Florida parents are warned: Dangerous ‘designer drugs’ are on the streets
Two synthetic “designer drugs” are killing people, or driving them to insane behavior, or both, according to reports in the media and from federal law enforcement. But instead of scaring people off because of their unpredictable and dangerous effects, the drugs are gaining in popularity among recreational drug abusers, especially teens and young adults.
The Drug Enforcement Agency (DEA), poison control centers and police forces are warning parents to be especially on the lookout for strange behavior from their kids. The effects of the newer crop of synthetic drugs are usually LSD-like, can be seriously dangerous and their side effects can last for days, perhaps longer. It’s been shown that some people can experience recurring LSD trips even years after taking the drug, and these drugs may cause the same effects.
Two notorious synthetic drugs are called “N-Bomb” and “flakka.” They’re both powerful hallucinogens that lead to extremely dangerous and violent activity. Emergency hospital admissions for synthetic drugs are rising across the country, and treatment usually involves having to manage “extreme agitation” while trying to prevent life-threatening organ damage. These drugs are, quite literally, dangerous poisons.
N-bomb has been marketed as “legal” or “natural” LSD for a few years, and it’s blamed for at least 19 deaths and possibly as many as 30, says the DEA. It was named a “Schedule 1” highly dangerous drug last November and is now illegal. N-bomb mimics the effects of LSD, but in much more erratic and unpredictable (and more dangerous) ways.
Patients admitted to emergency wards for N-bomb poisoning “require heavy sedation to calm aggression and violence as well as external cooling measures to treat hyperthermia, or overheating of the body,” according to a report in Medical Daily.
N-Bomb, is a relatively new synthetic drug from the “NBOMe” class of drugs, from whence it got its street name. NBOMes were originally developed for psychiatric drug purposes to map serotonin receptors in the brain. Today they’re one of the most frequently abused designer psychoactive substances. N-Bomb is sold as blotter paper, powder or liquid that can be ingested, snorted, or inserted rectally or vaginally, says the DEA.
Flakka is all over South Florida and is spreading like wildfire
The other drug, called flakka, is so new it hasn’t been assigned to a drug schedule. It can’t be seized as an illegal substance yet, and sellers can’t be busted for drug dealing. Flakka is made from the same type of chemicals that are used to make “bath salts,” a notoriously dangerous hallucinogenic with potentially fatal side effects.
Drug cops say flakka looks a little like crack cocaine or meth and has a unique “sweaty” odor. It is actually a form of crystal meth, usually made in overseas labs and sold over the Internet. Flakka can be swallowed, snorted, injected, smoked and easily concealed in electronic cigarettes or a vaporizer. It’s being sold on the streets of South Florida and spreading northwards. It’s in Texas and Ohio too, and cops say it’s only a matter of time before it spreads across the country.
A report in the Miami Herald, quoting from a police report last week, says a Miami man high on flakka proclaimed himself Thor, the Norse God of War, attacked a police officer and attempted to have sexual relations with a tree. The man was first seen running naked through a Brevard County community. The man was acting completely crazy and at first could not be subdued. When an officer tried to use a Taser, the guy pulled the electric probes out of his body and just punched the officer and tried to stab him with the cop’s badge. It took enormous effort to subdue the crazed victim of flakka psychosis.
Medical Daily reports that a man ran out of his Miami house last month after smoking some flakka, stripped his clothes off and screamed violently while police chased him. It took five officers to bring the man down. Police said he exhibited the same kind of super-strength that users of crystal meth often have. He was suffering from the hallucinations and paranoid delusions so often seen in people high on flakka.
CBS news reported recently that a man stoned on flakka was arrested for trying to break down a police station door, another man high on flakka was found naked and armed with a gun on a rooftop, and a third man, trying to climb a fence, slipped and impaled himself with a foot-long spike. This is a dangerous and terrible drug.
Jim Hall, an epidemiologist at the Center for Applied Research on Substance Use and Health Disparities at Nova Southeastern University, describes flakka as creating a “bizarre high” which will probably “sweep the nation if it isn’t stopped.”
“We’re starting to see a rash of cases of a syndrome referred to as ‘excited delirium,’” Hall told CBS News recently. “This is where the body goes into hyperthermia, generally a temperature of 105 degrees. The individual becomes psychotic. They often rip off their clothes and run out into the street violently and have an adrenaline-like strength, and police are called and it takes four or five officers to restrain them. Then, once they are restrained, if they don’t receive immediate medical attention they can die.”
Similar effects are caused by another new drug in Florida and elsewhere called butane hash oil, also known as BHO or Budder. People put it in room vaporizers and become intensely high, with unpredictable results. Budder is the active marijuana ingredient, THC, mixed with other harmful chemicals. And police say its use is increasing.
