President Trump Should Consider Stem Cell Therapy for His COVID-19

By A. Rahman Ford, PNN Columnist

President Trump remains hospitalized at Walter Reed Medical Center after being diagnosed with COVID-19 last week, along with First Lady Melania Trump. The president suffered from fever, congestion and fatigue, and received supplemental oxygen therapy before being admitted Friday.

Details about his current condition and treatment are scant, but Trump has reportedly received an experimental antibody drug and started a course of the antiviral drug remdesivir. In a video posted on Twitter Saturday night, the president said he was “starting to feel good” but the next few days would be “the real test.”

With few effective treatments available for coronavirus, the president and his doctors should seriously consider stem cell therapy, which is being investigated in dozens of clinical trials as a treatment for coronavirus. Other experimental therapies like hydroxychloroquine, remdesivir and blood plasma are not effective for all patients.

Coincidentally, President Trump has long been an advocate for stem cell therapy. In his 2017 State of the Union Address, he acknowledged the medical plight of a woman who was forced to travel to Mexico to use her own stem cells to treat her systemic idiopathic juvenile arthritis. Trump said seriously ill patients “should have access to experimental treatments” without traveling overseas and urged Congress to pass the Right to Try Act so that Americans can get help “right here at home.”

Stem cell therapy may be the safest and most effective treatment for the most life-threatening symptom of COVID-19, acute respiratory distress syndrome (ARDS), an inflammatory “cytokine storm” in the lungs that makes breathing difficult. The conventional intervention for ARDS – mechanical ventilation – is invasive, overused and can increase the likelihood of bacterial infections.

Stem cells have intrinsic immune supporting properties that can ease the deleterious effects of ARDS. They could also potentially heal any tissue damage that ARDS may cause to lungs.

Research Supports Stem Cells for COVID-19

Even if President Trump’s symptoms are mild, the prophylactic use of stem cells to prevent disease spread is worthy of investigation. Celltex Therapeutics is currently conducting a Phase 2 multi-center, double-blind, randomized, placebo-controlled trial to evaluate the prophylactic effectiveness of autologous, adipose-derived mesenchymal stromal cells (MSC).

A recent review of the scientific literature on MSC therapy concluded that “Cellular based therapies hold great promise for the treatment of COVID-19.” Another study echoed that finding, saying “MSCs possess both regenerative and immunomodulatory properties, the latter of which can be harnessed to reduce the severity and longevity of ARDS in patients under intensive care due to SARS-CoV-2 infection.”

Researchers in China have called MSC therapy a “promising strategy” for COVID-19, but cautioned that “there is not enough clinical evidence to prove the effectiveness of MSCs in the treatment of ARDS.”  They called for large-scale, multicenter trials to further explore the safety and efficacy of MSCs.  

Other recent studies have concluded that stem cells “may possibly be one of the most ideal therapeutics” for COVID-19 and “might be considered for compassionate use in critically ill patients.”

FDA Approved Trials

Early in the pandemic, the FDA approved several clinical trials of stem cells for treating COVID-19. These trials are now at various stages of progress, ranging from investigational new drug (IND) applications, to active recruitment of patients, to late stage clinical studies. Trial sponsors include: VetStem, M.D. Anderson Cancer Center, Personalized Stem Cells, Hope Biosciences, Thomas Advanced Medical, Restem, University of Miami, Mesoblast, NantKwest, Baylor College of Medicine, Athersys, Masonic Cancer Center, Celltex and Pluristem Therapeutics.

More recently, Baylx had its IND application approved for umbilical cord-derived MSC cells and Stemedica Cell Technologies’ IND application for intravenous allogeneic MSCs. The FDA has even cleared Pluristem Therapeutics’ existing stem cell product for treating ARDS, allowing the company to treat up to 100 severely affected COVID-19 patients outside of a clinical trial.

There are also several ongoing international trials of stem cells, including studies in Jordan, United Arab Emirates, Pakistan, Mexico and Brazil.

President Trump and First Lady Melania owe it to themselves – and to us – to consider every possible treatment for COVID-19. The administration should also ensure that all Americans have access to stem cell therapy for COVID-19, by expediting clinical trials, expanding compassionate use, and granting emergency use authorization for advanced stem cell products, as was done for convalescent plasma. Ultimately, the president and FDA should relax restrictions on the use of our own stem cells for indications beyond COVID-19.

We all wish the President and First Lady a full and speedy recovery.

A. Rahman Ford, PhD, is a lawyer and research professional. He is a graduate of Rutgers University and the Howard University School of Law, where he served as Editor-in-Chief of the Howard Law Journal. Rahman lives with chronic inflammation in his digestive tract and is unable to eat solid food. He has received stem cell treatment in China. 

Pre-Existing Conditions Deserve Affordable Treatment

By Dr. Lynn Webster, PNN Columnist

The National Institutes of Health reports that about 10 percent of Americans experience a substance use disorder (SUD) at some point in their lives. Most of those who suffer from an SUD receive no treatment.

About twice as many Americans – 20 percent -- have chronic pain. Many of them also cannot find adequate treatment or even a provider willing to treat them. 

Making treatment accessible for both of these conditions -- which are defined as pre-existing for insurance purposes -- is always a topic of concern. These days, it is of paramount concern that access to treatment is available. And it requires us to take action.

We’re All at Risk for Pain and Drug Abuse

Poverty and hopelessness are risk factors for drug abuse, even though not everyone who is economically challenged develops an SUD. Unfortunately, prevention and treatment programs for SUDs are less available to those who cannot pay for them and who most need them.

Anyone can suffer from chronic pain, but even those with resources may not have access to adequate pain management.

My concern is more than theoretical. It is personal. I have friends, former patients and family members who suffer from SUDs. If the Affordable Care Act (ACA) — widely known as Obamacare — ends and we lose coverage of pre-existing conditions, I fear they will be abandoned in exactly the same way as people in pain have been abandoned ever since the CDC issued its 2016 opioid prescribing guideline.

In recent years, I have received hundreds of emails and calls from people in pain. Their medications have been tapered and they don't know where to turn for help. Untreated chronic pain, as well as untreated SUDs, can result in ruinous consequences: disability, destitution, isolation, poverty and suicide.

We need to help healthcare providers find more effective ways to treat their patients. The Centers of Excellence in Pain Education (CoEPEs) program was created to teach healthcare professionals about pain and its treatment. Since this is something most doctors do not study adequately during medical school, it's important to have continuing medical education opportunities to learn about the stigma associated with pain treatment and substance abuse disorders.

Abolishing ACA Could Have Devastating Consequences

The current administration has appealed to the Supreme Court to abolish the ACA. President Trump has said that Obamacare "must fall." Given the fact that we're in the middle of a pandemic and millions of people are unemployed and may have lost access to employer-sponsored healthcare, the timing seems terrible.  

