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?”
When it comes to the virulent, deadly ebola epidemic that’s dominating the news these days, we’re just as nervous as everyone else. No vaccine, no cure, and anywhere from 50 to 90 percent fatality rates.
We’re glad the White House is taking the ebola threat seriously by creating a task force to help head off an ebola epidemic getting a foothold here in America. President Obama has hand-picked Ron Klain, the former chief of staff to Vice Presidents Joe Biden and Al Gore, to “coordinate the national response to the deadly virus.”
But because of what we do – help people overcome drug and alcohol dependence – we know how widespread and deadly addiction has become in America. By anyone’s definition it’s an epidemic. And we can’t help thinking that more could and should be done to deal with it too.
It may upset some people for us to say this, and it certainly wouldn’t be popular coming from any politicians or health officials these days, but statistically, the death count from the current and dreaded ebola epidemic in West Africa is actually trivial compared to the death count from drug and alcohol abuse, both here and around the world.
The hard and true facts are this: More Americans die every month from drug and alcohol related mishaps than have died from the current, dreaded ebola virus epidemic sweeping West Africa. They’ve been dying here in the US at that rate for decades. And it’s not really getting any better.
Here are some numbers to compare – and they’re rather shocking:
EBOLA (current outbreak, as of mid-October 2014)
- Deaths in Africa: 4,500 (estimated)
- Deaths in US: 2 (confirmed)
DRUGS AND ALCOHOL (for 2010, latest figures available)
- Alcohol-related deaths in US: 25,692
- Drug overdose deaths in US (not including alcohol): 38,329
- Pharmaceutical drugs: 22,134
- Pharmaceutical opioid analgesics: 16,651
- Illicit drug use: 17,000 (may include some of above events)
- World-wide drug related mortality (from UN): 247,000
Clearly, with drugs and alcohol addiction and deaths, we are dealing with an epidemic of such colossal proportions, one that has been going on for so long, that most people today just don’t “get it.” It’s too big, it’s been around too long, it’s too familiar – whatever – most people have become kind of numb to the whole thing.
Unfortunately, that includes many lawmakers, the people we elect to guide us and protect us, and allocate sufficient resources to head off dangerous threats to public health. And of course, that has to include the drug and alcohol epidemic that is claiming over 75,000 American lives every year.
When it comes to choosing its victims indiscriminately, drug and alcohol addiction isn’t too much different from most viruses including ebola. It strikes people of all ages in all walks of life, and like a virus, it spreads like a contagion – especially among our young people.
Yes, ebola (haemorrhagic fever) is a terrifying disease. It’s fatal in an average of 75 percent of cases. It spreads very quickly and there’s no effective cure or preventive vaccine. So we strongly support all necessary resources to prevent an actual ebola epidemic here at home.
And let’s make this perfectly clear: When we compare the figures for drug and alcohol fatalities to the ebola epidemic, we certainly aren’t suggesting that we shouldn’t be concerned about the ebola threat. Fact is, we’re just as worried as you are that more cases might pop up here in the US before we finally knock it out. And that’s plenty scary indeed.
What we are saying, however, is that the ebola epidemic threat is a big reminder of a deadly epidemic already here in America, and it needs more attention and more resources to deal with it. We’re saying that our lawmakers and public health officials should step back for a minute and take a look at what we consider the Number One public health epidemic in this country – drug and alcohol addiction.
There have been 2 deaths in the US from ebola. Yet in that same two or three weeks that it took those two very unfortunate people to succumb to ebola, roughly 4,300 Americans died from drug and alcohol related incidents – overdoses, accidents, murders, suicides – the list goes on.
And sadly, tragically, most of them died needlessly, because timely and effective intervention saves lives threatened by addiction. We could have saved them if the right resources – proven workable resources like medical, counseling, legal – had been available and active at the right time.
When you add to these needless deaths the enormous financial, emotional, familial and societal costs, the need for more and better prevention and treatment resources becomes even more evident.
Here at Novus, we certainly aren’t political activists – anything but. We’re a team of highly trained medical detox specialists who help people break free from dependence on drugs and alcohol. And we do that by using the safest, most comfortable and most modern medically-supervised detox protocols available anywhere. The only ‘movement’ we’re involved in is our own dedicated campaign to help set our patients free. But we always encourage friends and patients to do whatever they can to help spread the word – detox and treatment before it’s too late.
