A CDC report, an FDA-requested painkiller recall, and a federal crackdown on prescription abuses are all announced within a week.
The high-level focus on the opioid epidemic shows no signs of letting up during these warm midsummer days.
So far this month, there has been a report on doctors prescribing opioids, a Justice Department crackdown on physicians who abuse opioid prescriptions, and a recall of a popular painkiller.
Amid these actions, a major study was issued, urging the nation’s leaders to rethink the country’s overall strategy on the opioid crisis.
The announcements have come from three major government agencies, and reactions have come from a number of well-known health-related organizations.
“Drug overdose, driven largely by overdose related to the use of opioids, is now the leading cause of unintentional injury death in the United States. The ongoing opioid crisis lies at the intersection of two public health challenges: reducing the burden of suffering from pain, and containing the rising toll of the harms that can arise from the use of opioid medications,” stated the National Academies of Science, Engineering, and Medicine in their comprehensive report released last week.
In its latest
However, CDC officials also say opioid prescriptions remain at a “high level,” and the average supply of an opioid prescription has increased from 13 days in 2006 to 18 days in 2015.
They added the amount of opioids prescribed per capita was still three times higher in 2015 than it was in 1999.
“The amount of opioids prescribed in the U.S. is still too high, with too many opioid prescriptions for too many days at too high a dosage,” said Dr. Anne Schuchat, acting director of the CDC in a
Officials at the American Medical Association (AMA) said the report indicates doctors are beginning to adjust their practices amid the opioid crisis.
“The AMA is pleased that national prescribing data confirms that for the past several years physicians have made more judicious prescribing decisions, but continued progress and improvements are necessary,” said Dr. Patrice A. Harris, chair of the AMA Opioid Task Force, said in a
However, Dr. Indra Cidambi, an addiction medicine expert and the medical director at the Center for Network Therapy in New Jersey, said the CDC report might be a bit “misleading.”
Cidambi told Healthline the report doesn’t take into account people who are buying opioids online or obtaining them illegally through other means.
She said she believes opioid use is actually up and is reflected in the rising rate in opioid overdose deaths. In 2015, opioids killed more than
“What people are getting on the outside is more dangerous,” Cidambi said. “We need to look at the bigger picture. The prescriptions are only part of the pie.”
Officials at the CDC responded by saying fewer prescriptions does mean there are fewer opioids available for diversion. They compared it to less water coming from a faucet.
They acknowledged their report did not include illegal opioids such as heroin and illicit fentanyl.
“But in the long run, having fewer people starting from prescription opioids might lead to less use of illicit opioids,” Kun Zhang, PhD, a health scientist at the CDC’s Division of Unintentional Injury Prevention and a co-author of the Vital Signs report, said in an email to Healthline.
The same day the CDC report was released, a pharmaceutical company announced it was withdrawing a popular painkiller from the marketplace.
The
The opioid was first introduced in 2006 for management of moderate to severe pain over an extended period of time. It was reformulated in 2012.
The FDA said the reformulated version of the drug is being abused by people who inject it, causing a rise in HIV and hepatitis C infections.
This is the first time the agency has taken steps to remove an opioid pain medication because of public health consequences due to abuse.
The next day, officials at Endo International announced they would comply with the FDA request.
Company executives said they still believed in the “safety, efficacy, and favorable benefit-risk profile” of Opana ER when “used as intended.” The drug netted Endo nearly $160 million in sales in 2016.
However, Endo officials said they will voluntarily recall the product and work with the FDA on its removal, as well as with healthcare professionals to “minimize treatment disruption” for patients now taking the drug.
Cidambi said the recall is the right move.
“The benefits of the drug no longer outweigh the risks,” she said.
A week after the Opana ER recall, federal authorities announced they had charged 412 defendants for taking part in healthcare fraud and opioid scams.
Among those charged were 56 physicians.
Also targeted were a clinic in Houston, a medical group in Michigan, and a fake rehabilitation center in Florida.
The crimes, justice officials said, included selling opioid prescriptions for cash and intentionally writing unnecessary prescriptions.
In some instances, justice officials said, the organizations had billed the federal government for reimbursement under the Medicare of Medicaid systems.
Federal authorities said the defendants had defrauded taxpayers of $1.3 billion.
They added nearly 300 healthcare providers are now in the process of being suspended or being banned from participating in federal health programs.
“Too many trusted medical professionals like doctors, nurses, and pharmacists have chosen to violate their oaths and put greed ahead of their patients,” said Attorney General Jeff Sessions at a news conference last week. “Amazingly, some have made their practices into multimillion dollar criminal enterprises. They seem oblivious to the disastrous consequences of their greed.”
The indictments are part of a crackdown on so-called “pill mill doctors” who authorities say prescribe opioids for people to use as a recreational drugs.
On the same day as the Justice Department announcement, the National Academies of Science, Engineering, and Medicine (NASEM) released its report.
In it, organization officials recommended a multifaceted approach that combines reducing access to opioids with increased investment to treat people addicted to the painkilling drugs.
The panel urged states to stop increasing penalties for drug use. Instead, they said states should adopt policies such as needle exchange programs, safe havens for users of injected drugs, and increased access to naloxone to reduce overdose deaths.
The researchers said 8 percent of people who get prescription painkillers develop “opioid use disorders,” and that 15 to 26 percent show problematic behaviors that indicate they have become dependent on the drugs.
In past research, experts have said people suffering from chronic pain, as well as those recovering from surgery, are likely candidates to become addicted to opioids.
The epidemic has become so serious that officials say a “secondary industry” of medications used to help ease symptoms from opioid addiction treatment drugs is rapidly expanding.
Last week’s report had been requested by FDA officials last year.
After its release, the FDA director applauded the report’s recommendations.
This epidemic must be addressed as a public health emergency, and requires an all-of-the-above approach,” said Dr. Scott Gottlieb, the FDA commissioner, in a press statement. “As underscored in the NASEM report, the scope of this epidemic is so large, it’s going to require a coordinated effort that includes federal, state, and local partners to properly address its continued destruction of individual lives and families.”
Cidambi is in agreement.
She said efforts should continue to reduce the amount of opioid prescriptions.
At the same, she said, more money needs to be allocated for opioid education as well as for prevention programs.
She added more education programs are needed for both patients and doctors.
“We need to get to the deep root causes of the problem,” Cidambi said.