Tomorrow morning, June 27, the FDA Commissioner Scott Gottlieb, M.D. will host a one-day Online Opioid Summit. The guest list to the summit includes:
- Internet stakeholders
- Government entities
- Academic researchers
- Advocacy groups
The aim of the event is to discuss ways to collaboratively take stronger action in combatting the opioid crisis by reducing the availability of illicit opioids online. And when it comes to the internet, there are no bigger names in America than Google, Twitter, Instagram and Facebook. There will be presentations by the Food and Drug Administration and other organizations. A webcast will be available of the Opioid Summit for the general public.
So what will the FDA, Google and the biggest names in social media have to talk about?
Online Opioid Markets
Over the past decade, opioid-related deaths have continued to climb. According to data from the Centers for Disease Control and Prevention and FDA:
- In 2005 there were around 12,900 opioid-related deaths
- In 2016 there were well over 42,000
More recent figures show that on average, 115 Americans die every day from opioid abuse. There are a few elements that have contributed to this devastating trend, including the over-prescription of painkillers like Oxycontin and an influx of heroin into the country.
So what does the place you get your sponge-bob square-pants memes have to do with opioid abuse in America?
When we’ve taken a closer look at the opioid crisis, we have discovered that illicit sales of either prescription medications, illegal narcotics or synthetics like fentanyl from overseas have found a home in online marketplaces. According to a study by Carnegie Mellon University, revenues from illicit drug sales online have grown substantially over the last several years.
- 2012- online illicit drug sales were between $15 and $17 million
- 2015- those illicit drug sales online shut up to between $150 and $180 million
The National Association of Boards of Pharmacy conducted research by searching online for prescription opioids across the three major search engines. They found that nearly 91% of the first search results led users to an illegal online drug distributor offering prescription opioids.
Needless to say, those numbers show there are still dark corners of the internet dealers exploit for drug trafficking. In fact, when Facebook CEO Mark Zuckerberg testified before Congress in April, one of the big questions he was repeatedly confronted with was how Facebook intended to fight illegal drug sales on their site. This Opioid Summit is about a collaborative effort to do better about restricting online drug sales.
While dark websites like the notorious Silk Road have been a major component to digital drug dealing, social media sites, and search engines have found their formats being abuse for these activities as well. Between illegal online pharmacies, drug dealers and other criminals the use of the internet to distribute opioids with minimized risk has steadily increased.
The Opioid Summit will address the state of the opioid crisis and invite Internet stakeholders to present how their companies are working to fight the sale of opioids on their sites and protect their users. A statement by the FDA adds:
“One critical step to address this public health emergency is the adoption of a far more proactive approach by internet stakeholders to crack down on internet traffic in illicit drugs.”
Facebook has already announced new efforts to prevent the sales of opioids through their site. The approach by Zuckerberg and his team is actually unique. Facebook users who try to buy opioids or search for addiction treatment will be redirected toward information about finding free and confidential treatment referrals. Users will also be directed to the Substance Abuse and Mental Health Services Administration National Helpline.
On the Opioid Summit agenda, there are a few important discussions, including:
This will include a brief opioid crisis overview from Donald Ashley, J.D., Director, Office of Compliance, FDA. There will also be a presentation on the DEA Internet Investigation. And different experts will present research regarding the ease of purchasing opioids online.
This discussion will include a number of presentations, including one from the Center for Safe Internet Pharmacies. Even the Vice President of MasterCard, Paul Paolucci, will be part of the roundtable.
It is important to note that only the FDA speaker presentations will be webcast to the public.
The takeaway here is that hopefully as the illicit drug market evolves, using search engines and social media to try and carve out a space for trafficking, the biggest names in internet will also be working to actively prevent these illegal industries from flourishing on their sites. Hopefully, the summit will introduce new measures to make it harder for dealers to take advantage of social networking tools. Social media is for bringing people together. Sadly, some still use it to sell the drugs that tear communities and families apart. Next, there should be more discussion about comprehensive addiction treatment.
It is important that those with the ability to reduce drug trafficking take action where they can. An even more crucial aspect of putting an end to the ongoing opioid crisis is safe and effective treatment resources. For over 20 years, Palm Partners Recovery Center has been actively helping people struggling with addiction to transform their lives and heal. If you or someone you love is struggling with substance abuse or addiction, please call toll-free now. We want to help.