DEA says N-bomb revenues are helping finance terrorists
N-bomb, which has already caused many deaths, may be helping finance terrorists. The DEA says it’s been acting on credible reports that revenues from synthetic drugs like N-bomb are ending up in the pockets of terrorists and criminal organizations in the Middle East. A DEA crackdown has led to 200 warrants, 120 arrests and the seizure of $20 million in cash.
“[N-bomb] is a dangerous drug, it is potentially deadly, and parents, law enforcement, first responders, and physicians need to be aware of its existence and its effects,” says Dr. Donna Seger, professor of clinical medicine and medical director of the Tennessee Poison Center. “The recreational use of synthetic (designer) psychoactive substances with stimulant, euphoric, and/or hallucinogenic properties has risen dramatically in recent years.”
Seger adds that the quality control of these street drugs is nonexistent. Misjudging a dose could lead to significant toxicity, with such symptoms as hypertension, rapid or irregular heartbeat, hyperthermia, dilated pupils, agitation, aggressive behavior, delirium, hallucinations, seizures, and even renal failure or coma.
Here at Novus, we help patients overcome dependence and addiction to alcohol and drugs of all kinds. We don’t see people on synthetic designer drugs as a rule, but their capacity to create dependence and addiction has already begun to surface here and there across the country.
If you or someone you know has been experimenting with synthetic drugs like N-bomb or flakka, we strongly urge you to confront this problem right away. These are very dangerous drugs because their side effects are extremely unpredictable and are potentially lethal.
Categories: Drug Facts
A troubled Marine who overdosed and died in a VA psych ward is only one of many cases of overdose in recent years. But the VA assured the committee in March that the rampant opioid prescribing has begun to ease off and other measures are being taken.
The Veteran’s Affairs has come under the gun after a damning report by the Center for Investigative Reporting on opioid prescribing at a VA hospital in Wisconsin found a 14-fold increase in oxycodone pills prescribed.
The Center found opioid painkillers prescribed at the Tomah VA Medical Center soared from 50,000 hydrocodone pills in 2004 to 712,000 pills in 2012. There was apparently no significant increase in the number of patients – just in the number of oxycodone pills prescribed per patient.
Veterans also told a reporter that opioid use was so rampant at the hospital that the soldiers gave the place the nickname “Candy Land.”
When a 35-year-old Marine Corps veteran died of an opioid overdose while in the hospital’s psych ward last August, it was only the latest in a long string of heartbreaks for veteran’s families going back many years.
Numerous reports from the VA Inspector General (IG) over the past five years say veterans are dying from medication overdoses across the country. Whistleblowers have also alerted the IG several times about dangerous opioid and benzodiazapine prescribing practices – a particularly deadly cocktail.
Tests not being done, leaving patients at risk
Yet in spite of the deaths, whistleblower warnings and the IG’s official reports, routine drug tests to monitor narcotics uses and abuses are still not being performed in the nation’s VA hospitals or among the many thousands of outpatients receiving medications.
And according to the reports, doctors are even prescribing medications to patients they have not even seen in person. Although this is a violation of written VA policy, one would think it’s a violation of basic ethical medical practice anywhere.
And just a couple of weeks ago, a former pharmacist at the Tomah VA told the committee she was “discouraged by higher-ups” from performing drug tests, in contravention of VA guidelines.
Noelle Johnson, who was fired from that facility and now is employed as a VA pain management specialist in Des Moines, said pharmacists at Tomah were discouraged from testing patients for drug use for fear of what “prescribing physicians might learn.”
Johnson said she was told that if the tests were negative, it could indicate the patient wasn’t taking their meds and were instead maybe selling them. And if the tests were strongly positive, it could “suggest overuse or abuse” and the VA could be held liable “when something unfortunate happened.”
“I believe that this is the point of urine drug testing, to substantiate use and misuse of high-risk medications for the safety of veterans and the public,” Johnson told the committee. “What happened to the doctors’ oath of ‘First Do No Harm?’”
VA is taking steps, says spokesperson
Dr. Carolyn Clancy, the VA’s interim Under Secretary for Health, told the committee that the VA has gotten the message and is taking steps to remedy the situation. Clancy said that the best way to curtail prescription drug abuse and overdose is to avoid prescribing addictive medications like fentanyl, hydrocodone or oxycodone. She said that several VA programs are in place and already working to reduce the number of prescriptions and subsequent “accidental deaths.”
“Chronic pain management is challenging for veterans and clinicians,” Clancy told the Committee. “Opioids are an effective treatment but their use requires constant vigilance to minimize risk and adverse effects.”
Clancy said a program to educate physicians on the VA’s narcotics prescription guidelines was introduced in three areas in 2013 and has been adopted by about a third of the VA’s health regions. It’s already bringing about reductions in the number of prescriptions, and also beefing up appropriate testing and tracking of patients, she said, and the VA will expand the program to include all its medical centers.
Another program, Clancy said, is called the Opioid Safety Initiative, also started in 2013, and is also helping reduce the numbers of opiate prescriptions. Since 2012, the number of patients receiving opioids has declined by 13 percent, she said, and those using opioids and benzodiazepines together — a cocktail that can have fatal consequences if taken incorrectly — has dropped by 24 percent.