But even without a pandemic, reversing the ACA would be devastating for millions of Americans who have an SUD or chronic pain. President Trump signed an executive order on September 24 that claims to protect people with pre-existing conditions. However, experts dispute whether his executive order can actually do what it promises.

Regardless, eliminating the ACA will likely allow insurance companies to charge higher rates for people with pre-existing conditions. This would essentially render treatment for chronic pain and SUD unaffordable for many people, leading to an increase of the terrible consequences mentioned above. And, of course, SUDs and chronic pain are only two of the pre-existing conditions that would no longer be protected. 

It is time for everyone to understand the consequences that losing the ACA may have for their community, family, friends and themselves. There is still time to be heard, but you have to act quickly. Click here to find your federal, state, and local elected officials and express your views.  

Let us also send healing thoughts and prayers to President Trump, the First Lady and everyone else infected with COVID-19.

Lynn R. Webster, MD, is a vice president of scientific affairs for PRA Health Sciences and consults with the pharmaceutical industry. He is author of the award-winning book The Painful Truth, and co-producer of the documentary It Hurts Until You Die. Opinions expressed here are those of the author alone and do not reflect the views or policy of PRA Health Sciences. You can find Lynn on Twitter: @LynnRWebsterMD. 

Study Debunks Use of Hydroxychloroquine for COVID-19

By Pat Anson, PNN Editor

A large international study on the use of hydroxychloroquine and chloroquine for treating COVID-19 has found the antimalarial drugs offer no benefit for hospitalized coronavirus patients and appear to significantly raise the risk of death, particularly when taken with antibiotics.

The study, published in the peer-reviewed journal The Lancet, looked at data from nearly 15,000 patients with COVID-19 who received hydroxychloroquine or chloroquine, with or without the use of antibiotics. They were compared to a control group of over 81,000 patients who did not take the drugs. The study included patients being treated at 671 hospitals in North America, Europe, Asia, Africa, South America and Australia.

(Update: On June 4, The Lancet retracted this study after the authors said were unable to complete an independent audit of their research and concluded they “can no longer vouch for the veracity of the primary data sources.”)

“We found no evidence of benefit of hydroxychloroquine or chloroquine when used either alone or with a macrolide (antibiotic),” researchers said. “Our study included a large number of patients across multiple geographic regions and provides the most robust real-world evidence to date on the usefulness of these treatment regimens. Although observational studies cannot fully account for unmeasured confounding factors, our findings suggest not only an absence of therapeutic benefit but also potential harm.”

The study found that 9.3% of patients in the control group died in the hospital. Of those treated with chloroquine or hydroxychloroquine alone, 16.4% died. The outcomes were even worse for patients who used chloroquine with an antibiotic (22.2%) or hydroxychloroquine with an antibiotic (23.8%).

Researchers also found that serious cardiac arrhythmias, which cause the lower chamber of the heart to beat rapidly and irregularly, were more common in the groups that took hydroxychloroquine or chloroquine.

“This is the first large scale study to find statistically robust evidence that treatment with chloroquine or hydroxychloroquine does not benefit patients with COVID-19. Instead, our findings suggest it may be associated with an increased risk of serious heart problems and increased risk of death,” said lead author Mandeep Mehra, MD, Executive Director of the Brigham and Women’s Hospital Center for Advanced Heart Disease.

“Randomised clinical trials are essential to confirm any harms or benefits associated with these agents. In the meantime, we suggest these drugs should not be used as treatments for COVID-19 outside of clinical trials.”

President Trump disclosed this week that he has been taking hydroxychloroquine as a preventative treatment for COVID-19, even though there is only anecdotal evidence the drug may work against the virus. The president said he was prescribed the drug by his physician after two White House staff members were diagnosed with the virus. Trump said he would only take hydroxychloroquine for about two weeks.

The Food and Drug Administration has said hydroxychloroquine or chloroquine should not be used as frontline treatments for COVID-19 outside of hospitals and clinical trials.

The FDA has only approved chloroquine to treat malaria and hydroxychloquine as a treatment for lupus and rheumatoid arthritis. Both drugs have good safety profiles for those conditions.

Chloroquine and hydroxychloquine have been shown to have antiviral effects in laboratory tests, which has sparked interest in their use as potential treatments for COVID-19. Some countries have been stockpiling the drugs. In March, the FDA added hydroxychloquine and chloroquine to its list of drug shortages. Chloroquine was recently taken off the list.

“Several countries have advocated use of chloroquine and hydroxychloroquine, either alone or in combination, as potential treatments for COVID-19,” said co-author Frank Ruschitzka, MD, Director of the Heart Center at University Hospital Zurich.

“Justification for repurposing these medicines in this way is based on a small number of anecdotal experiences that suggest they may have beneficial effects for people infected with the SARS-CoV-2 virus. However, previous small-scale studies have failed to identify robust evidence of a benefit and larger, randomised controlled trials are not yet completed. However, we now know from our study that the chance that these medications improve outcomes in COVID-19 is quite low.”

In addition to their findings on chloroquine and hydroxychloroquine, researchers also noted that obesity, heart disease, diabetes and smoking raise the risk of death for hospitalized COVID-19 patients. Interestingly, patients being treated with statins or ACE inhibitors for high blood pressure had a lower risk of mortality, suggesting that medications that stabilize the cardiovascular system may be beneficial.

How Government Shutdowns Worsen the Opioid Crisis

By Lynn Webster, MD, Guest Columnist

On October 26, 2017— a little bit more than a year ago — President Donald Trump declared that the opioid crisis was a national Public Health Emergency. Most Americans seemed to back his initiative to stop opioid abuse, and to reduce drug supply and demand.

However, it seems the recent 35-day government shutdown and Trump's desire to build a border wall have been at cross-purposes with his concern about addressing the opioid crisis.

Two key aspects of Trump’s opioid plan were prevention and treatment of opioid use disorder. Prevention, in part, means reducing the supply. However, everything in the supply is not equally problematic.

Opioids fall into two major categories: those that are prescribed and those that are smuggled into the United States. The number of overdoses associated with prescription opioids has remained essentially unchanged since 2011, while the number of opioid overdoses due to illicit fentanyl and other synthetic opioids surged from 3,000 in 2013 to more than 29,000 in 2017. Most of these drugs originate in China.

One of Trump's major arguments for building a wall is that most drugs that kill Americans are coming over the southern border from Mexico. However, that conflicts with the final report of his opioid commission, which found that "we are losing this fight predominately through China."

Mexican cartels do smuggle illicit opioids across the southern border in passenger vehicles and tractor trailers, often at legal points of entry. Heroin and fentanyl are also smuggled into the U.S. by sea and air or through the mail. A physical barrier doesn’t block any of these types of entry.

The U.S. Food and Drug Administration (FDA) is tasked with inspecting mail to prevent drug smuggling. Before the government shutdown, FDA Commissioner Scott Gottlieb was calling for more postal inspectors to intercept shipments of opioids. He wanted the government to be able to inspect 100,000 suspicious packages per year, but that would have required double the number of personnel that he had.

