Dial-an-Ethicist-a bioethics marketing gimmick Stanford_NATURE

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[sSRI-Research] Dial-an-Ethicist-a bioethics marketing

gimmick Stanford_NATURE

 

 

 

Dial-an-Ethicist-a bioethics marketing gimmick Stanford_NATURE

 

ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP)

Promoting Openness, Full Disclosure, and Accountability

http://www.ahrp.org/cms/

 

FYI

 

A continuing stream of biomedical research scandals involving research

fraud, concealment of negative trial evidence, endangerment of human

subjects, data fabrication, and academics who pen their names to

ghostwritten journal reports, have so far not led to any substantive

reforms. Such reforms, AHRP believes, will only happen through

legislation providing mechanisms for accountability.

Bioethicists are seizing the opportunity the scandals present, to

expand their own marketability. The UK publication, NATURE, reports

about the latest bioethics gimmick that has sprung up at the Stanford

Center for Biomedical Ethics.

 

'Dial-an-ethicist,' a pilot project co-founded by two bioethicists,

David Magnus and Mildred Cho at Stanford. It offers biomedical

researchers " speedy practical advice on ethical concerns " during the

course of a clinical trial or " bench-side consultation service as it

is also known. "

 

" Over the past six months, the pilot service has given consultations

to seven different Stanford research groups. Topics ranged from

oncology trials to microarray analysis, and the ethical issues from

conflicts of interest to what to do with incidental findings. " The

project is voluntary-there is no process for holding anyone accountable.

 

Our concern that bioethicists serve merely as an added layer of

institutional rubber stampers who provide the appearance of legitimacy

without actually meeting ethical standards remains valid.

 

Nature reports that the stem-cell cloning research scam of Dr. Hwang

Woo-Suk had " obtained independent advice from at least two ethicists

in addition to IRB approval for research. But he violated ethical

guidelines by collecting eggs from laboratory juniors and other donors

who were not warned of possible side effects. "

 

Indeed, Nature reports, " About 20 of the donors have developed side

effects including abdominal pain, diarrhoea and vomiting. And their

eggs contributed to research that now appears to have been faked. The

kindness of the donors has been exploited, patient hopes shattered,

and public confidence in stem-cell research is in tatters. "

 

In the case example at Stanford, an ethical dispute involved

disclosure of findings to the parents of children who were the

subjects of a study of autism. The Stanford bioethicists obliged those

who favored withholding information from parents. They rationalized:

" that because the test results do not indicate a treatable or

preventable life-threatening condition, researchers are not required

to inform the parents. "

 

The position of this team of bioethicists represents a culture of

presumed authority and superiority: " we know what's best, " for other

people. That culture of arrogance by a fraternity of elitist

academics who are riding roughshod on individual human rights, as they

help industry circumvent (trample) the safeguards contained in The

Nuremberg Code and the Declaration of Helsinki, not to mention the

U.S. Common Rule (45 CFR 46).

 

As the Advisory Commission on Human Radiation Experiments (ACHRE)

acknowledged the moral and legal right of parents:

" Respect for the rights of parents is viewed as a mechanism for

valuing and fostering the institution of the family and the freedom of

adults to perpetuate family traditions and commitments. Another

important line of justification for respecting the authority of

parents.the view that the interests of the child are generally best

served by ceding decisional authority to the parent. The parent is

thought not only to be in the best position to determine what is in

the interests of the child but is also thought to be generally

motivated to act in the child's best interests. " [1]

 

Thus, while chattering about " transparency " and " respect " for

" participants " in research, bioethicists provide the framework for

circumventing the ethical / legal mandate of full disclosure to the

human subject-in the case of minors, to the parents; and lay the

ground for concealment of research information.

 

Why would any parent even consider subjecting their child to research

if they did not expect-absent a remedy-to obtain research results?

 

The claim, " To avoid potential criticisms, the Stanford team is

financially independent thanks to federal funding, " is an example of

disingenuousness. The fact is, the Stanford University Center for

Biomedical Ethics receives substantial research funding--including a

$1 million gift from SmithKlineBeecham for its program in genetics. [2]

 

Thus, to pretend to be " financially independent " is less than forthright.

 

1. ACHRE Report, Chapter 7 at:

http://www.eh.doe.gov/ohre/roadmap/achre/chap7.html

 

2. Carl Elliott, Pharma Buys a Conscience, American Prospect, <Volume

12, Issue 17. Sept-Oct, 2000.>

http://www.prospect.org/print-friendly/print/V12/17/elliott-c.html

 

 

 

Contact: Vera Hassner Sharav

212-595-8974

veracare

 

 

http://www.nature.com/news/2006/060424/full/4401104a.html

Nature

Published online: 26 April 2006

Bioethics: Dial 'E' for ethics

Facing a moral dilemma in the lab? No reason to panic. Helen Pilcher

meets the academic troubleshooters who promise a quick answer to any

ethical problem.