Clancy also told the Veteran’s Affairs Committee about VA’s Overdose Education and Naloxone Distribution program (OEND) which provides emergency kits containing the opioid overdose antidote drug naloxone to veterans on high doses of opiates or who use multiple medications to manage pain.
Naloxone program saving lives
Since its introduction last May, she said, more than 2,400 kits have been provided to such veterans, their families or friends. And at least 41 veterans have been rescued from overdoses since the OEND program began.
Naloxone instantly reverses the respiratory depression that kills the victims of opioid overdose. It’s administered by nasal spray or injection, and is easy enough for anyone with a few minutes of instruction to use. It’s normally carried in ambulances, is used at all ERs, and is carried by many police forces across the country, since cops are very often on the scene of overdoses even before the EMT people.
The overuse of opiates for pain management and the resulting widespread dependencies, abuses and addictions to these highly addictive medications is not just a VA problem. Dr. Thomas Frieden, director of the Centers for Disease Control and Prevention, recently called the overprescribing of opioids “a national epidemic.”
Frieden said the prescribing practices of America’s physicians is the primary source of the epidemic. But the VA’s physicians went to all the same med schools as the rest of America’s doctors. So we shouldn’t expect anything different at the VA.
The Institute of Medicine says a hundred million Americans are suffering from chronic pain on any given day. Yet medical schools devote less than two days – maybe 8 to 10 hours tops – to the treatment and management of pain, including chronic pain. There are only a few thousand actual certified pain specialists in the entire country – just a drop in the bucket.
Senator says he’s “angered and disgusted”
Ranking committee member Sen. Richard Blumenthal (D-CT) said he is “angered and disgusted” that so little appears to have been accomplished to address overprescribing since the committee’s last session on the same topic.
“I want this hearing to be different, to produce action,” Blumenthal said. “This epidemic has been with us for years and years and that’s one reason for my anger and astonishment that the VA system isn’t better than it is.”
Here at Novus, we’re also looking forward to a time when opioid prescribing in and out of the military is under control. Meanwhile we’re here 24/7 helping people who have fallen victim to prescription opioids. If you or someone you care about is suffering from the addictive effects of prescription pain meds, don’t hesitate to give us a call. We’re always here to help.
The number of babies born in Florida dependent on opioids like heroin and hydrocodone has increased more than 10-fold since 1995, says a new report from the Centers for Disease Control and Prevention (CDC). And the soaring 10-fold increase “far exceeds the three-fold increase observed nationally,” the report said.
The CDC added that only 10 percent of the mothers who used opioids during pregnancy received, or were even referred for, treatment for drug dependencies.
Babies exposed to addictive prescription or illicit drugs taken by a mother during pregnancy can suffer a wide range of physiologic and neurobehavioral side effects. The condition, called Neonatal Abstinence Syndrome (NAS), is terribly sickening and painful for newborns, and can be life threatening if not treated correctly.
CDC was helping Florida streamline patient information system
In February 2014, the Florida Department of Health asked the CDC to help assess the accuracy and validity of the state’s hospital inpatient discharge data linked to birth and infant death certificates. The state wanted to know if the information could correctly monitor NAS in the state, and if it accurately describes the characteristics of infants with NAS and their mothers.
This new CDC report only focuses on the second objective – describing maternal and infant characteristics.
The CDC studied the data for 242 confirmed cases of NAS during a 2-year period (2010–2011) identified in just three Florida hospitals. The conclusions were extrapolated to apply to the whole state.
97 percent of NAS babies had to be admitted to ICU
“Infants with NAS experienced serious medical complications with 97.1 percent being admitted to an intensive care unit,” the report states, “and had prolonged hospital stays for a mean duration of 26.1 days.”
In other words, many, if not most of those 242 newborns spent nearly a month in the hospital being weaned off the addictive drugs. And the story would be the same at any of the rest of the state’s several hundred hospitals. The cost of such treatment can reach six figures for each infant.
“The findings of this investigation underscore the important public health problem of NAS,” the CDC said, “and add to current knowledge on the characteristics of these mothers and infants.”
Partly as a result of the CDC study, as of June 2014, NAS became a mandatory reportable condition in Florida – that is, diagnosed cases must by law be reported to the Florida Department of Health.
Mothers involved in cases of NAS need intervention
As to the lack of care offered or provided to drug-using mothers, the CDC says intervention should be increased, not just for NAS mothers but for all women of child-bearing age. Such intervention is needed to:
- Increase the number and use of community resources available to drug-abusing and drug-dependent women of reproductive age
- Improve drug addiction counseling and rehabilitation referral and documentation policies, and
- Link women to these resources before or earlier in pregnancy.
