Heroin Deaths Double in the Past Two Years

From: Bloomberg News

The number of Americans dying from heroin overdoses doubled across 28 states in 2012 from 2010, according to the Centers for Disease Control and Prevention, fueled by easy access and rising rates of opioid addiction.

The unusual analysis published today in the CDC’s weekly bulletin stemmed from the agency’s effort to determine if reports from some states about spikes in heroin use and related deaths since 2010 were part of a larger nationwide trend. They found a growing problem with fatal overdoses of heroin.

Health officials have focused in recent years on reducing abuse of prescription opioid painkillers, such as OxyContin. Overdoses of those medicines quadrupled from 1999 through 2010, while heroin, a cheaper and more available alternative, increased by less than 50 percent. The report confirms heroin has made a comeback in 28 states, as noted by Vermont Governor Peter Shumlin who said in January his state was in a “full-blown heroin crisis.”

Deaths from heroin overdoses rose across the board: in both genders, all ages, all racial and ethnic groups and all regions of the country, the CDC report found.

“The findings indicate a need for intensified prevention efforts aimed at reducing overdose deaths from all types of opioids,” the report found. “Efforts to prevent expansion of the number of opioid pain reliever users who might use heroin when it is available should continue.”

Death Toll

There were 3,635 heroin deaths in 2012, an increase from 1,779 two years earlier. While the crackdown on opioid abuse may have led users to heroin, painkillers are still more deadly. Opioid overdoses killed 9,869 Americans in 2012, down 5.4 percent from 2010.

Additional data suggests that prescription painkillers may be a gateway drug to heroin use, the report said. Three-quarters of patients in a rehabilitation program who started using heroin after 2000 said the first opioid they took was a prescription medication. More than 80 percent of people who began using heroin in the 1960s said they started with the drug.

“Reducing inappropriate opioid prescribing remains a crucial public health strategy to address both prescription opioid and heroin overdoses,” said CDC Director Thomas Frieden. “Addressing prescription opioid abuse by changing prescribing is likely to prevent heroin use in the long term.”
 

NMS Labs Announces Crucial New Tool for Impaired Driving Investigation

NMS Labs, a leading international forensic and clinical reference laboratory, announces the branding of its DUID confirmatory testing results report—ProofPOSITIVE®, An NMS Labs Confirmation Report.

Awareness of the extent of involvement of both therapeutic and abused drugs in impaired driving investigations and fatal crashes continues to grow. The technology to complete the investigation, however, is often lacking, with inadequate testing being performed or lack of understanding of the implications of the drug test findings. NMS Labs has announced the release of its new branded drug confirmation test, ProofPOSITIVE®, to provide a targeted, economical solution to identifying the drugs or combinations of drugs that can account for impairment, and clear interpretive advice provided right on the report. Prepared based on a study of the most common drugs encountered in the Drug Recognition Expert (DRE) and Driving Under the Influence of Drugs (DUID) programs nationwide, ProofPOSITIVE® reinforces NMS Labs commitment to the DRE program, and its need for timely, intelligent, targeted, testing that is also economical.

Since not all tests are created equal, choosing a high-quality laboratory, well informed in the area of DUID testing is essential. NMS Labs ISO-level quality from leaders in forensic laboratories accreditation, ABFT and ASCLD-LAB, and it’s internationally recognized experts in DUID provide confidence to investigators that their tests are in the right hands.

The new test was developed by Dr. Barry Logan, nationally recognized for his leadership and contribution to the field of drug impaired driving. Logan explained, “We’ve added key new compounds to this test to reflect our discovery of the latest trends in drug use in vehicle fatalities and arrests. We expect that this will increase drug detection rates in DUID and vehicular crimes cases by about 10%.” In addition, Logan noted that the ProofPOSITIVE® service adds on testing for more exotic drugs in circumstances where the driver’s impairment cannot be accounted for by the initial screening results. NMS Labs experienced court qualified toxicologists review and sign each report, and provide testimony when required.

