Muscle Relaxer Rx Doubled Over 12-Year Span

As U.S. opioid prescriptions continue to trend downwards, skeletal muscle relaxer scripts are on the rise, according to an analysis of the CDC’s National Ambulatory Medical Care Survey (NAMCS).

Between 2005 and 2016, the number of office visits in which muscle relaxers were prescribed, most commonly for back pain and musculoskeletal conditions, doubled from 15.5 million to 30.7 million, reported Charles E. Leonard, PharmD, MSCE, of the University of Pennsylvania in Philadelphia, and colleagues.

While office visits resulting in new skeletal muscle relaxer prescriptions during this period remained relatively stable at about six million per year, visits for continued therapy tripled from 8.5 million to 24.7 million, the researchers wrote in JAMA Network Open.

The proportion of older adults receiving muscle relaxant prescriptions increased three-fold across the study period such that by 2016, adults over 65 accounted for 22.2% of visits in which a muscle relaxant was prescribed, the team added. Also, 67.2% of continued muscle relaxant visits in 2016 were completed while the patient was on concomitant opioids.

“For a number of years now, the American Geriatrics Society has warned providers of prescribing skeletal muscle relaxers for older adults, and the long-term treatment with skeletal muscle relaxers was particularly concerning to us because most of the available data really only support short-term use of these drugs,” Leonard told MedPage Today, adding that in some cases, especially among younger people, the drugs may be considered.

Nationally, opioid prescriptions decreased by about 20% between 2006 and 2017, in part due to the CDC’s 2016 guidelines on opioid prescribing. Between 2015 and 2018, close to 11% of adults reported being on at least one pain medication prescription, and 6% said they were on opioids, per CDC data.

Weighing the Risks-Benefit of Skeletal Muscle Relaxants

Since muscle relaxant side effects tend to be less severe than the adverse events associated with opioids, they may have been used to replace opioids for some chronic pain patients, commented Samer Narouze, MD, PhD, of Western Reserve Hospital in Cuyahoga Falls, Ohio, who wasn’t involved with the research.

“If the rate of muscle relaxant prescriptions is increasing, but this is accompanied by a waning of opioids, it would be a welcome thing because you are replacing an evil with a lesser evil,” Narouze told MedPage Today. “In the end, you are helping the patient.”

While the steady rate of new muscle relaxant prescriptions is “encouraging,” the increased rate of long-term use observed in this study is “concerning,” said Stephen Saklad, PharmD, BCPP, of the University of Texas at Austin and also not involved in the research.

“Even acutely, [muscle relaxers] are only moderately effective and have significant adverse effects in many people,” Saklad told MedPage Today in an email. “The increasing combination with opioids suggests ineffectiveness and is a problematic practice due to greatly increased adverse effects.”

Skeletal muscle relaxants can augment the central nervous system side effects and respiratory depression from opioids and benzodiazepines, and also carry an increased risk of falling for elderly patients, Narouze said.

Leonard said that although benzodiazepines were not in the top 10 list of concomitant medications prescribed along with skeletal muscle relaxers in this study, lorazepam and alprazolam were still concomitantly prescribed in hundreds of thousands of cases.

However, since the study did not collect data on clinical outcomes associated with muscle relaxant prescribing, such as emergency room visits coded for falls, it is unclear how many of these prescriptions resulted in negative outcomes for patients, Narouze said.

“The take-home message here is that muscle relaxers are being overprescribed and we need to be aware they are not really innocent medication,” he added.

Study Details, Further Findings

For the study, Leonard and co-authors collected data on ambulatory care visits from the NAMCS involving prescriptions of baclofen, carisoprodol, chlorzoxazone, cyclobenzaprine, metaxalone, methocarbamol, orphenadrine, and tizanidine.

The nearly 315 million office visits in the database formed a cohort that was a mean 53.5 years old and 61.8% of whom were male. Patient characteristics were similar across the study period and a snapshot of the 2016 cohort of 30,730,262 patients prescribed muscle relaxants was made up of 58.2% who were female. A majority were white (53.7%), 10.2% were African American, 1.2% were Asian, and 2.2% were Native American or Alaska Native.