If you or someone you care about is struggling with drug or alcohol dependence, don’t hesitate to call Novus and get all your questions answered about drug and alcohol detox. We’re always here to help.
For example, says Carl Hart, Ph.D., crack cocaine does not create addiction in someone the very first time they use it. Pure crack cocaine and powdered cocaine are chemically identical, and create identical effects on users if the amounts and delivery methods are the same.
In fact, he says, the same is true for any substance – no drug causes addiction the first time it’s used. Even if someone wants to use it immediately a second time, it doesn’t mean they are addicted, he said.
Speaking at a recent TED Talk, Hart said that 80 to 90 percent of drug users never become addicted at all – including those who try cocaine. He reminded the audience that our last three presidents – Obama, Bush and Clinton – all used drugs when they were younger. “Their drug use did not result in an inevitable downward spiral leading to debauchery and addiction,” Hart said. “And the experience of these men is the rule, not the exception.”
From a societal perspective, Hart said he has had to learn that drugs and drug addiction are not the cause of crime, violence and gang activity in our inner cities. Raised in a minority, crime-ridden neighborhood of Miami, he was personally involved in drugs and petty crime as a youth. He was constantly told, and thoroughly believed, that drugs were at the source of all the ills in “the ‘hood”.
“I came from a community where drug use was prevalent,” Hart told the TED Talk audience. “I kept a gun in my car, I engaged in petty crime, I used and sold drugs. But I also stand before you today, emphasis on ‘also’, a professor at Columbia University, who studies drug addiction. And I know what some of you are wondering – ‘How in the world did you get from there to here?’”
Hart made it through high school, and credits his joining the Air Force with sparking his interest in higher education. He received a Bachelor of Science degree and a Master of Science degree from the University of Maryland, and earned his Ph.D. in Neuroscience from the University of Wyoming. Finding a solution to addiction became his mission. He says he chose neuroscience specifically so he could solve the addiction problems in his old neighborhood.
And after more than a decade of research, he has convinced himself and his co-workers that crime, violence and gangs are based on poverty and the lack of opportunities and positive choices. Crime and violence exist independently of drug abuse and addiction, he says.
Many common ideas about addiction are based on old animal research from the 1960s and 1970s, he said, which has not stood up to the test of time. For example, in old research, rodents in cages could access a lever that would give them a shot of cocaine. They immediately began self-administering the drug, and wouldn’t stop until they died. This was the “scientific” basis for everything known about cocaine abuse.
Those rodents were never offered an alternative, he said. So Hart’s team ran experiments in which the rodents were also offered sweets and sexually active mates as well as the drugs. The results were fascinating. They no longer drugged themselves to death and chose the non-drug alternatives. They favored the sweets and the sexual partnerships more than the drugs.
Encouraged, Hart’s team began similar tests on human subjects. Hardened addicts who agreed to take part in controlled lab experiments were offered a free hit of their drug of choice or a small sum of money – $5 in the first round of experiments and $20 in a subsequent round.
The results were surprising, to say the least. More than half of the participants chose the money over the drugs. The experiments showed over and over again that even a majority of hardened coke and meth addicts, not beginners by a long shot, were more interested in an alternative that meant more to them than just getting stoned again.
Modern science and better, more creative research has taught Hart that the drug addiction problems in America will never be improved unless new ideas are brought to the table. Hart proposed three basic steps to begin reducing drug addiction and crime in a meaningful way.
The first is ensuring that employment and better education are available to all. It will require a huge shift in drug policy, but “important, attractive and meaningful ‘reinforcers’ as alternatives to drug use and abuse” are essential, Hart said.
“My research shows that attractive alternatives can decrease drug use,” he said. “Providing viable economic opportunity will go a long way in decreasing drug abuse.”
The second is decriminalization of drug possession – treating it like a traffic violation, Hart said. Hart pointed to other countries, such as Portugal and the Czech Republic, where drug addiction and crime have been significantly reduced through these methods.
“Significant portions of their society are not stigmatized, marginalized and unfairly incarcerated. If our goal in the U.S. is to have a legal system that treats everyone fairly, one that’s just…we must decriminalize drug possession” and change “selectively enforced” drug laws. For example, racial profiling is rampant in drug enforcement here in the U.S., where 80 percent of cocaine users are white, but 80 percent of people in prison for cocaine possession are black.
