Ethics experts call for refocus of scientific review to ensure integrity of research process

May 13, 2010

In a paper published this week in the journal Science, experts caution that important ethical issues in the testing of new therapies like stem cells may not be receiving the attention they deserve. Carnegie Mellon University's Alex John London joined McGill University's Jonathan Kimmelman and Marina Emborg of the Wisconsin National Primate Research Center at the University of Wisconsin-Madison to examine the way scientists, physicians, and regulators evaluate risk and benefit when testing new drugs in human beings for the first time. According to their report, scientists and regulators tend to focus on how individual patients should be protected from risks, and as a result, overlook how medical advance itself can be adversely affected by poorly designed clinical trials.

For the past few decades, numerous highly innovative therapies have been introduced into human testing, including genetic-based approaches, and therapies aimed at reprogramming the immune system. Patients with serious illnesses often flock to these studies in hope of a cure. These studies are often controversial, however, because some scientists and regulators consider them too risky while others suggest it is unethical to deny critically ill patients access to these studies.

London and his co-authors argue that debates over access neglect key ethical issues. "Right now, ethical oversight is highly focused on protecting research participants and giving individuals access to scientific developments," said London, associate professor of philosophy and director of Carnegie Mellon's Center for the Advancement of Applied Ethics and Political Philosophy. "These are important issues. But ethical oversight needs to also ensure that decisions about launching human testing are based on a range of considerations that are not easily captured in the current focus."

"What is often overlooked," said Kimmelman, "is that allowing studies of poor scientific quality to proceed potentially undermines the entire scientific enterprise, because they undermine trust, consume scarce research resources, and weaken incentives for medical scientists to perform the best research they can."

"Clinical research is like a scientific bucket-brigade," London added, "where one group of scientists hands knowledge to the next, and they do a trial and hand their results to the next, and a problem with one link in the chain can derail a whole program."

To safeguard the advancement of medical research, the authors suggest that four key questions must be answered when researchers propose human studies of new therapies. They are:

  • Did animal experiments show reliable effects on disease?
  • Are the animal models similar enough to human beings that favorable results are to also occur in human trials?
  • To what extent are researchers justified in believing that observations in animals will hold up in human beings? and
  • Will clinical trials apply the exact conditions that were used in successful animal studies?
The authors suggest that there are instances when human trials are initiated despite unsatisfactory answers to these questions.

"Without critical feedback between preclinical and clinical investigators, oversight committees and sponsors, experiments lose focus and trials risk failure," Emborg notes. "Multilevel cooperation is needed for obtaining meaningful results in translational studies."

"The knowledge and interventions that science produces are valuable social goods," London said. "Everyone who cares about medical advance has an interest in preserving the integrity of the process that makes these goods possible."

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User comments : 14

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stealthc
1 / 5 (3) May 14, 2010
ummm I have a hard time believing anything you scientists say nowadays without seeing cold hard evidence for myself in front of my face -- even then it could just be smoke and mirrors just like the pure and utter crap that comes out of the university of east anglia. The UEA is the planet's arsehole and their data, conclusions and research is a steaming pile of.....
peteraleff
1 / 5 (2) May 14, 2010
It is nice to say "Everyone who cares about medical advance has an interest in preserving the integrity of the process that makes these goods possible." Unfortunately, no one in the scientific community seems to actually do anything to help bring about that alleged integrity. Otherwise, blatant research frauds would not be routinely tolerated and permanently incorporated into the doctrine as they are now.

See, for instance, the series of medical research frauds against premature babies described at
retinopathyofprematurity.org. These have caused and maintain the current iatrogenic blinding epidemic of premature babies and continue to harm these most vulnerable of all patients in many other ways. Yet, no one in the "scientific" community does anything about this corruption of the process, except for the usual rote denial of obvious flaws, and for baseless assertions about some mythical mechanism of self-correction in science. They mislead.

Respectfully submitted, Peter Aleff
peteraleff
1 / 5 (1) May 14, 2010
One symptom of the hypocrisy in the "scientific" community about open discussions is to restrict all comments to an article like the above one to 1000 characters, all while complaining elsewhere that complex arguments should not be reduced to bumpersticker format. How about some self-awareness about how you stifle thoughtful discussion?