In 2016, the proportion of patients receiving muscle relaxers was highest among older adults, followed by adults ages 45-64 (48.5%), 25-44 (24.9%), 15-24 (4.1%), and adolescents under 15 (0.3%), the researchers reported. This age distribution was similar across all years of the study.

Specifically among older adults, the number of prescriptions for muscle relaxer agents that are considered to be potentially inappropriate for this age group — carisoprodol, chlorzoxazone, cyclobenzaprine, metaxalone, methocarbamol, and orphenadrine — nearly doubled from 2.2 million to 4.3 million across the study period, Leonard and co-authors added.

The most commonly prescribed concomitant therapy was hydrocodone-acetaminophen, followed by ibuprofen, naproxen, and tramadol.

Geographically, the most dramatic changes in muscle relaxant prescriptions observed across the study period occurred in the Northeast, where new muscle relaxant visits decreased by about 33% and continued visits increased by 325%. This pattern was similar but less pronounced in the South and the Midwest, and in the West, new and continued visits increased by 5.4% and 91.6%, respectively, the authors reported.

The study did not account for hospital visits resulting in a muscle relaxant prescription and did not include data on off-label use of muscle relaxers, which are limitations, Leonard said. There was also no way to track patients longitudinally using this dataset, he and his co-authors added.

Disclosures

The study was funded by the National Institutes of Health (NIH).

Leonard reported ties with Pfizer and John Wiley and Sons, as well as funding from the NIH, the American Diabetes Association, the American College of Clinical Pharmacy, and the University of Florida College of Pharmacy; he is also a special government employee of the FDA.

Another co-author also reported receiving support from the NIH, the University of Pennsylvania’s Center for Pharmacoepidemiology Research and Training (which receives funding from Pfizer), and other ties with industry.

The study was funded by the NIH.

Primary Source

JAMA Network Open

Source Reference: Soprano S, et al “Assessment of physician prescribing of muscle relaxants in the United States, 2005-2016” JAMA Netw Open 2020; DOI: 10.1001/jamanetworkopen.2020.7664.

https://www.medpagetoday.com/painmanagement/painmanagement/87236

Democrats’ Obamacare Bailout Could Extend The Pandemic

This week, the House of Representatives is set to vote on legislation designed to “stabilize” Obamacare. Democrats claim the plan, which extends exchange subsidies to a broader share of the population, will help more Americans afford health insurance in the midst of the pandemic and accompanying economic crisis.

But the legislation would do nothing to address the root causes of Obamacare’s unaffordability. Worse still, it would fund these new subsidies by taking money from drug companies through a combination of price controls and taxes.

The world desperately needs effective vaccines and treatments for Covid-19. And Democrats want to raid the coffers of the companies investing in that research, in order to line the pockets of insurance companies? That makes no sense.

The House Democrats’ plan would allow people who make more than 400% of the federal poverty level—$104,800 for a family of four—eligible for subsidized coverage through the exchanges. It would also increase the size of the subsidy for all people who qualify for subsidized coverage.

In addition to expanding subsidies, the measure would encourage states to enroll more people in Medicaid.

It’s easy to see why Democrats want to make exchange coverage more affordable. Since 2014, average benchmark premiums have risen 70%.

This increase has been fueled by the law’s many mandates. For example, Obamacare requires that every plan cover 10 “essential health benefits“—including pediatric dental care and substance abuse treatment—even if beneficiaries don’t want or need them. Insurers incur costs, of course, when they pay for each of those mandated benefits. They pass those costs onto consumers in the form of higher premiums.

Obamacare’s guaranteed issue and community rating requirements have also contributed to higher premiums. The former prohibits insurers from turning away enrollees, while the latter prevents them from charging older enrollees more than three times as much as younger ones. By forcing insurers to accept all enrollees and preventing them from charging more to cover those who cost more, Obamacare basically guaranteed premiums would increase.

Like many Democratic healthcare plans before it, the new stabilization proposal treats the symptoms, not the disease. Rather than rescinding some of these costly mandates, Democrats funnel even more money to insurers to cover the ballooning cost of their plans.

