Vaccines to Treat Opioid Abuse and Prevent Overdoses in Development

It should be beneficial once it’s developed. For today, it’s not widely known, but needles aren’t the only way to deliver Narcan (what’s used to respond to opioid overdoses) — there’s actually a nasal spray that exists now too.

Heroin and prescription opioid abuse and fatal overdoses are a public health emergency in the United States. Vaccines offer a potential new strategy to treat opioid abuse and prevent fatal opioid overdoses.
A team of scientists from the University of Minnesota Medical School and Minneapolis Medical Research Foundation at Hennepin Healthcare is developing vaccines against heroin and prescription opioids, such as oxycodone and fentanyl. These vaccines function by using the immune system to produce molecules (antibodies) that target, bind, and prevent opioids from reaching the brain (the site of drug action).
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Pre-clinical studies show that both heroin and oxycodone vaccines are effective in blocking heroin and oxycodone distribution to the brain when subjects are challenged with clinically-relevant opioid doses. Vaccination prevents addiction-relevant behaviors, including opioid self-administration that models human abuse patterns. These vaccines appear to be safe and may help in preventing opioid-induced respiratory depression, a hallmark of an opioid fatal overdose.

Importantly, vaccination does not prevent use of currently approved addiction treatment medications such as methadone, naltrexone, buprenorphine, and naloxone.

The research team is also working on biologics against other opioid targets, such as fentanyl, and developing more effective next-generation vaccine formulations.

“Opioid vaccines show promising pre-clinical efficacy, but the road from the laboratory to the clinic is still long,” said Principal Investigator Marco Pravetoni, Ph.D., Minneapolis Medical Research Foundation senior investigator and associate professor of medicine at the University of Minnesota Medical School.

Study: Legal Medical Cannabis Lowers Opioid Use

The pharmaceutical industry is generally among the biggest opponents of legalized marijuana for a reason. Interestingly enough, legal marijuana now polls at 55 to 60 percent majority support in the United States. If the country was a democracy instead of mainly a plutocracy, issues with majority support such as that one would be acted on much differently than is done today.

States that have approved medical cannabis laws saw a dramatic reduction in opioid use, according to a new study by researchers at the University of Georgia.

In a paper published today in the Journal of the American Medical Association, Internal Medicine, researchers examined the number of all opioid prescriptions filled between 2010 and 2015 under Medicare Part D, the prescription drug benefit plan available to Medicare enrollees.

In states with medical cannabis dispensaries, the researchers observed a 14.4 percent reduction in use of prescription opioids and nearly a 7 percent reduction in opiate prescriptions filled in states with home-cultivation-only medical cannabis laws.

“Some of the states we analyzed had medical cannabis laws throughout the five-year study period, some never had medical cannabis, and some enacted medical cannabis laws during those five years,” said W. David Bradford, study co-author and Busbee Chair in Public Policy in the UGA School of Public and International Affairs. “So, what we were able to do is ask what happens to physician behavior in terms of their opiate prescribing if and when medical cannabis becomes available.”

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The researches concede that if medical cannabis is to become an effective treatment, there is still much work to be done. Scientists are only just beginning to understand the effects of the compounds contained in cannabis, and an effective “dose” of cannabis would need to be defined clearly so that each patient receives a consistent dose.

“Regardless, our findings suggest quite clearly that medical cannabis could be one useful tool in the policy arsenal that can be used to diminish the harm of prescription opioids, and that’s worthy of serious consideration,” David Bradford said.

It should also be noted that marijuana can come with its own harms, particularly if smoked. Competent studies have consistently found for the last few years that marijuana smoke is about as harmful and perhaps even more harmful than tobacco smoke. In light of this, non-combustible alternatives such as the marijuana edibles should be recommended much more for those needing pain relief.

Giving Big Pharma Public Hearings, Inspired by the Big Tobacco Hearings

The U.S. Congress – in its decay over the last four decades after being further corrupted by big business interests – rarely has held public hearings in the last several years. It should hold many more public hearings, however, and it should do so on the most important issues facing society today.

Senator Sanders though provides yet another example of why he’s justifiably the most popular U.S. politician, as he continues to focus on the real problems (healthcare, wages, the opioid crisis, etc.) instead of on the regressively McCarthyist and largely nonsensical Russia drama that drains too much news focus. The proposal he has about making the pharmaceutical corporations pay to reimburse the communities they ruined is also clear-sighted and sensible.

Sen. Bernie Sanders (I-Vt.) called Monday for the Senate to hold pharmaceutical companies accountable for any role they’ve played in fueling the opioid epidemic that has spread despair in his state and across the U.S.

In a letter to Sen. Lamar Alexander (R-Tenn.), the chairman of the committee on health, education, labor and pensions, Sanders encouraged him to hold hearings on the matter just as the Senate had once compelled Big Tobacco executives to testify about the deadly hazards of smoking.