Government shutdowns handicap those efforts because it is difficult to hire during shutdowns. It can be challenging just to retain the employees you already have.

The Department of Homeland Security works with the U.S. Coast Guard and the U.S. Customs and Border Protection to patrol the South Pacific Ocean and the Caribbean Sea to stop drug smuggling. These efforts may have been impeded during the shutdown, because some of these "essential" employees had to decide whether to work without pay or call in sick. We can assume that some of them chose the latter course of action. Some government employees may be looking for other jobs because they want a reliable paycheck.

Ironically, due to increased scrutiny at the border, drug smugglers have gotten more creative, increasing their use of tunnels, boats, air and even catapults. These efforts may have been more successful due to the lack of personnel guarding trouble spots because of the shutdown.

Addiction Treatment Impacted

Government shutdowns increase the likelihood that opioids could find their way past our borders. And our ability to treat people with opioid addiction may also be compromised.

Providing treatment for addiction was the other important part of Trump's plan for addressing the opioid crisis. An estimated 2.1 million people had an opioid use disorder in 2016, yet only about 20% had access to treatment. One of the reasons so few people are treated is that not enough clinicians are trained and certified to treat opioid addiction. The president's initiative requires increasing the number of clinicians certified to treat addiction.

Buprenorphine (Subxone) is one of the tools physicians use to treat opioid use disorder. Doctors require special training and certification to prescribe the drug, as well as a waiver from the Drug Enforcement Agency. During the government shutdown, the DEA was still able to review doctors’ applications, but there were about 30% fewer certifications than there were before the shutdown. It is unclear if that was due to the shutdown or not.

Regardless of whether there will be a physical wall on our border with Mexico, we can see the potential damage that the recent government shutdown can have on curbing the opioid crisis. Congress will now discuss the merits of various options to secure the border, and President Trump is threatening another shutdown if a border wall isn’t funded.

But one thing we should take away from the recent experience is that there isn't much point in saving ourselves from illegal immigrants if we can't protect ourselves from the dangers posed by a government shutdown.

Lynn R. Webster, MD, is a vice president of scientific affairs for PRA Health Sciences and consults with the pharmaceutical industry. He is a former president of the American Academy of Pain Medicine. Webster is the author of “The Painful Truth: What Chronic Pain Is Really Like and Why It Matters to Each of Us.”

You can find him on Twitter: @LynnRWebsterMD. 

The information in this column should not be considered as professional medical advice, diagnosis or treatment. It is for informational purposes only and represents the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.

What Will Support Act Mean for Pain Patients?

By Pat Anson, PNN Editor

President Trump this week signed into law the Support for Patients and Communities Act, a comprehensive and mostly bipartisan legislation that combined over 70 bills passed by Congress aimed at fighting the opioid epidemic.

"Together we are going to end the scourge of drug addiction,” Trump said at a bill-signing ceremony at the White House. “Or at least make an extremely big dent in this terrible, terrible problem.”

While most of the Support Act is aimed at slowing the flow of illicit drugs and subsidizing the $35 billion dollar addiction treatment industry, there are some key elements that will affect millions of Americans who take opioids for chronic or acute pain.

Most are designed to limit access to opioid medication and further reduce the supply, which has nearly been cut in half since 2016.

The new law authorizes the Food and Drug Administration to require that some opioids be dispensed in so-called “blister packs” to limit the number of pills that can be prescribed and dispensed at one time. That type of packaging would primarily be for patients with short-term, acute pain who need only a few days’ supply. But it could also lead to a standardization of doses and make refills more difficult for patients who are slow to recover from surgery or trauma.

“The doses dispensed in the packs could be designed to align with evidence-based recommendations on what the proper dosing should be for common indications. These packs could then become the default option for more post procedure uses and could discourage physicians from prescribing long durations of use in situations where the evidence shows that short durations are clinically appropriate,” said FDA commissioner Scott Gottlieb, MD, in a statement.

“Ultimately, this approach could reduce the overall number of drugs in circulation and potentially lower the rate of new opioid addiction. It could also address the problem of excess supply, leading to fewer pills left in medicine cabinets that could be inappropriately accessed by family members, including children.”

The Support Act also gives the FDA the authority to require that opioids be dispensed with a mail-back pouch or other safe disposal options. The goal again is to get unused medications out of medicine cabinets where they could be stolen or diverted.

The new law also supports an effort recently launched by Gottlieb to develop opioid guidelines for acute pain. The guidelines won’t replace or change the CDC’s controversial guideline for chronic pain, but they will be developed with more transparency. Gottlieb has instructed the National Academies of Sciences, Engineering, and Medicine to hold a series of public meetings and to seek input from "a broad range of stakeholders" from different medical specialties. The CDC guideline was initially developed with no public hearings and with little input from pain management experts.

The Support Act also gives more authority to the FDA to require longer post-market studies on the safety and efficacy of drugs. Current evidence on the long-term use of all pain medication – not just opioids – is extremely limited. That has led to exaggerated claims from opioid critics that there is “no evidence” that opioids are safe or effective long term. Those same critics often call for greater use of non-opioid medications, such as gabapentin and pregabalin, when there is little long term evidence to support their use either.

The Support Act also calls on other federal agencies to enact measures to prevent the diversion and abuse of opioids and other controlled substances:

• All prescriptions for controlled substances covered under Medicare Part D or Medicare Advantage must be transmitted electronically starting Jan. 1, 2021.

• The Department of Health and Human Services (HHS) will develop guidelines for pharmacists to decline to fill prescriptions they think may be fraudulent or questionable.

• Medicaid programs will be required to have “safety edits” in place for opioid refills and to monitor the concurrent use of opioids with potentially risky drugs such as benzodiazepines.

• A web portal will be created to allow communication between HHS, CMS and Medicare Advantage insurers to share information about providers under investigation for inappropriate prescribing of opioids.

• HHS will develop guidelines to allow the inclusion of opioid addiction history in patient electronic health records.

One pain management expert cautioned that some provisions of the Support Act put too much of an emphasis on opioid medication.

“Excessive focus on reducing opioid supply in the legislation can lead to more harm than good. We cannot continue to ignore the needs of people in pain at the expense of preventing illicit drug use,” Lynn Webster, MD, past president of the American Academy of Pain Medicine told Pain Medicine News.

“We have seen draconian steps by the VA (Department of Veterans Affairs) and other payors to force opioid reduction in patients who have been stable and functional for years. This is cruel and simply not right. My hope is that the act is implemented with compassion for people with addiction and pain, but that they allow science and not prejudices and politics to inform policy.”

Trump Administration Proposes More Rx Opioid Cuts

By Pat Anson, Editor

For the third year in a row, the U.S. Drug Enforcement Administration is proposing another round of cuts in the supply of opioid pain medication – a 10% reduction in manufacturing quotas in 2019 for several widely used opioids.  The Trump Administration says the pain relievers are “frequently misused” and reducing their supply will help prevent addiction and abuse.

