From: <Opgeslagen met Microsoft Internet Explorer 5>
Subject: Alameda Times-Star Online - Op-Ed
Date: Mon, 21 Jun 2004 15:13:01 +0200
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href=3D"http://www.timesstar.com/Stories/0,1413,125%7E10859%7E,00.html"=20
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href=3D"http://www.timesstar.com/Stories/0,1413,125%7E10859%7E,00.html"=20
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href=3D"http://www.timesstar.com/Stories/0,1413,125%7E1486%7E,00.html"=20
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href=3D"http://www.timesstar.com/Stories/0,1413,125%7E30734%7E,00.html"=20
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href=3D"http://customwire.ap.org/specials/interactives/dailygallery/index=
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href=3D"http://www.timesstar.com/Stories/0,1413,125%7E1540%7E,00.html"=20
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            =
href=3D"http://www.timesstar.com/Stories/0,1413,125%7E1525%7E,00.html"=20
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href=3D"http://www.timesstar.com/Stories/0,1413,125%7E11080%7E,00.html"=20
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            =
href=3D"http://www.timesstar.com/Stories/0,1413,125%7E1505%7E,00.html"=20
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href=3D"http://www.timesstar.com/Stories/0,1413,125%7E27896%7E,00.html"=20
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            =
href=3D"http://www.timesstar.com/Stories/0,1413,125%7E1506%7E,00.html"=20
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            =
href=3D"http://www.timesstar.com/Stories/0,1413,125%7E29836%7E,00.html"=20
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            =
href=3D"http://www.timesstar.com/Stories/0,1413,125%7E1502%7E,00.html"=20
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            =
href=3D"http://www.timesstar.com/Stories/0,1413,125%7E11720%7E,00.html"=20
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href=3D"http://www.timesstar.com/Stories/0,1413,125%7E11719%7E,00.html"=20
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            =
href=3D"http://www.timesstar.com/Stories/0,1413,125%7E1503%7E,00.html"=20
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            =
href=3D"http://www.timesstar.com/Stories/0,1413,125%7E1507%7E,00.html"=20
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            =
href=3D"http://www.timesstar.com/Stories/0,1413,125%7E1508%7E,00.html"=20
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            =
href=3D"http://www.timesstar.com/Stories/0,1413,125%7E29399%7E,00.html"=20
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            =
href=3D"http://www.timesstar.com/Stories/0,1413,125%7E11717%7E,00.html"=20
            target=3D_self>Turn2</A></TD></TR>
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            =
href=3D"http://www.timesstar.com/Stories/0,1413,125%7E28136%7E,00.html"=20
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            =
href=3D"http://146.145.120.3/merge/tsnform.aspx?c=3Dbayarea&amp;page=3Dml=
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class=3Dnav>&nbsp;<!--NAV:SPACER-->&nbsp;</A></TD></TR>
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            =
href=3D"http://www.timesstar.com/Stories/0,1413,125%7E11079%7E,00.html"=20
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            =
href=3D"http://www.timesstar.com/Stories/0,1413,125%7E30994%7E,00.html"=20
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            =
href=3D"http://www.timesstar.com/Stories/0,1413,125%7E27218%7E,00.html"=20
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            =
href=3D"http://www.timesstar.com/Stories/0,1413,125%7E27223%7E,00.html"=20
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            =
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            =
href=3D"http://www.timesstar.com/Stories/0,1413,125%7E1511%7E,00.html"=20
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            =
href=3D"http://www.timesstar.com/Stories/0,1413,125%7E1523%7E,00.html"=20
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            =
href=3D"http://www.timesstar.com/Stories/0,1413,125%7E1524%7E,00.html"=20
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            =
href=3D"http://extras.insidebayarea.com/TalkBack/Opin_TalkBack.asp"=20
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class=3Dnav>&nbsp;<!--NAV:SPACER-->&nbsp;</A></TD></TR>
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            =
href=3D"http://www.timesstar.com/Stories/0,1413,125%7E1549%7E,00.html"=20
            target=3D_self>Bay Area Living</A></TD></TR>
        <TR>
          <TD class=3Dnavba><A class=3Dnavba=20
            =
href=3D"http://www.timesstar.com/Stories/0,1413,125%7E30226%7E,00.html"=20
            target=3D_self>Berkeley Rep</A></TD></TR>
        <TR>
          <TD class=3Dnavba><A class=3Dnavba=20
            =
href=3D"http://www.timesstar.com/Stories/0,1413,125%7E30715%7E,00.html"=20
            target=3D_self>Games</A></TD></TR>
        <TR>
          <TD class=3Dnavba><A class=3Dnavba=20
            =
href=3D"http://www.timesstar.com/Stories/0,1413,125%7E28078%7E,00.html"=20
            target=3D_self>Inside Out</A></TD></TR>
        <TR>
          <TD class=3Dnavba><A class=3Dnavba=20
            =
href=3D"http://www.timesstar.com/Stories/0,1413,125%7E28079%7E,00.html"=20
            target=3D_self>Food</A></TD></TR>
        <TR>
          <TD class=3Dnavba><A class=3Dnavba=20
            =
href=3D"http://www.timesstar.com/Stories/0,1413,125%7E30061%7E,00.html"=20
            target=3D_self>Columnists</A></TD></TR>
        <TR>
          <TD class=3Dnavba><A class=3Dnavba=20
            =
href=3D"http://www.timesstar.com/Stories/0,1413,125%7E27230%7E,00.html"=20
            target=3D_self>Behind the Wheel</A></TD></TR>
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          <TD class=3Dnavba><A class=3Dnavba=20
            =
href=3D"http://www.timesstar.com/Stories/0,1413,125%7E1550%7E,00.html"=20
            target=3D_self>Travel</A></TD></TR>
        <TR>
          <TD class=3Dnavba><A class=3Dnavba=20
            =
href=3D"http://alliance.zap2it.com/zp_mt_front_page/?site_code=3Dcahar2" =