“That committee had the courage to demand that the leading executives of the tobacco industry tell the American people what they knew and when they knew that tobacco was addictive … and had killed millions of people,” Sanders wrote. “Though all denied under oath believing tobacco was addictive, we now know they were lying. But the hearing eventually led to real change,” with the Food and Drug Administration regulating tobacco and the rate of smoking in the U.S. at a record low.

Sanders pointed out that the hearing helped states reach massive settlements with the tobacco industry. Several local jurisdictions have already filed lawsuits against painkiller manufacturers. Some have already received settlements. The opioid crisis, Sanders, wrote, “did not happen in a vacuum.” He praised investigative journalists for exposing Big Pharma’s lies about opioid painkillers not being addictive and how small-town pharmacies were flooded with opioids.

“Yet, while some of these companies have made billions each year in profits, not one of them has been held fully accountable for its role in this crisis,” Sanders wrote. “Individual states have received small settlements from companies after taking legal action, but not nearly enough to pay for the costs associated with the opioid epidemic. The states cannot do it alone.”

Sanders sees an economic cost as well as a human cost to the epidemic. And he wants the industry to be liable for the economic costs. Sanders noted in his letter that he plans to introduce legislation that would in part require companies to reimburse communities for the devastating economic consequences that their painkillers have caused.

Opioid Crisis Killing More People Than Breast Cancer

The opioid crisis is largely a result of greedy, profit-driven pharmaceutical corporations such as Purdue Pharma mass producing highly addictive opioids and then flooding economically weak (and thus despairing) communities with them. The problem must be attacked at the root — significantly alter the function of the pharmaceutical industry and fix much of the economic weakness that it thrives on. If neither of those solutions are applied, the problem will keep becoming worse, with all the innocent lives lost that go with it.

More than 63,600 lives were lost to drug overdose in 2016, the most lethal year yet of the drug overdose epidemic, according to a new report from the National Center for Health Statistics, part of the US Centers for Disease Control and Prevention.

Most of those deaths involved opioids, a family of painkillers including illicit heroin and fentanyl as well as legally prescribed medications such as oxycodone and hydrocodone. In 2016 alone, 42,249 US drug fatalities — 66% of the total — involved opioids, the report says. That’s over a thousand more than the 41,070 Americans who die from breast cancer every year.

Much of the increase was driven by the rise in illicit synthetic opioids like fentanyl and tramadol. The rate of deadly overdoses from synthetic opioids other than methadone has skyrocketed an average of 88% each year since 2013; it more than doubled in 2016 to 19,413, from 9,580 in 2015.

Heroin also continues to be a problem, the report says. Since 2014, the rate of heroin overdose deaths has jumped an average of 19% each year.

The opioid crisis has raised significant awareness of prescription painkillers. Between 1999 and 2009, the rate of overdoses from such drugs rose 13% annually, but the increase has since slowed to 3% per year.

In 2009, prescription narcotics were involved in 26% of all fatal drug overdoses, while heroin was involved in 9% and synthetics were involved in just 8%. By comparison, in 2016, prescription drugs were involved in 23% of all deadly overdoses. But heroin is now implicated in about a quarter of all drug fatalities, and synthetic opioids play a role in nearly a third.

These increases have contributed to a shortening of the US life expectancy for a second year in a row.

The states with the highest rates of overdose in 2016 were West Virginia, Ohio and New Hampshire, the report said. The rate of overdose in West Virginia was over 2.5 times the national average of 19.8 overdose deaths for every 100,000 people.

While the outlook nationwide is fairly bleak, it’s particularly bad in some states. Twenty-two states and the District of Columbia had overdose rates significantly higher than the national average.

While overdose rates increased in all age groups, rises were most significant in those between the ages of 25 and 54.

Provisional data for 2017 from the CDC show no signs of the epidemic abating, with an estimate of more than 66,000 overdose deaths for the year. “Based on what we’re seeing, it doesn’t look like it’s getting any better,” said Bob Anderson, chief of the mortality statistics branch at the National Center for Health Statistics.

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According to the 2016 Surgeon General’s Report on Alcohol, Drugs, and Health, 30% of Americans do not seek any sort of addiction treatment because they do not have insurance and cannot afford treatment.

The opioid epidemic is of course worst in West Virginia because of how economically ravaged the state has been by decades of neoliberalism, the increase in deaths being worst among those 25 to 54 notably follows the ages that are regularly considered to be those of prime age workers, and the lack of a national single-payer healthcare system shows itself as a flaw yet again.

Feature on the Opioid Crisis

The Empire Files program did a feature on the opioid crisis that focuses on the behavior of criminogenic pharmaceutical corporations. It is particularly notable for noting that big pharmaceutical corporations have targeted and still do target economically ravaged places suffering from significant despair.

Economic despair is at the core of the opioid epidemic. A lot of those people addicted to opioids would have done much better if they had meaningful work to occupy their time and give them a sense of purpose. Unfortunately though, in many sectors the economic system is so dysfunctional that it fails to provide even basic elements of meaningful community work for people.

