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The U.S. Food and Drug Administration (FDA) recently approved a digital pill embedded with a sensor designed to inform physicians whether their patients are taking their medications. The federal approval marks a growing trend towards addressing drug non-adherence among patients, according to a New York Times report.
The pill, called Abilify MyCite, is a modified version of Otsuka Pharmaceutical’s drug Abilify that is used in the treatment of schizophrenia, bipolar disorder, and depression. It is equipped with a small tracking device developed by Proteus Digital Health. The new tracking pill works by transmitting a message from the sensor to a wearable patch, which then sends data to a mobile app to enable patients to monitor drug ingestion on their smartphone.
Patients who agree to taking the tracking pill can sign consent forms that allow their health care providers and up to four other people including their family members to receive information about the date and time that the drugs are ingested. The technology is currently not approved for patients suffering from dementia-related psychosis.
“The FDA supports the development and use of new technology in prescription drugs and is committed to working with companies to understand how technology might benefit patients and prescribers,” says Mitchell Mathis of the FDA’s Center for Drug Evaluation and Research.
A 2014 report by the World Health Organization (WHO) reveals that as much as 50 percent of patients on prescription medications fail to take their drugs as instructed. In fact, psychiatric medicine practitioners note that taking medications between 70 and 80 percent of the time is already considered ‘good’ adherence. Experts add that noncompliance costs as much as $100 billion annually as patients only get sicker and spend more on additional treatments and hospitalizations.
The latest FDA approval has been met with ethical concerns, especially among the psychiatric circle. The American Psychiatric Association has stressed the importance of balance between psychiatric care and patient privacy. Likewise, an expert has cautioned that the new tracking pill may boost drug adherence but may also be doomed to backfire due in part to trust issues. Dr. Peter Kramer, a psychiatrist and the author of “Listening to Prozac,” also warns that the new technology seems coercive despite being technically ethical. (Related: Talk to the voices: Unconventional yet obvious ways to heal schizophrenia and average mental mayhem.)
“Psychotic disorders are often characterized by some degree of paranoia, often reaching delusional proportions, in which patients may believe that outside forces are trying to monitor and control them, including controlling minds or bodies or harm them in some way. The idea that we’re giving this group of patients a pill that, in fact, transmits info about them from inside their body to the people that are involved in their treatment almost seems like a confirmation of the worst paranoias of the worst patients,” says Dr. Paul Appelbaum, director of law, ethics and psychiatry at Columbia University’s psychiatry department.
What this article isn’t saying is that these tracking devices can change your DNA!!! You’ve been warned!
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One out of every three American adults take statins, and if you think that sounds like good news for statin manufacturers, you’re missing the bigger picture. All of Big Pharma benefits when people take statins. In fact, statins can really be thought of as gateway drugs. After all, they have so many side effects that you will likely end up taking several other medications after you start statins just to deal with them.
What can happen to you if you take these dangerous drugs? They suppress your body’s immune system, rendering it less able to fight off infections. They also inhibit production of coenzyme Q10, which helps to regulate your immune and nervous system and maintain a healthy heart and blood pressure. There’s also a higher risk of neurological diseases when you take statins, with many patients reporting forgetfulness, confusion and memory loss. But don’t worry – whatever happens to you, Big Pharma has a solution for that, too!
Statins also increase your risk of diabetes, so much so that the FDA has required that a warning label be placed on the package informing people of the link between statins, higher blood glucose levels and diabetes. The risk is especially heightened if you are an older woman. An Australian study found that elderly women who took high doses of statins had a 50 percent higher risk of developing diabetes. This could mean you’ll end up on diabetes medication for the rest of your life.
And for what benefit are you placing yourself at so much risk? According to research published in BMJ, taking statins over the course of two to five years adds just 3.2 days to a patient’s lifespan on average – if the side effects don’t kill them first. Yes, they’ve been approved by the FDA, but how many times has the FDA had to pull drugs after initially approving them as their dangers became too obvious to ignore?