            target=3D_new>Movie Listings</A></TD></TR>
        <TR>
          <TD class=3Dnavba><A class=3Dnavba=20
            =
href=3D"http://tvlistings.zap2it.com/partners/zipcode.asp?partner_id=3Dca=
har2"=20
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        <TR>
          <TD class=3Dnavba><A class=3Dnavba=20
            =
href=3D"http://www.timesstar.com/Stories/0,1413,125%7E1561%7E,00.html"=20
            target=3D_self>Soap Opera Recaps</A></TD></TR>
        <TR>
          <TD class=3Dnavba><A class=3Dnavba=20
            =
href=3D"http://www.timesstar.com/Stories/0,1413,125%7E23822%7E,00.html"=20
            target=3D_self>Horoscopes<!--NAV:SPACER--></A></TD></TR>
        <TR>
          <TD class=3Dnav><A =
class=3Dnav>&nbsp;<!--NAV:SPACER-->&nbsp;</A></TD></TR>
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            =
href=3D"http://www.timesstar.com/Stories/0,1413,125%7E27727%7E,00.html"=20
            target=3D_self>Special Reports</A></TD></TR>
        <TR>
          <TD class=3Dnavba><A class=3Dnavba=20
            =
href=3D"http://www.timesstar.com/Stories/0,1413,125%7E30407%7E,00.html"=20
            target=3D_self>100 Years of Flight</A></TD></TR>
        <TR>
          <TD class=3Dnavba><A class=3Dnavba=20
            =
href=3D"http://www.timesstar.com/Stories/0,1413,125%7E30928%7E,00.html"=20
            target=3D_self>Bond Series</A></TD></TR>
        <TR>
          <TD class=3Dnavba><A class=3Dnavba=20
            =
href=3D"http://www.timesstar.com/Stories/0,1413,125%7E27727%7E,00.html"=20
            target=3D_self>Are We Safer Now?</A></TD></TR>
        <TR>
          <TD class=3Dnavba><A class=3Dnavba=20
            =
href=3D"http://www.timesstar.com/Stories/0,1413,125%7E28402%7E,00.html"=20
            target=3D_self>Separate but =
Unequal<!--NAV:SPACER--></A></TD></TR>
        <TR>
          <TD class=3Dnav><A =
class=3Dnav>&nbsp;<!--NAV:SPACER-->&nbsp;</A></TD></TR>
        <TR>
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            href=3D"http://community.insidebayarea.com/"=20
          target=3D_new>Community</A></TD></TR>
        <TR>
          <TD class=3Dnavba><A class=3Dnavba =
href=3D"http://bayareabest.com/TS/"=20
            target=3D_new>Bay Area Best</A></TD></TR>
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          <TD class=3Dnavba><A class=3Dnavba=20
            href=3D"http://whatsup.insidebayarea.com/images/ot.pdf"=20
            target=3D_new>What's Up</A></TD></TR>
        <TR>
          <TD class=3Dnavba><A class=3Dnavba=20
            href=3D"http://www.insidebayarea.com/almanac/" =
target=3D_new>Alamanac<!--NAV:SPACER--></A></TD></TR>
        <TR>
          <TD class=3Dnav><A =
class=3Dnav>&nbsp;<!--NAV:SPACER-->&nbsp;</A></TD></TR>
        <TR>
          <TD class=3Dnavaa><A class=3Dnavaa=20
            href=3D"http://education.insidebayarea.com/"=20
          target=3D_new>Education</A></TD></TR>
        <TR>
          <TD class=3Dnavba><A class=3Dnavba=20
            href=3D"http://insidebayarea.greatschools.net/modperl/go/CA" =

