote:
>On 31 Jan 2001, at 12:56, Christian Munthe posed these questions:
>
> > The article conjectures: "Human cloning is a crime against human dignity
> > and humanity".
> >
> > Do you pepole agree? If so, why?
> >
> > If a person i created through a cloning procedure a la Dolly and this
> > person suffers no serious damages, who have then been wronged? Why would
> > that person be less "dignified" than other persons? And what does that
> > MEAN?? The person would be just like all of us, it's just that his/her
> > early history would be a bit different. In what way would other humans or
> > "humanity" suffer from such an event?
>
>
>Christian's questions deserve answers.  Since no one has
>volunteered any, I thought I would try playing devil's advocate.  Here
>are summaries of some arguments I have read.
>
>THERAPEUTIC CLONING
>
>It has been claimed that embryos have an inherent dignity that is
>derived from or based on what has variously been described as
>their "spiritual dimension" or their nature as persons or because
>they are ends in themselves or because they are created in the
>"image of God" or are gifts from God.
>
>Therapeutic cloning, which would be done for such ends as to
>create cultured tissues for use in transplantation, violates this
>dignity by treating embryos as raw materials in a manufacturing
>process.
>
>REPRODUCTIVE CLONING
>
>Reproductive cloning may involve selection of people on the basis
>of some particular trait or traits so as to accomplish some purpose
>other than simply reproducing. This implies "using" people and not
>accepting them for who they are.
>
>The resulting individual may claim a right to not have had his/her
>characteristics preselected.
>
>I would be very interested in any responses.
>
>Phil Tompkins
>
>
>
>Community email addresses:gwolbrin@...
>   Post message: Bioethics@egroups.com
>   Subscribe:    Bioethics-subscribe@egroups.com
>   Unsubscribe:  Bioethics-unsubscribe@egroups.com
>   List owner:   Bioethics-owner@egroups.com
>
>Shortcut URL to this page:
>   http://www.egroups.com/community/Bioethics

************************************************

Philip L.  Bereano
Professor
Department of Technical Communication
College of Engineering
Box 352195
University of Washington
Seattle, Wash.  98195

phone:  (206) 543-9037
fax:       (206) 543-8858
***************************

Now as this is a list which should primarily look at the impact on
disabled people may be some want to comment on Christans following part.
Indeed I believe it is for disabled people often problematic when the
safety reason is invoked because it nearly automatically works with a
medicalized individual model of disability and reinforces willingly or
unwillingly the already negative view of disabled people.



the below from Christian Munthe excerpt of a mail from the 31th. of
Jasnuary
Perhaps the best answer would be: but cloning is very unsafe, it will most
probably lead to a damaged child. This argument works as long as this claim
is true, but not necessarily eternally. Also, the lack of safety may be
outwheighed by other factors. Moreover, from a disability standpoint, this
line of reasoning would seem to be rather problematic, since it seems to
rest on the assumption that it is morally wrong willingly to bring damaged
children into existence. This seems to imply that saying no to prenatal
diagnosis and selective abortion of damaged fetuses is just as wrong as is
cloning... As a matter of fact, all people at risk for having damaged
children should abstain from procreation according to this line of thought.

Christian Munthe wrote:
>
> The article conjectures: "Human cloning is a crime against human
> dignity and humanity".

The argument that underlys this doesn't come from the condition of the
potential progeny of this process but rather the process itself.

One of the key things that give the human being its intrinsic value,
that
causes such strong mores as the porhibition against murder is the
human's irreplacability. Since life is so fragile at this date (placing
a pebble right here on the timeline) life is more valuble than anything.
No quantity of gold could buy back a human life. Now lets bring in the
kicking team and punt the pebble down the line a bit...

In this future time, A human being, or any other lifeform for that
matter, is worth only what it takes to produce it. Instead of being a
chance event that costs hundreds of thousands of dollars and the
cooperation of hundreds of people to bring to adulthood, you instead
have a machine that can stamp humanoid lifeforms that may be superior to
humans in almost every measure like BiC pens. The pen, of that brand, I
have here in front of me cost me about 15¢.

This outrages people because they understand that if new people can be
had for trivial sums then any person, including theselves, is worth only
that much. It scares the hell out of them...

I don't think it matters at all but then I come from a rather unusual
philisophical backround. (transhumanism)


> Do you pepole agree? If so, why?

I don't, Not at all.

--
Perhaps I will upgrade my OS from Win 3.11...
But It has to be more sophisticated than Win 3.11.
As well as less complicated than Win 3.11.
*AND* It must run on THE MACHINE!!!!
http://users.erols.com/alangrimes/  <my website.
Any usage of this e-mail account is subject to the terms and conditions
specified on my website.

Circare wrote:

> The new medical ethics has
> been shaped--neither by a reservoir of moral wisdom nor public
> standards of morality--but by a new school of moral arbiters,
> bioethics, which came into being afterr WW II. Bioethicists assume that
> they have a right to redefine moral values, and to take a chance, by
> giving biotechnology permission "to direct the future evolution of
> humanity."

That cannot be done.
Well it could but first I would have to have complete controll over all
humans. Specificly I would need comlpte controll over their reproductive
faculties... I suppose the best way to do that would be to unload
massive ammounts of the drug used to castrate sex offenders into the
water supply and administer it at any natural birth. From there I would
be in the position to dictate the next step in evolution. As for the
future of evolution, Well I'd have to be there to make another such
adjustment.

I am not that kind of evil.
I do not seek to dictate *anything*.
I could argue with you for hours over the nature of the universe but I
cannot do anything to change it.
In the course of human affairs, a realm over which I have considerably
more influence than the laws of gravity I only seek to thwart and
undermine people who DO seek to dictate to me anything you could name.

Most notably, in this context, I seek to frustrate those who would
propose to stop or hinder the progress of technology.

In this small regard I consider myself to be Good, the perfect
antithesis of the scenerio I began this section of my reply with...


>  The patriarch of bioethics, Joseph Fletcher, advocated the creation of
> "para-humans" part animal/part human to do the menial jobs--i.e.,
> slave laborers.

Oh, So bioethicists are now the Enemy. That's refreshing. =)

Okay back to the hard argument... This scenereo of creating a genetic
underclass to do labor is ANCIENT HISTORY!

Case and point: The ancient Hindu, of the Indian subcontinent, were
brilliantly successful in their breeding program... The caste system
that they established has resulted in the widest diversity of
intelligence that can be found on the face of the planet. Some of the
most brilliant people on the planet are hindu, and also quite a few
people who have little hope of ever constructing a gramatical
sentance...

I am having such difficulties right now as I have been reading and
writing intensively the entire day. It is difficult working with a brain
that wears out so quickly. =*(

The time is 8:20 pm and I slept longer last night than I usually do.


> But cloning threatens the cornerstone of our Western civilization.
> Unlike the literary Faust, it won't be those who made the pact with
> the Devil who will pay the price for their moral folly--we will.

Say What?
People have had genetic advantages since before there were people...
If you are talking about supporting Abominations, then the question
becomes wheather to persist in this notion of compulsory charity that
western civilization has imposed on the healthy...


> What are these supposedly "finest" genotypes?

Everybody in the field has his own vision... And nobody should be
pre-emptively barred from persuing it so long as it doesn't infringe on
any your expressed, implied, or assumed rights.


> Yet Fletcher, Silver, and most others of their ilk almost always miss
> the point that smart people are not necessarily good people.

That's not the issue.
My brain is utterly inadiquate for and incapable of the things which I
require.
I therefore seek that this problem be solved.

That is the beginning and the end. There is no "fettish" or foolishness
about it. I say this as I would say that I require a stronger cable to
lift an elevator safely.


> And they rarely discuss designing people with the most important human
> capacities of all:

Any statement that begins anything like this should be marked as being
completely and totally subjective.

> the ability to love unconditionally,

Discrimination is the gift of higher intelligence.
There is the good and there is the not so good.
There are the things that are, such as varriation among people.
Three are aditudes and beliefs among those people that will assist you.
And there are aditudes and beliefs among some people who will hinder
you.
One such belief that invariably hinders is this idea that anything not
nailed down by the laws of physics is or should be "unconditional."

> gentleness,

I will agree with this as a general asthetic but I must also require
that it be paired with the capacity to act with the most extreme and
prejudiced visciousness when it is neccessary and appropriate.

A human race that is de-clawed by a well intentioned biotechnology
cannot survive. I am in the process of writing a story that tries to
make this point.

> empathy,

The capacity for empathy cannot be argued against.
The action based on that empathy should be reasonable, deliberate, and
conditional.

> the deep desire to be helpful and productive.

Any "deep" desire can lead to irrational behavior.


> Ironically, these highest, best human characteristics are often found
> in people with Down syndrome or other developmental disabilities

These are charactoristics that are mirrored from the people who chose to
be involved in the care of such people. It can be argued that they have
no capacity to think in any creative way that does not reflect uppon
those who are around them.