“Third, I believe science should be driving our drug policy and drug education – even if it makes you and me uncomfortable. First we should be truthful about it.” He pointed to the massive media coverage of the recent rise in heroin abuse and overdose deaths in the country. The actual truth is that 75 percent of so-called heroin overdose deaths involved other sedative drugs, either alcohol or benzodiazapines.
“Rather than just vilifying heroin, the message should be, ‘If you’re going to use heroin, don’t combine it with another sedative!’”
People will always use drugs, Hart says. They always have used drugs. We must learn to live with this fact. Drugs will never be entirely eradicated no matter what approach is taken, and to think otherwise is naïve. Hart said that we already take this approach with other dangerous activities, such as sex, alcohol and even driving.
“I’ve come a long way since the mean streets of Miami, and even a longer way since the starry-eyed young man who wanted to eradicate drugs as the best way to deal with the drug problem. Today I no longer want to eradicate or eliminate drugs from our society. It would be naïve to think so.”
He added that he wants to “keep safe” the countless recreational drug users, the vast majority of drug users, who don’t have an addiction problem and who need the truth about drugs and who need real justice.
Hart closed his talk by saying he is dedicated to disseminating the real science about drugs and addiction to the public and he asked the audience to join him in these efforts. “What I know now is that drugs are not the problem. The real problems are poverty, unemployment, selective drug law enforcement, ignorance and the dismissal of science surrounding these drugs.”
Hart’s book, High Price: A Neuroscientist’s Journey of Self Discovery That Challenges Everything You Know About Drugs and Society, was published by Harper in June 2013. Called a “harrowing and inspiring memoir”, it won a PEN/E. O. Wilson Literary Science Writing Award.
At Novus, we also believe that ‘the drug problem’ can best be helped by applying proven advances in science and by sensible adjustments of social policies when needed. Here at Novus, we are dedicated to helping reverse the effects of addiction by using the most modern medical detox protocols available. We know what our role is, and we encourage anyone with a drug problem of any kind to call us any time. We are always here to help.
After more than 10 years of hemming and hawing, the Drug Enforcement Administration (DEA) has finally lowered the boom on prescription painkillers containing hydrocodone. It’s about time, since hydrocodone is among the top killer drugs in America.
The new ruling, which comes into effect the first week of October, 2014, moves a long list of painkillers such as Vicodin and Lortab from schedule III to schedule II, placing them in the same category as codeine and oxycodone. DEA says the long-awaited move is a response to the epidemic of prescription opioid overdose deaths across the country.
“Almost seven million Americans abuse controlled-substance prescription medications, including opioid painkillers, resulting in more deaths from prescription drug overdoses than auto accidents,” said DEA Administrator Michele Leonhart. “Today’s action recognizes that these products are some of the most addictive and potentially dangerous prescription medications available.”
What this means is that patients can only get prescriptions for 3 months tops, after which they must see the doctor for a renewal. In many states, only a physician will be able to write such a prescription, excluding the various categories of medical assistants, technicians, nurse practitioners and so on.
Drug schedules run from I down to V. Schedules II down to V must all have accepted medical uses. Schedule II is the highest potential for harm and abuse, with Schedules III, IV and V having progressively less potential for harm and abuse. Schedule I are controlled substances with no accepted medical use and no accepted procedures for safe use.
Hydrocodone Containing Products (HCPs) usually are hydrocodone in combination with such drugs as acetaminophen, ibuprophen or aspirin. When Congress passed the Controlled Substances Act in 1970, HCPs were listed as Schedule III, but hydrocodone by itself was placed in Schedule II, the class reserved for drugs with a higher potential for abuse than SIII.
Over the past decade, prescription drug abuse overtook abuse of illicit street drugs. There’s been no shortage of evidence that the rampant increase in abuse of HCPs has led to thousands of dependencies, abuses, addictions and fatal overdoses.
