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<p class="MsoNormal" style="mso-margin-top-alt:auto;mso-margin-bottom-alt:auto"><font size="3" color="black" face="Times New Roman"><span style="font-size:12.0pt;color:windowtext"><a href="http://www.washingtonpost.com/opinions/charles-lane-heed-massachusettss-cry-for-help-in-opioid-regulation/2014/04/16/cfa62e22-c575-11e3-9f37-7ce307c56815_story.html?wpisrc=nl_headlines">http://www.washingtonpost.com/opinions/charles-lane-heed-massachusettss-cry-for-help-in-opioid-regulation/2014/04/16/cfa62e22-c575-11e3-9f37-7ce307c56815_story.html?wpisrc=nl_headlines</a><o:p></o:p></span></font></p>
<p class="MsoNormal" style="mso-margin-top-alt:auto;mso-margin-bottom-alt:auto"><span class="entry-title"><b><font size="5" color="#000099" face="Times New Roman"><span lang="EN" style="font-size:18.0pt;font-weight:bold">Heed Massachusetts’s cry for help in
opioid regulation</span></font></b></span><b><font size="5" color="black"><span style="font-size:18.0pt;color:windowtext;font-weight:bold"><o:p></o:p></span></font></b></p>
<p class="MsoNormal" style="mso-margin-top-alt:auto;mso-margin-bottom-alt:auto"><b><font size="4" color="black" face="Times New Roman"><span lang="EN" style="font-size:13.5pt;color:windowtext;font-weight:bold">By
<a href="http://www.washingtonpost.com/charles-lane/2011/02/28/ABeqisM_page.html">
<font color="blue"><span style="color:blue">Charles Lane</span></font></a>, Published: April 16<o:p></o:p></span></font></b></p>
<p class="MsoNormal" style="mso-margin-top-alt:auto;mso-margin-bottom-alt:auto"><b><font size="4" color="black" face="Times New Roman"><span lang="EN" style="font-size:13.5pt;color:windowtext;font-weight:bold"><a href="mailto:lanec@washpost.com?subject=Reader%20feedback%20for%20'Heed%20Massachusetts’s%20cry%20for%20help%20in%20opioid%20regulation'"><font color="blue"><span style="color:blue">E-mail
the writer</span></font></a> <o:p></o:p></span></font></b></p>
<p class="MsoNormal" style="mso-margin-top-alt:auto;mso-margin-bottom-alt:auto"><font size="3" color="black" face="Times New Roman"><span lang="EN" style="font-size:12.0pt;color:windowtext">Massachusetts has lost its bid to ban a new prescription opioid pain
medication known as Zohydro. A <a href="http://www.washingtonpost.com/national/judge-blocks-massachusetts-ban-on-painkiller/2014/04/15/42747d86-c4e1-11e3-9ee7-02c1e10a03f0_story.html">
<font color="blue"><span style="color:blue">federal judge ruled</span></font></a> Tuesday that only the Food and Drug Administration can decide what medications are safe and effective enough for sale in the United States.<o:p></o:p></span></font></p>
<p class="MsoNormal" style="mso-margin-top-alt:auto;mso-margin-bottom-alt:auto"><font size="3" color="black" face="Times New Roman"><span lang="EN" style="font-size:12.0pt;color:windowtext">As a matter of law, the judge, Rya Zobel, was almost certainly correct;
Congress has had supremacy in this particular field ever since the <a href="http://www.fda.gov/regulatoryinformation/legislation/ucm148690.htm">
<font color="blue"><span style="color:blue">1906 Pure Food and Drug Act</span></font></a>.<o:p></o:p></span></font></p>
<p class="MsoNormal" style="mso-margin-top-alt:auto;mso-margin-bottom-alt:auto"><font size="3" color="black" face="Times New Roman"><span lang="EN" style="font-size:12.0pt;color:windowtext">As a matter of policy and morality, however, Massachusetts and its
Democratic governor, Deval Patrick, were in the right: <a href="http://www.mass.gov/governor/pressoffice/pressreleases/2014/0327-governor-declares-public-health-emergency.html">
<font color="blue"><span style="color:blue">The Bay State’s attempt to block Zohydro</span></font></a> was a cry for help that Congress and the Obama administration would be well-advised to heed.
<o:p></o:p></span></font></p>
<p class="MsoNormal" style="mso-margin-top-alt:auto;mso-margin-bottom-alt:auto"><font size="3" color="black" face="Times New Roman"><span lang="EN" style="font-size:12.0pt;color:windowtext">Patrick was responding to a surge in opiate overdoses, many of them
fatal. The trend is more than a decade old in the Bay State but has reached alarming heights in recent months, as prescription drug addicts turn to cheaper heroin.