“We needed to tell our story better, and ProofPOSITIVE® is simply the right message to resonate with those needing a dependable, quality confirmatory report and interpretive advice on the meaning of results in the court setting,” noted Julie Ruth, Sr. Director of Marketing at NMS Labs

The ProofPOSITIVE® confirmation report reflects NMS Labs alignment with National Safety Council’s recent recommendations for DUID drug testing, providing police with the most relevant targeted approach to DUID testing as well as contributing to the growing momentum around the use of oral fluid as an accepted forensic sample in DUID investigations. Additional details can be found on NMS Labs website.

 

Confusion & Controversy Surround Blood Thinner Pradaxa

From Health Feed at the University of Utah:

If you take the blood thinner Pradaxa, recent news may have left you concerned about its safety.

Pradaxa’s manufacturer, Boehringer Ingelheim, may have knowingly withheld information about risks associated with it, according to published reports in medical journal The BMJ.

Pradaxa, prescribed to people at risk for stroke due to atrial fibrillation, was originally touted as having a lower risk than the standard treatment, warfarin, known by the brand name Coumadin. The Food and Drug Administration approved its use without the need for frequent blood tests. But new evidence suggests frequent testing may reduce the risk of serious, sometimes fatal, bleeding events.

"Boehringer Ingelheim has failed to share with regulators information about the potential benefits of monitoring anticoagulant activity and adjusting the dose to make sure the drug is working as safely and effectively as possible," Deborah Cohen, The BMJ’s investigations editor, wrote in the report.

Gregory Hawryluk M.D., Ph.D., a neurosurgeon at University of Utah Health Care, says Pradaxa may now be a less attractive option than Coumadin.

“The fact that monitoring wasn’t recommended for Pradaxa was one of the main reasons that physicians prescribed it in the face of the difficulties reversing or neutralizing it,” he explains, noting a reversal agent for Pradaxa is currently in clinical trials. Coumadin, meanwhile, is readily reversible.

People taking Pradaxa who are thinking of stopping because of the controversy should speak to their doctors first. “It is very important that patients who are taking Pradaxa continue taking it as prescribed by their physician,” Hawryluk says. “It is very clear that although there are unavoidable risks inherent to Pradaxa, Coumadin and similar agents, the risks of treatment with these drugs as they are currently prescribed and monitored is lower than the risk of stroke that patients would face without them.”

The FDA agrees. A spokeswoman tells WebMD that the agency still believe that Pradaxa provides an important health benefit and recommends that health care professionals follow the recommendations on the approved drug label.

“Treatment with either Pradaxa or Coumadin is clearly better than no treatment,” Hawryluk says.

Update: Boehringer Ingelheim released a statement regarding the report in The BMJ. Read it here.
 

DEA Further Restricts Hydrocodone Combination Products

From: Medscape

The US Drug Enforcement Administration (DEA) voted today (Aug 21) to move forward with rescheduling hydrocodone combination products (HCPs) from schedule III to schedule II drugs. Schedule II medications are considered to be the most potentially harmful and open to abuse.

In addition to containing hydrocodone, HCPs also contain nonnarcotic substances such as aspirin or acetaminophen. Although hydrocodone by itself is classified as a schedule II drug, HCPs have been in the schedule III classification ever since the Controlled Substances Act (CSA) was first passed by Congress back in 1971.

"Based on the consideration of all comments, the scientific and medical evaluation and accompanying recommendation of the HHS,...the DEA finds that these facts and all other relevant data constitute evidence of potential for abuse of HCPs," write the DEA in their final rule.

"As such, the DEA is rescheduling HCPs as a schedule II controlled substance under the CSA," they add.

Substantial Feedback

HCPs are currently approved for marketing for the treatment of pain and for cough suppression.