To its credit, the DEA has been calling for a shift to Schedule II for HCPs for all that time. Surveys from multiple federal and nonfederal agencies, says the DEA, have clearly shown that HCPs indeed have “a high potential for abuse and abuse may lead to severe psychological or physical dependence.” The DEA pointed to federal Monitoring the Future surveys of 8th, 10th, and 12th graders, which showed twice as many high school seniors used the Schedule III HCP Vicodin non-medically as used the more tightly controlled Schedule II drug oxycodone and its popular delayed-release version, OxyContin.
Obviously, for those 10 years, other forces have been at work blocking the DEA’s attempts to tighten controls. Although they cite medical and financial concerns – tighter controls would make it more difficult for patients to get the pain relief they need and it would be more expensive – no credible study supports the argument.
Here in Florida, the damage done by prescription painkillers containing hydrocodone is no secret and no surprise. According to the state’s 2013 Medical Examiners Commission Interim Drug Report, hydrocodone is one of the top half-dozen killer drugs in the state. Deaths from hydrocodone increased 30 percent in the first 6 months of last year over the last 6 months of the year before.
But hydrocodone isn’t the state’s top killer – that’s a distinction reserved for the whole class of drugs called benzodiazapines, with alprazolam (Xanax) and diazepam (Valium) taking the top honors. Almost always, benzodiazapines are found in combination with other drugs, more often than not alcohol.
But any way you look at it, the picture in Florida is a grim reminder of the deadly grip prescription drugs have on the nation. In Florida, prescription drugs represent 78 percent of all overdoses in the state, outpacing illicit drugs like heroin and cocaine. After the benzodiazapines, the drugs that caused the most deaths were alcohol, cocaine, oxycodone, morphine, methadone and hydrocodone.
Hydrocodone is a ‘semi-synthetic’ opioid, meaning it is part natural and part man-made with chemicals from other sources. The natural part originally came from codeine, but most is made today from thebaine, another, much more toxic derivative of codeine. Codeine is a natural derivative of morphine, which in turn comes from opium, which is made from the sap extracted from the green seed pods of a flowering plant called the opium poppy.
The synthetic part simply means that some chemists started with a natural opioid and then tinkered with it in a lab to create the chemical properties of what is now called hydrocodone. And like almost all the opioid/opiates in our prescription painkillers, it originated in pre-WWII Germany in the 1920s and ‘30s.
Another interesting thing about hydrocodone is that it is not just used as a painkiller, but also as an antitussive – that is, a cough medicine, often in combination with acetaminophen or ibuprofen.
Maybe the most interesting thing about hydrocodone is that it’s prescribed predominantly in the United States and is rare everywhere else. The International Narcotics Control Board says 99 percent of the world supply is consumed here in the States.
And yet another interesting aspect of hydrocodone was the recent approval by the FDA of a new hydrocodone formulation, called Zohydro ER (for Extended Release). The FDA approved it over the objections of its own review panel, which said that if it was approved, it would likely “be abused, possibly at a rate greater than that of currently available hydrocodone combination products” such as Vicodin and all the others. At least 30 states asked the FDA not to approve it, some saying they would ban its sale in their jurisdictions. But after a federal judge overturned Massachusetts’ attempt to do so, citing that federal approval trumped state law, the states were forced to accept it.
The bottom line, of course is that the shift to Schedule II for hydrocodone containing products may mean very little in terms of dependencies, addictions and deaths. All one has to look at is the number of fatalities from oxycodone – triple or quadruple that of hydrocodone – and oxycodone containing products are and always have been in Schedule II.
Really, the only good news in all this is the fact that Novus Medical Detox Center has the answer for anyone in trouble with hydrocodone or any prescription or non-prescription opioid. Our medical opioid detox protocols offer the safest and most comfortable detox possible anywhere. Don’t hesitate to call Novus any time and get all your questions answered about opioid detox, or detox from any substance.
Medical scientists in Boston say early exposure to opioids like methadone, heroin, Subutex and opioid prescription painkillers may lead to permanent genetic changes in some infants, and that these changes could increase babies’ sensitivity to addictive substances later in their lifetimes.
It’s already well known that using opioids while pregnant causes Neonatal Abstinence Syndrome (NAS) – “cold turkey” withdrawal symptoms – in the newborn infant.
And it’s also well known that some infants have a much worse time of this horrible experience than others.
