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?”
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.