--
Perhaps I will upgrade my OS from Win 3.11...
But It has to be more sophisticated than Win 3.11.
As well as less complicated than Win 3.11.
*AND* It must run on THE MACHINE!!!!
http://users.erols.com/alangrimes/  <my website.
Any usage of this e-mail account is subject to the terms and conditions
specified on my website.

Phil Bereano wrote:

> not my burden to prove that it is a crime or anything else.

It definitely is your burden to proove that it *is* a crime, If you fail
to do so then you have absolutly no right to interfere with their
peaceful and unobtrusive activities.

You see, the long lost principle of democracy is that FREEDOM comes
first. The biotechnologist can do whatever the hell he wants to do
untill such time as you can bring evidence before a judge that prooves
that *YOU* have been harmed DIRECTLY by any of his actions.

I have a strong feeling that you will find it extremely difficult to
proove that activities that are largely confined to a single aparatus of
a single laboratory in a location that is entirely unknown to you, and
possibly quite distant, has had any affect on you, individually,
whatsoever.

--
Perhaps I will upgrade my OS from Win 3.11...
But It has to be more sophisticated than Win 3.11.
As well as less complicated than Win 3.11.
*AND* It must run on THE MACHINE!!!!
http://users.erols.com/alangrimes/  <my website.
Any usage of this e-mail account is subject to the terms and conditions
specified on my website.

-----Original Message-----
Subject: prenatal testing consultation paper objections - still no comment /
interest from the
gods.


this mail was copied to all 40 people who collectively objected last June to the
paper through the
UK DoH Human Genetics Commission (or a sub group of it which is now folded, the
Human Genetics and
Advisory Committeee).


the last available minutes from the Human Genetics Commision group looking at
the prenatal genetic
testing 'public consultation' (paper which we all objected to last year because
it was so
inaccessible) are here:
http://www.hgc.gov.uk/subgroups/genetic_testing_27july.htm

their next planned meeting was october, but no minutes or agenda from that
meeting are showing.
there was apparrently another meeting a couple of weeks ago, of which the
minutes are still not
available.  I check this site regular, late mentions of new consultations seem
to be their
speciality.


from reading the minutes, it seems they have no intention of maiking the paper
accessible (they
haven't mentioned the complaints about lack of access which made up the most
part of their
responses.  they seem to have chosen to ignore their remit of looking into the
social and ethical
issues.  they have decided to simply mention that there are some and leave it at
that becauser they
don't have time to worry about this.




they are also doing two other consultation at the moment which ave also taken a 
long time to reach
the webpages... this one is about the use of genetic information.  it finishes
on 27th Feb
www.hgc.gov.uk/business_consultations2summary.htm  (online survey linked to full
documents up for
comment).  the survey is a good way for some to join in, but is it accessible?

and

""Genetics and Insurance Information Gathering Day
What: The Human Genetics Commission (HGC) is holding a genetics and insurance
information
gathering
day. The aim of this meeting is to hear and discuss all sides of the 'genetics
and insurance'
debate with experts and stakeholders.
Where: Royal Commonwealth Club, 18 Northumberland Avenue, London, SW1.
When: 10.00am – 4.00pm, Friday 9 February 2001.  Members of the public are
invited to attend but
tickets are limited and available on a first come,
first served basis. Please contact Margaret Straughan at the HGC on 020 7972
1518 or email HGC with
your details.""




is it an accessible venue??  and since when does 'all sides of the debate' mean
only those who
profit one way or the other??!!  I don't know what access there is to these.  I
don't know why they
are consulting because they don't seem to care what interested people say..  any
one comments or
ideas what we could do if anything, our last efforts were just ignored?


NB there is also a current inaccessible DoH consultation about the Charging for
Care Services.. at
least they are consistent




clair lewis


P.s   some other info, I do not know these sources so can only assume this stuff
is
real, shocking stuff:

Genetic Services Enquiry Centre: Confidential Enquiry into Genetic Counselling
by Non-Geneticists
(CEGEN)
http://www.medicine.man.ac.uk/geneticenquiry/counsell.htm


Existence and quality of written antenatal screening policies in the United
Kingdom: postal survey
http://www.bmj.com/cgi/content/full/322/7277/22

Ah, nice to have some response! Comments below!

Christian

>On 31 Jan 2001, at 12:56, Christian Munthe posed these questions:
>
>> The article conjectures: "Human cloning is a crime against human dignity
>> and humanity".
>>
>> Do you pepole agree? If so, why?
>>
>> If a person i created through a cloning procedure a la Dolly and this
>> person suffers no serious damages, who have then been wronged? Why would
>> that person be less "dignified" than other persons? And what does that
>> MEAN?? The person would be just like all of us, it's just that his/her
>> early history would be a bit different. In what way would other humans or
>> "humanity" suffer from such an event?
>
>
>Christian's questions deserve answers.  Since no one has
>volunteered any, I thought I would try playing devil's advocate.  Here
>are summaries of some arguments I have read.

>THERAPEUTIC CLONING
>
>It has been claimed that embryos have an inherent dignity that is
>derived from or based on what has variously been described as
>their "spiritual dimension" or their nature as persons or because
>they are ends in themselves or because they are created in the
>"image of God" or are gifts from God.
>
>Therapeutic cloning, which would be done for such ends as to
>create cultured tissues for use in transplantation, violates this
>dignity by treating embryos as raw materials in a manufacturing
>process.

Ok, this is a way to argue, but not a way which makes cloning especially
morally troublesome. The argument implies that any activity having the
destruction of embryos as an effect (e.g., some very common contraceptives,
IVF, all human embryological research ) is as wrongful as therapeutic
cloning. That these embryos have been produced by cloning is not the thing
that makes these activities wrong, i.e., the production of an embryo
through nuclear transfer from a somatic cell to the "shell" of an oocyte is
perfectly ok in itself.
>
>REPRODUCTIVE CLONING
>
>Reproductive cloning may involve selection of people on the basis
>of some particular trait or traits so as to accomplish some purpose
>other than simply reproducing. This implies "using" people and not
>accepting them for who they are.
>
>The resulting individual may claim a right to not have had his/her
>characteristics preselected.

Oh well, we have all had our characteristics preselected, haven't we? After
all, our parents were allowed to choose what partner to mate with, when to
procreate with this person etc. All these factors are a part of what
determines our genetic (and social!) makeup (observe, "determines" should
be read in a non-deterministic sense, a bit like "influences").

And yes RP may be used for selecting what kind of people there should be.
But, as we all know, so is sterilisation. Is sterilisation morally wrong?
Moreover, so is good old-fashioned sexual intercourse, free choice of
sexual partner etc....

What's more: suppose RP is the only way for a particular child to come into
being. In that case, RP will not involve selection.

Well, Phil said he tried to play the devil's advocate. I don't know if that
makes me the Lord's legal counsellor (presumably not!). But, I think, Phil,
that you actually made even more clear what's so troublesome in the
standard rhethoric surrounding cloning.

Christian





__________________________________________________________
__________________________________________________________
Christian Munthe, Docent / Associate Professor
Department of Philosophy, Gothenburg University
Box 200, 405 30, Goteborg, SWEDEN
Tel (+46)Ø31-7734843 (Home: (+46)Ø31-7742447)
Fax (+46)Ø31-7734945
Email: Christian.Munthe@...
WWW: http://www.phil.gu.se/munthe/munthe.html

So, what you say is that there are no arguments against cloning as such,
but since there are no arguments for it either, there is no reason to
clone. I accept that in as much as there are no reason to clone, as is the
case at present, especially due to the sheer unsafety of the technical
procedure. However, if this unsafety is reduced (rest assured it will be
sooner or later) and there are couples whose only hope for having (their
biologically own) children is to clone we suddenly have a reason to clone
(at least as much reason as in the case of other types of assisted
reproduction), and then the force of the precautionary argument you advance
diminishes.