Scientists have theorized for some time that drug-related genetic changes in the mother or baby may explain why symptoms are more severe in some babies than in others. Now, researchers at Boston University School of Medicine (BUSM) and Boston Medical Center (BMC) have completed a study that appears to confirm the theory. But it also suggests an even more important theory – inherited genetic potential for addiction.
First of all, it’s known that in opioid users, changes occur to a specific gene called the mu-opioid receptor (OPRM1). Opioid receptors are the targets for opioids in the nervous system, and the OPRM1 gene is considered essential for opioid dependency in adults. The OPRM1 gene also plays an important role in dependence to other drugs of abuse, such as nicotine, cocaine and alcohol.
When opioids or alcohol hit the receptor, the receptor triggers the release of beta-endorphins, which in turn releases dopamine. This is the body’s “feel-good” reward system. The final result is more craving for the drug or alcohol, opening the door to dependence and addiction.
For the study, the researchers examined genetic data from 86 infants whose mothers had taken opioids while pregnant. As expected, some of the infants suffered far worse NAS withdrawal symptoms than the others. Their suffering not only was more intense, the babies also needed more medication than the others and their withdrawal lasted longer.
When the babies’ genetic information was compared, it was found that the infants who suffered severe NAS withdrawal symptoms had high levels of what’s called “DNA methylation” in their bodies. This told the researchers that the OPRM1 gene in those babies had been “silenced” or shut off – the typical effects of dependence. Such changes are also caused by external forces – called “epigenetic” changes – and they’re usually permanent.
What appears to be most interesting to the researchers is the distinct possibility that the change in the infant’s OPRM1 gene was inherited from the mother’s DNA at conception – she passed on the effects of her own opioid abuse to the baby, who was then born with the genetic mutation typical of an opioid, alcohol or cocaine addict.
“What makes these results so intriguing is that these epigenetic* changes could be passed on from mother to child, resulting in these children potentially having future issues and sensitivities around opioid and other addictive substances,” said Elisha Wachman, MD, a staff neonatologist at BMC and assistant professor of pediatrics at BUSM.
This is certainly food for thought for women who use and abuse addictive substances such as opioids. It’s bad enough to think you’ve caused your baby days of extreme discomfort. But it’s quite another thing to realize that your substance abuse might make your child more prone to substance abuse later in his or her life.
Here at Novus Medical Detox Center, we don’t treat pregnant women or babies. This is purely the job of expert neonatologists – specialist pediatricians who care for premature newborns or those with serious illness, including NAS.
What we try to do is to encourage women of child-bearing age to be extra careful to avoid pregnancy while they’re using or abusing any addictive substances. But even more important, we urge them to seek help to get and remain sober.
If you’re dependent or addicted to opioids and could possibly become pregnant, we ask that you make the all-important decision to get here to Novus for a medically supervised detox before you become pregnant. We are experts at providing safer, more comfortable opioid withdrawal for people who want to recover drug-free lives.
* processes by which inheritable modifications in gene function occur without a change in the sequence of the DNA
If you have teenagers in the house, or pre-teens who are on their way to adolescence, this blog is for you. And if you have teens in trouble with substance abuse, or know of any who are, keep reading, because you’re already involved.
Addiction experts and social scientists at Columbia University have reported that substance use and abuse by America’s teenagers should not be taken lightly. Rather than treating it as a harmless phase that all teens go through, it should be at the top of our list of adverse social situations.
The massive, 420-page report from the University’s National Center on Addiction and Substance Abuse (CASAColumbia), says it all by its title: Adolescent Substance Use: America’s #1 Public Health Problem. Smoking, drinking, using illegal drugs and misusing prescription drugs “is by any measure a public health problem of epidemic proportion, presenting clear and present danger to millions of America’s teenagers and severe and expensive long-range consequences for our entire population,” the scientists said. Ignoring or minimizing the problem not only adds to the soaring medical costs of substance use and addiction, it puts the future of America at risk, both socially and economically.
The report details the messages that pervade American culture that promote teen substance abuse, and then it examines the results:
- Widespread impairment of physical and mental health among millions of teenagers because of risky substance abuse
- Countless injuries, suicides, homicides and other fatalities related to substance use
- Risky driving, risky sex, and drug-related violence and crime
- The tragic losses of educational and life opportunities for tens of thousands of substance injured and addicted young people
- The terrible impact on families of the loss of sons and daughters to addiction
- The immeasurably negative loss to America’s vital work force
Adolescent substance use is also responsible for “the largest preventable and most costly public health problem in America today” says CASAColumbia. Teen substance abuse itself is costly, but research has shown that almost all adult substance abuse and addiction begins in adolescence:
- Annual costs directly stemming from teen substance use include $68 billion for underage drinking and $14.4 billion for substance-related juvenile justice programs.