The DEA published its formal proposal in February and asked for feedback, which could be given until April 28. The organization received 573 comments, of which 52% supported the recommended rescheduling, 41% opposed, and 7% did not voice a definitive opinion.

Patrick Morrisey, the attorney general from West Virginia, the state with the highest per capita rate of prescription drug overdoses in 2013, was among those who wrote in support of the rescheduling.

"This reclassification is not only justified given the high abuse and addiction potential of hydrocodone prescription painkillers, it is necessary to combat the drug abuse epidemic that is destroying so many...communities," wrote Morrisey.

"Rescheduling hydrocodone is one way to help prevent this drug from falling into the wrong hands and will ensure that these drugs are handled with the same precautions as other pain medications, such as oxycodone, hydromorphone, and fentanyl," he added in a release.

Also falling under the schedule II classification are illegal substances, such as methamphetamine and heroin, and prescribed medications, such as dextroamphetamine sulphate (Adderal, Teva Pharmaceuticals).

Once the final rule goes into effect, anybody who handles HCPs will be subject to the CSA's schedule II regulatory controls. This will include "administrative, civil, and criminal sanctions applicable to the manufacture, distribution, dispensing, importing, exporting, engaging in research, conducting instructional activities, and conducting chemical analysis" of these substances.

In addition, any individual who handles or desires to hand HCPs will need to register with the DEA.

The final rule will be published in the Federal Register on August 22, 2014.

 

FDA warns Lunesta sleeping pill users: Take half the dosage

From The Washington Times:

The Food and Drug Administration warned that anyone prescribed the sleeping medication Lunesta might want to start their dosages at half strength, to about 1 milligram.

The federal agency ordered the manufacturer, Sunovion Pharmaceuticals, to change its warning labels to reflect the new FDA recommendations, which are a scale-back of the current 2 milligram dose, The New York Times reported.

The FDA’s latest recommendation comes in part from research that involved 91 adults at the Surrey Clinical Research Center in Britain. The study found that 3 milligrams of Lunesa impairs memory and motor skills the next day and that the recommended 2 milligrams could prove a challenge for driving, memory and fine-motor skills for up to 11 hours after ingesting.

Posted: 5/16/2014 9:44:00 AM

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FDA Approval of Paroxetine for Menopausal Hot Flushes

From The New England Journal of Medicine:

The recent approval by the Food and Drug Administration (FDA) of paroxetine (Brisdelle, Noven) for the treatment of moderate-to-severe vasomotor symptoms associated with menopause was distinctive for at least two reasons. First, it offered the first nonhormonal option to women who cannot or do not want to use hormonal medications to treat their menopausal vasomotor symptoms. Second, the approval ran counter to the recommendation of the FDA Reproductive Health Drugs Advisory Committee, which had concluded, by a vote of 10 to 4, that the overall benefit–risk profile of Brisdelle did not support approval.

For decades, hormonal therapy had been the only FDA-approved treatment for menopausal vasomotor symptoms. Hormonal therapy is highly effective for treating vasomotor symptoms, but health risks in some women became apparent about a decade ago, with the release of reports from the Women's Health Initiative. Owing to these reports, many women either have chosen not to use hormonal therapy to treat their symptoms or have not been offered such therapy because of coexisting conditions. Overall, use of hormonal therapy has decreased considerably in the past decade — a trend that underscores an unmet need for a nonhormonal treatment option for vasomotor symptoms.

The efficacy of Brisdelle was established in two randomized, double-blind, placebo-controlled, multicenter clinical trials. More women who used Brisdelle than women who used placebo considered the reduction in frequency of their hot flushes to be clinically meaningful. In addition, Brisdelle remained efficacious at 6 months, the latest time point assessed. This is an important finding, because a lack of efficacy at 6 months after treatment initiation would call into question its usefulness for this fairly chronic condition.