CALL NOW 1-800-951-6135
Author: Justin Mckibben
People take supplements for all types of reasons. Some take them for weight loss, and others take them for energy and building muscle, and some might just be taking vitamins and food supplements to stay healthy and balanced.
However, a new study has found that these same supplements may not be nearly as healthy as you hoped, with the secret ingredient being a synthetic speed that’s never been tested on humans! 11 different supplements were discovered to contain this mystery mix, with the worst of it all being that the FDA has known about it for years.
Mixing Up the Medicine
Drugs manufactured by the pharmaceutical industry are hardly perfect. Some have nasty side effects, don’t always work for every patient, and can be misused or overprescribed. Given the dangers, most doctors have full knowledge of what proper ingredients are in a medication, but that is not always the case when people choose to take herbal supplements.
Authors from a study published in the journal Drug Testing and Analysis had collected samples of 21 products that claim to be manufactured from Acacia rigidula, most marketed as a weight-loss supplement. Out of those 21 over half of the products exposed the presence of a synthetic amphetamine.
This wouldn’t be so bad, except this chemical is ONLY made in a lab but is being marketed as a “natural” supplement. And even worse, it has never even been tested for the safety of its effects on humans. The ingredient in question just so happens to be ß-methylphenylethylamine (BMPEA). In 2013 the Food and Drug Administration (FDA) conducted its own study of these supplements that had found the exact same ingredient.
Reporting the Problem
There was hope that after the agency’s findings it would cause the removal of BMPEA from Acacia rigidula products, since they were sold as a natural supplement formula and that ingredient did not match the description. But in the new report researchers found a higher percentage of artificially enhanced powders and pills than discovered two years ago!
It was later reported that 10 of the supplements found to contain BMPEA were all manufactured by the same Georgia company, Hi-Tech Pharmaceuticals. Despite the president of the company’s claim that the amphetamine is a naturally occurring alkaloid produced by the plant itself, this newest study notes that BMPEA has never been found in extracts derived directly from the plant, so the president of Hi-Tech Pharmaceuticals statement was quickly disproven.
So why is it that this company is so adamant about using an unnatural amphetamine in its “natural” supplements?
The FDA’s Failure
One of the biggest problems with this whole thing is that manufacturers of dietary supplements don’t need FDA approval before advertising their merchandise. The FDA claims to enforce regulation by prohibiting “false or misleading statements” and demanding that products be safe for consumption, but these standards are very loosely enforced.
Law enforcement personnel, however, are beginning to pursue action against manufacturers that sell products that do not contain the ingredients listed on the bottle. Over a dozen state attorney generals in the nation are demanding Congress investigate the FDA’s role in policing the supplement industry and expand its regulatory authority.
Considering the dangers associated with drugs containing amphetamine and their abuse, the fact that supplements that are sold as a healthy resource actually consist of this kind of chemical is disturbing. Prescription drugs are put through a lengthy and in-depth process for approval to be used on the masses, rigorously examined for health benefits and adverse side-effects. So why would we not expect the same kind of care and consideration to be put into regulating supplements?
Why is the FDA willing to allow Big Pharma to distribute an amphetamine with essentially minimum data (if any at all) that suggests it is an acceptable and safe product?
Is there a possibility for supplement abuse to become something like prescription pill abuse? This raises too many questions, and there is no alternative to the truth.
Amphetamine is a key component in a handful of dangerous and deadly drug addictions, and whether it is in a prescription medication, an illicit street drug, or a supplement this is a scary secret ingredient that can create risky habits. If you or someone you love is struggling with substance abuse or addiction, please call toll-free 1-800-951-6135
Author: Justin Mckibben
When it comes to medications and prescriptions knowing the extent of the effects a drug can have on someone is paramount. Being aware of negative results is not just useful; it is essential to good science as well as personal health, and it is said that randomized clinical trials are considered the best way to test a drug.
When you get two groups of patients with the same problem, give one group an experimental treatment and see if it works better than no treatment you can find out all the ways it can affect someone’s health. When you accumulate the results of multiples of similar clinical trials, level the differences and draw even more precise conclusions from a larger amount of data, it’s called a systematic review.