Only 1 percent of mothers used heroin, 99 percent prescription drugs
Once again, more evidence of America’s appalling abuse of prescription drugs: Over 99 percent of drug-exposed mothers were using prescription drugs, not street drugs like heroin.
While the whole country is up in arms about “the heroin epidemic,” less than 1 percent of NAS mothers had used heroin during pregnancy. Here’s the whole drug-use-while-pregnant picture:
- Less than 1 percent of mothers were reported to have used heroin during pregnancy
- Approximately 82 percent of mothers were using one or more prescription opioids, such as oxycodone, morphine, hydrocodone, hydromorphone, tramadol or meperidine
- 59.9 percent were using methadone and 3.7 percent using buprenorphine – both drugs commonly used for treatment of opioid dependence
- 40.5 percent were using benzodiazepines such as Xanax, Klonopin, Lorazepam / Ativan and Valium (diazepam)
- After benzos came tobacco at 39.7 percent, marijuana at 24.4 percent and cocaine at 14.1percent
- Reasons reported for opioid use included illicit (nonmedical) at 55 percent, drug abuse treatment at 41.3 percent and chronic pain treatment at 21.5 percent
- The reason for opioid use during pregnancy was unknown for 10.3 percent of NAS mothers
- Only 10.3 percent of mothers apparently received or were referred for drug addiction rehabilitation or counseling during the infant’s birth hospitalization.
Over 99 percent of NAS was from opioids
- Nearly all infants with NAS – 99.6 percent – were exposed to opioids in utero, which definitely highlights the widespread issue of opioid use in women of childbearing age.
- Women face many barriers in accessing any type of substance abuse treatment, which might also be reflected in the finding that only 10.3 percent of mothers of infants with NAS received or were referred for drug addiction rehabilitation or counseling during their infant’s birth hospitalization, despite a high percentage of mothers with positive urine toxicology screen results.
- Because abstinent detoxification during pregnancy is dangerous to the fetus, medication assistance is recommended as the standard of care for pregnant women with opioid addiction.
- Comprehensive medication assistance coupled with correct prenatal care reduces the usual complications associated with untreated opioid use disorder.
Bottom line, even one baby born dependent on drugs is one too many. Here at Novus, we deeply care about the situation, and take care to help all our female patients of child-bearing age understand the vital need for all pregnancies to be drug-free of any addictive or other toxic substances.
If you know a woman of child-bearing age who is dependent on opioids, please help them to come off these drugs before pregnancy occurs. Have them call Novus, or contact us yourself and we will help.
Zohydro ER, the extended release hydrocodone prescription painkiller that caused a firestorm when the FDA approved it over a year ago, has finally been released in a new abuse-resistant formulation.
An extended release painkiller contains 5 or 6 times as much opioid as a single-dose pill. It’s intended to be released slowly over many hours after you take it.
But addicts want to get all that opioid in a single hit by crushing it into a powder and snorting it, or mixing it in a liquid and shooting it up with a syringe.
The new Zohydro ER is made using something called BeadTek technology, which is designed to deter abuse “without changing the release properties of hydrocodone when Zohydro ER is used as intended,” says the announcement from the pill’s maker, Zoegenix, Inc., of San Diego, CA.
The company claims that, when the new pill is crushed and mixed into a liquid or solvent, the BeadTek technology turns it into a viscous gel that’s impossible to use in a syringe.
The product label won’t include the abuse-deterrence claim until later in the year after the company finishes “Human Abuse Liability studies” of the pill’s new abuse-deterrent properties and submits the results to the FDA. These findings will affect the wording for the label.
Original FDA approval ignited a firestorm
Zohydro ER, the first pure hydrocodone extended release pill ever, with no abuse deterrence at all, was asking the FDA for approval to bring it to market.
We already knew that hydrocodone was the most abused prescription opioid in America – even mixed, as it always was with acetaminophen in drugs like Lortab, Norco and Vicodin.
Also, the country had already endured the horrors unleashed by Purdue Pharma’s OxyContin – a pure oxycodone extended release painkiller that triggered a decade of addictions, overdose deaths and ruined lives across the country.
Purdue Pharma had come out with an anti-abuse version of OxyContin back in 2012, and it was seen as making a difference. Well actually, sending most addicts on to heroin or over to the various other painkillers like hydrocodone, hydromorphone and others.
But now, here came Zohydro ER, pure hydrocodone with no built-in deterrence. It looked to everyone concerned like OxyContin all over again.
The FDA’s approval of the original Zohydro ER ignited a firestorm of adverse reaction in the media, letters to the FDA from institutions all over the country, even demands that the head of the FDA resign. Criticism came not just from the public, but also from a wide cross-section of the medical profession. The consensus was that Zohydro ER offered nothing but more danger of abuse and deaths from overdose, since there was no real need seen for more opioid painkillers.
Not only did the FDA approve Zohydro ER as-is in the face of all this criticism, it did so against the direct recommendation of its own medical, scientific and research advisory committee to disapprove the drug and keep it off the market.
