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9/25/14 3:30pm

Anti-Opioid Abuse Groups Call for Resignation of FDA Head

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Over a dozen groups concerned about the burgeoning prescription painkiller epidemic called for the resignation of the head of the Food and Drug Administration, Commissioner Dr. Margaret Hamburg, in a letter released on Wednesday.

Physicians for Responsible Opioid Prescribing, a 900-member advocacy group that petitioned (and were rejected by) the FDA to drastically restrict opioid use, and the National Coalition Against Prescription Drug Abuse, were among those who signed the letter addressed to Health and Human Services Secretary Sylvia Burwell, who oversees the FDA and other health agencies.

The FDA has been under intense scrutiny from public health officials, politicians, and law enforcement alike for approving a powerful new painkiller called Zohydro last October, against the recommendation of its own medical advisers.

“We are especially frustrated by the FDA’s continued approval of new, dangerous, high-dose opioid analgesics that are fueling high rates of addiction and overdose deaths,” the letter read.

Zohydro is the first pure hydrocodone medication to be approved by the FDA. It is up to five times stronger than other opioid medications currently on the market. The fact that it is easily crushable is problematic, because it can be snorted or injected.

Critics of the drug fear the Zohydro’s potential for abuse and addiction. Since Zohydro’s FDA approval, members of Congress from West Virginia, Massachusetts, and Kentucky have introduced legislation to ban the drug, and attorneys general from 28 states have asked the FDA to revoke Zohydro’s approval or require that the pills be reformulated to make them harder to crush for snorting or injection.

Commissioner Hamburg, who has led the agency since 2009, has defended the drug’s approval by saying that it fills an important medical niche.

“Dr. Hamburg’s support for using opioids to treat chronic non-cancer pain is squarely at odds with efforts by the CDC to discourage this widespread practice,” the letter said.

Deaths associated with prescription painkillers like OxyContin and Vicodin have more than tripled over the last 20 years to an estimated 17,000 in 2011.

A Department of Health and Human Services spokesman, Tait Sye, said that opioid abuse “is a serious issue and one that the secretary is focused on.” 

“Secretary Burwell appreciates hearing from stakeholders on the important issue of prescription opioid abuse, and looks forward to responding to their letter,” Sye added.

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By Victoria Kim

ignorance is bliss

9/25/14 1:00pm

Forbes Columnist Calls Drunk Women the 'Gravest Threat' to Frats, Gets Summarily Fired

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A scourge of “drunk female guests” are to blame for recriminations against fraternities—that is, according to Bill Frezza, who wrote an entire Forbes column about it. The article was posted yesterday and deleted soon after, but that was all the time the Internet needed to respond to his inflammatory post.

Frezza’s column, “Drunk Female Guests Are The Gravest Threat to Fraternities,” has lived on in its cached form. In the piece, Frezza argued that female students who binge drink before going to fraternity house parties are more responsible for frat closures and suspensions than the actions of the frat members themselves.

The fact that it is not “socially acceptable” for bouncers to eject drunk female students from parties is the problem, according to Frezza, who is president of the Beta Foundation, the house corporation for the Chi Phi fraternity at MIT.

“In our age of sexual equality, why drunk female students are almost never characterized as irresponsible jerks is a question I leave to the feminists,” he wrote.

His recommendations included identifying drunks at the door and barring them from house parties no matter “how pretty or flirtatious a young lady is; if she’s visibly intoxicated, don’t let her in.” He added a particularly disturbing anecdote after this tidbit of advice: “Although we were once reprimanded for turning away a drunk female student who ultimately required an ambulance when she passed out on our sidewalk, it would have gone a lot worse for us had she collapsed inside.”

And to avoid “false” accusations of rape “months after the fact triggered by regrets over a drunken hook-up or anger after a failed relationship,” Brezza recommended to “never, ever take a drunk female guest to your bedroom."

Brezza’s tone was ominous, warning that “all it takes is one [woman] to bring an entire fraternity system down.”

But TIME writer Eliana Dockterman argued that women are not the biggest threat to fraternities, but rather that fraternities are the biggest threat to themselves.

She noted that binge drinking within fraternities is so great that insurance companies factor it into their calculations for the organizations.

“The National Association of Insurance Commissioners ranked fraternities as the sixth worst insurance risk in this country, just behind hazardous waste disposal companies and asbestos contractors,” Douglas Feinberg, who represents victims of violence, wrote for TIME. “One insurance broker for fraternities boasts of handling more than 6,000 claims and $60,000,000 in payouts.”

In addition, sexual assault is so rampant in fraternity culture that it can be quantified.

“Of the many thousands of insurance claims that are made against fraternities each year, those for sexual assault are the second most common, so predictable, in fact, that the related expenses are built into annual budgets,” Caitlin Flanagan, a contributing editor at The Atlantic, wrote for TIME. Flanagan recently completed an in-depth investigation of fraternity culture.

Meanwhile, Forbes fired Frezza soon after pulling his column.

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By Victoria Kim

decriminalizing drugs

9/25/14 10:30am

Chicago Mayor Pushing For Relaxed Drug Laws Statewide

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Chicago Mayor Rahm Emanuel is pushing for more relaxed drug laws throughout the state, including decriminalizing marijuana and reducing minor drug possession to a misdemeanor.

Under his proposed plan, anyone caught with a gram or less of a controlled substance would not receive a felony charge. Emanuel is also seeking to expand Chicago’s marijuana ticketing law throughout the state, which would allow police to issue tickets of $250 to $500 for someone caught with up to 15 grams of pot — the equivalent of about 25 cigarette-sized joints.