That money would come from the Democrats’ favorite bogeymen—drug companies. The Lower Drug Costs Now Act, which passed the House in December and would fund this new effort, would allow the federal government to “negotiate” the prices of up to 250 popular, brand-name drugs.

These “negotiated” prices could not exceed 120% of the prices of those drugs in six developed countries: Australia, Canada, France, Germany, Japan, and the United Kingdom. The bill would let the U.S. government levy a tax of up to 95% on companies that refuse to accept those terms.

In other words, these “negotiations” are a thinly veiled cover for government price controls.

The Lower Cost Drugs Now Act would reduce drug companies’ revenues by $1 trillion over the next decade, according to the Congressional Budget Office. Since drug companies devote around 20% of their revenue to research and development, that means they’ll spend $200 billion less investigating new drugs over the next 10 years. That will result in the development of 100 fewer drugs over that period, according to the White House Council of Economic Advisers.

That would be problematic in the best of circumstances. As we continue the fight against Covid-19, it could cost people their lives. Over the past few months, American scientists have worked tirelessly to develop a vaccine that will defeat the coronavirus and help the country return to normal. These researchers need all the funding they can get as they continue their fight. Democrats’ plan would take that funding away.

Democrats claim their Obamacare stabilization plan will help Americans stay healthy during the pandemic. But by derailing drug development, the bill would make things much worse. If lawmakers want to improve public health, they’ll abandon this misguided proposal.

https://www.forbes.com/sites/sallypipes/2020/06/24/democrats-obamacare-bailout-could-extend-the-pandemic/#1dbe39c530d0

Only 4 States ‘On Track To Contain Coronavirus’

June 24, 2020

With medical experts increasingly worried about a resurgence of coronavirus—as several states in the West and South report record numbers of new cases—only New York, New Jersey, Massachusetts and Connecticut are “on track” to contain the spread of the virus, according to Covid Act Now.

KEY FACTS

New York, New Jersey, Connecticut and Massachusetts are seeing a steadily decreasing number of cases, according to Covid Act Now, a nonprofit that tracks the spread of the virus in real time by analyzing different metrics such as a state’s infection rate, positive test rate, ICU headroom, contact tracing efforts and future hospitalization trends.

All four states were hard-hit by the pandemic when it first arrived in the United States; New York, in particular, was for some time the global epicenter of coronavirus cases during its peak of infections in April.

While these states were among the first to institute widespread lockdown measures and enforce social distancing, many others took their time in doing so or implemented more lenient restrictions—like not requiring face masks.

After states began reopening and lifting lockdown measures, some are now seeing a record spike in new infections: California, Texas and Florida, for example, each have over 5,000 new cases per day, while the tri-state area is down to less than 1,000 combined.

Most of the country is experiencing “controlled disease growth,” but four states are at critical risk, with an “active or imminent outbreak” ongoing: Arizona, Missouri, Alabama and Georgia.

A total of 18 states—including Texas and Florida—are classified as “at risk” of an outbreak, with cases increasing at a rate likely to overwhelm hospitals, according to COVID Act Now.

News peg

New York, New Jersey and Connecticut on Wednesday announced they will require visitors from Florida, Texas and other states with a spike in new cases to quarantine for 14 days on arrival. “We worked very hard to get the viral transmission rate down. We don’t want to see it go up because a lot of people come into this region and they can literally bring the infection with them,” said New York Gov. Andrew Cuomo, in a joint press conference with New Jersey Gov. Phil Murphy and Connecticut Gov. Ned Lamont. The criteria for inclusion on the list is a positive test rate of 10% or higher or 10 new cases per 100,000 residents over a seven-day rolling average, Cuomo said. As of today, that order includes travelers from Alabama, Arkansas, Arizona, Florida, North Carolina, South Carolina, Washington, Utah and Texas. While individuals will be trusted to self-isolate on their own, if they violate the quarantine order they will be fined.

Key background

New cases in the U.S. recently hit their highest level since April, with worrying new single-day records of new cases in the nation’s three most populated states—Florida, California and Texas. The tri-state area was previously the main U.S. hotspot of coronavirus cases and related deaths in April and May, but has since seen new cases fall significantly while that number rises across much of the country.

https://www.forbes.com/sites/sergeiklebnikov/2020/06/24/these-are-the-only-4-states-on-track-to-contain-coronavirus/#152c84f317ba

In early trial, ancient drug shows promise against severe COVID-19

There’s new evidence that a 2,000-year-old medicine might offer hope against a modern scourge: COVID-19.

