[Pharmwaste] Heed Massachusetts’s cry for help in opioid regulation

DeBiasi, Deborah (DEQ) Deborah.DeBiasi at deq.virginia.gov
Thu Apr 17 10:28:02 EDT 2014

Heed Massachusetts’s cry for help in opioid regulation
By Charles Lane<http://www.washingtonpost.com/charles-lane/2011/02/28/ABeqisM_page.html>, Published: April 16
E-mail the writer<mailto:lanec at washpost.com?subject=Reader%20feedback%20for%20'Heed%20Massachusetts’s%20cry%20for%20help%20in%20opioid%20regulation'>
Massachusetts has lost its bid to ban a new prescription opioid pain medication known as Zohydro. A federal judge ruled<http://www.washingtonpost.com/national/judge-blocks-massachusetts-ban-on-painkiller/2014/04/15/42747d86-c4e1-11e3-9ee7-02c1e10a03f0_story.html> Tuesday that only the Food and Drug Administration can decide what medications are safe and effective enough for sale in the United States.
As a matter of law, the judge, Rya Zobel, was almost certainly correct; Congress has had supremacy in this particular field ever since the 1906 Pure Food and Drug Act<http://www.fda.gov/regulatoryinformation/legislation/ucm148690.htm>.
As a matter of policy and morality, however, Massachusetts and its Democratic governor, Deval Patrick, were in the right: The Bay State’s attempt to block Zohydro<http://www.mass.gov/governor/pressoffice/pressreleases/2014/0327-governor-declares-public-health-emergency.html> was a cry for help that Congress and the Obama administration would be well-advised to heed.
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.
Massachusetts is not unique. The Centers for Disease Control and Prevention reports that more than 16,500 people died from overdoses of prescription narcotics in 2010<http://www.usatoday.com/story/money/business/2013/07/28/deadly-epidemic-prescription-drug-overdoses/2584117/>; that’s quadruple the number in 1999.<http://www.cdc.gov/media/releases/2013/p0220_drug_overdose_deaths.html>
Among the most heavily abused pain medications is Vicodin<http://www.rxlist.com/vicodin-side-effects-drug-center.htm>, a blend of opioid hydrocodone and non-opioid acetaminophen. Zohydro, which the FDA approved in October, is pure hydrocodone<http://www.cbsnews.com/news/pure-hydrocodone-stronger-than-vicodin-approved-by-fda/>. And unlike newer, abuse-resistant versions of Vicodin, Zohydro comes in a form addicts can pulverize, then snort or inject for an immediate rush.
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.
Citing the same addiction risks, an FDA panel of expert advisers voted 11 to 2<http://www.drugfree.org/join-together/addiction/fda-panel-votes-against-recommending-zohydro-for-approval> in late 2012 against approval for Zohydro; more than two dozen state attorneys general<http://www.nydailynews.com/life-style/health/28-states-fda-rethink-approval-new-painkiller-article-1.1545864> also urged the FDA not to green-light the drug.
But the agency plowed ahead, citing the need for an opioid that patients with long-term pain can take without fear of liver damage, a potential side effect of acetaminophen<http://www.medicinenet.com/acetaminophen/article.htm>.
It was an astonishing decision, not only because of the countervailing public health considerations but also the fact that another company<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> was, and still is, close to producing a tamper-resistant equivalent drug. Why the hurry?
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.
But as the FDA’s approval of Zohydro shows, the supposed “crackdown” is easy to exaggerate.
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.
But this decline was from 241 million in 2012 to 229.5 million in 2013<http://www.jsonline.com/watchdog/opioid-prescriptions-down-but-not-as-much-as-some-expected-b99210372z1-247409631.html> — nearly triple the level of 20 years ago and still enough to medicate every adult in the United States.
“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.
Small wonder that a new CDC report<http://www.healthline.com/health-news/addiction-high-risk-opioid-users-get-doctor-prescriptions-030314> shows that 27.3 percent of opioid abusers still get them from a doctor. Doctors prescribed opioids to one out of eight privately insured pregnant women in 2011, the New York Times<http://www.nytimes.com/2014/04/15/science/surge-in-prescriptions-for-opioid-painkillers-for-pregnant-women.html?_r=0> reported this month.
As for the diversion to heroin, it preceded the “crackdown.” National Institute of Drug Abuse<http://www.drugabuse.gov/publications/research-reports/heroin/scope-heroin-use-in-united-states> 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.
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.
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.
Read more from Charles Lane’s archive<http://www.washingtonpost.com/charles-lane/2011/02/28/ABeqisM_page.html>, follow him on Twitter<https://twitter.com/ChuckLane1> or subscribe to his updates on Facebook<http://www.facebook.com/charlesmlane1>.

Deborah L. DeBiasi
Email:   Deborah.DeBiasi at deq.virginia.gov
WEB site address:  www.deq.virginia.gov<http://www.deq.virginia.gov/>
Virginia Department of Environmental Quality
Office of Water Permits
Industrial Pretreatment/Whole Effluent Toxicity (WET) Program
PPCPs, EDCs, and Microconstituents
Mail:          P.O. Box 1105, Richmond, VA  23218
Location:  629 E. Main Street, Richmond, VA  23219
PH:         804-698-4028      FAX:      804-698-4032

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