            target=3D_new>STAR Scores</A></TD></TR>
        <TR>
          <TD class=3Dnavba><A class=3Dnavba=20
            href=3D"http://insidebayarea.greatschools.net/modperl/go/CA" =

            target=3D_new>Great Schools</A></TD></TR>
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                              VON HOFFMAN </A></TD></TR>
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                            <TD class=3DotherArticlesLink>- <A=20
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                              =
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                              MANDELBAUM </A></TD></TR>
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                            <TD class=3DotherArticlesLink>- <A=20
                              class=3DotherArticlesLink=20
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                              MORRISON =
</A></TD></TR></TBODY></TABLE></A>
                        <P></P><!-- cdaFreeFormDetailByName.strSQL =3D =
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@Filter =3D 'Article', @LiveFilter =3D '1', @DateTimeContext =3D =
'6/21/2004 6:58:10 AM' --><!-- ArticleFreeform2 not found =
--></TD></TR></TBODY></TABLE></TD></TR></TBODY></TABLE><SPAN=20
            class=3DarticleHeadline>It's time to focus on information =
bias about=20
            drugs</SPAN>
            <P class=3DarticleSpacer></P>HEARING about an exciting new =
drug study=20
            can make a pill sound so fantastic that we can hardly wait =
to take=20
            it. We rush to our doctor's office to show her the newspaper =

            clippings, and for extra measure we bring along a few =
supporting=20
            documents that we have downloaded from the Internet.=20
            <P>But suppose that one glorious study we heard about was =
just that=20
            -- the one glorious study about that drug. Suppose that =
there=20
            existed three or four additional studies that made that drug =
seem=20
            undesirable or, at least, inglorious, and we had no way of =
knowing=20
            about them. Suppose those hidden studies contained =
information about=20
            side effects or contradictory data that suggested the drug =
really=20
            didn't work. <!-- cdaFreeFormDetailByName.strSQL =3D =
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AM' --><!-- ArticleAd not found -->
            <P>It's unsettling to consider these possibilities, but it's =