 

by Helen Pilcher

 

Stanford biomedical researchers can now phone a friend to discuss

their pangs of conscience.

 

Sometimes you're midway into a research project before an ethical

dilemma reveals itself. This was Joachim Hallmayer's experience at the

Stanford School of Medicine in California. About a year after he and

his team had begun recruiting children for a genetic study of autism,

they realized that they couldn't agree what results to share with the

parents.

 

" It's sometimes difficult to know what information will be useful and

what will be dangerous, " admits Hallmayer, a psychiatric geneticist.

 

But the team was in luck. Across campus, at the Stanford Center for

Biomedical Ethics, a pilot project offering biomedical researchers

speedy practical advice on ethical concerns was under way. Hallmayer

contacted the 'dial-an-ethicist' project, or bench-side consultation

service as it is also known, and three weeks later got professional

answers to his questions.

 

Hallmayer's team is now pursuing its autism study with a renewed sense

of harmony. But the Stanford service aims to go beyond ethical

troubleshooting, say co-founders David Magnus and Mildred Cho. " A lot

of scientists don't really see ethics as a part of their job, " says

Cho. By making the usually academic field of bioethics more

accessible, Magnus and Cho hope to promote a culture of ethical

thinking within the laboratory.

 

Often scientists don't think about ethics until it is too late -

sometimes when their research has already hit the headlines. In South

Korea, disgraced stem-cell pioneer Woo Suk Hwang not only fabricated

results, he also obtained eggs from women donors under questionable

circumstances. And he did it all while claiming to follow ethical

guidelines. It's an extreme example of the harm that can be caused

when ethics advice is ignored, but one that raises questions about the

role of bioethicists in the laboratory.

 

Some people doubt whether practical ethics advice can make a real

difference. Can bioethicists retain credibility when their advice is

sought but ignored? Are they liable when things go wrong? And what

about claims that they rubber-stamp most research proposals?

 

 

It's sometimes difficult to know what information will be dangerous.

Joachim Hallmayer

 

" Bench-side consultations are a way of integrating ethical thinking

into a scientist's everyday life, " says Magnus, director of the

Stanford centre. Like most of his colleagues he doesn't think

bioethicists should be expected to prevent misconduct. But he believes

his bench-side service can foster integrity in trainee scientists and

so indirectly prevent research going off the ethical rails.

 

The Stanford service is designed to help researchers identify the

ethical and social issues that arise in their work and aims to

complement, not replace, the bodies that regulate human and animal

studies. Institutional review boards (IRBs), for example, oversee all

federally funded US biomedical human studies. They evaluate the risks

and benefits to people who participate, from their recruitment through

to the confidentiality of results. An IRB seal of approval must be in

place before a study begins.

 

Unlike IRB approval, the Stanford service is voluntary, not mandatory,

and it yields confidential advice, rather than edict. The Stanford

team will advise researchers at any point in a study, although they

prefer to be involved at the start. The pilot seeks to address issues,

such as the broader societal implications of a study, that go beyond

the scope of IRBs. In fact, the project was set up, in part, to offer

advice on human embryonic stem-cell research, which initially fell

outside the IRB's purview.

 

Brisk business

 

Parents may be better off not knowing the findings of studies on their

autistic children.

 

Over the past six months, the pilot service has given consultations to

seven different Stanford research groups. Topics ranged from oncology

trials to microarray analysis, and the ethical issues from conflicts

of interest to what to do with incidental findings. Six of the queries

were easily resolved, most within 24 hours, and half of the responses

involved alerting researchers to existing rules rather than developing

new policies.

 

Hallmayer's request, however, required deeper analysis. The California

Autism Twin Study (CATS) plans to assess 300 twin pairs on a range of

skills, including intelligence, language and planning ability. To

date, more than 60 pairs of children have been recruited and around a

dozen tested. But as the data trickled in, ethical concerns grew about

how much to tell the parents about the test results.

 

This is partly because the CATS tests can differ from those used by

psychiatrists to diagnose autism and are administered by trained

researchers rather than clinicians. Such non-clinical test results

raise several problems. A presumed autistic child could, for example,

test normal, or a normal sibling could display mild, sub-clinical

problems. DNA tests designed to check whether twins are identical or

not, and to exclude children with the inherited mental impairment,

fragile X syndrome, create their own problems. A positive fragile X

result would suggest one parent is carrying the causal mutation, for

example.

 

Should we tell them?

