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Disclosure in Genetic Research and Therapy
An anonymous reader writes "The San Jose Mercury News has an interesting article on conflicts between financial pressure and scientific integrity in genetic research. For-profit experimenters tend to advertise (loudly) positive results and forget about pesky side effects.
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The article seems to be more about how science is going unreported since it is proprietary. Science now has to spend much time and resources on patents. Even those who have no interest in patent ownership must protect them selves from those who could patent a technique that they use.
Molecular genetics cannot be done in a vacuum. Kits must be purchased and patents apply. One never knows when someone is going to inform you that they own ½ of your discovery because you used their kit!
Oh how I wish I were a lawyer rather than a scientist.
Their research is extremely important, but there is a great deal of ignorance about the possibilities for and risks involved with gene therapy and other genetic research. Just as the cloning of Dolly triggered an enormous public response, many researchers in this and other biotech fields fear getting bad press. Based on the political pressure they have faced in the past two months because of the unreported "serious adverse events" in their trials, I would say their fears were well-founded. In fact, in the past months many gene therapy projects have slowed or even halted because of the political pressure.
That's not to say that financial worries have had no effect - it's just that those concerns are part of a bigger picture.
If you're interested in reading more about this and related issues in biotech, see the Biotech page of the Center for the Study of Technology and Society .
- A. Keiper
In highly experimental areas like gene therapy which are also politically experimental, the reporting requirements are very strict. They want you to report any suspiscious event as an adverse reaction immediately.
As we've seen, the trials can be halted at a moments notice based on an adverse effect thus the Doctors are a little slow to report an effect before they have a better understanding of it. The politically charged atmosphere leads to extremes of opinion on both sides and thus extreme interpretations of results. What may be considered minor to a gene therapy pundit is absolute proof the entire thing should be stopped by the anti-gene therapy advocate. Leaking of information to the press can kill a trial even if there is no validity to the leak. We need a situation where the Doctors can confortably report all events (adverse, unrelated, unknown, and positive) without fear of immature press leaks and with the publics confidence that the trial is being reviewed properly and safely.
If the trial subjects are going to die from their disease with or without treatment, then when one dies during treatment is it necessary to halt all trials?? Probably not. If the patient died due to the treatment, should that treatment be stopped? Yes, at least until they know why the patient died and can find a safe (risk balanced) way of doing it.
We probably need more onsite FDA review during trials to keep everyone honest yet with a high level of confidentiality to prevent hysteria due to sensational news stories.
my 2 cents
no sig.
According to the article, some researchers think the financial aspirations of scientific researchers are "a blatant conflict of interest, while others say only that the matter needs further scrutiny."
A. Keiper
The Center for the Study of Technology and Society
Wake me up when /. posts some real news for nerds or stuff that matters - like the disclosure of Natalie Portman's hot & tight jizz-box.