The DEA proposal involves six opioids classified as Schedule II controlled substances:  oxycodone, hydrocodone, oxymorphone, hydromorphone, morphine, and fentanyl. Some of the medications are already in short supply, forcing some hospitals to use other pain relievers to treat surgery and trauma patients.

“President Trump has set the ambitious goal of reducing opioid prescription rates by one-third in three years. We embrace that goal and are resolutely committed to reaching it,” Attorney General Jeff Sessions said in a statement. “We have already made significant progress in reducing prescription rates over the past year. Cutting opioid production quotas by an average of ten percent next year will help us continue that progress and make it harder to divert these drugs for abuse.”

The DEA has already made substantial cuts in opioid production quotas, reducing them by 25 percent in 2017, followed by another 20 percent cut in 2018.  

The production cuts have had no effect on reducing the nation’s soaring overdose rate. According to a preliminary report released this week by the CDC, over 72,000 Americans died of drug overdoses last year, a 6 percent increase from 2016. The rising death toll is primarily attributed to illicit fentanyl, heroin and cocaine. Overdoses involving prescription opioids appear to have leveled off.

The DEA’s latest round of production cuts is in line with President Trump’s “Safe Prescribing Plan” which seeks to reduce "the over-prescription of opioids” by cutting nationwide opioid prescription fills by one-third within three years.

“We’ve lost too many lives to the opioid epidemic and families and communities suffer tragic consequences every day,” said DEA Acting Administrator Uttam Dhillon. “This significant drop in prescriptions by doctors and DEA’s production quota adjustment will continue to reduce the amount of drugs available for illicit diversion and abuse while ensuring that patients will continue to have access to proper medicine.”

‘Serious Consequences’ for Patients

But legitimate patients are losing access to opioids.  Many hospitals and hospices now face a chronic shortage of three intravenous or injectable opioids --  morphine, hydromorphone and fentanyl -- which are used to treat patients recovering from surgery or trauma. Shortages of these "parenteral" drugs have been primarily blamed on manufacturing problems, although some critics say it has been worsened by the DEA production cuts.

“The shortage has serious consequences for patients and physicians. Parenteral opioids provide fast and reliable analgesia for patients admitted to the hospital with poorly controlled pain, patients who have undergone painful procedures such as major surgery, and those who were previously on oral opioid regimens but are unable to continue treatment by mouth,” Edward Bruera, MD, an oncologist at The University of Texas MD Anderson Cancer Center, wrote in an op/ed published this week in The New England Journal of Medicine.

“Shortages of the three best-known parenteral opioids may increase the risk for medication errors when it becomes necessary to switch a patient to a less familiar drug or to use opioid-sparing drug combinations. Opioids are already among the drugs most frequently involved in medication errors in hospitals. There are also increased risks of delayed time to analgesia and of side effects resulting in unnecessary patient suffering and delayed hospital discharge.”

Although opioid prescribing guidelines are only intended for physicians treating patients with “chronic non-cancer pain,” Bruera says some cancer patients are being affected by opioid shortages and over-zealous enforcement of prescribing guidelines.

“Most hospitalized patients and almost all patients with cancer need opioids, either on a temporary basis after surgery or painful treatments such as stem-cell transplantation, or longer for cancer-related pain or dyspnea,” he wrote. “It is impossible to appropriately treat such a large number of patients unless most physicians are able and willing to prescribe opioids. There were not enough palliative care and pain specialists to meet patient needs before the shortages began, and universal referral of patients who need parenteral opioids will therefore only result in more undertreated pain.”

The rationale behind the DEA’s production cuts defy some of the agency’s own analysis. Less than one percent of legally prescribed opioids are diverted, according to a 2017 DEA report, which also found that admissions for painkiller abuse to publicly funded addiction treatment facilities have declined significantly since 2011, the same year that opioid prescriptions began dropping.

A Pained Life: An Open Letter to President Trump

By Carol Levy, Columnist

Dear Mr. President Trump,

I have had trigeminal neuralgia, a chronic facial pain disorder, since 1976. For the last 30 years, I’ve been able to get all of the pain medications my doctors prescribed for me, including codeine, Demerol, morphine, Percodan, hydrocodone, and even an 8-ounce bottle of tincture of opium.

For the latter, I only had to go to 2 pharmacies. The first one didn’t carry it. The second store gave me the bottle with no questions asked.   I was trusted. My doctor was trusted. My doctor trusted me.

Many of us are now losing our doctors, who are fearful of being raided or arrested by the DEA because they prescribe opioids. Pain sufferers who were once able to get out of bed in the morning to work, watch their kids, and be a part of the world are joining the ranks of the disabled because opioids are being reduced or withdrawn completely.

Often patients get little or no warning when their pain management doctors decide they can no longer treat them.  Many doctors have closed their doors or decided not to prescribe opioids, no matter what the patient's condition or if they benefited from them. Often there is no rhyme or reason for this abandonment, other than fear of the DEA.

The Justice Department, CDC, VA and other federal agencies continue blaming patients and physicians for the opioid crisis, when the true “epidemic” involves illicit fentanyl and heroin. It has little to do with prescriptions.

This blaming of patients and pain management physicians has caused untold additional suffering.  The worst part is the many anecdotal stories of patients committing suicide because the opioids that were helping them are no longer available in the same dosage, if at all.

The damage is not just physical from the increased pain, there is psychological pain as well.  Sources that once may have been a comfort become accusers.

Patients tell story after story: “My family now calls me an addict because I am on opioids.”

Or they fear letting their friends know they take opioids for pain: “Then they’ll think I am an abuser or an addict.”

Yes, some doctors overprescribe and some patients abuse their opioids.  But they’re a small number. We don't sell our prescriptions and we don't give them away like candy.  We take them because they help our pain.  Often, it is the only treatment or option left to us.  We would be fools to give away, sell or abuse that which is helping. 

It is time, past time, for the "compassionate conservatism" of the Republican party be put into use. And Democrats need to show that the compassion they talk about is real.

We have enough trouble dealing with our physical pain. Please stop making it worse by taking away our medications. Let our doctors doctor us, not the government.

Carol Jay Levy has lived with trigeminal neuralgia, a chronic facial pain disorder, for over 30 years. She is the author of “A Pained Life, A Chronic Pain Journey.” 

Carol is the moderator of the Facebook support group “Women in Pain Awareness.” Her blog “The Pained Life” can be found here.

The information in this column should not be considered as professional medical advice, diagnosis or treatment. It is for informational purposes only and represent the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.

Do Hungry Mice Have the Answer to the Opioid Crisis?

By Pat Anson, Editor

Yes, that a silly headline. There have been a lot of them lately on how to end the opioid crisis, most of them involving new ways of treating chronic pain without the use of addictive drugs.

Some of these ideas are sincere, some are strange and others are just plain silly. There were a quite a few this week that produced some interesting headlines.