DEA classifies hydrocodone as even more dangerous
Last year, not too long after the FDA approved the original Zohydro ER and after more than a decade of hemming and hawing, the Drug Enforcement Administration (DEA) finally rescheduled hydrocodone-containing meds as Schedule II drugs, up from Schedule III.
In plain English, this meant it was finally acknowledged that hydrocodone is just as dangerous as oxycodone, which has always been Schedule II.
We at Novus were pleased to report on the DEA rescheduling of hydrocodone, since we see the harm that hydrocodone has brought to so many of our patients. Hydrocodone is among the top killer drugs in America.
And believe it or not, 99 percent of all hydrocodone is consumed right here in America. The rest of the world just isn’t interested, because there are plenty of other prescription opioids to choose from. And many, if not most pain management specialists, even here in America, question the need for more.
Also, late last year, Purdue Pharma came out with its own anti-abuse hydrocodone extended release painkiller, with the company’s abuse-resistance technology built in. Called Hysingla ER, it’s abuse-deterrent technology “discourages” chewing, crushing, snorting or injecting.
Even a legitimate prescription can lead to hydrocodone dependence
Let’s not forget that there are many medical patients who take legitimate, doctor-ordered hydrocodone or other opioids for pain, who then become dependent on the drugs – abuse-resistant or not. These people need to be carefully weaned off those drugs, but some of them actually become addicted.
So here we are, in a country awash in prescription opioid painkillers (there are dozens) and countless thousands of prescription opioid painkiller addicts, and we have not one, but two new ones. And doctors often find themselves stuck between a rock and a hard place – wanting to help their patients, but at the same time wanting to avoid over-medicating with seriously addictive painkillers.
There is a movement afoot among pain specialists and researchers to find solutions for mild and moderate pain other than opioids and opiates. Some approaches are already being used, but it’s rough going when the American public is demanding opioids, and nearly all regular doctors know very little about alternatives. Perhaps this will be the subject of a future blog.
Meanwhile, here at Novus, we’re known far and wide for our medical breakthroughs in opioid detoxification, including hydrocodone. Our proprietary opioid detox protocols result in much more comfortable detox experiences for our patients, and even improves patients’ overall health. Patients often remark as they’re leaving, “I haven’t felt this good in years, even before I got into trouble with (substance abuse).”
If you or someone you care for has a problem with opioid dependence or addiction, don’t hesitate to call us. We are always here to help.
The rate of babies being born in Canada’s province of Ontario suffering from opioid withdrawal has soared to more than 15 times what it was 20 years ago.
Newborn withdrawal, called neonatal abstinence syndrome (NAS), grew in Ontario from about 0.3 per 1,000 live births in 1992 to 4.3 per 1,000 in 2011 – in all, nearly 3,100 infants born suffering the same frightful withdrawal symptoms that adult addicts go through when kicking opioid dependence.
And newborn babies don’t have whatever tiny bit of comfort there might be in at least knowing why they’re in so much pain and that it will eventually be over.
Two major facts point at a most disturbing situation:
- Nearly all the mothers were dependent on prescription opioids like oxycodone, hydrocodone and morphine from their physicians, not street drugs like heroin or illicit opioid painkillers.
- Most of the increase occurred in just the past 5 years – over 1,900 babies, 2/3 of the total 3,100.
The past 5 years has seen negative publicity at an all-time high about the dangers of overprescribing opioid pain killers. Canadians should have expected their doctors to back off from the unhealthy rates of prescribing opioids that occurred through the 1990s and early 2000s. But it appears some Canadian doctors didn’t get the memo, as the saying goes.
The research, published in the Canadian Medical Association Journal, says women were prescribed opioids both before and during pregnancy. Principal researcher Dr. Suzanne Turner, a physician at St. Michael’s Hospital in Toronto who specializes in providing obstetrical care for women with addictions, said the study suggests that many women were prescribed opioid painkillers to treat pain prior to or during their pregnancies, and then at some point a dependence or an addiction was identified and they were switched to methadone.
Current medical opinion holds that methadone withdrawal is a little easier on newborns. Although switching one dependence (painkillers) for another (methadone) hardly sounds like treatment for most people. But in the case of pregnancy, an opioid- dependent mother-to-be must not attempt to detox because it is dangerous to the fetus.
“That’s really important because we know that methadone is actually good in [such a] pregnancy because it stabilizes mom, and babies are more likely to be born at term and at high birth weight and healthy.”
Of course, Turner’s use of the term “healthy” doesn’t mean that these newborns don’t face a week or two of methadone withdrawal hell, unless they are carefully weaned from a replacement drug such as morphine.
“The concern to me is how do we address the fact that they were prescribed opiates prior to pregnancy and is there something we can do at that stage to prevent the transition to addiction and then requiring methadone,” she asked. “This is a treatable condition. If the babies get morphine, which is typically the standard of care, they’re not in withdrawal and then we slowly wean them off that dose of morphine over time.”
