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COM 0882.009 2006-2008
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COM 0882.009 2006-2008
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Last modified
5/12/2008 4:38:36 AM
Creation date
5/8/2008 7:00:00 PM
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Communications
Communications - Type
COM
Communications - Council Term
2006-2008
Communication
0882
Point
009
Author
Jerry Konanui
Communications - Referred To
COUNCIL
Comments
Presented: 1/24/08
Document Relationships
AGE COUNCIL 2008/01/24 2006-2008
(Related)
Path:
\Council Records\Agendas\2006-2008\Council
RES 462 Draft 01 2006-2008
(Related)
Path:
\Council Records\Resolutions\2006-2008
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<br /> <br /> <br /> <br /> <br /> <br /> NAS's and Venter's warning should be carefully considered by scientists. We cannot have a two <br /> tiered system where some publish and share data and others hoard and keep secrets in the name <br /> of patent protection. Consider my own experience (based on a real example of malaria drug <br /> resistance). Suppose there are three drugs under investigation A, B and C. I publish (without <br /> patent) that drug A and B are ineffective based on a special analysis that I devised. The <br /> company reads the publication, confirms the results, discontinues development of A and B and <br /> pursues, patents and markets C. Shouldn't I receive some of the monetary rewards for sales of <br /> drug C or is publication my only reward? It is tempting to link patents only with <br /> commercialization of products - but in the above example the process is complicated and not <br /> clear. Not only did my advice stop the development of A and B but it resulted in a test to show <br /> that C was effective. Furthermore, once product C is marketed, will the company allow me <br /> access to the product to study other side effects? This too would affect the commercialization of <br /> the product but in a negative way and they may be inclined to restrict access via patent <br /> arguments. If, patents are taken on GM taro there must be credit given to the Hawaiians who <br /> have already contributed so much to the development and understanding of all aspects of non- <br /> GM taro. However, in light of the NAS review, I believe scientists are obliged to support <br /> publications over patents. For scientists who disagree, I would ask that their financial conflicts <br /> of interest be reviewed. <br /> <br /> If industry controls so much of the development budget and they are reluctant to look for side <br /> effects which might derail a product line, then how do we insure that adequate safety studies are <br /> funded? The only way to insure this is to have a strong regulatory agency demanding parallel <br /> studies for health and environmental safety. Our Food and Drug Administration (FDA) used to <br /> be such an agency, until it was crippled by conflict of interest. <br /> <br /> Recently there have been numerous articles in medical journals and a Senate Investigation <br /> criticizing the FDA for conflict of interest- Analogously, FDA staff were operating under a <br /> "conflict of fear". A few months ago the head of the FDA resigned under criticism for this <br /> problem. Several reports and articles pointedly, write: <br /> "Sccl rrrliets can be naive about politics, PR, and other external factors shaping their work <br /> and mfr become srdigrwnt at the suggestion gat their resin am shaped by their fording" <br /> - ReMptonr S Sit uwJ. Ressomb fwxAng, COIWW ofin<ereA and ft of <br /> public relabons, Public Health Reports, July 4ug 2002 (17); 331-9. <br /> FDA epidemiologist David Graham - " 1 would argue that the FDA as currently configured, is <br /> incapable of protecting America against another Vioxx. We are virtually defenseless." ...an <br /> atmosphere that that stifles debate ...Is very much driven by what industry wants ...more a <br /> cultureof fear." - Okie S. What Ails the FDA, 2005 NEJM 352(11), 1063-6. <br /> FDA panel met to discuss release of new 2 drugs - FDA says "because of the general nature <br /> of the discussions before the committee, these potential conflicts are mitigated." The panel <br /> members with financial interest themselves say that their ties did not influence their votes. <br /> Yet of those with Interests 93% votes were for the drugs compared to only 66% of those <br /> without interests. The drugs got approvals but if the conflicted members had not been <br /> allowed to vote the drugs would not have been approved. - Steinbrook R. Financial Conflicts of <br /> Interest and the FDA's Advisory Committees. 14 Jury 2005, NEJM 353(2), p 118-8. <br /> Upon resignation of FDA halal Dr Crawford, Senator Clinton said " Under his watch the <br /> agency faced scrutiny over ft response to various crises:...am failure to <br /> adequately separate science from what can only be sees as ideology-driven <br />
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