The big problem is a systematic review only works if the reviewers have all the information. Good, bad and inconclusive results should always been included so that companies and governments can decide whether drugs should be legal, and so that an individual can decide for themselves if the risk is worth it. Unfortunately, there has been plenty of history that shows that pharmaceutical companies have had a habit of keeping some of these symptoms a secret.
The revelation of hidden data reinforced a growing movement against “publication bias,” which is when scientists stash away mostly negative or inconclusive findings and broadcast only their positive results in order to fulfill their agenda. Concealing trial data has basically become routine in the pharmaceutical industry. PLOS Medicine reported last year that as many as half of all clinical trials are never published.
Publication bias in clinical trials was something only scientists cared about for the longest time. But lately the issue has raised a crop of lobbyists and gone mainstream. In 2005, John P.A. Ioannidis, a researcher at the Stanford School of Medicine, published a paper under the heading “Why Most Published Research Findings Are False” and mentioned publication bias. Meanwhile British doctor Ben Goldacre leads a movement called AllTrials, and his appearance on TED talks on publication bias has been seen 1.8 million times, so the word is slowly but surely making its way to the public as to the lies this industry has hidden behind.
The Tamiflu Fumble
Cochrane Collaboration, a London-based nonprofit has released evidence earlier this year that shows a significant amount of negative data from the drug Tamiflu. Clinical trials were conducted, but many reports were hidden from the public. The Food and Drug Administration (FDA) knew about it, but the medical community did not. Tamiflu has been implicated in several suicide deaths, and some circumstances of these incidents seemed too surreal to be coincidence.
Because of the withheld information the U.S. Centers for Disease Control and Prevention (CDC), which doesn’t have the same access to unpublished data as regulators, had recommended the drug without being able to see the full picture. When results from those unpublished trials finally emerged, they cast serious doubt over whether Tamiflu is as effective as the manufacturer says.
It is true that millions of people have taken Tamiflu without incident, and you are far more likely to die from the flu than you are to have a dangerous reaction to the drug. But if Tamiflu does nothing, and there’s even a slight chance of life-threatening side effects, why was it approved? And why do we continue to use it when there have been some reported cases of negative responses to the drug?
Accidents Can be Avoided
Sometimes the results of not sharing information are a lot easier to notice, and more obviously avoidable. Back in 2001 a 24-year-old technician at Johns Hopkins University named Ellen Roche volunteered for a study to find out how healthy people’s bodies avoid asthma attacks. She would receive a dose of the drug hexamethonium to induce a mild attack, and the idea behind the study was that her healthy body would overcome that attack, and then doctors would observe how her body accomplished this.
But despite the previous expectations, Roche would cough, her lung tissue broke down, and her kidneys failed. She was dead within a month. There was already data from 1978 in a study that had discovered this kind of reaction to hexamethonium, but because the paper that was published didn’t mention it, the information was not available to the doctors and researchers, and this death could have easily been avoided with the right information being published and accessible on a public level.
Putting More to the Public
Cochrane Collaboration has a respected reputation as one of the most rigorous reviewers of health science data. It takes results of multiple trials, looks for faults and draws conclusions. Very admirable is the fact that Cochrane does not even accept funding from businesses with a stake in its findings, thus actively working to avoid the conflict of interest.
National health agencies along with other organizations are working on solutions to the issue with publication bias. There are now innovations such as the online registries where researchers announce that they’re starting a trial and then post the results when they’re done. But so far neither resource has been utilized frequently enough to notice a definitive change.
So now, the World Health Organization (WHO) is preparing an official statement saying that “there is an ethical imperative” to use these registries. WHO’s “imperative” may or may not carry more force than the current laws that are in place, but without more serious personal consequences for violations, many suspect it’s not likely that too many of the big pharmaceutical companies will change.
With prescription medications causing more death than ever, and issues with substance abuse and addiction related to pharmaceuticals, there should be more of an outcry than ever to hold these massive medicine manufacturers to higher standards in testing. Publishing any and all data should be required and strictly enforced so that the government can be aware of the reality of the substances they allow to be available to the public, and so the people can know exactly what they are getting into. No one should die because a company sweeps things under the rug to get past the red tape.
Pharmaceutical companies must be held accountable for their products and the way they conduct business, especially with that business being one that endangers the lives of the customers. Too many people suffer because they did not know that something that was meant to heal them could hurt them so much. If you or someone you love is struggling with substance abuse or addiction, please call toll-free 1-800-951-6135