Addiction to prescription opioids now exceeds heroin addiction as the most common reason to offer methadone as a “treatment.” Turner says that preventing addiction by using alternative pain-relief therapies when possible would pay dividends for both mothers and their babies. “It speaks to the fact that doctors need to be aware there is the risk of addiction if women are prescribed opiates prior to pregnancy, and if they’re of child-bearing age, those risks should be assessed.”
Turner added that doctors and other caregivers need to counsel women that using any opioid during pregnancy can lead to NAS. She said this is especially important information for women with addictions because of the uncommonly high risk of unplanned pregnancies.
Here at Novus, we deal with opioid/opiate painkiller dependencies and addictions on a daily basis. If you or someone you care for needs help with opioid dependence, don’t hesitate to call us. We’ll help you find the right solution for your situation.
Image courtesy of arztsamui at FreeDigitalPhotos.net
Emergency responders such as police, ambulance and ER personnel, and the city, state and county administrators that pay their bills, aren’t happy with a recent price jump for nasal naloxone – the widely-used, life-saving drug that can reverse an opioid overdose in a matter of seconds.
Amphastar Pharmaceuticals, Inc., the only U.S. maker of naloxone in convenient single-dose nasal delivery cartridges, has suddenly more than doubled the wholesale price, averaging $13 to $15 per cartridge to as high as $30 to $35.
The company is now impressing Wall Street, according to the financial news, and its shareholders are delighted with the company‘s rising stock values. But the price hikes are causing a big problem for the legions of emergency personnel from coast to coast who depend on nasal naloxone to save lives.
State, county and city health departments are traditionally under-budgeted. But with the recent recession and unemployment rates these past few years, the squeeze has gotten worse than ever. And the price increases are making it especially difficult for the many non-profits across the country that provide nasal naloxone kits to addicts and their families. These street-level, store-front groups are under even tighter financial constraints these days, and they’re on the front lines helping saving lives every day too.
New York’s Attorney General Eric T. Schneiderman wrote a 2-page letter to the Amphastar’s CEO demanding an explanation for what he called the “unacceptable” rise in prices.
Chuck Wexler, the executive director of the Police Executive Research Forum that has urged putting naloxone into every police officers’ hands, told the New York Times that because it’s not an incremental increase, there’s “clearly something going on.”
And Dr. Phillip O. Coffin, director of substance abuse research at the San Francisco Department of Public Health, told the Times that the price hikes “will decrease access” to naloxone.
Naloxone has been around since back in the 1960s and has been a useful but little-known player in the ER. That’s where most overdose victims – the ones who are lucky enough to arrive alive – get another chance at life and hopefully, a new decision to get clean, all thanks to naloxone.
In more recent years, naloxone has been made available in many constituencies to all emergency responders, usually financed by state and local health care and law enforcement budgets. Naloxone kits are also offered to the general public, such as heroin and painkiller addicts and their friends and families, in some places even without a prescription.
In 2011, says the CDC, there were 16,917 prescription opioid deaths and 4,397 heroin overdose deaths – over 20,000 in all. This colossal annual death rate, which dwarfs every kind and type of epidemic since the world-wide 1917 influenza pandemic , will only increase until more funding, not less, is made available for safe and effective opioid medical detox and long-term treatment facilities.
Most heroin and opioid overdose victims who are pulled back from death’s door by the use of a nasal or injected dose of naloxone turn right around and go back to their dangerous habits. After all, they’re addicts, right? And naloxone is only emergency medicine, not heroin detox, not rehab, not addiction treatment by any stretch.
But once you’ve saved a life with naloxone, the seriousness, the impact of that event isn’t lost on the just-saved addict. It should open the door to at least a new discussion, if not a focused intervention, that might lead to treatment and recovery.
Saving a life, any life, is not just worthwhile but essential. And naloxone provides that opportunity hundreds of times a day across America. It seems ethically wrong on every level to deny anyone another chance at life when it is so easily, quickly and inexpensively possible.
Only time will tell if the soaring naloxone prices result in killing more Americans because of a board-room decision to make a killing on the stock market.
If you or someone you care for suffers from an opioid dependence or addiction, please call Novus right away. We’re here to help, and will try to answer all your questions about opioid detox and essential long-term treatment.
The Food and Drug Administration (FDA) has approved a new hydrocodone extended-release painkiller from Purdue Pharma called Hysingla ER (ER is for Extended Release) made with “abuse-deterrent” technology that discourages chewing, crushing, snorting or injecting.
The new hydrocodone painkiller also contains no acetaminophen, which is found in almost all other hydrocodone painkillers such as Vicodin, Norco and Lortab and many others, as well as over-the-counter painkillers like Tylenol. Acetaminophen is the leading cause of liver damage in America, which can lead to acute liver failure and death.