- Annual costs to federal, state and local governments for all abuse and addiction are at least $468 billion a year – roughly $1,500 for every single person in America every year – and most of the problems originated in adolescence.
This comprehensive report drew from sources all across the country, including:
- National surveys of 1,000 high school students, 1,000 parents of high school students and 500 school personnel (including teachers, principals, counselors and coaches)
- Analyses of 7 national data sets
- Interviews with approximately 50 leading experts in a broad range of fields related to this report
- 5 focus groups with students, parents and school personnel
- A review of more than 2,000 publications
CASAColumbia say that educators, health professionals and parents need to become more aware of the seriousness of the situation. Everyone needs to learn how to identify at-risk teens, while the health care system needs to provide more and better treatment for kids already in trouble with substance use and abuse. The report is aimed at everyone who has a stake in our future, and is in a position to do something about it:
- Health Care Professionals
- Educators and Community Organizations
The report has a comprehensive list of recommendations for each category of involvement. If you’re in this list, you’re involved. You can download your own copy of the report here.
Here at Novus, we couldn’t agree more with the CASAColumbia recommendations. Novus isn’t an adolescent treatment center, but we do deal with dependence and addiction on a daily basis. And it’s vital to understand that so many adult patients can trace the beginnings of their substance use problems back to their teenage years.
Picture credit: CASAColumbia
Researchers from Wayne State University and Indiana University compared the effects of both types of approach, using volunteers who were both substance dependent and non-substance dependent. The results, published in the journal Psychology of Addictive Behaviors, clearly showed that substance-dependent people respond more rationally to positive persuasion to avoid risky decisions than they do to negatively framed messages.
The researchers tested both groups of volunteers using the Iowa Gambling Task, which measures the ability to resist making unusually risky decisions while playing a card game.
When the risks involved were posed to the substance-dependent participants in negative terms, their ability to make rational decisions and control risky behavior was markedly reduced. But when positive persuasion was used that emphasized the benefits of avoiding risky decisions, the dependent group made obviously more rational decisions to control risky behavior.
Meanwhile, the non-dependent volunteers made rational, less risky decisions regardless of whether the messages were framed positive or negatively.
To back it all up with physical science, MRI brain scans were taken during the experiments of the areas of the brain which are normally active when people are consciously deciding to limit irrational or impulsive behavior.
When negative persuasion was used, the scans of the dependent individuals revealed a marked reduction of activity, which matched the actual risky decisions the participants were making. But with the positive persuasion, their scans showed normal, rational activity, right while they were making sensible, more rational decisions.
Again, supporting the actual decisions taken during the ‘game,’ the non-dependent group’s brain scans showed completely normal activity whether the messages were couched in positive or negative terms.
Given the life-style that most substance-dependent and addicted people have to endure just to survive, it makes sense that they’re plenty familiar already with all the negative stuff about their addiction – heck, they’re living it every day. And they’ve developed an efficient survival system of their own to deal with all the bad decisions they know they’re making.
Like the airbag in your car, this system is always poised and ready to instantly deploy and absorb any incoming negative energy. Every time you hammer away at them about how bad and wrong they are, how risky and dangerous and harmful their decisions are, how sad and terrible they‘re making everyone else feel – POW! That mental airbag pops open and shields them from the negativity. They’ll say, do or promise anything, and appear any way they think you want them to appear. But it’s just air – it’s the airbag talking, trying to avoid more incoming negativity.
This research proves what the successful addiction treatment experts have been saying for a long time: to persuade someone who’s dependent on drugs or alcohol to stop taking risks with their life, it’s better to be up-beat and positive about the benefits of sobriety. Stressing all the bad things about dependence and addiction just drives the addict further down.
Addicted people are still people, nevertheless. They need to be treated with the same respect and care you’d give anyone – especially someone in trouble. They need to see a hand reaching out to help, not raised to hit. Like everyone else in the world, addicts respond to positive messages; it’s the negative ones they’ve learned, the hard way, not to deal with.