Brisdelle's modest efficacy and concerns about suicidal ideation certainly influenced the advisory committee's 10-to-4 vote against approval. But recognizing that no hormone-free drug product had been approved to treat vasomotor symptoms, and after careful review of the efficacy results, the FDA concluded that Brisdelle offers a clinically meaningful benefit for some menopausal women. In addition, the Brisdelle clinical trials did not identify any new safety concerns regarding paroxetine.

Posted: 5/8/2014 1:39:00 PM

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Designer drugs put youths at risk, but recipe changes tie officers’ hands

Via Dallas News

 A week before he died, the 15-year-old honors student had taken an illustrated book to pastures near his Frisco home looking for psychedelic mushrooms. He didn’t find any, so he tried what he thought was LSD on Dec. 14. Convulsions began within an hour after he ingested 25I, a synthetic hallucinogen more potent than LSD. The Collin County medical examiner ruled that his death was connected to the drug. In what appears to be a growing problem, three more overdoses possibly linked to 25I were reported in McKinney last weekend. They appear not to have been fatal.

Efforts to criminalize emerging designer drugs in Texas fell flat in the most recent legislative session, making it more challenging for law enforcement agencies to crack down on the problem.

Nationally, at least 19 deaths have been linked to a set of synthetic drugs known as the NBOMe compounds, including 25I, according to the Drug Enforcement Administration. The users ranged from 15 to 29 years old. Texas Poison Control Network has tallied 25 calls related to NBOMe since 2012. Six came from the Dallas-Fort Worth area.

Stymied in Austin

In November, the DEA temporarily added three NBOMe drugs to Schedule I.  In February, the Department of State Health Services added three NBOMe compounds to the state’s list of controlled substances. The temporary move allows prosecutors to pursue criminal charges, but only misdemeanors, regardless of the amount of the drugs.

Though the state banned K2 in 2011, other kinds of “fake pot” have surfaced since. And if the chemistry is slightly different from what’s in the law, dealers can avoid prosecution.

Law enforcement and public health officials said Huffman’s bills would address that problem by outlawing certain designer drugs and other compounds with the same core chemical structure.

Dueling experts

Like the federal government, Texas has provisions to cover analogs — drugs that are substantially similar to some illegal substances based on their chemical makeup or effects on users.

For every case, prosecutors would have to prove in court that the compound in question was similar enough to an illegal narcotic.

“It comes down to a battle of the expert witnesses,” said Samms, who wrote to lawmakers in support of Huffman’s proposed legislation.

And some cases don’t even make it to court if law enforcement or health officials can’t trace a drug.

NMS Labs in Pennsylvania, which does forensic testing for medical and legal clients across the country, handled its first NBOMe case in 2012.

“They’re very potent, so it takes very little drug to have its effects,” toxicologist Donna Papsun said. “The challenge was creating a test with a low enough detection level so we could properly detect it in the fluids.”

Posted: 4/22/2014 10:42:00 AM

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New synthetic drug investigated in Fishers teen’s death

From: Fox59

HAMILTON COUNTY, Ind. - Police have opened a criminal investigation into the death of a Hamilton County teen who made have died after ingesting synthetic drugs.

John Joseph Romaine, 18, was found unresponsive in his Fishers home Friday evening. According to his obituary, the Hamilton Southeastern High School senior died of cardiac arrest. The Hamilton County coroner is waiting on toxicology results before ruling an official cause, but police are looking into a possible overdose of synthetic drugs.

Police told FOX59 they found illegal drugs inside the home along with three men, including Romaine, who was unconscious.

Officers got there and observed a male lying on the floor and immediately began CPR until medics arrived," said Officer James Alvis, a spokesman for Fisher Police. All three were hospitalized, and Romaine was later pronounced dead.

A Reddit post, which appears to be written by Romaine's older brother, describes the night in detail and points the blame on a new synthetic drug called N-Bomb or NBOME. The author warns people not to use the drug and expressed deep regret over his brother's death.