If all this make you want to keep your distance from statins, you will be pleased to know there are some great alternatives. Dr. Jack Wolfson, a Phoenix-area holistic cardiologist, believes that a wellness model needs to be followed rather than a sickness one.
In an interview with Mike Adams, the Health Ranger, he pointed out that cardiologists sometimes fall into the easy routine of blindly prescribing statins as Big Pharma tells them to and collecting a paycheck. After all, they’ve got medical school loans to pay off.
Dr. Wolfson asks why people would want to choose statins, which can reduce the risks associated with high cholesterol slightly yet put them at risk of many other problems, when they could take safe actions that bring their risks down to zero? He said that nobody says they feel better when they take statins and blood pressure medications. In contrast, those who turn to evidence-based supplements often report feeling great, losing weight, and having more energy.
Some of the alternatives he mentioned in the interview include beetroot powder, magnesium, and Omega 3. He says that we can make such a big difference in our health through food., and he also points out how powerful the sun can be in keeping us healthy. He also suggests that people get more physical activity, such as walking or gardening.
When your health is less than optimum, Dr. Wolfson says, your body is deficient in nutrients, not pharmaceuticals. Drugs might be good for emergencies, but when it comes to prevention, you can’t beat a healthy, well-rounded and nutritious diet, physical activity, and good old-fashioned sunshine. What do you have to lose by trying it?
Watch the full, shocking interview with Dr. Wolfson below.
When it comes to acknowledging the opioid epidemic, the U.S. has been faced with some harsh realities over the past several months. Perhaps most notable is a recent report from the Centers for Disease Control and Prevention that indicates the leading cause of death for Americans under 50 is now accidental death by drug overdose. The 2016 count of lives lost exceeds 64,000, a 19 percent increase from the previous year’s 52,000. These figures are heartbreaking.
Perhaps a more important statistic is that overdose deaths among adolescents (those ages 12 to 17) are up as well, with a strikingly similar 19 percent increase in the past year. This information is significant, and not just because it’s alarming. It also begs a different approach in how to address the problem.
Several governmental actions have been taken to curb the effects of this devastating crisis. Many states have adopted Good Samaritan laws, which encourage bystanders to call law enforcement for help if there’s concern for a potential overdose, without fear of prosecution for being involved in illicit activities themselves. There are also federal regulations with heavy sanctions on misguided prescribers who may be buffering their revenues by pumping out scripts for prescription opioids. Plus, there’s the overdose-reversing drug Narcan and subsequent funding for free community trainings, with ease of access through your physician or local pharmacy.
But where is the haste toward prevention?
In my 13 years working in the mental health and addictions counseling field, I can list over a dozen adolescent treatment programs (that I was personally acquainted with) that have closed simply due to lack of census. Services were being offered, but few were using them. Some of these programs, responding to an increase of young adults (18- to 26- year-olds) in need of treatment, converted their juvenile programs to fit the business’s needs.
Alongside the trend for more young adults seeking treatment, service providers continued to see further declines in adolescents accessing services. In essence, what we’re seeing is a decrease of identification in teens, and an increase as they transition into adulthood. There’s something horribly wrong with this picture. As a culture, we’re being reactive to a crisis as opposed to placing efforts to be proactive. This, unfortunately, is a making of the tragedy we see on the news each and every day.
Yes, prevention does exist; however, it’s fragmented at best. Most common prevention efforts take place in the school setting. One of the most frequently used school-based prevention programs has been empirically suggested to be ineffective, and yet the program gets renewed year after year in some states. Some states’ education departments require that school boards employ a specialist to handle substance use and other crises in their students; however, these professionals often occupy several roles within the district, and their time is often stretched too thin. Programming targeting parents to provide information on current trends and concerns regarding substance use are lightly attended. I’ve facilitated many of these workshops myself; in a student population of 1,200, if you can get 20 parents to attend, you’re in luck.