Christian

>May I invoke one of the elements of the Precautionary Principle (which many
>of us have been fighting to get better-recognized in international and
>domestic laws):  the burden of proof should be on the proponent of the new
>technology, the one who wishes to alter the natural order of things.  it is
>the proponents of cloning who must bear the burden of demonstrating why we
>should do it, not my burden to prove that it is a crime or anything
>else.  There are, in fact, no good reasons to do cloning, certainly none
>that the proponents have put forward,  so we don't need to show it would be
>"criminal".  Until they discharge their burden (if I may use the legal
>terminology in analogy)  the obligation doesn't shift to us.
>
>Phil
>
>
>At 12:06 AM 2/3/01 -0500, Phil Tompkins wrote:
>>On 31 Jan 2001, at 12:56, Christian Munthe posed these questions:
>>
>> > The article conjectures: "Human cloning is a crime against human dignity
>> > and humanity".
>> >
>> > Do you pepole agree? If so, why?
>> >
>> > If a person i created through a cloning procedure a la Dolly and this
>> > person suffers no serious damages, who have then been wronged? Why would
>> > that person be less "dignified" than other persons? And what does that
>> > MEAN?? The person would be just like all of us, it's just that his/her
>> > early history would be a bit different. In what way would other humans or
>> > "humanity" suffer from such an event?
>>
>>
>>Christian's questions deserve answers.  Since no one has
>>volunteered any, I thought I would try playing devil's advocate.  Here
>>are summaries of some arguments I have read.
>>
>>THERAPEUTIC CLONING
>>
>>It has been claimed that embryos have an inherent dignity that is
>>derived from or based on what has variously been described as
>>their "spiritual dimension" or their nature as persons or because
>>they are ends in themselves or because they are created in the
>>"image of God" or are gifts from God.
>>
>>Therapeutic cloning, which would be done for such ends as to
>>create cultured tissues for use in transplantation, violates this
>>dignity by treating embryos as raw materials in a manufacturing
>>process.
>>
>>REPRODUCTIVE CLONING
>>
>>Reproductive cloning may involve selection of people on the basis
>>of some particular trait or traits so as to accomplish some purpose
>>other than simply reproducing. This implies "using" people and not
>>accepting them for who they are.
>>
>>The resulting individual may claim a right to not have had his/her
>>characteristics preselected.
>>
>>I would be very interested in any responses.
>>
>>Phil Tompkins
>>
>>
>>
>>Community email addresses:gwolbrin@...
>>   Post message: Bioethics@egroups.com
>>   Subscribe:    Bioethics-subscribe@egroups.com
>>   Unsubscribe:  Bioethics-unsubscribe@egroups.com
>>   List owner:   Bioethics-owner@egroups.com
>>
>>Shortcut URL to this page:
>>   http://www.egroups.com/community/Bioethics
>
>************************************************
>
>Philip L.  Bereano
>Professor
>Department of Technical Communication
>College of Engineering
>Box 352195
>University of Washington
>Seattle, Wash.  98195
>
>phone:  (206) 543-9037
>fax:       (206) 543-8858
>***************************
>
>
>
>
>
>
>
>Community email addresses:gwolbrin@...
>  Post message: Bioethics@egroups.com
>  Subscribe:    Bioethics-subscribe@egroups.com
>  Unsubscribe:  Bioethics-unsubscribe@egroups.com
>  List owner:   Bioethics-owner@egroups.com
>
>Shortcut URL to this page:
>  http://www.egroups.com/community/Bioethics


__________________________________________________________
__________________________________________________________
Christian Munthe, Docent / Associate Professor
Department of Philosophy, Gothenburg University
Box 200, 405 30, Goteborg, SWEDEN
Tel (+46)Ø31-7734843 (Home: (+46)Ø31-7742447)
Fax (+46)Ø31-7734945
Email: Christian.Munthe@...
WWW: http://www.phil.gu.se/munthe/munthe.html

NEW: GRHF Online Discussion Forum

The Global Reproductive Health Forum would like to announce its newest
discussion forum - Reproductive Rights, Human Rights. Each week, the GRHF
will post an introductory message describing the topic for that week, and a
set of relevant discussion questions. The introductory message for this week
(Feb. 5 - 9) appears below.

To participate in the discussion, go to
http://www.hsph.harvard.edu/grhf/discuss

**** Week 1: The Human Rights Connection ****

There has been a great deal of emphasis placed on human rights in the last
few decades which has led to the overall acceptance of human rights as an
international norm. This can be seen in the numerous UN conventions,
international treaties, and documents centered around the idea of the
provision and enforcement of universal human rights. Basic human rights
treaties have also been used as a tool to gain numerous other associated
rights- reproductive rights being one example of this. The following excerpt
is from the Cairo Program of Action:

"Reproductive health is a state of complete physical, mental and social
well-being and not merely the absence of disease or infirmity, in all
matters relating to the reproductive system and to its functions and
processes. Reproductive health therefore implies that people are able to
have a satisfying and safe sex life and that they have the capability to
reproduce and the freedom to decide if, when and how often to do so.
Implicit in this last condition are the right of men and women to be
informed and to have access to safe, effective, affordable and acceptable
methods of family planning of their choice, as well as other methods of
their choice for regulation of fertility which are not against the law, and
the right of access to appropriate health-care services that will enable
women to go safely through pregnancy and childbirth and provide couples with
the best chance of having a healthy infant" *

However, there are groups that have traditionally been denied access to
reproductive health services, most notably adolescents. Rebecca J. Cook and
Mahmoud M. Fathalla write: "The Cairo Programme recognizes that the
reproductive health needs of adolescents as a group have been largely
ignored to date by existing reproductive health services. As a result, in
many countries, high rates of adolescent unmarried pregnancy are epidemic,
and in others appear endemic." **

Discussion Questions:

1) How does the human rights framework apply to reproductive rights? What
are the universal rights that relate to reproductive health?

2) Under international human rights treaties, states are both obligated to
refrain from interfering with individual freedoms, and required to take
active steps to promote the exercise of rights. The United States has been
one of the few nations to refuse to sign UN Conventions on human rights-
most notably the Convention on the Rights of the Child and the Women¹s
Convention- in order to avoid the enforcement of these conventions both at
home and abroad. Should the US take a more active role in the promotion and
enforcement of human rights abroad?

3) A basic principle of human rights is that they are so fundamental they
apply to every single human being in any circumstance. Are there cultural
circumstances which prevent universal application of human rights related to
reproduction?

4) When do reproductive rights extend to adolescents? Should adolescents
enjoy the same reproductive rights and freedoms as older individuals (such
as access to reproductive health education and services) even if they are
still being cared for by their parents?

Feel free to discuss the topic freely and openly- if you have other
questions, please post them! The associated readings and resources can
provide a background, but only participants can ignite the discussionŠ

To participate in the discussion, please visit
http://www.hsph.harvard.edu/grhf/discuss


*from Program of Action of the International Conference on Population and
Development, Cairo, Egypt, 5-13 September 1994, paragraaph 7.2

** from "Advancing Reproductive Rights: Beyond Cairo and Beijing", by
Rebecca J. Cook and Mahmoud M. Fathalla,  found in the resources section.


Visit the Global Reproductive Health Forum at
http://www.hsph.harvard.edu/grhf

From:  Vera Hassner Sharav,  President
CIRCARE: Citizens for Responsible Care & Research,
               A Human Rights Organization
              Tel. 212-595-8974    FAX: 212-595-9086
              veracare@...

FYI

"If your're testing kids for valuable information, that's one thing, but if
you're testing them just to make another half billion, that's exploitation."
Carol Ben-Maimon

"Drug Makers Find a Windfall Testing Adult Drugs on Kids," Feb 5, 2001
The Wall Street Journal reports about the drug industry's windfall, thanks
to a law-- which in essence bribes the drug industry with 6 month patent
extension if they  test the drugs on children. "Congress and regulators
warmed to the notion of financial incentives..." In fact, the Journal
reports, some pharmaceutical companies test drugs on children for conditions
not common in children.  Furthermore, the FDA further accommodates
industry's profit margins by extending patents for drugs that were already
known to be safe for children. It even extends their patent for drugs that
were not tested in the form in which they are being sold, but in an
injectable form--e.g., the ulcer drug, Zantac.

The extra "market exclusivity" provided by the law, the WSJ reports, "is
especially valuable for top-selling products." Less profitable, but
important drugs needed for children--such as pain killers--may not even get
promoted by the drug company.  For example, the Journal reports that when
Roche Holding's pain killer, Toradol, was found to be as effective as
morphine for postsurgical pain, with fewer narcotic side effects--it did not
bother to change the insert label because Toradol is "not one of our
promoted products."

The Journal estimates the addition to revenue that the 6 moonth patent
extension provides: for example, Claritin will bring in an additional $975
million;
Prozac will bring in an additional $831 million;
Pepsid will bring in an additional $290 million;

The WSJ reporter is wrong when she states: "the law shows it is also
producing an unintended consequence..."

On the contrary, the millions spent by the pharmaceutical industry to lobby
Congress and Government officials--with assistance from its paid advocates--
has yielded the industry a financial bonanza everytime.

It started with passage of the 1992 Presction Drug User Fee Act (PDUFA)
which ostensibly merely required the drug industry to pay for part of the
FDA's drug approval process costs, but in reality the FDA lost its
independence as a public watchdog agency.  That law opened the door to
conflicts of interest--which now permeate the FDA's drug approval process.
PDUFA  was extended by the 1997 Modernization Act, giving the drug industry
a speeded up drug approval process which has resulted in the approval of
harmful drugs that the FDA has had to recall AFTER the drugs killed people.

The recruitment of children into clinical trials--without adequate
safeguards in place--is an invitation to disaster. It demonstrates how the
Government puts the interests of a powerful industry ahead of the public
interest.  Has the FDA learned nothing from its recent devastating
experience? Devastating for the victims involved in clinical trials testing
the heartburn drug, Propulsid. The FDA had encouraged 100 babies to be
recruited in 1999 to test the drug--the unintended consequence of that trial
was that babies died.

The new policy targeting children / babies as test subjects in clinical
trials, will undoubtedly result in more deaths. According to the WSJ, there
are "about 200 proposals to test drugs on children or infants." If they get
the go-ahead, the companies can expect to earn an additional $6 billion.