“It's not just about saving taxpayer dollars. It's also about saving nonviolent offenders from a lifetime spent in and out of the criminal justice system," said Emanuel. "A felony conviction can slam the door on someone's future and make it harder to go to school, apply for financial aid and find housing. There are times when a felony conviction is no doubt warranted, but we have to ask ourselves whether it's too high a price for using drugs."

However, not all Chicago politicians are on board with this proposal. Many believe that Emanuel is only offering to relax drug sentences in exchanges for mandatory minimum sentences for gun possession. State Rep. Ken Dunkin, chairman of the Illinois Legislative Black Caucus, said that Emanuel’s plan amounted to “political grandstanding.”

Last June, Chicago filed a lawsuit against five major drug companies, including Johnson & Johnson, accusing them of creating addicts by pushing for excessive use of opioid painkillers. Lawyers for the city have accused these drug companies of hiding the risks associated with painkiller use while overstating the benefits. The city is seeking unspecified monetary damages, but reported spending $9,500,000 on paying for nearly 400,000 claims for opioid prescription fills.

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By McCarton Ackerman

pregnant addicts

9/25/14 8:30am

Montana Judge Dismisses Drug Charges Against Pregnant Woman

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A Montana woman who faced felony drug and child endangerment charges for allegedly taking drugs when she was 12 weeks pregnant has had her case dismissed by a judge.

Casey Gloria Allen, 21, was charged with putting her unborn fetus at "substantial risk of serious bodily injury or death" by ingesting opiates, benzodiazepines, and THC, the psychoactive compound in marijuana. Thorin Geist, Ravalli County deputy attorney, argued that a law passed last year by the Montana legislature, which modified the state’s homicide statutes to include criminalizing conduct related to killing “the fetus of another,” would naturally extend to killing or injuring one’s own fetus.

But District Judge Jeffrey Langton ordered on Monday that the state’s charges be dismissed because the state homicide statutes make no references to “fetus.” Allen’s attorney had argued that moving forward with the charges could create a "slippery slope where the state could arrest and file charges against pregnant women for engaging in any behavior deemed unhealthy to the fetus, which might include ingesting drugs (legally prescribed or not), drinking alcohol, smoking, failing to wear seat belts in a vehicle, not eating well, and exercising too little or too much."

Last April, the Tennessee legislature approved a bill to criminally prosecute addicted pregnant women if their child “is born addicted, is harmed or dies because of the drug.” They would be free of prosecution until the fetus becomes “viable” at 24 weeks, but any charges would be removed if they voluntarily entered a treatment program.

While bill sponsor and State Rep. Terri Weaver called the bill “an intervention,” most major medical associations are opposed to it and believe it will discourage drug-addicted pregnant women from seeking both prenatal care and help for their addiction.

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By McCarton Ackerman

headlines

9/25/14 7:00am

Morning Roundup: Sept. 25, 2014

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By Shawn Dwyer

help is on the way

9/24/14 7:30pm

Miraculous, Over-the-Counter, Overdose Protection Drug Coming to California Pharmacies

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The following first appeared on AlterNet.

In hushed tones, Janice (not her real name) slipped a desperate woman a blue-zippered pouch containing a vial of naloxone and two syringes. The scene played out like something illicit because, in Janice’s Southern red state, it is. Despite the risks involved with distributing a medication without a prescription, Janice, a Florida-based overdose prevention advocate, continues to do so because she knows it saves lives. Florida, like many other states, has no law allowing for the distribution of naloxone.

Overdose has surpassed even motor vehicle accidents to become the leading cause of injury death in the U.S., with 38,329 overdose deaths in 2010 alone. The mortality rate has increased 102% in a decade, escalating overdose to a national crisis. Naloxone, the only drug of its class, has been safely used to reverse opiate overdose since 1971, but in many areas of the country it is impossible to access outside of an ambulance or emergency room.

In light of this national epidemic, several states have enacted legislation to combat the rising tide of opiate overdose-related deaths. The latest legislative effort passed yesterday in California when Gov. Jerry Brown signed AB 1535. The bill, introduced by Assemblymember Richard Bloom and sponsored by the Drug Policy Alliance and the California Pharmacists Association, will enable California pharmacists to provide naloxone directly to consumers without the need for a prescription. The bill passed with widespread support from both Democrats and Republicans, illustrating a growing urgency to address the overdose crisis in new and innovative ways. 

California joins Rhode Island, New Mexico, and Washington, states that have used similar laws to provide drug users and their families with on-demand access to naloxone from local pharmacies. New York and Vermont have also recently passed similar legislation. Currently in California, naloxone can only be obtained by prescription or from one of a handful of poorly funded, community-based organizations that are struggling to meet the demand for this life-saving medication. 

Upon experiencing an opiate overdose, a person can slip from respiratory depression to full cardiac arrest within two to four minutes, often before police or paramedics can arrive. The ability to get naloxone from a local pharmacy will enable families to have this life-saving drug on hand when and where it is needed most—at the onset of an overdose. 

Although AB 1535 becomes law on Jan. 1, 2015, guidelines must be developed by the state’s pharmacy and medical boards before consumers can expect to purchase naloxone directly from pharmacies. Price has yet to be determined; a similar program in Rhode Island charges approximately $25 for injectable naloxone and $40 for a nasal spray form. 

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