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Thursday, April 17, 2014

Judge Blocks Ban On Zohydro ER

A federal judge has ruled that Massachusetts cannot ban the pure hydrocodone drug Zohydro ER (extended release), according to The Wall Street Journal. Zogenix, the makers of Zohydro, argued that banning the drug is unconstitutional, and U.S. District Judge Rya Zobel agreed, despite public health concerns.

“Today’s legal ruling was a positive step forward for Massachusetts patients,” Roger Hawley, Chief Executive Officer of Zogenix, said in a news release. “We invite concerned officials to engage with us to discuss fair and appropriate safeguards for pain medications like Zohydro ER rather than seeking to ban or restrict one specific treatment.”

In an attempt to stop the potentially dangerous drug Zohydro from adding to the nations already out of control prescription opioid epidemic, Massachusetts Governor Deval Patrick announced that the pure hydrocodone drug would be banned throughout the state.

The Food and Drug Administration (FDA) approved Zohydro ER in October, despite the FDA’s own panel of experts ruling against the approval. The FDA panel was concerned that Zohydro lacked tamper resistant properties that would prevent users of the drug from crushing the medication for snorting or injection. Without tamper resistant feature Zohydro will most certainly be abused, fueling America’s ever growing prescription drug epidemic.

Judge Rya Zobel issued a preliminary injunction on the ban, stating that it appears the Massachusetts government overstepped its authority. Zobel said that Zogenix would probably be able to permanently lift the ban. Judge Zobel said the ban would “undermine the FDA’s ability to make drugs available to promote and protect the public health.”

“Addiction is a serious enough problem already in Massachusetts without having to deal with another addictive narcotic painkiller sold in a form that isn’t tamper proof,” said Governor Patrick in a statement. “We will turn our attention now to other means to address this public-health crisis.”
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Tuesday, April 15, 2014

Pregnant Women Prescribed Opioids on Medicaid

Pregnant women need to be extra-conscience of what they put in their body, especially when it comes to mind-altering substances. In the wake of the prescription drug epidemic, many doctors are seeing babies born with a dependence to opioids, drugs that the mothers were prescribed during the pregnancy. A new study has found that almost a quarter of pregnant women (23 percent) receiving assistance from Medicaid in 2007 filled a prescription for opioids, up from 18.5 percent in 2000, The New York Times reports.

Medicaid covers medical expenses for 45 percent of births in the United States.

In 2007, there was an estimated 1.1 million pregnant women on Medicaid. That means there were around 250,000 babies exposed to opioids in one form or another that year and sadly the trend continues to grow. The reasons for prescribing opioids to pregnant women may have to do with back pain, but the research does not point to that with certainty.

“To hear that there’s such a high use of narcotics in pregnancy when I see so many women who worry about a cup of coffee seems incongruous,” Dr. Joshua A. Copel, a professor of obstetrics, gynecology and reproductive sciences at the Yale School of Medicine, told The New York Times.

There were regional differences in opioid prescribing to pregnant women found in the research. Among pregnant women on Medicaid who received opioids:
  • Utah (41.6 percent)
  • Idaho (35.6 percent)
  • New York (9.6 percent)
  • Oregon (9.5 percent)
“The regional variation really concerned me the most,” said Dr. Pamela Flood, a professor of anesthesiology and pain medicine at Stanford University. “It’s hard to imagine that pregnant women in the South have all that much more pain than pregnant women in the Northeast.”  

The study was published in Obstetrics & Gynecology.

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Wednesday, April 9, 2014

States Fail Medicaid Expansion Mental Health Coverage

Nearly 4 million Americans who suffer from mental illness lack insurance coverage as the result of a number of states failing to expand their Medicaid programs under the Affordable Care Act, according to USA Today. States that chose to refuse the Affordable Care Act left about 3.7 million Americans without coverage, people who need treatment for their mental illness or substance use disorder.