"I won't deny it's been a win for industry," says Ian Spatz, Merck's
executive director of public policy.

The voice of the Libertarian is heard in the land. . .   No social
responsibility necessary or desired.

Phil



At 10:26 AM 2/3/01 -0500, you wrote:
>Phil Bereano wrote:
>
> > not my burden to prove that it is a crime or anything else.
>
>It definitely is your burden to proove that it *is* a crime, If you fail
>to do so then you have absolutly no right to interfere with their
>peaceful and unobtrusive activities.
>
>You see, the long lost principle of democracy is that FREEDOM comes
>first. The biotechnologist can do whatever the hell he wants to do
>untill such time as you can bring evidence before a judge that prooves
>that *YOU* have been harmed DIRECTLY by any of his actions.
>
>I have a strong feeling that you will find it extremely difficult to
>proove that activities that are largely confined to a single aparatus of
>a single laboratory in a location that is entirely unknown to you, and
>possibly quite distant, has had any affect on you, individually,
>whatsoever.
>
>--
>Perhaps I will upgrade my OS from Win 3.11...
>But It has to be more sophisticated than Win 3.11.
>As well as less complicated than Win 3.11.
>*AND* It must run on THE MACHINE!!!!
>http://users.erols.com/alangrimes/  <my website.
>Any usage of this e-mail account is subject to the terms and conditions
>specified on my website.
>
>
>
>Community email addresses:gwolbrin@...
>   Post message: Bioethics@egroups.com
>   Subscribe:    Bioethics-subscribe@egroups.com
>   Unsubscribe:  Bioethics-unsubscribe@egroups.com
>   List owner:   Bioethics-owner@egroups.com
>
>Shortcut URL to this page:
>   http://www.egroups.com/community/Bioethics

************************************************

Philip L.  Bereano
Professor
Department of Technical Communication
College of Engineering
Box 352195
University of Washington
Seattle, Wash.  98195

phone:  (206) 543-9037
fax:       (206) 543-8858
***************************

From:  Vera Hassner Sharav,  President
CIRCARE: Citizens for Responsible Care & Research,
               A Human Rights Organization
              Tel. 212-595-8974    FAX: 212-595-9086
              veracare@...

FYI

Recollections of the ice pick lobotomist, Dr. Walter Freeman, induce a level
of fear, outrage, and revulsion, in psychiatric patients that comes close to
the feelings generated by the mention of the Nazi Dr. Mengele. The
difference is that Dr. Mengele's son would not feel free to discuss openly
his father's medical atrocities.  Nor would the Washington Post gloss over
the human carnage--which is the legacy of the doctor at Auschwitz.