FOX59 went to St. Vincent Carmel Hospital to find out more about the drug. Emergency room physician Dr. Marcus Hendry explained that it's a psychedelic drug that is often compared to LSD, but it is considered more powerful depending on the purity and dosage.

"They might experience agitation, hallucination, might get high fever, muscle injury, kidney failure, all the way to persistent seizures that may require the induction of a medical coma or even death as a result of persistent seizures or perhaps more commonly death." explained Hendry.

Police are now looking into the Reddit post and warning parents and teens to consider how dangerous synthetic drugs can be. They have not ruled out any arrests in this case.

Posted: 4/10/2014 2:18:00 PM

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Student fell to death after eating weed cookie

From theGrio:

An autopsy report lists marijuana intoxication as a “significant contributing factor” in the death of 19-year-old Levy Thamba Pongi, a native of the Republic of Congo who fell from a motel balcony on March 11.

Levy was a Wyoming college student who was visiting Denver on spring break. Investigators believe Pongi and his friends came to Colorado to try marijuana, Weiss-Samaras said.

Colorado legalized recreational sales of the drug in January. Colorado law bans the sale of recreational marijuana products to people under 21. It is also illegal for those under 21 to possess marijuana, and adults can be charged with a felony for giving it to someone under the legal age.

Authorities said one of Pongi’s friends was old enough to buy the cookie from a pot shop. It was unclear whether the friend might face charges.

It marked the first time the Denver medical examiner’s office has listed a marijuana edible as a contributor to a death, said Michelle Weiss-Samaras, a spokeswoman for the office.

The medical examiner’s office had Pongi’s body tested for at least 250 different substances, including bath salts and synthetic marijuana, which are known to cause strange behavior. His blood tested positive only for THC, the psychoactive ingredient in marijuana, according to the report.

The marijuana concentration in Pongi’s blood was 7.2 nanograms of active THC per milliliter of blood. Colorado law says juries can assume someone is driving while impaired by marijuana if their blood contains more than 5 nanograms per milliliter of the chemical.

Posted: 4/9/2014 2:58:00 PM

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School Board Votes to Test Student Athletes for Synthetic Drugs

From: Independant Herald

Synthetic drugs have been added to the substances for which Wyoming County student-athletes may be tested. The Board of Education unanimously approved the addition to the drug testing program at its meeting last Monday night.

“The normal test drugs did not include the synthetic drugs,” said Superintendent of Schools Frank “Bucky” Blackwell.

“Mr. (Jeff) Hylton wanted the board to know that the synthetic drugs are gaining in popularity,” he added. “It’s not actually detected under a regular drug test.

“Anybody who might be using the synthetic drugs would just go scot free,” Blackwell said. “Our whole goal is to catch it in time so that something could be done about it before it gets out of hand or somebody overdoses or has an accident.”

Testing for synthetic drugs is twice as costly as the regular testing, Blackwell noted, “Hopefully the costs will come down.”

“We’ve had great results,” the superintendent remarked. “We don’t catch too many, but we’ve never had a repeat offender.”

If there is a positive test result, Blackwell said, “you have to call Mom and Dad and law enforcement.

“That’s a shocker,” he continued. “Most parents have no idea their child would do something like that. As it has turned out, we have stopped a lot of kids from using drugs.”

Students who test positive are expelled, he pointed out, “and they have straightened up.”

With the addition of synthetic drugs, a student-athlete may be tested for one type of drug or both, Blackwell explained.  “We don’t pick up the phone and ask [the company] to test unless someone is behaving in such a way that would indicate they have a problem.”

He says the board “backs the program 100 percent. It’s paying dividends for our children.

“We feel we have to what we can to help prevent the use of drugs,” Blackwell observed.

Written by John Conely
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This is a great step in the right direction to helping solve the problem of designer drugs, especially with our youth.  Hopefully other districts will join suit and help convey the message that even though some of these drugs may be legal they are still very dangerous and shouldn't be used.