“Staying hungry may suppress chronic pain” was the headline in a Chinese website that reported on a study conducted at the University of Pennsylvania. Researchers there found that laboratory mice that weren’t fed for 24 hours still felt acute short-term pain, but their chronic pain was suppressed by hunger.

“We didn't set out having this expectation that hunger would influence pain sensation so significantly," says J. Nicholas Betley, an assistant professor of biology in Penn's School of Arts and Sciences. "But when we saw these behaviors unfold before us, it made sense. If you're an animal, it doesn't matter if you have an injury, you need to be able to overcome that in order to go find the nutrients you need to survive."

Betley isn’t suggesting that chronic pain patients stop eating or starve themselves, but he believes the finding could pave the way to new pain medications that target brain receptors that control survival behavior.  

“Chronic pain relief: How marine snails may be able to help” was the headline used by WNDU-TV to report on a recent study at the University of Utah. 

Researchers there say a compound in the venom of cone snails could someday be used in pain medication. The venom paralyzes small fish so that hungry cone snails can slowly eat their prey alive.  

"We really hope that we will find a drug that could be as effective for severe pain as opioids but has far less side effects and is not addictive," says Russell Teichert, PhD, a research associate professor in the Department of Biology.

Interestingly, the cone snail study is funded with a $10 million grant from the U.S. Department of Defense. Human trials are expected to begin in a couple years.

“Why Tai Chi Works So Well for Pain Relief” was the headline in Time about a study by researchers at Tufts Medical Center. The headline is a bit misleading, because the study only included fibromyalgia patients and compared the effectiveness of tai chi to aerobic exercise in relieving pain.

The last thing many fibromylagia sufferers want to do is practice tai chi, but the Chinese martial arts exercise was found to be just as good or better than aerobics, which is sometimes recommended as a non-drug treatment for fibromyalgia.

“It is low risk and minimally invasive, unlike surgery, and it will not harm your organs, like long term drug use,” said Amy Price, a trauma survivor who lives with chronic pain.

“Kellyanne Conway Tells Students to Eat Ice Cream and Fries Rather than Take Deadly Drug Fentanyl”  is how Newsweek summed up a speech by a top presidential advisor to a group of college students.

“On our college campuses, you folks are reading the labels, they won’t put any sugar in their body, they won’t eat carbs anymore, and they’re very, very fastidious about what goes into their body. And then you buy a street drug for $5 or $10, it’s laced with fentanyl and that’s it,” said Conway, who oversees the Trump administration’s response to the opioid crisis.

“So my short advice is, eat the ice cream, have the French fry, don’t buy the street drug—believe me, it all works out.”

Conway probably said this tongue-in-cheek, but critics were quick to pounce.

“Was feeling bad about my McDonalds ice cream cone today until I realized it helped me avert opioid addiction. Thanks Kellyanne Conway!” Lola Lovecraft tweeted.

 “I was considering doing fentanyl but now thanks to Kellyanne I’m just gonna 'have the French fry” instead. Saved me from a life on the streets!” tweeted Mike Stephens.

Conway’s boss had zinger of his own after signing a $1.3 trillion spending bill on Friday.

“We’re also spending $6 billion on, as you know, various forms of drug control, helping people that are addicted,” said President Trump.  “The level of drugs that are being put out there and the power of this addiction is hard to believe. People go to the hospital for a period of a week and they come out and they’re drug addicts.”

No, Mr. President, that’s a myth. Studies have repeatedly shown that it is rare for hospital patients to become addicted to opioids.

One study found that only 0.6% of patients recovering from surgery were later diagnosed with opioid misuse. Another study found that only 1.1% of patients treated with opioids in a hospital emergency room progressed to long term use.

What is true is that there’s a growing shortage of opioid medication in hospitals and hospices, and that’s leading to medical errors and the unnecessary suffering of patients. The shortage is due in part to manufacturing problems and severe cuts in opioid production quotas ordered by the DEA.

President Trump is aware that opioid prescribing has declined significantly, but he’d like to see more.  This week he called for opioid prescriptions to be cut by a third over the next three years. “Doctors are way down now in their orders of the opioids, way down. It’s a great thing,” he said.

Let's hope the hungry mice and cone snails share their secrets soon.

How Trump and Congress Can Champion Stem Cells

By A. Rahman Ford, Columnist

For the second straight year, President Trump has endorsed making life-saving treatments like stem cell therapies more available to more Americans.

In his 2017 Joint Address to Congress, Trump highlighted the case of Megan Crowley, a young woman whose father had to launch his own drug company to help treat her Pompe Disease.  Also in attendance that evening was Sarah hughes, who was forced to travel to Mexico to use her own stem cells to treat her systemic idiopathic juvenile arthritis.

In reference to both cases, the president lamented the pain and death caused by the “slow and burdensome approval process at the Food and Drug Administration” that “keeps too many advances … from reaching those in need.”  He argued that regulatory restraints at the FDA should be “slashed” so that more Americans could benefit from life-saving therapies.

President Trump is keeping up the pressure.  During this week's State of the Union address, he continued his theme of a patient-centered, less restrictive approach to medical treatment. 

He did so by voicing his clear support for “Right to Try” legislation, which would increase the medical options of the critically ill by helping them avoid the unduly burdensome and bureaucratic spider’s web of the FDA. 

In a seeming reference to Sarah Hughes and other stem cell medical tourists, Trump stated unequivocally that “patients with terminally conditions … should have access to experimental treatments immediately” and they “should not have to go from country to country to seek a cure.”  He then urged Congress to pass the Right to Try Act, so that Americans can get help “right here at home.”

How Right to Try Works

The language of the Right to Try legislation is simple, straightforward and offers protections for patients and manufacturers.  Under the Senate version, an “eligible patient” who has been diagnosed with a terminal illness may be prescribed an experimental drug or biological product to treat their illness, so long as the patient has a qualified physician certify that he or she has exhausted all other treatment options and is unable to participate in a clinical trial. The patient must also provide informed consent to the physician and the physician may not be compensated by the manufacturer of a treatment for certifying the patient.  The patient, physician and manufacturer must all agree on the treatment.

Furthermore, the medical product in question must have successfully completed a Phase 1 clinical trial and must be enrolled in an FDA clinical trial.  The treatment must be authorized by state law, which means that the state must have a Right to Try law – which 38 states currently have.

The manufacturers receive protection under Right to Try legislation, in that there can be no legal liability for injury that may result as a consequence of the medical product’s use, and adverse events that may occur during treatment will not negatively impact any eventual approval of the product by the FDA. 

In an overwhelming and increasingly rare bipartisan display (94-1), the Senate has already passed the Right to Try Act.  The House version is currently awaiting approval.

Critics Deny Democratic Choice 

Critics of Right to Try make several claims to undermine the expansion of choices it would bring to critically ill patients.  Some physicians and medical ethicists claim that the true goal of Right to Try is to weaken the FDA as the only objective and appropriate gatekeeper of drug approval and access.  Some also claim that the legislation is redundant because the FDA already fills this need through its expanded access program. 