There’s a disturbing graph that shows utilization of capacity, and it reveals that there are many, many billions of dollars being lost due to capacity such as buildings not being used. It isn’t because there’s a lack of needed work — on the contrary, looking around plenty of places will have a reasonable person saying that there’s a lot that needs to be done. So there’s a lot of work that needs to be done and a lot of capacity (23 percent in the graph) pointlessly sitting idle, and there’s an economic system that isn’t putting them together for productive benefits.

Screenshot-2017-12-5 Capacity Utilization Total Industry

The U.S. government could enact a massive infrastructure project that would create millions of jobs and/or it could provide low interest loans to support worker cooperatives in economically downtrodden communities. There are other solutions too, and they also need significant will to be applied. The point to make here though is that the situation doesn’t have to be that bleak for the communities, and there’s actually a clear enough method to reconstruct what has been mismanaged.

Opioid Epidemic Cost Revised to a Staggering $504 Billion Annually

The roots of the crisis are found in the criminogenic pharmaceutical corporations and the dysfunctional U.S. economic system. More Americans die every year (about 60,000) as a result of the opioid crisis than the number who died in the Vietnam War. With $500 billion in annual costs, it also means that two years of the opioid crisis will roughly equal the direct costs of fighting the Vietnam War.

The opioid epidemic sweeping the U.S. is far costlier than once thought, with the economic impact of the crisis exceeding half a trillion dollars, according to a new report by White House economists.

The epidemic cost the American economy $504 billion in 2015, which was the equivalent of 2.8 percent of gross domestic product that year, according to the report by the Council of Economic Advisers, or CEA. The White House’s figures are more than six times larger than a previous study because it incorporates the value of lives lost to the epidemic.

The findings come less than a month after the Trump administration declared widespread opioid abuse a public health emergency while stopping short of freeing up federal disaster funds to tackle the problem.

A study released last year estimated the cost of the opioid crisis in 2013 at $79.9 billion, adjusted to 2015 dollars. The White House economists said prior research (see table) didn’t capture the full impact because it at times only measured health-care expenditures or earnings lost from those who die — which overlooks “other valuable activities in life besides work.”

The CEA also said it made adjustments to more accurately measure the number of opioid-related deaths, which often go underreported, and focused on illicit opioids as well as prescription drugs.

“This is the first but not the last publication CEA plans to issue on the opioid crisis,” according to the report. “A better understanding of the economic causes contributing to the crisis is crucial for evaluating the success of various interventions to combat it.”

Pharmaceutical Corporation Faked Its Number of Cancer Patients to Sell Drugs

What was this fraud for? It was for selling more powerful opioids, for more corporate profits, even during the ongoing opioid crisis.

When Insys Therapeutics got approval to sell an ultra-powerful opioid for cancer patients with acute pain in 2012, it soon discovered a problem: finding enough cancer patients to use the drug.

When Insys Therapeutics got approval to sell an ultra-powerful opioid for cancer patients with acute pain in 2012, it soon discovered a problem: finding enough cancer patients to use the drug.

To boost sales, the company allegedly took patients who didn’t have cancer and made it look like they did.

The drug maker used a combination of tactics, such as falsifying medical records, misleading insurance companies and providing kickbacks to doctors in league with the company, according to a federal indictment and ongoing congressional investigation by Sen. Claire McCaskill, a Democrat from Missouri.

The new report by McCaskill’s office released Wednesday includes allegations about just how far the company went to push prescriptions of its sprayable form of fentanyl, Subsys.

Because of the high cost associated with Subsys, most insurers wouldn’t pay for it unless it was approved in advance. That process, likely familiar to anyone who’s taken an expensive medication, is called “prior-authorization.”

So Insys set up an elaborate charade — with employees that pretended to be doctors’ offices — to fool insurance companies into approving the drug, according to the Senate report.

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Insys is currently in the midst of an avalanche of criminal and civil legal trouble.
In December, federal prosecutors in Boston criminally charged six former Insys executives, including its former CEO, with fraud and racketeering charges related to Subsys. Prosecutors described a “nationwide conspiracy to bribe medical practitioners to unnecessarily prescribe a fentanyl-based pain medication and defraud health care insurers.”

“As alleged, top executives of Insys Therapeutics, Inc. paid kickbacks and committed fraud to sell a highly potent and addictive opioid that can lead to abuse and life threatening respiratory depression,” said Harold H. Shaw, special agent in charge of the Federal Bureau of Investigation’s Boston field office, in a statement in December.

Other federal charges have also subsequently been brought against individuals connected to Subsys, and several state attorneys general have filed lawsuits of their own.

The six executives in the original December case have pled not guilty, and their cases are currently pending. But other former employees have since made guilty pleas.

In May, Motahari, then just weeks into his new job, told analysts on a corporate earnings call that the company hoped to resolve the federal investigation against it with a settlement.

“We continue to engage in discussions with the DOJ and remain highly committed to resolving this matter,” Motahari told the analysts.