            important to remain vigilant about them. Clinically =
important -- and=20
            generally unfavorable -- information about drugs is often =
buried in=20
            publicly inaccessible archives. Our medical journals tend =
not to=20
            publish studies about drugs that were found to be duds in =
clinical=20
            trials.=20
            <P>Hidden drug data poses a serious and pervasive problem. =
For=20
            example, a recent study in the Journal of the American =
Medical=20
            Association analyzed 102 drug trials and found that 50 =
percent of=20
            efficacy data and 65 percent of harm outcomes were only =
partially=20
            reported.=20
            <P>In certain circumstances, the suppression of drug =
information can=20
            be heavy-handed. Researchers conducting trials funded by =
drug=20
            companies have been required to sign contracts that grant =
the=20
            companies the right to control which results get submitted =
for=20
            publication. A few years ago, a vaccine manufacturer even =
filed a=20
            multimillion-dollar lawsuit against a team of AIDS =
researchers who=20
            insisted on publishing results from a clinical trial that =
found the=20
            company's HIV vaccine to be worthless.=20
            <P>Furthermore, because there is no one place where all data =
about=20
            drug trials and their results are stored, it becomes a bit =
of a=20
            scavenger hunt to find all knowable information about a drug =
that=20
            might interest you.=20
            <P>This is not a healthy system when you don't know where to =
look=20
            for drug information, and you can't telepathically access =
what's=20
            been kept out of publication.=20
            <P>A lawsuit filed this month in New York promises to =
challenge the=20
            formidable power of the pharmaceutical companies to pick and =
choose=20
            the information that gets disseminated and promoted in the =
public=20
            domain. New York Attorney General Eliot Spitzer has decided =
to sue=20
            drug manufacturer GlaxoSmith-=20
            <P>Kline PLC, claiming that it committed consumer fraud by=20
            misrepresenting and withholding data about the use of its=20
            antidepressant paroxetine (Paxil) in children.=20
            <P>The human stakes in this case are considerable, because=20
            researchers elsewhere have raised serious concerns that some =

            antidepressants might actually increase the risk of suicide =
in=20
            children. Moreover, about 2.1 million paroxetine =
prescriptions were=20
            written for children in 2002.=20
            <P>Mr. Spitzer alleges that the drug manufacturer skewed =
information=20
            about paroxetine by widely disseminating the single study =
that was=20
            able to showcase the drug in a positive light. He charges =
Glaxo with=20
            suppressing four other studies conducted on children and =
adolescents=20
            in the late 1990s that found paroxetine to be either =
ineffective or=20
            suspect for increasing the potential risk of suicide.=20
            <P>According to the Associated Press, the lawsuit also =
exposes an=20
            internal Glaxo document indicating that the company intended =
to=20
            "manage the dissemination of data in order to minimize any =
potential=20
            negative commercial impact."=20
            <P>In summing up his mission, Mr. Spitzer succinctly stated =
his=20
            case: "Having doctors prescribe drugs without full knowledge =
of=20
            safety and efficacy is wrong."=20
            <P>Iapplaud Mr. Spitzer's efforts to drive out the forces =
that=20
            wittingly and unwittingly obscure or manipulate the =
information we=20
            need to evaluate the safety and efficacy of drugs. But he =
will need=20
            a good many deputies to help him.=20
            <P>Because the vast majority of drug trials are currently =
funded by=20
            the pharmaceutical companies, he will have to persuade that =
industry=20
            of the merits of his mission. If he's lucky, federal =
regulators like=20
            the FDA will be armed with reporting requirements and riding =
at his=20
            side. Perhaps he can commandeer the public wagons to circle =
tight=20
            around the research industry, closing in with demands that =
it=20
            consistently reveal and disseminate all drug trial =
information --=20
            whether it is good, neutral, or bad.=20
            <P>Hopefully, the medical community will posse up en masse. =
So far,=20
            the American Medical Association and the publishers of a =
dozen major=20
            medical journals have called for proposals that require drug =

            companies to register their studies in a central database at =
the=20
            outset of their trials. We could go further and decline =
arrangements=20
            with drug companies that allow them to own or silence the =
results of=20
            the research trials they fund.=20
            <P>Meanwhile, Mr. Spitzer's move is bold and courageous. It =
gives me=20
            hope that we may be nearing high noon in New York, about to =
witness=20
            an overdue showdown between the commercial interests of the =
drug=20
            marketplace and the health interests of humanity that drug =
science=20
            should serve.
            <P>Kate Scannell is a physician with Kaiser Permanente and =
the=20
            author of "Death of the Good Doctor."=20
            <P>
            <P></P></TD></TR>
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s_d.documentElement.offsetHeight;j=3D'1.3';if(!s_ismac&&s_d.body){
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'
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h=3Ds_gg('linkLeaveQueryString')||i<0?h:h.substring(0,i);l=3Ds_gg(
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------=_NextPart_000_0000_01C457A2.3E9FE040--