Still other critics try to dissuade patients by surreptitiously noting that “scary” conservative and libertarian think tanks like Freedom Partners and Americans for Prosperity, which are partially funded by the Koch brothers, favor passage of Right to Try legislation.  These criticisms warrant thoughtful consideration, but are not substantive enough to overcome overarching concerns of patients literally dying from their pain.    

Ultimately, Right to Try and stem cell therapy are issues that embody the deepening and broadening of healthcare choice -- a choice that should be embraced by an informed American citizenry, a forward-thinking medical establishment and government agencies that must be by and for the people. 

Carefully curated expansions of choice -- that privilege the humane while also giving due consideration to patient protection – serve as the foundation of all truly democratic institutions.  The FDA should accept that it can better serve people by acceding some of its authority and become more lean and nimble in the process.  Bigger is not always better.

Right to Try will not solve all the problems associated with stem cell therapy.  There is no way to predict with any precision how the law will operate legally or logistically, whether for stem cell therapies or other drugs and medical products.  Additionally, the Trump administration must revisit and revise the FDA’s stem cell guidance, specifically its limits on stem cells which are harvested, processed and administered to the same person to relieve conditions such as chronic pain.    

However, for advocates of stem cell therapy and health choice in general, Right to Try is a step in the right direction.

A. Rahman Ford, PhD, is a lawyer and research professional. He is a graduate of Rutgers University and the Howard University School of Law, where he served as Editor-in-Chief of the Howard Law Journal. He earned his PhD at the University of Pennsylvania.

Rahman lives with chronic inflammation in his digestive tract and is unable to eat solid food. He has received stem cell treatment in China.  

The information in this column should not be considered as professional medical advice, diagnosis or treatment. It is for informational purposes only and represent the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.

Lawmakers Ask Trump to Restore Marijuana Policy

By Pat Anson, Editor

A bipartisan group of lawmakers led by Sen. Elizabeth Warren (D-MA) and Rep. Jared Polis (D-CO) has urged President Trump to reinstate an Obama-era policy that instructed U.S. Attorneys not to investigate or prosecute marijuana cases in states that have legalized cannabis.

Earlier this month, Attorney General Jeff Sessions rescinded the so-called Cole memo, the lenient marijuana policy adopted by the Justice Department in 2013.  Sessions, who is a longtime critic of marijuana legalization, said the Colo memo was “unnecessary” and “undermines the rule of law.” He authorized U.S. Attorneys to use their own discretion in investigating and prosecuting marijuana cases.

In a letter to President Trump signed by 54 members of Congress (51 Democrats and 3 Republicans), the lawmakers said Sessions’ order will “have a chilling effect” in states where medical or recreational marijuana has been legalized.

“This action has the potential to unravel efforts to build sensible drug policies that encourage economic development as we are finally moving away from antiquated practices that have hurt disadvantaged communities. These new policies have instead helped eliminate the black market sale of marijuana and allowed law enforcement to focus on real threats to public health and safety,” the letter said.

The letter also pointed out that Trump promised during the 2016 campaign that he would not change the federal enforcement policy on marijuana.

“I wouldn’t do that, no,” Trump said in an interview. “I think it’s up to the states. I’m a states’ person. I think it’s up to the states, absolutely.”

“We trust that you still hold that belief, and we request that you urge the Attorney General to reinstate the Cole Memorandum. This step would create a pathway to a more comprehensive marijuana policy that respects state interests and prerogatives,” the letter from lawmakers said.

Although 29 states and the District of Columbia have legalized marijuana in some form, federal law still prohibits its sale or possession under the Controlled Substances Act.

According to a recent Gallup Poll, 64% of Americans believe marijuana should be legalized. The issue has broad bipartisan support, with 51% of Republicans and 72% of Democrats supporting legalization.

New Jersey Gov. Philip Murphy (D) signed an executive order this week instructing the state health department to expand access to medical marijuana. Although cannabis has been legal in the state since 2010, New Jersey’s medical marijuana law was so rigid that only 15,000 patients qualified for it in a state with 9 million people.

Murphy’s order directs the health department to lift restrictions on doctors that can prescribe cannabis, review the number of medical conditions for which it can be prescribed, allow more dispensaries to open, and consider the sale of edible marijuana products.

Opioid Commission Member Calls Panel a ‘Charade’

By Pat Anson, Editor

The Trump Administration and Congress have so neglected the country’s opioid crisis that they have turned the work of the president's opioid commission into a "charade" and a "sham," according to one panel member.

In a wide ranging interview with CNN, former Democratic Rep. Patrick Kennedy lamented a lack of focus and funding the opioid crisis has received since President Trump declared the overdose and addiction epidemic a national public health emergency last October.

"This and the administration's other efforts to address the epidemic are tantamount to reshuffling chairs on the Titanic," said Kennedy.

"The emergency declaration has accomplished little because there's no funding behind it. You can't expect to stem the tide of a public health crisis that is claiming over 64,000 lives per year without putting your money where your mouth is."

PATRICK KENNEDY

Without funding and resources, Kennedy said he believes the opioid commission's work had become a charade.

"I do. I honestly do. It means nothing if it has no funding to push it forward.... this thing's a charade,”” he told CNN. "I have to be true to the way I feel. This is essentially a sham."

President Trump appointed the bipartisan panel in March to give him a list of recommendations to combat drug addiction and the overdose crisis. 

COMMISSION on combating drug abuse and the opioid crisis

After a series of public hearings, the commission released its final report in November, an ambitious list of over four dozen recommendations aimed at treating addiction, preventing overdoses, and further restrictions on opioid prescribing.

But since the report’s release, little money has been set aside by Congress or the administration to implement the panel’s recommendations, except to increase border security and detect illegal drugs.

Last week President Trump proposed cutting the budget of the White House Office of National Drug Control Policy – which oversaw the opioid commission’s work -- by 95 percent.  After a year in office, the president has yet to appoint a permanent director for the office, which currently has a 24-year old deputy chief of staff fresh out of college with no prior experience in management or drug control policy.

"Everyone is willing to tolerate the intolerable -- and not do anything about it," said Kennedy, who is recovering from alcohol and opioid addiction, and is a prominent mental health advocate.

“I'm as cynical as I've ever been about this stuff,” he said. “We've got a human addiction tsunami, and we need all hands on deck."

Bertha Madras, another member of the opioid commission, told CNN the panel has never received any direct feedback from Trump about its work. But she praised the selection of presidential advisor Kellyanne Conway as the key point person for the administration in dealing with the opioid crisis.

"That is really a very significant issue, bringing the implementation directly into the White House, as opposed to having intra-agency meetings," said Madras, a professor of psychobiology at Harvard Medical School. "Having been in government 10 years ago or so, I know how difficult it is to be able to generate change without having executive leadership behind you."