<o:p></o:p></span></font></p>
<p class="MsoNormal" style="mso-margin-top-alt:auto;mso-margin-bottom-alt:auto"><font size="3" color="black" face="Times New Roman"><span lang="EN" style="font-size:12.0pt;color:windowtext">Massachusetts is not unique. The Centers for Disease Control and Prevention
reports that <a href="http://www.usatoday.com/story/money/business/2013/07/28/deadly-epidemic-prescription-drug-overdoses/2584117/">
<font color="blue"><span style="color:blue">more than 16,500 people died from overdoses of prescription narcotics in 2010</span></font></a>; that’s quadruple the
<a href="http://www.cdc.gov/media/releases/2013/p0220_drug_overdose_deaths.html">
<font color="blue"><span style="color:blue">number in 1999.</span></font></a><o:p></o:p></span></font></p>
<p class="MsoNormal" style="mso-margin-top-alt:auto;mso-margin-bottom-alt:auto"><font size="3" color="black" face="Times New Roman"><span lang="EN" style="font-size:12.0pt;color:windowtext">Among the most heavily abused
<a href="http://www.rxlist.com/vicodin-side-effects-drug-center.htm"><font color="blue"><span style="color:blue">pain medications is Vicodin</span></font></a>, a blend of opioid hydrocodone and non-opioid acetaminophen.
<a href="http://www.cbsnews.com/news/pure-hydrocodone-stronger-than-vicodin-approved-by-fda/">
<font color="blue"><span style="color:blue">Zohydro, which the FDA approved in October, is pure hydrocodone</span></font></a>. And unlike newer, abuse-resistant versions of Vicodin, Zohydro comes in a form addicts can pulverize, then snort or inject for an
immediate rush. <o:p></o:p></span></font></p>
<p class="MsoNormal" style="mso-margin-top-alt:auto;mso-margin-bottom-alt:auto"><font size="3" color="black" face="Times New Roman"><span lang="EN" style="font-size:12.0pt;color:windowtext">All Patrick wanted was to prevent sales of pure hydrocodone until “adequate
measures are in place to safeguard against the potential for diversion, overdose and misuse,” according to a statement.
<o:p></o:p></span></font></p>
<p class="MsoNormal" style="mso-margin-top-alt:auto;mso-margin-bottom-alt:auto"><font size="3" color="black" face="Times New Roman"><span lang="EN" style="font-size:12.0pt;color:windowtext">Citing the same addiction risks, an FDA panel of expert advisers
<a href="http://www.drugfree.org/join-together/addiction/fda-panel-votes-against-recommending-zohydro-for-approval">
<font color="blue"><span style="color:blue">voted 11 to 2</span></font></a> in late 2012 against approval for Zohydro;
<a href="http://www.nydailynews.com/life-style/health/28-states-fda-rethink-approval-new-painkiller-article-1.1545864">
<font color="blue"><span style="color:blue">more than two dozen state attorneys general</span></font></a> also urged the FDA not to green-light the drug.<o:p></o:p></span></font></p>
<p class="MsoNormal" style="mso-margin-top-alt:auto;mso-margin-bottom-alt:auto"><font size="3" color="black" face="Times New Roman"><span lang="EN" style="font-size:12.0pt;color:windowtext">But the agency plowed ahead, citing the need for an opioid that patients
with long-term pain can take without fear of <a href="http://www.medicinenet.com/acetaminophen/article.htm">
<font color="blue"><span style="color:blue">liver damage, a potential side effect of acetaminophen</span></font></a>.