Here at Novus, we don’t just treat substance dependence and then send people on their way. We treat people, helping them find the positive in their lives and eliminate the negative, under their own control. And we often make lifelong friends, too. Don’t hesitate to call Novus if you or someone you love has an addiction problem. We’re always here to help.
Suboxone is one of the pharmaceutical industry’s “blockbuster” drugs that most of America has never heard of. Suboxone has been making $billions ($1.7 billion last year alone) for its maker, Reckitt Benckiser Pharmaceuticals of the U.K. Even though it makes more money than Viagra and Adderall, it’s virtually unknown to the general public.
But Suboxone is the trade name for a compound of two generic drugs, buprenorphine and naloxone. These drugs are also money makers in the drug industry. Another brand, Subutex, is just buprenorphine by itself. And if you were to ask around about buprenorphine and naloxone, you’d probably get that same blank, questioning stare from most people.
So why haven’t most Americans heard about Suboxone? Or buprenorphine or naloxone for that matter? And why should we want know about these drugs anyway?
The first question is easy. We haven’t heard about them because they’re used mostly in the specialized treatment of opioid addiction. Buprenorphine was approved by the FDA in 2002 to treat opioid addiction. Buprenorphine is an opioid, but its narcotic and euphoric effects are less than heroin or opioid painkillers. Like methadone, it is prescribed to prevent withdrawal symptoms, while the addict comes off the stronger drug and works towards recovery.
That’s why buprenorphine and naloxone and compounds of the two like Suboxone are well known to addicts. And they’re an integral part of daily life for the addiction treatment community, as well as for law enforcement. If you’re not an opioid addict, or a treatment specialist, or in law enforcement, chances are you won’t hear about them.
Why should we care about these drugs?
The second question, however, is more important: Why should we want to know about them?
That answer is of deadly importance. Suboxone and buprenorphine on its own are being widely abused. Buprenorphine has become a serious player in the illicit narcotic drug underworld. According to the DEA’s national drug testing labs, buprenorphine is in the top three or four most-reported prescription narcotics confiscated by law enforcement across the country. (This includes combination drugs like Suboxone.)
In the Northeastern United States, where oxycodone and OxyContin are miles ahead of all the others, buprenorphine is number two – even ahead of hydrocodone (the biggest killer here in Florida). In the South, buprenorphine is number three and in the Midwest and West it’s number four.
A recent article in the New York Times told the story about a 38-year-old carpenter and rock musician who credits buprenorphine (Suboxone) with his recovery from opioid addiction and an attempted suicide. But the article also detailed the overdose death of a 20-year-old who tried buprenorphine with some friends one night, fell asleep, and never woke up. The young man who provided the buprenorphine is serving a 71-month sentence in a federal prison.
Another article, this one in Louisville’s The Courier-Journal, says prescriptions for Suboxone and its generic equivalents have soared 63 percent in Kentucky in the past year. The problem is that a huge number of those prescriptions are being diverted to the streets. “Suboxone abuse is huge,” a treatment official told the paper.
It’s a similar story across the country. That’s why everyone needs to know more about these drugs. If we see a Suboxone package or buprenorphine bottle where it shouldn’t be – that is, not in a treatment setting – we’ll know to take a closer look at what’s going on with that family member or friend. Suboxone and buprenorphine are not safe drugs to play around with. Not just weekend drug dabblers, but even serious opiate addicts are suffering from Suboxone and buprenorphine abuse.
Naloxone is important because it saves lives
Naloxone, the other Suboxone component, saves lives every day. It interrupts the deadly effects of an opioid overdose, like bringing the dead back to life. It’s in all hospital ERs, it’s carried by emergency responders, and in some cities and states, it’s available to the public.
If there’s an opioid addict or abuser in your family, you must know that the risk of opioid overdose is ever-present. Having a naloxone applicator or syringe handy could save that person’s life.
But an even better idea is to get that friend or family member into recovery before any overdose occurs. Why risk a life when you don’t have to? And if you or someone you love is already in trouble with Suboxone or buprenorphine, Novus is the place to call, because we are experts in handling buprenorphine and suboxone withdrawal and detox.
Call Novus today. We’re here to help.