The medication, called colchicine, is an anti-inflammatory taken as a pill. It’s long been prescribed for gout, a form of arthritis, and its history goes back centuries. The drug was first sourced from the autumn crocus flower.

Doctors also sometimes use colchicine to treat pericarditis, where the sac around the heart becomes inflamed.

Now, a team of Greek researchers reporting Wednesday in JAMA Network Open said their small trial suggests colchicine may indeed help curb severe COVID-19.

The trial involved 105 Greek patients hospitalized in April with COVID-19. Besides receiving standard antibiotics and antivirals (but not remdesivir), half of the participants got daily doses of colchicine for up to three weeks, while the other half did not.

The results “suggest a significant clinical benefit from colchicine in patients hospitalized with COVID-19,” according to the team led by Dr. Spyridon Deftereos, a cardiologist at Attikon Hospital in Attiki, Greece.

Specifically, while the condition of seven of 50 patients who didn’t get colchicine “clinically deteriorated” to a severe stage (for example, requiring mechanical ventilation to survive), this was true for just one of the 55 patients who did receive colchicine, the researchers said.

Writing in a journal editorial, a group of U.S. physicians agreed that the study has limits, but applauded the Greek team for “showing us that an old drug may still have new life.”

Dr. Amir Rabbani, a cardiologist at the University of California, Los Angeles, and colleagues stressed in the editorial that the study size was too small to offer a definitive statement on whether colchicine should be used routinely against COVID-19.

But they said that its effects on certain blood markers of heart function—as observed in the new study—suggest that colchicine has anti-inflammatory and anti-clotting effects that could help limit the cardiovascular damage wreaked by COVID-19.

Larger trial needed—and it’s on the way

Dr. Rajiv Bahl is an emergency medicine physician in Orlando, Fla., who’s seen the ravages of severe COVID-19 in patients firsthand. Reading over the Greek findings, he noted that colchicine “has also been used to prevent heart conditions such as pericarditis and other inflammatory conditions affecting the body.”

Still, the new study is too small, so although it “does show some early promise, future studies need to be conducted before we can incorporate colchicine as an extensively used medication to help combat COVID-19,” Bahl said.

That trial is already underway.

As first reported in April, researchers in the United States and Canada are testing colchicine’s ability to keep high-risk COVID-19 patients from getting sick enough to land in the hospital.

According to researcher Dr. Priscilla Hsue, a professor of medicine at the University of California, San Francisco (UCSF), “one of the unique aspects is that we’re trying to hit this before people need to be hospitalized.”

Colchicine is the medication of choice for a few reasons, Hsue explained: Unlike many drugs being tested in hospital patients—which are given by infusion or injection—colchicine tablets are easy to take and inexpensive, so it could easily be used at home. The medication also has a long history of safe use for gout, she added.

Beyond that, Hsue added, a recent trial found that low-dose colchicine benefits people who’ve recently suffered a heart attack. Patients who took one tablet a day curbed their risk of further heart complications or stroke over the next two years.

Heart injury is a common problem in people who become seriously ill with COVID-19—at least partly, researchers suspect, because of a runaway immune system reaction called a “cytokine storm.”

Unique design

Hsue believes it’s worth investigating whether colchicine could help prevent such heart issues.

The North American trial aims to enroll 6,000 patients newly diagnosed with COVID-19 who are at increased risk of serious illness—because they are older than 69, or have conditions like heart or lung disease.

To keep those patients isolated at home, the study has an unusual “contactless” design: Patients will receive the medication by courier, and have follow-up visits via video or phone. The researchers will look at whether the tactic lowers hospitalization rates and deaths over one month.

Dr. Randy Cron is a professor of pediatrics and medicine at the University of Alabama at Birmingham, and an expert on the “cytokine storm.”

While Cron believes that targeting cytokine storms in COVID-19 is wise, he had some reservations about giving colchicine to people with no signs of the severe immune reaction. Could any dampening of their immune response against the virus backfire?