<o:p></o:p></span></font></p>
<p class="MsoNormal" style="mso-margin-top-alt:auto;mso-margin-bottom-alt:auto"><font size="3" color="black" face="Times New Roman"><span lang="EN" style="font-size:12.0pt;color:windowtext">It was an astonishing decision, not only because of the countervailing
public health considerations but also the fact <a href="http://www.washingtonpost.com/national/health-science/maker-of-oxycotin-developing-tamper-resistant-hydrocodone-drug/2014/03/12/85df3dd2-aa0f-11e3-9e82-8064fcd31b5b_story.html">
<font color="blue"><span style="color:blue">that another company</span></font></a> was, and still is, close to producing a tamper-resistant equivalent drug. Why the hurry?<o:p></o:p></span></font></p>
<p class="MsoNormal" style="mso-margin-top-alt:auto;mso-margin-bottom-alt:auto"><font size="3" color="black" face="Times New Roman"><span lang="EN" style="font-size:12.0pt;color:windowtext">To be sure, more and more of the overdoses that alarm Patrick and others
are due to heroin, not prescription drugs. Critics of drug-control efforts say that government is to blame because of a crackdown on opioid prescriptions, which not only deprives legitimate patients but also forces addicts into the streets for chemically similar
heroin.<o:p></o:p></span></font></p>
<p class="MsoNormal" style="mso-margin-top-alt:auto;mso-margin-bottom-alt:auto"><font size="3" color="black" face="Times New Roman"><span lang="EN" style="font-size:12.0pt;color:windowtext">But as the FDA’s approval of Zohydro shows, the supposed “crackdown”
is easy to exaggerate. <o:p></o:p></span></font></p>
<p class="MsoNormal" style="mso-margin-top-alt:auto;mso-margin-bottom-alt:auto"><font size="3" color="black" face="Times New Roman"><span lang="EN" style="font-size:12.0pt;color:windowtext">Yes, in response to a massive surge in abuse, addiction and death,
government stirred itself in recent years, requiring greater monitoring of prescriptions and tamper-resistant pills. Opioid prescriptions fell in 2013 for the first time in more than 20 years.<o:p></o:p></span></font></p>
<p class="MsoNormal" style="mso-margin-top-alt:auto;mso-margin-bottom-alt:auto"><font size="3" color="black" face="Times New Roman"><span lang="EN" style="font-size:12.0pt;color:windowtext">But this decline
<a href="http://www.jsonline.com/watchdog/opioid-prescriptions-down-but-not-as-much-as-some-expected-b99210372z1-247409631.html">
<font color="blue"><span style="color:blue">was from 241 million in 2012 to 229.5 million in 2013</span></font></a> — nearly triple the level of 20 years ago and still enough to medicate every adult in the United States.<o:p></o:p></span></font></p>
<p class="MsoNormal" style="mso-margin-top-alt:auto;mso-margin-bottom-alt:auto"><font size="3" color="black" face="Times New Roman"><span lang="EN" style="font-size:12.0pt;color:windowtext">“Data” is not the plural of “anecdote.” Still: Amid the supposed “crackdown,”
in 2012, I took the victim of a minor auto accident, who was complaining of whiplash, to an emergency room. X-rays were negative, the pain non-crippling — yet the doctor sent the patient home with three opioid pills and a prescription for 30 more.
<o:p></o:p></span></font></p>
<p class="MsoNormal" style="mso-margin-top-alt:auto;mso-margin-bottom-alt:auto"><font size="3" color="black" face="Times New Roman"><span lang="EN" style="font-size:12.0pt;color:windowtext">Small wonder that
<a href="http://www.healthline.com/health-news/addiction-high-risk-opioid-users-get-doctor-prescriptions-030314">
<font color="blue"><span style="color:blue">a new CDC report</span></font></a> shows that 27.3 percent of opioid abusers still get them from a doctor. Doctors prescribed opioids to one out of eight privately insured
<i><span style="font-style:italic">pregnant women</span></i> in 2011, the <a href="http://www.nytimes.com/2014/04/15/science/surge-in-prescriptions-for-opioid-painkillers-for-pregnant-women.html?_r=0">
<font color="blue"><span style="color:blue">New York Times</span></font></a> reported this month.
<o:p></o:p></span></font></p>
<p class="MsoNormal" style="mso-margin-top-alt:auto;mso-margin-bottom-alt:auto"><font size="3" color="black" face="Times New Roman"><span lang="EN" style="font-size:12.0pt;color:windowtext">As for the diversion to heroin, it preceded the “crackdown.”
<a href="http://www.drugabuse.gov/publications/research-reports/heroin/scope-heroin-use-in-united-states">
<font color="blue"><span style="color:blue">National Institute of Drug Abuse</span></font></a> data show heroin use began rising in 2007, years before the first tamper-resistant version of OxyContin, a widely abused opioid. The reason: Addicts’ main source
of opioids was a doctor or friend with access to a legitimate user’s leftovers. As addicts’ tolerance of, and need for, drugs grew, they eventually exhausted these supplies and turned to the black market — first for pills and then, often, heroin.
<o:p></o:p></span></font></p>
<p class="MsoNormal" style="mso-margin-top-alt:auto;mso-margin-bottom-alt:auto"><font size="3" color="black" face="Times New Roman"><span lang="EN" style="font-size:12.0pt;color:windowtext;background:yellow;mso-highlight:yellow">Insofar as it reflects recent
modest restraint in opioid prescription, addicts’ shift to heroin is a regrettable but unavoidable result of a belated attempt to rein in over-prescription of widely abused medications that, in addition to their other deadly attributes, have long been gateway
drugs for heroin.</span></font><font color="black"><span lang="EN" style="color:windowtext"><o:p></o:p></span></font></p>
<p class="MsoNormal" style="mso-margin-top-alt:auto;mso-margin-bottom-alt:auto"><font size="3" color="black" face="Times New Roman"><span lang="EN" style="font-size:12.0pt;color:windowtext">Someday, historians will look back on this era of prescription drug
and heroin abuse, and its tragic human costs, and they will marvel at the powerful combination of industry greed, physician complaisance, government neglect — and plain old denial — that made it possible.