Under the Affordable Care Act states were required to expand Medicaid benefits, but in 2012, the U.S. Supreme Court gave states the ability to opt out.

In the twenty-four states that failed to expand their Medicaid programs, there are about 3 million people who were formerly uninsurable due to their mental health or substance use disorders, known as pre-existing conditions. Despite the Affordable Care Act making it illegal for insurers to refuse coverage because of pre-existing conditions, citizens in the states that failed to expand were left without any options, according to the American Mental Health Counselors Association (AMHCA) report.

“It is really a tragedy,” said Joel Miller, Executive Director of AMHCA. “When uninsured people with mental health conditions, such as depression, gain Medicaid coverage, they become healthier and life expectancy increases, but in states that refuse to expand Medicaid, citizens will see their hopes dashed for a better life and better health.”

The AMHCA’s findings come from the National Survey on Drug Use and Health. People with serious behavioral health conditions were tallied; the results showed that almost 75 percent (2.7 million adults) of uninsured people who lacked coverage live in 11 southern states that rejected the Medicaid expansion. What’s more, over 1.1 million uninsured people with mental health conditions reside in just two states — Texas (625,000) and Florida (535,000). Sadly, this group of 1.1 million people is eligible for insurance under the Medicaid expansion program, but they are unable to receive it in the state they live.

The 11 southern states are:
  • Alabama
  • Florida
  • Georgia
  • Louisiana
  • Mississippi
  • North Carolina
  • Oklahoma
  • South Carolina
  • Tennessee
  • Texas
  • Virginia
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Monday, April 7, 2014

75 Percent of Americans Think that Legalization is Inevitable

The attitude towards marijuana continues to evolve, with 75 percent of Americans thinking that legalization is inevitable, according to a new survey. What’s more, the survey showed that most Americans are in favor of ending mandatory minimum prison sentences for non-violent drug offenders, reports ABC News.

The survey, conducted by the Pew Research Center, found that more Americans are in favor of doing away with laws that would mandate jail time, especially for individuals possessing small amounts of the drug.

“Even people who don’t favor the legalization of marijuana think the possession of small amounts shouldn’t result in jail time,” said Carroll Doherty, Pew’s Director of Political Research.

The mindset of many Americans has changed in a relatively short period of time. Just four years ago, 52 percent of Americans were not in favor of legalization. This year, 54 percent are for legalization, with only 42 percent opposed to it. At least 30 states have modified penalties for drug crimes since 2009.

What’s interesting is that despite a majority of Americans favoring legalization, many remain concerned about the potential for abusing the drug. In fact, 32 percent of those surveyed called it a crisis and 55 percent said it is a serious national problem. With 54 percent thinking that legalization would lead to more underage people experimenting with marijuana.

U.S. Attorney General Eric Holder has testified in favor of reducing the average sentence for drug dealers. The Obama Administration supports changing guidelines, which would reduce drug sentences by about one year, from 62 months to 51 months, according to Holder.

It is hard to say what will happen, but if this trend continues, it's likely that federal legalization will be a reality before this decade is over. It will be interesting to see how the federal government deals with the inevitability of this, at times volatile, situation.
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Wednesday, April 2, 2014

Massachusetts Governor Will Ban Zohydro ER

The fight against pure hydrocodone continues; Massachusetts Governor Deval Patrick has announced that the drug Zohydro ER will be banned, according to Reuters. Sales of the drug will, without question, contribute to the ever growing problem of opioid addiction in the United States. Nipping Zohydro in the bud will forestall the drug's ability to exacerbate the prescription drug epidemic.

“The introduction of this new painkiller into the market poses a significant risk to individuals already addicted to opiates and to the public at large,” Governor Patrick said in a news release.

Whether from lack of oversight or lack of concern regarding America’s deadly opioid dependence, Zohydro formulators, Zogenix, designed the drug without tamper resistant properties. Users of the drug can easily crush the medication in order to snort or inject the medication for a quick high. Oxycodone lacked taper resistant features when it was first released and over the course of a few years the prescription drug epidemic inflated beyond belief.