“My concern is, could it make the infection worse?” Cron said.

Hsue, however, pointed to the safety record of the medication, and noted that the dose given in the trial will be lower than what’s routinely used for gout.

In the end, experts say the only way to definitively prove any medication works for COVID-19 is through clinical trials.

The colchicine study is currently recruiting patients, with UCSF and New York University School of Medicine being the first two U.S. sites involved.

https://medicalxpress.com/news/2020-06-early-trial-ancient-drug-severe.html

Common cancer treatments found not to worsen coronavirus infection

A team of researchers at Memorial Sloan Kettering Cancer Center (MSK) reported on the epidemiology of COVID-19 illness experienced at an NCI-designated cancer center during the height of pandemic in New York City.

The characterization of COVID-19 in patients with cancer remains limited in published studies and nationwide surveillance analyses. Reports from China and Italy have raised the possibility that patients with cancer on active therapy have a higher risk of COVID-19 related severe events, although there is a knowledge gap as to which aspects of cancer and its treatment increase the risk of severe COVID-19 disease.

A team of researchers at Memorial Sloan Kettering Cancer Center (MSK) reported on the epidemiology of COVID-19 illness experienced at an NCI-designated cancer center during the height of pandemic in New York City.

According to a new study from Memorial Sloan Kettering published June 24 in Nature Medicine, patients in active cancer treatment who develop COVID-19 infection don’t fare any worse than other hospitalized patients. Notably, metastatic disease, recent chemotherapy, or major surgery within the previous 30 days did not show a significant association with either hospitalization or severe respiratory illness due to COVID-19. Researchers say their findings suggest that no one should delay cancer treatment because of concerns about the virus.

“If you’re an oncologist and you’re trying to figure out whether to give patients chemotherapy, or if you’re a patient who needs treatment, these findings should be very reassuring,” says Ying Taur, MD, Ph.D., an Infectious Disease Specialist at MSK.

“The course and clinical spectrum of this disease is still not fully understood and this is just one of many studies that will need to be done on the connections between cancer and COVID-19,” explained Mini Kamboj, MD, Chief Medical Epidemiologist, Infection Control at MSK. “But the big message now is clear: People shouldn’t stop or postpone cancer treatment.”

The study looked at 423 MSK patients diagnosed with COVID-19 between March 10 and April 7. Overall, 40 percent were hospitalized for COVID-19, and 20 percent developed severe respiratory illness. About 9 percent had to be placed on a mechanical ventilator, and 12 percent died. The most frequent cancer types included solid tumors such as breast, colorectal, and lung cancer. Lymphoma was the most common hematologic malignancy. Over half of the cases were metastatic solid tumors.

Similar to other studies in the general population, the researchers found that age, race, cardiac disease, hypertension, and chronic kidney disease correlated with severe outcomes. The investigators found that patients taking immunotherapy drugs called immune checkpoint inhibitors were more likely to develop severe disease and require hospitalization. Further research is required to look at the effects of these drugs. But other cancer treatments, including chemotherapy and surgery, did not contribute to worse outcomes.

“Determinants of Severity in Cancer Patients with COVID-19 Illness” published in Nature Medicine on June 24, 2020.

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Explore further

Children with cancer are not at a higher risk for COVID-19 infection or morbidity

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More information: Elizabeth V. Robilotti et al, Determinants of COVID-19 disease severity in patients with cancer, Nature Medicine (2020). DOI: 10.1038/s41591-020-0979-0

https://medicalxpress.com/news/2020-06-common-cancer-treatments-dont-worsen.html

Sinovac’s quadrivalent influenza vaccine receives China approval

Sinovac Biotech (NASDAQ:SVA) received product license from China National Medical Products Administration for its quadrivalent influenza vaccine which would be available to China market for the 2020-2021 influenza season protecting a target group of 3 years or older.

Sinovac’s licensed influenza vaccine portfolio consists of three more vaccines thereby enabling the company to provide variety of solutions again.

https://seekingalpha.com/news/3585951-sinovacs-quadrivalent-influenza-vaccine-receives-china-approval