Hydrocodone-and-acetaminophen painkillers like Vicodin are not only the most prescribed painkillers in the country, contributing to countless cases of liver toxicity, but they’re also among the most widely abused drugs in the country. The need for abuse-resistant hydrocodone tablets without acetaminophen has been evident for years.
Hysingla ER is intended as a once-a-day treatment for patients with “severe, round-the-clock pain that cannot be managed with other treatments.” According to Purdue’s announcement, Hysingla ER is the third drug they have made using the company’s RESISTEC™ “proprietary extended-release solid oral dosage formulation platform.” The company says it’s the “first and only hydrocodone product to be recognized by the FDA as having abuse-deterrent properties that are expected to deter misuse and abuse via chewing, snorting and injection. However, abuse of Hysingla ER by the intravenous, intranasal, and oral routes is still possible,” the statement continued.
Studies of the effectiveness of its abuse resistance will continue after the drug’s release in the United States in early 2015. Purdue said it expects to launch Hysingla ER in dosages of 20 mg, 30 mg, 40 mg, 60 mg, 80 mg, 100 mg and 120 mg to be taken once every 24 hours.
After more than a decade of highly publicized abuse, addictions, overdose deaths and lawsuits, the company’s controversial extended-release oxycodone painkiller, OxyContin, was reformulated in 2010 using a similar abuse-deterrent system. Purdue claims that evidence shows the change in formulation has led to significantly less abuse.
Meanwhile, the FDA has had to face a firestorm of protests and criticism from both the medical community and the public since it approved Zohydro ER more than a year ago. More than 40 consumer protection, addiction specialist and citizen health care groups across the country have been urging that the FDA reverse its approval of the drug.
Zohydro ER, from drug-maker Zogenix, is also an all-hydrocodone extended-release painkiller like Purdue’s new Hysingla ER. But Zohydro ER has no built-in abuse-resistance at all, which critics insist makes Zohydro ER a massive risk for overdose injuries and deaths among opioid addicts across the country, just as OxyContin was before it was reformulated with abuse resistance.
In spite of the criticism, and even after its own expert medical safety panel gave the drug a firm thumbs down because of the drug’s obvious potential for abuse, the FDA’s hierarchy found some reason somewhere to approve it.
On the business side of things, Purdue’s Hysingla ER certainly will be a potent and potentially devastating commercial challenge to Zogenix’s much-maligned Zohydro ER. We can’t imagine doctors prescribing Zohydro ER with the safer Hysingla ER on the market. In response, Zogenix recently stated that the company is already hard at work to come up with its own abuse-resistant technology, and that it will reformulate Zohydro as soon as it has it perfected.
Here at Novus, we work with many patients who were addicted or made dependent “accidentally”, for want of a better term, while taking legitimate opioid painkiller prescriptions.
Opioids are prescribed for a wide range of ailments, from post-surgical pain to arthritis and even migraines.
But prescription opioid deaths have quadrupled since 1990 to nearly 17,000 a year, and the whole field of pain management is under a lot of pressure to re-evaluate its practices. While some experts argue that opioids should only be used for the most severe cases, such as cancer pain or end-of-life care, others maintain that less severe, short term pain management still requires opioids.
While the FDA continues to receive public pressure to take more effective action, the national epidemic of prescription opioid abuse continues. And here at Novus we continue to deal with it using the most innovative and effective medical detox available.
If you or anyone you care about is having a problem with prescription opioid painkillers or medications of any kind, don’t hesitate to call Novus. We’re always here to help, and will do our best to answer all your questions about prescription drug detox.
According to a 2011 White House study, nearly one out of every five driver fatalities in 2009 – 18 percent to be exact – involved “drugged driving,” the term that describes the growing epidemic of drug-impaired driving, similar to “drunk driving” for alcohol impairment. The latest figures show a rise from just 13 percent back in 2005.
Not all drivers killed in traffic accidents are tested for drugs. In fact, the average is only around 60 percent of them. But among drivers who were tested, 33 percent tested positive for drugs in 2009, while only 28 percent tested positive in 2005.
This rising trend of drugged driving fatalities is causing even more concern than you might expect, because in that same period, 2005 to 2009, the total number of all driver fatalities dropped significantly – from 27,491 in 2009 to 21,798 in 2009. Yet the percentage of drugged driver fatalities rose 5 percent.
These findings are described in Drug Testing and Drug-Involved Driving of Fatally Injured Drivers in the United States: 2005-2009, a report from the White House Office of National Drug Control Policy (ONDCP). It was based on figures from a National Highway Traffic Safety Administration (NHTSA) Fatality Analysis survey.
We’re just talking about drugs here, not alcohol. We already know from other studies that alcohol claims one-third of all driver fatalities. Alcohol was also involved in combination with drugs in some of this study’s findings. But drugs – stimulants, depressants and psych drugs – were the main focus of the study.
The study includes reams of information of lesser interest to most of us, such as comparing males to females (not much difference) or specific findings for counties. We’re more concerned with the big national picture. And it isn’t a pretty one.
