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Wednesday, April 30, 2014

Volkow Speaks Against Marijuana Legalization

Americans' view of marijuana continues to change and more states are considering legalizing the drug. However, there are still a number of experts who believe that legalization may be a poor decision. At a House subpanel hearing, world renowned substance abuse expert Dr. Nora Volkow, urged lawmakers this week to hold off on legalizing marijuana, saying that marijuana can act as a gateway drug.

Volkow is the Director of the National Institute on Drug Abuse (NIDA) and her opinion is highly respected in the field of substance abuse. She said that because of all the reports that show marijuana’s medicinal benefits that many people have the misconception that marijuana is harmless. Volkow claimed that studies show changes in the brain amongst people who use marijuana and that using marijuana may get certain users ready for harder drugs, The Hill reports.

Volkow wrote on NIDA website last year, “Regular marijuana use in adolescence is part of a cluster of behaviors that can produce enduring detrimental effects and alter the trajectory of a young person’s life—thwarting his or her potential. Beyond potentially lowering IQ, teen marijuana use is linked to school dropouts, other drug use, mental health problems, etc. Given the current number of regular marijuana users (about 1 in 15 high school seniors) and the possibility of this number increasing with marijuana legalization, we cannot afford to divert our focus from the central point: Regular marijuana use stands to jeopardize a young person’s chances of success—in school and in life.”

Whatever one’s view on marijuana, it is hard to argue with the fact that more research is needed before the United States moves forward with legalization. However, opposing marijuana legalization is difficult while alcohol continues to be a legal substance despite the negative health consequences that go with it.

Monday, April 28, 2014

National Rx Drug Abuse Summit PDMP Report

A meeting of more than 75 medical insurers, federal agency leaders and state Prescription Drug Monitoring Program (PDMP) administrators took place at the National Rx Drug Abuse Summit in Atlanta. One of the major issues discussed was better methods for utilizing prescription drug databases in order to prevent “doctor shopping” and reduce overdoses. A report by the Prescription Drug Monitoring Program (PDMP) Center of Excellence at Brandeis University, showed how health insurers could reduce overdoses by using state prescription monitoring databases.

As of right now most prescription drug databases are not connected and are managed on a state level, by sharing data between prescription monitoring databases, insurers would be able to detect inappropriate prescribing and dispensing, according to the report.

In most cases, insurance programs only look at data about prescriptions for which their particular plans have paid, MedicalXpress reports. However, PDMPs provide a complete outpatient prescription history for controlled substances. If all of their enrollees’ activity was visible to the insurer, it would allow them to spot patients who are “doctor shopping”, according to the report.

“At a time when the misuse and abuse of prescription opioids has reached epidemic levels, it’s important that third party payers be able to use states’ prescription monitoring data to make sure these drugs are prescribed appropriately,” Peter Kreiner, Principal Investigator of the Prescription Drug Monitoring Program Center of Excellence, said in a news release.

“Opioid abuse is the most urgent issue in workers’ compensation,” said Bruce Wood, Director of Workers’ Compensation with the American Insurance Association. “Giving workers’ compensation payers access to PDMP information would permit them to see if an injured worker is getting opioids from multiple sources.”

Thursday, April 24, 2014

FDA Panel Votes Against Moxduo

The new drug, Moxduo, is the first medication to combine both an opiate (morphine) and opioid (oxycodone), reports NPR. Both morphine and oxycodone are powerful and highly addictive drugs that have been widely abused in the United States. Combining the two drugs appears to be a recipe for disaster; approval of the drug would surely add to America’s ever growing prescription drug epidemic.

Panel members disagreed on whether studies conducted by the makers of Moxduo showed better pain relief with fewer side effects. The panel was not entirely convinced whether Moxduo had advantages over using oxycodone or morphine on their own, the article notes.

Despite Moxduo’s manufacturer, QRxPharma, claiming that the drug has fewer side-effects than opioids currently available on the market, the FDA’s advisory panel failed to see proof of such claims. The panel stated that QRxPharma had not sufficiently proved that Moxduo was less likely to cause respiratory suppression, a side-effect that is potentially life-threatening. Every opiate/opioid based drugs on the market is known for the side-effect of respiratory suppression, a side-effect that doctors would love to find a way to counter.

“I certainly wish that there was an opiate that could be counted on to decrease respiratory depression, and maybe one day there will be,” said panel member Gregory Terman of the University of Washington.

In a statement, QRxPharma Managing Director and Chief Executive Officer John Holaday said, “We are obviously disappointed in the outcome of today’s meeting, but remain confident in the advantages of Moxduo compared to morphine and oxycodone. This is a necessary therapy for patients with moderate to severe acute pain. We are committed to bringing to market safer therapies for pain, such as Moxduo, and preventing opioid abuse.”

The FDA usually follows the recommendations of its panels, but is not required to do so. As we saw with Zohydro ER, the FDA’s panel, as well as countless experts and legislators, were against Zohydro’s approval, but it was approved anyway.
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Monday, April 21, 2014

Sentencing Commission Recommends Shorter Prison Sentences

There are many who feel that it is time to do something about America’s overcrowded prisons. The United States' war on drugs has been the leading cause of overcrowding which has led the U.S. Sentencing Commission to recommend shorter prison sentences for most federal drug trafficking offenders, according to Reuters. If Congress does not oppose the recommendation it could lead to a huge reduction in prison populations in the years to come.

The new recommendation follows in the wake of U.S. Attorney General Eric Holder’s testimony in favor of reducing the average sentence for drug dealers. 

Holder informed the Sentencing Commission that the Obama Administration supports changing guidelines to reduce the average drug sentence by about one year, from 62 months to 51 months. This small change in sentencing guidelines would reduce the federal prison population by about 6,550 inmates over the next five years, the article notes.

As of now, half of the 215,000 federal inmates are serving time for drug crimes. 

“This modest reduction in drug penalties is an important step toward reducing the problem of prison overcrowding at the federal level in a proportionate and fair manner,” Commission Chair Judge Patti B. Saris said in a news release. “Reducing the federal prison population has become urgent, with that population almost three times where it was in 1991.”

If Congress goes along with the recommendation, the new rules will go into effect on November 1, the article notes.

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.

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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