<o:p></o:p></span></font></p>
<p class="MsoNormal" style="mso-margin-top-alt:auto;mso-margin-bottom-alt:auto"><i><font size="3" color="black" face="Times New Roman"><span lang="EN" style="font-size:12.0pt;color:windowtext;font-style:italic">Read more from
<a href="http://www.washingtonpost.com/charles-lane/2011/02/28/ABeqisM_page.html">
<font color="blue"><span style="color:blue">Charles Lane’s archive</span></font></a>,
<a href="https://twitter.com/ChuckLane1"><font color="blue"><span style="color:blue">follow him on Twitter</span></font></a> or
<a href="http://www.facebook.com/charlesmlane1"><font color="blue"><span style="color:blue">subscribe to his updates on Facebook</span></font></a>.</span></font></i><font color="black"><span lang="EN" style="color:windowtext"><o:p></o:p></span></font></p>
<p class="MsoNormal"><font size="3" color="#000099" face="Times New Roman"><o:p> </o:p></font></p>
<p class="MsoNormal"><font size="3" color="#000099" face="Times New Roman"><o:p> </o:p></font></p>
<p class="MsoNormal"><font size="2" color="navy" face="Times New Roman"><span style="font-size:10.0pt;color:navy">Deborah L. DeBiasi</span></font><font size="2" color="navy"><span style="font-size:11.0pt;color:navy"><br>
</span></font><b><font size="2" color="navy"><span style="font-size:10.0pt;color:navy;font-weight:bold">Email: Deborah.DeBiasi@deq.virginia.gov</span></font></b><b><i><font size="2" color="red"><span style="font-size:10.0pt;color:red;font-weight:bold;font-style:italic"><br>
</span></font></i></b><font size="2" color="navy"><span style="font-size:10.0pt;color:navy">WEB site address:
<a href="http://www.deq.virginia.gov/">www.deq.virginia.gov</a></span></font><font size="2" color="navy"><span style="font-size:11.0pt;color:navy"><br>
</span></font><font size="2" color="navy"><span style="font-size:10.0pt;color:navy">Virginia Department of Environmental Quality</span></font><font size="2" color="navy"><span style="font-size:11.0pt;color:navy"><br>
</span></font><font size="2" color="navy"><span style="font-size:10.0pt;color:navy">Office of Water Permits
</span></font><font size="2" color="navy"><span style="font-size:11.0pt;color:navy"><br>
</span></font><font size="2" color="navy"><span style="font-size:10.0pt;color:navy">Industrial Pretreatment/Whole Effluent Toxicity (WET) Program</span></font><font size="2" color="navy"><span style="font-size:11.0pt;color:navy"><br>
</span></font><font size="2" color="navy"><span style="font-size:10.0pt;color:navy">PPCPs, EDCs, and Microconstituents<o:p></o:p></span></font></p>
<p class="MsoNormal"><font size="2" color="navy" face="Times New Roman"><span style="font-size:11.0pt;color:navy"><a href="http://www.deq.virginia.gov/Programs/Water/PermittingCompliance/PollutionDischargeElimination/Microconstituents.aspx">http://www.deq.virginia.gov/Programs/Water/PermittingCompliance/PollutionDischargeElimination/Microconstituents.aspx</a></span></font><font size="2" color="navy"><span style="font-size:10.0pt;color:navy"><o:p></o:p></span></font></p>
<p class="MsoNormal"><font size="2" color="navy" face="Times New Roman"><span style="font-size:10.0pt;color:navy">Mail: P.O. Box 1105, Richmond, VA 23218</span></font><font size="2" color="navy"><span style="font-size:11.0pt;color:navy"><br>
</span></font><font size="2" color="navy"><span style="font-size:10.0pt;color:navy">Location: 629 E. Main Street, Richmond, VA 23219</span></font><font size="2" color="navy"><span style="font-size:11.0pt;color:navy"><br>
</span></font><font size="2" color="navy"><span style="font-size:10.0pt;color:navy">PH: 804-698-4028 FAX: 804-698-4032<o:p></o:p></span></font></p>
<p class="MsoNormal"><font size="3" color="#000099" face="Times New Roman"><o:p> </o:p></font></p>
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