Despite the drugs deadly auspices, the Food and Drug Administration (FDA) approved the drug even though a panel of experts assembled by the FDA itself voted against recommending approval. The FDA’s panel voted 11-2 against approval, saying that while the drug maker Zogenix met certain standards, the analgesic could be used by opioid addicts currently abusing oxycodone.

Public health groups and legislators are up in arms about the FDA’s approval, bombarding FDA Commissioner Margaret Hamburg with letters regarding the decision. Hamburg has also been contacted by 28 state attorneys general and four senators, pleading the FDA to reconsider its approval of Zohydro.

In a statement, Zogenix said, “We believe Governor Patrick’s ban on Zohydro ER only serves to unfairly restrict patient access to the only hydrocodone pain reliever available for long-term, daily, severe chronic pain patients who are obtaining relief with short-acting hydrocodone combination products, but who are at risk for potentially fatal liver toxicity due to their daily intake of acetaminophen. Ultimately, the ban on the prescription medication will add to patient suffering in the state.”

Zogenix has announced it will create an oversight board designed to spot misuse of Zohydro.
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Monday, March 31, 2014

College Student Stimulant Use Leads to Addiction

College students who use certain drugs may be at a greater risk of addiction later in life, according to a new study. At the University of California-San Diego School of Medicine, researchers led by Katia Harlé, PhD, uncovered impaired neuronal activity among those college students who had used stimulant drugs.

"Right now there are no treatments for stimulant addiction and the relapse rate is upward of 50%," says Dr. Martin Paulus, professor of psychiatry at UCSD and co-senior author of the study. "Early intervention is our best option."

"If you show me 100 college students and tell me which ones have taken stimulants a dozen times, I can tell you those students' brains are different," says Dr. Paulus. 

Plans are underway to do more extensive research in order to determine whether the brain changes are permanent, or whether they can be reversed. It might be possible to strengthen the areas of the brain that became weakened by stimulant use.

"Our study is telling us, it's not 'this is your brain on drugs,' it's 'this is the brain that does drugs.'" 

It may be possible to use brain activity patterns to predict whether youths are at risk of drug addiction before they start down that road, according to the findings.

The research is published in the Journal of Neuroscience.
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Wednesday, March 26, 2014

Alcohol Related Traffic Deaths Under-Reported

Drunk Driving Among US College Students Still ...
Traffic deaths make up significant number of deaths every year in the United States; it comes as no surprise that a large portion of those fatalities are related to alcohol. However, a new study has found that alcohol related traffic deaths are severely under-reported according to death certificates.

In the ten year period, from 1999 to 2009, researchers concluded that just over 3 percent of the 450,000 traffic related fatalities cited alcohol as a contributing factor on the death certificate. In fact, data from the National Highway Traffic Safety Administration (NHSTA) showed that 21 percent of those deaths actually involved legally drunk individuals, according to MedicalXpress.

Researchers believe the lack of reporting may have to do with impatience, medical examiners and coroners don’t feel like waiting for blood-alcohol reports to come back from the lab. In most places death certificates are required to be filled out within three to five days of the death, but toxicology reports usually take much longer.

States that rarely reported alcohol related factors on death certificates are:
  • Maryland
  • New Jersey
  • Nevada
  • New Hampshire
A researcher at the National Institute on Alcohol Abuse and Alcoholism (NIAAA), Ralph Hingson, believes that it is important to have an understanding of alcohol's role in the death of young people. Without proper reporting it is impossible for researchers to study the effects of alcohol related policies designed to reduce deaths, says Hingson. “You want to know how big the problem is, and if we can track it,” Hingson said in a news release. “Is it going up, or going down? And what policy measures are working?”  

The findings are published in the Journal of Studies on Alcohol and Drugs.
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