The depressing reality is that 21,978 Americans were killed in vehicle accidents in 2009 (latest available figures), and nearly a fifth of them – 3,952 – were killed while driving under the influence of drugs.
By way of comparison, that’s more than three times as many military fatalities in the more than 10 years of Iraq and Afghanistan wars.
Looking at it another way, drugged driving is killing more than 10 drivers every single day of the year. And when you add in the alcohol-related driver fatalities, the total is much higher.
And that’s only driver fatalities. Thousands more deaths occur among passengers in both the drug- and alcohol-impaired drivers’ cars; there are thousands more victims in the cars crashed into by impaired drivers; and hundreds of innocent pedestrians and cyclists that are also struck and killed by impaired drivers.
We also have to consider the countless thousands of injuries, from weeks or months of pain and misery to a lifetime of permanent disability. There are far more injuries than deaths, resulting in incalculable health care costs.
Now, when you add to the health costs the legal, law enforcement, loss of work and family costs, the financial impact on society is truly immeasurable. Estimates place the cost of drugged and drunk driving in the billions of dollars a year.
You can’t put a dollar value on the irreconcilable emotional losses among families, friends and coworkers of the dead and injured. But these are even more costly, in human terms, than the losses of dollars and cents.
When you consider that all these thousands and thousands of deaths were utterly needless and avoidable, the scope of this national tragedy is magnified almost beyond belief. All it would take, to save every one of these lives, is for anyone using drugs or alcohol to simply refuse to climb behind the wheel.
Just that one, single, simple decision would save thousands lives and heartbreaks every year.
What kind of people are we, that we would risk not just our own lives, but carelessly risk the lives of our fellow citizens – men, women, children and infants – by driving while on drugs or alcohol?
Why don’t we find ways to make our educational system really teach kids that reach middle and high school to not start using drugs and alcohol, let alone to drive a car while doing so?
At the bottom of it all, what kind of examples are we as parents setting for our kids? As parents, we are the product of the same educational system that has failed to get that essential message across. We clearly need to make some changes in our thinking. And our local, state and national policies need to be changed to ensure better educational results. No one wants this carnage on our streets and highways to continue.
Here at Novus, our patients come from all walks of life, but they have one thing in common – they’ve made that all-important, life-affirming decision to become free of drugs and alcohol. Part of that decision is always a clear look at the negative effects of substance abuse, and a resolve to never let it happen again.
If you or someone you know has a problem with drugs or alcohol, don’t hesitate to pick up your phone and call Novus. We’ll not only help you find the right solution, we’ll both be contributing in our small way to make our roadways safer.
Fetal alcohol spectrum disorders may affect up to 5 percent of U.S. children
There is a new report out this month that suggests that as many as one in 20 U.S. children may have health or behavioral problems related to alcohol exposure before birth. Especially these days, when “everyone knows” not to drink during pregnancy, the numbers are higher than anyone expected.
“Knowing not to drink during pregnancy and not doing so are two different things,” especially before a woman knows she is pregnant, said lead researcher Philip May, a professor of public health at the University of North Carolina at Chapel Hill.
Findings from the study were reported online Oct. 27 and in the November print issue of Pediatrics.
Fetal Alcohol Syndrome is at the most severe end of the spectrum of conditions resulting from drinking mothers. These conditions include abnormal facial features, structural brain abnormalities, growth problems and behavioral issues. Children on the milder end of conditions resulting from pre-natal alcohol use still suffer from things like impairment in the ability to complete tasks required to do well in school or other behavioral issues.
Knowing this, why would any pregnant woman take even one drink?
Dr. Lana Popova, a senior scientist at the Centre for Addiction and Mental Health and an assistant professor of epidemiology and of social work at the University of Toronto says, “There is no safe amount of alcohol or safe time to drink during pregnancy, or when planning on becoming pregnant. If a woman is unaware of her pregnancy, for whatever reason, she should discontinue drinking immediately upon pregnancy recognition.”
The study also found other alcohol factors that contribute to the potential severity of problems children might have. The longer it took a mother to learn she was pregnant, how frequently she drank three months before pregnancy, and the more alcohol the child’s father drank, the more likely it was that the child would have negative effects, were part of the findings.
Dr. Popova also cites two contributing factors to these unexpected percentages: a high number of unplanned pregnancies and a need to improve access to effective substance abuse treatment programs for women of childbearing age.
Over the years, we have always regularly received phone calls from pregnant women and it is our heartbreak that we can not help an already pregnant woman detox off of alcohol. So we work very hard to get the word out to women to please, please confront and handle alcohol problems before risking getting pregnant.
As Dr. Janet Williams, a professor of pediatrics at the University of Texas Health Science Center in San Antonio observed: “Alcohol is a neurotoxin, and alcohol exposure is the leading preventable cause of birth defects and intellectual and neuro-developmental disabilities. So why is it worth experimenting with your child?”