Yet, the author of the Post's article (below) seems uncertain about whether
the apparently brutal and cripling surgery is in the medical atrocity
category. Between 40,000 to 50,000 lobotomies were performed Americans
(mostly against their will) at 55 hospitals in the U.S. --including St.
Elizabeth's and NYS Psychiatric Institute.  One of Dr. Freeman's victims was
Sen. Edward Kennedy's sister.


~~~~~~~~~~~~~~~~~~~~~~~~~~~~

http://www.washingtonpost.com/ac2/wp-dyn/A4531-2001Jan30?language=printer
The Lobotomist

By Jack El-Hai
Special to The Washington Post
Sunday, February 4, 2001 ; Page W16


Frank Freeman remembers hiking with his father in the woods, going fishing
with him, and setting off on cross-country driving trips that could last for
weeks. He also recalls one occasion in 1952 when he helped his father
perform a trans-orbital lobotomy on a patient.

The procedure, which his father, Walter J. Freeman, popularized and
perfected, involved first knocking the patient unconscious with two or three
jolts of electricity from an electroshock therapy machine. "I was there to
hold the person's legs down," Frank Freeman says. "We all went for a ride
when he threw the switch."

After the convulsions subsided and the patient lay insensate, Walter Freeman
lifted the patient's eyelid and inserted an ice pick-like instrument called
a leucotome through a tear duct. A few taps with a surgical hammer breached
the bone. Freeman took a position behind the patient's head, pushed the
leucotome about an inch and a half into the frontal lobe of the patient's
brain, and moved the sharp tip back and forth. Then he repeated the process
with the other eye socket.

"I was kind of impressed," Frank Freeman recalls. "He made it look so easy."

For Walter Freeman, a neurologist and psychiatrist who practiced in
Washington for 28 years, it was easy. He kept record of 3,439 lobotomies he
performed during his career. His technique of trans-orbital lobotomy was
such a breeze that he could teach it in a day or two to state-hospital
psychiatrists who, like himself, had no certification in surgery. Freeman
gave lobotomies to children, adults, old people, and people with depression,
manic-depression, schizophrenia, obsessive-compulsive disorder and a variety
of undiagnosed psychiatric illnesses. He believed in lobotomy, defended it,
promoted it and demonstrated it during psychosurgical road trips he took to
more than 55 hospitals in 23 states. He felt certain that lobotomy could
return psychologically disabled people, many of whom had no other prospect
of effective medical treatment and who lived in oppressive psychiatric
wards, to useful lives.

"Lobotomy gets them home" was his motto.

Freeman's enthusiasm for lobotomy, which developed through his work with his
colleague James Watts at George Washington University Hospital, began a wave
of psychiatric surgery that was used on 40,000 to 50,000 Americans between
1936 and the late 1950s. It is difficult to say how many benefited. Few
controlled studies were ever conducted, and Freeman's own summaries of his
results were difficult for others to interpret.

By the time Freeman died in 1972, his theory that mental illness could be
cured by physically attacking the brain's frontal lobes had been
discredited. While things have not exactly come full circle since then,
there is much in today's neuropsychiatric climate that Freeman would
recognize.

Many psychiatrists no longer practice "talk" therapy and instead treat their
patients' brains. In 1999 Surgeon General David Satcher issued a 450-page
report on mental health making the case that many psychiatric illnesses are
actually brain disorders, and that often the most effective treatments
affect the transmission of messages in the brain's neuro-pathways.

Freeman would fully agree. He believed that lobotomy succeeded because it
severed neural connections between the frontal lobes of the brain and the
thalamus, which he characterized as the seat of human emotion. Mentally ill
people were too self-aware, he maintained, and their overactive emotions
caused them to obsess about their problems. Sixty years ago few of Freeman's
colleagues, especially psychiatrists for whom psychotherapy was the
preferred treatment for psychiatric disorders, believed that brain disorders
caused mental illness. Now we live in an era in which a biological and
brain-centered view of mental illness reigns supreme.

But do today's neuroscientists celebrate Freeman as a pioneer, far ahead of
his time in his focus on the brain in treating psychiatric disorders? Far
from it. Researchers investigating new methods of surgically treating the
brain for mental illnesses find his legacy a hindrance to the public's
understanding and acceptance of their research.

Why, 34 years after his final lobotomy, does Walter Freeman continue to cast
a shadow over psychiatric surgery? The answer lies in the complex tangle of
Freeman's personality and motivations, and in the public's fear of past
abuses.


When Freeman arrived in Washington in 1924 to direct the laboratories at St.
Elizabeths Hospital -- one of the nation's preeminent institutions for the
insane -- he carried with him more baggage than medical textbooks and
instruments. He also shouldered a load of high expectations, courtesy of his
family. Born and reared in Philadelphia, Freeman belonged to a prominent and
hard-working medical clan.

His maternal grandfather, William W. Keen, served as a surgeon during the
Civil War, removed a tumor from the jaw of President Grover Cleveland,
experimented with an early form of cardiopulmonary resuscitation, and was a
president of the American Medical Association. Freeman's father was an
otolaryngologist with a practice of modest attainments.

Freeman himself attended Yale and the University of Pennsylvania School of
Medicine before studying neurology and psychiatry in Europe. Initially, he
regarded mental hospitals with what he called in his unpublished memoirs "a
rather weird mixture of fear, disgust, and shame." These feelings soon were
transformed into indignation: "I looked around me at the hundreds of
patients and thought what a waste of manpower and womanpower." Freeman
thought the idleness and confinement of vast numbers of patients a great
social tragedy, and he wanted to do something about it.

He set about -- ultimately unsuccessfully -- to discover measurable
differences between normal brains and those of schizophrenics. While working
at St. Elizabeths, Freeman opened a private practice and joined the medical
faculty of George Washington University as a professor of neurology. By the
mid-1930s he had introduced several new therapies for mental patients at GW
Hospital: insulin shock therapy, metrazol shock therapy and
electroconvulsive therapy. All of these treatments were intended to fight
psychiatric disease by subjecting patients to chemicals or jolts of
electricity that might disrupt unhealthy neural activity in the brain.

It's easy to imagine Freeman -- his high forehead, steel-rimmed glasses and
goatee making him look the part of the consummate 1930s mental doctor --
convincing seriously ill patients and their desperate families that these
experimental treatments held the only hope for recovery. For many Americans
with psychiatric diseases, hospitals could offer little else except the
agonies of cold-water therapy and long-term storage in facilities that
echoed with the screams and moans of the hopeless.

In 1935 Freeman caught his first glimpse of yet another treatment that could
join his arsenal. At a London conference, he attended a presentation by a
Yale researcher on the behavioral effects of surgical damage to the frontal
lobes of chimpanzees. The animals became subdued and inactive. Rather
impulsively, another conference attendee, a Portuguese neurologist named
Egas Moniz, rushed home and began performing similar operations on mentally
ill people. Moniz's subsequent reports on these experiments crossed the
Atlantic and further intrigued Freeman.

To him, the intoxicating thing about psychosurgery -- Moniz's coined term
for psychiatric surgery -- was its potential to sever the links between the
over-excited emotions of an unhealthy thalamus and the behavioral functions
of the prefrontal lobes of the brain. If it worked, the destruction of these
nerve fibers would prevent the thalamus from poisoning patients' thinking.

He absorbed the details of Moniz's work and, with GW neurosurgeon Watts,
began figuring out how to adapt the Portuguese physician's techniques.
Freeman and Watts used brains from the hospital morgue to practice the
coring of sections of the prefrontal lobes with a leucotome. By the summer
of 1936 they were ready for a live patient: a Mrs. Hammatt from Topeka, Kan.

Sixty-three years old and suffering from agitated depression, she came to
Washington with her husband, desperate for an improvement to her sleepless
and hysteria-filled life. Freeman explained to her that without a
lobotomy -- the name he and Watts gave for their surgery -- she faced an
indefinite stay in a mental hospital. She decided to take her chances with
this new operation, which was scheduled for September 14, 1936.

When the day arrived, Mrs. Hammatt tried to change her mind when she found
out that her head had to be shaved. Freeman and Watts promised to spare as
much of her hair as they could, before forcibly anesthetizing her. Later,
Freeman recorded that her last words before surgery were, "Who is that man?
What does he want here? What's he going to do to me? Tell him to go away.
Oh, I don't want to see him," followed by a scream.

Freeman and Watts then performed America's first lobotomy. They drilled six
holes into the top of Mrs. Hammatt's skull and inserted a leucotome into
each. The two physicians shared the task of lesioning the brain, as they did
for all of the approximately 1,000 lobotomies they performed together. They
rinsed the openings with saline solution and sutured the wounds.

By Freeman's account, Mrs. Hammatt emerged a transformed woman. She felt a
great relief of her anxiety. After a hemorrhage scare on the third day of
recovery, she was discharged from GW Hospital about a week later. "She
survived five years, according to Mr. Hammatt the happiest years of her
life," Freeman noted in his autobiography. "As she expressed it, she could
go to the theatre and really enjoy the play without thinking what her back
hair looked like or whether her shoes pinched."

Thus encouraged, Freeman and Watts went on to perform more operations and
further refine their technique. They replaced Moniz's coring leucotome with
one resembling a butter knife and moved the entry holes to the sides of the
skull. They developed a "radical" procedure that made more cuts into the
brain. Some patients needed multiple lobotomies; others died. They operated
on an alcoholic lawyer and Rhodes scholar who escaped from the hospital on
Christmas Eve and was found, drunk, in a downtown Washington bar.

Freeman and Watts headquartered their increasingly lucrative private
practice in a house at 2014 R St. SW. Watts occupied an office at ground
level, their assistant manned the first floor, and Freeman worked upstairs.
Lobotomy Patient No. 157 once returned to threaten their lives and two
others pulled guns on Freeman when he recommended psychosurgery.

As much as some of Freeman's colleagues lamented the practice of damaging
healthy brain tissue in order to treat mental illness and the absence of
scientific evidence that lobotomy actually worked, doctors were even more
critical of Freeman's hunger for public recognition. More than once, AMA
members tried to censure him for advertising his services, which was then
considered an unethical practice for physicians. The suspect advertising
appeared, his accusers said, in the colorful lobotomy exhibits Freeman set
up every year from 1939 through the early '40s at the annual AMA convention.
Freeman targeted his displays not at other doctors, but at the press.

"I found the technique of getting noticed in the papers," he later
acknowledged. "It was to arrive a day or two ahead of the opening [of the
convention] and install the exhibit in the most graphic manner and then be
alert for prowling newsmen." Playing the role of barker, entertainer and
scientist, Freeman used hand-held clackers to draw reporters and frequently
displayed a lobotomized animal.

The results were immediate. Freeman described what happened after
journalists viewed the exhibit in 1939: "That night our monkey died but
Watts and I made the headlines even though we did not get an award." A photo
of Freeman and Watts in the operating room appeared in Time magazine in
November 1942, and many other magazines and newspapers published laudatory
accounts of the Freeman-Watts operation.

By his own reckoning, 52 percent of their first 623 surgeries yielded "good"
results, 32 percent "fair," and 13 percent "poor." Three percent died during
or after surgery. At first glance, those results seemed miraculous, given
that few other treatments held much promise for hard-core cases of
depression, agitation and obsessive behavior. But Freeman and Watts often
did not define what they considered improvement to be. Relapses frequently
occurred. In addition, a certain number of these cases were bound to get
better on their own. And the aftereffects of lobotomy, separate from the
symptoms of mental illness, often crippled the emotions, inhibitions and
personalities of patients.

Nurses who cared for Freeman-Watts patients immediately after the operations
grew accustomed to dealing with people who needed to be retaught how to eat
and use the bathroom. The patients often made clumsy passes at their
caregivers, urinated on their shoes, sat unmoving for hours, stubbornly
refused to follow instructions and behaved childishly. Nurses learned that
spanking and tickling could reliably distract patients from delusions and
perceived threats. The most famous failure of Freeman and Watts from this
period is Rosemary Kennedy (JFK's sister), who was probably the first
mentally retarded person to receive a lobotomy and who has needed full-time
care for the past 60 years.

Freeman believed that many of these changes were not only acceptable, but
also therapeutic. He saw laziness, indifference and dullness as signs that
the overcharged emotional impulses of the thalamus had successfully been
derailed. The less that patients paid attention to their own troubles, the
better.

Officials at state mental hospitals and veterans hospitals across the
country also found the trade-offs acceptable. (An exception was William
Alanson White, superintendent of Freeman's own St. Elizabeths, who never
allowed lobotomies in the hospital during his tenure.) Lobotomy arrived on
the scene at a time when these institutions overflowed with patients, many
of them servicemen who developed mental illnesses during World War II, with
no reliable courses of treatment ahead of them. Mental health practitioners