One thing is blatantly clear: When we’re not appropriately addressing substance use and addiction in adolescence, we are inundated with young adults literally fighting for their lives shortly thereafter.
I’m not saying that the approach we’re taking to the opioid crisis is wrong. Rather, it’s incomplete. We need to start the conversation about drug use and addiction at an early age. And no, “just say no” isn’t an acceptable means of prevention. “Just say no” is something that we feel more comfortable doing. We can just check it off the list, say that we “had the conversation,” and be done with it. In order to create change, we have to be OK with getting uncomfortable. This is how we’re going to save these kids lives.
Talk to your families about substance use. If you have a family history of addiction, there’s all the more reason to do this – your children may have a predisposition. Go to prevention programs offered in your community. Most, if not all, are free. Bring your kids with you. Talk about the program on the drive home. Have family dinners once in a while. Bring up any pop-culture or media references to overdose deaths, and listen to their reactions. Reach out and call the school your child attends to find out how they address prevention. Acquaint yourself with the personnel who coordinate it. Introduce your child, too. Research other agencies in your community, and participate or volunteer in their events from time to time.
There are limitless ways that we can make small impacts in our families and our communities. Stigma usually hold us back. Stigma also adds to this crisis. However, if we’re more active in our prevention efforts, not only will we see a reduction in adolescent overdoses, but over time we will not have an opioid epidemic on our hands.
When you’re sick or have suffered from a serious injury, the first few days after a visit to the doctor you rely heavily on the prescribed drug to ease the pain and get you through the day. However, you may reach a point where you feel compelled to continue taking the prescription long after you need it. If you think you or a loved one might have a problem with prescription drugs, there are some red flags you should watch out for.
The Cheat Sheet spoke with some of the country’s top addiction experts to learn more about prescription drug abuse.
One of the first signs of a prescription drug addiction is an abrupt change in behavior. If you suspect the abuse of prescription medication, take note of unusual behavior you hadn’t observed before.
Psychologist Matthew Polacheck, director of outpatient services at the Betty Ford Center in West Los Angeles, said behavioral changes may also be accompanied by cognitive and physical changes. “The first thing we look for is a change in behavior of any kind. [Someone] who never naps comes home and goes to sleep. [Someone] who is passive suddenly becomes more euphoric. More specific behavior includes nodding off, drowsiness, slurred speech, confused thinking, and pupils can also be constricted.”
If you or someone you know can’t seem to go a day without a prescription drug that was meant for short-term use, this is another red flag. Over time, short-term medication should be slowly tapered down until there is no longer a need for it.
Audrey Hope, an addictions specialist at Seasons in Malibu World Class Addiction Treatment, said if there is difficulty in stopping a drug, this should be a cause for concern. “The main sign that you are a prescription drug addict is that you use the drugs every day. You can’t function without them. You rely on them. You need them. You lie to yourself that it is for the ‘pain’ and because ‘the doctor prescribed it.’ You say it is OK to use them,” said Hope.
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“I truly believe no treatment will work on a person with an addiction if the patient hasn’t fully given themselves over to the fact that they have a disease that does not heal itself.”
Margaret F.’s words capture a core belief of the traditional type of treatment program she attended, one common in 12-step-based facilities. Leading professional organizations – including the American Medical Association, American Psychiatric Association, World Health Organization, and American Society of Addiction Medicine (ASAM) – subscribe to the notion that alcohol and other drug addictions are diseases.
However, a growing number of experts are challenging this view. One of them is neuroscientist Marc Lewis, Ph.D., who eloquently elucidates his reasoning in a new book, The Biology of Desire: Why Addiction is Not a Disease. Real-life stories of five different people who have struggled with addiction flesh out the framework he’s constructed from the latest neuropsychological findings.