Respectfully submitted, Peter Aleff
Skeptic_Heretic
May 14, 2010
This comment has been removed by a moderator.
JayK
May 14, 2010
This comment has been removed by a moderator.
frajo
not rated yet May 16, 2010
Unfortunately, no one in the scientific community seems to actually do anything to help bring about that alleged integrity.
No one? Do you know them all?
frajo
5 / 5 (1) May 16, 2010
One symptom of the hypocrisy in the "scientific" community about open discussions is to restrict all comments to an article like the above one to 1000 characters, all while complaining elsewhere that complex arguments should not be reduced to bumpersticker format.
Bumpersticker format would be 128 characters.
There are just too many gossipy people. The 1000 chars limit is a good method to fend (most of) them off.
marjon
1 / 5 (2) May 16, 2010
Where there is smoke there is fire.
http://www.the-sc...y/23061/

Science doesn't seem to be practiced in the manner taught in school: thorough documentation of the procedures, processes and data which is the open for critique.
Skeptic_Heretic
not rated yet May 16, 2010
marjon, it might appear that peer review is broken but if you understood what peer review was, perhaps you'd engage in it properly.

Peer review is during post publishing when your work hits the newsletters and so forth. Then your peers read it and attempt to replicate your experiment or go over your data and look for errors.

You're incapable of doing either as you're a creationist and cannot be trusted to objectively evaluate scientific statements.
marjon
1 / 5 (1) May 16, 2010
marjon, it might appear that peer review is broken but if you understood what peer review was, perhaps you'd engage in it properly.

Peer review is during post publishing when your work hits the newsletters and so forth. Then your peers read it and attempt to replicate your experiment or go over your data and look for errors.

You're incapable of doing either as you're a creationist and cannot be trusted to objectively evaluate scientific statements.

Don't take my word, read the article from Scientist.

From what you are saying, though, any article that is published in any journal, which is supposedly 'peer' reviewed, cannot be trusted until others have performed the experiment and published their 'peer' reviewed results?
If true, how can any published article be trusted?
Any journal is wasting its time reviewing articles then. Every scientist should then start their own blog, publish their results and let their colleagues critique away.
marjon
1 / 5 (2) May 16, 2010
"Appears" to be broken?
Free markets operate on incentives.
When a scientific career depends upon the quantity of papers published, it should be no surprise that a market will be created to meet that need.
If the incentives were to publish quality research, maybe more quality would be published. Emphasis on quality may help to weed out the fraud that has been permeating science lately.
The challenge is who defines quality? The market solution is to work with American Society of Quality and/or ISO to establish independent, non-government, review organizations.
There is no fool-proof solution, but the establishment of a proper, incentives based system would be a good start.
Recently der Spiegel published a review of the leaked AGW emails. Too bad the media had not done this sooner.
peteraleff
1 / 5 (1) May 16, 2010
To Frajo -- You quote and comment: Unfortunately, no one in the scientific community seems to actually do anything to help bring about that alleged integrity.
No one? Do you know them all?

My answer: I don't know all the members of the scientific community, but if any among them were actually exposing bogus research like the examples I discuss on my retinopathyofprematurity.org site then these patient-harming abuses would be stopped. However, since that postulated and much desired integrity is still lacking, and the abuses continue, no one among all the members of that "scientific community" has brought it about. Can you contradict that logic?
frajo
5 / 5 (1) May 17, 2010
Can you contradict that logic?
Yes. You don't consider the set of all scientists who don't know the content of your site. Your implication "no one ..." is plain wrong.
Skeptic_Heretic
5 / 5 (1) May 17, 2010
I don't know all the members of the scientific community, but if any among them were actually exposing bogus research like the examples I discuss on my retinopathyofprematurity.org site then these patient-harming abuses would be stopped.

The exposure of fraud is part of the peer review process. Scientists are the ones exposing other scientists during that process.

Would you care to learn more about how the system works?

Marjon,

The journal doesn't do the review, the readers of the journal do the review. And stop with the emails already. You have 3 potential lines in the entire set of thousands of emails over a decade and you pick 3 quotes out of context. It's getting really tired dealing with your ignorance across the board.
marjon
1 / 5 (2) May 17, 2010
The journal doesn't do the review, the readers of the journal do the review.

That is not what the 'Scientist' article states.
So you are saying 'Nature' and 'Science' will publish articles based upon the faith in the author?
Journals are no better than Physorg?
Skeptic_Heretic
not rated yet May 17, 2010
The journal doesn't do the review, the readers of the journal do the review.

That is not what the 'Scientist' article states.
So you are saying 'Nature' and 'Science' will publish articles based upon the faith in the author?
Journals are no better than Physorg?

Nature and Science publish works that have already been published elsewhere and reviewed by independent scientists. Those magazines are not pre-review journals or annals of scientific statement.

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