desperately needed new therapies.

By 1945, however, Freeman was starting to doubt the effectiveness of his
standard lobotomy procedure. The damage it caused was undeniable. Its cost
and requirement of a skilled neurosurgeon limited its application. Freeman
was also rethinking the standard wisdom that lobotomy should be the therapy
of last resort. He suspected that people who had been seriously disordered
for more than five years were usually too far gone to be helped, and that
lobotomy might work best for patients in the early stages of psychiatric
illness.

His research led him to the work of Amarro Fiamberti, an Italian
psychosurgeon who eliminated the need for boring holes into the skull by
breaking through the easily accessible bone at the rear of the eye socket
and injecting alcohol or formalin into the brain. Again practicing on
cadavers, Freeman altered this technique by replacing the injection with the
cuts of a sharp instrument -- first an ice pick from his kitchen whose
handle bore the name of the Uline Ice Company and later a type of leucotome
that he designed and always carried with him in a felt-lined case.

Freeman kept his new trans-orbital technique a secret from Watts. In January
1946, he performed the first such operation in his R Street office on a
patient named Ellen Ionesco. Eight more followed in quick succession. He
often sent patients home in a taxi an hour after the operation. Freeman
later wrote that during his 10th trans-orbital surgery, he called Watts to
his office to assess the operation. Watts later claimed, however, that he
entered Freeman's office unsummoned and found Freeman pushing an ice pick in
the eye socket of an unconscious man. Freeman audaciously asked Watts to
hold the ice pick so that Freeman could take a photograph. Whichever account
is true, no one disputes the result of this encounter: Watts threatened to
break off their partnership if Freeman persisted in performing lobotomies
himself and treating them as office procedures done without surgical gloves
or sterile draping. For the remainder of his association with Watts, Freeman
did these operations outside the office.

For the next 21 years, Freeman performed trans-orbital lobotomies almost
exclusively. One of his earliest setbacks came at the end of 1947 in the
case of a Washington-area police officer who hemorrhaged on both sides of
the brain after the operation and was left seriously disabled, "never able
to do more than the simplest tasks around the house," Freeman wrote. He
later wielded his leucotome and hammer in state hospitals in South Dakota
and Washington state, and from there to half of the other states. In the
late 1940s at Western State Hospital in Steilacoom, Wash., Freemen met the
movie actress Frances Farmer, according to Farmer's biographer William
Arnold.

Farmer had been a patient there for five years, the victim of her family's
intolerance of her unconventional and wild behavior. Whether Freeman
lobotomized her remains unclear, though Arnold says he did. Farmer's
relatives and Western State's staff psychiatrist at the time said it never
happened, but Frank Freeman says his father verified Farmer's operation and
identified her as the patient shown in the world's most famous lobotomy
photograph, an oft-reproduced shot showing Freeman using his hairy and
muscular arms to hammer the leucotome into a woman's eye at Western State as
a crowd watched. Filmed interviews of Farmer made after her discharge from
the hospital show a detached and flatly demeanored (though clearly
intelligent) woman, an outcome consistent with lobotomy.

Walter Freeman's championship of trans-orbital lobotomy revealed many of his
worst qualities. Shocking his colleagues, for instance, grew into a great
source of pleasure. Once, during a lobotomy demonstration at a nursing home
in Baltimore before a group of surgeons, he replaced his surgical hammer
with a carpenter's mallet. He delighted in reporting how other lobotomy
demonstrations made a Columbia University professor emeritus of neurology
weaken with faintness, sickened students in England, and so outraged a
German neurologist that Freeman said, "I almost had to push him out of the
way in order to perform the operation." Several times he showed off his
virtuosity with the leucotome by performing two-handed lobotomies, working
on both eye sockets simultaneously.

His cross-country trips in pursuit of lobotomy patients and his
self-appointment as the trans-orbital procedure's international ambassador
only heightened Freeman's sense of professional solitude -- and caused him
to commit serious errors of judgment. More than once he worked the leucotome
forcefully enough to break it inside a patient's brain. At Cherokee State
Hospital in Iowa, he accidentally killed a patient when he stepped back to
take a photo during the surgery and allowed the leucotome to sink deep into
the patient's midbrain.

Freeman had completed 400 trans-orbital lobotomies by 1949, and maintained a
brisk pace of work for the next five years. He had already alienated
psychiatrists by insisting that psychoses were actually organic brain
disorders, and now he invaded the turf of neurosurgeons by performing brain
operations and training other doctors lacking surgical certification to do
so. The superintendents of state hospitals continued welcoming Freeman to
their institutions, though, because some lobotomized patients went home and
many of the others were easier to manage. "The noise level of the ward went
down, 'incidents' were fewer, cooperation improved, and the ward could be
brightened when curtains and flowerpots were no longer in danger of being
used as weapons," Freeman wrote.

By the mid-1950s, new tranquilizers such as chlorpromazine had replaced
trans-orbital lobotomy as the treatment of choice in many of these same
hospitals. Meanwhile, Freeman's partnership with Watts had fallen apart. It
was a good time for a change of scenery. In 1954, Freeman abandoned
Washington -- whose summers he hated -- in favor of Los Altos, Calif. For
the next 18 years, California remained his home base as he continued
performing a steady trickle of lobotomies in his office and in state
hospitals, and indulged his passion for hiking and cross-country driving.

When the occasional opportunity presented itself, Freeman grabbed the chance
to further refine trans-orbital lobotomy. In a 1964 letter to a Japanese
colleague, he described an experiment he had tried on 14 "disturbed mental
defectives, mostly young schizophrenics," confined in a Delaware hospital.
In these cases, he followed the lobotomy with an injection of hot water into
the brain. "I was prepared to accept two fatalities," he wrote, "but
fortunately all the patients survived, and I have been invited to return
next May. I don't see how any of these patients could improve but at least
one can now be cared for at home."

Any physician today using a therapy with an expected fatality rate of 14
percent and offering no hope for improvement would probably end up in court
if not in prison. (Freeman was never sued for lobotomy malpractice, although
a suit was in preparation when he died.)

In 1967, Freeman received a visit from Helen Mortensen, a woman who had been
one of his first 10 trans-orbital patients in Washington in 1946. She
suffered a relapse of her psychiatric symptoms in 1956 and Freeman gave her
a second operation. Now, after several more years of working productively,
Mortensen wanted a third lobotomy.

Freeman did the surgery at Herrick Memorial Hospital in Berkeley, Calif.,
and severed a blood vessel in Mortensen's brain. Three days later, Mortensen
died. The hospital revoked Freeman's surgical privileges. During the last
five years of his life, he performed no more lobotomies. Freeman died from
cancer on May 31, 1972, at the age of 76.


Freeman has been dead for 28 years, and most of the lobotomy patients who
survived his treatment have followed him to the grave. Probably fewer than
20 brain operations are now conducted annually in the United States to treat
psychiatric disorders. These procedures are not lobotomies; they most often
use lasers or radiation to produce tiny lesions in the cingulate gyrus
region of the brain, which has been connected with the development of
obsessive-compulsive disorder (OCD). (Other operations that destroy parts of
the brain are done to help reduce or eliminate tremors in Parkinson's
patients.)

Nevertheless, Walter Freeman weighs heavily on the minds of a new generation
of neuroscientists. They think about his promotion of lobotomy to treat a
variety of unrelated disorders, his lack of interest in scientific
verification of lobotomy's effectiveness, his patients' permanently altered
personalities and emotional lives, and his recklessness, pride and craving
for public attention.

Joseph Fins, a medical ethicist at Weill Medical College of Cornell
University, holds Freeman partly responsible for the "therapeutic nihilism"
that has existed until recently -- a reluctance of researchers to
investigate new surgical treatments for psychiatric disorders and brain
injuries. "One reason is the consequences of lobotomy and [surgically]
destroying brain tissue. That didn't work, and people were horrified," he
says.

But the tide may be turning. In the past two years a few neuroscientists
have planned or carried out research into an entirely new form of
psychiatric surgery, one that uses an implanted "pacemaker" and small
electrodes to stimulate an area of the brain that might house the circuitry
responsible for OCD and some forms of depression. (Ironically, Freeman's
grandfather Keen used primitive electrical stimulation more than 100 years
ago to treat behavioral disorders.) The region of the brain frequently
targeted is the thalamus, the same area that Freeman held responsible for
the emotional over-excitement that he theorized was a cause of mental
illness.

Today's researchers view the thalamus differently. They see it as a
coordinator and regulator of neural activities in the cerebral cortex, the
part of the brain that accomplishes many of our highest mental functions. We
can move, speak and plan our lives because of intricate teamwork between the
thalamus and the cerebral cortex. If neurons in small regions of the
thalamus shut down, current neuroscientific theory holds, the corresponding
parts of the cerebral cortex run uncontrolled, producing Parkinson's
disease, OCD and other problems. Electrically stimulating those neurons can
restore them to wakefulness and rein in the cerebral cortex.

The surgery required to implant the electrodes is not dangerous, but
researchers believe the public is frightened of it. "I definitely believe
that there is a very important public stigma attached to surgical treatments
for psychiatric disorders, and that this is for good reasons," says Bart
Nuttin, a researcher at the Laboratory of Experimental Neurosurgery and
Neuroanatomy, Catholic University of Leuven in Belgium. "I am convinced that
in the past this kind of surgery has been abused."

Nuttin and his colleagues surgically installed electrodes in the brains of
four patients with cases of OCD that did not respond to standard treatments.
Three experienced relief of their symptoms when the electrical current was
on. One of these patients, a 39-year-old woman with a long history of
untreatable OCD, felt "an almost instantaneous feeling of being relieved of
anxiety and obsessive thinking," the team reported in the British medical
journal the Lancet in 1999. About 90 percent of her symptoms vanished.

Because brain stimulation, which the Food and Drug Administration recently
approved as a treatment for Parkinsonian tremors, causes no permanent
changes in the brain and can easily be shut off, Nuttin says it is in some
ways similar to drug therapy. Yet this is a form of brain surgery, and
Freeman's lapses of the past have left their mark. An ethics committee
oversees the use of brain stimulation, to ensure that patients are not taken
advantage of and subjected to unsafe therapy. "My greatest fear is that some
surgeons would start using this technique in a less controlled way than we
have," Nuttin says. "There remains a need for strict official control of
this kind of treatment."

Belgium's Catholic University is one of a handful of research centers that
have investigated brain stimulation as a treatment for psychiatric
disorders, or plan to. Another is the Cleveland Clinic. Ali Rezai, who heads
the section of stereotactic and functional neurosurgery at the Cleveland
Clinic, has mixed feelings about Freeman. "In some ways he was a pioneer,
but in others he did a disservice and slowed the pace of development by
being too much of a cowboy and acting too exuberantly without scientific
foundation," he says.

Freeman also spooks federal funding for this kind of research. The National
Institute of Mental Health does not currently fund any research on
psychiatric surgery and hasn't for many years. Although a spokeswoman for
NIMH says that psychiatric surgery is not barred from funding consideration,
Elliot S. Valenstein, a University of Michigan neuro-psychologist and author
of the psychosurgery history Great and Desperate Cures, believes there is a
political bias at work. "I think they're really concerned about the reaction
to the [perceived] notion that the government is supporting brain operations
and that there may be a resurgence of lobotomies in this country," he says.

Rezai hopes that his institution's brain stimulation research, set to begin
this year, will win NIMH funding. He emphasizes that this therapy, if it
works, will be best suited as a last resort for a small number of OCD
patients: those for whom all other treatments have failed. But it also holds
future promise for people with untreatable depression, speech disorders,
multiple sclerosis and chronic pain.

Lobotomy also raised high hopes in its day. During the late 1950s, when the
new tranquilizing drugs had grown popular in state hospitals, Freeman wrote
letters to his psychosurgical colleagues around the world, praying for a
time when brain operations would again gain wide favor in the battle against
mental illness. It didn't happen in his lifetime.

Now that it might happen in ours, Freeman's presence is unwelcome. He flits
around, a pesky spirit looking for the recognition he believes he is due, an
unwanted ghost causing sighs and regret.



© 2001 The Washington Post

From:  Vera Hassner Sharav,  President
CIRCARE: Citizens for Responsible Care & Research,
               A Human Rights Organization
              Tel. 212-595-8974    FAX: 212-595-9086
              veracare@...


FYI
America's medical motto seems to be: When safety and efficacy of drugs are
in doubt, first hand them out, then push for research to endorse the
practice... In its day, ice pick lobotomy surgery was also touted as "a
safe, and effective treatment..." for mental disorders--40,000 to 50,000
adults and children were the human casualties.