 

Any such findings could have repercussions for family dynamics,

insurance and state benefits, and so Hallmayer felt it wise to tell

parents less rather than more. " They may have a right to know, " he

says, " but the results can give a child a label that is unnecessary

and meaningless. " Others on the team, however, felt it was wrong to

withhold findings from parents.

 

If people are out to deliberately deceive you, there's nothing you can

do.

Insoo Hyun

 

Hallmayer contacted the Stanford ethics service last year. He and his

team discussed their problems with four consultants, including Cho and

Magnus. Three weeks later, they received a written list of

recommendations.

 

The ethics team concluded that because the test results do not

indicate a treatable or preventable life-threatening condition,

researchers are not required to inform the parents. Non-clinical test

results should not be disclosed, they advised, but other results can

be shared if the parents want to know. Positive fragile X tests should

always be replicated in a clinical laboratory, and parents should be

made aware of the possible implications for insurance and employment.

 

The CATS team tweaked its study design, received additional IRB

approval, and pursued its study. Both Hallmayer and the Stanford

ethicists are pleased with the outcome. But the bench-side experience

is not always a happy one.

 

Bioethicist Insoo Hyun, from Case Western Reserve University in

Cleveland, Ohio, spent three months in summer 2005 in Hwang's

laboratory studying the cultural, social and legal implications of the

Korean stem-cell research. He also helped to fine-tune Hwang's

informed-consent procedure for egg donation, publishing a paper

reporting the procedure in The American Journal of Bioethics (K. W.

Jung and I. Hyun Am. J. Bioeth. 6, W19-W22; 2006). When he learned in

December that Hwang had not followed the procedure he felt angry,

saddened and betrayed.

 

Hwang seems to have obtained independent advice from at least two

ethicists in addition to IRB approval for his research. But he

violated ethical guidelines by collecting eggs from laboratory juniors

and other donors who were not warned of possible side effects.

 

About 20 of the donors have developed side effects including abdominal

pain, diarrhoea and vomiting. And their eggs contributed to research

that now appears to have been faked. The kindness of the donors has

been exploited, patient hopes shattered, and public confidence in

stem-cell research is in tatters.

 

The scandal underscores the perils of ignoring ethical advice. But it

also highlights the limitations of ethical consultations in the

laboratory. Hyun and his co-author had to retract their paper when it

became clear that Hwang had ignored their recommendations (G. McGee,

Am. J. Bioeth. 6, W33; 2006). " My experience with Hwang has changed my

attitude to getting involved with other labs, " says Hyun.

 

In future, Hyun says he would be more sceptical. Magnus, who has also

written about the ethics of egg donation, believes that the ethicists

in Hwang's lab did little to find ethical flaws. " I am concerned that

too many of the bioethicists there were cheerleaders, " he says.

 

In his defence, Hyun says, bioethicists view themselves as pilots

through treacherous waters. " Being an ethical consultant doesn't put

you in a position to prevent misconduct, " he says. Consultants

presuppose that researchers have the integrity to take their advice

seriously. " If people are out to deliberately deceive you, there's

nothing you can do. "

 

Some view all ethical oversight with suspicion. Bioethicists merely

provide the veneer of a job well done, says Vera Sharav, president of

the Alliance for Human Research Protection, New York, a watchdog

organization that seeks to expose unethical research practices. Most,

she believes, issue ethical approval too easily and fail to offer

truly independent advice.

 

But Ronald Green, a bioethicist from the Dartmouth College Ethics

Institute, Hanover, New Hampshire, finds generalized accusations of

'bioethics for hire' preposterous. Green chairs the ethics advisory

board at Advanced Cell Technology, a US-based biotechnology company

developing stem-cell therapies. Any payment to ethicists is a minimal

daily stipend, and with ethical advice carrying no weight in law,

'buying it' simply doesn't make sense, he says. For his part, Hyun

believes his relationship with Hwang was sufficiently independent,

with funding from a Fulbright scholarship, to allay such concerns.

 

Blowing the whistle

 

Helen Pilcher is a freelancer based in Nottinghamshire, UK.

 

Article brought to you by: Nature

 

 

 

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ethical, and social justice issues, etc. It is believed that this

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material is distributed without profit.

 

 

 

 

 

FAIR USE NOTICE: This may contain copyrighted (© ) material the use of

which has not always been specifically authorized by the copyright

owner. Such material is made available for educational purposes, to

advance understanding of human rights, democracy, scientific, moral,

ethical, and social justice issues, etc. It is believed that this

constitutes a 'fair use' of any such copyrighted material as provided

for in Title 17 U.S.C. section 107 of the US Copyright Law. This

material is distributed without profit.