When asked by CNN about Kennedy's critique, she praised him for the "passion and depth he brings to the problem," but said it was premature for her to comment until she sees how much money is eventually allocated for the opioid crisis.

Trump: Overdose Crisis a ‘Public Health Emergency’

By Pat Anson, Editor

President Trump today declared the overdose crisis a nationwide “public health emergency,” a legal designation that falls well short of the national emergency sought by his own opioid commission.

The difference between the two is significant. Under a national emergency, the Trump administration could immediately access funds already set aside for disaster and emergency relief. There is little funding currently available -- only about $57,000 -- to pay for a public health emergency.

Despite the lack of funding, President Trump pledged his administration would act swiftly to end an overdose crisis that he said was killing 7 Americans every hour.

“Nobody has seen anything like what's going on now. As Americans, we cannot allow this to continue.  It is time to liberate our communities from this scourge of drug addiction,” Trump said.

“That is why, effective today, my administration is officially declaring the opioid crisis a national public health emergency under federal law, and why I am directing all executive agencies to use every appropriate emergency authority to fight the opioid crisis.  This marks a critical step in confronting the extraordinary challenge that we face.”

The president said he was awaiting a final report and recommendations from the White House opioid commission, which is expected next week. An interim report by the commission in July strongly urged the president to declare a national emergency.  

“Your declaration would empower your cabinet to take bold steps and would force Congress to focus on funding and empowering the Executive Branch even further to deal with this loss of life,” the report said. “You, Mr. President, are the only person who can bring this type of intensity to the emergency and we believe you have the will to do so and to do so immediately.”

Soon after the interim report was released, the president said he would declare a national emergency, but the White House never got around to actually declaring one -- amid reports of division in the administration about what should be done and how to pay for it.

Nearly $1 billion in federal funding to pay for addiction treatment was authorized by Congress in the final weeks of the Obama administration.

The National Safety Council released a statement saying the president’s declaration was “vague at a time when a clear path forward is critical.”

“The federal response must include adequate funding for implementing other evidence-based strategies as well, a move the president himself said is necessary,” the statement said.

Also expressing disappointment was Andrew Kolodny, MD, a psychiatrist and researcher at Brandeis University, who is the founder of Physicians for Responsible Opioid Prescribing (PROP), an anti-opioid activist group.

"Everything that was mentioned today sounds helpful, but mentioning a few helpful items is not a plan," Kolodny told Time Magazine.

Koldony, who is the former chief medical officer of Phoenix House, said a massive appropriation of $60 billion to subsidize the addiction treatment industry would be needed over the next decade.

The number of people seeking treatment for abuse of pain medication has actually been in decline for years. According to a recent DEA report, there were 128,175 admissions to publicly-funded treatment facilities for painkiller abuse in 2014, a decrease of about 32 percent since 2011.

‘Truly Evil’ Painkiller

President Trump outlined a number of steps his administration has taken or will take to combat opioid abuse. That includes filing lawsuits against pharmaceutical companies for their marketing of opioid pain medication, something many states are already doing.

“I will be looking at the potential of the federal government bringing major lawsuits against bad actors.  What they have and what they're doing to our people is unheard of.  We will be bringing some very major lawsuits against people and against companies that are hurting our people.  And that will start taking place pretty soon,” he warned. 

President Trump said one opioid painkiller was “truly evil” and should be taken off the market immediately because it had a high risk of abuse. That was apparently a reference to Opana ER, an extended released opioid that Endo International agreed to stop selling in July.

The president also praised CVS Health for its plan to limit opioid prescriptions for acute pain to 7-days’ supply and the CDC for launching a public awareness campaign that "put a face" on opioid abuse.    

Trump Opioid Commission Delays Final Report

By Pat Anson, Editor

The chairman of President Trump’s Commission on Combating Drug Addiction and the Opioid Crisis has asked for – and apparently been granted – a one month delay in releasing the panel’s final report.

In a letter posted on the White House website, New Jersey Gov. Chris Christie said the commission’s “research and policy development are still in progress,” and that he was extending the deadline from October 1 to November 1.

Christie said the opioid commission would hold its third public hearing September 27 at the White House. A notice published in the Federal Register indicates the meeting will focus on pain management and the diversion of opioid pain medication.

“The meeting will consist of statements to the Commission from invited government, nonprofit, and business organizations regarding Innovative Pain Management and Prevention Measures for Diversion followed by discussion of the issues raised,” the statement says. No list of attendees is included.

Christie’s letter also says the opioid commission will visit an Ohio medical center to learn about “innovative pain management strategies” and will meet in New Jersey with representatives of the pharmaceutical industry “to talk about partnership opportunities with the National Institutes of Health and the Food and Drug Administration.”

Until now the focus of the opioid commission has been on treating opioid addiction. An interim report released in July recommends increased access to addiction treatment, mandatory education for prescribers on the risks and benefits of opioid medication, and increased efforts to detect and stop the flow of illicit fentanyl into the country. There are no specific recommendations aimed at reducing access to prescription opioids or providing different forms of pain management.

Bondi Joins Commission

Another possible sign of a shift in the commission’s direction is the recent appointment of Florida Attorney General Pam Bondi to the panel. Bondi is now listed as member of the commission on the White House website,  although there has been no official announcement by the Trump administration. She is the fifth politician appointed to the six member panel.

Bondi played a prominent in shutting down on Florida’s pill mills several years ago, but critics say she has been slow to acknowledge that the opioid crisis has shifted away from prescription painkillers to street drugs like heroin and illicit fentanyl. Many pain patients in Florida still have trouble finding pharmacies willing to fill their opioid prescriptions.

Bondi recently joined other state attorneys general in asking pharmaceutical companies for information about their marketing, production and distribution of opioids.

“Florida citizens continue to become addicted to opioids and die daily -- meanwhile, prescription drug manufacturers, distributors and the medical profession all point fingers at each other as the cause of this national crisis,” Bondi said in a statement. “This far-reaching multistate investigation is designed to get the answers we need as quickly as possible. The industry must do the right thing. If they do not, we are prepared to litigate.”

Bondi also recently joined the National Association of Attorneys General in asking the insurance industry to do more to reduce opioid prescriptions and combat opioid abuse.

“Insurance companies can play an important role in reducing opioid prescriptions and making it easier for patients to access other forms of pain management treatment. Indeed, simply asking providers to consider providing alternative treatments is impractical in the absence of a supporting incentive structure,” the attorneys general said in a letter to an insurance industry trade group.

“Insurance companies thus are in a position to make a very positive impact in the way that providers treat patients with chronic pain.”

In addition to Bondi and Christie, opioid commission members include Gov. Charlie Baker of Massachusetts, Gov. Roy Cooper of North Carolina, Bertha Madras, PhD, a professor of psychobiology at Harvard Medical School, and Patrick Kennedy, a former Rhode Island congressman.

The Trump administration has still not officially declared that the opioid crisis is a national emergency – something the President said he would do in August.  