~~~~~~~~~~~~~~~~~~~
http://www.psych.org/pnews/
January 19, 2001
American Psychiatric Associaiton

Professional News

AMA Calls for Studies of Psychotropic Use in Children

The AMA acknowledges that more research must be done on the use of
psychotropic medications in children. However, experts agree that doing so
is no easy task.

By Jim Rosack

Joining APA, the American Academy of Child and Adolescent Psychiatry, and
the American Academy of Pediatrics, the American Medical Association last
month adopted a new policy calling on the pharmaceutical industry and
federal regulators to study the effects of psychotropic drugs in children
and acknowledged the need for training of additional qualified clinical
investigators to do so.

In a resolution passed by the AMA’s House of Delegates at its Interim
Meeting in Orlando, the AMA also acknowledged that physicians in general
need more training on the appropriate use of these medications in America’s
children.

Resolution 504, submitted by the AMA’s Medical Student Section, was amended
and passed by the House of Delegates after considerable testimony. Leading
the debate was David Fassler, M.D., the delegate of the American Academy of
Child and Adolescent Psychiatry (AACAP) and vice chair of the Section
Council on Psychiatry.

"We, both APA and AACAP, welcome the involvement of the AMA on this issue,"
Fassler told Psychiatric News. "Given the politically and ethically charged
nature of using these medications in children, it provides a good forum for
all of us to work collaboratively to push for research into the safe and
effective use of all medications, including psychotropic medications, in
children."

The problem stems from the fact that, with few exceptions, the evidence for
safety and efficacy of all classes of medications when used in children is
based solely on anecdotal accounts. Formal clinical trials of even the most
common drugs used in children, those to treat infections and asthma, have
only recently been considered. And the same is true of psychotropic drugs,
complicated by the fact that studying "potentially mind-altering" drugs in
children has been sensationalized in the popular press over the last few
years.

The original Resolution 504 made note of the much publicized study that last
year claimed to have found a 50 percent increase in the number of
prescriptions of psychotropic medications in children aged 2 to 4. Fassler,
however, challenged those data during Reference Committee testimony.

"In reality," Fassler testified, "we don’t yet have accurate and
comprehensive data on the increase in the use of psychotropic medications in
children. We do have some selective data from research on specific
populations, but we need to be very careful before we use such data to make
assumptions about the country as a whole or as the basis for broad public
policy."

Fassler, a child and adolescent psychiatrist who chairs APA’s Council on
Children, Adolescents, and Their Families, also told the Reference Committee
that his real concern was that due to the issue being sensationalized and
misrepresented in the media, parents may be frightened and therefore not
seek appropriate and effective treatment for their children.

One of the points of the original Resolution 504 called for the AMA to work
toward guidelines "to establish. . . criteria for use of these medications
in 2-4 year olds." Fassler called for the deletion of this part of the
resolution.

"Medication can be very helpful," Fassler told the Reference Committee, "and
even lifesaving for some children, but medication alone is rarely an
appropriate treatment for complex child psychiatric disorders, which really
require comprehensive multimodal intervention."

Fassler expressed concern about asking the AMA to develop guidelines that
focused only on medication, saying "I don’t really think it makes sense to
consider the use of medication in isolation, particularly when we are
dealing with young children."

Ultimately, Fassler’s testimony convinced the Reference Committee to delete
the call for developing guidelines, which resulted in changing the focus of
the resolution (and therefore the approved AMA policy) to encourage
research, education, and training.

The mission of Fassler and growing segments of organized medicine to
increase recognition of psychiatric illness in children and ultimately to
improve the quality of treatment, may finally be getting some help, from
none other than the U.S. government.

After years of "looking the other way" as many powerful medications,
including psychotropics, were widely prescribed, but unapproved for use in
children, the U.S. Food and Drug Administration (FDA) has begun implementing
new regulations born out of Section 505A of the Food and Drug Administration
Modernization Act of 1997 (FDAMA).

FDAMA required the FDA to develop a list of drugs "for which additional
pediatric information may produce health benefits in the pediatric
population." The initial list was published by the FDA in May 1998 and is
updated annually.

The "priority list" created by FDAMA acknowledged that the drugs on the list
were either being widely used in children or could potentially be of benefit
to the pediatric population, but no data existed to assess their efficacy or
safety in children. The FDA took the stance that it was finally time to
produce the data needed to prove that the drugs were, indeed, safe and
effective.

The original priority list included nearly 450 entries, from nearly all
classes of medications, including 25 psychotropic medications. The FDA
issued written requests for pediatric studies on 12 of the 25 drugs, and the
FDA has received the data on three of the original 25 psychotropics.

The government, realizing that for the pharmaceutical industry to spend the
time, money, and effort to conduct clinical trials in pediatric populations,
an incentive would have to be awarded for completing and submitting safety
and efficacy data. The concept of "pediatric exclusivity" was the FDA’s
answer.

Pediatric exclusivity provides an additional six months of patent protection
to the product, effectively delaying the debut of generic competition, not
only to the specific form tested, but to all forms of the medication
currently approved.

For the pharmaceutical companies, that spells dollars—in some cases,
potentially hundreds of millions of dollars on a single product. To the FDA
and the clinical community, it provides at least minimal data establishing
the safety, efficacy, and dosing of the medication in children. Pediatric
exclusivity does not necessarily mean, however, that a drug is "approved"
for use in children; it simply acknowledges a drug company’s efforts in
submitting the required data. Of the three psychotropics having received
exclusivity so far, only fluvoxamine has been approved for pediatric
labeling.

Problems of Studying Children

Researchers, clinicians, and regulators agree that conducting clinical
trials of medications in pediatric populations is no easy task. First of
all, pharmaceutical companies must find clinical investigators with the
expertise to conduct pediatric studies. Physicians must convince parents to
expose their children to unknown risk and subject them to monitoring and
testing they would normally not need. The potential pool of recruits for
pediatric studies is also inherently smaller than those on adults, simply
because the population of children with the disease or disorder being
studied is small.

In addition, children may not cooperate freely or completely with the
strictness of accepted research methods. And rating symptoms of illness,
especially psychiatric illness in children, is even more subjective than it
is in adults. Researchers must also worry about redesigning methods of
evaluation and monitoring. In the words of one researcher who presented
testimony on the subject to the FDA, "you simply can’t draw a bucket of
blood from babies."

And then there are the ethical questions. For years, researchers have
worried that studying children was unethical. Robert Ward, M.D., a professor
of pediatrics at the University of Utah and an expert in ethics of pediatric
studies, said he thinks the ethics concerns are largely coming to a close.

"Without controlled clinical trials, we are treating children with less than
optimal information about effectiveness, dosing, and safety," Ward said.
"You have to ask the question—Which is more unethical? To do that, or to
treat a child in a controlled clinical trial?"

But many still have great concerns. Placebo comparison is still the FDA’s
gold standard in clinical trials; however, it is extremely difficult, said
Ward, to get parents to sign informed consent when they really understand
that their child has the potential to receive no active treatment at all.

To address these and other critical issues, the FDA released last month its
"Guidance for Industry E11: Clinical Investigation of Medicinal Products in
the Pediatric Population."

While stating that "the pediatric population represents a vulnerable
subgroup," the guidance offers only general suggestions for review-board
participation and guidelines for recruitment, consent, and minimization of
risk. The guidance does note that "in order to minimize risk in pediatric
clinical studies, those conducting the study should be properly trained and
experienced in studying the pediatric population, including the evaluation
and management of potential pediatric adverse drug events."

New Data on Horizon

But new data are being developed and analyzed, thanks to the FDAMA
incentives and a new federal regulation that went into effect last December.
The new rule gives the FDA the power to require pediatric studies for drugs
that might directly benefit children. In fact, at the FDA’s discretion,
approval of the use of a drug in an adult may be withheld, pending at least
initiation of pediatric trials.

"The interest in developing the type of trials that need to be completed in
children has been somewhat overwhelming," said Dianne Murphy, associate
director for pediatrics at the FDA. "The important thing is, you can’t
simply decide to do any study—the FDA determines if there is a public health
benefit."