From his home in the Netherlands, this Canadian expat and Pro Talk columnist gave me several hours of his time to answer the following questions:
A: It’s not that all these brain changes aren’t involved in addiction – they are, but they’re also involved in becoming a basketball fan, falling in love, in becoming a jihadist, in developing any new passion. So why would we call addiction a disease that requires medical treatment?
Saying addiction is a disease suggests that the brain can no longer change…that it’s an end state. But no, it’s not end state. -MARC LEWIS
We know that treatment isn’t required by most to overcome addiction, so in that sense it’s not a disease. And the changes in the brain that occur because of addiction are not irreversible. We’ve been talking about neuroplasticity for decades. That is, the brain keeps on changing – due to changes in experience, self-motivated changes in behavior, as a result of practice, being in a different environment.
Saying addiction is a disease suggests that the brain can no longer change…that it’s an end state. But no, it’s not end state.
A: First, I’m not saying that addiction is not a serious problem – clearly it can be for many people. In terms of brain change, you could say that neuroplasticity has a dark side. But rather than a disease, I would say that addiction is a habit that grows and perpetuates itself relatively quickly when we repeatedly pursue the same highly attractive goal. This results in new pathways being built in the brain, which is always the case with learning: new pathways are formed and older pathways are pruned or eradicated.
…rather than a disease, I would say that addiction is a habit that grows and perpetuates itself relatively quickly when we repeatedly pursue the same highly attractive goal.-MARC LEWIS
But with addiction, much of this rewiring is accelerated by the action of dopamine, a neurotransmitter released in response to highly compelling goals, creating an ever-tightening feedback loop of wanting, getting, and loss.
As the addiction grows, billions of new connections form in the brain. This network of connections supports a pattern of thinking and feeling, a strengthening belief, that taking this drug, ‘this thing,’ is going to make you feel better – despite plenty of evidence to the contrary.
It’s motivated repetition that gives rise to what I call “deep learning.” Addictive patterns grow more quickly and become more deeply entrenched than other, less rewarding habits. In general, brain changes naturally settle into brain habits – this is the case in all forms of learning. In addition, the habits are learned more deeply, locked in more tightly, and are bolstered by the weakening of other, incompatible habits, like playing with your pet or caring for your kids. [In the book, Lewis describes in detail how addiction changes the brain.]
A: Such brain change may signify that by pursuing a single high-impact reward and letting other rewards fade, someone hasn’t been using his or her brain to its best advantage.
The notion that you never forget how to ride a bike reflects our recognition that normal habits can be deeply ingrained. Thus, deep ruts in the brain don’t make the brain damaged. And new ruts can be formed on top of or beside old ruts. For example, when you lose a relationship, the deep ruts are still there – they can cause pain and create barriers to a new relationship. But then you say, “Enough of that.” And with some effort, you meet a new person and the brain modifies itself, which it constantly does.
The notion that you never forget how to ride a bike reflects our recognition that normal habits can be deeply ingrained. Thus, deep ruts in the brain don’t make the brain damaged.-MARC LEWIS
Psychiatrist Norman Doidge, author of The Brain that Changes Itself reminds us of a classic remark by Alvaro Pascual-Leone, a renowned Harvard neuropsychologist: The brain is plastic, not elastic. It doesn’t just spring back to its former shape. Rather, like Play-Doh [before it hardens], it can continue to be modified from whatever shape it’s currently in.
A: Basically, most of our attention is committed to achieving the goal, not to the goal in and of itself – it’s all about the drive to get to the pot of gold at the end, not the pot itself.
Basically, most of our attention is committed to achieving the goal, not to the goal in and of itself – it’s all about the drive to get to the pot of gold at the end, not the pot itself.-MARC LEWIS
According to recent advances in addiction neuroscience, there is a “wanting” system (desire) that’s mostly independent of the “liking” system. “Wanting” is really what drives addictive behavior. In the book, I talk about eating pasta – before you eat it, your attention is converged on getting that food into your mouth. But once it’s there, your attention goes elsewhere; perhaps back to the people you’re dining with or the TV show you’re watching. How much attention you pay to the taste of that bite of food is a drop in the bucket compared with the amount you spent to get it to your mouth.