Pam Bondi to Join Trump Opioid Commission

By Pat Anson, Editor

Less than three weeks before its final report is due, President Trump’s opioid commission is getting a new member --   Florida Attorney General Pam Bondi.

Bondi is a longtime supporter of the president, served as a member of his transition team, and was once rumored to be the next head of the White House Office of National Drug Control Policy. There was speculation back in March that Bondi would be named to the opioid commission, but it was not until last week that the White House confirmed it was President Trump's "intent to appoint" Bondi to the panel, which currently has five members.

Curiously, Bondi’s office blamed New Jersey Gov. Chris Christie, the chair of the opioid commission, for the six month delay in getting her on board. Both Bondi and Christie are lame ducks serving out their final months in elected office.

“The President always intended for the Attorney General to be on the Commission – however, Governor Christie choose (sic) to begin the Commission with only himself and four others,” Whitney Ray, Bondi’s spokesman, said in an email.

“The announcement (of Bondi's appointment) is protocol before the Executive Order is signed next week. The Attorney General will continue to work with President Trump, General Kelly, Kellyanne Conway and other leaders to combat the national opioid epidemic.“

Bondi's spokesman also reportedly said that the October 1 deadline for the commission to release its final report would be extended. No such announcement has been made and the White House website still doesn’t list Bondi as a commission member.

FLORIDA ATTORNEY GENERAL PAM BONDI

The Trump administration has also yet to issue an official declaration that the opioid crisis is a national emergency – something the President said he would do over a month ago.  

"The opioid crisis is an emergency, and I am saying, officially right now, it is an emergency. It's a national emergency. We're going to spend a lot of time, a lot of effort and a lot of money on the opioid crisis,” Trump said on August 10.

Bondi played a prominent in shutting down Florida’s pill mills several years ago, but critics say she has been slow to acknowledge that the opioid crisis has shifted away from prescription painkillers to heroin and illicit fentanyl.

“The problem is Bondi isn't doing enough about the heroin epidemic,” the Miami Sun Sentinel said in an editorial.  “Considering that Bondi was once touted as a potential Trump drug czar — and infamously failed to investigate Trump University after receiving a major donation from Trump — it's no surprise that she was named to the commission. But she's still living off her reputation from the pill mill crack down.

“In fact, if you Google Bondi and heroin, by far the most you'll read about is when she slammed a drug dealer for stamping Trump's name on a batch of heroin. You won't find any solutions to our crisis.”

In a recent interview with WMBB-TV, Bondi warned that drug dealers were putting heroin and illicit fentanyl into counterfeit medications.

"It's a national epidemic and it truly affects everyone, and parents need to really warn their kids, their teens, adults need to know, never take a pill from someone you don't know, even if they say it is a Tylenol, an Advil or an aspirin. Don't take anything from someone who you don't know," said Bondi.

The initial focus of Trump's opioid commission has been on educating, preventing and treating opioid addiction. An interim report released by the commission in July recommends increased access to addiction treatment, mandatory education for prescribers on the risks and benefits of opioids, and increased efforts to detect and stop the flow of illicit fentanyl into the country.

There are no specific recommendations aimed at reducing access to prescription opioids, although they could be added to the commission’s final report.

In addition to Gov. Christie, commission members include Gov. Charlie Baker of Massachusetts, Gov. Roy Cooper of North Carolina, Bertha Madras, PhD, a professor of psychobiology at Harvard Medical School, and Patrick Kennedy, a former Rhode Island congressman. No pain patients, pain management experts or practicing physicians were appointed to the panel.

Trump Declares Opioid Crisis National Emergency

By Pat Anson, Editor

President Donald Trump said he would declare the opioid crisis a national emergency, just two days after his administration said a declaration wasn’t necessary.

"The opioid crisis is an emergency, and I am saying, officially right now, it is an emergency. It's a national emergency. We're going to spend a lot of time, a lot of effort and a lot of money on the opioid crisis,” Trump said outside the clubhouse of his golf course in Bedminster, New Jersey.  “We’re going to draw it up and we’re going to make it a national emergency. It is a serious problem the likes of which we have never had.”

In a brief statement after the President’s remarks, the White House said Trump had instructed the administration “to use all appropriate emergency and other authorities to respond to the crisis caused by the opioid epidemic.”

An estimated 142 Americans are dying every day from drug overdoses of all kinds, not just opioids. Prescription painkillers are often blamed as the cause of the problem, although deaths linked to opioid medication have leveled off in recent years. Heroin and illicit fentanyl are currently driving the overdose crisis and in some states are involved in over half of the overdose deaths.  

A White House commission last week urged the president to declare a national emergency, but administration officials indicated as recently as Tuesday that such a declaration wasn’t necessary because the administration was already treating the opioid crisis as an emergency.

“We believe at this point that the resources that we need or the focus that we need to bring to bear to the opioid crisis at this point can be addressed without the declaration of an emergency, although all things are on the table for the president,” said Health and Human Services Secretary Tom Price.

New Jersey Gov. Chris Christie, who chairs the opioid commission, applauded the apparent change of heart.

“It is a national emergency and the President has confirmed that through his words and actions today, and he deserves great credit for doing so. As I have said before, I am completely confident that the President will address this problem aggressively and do all he can to alleviate the suffering and loss of scores of families in every corner of our country,” Christie said in a statement.

“This declaration is only one of many steps we must take on the federal level to reduce the death toll and help people achieve long-term recovery – but it’s a start. I’m committed to working with the President and my fellow commissioners to end the opioid overdose epidemic,” said commission member and former congressman Patrick Kennedy.

It was not immediately clear what steps the administration will take now that an emergency has been declared. A 10-page interim report released by the opioid commission recommends increased access to addiction treatment, mandatory education for prescribers on the risks and benefits of opioids, and increased efforts to detect and stop the flow of illicit fentanyl into the country.

There are no specific recommendations aimed at reducing access to prescription opioids, although they could be added to the commission’s final report, which is due in October. Prescriptions for opioid medication – long a target of addiction treatment and anti-opioid activists – have been in decline for several years. The DEA has plans to reduce the supply of many painkillers even more in 2018.

Other measures recommended by the commission:

• Grant waivers to states to eliminate barriers to mental health and addiction treatment
• Increase availability of naloxone as an emergency treatment for opioid overdoses
• Amend the Controlled Substance Act to require additional training in pain management for all prescribers
• Prioritize funding to Homeland Security, FBI and DEA to quickly develop fentanyl detection sensors
• Stop the flow of synthetic opioids through the U.S. Postal Service
• Enhance the sharing of data between prescription drug monitoring programs (PDMPs)

No estimate was provided on the cost of any of these measures.

In a statement on Tuesday, President Trump suggested that law enforcement and abstinence should be used to address the opioid crisis. 

“The best way to prevent drug addiction and overdose is to prevent people from abusing drugs in the first place. If they don’t start, they won't have a problem.  If they do start, it's awfully tough to get off," Trump said, according to a White House transcript.