So far about 200 studies have been proposed by pharmaceutical companies,
including drugs for allergies, asthma, and, yes, depression. The proposed
research, Murphy said, could involve as many as 20,000 children. By
contrast, only 11 studies were completed in pediatric populations from 1991
through 1997, Murphy said.

The AMA resolution, while not likely to influence the FDA’s stance on the
issue, may play a role in the public’s mind.

"With this new policy, the AMA is focusing on the need for sound scientific
evidence to support treatment of children with medications," AACAP’s Fassler
told Psychiatric News.

The AMA resolution is posted on the Web at <www.ama-assn.org>. Click on the
Interim Meeting 2000 icon and select "Reports and Resolutions." More
information on pediatric exclusivity is posted on the FDA’s Web site at
<www.fda.gov/cder/pediatrics>. "Guidance for Industry E11: Clinical
Investigation of Medicinal Products in the Pediatric Population" is posted
at <www. fda.gov/cder/guidance/index.htm>.

Apologies, I meant to cancel. But having made the mistake, perhaps I
should complete the thought.

It appears the John Donne's "no man is an island" has itself washed out to
sea. Might the same criterion (no direct effect, no right to object) be
applied to the complaints raised by, say, Amnesty International?

Is the intention of those creating the clones to maximize the freedom of
the cloned, or to instrumentalize the cloned? Even in the case of, say, a
grieving mother or father, who wishes to 'return' a lost child, is that
(cloned)  child really granted freedom?

Kirk Allison

On Sat, 3 Feb 2001, Alan Grimes wrote:

> Phil Bereano wrote:
>
> > not my burden to prove that it is a crime or anything else.
>
> It definitely is your burden to proove that it *is* a crime, If you fail
> to do so then you have absolutly no right to interfere with their
> peaceful and unobtrusive activities.
>
> You see, the long lost principle of democracy is that FREEDOM comes
> first. The biotechnologist can do whatever the hell he wants to do
> untill such time as you can bring evidence before a judge that prooves
> that *YOU* have been harmed DIRECTLY by any of his actions.
>
> I have a strong feeling that you will find it extremely difficult to
> proove that activities that are largely confined to a single aparatus of
> a single laboratory in a location that is entirely unknown to you, and
> possibly quite distant, has had any affect on you, individually,
> whatsoever.
>
> --
> Perhaps I will upgrade my OS from Win 3.11...
> But It has to be more sophisticated than Win 3.11.
> As well as less complicated than Win 3.11.
> *AND* It must run on THE MACHINE!!!!
> http://users.erols.com/alangrimes/  <my website.
> Any usage of this e-mail account is subject to the terms and conditions
> specified on my website.
>
>
>
> Community email addresses:gwolbrin@...
>   Post message: Bioethics@egroups.com
>   Subscribe:    Bioethics-subscribe@egroups.com
>   Unsubscribe:  Bioethics-unsubscribe@egroups.com
>   List owner:   Bioethics-owner@egroups.com
>
> Shortcut URL to this page:
>   http://www.egroups.com/community/Bioethics
>
>

The funny thing is, what Phil B is holding up as a virtue of the simplistic
individualist version of libertarianism (consult the libertarian nestor
John Locke for more worked out libertarian ideas!) is what most of its
opponents hold to be its most unattractive features: the failure to take
into account socially/collectively produced harms/rights infringements.

Moreover, as an objection to the precautionary principle, it is a bit
silly. According to (this brand of) libertarianism, ANY state interventions
are absolutely immoral (for example the enforcement of traffic rules)
unless they are strictly necessary to prevent the infingement of some
particular individuals right to do what he/she wants. This argument is no
more impressive than the "it is murder to destroy embryos" argument against
cloning (which, after all, was the original topic for discussion).They both
use a nuclear bomb to kill a mosquito....

Christian

>The voice of the Libertarian is heard in the land. . .   No social
>responsibility necessary or desired.
>
>Phil
>
>
>
>At 10:26 AM 2/3/01 -0500, you wrote:
>>Phil Bereano wrote:
>>
>> > not my burden to prove that it is a crime or anything else.
>>
>>It definitely is your burden to proove that it *is* a crime, If you fail
>>to do so then you have absolutly no right to interfere with their
>>peaceful and unobtrusive activities.
>>
>>You see, the long lost principle of democracy is that FREEDOM comes
>>first. The biotechnologist can do whatever the hell he wants to do
>>untill such time as you can bring evidence before a judge that prooves
>>that *YOU* have been harmed DIRECTLY by any of his actions.
>>
>>I have a strong feeling that you will find it extremely difficult to
>>proove that activities that are largely confined to a single aparatus of
>>a single laboratory in a location that is entirely unknown to you, and
>>possibly quite distant, has had any affect on you, individually,
>>whatsoever.
>>
>>--
>>Perhaps I will upgrade my OS from Win 3.11...
>>But It has to be more sophisticated than Win 3.11.
>>As well as less complicated than Win 3.11.
>>*AND* It must run on THE MACHINE!!!!
>>http://users.erols.com/alangrimes/  <my website.
>>Any usage of this e-mail account is subject to the terms and conditions
>>specified on my website.
>>
>>
>>
>>Community email addresses:gwolbrin@...
>>   Post message: Bioethics@egroups.com
>>   Subscribe:    Bioethics-subscribe@egroups.com
>>   Unsubscribe:  Bioethics-unsubscribe@egroups.com
>>   List owner:   Bioethics-owner@egroups.com
>>
>>Shortcut URL to this page:
>>   http://www.egroups.com/community/Bioethics
>
>************************************************
>
>Philip L.  Bereano
>Professor
>Department of Technical Communication
>College of Engineering
>Box 352195
>University of Washington
>Seattle, Wash.  98195
>
>phone:  (206) 543-9037
>fax:       (206) 543-8858
>***************************
>
>
>
>
>
>
>
>Community email addresses:gwolbrin@...
>  Post message: Bioethics@egroups.com
>  Subscribe:    Bioethics-subscribe@egroups.com
>  Unsubscribe:  Bioethics-unsubscribe@egroups.com
>  List owner:   Bioethics-owner@egroups.com
>
>Shortcut URL to this page:
>  http://www.egroups.com/community/Bioethics


__________________________________________________________
__________________________________________________________
Christian Munthe, Docent / Associate Professor
Department of Philosophy, Gothenburg University
Box 200, 405 30, Goteborg, SWEDEN
Tel (+46)Ø31-7734843 (Home: (+46)Ø31-7742447)
Fax (+46)Ø31-7734945
Email: Christian.Munthe@...
WWW: http://www.phil.gu.se/munthe/munthe.html

http://www.ifg.org/nyc.html
Saturday
Panel #6 (8:00-11:00 p.m.): Biotechnology and the "Post Biological"
Sciences

                          "Remaking the nature of nature," science now
takes us beyond the biological realm to a "post biological" era that
includes promoting
                          biotechnology, eugenics, nanotechnology, and
robotics. This raises crucial questions about the irreversible alteration
of all life on earth.

                          Chris Desser Biotech Funders Working Group
                          Richard Hayes Exploratory Project on the New
Human Genetics
                          Pat Roy Mooney Rural Advancement Fund
International (Canada)
                          Arpad Putszai Former Chief Scientist, Rowett
Research Institute (Scotland)
                          Debra Harry Indigenous Peoples Council on
Biocolonialism
                          Martin Teitel Council on Responsible Genetics
                          Mae-Wan Ho Institute for Science in Society
(U.K.)
                          Vandana Shiva Research Foundation for Science,
Technology, and Ecology (India)


Sunday
HUMAN TECHNO-EUGENICS, NANOTECHNOLOGY & ROBOTICS
                          Chris Desser, Biotech Funders' Working Group
                          Richard Hayes, Exploratory Initiative on the New
Human Genetic Technologies
                          Pat Roy Mooney, Rural Advancement Foundation
International (RAFI)
                          Martin Teitel, Council for Responsible Genetics




have a look they talk about globalisation technology even eugenics and NO
DISABLED PEOPLE INVOLVED As usual USA discriminates against disabled
people they talk about social justice without disabled people.
It really becomes kind of boring how Anti Disabled the so called Social
Activist movement is run in USA.
Cheers
Gregor


Dr. Gregor Wolbring
webpage: http://www.thalidomide.ca/gwolbring
Founder and Coordinator of the International Network on Bioethics and
Disability; a Network supported by the International Association of
Bioethics
To subscribe to the Network go to
http://www.egroups.com/subscribe/Bioethics
or send a blank e-mail to bioethics-subscribe@egroups.com

and Biochemist at the
Dept. of Biochemistry and Molecular Biology
Faculty of Medicine
and Adjunct Assistant Professor
at the Dept. of Community Rehabilitation and Disability Studies
Faculty of Education
both University of Calgary
Phone 1-403-220-5448
Fax   1-403-283-4740
eFax  1-603-761-3704
e-mail gwolbrin@...

Mailing address:
Dr. Gregor Wolbring
Dept. of Med. Biochem.
University of Calgary
3330 Hospital Drive NW
T2N 4N1
Calgary Alberta Canada