Desire and expectancy make up most of the experience. The “wanting” part of the brain, called the striatum, underlies different variations of desire (impulsivity, drive, compulsivity, craving) – and the striatum is very large, while pleasure itself (the endpoint) occupies a relatively small part of the brain. Addiction relies on the “wanting” system, so it’s got a lot of brain matter at its disposal.
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President Trump’s Commission on Combating Drug Addiction and the Opioid Crisis released its final report on Wednesday, calling for expanding drug courts into all 94 federal court jurisdictions. The commission also recommended easier access to alternatives to opioids to treat pain, The Washington Post reports.
Drug courts are specialized court programs that target criminal defendants and offenders, juvenile offenders, and parents with pending child welfare cases who have alcohol and other drug dependency problems.
The commission made more than 50 recommendations, including requiring doctors and others who prescribe opioids to demonstrate they have received training in safely providing the drugs before they can renew their licenses to handle controlled substances with the Drug Enforcement Administration.
Providers should be required to check prescription drug monitoring databases to ensure patients aren’t “doctor shopping” for prescription drugs, the commission said. In some states, use of the databases is voluntary, the article notes.
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I almost never thought I’d see the day when a Big Pharma founder and owner was finally arrested for running a criminal drug cartel, but that day has arrived.
“Federal authorities arrested the billionaire founder and owner of Insys Therapeutics Thursday on charges of bribing doctors and pain clinics into prescribing the company’s fentanyl product to their patients,” reports the Daily Caller News Foundation, one of the best sources of real journalism in America today.
Addictive drugs that include opioids, we now know, are claiming over 64,000 lives a year in the United States alone.
From the DCNF:
The Department of Justice (DOJ) charged John Kapoor, 74, and seven other current and former executives at the pharmaceutical company with racketeering for a leading a national conspiracy through bribery and fraud to coerce the illegal distribution of the company’s fentanyl spray, which is intended for use as a pain killer by cancer patients. The company’s stock prices fell more than 20 percent following the arrests, according to the New York Post.
Kapoor stepped down as the company’s CEO in January amid ongoing federal probes into their Subsys product, a pain-relieving spray that contains fentanyl, a highly-addictive synthetic opioid. Fentanyl is more than 50 times stronger than morphine, and ingesting just two milligrams is enough to cause an adult to fatally overdose.
The series of arrests came just hours after President Donald Trump officially declared the country’s opioid epidemic a national emergency. Drug overdoses led to 64,070 deaths in 2016, which is more than the amount of American lives lost in the entire Vietnam War.
As the opioid crisis has developed, more and more states have begun holding doctors and opioid manufacturers accountable for over-prescribing and over-producing the highly-addictive painkillers.
“We will be bringing some major lawsuits against people and companies that are hurting our people,” Trump said Thursday. He also spoke about a program similar to Nancy Reagan’s “Just Say No” initiative.
“More than 20,000 Americans died of synthetic opioid overdoses last year, and millions are addicted to opioids. And yet some medical professionals would rather take advantage of the addicts than try to help them,” Attorney General Jeff Sessions said in a statement. “This Justice Department will not tolerate this. We will hold accountable anyone – from street dealers to corporate executives — who illegally contributes to this nationwide epidemic. And under the leadership of President Trump, we are fully committed to defeating this threat to the American people.
Under President Trump, who continues to fight to end the drug cartels and health care monopolies that are destroying this nation, we may see more and more drug companies finally facing the legal scrutiny they deserve for engaging in the mass medical murder of Americans with dangerous, deadly drugs.
And then there’s the question of vaccines, the autism cover-up and the criminal racket run by the CDC, Big Pharma and the lying mainstream media. When that medical fraud and corruption scandal blows sky-high, we may see dozens of pharmaceutical officials going to prison.
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